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32021R2085
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30.11.2021
EN
Official Journal of the European Union
L 427/17
COUNCIL REGULATION (EU) 2021/2085
of 19 November 2021
establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 187 and the first subparagraph of Article 188 thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Parliament (1),
Having regard to the opinion of the European Economic and Social Committee (2),
Whereas:
(1)
In order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union’s policy objectives, Regulation (EU) 2021/695 of the European Parliament and of the Council (3) (the ‘Horizon Europe Regulation’) established the policy and legal framework for European partnerships with private or public sector partners. European partnerships are a key element of the policy approach of Horizon Europe – the Framework Programme for Research and Innovation (‘Horizon Europe’). They are set up to deliver on Union priorities targeted by Horizon Europe and ensure a clear impact for the Union and its people, which can be achieved more effectively in partnership, through a strategic vision that is shared and committed to by partners, rather than by the Union alone.
(2)
In particular, European partnerships in the ‘Global Challenges and European Industrial Competitiveness’ pillar of Horizon Europe play an important role in achieving strategic objectives such as accelerating the transitions towards sustainable development goals and a green and digital Europe, and should contribute to recovery from the unprecedented crisis brought about by the COVID-19 pandemic. European partnerships address complex cross-border challenges that require an integrated approach. They make it possible to address the transformational, systemic and market failures described in the impact assessments accompanying this Regulation by bringing together a broad range of players across the value chains and ecosystems to work towards a common vision and translating it into concrete roadmaps and coordinated implementation of activities. Furthermore, they enable efforts and resources to be concentrated on common priorities to solve the complex challenges.
(3)
To deliver on priorities and impact, European partnerships should be developed through a broad involvement of relevant stakeholders across Europe including industry, research organisations, bodies with a public service mission at local, regional, national or international level, and civil society organisations such as foundations that support or carry out research and innovation. They should also be one of the measures to strengthen cooperation between private or public sector partners at the international level, including by joining up research and innovation programmes and cross-border investment in research and innovation, bringing mutual benefits to people and businesses while ensuring that the Union can uphold its interests in strategic areas.
(4)
The interim evaluation of Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (4) revealed that a considerable repertoire of partnership instruments and initiatives have been introduced over time, with seven forms of implementation and close to 120 partnership initiatives running under Horizon 2020. In addition to the complexity generated by the proliferation of instruments and initiatives, it has been assessed that their ability to contribute to related policies at Union and national level as a whole is not sufficient despite the fact that they deliver positive impact in progressing towards their objectives, for example by setting long-term agendas, structuring research and innovation cooperation between otherwise dispersed actors, and leveraging additional investments. The impact assessment of Horizon Europe identifies therefore the need to address and to rationalise the Union research and innovation funding landscape, in particular with respect to partnerships, as well as to re-orient partnerships towards more impact and delivery on Union priorities.
(5)
To address such concerns and to achieve the higher ambition for European investments, Horizon Europe should put forward a major simplification and reform for the Commission’s policy on research and innovation partnerships. In order to reflect its systemic nature that aims to contribute to Union-wide ‘transformations’ towards the sustainability objectives, Horizon Europe should make more effective use of those partnerships with a more strategic, coherent and impact-driven approach.
(6)
Regulation (EU) 2020/852 of the European Parliament and of the Council (5) establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of defining sustainable investments. It creates a common reference that investors, banks, industry and researchers can use when investing in projects and economic activities that have a substantial positive impact on climate and environment and cause no significant harm to either of them. It is the reference for green investments in the Union.
(7)
Where relevant, European partnerships should consider technical screening criteria referred to in Article 3 and the ‘do no significant harm’ principle set out in Article 17 of Regulation (EU) 2020/852 as an instrument to improve their projects’ readiness and access to green financing that will be crucial for market uptake and wider deployment of the innovative technologies and solutions they will deliver. Scientific evidence is at the core of those technical screening criteria. Research and innovation, pursued by European partnerships, should play an important role in helping economic operators to reach or go beyond the standards and thresholds set in that Regulation, and to keep those technical screening criteria up-to-date and consistent with the objectives set out in the Commission Communication of 11 December 2019 on ‘The European Green Deal’.
(8)
On the basis of the Horizon Europe Regulation, it should be possible for the European partnerships to be set up using three different forms, namely ‘co-funded’, ‘co-programmed’ and ‘institutionalised’. The setting-up of institutionalised European partnerships that are joint undertakings between private and public sector partners should involve new Union legislation and the establishment of dedicated implementing structures pursuant to Article 187 of the Treaty on the Functioning of the European Union (TFEU).
(9)
The Horizon Europe Regulation defines eight priority areas, in which institutionalised European partnerships established under Article 185 or 187 TFEU could be proposed. Across those priority areas, several initiatives for such institutionalised European partnerships are put forward and nine of them are covered by this Regulation.
(10)
The research and innovation activities undertaken by joint undertakings should be funded from Horizon Europe as provided in Articles 12 and 13 of the Horizon Europe Regulation. To achieve maximum impact, the joint undertakings should develop close synergies with other Horizon Europe initiatives and other Union programmes and funding instruments, particularly with those supporting the deployment of innovative solutions, education and regional development, in order to increase economic and social cohesion and reduce imbalances.
(11)
The new policy approach for European partnerships, and in particular institutionalised European partnerships, calls for a novel way of establishing the legal framework under which they would operate. While the setting-up of joint undertakings on the basis of Article 187 TFEU for the purpose of Horizon 2020 has proven to be effective as far as the implementation is concerned, it is necessary to step it up. Therefore, this Regulation aims to increase the coherence, efficiency, openness, effectiveness and impact-orientation of implementation by translating the Horizon Europe Regulation and the experience gained from programme implementation under Horizon 2020 into common provisions across the joint undertakings in a harmonised way. It aims to facilitate the creation of collaboration and synergies between European partnerships, thereby making full use of their interconnections at the organisational level. Joint undertakings should seek opportunities to involve representatives of other European partnerships in discussions during the drafting of their work programmes, identify the areas in which complementary or joint activities would address the challenges more effectively and efficiently, avoid overlaps, align timing of their activities and ensure access to results and other relevant means of knowledge exchange.
(12)
Following the identification of synergies between them, joint undertakings should aim to determine budget shares which should be used for complementary or joint activities between joint undertakings. Moreover, this Regulation aims to improve efficiencies and harmonisation of the rules through intensified operational collaboration and by exploring economies of scale, including the establishment of back office arrangements which should provide horizontal support functions to the joint undertakings. Those back office arrangements should make it easier to achieve greater impact and harmonisation on common points while retaining a certain degree of flexibility to meet the specific needs of each joint undertaking. The structure should be established using service level agreements to be concluded by the joint undertakings. The back office arrangements should cover coordination and administrative support functions in areas where their screening has proved efficient and cost-effective and should take into account as far as possible compliance with the requirement of accountability of each individual authorising officer and harmonisation of the rules, including intellectual property rights. The legal set-up should be designed to best serve the common needs of the joint undertakings, to ensure their close collaboration and to explore all possible synergies among the European partnerships and, as a consequence, between the various parts of Horizon Europe as well as between the other programmes managed by the joint undertakings.
(13)
The impact assessments regarding each joint undertaking accompanying the proposal for this Regulation have provided evidence that justifies the implementation of European partnerships in accordance with the Horizon Europe Regulation only where other parts of Horizon Europe, including other forms of European partnership, would not achieve the objectives or would not generate the necessary expected impacts, and whereby such implementation is justified by a long-term perspective and high degree of integration.
(14)
Horizon Europe introduces a more strategic, coherent and impact-driven approach to European partnerships, building on the lessons learned from the Horizon 2020 interim evaluation. In line with the new ambition, this Regulation aims to achieve a more effective use of institutionalised European partnerships, in particular by focusing on clear objectives, outcomes and impact that can be achieved by 2030, and by ensuring a clear contribution to the related Union policy priorities and policies. Close collaboration and synergies with other relevant initiatives at Union, national and regional level, in particular with other European partnerships, are key to achieving greater scientific, socioeconomic and environmental impact and ensuring uptake of results. For this purpose, the joint undertakings may apply Horizon Europe provisions enabling different types of synergies, such as alternative, cumulative or combined funding and transfer of resources. In assessing the overall impact, broader investments beyond the contributions from partners and triggered by the joint undertakings that contribute to achieving their objectives should be taken into account to facilitate the acceleration of market uptake of innovative solutions.
(15)
In order to ensure a coherent approach and capture the scientific, technological, economic, societal and environmental impacts of European partnerships in relation to the objectives of Horizon Europe and Union priorities, this Regulation should set out collective general and common specific objectives that should be delivered by all joint undertakings. All joint undertakings contribute collectively to achieving those objectives by reaching their individual objectives. In addition, the common parts of this Regulation define common operational objectives derived from the objectives set for the Specific Programme implementing Horizon Europe, established by Council Decision (EU) 2021/764 (6) (the ‘Specific Programme implementing Horizon Europe’). All joint undertakings should carry out their tasks in order to fulfil the principles and criteria set out for European partnerships in the Horizon Europe Regulation (Article 10 and Annex III) and deliver European added value compared to calls under the main Horizon Europe work programme. The objectives and tasks of the joint undertakings are complemented by additional ones specific to each joint undertaking. While taking into account their specificities and policy contexts, the alignment of the intervention logics of individual joint undertakings with Horizon Europe should support the coordinated assessment of progress of the joint undertakings as part of Horizon Europe monitoring and evaluation activities.
(16)
This Regulation is based on the principles and criteria set out in the Horizon Europe Regulation, including openness and transparency, a strong leverage effect and long-term commitments of all the involved parties. One of the objectives of this Regulation is to ensure the openness of the joint undertakings and their actions to a broad range of entities, including newcomers who will be monitored also within the framework of the strategic coordinating process for European partnerships provided under Article 6(5) of the Specific Programme implementing Horizon Europe. Such partnerships should be open to any entity that is willing and able to work towards the common goal, should promote broad and active participation of stakeholders in their activities, membership and governance, and should ensure that the results would be for the benefit of all Europeans, in particular through a broad dissemination of results and pre-deployment activities across the Union. As regards private members and their constituent or affiliated entities established in third countries, the interests of the Union and the joint undertaking on the grounds of security or public order should be safeguarded. To that end, the Commission should be able to request private members to take appropriate measures. Such measures could include the appropriate handling of confidential information or limitation of certain entities in specific operational activities of the private member.
(17)
To ensure the coherent application of Article 22(5) of the Horizon Europe Regulation, the joint undertakings should ensure coherence with the approach taken for actions funded under the Horizon Europe work programme regarding the application of that Article, as well as Union legislation and guidance relevant for its application in similar topics in the work programme of the joint undertaking concerned.
(18)
Where the Commission or the Member States consider limiting participation in specific actions of the joint undertaking in accordance with Article 22(5) of the Horizon Europe Regulation, the Commission and the Member States in the states’ representatives group should seek an agreed position on a case-by-case basis before the adoption of the work programme. In the case of joint undertakings with a Public Authorities Board, the application of that Article should be approved by the Public Authorities Board, following the request by the Commission, before the adoption of the work programme. Furthermore, following an invitation from the Chair, the Executive Director should inform regularly the relevant configuration of the Horizon Europe Programme Committee, further to the Commission’s responsibility to inform the Programme Committee under Article 14(7) and Annex III of the Specific Programme implementing Horizon Europe, and in particular before the adoption of the work programme of the joint undertaking concerned, in relation to the application of Article 22(5) of the Horizon Europe Regulation.
(19)
Annex III of the Horizon Europe Regulation requires that the financial or in-kind contributions from members other than the Union should be at least equal to 50 % and may reach up to 75 % of the aggregated joint undertaking budgetary commitments. Conversely, the Union contribution, including any additional funds from associated countries, should not exceed 50 % of the aggregated budgetary commitments of each joint undertaking. Consequently, this Regulation should set the required contribution from members other than the Union at the same level or higher than the Union contribution. The Union should be in a position to reduce its contribution if members other than the Union fail to fulfil their commitments.
(20)
In accordance with Article 10(1), point (c), of the Horizon Europe Regulation, the joint undertakings are to implement a central management of all financial contributions through a coordinated approach. Accordingly, each participating state should conclude one or more administrative agreements with the joint undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that participating state. In order to ensure coherence with their national strategic priorities, participating states should be provided with a right of veto over the use of their national financial contributions for applicants established in those participating states. In order to minimise the administrative burden for beneficiaries, achieve simplification and ensure a more efficient implementation, each participating state should strive to synchronise its payment schedule, reporting and audits with those of the joint undertakings and to converge its cost eligibility with the Horizon Europe Regulation. Beneficiaries established in participating states that entrusted the payment activities to the joint undertaking should sign a single grant agreement with the joint undertaking following Horizon Europe Regulation.
(21)
In line with the ambitions set out in the Horizon Europe Regulation, one of the preconditions of setting up institutionalised European partnerships is ensuring partners’ contributions throughout the lifetime of the joint undertakings. In this context, private partners should deliver a significant part of their contributions in the form of in-kind contributions to operational costs of the joint undertaking. Joint undertakings should be able to identify measures to facilitate those contributions through their work programmes, in particular by reducing funding rates. Those measures should be based on the specific needs of a joint undertaking and the underlying activities. In duly justified cases, it should be possible to introduce additional conditions that require the participation of a member of the joint undertaking or their constituent or affiliated entities, targeting activities where the industrial partners of the joint undertaking can play a key role such as large-scale demonstrations and flagship projects closer to the market, and contribute more via lower funding rates. The level of participation of members should be monitored by the executive director in order to empower the governing board to take appropriate actions, ensuring a balance between commitment from partners and openness. In duly justified cases, the capital expenditure for, for example, large-scale demonstrations or flagship projects may be considered as an eligible cost in line with the applicable legal framework.
(22)
It should be possible that, in accordance with Article 15(3) of the Horizon Europe Regulation, contributions from programmes co-financed by the European Regional Development Fund established by Regulation (EU) 2021/1058 of the European Parliament and of the Council (7) (ERDF), the European Social Fund Plus established by Regulation (EU) 2021/1057 of the European Parliament and of the Council (8) (ESF+), the European Maritime, Fisheries and Aquaculture Fund established by Regulation (EU) 2021/1139 of the European Parliament and of the Council (9) (EMFAF) and the European Agricultural Fund for Rural Development established by Regulation (EU) No 1306/2013 of the European Parliament and of the Council (10) (EAFRD) be considered to be a contribution of the participating states that are Member States to the joint undertakings, provided that Regulation (EU) 2021/1060 of the European Parliament and of the Council (11) and the fund-specific regulations are complied with. In addition, it should be possible that contributions from the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (12) (the ‘Facility’) be considered to be a contribution of the Member States that are participating states to the joint undertakings, provided that the provisions of the Facility and commitments set in the national recovery and resilience plans are complied with.
(23)
In line with the principle of fair sharing of contributions among the members of joint undertakings, financial contributions to the administrative costs of the joint undertakings should be divided equally between the Union and the members other than the Union. Deviations from that principle should only be considered in exceptional and duly justified cases such as where the size or the membership structure of a member of the joint undertaking other than the Union would result in contributions per constituent or affiliated entity, in particular small and medium-sized enterprises (SMEs), of such a high level as to seriously jeopardise the incentive to become or remain a constituent or affiliated entity of the member of the joint undertaking. In such cases, the minimum percentage of annual financial contribution to the administrative costs of the joint undertaking from members other than the Union should be 20 % of the total annual administrative costs and the contributions from SMEs should be significantly lower than those from larger constituent or affiliated entities. Once a critical mass of membership that allows for a contribution higher than 20 % of the total annual administrative costs is reached, annual contributions per constituent or affiliated entity should be maintained or increased with the aim of gradually increasing the share of the members other than Union in the overall contribution to the annual administrative costs of the joint undertaking. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to increase their contribution to 50 % of the administrative costs of the joint undertaking over its lifetime.
(24)
The Horizon Europe Regulation requires the partners to show their long term commitment, including through a minimum share of public or private investments. Consequently, it is necessary for the Union to identify in this Regulation founding members established in the Member States, countries associated to Horizon Europe or international organisations. However, where necessary it should be possible to expand the membership base of joint undertakings after they are established with associated members selected following open and transparent procedures, taking into account in particular the new technological developments or the association of additional countries to Horizon Europe.
(25)
Legal entities interested in supporting the joint undertakings’ objectives in their specific areas of research, without becoming a member, should also be offered the possibility to become contributing partners of those joint undertakings.
(26)
In accordance with Article 16(5) of the Horizon Europe Regulation, the allocation of the financial contributions from third countries associated to Horizon Europe should take into account the level of participation of the legal entities of the associated third countries. Accordingly, the Union contribution to the joint undertakings may be increased with contributions from third countries associated to Horizon Europe, taking into account the level of participation of such legal entities and provided that the total amount by which the Union contribution is increased is at least matched by the contribution of members other than the Union, or their constituent or affiliated entities.
(27)
The establishment of a joint undertaking ensures a mutually beneficial public-private partnership for the members involved, including by promoting certainty on major budget allocations for the relevant industries over a period of seven years. Becoming a founding member or associated member, or one of their constituent or affiliated entities, enables members to gain influence, either directly or through the industry representatives, in the governing board of the joint undertaking. The governing board is the decision-making body of the joint undertaking that decides on the long-term strategic orientation of the partnership, as well as its annual priorities. The Union, the participating states where relevant, the founding members and associated members should therefore be able to contribute to the joint undertaking’s agenda and priority-setting through the adoption and possible amendment of the Strategic Research and Innovation Agenda, as well as the adoption of the annual work programme, including the content of the calls for proposals, the applicable funding rate per call topic, and the related rules for submission, evaluation, selection, award and review procedures.
(28)
It is appropriate that the members other than the Union commit to the implementation of this Regulation by means of a letter of commitment, or a joint letter of commitment indicating the total amount of their contributions where appropriate, without imposing conditions regarding their accession. Such letters of commitment should be legally valid throughout the lifetime of the joint undertaking and closely monitored by the joint undertaking and the Commission. Joint undertakings should create a legal and organisational environment that enables members to deliver on their commitments, while ensuring attractiveness for all stakeholders, continuous openness of the joint undertakings and transparency during their implementation, in particular for priority setting and for participation in calls for proposals.
(29)
Further simplification is a cornerstone of Horizon Europe. In that context, there should be a simplified reporting mechanism for partners, who are no longer required to report on non-eligible costs. In-kind contributions to operational activities should be accounted for solely on the basis of eligible costs and should be reported and audited in accordance with the mechanism applicable to the specific grant agreement. Such accounting on the basis of eligible costs only allows for the automated calculation of in-kind contributions to operational activities via the Horizon Europe IT tools, lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. In-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared and made public by the executive director in order to establish whether the progress towards reaching the in-kind contributions targets is sufficiently satisfactory. The governing board should assess both the efforts made and the results achieved by the members contributing to operational activities, as well as other factors such as the level of participation of SMEs and attractiveness of the joint undertakings to newcomers. Where necessary it should take appropriate remedial and corrective measures, taking into account the principles of openness and transparency.
(30)
The joint undertakings should provide a systematic opportunity and incentive for members other than the Union to combine their research and innovation activities with those of the joint undertaking. Additional activities should not receive financial support from the joint undertaking. However, they can be accounted for as members’ in-kind contributions to additional activities when they contribute to the objectives of the joint undertaking and are directly linked to its activities, including non-eligible costs of indirect actions funded by the joint undertaking where this is provided for in the annual additional activities plan. That link can be established through the uptake of results from indirect actions funded by the joint undertaking or its preceding initiatives, or by demonstrating a significant Union added value. The respective costs should be certified by an independent audit body appointed by the entity concerned subject to the valuation method being open to verification by the joint undertaking in the event of uncertainty. This Regulation should lay down more specific provisions concerning the scope of additional activities for each joint undertaking, to the extent that it is necessary to achieve the desired directionality and impact. It should be further decided by joint undertakings’ governing boards whether, for the purposes of valuing these contributions, the use of simplifying methods such as lump sums or unit costs is necessary to achieve simplification, cost effectiveness and an appropriate level of protection of confidential commercial data.
(31)
The governance of joint undertakings should ensure that their decision-making processes are fit to keep pace with a fast-changing socioeconomic and technological environment and global challenges. Joint undertakings should benefit from expertise, advice and support from all relevant stakeholders, in order to effectively implement their tasks and ensure synergies at Union and national level. Therefore, joint undertakings should be empowered to set up advisory bodies with a view to providing them with expert advice and carrying out any other task of an advisory nature that is necessary for the achievement of the joint undertakings’ objectives. In setting up the advisory bodies, joint undertakings should ensure a balanced representation of experts within the scope of the activities of the joint undertaking, including with respect to gender balance. The advice provided by those bodies should bring in scientific perspectives, as well as those of national and regional authorities and of other stakeholders of joint undertakings.
(32)
Joint undertakings should ensure that Member States are sufficiently informed of the joint undertakings’ activities, can provide timely information on activities undertaken in the Member States and have the opportunity to contribute to the preparatory and decision-making processes. Such dialogue with Member States is particularly important in the context of synergies and the need to ensure the alignment of efforts and activities at national, regional, Union and European level to create more impact. Joint undertakings without the direct or indirect involvement of Member States as members or constituent entities should establish a state representatives group with the aim of aligning the joint undertakings’ activities with the policies and actions taken at national and regional level.
(33)
Joint undertakings should be able to set up an advisory body with a scientific advisory function. That body or its members should be in a position to provide independent scientific advice and support to the respective joint undertaking. The scientific advice should concern, in particular, annual work programmes and additional activities, as well as any other aspect of the joint undertakings’ tasks, as necessary.
(34)
With a view to ensuring that joint undertakings are aware of the positions and views of stakeholders from the entire value chain in their respective fields, joint undertakings should be able to set up their respective advisory stakeholders groups, to be consulted on horizontal issues or specific questions, as per the needs of each joint undertaking. Such groups should be open to public and private stakeholders, including organised interest groups and international interest groups from the Member States, associated countries or other countries, active in the field of the joint undertaking.
(35)
The joint undertakings should operate in an open and transparent way, providing all relevant information in a regular and timely manner to their appropriate bodies as well as promoting their activities, including information and dissemination activities, to the wider public. This includes timely information, subject to confidentiality rules and broken down by country on the application and participation in indirect actions funded by the joint undertaking, on the evaluation results of each call for proposals and project implementation, on synergies with other relevant Union programmes and other European partnerships, on additional activities, on committed and actually provided financial and in-kind contributions, on the execution of the budget of the joint undertaking, and on the link between the objectives of the joint undertaking and in-kind contributions to additional activities.
(36)
The joint undertakings should be implemented using a structure and rules that enhance efficiency and ensure simplification. To that effect, the joint undertakings should adopt financial rules specific to their needs in accordance with Article 71 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (13).
(37)
The implementation of the joint undertakings should be based on the criteria set out for institutionalised European partnerships in the Horizon Europe Regulation. It should be supported by the use of electronic means managed by the Commission. Information related to indirect actions funded by the joint undertakings, including results, is essential for the purposes of developing, implementing, monitoring and evaluating Union policies or programmes. Therefore, joint undertakings should ensure that Union institutions and Union bodies, offices or agencies have access to all information related to the indirect actions they fund, including contributions and results of beneficiaries participating in indirect actions. Such access rights should be limited to non-commercial and non-competitive use and should comply with applicable confidentiality rules. Staff of the Union institutions and Union bodies, offices or agencies should be granted access to this information subject to adequate IT security and information security standards and in accordance with the principles of necessity and proportionality.
(38)
Participation in indirect actions funded by the joint undertakings under Horizon Europe should comply with the rules set out in the Horizon Europe Regulation. The joint undertakings should ensure consistent application of those rules based on relevant measures adopted by the Commission. The joint undertakings should use the corporate model grant agreement prepared by the Commission. In relation to the period to object to transfers of ownership of results referred to in Article 40(4) of the Horizon Europe Regulation, the duration of innovation cycles in the areas covered by the respective joint undertakings should be taken into account.
(39)
One of the main purposes of joint undertakings is to foster the Union’s economic capacities and in particular its scientific and technological leadership. Moreover, the post-COVID-19 recovery highlights the need to invest in key technologies such as 5G, artificial intelligence (AI), cloud, cybersecurity and green tech and to valorise those technologies in the Union. The joint undertakings should contribute to fostering open science in accordance with Articles 14 and 39 of the Horizon Europe Regulation. Results generated by all participants will play an important role in this respect and all participants will benefit from Union funding through the results generated in the project and access rights thereto, even those participants not having received Union funding. Therefore, to protect Union interests, the right for joint undertakings to object to transfers of ownership of results or to grants of an exclusive licence regarding results should also apply to participants not having received Union funding. In exercising this right to object and in accordance with the principle of proportionality, the joint undertaking should strike a fair balance between Union interests and protection of fundamental rights as regards the results of the participants not having received Union funding, taking into account that those participants did not receive any Union funding for the action from which the results were generated.
(40)
The Union financial contribution should be managed in accordance with the principle of sound financial management and with the rules on indirect management set out in Regulation (EU, Euratom) 2018/1046.
(41)
For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with the Horizon Europe Regulation and other relevant Union funding programmes.
(42)
The financial interests of the Union and of the other members of the joint undertakings should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) 2018/1046. In view of the specific nature of the actions implemented by some of the joint undertakings requiring them to be phased out over several years, it should be possible to split multiannual budgetary commitments by the Commission and the relevant joint undertaking into annual instalments. In this respect, budgetary commitments of the Clean Aviation Joint Undertaking, of the Europe’s Rail Joint Undertaking and of the Single European Sky ATM Research 3 Joint Undertaking may be divided into annual instalments. Until 31 December 2024, the cumulative amount of those budgetary commitments should not exceed 50 % of the respective maximum Union contribution. From 1 January 2025, at least 20 % of the cumulative budget of the residual years should not be covered by annual instalments.
(43)
In view of the specific nature and the current status of the joint undertakings, they should continue to be subject to a separate discharge. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors.
(44)
In accordance with Article 10(2), point (c), of the Horizon Europe Regulation, joint undertakings should have a clear life cycle approach. In order to adequately protect the financial interests of the Union, joint undertakings should be set up for a period ending 31 December 2031 to allow them to exercise their responsibilities with regard to grant implementation until the last indirect actions launched have been completed. The joint undertakings should be financed by the Union programmes under the multiannual financial framework for 2021-2027 (‘MFF 2021-2027’). The joint undertakings should be able to launch calls for proposals by 31 December 2028, in duly justified cases related to availability of remaining budget stemming from the MFF 2021-2027.
(45)
In the context of the Commission’s priority of the European Green Deal supported by the communications from the Commission of 11 October 2018 on A sustainable Union Bioeconomy for Europe: Strengthening the connection between economy, society and the environment, of 28 November 2018 on A Clean Planet for All: A European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy, of 11 March 2020 on A new Circular Economy Action Plan: For a cleaner and more competitive Europe, of 20 May 2020 on EU Biodiversity Strategy for 2030: Bringing nature back into our lives, of 20 May 2020 on A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system and of 17 October 2020 on the Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, the European bio-based sector, including SMEs, regions and primary producers, should become climate neutral, more circular and more sustainable while remaining competitive on the global scale. A strong, resource-efficient and competitive bio-based innovation ecosystem can decrease dependency on and accelerate the substitution of non-renewable fossil raw materials and mineral resources. It can develop renewable bio-based products, materials, processes and nutrients from waste and biomass through sustainability and circularity-driven innovation. Such ecosystem can also create value from local feedstock, including waste, residues and side-streams, to deliver jobs, economic growth and development throughout the Union, not only in urban areas but also in rural and coastal territories where biomass is produced and which are often peripheral regions that rarely benefit from industrial development.
(46)
The Bio-based Industries Joint Undertaking established under Horizon 2020 has focused on sustainable resource use, especially in resource-intensive and high-impact sectors such as agriculture, textiles manufacturing and construction, in particular aiming at local operators, manufacturers, plants and factories. Its interim evaluation published in October 2017 included a strong set of 34 recommendations that are reflected in the design of the Circular Bio-based Europe Joint Undertaking established by this Regulation. The Circular Bio-based Europe Joint Undertaking is not a direct continuation of the Bio-Based Industries Joint Undertaking but rather a programme that builds on the achievements of the preceding initiative and addresses its shortcomings. In line with the recommendations, the Circular Bio-based Europe Joint Undertaking should involve a wider range of stakeholders including the primary sector (namely agriculture, aquaculture, fisheries and forestry) as well as providers of waste, residues and side streams, regional authorities and investors to prevent market failures and unsustainable bio-based processes. To deliver on its objectives, it should only fund projects that respect principles of circularity, sustainability and planetary boundaries.
(47)
The Circular Bio-based Europe Joint Undertaking should establish Deployment Groups that should serve as advisory bodies and actively participate in the strategic discussions that are to set the agenda for the partnership. It is crucial to include those advisory bodies in the governance structure to ensure wider participation and higher private investment in the circular bio-based sector. The Deployment Groups should in particular provide support to the strategic Governing Board meetings where industrial leaders and the stakeholders’ representatives together with high-level Commission representatives join the permanent Governing Board to discuss and set the strategic direction of the partnership.
(48)
The main objective of the Clean Aviation Joint Undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment, therefore significantly contributing to the ambitious environment impact mitigation goals of the European Green Deal and Regulation (EU) 2021/1119 of the European Parliament and of the Council (14) (‘European Climate Law’), that is to say a 55 % emissions reduction by 2030 compared to 1990 levels, and climate neutrality at the latest by 2050 in line with the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (15). This objective can only be achieved through accelerating and optimising the research and innovation processes in aeronautics and by improving the global competitiveness of the Union aviation industry. The Clean Aviation Joint Undertaking should also ensure that cleaner aviation remains safe, secure and efficient for the transportation of passengers and goods by air.
(49)
The Clean Aviation Joint Undertaking builds on the experience gained from the Clean Sky and Clean Sky 2 Joint Undertakings. The new European partnership should be more ambitious by focusing on developing breakthrough demonstrators. In line with the findings of the interim evaluation of the Clean Sky 2 Joint Undertaking, a new initiative should ensure that every demonstrator is on the critical path for the development of the next aircraft programmes in order for the technologies developed to really serve the key priority of earliest possible deployment. Therefore, the new joint undertaking should focus on increasing the visibility of its individual exploitation objectives and strengthening the monitoring, management and reporting capabilities of the joint undertaking to reflect the complexity of the research and innovation effort required for the European partnership to reach its objectives.
(50)
The Clean Aviation Joint Undertaking should build on a strong leadership from the European aviation industry and a diverse membership base, bringing together a broad spectrum of stakeholders and ideas across Europe. With a view to identifying the most promising approaches and entities capable of pursuing them, the Commission launched a call for expression of ideas and potential members. The Governing Board should be allowed to select associated members based on the results of that call and future calls in order to provide for a swift expansion of the group of members.
(51)
In order to maximise and accelerate the impact of the research and innovation activities undertaken by the Clean Aviation and Single European Sky ATM Research 3 Joint Undertakings on effective emission reduction and the digitalisation of the aviation industry, those joint undertakings should seek close collaboration with the European Union Aviation Safety Agency (EASA) in the work of the European partnership, ensuring an early exchange of knowledge on new technologies developed. That collaboration will be crucial to accelerate market uptake, by facilitating the certification process of resulting products and services as required by Regulation (EU) 2018/1139 of the European Parliament and of the Council (16).
(52)
In order to maximise synergies between programmes at Union, national and regional level, the members of the states’ representatives group of the Clean Aviation Joint Undertaking should explore possibilities to provide financial support at national level to excellent proposals that were not selected for funding by the Clean Aviation Joint Undertaking due to oversubscription.
(53)
Europe faces the challenge of having to play a leading role in accelerating the environmental transformation of the next generation of aircraft and internalising the societal costs of greenhouse gas emissions in the air transport business model while continuing to ensure a level playing field for European products in the global market. Therefore, the Clean Aviation Joint Undertaking should support the European representatives in international standardisation and international legislative efforts.
(54)
Interest in hydrogen has evolved dramatically in the last five years, with all Member States having signed and ratified the United Nations Framework Convention on Climate Change (Paris Agreement) at the 21st Conference of the Parties (COP21). The European Green Deal aims to transform the Union into a fair and prosperous society with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases at the latest by 2050. Priority areas include clean hydrogen, fuel cells, other alternative fuels and energy storage. Hydrogen is prominent in the communications from the Commission of 8 July 2020 on A hydrogen strategy for a climate-neutral Europe and on Powering a climate-neutral economy: EU Strategy for Energy System Integration, as well as for the launch of the European Clean Hydrogen Alliance that brings all stakeholders together to identify technology needs, investment opportunities and regulatory barriers to build a clean hydrogen ecosystem in the Union contributing to reducing the current dependence on fossil fuels and greenhouse gases emissions in relevant sectors. The Clean Hydrogen Joint Undertaking may enable the uptake of research and innovation (R&I) results by investment frameworks, such as the European Clean Hydrogen Alliance and Important Projects of Common European Interest (IPCEI) on Hydrogen.
(55)
Dedicated research and innovation activities related to hydrogen applications have been supported since 2008, mainly through the Fuel Cell and Hydrogen Joint Undertakings, namely FCH Joint Undertaking and FCH 2 Joint Undertaking, under the Seventh Framework Programme established by Decision No 1982/2006/EC of the European Parliament and of the Council (17) and Horizon 2020 as well as by traditional collaborative projects, covering all stages/fields of the hydrogen value chain. The Clean Hydrogen Joint Undertaking should strengthen and integrate Union scientific capacity to accelerate the development and improvement of advanced clean hydrogen applications ready for market, across energy, transport, building and industrial end-uses. That will only be possible if combined with strengthening competitiveness of the Union clean hydrogen value chain, and in particular SMEs.
(56)
To achieve the scientific objectives of the Clean Hydrogen Joint Undertaking, all sectors concerned by the hydrogen economy should be given the possibility to get involved in preparing and implementing its Strategic Research and Innovation Agenda. Actions undertaken by the Clean Hydrogen Joint Undertaking should take into account disruptive technological trajectories alternative to mainstream technologies. The public sector should be involved, especially regional and national authorities, the latter being responsible for setting up climate policies and measures related to market mechanisms, to fill in the gaps between ready-to-market technology development and large-scale uptake.
(57)
The Clean Hydrogen Joint Undertaking includes the research community as a member of the Hydrogen Europe Research association, and thus a body providing scientific advice should not be established.
(58)
Since hydrogen can be deployed as a fuel or an energy carrier and for storing energy, it is essential that the clean hydrogen partnership establishes structured collaboration with many other European partnerships, in particular for end-use. The clean hydrogen European partnership should interact in particular with the zero emission road and waterborne transport, Europe’s railway, clean aviation, processes for the planet and clean steel European partnerships. For that purpose, a structure should be set up reporting to the Governing Board in order to ensure the cooperation and synergies between those partnerships in the domain of hydrogen. The Clean Hydrogen Joint Undertaking would be the only partnership focused on addressing hydrogen production technologies. Collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications.
(59)
Railways contribute to the Single European Transport Area (SETA) and represent a fundamental element of the Union long-term sustainable development strategy policy. In terms of economic size, the direct gross added value of the European rail sector is EUR 69 billion and the indirect value amounts to EUR 80 billion. 1,3 million persons are directly employed in the rail sector and more than one million indirectly.
(60)
The communication from the Commission of 10 March 2020 on a New Industrial Strategy for Europe underlines that sustainable and smart mobility industries, such as the rail industry, have both the responsibility and the potential to drive the digital and green transition, support Europe’s industrial competitiveness and improve connectivity. Therefore road, rail, aviation and waterborne transport should all contribute to a 90 % reduction in transport emissions by 2050. As a matter of priority, a substantial part of the 75 % of inland freight carried today by road should shift onto rail and inland waterways.
(61)
The Shift2Rail Joint Undertaking was established in 2014 to manage the research, development and validation activities of the Shift2Rail preceding initiative by combining public and private sector funding provided by its members and by drawing on internal and external technical resources. It established new forms of collaboration, consistent with competition rules, between stakeholders from the entire rail value chain and from outside the traditional rail sector, and brought in the experience and expertise of the European Union Agency for Railways on issues relating to interoperability and safety.
(62)
The objective of Europe’s Rail Joint Undertaking should be to deliver a high capacity integrated European railway network by eliminating barriers to interoperability and providing solutions for full integration, covering traffic management, vehicles, infrastructure and services, aiming to achieve faster uptake and deployment of projects and innovations. That should exploit the huge potential for digitalisation and automation to reduce rail’s costs, increase its capacity and enhance its flexibility and reliability, and should be based upon a solid reference functional system architecture shared by the sector, in coordination with the European Union Agency for Railways.
(63)
The Europe’s Rail Joint Undertaking should define in its Master Plan its priority research and innovation activities, and overall system architecture and harmonised operational approach, including large-scale demonstration activities and flagship areas, required to accelerate the penetration of integrated, interoperable and standardised technological innovations necessary to support the Single European Railway Area.
(64)
Rail is a complex system, with very close interactions between infrastructure managers, rail undertakings (train operators) and their respective equipment (infrastructure and rolling stock). It is impossible to deliver innovation without common specifications and strategy across the rail system. Therefore, the System Pillar of the Europe’s Rail Joint Undertaking, which will gather input from relevant stakeholders from both outside and within the joint undertaking, should enable the sector to converge on a single operational concept and system architecture, including the definition of the services, functional blocks and interfaces, which form the basis of rail system operations. It should provide the overall framework to ensure that research targets customer requirements and operational needs that are commonly agreed and shared. The output of the System Pillar should support interoperability for the whole railway network, including TEN-T core and comprehensive network, and main lines and regional lines not included in the TEN-T. The governance model and the decision-making process of the Europe’s Rail Joint Undertaking should reflect the Commission’s leading role in unifying and integrating Europe’s railway system, especially in rapidly and effectively delivering the single operational concept and system architecture, while involving the private partners in advisory and technical support roles.
(65)
To ensure that the results of low technology readiness levels (TRLs) research are effectively used at higher TRLs, and in particular by the Europe’s Rail Joint Undertaking, the Europe’s Rail Joint Undertaking’s programme office should implement such activities.
(66)
Where necessary, in order to ensure swift transition and expansion of membership, the Governing Board of the Europe’s Rail Joint Undertaking should be allowed to select associated members on the basis of the results of a call for expression of interest launched by the Commission.
(67)
In the context of the Commission’s priorities of the United Nations Sustainable Development Goals, in particular Sustainable Development Goal 3, and the joint communication from the Commission of 9 March 2020 entitled ‘Towards a Comprehensive Strategy with Africa’, the Union is committed to contribute to ensuring healthy lives and promoting well-being for all, to building an even stronger partnership between the two continents and to supporting the development of research and innovation capacities within Africa. The Global Health EDCTP3 Joint Undertaking should address the lack of appropriate diagnostics, treatments and vaccines, among other so-called health technologies, to address infectious diseases, such as HIV, malaria and tuberculosis but also other poverty-related and neglected infectious diseases, that are prevalent in Africa, especially in sub-Saharan Africa. The COVID-19 pandemic has revealed that, with the increased connectivity of different regions in the world, through world trade and tourism, infectious diseases can rapidly spread all over the world. Developing health technologies is therefore crucial to limit the spread of infectious diseases, as well as to fight them once they have spread, to protect the health of citizens in the countries concerned and in the Union. In order to achieve a stronger global health leadership than the preceding EDCTP2 initiative, the scope of the partnership should be extended to cover response to emerging infectious diseases threats, the increasing problems of antimicrobial resistance and non-communicable diseases co-morbidities.
(68)
Tackling infectious diseases affecting sub-Saharan Africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. The Global Health EDCTP3 Joint Undertaking should broker productive and sustainable North–South and South–South networking and cooperation, building relationships with multiple private and public sector organisations to strengthen project and institutional collaborations. The programme should also help to establish new North–South and South–South collaborations to conduct multi-country, multi-site studies in sub-Saharan Africa. In addition, a regular international conference, the European and Developing Countries Clinical Trials Partnership (EDCTP) Forum, should provide a platform for scientists and relevant networks from Europe, Africa and elsewhere to share findings and ideas, and to establish collaborative links.
(69)
The Global Health EDCTP3 Joint Undertaking should build on the experience gained during the EDCTP and EDCTP2 programmes, achieving results by harnessing investments of the Union, the Member States, associated countries and African countries which could not have been achieved by individual countries or by the Union research framework programme alone. The EDCTP Association, representing the states participating in the programme, should contribute with additional activities and may contribute financially to the EDCTP3 Programme and its implementation. It should provide meaningful participation and involvement of the sub-Saharan countries in the decision-making process, which is essential for tackling the burden of diseases in sub-Saharan countries. The joint undertaking should include other international research funders, such as philanthropists, the pharmaceutical industry and other third countries, that should contribute to the partnership as contributing partners on an ad hoc basis. Furthermore, to increase the impact of the programme, the Global Health EDCTP3 Joint Undertaking should have, for specific calls, the possibility to identify legal entities that could participate in indirect actions. It should be possible to provide in the work programme that such legal entities would not be eligible for funding by the joint undertaking.
(70)
The Global Health EDCTP3 Joint Undertaking includes Member States and associated countries as members of the EDCTP Association, and thus a states’ representatives group should not be established.
(71)
It is essential that the research activities funded by Global Health EDCTP3 Joint Undertaking, or otherwise covered by its work programme, are in full compliance with the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, ethical principles included in the World Medical Association’s Declaration of Helsinki of 2008, the standards of good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, relevant Union legislation and local ethics requirements of the countries where the research activities are to be conducted. Furthermore, the Global Health EDCTP3 Joint Undertaking should require that the innovations and interventions developed based on results of the indirect actions supported by the programme be affordable and accessible for vulnerable populations.
(72)
For the Global Health EDCTP3 Joint Undertaking to succeed and incentivise participation in the partnership, the joint undertaking funding should be restricted to legal entities established in Member States or associated countries or established in constituent states of the EDCTP Association, in accordance with the Horizon Europe Regulation. The entities established in sub-Saharan African and other third countries should still be able to participate in the calls without receiving funding. Additionally it should also be possible for entities established in other countries than members of the EDCTP3 Association to be eligible for funding in specific call topics or in the event of a call addressing a public health emergency, where it is provided for in the work programme. The Global Health EDCTP3 Joint Undertaking should take all appropriate measures, including contractual, to protect the financial interests of the Union. The conclusion of science and technology agreements with third countries should be sought. Before their conclusion, where entities established in a third country without such an agreement participate with funding in an indirect action, alternative measures to safeguard Union interests should be applied by the Global Health EDCTP3 Joint Undertaking, namely the financial coordinator of the action should be established in a Member State or associated country and the amount of pre-financing as well as liability provisions of the grant agreement should be adapted to adequately take the financial risks into account.
(73)
In the context of the Commission’s priorities of ‘An economy that works for people’ and ‘A Europe fit for the digital age’, the European industry, including SMEs, should become greener, more circular and more digital while remaining competitive on the global scale. The Commission has emphasised the role of medical devices and digital technologies addressing emerging challenges and the use of e-health services to provide high-quality health care, along with a call for ensuring the supply of affordable medicines to meet the Union’s needs, whilst supporting an innovative and world-leading European pharmaceutical industry. The Innovative Health Initiative Joint Undertaking aims to contribute to strengthening the competitiveness of the Union’s health industry, a cornerstone of the Union’s knowledge-based economy, to an increased economic activity in the development of health technologies, in particular of integrated health solutions, and thus serve as a tool for increasing technological leadership and fostering the digital transformation of our societies. Such political priorities can be achieved by bringing together the crucial players, namely academia, companies of various sizes and end-users of health innovations, under the umbrella of a public-private partnership in health research and innovation. The Innovative Health Initiative Joint Undertaking should help reach the objectives of the ‘Europe’s Beating Cancer Plan’ and the ‘European One Health Action Plan against Antimicrobial Resistance’. The Innovative Health Initiative Joint Undertaking should be in line with the communications from the Commission of 10 March 2020 on A New Industrial Strategy for Europe, of 10 March 2020 on An SME Strategy for a sustainable and digital Europe and of 25 November 2020 on the Pharmaceutical Strategy for Europe.
(74)
The Innovative Health Initiative Joint Undertaking builds on the experience gained from the Innovative Medicine Initiative 2 Joint Undertaking (IMI2 Joint Undertaking) including the work done by that preceding initiative to combat the COVID-19 pandemic. In line with the recommendations of the interim evaluation of the IMI2 Joint Undertaking, a successor initiative needs to enable the active engagement of other industry sectors with the pharmaceutical industry to capitalise on their expertise in the development of new health care interventions. Therefore, the industry sectors need to cover the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area. The scope of the joint undertaking should cover prevention, diagnosis, treatment and disease management and must be established taking due account of the high burden for patients or society or both due to the severity of the disease or the number of people affected, as well as the high economic impact of the disease for patients and for health care systems. The funded actions must respond to the Union public health needs, supporting the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems.
(75)
To ensure the best opportunity for generating new scientific ideas and successful research and innovation activities, the key actors in Innovative Health Initiative Joint Undertaking should be researchers from various types of entities, public and private. At the same time, end-users such as Union citizens, health care professionals and health care providers should provide input into the strategic design and activities of the joint undertaking, ensuring that it addresses their needs. Furthermore, Union-wide and national regulatory authorities, health technology assessment bodies and health care payers should also provide early input to the partnership’s activities, while ensuring the absence of any conflicts of interest, in order to increase the likelihood that the results of funded actions meet the requirements necessary for uptake and thus achieve the expected impacts. All such input should help better target research efforts towards areas of unmet need.
(76)
Current health challenges and threats are global. Therefore, the Innovative Health Initiative Joint Undertaking should be open to participation by international academic, industrial and regulatory actors, in order to benefit from wider access to data and expertise, to respond to emerging health threats and to achieve the necessary societal impact, in particular improved health outcomes for Union citizens. At the same time, most of the partnership’s activities should be conducted in the Member States and in Horizon Europe associated countries.
(77)
The partnership’s objectives should focus on the pre-competitive area, thereby creating a safe space for efficient collaboration between companies active in different health technologies. To reflect the integrative nature of the Innovative Health Initiative Joint Undertaking, help break the silos between health industry sectors and strengthen industry-academia collaborations, the majority of the projects funded by the Joint Undertaking should be cross-sectoral.
(78)
The term Key Digital Technologies refers to electronic components and systems that underpin all major economic sectors. The Commission highlighted the need to master such technologies in Europe, in particular in the context of delivering on European policy priorities such as digital leadership. The importance of the area and the challenges faced by the stakeholders in the Union require urgent action in order to leave no weak link in Europe’s innovation and value chains. A mechanism at Union level should therefore be set up to combine and focus the provision of support to research and innovation in electronic components and systems by the Member States, the Union and the private sector.
(79)
The Key Digital Technologies Joint Undertaking should address clearly defined topics that would enable European industries at large to design, manufacture and use the most innovative technologies in electronic components and systems. Structured and coordinated financial support at European level is necessary to help research teams and European industries maintain their current strengths at the leading edge in a highly competitive international context and close the gap in technologies that are critical for a digital transformation in Europe that reflects core Union values including privacy and trust, security and safety. Collaboration among stakeholders of the ecosystem, representing all segments of the value chains, is essential for the development of new technologies and the fast market uptake of innovation. Openness and flexibility to integrate relevant stakeholders, including in particular SMEs, in emerging or adjacent areas of technology or in both, is also vital.
(80)
The Key Digital Technologies Joint Undertaking should combine the financial and technical means that are essential to master the escalating pace of innovation in this area, to generate important spill-overs for society, and to share risk-taking by aligning strategies and investments towards a common European interest. Therefore, the members of the Key Digital Technologies Joint Undertaking should be the Union, Member States and associated countries to Horizon Europe on a voluntary basis, and associations as private members representing their constituent entities. Participation of Member States will furthermore facilitate a coherent alignment with national programmes and strategies, reducing overlap and fragmentation of efforts while ensuring synergies across stakeholders and activities.
(81)
In implementing the contributions of the participating states to their national participants in indirect actions, the Key Digital Technologies Joint Undertaking should take into account that the participating states have to abide by strict national budgetary rules. In that respect, participating states should give indicative financial commitments prior to the adoption of each annual work programme and should conclude legally binding agreements with the joint undertaking, committing participating states to the payment arrangements of their contribution to indirect actions throughout the lifetime of the joint undertaking. Such agreements should be concluded in the context of the annual budgetary procedure and programming of the joint undertaking. The Governing Board should adopt the annual work programme taking due account of those indicative commitments. The Public Authorities Board should select proposals. Only after those steps, and in line with the joint undertaking’s financial rules, the authorising officer should make the budgetary and legal commitments for those indirect actions.
(82)
As a continuation of the practice established in the ECSEL Joint Undertaking, a derogation from Article 34 of the Horizon Europe Regulation is necessary in order to allow different funding rates depending on the type of participant, in particular SMEs and non-profit legal entities, and the type of action, to be applied invariably across beneficiaries from all participating states. That should ensure the right balance of stakeholder participation in the actions funded by the Key Digital Technologies Joint Undertaking and foster a higher level of involvement of SMEs as recommended in the ECSEL Joint Undertaking interim evaluation.
(83)
The Key Digital Technologies Joint Undertaking includes Member States and associated countries as members of the Public Authorities Board, and thus a state representative group should not be established.
(84)
The Union’s Single European Sky legal framework established by Regulation (EC) No 549/2004 of the European Parliament and of the Council (18) seeks to reform the European air traffic management (ATM) system through institutional, operational, technological and regulatory actions with the aim of improving its performance in terms of capacity, safety, efficiency and environmental impact.
(85)
The Single European Sky ATM Research and Development project (the ‘SESAR project’) established by Council Regulation (EC) No 219/2007 (19) aims to modernise ATM and to bundle technological and operational innovation in support of the Single European Sky. It aims to provide the technological solutions for a highly performing ATM by 2035 to enable an uncongested, even safer and more environmentally and climate friendly functioning of the air transport sector, in line with the European Green Deal and the European Climate Law. The SESAR project comprises three interrelated, continuous and evolving collaborative processes that define, develop and deploy innovative technological systems and operational procedures underlying the digital European sky defined in the European ATM Master Plan referred to in Council Decision 2009/320/EC (20).
(86)
The European ATM Master Plan is the planning tool for ATM modernisation across Europe, connecting ATM research and innovation activities with deployment activities scenarios to achieve the Single European Sky performance objectives.
(87)
The SESAR Joint Undertaking was established with the objective of managing the definition and development phases of the SESAR project, by combining public and private sector funding provided by its members and by drawing on internal and external technical resources, as well as to execute and update, when necessary, the European ATM Master Plan. It established a new and efficient form of collaboration between stakeholders in a sector where progress is only possible when all stakeholders implement new solutions in a synchronised manner. Given the successful establishment of the SESAR brand name, the new Single European Sky ATM Research 3 Joint Undertaking should continue to make use of it.
(88)
The Single European Sky ATM Research 3 Joint Undertaking should build on the experience of the SESAR Joint Undertaking and continue its coordination role for ATM research in the Union. The main objectives of the Single European Sky ATM Research 3 Joint Undertaking should be to strengthen and further integrate the research and innovation capacity in Europe, helping to accelerate the digitalisation of the sector and rendering it more resilient and scalable to fluctuations in traffic. It should strengthen, through innovation, the competitiveness of manned and unmanned air transport and ATM services, to support economic recovery and growth. It should develop and accelerate the market uptake of innovative solutions to establish the Single European Sky airspace as the most efficient and environmentally friendly sky to fly in the world.
(89)
The new Single European Sky ATM Research 3 Joint Undertaking should be able to develop and validate technical input assisting the Commission with regulatory activities in ATM, for example preparing all the technical documentation for the common projects established under a Regulation of the European Parliament and of the Council on the implementation of the Single European Sky, conducting technical studies or supporting standardisation activities. It should also ensure the stewardship of the European ATM Master Plan endorsed by Decision 2009/320/EC, including its monitoring, reporting and updating. In addition, the Commission should have votes in proportion to the Union contribution to the budget, and at least 25 % of votes. This set-up ensures that the Commission retains a strong ability to steer, from a policy perspective, the work carried out by the Joint Undertaking in relation to those tasks through the strengthened supervision mechanisms established for such bodies.
(90)
Participation in the Single European Sky ATM Research 3 Joint Undertaking should be open to the widest possible range and representation of stakeholders from all Member States and countries associated to Horizon Europe, including SMEs, through different forms of participation. In particular, participation should ensure a proper balance between equipment manufacturers for both manned and unmanned aviation, airspace users, air navigation service providers, airports, military and professional staff associations, and offer opportunities to SMEs, academia and research organisations. With a view to identifying the most promising approaches and entities capable of pursuing them, the Commission launched a call for expression of interest for potential members. The Governing Board should be allowed to select associated members on the basis of the results of that call in order to provide for a swift expansion of the group of members.
(91)
Route charges are entirely borne by airspace users, who contribute indirectly to the research and development efforts financed by major ATM stakeholders like air navigation service providers or the manufacturing industry building and equipping the aircrafts used by the airspace users. Therefore, airspace users should be given appropriate representation within the Single European Sky ATM Research 3 Joint Undertaking’s Governing Board.
(92)
To ensure that the results of ATM exploratory (low TRLs) research are effectively used at higher TRLs, and in particular by the Single European Sky ATM Research 3 Joint Undertaking, the joint undertaking’s programme office should manage such activities.
(93)
The Eurocontrol Agency possesses an appropriate infrastructure and the necessary administrative, IT, communications and logistics support services. The Single European Sky ATM Research 3 Joint Undertaking should benefit from such infrastructure and services from Eurocontrol. In this context, there are few potential synergies that could be gained from pooling administrative resources with other Joint Undertakings through a common back office. For this reason, the Single European Sky ATM Research 3 Joint Undertaking should opt out from the back office arrangements established by this Regulation.
(94)
With the purpose of creating a broad stakeholder base for ensuring the Smart Networks and Services partnership’s objectives, the 6G Smart Networks and Services Industry Association (6G-IA)has been established building on the predecessor association. While the new industry association, in the first years following its establishment, is expected to have only a limited number of constituent and affiliated entities, it has the objective to include new members from stakeholder constituencies active in the Smart Network and Services value chain. Considering its expected modest size and the impact on its SMEs constituent entities, it is not sustainable for the association to contribute to 50 % of the administrative costs of the Smart Networks and Services Joint Undertaking over its lifetime, in particular in the first years following its establishment. Additionally, the crisis brought about by the COVID-19 pandemic and its impact on the economy has posed challenges for the European economic actors including in the field of information and communications technology. Therefore it should be ensured that the private partners of the joint undertaking are able to fulfil their commitments, while the conditions remain attractive and incentivise new partners to join the association. The minimum percentage of annual financial contribution to the administrative costs from members other than the Union should therefore be 20 % of the total annual administrative costs. In particular, it should be possible that SMEs constituent entities contribute less than bigger enterprises. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to increase their contribution to 50 % of the administrative costs of the joint undertaking over its lifetime.
(95)
In the context of Commission priorities for 2019-2024 ‘A Europe fit for the digital age’, ‘An economy that works for people’ and the policy objectives set out in the context of its communication on ‘Shaping Europe’s digital future’, Europe needs to develop critical digital infrastructures based on 5G networks and build its technological capacities towards 6G with a time horizon of 2030. In this context, the Commission has emphasised the strategic importance of a European partnership for Smart Networks and Services to provide secure connectivity-based services to consumers and businesses. Those priorities can be achieved by bringing together the key players, namely industry, academia and public authorities, under the umbrella of a European partnership that builds on the achievements of the 5G Infrastructure Public Private Partnership preceding initiative, which successfully developed 5G technology and standards.
(96)
The Smart Networks and Services Joint Undertaking is designed to address policy issues in the field of digital infrastructure, to support 5G infrastructure deployment within the scope of the Connecting Europe Facility 2 (CEF2) Digital programme established by Regulation (EU) 2021/1153 of the European Parliament and of the Council (21) and to extend the technology scope of research and innovation for 6G networks. It should, with close involvement of the Member States, strengthen the response to Union policy and social needs regarding network energy efficiency, cybersecurity, technological leadership, privacy and ethics and should extend the research and innovation scope from networks to cloud-based service provisioning as well as components and devices enabling services for citizens and a broad range of economic sectors such as health care, transport, manufacturing and media.
(97)
The public policy objectives related to Smart Networks and Services cannot be addressed solely by the industry and the Commission. Addressing them from a holistic and coordinated perspective requires in particular the strategic involvement of the Member States as part of the governance structure. Therefore, the Governing Board should take utmost account of the opinions of the states’ representatives group, in particular as regards strategic guidance concerning work programmes and funding decisions.
(98)
Advanced 5G infrastructures will be the basis for developing the ecosystems for the digital and green transitions and, in the next step, for Europe’s position to adopt 6G technology. The CEF2 Digital programme as well as the Digital Europe Programme (DEP) established by Regulation (EU) 2021/694 of the European Parliament and of the Council (22) and InvestEU established by Regulation (EU) 2021/523 of the European Parliament and of the Council (23) offer opportunities for the development of 5G- and later 6G-based digital ecosystems. Taking into account the broad set of public and private stakeholders involved in such deployment projects, it is essential to coordinate the setting-up of a strategic agenda, the contribution to the programming and the stakeholder information and engagement related to such programmes. As a strategic basis for those tasks, the Smart Networks and Services Joint Undertaking should coordinate the development of Strategic Deployment Agendas for the relevant areas of deployment, such as 5G systems along roads and along railways. Those agendas should, inter alia, support setting out deployment roadmaps, the main options for cooperation models and other strategic issues.
(99)
Article 20(3) of the Horizon Europe Regulation provides that, where appropriate, the Commission or funding body has to carry out a security scrutiny for proposals raising security issues.
(100)
Pursuant to the Council Conclusions of 3 December 2019 and the Recommendation of 26 March 2019 on Cybersecurity of 5G networks for coordinated action at Union level, the Member States’ Cooperation Group on Network and Information Security published the EU toolbox of risk mitigating measures concerning cyber-security of 5G networks of January 2020 (the ‘toolbox’). The toolbox includes a set of strategic and technical measures as well as supporting actions in order to mitigate the main cybersecurity risks of 5G networks, which have been identified in the Union coordinated risk assessment report, and to provide guidance for the selection of measures that should be prioritised in mitigation plans at national and at Union level. The Commission Communication of 29 January 2020 on Implementing the EU toolbox endorses all measures and guidance set out in the toolbox and emphasises the need for restrictions, including necessary exclusions, concerning suppliers considered to be high risk based on the factors specified in the Union coordinated risk assessment as well as measures to avoid dependency on those suppliers. It also identifies a set of specific actions for the Commission, in particular to ensure that participation in Union funding programmes in relevant technology domains will be conditional on compliance with security requirements, by making full use of and further implementing security conditions. Therefore, the implementation of this Regulation should introduce appropriate provisions to reflect the security measures through actions funded by the SNS Joint Undertaking and, on the basis of its recommendations, by other funding bodies implementing other Union programmes in the area of smart networks and services.
(101)
The joint undertakings under Horizon 2020 were set up for a period up to 31 December 2024. The joint undertakings should provide continued support to the respective research programmes by implementing the remaining actions initiated or continued under Council Regulations (EC) No 219/2007,(EU) No 557/2014 (24), (EU) No 558/2014 (25), (EU) No 559/2014 (26), (EU) No 560/2014 (27), (EU) No 561/2014 (28) and (EU) No 642/2014 (29) and in accordance with those Regulations until their winding-up. In the interest of legal certainty and clarity those Regulations should therefore be repealed.
(102)
The Union should act only where there is a demonstrable advantage that action at Union level is more effective than action taken at national, regional or local level. The joint undertakings focus on areas where there is a demonstrable added value in acting at the Union level due to the scale, speed and scope of the efforts needed for the Union to meet its long-term TFEU objectives and deliver on its strategic policy priorities and commitments. In addition, the proposed joint undertakings should be seen as complementary to and should reinforce national and sub-national activities in the same area.
(103)
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding unnecessary duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(104)
In order to ensure continuity in providing support in the relevant policy areas, this Regulation should enter into force as a matter of urgency on the day of its publication,
HAS ADOPTED THIS REGULATION:
PART ONE
COMMON PROVISIONS
TITLE I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation sets up nine joint undertakings within the meaning of Article 187 TFEU for the implementation of institutionalised European partnerships referred to in Article 10(1), point (c), of the Horizon Europe Regulation. It determines their objectives and tasks, membership, organisation and other operating rules.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
1.
‘member other than the Union’ means any participating state, private member or international organisation that is a member of a joint undertaking;
2.
‘founding member’ means any legal entity established in a Member State, a country associated to Horizon Europe, or an international organisation that is identified as a member of a joint undertaking in this Regulation or in one of its Annexes;
3.
‘associated member’ means any legal entity established in a Member State, a country associated to Horizon Europe, or an international organisation that accedes to a joint undertaking by signing a letter of commitment in accordance with Article 6(3) and subject to an approval in accordance with Article 7;
4.
‘participating state’ means any Member State or country associated to Horizon Europe upon notification of its participation in the activities of the relevant joint undertaking by means of a letter of commitment;
5.
‘private member’ means any legal entity established under public or private law that is a member of a joint undertaking other than the Union, participating states or international organisations;
6.
‘constituent entities’ means the entities that constitute a private member of a joint undertaking, where the private member is an association according to that member’s statutes;
7.
‘contributing partner’ means any country, international organisation or legal entity other than a member of a joint undertaking, or a constituent entity of a member or an affiliated entity of either, that supports the objectives of a joint undertaking in its specific area of research and whose application has been approved in accordance with Article 9;
8.
‘in-kind contributions to operational activities’ means contributions by private members, constituent entities or the affiliated entities of either, by international organisations and by contributing partners, consisting of the eligible costs incurred by them in implementing indirect actions less the contribution of that joint undertaking and of the participating states of that joint undertaking to those costs;
9.
‘additional activity’ means an activity, included in the annual additional activities plan annexed to the main part of the work programme, that does not receive financial support from the joint undertaking but contributes to its objectives and is directly linked to the uptake of results from projects under that joint undertaking or its preceding initiatives or that has a significant Union added value;
10.
‘in-kind contributions to additional activities’ means contributions by the private members, constituent entities or the affiliated entities of either, and by international organisations, consisting of the costs incurred by them in implementing additional activities less any contribution to those costs from the Union and from the participating states of that joint undertaking;
11.
‘preceding initiative’ means any partnership in one of the areas covered by a joint undertaking that received financial support from one of the previous Union framework programmes for research;
12.
‘Strategic Research and Innovation Agenda’ means the document covering the duration of Horizon Europe that identifies the key priorities and the essential technologies and innovations required to achieve the objectives of a joint undertaking;
13.
‘work programme’ means the document referred to in Article 2, point (25), of the Horizon Europe Regulation;
14.
‘conflict of interest’ means a situation involving a financial actor or other person as referred to in Article 61 of Regulation (EU, Euratom) 2018/1046;
15.
‘newcomer’ means an entity that is, for the first time, a beneficiary of a grant awarded by an individual joint undertaking or its preceding initiative and that is not a founding member of that joint undertaking or its preceding initiative.
Article 3
Establishment
1. The following joint undertakings are set up as Union bodies for a period ending on 31 December 2031 and financed under the MFF 2021-2027:
(a)
the Circular Bio-based Europe Joint Undertaking;
(b)
the Clean Aviation Joint Undertaking;
(c)
the Clean Hydrogen Joint Undertaking;
(d)
the Europe’s Rail Joint Undertaking;
(e)
the Global Health EDCTP3 Joint Undertaking;
(f)
the Innovative Health Initiative Joint Undertaking;
(g)
the Key Digital Technologies Joint Undertaking;
(h)
the Single European Sky ATM Research 3 Joint Undertaking;
(i)
the Smart Networks and Services Joint Undertaking.
2. The Union bodies referred to in paragraph 1 shall be collectively referred to as the ‘joint undertakings’.
3. In order to take into account the duration of Horizon Europe, calls for proposals under the joint undertakings shall be launched at the latest by 31 December 2027. In duly justified cases, calls for proposals may be launched by 31 December 2028, at the latest.
4. The joint undertakings shall have legal personality. In each of the Member States, they shall enjoy the most extensive legal capacity accorded to legal persons under the laws of that Member State. They may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.
5. The seat of the joint undertakings shall be in Brussels, Belgium.
6. Unless specified otherwise, the provisions set out in Part One and Part Three shall apply to all joint undertakings. The provisions set out in Part Two shall apply to individual joint undertakings, as appropriate.
7. For the purposes of Parts One and Three and unless specified otherwise, a reference to an individual joint undertaking or body shall denote a reference to each joint undertaking or each equivalent body of the individual joint undertakings and its competences in relation to other bodies of the same joint undertaking.
TITLE II
FUNCTIONING OF THE JOINT UNDERTAKINGS
CHAPTER 1
Objectives and tasks
Article 4
Objectives and principles
1. The joint undertakings referred to in Article 3 of this Regulation shall contribute to the general and specific objectives of the Horizon Europe Regulation as set out in Article 3 thereof.
2. The joint undertakings shall, through the involvement and commitment of partners in designing and implementing a programme of research and innovation activities with European added value, deliver collectively on the following general objectives:
(a)
strengthening and integrating the scientific, innovation and technological capacities and facilitating collaborative links across the Union to support the creation and diffusion of high-quality new knowledge and skills, in particular with a view to delivering on global challenges, securing and enhancing Union competitiveness, European added value, resilience and sustainability and contributing to a reinforced European Research Area (ERA);
(b)
securing sustainability-driven global leadership and resilience of Union value chains in key technologies and industries in line with the industrial and SMEs strategies for Europe, the European Green Deal, the European Recovery Plan and other relevant Union policies;
(c)
developing and accelerating the uptake of innovative solutions throughout the Union addressing climate, environmental, health, digital and other global challenges contributing to Union strategic priorities, accelerating the economic growth of the Union and fostering the innovation ecosystem, while reaching the United Nations Sustainable Development Goals and achieving climate neutrality in the Union at the latest by 2050, in line with the Paris Agreement, thereby improving the quality of life of European citizens.
3. The joint undertakings shall deliver on the following specific objectives:
(a)
enhance the critical mass and scientific and technological capabilities and competences in collaborative, cross-sectoral, cross policy, cross-border and interdisciplinary research and innovation across the Union as well as facilitate their integration into European ecosystems;
(b)
accelerate the green and digital transitions as well as economic, social and societal transformations in areas and sectors of strategic importance for Union priorities, in particular to reduce greenhouse gas emissions by 2030 in accordance with the climate and energy targets set in line with the European Green Deal and the European Climate Law;
(c)
enhance the research and innovation capabilities and performance of existing and new European innovation ecosystem and economic value chains, including in start-ups and SMEs;
(d)
accelerate the deployment, uptake and diffusion of innovative solutions, technologies, services and skills in reinforced European research and innovation ecosystems and industrial ecosystems, including through wide and early engagement and co-creation with end-users, including SMEs and start-ups, citizens and regulatory and standardisation bodies;
(e)
deliver environmental, energy, resource-saving, societal, circularity and productivity improvements in new products, technologies, applications and services by exploiting Union capabilities and resources.
4. The joint undertakings shall also have the additional objectives set out in Part Two.
5. In the implementation of the Horizon Europe Regulation, the joint undertakings shall respect the principles set out in Article 7 of that Regulation.
6. The joint undertakings shall adhere to the conditions and criteria for European partnerships set out in Article 10 of and Annex III to the Horizon Europe Regulation.
Article 5
Operational objectives and tasks
1. The joint undertakings shall adhere to the following operational objectives in accordance with the criteria set out in Annex III to the Horizon Europe Regulation, and contribute to the operational objectives of Horizon Europe set out in the Specific Programme implementing Horizon Europe:
(a)
reinforce and spread excellence, including by fostering wider participation and boosting collaborative links throughout the Union;
(b)
strengthen scientific excellence, including by considering, where relevant, state-of-the-art basic and frontier research findings in the implementation of their activities;
(c)
stimulate research and innovation activities in SMEs and contribute to the creation and scaling-up of innovative companies, in particular start-ups, SMEs and, in exceptional cases, small mid-caps;
(d)
reinforce the link between research, innovation and, where appropriate, education, training and other policies, including complementarities with national, regional and Union research and innovation policies and activities;
(e)
strengthening gender mainstreaming, including the integration of gender dimension in the research and innovation content;
(f)
increase collaboration links in European research and innovation and across sectors and disciplines, including social sciences and humanities;
(g)
strengthen international cooperation in support of Union policy objectives and international commitments;
(h)
increase public awareness and acceptance, respond to demand and encourage the diffusion and uptake of new solutions by involving, where appropriate, citizens and end-users in co-design and co-creation processes;
(i)
encourage exploitation of research and innovation results and actively disseminate and exploit results, in particular for leveraging private investments and for policy development;
(j)
accelerate industrial transformation and resilience across the value chains, including through improving skills for innovation and advancing digital technology;
(k)
support the scientific evidence-based implementation of related Union policies, as well as regulatory, standardisation and sustainable investment activities at national, European and global levels.
2. The joint undertakings shall carry out the following tasks by adopting a systemic approach in achieving the objectives:
(a)
provide financial support, mainly in the form of grants, to research and innovation indirect actions, selected following open, transparent and competitive calls except in duly justified cases specified in their work programme in order to set additional conditions requiring the participation of members of the joint undertaking or their constituent or affiliated entities;
(b)
develop close cooperation and ensure coordination with other European partnerships, including by dedicating, where appropriate, a part of the joint undertaking’s budget to joint calls;
(c)
seek and maximise synergies with and, where appropriate, possibilities for further funding from relevant activities and programmes at Union, national and regional level, in particular with those supporting the deployment and uptake of innovative solutions, training, education and regional development, such as Cohesion Policy Funds, or the national Recovery and Resilience Plans;
(d)
ensure their operations contribute towards the strategic multiannual planning, reporting, monitoring and evaluation and other requirements of Horizon Europe set out in Articles 50 and 52 of the Horizon Europe Regulation, such as the implementation of the common policy feedback framework;
(e)
promote the involvement of SMEs and start-ups in their activities and ensure the provision of timely information to them, in line with the objectives of Horizon Europe;
(f)
develop a targeted approach within their Strategic Research and Innovation Agenda to implement measures for attracting newcomers, in particular SMEs, higher education institutions and research organisations, for expanding collaborative networks;
(g)
mobilise the public and private sector resources needed to achieve the objectives set out in this Regulation;
(h)
monitor progress towards the achievement of the objectives set out in this Regulation, as well as in accordance with the provisions set out in Article 50 of and Annexes III and V to the Horizon Europe Regulation;
(i)
define and implement their work programme;
(j)
liaise with the most extensive range of stakeholders including, but not limited to, decentralised agencies, research organisations and higher education institutions, end users and public authorities, in particular for the purpose of defining the priorities and activities of each joint undertaking as well as to ensure transparency, openness and inclusiveness, and benefits to society;
(k)
engage in information, communication, publicity and dissemination and exploitation activities by applying mutatis mutandis Article 51 of the Horizon Europe Regulation, including by making the detailed and coherent information on results from funded research and innovation activities available and accessible in a common Horizon Europe e-database, in a timely manner;
(l)
provide the Commission with the necessary technical, scientific and administrative support to carry out its tasks for the purposes of ensuring the proper functioning and development in the Union of the specific areas addressed by the joint undertaking;
(m)
contribute to developing a more effective science-policy interface, to fostering open science by ensuring better use of results and to addressing policy needs, as well as to promoting faster exploitation, dissemination and uptake of results in accordance with Articles 14 and 39 of the Horizon Europe Regulation;
(n)
identify and report, in line with the common policy feedback framework and with strategies and actions to support the European Green Deal objectives, the relevant knowledge acquired from the management of research and innovation projects and their results to the Commission to serve as input for monitoring, evaluating and rectifying, where necessary, existing policy measures or shaping new policy initiatives and decisions;
(o)
support the Commission in the development and implementation of robust science-based technical screening criteria pursuant to Article 3 of Regulation (EU) 2020/852 on sustainable investments, by monitoring and assessing their implementation within the economic sector in which they operate, in order to provide ad hoc feedback to policy-making, when needed;
(p)
consider the ‘do no significant harm’ principle pursuant to Article 17 of Regulation (EU) 2020/852 for activities of the joint undertakings falling within the scope of that Regulation and take into account the provisions of that Regulation to improve access to sustainable finance, where relevant;
(q)
perform any other task necessary to achieve the objectives set out in this Regulation.
3. In addition to the tasks set out in this Article and in Part Two, the joint undertakings may be entrusted with the implementation of additional tasks requiring cumulative, complementary or combined funding between Union programmes.
CHAPTER 2
Members, contributing partners and contributions
Article 6
Members
1. The members of the joint undertakings referred to in Article 3 shall be the Union, represented by the Commission, and any of the following, as specified in Part Two:
(a)
participating states;
(b)
founding members;
(c)
associated members.
2. Membership of a joint undertaking may not be transferred to a third party without the prior agreement of the governing board referred to in Chapter 3, Section 1 of this Title.
3. A letter of commitment shall be signed by founding members and associated members and shall detail the scope of the membership in terms of content, activities and its duration, as well as the founding members’ and associated members’ contributions to the joint undertaking, including an indication of the envisaged additional activities referred to in Article 11(1), point (b).
Article 7
Selection of associated members
1. Joint undertakings may launch open and transparent calls for expression of interest with a view to selecting associated members with the potential to contribute to the achievement of the objectives of the joint undertakings. Joint undertakings whose founding members are listed in Annexes I, II and III shall launch such calls. The call for expression of interest shall set out the key capacities needed in order to achieve the objectives of the joint undertaking and may request applicants to provide an indication of their potential contributions. All calls shall be published on the joint undertaking’s website and communicated through all appropriate channels including, where applicable, the states’ representatives group, in order to ensure the widest possible participation in the interest of achieving the objectives of the joint undertaking.
2. The executive director shall assess the applications for membership with the assistance of independent experts and, where appropriate, of relevant bodies of the joint undertaking, on the basis of documented knowledge, experience and added value of the applicant in achieving the objectives of the joint undertaking, the applicant’s financial soundness and long-term commitment for financial and in-kind contributions to the joint undertaking, and taking into account potential conflicts of interest.
3. The governing board shall assess and approve or reject applications for membership.
Article 8
Changes to or termination of membership
1. Any member of a joint undertaking may terminate its membership of that joint undertaking. The termination shall become effective and irrevocable six months after notification to the executive director of the joint undertaking, who shall inform the other members. As from the date of termination, the member shall be discharged from any obligations other than those approved or incurred by the joint undertaking prior to terminating the membership, unless mutually agreed otherwise.
2. Each private member shall inform in a timely manner the joint undertaking of any merger or acquisition between members likely to affect the joint undertaking or any takeover of a member by an entity that is not a member of the joint undertaking.
3. The governing board shall decide whether to terminate the membership of any member referred to in paragraph 2, with a view to ensuring business continuity and protecting the Union’s or the joint undertaking’s interest. The termination shall become effective and irrevocable no later than six months from the decision of the governing board or on the date specified in that decision, whichever is earlier. The member or members concerned shall not participate in the vote of the governing board.
4. Each private member shall inform in a timely manner the joint undertaking of any other significant changes in its ownership, control or composition. Where the Commission considers that the change is likely to affect the Union’s or the joint undertaking’s interest on grounds of security or public order, it may propose to the governing board to terminate the membership of the concerned private member. The governing board shall decide on a termination of the membership of the private member concerned. The private member concerned shall not participate in the vote of the governing board.
5. The termination shall become effective and irrevocable not later than six months from the decision of the governing board or on the date specified in that decision, whichever is earlier.
6. The governing board may terminate the membership of any member that fails to fulfil its obligations pursuant to this Regulation. The procedure set out in Article 28(6) applies mutatis mutandis.
7. Where appropriate, the Commission may request private members to take appropriate measures to ensure that the Union’s and the joint undertaking’s interest on grounds of security or public order are safeguarded.
8. Where there is a change to membership or termination, the joint undertaking shall immediately publish on its website an updated list of its members, together with the date when such change shall take effect.
9. Where appropriate and subject to Article 16(3), the governing board shall decide on a redistribution of the voting rights in the governing board due to the change to membership or due to termination.
Article 9
Contributing partners
1. Any candidate contributing partner as defined in Article 2, point (7), shall submit a letter of endorsement to the governing board. The letter of endorsement shall specify the scope of the partnership in terms of subject matter, activities and their duration and detail the applicant’s contribution to the joint undertaking.
2. The governing board shall assess the letter of endorsement and shall approve or reject the application.
3. Contributing partners shall not have voting rights in the governing board of a joint undertaking.
Article 10
Union financial contribution
1. The Union financial contribution to the joint undertakings, including European Economic Area (EEA) appropriations, shall cover administrative and operational costs up to the maximum amounts specified in Part Two, provided that that amount is at least matched by the contribution of members other than the Union or their constituent or affiliated entities.
2. The amount of the Union contribution specified in Part Two may be increased with contributions from third countries associated to Horizon Europe in line with Article 16(5) of the Horizon Europe Regulation and provided that the total amount by which the Union contribution is increased is at least matched by the contribution of members other than the Union, or their constituent or affiliated entities.
3. The Union contribution shall be paid from the appropriations in the general budget of the Union allocated to the Specific Programme implementing Horizon Europe, in accordance with Article 62(1), point (c)(iv), and Article 154 of Regulation (EU, Euratom) 2018/1046 in the case of bodies referred to in Article 71 of that Regulation.
4. Additional Union funds complementing the contribution referred to in paragraph 3 of this Article may be entrusted to the joint undertakings in accordance with Article 62(1), point (c)(iv), and Article 154 of Regulation (EU, Euratom) 2018/1046.
5. For contributions corresponding to additional tasks entrusted to a Joint Undertaking in accordance with paragraph 4 of this Article or Article 5(3) of this Regulation, the requirements of Article 155 of Regulation (EU, Euratom) 2018/1046 are applicable.
6. Additional contributions from Union programmes corresponding to additional tasks entrusted to a joint undertaking pursuant to paragraph 4 of this Article or Article 5(3) shall not be accounted for in the calculation of the Union maximum financial contribution specified in Part Two.
Article 11
Contributions from members other than the Union and contributing partners
1. Unless specified otherwise in Part Two, the contributions of private members shall consist of financial contributions and of any of the following:
(a)
in-kind contributions to operational activities;
(b)
in-kind contributions to additional activities, approved by the governing board in accordance with Article 17(2), point (n).
2. Unless specified otherwise in Part Two, the private members shall report by 31 May each year at the latest to their respective governing board on the value of the contributions referred to in paragraph 1, point (b), made in each of the previous financial years. For the purpose of valuing these contributions, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where the entity is established, and to the applicable International Accounting Standards and International Financial Reporting Standards. The costs shall be certified by an independent audit body appointed by the entity concerned and shall not be audited by the joint undertaking concerned or any Union body. The valuation method may be verified by the joint undertaking concerned should there be any uncertainty arising from the certification. In duly specified cases, the governing board may authorise the use of lump sums or unit costs for valuing those contributions.
3. The contributions from participating states shall consist of financial contributions. The participating states shall report by 31 January of each year to the governing board on the financial contributions made in the previous financial year.
4. The contributions from international organisations shall consist of financial contributions and in-kind contributions to operational activities, unless specified otherwise in Part Two.
5. The contributions from contributing partners shall correspond to the amounts they have committed in the letter of endorsement when becoming a contributing partner and shall consist of financial contributions and in-kind contributions to operational activities.
6. The Commission may terminate, proportionally reduce or suspend the Union financial contribution to a joint undertaking or trigger the winding-up procedure referred to in Article 45 in any of the following cases:
(a)
where the joint undertaking concerned fails to meet the conditions for the entrustment of the Union contribution;
(b)
where the members other than the Union or their constituent or affiliated entities fail to contribute, contribute only partially, do not respect the time limits set out in paragraph 2 with regard to the contribution referred to in paragraphs 1, 4 and 5 of this Article;
(c)
as a result of the evaluations referred to in Article 171(2).
7. The Commission’s decision to terminate, proportionally reduce or suspend the Union financial contribution shall not hinder the reimbursement of eligible costs already incurred by the members other than the Union before the decision is notified to the joint undertaking.
8. Following the procedure set out in Article 28(6), any member of the joint undertaking other than the Union that fails to meet their commitments concerning the contributions referred to in this Regulation shall be disqualified from voting in the governing board until their obligations have been met. Where any such member fails to meet their obligations upon expiry of an additional six-month period, their membership shall be revoked, unless the governing board decides otherwise in duly justified cases. The entity concerned shall not participate in the vote of the governing board.
Article 12
Management of contributions from the participating states
1. Each participating state shall make an indicative commitment of the amount of their national financial contributions to the joint undertaking. Such commitment shall be made prior to the adoption of the work programme.
In addition to criteria set out in Article 22 of the Horizon Europe Regulation, the work programme may include, as an annex, eligibility criteria regarding national legal entities.
Each participating state shall entrust the joint undertaking with the evaluation of the proposals according to the Horizon Europe Regulation.
The selection of proposals shall be based on the ranking list provided by the evaluation committee. The body responsible for selection may deviate from that list in duly justified cases as set out in the work programme to ensure the overall consistency of the portfolio approach.
Each participating state shall have a right of veto on all issues concerning the use of its own national financial contributions to the joint undertaking for applicants established in those participating states, on the basis of national strategic priorities.
2. Each participating state shall conclude one or more administrative agreements with the joint undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that participating state. This agreement shall include the schedule, conditions of payment, reporting and audit requirements.
Each participating state shall strive to synchronise its payment schedule, reporting and audits with those of the joint undertaking and to converge its cost eligibility rules with Horizon Europe’s rules.
3. In the agreement referred to in paragraph 2, each participating state may entrust the joint undertaking with the payment of its contribution to its beneficiaries. After the selection of proposals, the participating state shall commit the amount necessary for payments. The audit authorities of the participating state may audit the respective national contributions.
CHAPTER 3
Organisation of the joint undertakings
Article 13
Synergies and efficiencies in back office arrangements
1. Joint undertakings shall, within one year following the date of entry into force of this Regulation, operate back office arrangements by concluding service level agreements, unless specified otherwise in Part Two and subject to the need to guarantee an equivalent level of protection of the Union’s financial interest when entrusting budgetary implementation tasks to joint undertakings. Such arrangements shall include at least the following areas, subject to confirmation of viability and following screening of resources:
(a)
human resource support;
(b)
legal support;
(c)
information and communication technologies;
(d)
accounting (excluding treasury);
(e)
communication;
(f)
logistics, events and meeting room management;
(g)
support for audit and anti-fraud strategy.
2. The back office arrangements referred to in paragraph 1 shall be provided by one or more selected joint undertakings to all others. Interrelated arrangements shall be kept within the same joint undertaking to the extent appropriate for efficient and effective implementation of the tasks concerned in order to ensure a coherent organisational structure.
3. The service level agreements referred to in paragraph 1 shall enable the transfer of appropriations or the recovery of costs for the provision of the common services between the joint undertakings.
4. Without prejudice to the reassignment to other tasks within the joint undertaking, or to other administrative arrangements, which do not impact contracts of employment, staff assigned to the functions transferred for the purpose of the back office arrangements, hosted by another joint undertaking, may be transferred to that joint undertaking. Where a member of the staff concerned expresses his or her refusal in writing, the contract of that member of staff may be terminated by the joint undertaking under the conditions referred to in Article 47 of the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (30) (CEOS).
5. Staff referred to in paragraph 4, who are transferred to the joint undertaking hosting the back office arrangements, shall keep the same type of contract and function group and grade, and shall be deemed to have served their entire service in that joint undertaking.
Article 14
Bodies of the joint undertakings
1. Each joint undertaking shall have a governing board, an executive director and, except in joint undertakings where states are represented in the Governing Board, a states’ representatives group.
2. A joint undertaking may also have a scientific advisory body and a stakeholders group and any other body in accordance with the provisions in Part Two.
3. When carrying out its tasks, each body of the joint undertakings shall only pursue the objectives set out in this Regulation and shall only act within the scope of the activities of the joint undertaking for the purpose of which it was established.
4. Without prejudice to paragraph 3, bodies of two or more joint undertakings may decide to establish a structured cooperation, including through regular meetings or joint committees.
Section 1
Governing Board
Article 15
Composition of the governing board
1. The governing board shall be composed of at least two representatives of the Commission on behalf of the Union and of the number of representatives from each of the members of the joint undertaking other than the Union as set out in Part Two in relation to each joint undertaking.
2. Where, in accordance with Article 6(1), point (b), the members of the joint undertaking include participating states, one representative of each participating state shall be appointed to the governing board.
Article 16
Functioning of the governing board
1. The representatives of the members in the governing board shall make every effort to adopt decisions by consensus. Failing consensus a vote shall be held. A decision shall be deemed adopted by a majority of at least 75 % of the votes including the votes of representatives who are absent, but excluding abstentions.
Adoption of decisions by the governing board may also be subject to any relevant specific rules set out in Part Two.
2. The presence of the Commission, of at least 50 % of the private members and, if applicable, of at least 50 % of participating states’ delegates is required to enable the governing board to vote.
3. The Union shall hold 50 % of the voting rights, unless specified otherwise in Part Two. The voting rights of the Union shall be indivisible.
The voting rights of the members other than the Union shall be subject to the specific rules set out in Part Two. Unless specified otherwise in Part Two, each of the representatives of the members other than the Union shall hold an equal number of votes.
4. The chairperson of the governing board shall be appointed on a rotating annual basis by the Union and by the other representatives, in turn, unless otherwise provided in Part Two.
5. The governing board shall hold ordinary meetings at least twice a year. Extraordinary meetings may be convened at the request of the chairperson, the executive director, the Commission or a majority of the representatives of the members other than the Union or of the participating states. The meetings of the governing board shall be convened by the chairperson and shall take place at the seat of the joint undertaking concerned, unless decided otherwise by the governing board in duly justified cases. The agenda of meetings and decisions shall be made publicly available in a timely manner on the website of the respective joint undertaking.
6. The executive director shall attend the meetings and shall have the right to take part in the deliberations but shall have no voting rights.
7. The chairperson and vice-chairperson of the states’ representatives group shall have observer status in the governing board meetings. The chairpersons of the other bodies of the joint undertaking concerned shall have the right to attend meetings of the governing board as observers whenever issues falling within the scope of their tasks are discussed. Observers may take part in deliberations but shall have no voting rights.
8. Other persons, in particular representatives of other European partnerships, executive or regulatory agencies, regional authorities within the Union and European technology platforms may also be invited to attend by the chairperson as observers on a case-by-case basis subject to the rules on confidentiality and conflict of interest.
9. The representatives of the members shall not be personally liable for actions they have taken in their capacity as representatives on the governing board except in cases of gross negligence or wilful misconduct.
10. The governing board shall adopt its own rules of procedure.
11. The representatives of the members and observers shall be bound by the provisions of a code of conduct which shall establish their obligations to safeguard the integrity and reputation of the joint undertaking concerned and of the Union.
Article 17
Tasks of the governing board
1. The governing board is the decision-making body of each joint undertaking. It shall have overall responsibility for the strategic orientation, coherence with relevant Union objectives and policies, and operations of that joint undertaking and shall supervise the implementation of its activities.
The Commission, in its role in the governing board, shall seek to ensure coordination and coherence between the activities of the joint undertakings and the relevant activities of Union funding programmes with a view to promoting synergies and complementarities while avoiding duplications when identifying priorities covered by collaborative research.
2. The governing board shall carry out the following tasks:
(a)
take measures to implement the joint undertaking’s general, specific and operational objectives, assess their effectiveness and impact, ensure close and timely monitoring of the progress of the joint undertaking’s research and innovation programme and individual actions in relation to the priorities of the Union and the Strategic Research and Innovation Agenda, including in relation to complementarity with regional or national programmes, and take corrective measures where needed to ensure that the joint undertaking meets its objectives;
(b)
assess, accept or reject applications for membership in accordance with Article 7;
(c)
assess, accept or reject applications of prospective contributing partners in accordance with Article 9;
(d)
decide on the termination of the membership in the joint undertaking with regard to any member that does not fulfil its obligations pursuant to this Regulation or in accordance with Article 8(2) and (3);
(e)
adopt the financial rules of the joint undertaking in accordance with Article 27;
(f)
adopt the annual budget and the staff establishment plan including the number of permanent and temporary posts by function group and by grade as well as the number of contract staff and seconded national experts expressed in full-time equivalents;
(g)
decide on the distribution of administrative costs among the members other than the Union, where these members fail to reach an agreement in accordance with Article 28(2), taking into account possible imbalances in their administrative commitments compared to their participation;
(h)
exercise, in accordance with paragraph 4 of this Article and with regard to the staff of the joint undertaking, the powers conferred by the Staff Regulations of Officials of the European Union laid down in Regulation (EEC, Euratom, ECSC) No 259/68 (the ‘Staff Regulations’) on the Appointing Authority and by the CEOS on the Authority Empowered to Conclude a Contract of Employment (the ‘appointing authority powers’);
(i)
appoint, dismiss, extend the term of office, provide guidance and monitor the performance of the executive director;
(j)
adopt the Strategic Research and Innovation Agenda at the beginning of the joint undertaking and update it throughout the duration of Horizon Europe, where necessary. The Strategic Research and Innovation Agenda shall identify the partnership’s targeted impact, foreseen portfolio of activities, measurable expected outcomes, resources, deliverables and milestones within a defined timeframe. It shall also identify the other European partnerships with which the joint undertaking shall establish a formal and regular collaboration and the possibilities for synergies between the joint undertaking’s actions and national or regional initiatives and policies based on information received by the participating states or the states’ representatives group as well as synergies with other Union programmes and policies;
(k)
adopt the work programme and corresponding expenditure estimates as proposed by the executive director, after taking into consideration the states’ representatives group’s opinion, to implement the Strategic Research and Innovation Agenda, including the administrative activities, the content of the calls for proposals, possible conditions for dealing with ex aequo proposals in accordance with Article 28(3) of Horizon Europe and its work programmes, the research areas subject to joint calls and cooperation with other partnerships and synergies with other Union programmes, the applicable funding rate, and the related rules for submission, evaluation, selection, award and review procedures with particular attention to the feedback to policy requirements;
(l)
where appropriate, limit the participation in specific actions in the work programme in accordance with Article 22(5) of the Horizon Europe Regulation and in accordance with the position agreed on a case-by-case basis between the Commission and the Member States in the states’ representatives group, unless specified otherwise in Part Two;
(m)
adopt measures for attracting newcomers, in particularly SMEs, higher education institutions and research organisations, into the activities and actions of the joint undertaking, including where applicable by encouraging them to become private members or constituent entities of the private members;
(n)
approve the annual additional activities plan, set out in an annex to the main part of the work programme, on the basis of a proposal from the members other than the Union and after having consulted the scientific advisory body or such body as set out in Part Two and after taking into consideration the states’ representatives group’s opinion;
(o)
provide strategic orientation as regards the collaboration with other European partnerships in accordance with the Strategic Research and Innovation Agenda;
(p)
assess and approve the consolidated annual activity report, including the corresponding expenditure and the budget dedicated to joint calls with other European partnerships;
(q)
deliver an opinion on the joint undertaking’s final accounts;
(r)
make arrangements, as appropriate, for the establishment of an internal audit capability of the joint undertaking;
(s)
approve the organisational structure of the programme office upon recommendation of the executive director;
(t)
approve the joint undertaking’s communication policy upon recommendation by the executive director;
(u)
unless specified otherwise in Part Two, approve the list of actions selected for funding;
(v)
adopt implementing rules for giving effect to the Staff Regulations and the CEOS in accordance with Article 110(2) of the Staff Regulations;
(w)
adopt rules on the secondment of national experts to the joint undertakings or the use of trainees;
(x)
set up, as required, advisory or working groups, including in collaboration with other joint undertakings, in addition to the bodies of the joint undertaking referred to in Article 14, for a determined period of time and to fulfil a specific purpose;
(y)
submit to the Commission, where appropriate, requests to amend this Regulation;
(z)
request scientific advice or analysis on specific issues to the joint undertaking’s scientific advisory body or its members, including as regards developments in adjacent sectors;
(a1)
adopt by the end of 2023 a plan for the phasing-out of the joint undertaking from Horizon Europe funding upon recommendation of the executive director;
(b1)
ensure the performance of any task that is not specifically assigned to a particular body of a joint undertaking, subject to the possibility that the governing board may assign such task to another body of the joint undertaking concerned.
3. The governing board of a joint undertaking may also be subject to specific rules set out in Part Two.
4. The governing board shall adopt, in accordance with Article 110(2) of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the CEOS, delegating relevant appointing authority powers to the executive director and defining the conditions under which that delegation of powers can be suspended. The executive director shall be authorised to sub-delegate those powers.
5. The governing board shall take the utmost account of the states’ representatives group’s opinions, recommendations or proposals, if any, before voting. The governing board shall inform without undue delay the states’ representatives group of the follow-up it has given to such opinions, recommendations or proposals, or it shall give reasons if they are not followed up.
Section 2
Executive Director
Article 18
Appointment, dismissal and extension of the term of office of the executive director
1. The Commission shall propose a list of candidates, preferably at least three, for executive director after consultation with the members other than the Union of the joint undertaking. For the purpose of such consultation, each type of members other than the Union of the joint undertaking shall appoint one representative as well as one observer on behalf of the governing board.
2. The executive director shall be appointed by the governing board on the basis of merit and skills, from the list of candidates proposed by the Commission, following an open and transparent selection procedure, which shall respect the principle of gender balance.
3. The executive director shall be a member of staff and shall be engaged as a temporary agent of the joint undertaking under Article 2, point (a), of the CEOS.
For the purpose of concluding the contract of the executive director, the joint undertaking shall be represented by the chairperson of the governing board.
4. The term of office of the executive director shall be four years. By the end of that period, the Commission after consulting the members other than the Union shall carry out an assessment of the performance of the executive director and the future tasks and challenges of the joint undertaking.
5. The governing board of the joint undertaking, acting on a proposal from the Commission which takes into account the assessment referred to in paragraph 4, may extend the term of office of the executive director once, for a period of not more than three years.
6. An executive director whose term of office has been extended may not participate in another selection procedure for the same post.
7. An executive director may be dismissed only upon a decision of the governing board acting on a proposal from the Commission, after consulting the states’ representatives group and the members other than the Union of the joint undertaking.
Article 19
Tasks of the executive director
1. The executive director shall be the chief executive responsible for the day-to-day management of the joint undertaking in accordance with the decisions of the governing board. He or she shall provide the governing board with all information necessary for the performance of its functions. Without prejudice to the respective competencies of the Union institutions and the governing board, the executive director shall neither seek nor take instructions from any government or from any other body.
2. The executive director shall be the legal representative of the joint undertaking. He or she shall be accountable to the governing board of the joint undertaking.
3. The executive director shall implement the budget of the joint undertaking and shall ensure coordination between the different bodies and services of the joint undertaking.
4. The executive director shall carry out the following tasks for the joint undertaking:
(a)
ensure sustainable and efficient management of the joint undertaking and efficient implementation of the work programme;
(b)
prepare and submit for adoption to the governing board the draft annual budget and the staff establishment plan;
(c)
prepare and, after having taken into account the opinion of the states’ representatives group or the Public Authorities Board as appropriate, submit for adoption to the governing board the work programme and the corresponding expenditure estimates for the joint undertaking, to implement the Strategic Research and Innovation Agenda;
(d)
submit for opinion to the governing board the annual accounts for the joint undertaking;
(e)
prepare and submit for assessment and approval to the governing board the consolidated annual activity report, including information on the corresponding expenditure and contributions from members other than the Union referred to in Article 11(1);
(f)
monitor the contributions referred to in Article 11(1), report to the governing board regularly on the progress in achieving the targets and propose remedial or corrective measures, where necessary;
(g)
monitor the implementation of measures for attracting newcomers, in particularly SMEs, higher education institutions and research organisations;
(h)
establish a formal and regular collaboration with the European partnerships identified in the Strategic Research and Innovation Agenda and in accordance with the strategic orientation provided by the governing board;
(i)
following an invitation from the Chair, inform regularly the relevant configuration of the Horizon Europe Programme Committee, further to the Commission responsibility to inform the Programme Committee under Article 14(7) and Annex III to the Specific Programme implementing Horizon Europe, and in particular, before adoption of the work programme of the joint undertaking, in relation to the application of Article 22(5) of the Horizon Europe Regulation;
(j)
submit for approval to the governing board or to the Public Authorities Board as appropriate the list of actions to be selected for funding by the joint undertaking;
(k)
assess applications for associated members to the joint undertaking following an open call for expression of interest and submit proposals for associated members to the governing board;
(l)
inform regularly the other bodies of the joint undertaking on all matters relevant to their role;
(m)
sign individual grant agreements and decisions in his or her remit on behalf of the joint undertaking;
(n)
sign procurement contracts on behalf of the joint undertaking;
(o)
ensure the programme’s monitoring and assessment of the progress compared to relevant impact indicators and the joint undertaking’s specific objectives as defined in Part Two, under the supervision of the governing board and in coordination with advisory bodies where relevant, and in accordance with Article 171;
(p)
implement the communications policy of the joint undertaking;
(q)
organise, direct and supervise the operations and the staff of the joint undertaking within the limits of the delegations by the governing board;
(r)
establish and ensure the functioning of an effective and efficient internal control system and report any significant change to it to the governing board;
(s)
protect the financial interests of the Union and of other members by applying preventive measures against fraud, corruption and any other illegal activities by means of effective checks and, if irregularities are detected, by recovering amounts that were wrongly paid and, where appropriate, imposing effective, proportionate and dissuasive administrative and financial penalties;
(t)
ensure the carrying out of risk assessments and risk management for the joint undertaking;
(u)
take any other measures necessary for assessing the progress of the joint undertaking towards achieving its objectives;
(v)
prepare and submit for adoption to the governing board a plan for the phasing out of the joint undertaking from Horizon Europe funding;
(w)
perform any other tasks entrusted or delegated to him or her by the governing board or as may be required by this Regulation;
(x)
have the power to delegate his or her powers to other staff members subject to rules to be adopted in accordance with Article 17(4).
5. The executive director may also be subject to any specific rules set out in Part Two.
6. The executive director shall set up a programme office for the execution, under his or her responsibility, of all support tasks of the joint undertaking deriving from this Regulation. The programme office shall be composed of the staff of the joint undertaking and shall in particular carry out the following tasks:
(a)
provide support in establishing and managing an appropriate accounting system in accordance with the financial rules for the joint undertaking;
(b)
manage the implementation of the work programme of the joint undertaking throughout the implementation cycle;
(c)
provide to the members of the joint undertaking and its bodies all relevant and timely information and support necessary for them to perform their duties;
(d)
act as the secretariat of the bodies of the joint undertaking and provide support to advisory groups set up by the governing board, if any.
Section 3
Advisory bodies
Article 20
The states’ representatives group
1. Except in cases where Member States and associated countries participate in a joint undertaking as members or constituent entities of members, joint undertakings shall establish a states’ representatives group as specified in Part Two subject to the provisions in this Article.
2. The states’ representatives group shall consist of up to two representatives and up to two alternates from each Member State and from each associated country. The states’ representatives group shall elect a chairperson and vice-chairperson from among its members.
3. The states’ representatives group shall meet at least twice a year. The meetings shall be convened by the chairperson or by at least one third of the states’ representatives group members. The chairperson of the governing board and the executive director or their representatives shall attend the meetings as observers upon request of the chairperson of the states’ representatives group for the purpose of delivering information on specific matters.
4. The meetings of the states’ representatives group may be regulated by any relevant specific provisions set out in Part Two.
5. The chairperson of the states’ representatives group may invite other persons to attend its meetings as observers, in particular representatives of relevant federal or regional authorities within the Union, representatives of higher education institutions and research performing organisations, SME associations or industry associations and representatives of other bodies of the joint undertaking.
6. The agenda and supporting documents of the state representatives group’s meetings shall be circulated sufficiently in advance to ensure appropriate representation by each Member State and associated country. The agenda shall also be circulated for information to the governing board in a timely manner.
7. The states’ representatives group shall be consulted and, in particular, it shall review information and provide opinions on the following matters:
(a)
programme progress of the joint undertaking and achievement of its targets and expected impacts as part of Horizon Europe, including the information on calls for proposals and proposals received as well as on the proposal evaluation process;
(b)
updating of the Strategic Research and Innovation Agenda or equivalent in line with the Horizon Europe strategic planning and with other Union and Member States funding instruments;
(c)
links to Horizon Europe and other Union, national and, where relevant, regional initiatives, including cohesion policy funds in line with smart specialisation strategies;
(d)
draft work programmes, including the content of calls for proposals, especially on lower TRL research topics included in the draft work programme and on the application of eligibility criteria;
(e)
involvement of SMEs, start-ups, higher education institutions and research organisations, and measures taken for promoting participation of newcomers;
(f)
actions taken for dissemination and exploitation of results along the value chain;
(g)
annual activity report.
8. For the purpose of seeking the agreed position referred to in Article 17(2), point (l), the states’ representatives group shall solely include Member States. The rules of procedure of the states’ representatives group shall further specify the procedure for agreeing that position.
9. Where applicable, the states’ representatives group shall also regularly report to the governing board, and act as an interface with the joint undertaking on the following matters:
(a)
the status of relevant national or regional research and innovation programmes and identification of potential areas of cooperation, including concrete actions taken or envisaged for the deployment and uptake of relevant technologies and innovative solutions;
(b)
specific measures taken at national level or regional level with regard to dissemination events, dedicated technical workshops and communication activities;
(c)
specific measures at national or regional level with regard to deployment activities in relation to each respective joint undertaking;
(d)
national or regional policies and initiatives with a view to ensuring complementarities with regard to the joint undertaking’s Strategic Research and Innovation Agenda and annual work programmes.
10. The states’ representatives group shall submit, at the end of each calendar year, a report describing the national or regional policies in the scope of the joint undertaking and identifying specific ways of cooperation with the actions funded by the joint undertaking.
11. The states’ representatives group may issue, on its own initiative, opinions, recommendations or proposals to the governing board or the executive director on technical, managerial and financial matters as well as on work programmes and other documents, in particular when those matters affect national or regional interests.
12. The states’ representatives group shall receive timely and relevant information on a regular basis, including a breakdown by country, among other data on the application and participation in indirect actions funded by the joint undertaking, on the evaluation results of each call for proposals and project implementation, on synergies with other relevant Union programmes and other European partnerships, on additional activities, on committed and actually provided financial and in-kind contributions and on the execution of the budget of the joint undertaking.
13. The states’ representatives group shall adopt its own rules of procedure with due consideration to Articles 33 and 42.
14. One or more joint undertakings may establish a joint state representatives group in accordance with the relevant provisions set out in Part Two.
Article 21
Scientific advice
1. Unless specified otherwise in Part Two, joint undertakings shall seek independent scientific advice by means of:
(a)
a scientific advisory body to be set up by the joint undertaking in accordance with the relevant provisions set out in Part Two, and subject to the provisions in this Article; or
(b)
ad hoc requests for independent expertise by the governing board to the joint undertaking on specific questions.
2. There shall be a balanced representation of experts among the members of the scientific advisory body, within the scope of the activities of the joint undertaking, including with respect to gender and geographical balance. Collectively, the members of the scientific advisory body shall have the necessary competences and expertise covering the technical domain in order to make science-based recommendations to the joint undertaking, taking into account the climate, environmental and socioeconomic impact of such recommendations and the objectives of the joint undertaking.
3. The members of the scientific advisory body, as well as invited observers, shall be subject to the obligation of professional secrecy which, by virtue of the Treaties and the rules implementing them, applies to all members of the institutions and their staff, as well as to the Commission’s rules on security regarding the protection of sensitive non-classified and Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 (31) and (EU, Euratom) 2015/444 (32) respectively.
4. The governing board shall establish an open selection process including specific criteria for the composition of the scientific advisory body of the joint undertaking and shall appoint its members. The governing board shall take into consideration the potential candidates proposed by the states’ representatives group.
5. The scientific advisory body shall elect its chair from among its members.
6. The scientific advisory body shall meet at least twice a year and meetings shall be convened by the chairperson. The chairperson may invite other persons to attend its meetings as observers. The scientific advisory body shall adopt its own rules of procedure. The agenda of meetings shall be made publicly available in a timely manner on the website of the respective joint undertaking.
7. The scientific advisory body shall carry out the following tasks:
(a)
advise on the scientific priorities to be addressed in the work programmes including on scope of calls for proposals, in line with the Strategic Research and Innovation Agenda and the Horizon Europe strategic planning;
(b)
advise on the scientific achievements to be described in the annual activity report;
(c)
suggest, in view of the progress of the Strategic Research and Innovation Agenda and individual actions, corrective measures or re-orientations to the governing board, where necessary;
(d)
provide independent advice and scientific analysis on specific issues as requested by the governing board, in particular as regards developments in adjacent sectors or to support the assessment of applications of potential associated members and contributing partners;
(e)
where specified in Part Two, evaluate the results from technology and innovation actions that are funded by the joint undertaking and report to the governing board;
(f)
where specified in Part Two, participate in sector integration committees specifically set up between European partnerships under Horizon Europe to enable synergies;
(g)
carry out any other task, as specified in Part Two.
8. After each meeting of the scientific advisory body, its chairperson shall submit to the governing board a report outlining the body’s and its members’ opinions on the matters discussed during the meeting. To the extent possible, the report shall be made publicly available on the website of the respective joint undertaking.
9. The scientific advisory body may, of its own initiative, advise the governing board to consult it on specific points not covered by the tasks set out in paragraph 7. To the extent possible, the report shall be made publicly available on the website of the respective joint undertaking.
10. The scientific advisory body shall be informed of the reasons in the event that its advice on the work programme and the Strategic Research and Innovation Agenda is not followed.
Article 22
The stakeholders group
1. Joint undertakings may establish a stakeholders group in accordance with the relevant provisions in Part Two and subject to this Article.
2. The stakeholders group shall be open to all public and private stakeholders, including organised groups, active in the field of the joint undertaking, international interest groups from Member States, associated countries or other countries.
3. The governing board shall establish the specific criteria and selection process for the composition of the stakeholders group and shall aim to balance representation in terms of geographical distribution, gender, sector and stakeholders’ expertise. Where relevant, the governing board shall take into account the potential candidates proposed by the states’ representatives group.
4. The stakeholders group shall be regularly informed of the activities of the joint undertaking and shall be invited to provide comments on the joint undertaking’s planned initiatives.
5. The meetings of the stakeholders group shall be convened by the executive director.
6. The executive director may advise the governing board to consult the stakeholders group on specific questions. Where such consultation takes place, a report shall be submitted to the governing board and to the states’ representatives group after the relevant discussion in the stakeholders group and be made publicly available on the website of the respective joint undertaking.
CHAPTER 4
Financial and operational provisions
Section 1
General provisions
Article 23
Coherent application of limitation to participation
The joint undertakings shall ensure coherence with the approach taken for actions funded under the Horizon Europe work programme adopted in accordance with Article 13(2), point (b), of the Specific Programme implementing Horizon Europe regarding the application of Article 22(5) of the Horizon Europe Regulation, as well as Union legislation and guidance relevant for its application in similar topics in the work programme of the joint undertaking concerned.
Article 24
Rules applicable to the activities funded by the joint undertakings
1. The Horizon Europe Regulation shall apply to the actions funded by the joint undertakings under Horizon Europe. In accordance with that Regulation, each joint undertaking shall be considered as a funding body and shall provide financial support to indirect actions pursuant to Article 6 of that Regulation.
2. Actions funded by the joint undertakings under Horizon Europe may also be subject to any specific provisions set out in Part Two.
3. By way of derogation from Article 40(4), point (a), of the Horizon Europe Regulation, the right to object shall also apply to participants generating the results that have not received funding from a joint undertaking.
Article 25
Operational and financial planning
1. The executive director shall submit for adoption to the governing board a draft work programme.
2. The work programme shall be adopted by the end of the year prior to its implementation. The work programme and the calls for proposals shall be published on the website of the joint undertaking and on the Horizon Europe website, and, to support the coordination with the overall strategy of Horizon Europe, be shared with the relevant configuration of the Programme Committee for information.
3. The executive director shall prepare a draft annual budget for the following year and submit it to the governing board for adoption.
4. The annual budget for a particular year shall be adopted by the governing board by the end of the year prior to its implementation.
5. The annual budget shall be adapted in order to take into account the amount of the Union financial contribution as set out in the Union budget and, where applicable, the amounts of the financial contributions from members other than the Union and from contributing partners, if any.
Article 26
Operational and financial reporting
1. The executive director shall provide the governing board with a consolidated annual activity report on the performance of his or her duties in accordance with the financial rules of the joint undertaking. The consolidated annual activity report shall be made public in a timely manner on the website of the respective joint undertaking.
2. The consolidated annual activity report shall include, among other things, information on the following matters:
(a)
research, innovation and other actions carried out and the corresponding expenditure;
(b)
the proposals submitted, including a breakdown by country where the legal entity is established, and by participant type, in particular SMEs and newcomers;
(c)
the indirect actions selected for funding, including a breakdown by participant type, including SMEs, and by country and indicating the contribution of the respective joint undertaking to the individual participants and actions;
(d)
information regarding the openness of the joint undertakings, including monitoring of collaborative links;
(e)
the additional activities undertaken by the members other than the Union, including a breakdown by country where the private members, their constituent entities or the affiliated entities of either is established;
(f)
the collaboration with other European partnerships, including joint calls, and synergies between the joint undertaking’s actions and national or regional initiatives and policies.
3. The accounting officer of the joint undertaking shall send the provisional accounts to the Commission’s accounting officer and the Court of Auditors in accordance with the financial rules of the joint undertaking.
4. The executive director shall send the report on the budgetary and financial management to the European Parliament, the Council and the Court of Auditors in accordance with the financial rules of the joint undertaking.
5. The discharge procedure shall be carried out in accordance with the financial rules of the joint undertaking.
Section 2
Financial provisions
Article 27
Financial rules
1. The joint undertakings shall adopt their financial rules in accordance with Article 71 of Regulation (EU, Euratom) 2018/1046.
2. The financial rules shall be published on the website of the respective joint undertaking.
Article 28
Sources of financing
1. Each joint undertaking shall be jointly funded by the Union, the members other than the Union and the contributing partners through financial contributions and in-kind contributions to operational activities.
2. The members other than the Union shall agree on how to share their collective contribution among them in accordance with the applicable financial rules.
3. The operational costs of a joint undertaking shall be covered by means of the:
(a)
financial contribution by the Union;
(b)
financial contributions by the private members or their constituent or affiliated entities, by contributing partners or by an international organisation that is a member of a joint undertaking;
(c)
where applicable, financial contributions by the participating states;
(d)
in-kind contributions defined in Article 2, point (8).
4. In accordance with Articles 10 and 11, the resources of a joint undertaking entered in its budget shall be composed of the following contributions:
(a)
members’ financial contributions to the joint undertaking for the administrative costs, divided equally on an annual basis between the Union and the members other than the Union, unless specified otherwise in Part Two due to the specific membership nature of a joint undertaking;
(b)
members’ or contributing partners’ financial contributions to the joint undertaking for the operational costs;
(c)
any revenue generated by the joint undertaking;
(d)
any other financial contributions, resources and revenues.
Any interest yielded by the contributions referred to in this paragraph shall be considered to be its revenue.
5. Any unused part of the contribution for administrative costs may be made available to cover the operational costs of the joint undertaking concerned.
6. Should a member other than the Union of the joint undertaking be in default of its commitment concerning its contribution, the executive director shall inform it in writing and shall set a reasonable period within which such default should be remedied. Where, on the expiry of that period, the member other than the Union concerned is still in default, the executive director shall inform the Commission and the participating states, where applicable, in view of potential measures pursuant to Article 11(8) and inform the member concerned that it is disqualified from voting in the governing board in line with that Article.
7. The resources of the joint undertaking and its activities shall be used for the fulfilment of its objectives and tasks.
8. The joint undertaking shall own all assets generated by it or transferred to it for the fulfilment of its objectives and tasks.
9. Except where the joint undertaking is wound up, any excess revenue over expenditure shall not be paid to the members of that joint undertaking, unless decided otherwise by the governing board.
Article 29
Financial commitments
1. The financial commitments of a joint undertaking shall not exceed the amount of financial resources available or committed to its budget by its members and contributing partners.
2. Budgetary commitments of the joint undertakings referred to in Article 3(1), points (b), (d) and (h), may be divided into annual instalments. Until 31 December 2024, the cumulative amount of those budgetary commitments in instalments shall not exceed 50 % of the maximum Union contribution set out in Article 10. From January 2025, at least 20 % of the cumulative budget of the residual years shall not be covered by annual instalments.
Article 30
Protection of the financial interests of the members
1. The joint undertaking shall grant Commission staff and other persons authorised by the respective joint undertaking or the Commission, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits.
2. The European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (33) and Regulation (EC, Euratom) No 883/2013 of the European Parliament and of the Council (34) and with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with an agreement, a decision or a contract funded under this Regulation.
3. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Council Regulation (EU) 2017/1939 (35), to investigate and prosecute criminal offences affecting the financial interests of the Union as set out in Article 4 of that Regulation.
4. Notwithstanding paragraphs 1 to 3, agreements, decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the respective joint undertaking, the Court of Auditors, the EPPO and OLAF to conduct such audits, on-the spot checks and investigations in accordance with their respective competences.
5. Each joint undertaking shall ensure that the financial interests of its members are adequately protected by carrying out or commissioning appropriate internal and external controls.
6. Each joint undertaking shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council and the Commission concerning internal investigations by the European Anti-Fraud Office (OLAF) (36). Each joint undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF.
7. The joint undertaking shall grant each national court of auditors on their request access to all the information related to the national contributions of the respective participating state, including information in electronic format, needed in order to conduct their audits.
Article 31
Ex post audits
Audits of expenditure on indirect actions shall be carried out in accordance with Article 53 of the Horizon Europe Regulation as part of the Horizon Europe indirect actions, in particular in line with the audit strategy referred to in Article 53(2) of that Regulation.
Article 32
Internal audit
1. The Commission’s internal auditor shall exercise the same powers over the joint undertakings as those exercised in respect of the Commission and shall endeavour to reduce the administrative burden of the joint undertaking.
2. The governing board may establish an internal audit capability in accordance with the financial rules of the joint undertaking concerned.
Section 3
Operational provisions
Article 33
Confidentiality
Without prejudice to Articles 34 and 36, each joint undertaking shall ensure the protection of confidential information the disclosure of which beyond Union institutions and other Union bodies, offices or agencies could damage the interests of its members or of participants in the activities of the respective joint undertaking. Such confidential information includes but is not limited to personal, commercial, sensitive non-classified and classified information.
Article 34
Transparency
Regulation (EC) No 1049/2001 of the European Parliament and of the Council (37) shall apply to documents held by a joint undertaking.
Article 35
Processing of personal data
Where the implementation of this Regulation requires the processing of personal data, this shall be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (38).
Article 36
Access to results and information on proposals
1. The joint undertaking shall provide the Union institutions and Union bodies, offices or agencies, as well as the authorities of the participating states where applicable, access to all information related to the indirect actions it funds. Such information shall include contributions and results of beneficiaries participating in indirect actions of the joint undertaking, or any other information deemed necessary for developing, implementing, monitoring and evaluating Union or where applicable participating states’ policies or programmes. Such access rights are limited to non-commercial and non-competitive use and shall comply with applicable confidentiality rules.
2. For the purposes of developing, implementing, monitoring and evaluating Union policies or programmes, the joint undertaking shall provide the Commission with the information included in submitted proposals. This shall apply mutatis mutandis to participating states where applicable regarding proposals which include applicants established in their territories, limited to non-commercial and non-competitive use and in accordance with applicable confidentiality rules.
CHAPTER 5
Staff and liability
Section 1
Staff, privileges and immunities
Article 37
Staff
1. The Staff Regulations and the CEOS and the rules adopted jointly by the institutions of the Union for the purpose of applying the Staff Regulations and the CEOS shall apply to the staff of the joint undertakings.
2. The staff resources shall be determined in the staff establishment plan of each joint undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents, in line with its annual budget.
3. The staff of the joint undertaking shall consist of temporary staff and contract staff.
4. All costs related to staff shall be borne by the joint undertaking.
Article 38
Seconded national experts and trainees
1. A joint undertaking may make use of seconded national experts and trainees not employed directly by it. The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff resources as referred to in Article 37(2) in accordance with the annual budget of the joint undertaking concerned.
2. The governing board of the joint undertaking concerned shall adopt a decision laying down rules on the secondment of national experts to the respective joint undertaking and on the employment of trainees.
Article 39
Privileges and Immunities
Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and the TFEU, shall apply to the joint undertakings and their staff.
Section 2
Liability
Article 40
Liability of the joint undertakings
1. The contractual liability of a joint undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question.
2. Where liability is of a non-contractual nature, a joint undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties.
3. Any payment by a joint undertaking in respect of the liability referred to in paragraphs 1 and 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the joint undertaking and shall be covered by its resources.
4. Joint undertakings shall be solely responsible for meeting their obligations.
Article 41
Liability of members and insurance
1. The financial liability of the members of a joint undertaking for its debts shall be limited to their financial contributions made to the joint undertaking.
2. The joint undertakings shall take out and maintain appropriate insurance.
Article 42
Conflicts of interest
1. The joint undertaking, its bodies and staff shall avoid any conflict of interest in carrying out their activities.
2. The governing board shall adopt rules for the prevention, avoidance and management of conflicts of interest in respect of the staff of the joint undertaking, the members and other persons serving the governing board and in the other bodies or groups of the joint undertaking, in accordance with the financial rules of the joint undertaking and with the Staff Regulations in respect of staff.
CHAPTER 6
Dispute resolution
Article 43
Jurisdiction of the Court of Justice and applicable law
1. The Court of Justice of the European Union shall have jurisdiction:
(a)
pursuant to any arbitration clause contained in agreements or contracts concluded by a joint undertaking, or in its decisions;
(b)
in disputes relating to compensation for damage caused by the staff of the joint undertaking in the performance of their duties;
(c)
in any dispute between the joint undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the CEOS.
2. Regarding any matter not covered by this Regulation or by other Union legal acts, the law of the state where the seat of the joint undertaking is located shall apply.
Article 44
Complaints to the Ombudsman
Decisions taken by a joint undertaking in the implementation of this Regulation may form the subject of a complaint to the Ombudsman in accordance with Article 228 of the TFEU.
CHAPTER 7
Winding up
Article 45
Winding up
1. Joint undertakings shall be wound up at the end of the period laid down in Article 3.
2. In addition to paragraph 1, the winding-up procedure of a joint undertaking shall be automatically triggered where the Union or all members other than the Union withdraw from the joint undertaking.
3. For the purpose of conducting the winding-up proceedings of a joint undertaking, the governing board shall appoint one or more liquidators, who shall comply with the decisions of the governing board.
4. During the winding-up procedure, the assets of the joint undertaking shall be used to cover its liabilities and the expenditure relating to its winding up. Any surplus shall be distributed among the members of the joint undertaking at the time of the winding up in proportion to their financial contribution to the joint undertaking. Any such surplus distributed to the Union shall be returned to the Union budget.
5. An ad hoc procedure shall be set up to ensure the appropriate management of any agreement concluded or decision adopted by the joint undertaking being wound up as well as any procurement contract the duration of which extends beyond the duration of the joint undertaking.
PART TWO
SPECIFIC PROVISIONS OF INDIVIDUAL JOINT UNDERTAKINGS
TITLE I
CIRCULAR BIO-BASED EUROPE JOINT UNDERTAKING
Article 46
Additional objectives of the Circular Bio-based Europe Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Circular Bio-based Europe Joint Undertaking shall have the following general objectives:
(a)
accelerate the innovation process and development of bio-based innovative solutions;
(b)
accelerate market deployment of the existing mature and innovative bio-based solutions;
(c)
ensure a high level of environmental performance of bio-based industrial systems.
2. The Circular Bio-based Europe Joint Undertaking shall also have the following specific objectives:
(a)
increase the intensity of cross-disciplinary research and innovation activities to reap the benefits of the advancement in life sciences and in other scientific disciplines for the development and demonstration of sustainable bio-based solutions;
(b)
increase and integrate the research and innovation capacity of stakeholders across the Union to exploit the local bioeconomy potential, including in regions with underdeveloped capacity;
(c)
increase the research and innovation capacity for addressing environmental challenges and development of more sustainable bio-based innovations by ensuring that sustainability issues and environmental performance are integrated throughout the whole innovation chain and in future innovative solutions;
(d)
reinforce the integration of bio-based research and innovation in the Union bio-based industry and increase the involvement of R&I actors including feedstock providers in the bio-based value chains;
(e)
reduce the risk for research and innovation investment in bio-based companies and projects;
(f)
ensure that circularity and environmental considerations, including contributions to climate neutrality and zero pollution objectives, are taken into account in the development and implementation of research and innovation bio-based projects and facilitate societal acceptance.
Article 47
Additional tasks of the Circular Bio-Based Europe Joint Undertaking
In addition to the tasks set out in Article 5, the Circular Bio-based Europe Joint Undertaking shall carry out the following tasks:
(a)
ensure that its objectives are reached through the programming of research and innovation activities of the public and private partners;
(b)
mobilise public and private funding for its research and innovation activities;
(c)
support high impact multidisciplinary research and innovation projects that enhance the industrial bio-based innovation to deliver on its objectives;
(d)
intensify its research and innovation activities along the whole innovation chain from low to high TRLs;
(e)
mobilise and integrate research and innovation actors including feedstock providers from rural, coastal, urban areas and regions with unexploited potential for bio-based value chain development to cooperate in project activities;
(f)
ensure that research and innovation activities under it focus on issues of public interest, specifically on the environmental and climate performance of the bio-based industry, both in terms of understanding the relevant problems and developing solutions to them;
(g)
promote communication and collaboration between research and innovation actors and industrial stakeholders under it to raise awareness about rapidly evolving knowledge and technology, facilitate cross-disciplinary and cross-sectorial collaboration and facilitate market uptake of innovative bio-based solutions;
(h)
mobilise national and regional authorities that are able to create more favourable conditions for market uptake of bio-based innovations;
(i)
support the reflection towards the development of standards in order to facilitate the market uptake of bio-based innovations;
(j)
set scientifically robust sustainability criteria and performance benchmarks, apply and monitor them in all its research and innovation activities, and promote them beyond the initiative to the bio-based industry;
(k)
communicate and promote innovative bio-based solutions towards policy makers, industry, NGOs, civil society and consumers at large.
Article 48
Members
The members of the Circular Bio-based Europe Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the Bio-based Industries Consortium, a non-profit organisation registered under Belgian law, upon notification of its decision to accede to the Circular Bio-based Europe Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation;
(c)
the associated members selected in accordance with Article 7, subject to a decision of the governing board.
Article 49
Union financial contribution
The Union financial contribution to the Circular Bio-based Europe Joint Undertaking, including EEA appropriations, to cover administrative and operational costs shall be up to EUR 1 000 000 000, including up to EUR 23 500 000 for administrative costs.
Article 50
Contributions from members other than the Union
The members of the Circular Bio-based Europe Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 1 000 000 000, including up to EUR 23 500 000 for administrative costs, over the period set out in Article 3.
Article 51
Scope of additional activities
1. Notwithstanding the Governing Board’s power of decision concerning the additional activities plan pursuant to Article 17(2), point (n), and within the scope of Article 2, points (9) and (10), the Bio-based Industries Consortium or their constituent or affiliated entities shall each year make a proposal for the additional activities. The additional activities are those directly linked to projects and activities of the Circular Bio-based Europe Joint Undertaking, including in particular:
(a)
investments in new facilities demonstrating a new value chain, including investments in durable equipment, tools and accompanying infrastructure, in particular related to regional deployment and its sustainability verification;
(b)
investments in a new innovative and sustainable production plant or flagship;
(c)
investments in new research and innovation and justified infrastructure, including facilities, tools, durable equipment or pilot plants (research centres);
(d)
standardisation activities;
(e)
communication, dissemination and awareness-raising activities.
2. The investments directly linked to projects are in particular:
(a)
non-eligible investments needed for the implementation of a Circular Bio-based Europe Joint Undertaking project during the duration of that project;
(b)
investment made in parallel with a Circular Bio-based Europe Joint Undertaking project, complementing the results of the project and bringing it to a higher TRL;
(c)
investments needed for the deployment of a Circular Bio-based Europe Joint Undertaking project’s results following the closure of the project until the winding up of the Circular Bio-based Europe Joint Undertaking. In justified cases, the investment related to deployment of results of projects from the preceding initiative (BBI Joint Undertaking) may be taken into account.
Article 52
Bodies of the Circular Bio-based Europe Joint Undertaking
The bodies of the Circular Bio-based Europe Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the Scientific Committee;
(e)
the Deployment Groups.
Article 53
Composition of the Governing Board
The Governing Board shall be composed as follows:
(a)
five representatives of the Commission, on behalf of the Union; and
(b)
five representatives of the members other than the Union, at least one of which should represent SMEs.
Article 54
Functioning of the Governing Board
1. The members other than the Union shall collectively hold 50 % of the voting rights.
2. By derogation from Article 16(4), the Governing Board shall elect its chairperson for a period of two years.
3. The Governing Board shall hold its ordinary meetings four times a year.
4. In addition to the meetings referred to in paragraph 2, the Governing Board shall also convene a strategic meeting at least once a year, with the primary objectives of identifying challenges and opportunities for sustainable bio-based industry and providing additional strategic orientation for the Circular Bio-based Europe Joint Undertaking.
5. Additional chief executive officers or officers with decision-making power of leading European bio-based companies and the Commission shall be invited to the strategic meeting.
Article 55
The Scientific Committee
1. The Scientific Committee shall be the scientific advisory body of the Circular Bio-based Europe Joint Undertaking referred to in Article 21(1).
2. The Scientific Committee shall have no more than 15 permanent members.
3. The chairperson of the Scientific Committee shall be elected for a period of two years.
4. The Scientific Committee shall set up a task force composed of experts with the appropriate profiles to contribute to ensuring sufficient focus on all sustainability aspects of the work programme. Whenever possible, advice of the Scientific Committee on the work programme shall include aspects related to circularity, environmental sustainability, biodiversity preservation and enhancement, as well as broader aspects of sustainability of the bio-based systems and related value chains.
Article 56
The Deployment Groups
1. One or more Deployment Groups shall be established pursuant to Article 22. The role of the Deployment Groups is to advise the Governing Board on issues critical to market uptake of bio-based innovation and to promote deployment of sustainable circular bio-based solutions.
2. The composition of the Deployment Groups shall ensure appropriate thematic focus and representativeness of a broad range of the bio-based innovation stakeholders. Any stakeholder other than the members of the Bio-Based Industries Consortium, their constituents or their affiliated entities may express its interest in becoming a member of a Deployment Group. The Governing Board shall set out the envisaged size and composition of the Deployment Groups, the duration of the mandates and the possibility of renewal of its members, and select their members.
3. The Deployment Groups shall meet at least once per year. At the first meeting, the Deployment Groups shall adopt their rules of procedure. Those rules of procedure shall be approved by the Governing Board. Extraordinary meetings of the Deployment Groups shall be called upon a request from the Governing Board, the chairperson or a majority of the relevant Deployment Group.
4. The Deployment Groups shall elect a chairperson, and a vice-chair per thematic focus, for a period of two years. The chairperson coordinates activities and represents the Deployment Group. The chairperson may be invited as an observer to meetings of the Scientific Committee and the states’ representatives group.
5. The Deployment Groups shall provide recommendations on the issues related to the deployment of bio-based innovation upon request from the Governing Board. The Deployment Groups can also issue recommendations to the Governing Board at any time on their own initiative.
TITLE II
CLEAN AVIATION JOINT UNDERTAKING
Article 57
Additional objectives of the Clean Aviation Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Clean Aviation Joint Undertaking shall have the following general objectives:
(a)
to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for earliest possible deployment, therefore significantly contributing to the achievement of the general goals of the European Green Deal, in particular in relation to the Union-wide net greenhouse gas emissions reduction target of at least 55 % by 2030, compared to 1990 levels, and to a pathway towards reaching climate neutrality at the latest by 2050;
(b)
to ensure that aeronautics-related research and innovation activities, with particular focus on breakthrough technology initiatives, contribute to the global sustainable competitiveness of the Union aviation industry, and to ensure that climate-neutral aviation technologies meet the relevant aviation safety and security requirements, and that aviation remains a secure, reliable, cost-effective and efficient means of passenger and freight transportation;
(c)
to advance the European aviation research and innovation capacity.
2. The Clean Aviation Joint Undertaking shall also have the following specific objectives:
(a)
to integrate and demonstrate disruptive aircraft technological innovations able to decrease net emissions of greenhouse gases by no less than 30 % by 2030, compared to 2020 state-of-the-art technology, while paving the ground towards climate-neutral aviation by 2050;
(b)
to ensure that the technological and the potential industrial readiness of innovations can support the launch of disruptive new products and services by 2035, with the aim of replacing 75 % of the operating fleet by 2050 and developing an innovative, reliable, safe and cost-effective European aviation system that is able to meet the objective of climate neutrality at the latest by 2050;
(c)
to expand and foster integration of the climate-neutral aviation research and innovations value chains, including academia, research organisations, industry and SMEs, also by benefiting from exploiting synergies with other national and European related programmes and by supporting the uptake of industry-related skills across the value chain.
Article 58
Additional tasks of the Clean Aviation Joint Undertaking
In addition to the tasks set out in Article 5, the Clean Aviation Joint Undertaking shall carry out the following tasks:
(a)
publish on its website and on relevant Commission websites all the information necessary for the preparation and submission of proposals to open calls of the Clean Aviation Joint Undertaking;
(b)
monitor and assess technological progress towards the achievement of the general and specific objectives set out in Article 57;
(c)
facilitate full access to data and information for the independent impact monitoring of aviation research and innovation, carried out under the supervision of the Commission;
(d)
assist the Commission upon its request with the establishment and development coordination of regulations and standards supporting market uptake of clean aviation solutions, in particular by conducting studies, simulations and providing technical advice, while taking into account the need to eliminate barriers to market entry.
Article 59
Members
1. The members of the Clean Aviation Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the founding members listed in Annex I, upon notification of their decision to accede to the Clean Aviation Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding their accession other than those set out in this Regulation;
(c)
the associated members to be selected in accordance with Article 7 subject to a decision of the Governing Board.
2. In addition to Article 7(1), the Governing Board may, during the first six months following the establishment of Clean Aviation Joint Undertaking, select associated members from a list drawn up after an open call for expression of interest launched by the Commission prior to its establishment. The conditions of Article 7(2) shall apply mutatis mutandis.
Article 60
Union financial contribution
The Union financial contribution to the Clean Aviation Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 1 700 000 000, including up to EUR 39 223 000 for administrative costs.
Article 61
Contributions from members other than the Union
The members of the Clean Aviation Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 2 400 000 000, including up to EUR 39 223 000 for administrative costs, over the period set out in Article 3.
Article 62
Scope of additional activities
1. For the purpose of Article 11(1), point (b), additional activities may include:
(a)
activities covered under the indirect actions of the Clean Aviation Joint Undertaking but not funded under such indirect actions;
(b)
activities directly linked to the Clean Aviation Joint Undertaking work programme;
(c)
research and innovation activities building on activities funded by the Clean Aviation Joint Undertaking or its preceding initiative;
(d)
the research and innovation activities of projects with a clear link to the Strategic Research and Innovation Agenda, and co-funded under national or regional programmes within the Union;
(e)
private research and innovation projects complementing projects on the Strategic Research and Innovation Agenda as well as activities contributing to the uptake of industry-specific skills across the value chain;
(f)
activities leading to the deployment or uptake of project results from the Clean Aviation Joint Undertaking or its preceding initiatives, or from both, that have not received any Union funding;
(g)
European standardisation and certification activities related to clean aviation solutions from the Clean Aviation Joint Undertaking projects or its preceding initiatives.
2. Additional activities shall have clearly defined deliverables.
Article 63
Bodies of the Clean Aviation Joint Undertaking
The bodies of the Clean Aviation Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the Technical Committee;
(e)
the European Clean Aviation Scientific Advisory Body.
Article 64
Composition of the Governing Board
The Governing Board shall be composed as follows:
(a)
two representatives of the Commission on behalf of the Union;
(b)
fifteen representatives of the members other than the Union chosen by and from the founding members and associated members ensuring a balanced representation of the aeronautical value chain such as aircraft integrators, engine manufacturers and equipment manufacturers. The governing board shall establish in its rules of procedure a rotation mechanism for the allocation of the seats of the members other than the Union taking into account gender balance. The selected representatives shall include at least one representative of the European SMEs, at least two representatives of the research organisations and at least one representative of the higher education institutions.
Article 65
Functioning of the Governing Board
1. The members other than the Union shall collectively hold 50 % of the voting rights.
2. By derogation from Article 16(4), the Governing Board shall be chaired by the Commission on behalf of the Union and co-chaired by a representative from the members other than the Union.
3. The chairpersons of the European Clean Aviation Scientific Advisory Body, of the Technical Committee and of the states’ representatives group and one representative from EASA shall attend the meetings of the Governing Board as observers.
4. The Governing Board shall ensure a direct link and coordination between the activities of the states’ representatives group or other advisory bodies. To that effect, the Governing Board may also delegate a member to follow activities of those bodies.
Article 66
Additional tasks of the Governing Board
1. In addition to the tasks listed in Article 17, the Governing Board of the Clean Aviation Joint Undertaking shall carry out the following tasks:
(a)
oversee the relevance for clean aviation of the strategies for additional activities of the members other than the Union;
(b)
promote the market uptake of technologies and solutions for contributing to achieving the European Green Deal’s objectives and ensure the achievement of the Joint Undertaking’s specific objectives set out in Article 57;
(c)
pursue synergies between research and demonstration activities at regional, national or Union level that relate to the Strategic Research and Innovation Agenda and the Clean Aviation Joint Undertaking’s work programme;
(d)
supervise the programme’s monitoring and assessment of the progress compared to impact indicators and the Clean Aviation Joint Undertaking’s specific objectives set out in Article 57(2);
(e)
ensure the continued steering and management of the transition of the Clean Sky 2 programme technical priorities and research and innovation activities until their completion, in line with the objectives of the Clean Aviation Joint Undertaking and ensure, where relevant, the transfer of results to the Clean Aviation programme.
2. The Governing Board shall assess and decide in relation to the implementation of the programme and to the delivery on the Clean Aviation Joint Undertaking objectives, including on:
(a)
the strategic multiannual planning of Clean Aviation calls and their alignment with the objectives of Horizon Europe and the related work programmes and the technical priorities and research actions;
(b)
revisions or optimisation of the technical scope of the programme to align the work programme and the objectives of the Clean Aviation Joint Undertaking with the overall Horizon Europe and other European partnership’ related work programmes;
(c)
the recommendations by advisory bodies and specific actions set out in Article 58 to increase market penetration and impact of clean aviation solutions in line with the European Green Deal and related policy actions to improve it.
Article 67
Additional tasks of the Executive Director
In addition to the tasks set out in Article 19, the Executive Director of the Clean Aviation Joint Undertaking shall carry out the following tasks:
(a)
take appropriate action to manage interactions between projects supported by the joint undertaking, avoiding undue overlaps between them and boosting synergies across the whole programme;
(b)
ensure that deadlines are met for the transmission of necessary information to the various bodies of the Clean Aviation Joint Undertaking;
(c)
facilitate coordination by the Commission in accordance with the advice of the advisory bodies between the activities of the Clean Aviation Joint Undertaking and the relevant research and innovation activities within Horizon Europe with a view to avoiding overlaps and promoting synergies;
(d)
ensure that the Joint Undertaking facilitates full access to data and information for the independent impact monitoring of aviation research and innovation carried out under the direct supervision of the Commission and takes any appropriate action needed to ensure the independence of that process from the Clean Aviation Joint Undertaking itself, such as by means of public procurement, independent evaluations, reviews or ad-hoc analysis. The programme’s monitoring and assessment report shall be presented to the Governing Board once a year;
(e)
assist the Governing Board adaptations of the technical content and budget allocations of the work programme during the implementation of the Strategic Research and Innovation Agenda in order to maximise the achievements of the Clean Aviation Joint Undertaking.
Article 68
The states’ representatives group
1. The states’ representatives group shall hold coordination meetings with the states’ representatives group of other relevant joint undertakings, such as the Single European Sky ATM Research 3 Joint Undertaking, at least twice a year, with the aim of creating an interface between the national and regional authorities and the Clean Aviation Joint Undertaking and providing advice to the Clean Aviation Joint Undertaking on this basis.
2. In addition to Article 20, the states’ representatives group shall also have the following additional tasks:
(a)
propose measures to improve the complementarity between the Clean Aviation Research and Innovation actions and national research programmes contributing to the objectives of the Strategic Research and Innovation Agenda, as well as with international and other national initiatives and projects;
(b)
promote specific measures at national or regional level that aim to increase the involvement of SMEs in Clean Aviation Research and Innovation, including through dissemination events, dedicated technical workshops and communication, and any other actions that aim to promote cooperation and deployment of aeronautical technologies;
(c)
promote research and innovation investment from Cohesion Policy funds such as the European Regional Development Funds, the European Social funds, the Just Transition Funds and Next Generation EU Funds into the context of the Clean Aviation Joint Undertaking.
Article 69
The Technical Committee
1. The Technical Committee shall be composed as follows:
(a)
up to four Commission representatives and Union bodies, as decided by the representatives of the Union in the Governing Board;
(b)
one representative from each member other than the Union;
(c)
one representative of the EASA.
2. The Technical Committee shall be co-chaired by a representative of the founding members, rotating on a two-yearly basis, and the Commission. It shall report to the Governing Board and its secretariat shall be provided by the Clean Aviation Joint Undertaking.
3. The Executive Director shall be a permanent observer in the Technical Committee. Representatives of the states’ representatives group and the European Clean Aviation Scientific Advisory Body may attend as observers upon invitation of the chair, or on their own request, in which case their attendance shall be subject to the agreement of the chair and the Joint Undertaking’s representatives.
4. The Technical Committee shall propose its rules of procedure and shall submit them for adoption by the Governing Board.
5. The Technical Committee shall develop and maintain the technological roadmap and strategy of the programme. It shall propose and prepare for adoption by the Governing Board, as appropriate, the scope and programming of the research actions, the technical strategy and the overall research roadmap of the Clean Aviation Joint Undertaking. A Governing Board member may be delegated to follow the activities therein.
6. The Technical Committee shall carry out the following tasks:
(a)
prepare proposals for the amendment of the Strategic Research and Innovation Agenda as needed for deliberation and final decision by the Governing Board;
(b)
prepare proposals for the technical priorities and research actions to be included in the work programme and the research topics for open calls for proposals;
(c)
provide information on research actions planned or in progress at national, regional or other non-Union levels and make recommendations on the actions necessary to maximise possible synergies of the Clean Aviation Joint Undertaking’s programme;
(d)
propose for deliberation and final decision by the Governing Board revisions or optimisation of the technical scope of the programme in order to align the work programme and the objectives of the Clean Aviation Joint Undertaking with the overall Horizon Europe and other European partnerships’ related work programmes, as identified in the Strategic Research and Innovation Agenda;
(e)
make recommendations on maximising the impact in line with the European Green Deal objectives and the potential market uptake of the programme’s results from indirect actions funded by the Joint Undertaking.
Article 70
The European Clean Aviation Scientific Advisory Body
1. The European Clean Aviation Scientific Advisory Body shall be the scientific advisory body of the Clean Aviation Joint Undertaking set up in accordance with Article 21(1), point (a), and with Article 21(4).
2. The European Clean Aviation Scientific Advisory Body shall have no more than 15 permanent members and those members shall not be members of any other body under this Joint Undertaking.
3. The chairperson of the European Clean Aviation Scientific Advisory Body shall be elected for the duration of two years.
4. A representative of the EASA shall be a permanent member of the European Clean Aviation Scientific Advisory Body.
5. In carrying out its tasks the European Clean Aviation Scientific Advisory Body shall cooperate with relevant European aviation stakeholders’ fora, such as the Advisory Council for Aeronautics Research in Europe (ACARE).
6. The European Clean Aviation Scientific Advisory Body shall, pursuant to Article 21(7), point (f), hold coordination meetings with the advisory bodies of other relevant joint undertakings such as the Single European Sky ATM Research 3 Joint Undertaking, with the aim of promoting synergies and cooperation among relevant Union research and innovation initiatives in aviation and providing advice to that effect to the Clean Aviation Joint Undertaking on this basis.
7. The European Clean Aviation Scientific Advisory Body shall also advise and support the Commission and the Clean Aviation Joint Undertaking on initiatives that promote aviation research in the European education systems, and provide recommendations on aeronautical skills and competences development and updated aeronautical engineering curricula.
Article 71
Certification of new technologies
1. The EASA may be invited by applicants, beneficiaries or the Executive Director to advise on individual projects and demonstration activities on issues related to compliance with aviation safety, interoperability and environmental standards, to ensure that these lead to timely development of relevant standards, testing capacity and regulatory requirements for product development and deployment of new technologies.
2. Certification activities and services provided shall be subject to the provisions regarding fees and charges set out in Regulation (EU) 2018/1139.
Article 72
Derogation from the rules for participation
Where it is duly justified in the description of relevant topics in the work programme, a single legal entity established in a Member State or associated country or consortia not meeting the condition laid down in Article 22(2) of the Horizon Europe Regulation shall be eligible to participate in indirect actions funded by the Clean Aviation Joint Undertaking.
TITLE III
CLEAN HYDROGEN JOINT UNDERTAKING
Article 73
Additional objectives of the Clean Hydrogen Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Clean Hydrogen Joint Undertaking shall have the following general objectives:
(a)
to contribute to the objectives set out in the communication from the Commission of 17 September 2020 on Stepping up Europe’s 2030 climate ambition: Investing in a climate-neutral future for the benefit of our people, the European Green Deal and the European Climate Law by raising the Union’s ambition on reducing greenhouse gas emissions to at least 55 % below 1990 levels by 2030, and climate neutrality at the latest by 2050;
(b)
to contribute to the implementation of the 2020 Commission’s Hydrogen Strategy for a climate neutral Europe;
(c)
to strengthen the competitiveness of the Union clean hydrogen value chain, with a view to supporting, in particular for SMEs, the acceleration of the market entry of innovative competitive clean solutions;
(d)
to stimulate research and innovation on clean hydrogen production, distribution, storage and end use applications.
2. The Clean Hydrogen Joint Undertaking shall also have the following specific objectives:
(a)
improve through research and innovation, including activities related to lower TRLs, the cost-effectiveness, efficiency, reliability, quantity and quality of clean hydrogen solutions, including production, distribution, storage and end uses developed in the Union;
(b)
strengthen the knowledge and capacity of scientific and industrial actors along the Union’s hydrogen value chain while supporting the uptake of industry-related skills;
(c)
carry out demonstrations of clean hydrogen solutions with a view to local, regional and Union-wide deployment, aiming to involve stakeholders in all Member States and addressing renewable production, distribution, storage and use for transport and energy-intensive industries as well as other applications;
(d)
increase public and private awareness, acceptance and uptake of clean hydrogen solutions, in particular through cooperation with other European partnerships under Horizon Europe.
Article 74
Additional tasks of the Clean Hydrogen Joint Undertaking
In addition to the tasks set out in Article 5, the Clean Hydrogen Joint Undertaking shall carry out the following tasks:
(a)
assess and monitor technological progress and technological, economic and societal barriers to market entry, including in emerging hydrogen markets;
(b)
notwithstanding the Commission’s policy prerogatives, under the Commission’s policy guidance and supervision, contribute to the development of regulations and standards with the view to eliminating barriers to market entry and to supporting interchangeability, inter-operability and trade across the internal market and globally;
(c)
support the Commission, including through technical expertise, in its international initiatives on the hydrogen strategy, such as the International Partnership on the Hydrogen Economy (IPHE), Mission Innovation and the Clean Energy Ministerial Hydrogen Initiative.
Article 75
Members
The members of the Clean Hydrogen Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the Hydrogen Europe AISBL, a non-profit organisation registered under Belgian Law (the ‘Industry Grouping’), upon notification of its decision to accede to the Clean Hydrogen Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation;
(c)
the Hydrogen Europe Research AISBL, a non-profit organisation registered under Belgian Law (the ‘Research Grouping’), upon notification of its decision to accede to the Clean Hydrogen Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation.
Article 76
Union financial contribution
The Union financial contribution to the Clean Hydrogen Joint Undertaking, including EEA appropriations, to cover administrative and operational costs shall be up to EUR 1 000 000 000, including up to EUR 30 193 000 for administrative costs.
Article 77
Contributions from members other than the Union
The members of the Clean Hydrogen Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 1 000 000 000, including up to EUR 30 193 000 for administrative costs, over the period set out in Article 3.
Article 78
Scope of additional activities
1. For the purpose of Article 11(1), point (b), additional activities may include activities directly linked to the activities of the Clean Hydrogen Joint Undertaking and contributing to its objectives, including the following:
(a)
pre-commercial trials and field tests;
(b)
proof of concept;
(c)
improvement of existing production lines for up-scaling;
(d)
large scale case studies;
(e)
awareness-raising activities on hydrogen technologies and safety measures;
(f)
uptake of results from projects into products, further exploitation and activities within the research chain either at higher TRLs or in parallel strands of activity;
(g)
the research and innovation activities of projects with a clear link to the Strategic Research and Innovation Agenda, and co-funded under national or regional programmes within the Union.
2. Additional activities of the Clean Hydrogen Joint Undertaking shall aim to ensure synergies with the Clean Hydrogen Alliance, Mission Innovation Challenge ‘Renewable and Clean Hydrogen’, the European Union Innovation Fund, the H2 Regions Smart Specialisation Strategy (S3) platform and the ERA pilot on green hydrogen.
Article 79
Bodies of the Clean Hydrogen Joint Undertaking
The bodies of the Clean Hydrogen Joint Undertaking shall be the following:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group; and
(d)
the stakeholders group.
Article 80
Composition of the Governing Board
The Governing Board shall be composed of the following:
(a)
representatives of the Commission on behalf of the Union;
(b)
six representatives of the Industry Grouping, having regard to geographical, gender, company size and sector representation;
(c)
one representative of the Research Grouping.
Article 81
Functioning of the Governing Board
1. In addition to the voting rules set out in Article 16(3), the Industry Grouping shall hold 43 % of the voting rights and the Research Grouping 7 % of the voting rights in the Governing Board.
2. The chairperson of the Governing Board shall be a representative of the private members and shall be appointed by the Governing Board.
Article 82
Additional tasks of the Governing Board
In addition to the tasks set out in Article 17, the Governing Board of the Clean Hydrogen Joint Undertaking shall carry out the following tasks:
(a)
foster synergies with relevant activities and programmes at Union, national or regional level, in particular with those supporting the deployment of research and innovation solutions, infrastructure, education and regional development on the use of clean hydrogen;
(b)
provide pursuant to Article 5(2), point (b), and Article 17(n) strategic orientation as regards the collaboration with other European partnerships, including the partnerships towards zero emission road transport, zero emission waterborne, Europe’s rail, clean aviation, processes for the planet and clean steel in accordance with their respective Strategic Research and Innovation Agendas or other equivalent document;
(c)
encourage market uptake of technologies and solutions for achieving the European Green Deal’s objectives;
(d)
ensure that independent opinions and advice of the wider scientific community on the Strategic Research and Innovation Agenda, work programmes and developments in adjacent sectors are gathered through an independent scientific advisory workshop as part of the European Clean Hydrogen partnership forum.
Article 83
Additional tasks of the Executive Director
In addition to the tasks set out in Article 19, the Executive Director of the Clean Hydrogen Joint Undertaking shall carry out the following tasks:
(a)
propose and implement activities that boost synergies with relevant activities and programmes at Union, national or regional level;
(b)
support and contribute to other Union initiatives related to hydrogen, subject to approval by the Governing Board;
(c)
convene, subject to approval by the Governing Board, an annual European Clean Hydrogen partnership forum, including the independent scientific advisory workshop referred to in Article 82(d); the partnership forum, where possible, shall be held jointly and in parallel with the European Hydrogen Forum of the Clean Hydrogen Alliance.
Article 84
The stakeholders group
1. The stakeholders group shall consist of representatives of sectors which generate, distribute, store, need or use clean hydrogen across the Union, including the representatives of other relevant European partnerships, as well as representatives of the European Hydrogen Valleys Interregional Partnership and of the scientific community.
2. In addition to the tasks set out in Article 22, the stakeholders group shall have the following tasks:
(a)
provide input on the strategic and the technological priorities to be addressed by the Clean Hydrogen Joint Undertaking as laid down in the Strategic Research and Innovation Agenda or any other equivalent document and associated detailed technological roadmaps, taking due account of the progress and needs in adjacent sectors;
(b)
provide suggestions to enable concrete synergies to take place between the Clean Hydrogen Joint Undertaking and the adjacent sectors or any sector with which synergies are deemed of added value;
(c)
provide input to the European Clean Hydrogen partnership forum and to the European Hydrogen Forum of the Clean Hydrogen Alliance.
TITLE IV
EUROPE’S RAIL JOINT UNDERTAKING
Article 85
Additional objectives of the Europe’s Rail Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Europe’s Rail Joint Undertaking shall have the following general objectives:
(a)
contribute towards the achievement of the Single European Railway Area;
(b)
ensure a fast transition to more attractive, user-friendly, competitive, affordable, easy to maintain, efficient and sustainable European rail system, integrated into the wider mobility system;
(c)
support the development of a strong and globally competitive European rail industry.
2. In addition to the objectives set out in paragraph 1, the Europe’s Rail Joint Undertaking shall have the following specific objectives:
(a)
facilitate research and innovation activities to deliver an integrated European railway network by design, eliminating barriers to interoperability and providing solutions for full integration, covering traffic management, vehicles, infrastructure also including integration with national gauges, such as 1 520, 1 000 or 1 668 mm railway, and services, and providing the best answer to the needs of passengers and businesses, accelerating uptake of innovative solutions to support the Single European Railway Area, while increasing capacity and reliability and decreasing costs of railway transport;
(b)
deliver a sustainable and resilient rail system by developing a zero-emission, silent rail system and climate resilient infrastructure, applying circular economy to the rail sector, piloting the use of innovative processes, technologies, designs and materials in the full life-cycle of rail systems and developing other innovative solutions to guided surface transport;
(c)
develop through its System Pillar a unified operational concept and a functional, safe and secure system architecture, with due consideration of cyber-security aspects, focused on the European railway network to which Directive (EU) 2016/797 of the European Parliament and of the Council (39) applies, for integrated European rail traffic management, command, control and signalling systems, including automated train operation which shall ensure that research and innovation is targeted on commonly agreed and shared customer requirements and operational needs and is open to evolution;
(d)
facilitate research and innovation activities related to rail freight and intermodal transport services to deliver a competitive green rail freight fully integrated into the logistic value chain, with automation and digitalisation of freight rail at the core;
(e)
develop demonstration projects in interested Member States;
(f)
contribute to the development of a strong and globally competitive European rail industry;
(g)
enable, promote and exploit synergies with other Union policies, programmes, initiatives, instruments or funds in order to maximise its impact and added value.
3. In carrying out its activities, the Europe’s Rail Joint Undertaking shall seek a geographically balanced involvement of members and partners in its activities. It shall also establish the necessary international connections in relation to rail research and innovation, in line with the Commission priorities.
Article 86
Additional tasks of the Europe’s Rail Joint Undertaking
1. In addition to the tasks set out in Article 5, the Europe’s Rail Joint Undertaking together with the Commission shall prepare and, after consultation of the states’ representatives group, submit for adoption by the Governing Board the Master Plan, developed in consultation with all relevant stakeholders in the railway system and rail supply industry.
2. The Commission may start the preparation of the Master Plan prior to the establishment of the Europe’s Rail Joint Undertaking, in consultation with Member States’ representatives and all relevant stakeholders.
3. The Master Plan shall constitute a common, forward-looking roadmap based on a system view. It shall identify the areas of intervention within the scope of the Europe’s Rail Joint Undertaking. The objectives set out in the Master Plan shall be performance driven and structured around the objectives set out in Article 85.
4. The Master Plan shall be adopted by the Governing Board and endorsed by the Commission in accordance with Article 16 with the exception of the section of the Master Plan relating to the System Pillar that shall be adopted in accordance with Article 93(4). Before endorsement, the Commission shall present the Master Plan to the Council and to the European Parliament. Subsequently, any modification shall be communicated to the Council and the European Parliament.
5. The Master Plan shall constitute the Europe’s Rail Joint Undertaking’s Strategic Research and Innovation Agenda within the meaning of Article 2, point (12). It shall provide guidance for the Europe’s Rail Joint Undertaking’s more specific tasks, namely:
(a)
develop in its System Pillar a system view that reflects the needs of the rail manufacturing industry, the rail operating community, Member States and other rail private and public stakeholders, including bodies representing customers, such as passengers and freight and staff, as well as relevant actors outside the traditional rail sector. The ‘system view’ shall encompass:
(i)
the development of the operational concept and system architecture, including the definition of the services, functional blocks, and interfaces which form the basis of rail system operations;
(ii)
the development of associated specifications including interfaces, functional requirement specifications and system requirement specifications to feed into Technical Specifications for Interoperability (TSI) established pursuant to Directive (EU) 2016/797 or standardisation processes to lead to higher levels of digitalisation and automation;
(iii)
ensuring the system is maintained, error-corrected and able to adapt over time and ensure migration considerations from current architectures;
(iv)
ensuring that the necessary interfaces with other modes, as well as with metro and trams or light rail systems, are assessed and demonstrated, in particular for freight and passenger flows;
(b)
facilitate the research and innovation activities necessary to achieve the objectives of the Europe’s Rail Joint Undertaking, including low TRLs rail-focused research and innovation activities. In that respect, the Europe’s Rail Joint Undertaking shall:
(i)
define and organise the research, innovation, demonstration, validation and study activities to be carried out under its authority, while avoiding fragmentation of such activities;
(ii)
exploit standardisation and modularity opportunities, and facilitate the interfaces with other modes and systems;
(iii)
develop demonstration projects;
(iv)
develop close cooperation and ensure coordination with related European, national and international research and innovation activities in the rail sector and beyond as necessary, in particular under Horizon Europe, thereby enabling the Europe’s Rail Joint Undertaking to play a major role in rail-related research and innovation while also benefiting from scientific and technological advances reached in other sectors;
(v)
ensure, through the cooperation referred to in point (iv), the translation of research into effective development effort and development of pioneering innovations and ultimately into market focused innovation through demonstration and deployment;
(c)
perform any tasks necessary to achieve the objectives set out in Articles 4 and 85.
Article 87
Members
1. The members of the Europe’s Rail Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the founding members listed in Annex II, upon notification of their decision to accede to the Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding their accession other than those set out in this Regulation;
(c)
the associated members to be selected in accordance with Article 7. The list of the associated members shall be endorsed by the Commission.
2. In addition to Article 7(1), the Governing Board may, during the first six months following the establishment of the Europe’s Rail Joint Undertaking, select associated members from a list drawn up after an open call for expression of interest launched by the Commission prior to its establishment. The conditions of Article 7(2) shall apply mutatis mutandis.
Article 88
Union financial contribution
The Union financial contribution to the Europe’s Rail Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 600 000 000, including at least EUR 50 000 000 for the System Pillar and up to EUR 24 000 000 for administrative costs.
Article 89
Contributions from members other than the Union
The members of the Europe’s Rail Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 600 000 000, including up to EUR 24 000 000 for administrative costs, over the period set out in Article 3.
Article 90
Scope of additional activities
1. For the purposes of Article 11(1), point (b), additional activities may include:
(a)
activities covered under the indirect actions of the Europe’s Rail Joint Undertaking but not funded under such indirect actions;
(b)
activities directly linked to the Europe’s Rail Joint Undertaking work programme;
(c)
research and innovation activities building on activities funded by the Europe’s Rail Joint Undertaking or Shift2Rail Joint Undertaking;
(d)
complementary research and innovation activities funded by the members other than the Union, having a clear Union added value and contributing to achieving the objectives of the Europe’s Rail Joint Undertaking;
(e)
activities funded by the members other than the Union in projects funded by national programmes or by regional programmes which complement activities funded by the Europe’s Rail Joint Undertaking;
(f)
uptake of results of activities funded under the Shift2Rail and Europe’s Rail Joint Undertakings, further exploitation, demonstration activities, standardisation and development of recommendations for seamless transition strategies, migration paths and updates of TSI, and European authorisation and certification activities not linked to wider deployment.
2. With regard to activities funded by the members other than the Union in projects funded by other European partnerships or by other Union programmes or by other research and innovation efforts and investments that have a significant Union added value and contribute to achieving the objectives of the Europe’s Rail Joint Undertaking and its complement activities funded by it, the value of such activities shall be reported, indicating the type, level and source of Union funding to avoid double counting.
Article 91
Bodies of the Europe’s Rail Joint Undertaking
1. The bodies of the Europe’s Rail Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the System Pillar steering group;
(e)
the Deployment Group.
2. The Europe’s Rail Joint Undertaking may set up a scientific steering group or seek scientific advice from independent academic experts or from shared scientific advisory bodies.
Article 92
Composition of the Governing Board
The Governing Board shall be composed as follows:
(a)
two representatives from the Commission on behalf of the Union;
(b)
one representative from each of the members other than the Union.
Article 93
Functioning of the Governing Board
1. By derogation from Article 16(4), the Governing Board shall be chaired by the Commission on behalf of the Union.
2. The members other than the Union shall collectively hold 50 % of the voting rights.
3. Representatives of the European Union Agency for Railways and of the European Rail Research Advisory Council (ERRAC) shall be invited to attend meetings of the Governing Board as observers and take part in its deliberation, but shall have no voting rights.
4. By derogation from Article 16(1) with regard to activities to be performed under the System Pillar, a decision shall be deemed adopted by a majority of at least 55 % of the votes including the votes of representatives who are absent.
5. In addition to Article 16(5), the Governing Board shall meet once a year in a general assembly and all participants to the research and innovation activities of the Europe’s Rail Joint Undertaking shall be invited to attend. The assembly shall stimulate reflection on the overall direction of the activities of the Europe’s Rail Joint Undertaking while conducting an open and transparent discussion on the progress of the Master Plan implementation.
Article 94
Additional tasks of the Governing Board
In addition to the tasks set out in Article 17, the Governing Board of the Europe’s Rail Joint Undertaking shall carry out the following tasks:
(a)
adopt the Master Plan and any proposal for its modification;
(b)
adopt the work programmes, including the budget and implementation plan, of the System Pillar and their amendments based on recommendations made by the System Pillar steering group and on the proposals of the Executive Director.
Article 95
The states’ representatives group
In addition to Article 20, the Member States shall ensure that their respective representatives present a coordinated position that reflects their Member State’s views expressed in:
(a)
the committee established by Article 51 of Directive (EU) 2016/797;
(b)
the Programme Committee under Horizon Europe configuration ‘Climate, Energy and Mobility’;
(c)
the Single European Rail Area Committee, established by Article 62 of Directive 2012/34/EU of the European Parliament and of the Council (40).
Article 96
The System Pillar steering group
1. The System Pillar steering group shall be an advisory body of the Europe’s Rail Joint Undertaking in charge of providing advice on System Pillar issues.
2. The System Pillar steering group shall be composed of representatives of the Commission, representatives of the rail and mobility sector and of relevant organisations, the Executive Director of the Europe’s Rail Joint Undertaking, the chairperson of the states’ representatives group and representatives of the European Union Agency for Railways and of the ERRAC. The Commission shall take the final decision on the composition of the Group. When justified, the Commission may invite additional relevant experts and stakeholders to attend the meetings of the System Pillar steering group as observers. The System Pillar steering group shall regularly report to the states’ representatives group on its activities.
3. The System Pillar Steering group shall be chaired by the Commission.
4. The recommendations of the System Pillar steering group shall be adopted by consensus. Where no consensus is reached, the Executive Director of the Europe’s Rail Joint Undertaking shall prepare a report for the Governing Board, in consultation with the European Union Agency for Railways and the Commission, outlining the key common points and diverging views. In this case, the states’ representatives group shall also prepare an opinion for the Governing Board.
5. The System Pillar steering group shall adopt its own rules of procedure.
6. The System Pillar steering group shall be responsible for providing advice to the Executive Director and Governing Board on any of the following:
(a)
the approach to operational harmonisation and the development of system architecture, including on the relevant part of the Master Plan;
(b)
delivering on the specific objective set out in Article 85(2), point (c);
(c)
carrying out the task set out in Article 86(5), point (a);
(d)
the detailed annual implementation plan for the System Pillar in line with the work programmes adopted by the Governing Board in accordance with Article 94, point (b);
(e)
monitoring the progress of the System Pillar.
Article 97
The Deployment Group
1. The Deployment Group shall be established pursuant to Article 22. The role of the Deployment Group shall be to advise the Governing Board on the market uptake of rail innovation developed in the Europe’s Rail Joint Undertaking and to support deployment of the innovative solutions.
2. The Deployment Group shall be open to all stakeholders. The composition of the Deployment Group shall ensure appropriate thematic focus and representativeness. The Commission shall take the final decision on the composition of the Group. The list of members shall be published on the website of the Europe’s Rail Joint Undertaking.
3. The Deployment Group shall provide recommendations on issues related to the deployment of rail innovative solutions upon request of the Governing Board. The Deployment Group may also issue recommendations on its own initiative.
Article 98
Collaboration with the European Union Agency for Railways
The Europe’s Rail Joint Undertaking shall ensure a close collaboration with the European Union Agency for Railways, in particular with regard to the implementation of the Master Plan. Pursuant to Article 40 of Regulation (EU) 2016/796 of the European Parliament and of the Council (41), that collaboration shall consist of the following advisory tasks:
(a)
input on research needs relating to the realisation of the Single European Railway Area for consideration by the Europe’s Rail Joint Undertaking in the Master Plan and its amendments as well as in the work programmes;
(b)
feedback and advice on interoperability and safety to be considered in the research innovation activities and, more specifically, in the context of project activities and results for the objectives identified in Article 86(5), point (a);
(c)
support to the Europe’s Rail Joint Undertaking in identifying needs for any additional specific validation or studies to be performed by it, including via the involvement of national safety authorities;
(d)
provide advice as regards the System Pillar;
(e)
ensure that the development of specifications including interfaces, functional requirement specifications, and system requirement specifications takes into consideration the experience and feedback on TSI or standards.
TITLE V
GLOBAL HEALTH EDCTP3 JOINT UNDERTAKING
Article 99
Additional objectives of the Global Health EDCPT3 Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Global Health EDCTP3 Joint Undertaking shall have the following general objectives:
(a)
to contribute to the reduction of the socioeconomic burden of infectious diseases in sub-Saharan Africa by promoting the development and uptake of new or improved health technologies;
(b)
to contribute to the increase of health security in sub-Saharan Africa and globally by strengthening the research- and innovation-based capacities for preparedness and response to control infectious diseases.
2. The Global Health EDCTP3 Joint Undertaking shall also have the following specific objectives:
(a)
to advance the development and use of new or improved health technologies for tackling infectious diseases by supporting the conduct of the clinical trials, in sub-Saharan Africa;
(b)
to strengthen research and innovation capacity and the national health research systems in sub-Saharan Africa for tackling infectious diseases;
(c)
to facilitate better alignment of Member States, associated countries and sub-Saharan countries around a common Strategic Research and Innovation Agenda in the field of global health to increase the cost-effectiveness of European public investment;
(d)
to strengthen capacity in sub-Saharan Africa for epidemic preparedness through effective and rapid research response to develop essential diagnostics, vaccines and therapeutics for early detection and control of emerging diseases of epidemic potential;
(e)
to promote productive and sustainable networking and partnerships in the area of global health research building North–South and South–South relationships with multiple private and public-sector organisations.
Article 100
Additional tasks of the Global Health EDCTP3 Joint Undertaking
In addition to the tasks set out in Article 5, the Global Health EDCTP3 Joint Undertaking shall carry out the following tasks:
(a)
fostering productive relationships between European and African individuals, groups and institutions;
(b)
raising awareness of common interests and shared goals between institutions and research groups to facilitate and strengthen project and institutional collaborations;
(c)
contributing to facilitating alignment of global health strategies of European and African funders, institutions and authorities;
(d)
attracting additional investment involving partners from the private, public, and charitable sectors;
(e)
promoting synergies, collaboration and joint actions with the Neighbourhood, Development and International Cooperation Instrument established by Regulation (EU) 2021/947 of the European Parliament and of the Council (42), in particular for capacity building and sharing facilities and infrastructures.
Article 101
Members
The members of the Global Health EDCTP3 Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the EDCTP Association, a non-profit organisation registered under Dutch law, upon notification of its decision to accede to the Global Health EDCTP3 joint undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation.
Article 102
Union financial contribution
The Union financial contribution to the Global Health EDCTP3 Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 800 000 000, including up to EUR 59 756 000 for administrative costs, and shall consist of the following:
(a)
up to EUR 400 000 000 provided that the contribution of members other than the Union, or its constituent or affiliated entities, is at least equal to this amount;
(b)
up to EUR 400 000 000 provided that the contributions from contributing partners, or from their constituent or affiliated entities, are at least equal to this amount.
In the event that the condition under point (b) is not met, the amount under point (a) shall be increased by up to EUR 400 000 000, provided that the total amount by which it is increased shall be at least matched by the contribution of members other than the Union, or their constituent or affiliated entities, as set out in Article 103(1).
Article 103
Contributions from members other than the Union
1. The members of the Global Health EDCTP3 Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 439 878 000 over the period set out in Article 3.
2. The contributions referred to in paragraph 1 of this Article shall consist of contributions to the Global Health EDCTP3 Joint Undertaking as laid down in Article 11(1). By derogation from Article 11(1), those contributions may consist of financial contributions.
Article 104
Scope of additional activities
1. Additional activities of the Global Health EDCTP3 Joint Undertaking shall be developed and implemented in an aligned, integrated and coherent manner by the EDCTP Association and its constituent or affiliated entities and shall follow the Global Health EDCTP3 Strategic Research and Innovation Agenda.
2. For the purpose of Article 11(1), point (b), additional activities may include activities directly linked to the activities of the Global Health EDCTP3 Joint Undertaking and contributing to its objectives, including the following:
(a)
activities of constituent or affiliated entities of the EDCTP Association aligned with similar activities from other constituent or affiliated entities of the EDCTP Association and independently managed in accordance with national funding rules;
(b)
activities implemented by sub-Saharan African governmental research organisations;
(c)
activities which promote networking and partnerships building relationships with multiple private and public-sector organisations;
(d)
support for the development of research infrastructures such as clinical trial networks or cohorts related to the scope of the Global Health EDCTP3 Joint Undertaking, and support for strengthening health systems’ preparedness for carrying out research activities within the scope of the Global Health EDCTP3 Joint Undertaking.
Article 105
Bodies of the Global Health EDCTP3 Joint Undertaking
The bodies of the Global Health EDCTP3 Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the Scientific Committee;
(d)
the stakeholders group.
Article 106
Composition of the Governing Board
The Governing Board shall be composed of the following:
(a)
six representatives of the Commission on behalf of the Union;
(b)
six representatives of the EDCTP Association.
Article 107
Functioning of the Governing Board
The EDCTP Association shall hold 50 % of the voting rights.
Article 108
The Scientific Committee
1. Pursuant to Article 21(1), point (a), the Scientific Committee shall be the scientific advisory body of the Global Health EDCTP3 Joint Undertaking.
2. In addition to Article 21(2), the Scientific Committee shall ensure the inclusion of scientific expertise from African countries.
3. In addition to the tasks listed in Article 21, the Scientific Committee shall perform the following tasks:
(a)
assist in the design of the strategic and scientific planning of the activities of the Global Health EDCTP3 Joint Undertaking;
(b)
advise on strategies to foster synergies and partnerships with all stakeholders;
(c)
contribute to the preparation of strategic and scientific documents relevant to the Global Health EDCTP3 Joint Undertaking, as required;
(d)
provide strategic and scientific advice to the Global Health EDCTP3 Joint Undertaking and ensure the successful completion of on-going projects;
(e)
identify strategic needs and priorities for accelerating the development of new or improved clinical interventions, including the required training, networking and capacity building to be undertaken to achieve those objectives;
(f)
review the landscape of poverty-related and neglected diseases to identify the Global Health EDCTP3 Joint Undertaking’s role in partnership with other stakeholders to accelerate the development or improvement of interventions against those diseases;
(g)
assess the state of global product development pathways and the critical path opportunities for future product development;
(h)
provide advice on the review of any calls for proposals and other programmes;
(i)
provide support and input on the monitoring and evaluation framework of the Global Health EDCTP3 Joint Undertaking, as well as in the monitoring of scientific outcomes and strategic impacts of the grants funded by the Global Health EDCTP3 Joint Undertaking;
(j)
advise, assist and participate in Global Health EDCTP3 Joint Undertaking working groups, stakeholder meetings, EDCTP Forum and other relevant events.
4. The chairperson shall prepare an annual report on the previous year’s activities and achievements of the Scientific Committee and submit it for approval by the Governing Board.
Article 109
The stakeholders group
1. The stakeholders group shall have a balanced representation of stakeholders from a geographic, thematic and gender perspective, including in particular African expertise.
2. In addition to the tasks set out in Article 22, the Stakeholders’ Group shall also perform the following tasks:
(a)
provide input on the scientific, strategic and the technological priorities to be addressed by the Global Health EDCTP3 Joint Undertaking as laid down in the Strategic Research and Innovation Agenda or any other equivalent document taking account the progress and needs of the Global Health and adjacent sectors;
(b)
provide suggestions to enable concrete synergies to take place between the Global Health EDCTP3 Joint Undertaking and the adjacent sectors or any sector with which synergies will be deemed of added value;
(c)
provide input to the EDCTP Forum.
Article 110
Eligibility for funding
1. In accordance with Article 17(2) of the Horizon Europe Regulation and by derogation from Article 23(1) thereof, funding from the Global Health EDCTP3 Joint Undertaking shall be restricted to legal entities established in Member States or associated countries or in the constituent states of the EDCTP Association. Exceptionally and if provided for in the work programme, entities established in other states may be eligible for funding from the Global Health EDCTP3 Joint Undertaking in specific call topics or in the event of a call addressing a public health emergency.
2. The Union shall seek to conclude agreements with third countries that allow the protection of the financial interest of the Union. Before their conclusion and in order to safeguard Union financial interests, where entities established in a third country without such an agreement participate with funding in an indirect action, the financial coordinator of the indirect action shall be established in a Member State or associated country, the amount of pre-financing shall be adequately adapted and liability provisions of the grant agreement shall take due account of the financial risks.
Article 111
Identified participants
The participation of entities identified by the Global Health EDCTP3 Joint Undertaking may be an eligibility criterion in the call for proposals. It shall be duly justified in the work programme which may also provide that such identified participants shall not be eligible for funding from the Global Health EDCTP3 Joint Undertaking under the selected indirect actions.
Article 112
Ethical principles
The clinical trials and implementation research conducted under the Global Health EDCTP3 Joint Undertaking shall be implemented in compliance with fundamental ethical principles, recognised international regulatory standards and good participatory practices.
Article 113
Collaboration with the European Medicines Agency and European Centre for Disease Prevention and Control
The Global Health EDCTP3 Joint Undertaking shall ensure a close collaboration with the European Medicines Agency and European Centre for Disease Prevention and Control, as well as with relevant African agencies and organisations.
Article 114
Affordable access
Participants to indirect actions funded by the Global Health EDCTP3 Joint Undertaking shall ensure that the products and services that they develop based or partly based on the results of clinical studies undertaken as part of an indirect action are affordable, available and accessible to the public at fair and reasonable conditions. For that purpose, where relevant, the work programme shall specify additional exploitation obligations applicable to specific indirect actions.
TITLE VI
INNOVATIVE HEALTH INITIATIVE JOINT UNDERTAKING
Article 115
Additional objectives of the Innovative Health Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Innovative Health Initiative Joint Undertaking shall reach the following general objectives by 2030:
(a)
contribute towards the creation of a Union-wide health research and innovation ecosystem that facilitates translation of scientific knowledge into innovations, in particular by launching at least 30 large-scale cross-sectoral projects, focusing on health innovations;
(b)
foster the development of safe, effective, people-centred and cost-effective innovations that respond to strategic unmet public health needs, by exhibiting, in at least five examples, the feasibility of integrating health care products or services, with demonstrated suitability for uptake by health care systems. The related projects should address the prevention, diagnosis, treatment or management of diseases affecting the Union population, including contribution to Europe’s Beating Cancer Plan;
(c)
drive cross-sectoral health innovation for a globally competitive European health industry, and contribute to reaching the objectives of the new Industrial Strategy for Europe and the Pharmaceutical Strategy for Europe.
2. The Innovative Health Initiative Joint Undertaking shall also have the following specific objectives:
(a)
contribute towards a better understanding of the determinants of health and priority disease areas;
(b)
integrate fragmented health research and innovation efforts bringing together health industry sectors and other stakeholders, focusing on unmet public health needs, to enable the development of tools, data, platforms, technologies and processes for improved prediction, prevention, interception, diagnosis, treatment and management of diseases, meeting the needs of end-users;
(c)
demonstrate the feasibility of people-centred integrated health care solutions;
(d)
exploit the full potential of digitalisation and data exchange in health care;
(e)
enable the development of new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated health care solutions.
Article 116
Additional tasks of the Innovative Health Initiative Joint Undertaking
In addition to the tasks set out in Article 5, the Innovative Health Initiative Joint Undertaking shall carry out the following tasks:
(a)
foster close and long-term cooperation between the Union, other members, contributing partners, and other stakeholders involved in health care such as other relevant industries, health care authorities (such as regulatory bodies, health technology assessment bodies and payers), patient organisations, health care professionals and providers, as well as academia;
(b)
effectively support pre-competitive health research and innovation, especially actions that bring together entities of several health care industry sectors to work jointly on areas of unmet public health need;
(c)
ensure that all stakeholders have the possibility of proposing areas for future calls for proposals;
(d)
regularly review and make any necessary adjustments to the Strategic Research and Innovation Agenda of the Innovative Health Initiative Joint Undertaking in light of scientific developments occurring during its implementation or emerging public health needs;
(e)
publish information on the projects, including participating entities and the amount of the financial contribution of the Innovative Health Initiative Joint Undertaking and committed in-kind contributions per participant;
(f)
organise regular communication, including at least one annual meeting with interest groups and with its stakeholders to ensure openness and transparency of the research and innovation activities of the Innovative Health Initiative Joint Undertaking;
(g)
any other task necessary to achieve the objectives referred to in Article 115.
Article 117
Members
The members of the Innovative Health Initiative Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry (COCIR) registered under Belgian law, the European Federation of Pharmaceutical Industries and Associations, including its subgroup Vaccines Europe, registered under Luxemburgish law, EuropaBio registered under Belgian law and MedTech Europe registered under Belgian law, upon notification of their respective decisions to accede to the Innovative Health Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding their accession other than those set out in this Regulation;
(c)
the associated members to be selected in accordance with Article 7.
Article 118
Union financial contribution
The Union financial contribution to the Innovative Health Initiative Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 1 200 000 000, including up to EUR 30 212 000 for administrative costs, and shall consist of the following:
(a)
up to EUR 1 000 000 000 provided that that amount is matched by the contribution of members other than the Union, or its constituent or affiliated entities;
(b)
up to EUR 200 000 000 provided that that amount is matched by the additional contributions from contributing partners, or from their constituent or affiliated entities.
Article 119
Contributions from members other than the Union
1. The members of the Innovative Health Initiative Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 1 000 000 000, including up to EUR 30 212 000 for administrative costs, over the period set out in Article 3.
2. In-kind contributions to additional activities shall not constitute more than 40 % of in-kind contributions of members other than the Union, at the level of the Innovative Health Initiative Joint Undertaking.
3. Contributions provided by participants to indirect actions funded by the Innovative Health Initiative Joint Undertaking shall amount to at least 45 % of an indirect action’s eligible costs and costs of its related additional activities. When justified, the work programme may exceptionally allow a lower proportion of contributions at the level of an individual indirect action and its related additional activities.
4. Costs incurred in indirect actions in third countries other than countries associated to Horizon Europe shall be justified and relevant to the objectives set out in Article 115. They shall not exceed 20 % of the in-kind contributions to operational costs provided by members other than the Union and by contributing partners at the level of the Innovative Health Initiative Joint Undertaking. Costs in excess of 20 % of the in-kind contributions to operational costs at the level of the Innovative Health Initiative Joint Undertaking shall not be considered as in-kind contributions to operational costs.
5. In duly justified cases, work programmes of the Innovative Health Initiative Joint Undertaking may set out specific limits for in-kind contributions to operational costs incurred in third countries other than countries associated with Horizon Europe at an indirect action level. The decisions on such specific limits shall take into account in particular the objectives and the impact sought by the actions concerned and shall not result in an excess of the ceiling set out in paragraph 4 at the Innovative Health Initiative Joint Undertaking level.
Article 120
Conditions related to additional activities
1. For the purpose of Article 11(1), point (b), additional activities shall be carried out in the Union or countries associated with Horizon Europe and may include:
(a)
activities contributing towards the achievement of objectives of indirect actions funded by the Innovative Health Initiative Joint Undertaking;
(b)
activities contributing towards the dissemination, sustainability or exploitation of results of indirect actions funded by the Innovative Health Initiative Joint Undertaking.
2. Where relevant, project proposals shall include a plan for their related additional activities. Costs associated to such project-specific additional activities must be incurred between the date of submission of the proposal and up to two years after the end date of the indirect action.
3. In order for the costs to be accounted for as in-kind contributions referred to in Article 11(1), point (b), the underlying additional activities shall be carried out within the Union or countries associated to Horizon Europe.
Article 121
Bodies of the Innovative Health Initiative Joint Undertaking
The bodies of the Innovative Health Initiative Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the Science and Innovation Panel.
Article 122
Composition of the Governing Board
The Governing Board shall be composed of the following:
(a)
four representatives of the Commission on behalf of the Union;
(b)
one representative per member other than the Union.
Article 123
Functioning of the Governing Board
The members other than the Union shall collectively hold 50 % of the voting rights.
Article 124
The Science and Innovation Panel
1. The Science and Innovation Panel shall advise the Governing Board on matters relevant to the research and innovation activities of the Innovative Health Initiative Joint Undertaking in accordance with Article 21.
2. The Science and Innovation Panel shall be composed of the following permanent panellists:
(a)
two representatives of the Commission on behalf of the Union;
(b)
four representatives of the members other than the Union;
(c)
two representatives of the states’ representatives group;
(d)
four representatives of the scientific community, appointed by the Governing Board following an open selection process in accordance with Article 21(4);
(e)
up to six other permanent panellists, appointed by the Governing Board following an open selection process in application of Article 21(4), ensuring in particular appropriate representation of stakeholders involved in health care, covering in particular the public sector, including regulatory bodies, patients and end-users in general.
3. The permanent panellists referred to in paragraph 2, points (a), (b) and (c), may invite ad hoc panellists where appropriate to discuss specific subjects. They may jointly invite a maximum of six ad hoc panellists for each meeting.
Such ad hoc panellists shall be invited based on their scientific or technical expertise on the subjects to be discussed at given meetings or taking into account the need to create synergies with other research programmes.
The permanent panellists referred to in paragraph 2, points (a), (b) and (c), shall invite ad hoc panellists consensually. They shall communicate their decisions to the Governing Board, the states’ representatives group and the other permanent panellists.
4. In addition to Article 21(7), the Science and Innovation Panel shall provide advice to the Governing Board, at its request or on its own initiative, on scientific and technological matters related to the Innovative Health Initiative Joint Undertaking’s objectives, in particular about:
(a)
scientific priorities, including in the context of updating the Strategic Research and Innovation Agenda;
(b)
the draft work programme, including the content of calls for proposals;
(c)
the planning of additional activities of members other than the Union referred to in Article 120;
(d)
the set-up of advisory groups focused on specific scientific priorities in accordance with Article 17(2), point (x), and following an open selection process for their members in accordance with Article 21(4);
(e)
creation of synergies with other Horizon Europe activities, including other European partnerships, as well as other Union funding programmes and national funding programmes.
5. In addition to Article 21(5), the Science and Innovation Panel shall elect its chair among the representatives provided in paragraph 2, point (d), of this Article.
Article 125
Conditions applicable to indirect actions
1. For the purpose of this Regulation, an unmet public health need shall be defined as a need currently not addressed by the health care systems for availability or accessibility reasons, for example where there is no satisfactory method of diagnosis, prevention or treatment for a given health condition or if people’s access to health care is limited because of cost, distance to health facilities or waiting times. People-centred care refers to an approach to care that consciously adopts individuals’, carers’, families’ and communities’ perspectives and considers them as participants as well as beneficiaries of health care systems that are organised around their needs and preferences rather than individual diseases.
2. Indirect actions funded by the Innovative Health Initiative Joint Undertaking may include clinical studies where the targeted area or the intended use represents an unmet public health need, significantly affecting or threatening the Union’s population.
3. Participants to indirect actions funded by the Innovative Health Initiative Joint Undertaking must ensure that the products and services that they develop based or partly based on the results of clinical studies undertaken as part of an indirect action are affordable, available and accessible to the public at fair and reasonable conditions. For that purpose, where relevant, the work programme shall specify additional exploitation obligations applicable to specific indirect actions.
4. Where provided for in the work programme and in addition to Article 5(2), point (a), legal entities identified by the Innovative Health Initiative Joint Undertaking may be required to participate in specific indirect actions. Those entities shall not be eligible for funding from the Innovative Health Initiative Joint Undertaking.
5. Any legal entities participating in specific indirect actions with the identified legal entities referred to in paragraph 4 shall not be eligible for funding where:
(a)
they are for-profit legal entities with an annual turnover of EUR 500 million or more;
(b)
they are under the direct or indirect control of a legal entity described in point (a), or under the same direct or indirect control as a legal entity described in point (a);
(c)
they are directly or indirectly controlling a legal entity referred to in point (a).
TITLE VII
KEY DIGITAL TECHNOLOGIES JOINT UNDERTAKING
Article 126
Additional objectives of the Key Digital Technologies Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Key Digital Technologies Joint Undertaking shall have the following general objectives:
(a)
reinforce the Union’s strategic autonomy in electronic components and systems to support future needs of vertical industries and the economy at large. The overall target is to contribute towards doubling the value of the design and production of electronic components and systems in Europe by 2030, in line with the weight of the Union in products and services;
(b)
establish Union scientific excellence and innovation leadership in emerging components and systems technologies, including in activities related to lower TRLs; and promote the active involvement of SMEs, which shall represent at least one third of the total number of participants in indirect actions and at least 20 % of public funding should go to them;
(c)
ensure that components and systems technologies address Europe’s societal and environmental challenges. The target is to align with the Union policy on energy efficiency and contribute towards the reduction of energy consumption by 32,5 % in 2030.
2. In addition to the objectives set out in paragraph 1, the Key Digital Technologies Joint Undertaking shall have the following specific objectives:
(a)
support research and development for establishing design and production capabilities in Europe for strategic application areas;
(b)
launch a balanced portfolio of large and small projects supporting the fast transfer of technologies from the research to the industrial environment;
(c)
foster a dynamic Union-wide ecosystem based on digital value-chains with simplified access to newcomers;
(d)
support research and development for enhancing component technologies that guarantee security, trust and energy-efficiency for critical infrastructures and sectors in Europe;
(e)
foster mobilisation of national resources and ensure coordination of Union and national research and innovation programmes in the field of electronic components and systems;
(f)
establish coherence between the Strategic Research and Innovation Agenda of the Key Digital Technologies Joint Undertaking and Union policies so that electronics components and systems technologies contribute efficiently.
Article 127
Members
1. The members of the Key Digital Technologies Joint Undertaking shall be:
(a)
the public authorities consisting of:
(i)
the Union, represented by the Commission;
(ii)
the following participating states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
(b)
the private members consisting of the following industrial associations: the AENEAS Association registered under French law; the Inside Industry Association (INSIDE) registered under Dutch law; the EPoSS e.V. Association registered under German law.
2. Each participating state shall appoint its representatives in the bodies of the Key Digital Technologies Joint Undertaking and shall designate the national entity or entities responsible for fulfilling its obligations with respect to the activities of the Key Digital Technologies Joint Undertaking.
Article 128
Union financial contribution
The Union financial contribution to the Key Digital Technologies Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 1 800 000 000, including up to EUR 26 331 000 for administrative costs.
Article 129
Contributions from members other than the Union
1. Over the period set out in Article 3, the participating states of the Key Digital Technologies Joint Undertaking shall make a total contribution that is commensurate to the amount of the Union contribution to operational costs referred to in Article 128. The participating states shall arrange among them their collective contributions and how they will deliver those. This shall not affect the ability of each participating state to define its national financial contribution in accordance with Article 12. By derogation from Article 28(4), point (a), the participating states shall not make a contribution to administrative costs.
2. Over the period set out in Article 3, the private members of the Key Digital Technologies Joint Undertaking shall make or arrange for their constituent or affiliated entities to make contributions of at least EUR 2 511 164 000 to the Key Digital Technologies Joint Undertaking.
3. In line with Article 28(4), the private members shall make or arrange for their constituent and affiliated entities to make a financial contribution of up to EUR 26 331 000 for administrative costs of the Key Digital Technologies Joint Undertaking.
4. The contributions referred to in paragraph 1 shall consist of contributions laid down in Article 11(3). The contributions referred to in paragraph 2 of this Article shall consist of contributions laid down in Article 11(1), including at least 90 % of contributions laid down in Article 11(1), point (a).
Article 130
Scope of additional activities
1. The Governing Board of the Key Digital Technologies Joint Undertaking may approve where necessary the additional activities plan referred to in Article 11(1), point (b), following a proposal by the Private Members Board, taking into account the opinion of the Public Authorities Board.
2. For the purpose of Article 11(1), point (b), additional activities may include:
(a)
investment aiming to industrialise the Key Digital Technologies, ECSEL, ARTEMIS and ENIAC Joint Undertakings’ projects’ results;
(b)
pilots, demonstrators, applications, deployments, industrialisation, including relevant capital expenditure, including projects under the IPCEIs on microelectronics;
(c)
related research and development activities that are not publicly funded;
(d)
activities financed by loans of the European Investment Bank and not funded under a grant by the Union;
(e)
activities to develop the ecosystem supporting the cooperation of technology users and suppliers.
Article 131
Bodies of the Key Digital Technologies Joint Undertaking
The bodies of the Key Digital Technologies Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the Public Authorities Board;
(d)
the Private Members Board.
Article 132
Composition of the Governing Board
Each member of the Key Digital Technologies Joint Undertaking shall appoint its representatives and a lead delegate who shall hold the voting rights of the member in the Governing Board.
Article 133
Functioning of the Governing Board
1. The voting rights in the Governing Board shall be distributed as follows:
(a)
one third for the Commission;
(b)
one third for the private members collectively; and
(c)
one third for the participating states collectively.
2. For the first two financial years following the establishment of the Key Digital Technologies Joint Undertaking, the voting rights of the participating states shall be distributed as follows:
(a)
1 % for each participating state;
(b)
the remaining percentage distributed annually among the participating states in proportion to their actual financial contributions to the Key Digital Technologies Joint Undertaking or to its preceding initiative over the past two years.
3. For the subsequent financial years, the distribution of the voting rights of the participating states shall be established annually and in proportion to the funds they have committed to indirect actions over the past two financial years.
4. The voting rights of the private members shall be distributed equally amongst the industrial associations unless decided otherwise by the Private Members Board.
5. Voting rights for any new member of the Key Digital Technologies Joint Undertaking that is not a Member State or an associated country shall be determined by the Governing Board before that member joins the Key Digital Technologies Joint Undertaking.
Article 134
Limitation to participation in specific actions
By derogation from Article 17(2), point (l), where the Commission so requests, following approval of the Public Authorities Board, participation in specific actions shall be limited in accordance with Article 22(5) of the Horizon Europe Regulation.
Article 135
Composition of the Public Authorities Board
The Public Authorities Board shall be composed of representatives of the public authorities of the Key Digital Technologies Joint Undertaking.
Each public authority shall appoint its representatives and a lead delegate who shall hold the voting rights in the Public Authorities Board.
Article 136
Functioning of the Public Authorities Board
1. The voting rights in the Public Authorities Board shall be assigned to the public authorities on an annual basis in proportion to their financial contribution to the activities of the Key Digital Technologies Joint Undertaking for that year in accordance with Article 12, and with an upper limit for any given member of 50 % of the total voting rights in the Public Authorities Board.
2. For the purpose of Article 134, the Public Authorities Board shall solely include public authorities that are Member States. Paragraph 1 shall apply mutatis mutandis.
3. If fewer than three participating states have communicated to the Executive Director their financial contribution according to Article 12(3), the Commission shall hold 50 % of the voting rights and the remaining 50 % shall be distributed equally amongst the participating states until such time as more than three Key Digital Technologies participating states have communicated their contribution.
4. The public authorities shall make every effort to adopt decisions by consensus. Failing consensus, a vote shall be held. A decision shall be adopted by a majority of at least 75 % of the votes including the votes of the participating states who are absent, but excluding abstentions.
5. The Public Authorities Board shall elect its chairperson from among its members for a period of at least two years.
6. The chairperson may invite other persons to attend its meetings as observers, in particular representatives of regional authorities within the Union, representatives of SME associations and representatives of other bodies of the Key Digital Technologies Joint Undertaking.
7. The Public Authorities Board shall hold its ordinary meetings at least twice a year. It may hold extraordinary meetings at the request of the Commission or of a majority of the representatives of the participating states, or at the request of the chairperson. The meetings of the Public Authorities Board shall be convened by its chairperson and shall normally take place at the seat of the Key Digital Technologies Joint Undertaking.
8. The quorum of the Public Authorities Board shall be constituted by the Commission and at least three participating states’ lead delegates.
9. The Executive Director shall attend the meetings of the Public Authorities Board meetings, unless decided otherwise by the Public Authorities Board, but shall have no voting rights.
10. Upon invitation from the Public Authorities Board, any Member State or associated country that is not a member of the Key Digital Technologies Joint Undertaking may participate in the Public Authorities Board meetings as an observer. Observers shall receive all relevant documents and may give advice on any decision taken by the Public Authorities Board. All such observers will be bound by the confidentiality rules applying to the Public Authorities Board members.
11. The Public Authorities Board may appoint working groups where necessary under the overall coordination of one or more public authorities.
12. The Public Authorities Board shall adopt its own rules of procedure.
13. Articles 11(8) and 28(6) shall also apply mutatis mutandis to the Public Authorities Board.
Article 137
Tasks of the Public Authorities Board
The Public Authorities Board shall:
(a)
contribute to the drafting of the Strategic Research and Innovation Agenda;
(b)
provide input to the draft work programme, in particular the calls for proposals, including the rules for evaluation, selection and monitoring of indirect actions;
(c)
approve the launch of calls for proposals, in accordance with the work programme;
(d)
select proposals in accordance with Articles 12(1) and 17(2), point (s);
(e)
provide an opinion on the draft additional activities plan referred to in Article 11(1), point (b).
Article 138
Composition of the Private Members Board
1. The Private Members Board shall be composed of representatives of the private members of the Key Digital Technologies Joint Undertaking.
2. Each private member shall appoint its representatives and a lead delegate who shall hold the voting rights in the Private Members Board.
Article 139
Functioning of the Private Members Board
1. The Private Members Board shall meet at least twice a year.
2. The Private Members Board may appoint working groups where necessary under the overall coordination of one or more members.
3. The Private Members Board shall elect its chairperson from among its members.
4. The Private Members Board shall adopt its rules of procedure.
Article 140
Tasks of the Private Members Board
The Private Members Board shall:
(a)
draw up and regularly update the draft Strategic Research and Innovation Agenda for achieving the objectives of the Key Digital Technologies Joint Undertaking set out in Articles 4 and 126 taking into account the input of the Public Authorities Board;
(b)
submit to the Executive Director the draft Strategic Research and Innovation Agenda within the deadlines set by the Governing Board;
(c)
organise an advisory Stakeholder Forum that is open to all public and private stakeholders having an interest in the field of key digital technologies to inform them about and collect feedback on the draft Strategic Research and Innovation Agenda for a given year;
(d)
where appropriate, and taking into account Article 130, draw up and submit for approval to the Governing Board the draft additional activities plan referred to in Article 11(1), point (b), taking into account the opinion of the Public Authorities Board.
Article 141
Funding rates
In accordance with Article 17(2) of the Horizon Europe Regulation and by way of derogation from Article 34 of that Regulation, the Key Digital Technologies Joint Undertaking may apply different funding rates for the Union funding within an action depending on the type of participant, in particular SMEs and non-profit legal entities, and the type of action. The funding rates shall be indicated in the work programme.
TITLE VIII
SINGLE EUROPEAN SKY ATM RESEARCH 3 JOINT UNDERTAKING
Article 142
Additional objectives of the Single European Sky ATM Research 3 Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Single European Sky ATM Research 3 Joint Undertaking shall have the following general objectives:
(a)
strengthen and integrate the Union’s research and innovation capacity in the ATM sector, making it more resilient and scalable to fluctuations in traffic while enabling the seamless operation of all aircraft;
(b)
strengthen, through innovation, the competitiveness of manned and unmanned air transport in the Union, and ATM services’ markets to support economic growth in the Union;
(c)
develop and accelerate the market uptake of innovative solutions to establish the Single European Sky airspace as the most efficient and environmentally friendly sky to fly in the world.
2. The Single European Sky ATM Research 3 Joint Undertaking shall also have the following specific objectives:
(a)
develop a research and innovation ecosystem covering the entire ATM and U-space airspace value chains allowing to build the Digital European Sky defined in the European ATM Master plan, enabling the collaboration and coordination needed between air navigation services providers and airspace users to ensure a single harmonised Union ATM system for both manned and unmanned operations;
(b)
develop and validate ATM solutions supporting high levels of automation;
(c)
develop and validate the technical architecture of the Digital European Sky;
(d)
support an accelerated market deployment of innovative solutions through demonstrators;
(e)
coordinate the prioritisation and planning for the Union’s ATM modernisation efforts, based on a consensus-led process among the ATM stakeholders;
(f)
facilitate the development of standards for the industrialisation of SESAR solutions.
3. For the purpose of the Single European Sky ATM Research 3 Joint Undertaking, the following definitions apply:
(a)
‘U-space airspace’ means an unmanned airborne system (UAS) geographical zone designated by Member States, where UAS operations are only allowed to take place with the support of U-space services provided by a U-Space service provider;
(b)
‘Digital European Sky’ refers to the vision of the European ATM Master Plan, seeking to transform Europe’s aviation infrastructure enabling it to handle the future growth and diversity of air traffic safely and efficiently, while minimising environmental impact;
(c)
‘architecture of the Digital European Sky’ refers to the vision of the European ATM Master Plan, seeking to address the current inefficient airspace architecture in the medium to long term by combining airspace configuration and design with technologies to decouple service provision from local infrastructure and progressively increase the levels of collaboration and automation support;
(d)
‘SESAR definition phase’ means the phase comprising the establishment and updating of the long-term vision of the SESAR project, of the related concept of operations enabling improvements at every stage of flight, of the required essential operational changes within the European ATM Network and of the required development and deployment priorities;
(e)
‘SESAR deployment phase’ means the successive phases of industrialisation and implementation, during which the following activities are conducted: standardisation, production and certification of ground and airborne equipment and processes necessary to implement SESAR solutions (industrialisation); and procurement, installation and putting into service of equipment and systems based on SESAR solutions, including associated operational procedures (implementation).
Article 143
Additional tasks of the Single European Sky ATM Research 3 Joint Undertaking
In addition to the tasks set out in Article 5, the Single European Sky ATM Research 3 Joint Undertaking shall carry out the following tasks:
(a)
coordinate the tasks of the Single European Sky ATM Research definition phase, monitor the implementation of the SESAR project and amend, where necessary, the European ATM Master Plan;
(b)
implement the research and development aspects of the European ATM Master Plan, in particular by:
(i)
organising, coordinating and monitoring the work of the SESAR development phase in accordance with the European ATM Master Plan, including low TRLs (0 to 2) research and innovation activities;
(ii)
delivering SESAR solutions, which are deployable outputs of the SESAR development phase introducing new or improved standardised and interoperable operational procedures or technologies;
(iii)
ensuring the involvement of the civil and military stakeholders of the aviation sector, in particular air navigation service providers, airspace users, professional staff associations, airports, manufacturing industry and the relevant scientific institutions and scientific community;
(c)
facilitate an accelerated market uptake of SESAR solutions by:
(i)
organising and coordinating large-scale demonstrations activities;
(ii)
coordinating closely with EASA in order to enable timely development by EASA of regulatory measures that fall under Regulation (EU) 2018/1139 and the relevant implementing rules;
(iii)
supporting the related standardisation activities, in close cooperation with standardisation bodies and EASA, as well as with the entity established to coordinate the tasks of the SESAR deployment phase in line with Commission Implementing Regulation (EU) No 409/2013 (43).
Article 144
Members
1. The members of the Single European Sky ATM Research 3 Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the European Organisation for the Safety of Air Navigation (Eurocontrol), represented by its Agency, upon notification of its decision to accede to the Single European Sky ATM Research 3 Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation;
(c)
the founding members listed in Annex III to this Regulation, upon notification of their decision to accede to the Single European Sky ATM Research 3 Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation;
(d)
the associated members to be selected in accordance with Article 7.
2. In addition to Article 7(1), the Governing Board may, during the first six months following the establishment of the Single European Sky ATM Research 3 Joint Undertaking, select associated members from a list drawn up after an open call for expression of interest launched by the Commission prior to its establishment. The conditions of Article 7(2) shall apply mutatis mutandis.
3. In selecting associated members, the Governing Board shall seek to ensure the proper representation of the entire ATM value chain and, where necessary, the selection of relevant players from outside the sector. Any public or private entity or body including those from third countries that have concluded at least one agreement with the Union in the field of air transport may be selected as associated members of the Single European Sky ATM Research 3 Joint Undertaking.
Article 145
Union financial contribution
The Union financial contribution to the Single European Sky ATM Research 3 Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 600 000 000, including up to EUR 30 000 000 for administrative costs.
Article 146
Contributions from members other than the Union
1. The private members of the Single European Sky ATM Research 3 Joint Undertaking shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 500 000 000, including up to EUR 25 000 000 for administrative costs, over the period set out in Article 3.
2. Eurocontrol shall make a total contribution of up to EUR 500 000 000, including up to EUR 25 000 000 for administrative costs, over the period set out in Article 3. In addition to Article 11(4), the contribution shall also consist of in-kind contributions to additional activities.
Article 147
Scope of additional activities
For the purposes of Article 11(1), point (b), additional activities may include:
(a)
activities covering all the non-Union funded part of the Single European Sky ATM Research projects that contribute to the achievement of the agreed work programme of the Joint Undertaking;
(b)
industrialisation activities, including standardisation, certification and production, related to SESAR Solutions from the Single European Sky ATM Research 3 Joint Undertaking or the preceding initiative, the SESAR Joint Undertaking;
(c)
communication and outreach activities related to SESAR Solutions from the Single European Sky ATM Research 3 Joint Undertaking or the preceding initiative, the SESAR Joint Undertaking;
(d)
activities ensuring the global ATM harmonisation based on SESAR Solutions from the Single European Sky ATM Research 3 Joint Undertaking or the preceding initiative, the SESAR Joint Undertaking;
(e)
deployment or uptake of results from projects under the Single European Sky ATM Research 3 Joint Undertaking or the preceding initiative, the SESAR Joint Undertaking, which have not received any Union funding.
Article 148
Bodies of the Single European Sky ATM Research 3 Joint Undertaking
The bodies of the Single European Sky ATM Research 3 Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the Scientific Advisory Body.
Article 149
Composition of the Governing Board
The Governing Board shall be composed as follows:
(a)
two representatives of the Commission on behalf of the Union;
(b)
one representative from each of the members other than the Union.
Article 150
Functioning of the Governing Board
1. By derogation to Article 16(4), the Governing Board shall be chaired by the Commission on behalf of the Union.
2. The Governing Board shall have the following permanent observers:
(a)
a representative of the European Defence Agency;
(b)
a representative of civil users of airspace, designated by their representative organisation at European level;
(c)
an air navigation service providers’ representative, designated by their representative organisation at European level;
(d)
an equipment manufacturers’ representative, designated by their representative organisation at European level;
(e)
an airports’ representative, designated by their representative organisation at European level;
(f)
a representative from the bodies representing staff in the ATM sector, designated by their representative organisation at European level;
(g)
a representative of the relevant scientific institutions or the relevant scientific community, designated by their representative organisation at European level:
(h)
a representative of the EASA;
(i)
a representative of the European standardisation organisation in aviation;
(j)
a representative of the unmanned aerial vehicle industry, designated by their representative organisation at European level.
3. The number of votes of the members of the Single European Sky ATM Research 3 Joint Undertaking shall be in proportion to their contribution to the budget of the joint undertaking. However, the Union and Eurocontrol shall each have at least 25 % of the total number of votes and the representative of the civil users of airspace referred to in paragraph 2, point (b), shall have at least 10 % of the total number of votes.
4. Decisions of the Governing Board shall be adopted by a simple majority of the votes cast. Where the votes are evenly divided, the Union shall have the deciding vote.
5. Decisions relating to the revision of the European ATM Master Plan shall require the positive votes of the Union and Eurocontrol. Such decisions shall take into account the opinions expressed by all permanent observers referred to in paragraph 2 and the states’ representatives group.
Article 151
Additional tasks of the Governing Board
In addition to the tasks listed in Article 17, the Governing Board of the Single European Sky ATM Research 3 Joint Undertaking shall supervise the delivery of the research and development components identified in the European ATM Master Plan.
Article 152
Additional tasks of the Executive Director
In addition to the tasks listed in Article 19, the Executive Director of the Single European Sky ATM Research 3 Joint Undertaking shall carry out the following tasks:
(a)
direct the execution of the definition and development phases of the SESAR project within the guidelines established by the Governing Board;
(b)
submit to the Governing Board any proposal involving changes in the design of the development phase of the SESAR project.
Article 153
The states’ representatives group
In addition to Article 20, the Member States shall ensure that their respective representatives present a coordinated position that reflects their Member State’s views expressed in:
(a)
the Single Sky Committee, established by Article 5 of Regulation (EC) No 549/2004;
(b)
the Programme Committee under Article 14 of the Specific Programme implementing Horizon Europe.
Article 154
The Scientific Committee
1. The scientific advisory body of the Single European Sky ATM Research 3 Joint Undertaking referred to in Article 21(1), point (a), shall be the Scientific Committee.
2. The Scientific Committee shall have no more than 15 permanent members.
3. The chairman of the Scientific Committee shall be elected for a period of two years.
4. The Scientific Committee may advise on request of the Governing Board and other bodies of the Single European Sky ATM Research 3 Joint Undertaking, or on its own initiative, in particular on activities related to low TRLs (0 to 2).
5. The Scientific Committee shall collaborate with the relevant advisory bodies set up under Horizon Europe.
Article 155
Implementing acts to establish the position of the Union concerning the amendment of the European ATM Master Plan
1. The Commission shall adopt implementing acts with the view to establishing the position of the Union concerning the amendment of the European ATM Master Plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council (44).
2. The Commission shall be assisted by the Single Sky Committee established by Regulation (EC) No 549/2004. The Single Sky Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Article 156
Certification of new technologies
1. The EASA may be invited by applicants, participants or the Executive Director to advise on individual projects and demonstration activities on issues related to compliance with aviation safety, interoperability and environmental standards, to ensure that those lead to timely development of relevant standards, testing capacity and regulatory requirements for product development and deployment of new technologies.
2. Certification activities and services provided shall be subject to the provisions regarding fees and charges set out in Regulation (EU) 2018/1139.
Article 157
Agreement with Eurocontrol
As founding member of the Single European Sky ATM Research 3 Joint Undertaking, Eurocontrol’s role and contribution shall be set out in an administrative agreement between the two parties, the Single European Sky ATM Research 3 Joint Undertaking and Eurocontrol. That agreement shall describe Eurocontrol’s tasks, responsibilities and contribution to the activities of the Single European Sky ATM Research 3 Joint Undertaking as regards the following:
(a)
organising Eurocontrol’s research, development and validation activities in accordance with the work programme of the Single European Sky ATM Research 3 Joint Undertaking;
(b)
providing specialist support and advice to the Single European Sky ATM Research 3 Joint Undertaking on its request;
(c)
supporting and advising on the common developments for the future European ATM systems, in particular related to the future airspace architecture;
(d)
supporting the monitoring of the implementation of SESAR Solutions in line with the European ATM Master Plan;
(e)
engaging with Eurocontrol Member States to secure wide support for the Union’s policy objectives and results of research, validation and demonstration activities amongst pan-European network partners;
(f)
providing support to programme management;
(g)
contributing to the administrative costs of the Single European Sky ATM Research 3 Joint Undertaking and providing information technology, communications and logistics support to the Single European Sky ATM Research 3 Joint Undertaking.
Article 158
Back office arrangements
Article 13 shall not apply to the Single European Sky ATM Research 3 Joint Undertaking. The back office arrangement shall be provided by Eurocontrol.
TITLE IX
SMART NETWORKS AND SERVICES JOINT UNDERTAKING
Article 159
Additional objectives of the Smart Networks and Services Joint Undertaking
1. In addition to the objectives set out in Articles 4 and 5, the Smart Networks and Services Joint Undertaking shall have the following general objectives:
(a)
foster Europe’s technological leadership in future smart networks and services by reinforcing current industrial strengths and by extending the scope from 5G connectivity to the broader strategic value chain including cloud-based service provisioning as well as components and devices;
(b)
align strategic roadmaps of a wider range of industrial players, including not only the telecommunication industry, but also actors from the internet of Things, cloud, and components and devices;
(c)
advance European technological and scientific excellence to support European leadership to shape and master 6G systems by 2030;
(d)
strengthen the deployment of digital infrastructures and uptake of digital solutions in the European markets, in particular by ensuring a strategic coordination mechanism for the CEF2 Digital programme as well as synergies within CEF2, and with DEP and InvestEU as part of the scope and governance of the Smart Networks and Services Joint Undertaking;
(e)
prepare the European smart networks and services supply industry for the longer term opportunities emerging from the development of vertical markets for 5G and later 6G infrastructures and services in Europe;
(f)
facilitate digital innovation, by 2030, meeting European market needs and public policy requirements, including the most demanding requirements of vertical industries, as well as societal requirements in fields including security, energy efficiency and electromagnetic fields;
(g)
support the alignment of future smart networks and services with Union policy objectives including European Green Deal, network and information security, ethics and privacy, as well as a human-centric and sustainable internet.
2. The Smart Networks and Services Joint Undertaking shall also have the following specific objectives:
(a)
facilitate the development of technologies able to meet advanced communication requirements while supporting European excellence in smart networks and services technologies and architectures and their evolution towards 6G, including strong European positions on standards, essential patents, and key requirements such as requirements for spectrum bands needed for future advanced smart network technologies;
(b)
accelerate the development of energy-efficient network technologies with the aim of significantly reducing the energy and resource consumption of the whole digital infrastructure by 2030 and decreasing the energy consumption of key verticals industries supported by smart networks and services technologies;
(c)
accelerate the development and widespread deployment of 5G by 2025 and later 6G infrastructure in Europe by, in particular, promoting the coordination and strategic support of 5G deployment for Connected and Automated Mobility along cross-border corridors, by using the CEF2 Digital programme and by promoting deployment under CEF2, DEP and InvestEU;
(d)
foster a sustainable and diverse supply and value chain in line with the 5G Cybersecurity toolbox;
(e)
strengthen the positioning of the Union’s industry in the global smart network and services value chain by creating a critical mass of public and private actors, in particular by increasing the contribution from software and internet of Things actors, leveraging national initiatives and supporting the emergence of new actors;
(f)
support alignment with ethical and security requirements, including them in the Strategic Research and Innovation Agendas and providing input to the Union’s legislative process as appropriate.
Article 160
Additional tasks of the Smart Networks and Services Joint Undertaking
In addition to the tasks set out in Article 5, the Smart Networks and Services Joint Undertaking shall carry out the following tasks:
(a)
contribute to the work programmes of other Union programmes, such as CEF2 Digital programme, DEP and InvestEU that are implementing activities in the area of smart networks and services;
(b)
coordinate Union trialling, piloting and deployment initiatives in the field of smart networks and services, such as pan-European 5G corridors for connected and automated mobility under CEF2 Digital programme, in liaison with the Commission and competent relevant funding bodies;
(c)
promote synergies among relevant Union-funded trials, pilots and deployment activities in the area of smart networks and services, such as those funded under CEF2 Digital programme, DEP and InvestEU, and ensure effective dissemination and leveraging of the knowledge and know-how gathered in the context of those activities;
(d)
develop and coordinate the strategic deployment agendas for pan-European 5G corridors for connected and automated mobility with the involvement of stakeholders. Those agendas shall provide strategic non-binding guidance covering the duration of CEF2 Digital programme by defining a common vision for the development of 5G-enabled ecosystems and the underpinning network and services requirements, and identifying deployment objectives and roadmaps as well as potential cooperation models.
Article 161
Members
The members of the Smart Networks and Services Joint Undertaking shall be:
(a)
the Union, represented by the Commission;
(b)
the 6G-IA registered under Belgian law, upon notification of its decision to accede to the Smart Networks and Services Joint Undertaking by means of a letter of commitment, which shall not contain conditions regarding its accession other than those set out in this Regulation.
Article 162
Union financial contribution
The Union financial contribution to the Smart Networks and Services Joint Undertaking, including EEA appropriations, to cover administrative costs and operational costs shall be up to EUR 900 000 000, including up to EUR 18 519 000 for administrative costs.
Article 163
Contributions from members other than the Union
1. The members of the Smart Networks and Services Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make a total contribution of at least EUR 900 000 000 over the period set out in Article 3.
2. The members of the Smart Networks and Services Joint Undertaking other than the Union shall make or arrange for their constituent or affiliated entities to make an annual financial contribution to the administrative costs of the Smart Networks and Services Joint Undertaking of at least 20 % of the total administrative costs. They shall endeavour to increase their number of constituent or affiliated entities in order to increase their contribution to 50 % of the administrative costs of the Smart Networks and Services Joint Undertaking over its lifetime, taking due account of constituent and affiliated entities that are SMEs.
Article 164
Scope of additional activities
For the purpose of Article 11(1), point (b), additional activities may include:
(a)
spin-off research and development activities;
(b)
contributions to standardisation;
(c)
contributions to consultations in the context of Union regulatory processes;
(d)
activities financed by loans of the European Investment Bank and not funded under a grant by the Union;
(e)
contributions to activities of the members other than the Union and any other group or association of stakeholders in the area of the Smart Networks and Services Joint Undertaking, not funded under a grant by the Union;
(f)
activities to develop the ecosystem including building cooperation with verticals;
(g)
dissemination activities of results globally to achieve consensus on supported technologies as preparation of future standards;
(h)
trials, demos, pilots, go to market and early deployment of technologies;
(i)
international cooperation not funded under a grant by the Union;
(j)
activities related to the preparation of, and participation in, research and innovation projects funded by private or public bodies other than the Union.
Article 165
Bodies of the Smart Networks and Services Joint Undertaking
The bodies of the Smart Networks and Services Joint Undertaking shall be:
(a)
the Governing Board;
(b)
the Executive Director;
(c)
the states’ representatives group;
(d)
the stakeholders group.
Article 166
Composition of the Governing Board
1. The Governing Board shall be composed of the following:
(a)
two representatives of the Commission on behalf of the Union;
(b)
five representatives of the 6G-IA.
2. Notwithstanding Article 42, the representatives of the private members shall disclose immediately to the Governing Board their involvement in professional activities with entities that are not established in the Union, or with entities that are not controlled by legal persons or entities established in the Union. In such a case, the representatives of the Union may decide to request the member concerned to appoint another representative.
Article 167
Functioning of the Governing Board
The 6G-IA shall hold 50 % of the voting rights.
Article 168
Additional tasks of the Governing Board
In addition to the tasks listed in Article 17, the Governing Board of the Smart Networks and Services Joint Undertaking shall carry out the following tasks:
(a)
adopt strategic deployment agendas as non-binding contributions under CEF2 Digital programme with regard to 5G corridors and, if appropriate, amend them throughout the duration of CEF2 Digital programme;
(b)
ensure that Union cybersecurity legislation and Member States’ existing and future coordinated guidance are taken into consideration in all the activities of the Smart Network and Services Joint Undertaking;
(c)
promote synergies and complementarities between the digital, transport and energy sectors of CEF2 Digital programme through the identification of intervention areas and contribution to the work programmes, as well as synergies and complementarities with the other relevant Union programmes.
Article 169
The states’ representatives group
In addition to Article 20, the representatives shall ensure that they present a coordinated position that reflects their state’s views expressed in any of the following:
(a)
the research and innovation matters related to Horizon Europe;
(b)
the strategic deployment agenda and the deployment activities related to other Union programmes, in particular CEF2 Digital programme, but also activities under DEP and InvestEU that are in scope of the Smart Networks and Services Joint Undertaking.
Article 170
Security
1. When deemed relevant, the Governing Board may mandate that an action funded by the Smart Networks and Services Joint Undertaking shall ensure that network elements deployed for large-scale experimentation or piloting follow security scrutiny assessments. The assessments shall reflect Union cybersecurity legislation and policies, as well as Member States’ existing and future coordinated guidance.
2. In relation to its task referred to in Article 160, point (a), the Governing Board shall advise that other funding bodies apply paragraph 1 of this Article and Article 17(2), point (l), to their actions mutatis mutandis, where it deems it appropriate and where this is authorised by the basic act of the respective Union funding programme.
PART THREE
FINAL PROVISIONS
Article 171
Monitoring and evaluation
1. The activities of the joint undertakings shall be subject to continuous monitoring and periodic reviews in accordance with their financial rules, to ensure the highest impact, scientific excellence and the most effective and efficient use of resources. The outcomes of monitoring and periodic reviews shall feed into the monitoring of European partnerships and evaluations of the joint undertakings as part of Horizon Europe evaluations, as specified in Articles 50 and 52 of the Horizon Europe Regulation.
2. The joint undertakings shall organise the continuous monitoring and reporting of the management and implementation of their activities and periodic reviews of the outputs, results and impacts of the funded indirect actions implemented in accordance with Article 50 of and Annex III to the Horizon Europe Regulation. That monitoring and reporting shall include:
(a)
time-bound indicators for the purpose of reporting on an annual basis on the progress of their activities towards the achievement of the general, specific and operational objectives, including joint undertakings’ additional objectives laid down in Part Two, as well as along impact pathways set out in Annex V to the Horizon Europe Regulation;
(b)
information on synergies between the joint undertaking’s actions and national or regional initiatives and policies based on information received by the participating states or the states’ representatives group as well as on synergies with other Union programmes and other European partnerships;
(c)
information on the level of mainstreaming social sciences and humanities, the ratio between lower and higher TRLs in collaborative research, the progress on widening countries’ participation, the geographical composition of consortia in collaborative projects, the use of two-stage submission and evaluation procedure, the measures that aim to facilitate collaborative links in European research and innovation, the use of the evaluation review and the number and types of complaints, the level of climate mainstreaming and related expenditures, SME participation, private sector participation, gender participation in funded actions, evaluation panels, boards and advisory groups, the co-funding rate, the complementary and cumulative funding from other Union funds, the time-to-grant, the level of international cooperation, engagement of citizens’ and civil society participation;
(d)
the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area;
(e)
the level of oversubscription, in particular the number of proposals and for each call for proposals, the average score, the share of proposals above and below quality thresholds;
(f)
information on quantitative and qualitative leverage effects, including on committed and actually provided financial and in-kind contributions, visibility and positioning in the international context, impact on research and innovation related risks of private sector investments;
(g)
information on measures for attracting newcomers, in particularly SMEs, higher education institutions and research organisations, and for expanding collaborative networks.
3. Evaluations of the joint undertakings’ operations shall be carried out in a timely manner to feed into the overall interim and final evaluations of Horizon Europe and the related decision-making process on Horizon Europe, its successor and other initiatives relevant to research and innovation, referred to in Article 52 of the Horizon Europe Regulation.
4. The Commission shall carry out an interim and a final evaluation of each Joint Undertaking feeding into the Horizon Europe evaluations, as specified in Article 52 of the Horizon Europe Regulation. The evaluations shall examine how each joint undertaking fulfils its mission and objectives, cover all activities of the joint undertaking and evaluate the joint undertaking’s concerned European added value, effectiveness, efficiency, including its openness and transparency, the relevance of the activities pursued and their coherence and complementarity with relevant regional, national and Union policies, including synergies with other parts of Horizon Europe, such as missions, clusters or thematic or specific programmes. The evaluations shall take into account the views of stakeholders, at both European and national level and shall, where relevant, also include an assessment of the long-term scientific, societal, economic and technological impacts of the joint undertakings referred to in Article 174(3) to (9). The evaluations shall also include, where relevant, an assessment of the most effective policy intervention mode for any future action, as well as the relevance and coherence of any possible renewal of each joint undertaking given the overall policy priorities and the research and innovation support landscape, including its positioning against other initiatives supported through the Framework Programme, in particular European partnerships or missions. The evaluations shall also take due account of the phasing-out plan adopted by the Governing Board in accordance with Article 17(2), point (a1).
5. On the basis of the conclusions of an interim evaluation referred to in paragraph 2 of this Article, the Commission may act in accordance with Article 11(6) or take any other appropriate action.
6. The Commission may carry out further evaluations of themes or topics of strategic relevance, with the assistance of external independent experts selected on the basis of a transparent process, to examine the progress made by a joint undertaking towards the objectives set, identify the factors contributing to the implementation of the activities and identify best practices. By carrying out those further evaluations, the Commission shall fully consider the administrative impact on the joint undertaking.
7. Joint undertakings shall perform periodic reviews of their activities to serve as a basis for their interim and final evaluations as part of Horizon Europe evaluations referred to in Article 52 of the Horizon Europe Regulation.
8. Periodic reviews and evaluations shall be taken into consideration in the winding up or phasing out of the joint undertaking referred to in Article 45 of this Regulation, in line with Annex III to the Horizon Europe Regulation. Within six months after the winding up of a joint undertaking, but no later than four years after the triggering of the winding-up procedure referred to in Article 45 of this Regulation, the Commission shall conduct a final evaluation of that joint undertaking in line with the final evaluation of Horizon Europe.
9. The Commission shall publish and communicate the results of the evaluations of the joint undertakings, which shall include conclusions of the evaluation and observations by the Commission, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions as part of the Horizon Europe evaluations referred to in Article 52 of the Horizon Europe Regulation.
Article 172
Support from the host state
An administrative agreement may be concluded between a joint undertaking and the Member State where its seat is located concerning privileges and immunities and other support to be provided by that Member State to the joint undertaking concerned.
Article 173
Initial actions
1. The Commission shall be responsible for the establishment and initial operation of the Global Health EDCTP3 Joint Undertaking and the Smart Networks and Services Joint Undertaking until they have the operational capacity to implement their own budget. The Commission shall carry out all necessary actions in collaboration with the other members and with the involvement of the competent bodies of those joint undertakings.
2. For the purpose of paragraph 1:
(a)
until the Executive Director takes up his or her duties following his or her appointment by the Governing Board in accordance with Article 18(2), the Commission may designate a Commission official to act as interim Executive Director and exercise the duties assigned to the Executive Director;
(b)
by derogation from Article 17(2), point (h), the interim Executive Director shall exercise the relevant appointing authority powers in respect of any staff positions that need to be filled before the Executive Director takes up his or her duties in accordance with Article 18(2);
(c)
the Commission may assign a limited number of its officials on an interim basis.
3. The interim Executive Director may authorise all payments covered by the appropriations provided in the annual budget of the Joint Undertakings referred to in paragraph 1 after they are approved by the Governing Board and may conclude agreements, decisions and contracts, including staff employment contracts, following the adoption of the staff establishment plan of those joint undertakings.
4. The interim Executive Director shall, with the agreement of the incoming Executive Director and subject to the approval of the Governing Board, determine the date on which the joint undertaking concerned will be deemed to have the capacity to implement its own budget. From that date, the Commission shall abstain from making commitments and executing payments for the activities of that joint undertaking.
Article 174
Repeal and transitional provisions
1. Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014 are repealed.
2. Actions initiated or continued under the Regulations referred to in paragraph 1 and the financial obligations related to such actions shall continue to be governed by those Regulations until their completion.
3. The Circular Bio-based Europe Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the Bio-based Industries Joint Undertaking established by Regulation (EU) No 560/2014, which it shall replace and succeed.
4. The Clean Aviation Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the Clean Sky 2 Joint Undertaking established by Regulation (EU) No 558/2014, which it shall replace and succeed.
5. The Clean Hydrogen Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the Fuel Cells and Hydrogen 2 Joint Undertaking established by Regulation (EU) No 559/2014, which it shall replace and succeed.
6. The Europe’s Rail Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the Shift2Rail joint undertaking established by Regulation (EU) No 642/2014, which it shall replace and succeed.
7. The Innovative Health Initiative Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the Innovative Medicines Initiative 2 Joint Undertaking established by Regulation (EU) No 557/2014, which it shall replace and succeed.
8. The Key Digital Technologies Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the ECSEL joint undertaking established by Regulation (EU) No 561/2014, which it shall replace and succeed.
9. The Single European Sky ATM Research 3 Joint Undertaking shall be the legal and universal successor in respect of all contracts, including employment contracts and grant agreements, liabilities and acquired property of the SESAR Joint Undertaking established by Regulation (EC) No 219/2007, which it shall replace and succeed.
10. This Regulation does not affect the rights and obligations of staff engaged under the Regulations referred to in paragraph 1.
11. The Executive Directors appointed under the Regulations referred to in paragraph 1 of this Article shall, for their remaining term of office, be assigned to the functions of Executive Director as provided for in this Regulation with effect from the date of entry into force of this Regulation. The other conditions of the contract shall remain unchanged.
12. In its first meeting, the Governing Board of each joint undertaking shall adopt a list of decisions adopted by the Governing Board of the preceding joint undertakings referred to in paragraphs 3 to 9 that shall continue to apply for the joint undertaking concerned established by this Regulation.
13. The interim evaluations referred to in Article 171(2) shall include a final evaluation of the preceding joint undertakings referred to in paragraphs 3 to 9 of this Article.
14. Any unused appropriations under the Regulations referred to in paragraph 1 shall be transferred to the corresponding joint undertaking established by this Regulation. Any unused operational appropriations so transferred shall first be used to provide financial support to indirect actions initiated under Horizon 2020. Remaining operational appropriations may be used for indirect actions initiated under this Regulation. Where such operational appropriations are used for indirect actions initiated under this Regulation, they shall count against the financial contribution to be provided by the Union to the respective joint undertaking under this Regulation.
Article 175
Entry into force
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 November 2021.
For the Council
The President
J. BORRELL FONTELLES
(1) Opinion of 21 October 2021 (not yet published in the Official Journal).
(2) OJ C 341, 24.8.2021, p. 29.
(3) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1).
(4) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104).
(5) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
(6) Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe – the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167 I, 12.5.2021, p. 1).
(7) Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (OJ L 231, 30.6.2021, p. 60).
(8) Regulation (EU) 2021/1057 of the European Parliament and of the Council of 24 June 2021 establishing the European Social Fund Plus (ESF+) and repealing Regulation (EU) No 1296/2013 (OJ L 231, 30.6.2021, p. 21).
(9) Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, p. 1).
(10) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).
(11) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159).
(12) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).
(13) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(14) Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
(15) OJ L 282, 19.10.2016, p. 4.
(16) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
(17) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1).
(18) Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European Sky (OJ L 96, 31.3.2004, p. 1).
(19) Council Regulation (EC) No 219/2007 of 27 February 2007 on the establishment of a Joint Undertaking to develop the new generation European air traffic management system (SESAR) (OJ L 64, 2.3.2007, p. 1).
(20) Council Decision 2009/320/EC of 30 March 2009 endorsing the European Air Traffic Management Master Plan of the Single European Sky ATM Research (SESAR) project (OJ L 95, 9.4.2009, p. 41).
(21) Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, p. 38).
(22) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1).
(23) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30).
(24) Council Regulation (EU) No 557/2014 of 6 May 2014 establishing the Innovative Medicines Initiative 2 Joint Undertaking (OJ L 169, 7.6.2014, p. 54).
(25) Council Regulation (EU) No 558/2014 of 6 May 2014 establishing the Clean Sky 2 Joint Undertaking (OJ L 169, 7.6.2014, p. 77).
(26) Council Regulation (EU) No 559/2014 of 6 May 2014 establishing the Fuel Cells and Hydrogen 2 Joint Undertaking (OJ L 169, 7.6.2014, p. 108).
(27) Council Regulation (EU) No 560/2014 of 6 May 2014 establishing the Bio-based Industries Joint Undertaking (OJ L 169, 7.6.2014, p. 130).
(28) Council Regulation (EU) No 561/2014 of 6 May 2014 establishing the ECSEL Joint Undertaking (OJ L 169, 7.6.2014, p. 152).
(29) Council Regulation (EU) No 642/2014 of 16 June 2014 establishing the Shift2Rail Joint Undertaking (OJ L 177, 17.6.2014, p. 9).
(30) OJ L 56, 4.3.1968, p. 1.
(31) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
(32) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
(33) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(34) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(35) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
(36) OJ L 136, 31.5.1999, p. 15.
(37) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(38) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(39) Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).
(40) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32).
(41) Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L 138, 26.5.2016, p. 1).
(42) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, p. 1).
(43) Commission Implementing Regulation (EU) No 409/2013 of 3 May 2013 on the definition of common projects, the establishment of governance and the identification of incentives supporting the implementation of the European Air Traffic Management Master Plan (OJ L 123, 4.5.2013, p. 1).
(44) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
ANNEX I
Founding members of the Clean Aviation Joint Undertaking
(1)
Aciturri Aeronáutica S.L.U., registered under Spanish law (registration number: BU12351), with its registered office in P.I. Bayas, calle Ayuelas, 22, 09200, Miranda de Ebro (Burgos), Spain;
(2)
Aernnova Aerospace SAU, registered under Spanish law (registration number: VI6749), with its registered office in Parque Tecnológico de Álava, C/Leonardo da Vinci num. 13, Miñano (Álava), Spain;
(3)
Airbus SAS, registered under French law (registration number: 383 474 814), with its registered office in 2 Rond-Point Emile Dewoitine, 31707 Blagnac, France;
(4)
Centro Italiano Ricerche Aerospaziali SCPA (CIRA), registered under Italian law (registration number: 128446), with its registered office in Via Maiorise 1, Capua-Caserta 81043, Italy;
(5)
Dassault Aviation SA, registered under French law (registration number: 712042456), with its registered office in 9, Rond-Point des Champs-Elysées Marcel-Dassault, 78008 Paris, France;
(6)
Deutsches Zentrum für Luft- und Raumfahrt e.V. (DLR), registered under German law (registration number: VR2780), with its registered office in Linder Höhe, 51147 Köln, Germany;
(7)
Fraunhofer-Gesellschaft zur Förderung der Angewandten Forschung e.V., registered under German law (registration number: VR4461), with its registered office in 27C, Hansastrasse, 80686 München, Germany;
(8)
Fokker Technologies Holding BV, registered under Dutch law (registration number: 50010964), with its registered office in Industrieweg 4, 3351 LB Papendrecht, The Netherlands;
(9)
GE Avio S.r.l., registered under Italian law (registration number: 1170622CF10898340012), with its registered office in Rivalta di Torino (TO), Via I Maggio no. 99, Italy;
(10)
GKN Aerospace, Sweden AB, registered under Swedish law (registration number: 5560290347), with its registered office in Flygmotorvägen 1, SE-461 81 Trollhättan, Sweden;
(11)
Honeywell International s.r.o., registered under Czech law (registration number: 27617793), with its registered office in V Parku 2325/18, 148 00 Praha 4 – Chodov, Prague, Czech Republic;
(12)
Industria de Turbo Propulsores S.A.U., registered under Spanish law (registration number: BI5062), with its registered office in Parque Tecnológico, Edificio 300, 48170 Zamudio, Spain;
(13)
Leonardo SpA, registered under Italian law (registration number: 7031), with its registered office in Piazza Monte Grappa 4, 00195 Rome, Italy;
(14)
Liebherr-Aerospace & Transportation SAS, registered under French law (registration number: 552016834), with its registered office in 408 avenue des Etats-Unis, 31016 Toulouse Cedex 2, France;
(15)
Lufthansa Technik AG, registered under German law (registration number: HRB 56865), with its registered office in Weg beim Jäger 193, 22335 Hamburg, Germany;
(16)
Łukasiewicz Research Network – Institute of Aviation, registered under Polish law (registration number: 387193275), with its registered office in Al. Krakowska 110/114, 02-256 Warsaw, Poland;
(17)
MTU Aero Engines AG, registered under German law (registration number: HRB 157206), with its registered office in Dachauer Str. 665, 80995 München, Germany;
(18)
National Institute for Aerospace Research (INCAS), registered under Romanian law (registration number: J40649215071991), with its registered office in B-dul Iuliu Maniu no. 220, sect 6, 061126 Bucharest, Romania;
(19)
Office National d’Etudes et de Recherches Aérospatiales (ONERA), registered under French law (registration number: 775722879), with its registered office in BP 80100 – 91123 Palaiseau, France;
(20)
Piaggio Aero Industries, registered under Italian law (registration number: 903062), with its registered office in Viale Generale Disegna, 1, 17038 Villanova d’Albenga, Savona, Italy;
(21)
Pipistrel Vertical Solutions d.o.o., registered under Slovenian law (registration number: 7254466000), with its registered office in Vipavska cesta 2, SI-5270 Ajdovščina, Slovenia;
(22)
Rolls-Royce Deutschland Ltd & Co KG, registered under German law (registration number: HRA 2731P), with its registered office in Eschenweg 11, Dahlewitz, 15827 Blankenfelde-Mahlow, Germany;
(23)
Safran, registered under French law (registration number: 562 082 909), with its registered office in 2, Bvd. du General Martial-Valin, 75015 Paris, France;
(24)
Stichting Nationaal Lucht- en Ruimtevaartlaboratorium, registered under Dutch law (registration number: 41150373), with its registered office in Anthony Fokkerweg 2, 1059 CM Amsterdam, The Netherlands;
(25)
Thales AVS France SAS, registered under French law (registration number: 612039495), with its registered office in 75-77 Avenue Marcel Dassault, 33700 Mérignac, France;
(26)
United Technologies Research Centre Ireland, Ltd, registered under Irish law (registration number: 472601), with its registered office in Fourth Floor, Penrose Business Centre, Penrose Wharf, Cork T23 XN53, Ireland;
(27)
University of Patras, registered under Greek law (registration number: EL998219694 (VAT)), with its registered office in University Campus, 26504 Rio Achaia, Greece.
ANNEX II
Founding members of the Europe’s Rail Joint Undertaking
(1)
Administrador de Infraestructuras Ferroviarias (ADIF), Entidad Pública Empresarial, a public corporate company registered under Spanish law (registration number: Q2801660H), with its registered office at Calle Sor Ángela de la Cruz, 3, 28020 Madrid, Spain;
(2)
Alstom Transport SA, registered under French law (registration number 389 191 982), with its registered office in 48, rue Albert Dhalenne, 93482 Saint-Ouen, France;
(3)
ANGELRAIL consortium led by MER MEC S.p.A., registered under Italian law (registration number: 05033050963), with its registered office in Monopoli (BA) 70043 Via Oberdan, 70 Italy;
(4)
AŽD Praha s.r.o., registered under Czech law (registration number: 48029483), with its registered office in Žirovnická 3146/2, Záběhlice, 106 00, Praha 10, Czech Republic;
(5)
Construcciones y Auxiliar de Ferrocarriles, S.A. (CAF), registered under Spanish law (registration number: Volume 983, Folio 144, Sheet number SS-329, entry 239a), with its registered office in calle José Miguel Iturrioz n° 26, 20200, Beasain (Gipuzkoa), Spain;
(6)
Asociación Centro Tecnológico CEIT, registered under Spanish law (registration number: 28/1986 Registry of Associations of the government of the autonomous community of the Basque Country), with its registered office in Paseo Manuel Lardizabal, n° 15. Donostia-San Sebastián, Spain;
(7)
České dráhy, a.s., registered under Czech law (registration number: 70994226, entered in the Commercial Register kept by the Municipal Court in Prague, section B, insert 8039), with its registered office in Prague 1, Nábřeží L. Svobody 1222, postal code 110 15, Czech Republic;
(8)
Deutsche Bahn AG, Germany;
(9)
Deutsches Zentrum für Luft- und Raumfahrt e.V. (DLR), registered under German law (registration number: VR 2780 at Amtsgericht Bonn), with its registered office in Linder Höhe, 51147 Cologne, Germany;
(10)
European Smart Green Rail Joint Venture (eSGR JV), represented by Centro de Estudios de Materiales y Control de Obra S.A (CEMOSA), registered under Spanish law (registration number: A-29021334), with its registered office in Benaque 9, 29004 Málaga, Spain;
(11)
Faiveley Transport SAS, registered under French law (registration number 323 288 563 RCS Nanterre), with its registered office in 3, rue du 19 mars 1962, 92230 Gennevilliers, France;
(12)
Ferrovie dello Stato Italiane S.p.A. (FSI), registered under Italian law (registration number: R.E.A. 962805), with its registered office in piazza della Croce Rossa 1 – 00161 Roma, Italy;
(13)
Hitachi Rail STS S.p.A., registered under Italian law, registration number R.E.A. GE421689, with its registered office in Genova, Italy;
(14)
INDRA SISTEMAS S.A & PATENTES TALGO S.L.U.
INDRA SISTEMAS S.A., registered under Spanish law (registration number: A-28599033), with its registered office in Avenida de Bruselas n° 35, 28108 Alcobendas, Madrid, Spain;
PATENTES TALGO S.L.U., registered under Spanish law (registration number: B-84528553), with registered office in Paseo del tren Talgo, n° 2, 28290 Las Rozas de Madrid, Madrid, Spain;
(15)
Jernbanedirektorate (Norwegian Rail Directorate), Oslo, Norway;
(16)
Knorr-Bremse Systems für Schienenfahrzeuge GmbH, registered under German law (registration number: HRB91181), with its registered office in Moosacher Str. 80, 80809 München, Germany;
(17)
Österreichische Bundesbahnen-Holding Aktiengesellschaft (ÖBB-Holding AG), registered under Austrian law (registration number: FN 247642f), with its registered office in Am Hauptbahnhof 2, 1100 Vienna, Austria;
(18)
Polskie Koleje Państwowe Spółka Akcyjna (PKP), registered under Polish law (registration number: 0000019193), with its registered office Al. Jerozolimskie 142A, 02-305 Warszawa, Poland;
(19)
ProRail B.V. & NS Groep N.V.
ProRail B.V., registered under Dutch law (registration number: 30124359), with its registered office in Utrecht (PIC-nr.: 998208668), The Netherlands;
NS Groep N.V., registered under Dutch law (registration number: 30124358), with its registered office in Utrecht (PIC-nr.: 892354217), The Netherlands;
(20)
Siemens Mobility GmbH, registered under German law (registration number HRB 237219), with its registered office in Otto-Hahn-Ring 6, Munich, Germany;
(21)
Société nationale SNCF, société anonyme, registered under French law (registration number: 552 049 447), with its registered office in 2 Place aux Étoiles, 93200 Saint-Denis, France;
(22)
Strukton Rail Nederland B.V., registered under Dutch law (registration number: 30139439 Chamber of commerce Utrecht), The Netherlands;
(23)
THALES SIX GTS France SAS, registered under French law (registration number: 383 470 937), with its registered office in 4 Avenue des Louvresses – 92230 Gennevilliers, France;
(24)
Trafikverket, a Public Sector Body, registered under Swedish law (registration number: 202100-6297), with its registered office in 781 89 Borlänge, Sweden;
(25)
voestalpine Railway Systems GmbH, registered under Austrian law (registration number: FN 126714w), with its registered office in Kerpelystrasse 199, 8700 Leoben, Austria.
ANNEX III
Founding members of the Single European Sky Research 3 Joint Undertaking
(1)
Aeroporti di Roma SpA, a company incorporated under Italian law, subject to the management and coordination of Atlantia SpA, with registered office at Via Pier Paolo Racchetti 1, Fiumicino (Rome), Italy, Tax Code and Rome Business and Trade Registry number 13032990155;
(2)
AENA Sociedad Mercantil Estatal, Sociedad Anónima (AENA S.M.E.S.A), registered under Spanish law (official registration C.I.F Tax identification certificate.: A-86212420), with its legal address at Calle Peonías 12, 28042, Madrid, Spain. Telephone number +34 913 211 000;
(3)
AEROPORTS DE PARIS, Société Anonyme, registered under French law (official registration RCS Bobigny B 552 016 628), with its registered office in 1 rue de France, 93290 Tremblay-en-France, France;
(4)
Société Air France SA, registered under French law, 420 495 178 RCS Bobigny, 45 rue de Paris, 95747 Roissy-CDG, France, FR 61 420 495 178;
(5)
Air Navigation Services of the Czech Republic (ANS CR), state enterprise, established and organised under the laws of the Czech Republic, with its registered office at Navigační 787, 252 61 Jeneč, Czech Republic, Company Identification Number: 497 10 371, VAT Identification Number: CZ699004742, registered in the Commercial Register administered by the Municipal Court in Prague, under Section A, Insert 10771;
(6)
Airbus SAS, registered under French law (registration number: 383 474 814 R.C.S. Toulouse), with its registered office in 2 Rond Point Émile Dewoitine, 31700 Blagnac, France;
(7)
Airtel ATN Limited, registered under Irish law (registration number: 287698), with its registered office in 2 Harbour Square, Crofton Road, Dun Laoghaire, County Dublin, A96 D6RO, Ireland;
(8)
Alliance for New Mobility Europe (AME), a non-profit organisation (‘Association sans but lucratif / Vereniging zonder winstoogmerk’), registered under Belgian law with registration number 0774.408.606, with its registered office in 227, rue de la Loi, 1000 Brussels, Belgium;
(9)
Athens International Airport S.A, registered under Greek Law (official registration: General Electronic Commercial Registry under G.E.MI. number 2229601000), with its registered premises at Spata Attica, Greece, postal code 19019;
(10)
Austro Control Österreichische Gesellschaft für Zivilluftfahrt mit beschränkter Haftung, a company with limited liability, registered under the Laws of Austria (registration number 71000m), with its registered office at Wagramer Strasse 19, A-1220 Vienna, Austria;
(11)
Brussels Airport Company NV/SA, a limited liability company incorporated and existing under the laws of Belgium, registered with the Crossroads Bank of Enterprises under number 0890.082.292 and with its registered offices in Auguste Reyerslaan 80, 1030 Brussels, Belgium;
(12)
Boeing Aerospace Spain, SL, registered under Spanish law, VAT number: B-83053835, with its registered office in Avenida Sur del Aeropuerto de Barajas 38, Madrid, 28042, Spain;
(13)
State enterprise “Air traffic services authority” (BULATSA), state enterprise, registered under Bulgarian law (registration number 000697179), with its registered office in Bulgaria, 1 Brussels blvd, 1540 Sofia;
(14)
Centro Italiano Ricerche Aerospaziali C.I.R.A. SCpA, registered under Italian law (registration number: CE-128446), with its registered office in Via Maiorise snc – 81043 Capua (CE) – Italy;
(15)
Croatia Control Ltd, (CCL), registered under the Laws of Croatia (registration number 080328617), with its registered office at Rudolfa Fizira 2, Velika Gorica, Croatia;
(16)
Deutsche Lufthansa AG; registered under German law, District Court of Cologne HRB 2168, Venloer Str. 151-153, D-50672 Cologne, Germany, DE 122 652 565;
(17)
Deutsches Zentrum fur Luft- und Raumfahrt e.V. (DLR), registered under German law (registration number: VR 2780 at Amtsgericht Bonn), with its registered office in Linder Höhe, 51147 Cologne, Germany;
(18)
DFS Deutsche Flugsicherung GmbH, registered under the Private Law (Registration number: HRB 34977), with its registered office in Langen (Hessen), Germany;
(19)
The French State – Ministry for an ecological transition, Direction générale de l’aviation civile (DGAC), Direction des services de la navigation aérienne DSNA, registered under French law (registration number: SIREN 120 064 019 00074), with its registered office at 50 rue Henry Farman 75 720 Paris Cedex 15, France;
(20)
Drone Alliance Europe, non-profit organisation (‘Association sans but lucratif / Vereniging zonder winstoogmerk’), registered under Belgian law with registration number 0693.860.794, with its registered office in rue Breydel 34 – 36, 1040 Brussels, Belgium;
(21)
Droniq GmbH, registered under German law, Ginnheimer Stadtweg 88, 60431 Frankfurt, Germany, Amtsgericht Frankfurt am Main, HRB 115576, DE324815501;
(22)
easyJet Europe Airline GmbH, registered under the Laws of Austria (registration number FN 452433 v), with its registered office at Wagramer Strasse 19, IZD Tower, 11. Stock, 1220 Vienna, Austria;
(23)
Ecole Nationale de l’Aviation Civile (ENAC), registered under French law registration number: n°193 112 562 00015, with its registered office on 7 avenue Edouard Belin, CS 54005 – 31055 TOULOUSE cedex 4, France;
(24)
ENTIDAD PUBLICA EMPRESARIAL ENAIRE, a public business entity registered under the law 4/1990 of June 29th and Law 18/2014 of October 15th, VAT number: Q2822001J, and with its registered office in Parque Empresarial las Mercedes. Edificio n°2 Avda. de Aragón, 330. 28022 Madrid, Spain;
(25)
ENAV S.p.A., a Joint-Stock Company registered under the laws of Italy, registration number: R.E.A. 965162, with its registered office in Via Salaria, 716 – 00138, Rome, Italy;
(26)
Flughafen München GmbH, registered under German law (registration number: HRB 5448, Munich local court), with its registered office at Nordallee 25, 85356 Munich-Airport, Germany;
(27)
Frequentis AG, registered under Austrian law (registration number: FN 72115 b), with its registered office in Innovationsstraße 1, 1100 Vienna, Austria;
(28)
Honeywell International s.r.o., registered under Czech law, ID No.: 276 17 793, with its registered office in V Parku 2325/16, 148 00 Prague 4, Czech Republic;
(29)
HungaroControl Hungarian Air Navigation Services Private Limited Company, registered under Hungarian law (registration number: 01-10-045570), with its registered office in Igló utca 33-35, 1185 Budapest, Hungary;
(30)
Indra Sistemas, S.A., registered under Spanish law, with Tax Identification Code A-28599033, registered in the Mercantile Registry of Madrid in Volume 5465 general, 4554 of section 3 of the Corporate Ledger, Folio 80, Sheet number43677, 1st entry, with its registered office at Avenida de Bruselas, NUM 35, 28108 Alcobendas – Madrid;
(31)
Irish Aviation Authority (IAA), registered under the Laws of Ireland (registration number 211082), with its registered office at The Times Building, 11-12 D’Olier Street, Dublin 2, Ireland;
(32)
Københavns Lufthavne A/S, registered under Danish law (official registration CVR 14707204), with its registered office in Lufthavnsboulevarden 6, 2770 Kastrup;
(33)
L’OFFICE NATIONAL D’ÉTUDES ET DE RECHERCHES AÉROSPATIALES (ONERA), a French agency (Établissement public à caractère industriel et commercial), registered under French Law with the Évry commercial and companies registry (number 775 722 879), having its head office at: BP 80100 – FR-91123 Palaiseau Cedex – France;
(34)
Leonardo Società per azioni; Short name: Leonardo S.p.A. – registered under the Italian Law (Fiscal Code and Registration number: 00401990585), with its registered office in Piazza Monte Grappa n. 4, 00195 Roma, Italy;
(35)
Letiště Praha, a. s. („Prague Airport“), a Joint-Stock Company registered under the law of Czech Republic, registration number: 28244532, with its registered office in K Letišti 6/1019, Prague 6, Czech Republic;
(36)
Luftfartsverket (LFV), registered under the Laws of Sweden (registration number 202195-0795) with its registered office at Hospitalsgatan 30, S-601 79 Norrköping – Sweden;
(37)
Luchtverkeersleiding Nederland (LVNL) a public body established by the Dutch Aviation Act, registered under Dutch law (registration number: 34367959), with its registered office at Stationsplein ZuidWest 1001, 1117 CV Schiphol, The Netherlands;
(38)
NAVEGAÇÃO AÉREA DE PORTUGAL – NAV Portugal E.P.E, registered under the Laws of Portugal (registration number 504448064) with its registered office at Rua D, Edifício 121, Aeroporto de Lisboa, 1700-008 Lisboa, Portugal;
(39)
NAVIAIR, registered under the Laws of Denmark, including the law on Naviair of 26 May 2010, (registration number 26059763) with its registered office is at Naviair Allé 1 2770 Kastrup, Denmark;
(40)
Stichting Koninklijk Nederlands Lucht- en Ruimtevaartcentrum (NLR), a foundation under Dutch law with Chamber of Commerce registration number: 41150373, with its registered office in Amsterdam, The Netherlands, with address at Anthony Fokkerweg 2, 1059 CM Amsterdam, The Netherlands;
(41)
Pipistrel Vertical Solutions d.o.o., registered under Slovenian law (registration number: 7254466000), with its registered office in Ajdovščina, Slovenia;
(42)
Polish Air Navigation Services Agency PANSA, state legal entity, organised and operating under the Act of 8 December, 2006 on Polish Air Navigation Services Agency, National Business Registry Number: 140886771, tax identification number: 5222838321, located at Wieżowa 8 street, 02-147 Warszawa, Poland;
(43)
Régie autonome ”Romanian Air Traffic Services Administration” – ROMATSA, state legal entity registered under Romanian Trade Register’s Office No. J40/1012/1991, Tax Code No. RO1589932, located at 10, Ion Ionescu de la Brad Blvd., 013813, Bucharest, Romania;
(44)
Ryanair Holdings plc, registered under Irish law, Ryanair Dublin Office, Airside Business Park, Swords, County Dublin, Ireland, Company No 249885;
(45)
Saab AB (publ), registered under Swedish law (registration number 556036-0793), with its registered office 581 88 Linköping, Sweden;
(46)
SAFRAN, registered under French law (Registration number: 562 082 909 R.C.S. Paris), with its registered office in Paris, France;
(47)
SINTEF AS, a non-profit Research and Technology Organisation, registered under Norwegian law (registration number: 919 303 808), with its registered office in Strindvegen 4 7034 TRONDHEIM, Norway;
(48)
SCHIPHOL NEDERLAND BV, registered under Dutch law (Chambers of Commerce number: 34166584), with its registered office in SHG, Evert van de Beekstraat 202, 1118 CP Schiphol, The Netherlands;
(49)
Societa per Azioni Esercizi Aeroportuali (S.E.A), official registration No: 00826040156, with its registered office at Aeroporto Milano Linate, Segrate, 20090, Italy, VAT number: 00826040156;
(50)
SWEDAVIA AB, a public limited company, registered under Swedish law on 14 December 2009 with the official registration number 556797-0818, having its registered office in Sigtuna with the address 190 45 Stockholm-Arlanda;
(51)
THALES AVS SAS FRANCE, Société simplifiée par actions, registered under THALES AVS law of France registration number RCS Bordeaux 612 039 495, with its registered office in 73-75 Avenue Marcel Dassault 33700 Mérignac, France;
(52)
THALES LAS FRANCE SAS, registered under French law (registration number: 319 159 877), with its registered office in 2, Avenue Gay Lussac, 78990 Elancourt, France;
(53)
United Technologies Research Centre Ireland Limited, registered under Irish laws (registration number: 472601), with its registered office in Penrose Business Centre, Penrose Wharf, Cork, Ireland;
(54)
Volocopter GmbH registered under German law (registration number HRB 702987), with its registered office in Zeiloch 20, 76646 Bruchsal, Germany;
(55)
VTT Technical Research Centre of Finland Ltd, registered under Finnish law (registration number: 2647375-4), with its registered office in Espoo, Finland and registered address P.O. Box 1000, FI-02044 VTT, Finland.
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Public–private partnerships under Horizon Europe
Public–private partnerships under Horizon Europe
SUMMARY OF:
Regulation (EU) 2021/2085 establishing the joint undertakings under Horizon Europe
WHAT IS THE AIM OF THE REGULATION?
The regulation:
sets up nine joint undertakings as public–private partnerships under the Horizon Europe programme, as provided for in Article 187 of the Treaty on the Functioning of the European Union;
determines their objectives and tasks, membership, organisation and other operating rules.
KEY POINTS
General objectives
The nine joint undertakings are collectively designed to:
strengthen and integrate scientific, innovative and technological capacities and collaboration;
support knowledge and skills;
deliver on global challenges;
enhance competitiveness, resilience and sustainability;
help achieve a stronger European research area;
secure sustainability-driven global leadership and resilience in important technologies and industries in line with industrial and small and medium-sized enterprise strategies, the European Green Deal, the European recovery plan and other policies;
improve the uptake of innovative solutions, addressing climate, environmental, health and other global challenges;
contribute to European Union (EU) strategic priorities and economic growth;
help achieve the United Nations sustainable development goals and climate neutrality by 2050, in line with the Paris Agreement.
The following joint undertakings are set up as EU bodies for a period ending on 31 December 2031, financed under the 2021–2027 multiannual financial framework.
Circular Bio-based Europe, designed to:
speed up the development of innovative bio-based solutions;
accelerate market deployment of existing solutions;
ensure that bio-based industrial systems perform at a high level.
Clean Aviation, designed to :
help reduce the carbon footprint of aviation by accelerating the development of climate-neutral aviation technologies;
ensure that aeronautics research and innovation (R & I) contributes to EU aviation industry competitiveness;
advance EU aviation R & I capacity.
Clean Hydrogen, designed to:
help with EU ambitions to reduce greenhouse gas emissions through the 2020 hydrogen strategy for a climate-neutral Europe;
strengthen the EU clean hydrogen value chain's competitiveness, bringing innovative clean solutions to the market more rapidly;
stimulate R & I on clean hydrogen.
Europe’s Rail, designed to:
help achieve the single European railway area;
ensure fast transition to a more attractive, user-friendly, competitive, affordable, easy-to-maintain, efficient, integrated and sustainable rail system;
support a strong and globally competitive European rail industry.
Global Health European and developing countries clinical trials partnership 3, designed to:
help reduce the socioeconomic burden of infectious diseases in sub-Saharan Africa by promoting new or improved health technologies;
strengthen preparedness and response to infectious diseases to contribute to health security in sub-Saharan Africa and globally.
Innovative Health Initiative, designed to:
create a health R & I ecosystem, helping translate scientific knowledge into innovations;
develop safe, cost-effective innovations to respond to strategic unmet public health needs;
drive innovation for a competitive and effective European health industry, industrial strategy for Europe and pharmaceutical strategy for Europe.
Key Digital Technologies, designed to:
reinforce autonomy in electronic components and systems to support future needs of vertical industries and the economy;
establish scientific excellence and innovation leadership in emerging components and systems technologies, particularly involving small and medium-sized enterprises;
ensure Europe’s societal and environmental challenges are addressed by components and systems technologies.
Single European Sky ATM Research 3, designed to:
strengthen and integrate EU R & I capacity in air traffic management, making it more resilient and scalable;
strengthen, through innovation, the competitiveness of manned and unmanned air transport;
develop and speed up the market uptake of innovative solutions to establish the single European sky as the world’s most efficient and environmentally friendly airspace.
Smart Networks and Services, designed to:
foster Europe’s technological leadership in future smart networks and services;
achieve better strategic alignment with the telecoms industry, along with the internet of things, the cloud, and components and devices;
advance European technological and scientific leadership to shape and master 6G systems by 2030;
strengthen digital infrastructure deployment and the uptake of digital solutions in the European markets;
support the alignment of future smart networks and services with policy objectives including the European Green Deal, security, ethics and privacy, together with a human-centric and sustainable internet.
Monitoring and evaluation
The joint undertakings are continuously monitored to ensure the greatest impact, their scientific excellence and the most effective and efficient use of resources. Results will be fed back to the Horizon Europe project.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 30 November 2021.
BACKGROUND
For further information, see:
European partnerships in Horizon Europe (European Commission)
European partnership – FAQs (European Commission).
MAIN DOCUMENT
Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014 (OJ L 427, 30.11.2021, pp. 17–119).
RELATED DOCUMENTS
Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1–68).
Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, pp. 13–43).
Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions – The European Green Deal (COM(2019) 640 final, 11.12.2019).
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1–222).
Consolidated version of the Treaty on the Functioning of the European Union – Part Three – Union policies and internal actions – Title XIX – Research and technological development and space – Article 187 (ex Article 171 TEC) (OJ C 202, 7.6.2016, p. 131).
last update 10.02.2022
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32021R0765
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12.5.2021
EN
Official Journal of the European Union
LI 167/81
COUNCIL REGULATION (Euratom) 2021/765
of 10 May 2021
establishing the Research and Training Programme of the European Atomic Energy Community for the period 2021-2025 complementing Horizon Europe – the Framework Programme for Research and Innovation and repealing Regulation (Euratom) 2018/1563
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular the first paragraph of Article 7 thereof,
Having regard to the proposal from the European Commission,
After consulting the Scientific and Technical Committee,
Whereas:
(1)
One of the aims of the European Atomic Energy Community (the ‘Community’) is to contribute to the raising of the standard of living in the Member States, including by promoting and facilitating nuclear research in the Member States and complementing it by carrying out a Community research and training programme.
(2)
Nuclear research can contribute to social well-being, economic prosperity and environmental sustainability by improving nuclear safety, security and radiation protection. Research on radiation protection has led to improvements in medical technologies from which many citizens benefit, and that research can lead to improvements in other sectors such as industry, agriculture, environment and security.
(3)
In full respect of the Member States’ right to decide on their energy mix, research results of the programme established by this Regulation could potentially contribute towards a climate neutral energy system in a safe, efficient and secure way.
(4)
In order to ensure the continuity of nuclear research at Community level, it is necessary to establish the Research and Training Programme of the Community for the period from 1 January 2021 to 31 December 2025 (the ‘Euratom Programme’). The Euratom Programme should continue carrying out the key research activities of previous programmes, while introducing new specific objectives and using the same mode of implementation.
(5)
The Commission’s Report on the interim evaluation of the 2014-18 Euratom Research and Training Programme contains a set of guiding principles for the Euratom Programme. These include: continuing to support nuclear research focused on nuclear safety, safeguards, security, waste management, radiation protection and development of fusion; together with beneficiaries, further improving the organisation and management of the European Joint Programmes in the nuclear field; continuing and reinforcing the Euratom education and training actions for developing relevant competencies which underpin all aspects of nuclear safety, security and radiation protection; further exploiting synergies between Euratom programmes and the other thematic areas of the Union Framework Programme; and further exploiting synergies between direct and indirect actions of the Euratom Programme.
(6)
The conception and design of the Euratom Programme is set against the need to establish a critical mass of supported activities. This is to be achieved by establishing a limited number of specific objectives focussed on safe use of nuclear fission for power and non-power applications, maintaining and developing necessary expertise, fostering fusion energy and supporting the policies of the Union and its Member States on nuclear safety, safeguards and security.
(7)
The Euratom Programme is a crucial part of the Union’s efforts to further develop technological leadership and promote excellence in nuclear research and innovation, in particular to ensure the highest standards of safety, security, safeguards, radiation protection, safe spent fuel, radioactive waste management and decommissioning in the nuclear field, in accordance with the programme objectives set out in this Regulation.
(8)
As all Member States make use of radioactive materials, for example for medical purposes, or have nuclear installations, it is important to ensure the responsible and safe management of spent fuel and radioactive waste, as required by the Council Directive 2011/70/Euratom (1), in order to avoid imposing undue burdens on future generations. The Euratom Programme should continue to improve and support research and development relating to technologies and competencies in the area of spent fuel and radioactive waste management.
(9)
In the context of this Regulation, fusion energy research is being implemented in accordance with the European Fusion Roadmap, which outlines the research and developments required to provide the basis for an electricity-generating fusion power plant, and with Council Decision 2007/198/Euratom (2). In the short-to-medium term the key step is the completion of the construction and initial operation of ITER and a vigorous fusion research programme should complement the European activities on ITER in order to support the future ITER operations and the preparation for the demonstration reactor DEMO.
(10)
By supporting nuclear research, the Euratom Programme should contribute to achieving the objectives of the Horizon Europe – the Framework Programme for Research and Innovation (‘Horizon Europe’) established by Regulation (EU) 2021/695 of the European Parliament and of the Council (3) and should facilitate the implementation of the Europe 2030 strategy and the strengthening of the European research area.
(11)
The Euratom Programme should seek synergies with Horizon Europe and other Union programmes, from their design and strategic planning, through project selection, management, communication, dissemination and exploitation of results, to monitoring, auditing and governance.
(12)
The Euratom Programme’s actions should be proportionate, without duplicating or crowding out private financing, and should have a clear European added value. This will ensure consistency between the actions of the Euratom Programme and Union State aid rules, avoiding undue distortions of competition in the internal market.
(13)
While it is for each Member State to choose whether or not to make use of nuclear power, it is also acknowledged that nuclear energy plays different roles in different Member States. The Euratom Programme will also contribute through its research activities to fostering a broad discussion among all relevant stakeholders regarding the opportunities and risks of nuclear energy.
(14)
To address the needs for education and training, the Euratom Programme should offer support through financial contributions so that researchers in the nuclear field become eligible to benefit from Marie Skłodowska-Curie Actions (MSCA) on an equal footing with researchers in other fields.
(15)
This Regulation lays down a financial envelope for the entire duration of the Euratom Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (4), for the European Parliament and the Council during the annual budgetary procedure.
(16)
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (5) (the ‘Financial Regulation’) applies to the Euratom Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. Rules adopted on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) also include a general regime of conditionality for the protection of the Union budget.
(17)
The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their suitability to achieving the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. For grants, this should include consideration of the use of lump sums, flat rates and unit costs.
(18)
Particular attention should be paid to ensuring adequate participation of small and medium-sized enterprises (SMEs) and the private sector in general. Quantitative and qualitative assessments of SME participation should be undertaken as part of the evaluation and monitoring arrangements.
(19)
The activities developed under the Euratom Programme should aim at eliminating gender inequalities and promoting equality between women and men in research and innovation, in accordance with Articles 2 and 3 of the Treaty on European Union and Article 8 TFEU. The gender dimension should be integrated in research and innovation and followed through at all stages of the research cycle.
(20)
With the aim of deepening the relationship between science and society and reinforcing public confidence in science, the Euratom Programme should favour the informed engagement of citizens and civil society in research and innovation matters by promoting science education, making scientific knowledge more accessible, developing responsible research and innovation agendas that meet the concerns and expectations of citizens and civil society, and facilitating the participation of citizens and civil society in activities under the Euratom Programme.
(21)
Actions which fall within the scope of the Euratom Programme should respect fundamental rights and observe the principles acknowledged in particular by the Charter of Fundamental Rights of the European Union.
(22)
It is important to continue to facilitate the exploitation of intellectual property developed by participants, while protecting the legitimate interests of other participants and the Community in accordance with Title II, Chapter 2 of the Treaty establishing the European Atomic Energy Community (‘the Euratom Treaty’).
(23)
In order to ensure the greatest possible impact of Euratom funding, the Community may, where appropriate, consider European Partnerships with public or private sector partners provided that the desired impact can be obtained more effectively in partnership than by the Community alone, when compared to other forms of support of the Euratom Programme. This Regulation should ensure that such partnerships have a clear life-cycle approach of European Partnerships and follow a transparent selection and decision-making process in accordance with Annex III of Regulation (EU) 2021/695.
(24)
It should also be possible to address the objectives of the Euratom Programme through financial instruments and budgetary guarantees under programmes based on the TFEU, provided that actions comply with the objectives and rules of such programmes.
(25)
In order to ensure the most efficient implementation possible and to achieve a coherent, comprehensive and transparent framework for beneficiaries, participation in the Euratom Programme and dissemination of research results should be subject to the relevant rules of Regulation (EU) 2021/695, with certain adaptations or exceptions. The relevant definitions and main types of action set out in that Regulation should apply to the Euratom Programme.
(26)
The participant guarantee fund set up under Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and the Council (6) and managed by the Commission has proved to be an important safeguard mechanism which mitigates the risks associated with the amounts due and not reimbursed by defaulting participants. Therefore, this safeguard mechanism should be continued. The mutual insurance mechanism established pursuant to Regulation (EU) 2021/695 should cover actions under this Regulation.
(27)
The Joint Research Centre (the ‘JRC’) should continue to provide Union and Member States, as appropriate, with independent customer-driven scientific evidence and technical support throughout the whole policy cycle. The direct actions of the JRC should be implemented in a flexible, efficient and transparent manner, taking into account the relevant needs of the users of the JRC and the needs of Union policies, in particular in the field of nuclear safety, safeguards and security, and ensuring the protection of the financial interests of the Union. According to the Council conclusions of 26 April 1994 on the role of the JRC, the JRC should continue to generate additional resources through competitive support activities for Union policies or on behalf of third parties. The JRC should be able to participate in indirect actions, where the relevant work programme so provides.
(28)
In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (7) and Council Regulations (EC, Euratom) No 2988/95 (8), (Euratom, EC) No 2185/96 (9) and (EU) 2017/1939 (10), the financial interests of the Union are to be protected by means of proportionate measures, including measures related to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union.
The European Public Prosecutor’s Office (the ‘EPPO’) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (11). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights.
(29)
Third countries may participate on the basis of their respective legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exert their respective competences.
(30)
In order to ensure uniform conditions for the implementation of the actions under the Euratom Programme and their monitoring and evaluation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12).
(31)
Pursuant to paragraph 22 and 23 of the Interinstitutional agreement of 13 April 2016 on Better Law-Making (13), the Euratom Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Euratom Programme on the ground.
(32)
The Board of Governors of the JRC, set up by Commission Decision 96/282/Euratom (14), has been consulted on the scientific and technological content of the direct actions of the JRC.
(33)
The European Parliament has been consulted on a voluntary basis and has delivered an opinion (15). The European Economic and Social Committee has also been consulted on a voluntary basis and has delivered an opinion (16).
(34)
For reasons of legal certainty, Council Regulation (Euratom) 2018/1563 (17) should be repealed.
(35)
In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021,
HAS ADOPTED THIS REGULATION:
CHAPTER I
General provisions
Article 1
Subject matter
This Regulation establishes the Research and Training Programme of the European Atomic Energy Community for the period from 1 January 2021 to 31 December 2025 (the ‘Euratom Programme’) and the rules for participation and dissemination in indirect actions under the Euratom Programme, complementing Horizon Europe.
It lays down the objectives of the Euratom Programme, the budget for the period 2021-2025, the forms of funding and the rules for providing such funding.
Article 2
Definitions
For the purposes of this Regulation, the relevant definitions set out in Regulation (EU) 2021/695 apply. References in those definitions to the Union and Horizon Europe shall be construed as references to the European Atomic Energy Community (the ‘Community’) and the Euratom Programme, respectively. However, for the purposes of this Regulation, ‘work programme’ means the document adopted by the Commission for the implementation of the Euratom Programme in accordance with Article 16 of this Regulation.
All references in this Regulation to Regulation (EU) 2021/695 are to the version in force on 12 May 2021.
Article 3
Programme objectives
1. The general objective of the Euratom Programme is to pursue nuclear research and training activities, with an emphasis on the continuous improvement of nuclear safety, security and radiation protection, as well as to complement the achievement of Horizon Europe’s objectives inter alia in the context of the energy transition.
2. The Euratom Programme has the following specific objectives:
(a)
improve and support nuclear safety, security, safeguards, radiation protection, safe spent fuel and radioactive waste management and decommissioning, including the safe and secure use of nuclear power and of non-power applications of ionizing radiation;
(b)
maintain and further develop expertise and competence in the nuclear field within the Community;
(c)
foster the development of fusion energy as a potential future energy source for electricity production and contribute to the implementation of the European fusion roadmap;
(d)
support the policy of the Union and its Member States on continuous improvement of nuclear safety, safeguards and security.
3. The objectives listed in paragraphs 1 and 2 shall be implemented in accordance with Annex I. The implementation of those objectives may, if duly justified, include responses to emerging opportunities, crises and threats.
Article 4
Budget
1. The financial envelope for the implementation of the Euratom Programme for the period from 1 January 2021 to 31 December 2025 shall be EUR 1 382 000 000 in current prices.
2. The indicative distribution of the amount referred to in paragraph 1 shall be:
(a)
EUR 583 273 000 for indirect actions in fusion research and development;
(b)
EUR 266 399 000 for indirect actions in nuclear fission, safety and radiation protection;
(c)
EUR 532 328 000 for direct actions undertaken by the Joint Research Centre.
The Commission may not deviate from the amount referred to in point (c) of this paragraph.
3. The amount referred to in paragraph 1 may also be used to cover expenses for preparation, monitoring, control, audit, evaluation and other activities and expenditures necessary for managing and implementing the Euratom Programme, including all administrative expenditure, as well as evaluating the achievement of its objectives. The administrative expenses related to indirect actions shall not exceed 6 % of the amount distributed to indirect actions of the Euratom Programme referred to in points (a) and (b) of paragraph 2. In addition, the amount referred to in paragraph 1 may also cover:
(a)
in so far as they are related to the objectives of the Euratom Programme, expenses relating to studies, meetings of experts, information and communication actions;
(b)
expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Euratom Programme.
4. If necessary to enable the management of actions not completed by 31 December 2025, appropriations may be entered in the budget beyond 2025 to cover the expenses provided for in paragraph 3.
5. Budgetary commitments for actions extending over more than one financial year may be broken down into annual instalments over several years.
6. Without prejudice to the Financial Regulation, expenditure for actions resulting from projects included in the first work programme may be eligible as from 1 January 2021.
7. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Euratom Programme subject to the conditions set out in the relevant provisions of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the ‘Common Provisions Regulation for 2021-2027’). The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned.
Article 5
Third countries associated to the Euratom Programme
1. The Euratom Programme shall be open to association of the following third countries:
(a)
acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Community programmes established in the respective framework agreements and Association Council decisions or similar agreements and in accordance with the specific conditions laid down in agreements between the Community and those countries;
(b)
European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Community programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Community and those countries;
(c)
third countries and territories that fulfil all of the following criteria:
(i)
a good capacity in science, technology and innovation;
(ii)
commitment to a rules-based open market economy, including fair and equitable dealing with intellectual property rights, backed by democratic institutions;
(iii)
active promotion of policies to improve the economic and social well-being of citizens.
2. Association to the Euratom Programme of each of the third countries under point (c) of paragraph 1 shall be in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Community or Union programme, provided that the agreement:
(a)
ensures a fair balance as regards the contributions and benefits of the third country participating in the Community or Union programmes;
(b)
lays down the conditions of participation in the Community or Union programmes, including the calculation of financial contributions to the individual programmes and their administrative costs;
(c)
does not confer to the third country a decisional power in respect of the Euratom Programme;
(d)
guarantees the rights of the Union to ensure sound financial management and to protect the Union’s financial interests.
The contributions referred to in point (b) of the first subparagraph of this paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation.
3. The scope of association of each third country to the Euratom Programme shall take into account the objective of driving economic growth in the Union through innovation. Accordingly, with the exception of acceding countries, candidate countries and potential candidates, parts of the Euratom Programme may be excluded from an association agreement for a specific country.
4. The association agreement shall, where appropriate, provide for the reciprocal participation of legal entities established in the Union in equivalent programmes of associated countries in accordance with the conditions laid down in those programmes.
5. Where appropriate, the conditions determining the level of financial contribution shall ensure an automatic correction of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the Euratom Programme, taking into account the costs in the management, execution and operation of the Euratom Programme.
Article 6
Implementation and forms of funding
1. The Euratom Programme shall be implemented by means of direct management in accordance with the Financial Regulation or by means of indirect management by funding bodies referred to in point (c) of the first subparagraph of Article 62(1) of the Financial Regulation.
2. Funding under the Euratom Programme may be provided in any of the forms laid down in the Financial Regulation, however, grants shall be the main form of support for indirect actions under the Euratom Programme. Funding under the Euratom Programme may also be provided through prizes, procurement and financial instruments within blending operations.
3. The main types of action to be used under the Euratom Programme are set out and defined in Article 2 of Regulation (EU) 2021/695, such as research and innovation actions, innovation actions, innovation and market deployment actions, training and mobility actions, programme co-fund actions, pre-commercial procurement actions, public procurement of innovative solutions actions, coordination and support actions, inducement prizes and recognition prizes.
The forms of funding, referred to in paragraph 2 of this Article, shall be used in a flexible manner across all objectives of the Euratom Programme with their use being determined on the basis of the needs and the characteristics of the particular objectives.
4. The Euratom Programme shall also support direct actions undertaken by the JRC.
Article 7
European Partnerships
1. Parts of the Euratom Programme may be implemented through European Partnerships.
2. The involvement of the Community in European Partnerships may take any of the following forms:
(a)
participation in partnerships set up on the basis of memoranda of understanding or contractual arrangements between the Commission and public or private partners specifying the objectives of the European Partnership, related commitments from all involved sides regarding their financial or in-kind contributions, key performance and impact indicators, the results to be delivered and reporting arrangements; they include the identification of complementary research and innovation activities that are implemented by the partners and by the Euratom Programme (Co-programmed European Partnerships);
(b)
participation in and financial contribution to a programme of research and innovation activities, specifying the objectives, key performance and impact indicators, and the results to be delivered, based on the commitment of the partners regarding their financial or in-kind contributions and the integration of their relevant activities using a Euratom Programme co-fund action (Co-funded European Partnerships).
3. European Partnerships shall:
(a)
be established in cases where the objectives of the Euratom Programme would be achieved more effectively than by the Community alone when compared to other forms of support under the Euratom Programme; an appropriate share of the budget of the Euratom Programme shall be allocated to those parts;
(b)
adhere to the principles of Union added value, transparency and openness, and to having impact within and for Europe, strong leverage effect on sufficient scale, long-term commitments of all involved parties, flexibility in implementation, coherence, coordination and complementarity with Union, local, regional, national and, where relevant, international initiatives or other European Partnerships;
(c)
have a clear life-cycle approach, be limited in time and include conditions for phasing-out the Euratom Programme funding.
4. Provisions and criteria for the selection, implementation, monitoring, evaluation and phasing-out of European Partnerships are set out in Annex III to Regulation (EU) 2021/695.
Article 8
Open Science
The provisions on open science set out in Regulation (EU) 2021/695 apply to the Euratom Programme.
Article 9
Eligible actions and rules for participation and dissemination of research results
1. Only actions implementing the objectives referred to in Article 3 are eligible for funding.
2. Subject to the paragraphs 3 and 4 of this Article, Title II on rules for participation and dissemination of Regulation (EU) 2021/695 applies to actions supported under the Euratom Programme. References in Regulation (EU) 2021/695 to the Union and Horizon Europe shall be construed as references to the Community and the Euratom Programme, where appropriate. References in Regulation (EU) 2021/695 to ‘security rules’ shall be construed to include the defence interests of the Member States within the meaning of Article 24 of the Euratom Treaty.
3. By way of derogation from Article 40(4) of Regulation (EU) 2021/695, the right to object to transfers of ownership of results, or to grants of an exclusive licence regarding results, may extend to grants of non-exclusive licenses.
4. By way of derogation from Article 41(9) of Regulation (EU) 2021/695, a beneficiary that has received Community funding shall grant access to its results on a royalty-free basis to the Community institutions, funding bodies or the European Joint Undertaking for ITER and the Development of Fusion Energy (Fusion for Energy) established by Decision 2007/198/Euratom (the ‘Joint Undertaking Fusion for Energy’), for the purpose of developing, implementing and monitoring Community policies and programmes or obligations under international cooperation with third countries and international organisations. Such access rights shall include the right to authorise third parties to use the results in public procurement and the right to sub-license. Access rights shall be limited to non-commercial and non-competitive use.
5. The mutual insurance mechanism established pursuant to Regulation (EU) 2021/695 shall cover the risk associated with non-recovery of sums due by beneficiaries to the Commission or funding bodies under this Regulation.
Article 10
Cumulative, alternative and combined funding
1. The Euratom Programme shall be implemented in synergy with Horizon Europe and with other Union programmes.
2. In order to achieve the objectives of the Euratom Programme and to address challenges common to the Euratom Programme and to Horizon Europe, activities cutting across the objectives set out in the Euratom Programme or those implementing Horizon Europe, or both, may benefit from the Community financial contribution, subject to Article 9. In particular, the Euratom Programme may provide a financial contribution to the Marie Skłodowska-Curie Actions (MSCA) in order to support activities relevant for nuclear research.
3. An action that has received a contribution from another Union programme may also receive a contribution under the Euratom Programme, provided that the contributions do not cover the same costs. The rules of the relevant programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support.
4. Actions may receive support from the European Regional Development Fund or the European Social Fund Plus in accordance with the relevant provisions of the Common Provisions Regulation for 2021-2027, where they have been awarded a Seal of Excellence label under the Euratom Programme by virtue of complying with the following cumulative conditions:
(a)
they have been assessed in a call for proposals under the Euratom Programme;
(b)
they comply with the minimum quality requirements of that call for proposals;
(c)
they may not be financed under that call for proposals due to budgetary constraints.
CHAPTER II
Programming, monitoring, evaluation and control
Article 11
Work programmes
1. The indirect actions of the Euratom Programme shall be implemented by work programmes as referred to in Article 110 of the Financial Regulation. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. The Commission shall adopt work programmes by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(4).
2. In addition to the requirements of Article 110 of the Financial Regulation, the work programmes shall include the following, as appropriate:
(a)
an indication of the amount allocated to each action and an indicative implementation timetable;
(b)
for grants, the priorities, the selection and award criteria, the relative weight of the different award criteria and the maximum rate of funding of the total eligible costs;
(c)
any additional obligations on beneficiaries, in accordance with Articles 39 and 41 of Regulation (EU) 2021/695;
(d)
a multiannual approach and strategic orientations for the following years of implementation.
3. The Commission shall draw up a multi-annual work programme on direct actions undertaken by the JRC in accordance with Decision 96/282/Euratom.
Article 12
Monitoring and reporting
1. The Commission shall monitor continuously the management and implementation of the Euratom Programme. In order to enhance transparency, those data shall be made publicly available in an accessible manner on the Commission’s webpage in accordance with the latest update of those data.
Indicators to report on an annual basis on the progress of the Euratom Programme towards the achievement of the objectives laid down in Article 3 are set out in Annex II along impact pathways.
2. To ensure the effective assessment of the Euratom Programme’s progress towards the achievement of its objectives, the Commission shall adopt implementing acts concerning the implementation of the monitoring and evaluation framework, in particular by setting baselines and targets in accordance with Annex II. Those implementing acts shall be adopted in accordance with the advisory procedure pursuant to Article 16(3).
3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Euratom Programme are collected efficiently, effectively and in a timely manner without increasing the administrative burden on beneficiaries. To that end, proportionate reporting requirements shall be imposed on recipients of Community funds and, where appropriate, on Member States.
Article 13
Information, communication, publicity and dissemination and exploitation
1. The recipients of the Euratom Programme funding shall acknowledge the origin of those funds and ensure the visibility of the Community funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.
2. The Commission shall implement information and communication actions relating to the Euratom Programme, to actions under the Euratom Programme and to the results obtained. In addition, it shall provide timely and thorough information to Member States and beneficiaries. Evidence-based matchmaking services informed by analytics and network affinities shall be provided to interested entities in order to form consortia for collaborative projects, with particular attention to identifying networking opportunities for legal entities from low research and innovation performing Member States. On the basis of such analysis, targeted matchmaking events may be organised in function of specific calls for proposals.
3. The Commission shall also establish a dissemination and exploitation strategy for increasing the availability and diffusion of the Euratom Programme’s research and innovation results and knowledge to accelerate exploitation towards market uptake and boost the impact of the Euratom Programme.
4. Financial resources allocated to the Euratom Programme shall also contribute to the corporate communication of the political priorities of the Community as well as information, communication, publicity, dissemination and exploitation activities as far as they are related to the objectives referred to in Article 3.
Article 14
Evaluation
1. Euratom Programme evaluations shall be carried out in a timely manner to feed into the decision-making process on the Euratom Programme, its successor and other initiatives relevant to research and innovation.
2. The interim evaluation of the Euratom Programme shall be carried out with the assistance of independent experts selected on the basis of a transparent process once there is sufficient information available about the implementation of the Euratom Programme, but no later than three years after the start of the Euratom Programme implementation. It shall include an assessment of the long-term impact of previous Euratom Research and Training Programmes and shall form the basis to adjust the Euratom Programme implementation or review the Euratom Programme, as appropriate. It shall assess the Euratom Programme’s effectiveness, efficiency, relevance, coherence, and Community added value.
3. At the end of the implementation of the Euratom Programme, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Euratom Programme shall be carried out by the Commission. It shall include an assessment of the long-term impact of previous Euratom Research and Training Programmes.
4. The Commission shall publish and communicate the conclusions of the evaluations accompanied by its observations to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Article 15
Audits
1. The control system for the Euratom Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Euratom Programme.
2. Actions that receive joint funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules.
3. In addition, the Commission or the relevant funding body may rely on combined systems reviews at beneficiary level. Those combined reviews shall be optional for certain types of beneficiaries and shall consist in a systems and process audit, complemented by an audit of transactions. Such audits of transactions shall be carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC of the European Parliament and of the Council (18). The system and processes audits may be used by the Commission or the relevant funding body to determine overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex-post audits and certificates on financial statements.
4. In accordance with Article 127 of the Financial Regulation, the Commission or the funding body may rely on audits on the use of Community contributions carried out by other independent and competent persons or entities, including by other than those mandated by the Union institutions or bodies.
5. Audits may be carried out up to two years after the payment of the balance.
6. The Commission shall publish audit guidelines, aiming to ensure a reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the Euratom Programme.
Article 16
Committee procedure
1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. The Committee shall meet in two different configurations, dealing respectively with the fission related aspects and fusion related aspects of the Euratom Programme.
With a view to facilitating the implementation of the Euratom Programme, for each meeting of the Committee as defined in the agenda, the Commission will reimburse the expenses of one representative per Member State, as well as one expert or adviser per Member State for those agenda items where a Member State requires specific expertise, in accordance with Commission’s established guidelines.
3. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
5. Where the opinion of the Committee is to be obtained by written procedure, that procedure shall be terminated without result where the chair of the Committee so decides or a simple majority of Committee members so requests within the time-limit for delivery of the opinion.
6. The Commission shall regularly inform the Committee of the overall progress of the implementation of the Euratom Programme and shall provide the Committee with timely information on all actions proposed or funded under the Euratom Programme.
Article 17
Protection of financial interests of the Union
Where a third country participates in the Euratom Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013.
CHAPTER III
Transitional and final provisions
Article 18
Repeal
Regulation (Euratom) 2018/1563 is repealed.
Article 19
Transitional provisions
1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (Euratom) 2018/1563, which shall continue to apply to those actions until their closure.
2. Where necessary, any remaining tasks of the Committee established by Regulation (Euratom) 2018/1563 shall be undertaken by the Committee referred to in Article 16 of this Regulation.
3. The financial envelope for the Euratom Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Euratom Programme and the measures adopted pursuant to Regulation (Euratom) 2018/1563.
Article 20
Entry into force
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 May 2021.
For the Council
The President
J. BORRELL FONTELLES
(1) Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011, p. 48).
(2) Council Decision 2007/198/Euratom of 27 March 2007 establishing the European Joint Undertaking for ITER and the Development of Fusion Energy and conferring advantages upon it (OJ L 90, 30.3.2007, p. 58).
(3) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1).
(4) OJ L 433I, 22.12.2020, p. 28.
(5) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(6) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104).
(7) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(8) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.95, p. 1).
(9) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(10) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
(11) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).
(12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(13) OJ L 123, 12.5.2016, p. 1.
(14) Commission Decision 96/282/Euratom of 10 April 1996 on the reorganization of the Joint Research Centre (OJ L 107, 30.4.1996, p. 12).
(15) Opinion of 16.1.2019 (not yet published in the Official Journal).
(16) Opinion of 12.12.2018 (OJ C 110, 22.3.2019, p. 132).
(17) Council Regulation (Euratom) 2018/1563 of 15 October 2018 on the Research and Training Programme of the European Atomic Energy Community (2019–2020) complementing the Horizon 2020 Framework Programme for Research and Innovation, and repealing Regulation (Euratom) No 1314/2013 (OJ L 262, 19.10.2018, p. 1).
(18) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87).
ANNEX I
ACTIVITIES
The specific objectives referred to in Article 3(2) shall be pursued across the Euratom Programme, according to the broad lines of activity described in this Annex. By implementing those specific objectives, the Euratom Programme supports Member States in the implementation of the Euratom legislation (1) and reinforces their research efforts and those of the private sector. Those specific objectives should contribute to maintain and further develop the technological leadership in the nuclear domain.
In order to achieve the specific objectives referred to in Article 3(2), the Euratom Programme will support cross-cutting activities that ensure synergy of research efforts in solving common challenges. Appropriate links and interfaces, such as joint calls with Horizon Europe, will be ensured. Related research and innovation activities may also benefit from financial support provided by the funds under the Common Provisions Regulation for 2021-2027 as far as in line with those funds’ objectives and regulations.
Activities listed in this Annex include international cooperation in nuclear research and innovation for peaceful uses, based on shared goals and mutual trust with the aim of providing clear and significant benefits for the Union, its citizens and environment. This includes international cooperation through multilateral frameworks. The JRC as the formally recognised Euratom Implementing Agent for Generation IV International Forum (GIF) (2) will continue facilitating and coordinating the contribution and participation of the Euratom Community in GIF’s research and training activities. The contribution to GIF’s activities under the scope of the Euratom Programme is focused on safety, radiation protection, safeguards and non-proliferation research and training activities specific to Generation IV systems.
Any new activity assigned to the JRC shall be analysed by the Board of Governors of the JRC to check its consistency with existing activities in the Member States and to avoid duplication of nuclear research and development in the Union.
The priorities of the work programmes are to be established by the Commission on the basis of inputs from public authorities, nuclear research stakeholders and any relevant organisation or forum of nuclear stakeholders.
Research and training in the following fields will be eligible for funding from the Euratom Programme:
(a)
improve and support nuclear safety, security, safeguards, radiation protection, safe spent fuel and radioactive waste management and decommissioning, including the safe and secure use of nuclear power and of non-power applications of ionizing radiation (3):
(i)
nuclear safety: safety of reactor systems and fuel cycles, in use in the Community or, to the extent necessary, in order to maintain broad nuclear safety expertise in the Community, those reactor types and their whole fuel cycles such as partitioning and transmutation, which may be used in the future;
(ii)
safe spent fuel and radioactive waste management: the management and in particular pre-disposal activities and disposal of intermediate, high-level and long-lived radioactive waste and spent nuclear fuel, and of other radioactive waste streams and types for which industrially mature processes currently do not exist or could be improved; radioactive waste minimisation and reducing the radiotoxicity of this waste; the management and transfer of knowledge and competences between generations and across Member States’ programmes in radioactive waste and spent fuel management;
(iii)
decommissioning: research for the development and evaluation of technologies for decommissioning and environmental remediation of nuclear facilities; support for sharing best practices and knowledge on decommissioning;
(iv)
nuclear science and ionizing radiation applications, radiation protection, emergency preparedness:
—
applications of nuclear science and ionizing radiation technologies in medical, industrial and other research fields;
—
effects and risks from low doses from industrial, medical or environmental exposure;
—
emergency preparedness for accidents involving radiation, and research on radioecology;
—
secure and safe supply and use of radioisotopes;
—
models for radiological dispersion in the environment, and support for data exchange, alert systems and cooperation on measurement techniques (4) (to be implemented by direct actions);
(v)
nuclear security, safeguards and non-proliferation (to be implemented by direct actions):
—
methods and technology to support and strengthen the Community’s and international safeguards;
—
operational support and training to the Euratom safeguards system;
—
technical support to the implementation of the Non-Proliferation Treaty in the field of nuclear safeguards including support to strengthen Union export control regime;
—
research and support for enhancing nuclear and radiological safety and security in the context of the global CBRN (Chemical, Biological, Radiological, Nuclear) framework and related Union strategies;
—
methods and technology for the detection of nuclear and radioactive materials outside regulatory control and the prevention of and responses to incidents involving such materials, including nuclear forensics;
—
support for the capacity building on nuclear security using the European Nuclear Security Training Centre;
(b)
maintain and further develop expertise and competence in the nuclear field within the Community:
(i)
education, training and mobility, including education and training schemes such as Marie Skłodowska-Curie Actions (MSCA);
(ii)
promotion of innovation, knowledge management, dissemination and exploitation of nuclear science and technology, in particular for nuclear safety, security, safeguards and radiation protection;
(iii)
support for technology transfer from the research to industry;
(iv)
support for the preparation and development of a competitive European fusion industrial capacity;
(v)
support for the provision, availability and appropriate access of European and international research infrastructures, including JRC’s infrastructures (5);
(vi)
for fostering nuclear science as a base to support standardisation, direct actions will provide state-of-the-art reference data, materials and measurements related to nuclear safety, safeguards and security, as well as other applications as nuclear medicine;
(c)
foster the development of fusion energy and contribute to the implementation of the European fusion roadmap:
a Co-funded European Partnership in fusion research will implement the roadmap towards the goal of fusion electricity production by the second half of this century. This may include inter alia:
(i)
exploiting existing and future fusion facilities, including the allocation of operating grants to fusion research infrastructures when appropriate;
(ii)
preparation for future fusion power plants by developing all relevant aspects including materials, technologies and designs;
(iii)
implementing a focused education and training programme in addition to activities under (b)(i);
(iv)
coordination of common activities with the Joint Undertaking Fusion for Energy;
(v)
collaboration with the ITER Organisation;
(vi)
scientific collaboration in the framework of the Euratom international agreements;
the Co-funded European Partnership in fusion will be implemented through a grant to be awarded to the legal entities established or designated by the Member States and any third country associated to the Euratom Programme. The grant may include resources in kind from the Community, or the secondment of Commission staff;
(d)
support the policy of the Union and its Member States on nuclear safety, safeguards and security:
the direct actions will support the policy on nuclear safety, safeguards and security and implementation of the relevant legislation by providing independent scientific and technical evidence and expertise.
(1) In particular Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel (OJ L 337, 5.12.2006, p. 21); Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18); Council Directive 2011/70/Euratom; Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12); Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1) and Council Regulation (Euratom) 2016/52 of 15 January 2016 laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90 (OJ L 13, 20.1.2016, p. 2).
(2) In accordance with Article III.2 of the Framework Agreement for International Collaboration on Research and Development of Generation IV Nuclear Energy Systems.
(3) Apart from nuclear security, safeguards and non-proliferation, these activities may be implemented through direct and indirect actions.
(4) Art. 35, 36, 38 Euratom Treaty; Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of a radiological emergency (OJ L 371, 30.12.1987, p. 76).
(5) On the basis of the rolling investment plan for the JRC’s infrastructures.
ANNEX II
KEY IMPACT PATHWAY INDICATORS
Impact pathways, and related key impact pathway indicators, shall structure the monitoring of the Euratom Programme’s performance towards its specific objectives as referred to in Article 3(2). The impact pathways shall be time-sensitive: they distinguish between the short, medium and long term. Impact pathway indicators serve as proxies to report on the progress made towards achievement of specific objectives. The micro-data behind the key impact pathway indicators, which are shared with the Horizon Europe, are collected in a centrally managed and harmonised way, with minimal reporting burden on the beneficiaries.
Scientific impact pathways indicators
The Euratom Programme is expected to make progress as regards knowledge for reinforcing nuclear safety and security; safe applications of ionising radiation; spent fuel and radioactive waste management; radiation protection; and the development of fusion energy. Progress in this area will be measured by indicators concerning scientific publications, progress in the implementation of the fusion roadmap, development of expertise and skills, and access to research infrastructures.
Towards scientific impacts
Short-term
Medium-term
Longer-term
Improving the safe and secure use of nuclear energy and non-power applications of ionizing radiation, including nuclear safety, security, safeguards, radiation protection, safe spent fuel and radioactive waste management and decommissioning
Publications –
number of Euratom peer-reviewed scientific publications
Citations –
Field-Weighted Citation Index of Euratom peer-reviewed scientific publications
World-class science – Number and share of peer reviewed publications from Euratom Programme that are core contribution to scientific fields
Shared knowledge –
Share of research outputs (open data/publication/software etc.) shared through open knowledge infrastructure
Knowledge diffusion – Share of open access research outputs actively used/cited
New collaborations – Share of Euratom beneficiaries having developed new transdisciplinary/trans-sectoral collaborations with users of their open Euratom R&I outputs
Fostering the development of fusion energy
Progress in the implementation of the fusion roadmap –
Percentage of the fusion roadmap’s milestones established for the period 2021-2025 reached by the Euratom Programme
Maintaining and further developing expertise and excellence in the Union
Skills –
Number of researchers having benefitted from upskilling activities of the Euratom Programme (through training, mobility and access to infrastructure)
Careers –
Number and share of upskilled researchers with more influence in their R&I field
Working conditions –
Number and share of upskilled researchers with improved working conditions
The number of researchers having access to research infrastructure through the Euratom Programme support
Reference materials delivered and reference measurements incorporated to a library
Number of international standards modified
Societal impacts pathways indicators
The Euratom Programme helps to address Community policy priorities concerning nuclear safety and security, radiation protection and ionising radiation applications through research and innovation, as shown by the portfolios of projects generating outputs contributing to tackling challenges in these fields. Societal impact is also measured in terms of specific development in the field of nuclear security and safeguards.
Towards societal impacts
Short-term
Medium-term
Longer-term
Improving the safe and secure use of nuclear energy and non-power applications of ionizing radiation, including nuclear safety, security, safeguards, radiation protection, safe spent fuel and radioactive waste management and decommissioning
Outputs –
Number and share of outputs aimed at addressing specific policy priorities
Solutions –
Number and share of innovations and scientific results addressing specific policy priorities
Benefits –
Aggregated estimated effects from use of Euratom-funded results, on tackling specific policy priorities, including contribution to the policy and law-making cycle
Number of services delivered in support of safeguards
Number of technical systems provided and in use
Number of training sessions delivered to front-line officers
Co-creation –
Number and share of Euratom projects where Union citizens and end-users contribute to the co-creation of R&I content
Engagement –
Number and share of Euratom beneficiary entities with citizen and end-users engagement mechanisms after Euratom project
Societal R&I uptake
Uptake and outreach of Euratom co-created scientific results and innovative solutions
Innovation impact pathway indicators
The Euratom Programme is expected to deliver innovation impacts supporting progress towards its specific objectives. Progress in this area will be measured by indicators concerning intellectual property rights (IPR), innovative products, methods and processes and their use, along with job creation.
Towards economic/innovation impact
Short-term
Medium-term
Longer-term
Improving the safe and secure use of nuclear energy and non-power applications of ionizing radiation, including nuclear safety, security, safeguards, radiation protection, safe spent fuel and radioactive waste management and decommissioning
Fostering the development of fusion energy
Maintaining and further developing expertise and excellence in the Union
Innovative outputs –
Number of innovative products, processes or methods from Euratom Programme (by type of innovation) and IPR applications
Innovations –
Number of innovations from Euratom projects (by type of innovation) including from awarded IPRs
Economic growth –
Creation, growth and market shares of companies having developed Euratom funded innovations
Supported employment –
Number of FTE jobs created and jobs maintained in beneficiary entities for the Euratom project (by type of job)
Sustained employment –
Increase of FTE jobs in beneficiary entities following Euratom project (by type of job)
Total employment – Number of direct and indirect jobs created or maintained due to diffusion of Euratom results (by type of job)
Amount of public and private investment mobilised with the initial Euratom investment
Amount of public and private investment mobilised to exploit or scale up Euratom results
Union progress towards 3 % GDP due to Euratom Programme
Policy impact pathways indicators
The Euratom Programme provides scientific evidence for policy-making. This in particular concerns scientific support for other Commission services, such as the support to Euratom safeguards, or to the implementation by Member States of Directives related to nuclear and ionising radiation (1).
Towards policy impact
Short-term
Medium-term
Longer-term
Supporting policy on nuclear safety, safeguards and security
Number and share of Euratom projects producing policy-relevant findings
Number of outputs having a demonstrable impact on the policy
Number and share of Euratom projects findings cited in policy/programmatic documents
Targets will be defined for both indirect and direct actions to reflect the expected results for each part of the Euratom Programme.
(1) Commission Regulation (Euratom) No 302/2005 of 8 February 2005 on the application of Euratom safeguards (OJ L 54, 28.2.2005, p. 1); Council Directive 2011/70/Euratom and Council Directive 2014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations (OJ L 219, 25.7.2014, p. 42).
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Horizon Europe: research and training programme (2021-2025)
Horizon Europe: research and training programme (2021-2025)
SUMMARY OF:
Regulation (Euratom) 2021/765 establishing the Research and Training Programme of the European Atomic Energy Community for 2021-2025 complementing Horizon Europe
WHAT IS THE AIM OF THE REGULATION?
It sets up the European Atomic Energy Community’s Research and Training Programme for the period from 1 January 2021 to 31 December 2025 (the Euratom programme). It is part of the Horizon Europe programme and shares the same rules for participation.
KEY POINTS
The programme runs for 5 years, from 2021 to 2025, to be extended in 2025 by 2 years in order to be aligned with the European Union’s (EU) 2021-2027 multiannual financial framework.
Parts of the programme may be implemented through European partnerships.
The programme applies an open science approach to the scientific process, based on open cooperation and tools, and diffusing knowledge.
The programme is subject to monitoring, reporting, evaluation and audit.
Regulation (Euratom) 2018/1563 is repealed.
The programme has direct and indirect actions.
Direct actions are activities undertaken by the European Commission’s Joint Research Centre as outlined in a multiannual work programme created by the Commission.
Indirect actions are research activities undertaken by multipartner consortia and implemented by work programmes, including an estimate of the distribution of the sums allocated to each action and a timetable.
Budget
The programme has a total budget of €1.38 billion:
€583 million for indirect actions in fusion research and development;
€266 million for indirect actions in nuclear fission, safety and radiation protection;
€532 million for direct actions undertaken by the Joint Research Centre.
Programme objectives and areas eligible for funding:
improved nuclear safety, security, safeguards and radiation protection;
safe and secure use of nuclear power;
safe spent fuel and radioactive waste management and decommissioning;
safe use and expanded research into non-power applications of ionising radiation;
continued development of nuclear expertise and competence;
fostering fusion energy as a potential future energy source;
support for EU and EU Member States’ continuous improvement policies on nuclear safety and security;
improved education, training and access to research infrastructures;
improved nuclear scientist mobility.
Involvement of non-EU countries
Horizon Europe is open to the participation of legal entities from anywhere in the world, under the conditions set out in the rules, and where applicable together with any additional condition at work programme / call level. Participation in the programme in the form of associations of non-EU countries is open to:
European Economic Area (EEA) and European Free Trade Association (EFTA) countries;
acceding countries, candidate countries and potential candidates;
European neighbourhood policy countries;
non-EU countries with a good capacity in science, technology and innovation and a commitment to a rules-based open market economy.
Communication and publicity
Recipients must acknowledge the origin of programme funding, especially when promoting the actions and their results, with coherent and effective information campaigns targeted to multiple audiences, including the media and the public.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2021.
BACKGROUND
Factsheet: Euratom research and training programme 2021-2025 (European Commission)
Horizon Europe (European Commission).
MAIN DOCUMENT
Council Regulation (Euratom) 2021/765 of 10 May 2021 establishing the Research and Training Programme of the European Atomic Energy Community for the period 2021-2025 complementing Horizon Europe — the Framework Programme for Research and Innovation and repealing Regulation (Euratom) 2018/1563 (OJ L 167I, 12.5.2021, pp. 81-100)
RELATED DOCUMENTS
Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe — the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167I, 12.5.2021, pp. 1-80)
Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe — the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1-68)
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222)
last update 07.07.2021
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32021R0100
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1.2.2021
EN
Official Journal of the European Union
L 34/3
COUNCIL REGULATION (Euratom) 2021/100
of 25 January 2021
establishing a dedicated financial programme for the decommissioning of nuclear facilities and the management of radioactive waste, and repealing Regulation (Euratom) No 1368/2013
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 203 thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Parliament (1),
Whereas:
(1)
In line with the Rome Declaration of the Leaders of 27 Member States and of the European Council, the European Parliament and the European Commission of 25 March 2017, the Union budget should enable a safe and secure Europe. Nuclear decommissioning programmes have already contributed in this respect and can further contribute. After the shutdown of a nuclear facility, the main positive impact to be achieved is the progressive reduction of radiological risk for the workers, the public and the environment in the Member States concerned as well as in the Union as a whole.
(2)
A dedicated financial programme can bring additional EU added value by becoming a benchmark within the Union for the safe management of technological issues in nuclear decommissioning and the dissemination of knowledge. Financial assistance under such a financial programme should be provided on the basis of an ex ante evaluation identifying the specific needs and demonstrating the EU added value, with the aim of supporting the decommissioning of nuclear facilities and the safe management of radioactive waste.
(3)
The activities covered by this Regulation should comply with applicable Union and national law. Financial assistance under this Regulation should remain exceptional, without prejudice to the principles and objectives stemming from Union law on nuclear safety, namely Council Directive 2009/71/Euratom (2), and waste management, namely Council Directive 2011/70/Euratom (3). Pursuant to Articles 4(1) and 7(1) of Directive 2011/70/Euratom, the ultimate responsibility for the safe management of the spent fuel and radioactive waste generated remains with the Member States.
(4)
In accordance with the Protocol concerning the conditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union (4) annexed to the Treaty concerning the accession of the Republic of Bulgaria and Romania to the European Union (5) (‘Treaty of Accession’), Bulgaria committed to the closure of Units 1 and 2 and Units 3 and 4 of the Kozloduy Nuclear Power Plant by 31 December 2002 and 31 December 2006 respectively, and to the subsequent decommissioning of those units. The decommissioning has resulted in a significant financial burden of direct and indirect cost for Bulgaria. In line with its obligations, Bulgaria shut down all units concerned within the respective deadlines.
(5)
In accordance with Protocol No 9 on unit 1 and unit 2 of the Bohunice V1 nuclear power plant in Slovakia attached to the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (6) (‘Act of Accession’), Slovakia committed itself to the closure of Unit 1 and Unit 2 of the Bohunice V1 Nuclear Power Plant by 31 December 2006 and 31 December 2008 respectively, and to the subsequent decommissioning of those units. The decommissioning has resulted in a significant financial burden of direct and indirect cost for Slovakia. In line with its obligations, Slovakia shut down all units concerned within the respective deadlines.
(6)
In line with their obligations under, respectively, the Treaty of Accession and the Act of Accession, and with Union assistance, Bulgaria and Slovakia have made significant progress towards the decommissioning of the Kozloduy and Bohunice V1 nuclear power plants. Further work is necessary in order to safely achieve the decommissioning end state. Based on the current decommissioning plans, the decommissioning work is scheduled to be completed by the end of 2030 for Kozloduy Nuclear Power Plant and by 2025 for the Bohunice V1 Nuclear Power Plant.
(7)
The Joint Research Centre (‘JRC’) of the European Commission was established by Article 8 of the Treaty establishing the European Atomic Energy Community (‘Euratom Treaty’). In application of that Article, site agreements were signed during the period 1960-1962 between the Community, Germany, Belgium, Italy and the Netherlands. In the cases of Italy and the Netherlands, national nuclear installations were transferred to the Community. An infrastructure geared to nuclear research and comprising new installations was put in place at the four sites. Some of those installations are still in use today, while others have been shut down, in some instances more than 20 years ago, and have mostly become obsolete.
(8)
On the basis of Article 8 of the Euratom Treaty, and pursuant to Article 7 of Directive 2011/70/Euratom, the JRC, as a licence holder, is to manage its historical nuclear liabilities and decommission its nuclear installations that have been shut down in accordance with the relevant national legislation. Accordingly, the Nuclear Decommissioning and Waste Management Programme at the JRC was launched in 1999 with a communication to the European Parliament and the Council, and since then the Commission has provided regular updates on the progress of that programme.
(9)
The Commission has concluded that the best option to satisfy requirements stemming from point (f) of Article 5(1) and Article 7 of Directive 2011/70/Euratom is to pursue a strategy combining decommissioning and waste management activities while initiating the discussions between the JRC and host Member States regarding a potential transfer of the decommissioning and spent fuel and radioactive waste management liabilities in the case of mutual agreements between the Commission and the host Member States. The JRC should provide for and maintain adequate resources to fulfil its obligations with respect to decommissioning and the safety of spent fuel and radioactive waste management.
(10)
This Regulation responds to the needs identified for the Multiannual Financial Framework for the period from 1 January 2021 to 31 December 2027 and lays down a financial envelope for the entire duration of the nuclear decommissioning assistance programmes of Units 1 to 4 of the Kozloduy Nuclear Power Plant in Bulgaria (‘Kozloduy programme’) and Units 1 and 2 of the Bohunice V1 Nuclear Power Plant in Slovakia (‘Bohunice programme’), and for the decommissioning and spent fuel and radioactive waste management of the Commission’s nuclear installations at the JRC sites, namely JRC-Geel in Belgium, JRC-Karlsruhe in Germany, JRC-Ispra in Italy and JRC-Petten in the Netherlands (‘JRC decommissioning and waste management programme’). That financial envelope is to constitute the prime reference amount within the meaning of point 17 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (7) for the European Parliament and the Council during the annual budgetary procedure.
(11)
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (8) (the ‘Financial Regulation’) applies to the dedicated financial programme for the decommissioning of nuclear facilities and the management of radioactive waste (the ‘Programme’). The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts.
(12)
In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (9), Council Regulations (EC, Euratom) No 2988/95 (10), (Euratom, EC) No 2185/96 (11) and (EU) 2017/1939 (12), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union.
The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (13). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights.
(13)
This Regulation does not prejudge the outcome of any future State aid procedures that may be undertaken in accordance with Articles 107 and 108 of the Treaty on the Functioning of the European Union (TFEU).
(14)
The amount of the appropriations allocated to the Programme, as well as the programming period and the distribution of funds among the activities, may be reviewed based on the results of the interim and final evaluation reports. It should be possible for additional budgetary flexibility to be obtained by redistributing funds among activities where and when needed, while giving priority to the activities contributing to addressing safety challenges in respect of the decommissioning and radioactive waste management of Units 1 to 4 of the Kozloduy Nuclear Power Plant in Bulgaria and of Units 1 and 2 of the Bohunice V1 Nuclear Power Plant in Slovakia, without prejudice to other activities carried out under this Regulation and in accordance with the Financial Regulation.
(15)
The Programme should also involve the creation of knowledge and the sharing of experience. Knowledge and experience gained and lessons learnt under the Programme with regard to the nuclear decommissioning process should be disseminated in the Union, in coordination and synergy with the Union programme for decommissioning activities in Lithuania, as such measures bring the greatest EU added value and contribute to the safety of the workers and the general public as well as protection of the environment. The scope, procedure and economic aspects of cooperation should be detailed in the multiannual work programme and could also be subject to agreements between the Member States and/or with the Commission.
(16)
The JRC should facilitate the dissemination of knowledge among different Union stakeholders in a coordinated way, for example by carrying out market analysis, reviews and assessments of knowledge needs in the Union, identifying potential directions for cooperation, interested stakeholders and spheres in which knowledge created in the implementation of the Programme would bring the greatest added value, and developing formats for knowledge sharing. The dissemination of knowledge created should be financed by the JRC. Any Member State should be able to initiate the development of ties and exchanges for knowledge dissemination.
(17)
The decommissioning of the nuclear facilities and radioactive waste management covered by this Regulation should be carried out with recourse to the best available technical expertise, and with due regard to the nature and technological specifications of the installations to be decommissioned, in order to ensure safety and the highest possible efficiency, thus taking into account international best practices.
(18)
Effective monitoring and control of the evolution of the decommissioning process should be ensured by Bulgaria, Slovakia and the Commission in order to assure the highest EU added value of the funding allocated under this Regulation, although the ultimate responsibility for the decommissioning rests with the two Member States concerned. This includes effective measurement of progress and performance, and the enacting of corrective measures where necessary. To that end, a committee with monitoring and information functions should be established and co-chaired by a representative of the Commission and of the Member State concerned. Similarly, a group of independent experts from the Member States appointed by the Commission assists the JRC decommissioning and waste management programme.
(19)
Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (14), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground.
(20)
The activities under the Kozloduy programme and Bohunice programme should be identified within the boundaries defined by the decommissioning plans submitted by Bulgaria and Slovakia in accordance with Council Regulation (Euratom) No 1368/2013 (15). Those plans define the scope of those programmes, as well as the decommissioning end states, target dates and end-dates. They also cover the decommissioning activities, their associated schedule, costs and required human resources.
(21)
Activities under the Kozloduy programme and Bohunice programme should be conducted with a joint financial effort of the Union and Bulgaria and Slovakia respectively, in line with the co-financing practice established under the predecessor programmes.
(22)
Regulation (Euratom) No 1368/2013 should therefore be repealed.
(23)
Due account has been taken of the Special Report No 22/2016 of the Court of Auditors entitled ‘EU nuclear decommissioning assistance programmes in Lithuania, Bulgaria and Slovakia: some progress made since 2011, but critical challenges ahead’.
(24)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (16).
(25)
Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 of the TFEU also concern the general regime of conditionality for the protection of the Union’s budget.
(26)
The methods of implementation and forms of Union funding laid down in this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the activities and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in point (a) of Article 125(1) of the Financial Regulation,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1. This Regulation establishes the dedicated financial programme for the decommissioning of nuclear facilities and management of radioactive waste (the ‘Programme’) for the period from 1 January 2021 to 31 December 2027, with the focus on needs identified on a current basis. It shall support:
(a)
the safe decommissioning of Units 1 to 4 of the Kozloduy Nuclear Power Plant in Bulgaria and Units 1 and 2 of the Bohunice V1 Nuclear Power Plant in Slovakia, including the management of radioactive waste, in line with the needs identified in the respective decommissioning plan; and
(b)
the implementation of the decommissioning process and management of radioactive waste of the Commission’s nuclear installations at the Joint Research Centre (JRC) sites, namely JRC-Geel in Belgium, JRC-Karlsruhe in Germany, JRC-Ispra in Italy and JRC-Petten in the Netherlands.
2. This Regulation lays down the objectives of the Programme, its budget for the period from 1 January 2021 to 31 December 2027, the methods of implementation and the forms of Union funding.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘decommissioning’ means administrative and technical measures in accordance with national law which allow the removal of some or all of the regulatory controls from a nuclear facility and which aim to ensure the long-term protection of the public and the environment, including the reduction of the levels of residual radionuclides in the materials and on the site of the nuclear facility;
(2)
‘decommissioning plan’ means a document that contains detailed information on the proposed decommissioning and covers the following: the selected decommissioning strategy; the schedule, type and sequence of decommissioning activities; the waste management strategy applied, including clearance; the proposed end state; the storage and disposal of the waste from decommissioning; the timeframe for decommissioning; the cost estimates for the completion of decommissioning; and the objectives, expected results, milestones, target dates, as well as the corresponding key performance indicators, including, where appropriate, earned-value-based indicators. The decommissioning plan is prepared by the nuclear facility licence holder and is reflected in the multiannual work programmes of the Programme;
(3)
‘Kozloduy programme’ means the part of the Programme that concerns the nuclear decommissioning of Units 1 to 4 of the Kozloduy Nuclear Power Plant, located in Kozloduy, Bulgaria;
(4)
‘Bohunice programme’ means the part of the Programme that concerns the nuclear decommissioning of Units 1 and 2 of the Bohunice V1 Nuclear Power Plant, located in Jaslovské Bohunice, Slovakia;
(5)
‘JRC decommissioning and waste management programme’ means the part of the Programme that concerns the nuclear decommissioning and radioactive waste management of the Commission’s nuclear installations at the JRC sites, namely JRC-Geel in Belgium, JRC-Karlsruhe in Germany, JRC-Ispra in Italy and JRC-Petten in the Netherlands.
Article 3
Objectives of the Programme
1. The general objective of the Programme is to provide funding for the decommissioning of nuclear facilities and the management of radioactive waste, in line with the needs identified in the respective decommissioning plan.
2. On the basis of the current needs for the period from 1 January 2021 to 31 December 2027, the Programme, in addition to creating knowledge with regard to the nuclear decommissioning process and the management of radioactive waste resulting from the decommissioning activities, aims in particular to:
(a)
assist Bulgaria and Slovakia in implementing the Kozloduy programme and the Bohunice programme respectively, including with regard to the management and storage of radioactive waste in line with the needs identified in the respective decommissioning plan, with specific emphasis on managing the safety challenges in respect thereof; and
(b)
support the JRC decommissioning and waste management programme.
3. The specific objectives of the Programme are as follows:
(a)
to carry out the activities included in the respective decommissioning plans, the dismantling and decontamination of Units 1 to 4 of the Kozloduy Nuclear Power Plant and Units 1 and 2 of the Bohunice Nuclear Power Plant, including associated systems, structures and components and auxiliary buildings, the safe management of radioactive waste in line with the needs identified in the respective decommissioning plans, and human resources support; and to pursue the release of Units 1 to 4 of the Kozloduy Nuclear Power Plant and Units 1 and 2 of the Bohunice Nuclear Power Plant from regulatory controls;
(b)
to support the decommissioning plan and to carry out the activities in accordance with the national law of the host Member State for the dismantling and decontamination of the Commission’s nuclear installations at the JRC sites, to carry out the safe management of associated radioactive waste and, when appropriate, to prepare the optional transfer of the related nuclear liabilities from the JRC to the host Member State;
(c)
for the JRC to develop ties and exchanges among Union stakeholders on nuclear decommissioning, with a view to ensuring the dissemination of knowledge and the sharing of experience in all relevant areas, such as research and innovation, regulation and training, and developing potential Union synergies.
The transfer referred to in point (b) of the first subparagraph shall not be imposed on any host Member State and shall be subject to a mutual bilateral agreement concluded between the Commission and the host Member State. That mutual bilateral agreement shall stipulate that all costs of the decommissioning of the Commission’s nuclear installations at the JRC sites and storage of the associated radioactive waste are to be paid by the Union and shall fully comply with Directive 2011/70/Euratom.
4. A detailed description of the specific objectives is set out in Annexes I, II and III. Based on the result of the evaluations carried out in accordance with Article 11, the Commission may amend, by means of implementing acts, Annex I or II, in accordance with the examination procedure referred to in Article 13(2).
Article 4
Budget of the Programme
1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 466 000 000 in current prices.
2. The distribution of the amount referred to in paragraph 1 shall be broken down in the following categories of expenditure:
(a)
EUR 63 000 000 for activities under the Kozloduy programme;
(b)
EUR 55 000 000 for activities under the Bohunice programme;
(c)
EUR 348 000 000 for activities under the JRC decommissioning and waste management programme, including activities for accomplishing the specific objective laid down in point (c) of Article 3(3).
3. Budgetary flexibility may be obtained by redistributing funds among the activities under the Programme, after the evaluations carried out in accordance with Article 11 and pursuant to the Financial Regulation, while giving priority to the activities contributing to addressing safety challenges in respect of decommissioning and radioactive waste management.
4. The amount referred to in paragraph 1 may cover expenses related to the activities included in the respective decommissioning plans for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems.
5. Budgetary commitments for activities extending over more than one financial year may be broken down over several years into annual instalments.
Article 5
Dissemination of knowledge
1. Knowledge created in the implementation process of the Programme shall be disseminated at the Union level.
2. Activities for accomplishing the activity referred to in paragraph 1 shall be financed under the JRC decommissioning and waste management programme. The JRC shall coordinate the structuring and dissemination of knowledge to Member States.
3. The process of dissemination of knowledge shall be included and defined in the work programmes referred to in Article 9.
Article 6
Methods of implementation and forms of Union funding
1. The Programme shall be implemented under direct management in accordance with the Financial Regulation or under indirect management with entities listed in point (c) of Article 62(1) of the Financial Regulation.
2. Union funding under the Programme may be provided in any form laid down in the Financial Regulation.
Article 7
Eligible activities
Only activities implementing the objectives set out in Article 3 shall be eligible for Union funding.
Article 8
Co-financing rates
Without prejudice to Article 190(1) of the Financial Regulation, the maximum Union co-financing rate applicable over the period referred to in Article 4(1) of this Regulation shall be no higher than 50 % for the Kozloduy programme and no higher than 50 % for the Bohunice programme. The remaining co-financing shall be provided by Bulgaria and Slovakia respectively. The activities necessary for the dissemination of knowledge referred to in Article 5 of this Regulation shall be funded by the Union at a rate of 100 %.
Article 9
Work programmes
1. The Kozloduy programme and the Bohunice programme shall be implemented by multiannual work programmes referred to in Article 110 of the Financial Regulation. The multiannual work programmes shall be adopted in accordance with the procedure referred to in Article 13(2).
2. The JRC decommissioning and waste management programme shall be implemented by multiannual work programmes and shall be adopted in accordance with the procedure set out in Article 4 of Commission Decision 96/282/Euratom (17).
3. The multiannual work programmes referred to in paragraphs 1 and 2 shall reflect the decommissioning plans that serve as baseline for monitoring and evaluation of the Kozloduy programme and the Bohunice programme.
4. The multiannual work programmes referred to in paragraphs 1 and 2 shall specify the current state, the objectives, the expected results, the related performance indicators and the timeline for the use of funds and shall define the details for the dissemination of knowledge.
Article 10
Reporting and monitoring
1. Indicators to report on the progress of the Programme towards the achievement of the objectives set out in Article 3 are laid down in Annex IV.
2. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner. To that end, reporting requirements proportionate to the overall costs and Programme-related risks shall be imposed on recipients of Union funds and, where appropriate, on Member States.
3. At the end of each year, the Commission shall draw up a progress report on the implementation of the work carried out in the previous years, including the rate of activities resulting from calls for tenders, and shall present it to the European Parliament and to the Council.
Article 11
Evaluation
1. Evaluations shall be carried out in a timely manner to feed into the decision-making process.
2. The interim evaluation of the Programme shall be performed once there is sufficient information available about the implementation of the Programme, but no later than four years after the start of the period specified in Article 1(1). The interim evaluation shall also address the scope for modification of the multiannual work programmes referred to in Article 9.
3. At the end of the implementation of the Programme, but no later than five years after the end of the period specified in Article 1(1), a final evaluation of the Programme shall be carried out by the Commission.
4. The Commission shall communicate the conclusions of the evaluations, together with its observations, to the European Parliament and to the Council.
Article 12
Audits
Audits on the use of the Union and national contribution carried out by persons or entities, including persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance within the meaning of Article 127 of the Financial Regulation.
Article 13
Committee
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result if, within the time limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so requests.
Article 14
Information, communication and publicity
1. The recipients of Union funds shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the activities and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.
2. The Commission shall implement information and communication actions relating to the Programme, to activities carried out pursuant to the Programme and to the results obtained.
3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives set out in Article 3.
Article 15
Repeal
Regulation (Euratom) No 1368/2013 is repealed.
Article 16
Transitional provisions
1. This Regulation shall not affect the continuation of or modification of the activities initiated pursuant to Regulation (Euratom) No 1368/2013, which shall continue to apply to those activities until their closure.
2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Kozloduy programme and Bohunice programme and the measures adopted pursuant to Regulation (Euratom) No 1368/2013.
3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 4(3), to enable the management of activities not completed by 31 December 2027.
Article 17
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 January 2021.
For the Council
The President
J. BORRELL FONTELLES
(1) Opinion of 16 January 2019 (OJ C 411, 27.11.2020, p. 494).
(2) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18).
(3) Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011, p. 48).
(4) OJ L 157, 21.6.2005, p. 29.
(5) OJ L 157, 21.6.2005, p. 11.
(6) OJ L 236, 23.9.2003, p. 33.
(7) OJ C 373, 20.12.2013, p. 1.
(8) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(9) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(10) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1).
(11) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(12) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
(13) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).
(14) OJ L 123, 12.5.2016, p. 1.
(15) Council Regulation (Euratom) No 1368/2013 of 13 December 2013 on Union support for the nuclear decommissioning assistance programmes in Bulgaria and Slovakia, and repealing Regulations (Euratom) No 549/2007 and (Euratom) No 647/2010 (OJ L 346, 20.12.2013, p. 1).
(16) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(17) Commission Decision 96/282/Euratom of 10 April 1996 on the reorganization of the Joint Research Centre (OJ L 107, 30.4.1996, p. 12).
ANNEX I
Detailed description of the objectives of the Kozloduy programme
1.
The general objective of the Kozloduy programme is to assist Bulgaria in managing the safety challenges in respect of the decommissioning of Units 1 to 4 of the Kozloduy Nuclear Power Plant. The major safety challenges to be addressed by the Kozloduy programme are:
(a)
the dismantling and decontamination of the reactors’ buildings and components in accordance with the decommissioning plans. Progress made in respect of this objective is to be measured by the quantity and type of materials removed as well as earned value;
(b)
the safe management of the decommissioning and radioactive waste in line with the needs identified in the respective decommissioning plan and of activated materials and dismantling materials, including their decontamination up to interim storage or to disposal (depending on the waste category), as well as the completion of the waste and material management infrastructure where necessary. This objective has to be accomplished in accordance with the decommissioning plan and subject to the necessary management of radioactive waste. Progress made in respect of this objective is to be measured by the quantity and type of material released from regulatory control and waste safely stored or disposed as well as earned value; and
(c)
to continue the downgrading of radiological hazards. Progress made in respect of this objective is to be measured through the safety assessments of the activities and the facility, identifying ways in which potential exposures could occur and estimating the probabilities and magnitude of potential exposures. In the Kozloduy programme, the release of the facilities from regulatory control up to corresponding regulatory free-release levels is due to take place by the end of 2030.
2.
The general objective of the Kozloduy programme is complemented by the aim of enhancing the EU added value of that programme by contributing to the dissemination of knowledge on the decommissioning process (thereby generated) to all Member States. In the financing period starting as of 2021, the Kozloduy programme has to deliver the following:
(a)
develop ties and exchanges among Union stakeholders (e.g. Member States, safety authorities, and utilities and decommissioning operators);
(b)
document explicit knowledge and make it available through multilateral knowledge transfers on decommissioning and waste management governance issues, managerial best practices, and technological challenges and decommissioning processes at both operational and organisational level, with a view to developing potential Union synergies.
These activities can be funded by the Union at a rate of 100 %.
Progress made in respect of this objective is to be measured by the amount of knowledge products created and their reach.
3.
The disposal of spent fuel and radioactive waste in a deep geological repository and the preparation thereof is excluded from the financial envelope referred to in Article 4(1).
ANNEX II
Detailed description of the objectives of the Bohunice programme
1.
The general objective of the Bohunice programme is to assist Slovakia in managing the safety challenges in respect of the decommissioning of Units 1 and 2 of the Bohunice V1 Nuclear Power Plant. The major safety challenges to be addressed by the Bohunice programme are:
(a)
the dismantling and decontamination of the reactors’ buildings and components in accordance with the decommissioning plans. Progress made in respect of this objective is to be measured by the quantity and type of materials removed as well as earned value;
(b)
the safe management of the decommissioning and radioactive waste in line with the needs identified in the respective decommissioning plan and of activated materials and dismantling materials, including their decontamination up to interim storage or to disposal (depending on the waste category), as well as the completion of the waste and material management infrastructure where necessary. This objective has to be accomplished in accordance with the decommissioning plan and subject to the necessary management of radioactive waste. Progress made in respect of this objective is to be measured by the quantity and type of material released from regulatory control and waste safely stored or disposed as well as earned value; and
(c)
to continue the downgrading of radiological hazards. Progress made in respect of this objective is to be measured through the safety assessments of the activities and the facility, identifying ways in which potential exposures could occur and estimating the probabilities and magnitude of potential exposures. In the Bohunice programme, the release of the facilities from regulatory control up to corresponding regulatory free-release levels is due to take place by 2025.
2.
The general objective of the Bohunice programme is complemented by the aim of enhancing the EU added value of that programme by contributing to the dissemination of knowledge on the decommissioning process (thereby generated) to all Member States. In the financing period starting as of 2021, the Bohunice programme has to deliver the following:
(a)
develop ties and exchanges among Union stakeholders (e.g. Member States, safety authorities, and utilities and decommissioning operators);
(b)
document explicit knowledge and make it available through multilateral knowledge transfers on decommissioning and waste management governance issues, managerial best practices, and technological challenges and decommissioning processes at both operational and organisational level, with a view to developing potential Union synergies.
These activities can be funded by the Union at a rate of 100 %.
Progress made in respect of this objective is to be measured by the amount of knowledge products created and their reach.
3.
The disposal of spent fuel and radioactive waste in a deep geological repository and the preparation thereof is excluded from the financial envelope referred to in Article 4(1).
ANNEX III
Detailed description of the objectives of the JRC decommissioning and waste management programme
1.
The general objective of the JRC decommissioning and waste management programme is to pursue the decommissioning of the Commission’s nuclear installations at the JRC sites, namely JRC-Geel in Belgium, JRC-Karlsruhe in Germany, JRC-Ispra in Italy and JRC-Petten in the Netherlands, and to safely manage the spent fuel, nuclear material and radioactive waste. The general objective of the JRC decommissioning and waste management programme is complemented by the aim of enhancing the EU added value of that programme by contributing to the dissemination of knowledge on the decommissioning process (thereby generated) to all Member States. In the financing period starting as of 2021, the JRC decommissioning and waste management programme has to deliver the following:
1.1.
At all sites:
(a)
safely manage radioactive waste, nuclear material and spent fuel;
(b)
explore and develop options for the transfer of decommissioning and waste management liabilities to the host Member State, based on the mutual bilateral agreement concluded between the Commission and the host Member State;
(c)
develop ties and exchanges among Union stakeholders (e.g. Member States, safety authorities, and utilities and decommissioning operators);
(d)
document explicit knowledge and make it available through multilateral knowledge transfers on decommissioning and waste management governance issues, managerial best practices, and technological challenges and decommissioning processes at both operational and organisational level, with a view to developing potential Union synergies.
1.2.
At the JRC-Ispra site (depending on release of the relevant authorisations by the Italian safety authorities), in accordance with national law:
(a)
retrieve, treat and safely store historical waste;
(b)
retrieve, treat and safely store nuclear material and spent fuel;
(c)
decommission facilities that have been shut down.
1.3.
At the JRC-Karlsruhe site (depending on release of the relevant authorisations by the German safety authorities), in accordance with national law:
(a)
decommission obsolete equipment;
(b)
minimise the inventory of radioactive waste, nuclear material and spent fuel;
(c)
decommission facilities that have been shut down and store associated radioactive waste;
(d)
preparatory phases of the decommissioning of building parts.
1.4.
At the JRC-Petten site (depending on release of the relevant authorisations by the Dutch safety authorities), in accordance with national law:
(a)
minimise the inventory of radioactive waste, nuclear material and spent fuel;
(b)
retrieve, treat and safely manage the historical radioactive waste;
(c)
preparatory phases of the decommissioning of the high-flux reactor;
(d)
decommission the high-flux reactor facilities and safely manage associated radioactive waste.
1.5.
At the JRC-Geel site (depending on release of the relevant authorisations by the Belgian safety authorities), in accordance with national law:
(a)
decommission obsolete equipment;
(b)
minimise the inventory of radioactive waste and nuclear material;
(c)
preparatory phases of the decommissioning of building parts.
Progress made in respect of this objective is to be measured by the quantity and type of safely stored or disposed-of waste, by the quantity and type of safely stored or disposed-of nuclear material and spent fuel and by the quantity and type of materials removed, as appropriate. The progress of the JRC decommissioning and waste management programme is to be generally measured by expected results, milestones, target dates, as well as the corresponding key performance indicators, including, where appropriate, earned-value-based indicators.
2.
The general objective of the JRC decommissioning and waste management programme is complemented by the aim of enhancing the EU added value of that programme by contributing to the dissemination of knowledge on the decommissioning process (thereby generated) to all Member States. In the financing period starting as of 2021, the JRC decommissioning and waste management programme has to deliver the following:
2.1.
develop ties and exchanges among Union stakeholders (e.g. Member States, safety authorities, and utilities and decommissioning operators);
2.2.
document explicit knowledge and make it available through multilateral knowledge transfers on decommissioning and waste management governance issues, managerial best practices, and technological challenges and decommissioning processes at both operational and organisational level, with a view to developing potential Union synergies.
Progress made in respect of this objective is to be measured by the amount of knowledge products created and their reach.
3.
The disposal of spent fuel and radioactive waste in a deep geological repository is included in the scope of the JRC decommissioning and waste management programme, as required by Directive 2011/70/Euratom.
ANNEX IV
Indicators to report on the progress of the Programme towards the achievement of the objectives set out in Article 3
(1)
Radioactive waste management:
—
quantity and type of waste safely stored or disposed of, with annual objectives by type, meeting the milestones of the Programme;
(2)
Dismantling and decontamination:
—
quantity and type of materials removed, with annual objectives by type, meeting the milestones of the Programme.
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Nuclear facilities and radioactive waste — EU decommissioning assistance (2021-2027)
Nuclear facilities and radioactive waste — EU decommissioning assistance (2021-2027)
SUMMARY OF:
Regulation (Euratom) 2021/100 establishing a dedicated financial programme for the decommissioning of nuclear facilities and the management of radioactive waste
Regulation (EU) 2021/101 establishing the nuclear decommissioning assistance programme of the Ignalina nuclear power plant in Lithuania
WHAT IS THE AIM OF THE REGULATIONS?
Regulation (Euratom) 2021/100 establishes a financial programme for decommissioning* nuclear facilities, and managing radioactive waste of the Commission’s nuclear installations and of specified installations in Bulgaria and Slovakia.
Regulation (EU) 2021/101 establishes a nuclear decommissioning assistance programme in Lithuania.
KEY POINTS
The 2 multiannual programmes have the following in common:
each runs from 1 January 2021 to 31 December 2027;
the knowledge gained is shared among all EU Member States;
the European Commission must present to the European Parliament and the Council: a progress report at the end of each year based on radioactive waste management, dismantling and decontamination indicators;an interim evaluation within 4 years of the start of the programmes and a final evaluation, no later than 5 years after they end;
recipients of EU funding must ensure the visibility of the EU funding to various audiences, including the media and public.
Regulation (Euratom) 2021/100:
supports the safe decommissioning of: the Kozloduy nuclear power plant in Bulgaria,the Bohunice V1 plant in Slovakia;
implements the decommissioning process and manages radioactive waste at four Joint Research Centre (JRC) sites: JRC-Geel (Belgium),JRC-Karlsruhe (Germany),JRC-Ispra (Italy),JRC-Petten (the Netherlands);
supports the JRC to: manage radioactive waste, nuclear material and spent fuel safely;explore and develop options for transferring decommissioning and waste management liabilities to the host Member States;develop ties and exchange knowledge among those involved, such as governments, safety authorities, utilities and decommissioning operators;document knowledge gained and make this available;
has a €466 million budget shared between the programmes as follows: €63 million for the Kozloduy programme;€55 million for the Bohunice programme;€348 million for the JRC;
states that the EU will provide no more than 50% of the costs of the Kozloduy and Bohunice programmes, with Bulgaria and Slovakia covering the rest;
repeals Regulation (Euratom) No 1368/2013.
Regulation (EU) 2021/101:
supports the safe decommissioning of the Ignalina nuclear power plant in Lithuania, including: dismantling and decontaminating the reactor shafts;managing safely the decommissioning and the legacy waste;implementing the building demolition programme;obtaining the decommissioning licence;downgrading radiological hazards;
has a €552 million budget;
states that the EU will provide no more than 86% of the costs involved, with the remainder to be covered by Lithuania and other sources;
repeals Regulation (EU) No 1369/2013.
FROM WHEN DO THE REGULATIONS APPLY?
Both have applied since 1 January 2021.
BACKGROUND
Decommissioning a nuclear power plant is the final step in its life cycle. The long process involves activities from shutdown and removal of nuclear material to environmental restoration of the site.
Directives 2011/70/Euratom on radioactive waste (see summary) and 2009/71/Euratom on the safety of nuclear installations (see summary) set out Member States’ ultimate responsibility for nuclear safety. This includes decommissioning and safe management of spent fuel and radioactive waste.
KEY TERMS
Decommissioning: administrative and technical measures to dismantle a nuclear facility until it no longer requires radiation protection.
MAIN DOCUMENTS
Council Regulation (Euratom) 2021/100 of 25 January 2021 establishing a dedicated financial programme for the decommissioning of nuclear facilities and the management of radioactive waste, and repealing Regulation (Euratom) No 1368/2013 (OJ L 34, 1.2.2021, pp. 3-17)
Council Regulation (EU) 2021/101 of 25 January 2021 establishing the nuclear decommissioning assistance programme of the Ignalina nuclear power plant in Lithuania and repealing Regulation (EU) No 1369/2013 (OJ L 34, 1.2.2021, pp. 18-28)
RELATED DOCUMENTS
Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011, pp. 48-56)
Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, pp. 18-22)
Successive amendments to Directive 2009/71/Euratom have been incorporated into the original text. This consolidated version is of documentary value only.
last update 05.05.2021
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32010R0995
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12.11.2010
EN
Official Journal of the European Union
L 295/23
REGULATION (EU) No 995/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 20 October 2010
laying down the obligations of operators who place timber and timber products on the market
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
Forests provide a broad variety of environmental, economic and social benefits including timber and non-timber forest products and environmental services essential for humankind, such as maintaining biodiversity and ecosystem functions and protecting the climate system.
(2)
Due to the growing demand for timber and timber products worldwide, in combination with the institutional and governance deficiencies that are present in the forest sector in a number of timber-producing countries, illegal logging and the associated trade have become matters of ever greater concern.
(3)
Illegal logging is a pervasive problem of major international concern. It poses a significant threat to forests as it contributes to the process of deforestation and forest degradation, which is responsible for about 20 % of global CO2 emissions, threatens biodiversity, and undermines sustainable forest management and development including the commercial viability of operators acting in accordance with applicable legislation. It also contributes to desertification and soil erosion and can exacerbate extreme weather events and flooding. In addition, it has social, political and economic implications, often undermining progress towards good governance and threatening the livelihood of local forest-dependent communities, and it can be linked to armed conflicts. Combating the problem of illegal logging in the context of this Regulation is expected to contribute to the Union’s climate change mitigation efforts in a cost-effective manner and should be seen as complementary to Union action and commitments in the context of the United Nations Framework Convention on Climate Change.
(4)
Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (3) identifies as a priority action the examination of the possibility of taking active measures to prevent and combat trade in illegally harvested wood and the continuation of the active participation of the Union and of Member States in the implementation of global and regional resolutions and agreements on forest-related issues.
(5)
The Commission Communication of 21 May 2003 entitled ‘Forest Law Enforcement, Governance and Trade (FLEGT): Proposal for an EU Action Plan’ proposed a package of measures to support international efforts to tackle the problem of illegal logging and associated trade in the context of overall efforts of the Union to achieve sustainable forest management.
(6)
The European Parliament and the Council welcomed that Communication and recognised the need for the Union to contribute to global efforts to address the problem of illegal logging.
(7)
In accordance with the aim of that Communication, namely to ensure that only timber products which have been produced in accordance with the national legislation of the timber-producing country enter the Union, the Union has been negotiating Voluntary Partnership Agreements (FLEGT VPAs) with timber-producing countries (partner countries), which create a legally binding obligation for the parties to implement a licensing scheme and to regulate trade in timber and timber products identified in those FLEGT VPAs.
(8)
Given the major scale and urgency of the problem, it is necessary to support the fight against illegal logging and related trade actively, to complement and strengthen the FLEGT VPA initiative and to improve synergies between policies aimed at the conservation of forests and the achievement of a high level of environmental protection, including combating climate change and biodiversity loss.
(9)
The efforts made by countries which have concluded FLEGT VPAs with the Union and the principles incorporated in them, in particular with regard to the definition of legally produced timber, should be recognised and further encouragement for countries to conclude FLEGT VPAs should be given. It should be also taken into account that under the FLEGT licensing scheme only timber harvested in accordance with the relevant national legislation and timber products derived from such timber are exported into the Union. Therefore, timber embedded in timber products listed in Annexes II and III to Council Regulation (EC) No 2173/2005 of 20 December 2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (4), originating in partner countries listed in Annex I to that Regulation, should be considered to have been legally harvested provided those timber products comply with that Regulation and any implementing provisions.
(10)
Account should also be taken of the fact that the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) places a requirement on parties to CITES only to grant a CITES permit for export when a CITES-listed species has been harvested, inter alia, in compliance with national legislation in the exporting country. Therefore timber of species listed in Annex A, B or C to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (5) should be considered to have been legally harvested provided it complies with that Regulation and any implementing provisions.
(11)
Bearing in mind that the use of recycled timber and timber products should be encouraged, and that including such products in the scope of this Regulation would place a disproportionate burden on operators, used timber and timber products that have completed their lifecycle, and would otherwise be disposed of as waste, should be excluded from the scope of this Regulation.
(12)
The placing on the internal market for the first time of illegally harvested timber or timber products derived from such timber should be prohibited as one of the measures of this Regulation. Taking into account the complexity of illegal logging, its underlying causes and its impacts, specific measures should be taken, such as those that target the behaviour of operators.
(13)
In the context of the FLEGT Action Plan the Commission and, where appropriate, Member States may support and conduct studies and research on the levels and nature of illegal logging in different countries and make such information publicly available, as well as support the provision of practical guidance to operators on applicable legislation in timber-producing countries.
(14)
In the absence of an internationally agreed definition, the legislation of the country where the timber was harvested, including regulations as well as the implementation in that country of relevant international conventions to which that country is party, should be the basis for defining what constitutes illegal logging.
(15)
Many timber products undergo numerous processes before and after they are placed on the internal market for the first time. In order to avoid imposing any unnecessary administrative burden, only operators that place timber and timber products on the internal market for the first time should be subject to the due diligence system, while a trader in the supply chain should be required to provide basic information on its supplier and its buyer to enable the traceability of timber and timber products.
(16)
On the basis of a systemic approach, operators placing timber and timber products for the first time on the internal market should take the appropriate steps in order to ascertain that illegally harvested timber and timber products derived from such timber are not placed on the internal market. To that end, operators should exercise due diligence through a system of measures and procedures to minimise the risk of placing illegally harvested timber and timber products derived from such timber on the internal market.
(17)
The due diligence system includes three elements inherent to risk management: access to information, risk assessment and mitigation of the risk identified. The due diligence system should provide access to information about the sources and suppliers of the timber and timber products being placed on the internal market for the first time, including relevant information such as compliance with the applicable legislation, the country of harvest, species, quantity, and where applicable sub-national region and concession of harvest. On the basis of this information, operators should carry out a risk assessment. Where a risk is identified, operators should mitigate such risk in a manner proportionate to the risk identified, with a view to preventing illegally harvested timber and timber products derived from such timber from being placed on the internal market.
(18)
In order to avoid any unnecessary administrative burden, operators already using systems or procedures which comply with the requirements of this Regulation should not be required to set up new systems.
(19)
In order to recognise good practice in the forestry sector, certification or other third party verified schemes that include verification of compliance with applicable ĺegislation may be used in the risk assessment procedure.
(20)
The timber sector is of major importance for the economy of the Union. Organisations of operators are important actors in the sector as they represent the interests of the latter on a large scale and interact with a diverse range of stakeholders. Those organisations also have the expertise and capacity to analyse relevant legislation and facilitate the compliance of their members, but should not use this competence to dominate the market. In order to facilitate the implementation of this Regulation and to contribute to the development of good practices it is appropriate to recognise organisations which have developed due diligence systems meeting the requirements of this Regulation. Recognition and withdrawal of recognition of monitoring organisations should be performed in a fair and transparent manner. A list of such recognised organisations should be made public in order to enable operators to use them.
(21)
Competent authorities should carry out checks at regular intervals on monitoring organisations to verify that they effectively fulfil the obligations laid down in this Regulation. Moreover, competent authorities should endeavour to carry out checks when in possession of relevant information, including substantiated concerns from third parties.
(22)
Competent authorities should monitor that operators effectively fulfil the obligations laid down in this Regulation. For that purpose the competent authorities should carry out official checks, in accordance with a plan as appropriate, which may include checks on the premises of operators and field audits, and should be able to require operators to take remedial actions where necessary. Moreover, competent authorities should endeavour to carry out checks when in possession of relevant information, including substantiated concerns from third parties.
(23)
Competent authorities should keep records of the checks and the relevant information should be made available in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (6).
(24)
Taking into account the international character of illegal logging and related trade, competent authorities should cooperate with each other and with the administrative authorities of third countries and the Commission.
(25)
In order to facilitate the ability of operators who place timber or timber products on the internal market to comply with the requirements of this Regulation, taking into account the situation of small and medium-sized enterprises, Member States, assisted by the Commission where appropriate, may provide operators with technical and other assistance and facilitate the exchange of information. Such assistance should not release operators from their obligation to exercise due diligence.
(26)
Traders and monitoring organisations should refrain from measures which could jeopardise the attainment of the objective of this Regulation.
(27)
Member States should ensure that infringements of this Regulation, including by operators, traders and monitoring organisations, are sanctioned by effective, proportionate and dissuasive penalties. National rules may provide that, after effective, proportionate and dissuasive penalties are applied for infringements of the prohibition of placing on the internal market of illegally harvested timber or timber products derived from such timber, such timber and timber products should not necessarily be destroyed but may instead be used or disposed of for public interest purposes.
(28)
The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) concerning the procedures for the recognition and withdrawal of recognition of monitoring organisations, concerning further relevant risk assessment criteria that may be necessary to supplement those already provided for in this Regulation and concerning the list of timber and timber products to which this Regulation applies. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
(29)
In order to ensure uniform conditions for implementation, implementing powers should be conferred on the Commission to adopt detailed rules with regard to the frequency and the nature of the checks by competent authorities on monitoring organisations and to the due diligence systems except as regards further relevant risk assessment criteria. In accordance with Article 291 TFEU, rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.
(30)
Operators and competent authorities should be given a reasonable period in order to prepare themselves to meet the requirements of this Regulation.
(31)
Since the objective of this Regulation, namely the fight against illegal logging and related trade, cannot be achieved by the Member States individually and can therefore, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation lays down the obligations of operators who place timber and timber products on the internal market for the first time, as well as the obligations of traders.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a)
‘timber and timber products’ means the timber and timber products set out in the Annex, with the exception of timber products or components of such products manufactured from timber or timber products that have completed their lifecycle and would otherwise be disposed of as waste, as defined in Article 3(1) of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (8),
(b)
‘placing on the market’ means the supply by any means, irrespective of the selling technique used, of timber or timber products for the first time on the internal market for distribution or use in the course of a commercial activity, whether in return for payment or free of charge. It also includes the supply by means of distance communication as defined in Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (9). The supply on the internal market of timber products derived from timber or timber products already placed on the internal market shall not constitute ‘placing on the market’;
(c)
‘operator’ means any natural or legal person that places timber or timber products on the market;
(d)
‘trader’ means any natural or legal person who, in the course of a commercial activity, sells or buys on the internal market timber or timber products already placed on the internal market;
(e)
‘country of harvest’ means the country or territory where the timber or the timber embedded in the timber products was harvested;
(f)
‘legally harvested’ means harvested in accordance with the applicable legislation in the country of harvest;
(g)
‘illegally harvested’ means harvested in contravention of the applicable legislation in the country of harvest;
(h)
‘applicable legislation’ means the legislation in force in the country of harvest covering the following matters:
—
rights to harvest timber within legally gazetted boundaries,
—
payments for harvest rights and timber including duties related to timber harvesting,
—
timber harvesting, including environmental and forest legislation including forest management and biodiversity conservation, where directly related to timber harvesting,
—
third parties’ legal rights concerning use and tenure that are affected by timber harvesting, and
—
trade and customs, in so far as the forest sector is concerned.
Article 3
Status of timber and timber products covered by FLEGT and CITES
Timber embedded in timber products listed in Annexes II and III to Regulation (EC) No 2173/2005 which originate in partner countries listed in Annex I to that Regulation and which comply with that Regulation and its implementing provisions shall be considered to have been legally harvested for the purposes of this Regulation.
Timber of species listed in Annex A, B or C to Regulation (EC) No 338/97 and which complies with that Regulation and its implementing provisions shall be considered to have been legally harvested for the purposes of this Regulation.
Article 4
Obligations of operators
1. The placing on the market of illegally harvested timber or timber products derived from such timber shall be prohibited.
2. Operators shall exercise due diligence when placing timber or timber products on the market. To that end, they shall use a framework of procedures and measures, hereinafter referred to as a ‘due diligence system’, as set out in Article 6.
3. Each operator shall maintain and regularly evaluate the due diligence system which it uses, except where the operator makes use of a due diligence system established by a monitoring organisation referred to in Article 8. Existing supervision systems under national legislation and any voluntary chain of custody mechanism which fulfil the requirements of this Regulation may be used as a basis for the due diligence system.
Article 5
Obligation of traceability
Traders shall, throughout the supply chain, be able to identify:
(a)
the operators or the traders who have supplied the timber and timber products; and
(b)
where applicable, the traders to whom they have supplied timber and timber products.
Traders shall keep the information referred to in the first paragraph for at least five years and shall provide that information to competent authorities if they so request.
Article 6
Due diligence systems
1. The due diligence system referred to in Article 4(2) shall contain the following elements:
(a)
measures and procedures providing access to the following information concerning the operator’s supply of timber or timber products placed on the market:
—
description, including the trade name and type of product as well as the common name of tree species and, where applicable, its full scientific name,
—
country of harvest, and where applicable:
(i)
sub-national region where the timber was harvested; and
(ii)
concession of harvest,
—
quantity (expressed in volume, weight or number of units),
—
name and address of the supplier to the operator,
—
name and address of the trader to whom the timber and timber products have been supplied,
—
documents or other information indicating compliance of those timber and timber products with the applicable legislation;
(b)
risk assessment procedures enabling the operator to analyse and evaluate the risk of illegally harvested timber or timber products derived from such timber being placed on the market.
Such procedures shall take into account the information set out in point (a) as well as relevant risk assessment criteria, including:
—
assurance of compliance with applicable legislation, which may include certification or other third-party-verified schemes which cover compliance with applicable legislation,
—
prevalence of illegal harvesting of specific tree species,
—
prevalence of illegal harvesting or practices in the country of harvest and/or sub-national region where the timber was harvested, including consideration of the prevalence of armed conflict,
—
sanctions imposed by the UN Security Council or the Council of the European Union on timber imports or exports,
—
complexity of the supply chain of timber and timber products.
(c)
except where the risk identified in course of the risk assessment procedures referred to in point (b) is negligible, risk mitigation procedures which consist of a set of measures and procedures that are adequate and proportionate to minimise effectively that risk and which may include requiring additional information or documents and/or requiring third party verification.
2. Detailed rules necessary to ensure the uniform implementation of paragraph 1, except as regards further relevant risk assessment criteria referred to in the second sentence of paragraph 1(b) of this Article, shall be adopted in accordance with the regulatory procedure referred to in Article 18(2). Those rules shall be adopted by 3 June 2012.
3. Taking into account market developments and the experience gained in the implementation of this Regulation, in particular as identified through the exchange of information referred to in Article 13 and the reporting referred to in Article 20(3), the Commission may adopt delegated acts in accordance with Article 290 TFEU as regards further relevant risk assessment criteria that may be necessary to supplement those referred to in the second sentence of paragraph 1(b) of this Article with a view to ensuring the effectiveness of the due diligence system.
For the delegated acts referred to in this paragraph the procedures set out in Articles 15, 16 and 17 shall apply.
Article 7
Competent authorities
1. Each Member State shall designate one or more competent authorities responsible for the application of this Regulation.
Member States shall inform the Commission of the names and addresses of the competent authorities by 3 June 2011. Member States shall inform the Commission of any changes to the names or addresses of the competent authorities.
2. The Commission shall make publicly available, including on the Internet, a list of the competent authorities. The list shall be regularly updated.
Article 8
Monitoring organisations
1. A monitoring organisation shall:
(a)
maintain and regularly evaluate a due diligence system as set out in Article 6 and grant operators the right to use it;
(b)
verify the proper use of its due diligence system by such operators;
(c)
take appropriate action in the event of failure by an operator to properly use its due diligence system, including notification of competent authorities in the event of significant or repeated failure by the operator.
2. An organisation may apply for recognition as a monitoring organisation if it complies with the following requirements:
(a)
it has legal personality and is legally established within the Union;
(b)
it has appropriate expertise and the capacity to exercise the functions referred to in paragraph 1; and
(c)
it ensures the absence of any conflict of interest in carrying out its functions.
3. The Commission, after consulting the Member State(s) concerned, shall recognise as a monitoring organisation an applicant that fulfils the requirements set out in paragraph 2.
The decision to grant recognition to a monitoring organisation shall be communicated by the Commission to the competent authorities of all the Member States.
4. The competent authorities shall carry out checks at regular intervals to verify that the monitoring organisations operating within the competent authorities’ jurisdiction continue to fulfil the functions laid down in paragraph 1 and comply with the requirements laid down in paragraph 2. Checks may also be carried out when the competent authority of the Member State is in possession of relevant information, including substantiated concerns from third parties or when it has detected shortcomings in the implementation by operators of the due diligence system established by a monitoring organisation. A report of the checks shall be made available in accordance with Directive 2003/4/EC.
5. If a competent authority determines that a monitoring organisation either no longer fulfils the functions laid down in paragraph 1 or no longer complies with the requirements laid down in paragraph 2, it shall without delay inform the Commission.
6. The Commission shall withdraw recognition of a monitoring organisation when, in particular on the basis of the information provided pursuant to paragraph 5, it has determined that the monitoring organisation no longer fulfils the functions laid down in paragraph 1 or the requirements laid down in paragraph 2. Before withdrawing recognition of a monitoring organisation, the Commission shall inform the Member States concerned.
The decision to withdraw recognition of a monitoring organisation shall be communicated by the Commission to the competent authorities of all the Member States.
7. In order to supplement the procedural rules with regard to the recognition and withdrawal of recognition of monitoring organisations and, if experience so requires, to amend them, the Commission may adopt delegated acts in accordance with Article 290 TFEU, while ensuring that the recognition and withdrawal of recognition are performed in a fair and transparent manner.
For the delegated acts referred to in this paragraph the procedures set out in Articles 15, 16 and 17 shall apply. Those acts shall be adopted by 3 March 2012.
8. Detailed rules concerning the frequency and the nature of the checks referred to in paragraph 4, necessary to ensure the effective oversight of monitoring organisations and the uniform implementation of that paragraph, shall be adopted in accordance with the regulatory procedure referred to in Article 18(2). Those rules shall be adopted by 3 June 2012.
Article 9
List of monitoring organisations
The Commission shall publish the list of the monitoring organisations in the Official Journal of the European Union, C series, and shall make it available on its website. The list shall be regularly updated.
Article 10
Checks on operators
1. The competent authorities shall carry out checks to verify if operators comply with the requirements set out in Articles 4 and 6.
2. The checks referred to in paragraph 1 shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. In addition, checks may be conducted when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning compliance by an operator with this Regulation.
3. The checks referred to in paragraph 1 may include, inter alia:
(a)
examination of the due diligence system, including risk assessment and risk mitigation procedures;
(b)
examination of documentation and records that demonstrate the proper functioning of the due diligence system and procedures;
(c)
spot checks, including field audits.
4. Operators shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1, notably as regards access to premises and the presentation of documentation or records.
5. Without prejudice to Article 19, where, following the checks referred to in paragraph 1, shortcomings have been detected, the competent authorities may issue a notice of remedial actions to be taken by the operator. Additionally, depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia:
(a)
seizure of timber and timber products;
(b)
prohibition of marketing of timber and timber products.
Article 11
Records of checks
1. The competent authorities shall keep records of the checks referred to in Article 10(1), indicating in particular their nature and results, as well as of any notice of remedial actions issued under Article 10(5). Records of all checks shall be kept for at least five years.
2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC.
Article 12
Cooperation
1. Competent authorities shall cooperate with each other, with the administrative authorities of third countries and with the Commission in order to ensure compliance with this Regulation.
2. The competent authorities shall exchange information on serious shortcomings detected through the checks referred to in Articles 8(4) and 10(1) and on the types of penalties imposed in accordance with Article 19 with the competent authorities of other Member States and with the Commission.
Article 13
Technical assistance, guidance and exchange of information
1. Without prejudice to the operators’ obligation to exercise due diligence under Article 4(2), Member States, assisted by the Commission where appropriate, may provide technical and other assistance and guidance to operators, taking into account the situation of small and medium-sized enterprises, in order to facilitate compliance with the requirements of this Regulation, in particular in relation to the implementation of a due diligence system in accordance with Article 6.
2. Member States, assisted by the Commission where appropriate, may facilitate the exchange and dissemination of relevant information on illegal logging, in particular with a view to assisting operators in assessing risk as set out in Article 6(1)(b), and on best practices regarding the implementation of this Regulation.
3. Assistance shall be provided in a manner which avoids compromising the responsibilities of competent authorities and preserves their independence in enforcing this Regulation.
Article 14
Amendments of the Annex
In order to take into account, on the one hand, the experience gained in the implementation of this Regulation, in particular as identified through the reporting referred to in Article 20(3) and (4) and through the exchange of information as referred to in Article 13, and, on the other hand, developments with regard to technical characteristics, end-users and production processes of timber and timber products, the Commission may adopt delegated acts in accordance with Article 290 TFEU by amending and supplementing the list of timber and timber products set out in the Annex. Such acts shall not create a disproportionate burden on operators.
For the delegated acts referred to in this Article the procedures set out in Articles 15, 16 and 17 shall apply.
Article 15
Exercise of the delegation
1. The power to adopt the delegated acts referred to in Articles 6(3), 8(7) and 14 shall be conferred on the Commission for a period of seven years from 2 December 2010. The Commission shall make a report in respect of the delegated powers not later than three months before the end of a three-year period after the date of application of this Regulation. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 16.
2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 16 and 17.
Article 16
Revocation of the delegation
1. The delegation of powers referred to in Articles 6(3), 8(7) and 14 may be revoked at any time by the European Parliament or by the Council.
2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Article 17
Objections to delegated acts
1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months.
2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
3. If the European Parliament or the Council objects to a delegated act, the act shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.
Article 18
Committee
1. The Commission shall be assisted by the Forest Law Enforcement Governance and Trade (FLEGT) Committee established under Article 11 of Regulation (EC) No 2173/2005.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 19
Penalties
1. The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
2. The penalties provided for must be effective, proportionate and dissuasive and may include, inter alia:
(a)
fines proportionate to the environmental damage, the value of the timber or timber products concerned and the tax losses and economic detriment resulting from the infringement, calculating the level of such fines in such way as to make sure that they effectively deprive those responsible of the economic benefits derived from their serious infringements, without prejudice to the legitimate right to exercise a profession, and gradually increasing the level of such fines for repeated serious infringements;
(b)
seizure of the timber and timber products concerned;
(c)
immediate suspension of authorisation to trade.
3. The Member States shall notify those provisions to the Commission and shall notify it without delay of any subsequent amendments affecting them.
Article 20
Reporting
1. Member States shall submit to the Commission, by 30 April of every second year following 3 March 2013, a report on the application of this Regulation during the previous two years.
2. On the basis of those reports the Commission shall draw up a report to be submitted to the European Parliament and to the Council every two years. In preparing the report, the Commission shall have regard to the progress made in respect of the conclusion and operation of the FLEGT VPAs pursuant to Regulation (EC) No 2173/2005 and their contribution to minimising the presence of illegally harvested timber and timber products derived from such timber on the internal market.
3. By 3 December 2015 and every six years thereafter, the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation, including in preventing illegally harvested timber or timber products derived from such timber being placed on the market. It shall in particular consider the administrative consequences for small and medium-sized enterprises and product coverage. The reports may be accompanied, if necessary, by appropriate legislative proposals.
4. The first of the reports referred to in paragraph 3 shall include an evaluation of the current Union economic and trade situation with regard to the products listed under Chapter 49 of the Combined Nomenclature, taking particularly into account the competitiveness of the relevant sectors, in order to consider their possible inclusion in the list of timber and timber products set out in the Annex to this Regulation.
The report referred to in the first subparagraph shall also include an assessment of the effectiveness of the prohibition of the placing on the market of illegally harvested timber and timber products derived from such timber as set out in Article 4(1) as well as of the due diligence systems set out in Article 6.
Article 21
Entry into force and application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply as from 3 March 2013. However, Articles 6(2), 7(1), 8(7) and 8(8) shall apply as from 2 December 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 20 October 2010.
For the European Parliament
The President
J. BUZEK
For the Council
The President
O. CHASTEL
(1) OJ C 318, 23.12.2009, p. 88.
(2) Position of the European Parliament of 22 April 2009 (OJ C 184 E, 8.7.2010, p. 145), position of the Council at first reading of 1 March 2010 (OJ C 114 E, 4.5.2010, p. 17) and position of the European Parliament of 7 July 2010 (not yet published in the Official Journal).
(3) OJ L 242, 10.9.2002, p. 1.
(4) OJ L 347, 30.12.2005, p. 1.
(5) OJ L 61, 3.3.1997, p. 1.
(6) OJ L 41, 14.2.2003, p. 26.
(7) OJ L 184, 17.7.1999, p. 23.
(8) OJ L 312, 22.11.2008, p. 3.
(9) OJ L 144, 4.6.1997, p. 19.
ANNEX
Timber and timber products as classified in the Combined Nomenclature set out in Annex I to Council Regulation (EEC) No 2658/87
(1)
, to which this Regulation applies
—
4401 Fuel wood, in logs, in billets, in twigs, in faggots or in similar forms; wood in chips or particles; sawdust and wood waste and scrap, whether or not agglomerated in logs, briquettes, pellets or similar forms
—
4403 Wood in the rough, whether or not stripped of bark or sapwood, or roughly squared
—
4406 Railway or tramway sleepers (cross-ties) of wood
—
4407 Wood sawn or chipped lengthwise, sliced or peeled, whether or not planed, sanded or end-jointed, of a thickness exceeding 6 mm
—
4408 Sheets for veneering (including those obtained by slicing laminated wood), for plywood or for other similar laminated wood and other wood, sawn lengthwise, sliced or peeled, whether or not planed, sanded, spliced or end-jointed, of a thickness not exceeding 6 mm
—
4409 Wood (including strips and friezes for parquet flooring, not assembled) continuously shaped (tongued, grooved, rebated, chamfered, V-jointed, beaded, moulded, rounded or the like) along any of its edges, ends or faces, whether or not planed, sanded or end-jointed
—
4410 Particle board, oriented strand board (OSB) and similar board (for example, waferboard) of wood or other ligneous materials, whether or not agglomerated with resins or other organic binding substances
—
4411 Fibreboard of wood or other ligneous materials, whether or not bonded with resins or other organic substances
—
4412 Plywood, veneered panels and similar laminated wood
—
4413 00 00 Densified wood, in blocks, plates, strips or profile shapes
—
4414 00 Wooden frames for paintings, photographs, mirrors or similar objects
—
4415 Packing cases, boxes, crates, drums and similar packings, of wood; cable-drums of wood; pallets, box pallets and other load boards, of wood; pallet collars of wood
(Not packing material used exclusively as packing material to support, protect or carry another product placed on the market.)
—
4416 00 00 Casks, barrels, vats, tubs and other coopers’ products and parts thereof, of wood, including staves
—
4418 Builders’ joinery and carpentry of wood, including cellular wood panels, assembled flooring panels, shingles and shakes
—
Pulp and paper of Chapters 47 and 48 of the Combined Nomenclature, with the exception of bamboo-based and recovered (waste and scrap) products
—
9403 30, 9403 40, 9403 50 00, 9403 60 and 9403 90 30 Wooden furniture
—
9406 00 20 Prefabricated buildings
(1) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
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Combating illegal logging
Combating illegal logging
SUMMARY OF:
Regulation (EU) No 995/2010 on the obligations of operators who place timber and timber products on the market
WHAT IS THE AIM OF THE REGULATION?
It prohibits illegally harvested timber from being placed on the EU market, and sets out preconditions for the marketing of timber and timber products in the EU.
KEY POINTS
The regulation requires ‘operators’ who place timber products on the EU market for the first time to exercise ‘due diligence’* to ensure they supply products made of legally harvested timber. To this end, operators must use a due diligence system.
Operators may set up their own due diligence systems or use one created by a monitoring organisation.
Monitoring organisations are recognised as such by the European Commission. Their role is to assist operators comply with the requirements of the regulation.
To facilitate the traceability of timber products, all traders who buy and sell timber on the market must keep records of their suppliers and customers.
The regulation, which applies both to EU-harvested and imported timber, covers a wide range of timber products that are listed in the annex and are in accordance with the Union Customs Code.
The regulation considers timber/timber products to be legally harvested if they have a Forest Law Enforcement, Governance and Trade (FLEGT) licence (established with Regulation (EC) No 2173/2005), or a CITES permit (Regulation (EC) No 338/97).
Monitoring of implementation and access to information
At the latest by 30 April of each year, countries covered by the regulation must make available to the public and the European Commission information on the application of this regulation during the previous calendar year. The Commission will also make available to the public a EU-wide overview on the basis of the data submitted by all EU countries.
By 3 December 2021 and every 5 years thereafter, the Commission must review the functioning and effectiveness of this regulation on the basis of the information received each year and the experience with its application.
BACKGROUND
Illegal logging* is a pervasive environmental, economic and social problem that contributes to climate change, the loss of biodiversity, lost revenue, conflicts (sometimes armed) over land and resources, and corruption.
For more information, see:
Illegal logging (European Commission).
KEY TERMS
Due diligence: a risk management exercise to minimise the risk of illegally harvested timber (or products containing it) being offered for sale on the EU market.
Illegal logging: the harvesting of timber in violation of the laws of the country of harvest.
MAIN DOCUMENT
Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (OJ L 295, 12.11.2010, pp. 23-34)
RELATED DOCUMENTS
Commission Delegated Regulation (EU) No 363/2012 of 23 February 2012 on the procedural rules for the recognition and withdrawal of recognition of monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (OJ L 115, 27.4.2012, pp. 12-16)
Commission Implementing Regulation (EU) No 607/2012 of 6 July 2012 on the detailed rules concerning the due diligence system and the frequency and nature of the checks on monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (OJ L 177, 7.7.2012, pp. 16-18)
Council Regulation (EC) No 2173/2005 of 20 December 2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (Official Journal L 347, 30.12.2005, pp. 1-6)
Successive amendments to Council Regulation (EC) No 2173/2005 have been incorporated in the original text. This consolidated version is of documentary value only.
Commission Regulation (EC) No 1024/2008 of 17 October 2008 laying down detailed measures for the implementation of Council Regulation (EC) No 2173/2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (OJ L 277, 18.10.2008, pp. 23-29)
last update 29.08.2019
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32009R0470
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16.6.2009
EN
Official Journal of the European Union
L 152/11
REGULATION (EC) No 470/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 6 May 2009
laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 and Article 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),
Whereas:
(1)
As a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicinal products in foodstuffs at ever lower levels.
(2)
In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamination, as well as the microbiological and pharmacological effects of residues. Account should also be taken of other scientific assessments of the safety of substances concerned which may have been undertaken by international organisations or scientific bodies established within the Community.
(3)
This Regulation directly concerns public health and is relevant to the functioning of the internal market in products of animal origin included in Annex I to the Treaty. It is therefore necessary to establish maximum residue limits for pharmacologically active substances in respect of various foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
(4)
Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (3) introduced Community procedures to evaluate the safety of residues of pharmacologically active substances in accordance with human food safety requirements. A pharmacologically active substance may be used in food-producing animals only if evaluated favourably. Maximum residue limits are established for such substances where they are considered necessary for the protection of human health.
(5)
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products (4) provides that veterinary medicinal products may be authorised or used in food-producing animals only if pharmacologically active substances contained therein have been assessed as safe according to Regulation (EEC) No 2377/90. Moreover that Directive contains rules concerning the documentation of use, re-designation (off label use), prescription and distribution of veterinary medicinal products intended for use in food-producing animals.
(6)
In the light of the European Parliament’s resolution of 3 May 2001 (5) on the availability of veterinary medicinal products, the Commission’s public consultation undertaken in 2004 and its assessment of the experience gained, it has proved necessary to modify the procedures for setting maximum residue limits while maintaining the overall system for setting such limits.
(7)
Maximum residue limits are the points of reference for the establishment, in accordance with Directive 2001/82/EC, of withdrawal periods in marketing authorisations for veterinary medicinal products to be used in food-producing animals as well as for the control of residues in food of animal origin in the Member States and at border inspection posts.
(8)
Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and of β-agonists (6) prohibits the use of certain substances for specific purposes in food-producing animals. This Regulation should apply without prejudice to any Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal action.
(9)
Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (7) lays down specific rules for substances not resulting from intentional administration. Those substances should not be subject to legislation on maximum residue limits.
(10)
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (8) lays down the framework for food legislation at Community level and provides for definitions in that area. It is appropriate that those definitions apply for the purposes of legislation on maximum residue limits.
(11)
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (9) lays down general rules for the control of food in the Community and provides for definitions in that area. It is appropriate that those rules and definitions apply for the purposes of legislation on maximum residue limits. Priority should be given to the detection of the illegal use of substances and part of the samples should be selected according to a risk-based approach.
(12)
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (10) entrusts the European Medicines Agency (the Agency) with the task of advising on the maximum residue limits for veterinary medicinal products which may be accepted in food of animal origin.
(13)
Maximum residue limits should be set for pharmacologically active substances used or intended to be used in veterinary medicinal products placed on the market in the Community.
(14)
It appears from the public consultation and from the fact that only a small number of veterinary medicinal products for food-producing animals have been authorised in recent years that Regulation (EEC) No 2377/90 has resulted in such medicinal products being less readily available.
(15)
In order to ensure animal health and welfare, it is necessary that veterinary medicinal products are available to treat specific disease conditions. Furthermore, the lack of availability of appropriate veterinary medicinal products for a specific treatment for a specific species may contribute to the misuse or illegal use of substances.
(16)
The system established by Regulation (EEC) No 2377/90 should therefore be modified with a view to increasing the availability of veterinary medicinal products for food-producing animals. In order to serve that objective, provision should be made for the systematic consideration by the Agency of the use of a maximum residue limit established for one species or foodstuff for another species or another foodstuff. In this respect, the adequacy of the safety factors already inherent in the system should be taken into account in order to ensure that food safety and animal welfare are not compromised.
(17)
It is recognised that, in certain cases, scientific risk assessments alone cannot provide all the information on which risk management decisions should be based and that other factors relevant to the matter under consideration should legitimately be taken into account, including the technological aspects of food production and the feasibility of controls. The Agency should therefore provide an opinion consisting of a scientific risk assessment and risk management recommendations on residues of pharmacologically active substances.
(18)
Detailed rules on the format and content of applications for the establishment of maximum residue limits and on methodological principles of risk assessment and of risk management recommendations are necessary for the smooth functioning of the whole framework of maximum residue limits.
(19)
Besides veterinary medicinal products, other products which are not subject to specific legislation on residues, such as biocidal products, are used in animal husbandry. These biocidal products are defined in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (11). Furthermore, veterinary medicinal products not having a marketing authorisation in the Community may be authorised in countries outside the Community. That may be because in other regions different diseases or target species are more prevalent or because companies have chosen not to market a product in the Community. The fact that a product is not authorised in the Community does not necessarily indicate that its use is unsafe. For the pharmacologically active substances of such products, the Commission should be enabled to set a maximum residue limit for food, following an opinion by the Agency, in accordance with the principles set for pharmacologically active substances intended for use in veterinary medicinal products. It is also necessary to amend Regulation (EC) No 726/2004 to include, within the tasks of the Agency, advising on the maximum levels of residues of active substances in biocidal products.
(20)
Under the system established by Directive 98/8/EC, operators having placed or seeking to place biocidal products on the market are obliged to pay charges for the evaluations carried out pursuant to different procedures associated with that Directive. This Regulation provides that the Agency is to carry out evaluations related to the establishment of the maximum residue limit for pharmacologically active substances intended to be used in biocidal products. As a consequence, this Regulation should clarify how those evaluations are financed, in order to take due account of fees already collected for evaluations carried out, or to be carried out, under that Directive.
(21)
The Community contributes, in the context of the Codex Alimentarius, to the development of international standards on maximum residue limits, while ensuring that the high level of protection of human health maintained in the Community is not reduced. The Community should therefore take over without a further risk assessment those Codex Alimentarius maximum residue limits it has supported in the relevant Codex Alimentarius Commission meetings. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced.
(22)
Foodstuffs are subject to controls on residues of pharmacologically active substances in accordance with Regulation (EC) No 882/2004. Even if residue limits are not set for such substances pursuant to this Regulation, residues of such substances might occur due to environmental contamination or the occurrence of a natural metabolite in the animal. Laboratory methods are capable of finding such residues at ever lower levels. Such residues have caused different control practices in Member States.
(23)
Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (12) requires that each consignment imported from a third country is subject to veterinary controls, and Commission Decision 2005/34/EC (13) lays down harmonised standards for the testing for certain residues in products of animal origin imported from third countries. It is appropriate to extend the provisions of Decision 2005/34/EC to all products of animal origin placed on the Community market.
(24)
A number of pharmacologically active substances are prohibited or currently not authorised under Regulation (EC) No 2377/90, Directive 96/22/EC or Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (14). The residues of pharmacologically active substances in products of animal origin arising, in particular, from illegal use or from environmental contamination should be carefully controlled and monitored in accordance with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (15), regardless of the origin of the product.
(25)
It is appropriate for the Community to provide for procedures to set reference points for action at concentrations of the residues for which laboratory analysis is technically feasible in order to facilitate intra-Community trade and imports, without undermining a high level of protection of human health in the Community. However, the setting of reference points for action should in no way serve as a pretext for condoning the illegal use of prohibited or non-authorised substances to treat food-producing animals. Therefore, any residues of those substances in food of animal origin should be considered undesirable.
(26)
It is also appropriate for the Community to establish a harmonised approach for situations where Member States find evidence of a recurrent problem, since such a finding could suggest a pattern of misuse of a particular substance or a disregard for guarantees provided by third countries concerning the production of food intended for import into the Community. Member States should notify the Commission of recurring problems, and appropriate follow-up measures should be taken.
(27)
The current legislation on maximum residue limits should be simplified by placing together in one single Commission regulation all decisions classifying pharmacologically active substances as regards residues.
(28)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (16).
(29)
In particular, the Commission should be empowered to adopt methodological principles for the risk assessment and risk management recommendations regarding the establishment of maximum residue limits, rules on the conditions for extrapolation, measures setting reference points for action, including measures reviewing those reference points, as well as methodological principles and scientific methods for the establishment of reference points for action. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(30)
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures setting reference points for action and measures reviewing those reference points.
(31)
Since the objectives of this Regulation, namely the protection of human and animal health and ensuring the availability of appropriate veterinary medicinal products, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(32)
In the interests of clarity, it is therefore necessary to replace Regulation (EEC) No 2377/90 with a new regulation.
(33)
A transitional period should be provided for in order to allow the Commission to prepare and adopt a regulation incorporating the pharmacologically active substances and their classification regarding maximum residue limits as laid down in Annexes I to IV to Regulation (EEC) No 2377/90, as well as certain implementing provisions for that new regulation,
HAVE ADOPTED THIS REGULATION:
TITLE I
GENERAL PROVISIONS
Article 1
Subject matter and scope
1. For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish:
(a)
the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit);
(b)
the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation (reference point for action).
2. This Regulation shall not apply:
(a)
to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;
(b)
to substances falling within the scope of Regulation (EEC) No 315/93.
3. This Regulation shall apply without prejudice to Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by Directive 96/22/EC.
Article 2
Definitions
In addition to the definitions laid down in Article 1 of Directive 2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and Articles 2 and 3 of Regulation (EC) No 178/2002, the following definitions shall apply for the purposes of this Regulation:
(a)
‘residues of pharmacologically active substances’ means all pharmacologically active substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals;
(b)
‘food-producing animals’ means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.
TITLE II
MAXIMUM RESIDUE LIMITS
CHAPTER I
Risk assessment and risk management
Section 1
Pharmacologically active substances intended for use in veterinary medicinal products in the Community
Article 3
Application for an opinion of the Agency
Except in cases where the Codex Alimentarius procedure referred to in Article 14(3) of this Regulation applies, any pharmacologically active substance intended for use in the Community in veterinary medicinal products which are to be administered to food-producing animals shall be subject to an opinion of the European Medicines Agency (the Agency) established by Article 55 of Regulation (EC) No 726/2004 on the maximum residue limit, formulated by the Committee for Medicinal Products for Veterinary Use (the Committee) established by Article 30 of that Regulation.
To that end, the applicant for a marketing authorisation for a veterinary medicinal product in which such a substance is used, a person intending to apply for such a marketing authorisation or, where appropriate, the holder of such a marketing authorisation, shall submit an application to the Agency.
Article 4
Opinion of the Agency
1. The opinion of the Agency shall consist of a scientific risk assessment and risk management recommendations.
2. The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products. The opinion shall take account of any relevant scientific findings of the European Food Safety Authority (EFSA) established by Article 22 of Regulation (EC) No 178/2002.
Article 5
Extrapolation
With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing animals, the Agency, while ensuring a high level of protection of human health, shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using maximum residue limits established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or maximum residue limits established for a pharmacologically active substance in one or more species for other species.
Article 6
Scientific risk assessment
1. The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI). Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 13(2).
2. The scientific risk assessment shall concern the following:
(a)
the type and amount of residue considered not to present a safety concern for human health;
(b)
the risk of toxicological, pharmacological or microbiological effects in human beings;
(c)
residues that occur in food of plant origin or that come from the environment.
3. If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.
Article 7
Risk management recommendations
The risk management recommendations shall be based on the scientific risk assessment performed in accordance with Article 6 and shall consist of an assessment of the following:
(a)
the availability of alternative substances for the treatment of the relevant species or the necessity of the substance evaluated in order to avoid unnecessary suffering for animals or to ensure the safety of those treating them;
(b)
other legitimate factors, such as the technological aspects of food and feed production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products, good practice in the use of veterinary medicinal and biocidal products and the likelihood of misuse or illegal use;
(c)
whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;
(d)
whether the data provided are not sufficient to allow a safe limit to be identified, or whether a final conclusion concerning human health with regard to residues of a substance cannot be established given the lack of scientific information. In either case, no maximum residue limit may be recommended.
Article 8
Applications and procedures
1. The application referred to in Article 3 shall comply with the format and content laid down by the Commission as provided for in Article 13(1) and shall be accompanied by the fee payable to the Agency.
2. The Agency shall ensure that the opinion of the Committee is given within 210 days of receipt of a valid application in accordance with Article 3 and paragraph 1 of this Article. This time limit shall be suspended where the Agency requests the submission of supplementary information on the given substance within a specific time period, and shall remain suspended until such time as the requested supplementary information has been provided.
3. The Agency shall forward the opinion referred to in Article 4 to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to request a re-examination of the opinion. In that case the applicant shall submit the detailed grounds for his request to the Agency within 60 days of receipt of the opinion.
Within 60 days of receipt of the applicant’s grounds for a re-examination request, the Committee shall consider whether its opinion should be revised and adopt the final opinion. The reasons for the conclusion reached on the request shall be annexed to the final opinion.
4. Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and the applicant, stating the grounds for its conclusions.
Section 2
Other pharmacologically active substances for which an opinion of the Agency may be requested
Article 9
Opinion of the Agency requested by the Commission or a Member State
1. The Commission or a Member State may submit to the Agency a request for an opinion on maximum residue limits in either of the following circumstances:
(a)
where the substance in question is authorised for use in a veterinary medicinal product in a third country and no application for the establishment of a maximum residue limit for that substance in respect of the foodstuff or species concerned has been submitted pursuant to Article 3;
(b)
where the substance in question is included in a medicinal product intended to be used pursuant to Article 11 of Directive 2001/82/EC and no application for the establishment of a maximum residue limit for that substance in respect of the foodstuff or species concerned has been submitted pursuant to Article 3 of this Regulation.
In the circumstances of point (b) of the first subparagraph, where minor species or minor uses are concerned, the request may be submitted to the Agency by an interested party or organisation.
Articles 4 to 7 shall apply.
A request for an opinion referred to in the first subparagraph of this paragraph shall comply with the format and content requirements laid down by the Commission pursuant to Article 13(1).
2. The Agency shall ensure that the opinion of the Committee is given within 210 days of receipt of the request by the Commission, a Member State or an interested party or organisation. This time limit shall be suspended if the Agency requests the submission of supplementary information on the given substance within a specific time period and until such time as the requested supplementary information has been provided.
3. Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and, as applicable, to the Member State or the interested party or organisation which made the request, stating the grounds for its conclusions.
Article 10
Pharmacologically active substances contained in biocidal products used in animal husbandry
1. For the purposes of Article 10(2)(ii) of Directive 98/8/EC, for pharmacologically active substances intended to be used in a biocidal product used in animal husbandry, the maximum residue limit shall be established:
(a)
following the procedure referred to in Article 9 of this Regulation for:
(i)
active substances/product type combinations included in the 10-year programme of work referred to in Article 16(2) of Directive 98/8/EC;
(ii)
active substances/product type combinations to be included in Annexes I, IA or IB to Directive 98/8/EC for which a dossier has been accepted by the competent authority as referred to in Article 11(1)(b) of that Directive before 6 July 2009;
(b)
following the procedure referred to in Article 8 of this Regulation and on the basis of an application submitted in accordance with Article 3 of this Regulation for all other active substances/product type combinations to be included in Annexes I, IA or IB to Directive 98/8/EC for which the establishment of a maximum residue limit is deemed necessary by the Member States or the Commission.
2. The Commission shall classify the pharmacologically active substances referred to in paragraph 1 in accordance with Article 14. For the purposes of classification, a regulation as referred to in Article 17(1) shall be adopted by the Commission.
However, any specific provisions relating to the conditions of use of the substances classified in accordance with the first subparagraph of this paragraph shall be laid down pursuant to Article 10(2) of Directive 98/8/EC.
3. The costs of evaluations carried out by the Agency following a request made in accordance with paragraph 1(a) of this Article shall be covered by the budget of the Agency as referred to in Article 67 of Regulation (EC) No 726/2004. However, this shall not apply to the evaluation costs of a rapporteur designated, in accordance with Article 62(1) of that Regulation, for the establishment of a maximum residue limit where that rapporteur has been appointed by a Member State that has already received a fee for that evaluation on the basis of Article 25 of Directive 98/8/EC.
The amount of the fees for evaluations carried out by the Agency and the rapporteur following an application made in accordance with paragraph 1(b) of this Article shall be established in accordance with Article 70 of Regulation (EC) No 726/2004. Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (17) shall apply.
Section 3
Common provisions
Article 11
Review of an opinion
Where the Commission, the applicant under Article 3 or a Member State, as a result of new information, considers that a review of an opinion is necessary in order to protect human or animal health, it may request the Agency to issue a new opinion on the substances in question.
Where a maximum residue limit has been established in accordance with this Regulation for specific foodstuffs or species, Articles 3 and 9 shall apply for the establishment of a maximum residue limit for that substance for other foodstuffs or species.
The request referred to in the first subparagraph shall be accompanied by information explaining the issue to be addressed. Article 8(2) to (4) or Article 9(2) and (3), as appropriate, shall apply to the new opinion.
Article 12
Publication of opinions
The Agency shall publish the opinions referred to in Articles 4, 9 and 11 after deleting any information of a commercially confidential nature.
Article 13
Implementing measures
1. In accordance with the regulatory procedure referred to in Article 25(2), the Commission shall, in consultation with the Agency, adopt measures regarding the form and content of the applications and requests referred to in Articles 3 and 9.
2. The Commission shall, in consultation with the Agency, Member States and interested parties, adopt measures regarding:
(a)
the methodological principles for the risk assessment and risk management recommendations referred to in Articles 6 and 7, including technical requirements in accordance with internationally agreed standards;
(b)
rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or a maximum residue limit established for a pharmacologically active substance in one or more species for other species, as referred to in Article 5. Those rules shall specify how and under what circumstances scientific data on residues in a particular foodstuff or in a species or more species may be used for setting a maximum residue limit in other foodstuffs, or other species.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).
CHAPTER II
Classification
Article 14
Classification of pharmacologically active substances
1. The Commission shall classify the pharmacologically active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Article 4, 9 or 11, as appropriate.
2. The classification shall include a list of pharmacologically active substances and the therapeutic classes to which they belong. The classification shall also establish, in relation to each such substance, and, where appropriate, specific foodstuffs or species, one of the following:
(a)
a maximum residue limit;
(b)
a provisional maximum residue limit;
(c)
the absence of the need to establish a maximum residue limit;
(d)
a prohibition on the administration of a substance.
3. A maximum residue limit shall be laid down where it appears necessary for the protection of human health:
(a)
pursuant to an opinion of the Agency in accordance with Article 4, 9 or 11, as appropriate; or
(b)
pursuant to a decision of the Codex Alimentarius Commission, without objection from the Community Delegation, in favour of a maximum residue limit for a pharmacologically active substance intended for use in a veterinary medicinal product, provided that the scientific data taken into consideration have been made available to the Community Delegation prior to the decision of the Codex Alimentarius Commission. In this case, an additional assessment by the Agency shall not be required.
4. A provisional maximum residue limit may be established in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of that substance at the level proposed constitute a hazard to human health.
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years. That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow completion of scientific studies in progress.
5. No maximum residue limit shall be established where, pursuant to an opinion in accordance with Article 4, 9 or 11, as appropriate, it is not necessary for the protection of human health.
6. The administration of a substance to food-producing animals shall be prohibited, pursuant to an opinion in accordance with Article 4, 9 or 11, as appropriate, in either of the following circumstances:
(a)
where any presence of a pharmacologically active substance or residues thereof in foods of animal origin may constitute a hazard to human health;
(b)
where no final conclusion concerning the effect on human health of residues of a substance can be drawn.
7. Where it appears necessary for the protection of human health, the classification shall include conditions and restrictions for the use or application of a pharmacologically active substance used in veterinary medicinal products which is subject to a maximum residue limit, or for which no maximum residue limit has been set.
Article 15
Accelerated procedure for an opinion of the Agency
1. In specific cases where a veterinary medicinal product or a biocidal product needs to be authorised as a matter of urgency for reasons relating to the protection of public health or of animal health or welfare, the Commission, any person who has submitted an application for an opinion pursuant to Article 3 or a Member State may ask the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit of a pharmacologically active substance contained in those products.
2. The format and content of the application referred to in paragraph 1 of this Article shall be laid down by the Commission pursuant to Article 13(1).
3. By way of derogation from the time limits laid down in Article 8(2) and Article 9(2), the Agency shall ensure that the opinion of the Committee is given within 120 days of receipt of the application.
Article 16
Administration of substances to food-producing animals
1. Only pharmacologically active substances which are classified in accordance with Article 14(2)(a), (b) or (c) may be administered to food-producing animals within the Community, provided that such administration is in accordance with Directive 2001/82/EC.
2. Paragraph 1 shall not apply in the case of clinical trials which are accepted by the competent authorities following notification or authorisation in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health.
Article 17
Procedure
1. For the purposes of the classification provided for in Article 14, the Commission shall prepare a draft regulation within 30 days of receipt of an opinion of the Agency as referred to in Article 4, 9 or 11, as appropriate. The Commission shall also prepare a draft regulation within 30 days of receipt of the decision of the Codex Alimentarius Commission, without objection from the Community Delegation, in favour of the establishment of a maximum residue limit as referred to in Article 14(3).
Where the opinion of the Agency is required and the draft regulation is not in accordance with this opinion, the Commission shall provide a detailed explanation of the reasons for the divergence.
2. The regulation referred to in paragraph 1 of this Article shall be adopted by the Commission in accordance with, and within 30 days of the end of, the regulatory procedure referred to in Article 25(2).
3. In the case of an accelerated procedure as referred to in Article 15, the Commission shall adopt the regulation referred to in paragraph 1 of this Article in accordance with, and within 15 days of the end of, the regulatory procedure referred to in Article 25(2).
TITLE III
REFERENCE POINTS FOR ACTION
Article 18
Establishment and review
When it is deemed necessary in order to ensure the functioning of controls of food of animal origin imported or placed on the market in accordance with Regulation (EC) No 882/2004, the Commission may establish reference points for action for residues from pharmacologically active substances which are not subject to a classification in accordance with Article 14(2)(a), (b) or (c).
The reference points for action shall be reviewed regularly in the light of new scientific data relating to food safety, the outcome of the investigations and analytical tests referred to in Article 24 and technological progress.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 26(4).
Article 19
Methods for establishing reference points for action
1. The reference points for action to be established pursuant to Article 18 shall be based on the content of an analyte in a sample, which can be detected and confirmed by official control laboratories designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated in accordance with Community requirements. The reference point for action should take into account the lowest residue concentration which can be quantified with an analytical method validated in accordance with Community requirements. The Commission shall be advised on the performance of analytical methods by the relevant Community reference laboratory.
2. Without prejudice to the second subparagraph of Article 29(1) of Regulation (EC) No 178/2002, the Commission shall, where appropriate, submit a request to EFSA for a risk assessment as to whether the reference points for action are adequate to protect human health. In those cases, EFSA shall ensure that the opinion is given to the Commission within 210 days of receipt of the request.
3. The principles of risk assessment shall be applied in order to guarantee a high level of protection of health. The risk assessment shall be based on methodological principles as well as scientific methods to be adopted by the Commission in consultation with EFSA.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3).
Article 20
Community contribution to the support measures for reference points for action
If the application of this Title requires the Community to finance measures in support of the establishment and functioning of reference points for action, Article 66(1)(c) of Regulation (EC) No 882/2004 shall apply.
TITLE IV
MISCELLANEOUS PROVISIONS
Article 21
Analytical methods
The Agency shall consult Community reference laboratories for laboratory analysis of residues designated by the Commission in accordance with Regulation (EC) No 882/2004 on appropriate analytical methods for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 14 of this Regulation. For the purposes of harmonised controls, the Agency shall provide information regarding those methods to the Community reference laboratories and national reference laboratories designated in accordance with Regulation (EC) No 882/2004.
Article 22
Circulation of foodstuffs
Member States may not prohibit or impede the import or the placing on the market of food of animal origin on grounds related to maximum residue limits or reference points for action where this Regulation and its implementing measures have been complied with.
Article 23
Placing on the market
Food of animal origin containing residues of a pharmacologically active substance:
(a)
classified in accordance with Article 14(2)(a), (b) or (c) at a level exceeding the maximum residue limit established pursuant to this Regulation; or
(b)
not classified in accordance with Article 14(2)(a), (b) or (c), except where a reference point for action has been set for that substance pursuant to this Regulation and the level of residues does not equal or exceed that reference point for action;
shall be considered not to comply with Community legislation.
Detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated under Article 11 of Directive 2001/82/EC shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 26(2) of this Regulation.
Article 24
Action in case of confirmed presence of a prohibited or non-authorised substance
1. Where the results of analytical tests are below the reference points for action, the competent authority shall carry out the investigations provided for by Directive 96/23/EC to determine whether there has been illegal administration of a prohibited or non-authorised pharmacologically active substance and, where relevant, shall apply the penalty provided for.
2. Where the results of those investigations or analytical tests on products of the same origin show a recurrent pattern indicating a potential problem, the competent authority shall retain a record of the findings and inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health referred to in Article 26.
3. Where appropriate, the Commission shall submit proposals, and in the case of products of third country origin, bring the matter to the attention of the competent authority of the country or countries concerned requesting clarification as to the recurrent presence of residues.
4. Detailed rules on the application of this Article shall be adopted. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3).
TITLE V
FINAL PROVISIONS
Article 25
Standing Committee on Veterinary Medicinal Products
1. The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 26
Standing Committee on the Food Chain and Animal Health
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4. Where reference is made to this paragraph, Article 5a(1),(2),(4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 27
Classification of pharmacologically active substances under Regulation (EEC) No 2377/90
1. By 4 September 2009, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 25(2), a regulation incorporating the pharmacologically active substances and their classification regarding maximum residues limits as laid down in Annexes I to IV to Regulation (EEC) No 2377/90 without any modification.
2. For any substance referred to in paragraph 1 for which a maximum residue limit has been established under Regulation (EEC) No 2377/90, the Commission or a Member State may also submit to the Agency a request for an opinion on extrapolation to other species or tissues in accordance with Article 5.
Article 17 shall apply.
Article 28
Reporting
1. By 6 July 2014, the Commission shall submit a report to the European Parliament and to the Council.
2. The report shall, in particular, review the experience gained from the application of this Regulation, including experience with substances classified under this Regulation which have a multiple use.
3. The report shall, if appropriate, be accompanied by relevant proposals.
Article 29
Repeal
Regulation (EEC) No 2377/90 is hereby repealed.
Annexes I to IV to the repealed Regulation shall continue to apply until the entry into force of the regulation referred to in Article 27(1) of this Regulation, and Annex V to the repealed Regulation shall continue to apply until the entry into force of the measures referred to in Article 13(1) of this Regulation.
References to the repealed Regulation shall be construed as references to this Regulation or, as appropriate, to the regulation referred to in Article 27(1) of this Regulation.
Article 30
Amendments to Directive 2001/82/EC
Directive 2001/82/EC is hereby amended as follows:
1.
Article 10(3) shall be replaced by the following:
‘3. By way of derogation from Article 11, the Commission shall establish a list of substances:
—
which are essential for the treatment of equidae, or
—
which bring added clinical benefit compared to other treatment options available for equidae,
and for which the withdrawal period shall not be less than six months according to the control mechanisms laid down in Decisions 93/623/EEC and 2000/68/EC.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’;
2.
in Article 11(2), the third subparagraph shall be replaced by the following:
‘The Commission may modify these withdrawal periods or establish other withdrawal periods. In so doing, the Commission may differentiate between foodstuffs, species, routes of administration and annexes to Regulation (EEC) No 2377/90. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’.
Article 31
Amendment to Regulation (EC) No 726/2004
Article 57(1)(g) of Regulation (EC) No 726/2004 shall be replaced by the following:
‘(g)
advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (18).
Article 32
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 6 May 2009.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
J. KOHOUT
(1) OJ C 10, 15.1.2008, p. 51.
(2) Opinion of the European Parliament of 17 June 2008 (not yet published in the Official Journal), Council Common Position of 18 December 2008 (OJ C 33 E, 10.2.2009, p. 30) and Position of the European Parliament of 2 April 2009 (not yet published in the Official Journal).
(3) OJ L 224, 18.8.1990, p. 1.
(4) OJ L 311, 28.11.2001, p. 1.
(5) OJ C 27 E, 31.1.2002, p. 80.
(6) OJ L 125, 23.5.1996, p. 3.
(7) OJ L 37, 13.2.1993, p. 1.
(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 165, 30.4.2004, p. 1;. corrected by OJ L 191, 28.5.2004, p. 1.
(10) OJ L 136, 30.4.2004, p. 1.
(11) OJ L 123, 24.4.1998, p. 1.
(12) OJ L 24, 30.1.1998, p. 9.
(13) OJ L 16, 20.1.2005, p. 61.
(14) OJ L 268, 18.10.2003, p. 29.
(15) OJ L 125, 23.5.1996, p. 10.
(16) OJ L 184, 17.7.1999, p. 23.
(17) OJ L 35, 15.2.1995, p. 1.
(18) OJ L 152, 16.6.2009, p. 11’.
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Residues of veterinary medicinal products in foodstuffs of animal origin
Residues of veterinary medicinal products in foodstuffs of animal origin
SUMMARY OF:
Regulation (EC) No 470/2009 — EU procedures for establishing residue limits of pharmacologically active substances in foodstuffs of animal origin
WHAT IS THE AIM OF THE REGULATION?
It lays down rules on maximum residue limits for pharmacologically active substances, such as antibiotics, used in veterinary medicine in respect of food of animal origin, including meat, fish, milk, eggs and honey — in order to ensure food safety.
In this regard, it establishes:
the maximum residue limit*
the reference point for action* regarding cases where a maximum residue limit has not been calculated.
KEY POINTS
The applicant for a marketing authorisation for a veterinary medicinal product — in which any pharmacologically active substance is used — must submit an application to the European Medicines Agency. The agency must give an opinion consisting of a scientific risk assessment and risk management recommendations.
The agency decides whether to apply established maximum residue limits for a particular food or species. The European Commission fixes rules on the conditions regarding this calculation of residue limits.
The risk assessment must weigh up whether the type and amount of residue considered presents a safety concern for human health.
Risk management recommendations must assess a variety of factors, including the availability of alternative substances for the treatment of the relevant species.
The Commission classifies the pharmacologically active substances that have already been subject to an opinion from the agency. It can establish reference points for action for residues of pharmacologically active substances that are not classified.
In certain cases, the Commission or an EU country may submit a request for an opinion on maximum residue limits to the agency. Such cases include circumstances where the substance in question is authorised for use in a non-EU country.
A number of substances are excluded from the scope of this regulation, including substances covered by the EU’s Regulation (EEC) No 315/93 on contaminants in food.
In January 2017, the Commission adopted Implementing Regulation (EU) 2017/12. This lays down the form and content of applications and requests to the agency for the establishment of maximum residue limits.
In June 2017, the Commission adopted Regulation (EU) 2017/880. This lays down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species (i.e. the extrapolation of maximum residue limits).
FROM WHEN DOES THIS REGULATION APPLY?
It has applied since 6 July 2009.
BACKGROUND
Previous EU rules on this issue were too complex and led to a decrease in the availability of medicines for food-producing animals in the EU. This regulation was introduced to ensure both consumer safety and the availability of veterinary medicines to treat specific diseases.
Residues of Veterinary Medicinal Products (European Commission)
Residues of veterinary medicines (European Commission).
KEY TERMS
Maximum residue limit (MRL): the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin.
Reference point for action: the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down. The reference points for action are established in consultation with official control laboratories.
MAIN DOCUMENT
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, pp. 11-22)
RELATED DOCUMENTS
Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, pp. 1-5)
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, pp. 1-7)
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, pp. 1-72)
Successive amendments to Regulation (EU) No 37/2010 have been incorporated into the original text. This consolidated version is of documentary value only.
Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, pp. 1-3)
See consolidated version.
last update 23.11.2017
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32009R1069
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14.11.2009
EN
Official Journal of the European Union
L 300/1
REGULATION (EC) No 1069/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 21 October 2009
laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
Animal by-products not intended for human consumption are a potential source of risks to public and animal health. Past crises related to outbreaks of foot-and-mouth disease, the spread of transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and the occurrence of dioxins in feedingstuffs have shown the consequences of the improper use of certain animal by-products for public and animal health, the safety of the food and feed chain and consumer confidence. In addition, such crises may also have a wider adverse impact on society as a whole, by their impact on the socioeconomic situation of the farmers and of the industrial sectors concerned and on consumer confidence in the safety of products of animal origin. Disease outbreaks could also have negative consequences for the environment, not only due to the disposal problems posed, but also as regards biodiversity.
(2)
Animal by-products arise mainly during the slaughter of animals for human consumption, during the production of products of animal origin such as dairy products, and in the course of the disposal of dead animals and during disease control measures. Regardless of their source, they pose a potential risk to public and animal health and the environment. This risk needs to be adequately controlled, either by directing such products towards safe means of disposal or by using them for different purposes, provided that strict conditions are applied which minimise the health risks involved.
(3)
The disposal of all animal by-products is not a realistic option, as it would lead to unsustainable costs and risks for the environment. Conversely, there is a clear interest for all citizens that, provided the health risks are minimised, a wide range of animal by-products are safely used for various applications in a sustainable manner. A wide range of animal by-products are indeed commonly used in important productive sectors, such as the pharmaceutical, feed and leather industries.
(4)
New technologies have widened the possible use of animal by-products or derived products to a large number of productive sectors, in particular for the generation of energy. However, the use of those new technologies might pose health risks that must also be minimised.
(5)
Community health rules for collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use or disposal of animal by-products should be laid down in a coherent and comprehensive framework.
(6)
Those general rules should be proportionate to the risk to public and animal health which animal by-products pose when they are dealt with by operators at different stages of the chain from collection to their use or disposal. The rules should also take into account the risks for the environment posed during those operations. The Community framework should include health rules on the placing on the market, including intra-Community trade and import, of animal by-products, where appropriate.
(7)
In Regulation (EC) No 1774/2002 (3), the European Parliament and the Council laid down Community health rules concerning animal by-products not intended for human consumption. Based on scientific advice and as an action under the Commission White Paper of 12 January 2000 on Food Safety, that Regulation introduced a set of rules aimed at protecting the safety of the food and feed chain, which is complementary to Community legislation on food and feed. Those rules have significantly improved the level of protection in the Community against the risks posed by animal by-products.
(8)
Regulation (EC) No 1774/2002 introduced the classification of animal by-products into three categories according to the degree of risk involved. It requires operators to keep animal by-products of different categories separate from each other if they wish to make use of animal by-products which do not pose a significant risk to public or animal health, in particular if such products are derived from material fit for human consumption. That Regulation also introduced the principle that high-risk material should not be fed to farmed animals, and that material derived from animals is not to be fed to animals of the species from which it is derived. Pursuant to that Regulation, only material from animals which have undergone veterinary inspection is to enter the feed chain. In addition, it lays down rules for processing standards which ensure the reduction of risks.
(9)
Under Article 35(2) of Regulation (EC) No 1774/2002, the Commission is to submit a report to the European Parliament and to the Council on the measures taken by the Member States to ensure compliance with that Regulation. The report is to be accompanied, if appropriate, by legislative proposals. The report was submitted on 21 October 2005 and emphasised that the principles of Regulation (EC) No 1774/2002 should be maintained. In addition, it highlighted the areas where amendments to that Regulation were considered necessary, in particular clarifications as regards the applicability of the rules to finished products, the relationship with other Community legislation and the classification of certain material. The findings of a series of fact-finding missions carried out in the Member States by the Food and Veterinary Office of the Commission (FVO) in 2004 and 2005 support those conclusions. According to the FVO, improvements are necessary as regards the traceability of the flow of animal by-products and the effectiveness and harmonisation of official controls.
(10)
The Scientific Steering Committee, which was superseded by the European Food Safety Authority (EFSA) in 2002, has adopted a number of opinions concerning animal by-products. Those opinions demonstrate the need to maintain the main principles of Regulation (EC) No 1774/2002; in particular that animal by-products derived from animals shown not to be fit for human consumption as a result of a health inspection should not enter the feed chain. However, those animal by-products may be recovered and used for the production of technical or industrial products under specified health conditions.
(11)
The conclusions of the Presidency of the Council on the Commission report of 21 October 2005 which were adopted in December 2005, and the subsequent consultations carried out by the Commission, have highlighted that the rules laid down in Regulation (EC) No 1774/2002 should be improved. The chief objectives of the rules on animal by-products, namely the control of risks to public and animal health and the protection of the safety of the food and feed chain, should be clearly laid down. The provisions of this Regulation should permit the achievement of those objectives.
(12)
The rules on animal by-products laid down in this Regulation should apply to products that may not be used for human consumption under Community legislation, in particular where they do not comply with food hygiene legislation or where they may not be placed on the market as food since they are unsafe either because they are injurious to health or unfit for human consumption (animal by-products ‘by law’). Those rules should, however, also apply to products of animal origin which do comply with certain rules regarding their possible use for human consumption, or which are raw materials for the production of products for human consumption, even if they are eventually destined for other purposes (animal by-products ‘by choice’).
(13)
In addition, in order to prevent risks arising from wild animals, bodies or parts of bodies of such animals suspected of being infected with a transmissible disease should be subject to the rules laid down in this Regulation. This inclusion should not imply an obligation to collect and dispose of bodies of wild animals that have died or that are hunted in their natural habitat. If good hunting practices are observed, intestines and other body parts of wild game may be disposed of safely on site. Such practices for the mitigation of risks are well-established in Member States and are in some cases based on cultural traditions or on national legislation which regulates the activities of hunters. Community legislation, in particular Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (4), lays down rules for handling of meat and animal by-products from wild game. Those rules also place the responsibility for the prevention of risks on trained persons such as hunters. In view of the potential risks for the food chain, animal by-products from killed wild game should only be subject to this Regulation in so far as food hygiene legislation applies to the placing on the market of such game and involves operations carried out by game-handling establishments. In addition, animal by-products for the preparation of game trophies should be covered by this Regulation in order to prevent animal health risks arising from such by-products.
(14)
The rules laid down in this Regulation should apply to animal by-products derived from aquatic animals, other than material from vessels operating under Community food hygiene legislation. However, risk-proportionate measures should be adopted as regards the handling and disposal of material which arises on board fishing vessels from the evisceration of fish and which shows signs of disease. Such measures for the implementation of this Regulation should be adopted on the basis of a risk assessment carried out by the appropriate scientific institution in view of the available evidence regarding the effectiveness of certain measures to combat the spread of diseases communicable to humans, in particular of certain parasites.
(15)
Due to the limited risks arising from materials used as raw pet food on farm or supplied to end users by food businesses, certain activities related to such raw pet food should not be covered by the rules laid down in this Regulation.
(16)
It is appropriate to clarify in this Regulation which animals are to be classified as pet animals, so that by-products derived from such animals are not used in feed for farmed animals. In particular, animals kept for purposes other than farming, such as for companionship, should be classified as pet animals.
(17)
For the sake of consistency of Community legislation, certain definitions set out in Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (5) and in Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (6) should be used in this Regulation. The reference to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (7) should be clarified.
(18)
For the sake of consistency of Community legislation, the definition of ‘aquatic animal’ as laid down in Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (8) should be used in this Regulation. At the same time, aquatic invertebrates which are not covered by that definition and which pose no risk of disease transmission should be subject to the same requirements as aquatic animals.
(19)
Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (9) specifies the conditions for the issuing of a permit for a landfill. This Regulation should provide for the disposal of animal by-products on landfills for which such a permit has been issued.
(20)
The primary responsibility for carrying out operations in accordance with this Regulation should rest with operators. At the same time, the public interest in preventing risks to public and animal health requires that a collection and disposal system is in place to ensure the safe use or the safe disposal of animal by-products which may not be used, or which are not used for economic reasons. The scope of the collection and disposal system should take into account the actual amount of animal by-products which accrue in the particular Member State. It should also reflect, on a precautionary basis, the need for extended disposal capacities in the event of major outbreaks of transmissible diseases or of temporary technical failures in an existing disposal facility. Member States should be permitted to cooperate with each other and third countries provided that the objectives of this Regulation are met.
(21)
It is important to determine the starting point in the life cycle of animal by-products from which the requirements of this Regulation should apply. Once a product has become an animal by-product, it should not re-enter the food chain. Special circumstances apply for the handling of certain raw materials, such as hides, handled in establishments or plants integrated at the same time into the food chain and the animal by-products chain. In those cases, the necessary measures should be taken by means of segregation to mitigate potential risks for the food chain which can arise from cross-contamination. For other establishments, risk-based conditions should be determined to prevent cross-contamination, in particular through separation between the animal by-products chain and the food chain.
(22)
For reasons of legal certainty and proper control of potential risks, an end point in the manufacturing chain should be determined for products which no longer have direct relevance for the safety of the feed chain. For certain products regulated under other Community legislation, such an end point should be determined at the stage of manufacturing. Products which have reached this end point should be exempt from controls under this Regulation. In particular, products beyond the end point should be allowed to be placed on the market without restriction under this Regulation and to be handled and transported by operators which have not been approved or registered in accordance with this Regulation.
(23)
However, it should be possible to modify such an end point, particularly in the case of newly emerging risks. Regulation (EC) No 1774/2002 exempts certain products, notably guano, certain hides to which particular forms of treatment such as tanning have been applied, and certain game trophies from its requirements. Similar exemptions should be provided for in the implementing measures to be adopted under this Regulation for products such as oleochemical products and the end products resulting from the production of biodiesel, under appropriate conditions.
(24)
In order to ensure a high level of protection of public and animal health, Member States should continue to take the necessary measures to prevent the dispatch of animal by-products from restricted areas or establishments, in particular in the event of an outbreak of a disease listed in Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (10).
(25)
Operations with animal by-products which give rise to a considerable degree of risk to public and animal health should only be carried out in establishments or plants which have been approved in advance for such operations by the competent authority. That condition should apply in particular to processing establishments or plants and other establishments or plants which handle or store animal by-products with a direct relevance for the safety of the feed chain. It should be permitted for animal by-products of more than one category to be handled in the same establishment or plant provided cross-contamination is prevented. It should further be permitted to amend those conditions if the amount of material for disposal and processing rises due to a major outbreak of disease, provided it is ensured that the temporary use under such amended conditions does not lead to the propagation of disease risks.
(26)
However, such approvals should not be necessary for establishments or plants which process or handle certain safe materials, such as products processed to such an extent that they no longer pose a risk to public and animal health. Such establishments or plants should be registered so as to permit official control over the flow of material and ensure their traceability. That registration requirement should apply also to operators who transport animal by-products or derived products, unless they are no longer subject to any control since an end point in the chain has been determined.
(27)
Establishments or plants should be approved following the submission of information to the competent authority and following a visit carried out on site which demonstrates that the requirements of this Regulation for the infrastructure and equipment of the establishment or plant will be met, so that any risks to public and animal health arising from the process used will be adequately contained. It should be possible to grant the approvals conditionally in order to allow operators to rectify deficiencies before the establishment or plant obtains full approval.
(28)
Establishments or plants whose operations have already been approved in accordance with Community legislation on food hygiene should not be required to be approved or registered under this Regulation, as approvals or registrations under that Community legislation already take into account the objectives of this Regulation. However, establishments or plants which have been approved or registered under hygiene legislation should be obliged to comply with the requirements of this Regulation and subject to official controls carried out for the purposes of verifying compliance with the requirements of this Regulation.
(29)
Animal by-products and derived products should be classified into three categories which reflect the degree of risk that they pose to public and animal health, on the basis of risk assessments. While animal by-products and derived products posing a high risk should only be used for purposes outside the feed chain, their use posing a lower risk should be permitted under safe conditions.
(30)
Progress in science and technology may lead to the development of processes which eliminate or minimise the risks to public and animal health. Amendments to the lists of animal by-products set out in this Regulation should be possible, in order to take account of such progress. Prior to any such amendments, and in accordance with the general principles of Community legislation aimed at ensuring a high level of protection of public and animal health, a risk assessment should be carried out by the appropriate scientific institution, such as EFSA, the European Medicines Agency or the Scientific Committee for Consumer Products, depending on the type of animal by-products for which risks are to be assessed. However, it should be clear that once animal by-products of different categories are mixed, the mixture should be handled in accordance with the standards laid down for the proportion of the mixture belonging to the highest risk category.
(31)
Due to the high risk to public health, animal by-products giving rise to a risk of transmissible spongiform encephalopathy (TSE) should, in particular, not be used for feed. This restriction should also apply to wild animals through which a communicable disease may be transmitted. The restriction on the feeding of animal by-products giving rise to a TSE risk should be without prejudice to the feeding rules laid down in Regulation (EC) No 999/2001.
(32)
Animal by-products from animals used for experiments as defined in Directive 86/609/EEC should also be excluded from use in feed, due to the potential risks arising from those animal by-products. However, Member States may allow the use of animal by-products from animals which have been used for experiments to test new feed additives, in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (11).
(33)
The use of certain substances and products is unlawful under Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in food stuffs of animal origin (12) and Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß agonists (13). In addition, Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (14) lays down further rules on the monitoring of certain substances and residues thereof in live animals and animal products. Directive 96/23/EC also lays down rules which apply where the presence of residues of authorised substances or contaminants exceeding certain permitted levels has been established. In order to ensure the coherence of Community legislation, products of animal origin in which substances are detected in breach of Regulation (EEC) No 2377/90 and Directives 96/22/EC and 96/23/EC should be classified as Category 1 or Category 2 material, as appropriate, in view of the risk they pose to the food and feed chain.
(34)
Manure and digestive tract content should not need to be disposed of, provided that proper treatment ensures that diseases are not transmitted during their application to land. Animal by-products from animals that die on farm and animals killed for the eradication of diseases should not be used in the feed chain. This restriction should also apply to imported animal by-products which are allowed into the Community, where they do not comply with Community legislation upon inspection at the Community border post, and to products which do not comply with the applicable requirements during checks carried out within the Community. Non-compliance with Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (15) and with Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (16) should not result in the exclusion from the feed chain of products presented for border inspection.
(35)
Since the date of entry into force of Regulation (EC) No 1774/2002, the classification of certain animal by-products by default as Category 2 material limits their possible uses severely, while not necessarily being proportionate to the risks involved. Accordingly those animal by-products should be reclassified as Category 3 material, so as to allow their use for certain feeding purposes. For any other animal by-products which are not listed under one of the three categories, the categorisation by default as Category 2 material should be maintained for precautionary reasons, in particular to reinforce the general exclusion of such material from the feed chain for farmed animals, other than fur animals.
(36)
Other legislation which has entered into force following the adoption of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (17), namely Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (18), Regulation (EC) No 853/2004 and Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (19), and to which Regulation (EC) No 1774/2002 is complementary, places the primary duty of complying with Community legislation, aimed at protecting public and animal health, on the food and feed business operators. In line with that legislation, operators carrying out activities under this Regulation should also be primarily responsible for ensuring compliance with this Regulation. That obligation should be further clarified and specified as regards the means by which traceability is ensured, such as separate collection and channelling of animal by-products. Established systems ensuring traceability for products exclusively circulating at national level by other means should continue to operate, if they provide equivalent information. Every effort should be made to promote the use of electronic and other means of documentation which do not involve paper records, as long as they ensure full traceability.
(37)
A system of own checks is necessary to ensure that, within an establishment or plant, the requirements of this Regulation are fulfilled. During official controls the competent authorities should take into account the performance of own checks. In certain establishments or plants own checks should be carried out through a system based on the hazard analysis and critical control points (HACCP) principles. The HACCP principles should be based on the experience of their implementation under Community legislation on food and feed hygiene. In this respect, national guides to good practice could serve as a useful tool to facilitate the practical implementation of the HACCP principles, and of other aspects of this Regulation.
(38)
Animal by-products should only be used if the risks to public and animal health are minimised in the course of their processing and the placing on the market of derived products manufactured on the basis of animal by-products. If this option is not available, the animal by-products should be disposed of under safe conditions. The options available for the use of animal by-products of the different categories should be clarified in coherence with other Community legislation. In general, the options for a higher risk category should be available for the lower risk categories as well, unless special considerations apply in view of the risk attached to certain animal by-products.
(39)
Disposal of animal by-products and derived products should take place in accordance with environmental legislation regarding landfilling and waste incineration. In order to ensure consistency, incineration should take place in accordance with Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste (20). Co-incineration of waste – either as a recovery or disposal operation – is subject to similar conditions regarding approval and operation to those regarding waste incineration, in particular as to air emission limit values, waste water and residue discharge, control and monitoring and measurement requirements. Consequently, direct co-incineration, without prior processing, of all three categories of materials should be permitted. In addition, specific provisions should be enacted for the approval of low and high-capacity incineration plants.
(40)
The use of animal by-products or derived products as a fuel in the combustion process should be authorised and should not be considered as a waste disposal operation. However, such use should take place under conditions which ensure the protection of public and animal health, as well as the appropriate environmental standards.
(41)
This Regulation should provide for the possibility to lay down parameters for processing methods regarding time, temperature and pressure for animal by-products, in particular for the methods currently referred to as methods 2 to 7 under Regulation (EC) No 1774/2002.
(42)
Shells from shellfish from which the soft tissue or flesh have been removed, should be excluded from the scope of the Regulation. Due to the various practices in the Community regarding the removal of such soft tissue or flesh from shells, it should be possible to use shells from which the entire soft tissue or flesh has not been removed, provided such use does not lead to a risk arising to public and animal health. National guides to good practice could assist in the dissemination of knowledge regarding proper conditions under which such use would be possible.
(43)
In view of the limited risk to public or animal health arising from such products, the competent authority should be able to authorise the preparation and application to land of biodynamic preparations, on the basis of Category 2 and Category 3 materials, as referred to in Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (21).
(44)
Novel technologies which are being developed offer advantageous ways of generating energy on the basis of animal by-products or of providing for the safe disposal of such products. Safe disposal may take place through a combination of methods for the safe containment of animal by-products on site with established disposal methods, and through a combination of authorised processing parameters with new standards which have been favourably assessed. In order to take account of the related progress in science and technology, such technologies should be authorised as alternative methods for the disposal or use of animal by-products throughout the Community. If a technological process has been developed by an individual, an application checked by the competent authority should be examined by EFSA before such authorisation is granted, in order to ensure that an assessment of the risk reduction potential of the process is carried out and that the rights of individuals, including the confidentiality of business information, is preserved. In order to provide advice to applicants a standard format for application should be adopted. Since that document is intended only to be indicative it should be adopted in accordance with the advisory procedure in collaboration with EFSA.
(45)
It is appropriate to clarify the requirements applicable to the placing on the market of animal by-products and derived products intended for feeding purposes and of organic fertilisers and soil improvers, so as to ensure the protection of the food and feed chain. Only Category 3 material should be used for feeding farmed animals other than fur animals. Fertilisers produced on the basis of animal by-products may affect the safety of the feed and food chain. Where they have been manufactured from meat-and-bone meal derived from Category 2 material or from processed animal protein, a component, such as an inorganic or an indigestible substance, should be added in order to prevent their direct use for feeding purposes. Such mixing should not be required if the composition or packaging of products, in particular of products destined for use by the final consumer, prevents the misuse of the product for feeding purposes. When determining the components, different circumstances regarding climate and soil and the objective for the use of particular fertilisers should be taken into account.
(46)
Regulation (EC) No 1523/2007 of the European Parliament and of the Council of 11 December 2007 banning the placing on the market and the import to, or export from, the Community of cat and dog fur, and products containing such fur (22) lays down a general prohibition on the placing on the market and the import and export of cat and dog fur and products containing such fur. However, that prohibition should not affect the obligation under this Regulation to dispose of animal by-products from cats and dogs, including fur.
(47)
The promotion of science and research, and artistic activities may require the use of animal by-products or derived products of all categories, sometimes in quantities below the scale of commercial exchanges. In order to facilitate the import and use of such animal by-products or derived products, the competent authority should be able to fix the conditions for such operations on a case-specific basis. Harmonised conditions should be laid down where action at a Community level is necessary.
(48)
Regulation (EC) No 1774/2002 contains detailed provisions which allow, by way of derogation, the feeding of Category 2 and Category 3 materials to zoo animals. Similar provisions should be laid down in this Regulation and the feeding of certain Category 1 material should be allowed and complemented by the possibility to lay down detailed rules to control any possible risks arising to public or animal health.
(49)
Regulation (EC) No 1774/2002 allows for the feeding of Category 1 material to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity. In order to provide an adequate tool for the preservation of those species, that feeding practice should continue to be permitted under this Regulation, in accordance with conditions laid down to prevent the spread of diseases. At the same time, health conditions should be laid down in the implementing measures permitting the use of such Category 1 material for feeding purposes in extensive grazing systems and for feeding to other carnivore species, such as bears and wolves. It is important that such health conditions take into account the natural consumption patterns of the species concerned as well as Community objectives for the promotion of biodiversity as referred to in the Communication from the Commission of 22 May 2006 entitled ‘Halting the loss of biodiversity by 2010 – and beyond’.
(50)
Burial and burning of animal by-products, in particular of dead animals may be justified in specific situations, in particular in remote areas, or in disease control situations requiring the emergency disposal of the animals killed as a measure to control an outbreak of a serious transmissible disease. In particular, disposal on site should be allowed under special circumstances, since the available rendering or incinerator capacity within a region or a Member State could otherwise be a limiting factor in the control of a disease.
(51)
The current derogation concerning burial and burning of animal by-products should be extended to areas where access is not practically possible or presents a risk to the health and safety of the collection personnel. Experience gained with the application of Regulation (EC) No 1774/2002 and with natural disasters such as forest fires and floods in certain Member States has shown that under such exceptional circumstances, disposal by burial or burning on site can be justified so as to ensure the swift disposal of animals and to avoid the propagation of disease risks. The overall size of remote areas in a Member State should be limited, on the basis of the experience gained with the application of Regulation (EC) No 999/2001 so as to ensure that the general obligation to have in place a proper disposal system which complies with the rules laid down in this Regulation is fulfilled.
(52)
Certain establishments or plants which handle only small quantities of animal by-products which do not pose a risk to public and animal health should be allowed to dispose of such by-products by means other than disposal in accordance with this Regulation, under official supervision. However, the criteria for such exceptional circumstances should be laid down at Community level, so as to ensure their uniform application, based on the actual situation of certain sectors and the availability of other disposal systems in certain Member States.
(53)
The possible courses of action which the competent authority can take when carrying out official controls should be specified in order to ensure legal certainty, in particular regarding the suspension or permanent prohibition of operations or the imposition of conditions to ensure the proper application of this Regulation. These official controls should be carried out in the framework of multi-annual control plans under Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (23).
(54)
In order to ensure that Member States may control the quantity of material which is introduced for disposal into their territory, the competent authority should authorise the receipt of such material to its territory.
(55)
Pressure sterilisation and auxiliary transport conditions may be imposed so as to ensure the control of possible risks. In order to ensure traceability and cooperation between the competent authorities of Member States controlling the dispatch of animal by-products or derived products, the Traces system introduced by Commission Decision 2004/292/EC (24) should be used to provide information on the dispatch of Category 1 and Category 2 materials and meat-and-bone meal or animal fat derived from Category 1 and Category 2 materials, and processed animal protein derived from Category 3 material. For materials typically sent in small quantities for research, educational, artistic or diagnostic use, special conditions should be laid down to facilitate the movement of such materials within the Community. Bilateral arrangements facilitating the control of materials moved between the Member States sharing a common border should be permitted under special circumstances.
(56)
In order to facilitate the transport of consignments through third countries neighbouring more than one Member State, a special regime for the dispatch of consignments from the territory of one Member State to another through the territory of a third country should be introduced in order to ensure, in particular, that consignments re-entering Community territory are subject to veterinary checks in accordance with Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (25).
(57)
For the sake of coherence of Community legislation, it is necessary to clarify the relationship between the rules laid down in this Regulation and Community legislation on waste. In particular, consistency should be ensured with the prohibitions on waste exports laid down in Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (26). In order to prevent potentially detrimental effects for the environment, the export of animal by-products and derived products destined for disposal by incineration and by landfill should be prohibited. The export of animal by-products and derived products should also be prevented where the objective is to use them in a biogas or composting plant to third countries which are not members of the Organisation for Economic Cooperation and Development (OECD), in order to prevent potentially adverse environmental impacts and risks to public and animal health. When applying the provisions to derogate from the export ban, the Commission is obliged to fully respect in its decisions the Basel Convention on the control of transboundary movements of hazardous waste and their disposal, as concluded, on behalf of the Community, by Council Decision 93/98/EEC (27), and the amendment to this Convention laid down in Decision III/1 of the Conference of the Parties, as approved, on behalf of the Community, by Council Decision 97/640/EC (28), and implemented by Regulation (EC) No 1013/2006.
(58)
In addition, it should be ensured that animal by-products mixed or contaminated with hazardous waste, as listed in Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (29) are only imported, exported or dispatched between Member States in accordance with Regulation (EC) No 1013/2006. It is also necessary to lay down rules concerning the dispatch of such material within a Member State.
(59)
The Commission should be able to carry out controls in Member States. Community controls in third countries should be carried out in accordance with Regulation (EC) No 882/2004.
(60)
The import of animal by-products and derived products into the Community and the transit of such material should take place in accordance with rules which are at least as strict as those applicable within the Community. Alternatively, the rules applicable to animal by-products and derived products in third countries may be recognised to be equivalent to the rules laid down in Community legislation. Due to the potential risk arising from them, a simplified set of import rules should be applicable to products which are destined for uses outside the feed chain.
(61)
Community legislation on the manufacture of derived products intended for use as cosmetic products, medicinal products or medical devices comprises a comprehensive framework for the placing on the market of such products: Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products (30), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (31), Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (32), Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (33), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (34) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (35) (the specific Directives). However, the specific Directives on cosmetic products and medical devices do not provide for protection against risks to animal health. In such cases, this Regulation should apply to those risks and recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 should be possible.
(62)
Animal by-products or derived products that are supplied as material or ingredients for the manufacture of such derived products should also be subject to the requirements of the specific Directives, in so far as they lay down rules controlling risks to public and animal health. Those specific Directives already regulate starting material of animal origin which may be used for the manufacture of the derived products referred to and impose certain conditions to ensure the protection of public or animal health. In particular, Directive 76/768/EEC excludes Category 1 and Category 2 materials as part of the composition of a cosmetic product and obliges manufacturers to apply good manufacturing practices. Commission Directive 2003/32/EC (36) introduces detailed specifications with respect to medical devices manufactured utilising tissues of animal origin.
(63)
However, where those conditions have not yet been laid down in the specific Directives or where they do not cover certain risks to public and animal health, this Regulation should apply, and recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 should be possible.
(64)
Certain derived products do not enter the feed chain or are not applied to land which is grazed by farmed animals or from which herbage for feed is cut. Such derived products include products for technical uses, such as treated hides for leather production, processed wool for the textile industry, bone products for glue and processed material destined for petfood. Operators should be permitted to place such products on the market provided that they are either derived from raw material requiring no treatment or the treatment or the end use of the treated material ensures adequate risk control.
(65)
Certain failures to comply with the rules laid down in Regulation (EC) No 1774/2002 have been revealed in a number of Member States. Accordingly, in addition to the strict enforcement of those rules, criminal and other sanctions against operators which do not comply with those rules are needed. Therefore, it is necessary that Member States lay down rules on penalties applicable to infringements of this Regulation.
(66)
Since the objective of this Regulation, namely to lay down public and animal health rules for animal by-products and derived products in order to prevent and minimise risks to public and animal health arising from those products and, in particular, to protect the safety of the food and feed chain, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(67)
In order to enhance legal certainty and in the light of the Commission’s general objective to simplify Community legislation, a coherent framework of rules should be laid down in this Regulation, taking into account the rules laid down in Regulation (EC) No 1774/2002, as well as the experience gained and progress made since the date of entry into force of that Regulation. Regulation (EC) No 1774/2002 should therefore be repealed and replaced by this Regulation.
(68)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (37).
(69)
In order to improve coherence and clarity of Community legislation, the technical rules concerning specific operations involving animal by-products, which are currently laid down in the Annexes to Regulation (EC) No 1774/2002, as well as in implementing measures adopted by the Commission on the basis of that Regulation (38), should be laid down in separate implementing acts. Consultation and information of consumers and socio-professional circles concerned with issues related to this Regulation should be carried out in accordance with Commission Decision 2004/613/EC of 6 August 2004 concerning the creation of an advisory group on the food chain and animal and plant health (39).
(70)
In particular, the Commission should be empowered to adopt rules modifying the end point in the manufacturing chain of certain derived products and establishing such an end point for certain other derived products, rules in regard to serious transmissible diseases in the presence of which the dispatch of animal by-products and derived products should not be allowed and/or the conditions allowing such a dispatch, measures changing the categorisation of animal by-products and derived products, measures regarding restrictions on the use and disposal of animal by-products and derived products, measures laying down conditions for the application of certain derogations regarding the use, collection and disposal of animal by-products and derived products and measures authorising or rejecting a particular alternative method for the use and disposal of animal by-products and derived products.
(71)
In addition, the Commission should be empowered to adopt more specific rules concerning collection and transport of animal by-products and derived products, the infrastructure, equipment and hygiene requirements for establishments or plants handling animal by-products and derived products, the conditions and technical requirements for the handling of animal by-products and derived products, including the evidence to be presented for the purpose of validation of such treatment, conditions for the placing on the market of animal by-products and derived products, requirements related to safe sourcing, safe treatment and safe end uses, conditions for the import, transit and export of animal by-products and derived products, detailed arrangements for implementing official controls including rules concerning the reference methods for microbiological analyses as well as conditions for the control of the dispatch of certain animal by-products and derived products between Member States. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(72)
On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of measures specifying the conditions for the dispatch of animal by-products from restricted holdings, plants or zones. On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures modifying the end point in the manufacturing chain for certain products,
HAVE ADOPTED THIS REGULATION:
TITLE I
GENERAL PROVISIONS
CHAPTER I
Common provisions
Section 1
Subject matter, scope and definitions
Article 1
Subject matter
This Regulation lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain.
Article 2
Scope
1. This Regulation shall apply to:
(a)
animal by-products and derived products which are excluded from human consumption under Community legislation; and
(b)
the following products which pursuant to a decision by an operator, which shall be irreversible, are destined for purposes other than human consumption:
(i)
products of animal origin which may be destined for human consumption under Community legislation;
(ii)
raw materials for the production of products of animal origin.
2. This Regulation shall not apply to the following animal by-products:
(a)
entire bodies or parts of wild animals, other than wild game, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes;
(b)
entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice, without prejudice to Regulation (EC) No 853/2004;
(c)
animal by-products from wild game and from wild game meat referred to in Article 1(3)(e) of Regulation (EC) No 853/2004;
(d)
oocytes, embryos and semen destined for breeding purposes;
(e)
raw milk, colostrum and products derived therefrom which are obtained, kept, disposed of or used on the farm of origin;
(f)
shells from shellfish with the soft tissue and flesh removed;
(g)
catering waste, except if it:
(i)
originates from means of transport operating internationally;
(ii)
is destined for feeding purposes;
(iii)
is destined for processing by pressure sterilisation or for processing by methods referred to in point (b) of the first subparagraph of Article 15(1) or for transformation into biogas or for composting;
(h)
without prejudice to Community environmental legislation, material from vessels complying with Regulations (EC) No 852/2004 and (EC) No 853/2004, which has arisen in the course of their fishing operations and is disposed of at sea, except material derived from on-board evisceration of fish showing signs of disease, including parasites, that are communicable to humans;
(i)
raw pet food originating from retail shops, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot;
(j)
raw pet food derived from animals which are slaughtered on the farm of origin for private domestic consumption; and
(k)
excrement and urine other than manure and non-mineralised guano.
3. This Regulation shall be without prejudice to Community veterinary legislation having as its objective the control and eradication of animal diseases.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
1.
‘animal by-products’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen;
2.
‘derived products’ means products obtained from one or more treatments, transformations or steps of processing of animal by-products;
3.
‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004;
4.
‘carcase’ means carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;
5.
‘animal’ means any invertebrate or vertebrate animal;
6.
‘farmed animal’ means:
(a)
any animal that is kept, fattened or bred by humans and used for the production of food, wool, fur, feathers, hides and skins or any other product obtained from animals or for other farming purposes;
(b)
equidae;
7.
‘wild animal’ means any animal not kept by humans;
8.
‘pet animal’ means any animal belonging to species normally nourished and kept but not consumed, by humans for purposes other than farming;
9.
‘aquatic animals’ means aquatic animals as defined in Article 3(1)(e) of Directive 2006/88/EC;
10.
‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that competence has been delegated; it also includes, where appropriate, the corresponding authority of a third country;
11.
‘operator’ means the natural or legal persons having an animal by-product or derived product under their actual control, including carriers, traders and users;
12.
‘user’ means the natural or legal persons using animal by-products and derived products for special feeding purposes, for research or for other specific purposes;
13.
‘establishment’ or ‘plant’ means any place where any operation involving the handling of animal by-products or derived products is carried out, other than a fishing vessel;
14.
‘placing on the market’ means any operation the purpose of which is to sell animal by-products or derived products to a third party in the Community or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;
15.
‘transit’ means movement through the Community from the territory of a third country to the territory of another third country, other than by sea or by air;
16.
‘export’ means movement from the Community to a third country;
17.
‘transmissible spongiform encephalopathies (TSEs)’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001;
18.
‘specified risk material’ means specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;
19.
‘pressure sterilisation’ means the processing of animal by-products, after reduction in particle size to not more than 50 mm, to a core temperature of more than 133 °C for at least 20 minutes without interruption at an absolute pressure of at least 3 bar;
20.
‘manure’ means any excrement and/or urine of farmed animals other than farmed fish, with or without litter;
21.
‘authorised landfill’ means a landfill for which a permit has been issued in accordance with Directive 1999/31/EC;
22.
‘organic fertiliser’ and ‘soil improver’ means materials of animal origin used to maintain or improve plant nutrition and the physical and chemical properties and biological activities of soils, either separately or together; they may include manure, non-mineralised guano, digestive tract content, compost and digestion residues;
23.
‘remote area’ means an area where the animal population is so small, and where disposal establishments or plants are so far away that the arrangements necessary for the collection and transport of animal by-products would be unacceptably onerous compared to local disposal;
24.
‘food’ or ‘foodstuff’ means food or foodstuff as defined in Article 2 of Regulation (EC) No 178/2002;
25.
‘feed’ or ‘feedingstuff’ means feed or feedingstuff as defined in Article 3(4) of Regulation (EC) No 178/2002;
26.
‘centrifuge or separator sludge’ means material collected as a by-product after purification of raw milk and separation of skimmed milk and cream from raw milk;
27.
‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC.
Section 2
Obligations
Article 4
Starting point in the manufacturing chain and obligations
1. As soon as operators generate animal by-products or derived products falling within the scope of this Regulation, they shall identify them and ensure that they are dealt with in accordance with this Regulation (starting point).
2. Operators shall ensure at all stages of collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use and disposal within the businesses under their control that animal by-products and derived products satisfy the requirements of this Regulation which are relevant to their activities.
3. Member States shall monitor and verify that the relevant requirements of this Regulation are fulfilled by operators along the entire chain of animal by-products and derived products as referred to in paragraph 2. For that purpose, they shall maintain a system of official controls in accordance with relevant Community legislation.
4. Member States shall ensure that an adequate system is in place on their territory ensuring that animal by-products are:
(a)
collected, identified and transported without undue delay; and
(b)
treated, used or disposed of in accordance with this Regulation.
5. Member States may fulfil their obligations under paragraph 4 in cooperation with other Member States or third countries.
Article 5
End point in the manufacturing chain
1. Derived products referred to in Article 33 which have reached the stage of manufacturing regulated by the Community legislation referred to in that Article shall be regarded as having reached the end point in the manufacturing chain, beyond which they are no longer subject to the requirements of this Regulation.
Those derived products may subsequently be placed on the market without restrictions under this Regulation and shall no longer be subject to official controls in accordance with this Regulation.
The end point in the manufacturing chain may be modified:
(a)
for products referred to in Article 33(a) to (d), in case of risks to animal health;
(b)
for products referred to in Article 33(e) and (f), in case of risks to public or animal health.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(6).
2. For derived products referred to in Articles 35 and 36 which no longer pose any significant risk to public or animal health, an end point in the manufacturing chain may be determined, beyond which they are no longer subject to the requirements of this Regulation.
Those derived products may subsequently be placed on the market without restrictions under this Regulation and shall no longer be subject to official controls in accordance with this Regulation.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(5).
3. In the event of risks to public or animal health, Articles 53 and 54 of Regulation (EC) No 178/2002 concerning emergency measures shall apply mutatis mutandis to the derived products referred to in Articles 33 and 36 of this Regulation.
Section 3
Animal health restrictions
Article 6
General animal health restrictions
1. Animal by-products and derived products from susceptible species shall not be dispatched from holdings, establishments, plants or zones which are subject to restrictions:
(a)
pursuant to Community veterinary legislation; or
(b)
due to the presence of a serious transmissible disease:
(i)
listed in Annex I to Directive 92/119/EEC; or
(ii)
laid down in accordance with the second subparagraph.
The measures referred to in point (b)(ii) of the first subparagraph, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
2. Paragraph 1 shall not apply where animal by-products and derived products are dispatched under conditions designed to prevent the spread of diseases transmissible to humans or animals.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(5).
Section 4
Categorisation
Article 7
Categorisation of animal by-products and derived products
1. Animal by-products shall be categorised into specific categories which reflect the level of risk to public and animal health arising from those animal by-products, in accordance with the lists laid down in Articles 8, 9 and 10.
2. Derived products shall be subject to the rules for the specific category of animal by-products from which they have been derived, unless otherwise specified in this Regulation, or provided for in measures for the implementation of this Regulation which may specify the conditions under which derived products are not subject to those rules adopted by the Commission.
3. Articles 8, 9 and 10 may be amended in order to take into account scientific progress as regards the assessment of the level of risk, provided such progress can be identified on the basis of a risk assessment carried out by the appropriate scientific institution. However, no animal by-products listed in those Articles may be removed from those lists, only changes of categorisation or additions may be made.
4. The measures referred to in paragraphs 2 and 3, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 8
Category 1 material
Category 1 material shall comprise the following animal by-products:
(a)
entire bodies and all body parts, including hides and skins, of the following animals:
(i)
animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001 or in which the presence of a TSE has been officially confirmed;
(ii)
animals killed in the context of TSE eradication measures;
(iii)
animals other than farmed and wild animals, including in particular pet animals, zoo animals and circus animals;
(iv)
animals used for experiments as defined by Article 2(d) of Directive 86/609/EEC without prejudice to Article 3(2) of Regulation (EC) No 1831/2003;
(v)
wild animals, when suspected of being infected with diseases communicable to humans or animals;
(b)
the following material:
(i)
specified risk material;
(ii)
entire bodies or parts of dead animals containing specified risk material at the time of disposal;
(c)
animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;
(d)
animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation;
(e)
animal by-products collected during the treatment of waste water required by implementing rules adopted under point (c) of the first paragraph of Article 27:
(i)
from establishments or plants processing Category 1 material; or
(ii)
from other establishments or plants where specified risk material is being removed;
(f)
catering waste from means of transport operating internationally;
(g)
mixtures of Category 1 material with either Category 2 material or Category 3 material or both.
Article 9
Category 2 material
Category 2 material shall comprise the following animal by-products:
(a)
manure, non-mineralised guano and digestive tract content;
(b)
animal by-products collected during the treatment of waste water required by implementing rules adopted under point (c) of the first paragraph of Article 27:
(i)
from establishments or plants processing Category 2 material; or
(ii)
from slaughterhouses other than those covered by Article 8(e);
(c)
animal by-products containing residues of authorised substances or contaminants exceeding the permitted levels as referred to in Article 15(3) of Directive 96/23/EC;
(d)
products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies in those products;
(e)
products of animal origin, other than Category 1 material, that are:
(i)
imported or introduced from a third country and fail to comply with Community veterinary legislation for their import or introduction into the Community except where Community legislation allows their import or introduction subject to specific restrictions or their return to the third country; or
(ii)
dispatched to another Member State and fail to comply with requirements laid down or authorised by Community legislation except where they are returned with the authorisation of the competent authority of the Member State of origin;
(f)
animals and parts of animals, other than those referred to in Article 8 or Article 10,
(i)
that died other than by being slaughtered or killed for human consumption, including animals killed for disease control purposes;
(ii)
foetuses;
(iii)
oocytes, embryos and semen which are not destined for breeding purposes; and
(iv)
dead-in-shell poultry;
(g)
mixtures of Category 2 material with Category 3 material;
(h)
animal by-products other than Category 1 material or Category 3 material.
Article 10
Category 3 material
Category 3 material shall comprise the following animal by-products:
(a)
carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons;
(b)
carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Community legislation:
(i)
carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Community legislation, but which did not show any signs of disease communicable to humans or animals;
(ii)
heads of poultry;
(iii)
hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of:
—
animals, other than ruminants requiring TSE testing, and
—
ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001;
(iv)
pig bristles;
(v)
feathers;
(c)
animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004, which did not show any signs of disease communicable to humans or animals;
(d)
blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from the following animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Community legislation:
(i)
animals other than ruminants requiring TSE testing; and
(ii)
ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001;
(e)
animal by-products arising from the production of products intended for human consumption, including degreased bones, greaves and centrifuge or separator sludge from milk processing;
(f)
products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;
(g)
petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;
(h)
blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show any signs of disease communicable through that product to humans or animals;
(i)
aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of disease communicable to humans or animals;
(j)
animal by-products from aquatic animals originating from establishments or plants manufacturing products for human consumption;
(k)
the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i)
shells from shellfish with soft tissue or flesh;
(ii)
the following originating from terrestrial animals:
—
hatchery by-products,
—
eggs,
—
egg by-products, including egg shells,
(iii)
day-old chicks killed for commercial reasons;
(l)
aquatic and terrestrial invertebrates other than species pathogenic to humans or animals;
(m)
animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g);
(n)
hides and skins, hooves, feathers, wool, horns, hair and fur originating from dead animals that did not show any signs of disease communicable through that product to humans or animals, other than those referred to in point (b) of this Article;
(o)
adipose tissue from animals which did not show any signs of disease communicable through that material to humans or animals, which were slaughtered in a slaughterhouse and which were considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Community legislation;
(p)
catering waste other than as referred to in Article 8(f).
CHAPTER II
Disposal and use of animal by-products and derived products
Section 1
Restrictions on use
Article 11
Restrictions on use
1. The following uses of animal by-products and derived products shall be prohibited:
(a)
the feeding of terrestrial animals of a given species other than fur animals with processed animal protein derived from the bodies or parts of bodies of animals of the same species;
(b)
the feeding of farmed animals other than fur animals with catering waste or feed material containing or derived from catering waste;
(c)
the feeding of farmed animals with herbage, either directly by grazing or by feeding with cut herbage, from land to which organic fertilisers or soil improvers, other than manure, have been applied unless the cutting or grazing takes place after the expiry of a waiting period which ensures adequate control of risks to public and animal health and is at least 21 days; and
(d)
the feeding of farmed fish with processed animal protein derived from the bodies or parts of bodies of farmed fish of the same species.
2. Measures relating to the following may be laid down:
(a)
the checks and controls to be carried out to ensure the application of the prohibitions referred to in paragraph 1, including detection methods and tests to be used to verify the presence of materials originating from certain species and thresholds for insignificant amounts of processed animal proteins referred to in points (a) and (d) of paragraph 1 which are caused by adventitious and technically unavoidable contamination;
(b)
the conditions for the feeding of fur animals with processed animal protein derived from bodies or parts of bodies of animals of the same species; and
(c)
the conditions for the feeding of farmed animals with herbage from land to which organic fertilisers or soil improvers have been applied, in particular a modification of the waiting period as referred to in paragraph 1(c).
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Section 2
Disposal and use
Article 12
Disposal and use of Category 1 material
Category 1 material shall be:
(a)
disposed of as waste by incineration:
(i)
directly without prior processing; or
(ii)
following processing, by pressure sterilisation if the competent authority so requires, and permanent marking of the resulting material;
(b)
recovered or disposed of by co-incineration, if the Category 1 material is waste:
(i)
directly without prior processing; or
(ii)
following processing, by pressure sterilisation if the competent authority so requires, and permanent marking of the resulting material;
(c)
in the case of Category 1 material other than material referred to in Article 8(a)(i) and (ii), disposed of by processing by pressure sterilisation, permanent marking of the resulting material and burial in an authorised landfill;
(d)
in the case of Category 1 material referred to in Article 8(f), disposed of by burial in an authorised landfill;
(e)
used as a fuel for combustion with or without prior processing; or
(f)
used for the manufacture of derived products referred to in Articles 33, 34 and 36 and placed on the market in accordance with those Articles.
Article 13
Disposal and use of Category 2 material
Category 2 material shall be:
(a)
disposed of as waste by incineration:
(i)
directly without prior processing; or
(ii)
following processing, by pressure sterilisation if the competent authority so requires, and permanent marking of the resulting material;
(b)
recovered or disposed of by co-incineration, if the Category 2 material is waste:
(i)
directly without prior processing; or
(ii)
following processing, by pressure sterilisation if the competent authority so requires, and permanent marking of the resulting material;
(c)
disposed of in an authorised landfill, following processing by pressure sterilisation and permanent marking of the resulting material;
(d)
used for the manufacturing of organic fertilisers or soil improvers to be placed on the market in accordance with Article 32 following processing by pressure sterilisation, when applicable, and permanent marking of the resulting material;
(e)
composted or transformed into biogas:
(i)
following processing by pressure sterilisation and permanent marking of the resulting material; or
(ii)
in the case of manure, digestive tract and its content, milk, milk-based products, colostrum, eggs and egg products which the competent authority does not consider to present a risk for the spread of any serious transmissible disease, following or without prior processing;
(f)
applied to land without processing, in the case of manure, digestive tract content separated from the digestive tract, milk, milk-based products and colostrum which the competent authority does not consider to present a risk for the spread of any serious transmissible disease;
(g)
in the case of material originating from aquatic animals, ensiled, composted or transformed into biogas;
(h)
used as a fuel for combustion with or without prior processing; or
(i)
used for the manufacture of derived products referred to in Articles 33, 34 and 36 and placed on the market in accordance with those Articles.
Article 14
Disposal and use of Category 3 material
Category 3 material shall be:
(a)
disposed of as waste by incineration, with or without prior processing;
(b)
recovered or disposed of by co-incineration, with or without prior processing, if the Category 3 material is waste;
(c)
disposed of in an authorised landfill, following processing;
(d)
processed, except in the case of Category 3 material which has changed through decomposition or spoilage so as to present an unacceptable risk to public or animal health, through that product, and used:
(i)
for the manufacturing of feed for farmed animals other than fur animals, to be placed on the market in accordance with Article 31, except in the case of material referred to in Article 10(n), (o) and (p);
(ii)
for the manufacturing of feed for fur animals, to be placed on the market in accordance with Article 36;
(iii)
for the manufacturing of pet food, to be placed on the market in accordance with Article 35; or
(iv)
for the manufacturing of organic fertilisers or soil improvers, to be placed on the market in accordance with Article 32;
(e)
used for the production of raw petfood, to be placed on the market in accordance with Article 35;
(f)
composted or transformed into biogas;
(g)
in the case of material originating from aquatic animals, ensiled, composted or transformed into biogas;
(h)
in the case of shells from shellfish, other than those referred to in Article 2(2)(f), and egg shells, used under conditions determined by the competent authority which prevent risks arising to public and animal health;
(i)
used as a fuel for combustion with or without prior processing;
(j)
used for the manufacture of derived products referred to in Articles 33, 34 and 36 and placed on the market in accordance with those Articles;
(k)
in the case of catering waste referred to in Article 10(p) processed by pressure sterilisation or by processing methods referred to in point (b) of the first subparagraph of Article 15(1) or composted or transformed into biogas; or
(l)
applied to land without processing, in the case of raw milk, colostrum and products derived therefrom, which the competent authority does not consider to present a risk of any disease communicable through those products to humans or animals.
Article 15
Implementing measures
1. Measures for the implementation of this Section may be laid down relating to the following:
(a)
special conditions for the on-board handling and the disposal of material derived from on-board evisceration of fish showing signs of disease, including parasites, that are communicable to humans;
(b)
processing methods for animal by-products other than pressure sterilisation, in particular as regards the parameters to be applied for those processing methods, in particular the time, temperature, pressure and size of particles;
(c)
parameters for the transformation of animal by-products, including catering waste, into biogas or compost;
(d)
conditions for the incineration and co-incineration of animal by-products and derived products;
(e)
conditions for the combustion of animal by-products and derived products;
(f)
conditions for the generation and handling of animal by-products referred to in Article 10(c);
(g)
ensilage of material originating from aquatic animals;
(h)
permanent marking of animal by-products;
(i)
the application to land of certain animal by-products, organic fertilisers and soil improvers;
(j)
the use of certain animal by-products for feeding to farmed animals; and
(k)
the level of risk to public or animal health with respect to certain material which is considered as unacceptable as referred to in Article 14(d).
Those measures designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
2. Pending the adoption of rules referred to:
(a)
in points (c), (f) and (g) of the first subparagraph of paragraph 1, Member States may adopt or maintain national rules for:
(i)
the generation and handling of animal by-products referred to in Article 10(c);
(ii)
the transformation of animal by-products referred to in Article 10(p); and
(iii)
for the ensilage of material originating from aquatic animals;
(b)
in point (a) of the first subparagraph of paragraph 1, animal by-products referred to therein may be disposed of at sea, without prejudice to Community environmental legislation.
Section 3
Derogations
Article 16
Derogations
By way of derogation from Articles 12, 13 and 14, animal by-products may be:
(a)
in the case of animal by-products referred to in point (a) of the first subparagraph of Article 15(1), handled and disposed of in accordance with special conditions laid down pursuant to that point;
(b)
used for research and other specific purposes in accordance with Article 17;
(c)
in the case of animal by-products referred to in Article 18, used for special feeding purposes in accordance with that Article;
(d)
in the case of animal by-products referred to in Article 19, disposed of in accordance with that Article;
(e)
disposed of or used in accordance with alternative methods which have been authorised in accordance with Article 20, based on parameters which may include pressure sterilisation or other requirements of this Regulation or the implementing measures thereof;
(f)
in the case of Category 2 and Category 3 materials and if authorised by the competent authority, used for the preparation and application to land of bio-dynamic preparations as referred to in Article 12(1)(c) of Regulation (EC) No 834/2007;
(g)
in the case of Category 3 material and, if authorised by the competent authority, used for feeding to pet animals;
(h)
in the case of animal by-products, except for Category 1 material, which arise in the course of surgical intervention on live animals or during birth of animals on farm and, if authorised by the competent authority, disposed of on that farm.
Article 17
Research and other specific purposes
1. The competent authority may, by way of derogation from Articles 12, 13 and 14, authorise the use of animal by-products and derived products for exhibitions, artistic activities, and for diagnostic, educational or research purposes under conditions which ensure the control of risks to public and animal health.
Such conditions shall include:
(a)
the prohibition of any subsequent use of the animal by-products or derived products for other purposes; and
(b)
the obligation to dispose of the animal by-products or derived products safely, or to re-dispatch them to their place of origin, if appropriate.
2. In the case of risks to public and animal health which require the adoption of measures for the whole territory of the Community, in particular in the case of newly emerging risks, harmonised conditions for the import and use of the animal by-products and derived products referred to in paragraph 1 may be laid down. Such conditions may include requirements regarding storage, packaging, identification, transport and disposal.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 18
Special feeding purposes
1. The competent authority may, by way of derogation from Articles 13 and 14, authorise, under conditions which ensure the control of risks to public and animal health, the collection and use of Category 2 material, provided that it comes from animals which were not killed or did not die as a result of the presence or suspected presence of a disease communicable to humans or animals, and of Category 3 material for feeding to:
(a)
zoo animals;
(b)
circus animals;
(c)
reptiles and birds of prey other than zoo or circus animals;
(d)
fur animals;
(e)
wild animals;
(f)
dogs from recognised kennels or packs of hounds;
(g)
dogs and cats in shelters;
(h)
maggots and worms for fishing bait.
2. The competent authority may authorise, by way of derogation from Article 12, and in accordance with the conditions laid down pursuant to paragraph 3 of this Article:
(a)
the feeding of the Category 1 material referred to in Article 8(b)(ii) and of material derived from zoo animals for feeding to zoo animals; and
(b)
the feeding of the Category 1 material referred to in Article 8(b)(ii) to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity.
3. Measures for the implementation of this Article may be laid down relating to the following:
(a)
conditions under which the collection and use as referred to in paragraph 1 may be authorised with respect to the movement, storage and use of Category 2 material and of Category 3 material for feeding, including in the case of newly emerging risks; and
(b)
conditions under which, in certain cases by way of derogation from the obligation laid down in Article 21(1), the feeding of Category 1 material as referred to in paragraph 2 of this Article may be authorised, including:
(i)
the endangered or protected species of necrophagous birds and other species in certain Member States to which such material may be fed;
(ii)
measures to prevent risks to public and animal health.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 19
Collection, transport and disposal
1. The competent authority may, by way of derogation from Articles 12, 13, 14 and 21, authorise the disposal:
(a)
by burial of dead pet animals and equidae;
(b)
by burning or burial on site or by other means under official supervision which prevent the transmission of risks to public and animal health of Category 1 material referred to in Article 8(a)(v) and (b)(ii), Category 2 and Category 3 materials in remote areas;
(c)
by burning or burial on site or by other means under official supervision which prevent the transmission of risks to public and animal health of Category 1 material referred to in Article 8(b)(ii), Category 2 and Category 3 materials in areas where access is practically impossible or where access would only be possible under circumstances, related to geographical or climatic reasons or due to a natural disaster, which would pose a risk to the health and safety of the personnel carrying out the collection or where access would necessitate the use of disproportionate means of collection;
(d)
by means other than burning or burial on site, under official supervision, in the case of Category 2 and Category 3 materials which do not pose a risk to public and animal health, when the amounts of materials do not exceed a particular volume per week, this volume being determined in relation to the nature of the activities carried out and the species of origin of the animal by-products concerned;
(e)
by burning or burial on site, under conditions which prevent the transmission of risks to public and animal health, of animal by-products other than Category 1 material referred to in Article 8(a)(i) in the event of an outbreak of a notifiable disease, if transport to the nearest plant approved for processing or disposal of the animal by-products would increase the danger of propagation of health risks or, in case of a widespread outbreak of an epizootic disease, would mean that the disposal capacities of such plants were exceeded; and
(f)
by burning or burial on site, under conditions which prevent the transmission of risks to public and animal health, of bees and apiculture by-products.
2. The animal population of a particular species in the remote areas referred to in paragraph 1(b) shall not exceed a maximum percentage of the animal population of this species in the Member State concerned.
3. Member States shall make available to the Commission information on:
(a)
the areas that they categorise as remote areas for the purpose of applying paragraph 1(b) and the reasons for that categorisation, and updated information concerning any change to such categorisation; and
(b)
the use they make of the authorisations provided for in points (c) and (d) of paragraph 1 with respect to Category 1 and Category 2 materials.
4. Measures for the implementation of this Article shall be laid down relating to the following:
(a)
conditions aimed at ensuring control of risks to public and animal health in the event of burning and burial on site;
(b)
the maximum percentage of the animal population as referred to in paragraph 2;
(c)
the volume of animal by-products, in relation to the nature of activities and the species of origin, as referred to in paragraph 1(d); and
(d)
the list of diseases referred to in paragraph 1(e).
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Section 4
Alternative methods
Article 20
Authorisation of alternative methods
1. The procedure for authorisation of an alternative method of use or disposal of animal by-products or derived products may be initiated either by the Commission or, following an application, by a Member State or by an interested party, which may represent several interested parties.
2. Interested parties shall send their applications to the competent authority of the Member State where they intend to use the alternative method.
The competent authority shall evaluate, within a period of two months following receipt of a complete application, whether the application complies with the standard format for applications referred to in paragraph 10.
3. The competent authority shall communicate the applications of the Member States and interested parties, together with a report on its evaluation to the European Food Safety Authority (EFSA) and inform the Commission thereof.
4. When the Commission initiates the procedure for authorisation, it shall send a report on its evaluation to EFSA.
5. EFSA shall assess, within six months following receipt of a complete application, whether the method submitted ensures that risks to public or animal health are:
(a)
controlled in a manner which prevents their proliferation before disposal in accordance with this Regulation or the implementing measures thereof; or
(b)
reduced to a degree which is at least equivalent, for the relevant category of animal by-products, to the processing methods laid down pursuant to point (b) of the first subparagraph of Article 15(1).
EFSA shall issue an opinion on the application submitted.
6. In duly justified cases where EFSA requests additional information from applicants, the period provided for in paragraph 5 may be extended.
After consulting the Commission or the applicant, EFSA shall decide on a period within which that information shall be provided to it and inform the Commission and the applicant as appropriate of the additional period needed.
7. Where applicants wish to submit additional information on their own initiative, they shall send it directly to EFSA.
In that case the period provided for in paragraph 5 shall not be extended by an additional period.
8. EFSA shall forward its opinion to the Commission, the applicant and the competent authority of the Member State concerned.
9. Within three months following receipt of the opinion of EFSA and taking account of that opinion, the Commission shall inform the applicant of the proposed measure to be adopted in accordance with paragraph 11.
10. A standard format for applications for alternative methods shall be adopted in accordance with the advisory procedure referred to in Article 52(2).
11. Following receipt of the opinion of EFSA, the following shall be adopted:
(a)
either a measure authorising an alternative method of use or disposal of animal by-products or derived products; or
(b)
a measure rejecting the authorisation of such an alternative method.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
TITLE II
OBLIGATIONS OF OPERATORS
CHAPTER I
General obligations
Section 1
Collection, transport and traceability
Article 21
Collection and identification as regards category and transport
1. Operators shall collect, identify and transport animal by-products without undue delay under conditions which prevent risks arising to public and animal health.
2. Operators shall ensure that animal by-products and derived products are accompanied during transport by a commercial document or, when required by this Regulation or by a measure adopted in accordance with paragraph 6, by a health certificate.
By way of derogation from the first subparagraph, the competent authority may authorise the transport of manure between two points located on the same farm or between farms and users of manure within the same Member State without a commercial document or health certificate.
3. Commercial documents and health certificates accompanying animal by-products or derived products during transport shall at least include information on the origin, the destination and the quantity of such products, and a description of the animal by-products or derived products and their marking, when such marking is required by this Regulation.
However, for animal by-products and derived products transported within the territory of a Member State, the competent authority of the Member State concerned may authorise transmission of the information referred to in the first subparagraph by way of an alternative system.
4. Operators shall collect, transport and dispose of Category 3 catering waste, in accordance with national measures foreseen in Article 13 of Directive 2008/98/EC.
5. The following shall be adopted in accordance with the regulatory procedure referred to in Article 52(3):
(a)
models for commercial documents which are required to accompany animal by-products during transport; and
(b)
models for health certificates and the conditions governing the way they must accompany animal by-products and derived products during transport.
6. Measures for the implementation of this Article may be laid down relating to the following:
(a)
cases where a health certificate is required, having regard to the level of risk to public and animal health arising from certain derived products;
(b)
cases where, by way of derogation from the first subparagraph of paragraph 2 and having regard to the low level of risk to public and animal health arising from certain animal by-products or derived products, transport of derived products may take place without the documents or certificates referred to in that paragraph;
(c)
requirements for the identification, including labelling, and for the separation of different categories of animal by-products during transport; and
(d)
conditions to prevent risks to public and animal health arising during the collection and transport of animal by-products, including conditions for the safe transport of those products with respect to containers, vehicles and packaging material.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 22
Traceability
1. Operators consigning, transporting or receiving animal by-products or derived products shall keep a record of consignments and related commercial documents or health certificates.
However, the first subparagraph shall not apply when an authorisation to transport animal by-products or derived products without commercial documents or health certificates has been granted in accordance with the second subparagraph of Article 21(2) or in accordance with implementing measures adopted under Article 21(6)(b).
2. The operators referred to in paragraph 1 shall have in place systems and procedures to identify:
(a)
the other operators to which their animal by-products or derived products have been supplied; and
(b)
the operators from whom they have been supplied.
This information shall be made available to the competent authorities on request.
3. Measures for the implementation of this Article may be adopted in accordance with the regulatory procedure referred to in Article 52(3), in particular on:
(a)
the information to be made available to the competent authorities;
(b)
the period of time during which this information must be kept.
Section 2
Registration and approval
Article 23
Registration of operators, establishments or plants
1. With a view to registration, operators shall:
(a)
before commencing operations, notify the competent authority of any establishments or plants under their control which are active at any stage of the generation, transport, handling, processing, storage, placing on the market, distribution, use or disposal of animal by-products and derived products;
(b)
provide the competent authority with information on:
(i)
the category of animal by-products or derived products under their control;
(ii)
the nature of the operations performed using animal by-products or derived products as starting material.
2. Operators shall provide the competent authority with up-to-date information on any establishments or plants under their control as referred to in point (a) of paragraph 1, including any significant change in activities such as any closure of an existing establishment or plant.
3. Detailed rules regarding registration as referred to in paragraph 1 may be adopted in accordance with the regulatory procedure referred to in Article 52(3).
4. By way of derogation from paragraph 1, no notification with a view to registration shall be required for activities with respect to which establishments generating animal by-products have already been approved or registered in accordance with Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004; and for activities with respect to which establishments or plants have already been approved in accordance with Article 24 of this Regulation.
The same derogation shall apply for the activities involving the generation of animal by-products on site only, which are carried out on farms or other premises where animals are kept, bred or taken care of.
Article 24
Approval of establishments or plants
1. Operators shall ensure that establishments or plants under their control are approved by the competent authority, where such establishments or plants carry out one or more of the following activities:
(a)
processing of animal by-products by pressure sterilisation, by processing methods referred to in point (b) of the first subparagraph of Article 15(1) or by alternative methods authorised in accordance with Article 20;
(b)
disposal, as waste, by incineration of animal by-products and derived products, excluding establishments or plants which have a permit to operate in accordance with Directive 2000/76/EC;
(c)
disposal or recovery of animal by-products and derived products, if they are waste, by co-incineration, excluding establishments or plants which have a permit to operate in accordance with Directive 2000/76/EC;
(d)
use of animal by-products and derived products as fuel for combustion;
(e)
manufacturing of pet food;
(f)
manufacturing of organic fertilisers and soil improvers;
(g)
transformation of animal by-products and/or derived products into biogas or compost;
(h)
handling of animal by-products after their collection, by way of operations such as sorting, cutting, chilling, freezing, salting, removal of hides and skins or of specified risk material;
(i)
storage of animal by-products;
(j)
storage of derived products intended to be:
(i)
disposed of by landfill or incineration or intended to be recovered or disposed of by co-incineration;
(ii)
used as fuel for combustion;
(iii)
used as feed, excluding establishments or plants approved or registered in accordance with Regulation (EC) No 183/2005;
(iv)
used as organic fertilisers and soil improvers, excluding storage at a place of direct application.
2. The approval referred to in paragraph 1 shall specify if the establishment or plant is approved for operations with animal by-products and/or derived products of:
(a)
a particular category referred to in Articles 8, 9 or 10; or
(b)
more than one category referred to in Articles 8, 9 or 10, indicating if such operations are carried out:
(i)
permanently under conditions of strict separation which prevent any risk to public and animal health; or
(ii)
temporarily under conditions which prevent contamination, in response to a shortage of capacity for such products arising due to:
—
a widespread outbreak of an epizootic disease, or
—
other extraordinary and unforeseen circumstances.
Article 25
General hygiene requirements
1. Operators shall ensure that establishments or plants under their control carrying out the activities referred to in Article 24(1)(a) and (h):
(a)
are constructed in a way permitting their effective cleaning and disinfection and where appropriate the construction of floors facilitates the draining of liquids;
(b)
have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins for staff;
(c)
have appropriate arrangements for protection against pests, such as insects, rodents and birds;
(d)
keep installations and equipment in good condition and ensure that measuring equipment is calibrated regularly; and
(e)
have appropriate arrangements for the cleaning and the disinfection of containers and vehicles in place to avoid risks of contamination.
2. Any person working in the establishment or plant referred to in paragraph 1 shall wear suitable, clean and, where necessary, protective clothing.
Where appropriate in a particular establishment or plant:
(a)
persons working in the unclean sector shall not enter the clean sector without first changing their work clothes and shoes or without having disinfected them;
(b)
equipment and machinery shall not be moved from the unclean to the clean sector without first being cleaned and disinfected; and
(c)
the operator shall establish a procedure relating to the movements of persons in order to monitor their movements and describe the correct use of footbaths and wheel baths.
3. In establishments or plants carrying out the activities referred to in Article 24(1)(a):
(a)
animal by-products shall be handled in such a way as to avoid risks of contamination;
(b)
animal by-products shall be processed as soon as possible. After processing, derived products shall be handled and stored in such a way as to avoid risks of contamination;
(c)
where appropriate, during any processing applied to animal by-products and derived products every part of the animal by-product and derived products shall be treated to a given temperature for a given period of time and risks of re-contamination shall be prevented;
(d)
the operators shall check regularly the applicable parameters, particularly temperature, pressure, time, size of particles, where appropriate by automatic devices;
(e)
cleaning procedures shall be established and documented for all parts of the establishments or plants.
Article 26
Handling of animal by-products within food businesses
1. The treatment, processing or storage of animal by-products in establishments or plants approved or registered in accordance with Article 4 of Regulation (EC) No 853/2004 or in accordance with Article 6 of Regulation (EC) No 852/2004 shall be carried out under conditions which prevent cross-contamination and if appropriate in a dedicated part of the establishment or plant.
2. Raw materials for the production of gelatine and collagen not intended for human consumption may be stored, treated or processed in the establishments specifically authorised in accordance with Regulation (EC) No 853/2004, Annex III, Section XIV, Chapter I, point 5, and Section XV, Chapter I, point 5, provided the transmission of disease risk is prevented by segregation of such raw materials from the raw materials for the production of products of animal origin.
3. Paragraphs 1 and 2 shall apply without prejudice to more specific requirements laid down in Community veterinary legislation.
Article 27
Implementing measures
Measures for the implementation of this Section and Section 1 of this Chapter shall be laid down relating to the following:
(a)
infrastructure and equipment requirements applicable within establishments or plants;
(b)
hygiene requirements applicable to all types of handling of animal by-products and derived products, including measures modifying hygiene requirements for establishments or plants referred to in Article 25(1);
(c)
conditions and technical requirements for the handling, treatment, transformation, processing and storage of animal by-products or derived products and conditions for treatment of waste water;
(d)
evidence to be presented by the operator for the purpose of validation of the treatment, transformation and processing of animal by-products or derived products, on their ability to prevent public and animal health risks;
(e)
conditions for the handling of animal by-products or derived products of more than one category referred to in Articles 8, 9 or 10 in the same establishment or plant:
(i)
where such operations are carried out separately;
(ii)
where such operations are carried out temporarily in certain circumstances;
(f)
conditions for the prevention of cross-contamination when animal by-products are stored, treated or processed in a dedicated part of an establishment or plant referred to in Article 26;
(g)
standard transformation parameters for biogas and composting plants;
(h)
requirements applicable to the incineration or co-incineration in plants of high and low capacity as referred to in Article 24(1)(b) and (c); and
(i)
requirements applicable to the combustion of animal by-products and derived products as referred to in Article 24(1)(d).
Those measures, designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Section 3
Own checks and hazard analysis and critical control points
Article 28
Own checks
Operators shall put in place, implement and maintain own checks in their establishments or plants in order to monitor compliance with this Regulation. They shall ensure that no animal by-products or derived products suspected or discovered not to comply with this Regulation leave the establishment or plant, unless destined for disposal.
Article 29
Hazard analysis and critical control points
1. Operators carrying out one of the following activities shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (HACCP) principles for the:
(a)
processing of animal by-products;
(b)
transformation of animal by-products into biogas and compost;
(c)
handling and storage of more than one category of animal by-products or derived products in the same establishment or plant;
(d)
manufacturing of pet food.
2. Operators as specified in paragraph 1 shall in particular:
(a)
identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
(b)
identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;
(c)
establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;
(d)
establish and implement effective monitoring procedures at critical control points;
(e)
establish corrective action when monitoring indicates that a critical control point is not under control;
(f)
establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly;
(g)
establish documents and records commensurate with the nature and size of the businesses to demonstrate the effective application of the measures set out in points (a) to (f).
3. When any modification is made to a product, process or any stage of production, processing, storage or distribution, operators shall review their procedures and make the necessary changes.
4. Measures to facilitate the implementation of this Article may be adopted in accordance with the regulatory procedure referred to in Article 52(3).
Article 30
National guides to good practice
1. Where necessary, competent authorities shall encourage the development, dissemination and voluntary use of national guides to good practice in particular for the application of HACCP principles as referred to in Article 29. Operators may use such guides on a voluntary basis.
2. The competent authority shall assess national guides to ensure that:
(a)
they have been developed in consultation with representatives of parties whose interests may be substantially affected, and have been disseminated by sectors of operators; and
(b)
their contents are practicable for the sectors to which they refer.
CHAPTER II
Placing on the market
Section 1
Animal by-products and derived products for feeding to farmed animals excluding fur animals
Article 31
Placing on the market
1. Animal by-products and derived products destined for feeding to farmed animals, excluding fur animals, may only be placed on the market provided:
(a)
they are or they are derived from Category 3 material other than material referred to in Article 10(n), (o) and (p);
(b)
they have been collected or processed, as applicable, in accordance with the conditions for pressure sterilisation or other conditions to prevent risks arising to public and animal health in accordance with measures adopted pursuant to Article 15 and any measures which have been laid down in accordance with paragraph 2 of this Article; and
(c)
they come from approved or registered establishments or plants, as applicable for the animal by-product or derived product concerned.
2. Measures for the implementation of this Article may be laid down relating to the public and animal health conditions for the collection, processing and treatment of animal by-products and derived products referred to in paragraph 1.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Section 2
Organic fertilisers and soil improvers
Article 32
Placing on the market and use
1. Organic fertilisers and soil improvers may be placed on the market and used provided:
(a)
they are derived from Category 2 or Category 3 material;
(b)
they have been produced in accordance with the conditions for pressure sterilisation or with other conditions to prevent risks arising to public and animal health, in accordance with the requirements laid down pursuant to Article 15 and any measures which have been laid down in accordance with paragraph 3 of this Article;
(c)
they come from approved or registered establishments or plants, as applicable; and
(d)
in the case of meat-and-bone meal derived from Category 2 material and processed animal proteins intended to be used as or in organic fertilisers and soil improvers, they have been mixed with a component to exclude the subsequent use of the mixture for feeding purposes and marked when required by measures adopted under paragraph 3.
In addition, digestion residues from transformation into biogas or compost may be placed on the market and used as organic fertilisers or soil improvers.
Member States may adopt or maintain national rules imposing additional conditions for or restricting the use of organic fertilisers and soil improvers, provided that such rules are justified on grounds of the protection of public and animal health.
2. By way of derogation from point (d) of paragraph 1, mixing shall not be required for materials whose use for feeding purposes is excluded due to their composition or packaging.
3. Measures for the implementation of this Article may be laid down relating to the following:
(a)
public and animal health conditions for the production and use of organic fertilisers and soil improvers;
(b)
components or substances for the marking of organic fertilisers or soil improvers;
(c)
components to be mixed with organic fertilisers or soil improvers;
(d)
supplementary conditions, such as the methods to be used for marking and the minimum proportions to be observed when preparing the mixture, in order to exclude the use of such fertilisers or soil improvers for feeding purposes; and
(e)
cases where the composition or packaging allows the materials to be exempted from the mixing requirement.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Section 3
Derived products regulated by certain other Community legislation
Article 33
Placing on the market
Operators may place on the market the following derived products:
(a)
cosmetic products as defined in Article 1(1) of Directive 76/768/EEC;
(b)
active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC;
(c)
medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC;
(d)
in vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC;
(e)
veterinary medicinal products as defined in Article 1(2) of Directive 2001/82/EC;
(f)
medicinal products as defined in Article 1(2) of Directive 2001/83/EC.
Article 34
Manufacture
1. The import, collection and movement of animal by-products and derived products destined for establishments or plants for the manufacture of the derived products referred to in Article 33 and the manufacture of those derived products shall be carried out in accordance with the Community legislation referred to in that Article.
Unused material from such establishments or plants shall be disposed of in accordance with that legislation.
2. However, this Regulation shall apply where the Community legislation referred to in Article 33 does not provide for conditions controlling potential risks to public and animal health in accordance with the objectives of this Regulation.
Section 4
Other derived products
Article 35
Placing on the market of pet food
Operators may place pet food on the market provided:
(a)
the products are derived:
(i)
from Category 3 material, other than material referred to in Article 10(n), (o) and (p);
(ii)
in the case of imported pet food or of pet food produced from imported materials, from Category 1 material referred to in Article 8(c), subject to conditions laid down pursuant to point (a) of the first paragraph of Article 40; or
(iii)
in the case of raw petfood, from material referred to in Article 10(a) and (b)(i) and (ii); and
(b)
they ensure the control of risks to public and animal health by safe treatment in accordance with Article 38, where safe sourcing in accordance with Article 37 does not ensure sufficient control.
Article 36
Placing on the market of other derived products
Operators may place on the market derived products, other than the products referred to in Articles 31, 32, 33 and 35, provided:
(a)
those products are:
(i)
not intended for use for the feeding to farmed animals or for application to land from which such animals are to be fed; or
(ii)
intended for feeding to fur animals; and
(b)
they ensure the control of risks to public and animal health by:
(i)
safe sourcing in accordance with Article 37;
(ii)
safe treatment in accordance with Article 38, where safe sourcing does not ensure sufficient control; or
(iii)
verifying that the products are only used for safe end uses in accordance with Article 39 where safe treatment does not ensure sufficient control.
Article 37
Safe sourcing
1. Safe sourcing shall include the use of material:
(a)
from which no unacceptable risks to public and animal health arise;
(b)
which has been collected and transported from the point of collection to the manufacturing establishment or plant under conditions which exclude risks to public and animal health; or
(c)
which has been imported into the Community and transported from the point of first entry to the manufacturing establishment or plant under conditions which exclude risks to public and animal health.
2. For the purpose of safe sourcing, operators shall provide documentation of the requirements of paragraph 1, including, where necessary, proof of the safety of bio-security measures taken in order to exclude risks arising to public and animal health from starting material.
Such documentation shall be kept available to the competent authority upon request.
In the case referred to in point (c) of paragraph 1, the consignments shall be accompanied by a health certificate corresponding to a model adopted in accordance with the regulatory procedure referred to in Article 52(3).
Article 38
Safe treatment
Safe treatment shall include application of a manufacturing process to the material used which reduces to an acceptable level risks to public and animal health arising from the material used or from other substances resulting from the manufacturing process.
It shall be ensured that the derived product poses no unacceptable risks to public and animal health, in particular by means of testing of the end product.
Article 39
Safe end uses
Safe end uses shall include the use of derived products:
(a)
under conditions which pose no unacceptable risks to public and animal health; or
(b)
which may pose a risk to public and animal health, for specific purposes provided that such use is justified by objectives set out in Community legislation, in particular for the protection of public and animal health.
Article 40
Implementing measures
Measures for the implementation of this Section may be laid down relating to the following:
(a)
conditions for the placing on the market of imported pet food or of pet food produced from imported materials, from Category 1 material referred to in Article 8(c);
(b)
conditions for the safe sourcing and movement of material to be used under conditions which exclude risks to public and animal health;
(c)
documentation as referred to in the first subparagraph of Article 37(2);
(d)
parameters for the manufacturing process as referred to in the first paragraph of Article 38, in particular as regards the application of physical or chemical treatments to the material used;
(e)
testing requirements applicable to the end product; and
(f)
conditions for the safe use of derived products which pose a risk to public or animal health.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
CHAPTER III
Import, transit and export
Article 41
Import and transit
1. Animal by-products and derived products shall be imported into, or sent in transit through, the Community in accordance with:
(a)
the relevant requirements of this Regulation and the implementing measures thereof for the particular animal by-product or derived product which are at least as stringent as those applicable to the production and marketing of such animal by-products or derived products within the Community;
(b)
conditions recognised to be at least equivalent to the requirements applicable to the production and marketing of such animal by-products or derived products under Community legislation; or
(c)
in the case of animal by-products and derived products referred to in Articles 33, 35 and 36, the requirements set out in those Articles.
The measures referred to in point (b) of the first subparagraph, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
2. By way of derogation from paragraph 1, the import and transit of:
(a)
specified risk material shall take place only in accordance with Regulation (EC) No 999/2001;
(b)
animal by-products or derived products mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall take place only subject to the requirements of Regulation (EC) No 1013/2006;
(c)
Category 1 material, Category 2 material and products derived therefrom which are not intended for the manufacture of derived products referred to in Articles 33, 35 and 36, shall only take place provided that rules for their import have been adopted in accordance with Article 42(2)(a);
(d)
animal by-products and derived products destined for the purposes referred to in Article 17(1) shall take place in accordance with national measures which ensure the control of risks to public and animal health, pending the adoption of harmonised conditions referred to in Article 17(2).
3. In the case of import and transit of Category 3 material and products derived therefrom, the relevant requirements as referred to in point (a) of the first subparagraph of paragraph 1 shall be laid down.
Those requirements may specify that consignments:
(a)
must come from a third country or part of a third country listed in accordance with paragraph 4;
(b)
must come from establishments or plants approved or registered by the competent authority of the third country of origin and listed by that authority for that purpose; and
(c)
must be accompanied at the point of entry into the Community where the veterinary checks take place by documentation such as a commercial document or a health certificate and where appropriate by a declaration, which corresponds to a model laid down pursuant to point (d) of the first subparagraph of Article 42(2).
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Pending the adoption of the requirements referred to in points (a) and (c) of the second subparagraph, the Member States shall specify those requirements in national measures.
4. Lists of third countries or parts of third countries from which animal by-products or derived products may be imported or transit through the Community shall be drawn up in accordance with the regulatory procedure referred to in Article 52(3), taking into account in particular:
(a)
the legislation of the third country;
(b)
the organisation of the competent authority and its inspection services in the third country, the powers of those services, the supervision to which they are subject, and their authority to monitor effectively the application of their legislation;
(c)
the actual health conditions applied to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;
(d)
the assurances the third country can give regarding compliance with the relevant health conditions;
(e)
experience of marketing the product from the third country and the results of import checks carried out;
(f)
the result of any Community inspections in the third country;
(g)
the health status of the livestock, other domestic animals and wildlife in the third country, having particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;
(h)
the regularity and speed with which the third country supplies information about the existence of infectious animal diseases in its territory, in particular the diseases listed in the Terrestrial Animal Health Code and the Aquatic Animal Health Code of the World Organisation for Animal Health;
(i)
the regulations on the prevention and control of infectious animal diseases in force in the third country and their implementation, including rules on imports from other third countries.
The lists of establishments or plants referred to in point (b) of the second subparagraph of paragraph 3 shall be kept up to date and communicated to the Commission and the Member States and made available to the public.
Article 42
Implementing measures
1. Measures for the implementation of Article 41 which may exclude animal by-products or derived products manufactured in certain establishments or plants from import or transit in order to protect public or animal health shall be adopted in accordance with the regulatory procedure referred to in Article 52(3).
2. Other measures for the implementation of Article 41 shall be laid down relating to the following:
(a)
conditions for the import and transit of Category 1 and Category 2 materials and for products derived therefrom;
(b)
restrictions regarding public or animal health applicable to imported Category 3 material or products derived therefrom which may be laid down by reference to Community lists of third countries or parts of third countries drawn up in accordance with Article 41(4) or for other public or animal health purposes;
(c)
conditions for the manufacture of animal by-products or derived products in establishments or plants in third countries; such conditions may include the arrangements for controls of such establishments or plants by the competent authority concerned and may exempt certain types of establishments or plants handling animal by-products or derived products from approval or registration as referred to in point (b) of the second subparagraph of Article 41(3); and
(d)
models for health certificates, commercial documents and declarations which are to accompany consignments, specifying the conditions under which it can be stated that the animal by-products or derived products concerned have been collected or manufactured in accordance with the requirements of this Regulation.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 43
Export
1. The export of animal by-products and derived products destined for incineration or landfill shall be prohibited.
2. The export of animal by-products and derived products to third countries which are not members of the OECD for use in a biogas or composting plant shall be prohibited.
3. Category 1 material, Category 2 material and products derived therefrom shall only be exported for purposes other than those referred to in paragraphs 1 and 2 provided that rules for their export have been laid down.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
4. Article 12 of Regulation (EC) No 178/2002 concerning food and feed exported from the Community shall apply mutatis mutandis to the export of Category 3 material or products derived therefrom in compliance with this Regulation.
5. By way of derogation from paragraphs 3 and 4, the export of:
(a)
specified risk material shall take place only in accordance with Regulation (EC) No 999/2001;
(b)
animal by-products or derived products mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall take place only subject to the requirements of Regulation (EC) No 1013/2006.
TITLE III
OFFICIAL CONTROLS AND FINAL PROVISIONS
CHAPTER I
Official controls
Article 44
Procedure for approval
1. The competent authority shall approve establishments or plants only where an on site visit, prior to start-up of any activity, has demonstrated that they meet the relevant requirements laid down in accordance with Article 27.
2. The competent authority may grant conditional approval if it appears, from the on site visit, that the establishment or plant meets all the infrastructure and equipment requirements with a view to ensuring the application of the operational procedures in compliance with this Regulation. It shall grant full approval only if it appears, from another on site visit carried out within three months of granting conditional approval, that the establishment or plant meets the other requirements referred to in paragraph 1. If clear progress has been made, but the establishment or plant still does not meet all of these requirements, the competent authority may extend conditional approval. However, conditional approval shall not exceed a total of six months.
3. Operators shall ensure that an establishment or plant ceases to operate if the competent authority withdraws its approval or in the case of conditional approval fails to extend it or to grant full approval.
Article 45
Official controls
1. Without prejudice to Article 5, the competent authority shall at regular intervals carry out official controls and supervision of the handling of animal by-products and derived products falling within the scope of this Regulation.
2. Articles 41 and 42 of Regulation (EC) No 882/2004 shall apply mutatis mutandis to official controls carried out to verify compliance with this Regulation.
3. The competent authority may take into account adherence to guides to good practice, when carrying out its official controls.
4. Detailed arrangements for implementing this Article, including rules concerning the reference methods for microbiological analyses, may be laid down.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 46
Suspensions, withdrawals and prohibitions on operations
1. If the official controls and supervision carried out by the competent authority reveal that one or more of the requirements of this Regulation are not met, it shall take appropriate action.
The competent authority shall in particular, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health:
(a)
suspend approvals of establishments or plants approved pursuant to this Regulation, if:
(i)
the conditions for approving or operating the establishment or plant are no longer fulfilled;
(ii)
the operator can be expected to remedy the deficiencies within a reasonable period of time; and
(iii)
the potential risks to public and animal health do not require action in accordance with point (b);
(b)
withdraw approvals of establishments or plants approved pursuant to this Regulation, if:
(i)
the conditions for approving or operating the establishment or plant are no longer fulfilled; and
(ii)
the operator cannot be expected to remedy the deficiencies within a reasonable period of time:
—
for reasons relating to the infrastructure of the establishment or plant,
—
for reasons relating to the personal capacity of the operator or the staff under his supervision, or
—
because of serious risks to public and animal health requiring major adjustments to the operation of the establishment or plant before the operator may apply for re-approval;
(c)
impose specific conditions on establishments or plants in order to rectify existing deficiencies.
2. The competent authority shall, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health, temporarily or permanently prohibit operators referred to in Articles 23(1) and (3) and Article 24(1) from carrying out operations under this Regulation, as appropriate, following receipt of information indicating:
(a)
that the requirements of Community legislation are not met; and
(b)
potential risks to public or animal health arising from such operations.
Article 47
Lists
1. Each Member State shall draw up a list of establishments, plants and operators which have been approved or registered in accordance with this Regulation within its territory.
It shall assign an official number to each approved or registered establishment, plant or operator, which identifies the establishment, plant or operator with respect to the nature of its activities.
Member States shall indicate, if applicable, an official number which has been assigned to the establishment, plant or operator under other Community legislation.
Member States shall make the lists of approved or registered establishments, plants and operators available to the Commission and other Member States.
Member States shall keep up-to-date the lists of approved or registered establishments, plants and operators and make them available to other Member States and to the public.
2. Measures for the implementation of this Article may be laid down in accordance with the regulatory procedure referred to in Article 52(3), in particular on:
(a)
the format for the lists referred to in paragraph 1; and
(b)
the procedure for making the lists referred to in paragraph 1 available.
Article 48
Controls for dispatch to other Member States
1. Where an operator intends to dispatch Category 1 material, Category 2 material and meat-and-bone meal or animal fat derived from Category 1 and Category 2 materials to another Member State, it shall inform the competent authority of the Member State of origin and the competent authority of the Member State of destination.
The competent authority of the Member State of destination shall decide upon application by the operator, within a specified time period:
(a)
to refuse receipt of the consignment;
(b)
to accept the consignment unconditionally; or
(c)
to make receipt of the consignment subject to the following conditions:
(i)
if the derived products have not undergone pressure sterilisation, it must undergo such treatment; or
(ii)
the animal by-products or derived products must comply with any conditions for the dispatch of the consignment which are justified for the protection of public and animal health in order to ensure that animal by-products and derived products are handled in accordance with this Regulation.
2. Formats for applications by operators referred to in paragraph 1 may be adopted in accordance with the regulatory procedure referred to in Article 52(3).
3. The competent authority of the Member State of origin shall inform the competent authority of the Member State of destination, by means of the Traces system in accordance with Decision 2004/292/EC, of the dispatch of each consignment sent to the Member State of destination, of
(a)
animal by-products or derived products referred to in paragraph 1;
(b)
processed animal protein derived from Category 3 material.
When informed of the dispatch, the competent authority of the Member State of destination shall inform the competent authority of the Member State of origin of the arrival of each consignment by means of the Traces system.
4. Category 1 and Category 2 materials, meat-and-bone meal and animal fat referred to in paragraph 1 shall be transported directly to the establishment or plant of destination, which must have been registered or approved in accordance with Articles 23, 24 and 44 or, in the case of manure, to the farm of destination.
5. When animal by-products or derived products are sent to other Member States via the territory of a third country, they shall be sent in consignments which have been sealed in the Member State of origin and shall be accompanied by a health certificate.
The sealed consignments shall re-enter the Community only via a border inspection post, in accordance with Article 6 of Directive 89/662/EEC.
6. By way of derogation from paragraphs 1 to 5, animal by-products or derived products referred to therein which have been mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall be sent to other Member States only subject to the requirements of Regulation (EC) No 1013/2006.
7. Measures for the implementation of this Article may be adopted relating to the following:
(a)
a specified time period for the decision of the competent authority as referred to in paragraph 1;
(b)
supplementary conditions for the dispatch of animal by-products or derived products referred to in paragraph 4;
(c)
models for the health certificates which have to accompany consignments sent in accordance with paragraph 5; and
(d)
conditions under which animal by-products or derived products intended to be used for exhibitions, artistic activities, for diagnostic, educational or research purposes may be sent to other Member States, by way of derogation from paragraph 1 to 5 of this Article.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
8. Measures for the implementation of this Article may specify the conditions subject to which, by way of derogation from paragraphs 1 to 4, the competent authorities may allow:
(a)
the dispatch of manure transported between two points located on the same farm or between farms located in the border regions of Member States sharing a common border;
(b)
the dispatch of other animal by-products transported between establishments or plants located in the border regions of Member States sharing a common border; and
(c)
the transport of a dead pet animal for incineration to an establishment or plant located in the border region of another Member State sharing a common border.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).
Article 49
Community controls in Member States
1. Experts from the Commission may make on-the-spot checks, in cooperation with the competent authorities of Member States, in so far as is necessary for the uniform application of this Regulation.
The Member State on whose territory the checks are made shall provide the experts with all the assistance necessary for carrying out their duties.
The Commission shall inform the competent authority of the results of the checks made.
2. Measures for the implementation of this Article may be adopted in accordance with the regulatory procedure referred to in Article 52(3), in particular on the procedure for the cooperation with national authorities.
Article 50
Application of Regulation (EC) No 882/2004 for the purposes of certain controls
1. Article 46 of Regulation (EC) No 882/2004 shall apply mutatis mutandis to Community controls in third countries carried out to verify compliance with this Regulation.
2. Article 50(1)(a) of Regulation (EC) No 882/2004 shall apply mutatis mutandis to the phased introduction of the requirements of Article 41(3) of this Regulation.
3. Article 52 of Regulation (EC) No 882/2004 shall apply mutatis mutandis to third-country controls in Member States related to operations under this Regulation.
CHAPTER II
Final provisions
Article 51
National provisions
Member States shall communicate to the Commission the text of the provisions of national law they adopt in areas under their competence which directly concern the proper implementation of this Regulation.
Article 52
Committee procedure
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
5. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be two months, one month and two months respectively.
6. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 53
Penalties
The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 4 June 2011 and shall notify it without delay of any subsequent amendment affecting them.
Article 54
Repeal
Regulation (EC) No 1774/2002 shall be repealed with effect from 4 March 2011.
References to Regulation (EC) No 1774/2002 shall be construed as references to this Regulation and shall be read in accordance with the correlation table laid down in the Annex.
Article 55
Transitional measure
Establishments, plants and users approved or registered in accordance with Regulation (EC) No 1774/2002 before 4 March 2011 shall be deemed to be approved or registered, as required, in accordance with this Regulation.
Article 56
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 4 March 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 21 October 2009.
For the European Parliament
The President
J. BUZEK
For the Council
The President
C. MALMSTRÖM
(1) OJ C 100, 30.4.2009, p. 133.
(2) Opinion of the European Parliament of 24 April 2009 (not yet published in the Official Journal) and Council Decision of 7 September 2009.
(3) OJ L 273, 10.10.2002, p. 1.
(4) OJ L 139, 30.4.2004, p. 55.
(5) OJ L 147, 31.5.2001, p. 1.
(6) OJ L 312, 22.11.2008, p. 3.
(7) OJ L 358, 18.12.1986, p. 1.
(8) OJ L 328, 24.11.2006, p. 14.
(9) OJ L 182, 16.7.1999, p. 1.
(10) OJ L 62, 15.3.1993, p. 69.
(11) OJ L 268, 18.10.2003, p. 29.
(12) OJ L 224, 18.8.1990, p. 1.
(13) OJ L 125, 23.5.1996, p. 3.
(14) OJ L 125, 23.5.1996, p. 10.
(15) OJ L 109, 6.5.2000, p. 29.
(16) OJ L 229, 1.9.2009, p. 1.
(17) OJ L 31, 1.2.2002, p. 1.
(18) OJ L 139, 30.4.2004, p. 1.
(19) OJ L 35, 8.2.2005, p. 1.
(20) OJ L 332, 28.12.2000, p. 91.
(21) OJ L 189, 20.7.2007, p. 1.
(22) OJ L 343, 27.12.2007, p. 1.
(23) OJ L 165, 30.4.2004, p. 1.
(24) OJ L 94, 31.3.2004, p. 63.
(25) OJ L 395, 30.12.1989, p. 13.
(26) OJ L 190, 12.7.2006, p. 1.
(27) OJ L 39, 16.2.1993, p. 1.
(28) OJ L 272, 4.10.1997, p. 45.
(29) OJ L 226, 6.9.2000, p. 3.
(30) OJ L 262, 27.9.1976, p. 169.
(31) OJ L 311, 28.11.2001, p. 67.
(32) OJ L 311, 28.11.2001, p. 1.
(33) OJ L 189, 20.7.1990, p. 17.
(34) OJ L 169, 12.7.1993, p. 1.
(35) OJ L 331, 7.12.1998, p. 1.
(36) OJ L 105, 26.4.2003, p. 18.
(37) OJ L 184, 17.7.1999, p. 23.
(38) Regulation (EC) No 811/2003 on the intra-species recycling ban for fish, and the burial and burning of certain animal by-products (OJ L 117, 13.5.2003, p. 14); Decision 2003/322/EC on the feeding of certain necrophagous birds with certain Category 1 materials (OJ L 117, 13.5.2003, p. 32); Decision 2003/324/EC on a derogation from the intra-species recycling ban for fur animals (OJ L 117, 13.5.2003, p. 37); Regulation (EC) No 92/2005 on means of disposal or uses (OJ L 19, 21.1.2005, p. 27); Regulation (EC) No 181/2006 on organic fertilisers and soil improvers other than manure (OJ L 29, 2.2.2006, p. 31); Regulation (EC) No 1192/2006 on lists of approved plants (OJ L 215, 5.8.2006, p. 10); Regulation (EC) No 2007/2006 on the importation and transit of certain intermediate products derived from Category 3 material (OJ L 379, 28.12.2006, p. 98).
(39) OJ L 275, 25.8.2004, p. 17.
ANNEX
CORRELATION TABLE
Regulation (EC) No 1774/2002
This Regulation
Article 1
Articles 1 and 2
Article 2
Article 3
Article 3(1)
Article 4(1) and(2)
Article 3(2)
Article 41(3), fourth subparagraph
Article 3(3)
Article 4(3), (4) and (5)
Article 4(1)
Article 8
Article 4(2)
Articles 12, 15 and 16
Article 4(3)
Article 24(h), (i) and (j)
Article 4(4)
Article 41(2)(c), Article 43(3) and (5)(a)
Article 5(1)
Article 9
Article 5(2)
Articles 13, 15 and 16
Article 5(3)
Article 24(h), (i) and (j)
Article 5(4)
Article 41(2)(c) and Article 43(3)
Article 6(1)
Article 10
Article 6(2)
Articles 14, 15 and 16
Article 6(3)
Article 24(h), (i) and (j)
Article 7
Article 21
Article 8
Article 48
Article 9
Article 22
Articles 10 to 15, 17 and 18
Articles 23, 24, 27 and 44
Article 16
Article 6
Article 19
Article 31
Article 20(1)
Articles 35 and 36
Article 20(2)
Article 32
Article 20(3)
Article 36
Article 21
—
Article 22
Article 11
Article 23
Articles 17 and 18
Article 24
Article 19
Article 25
Articles 28 and 29
Article 26
Articles 45, 46 and 47
Article 27
Article 49
Article 28
Article 35(a)(ii) and Article 41(1)
Article 29
Articles 41 and 42
Article 30
Article 41(1)(b)
Article 31
Article 50(1)
Article 32
—
Article 33
Article 52
Article 34
—
Article 35
Article 15(2) and Article 51
Article 36
—
Article 37
Article 54
Article 38
Article 56
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Animal by-products not intended for human consumption
Animal by-products not intended for human consumption
SUMMARY OF:
Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption
WHAT IS THE AIM OF THE REGULATION?
It seeks to lay down public health and animal health rules for animal by-products* and derived products*.
These rules are designed to prevent and minimise risks to human and animal health, and to ensure the food and feed chain is kept safe.
KEY POINTS
The legislation applies to: animal by-products and derived products which, by law, may not be used for human consumption;animal-origin products which may be used for human consumption but are instead used for other purposes;raw materials to manufacture animal origin products not intended for human consumption.
Producers of animal by-products and derived products must ensure they comply with the legislation from the start to the end of the manufacturing chain.
They must keep a record of the products they dispatch, transport or receive, along with the required documentation.
They must inform national authorities of the products and premises they use during the manufacturing chain. The latter must meet certain hygiene standards and require formal approval.
EU countries operate official checks to ensure producers collect, identify and transport animal by-products without delay and treat, use or dispose of them according to the rules.
Derived products, such as cosmetics, medical devices and veterinary medicines, which comply with other pieces of EU legislation, may be offered for sale when they reach the end of the manufacturing chain.
Animal by-products are graded in 3 categories depending on the level of health risk they pose to the public or animals. These determine how they should be disposed of or recovered.
Restrictions exist on the use of animal by-products and derived products. For instance, they may not be used to feed animals or farmed fish of the same species.
Imports of both products must satisfy EU standards.
A ban exists on the export of both products for incineration or landfill, or to countries which are not members of the Organisation for Economic Co-operation and Development (OECD) for use in a biogas or composting plant.
Amendments to Regulation (EC) No 1069/2009
In 2013, the legislation was amended to give Mayotte, as a new outermost region of the EU, until 1 January 2021 to comply with its rules.
Some of the definitions used in the regulation (i.e. ‘transit’ and ‘competent authority’) are realigned with those used in Regulation (EU) 2017/625 (the ‘Official Controls Regulation’), which lays down the rules on checks carried out along the agri-food chain. Regulation (EU) 2017/625 also ensures that animal by-products and derived products, previously not covered by the EU’s official controls legislation, now fall within its scope.
Regulation (EU) 2019/1009 which lays down EU rules on fertilisers, amends Regulation (EC) No 1069/2009 to enable derived products no longer posing significant risks to animal health to move freely on the EU market as fertilising products.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 4 March 2011. The changes introduced by the amending Regulation (EU) 2019/1009 have applied since 15 July 2019.
BACKGROUND
For more information, see:
EU rules on animal by-products (ABPs) (European Commission).
KEY TERMS
Animal by-products: entire bodies or parts of animals which are not intended for human consumption.
Derived products: items obtained from processing of animal by-products.
MAIN DOCUMENT
Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, pp. 1-33)
The successive amendments to Regulation (EC) No 1069/2009 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, pp. 1-254)
See consolidated version.
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142)
See consolidated version.
last update 19.03.2020
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32009R0767
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1.9.2009
EN
Official Journal of the European Union
L 229/1
REGULATION (EC) No 767/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 July 2009
on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
The pursuit of a high level of protection of human and animal health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3). That Regulation also established the farm-to-fork approach designating feed as a sensitive stage at the beginning of the food chain. To ensure a high level of protection of public health is one of the fundamental objectives of this Regulation.
(2)
The production of feed is an important end for European agricultural products, given that most of the materials used for the production of feed are agricultural products listed in Annex I to the Treaty. Furthermore, feed is of crucial significance for the 5 million livestock farmers in the Community because it represents the greatest expense.
(3)
Feed may take the form of feed materials, compound feed, feed additives, premixtures or medicated feedingstuffs. The rules for the marketing of feed additives are set out in Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (4) and for medicated feedingstuffs in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (5).
(4)
The existing legislation on the circulation and use of feed materials and compound feed, which includes pet food, namely Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feedingstuffs (6), Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (7) (dietetic feed), Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials (8) and Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (9) (bio-proteins), needs to be updated and replaced by a single regulation. In the interests of clarity, Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition (10) and Commission Directive 80/511/EEC of 2 May 1980 authorising, in certain cases, the marketing of compound feedingstuffs in unsealed packages or containers (11) should be repealed.
(5)
As a consequence of the repeal of Directive 79/373/EEC by this Regulation, Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition (12) should also be repealed. Also, in view of the repeal of Directive 79/373/EEC, and given that this Regulation includes rules concerning the labelling of feed containing additives, Article 16 of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (13), which remained in force after the repeal of Directive 70/524/EEC by Regulation (EC) No 1831/2003, should be repealed.
(6)
Unlike food, as defined in Regulation (EC) No 178/2002, the definition of feed does not include water. Furthermore, given that water is not marketed for animal nutrition purposes, this Regulation should not include conditions for water used in animal nutrition. It should, however, apply to feed administered in water. The use of water by feed businesses is covered by Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (14), which stipulates that clean water should be used whenever necessary in order to prevent contamination that could prove hazardous and that water used in feed manufacture should be of suitable quality.
(7)
Given the risk of contamination of the feed and food chain, it is appropriate that this Regulation apply to feed for both food and non-food producing animals, including wild animals.
(8)
The responsibilities of the feed business operators laid down in Regulation (EC) No 178/2002 and Regulation (EC) No 183/2005 should apply, mutatis mutandis, in respect of feed for non-food producing animals.
(9)
In order to enforce compliance with this Regulation, Member States should carry out official controls in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (15). Those controls should include not only the mandatory but also the voluntary labelling particulars. In order to allow control of the compositional data, acceptable tolerances for the labelled values should be determined.
(10)
To manage feed safety risks, the list of materials whose placing on the market for animal nutrition purposes is prohibited, as currently provided for in Commission Decision 2004/217/EC (16), together with a list of materials whose placing on the market for animal nutrition purposes is restricted, should be included in an Annex to this Regulation. The existence of such an Annex should not, however, be interpreted to mean that all products not listed can, as such, be considered safe.
(11)
The distinction between feed materials, feed additives, and other products such as veterinary drugs has implications for the conditions for the placing of such products on the market. Feed materials are primarily used to meet animals’ needs, for example for energy, nutrients, minerals or dietary fibres. They are usually not chemically well-defined except for basic nutritional constituents. Effects which can be justified by scientific assessment and which are exclusive to feed additives or veterinary drugs should be excluded from the objective uses of feed materials. It is, therefore, appropriate to draw up non-binding guidelines for distinguishing between these kinds of products. In duly justified cases, the Commission should be empowered to clarify whether a product constitutes feed for the purposes of this Regulation.
(12)
The definition of complementary feedingstuffs in Directive 79/373/EEC gave rise to application problems in various Member States. It is appropriate to clarify the distinction between complementary feedingstuffs and premixtures for the purposes of applying Regulation (EC) No 183/2005.
(13)
In order to allow a uniform application of the legislation, feed materials and complementary feed should not contain additives above a certain level. However, highly concentrated feed, such as licking buckets containing minerals, may be used for direct feeding if the composition meets the particular nutritional purpose in respect of the relevant intended use. Conditions governing the use of such feed should appear on the labelling in order to ensure that the rules regarding the content of feed additives in the daily ration are complied with.
(14)
Directive 82/471/EEC aims to improve the supply of feed used as direct and indirect protein sources in the Community. That Directive requires a pre-market authorisation procedure for all possible bio-proteins. However, only very few new authorisations have been granted to date and the shortage of protein-rich feed is still evident. Thus, the general pre-market authorisation requirement has proved to be prohibitive, and safety risks could be tackled instead by means of prohibiting risky products based on market surveillance. In cases where the outcome of the risk assessment of a bio-protein is negative, its circulation or use should be prohibited. Hence, the special requirement of a general pre-market authorisation procedure for bio-proteins should be abolished, with the consequence that the safety system for such products be the same as for all other feed materials. The existing restrictions or prohibition of certain bio-proteins should not be affected.
(15)
The provisions of Directive 93/74/EEC implemented by Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (17) have proved to be working well. The list of intended uses thus established should, therefore, be maintained and provision should be made in this Regulation for its updating. In particular, the European Food Safety Authority should be consulted on the efficacy and the safety of such feed when, on the basis of available scientific and technological information, there are reasons to believe that the use of the feed in question may not meet the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment or animal welfare.
(16)
Scientific substantiation should be the main factor to be taken into account for the purpose of making claims in respect of feed, and feed business operators making such claims should be able to substantiate them. A claim may be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.
(17)
Labelling serves enforcement, traceability and control purposes. In addition, labelling should provide the necessary information to purchasers to enable them to make the optimal choice for their needs, and it should be consistent, coherent, transparent and understandable. As purchasers, in particular livestock farmers, make their choices not only at the point of sale where they can inspect the packaging of the feed, the requirements concerning information provided on the labelling must apply, not only to the labels which appear on the products, but also to other kinds of communication between the vendor and the purchaser. Furthermore, those principles should apply also to the presentation and the advertising of feed.
(18)
Mandatory and voluntary information is provided on labelling. The mandatory information should combine general labelling requirements and specific requirements for feed materials or compound feed respectively, and additional requirements in the case of dietetic feed, contaminated material and pet food.
(19)
The present situation with respect to chemical impurities resulting from the manufacturing process of feed materials and from processing aids is not satisfactory. In order to ensure a high level of feed safety, and thus a high level of protection of public health, and in order to improve transparency, provisions should be adopted laying down acceptable levels of such chemical impurities in accordance with good practice as referred to in Regulation (EC) No 183/2005.
(20)
The principle that only certain feed additives have to be labelled once they are used in feed materials and compound feed is working well. However, the categorisation resulting from Regulation (EC) No 1831/2003 needs to be updated and modernised, due also to the fact that pet owners, in particular, might be confused by some additive labelling.
(21)
As a consequence of the bovine spongiform encephalopathy (BSE) and the dioxin crises, the obligation to indicate the percentage by weight of all feed materials incorporated in compound feed was introduced in 2002 by Directive 2002/2/EC of the European Parliament and of the Council of 28 January 2002 amending Council Directive 79/373/EEC on the circulation of compound feedingstuffs (18), at the initiative of the European Parliament. Furthermore, the level of food and feed safety has been significantly improved as a result of Regulation (EC) No 178/2002 and Regulation (EC) No 183/2005 and their implementing measures, in particular as a result of the focus put on the responsibility placed on feed and food business operators, the improved traceability system, the introduction of the hazard analysis and critical control points (HACCP) principle in feed businesses and the creation of guides to good hygiene practice in feed businesses. In light of these positive achievements, mirrored in the notifications to the Rapid Alert System for Food and Feed (RASFF), the obligation to indicate the percentage by weight of all feed materials incorporated in compound feed on the labelling is no longer necessary for the purpose of ensuring a high level of feed safety and thus a high level of protection of public health. The exact percentages may, however, be provided on a voluntary basis for the purpose of providing adequate information to purchasers. Furthermore, given that the competent authorities have access to information on the exact percentages by weight of all feed materials incorporated in compound feed, they should be able, on the ground of any urgency relating to human or animal health or to the environment, and in accordance with Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (19), to provide further information to purchasers.
(22)
To ensure proper information for, and to avoid misleading, the purchaser, the exact percentage by weight should, however, be required in those cases where the feed material in question is emphasised on the labelling of a compound feed.
(23)
The indication of the feed materials incorporated in compound feed in descending order of weight already provides important information on compositional data. In certain areas where the producer is not obliged to label particulars, the purchaser should be able to request additional information. In such cases, a margin of +/– 15 % of the declared value should be maintained.
(24)
The intellectual property rights of producers should be protected. For the enforcement of such intellectual property rights, Directive 2004/48/EC should apply. It should also be acknowledged that the quantitative composition of compound feed, unlike the names of feed materials contained therein, can, under certain conditions, be considered confidential information to be protected.
(25)
Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (20) does not apply to the labelling of feed with excessive levels of undesirable substances. Provisions should therefore be laid down in order to ensure adequate labelling and proper implementation of the dilution ban provided for in Article 5 of that Directive, until such contaminated materials have been detoxified by a detoxification establishment, approved in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005, or until they have been cleaned.
(26)
Derogations from the general labelling requirements should be provided for in so far as the application of such requirements is not necessary to protect human or animal health or consumer interests and would unduly burden the producer or the feed business operators responsible for the labelling. On the basis of experience, such derogations should be provided for, in particular with respect to feed delivered by one farmer to another for use on his farm, for small quantities, for compound feed not containing more than three feed materials and for mixes of whole plant grains, seeds and fruits.
(27)
As a general rule, compound feed should be marketed in sealed containers, but appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent an excessive burden for the feed business operators.
(28)
Part B of the Annex to Directive 96/25/EC and columns 2 to 4 of the Annex to Directive 82/471/EEC contain lists of designations, descriptions and labelling provisions for certain feed materials. Those lists facilitate the exchange of information on the product properties between the producer and the purchaser. The experience of encouraging stakeholders to set voluntary standards by means of Community guidelines in the field of feed hygiene has been positive throughout. A more extensive listing could be achieved more flexibly, and could be better adapted to the information needs of the user, if undertaken by the stakeholders rather than by the legislator. The stakeholders can decide on the efforts they expend depending on the value of a list of feed materials. It is desirable, therefore, to establish a non-exhaustive Catalogue of feed materials to be used by feed business operators on a voluntary basis, except as regards use of the name of the feed material.
(29)
The current lists of feed materials contained in Part B of the Annex to Directive 96/25/EC and columns 2 to 4 of the Annex to Directive 82/471/EEC should constitute the initial version of the Community Catalogue of feed materials. This initial version should subsequently be supplemented at the initiative of the stakeholders in accordance with their interests, including by the addition of emerging feed materials.
(30)
In the interests of transparency, it is appropriate that the representatives of the stakeholders are notified of a feed material which is not listed in the catalogue as soon as such feed material is placed on the market for the first time.
(31)
Modern labelling facilitates a competitive market environment in which dynamic, efficient, innovative operators can make full use of labelling to sell their products. Having regard to both the business-to-business relationship in the marketing of livestock feed and the relationship between the producer and the purchaser of pet food, Codes of good labelling for these two areas could be a useful means of achieving the objectives of modern labelling. The Codes should lay down provisions that would enable the purchaser to make informed choices. They should also give the person responsible for the labelling important guidance on different elements of the labelling. They may assist in the interpretation of the framework for voluntary labelling or the presentation of mandatory labelling. The Codes should be used on a voluntary basis, except in cases where use of the Codes is indicated on the labelling.
(32)
Involvement of all parties concerned is the crucial element for ensuring the quality and appropriateness of the Catalogue and the Codes for good labelling. In order to strengthen the rights of users to proper information, their interests must be taken into consideration. This can be ensured by approval by the Commission of the Catalogue and the Codes, provided that the content thereof is practicable and that they are suitable for meeting the objectives of this Regulation.
(33)
The Member States should lay down penalties for infringement of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Such penalties should be effective, proportionate and dissuasive.
(34)
A transitional period is necessary, in particular in respect of feed which fulfils a particular nutritional purpose and in respect of the acceptable level of chemical impurities resulting from the manufacturing process and from processing aids. The marketing of existing stock should also be permitted until it is exhausted. Furthermore, it may be appropriate to specify conditions under which feed may be labelled in accordance with this Regulation prior to the date of its application.
(35)
Since the objective of this Regulation, namely harmonisation of the conditions for the placing on the market and the use of feed, in order to ensure a high level of feed safety and thus a high level of protection of public health as well as to provide adequate information for users and consumers and to strengthen the effective functioning of the internal market, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(36)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (21).
(37)
In particular, the Commission should be empowered to amend the list of materials restricted or prohibited for use as feed, to authorise feed intended for particular nutritional purposes, to establish a list of labelling categories of feed materials for non-food producing animals except fur animals, to adopt amendments to the Catalogue setting the maximum content of chemical impurities or levels of botanical purity or the levels of moisture content or particulars replacing the compulsory declaration, to adapt the Annexes in light of scientific and technological developments and to adopt transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(38)
On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the adoption of updates to the list of intended uses. When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited.
(39)
Article 16 of Regulation (EC) No 1831/2003 lays down provisions for the labelling and packaging of feed additives and premixtures. Implementation of the rules concerning premixtures has, in particular, caused practical problems for the industry and the competent authorities. In order to allow for a more consistent labelling of premixtures, that Article should be amended,
HAVE ADOPTED THIS REGULATION:
CHAPTER 1
INTRODUCTORY PROVISIONS
Article 1
Objective
The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to harmonise the conditions for the placing on the market and the use of feed, in order to ensure a high level of feed safety and thus a high level of protection of public health, as well as to provide adequate information for users and consumers and to strengthen the effective functioning of the internal market.
Article 2
Scope
1. This Regulation lays down rules on the placing on the market and use of feed for both food-producing and non-food producing animals within the Community, including requirements for labelling, packaging and presentation.
2. This Regulation shall apply without prejudice to other Community provisions applicable in the field of animal nutrition, in particular:
(a)
Directive 90/167/EEC;
(b)
Directive 2002/32/EC;
(c)
Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (22);
(d)
Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (23);
(e)
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (24);
(f)
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (25);
(g)
Regulation (EC) No 1831/2003; and
(h)
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (26).
3. This Regulation shall not apply to water, either taken in directly by the animals or intentionally incorporated into feed. It shall, however, apply to feed designed to be administered in water.
Article 3
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a)
the definitions of ‘feed’, ‘feed business’, and ‘placing on the market’ as laid down in Regulation (EC) No 178/2002;
(b)
the definitions of ‘feed additive’, ‘premixture’, ‘processing aids’ and ‘daily ration’ as laid down in Regulation (EC) No 1831/2003; and
(c)
the definitions of ‘establishment’ and ‘competent authority’ as laid down in Regulation (EC) No 183/2005.
2. The following definitions shall also apply:
(a)
‘feed-business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control;
(b)
‘oral feeding of animals’ means the introduction of feed into an animal’s gastrointestinal tract through the mouth with the aim of meeting the animal’s nutritional needs and/or maintaining the productivity of normally healthy animals;
(c)
‘food-producing animal’ means any animal that is fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption, but that belong to a species that is normally used for human consumption in the Community;
(d)
‘non-food producing animals’ means any animal that is fed, bred or kept but that is not used for human consumption, such as fur animals, pets and animals kept in laboratories, zoos or circuses;
(e)
‘fur animals’ means any non-food producing animal fed, bred or kept for the production of fur, and which is not used for human consumption;
(f)
‘pet’ or ‘pet animal’ means any non-food producing animal belonging to species fed, bred or kept, but not normally used for human consumption in the Community;
(g)
‘feed materials’ means products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures;
(h)
‘compound feed’ means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed;
(i)
‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration;
(j)
‘complementary feed’ means compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;
(k)
‘mineral feed’ means complementary feed containing at least 40 % crude ash;
(l)
‘milk replacer’ means compound feed administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a complement to, or substitute for, post-colostral milk or for feeding young animals such as calves, lambs or kids intended for slaughter;
(m)
‘carrier’ means a substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to facilitate its handling, application or use without altering its technological function and without exerting any technological effect itself;
(n)
‘particular nutritional purpose’ means the purpose of meeting the specific nutritional needs of animals whose process of assimilation, absorption or metabolism is, or could be, temporarily or irreversibly impaired and who can therefore benefit from the ingestion of feed appropriate to their condition;
(o)
‘feed intended for particular nutritional purposes’ means feed which can satisfy a particular nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs within the meaning of Directive 90/167/EEC;
(p)
‘contaminated materials’ means feed containing a level of undesirable substances in excess of that which is acceptable under Directive 2002/32/EC;
(q)
‘minimum storage life’ means the period during which, under proper storage conditions, the person responsible for the labelling guarantees that the feed retains its declared properties; only one minimum storage life may be indicated in respect of the feed as a whole, and it is determined on the basis of the minimum storage life of each of its components;
(r)
‘batch’ or ‘lot’ means an identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together;
(s)
‘labelling’ means the attribution of any words, particulars, trade marks, brand name, pictorial matter or symbol to a feed by placing this information on any medium referring to or accompanying such feed, such as packaging, container, notice, label, document, ring, collar or the Internet, including for advertising purposes;
(t)
‘label’ means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, impressed on, or attached to the packaging or the container of feed; and
(u)
‘presentation’ means the shape, appearance or packaging and the packaging materials used for the feed, further to the way in which it is arranged and the setting in which it is displayed.
CHAPTER 2
GENERAL REQUIREMENTS
Article 4
Safety and marketing requirements
1. Feed may only be placed on the market and used if:
(a)
it is safe; and
(b)
it does not have a direct adverse effect on the environment or animal welfare.
The requirements set out in Article 15 of Regulation (EC) No 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals.
2. In addition to the requirements set out in paragraph 1 of this Article, feed business operators placing feed on the market shall ensure that the feed:
(a)
is sound, genuine, unadulterated, fit for its purpose and of merchantable quality; and
(b)
is labelled, packaged and presented in accordance with the provisions laid down in this Regulation and other applicable Community legislation.
The requirements set out in Article 16 of Regulation (EC) No 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals.
3. Feed shall comply with the technical provisions on impurities and other chemical determinants set out in Annex I to this Regulation.
Article 5
Responsibilities and obligations of feed businesses
1. Feed business operators shall comply, mutatis mutandis, with obligations set out in Articles 18 and 20 of Regulation (EC) No 178/2002 and Article 4(1) of Regulation (EC) No 183/2005 in respect of feed for non-food producing animals.
2. The person responsible for the labelling of feed shall make available to the competent authorities any information concerning the composition or claimed properties of the feed placed on the market by that person, which allows the accuracy of the information given by the labelling to be verified, including the exact percentages by weight of feed materials used in compound feed.
3. In the event of any urgency relating to human or animal health or to the environment and without prejudice to the provisions of Directive 2004/48/EC, the competent authority may provide the purchaser with information that is available to it under paragraph 2 of this Article provided that, after having balanced the respective legitimate interests of the manufacturers and the purchasers, it concludes that the provision of such information is justified. If appropriate, the competent authority shall provide such information subject to the signing of a confidentiality clause by the purchaser.
Article 6
Restriction and prohibition
1. Feed shall not contain or consist of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited. The list of such materials is set out in Annex III.
2. The Commission shall amend the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited taking into account in particular scientific evidence, technological developments, notifications under the Rapid Alert System for Food and Feed (RASFF) or results of official controls pursuant to Regulation (EC) No 882/2004.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 28(5) with a view to adopting those measures.
CHAPTER 3
PLACING ON THE MARKET OF SPECIFIC TYPES OF FEED
Article 7
Characteristics of types of feed
1. In accordance with the regulatory procedure referred to in Article 28(3), the Commission may adopt guidelines clarifying the distinction between feed materials, feed additives and other products such as veterinary drugs.
2. The Commission may, where necessary, adopt measures in order to clarify whether a certain product constitutes feed for the purposes of this Regulation.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
Article 8
Content of feed additives
1. Without prejudice to the conditions of use provided for in the relevant legal act authorising the respective feed additive, feed materials and complementary feed shall not contain levels of feed additives that are higher than 100 times the relevant fixed maximum content in complete feed or five times in case of coccidiostats and histomonostats.
2. The level of 100 times the relevant fixed maximum content in complete feed referred to in paragraph 1 may only be exceeded if the composition of the products concerned fulfils the particular nutritional purpose in respect of the relevant intended use under Article 10 of this Regulation. The conditions of use for such feed shall be further specified in the list of intended uses. Establishments under the control of a producer of such feed who uses feed additives referred to in Chapter 2 of Annex IV to Regulation (EC) No 183/2005 must be approved in accordance with point 1(b) of Article 10 of that Regulation.
Article 9
Marketing of feed intended for particular nutritional purposes
Feed intended for particular nutritional purposes may only be marketed as such if its intended use is included in the list of intended uses established in accordance with Article 10 and if it meets the essential nutritional characteristics for the respective particular nutritional purpose set forth in that list.
Article 10
List of intended uses of feed intended for particular nutritional purposes
1. The Commission may update the list of intended uses set out in Directive 2008/38/EC by adding an intended use, withdrawing an intended use or by adding, removing or changing the conditions associated with a particular intended use.
2. The procedure for updating the list of intended uses may be started by the submission to the Commission of an application by a natural or legal person established in the Community or by a Member State. A valid application shall include a dossier demonstrating that the specific composition of the feed fulfils the particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment or animal welfare.
3. The Commission shall make the application, including the dossier, available to the Member States without delay.
4. If, on the basis of available scientific and technological information, the Commission, has reason to believe that the use of the specific feed may not fulfil the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment or animal welfare, the Commission shall, within three months of receipt of a valid application, seek an opinion from the European Food Safety Authority (hereinafter referred to as ‘the Authority’). The Authority shall give an opinion within six months of receipt of the request. This time limit shall be extended whenever the Authority seeks supplementary information from the applicant.
5. Within six months of receipt of a valid application or, where appropriate, after receiving the opinion of the Authority, the Commission shall adopt a Regulation updating the list of intended uses if the conditions laid down in paragraph 2 are met.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(6).
6. By way of derogation from paragraph 5, within six months after receiving a valid application or, where appropriate, after receiving the opinion of the Authority, the Commission shall end the procedure and decide not to proceed with the update, at any stage of the procedure, if it considers that such an update is not justified. The Commission shall do so in accordance with the regulatory procedure referred to in Article 28(3).
In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for failing to consider the update justified.
7. The Commission may, in accordance with the regulatory procedure referred to in Article 28(3), adopt implementing measures concerning the preparation and presentation of the application.
CHAPTER 4
LABELLING, PRESENTATION AND PACKAGING
Article 11
Principles for labelling and presentation
1. The labelling and the presentation of feed shall not mislead the user, in particular:
(a)
as to the intended use or characteristics of the feed, in particular, the nature, method of manufacture or production, properties, composition, quantity, durability, species or categories of animals for which it is intended;
(b)
by attributing to the feed effects or characteristics that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feeds possess such characteristics; or
(c)
as to the compliance of the labelling with the Community Catalogue and the Community Codes referred to in Articles 24 and 25.
2. Feed materials or compound feed marketed in bulk or in unsealed packages or containers in accordance with Article 23(2) shall be accompanied by a document containing all mandatory labelling particulars required under this Regulation.
3. Where feed is offered for sale by means of distance communication as defined in Article 2 of Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (27) the mandatory labelling particulars required by this Regulation, except for the particulars provided for in Articles 15(b), (d), (e), and 16(2)(c) or 17(1)(d), shall appear on the material supporting the distance selling or they shall be provided through other appropriate means prior to the conclusion of a distance contract. The particulars referred to in Articles 15(b), (d), (e), and 16(2)(c) or 17(1)(d) shall be provided at the latest at the time of delivery of the feed.
4. Labelling provisions additional to those set forth in this Chapter are laid down in Annex II.
5. Permitted tolerances for discrepancies between the labelled compositional values of a feed material or compound feed and the values analysed in official controls in compliance with Regulation (EC) No 882/2004 are listed in Annex IV to this Regulation.
Article 12
Responsibility
1. The person responsible for the labelling shall ensure the presence and substantive accuracy of the labelling particulars.
2. The person responsible for the labelling shall be the feed business operator who first places feed on the market or, where applicable, the feed business operator under whose name or business name the feed is marketed.
3. To the extent that their activities affect labelling within the business under their control, feed business operators shall ensure that the information provided through whatever medium satisfies the requirements of this Regulation.
4. Feed business operators responsible for retail or distribution activities which do not affect labelling shall act with due care to help ensure compliance with the labelling requirements, in particular by refraining from supplying feed which they know or should have presumed, on the basis of the information in their possession and as professionals, does not comply with those requirements.
5. Within the businesses under their control feed business operators shall ensure that mandatory labelling particulars are transmitted throughout the food chain in order to allow the information to be provided to the final feed user in accordance with this Regulation.
Article 13
Claims
1. The labelling and the presentation of feed materials and compound feed may draw particular attention to the presence or the absence of a substance in the feed, to a specific nutritional characteristic or process or to a specific function related to any of these, provided that the following conditions are met:
(a)
the claim is objective, verifiable by the competent authorities and understandable by the user of the feed; and
(b)
the person responsible for the labelling provides, at the request of the competent authority, scientific substantiation of the claim, either by reference to publicly available scientific evidence or through documented company research. The scientific substantiation shall be available at the time the feed is placed on the market. Purchasers shall have the right to bring to the attention of the competent authority their doubts in respect of the truthfulness of the claim. Where the conclusion is reached that the claim is not sufficiently substantiated, the labelling in respect of such claim shall be considered misleading for the purposes of Article 11. Where the competent authority has doubts regarding the scientific substantiation of the claim concerned, it may submit the issue to the Commission. The Commission may adopt a decision, where appropriate after obtaining an opinion from the Authority, in accordance with the advisory procedure laid down in Article 28(2).
2. Without prejudice to paragraph 1, claims concerning optimisation of the nutrition and support or protection of the physiological conditions are permitted, unless they contain a claim of the type referred to in paragraph 3(a).
3. The labelling or the presentation of feed materials and compound feed shall not claim that:
(a)
it will prevent, treat or cure a disease, except for coccidiostats and histomonostats as authorised under Regulation (EC) No 1831/2003; this point shall not, however, apply to claims concerning nutritional imbalances provided that there is no pathological symptom associated therewith;
(b)
it has a particular nutritional purpose, as provided for in the list of intended uses as referred to in Article 9, unless it satisfies the requirements laid down therein.
4. Specifications relating to the requirements laid down in paragraphs 1 and 2 may be included in the Community Codes referred to in Article 25.
Article 14
Presentation of labelling particulars
1. The mandatory labelling particulars shall be given in their entirety in a prominent place on the packaging, the container, on a label attached thereto or on the accompanying document provided for in Article 11(2), in a conspicuous, clearly legible and indelible manner, in the official language or at least one of the official languages of the Member State or region in which it is placed on the market.
2. The mandatory labelling particulars shall be easily identifiable and shall not be obscured by any other information. They shall be displayed in a colour, font and size that does not obscure or emphasise any part of the information, unless such variation is to draw attention to precautionary statements.
3. Specifications relating to the requirements laid down in paragraphs 1 and 2 and the presentation of the voluntary labelling referred to in Article 22 may be included in the Community Codes referred to in Article 25.
Article 15
General mandatory labelling requirements
A feed material or compound feed shall not be placed on the market unless the following particulars are indicated by labelling:
(a)
the type of feed: ‘feed material’, ‘complete feed’ or ‘complementary feed’, as appropriate;
—
for ‘complete feed’, the designation ‘complete milk replacer feed’ may be used, if appropriate,
—
for ‘complementary feed’, the following designations may be used if appropriate: ‘mineral feed’ or ‘complementary milk replacer feed’,
—
for pets other than cats and dogs, ‘complete feed’ or ‘complementary feed’ may be replaced by ‘compound feed’;
(b)
the name or business name and the address of the feed business operator responsible for the labelling;
(c)
if available, the establishment approval number of the person responsible for the labelling granted in accordance with Article 13 of Regulation (EC) No 1774/2002 for establishments authorised in accordance with Article 23(2)(a), (b) and (c) of Regulation (EC) No 1774/2002 or Article 17 of Regulation (EC) No 1774/2002 or with Article 10 of Regulation (EC) No 183/2005. If a person responsible for the labelling has several approval numbers he shall use the one granted in accordance with Regulation (EC) No 183/2005;
(d)
the batch or lot reference number;
(e)
the net quantity expressed in units of mass in the case of solid products, and in units of mass or volume in the case of liquid products;
(f)
the list of feed additives preceded by the heading ‘additives’ in accordance with Chapter I of Annex VI or VII, as applicable, and without prejudice to labelling provisions laid down in the legal act authorising the respective feed additive; and
(g)
the moisture content in accordance with point 6 of Annex I.
Article 16
Specific mandatory labelling requirements for feed materials
1. In addition to the requirements provided for in Article 15, the labelling of feed materials shall also include:
(a)
the name of the feed material; the name shall be used in compliance with Article 24(5); and
(b)
the compulsory declaration corresponding to the respective category as set out in the list in Annex V; the compulsory declaration may be replaced by the particulars laid down in the Community Catalogue referred to in Article 24 for each feed material in the respective category.
2. In addition to the requirements provided for in paragraph 1, the labelling of feed materials shall include the following when additives are incorporated:
(a)
the species or categories of animals for which the feed material is intended where the additives in question have not been authorised for all animal species or have been authorised with maximum limits for some species;
(b)
instructions for proper use in accordance with point 4 of Annex II, where a maximum content of the additives in question is set; and
(c)
the minimum storage life for additives other than technological additives.
Article 17
Specific mandatory labelling requirements for compound feed
1. In addition to the requirements provided for in Article 15, the labelling of compound feed shall also include the following:
(a)
the species or categories of animals for which the compound feed is intended;
(b)
the instructions for proper use indicating the purpose for which the feed is intended; such instructions shall, where applicable, be in accordance with point 4 of Annex II;
(c)
in cases where the producer is not the person responsible for the labelling, the following shall be provided:
—
the name or business name and address of the producer, or
—
the approval number of the producer as referred to in Article 15(c) or an identifying number in accordance with Articles 9, 23 or 24 of Regulation (EC) No 183/2005; if such number is not available, an identifying number allocated at the request of the producers or the importing feed business operator, which shall be in accordance with the format laid down in Chapter II of Annex V to Regulation (EC) No 183/2005;
(d)
the indication of the minimum storage life in accordance with the following requirements:
—
‘use before …’ followed by the date indicating a certain day in the case of feed highly perishable due to degradation processes,
—
‘best before …’ followed by the date indicating a certain month in the case of other feed.
If the date of manufacture is indicated on the label, the date indicating minimum storage life may be provided as well as ‘… (time period in days or months) after the date of manufacture’;
(e)
a list of the feed materials of which the feed is composed, bearing the heading ‘composition’ and indicating the name of each feed material in accordance with Article 16(1)(a), and listing those feed materials in descending order by weight calculated on the moisture content in the compound feed; that list may include the percentage by weight; and
(f)
the compulsory declarations provided for in Chapter II of Annex VI or VII, as applicable.
2. As regards the list provided for in paragraph 1(e), the following requirements shall apply:
(a)
the name and percentage by weight of a feed material shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics;
(b)
if the percentages by weight of the feed materials contained in compound feed for food-producing animals are not indicated on the labelling, the person responsible for the labelling shall, without prejudice to Directive 2004/48/EC, make available to the purchaser, on request, information on the quantitative composition data within a range of +/– 15 % of the value according to the feed formulation; and
(c)
in the case of compound feed intended for non-food producing animals except fur animals, the indication of the specific name of the feed material may be replaced by the name of the category to which the feed materials belong.
3. In the event of any urgency relating to human or animal health or to the environment, and without prejudice to Directive 2004/48/EC, the competent authority may provide the purchaser with information that is available to it under Article 5(2), provided that, after having balanced the respective legitimate interests of the manufacturers and the purchasers, it concludes that the provision of such information is justified. If appropriate, the competent authority shall provide such information subject to the signing of a confidentiality clause by the purchaser.
4. For the purposes of paragraph 2(c), the Commission shall establish a list of categories of feed materials which may be indicated instead of individual feed materials on the labelling of feed for non-food producing animals except fur animals.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
Article 18
Additional mandatory labelling requirements for feed intended for particular nutritional purposes
In addition to the general mandatory requirements laid down in Articles 15, 16 and 17, as applicable, the labelling of feed intended for particular nutritional purposes shall also include:
(a)
the qualifying expression ‘dietetic’, in the case, exclusively, of feed intended for particular nutritional purposes, next to the designation of the feed as laid down in Article 15(a);
(b)
the particulars prescribed for the respective intended use in columns 1 to 6 of the list of intended uses referred to in Article 9; and
(c)
an indication that the opinion of a nutrition expert or veterinarian should be sought before using the feed or before extending its period of use.
Article 19
Additional mandatory labelling requirements for pet food
On the label of pet food a free telephone number or other appropriate means of communication shall be indicated in order to allow the purchaser to obtain information in addition to the mandatory particulars on:
(a)
the feed additives contained in the pet food; and
(b)
the feed materials contained therein that are designated by category as referred to in Article 17(2)(c).
Article 20
Additional mandatory labelling requirements for non-compliant feed
1. In addition to the requirements laid down in Articles 15, 16, 17 and 18, feed which does not comply with the requirements under Community law set out in Annex VIII, such as contaminated materials, shall bear the labelling particulars laid down in that Annex.
2. The Commission may amend Annex VIII in order to bring it into line with legislative progress towards the development of standards.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
Article 21
Derogations
1. The particulars referred to in Article 15(c), (d), (e), and (g) and Article 16(1)(b) shall not be required where, before each transaction, the purchaser has stated in writing that he does not require this information. A transaction may consist of several consignments.
2. On packaged feed the particulars referred to in Article 15(c), (d) and (e) and Article 16(2)(c) or Article 17(1)(c), (d), and (e) may be given on the packaging outside the place of the label as referred to in Article 14(1). In such cases it shall be pointed out where these particulars appear.
3. Without prejudice to Annex I to Regulation (EC) No 183/2005, the particulars referred to in Article 15(c), (d), (e) and (g) and Article 16(1)(b) of this Regulation shall not be mandatory for feed materials that do not contain feed additives, with the exception of preservatives or silage additives, and which are produced and delivered by a feed business operator in accordance with Article 5(1) of Regulation (EC) No 183/2005 to a feed user involved in primary production for use within his own holding.
4. The compulsory declarations referred to in Article 17(1)(f) shall not be required for mixes of whole plant grains, seeds and fruit.
5. In the case of compound feed constituted from no more than three feed materials the particulars referred to in Article 17(1)(a) and (b) shall not be required where the feed materials used are clearly indicated in the description.
6. For quantities not exceeding 20 kg of feed materials or compound feed intended for the final user and sold in bulk, the particulars referred to in Articles 15, 16 and 17 may be brought to the purchaser’s attention by means of an appropriate notice at the point of sale. In such cases, the particulars referred to in Article 15(a) and Article 16(1) or Article 17(1)(a) and (b), as appropriate, shall be provided for the purchaser at the latest on or with the invoice.
7. For quantities of pet food sold in packages with several containers, the particulars referred to in Article 15(b), (c), (f) and (g) and Article 17(1)(b), (c), (e) and (f) may be given only on the outer packaging instead of on each container, provided that the combined total weight of the package does not exceed 10 kg.
8. By way of derogation from the provisions of this Regulation, Member States may apply national provisions for feed intended for animals kept for scientific or experimental purposes on condition that such purpose is clearly indicated on the label. The Member States shall notify those provisions to the Commission without delay.
Article 22
Voluntary labelling
1. In addition to the mandatory labelling requirements, the labelling of feed materials and compound feed may also include voluntary labelling particulars, provided that the general principles laid down in this Regulation are complied with.
2. Further conditions for voluntary labelling may be provided in the Community Codes referred to in Article 25.
Article 23
Packaging
1. Feed materials and compound feed may be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.
2. By way of derogation from paragraph 1, the following feed may be placed on the market in bulk or in unsealed packages or containers:
(a)
feed materials;
(b)
compound feed obtained exclusively by mixing grain or whole fruit;
(c)
deliveries between producers of compound feed;
(d)
deliveries of compound feed directly from the producer to the feed user;
(e)
deliveries from producers of compound feed to packaging firms;
(f)
quantities of compound feed not exceeding 50 kilograms in weight which are intended for the final user and are taken directly from a sealed package or container; and
(g)
blocks or licks.
CHAPTER 5
COMMUNITY CATALOGUE OF FEED MATERIALS AND COMMUNITY CODES OF GOOD LABELLING PRACTICE
Article 24
Community Catalogue of feed materials
1. The Community Catalogue of feed materials (hereinafter ‘the Catalogue’) shall be created as a tool to improve the labelling of feed materials and compound feed. The Catalogue shall facilitate the exchange of information on the product properties and list feed materials in a non-exhaustive manner. It shall include for each feed material listed at least the following particulars:
(a)
the name;
(b)
the identification number;
(c)
a description of the feed material including information on the manufacturing process, if appropriate;
(d)
particulars replacing the compulsory declaration for the purpose of Article 16(1)(b); and
(e)
a glossary with the definition of the different processes and technical expressions mentioned.
2. The first version of the Community Catalogue shall be adopted in accordance with the advisory procedure referred to in Article 28(2) by 21 March 2010 at the latest and its entries shall consist of those listed in Part B of the Annex to Directive 96/25/EC and columns 2 to 4 of the Annex to Directive 82/471/EEC. Point IV of Part A of the Annex to Directive 96/25/EC shall constitute the glossary.
3. The procedure laid down in Article 26 shall apply to amendments to the Catalogue.
4. This Article applies without prejudice to the safety requirements laid down in Article 4.
5. Use of the Catalogue by the feed business operators shall be voluntary. However, the name of a feed material listed in the Catalogue may be used only on condition that all relevant provisions of the Catalogue are complied with.
6. The person who, for the first time, places on the market a feed material that is not listed in the Catalogue shall immediately notify its use to the representatives of the European feed business sectors referred to in Article 26(1). The representatives of the European feed business sectors shall publish a register of such notifications on the Internet and update the register on a regular basis.
Article 25
Community Codes of good labelling practice
1. The Commission shall encourage the development of two Community Codes of good labelling practice (hereinafter ‘the Codes’), one for pet food and one for compound feed for food producing animals, which may include a section concerning compound feed for fur animals.
2. The Codes shall aim to improve the appropriateness of the labelling. They shall, in particular, include provisions on the presentation of labelling particulars provided for in Article 14, on the voluntary labelling provided for in Article 22 and on the use of claims provided for in Article 13.
3. The procedure laid down in Article 26 shall apply for the establishment of the Codes and for any amendment thereto.
4. Use of the Codes by the feed business operators shall be voluntary. However, use of any of the Codes may be indicated on the labelling only on condition that all relevant provisions of such Code are complied with.
Article 26
Establishment of the Codes and amendments to the Community Catalogue and the Community Codes
1. The draft amendments to the Community Catalogue and drafts of the Codes as well as any draft amendments thereof shall be developed and amended by all appropriate representatives of European feed business sectors:
(a)
in consultation with other concerned parties, such as feed users;
(b)
in collaboration with the competent authorities of the Member States and, where appropriate, the Authority;
(c)
taking into account relevant experience from opinions issued by the Authority and scientific or technological developments.
2. Without prejudice to paragraph 3, the Commission shall approve measures for the purposes of this Article in accordance with the advisory procedure referred to in Article 28(2).
3. Amendments to the Community Catalogue setting the maximum content of chemical impurities as referred to in point 1 of Annex I or levels of botanical purity as referred to in point 2 of Annex I or levels of moisture content as referred to in point 6 of Annex I or particulars replacing the compulsory declaration as referred to in Article 16(1)(b), shall be adopted. Such measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
4. Measures under this Article shall be adopted only on condition that the following conditions are met:
(a)
they have been developed in accordance with paragraph 1;
(b)
their content is capable of being applied throughout the Community in the sectors to which they refer; and
(c)
they are suitable for meeting the objectives of this Regulation.
5. The Catalogue shall be published in the L Series of the Official Journal of the European Union. The title and the references of the Codes shall be published in the C Series of the Official Journal of the European Union.
CHAPTER 6
GENERAL AND FINAL PROVISIONS
Article 27
Implementing measures
1. The Commission may amend the Annexes in order to adapt them in light of scientific and technological developments.
Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
2. Other implementing measures necessary for the application of this Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 28(3), unless specifically provided otherwise.
Article 28
Committee procedure
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002 (hereinafter referred to as ‘the Committee’).
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
6. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.
Article 29
Amendment to Regulation (EC) No 1831/2003
Article 16 of Regulation (EC) No 1831/2003 shall be amended as follows:
1.
paragraph 1 is amended as follows:
(a)
point (d) is replaced by the following:
‘(d)
where appropriate, the approval number of the establishment manufacturing or placing on the market the feed additive or the premixture pursuant to Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (28) or, as applicable, to Article 5 of Directive 95/69/EC;
(b)
the following subparagraph is added at the end of paragraph 1:
‘In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives.’;
2.
paragraph 3 is replaced by the following:
‘3. In addition to the information specified in paragraph 1, the packaging or container of a feed additive belonging to a functional group specified in Annex III or of a premixture containing an additive belonging to a functional group specified in Annex III shall bear the information, presented in a conspicuous, clearly legible and indelible manner, indicated in that Annex.’;
3.
paragraph 4 is replaced by the following:
‘4. In the case of premixtures, the word “premixture” shall appear on the label. Carriers shall be declared, in the case of feed materials, in compliance with Article 17(1)(e) of Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (29), and, where water is used as a carrier, the moisture content of the premixture shall be declared. Only one minimum storage life may be indicated in respect of each premixture as a whole; such minimum storage life shall be determined on the basis of the minimum storage life of each of its components.
Article 30
Repeal
Article 16 of Directive 70/524/EEC and Directives 79/373/EEC, 80/511/EEC, 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC, and Decision 2004/217/EC are repealed with effect from 1 September 2010.
References to the repealed Directives and to the repealed Decision shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IX.
Article 31
Penalties
Member States shall lay down penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
Member States shall notify such provisions to the Commission by 1 September 2010 at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 32
Transitional measures
1. By way of derogation from the second subparagraph of Article 33, feed placed on the market or labelled in accordance with Directives 79/373/EEC, 82/471/EEC, 93/74/EEC and 96/25/EC before 1 September 2010 may be placed or remain on the market until stocks are exhausted.
2. By way of derogation from Article 8(2), types of feed referred to in that Article that have already been legally placed on the market before 1 September 2010 may be placed or remain on the market until a decision on the application for updating the list of intended uses as referred to in Article 10 has been taken, provided that such application has been submitted before 1 September 2010.
3. By way of derogation from point 1 of Annex I to this Regulation, feed materials may be placed on the market and used until the specific maximum content of chemical impurities resulting from their manufacturing process and from processing aids is fixed, provided that they comply at least with the conditions set out in point 1 of Part A, Title II of the Annex to Directive 96/25/EC. This derogation shall cease to apply, however, on 1 September 2012.
4. Measures may be adopted in order to facilitate transition to the application of this Regulation. In particular, conditions may be specified under which feed may be labelled in accordance with this Regulation prior to the date of its application. Such measures, designed to amend the non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
Article 33
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 September 2010.
However, Articles 31 and 32 shall apply from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 July 2009.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
E. ERLANDSSON
(1) OJ C 77, 31.3.2009, p. 84.
(2) Opinion of the European Parliament of 5 February 2009 (not yet published in the Official Journal) and Council Decision of 22 June 2009.
(3) OJ L 31, 1.2.2002, p. 1.
(4) OJ L 268, 18.10.2003, p. 29.
(5) OJ L 92, 7.4.1990, p. 42.
(6) OJ L 86, 6.4.1979, p. 30.
(7) OJ L 237, 22.9.1993, p. 23.
(8) OJ L 125, 23.5.1996, p. 35.
(9) OJ L 213, 21.7.1982, p. 8.
(10) OJ L 126, 13.5.1983, p. 23.
(11) OJ L 126, 21.5.1980, p. 14.
(12) OJ L 334, 31.12.1993, p. 17.
(13) OJ L 270, 14.12.1970, p. 1.
(14) OJ L 35, 8.2.2005, p. 1.
(15) OJ L 165, 30.4.2004, p. 1.
(16) OJ L 67, 5.3.2004, p. 31.
(17) OJ L 62, 6.3.2008, p. 9.
(18) OJ L 63, 6.3.2002, p. 23.
(19) OJ L 157, 30.4.2004, p. 45.
(20) OJ L 140, 30.5.2002, p. 10.
(21) OJ L 184, 17.7.1999, p. 23.
(22) OJ L 147, 31.5.2001, p. 1.
(23) OJ L 273, 10.10.2002, p. 1.
(24) OJ L 268, 18.10.2003, p. 1.
(25) OJ L 268, 18.10.2003, p. 24.
(26) OJ L 189, 20.7.2007, p. 1.
(27) OJ L 144, 4.6.1997, p. 19.
(28) OJ L 35, 8.2.2005, p. 1.’;
(29) OJ L 229, 1.9.2009, p. 1.’.
ANNEX I
Technical provisions on impurities, milk replacer, feed materials for binding or denaturising, the ash level and moisture content as referred to in Article 4
1.
In accordance with good practice as referred to in Article 4 of Regulation (EC) No 183/2005, feed materials shall be free from chemical impurities resulting from their manufacturing process and from processing aids, unless a specific maximum content is fixed in the Catalogue referred to in Article 24.
2.
The botanical purity of feed materials shall not be less than 95 %, unless a different level has been laid down in the Catalogue referred to in Article 24. Botanical impurities comprise impurities of plant materials which do not have adverse effects on the animals e.g. straw and seeds of other cultivated species or weeds. Botanical impurities such as residues of other oil seeds or oil fruits derived from a previous manufacturing process, shall not exceed 0,5 % for each type of oil seed or fruit.
3.
The iron level in milk replacer feed for calves of a live weight less than or equal to 70 kilograms shall be at least 30 milligrams per kilogram of the complete feed at a moisture content of 12 %.
4.
Where feed materials are used to denature or bind other feed materials, the product may still be considered to be a feed material. Name, nature and quantity of the feed material used to bind or denature shall be labelled. If a feed material is bound by another feed material the percentage of the latter shall not exceed 3 % of the total weight.
5.
The level of ash insoluble in hydrochloric acid shall not exceed 2,2 % of the dry matter. The 2,2 % level may, however, be exceeded for:
—
feed materials,
—
compound feed containing authorised mineral binding agents,
—
mineral feed,
—
compound feed containing more than 50 % of rice or sugar beet by-products,
—
compound feed intended for farmed fish with a fish meal content of over 15 %,
provided that the level is declared on the label.
6.
Provided that no other level is laid down in Annex V or the Catalogue referred to in Article 24 the moisture content of the feed must be stated if it exceeds:
—
5 % in the case of mineral feed containing no organic substances,
—
7 % in the case of milk replacer feeds and other compound feed with a milk-product content exceeding 40 %,
—
10 % in the case of mineral feed containing organic substances,
—
14 % in the case of other feed.
ANNEX II
General provisions on labelling as referred to in Article 11(4)
1.
Contents or levels indicated or to be declared relate to the weight of the feed, unless otherwise stated.
2.
The numeric indication of dates shall follow the order of day, month and year and the format shall be indicated on the label by means of the following abbreviation: ‘DD/MM/YY’.
3.
Synonymic expressions in certain languages;
(a)
in Czech the designation ‘krmiva’ may be replaced by ‘produkty ke krmení’ as applicable; in German the designation ‘Einzelfuttermittel’ may be replaced by ‘Futtermittel-Ausgangserzeugnis’; in Greek ‘πρώτη ύλη ζωοτροφών’ may be replaced by ‘απλή ζωοτροφή’; in Italian ‘materia prima per mangimi’ may be replaced by ‘mangime semplice’;
(b)
in the designation of feed for pets the following expressions shall be allowed: in Bulgarian ‘храна’; in Spanish ‘alimento’; in Czech the designation ‘kompletní krmná směs’ may be replaced by ‘kompletní krmivo’ and ‘doplňková krmná směs’ may be replaced by ‘doplňkové krmivo’; in English ‘pet food’; in Italian ‘alimento’; in Hungarian ‘állateledel’; in Dutch ‘samengesteld voeder’; in Polish ‘karma’; in Slovenian ‘hrana za hišne živali’; in Finnish ‘lemmikkieläinten ruoka’.
4.
The instructions for proper use of complementary feed and feed materials containing additives in excess of the maximum levels fixed for complete feed shall state the maximum quantity:
—
in grams or kilograms or units of volume of complementary feed and feed materials per animal per day, or
—
percentage of the daily ration, or
—
per kilo of complete feed or percentage in complete feed,
in order to ensure that the respective maximum contents of feed additives in the daily ration are complied with.
5.
Without affecting the analytical methods, for pet food the expression ‘crude protein’ may be replaced by ‘protein’, ‘crude oils and fats’ may be replaced by ‘fat content’ and ‘crude ash’ may be replaced by ‘incinerated residue’ or ‘inorganic matter’.
ANNEX III
List of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited as referred to in Article 6
Chapter 1: Prohibited materials
1.
Faeces, urine and separated digestive tract content resulting from the emptying or removal of digestive tract, irrespective of any form of treatment or admixture.
2.
Hide treated with tanning substances, including its waste.
3.
Seeds and other plant-propagating materials which, after harvest, have undergone specific treatment with plant-protection products for their intended use (propagation), and any by-products derived therefrom.
4.
Wood, including sawdust or other materials derived from wood, which has been treated with wood preservatives as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1).
5.
All waste obtained from the various phases of the urban, domestic and industrial waste water as defined in Article 2 of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (2), irrespective of any further processing of such waste and irrespective also of the origin of the water.
6.
Solid urban waste, such as household waste.
7.
Packaging from the use of products from the agri-food industry, and parts thereof.
Chapter 2: Restricted materials
(1) OJ L 123, 24.4.1998, p. 1.
(2) OJ L 135, 30.5.1991, p. 40.
ANNEX IV
Permitted tolerances for the compositional labelling of feed materials or compound feed as referred to in Article 11(5)
1.
The tolerances laid down in this Annex include technical and analytical deviations. Once analytical tolerances covering measurement uncertainties and procedural variations are fixed at Community level, the values set out in paragraph 2 should be adapted accordingly in order to cover only the technical tolerances.
2.
Where the composition of a feed material or compound feed is found to depart from the labelled composition in a manner such as to reduce its value, the following tolerances are permitted:
(a)
for crude protein, sugars, starch and inulin:
—
3 units for declared contents of 30 % or more,
—
10 % of the declared content for declared contents of less than 30 % but not less than 10 %,
—
1 unit for declared contents of less than 10 %;
(b)
for crude fibre, crude oil and fats:
—
2,2 units for declared contents of 15 % or more,
—
15 % of the declared content for declared contents of less than 15 % but not less than 5 %,
—
0,8 units for declared contents of less than 5 %;
(c)
for moisture, crude ash, ash insoluble in hydrochloric acid and chlorides expressed as NaCl, total phosphorus, sodium, calcium carbonate, calcium, magnesium, acid index and matter insoluble in light petroleum:
—
1,5 units for declared contents (values) of 15 % (15) or more, as appropriate,
—
10 % of the declared content (value) for declared contents (values) of less than 15 % (15), but not less than 2 % (2), as appropriate,
—
0,2 units for declared contents (values) of less than 2 % (2), as appropriate;
(d)
for the energy value 5 % and for the protein value 10 %;
(e)
for feed additives (1);
—
10 % if the declared content is 1 000 units or more,
—
100 units for declared contents of less than 1 000 units but not less than 500 units,
—
20 % of the declared content of less than 500 units but not less than 1 unit,
—
0,2 units for declared contents of less than 1 unit but not less than 0,5 units,
—
40 % of the declared content of less than 0,5 units.
These tolerances shall apply also to the maximum levels of feed additives in compound feed.
3.
As long as the fixed maximum level for each feed additive is not exceeded, the variation from the declared content may be up to three times the relevant tolerance laid down in paragraph 2.
4.
For feed additives belonging to the group of micro-organisms the acceptable upper limit shall correspond to the fixed maximum level.
(1) 1 unit in this paragraph means 1 mg, 1 000 IU, 1 × 109 CFU or 100 enzyme activity units of the respective feed additive.
ANNEX V
Compulsory declaration for feed materials as referred to in Article 16(1)(b)
Feed material consisting of
Compulsory declaration of
1.
Forages and roughage
Crude protein, if > 10 %
Crude fibre
2.
Cereal grains
3.
Products and by-products of cereal grains
Starch, if > 20 %
Crude protein, if > 10 %
Crude oils and fats, if > 5 %
Crude fibre
4.
Oil seeds, oil fruits
5.
Products and by-products of oil seeds, oil fruits
Crude protein, if > 10 %
Crude oils and fats, if > 5 %
Crude fibre
6.
Legume seeds
7.
Products and by-products of legume seeds
Crude protein, if > 10 %
Crude fibre
8.
Tubers, roots
9.
Products and by-products of tubers and roots
Starch
Crude fibre
Ash insoluble in HCl, if > 3,5 % of dry matter
10.
Products and by-products of the sugar beet processing industry
Crude fibre, if > 15 %
Total sugar, calculated as sucrose
Ash insoluble in HCl, if > 3,5 % of dry matter
11.
Products and by-products of the sugar cane processing industry
Crude fibre, if > 15 %
Total sugar calculated as sucrose
12.
Other seeds and fruits, their products and by-products, except those mentioned in 2-7
Crude protein
Crude fibre
Crude oils and fats, if > 10 %
13.
Other plants, their products and by-products, except those mentioned in 8-11
Crude protein, if > 10 %
Crude fibre
14.
Milk products and by-products
Crude protein
Moisture, if > 5 %
Lactose, if > 10 %
15.
Land animal products and by-products
Crude protein, if > 10 %
Crude oils and fats, if > 5 %
Moisture, if > 8 %
16.
Fish, other marine animals, their products and by-products
Crude protein, if > 10 %
Crude oils and fats, if > 5 %
Moisture, if > 8 %
17.
Minerals
Calcium
Sodium
Phosphorus
Other relevant minerals
18.
Miscellaneous
Crude protein, if > 10 %
Crude fibre
Crude oils and fats, if > 10 %
Starch, if > 30 %
Total sugar, as sucrose, if > 10 %
Ash insoluble in HCl, if > 3,5 % of dry matter
ANNEX VI
Labelling particulars for feed materials and compound feed for food-producing animals
Chapter I: Labelling of feed additives as referred to in Articles 15(f) and 22(1)
1.
The following additives shall be listed with their specific names as defined in the relevant legal act authorising the feed additive in question, added amount, identification number and name of the functional group as laid down in Annex I to Regulation (EC) No 1831/2003 or the category referred to in Article 6(1) of that Regulation:
(a)
additives where a maximum content is set for any kind of target species;
(b)
additives belonging to the categories ‘zootechnical additives’ and ‘coccidiostats and histomonostats’;
(c)
additives belonging to the functional group of ‘urea and its derivatives’ of the category ‘nutritional additives’ as laid down in Annex I to Regulation (EC) No 1831/2003.
2.
The name as laid down in the relevant legal act authorising the feed additive in question and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics.
3.
The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser at his request.
4.
Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form laid down in paragraph 1 or partially.
5.
If a sensory or nutritional feed additive as referred to in Annex I to Regulation (EC) No 1831/2003 is labelled on a voluntary basis, its added amount shall be indicated.
6.
If an additive belongs to more than one of the functional groups, the functional group or category appropriate to its principal function in the case of the feed in question shall be indicated.
Chapter II: Labelling of analytical constituents as referred to in Articles 17(1)(f) and 22(1)
1.
The analytical constituents of compound feed for food producing animals shall be labelled as follows:
Feed
Analytical constituents and levels
Target species
Complete feed
—
Crude protein
All species
—
Crude fibre
All species
—
Crude oils and fats
All species
—
Crude ash
All species
—
Lysine
Pigs and poultry
—
Methionine
Pigs and poultry
—
Calcium
All species
—
Sodium
All species
—
Phosphorus
All species
Complementary feed — Mineral
—
Lysine
Pigs and poultry
—
Methionine
Pigs and poultry
—
Calcium
All species
—
Sodium
All species
—
Phosphorus
All species
—
Magnesium
Ruminants
Complementary feed — Other
—
Crude protein
All species
—
Crude fibre
All species
—
Crude oils and fats
All species
—
Crude ash
All species
—
Lysine
Pigs and poultry
—
Methionine
Pigs and poultry
—
Calcium ≥ 5 %
All species
—
Sodium
All species
—
Phosphorus ≥ 2 %
All species
—
Magnesium ≥ 0,5 %
Ruminants
2.
If amino acids, vitamins and/or trace elements are indicated under the heading of analytical constituents, they shall be declared, along with the total amount thereof.
3.
If the energy value and/or protein value are indicated, such indication shall be in accordance with the EC method, if available or with the respective official national method in the Member State where the feed is placed on the market, if available.
ANNEX VII
Labelling particulars for feed materials and compound feed for non-food producing animals
Chapter I: Labelling of feed additives as referred to in Articles 15(f) and 22(1)
1.
The following additives shall be listed, along with their specific names as defined in the relevant legal act authorising the feed additive in question and/or its identification number, added amount and the name of the functional group as laid down in Annex I to Regulation (EC) No 1831/2003 or the category referred to in Article 6(1) of that Regulation:
(a)
additives where a maximum content is set for any kind of target species;
(b)
additives belonging to the categories ‘zootechnical additives’ and ‘coccidiostats and histomonostats’;
(c)
additives belonging to the functional group of ‘urea and its derivatives’ of the category ‘nutritional additives’ as laid down in Annex I to Regulation (EC) No 1831/2003.
2.
By way of derogation from paragraph 1, for additives of the functional groups ‘preservatives’, ‘antioxidants’ and ‘colourants’ as laid down in Annex I to Regulation (EC) No 1831/2003, only the functional group in question need be indicated.
In this case the information pursuant to paragraph 1 shall be disclosed by the person responsible for the labelling to the purchaser at his request.
3.
The name as laid down in the relevant legal act authorising the feed additive in question and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics.
4.
The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser at his request.
5.
Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form laid down in paragraph 1 or partially.
6.
If a sensory or nutritional feed additive as referred to in Annex I to Regulation (EC) No 1831/2003 is labelled on a voluntary basis, its added amount shall be indicated.
7.
If an additive belongs to more than one of the functional groups, the functional group or category appropriate to its principal function in the case of the feed in question shall be indicated.
8.
The person responsible for the labelling shall make available to the competent authorities any information concerning the composition or claimed properties of the feed placed on the market by such person which enables the accuracy of the information given on the labelling to be verified, including complete information on all additives used.
Chapter II: Labelling of analytical constituents as referred to in Articles 17(1)(f) and 22(1)
1.
The analytical constituents of compound feed for non-food producing animals shall be labelled as follows:
Feed
Analytical constituents
Target species
Complete feed
—
Crude protein
Cats, dogs and fur animals
—
Crude fibres
Cats, dogs and fur animals
—
Crude oils and fats
Cats, dogs and fur animals
—
Crude ash
Cats, dogs and fur animals
Complementary feed — Mineral
—
Calcium
All species
—
Sodium
All species
—
Phosphorus
All species
Complementary feed — Other
—
Crude protein
Cats, dogs and fur animals
—
Crude fibres
Cats, dogs and fur animals
—
Crude oils and fats
Cats, dogs and fur animals
—
Crude ash
Cats, dogs and fur animals
2.
If amino acids, vitamins and/or trace elements are indicated under the heading of analytical constituents, they shall be declared, along with the total amount thereof.
3.
If the energy value and/or protein value are indicated, such indication shall be in accordance with the EC method, if available, or with the respective official national method in the Member State where the feed is placed on the market, if available.
ANNEX VIII
Specific provisions for the labelling of feed which does not comply with safety and marketing requirements under Community law as referred to in Article 20(1)
1.
Contaminated materials shall be labelled as ‘feed with excessive level(s) of … (designation of the undesirable substance(s) in accordance with Annex I to Directive 2002/32/EC), only to be used as feed after detoxification in authorised establishments’. The authorisation of such establishments shall be in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005.
2.
Where the contamination is intended to be reduced or eliminated by cleaning, the labelling of contaminated materials shall contain the following addition: ‘feed with excessive level(s) of … (designation of the undesirable substance(s) in accordance with Annex I to Directive 2002/32/EC), only to be used as feed after adequate cleaning’.
ANNEX IX
CORRELATION TABLE
Directive 79/373/EEC
Directive 96/25/EC
Other acts: Directives 80/511/EEC (1), 82/471/EEC (2), 93/74/EEC (3), 93/113 EC (4), or Decision 2004/217/EC (5)
This Regulation
—
—
—
Article 1
Article 1
Article 1
(2), (4): Article 1
(3): Article 4
Article 2
Article 2
Article 2
(2), (3): Article 2
Article 3
—
—
—
Article 4(1)
Article 3
Article 3
(3): Article 1(2)
Article 4(2)
Article 4
Article 4(3)
—
—
—
Article 5(1)
Article 12
(3): Article 10(2)
Article 5(2)
Article 10a(3)
Article 11(b)
(2): Article 8
Article 6
—
—
—
Article 7
—
—
—
Article 8
(3): Article 3
Article 9
(3): Article 6
Article 10
Article 5e
Article 11(1)
Article 5(2)
Article 5(1)
(2): Article 5(2)
Article 11(2)
—
—
—
Article 11(3)
Article 5(6)
Articles 4 and 6(4)
Article 11(4)
Article 6
Article 4
Article 11(5)
Article 5(1)
Article 5(1)
Article 12
Article 5e
Article 5(2)
(3): Article 5(6)
Article 13
Article 5(1), Article 11
Article 5(1), Article 9
Article 14
Articles 5(1) and 5(5)(c)
Article 5(1)
(4): Article 7(1)E and Directive 70/524/EEC: Article 16
Article 15
Article 5(1)(c), (d) and 7
Article 16
Articles 5(1), 5c and 5d
Article 17(1)
—
—
—
Article 17(2)
Article 5c(3)
Article 17(3)
(3): Articles 5(1), (4), (7) and 6(a)
Article 18
—
—
—
Article 19
Article 8
Article 20
Article 6(1)(a)
Article 21(1)
Article 5(5)(d)
Article 21(2)
Article 6(3)(a)
Article 21(3)
Article 5(5)(b)
Article 21(4)
Article 5(5)(a)
Article 21(5)
Article 5(2)
Article 5(3), 6(1)(b)
Article 21(6)
—
—
—
Article 21(7)
Article 14(c)
Article 21(8)
Article 5(3), 5c(4) and 5e
Article 5(2)
Article 22
Article 4(1)
(1): Article 1
Article 23
—
—
—
Article 24
—
—
—
Article 25
—
—
—
Article 26
Article 10
Article 11
Article 27
Article 13
Article 13
(2): Articles 13 and 14
(3): Article 9
Article 28
—
—
—
Article 29
—
—
—
Article 30
—
—
—
Article 31
—
—
—
Article 32
—
—
—
Article 33
Annex Part A(2), (3), (4)
Annex Part A(II), (VI),
Annex I
Annex Part A(1) and
Article 5(6),
Article 6(4)
Annex II
(5): Annex
Annex III
Annex Part A(5), (6)
Annex Part A(VII)
Annex IV
Annex Part C
Annex V
Annex Part B
Annex VI
Annex Part B
Annex VII
|
Marketing of animal feed: EU rules
Marketing of animal feed: EU rules
SUMMARY OF:
Regulation (EC) No 767/2009 — placing on the market and use of animal feed
SUMMARY
WHAT DOES THIS REGULATION DO?
It lays down rules on the placing on the market and use of feed for food-producing animals or pets.
It also lays down labelling, packaging and presentation requirements.
KEY POINTS
Feed
The regulation covers any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.
It applies independently of and without having any effect on other EU rules in the field of animal nutrition, concerning:
medicated feedingstuffs,
undesirable substances,
transmissible spongiform encephalopathies (such as BSE),
animal by-products not intended for human consumption,
genetically modified food and feed,
the traceability and labelling of genetically modified organisms,
additives,
the production and labelling of organic products.
Marketing and use
Animal feed must comply with safety and marketing requirements. In particular, it must:
be safe,
not have a direct adverse effect on the environment or animal welfare,
be sound, genuine, unadulterated, fit for its purpose and of merchantable quality,
be labelled, packaged and presented in accordance with the applicable legislation.
It must not contain materials which are restricted or prohibited from being placed on the market.
Traceability
It must be possible to trace the feed at all stages of production, processing and distribution. Feed business operators must be able to identify who has provided them with:
feed,
a food-producing animal, or
any substance intended to be or likely to be incorporated into feed.
Feed which is or is likely to be placed on the market in the EU must be labelled or identified in such a way that it can be traced.
Labelling and presentation
This regulation establishes general provisions for the labelling and presentation of all feed, such as the obligation to indicate:
the type of feed,
the name and address of the feed business operator,
the batch or lot reference number,
the net weight,
the list of additives used,
the moisture content.
The labelling and presentation must be clearly legible and indelible. It must not mislead the user concerning the intended use or characteristics of the feed.
The European Commission has published further advice to assist companies and authorities in this respect including:
Guidelines on the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products, and
Code of good labelling practice for pet food.
Packaging
Feed materials and compound feed must be placed on the market in sealed packages and containers. However, certain feed may be placed on the market in bulk or in unsealed packages or containers. This includes:
feed materials,
mixtures of grain and whole fruit,
deliveries of compound feed between producers,
feed in the form of blocks or licks.
WHEN DOES THIS REGULATION APPLY?
It entered into force on 21 September 2009.
BACKGROUND
‘Animal nutrition — marketing of feed’ on the European Commission's website
ACT
Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, pp. 1–28).
Subsequent amendments to Regulation (EC) No 767/2009 have been incorporated in the basic text. This consolidated version has a purely documentary value.
RELATED ACTS
Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, pp. 1–64)
last update 03.02.2016
|
32012R1025
|
14.11.2012
EN
Official Journal of the European Union
L 316/12
REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 25 October 2012
on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
The primary objective of standardisation is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply. Standardisation can cover various issues, such as standardisation of different grades or sizes of a particular product or technical specifications in product or services markets where compatibility and interoperability with other products or systems are essential.
(2)
European standardisation is organised by and for the stakeholders concerned based on national representation (the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec)) and direct participation (the European Telecommunications Standards Institute (ETSI)), and is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency (‘the founding principles’). In accordance with the founding principles, it is important that all relevant interested parties, including public authorities and small and medium-sized enterprises (SMEs), are appropriately involved in the national and European standardisation process. National standardisation bodies should also encourage and facilitate the participation of stakeholders.
(3)
European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network interoperability, means of communication, technological development and innovation. European standardisation reinforces the global competitiveness of European industry especially when established in coordination with the international standardisation bodies, namely the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU). Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing safety and value for consumers.
(4)
European standards are adopted by the European standardisation organisations, namely CEN, Cenelec and ETSI.
(5)
European standards play a very important role within the internal market, for instance through the use of harmonised standards in the presumption of conformity of products to be made available on the market with the essential requirements relating to those products laid down in the relevant Union harmonisation legislation. Those requirements should be precisely defined in order to avoid misinterpretation on the part of the European standardisation organisations.
(6)
Standardisation plays an increasingly important role in international trade and the opening-up of markets. The Union should seek to promote cooperation between European standardisation organisations and international standardisation bodies. The Union should also promote bilateral approaches with third countries to coordinate standardisation efforts and promote European standards, for instance when negotiating agreements or by seconding standardisation experts to third countries. Furthermore the Union should encourage contact between European standardisation organisations and private forums and consortia, while maintaining the primacy of European standardisation.
(7)
European standardisation is governed by a specific legal framework consisting of three different legal acts, namely Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (3), Decision No 1673/2006/EC of the European Parliament and of the Council of 24 October 2006 on the financing of European standardisation (4) and Council Decision 87/95/EEC of 22 December 1986 on standardisation in the field of information technology and telecommunications (5). However, the current legal framework is no longer up to date with developments in European standardisation over recent decades. Therefore, the current legal framework should be simplified and adapted in order to cover new aspects of standardisation to reflect those latest developments and future challenges in European standardisation. That relates in particular to the increased development of standards for services and the evolution of standardisation deliverables other than formal standards.
(8)
The European Parliament’s Resolution of 21 October 2010 on the future of European standardisation (6), as well as the report of the Expert Panel for the Review of the European Standardization System (Express) of February 2010 entitled ‘Standardization for a competitive and innovative Europe: a vision for 2020’, have set out an important number of strategic recommendations regarding the review of the European standardisation system.
(9)
In order to ensure the effectiveness of standards and standardisation as policy tools for the Union, it is necessary to have an effective and efficient standardisation system which provides a flexible and transparent platform for consensus building between all participants and which is financially viable.
(10)
Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (7) establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services. It obliges the Member States to encourage, in cooperation with the Commission, the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different Member States, the provision of information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. Furthermore, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards for products from standards for services. Many standards for products have a service component while standards for services often also partly relate to products. Thus, it is necessary to adapt the current legal framework to these new circumstances by extending its scope to standards for services.
(11)
Like other standards, standards for services are voluntary and should be market-driven, whereby the needs of the economic operators and stakeholders directly or indirectly affected by such standards prevail, and should take into account the public interest and be based on the founding principles, including consensus. They should primarily focus on services linked to products and processes.
(12)
The legal framework allowing the Commission to request one or several European standardisation organisations to draft a European standard or European standardisation deliverable for services should be applied while fully respecting the distribution of competences between the Union and the Member States as laid down in the Treaties. This concerns in particular Articles 14, 151, 152, 153, 165, 166 and 168 of the Treaty on the Functioning of the European Union (TFEU) and Protocol (No 26) on Services of General Interest annexed to the Treaty on European Union (TEU) and to the TFEU in accordance with which it remains the exclusive competence of the Member States to define the fundamental principles of their social security, vocational training and health systems and to shape the framework conditions for the management, financing, organisation and delivery of the services supplied within those systems, including - without prejudice to Article 168(4) TFEU and to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (8) - the definition of requirements, quality and safety standards applicable to them. The Commission should not, by means of such a request, affect the right to negotiate, conclude and enforce collective agreements and to take industrial action in accordance with national law and practices which respect Union law.
(13)
The European standardisation organisations are subject to competition law to the extent that they can be considered to be an undertaking or an association of undertakings within the meaning of Articles 101 and 102 TFEU.
(14)
Within the Union, national standards are adopted by national standardisation bodies which could lead to conflicting standards and technical impediments in the internal market. Therefore, it is necessary for the internal market and for the effectiveness of standardisation within the Union to confirm the existing regular exchange of information between the national standardisation bodies, the European standardisation organisations and the Commission, about their current and future standardisation activities as well as the standstill principle applicable to the national standardisation bodies within the framework of the European standardisation organisations which provides for the withdrawal of national standards after the publication of a new European standard. The national standardisation bodies and European standardisation organisations should also observe the provisions on exchange of information in Annex 3 to the Agreement on Technical Barriers to Trade (9).
(15)
The Member States’ obligation to notify the Commission of their national standardisation bodies should not require the adoption of a specific national legislation for the purposes of recognition of those bodies.
(16)
The regular exchange of information between the national standardisation bodies, the European standardisation organisations and the Commission should not prevent national standardisation bodies from complying with other obligations and commitments, and in particular with Annex 3 to the Agreement on Technical Barriers to Trade.
(17)
The representation of societal interests and societal stakeholders in European standardisation activities refers to the activities of organisations and parties representing interests of greater societal relevance, for instance environmental, consumer interests or employee interests. However, the representation of social interests and social stakeholders in European standardisation activities refers particularly to the activities of organisations and parties representing employees and workers’ basic rights, for instance trade unions.
(18)
In order to speed up the decision-making process, national standardisation bodies and European standardisation organisations should facilitate accessible information on their activities through the promotion of the use of information and communication technologies (ICT) in their respective standardisation systems, for example by providing to all relevant stakeholders an easy-to-use online consultation mechanism for the submission of comments on draft standards and by organising virtual meetings, including by means of web conferencing or video conferencing, of technical committees.
(19)
Standards can contribute to helping Union policy address the major societal challenges such as climate change, sustainable resource use, innovation, ageing population, integration of people with disabilities, consumer protection, workers’ safety and working conditions. By driving the development of European or international standards for goods and technologies in the expanding markets in those areas, the Union could create a competitive advantage for its enterprises and facilitate trade, in particular for SMEs, which account for a large part of European enterprises.
(20)
Standards are important tools for the competitiveness of undertakings and especially SMEs, whose participation in the standardisation process is important for technological progress in the Union. Therefore it is necessary that the standardisation framework encourage SMEs to actively participate in and provide their innovative technology solutions to standardisation efforts. This includes improving their participation at national level where they can be more effective due to lower costs and lack of linguistic barriers. Consequently this Regulation should improve representation and participation of SMEs in both national and European technical committees and should facilitate their effective access to and awareness of standards.
(21)
European standards are of vital interest for the competitiveness of SMEs which, however, are in some cases under-represented in European standardisation activities. Thus, this Regulation should encourage and facilitate appropriate representation and participation of SMEs in the European standardisation process by an entity that is effectively in contact with, and duly representative of, SMEs and organisations representing SMEs at national level.
(22)
Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, workers’ safety and working conditions, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the development of standards are strengthened, through the reinforced support of organisations representing consumers and environmental and social interests.
(23)
The obligation of the European standardisation organisations to encourage and facilitate representation and effective participation of all relevant stakeholders does not entail any voting rights for these stakeholders unless such voting rights are prescribed by the internal rules of procedure of the European standardisation organisations.
(24)
The European standardisation system should also fully take into account the United Nations Convention on the Rights of Persons with Disabilities (10). It is therefore important that organisations representing the interests of consumers sufficiently represent and include the interests of people with disabilities. In addition, the participation of people with disabilities in the standardisation process should be facilitated by all available means.
(25)
Due to the importance of standardisation as a tool to support Union legislation and policies and in order to avoid ex-post objections to and modifications of harmonised standards, it is important that public authorities participate in standardisation at all stages of the development of those standards where they may be involved and especially in the areas covered by Union harmonisation legislation for products.
(26)
Standards should take into account environmental impacts throughout the life cycle of products and services. Important and publicly available tools for evaluating such impacts throughout the life cycle have been developed by the Commission’s Joint Research Centre (JRC). Thus, this Regulation should ensure that the JRC can play an active role in the European standardisation system.
(27)
The viability of the cooperation between the Commission and the European standardisation system depends on careful planning of future requests for the development of standards. This planning could be improved, in particular through the input of interested parties, including national market surveillance authorities, by introducing mechanisms for collecting opinions and facilitating the exchange of information among all interested parties. Since Directive 98/34/EC already provides for the possibility to request the European standardisation organisations to develop European standards, it is appropriate to put in place a better and more transparent planning in an annual work programme which should contain an overview of all requests for standards which the Commission intends to submit to European standardisation organisations. It is necessary to ensure a high level of cooperation between the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation and the Commission in the establishment of its annual Union work programme for standardisation and in the preparation of requests for standards in order to analyse the market relevance of the proposed subject matter and the policy objectives set by the legislator, and to allow the European standardisation organisations to respond more quickly to the requested standardisation activities.
(28)
Before bringing a matter regarding requests for European standards or European standardisation deliverables, or objections to a harmonised standard before the committee set up by this Regulation, the Commission should consult experts of the Member States, for instance through the involvement of committees set up by the corresponding Union legislation or by other forms of consultation of sectoral experts, where such committees do not exist.
(29)
Several directives harmonising the conditions for the marketing of products specify that the Commission may request the adoption, by the European standardisation organisations, of harmonised standards on the basis of which conformity with the applicable essential requirements is presumed. However, many of those directives contain a wide variety of provisions on objections to these standards when the latter do not, or do not entirely, cover all applicable requirements. Diverging provisions which lead to uncertainty for economic operators and European standardisation organisations are in particular contained in Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (11), Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses (12), Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (13), Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (14), European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (15), Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (16), Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (17), Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles (18), Directive 2009/23/EC of the European Parliament and of the Council of23 April 2009 on non-automatic weighing instruments (19) and Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels (20). Therefore, it is necessary to include in this Regulation the uniform procedure provided for in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (21), delete the relevant provisions in those Directives and extend to the European Parliament the right to object to a harmonised standard in accordance with this Regulation.
(30)
Public authorities should make best use of the full range of relevant technical specifications when procuring hardware, software and information technology services, for example by selecting technical specifications which can be implemented by all interested suppliers, allowing for more competition and reduced risk of lock-in. Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (22), Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (23), Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security (24) and Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (25) specify that technical specifications in public procurement should be formulated by reference to national standards transposing European standards, European technical approvals, common technical specifications, international standards, other technical reference systems established by the European standardisation organisations or - when these do not exist - to national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products, or equivalent. ICT technical specifications, however, are often developed by other standard developing organisations and do not fall in any of the categories of standards and approvals laid down in Directives 2004/17/EC, 2004/18/EC or 2009/81/EC or Regulation (EC, Euratom) No 2342/2002. Therefore, it is necessary to provide for the possibility that technical specifications for public procurement could refer to ICT technical specifications, in order to respond to the fast evolution in the field of ICT, facilitate the provision of cross-border services, encourage competition and promote interoperability and innovation.
(31)
Technical specifications not adopted by European standardisation organisations do not hold an equivalent status to European standards. Some ICT technical specifications are not developed in accordance with the founding principles. Therefore, this Regulation should lay down a procedure for the identification of ICT technical specifications that could be referenced in public procurement, involving a broad consultation of a large spectrum of stakeholders, including the European standardisation organisations, enterprises and public authorities. This Regulation should also lay down requirements, in the form of a list of criteria, for such technical specifications and their associated development processes. The requirements for the identification of ICT technical specifications should ensure that public policy objectives and societal needs are respected, and should be based on the founding principles.
(32)
In order to further innovation and competition, the identification of a particular technical specification should not disqualify a competing technical specification from being identified in accordance with the provisions of this Regulation. Any identification should be subject to the criteria being fulfilled and to the technical specification having achieved a significant level of market acceptance.
(33)
The identified ICT technical specifications could contribute to the implementation of Decision No 922/2009/EC of the European Parliament and of the Council of 16 September 2009 on interoperability solutions for European public administrations (ISA) (26) which establishes, for the period 2010-2015, a programme on interoperability solutions for European public administrations and institutions and bodies of the Union, providing common and shared solutions facilitating interoperability.
(34)
Situations may arise in the field of ICT where it is appropriate to encourage the use of, or require compliance, with relevant standards at Union level in order to ensure interoperability in the single market and to improve freedom of choice for users. In other circumstances, it may also happen that specified European standards no longer meet consumers’ needs or are hampering technological development. For these reasons, Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (27) enables the Commission, where necessary, to request European standardisation organisations to draw up standards, to establish and publish in the Official Journal of the European Union a list of standards or specifications with the view to encourage their use, or to make their implementation compulsory, or to remove standards or specifications from that list.
(35)
This Regulation should not prevent European standardisation organisations from continuing to develop standards in the field of ICT and to increase their cooperation with other standard developing bodies, especially in the field of ICT, in order to ensure coherence and avoid fragmentation or duplication during implementation of standards and specifications.
(36)
The procedure for identification of ICT technical specifications provided for in this Regulation should not undermine the coherence of the European standardisation system. Therefore, this Regulation should also lay down the conditions under which it can be considered that a technical specification does not conflict with other European standards.
(37)
Before identifying ICT technical specifications which may be eligible for referencing in public procurement, the Multi Stakeholder Platform established by the Commission Decision of 28 November 2011 (28) should be used as a forum for consultation of European and national stakeholders, European standardisation organisations and Member States in order to ensure legitimacy of the process.
(38)
Decision No 1673/2006/EC establishes the rules concerning the contribution of the Union to the financing of European standardisation in order to ensure that European standards and other European standardisation deliverables are developed and revised in support of the objectives, legislation and policies of the Union. It is appropriate, for the purpose of administrative and budgetary simplification, to incorporate the provisions of that Decision into this Regulation and to use wherever possible the least burdensome procedures.
(39)
In view of the very broad field of involvement of European standardisation in support of Union legislation and policies and the different types of standardisation activity, it is necessary to provide for different financing arrangements. This mainly concerns grants without calls for proposals to the European standardisation organisations and national standardisation bodies in accordance with the second subparagraph of Article 110(1) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (29) and point (d) of Article 168(1) of Regulation (EC, Euratom) No 2342/2002. Furthermore, the same provisions should apply to those bodies which, whilst not recognised as European standardisation organisations in this Regulation, have been mandated in a basic act and have been entrusted with carrying out preliminary work in support of European standardisation in cooperation with the European standardisation organisations.
(40)
Inasmuch as European standardisation organisations provide ongoing support for Union activities, they should have effective and efficient central secretariats. The Commission should therefore be allowed to provide grants to those organisations that are pursuing an objective of general European interest without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.
(41)
Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (30), Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013) (31) and Regulation (EC) No 614/2007 of the European Parliament and of the Council of 23 May 2007 concerning the Financial Instrument for the Environment (LIFE+) (32) already provide for the possibility of financial support of European organisations representing SMEs, consumers and environmental interests in standardisation, while specific grants are paid to European organisations representing social interests in standardisation. The financing under Decision No 1639/2006/EC, Decision No 1926/2006/EC and Regulation (EC) No 614/2007 will end on 31 December 2013. It is essential for the development of European standardisation to continue fostering and encouraging the active participation of European organisations representing SMEs, consumers and environmental and social interests. Such organisations pursue an aim of general European interest and constitute, by virtue of the specific mandate that national non-profit organisations have given them, a European network representing non-profit organisations active in the Member States and promoting principles and policies consistent with the objectives of the Treaties. Because of the context in which they operate and their statutory objectives, European organisations representing SMEs, consumers and environmental and social interests in European standardisation have a permanent role which is essential for Union objectives and policies. Therefore, the Commission should be in a position to continue providing grants to those organisations without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.
(42)
The financing of standardisation activities should also be capable of covering preliminary or ancillary activities in connection with the establishment of European standards or European standardisation deliverables for products and for services. This is necessary primarily for work involving research, the preparation of preliminary documents for legislation, inter-laboratory tests and the validation or evaluation of standards. The promotion of standardisation at European and international level should also continue through programmes relating to the technical assistance to, and cooperation with, third countries. With a view to improving market access and boosting the competitiveness of enterprises in the Union, it should be possible to give grants to other bodies through calls for proposals or, where necessary, by awarding contracts.
(43)
Union financing should seek to establish European standards or European standardisation deliverables for products and for services, to facilitate their use by enterprises through the enhanced support for their translation into the various official Union languages, in order to allow SMEs to fully benefit from the understanding and application of the European standards, to strengthen the cohesion of the European standardisation system and to ensure fair and transparent access to European standards for all market players throughout the Union. This is especially important in cases where the use of standards enables compliance with relevant Union legislation.
(44)
In order to ensure the effective application of this Regulation, there should be the possibility of using the requisite expertise, particularly with regard to auditing and financial management, as well as administrative support resources capable of facilitating implementation, and of evaluating on a regular basis the relevance of the activities receiving Union financing in order to ensure their usefulness and impact.
(45)
Appropriate measures should also be taken to avoid fraud and irregularities and to recover funds unduly paid in accordance with Council Regulations (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (33) and (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (34) and Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (35).
(46)
In order to update the list of European standardisation organisations and to adapt the criteria for organisations representing SMEs and societal stakeholders to further developments as regards their non-profit making nature and representativity, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(47)
The committee set up by this Regulation should assist the Commission in all matters related to the implementation of this Regulation, having due regard for the views of sectoral experts.
(48)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (36).
(49)
The advisory procedure should be used for the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the essential requirements set out in the applicable Union harmonisation legislation.
(50)
The examination procedure should be used for each standardisation request submitted to European standardisation organisations and the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have already been published in the Official Journal of the European Union, given that such decision could have consequences on the presumption of conformity with the applicable essential requirements.
(51)
In order to achieve the main objectives of this Regulation and to facilitate speedy decision-making procedures as well as reducing the overall development time for standards, use should be made as far as possible of the procedural measures provided for in Regulation (EU) No 182/2011, which enables the chair of the relevant committee to lay down a time limit within which the committee should deliver its opinion, according to the urgency of the matter. Moreover, where justified, it should be possible for the opinion of the committee to be obtained by written procedure, and silence on the part of the committee member should be regarded as tacit agreement.
(52)
Since the objectives of this Regulation, namely to ensure the effectiveness and efficiency of standards and standardisation as policy tools for the Union through cooperation between European standardisation organisations, national standardisation bodies, Member States and the Commission, the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, the identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation cannot be sufficiently achieved by the Member States and can, therefore, by reason of their effect, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(53)
Directives 89/686/EEC, 93/15/EEC, 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC should therefore be amended accordingly.
(54)
Decision No 1673/2006/EC and Decision 87/95/EEC should be repealed,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation establishes rules with regard to the cooperation between European standardisation organisations, national standardisation bodies, Member States and the Commission, the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, the identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)
‘standard’ means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:
(a)
‘international standard’ means a standard adopted by an international standardisation body;
(b)
‘European standard’ means a standard adopted by a European standardisation organisation;
(c)
‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation;
(d)
‘national standard’ means a standard adopted by a national standardisation body;
(2)
‘European standardisation deliverable’ means any other technical specification than a European standard, adopted by a European standardisation organisation for repeated or continuous application and with which compliance is not compulsory;
(3)
‘draft standard’ means a document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the relevant standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny;
(4)
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following:
(a)
the characteristics required of a product including levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
(b)
production methods and processes used in respect of agricultural products as defined in Article 38(1) TFEU, products intended for human and animal consumption, and medicinal products, as well as production methods and processes relating to other products, where these have an effect on their characteristics;
(c)
the characteristics required of a service including levels of quality, performance, interoperability, environmental protection, health or safety, and including the requirements applicable to the provider as regards the information to be made available to the recipient, as specified in Article 22(1) to (3) of Directive 2006/123/EC;
(d)
the methods and the criteria for assessing the performance of construction products, as defined in point 1 of Article 2 of Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products (37), in relation to their essential characteristics;
(5)
‘ICT technical specification’ means a technical specification in the field of information and communication technologies;
(6)
‘product’ means any industrially manufactured product and any agricultural product, including fish products;
(7)
‘service’ means any self-employed economic activity normally provided for remuneration, as defined in Article 57 TFEU;
(8)
‘European standardisation organisation’ means an organisation listed in Annex I;
(9)
‘international standardisation body’ means the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU);
(10)
‘national standardisation body’ means a body notified to the Commission by a Member State in accordance with Article 27 of this Regulation.
CHAPTER II
TRANSPARENCY AND STAKEHOLDER PARTICIPATION
Article 3
Transparency of work programmes of standardisation bodies
1. At least once a year, each European standardisation organisation and national standardisation body shall establish its work programme. That work programme shall contain information on the standards and European standardisation deliverables which a European standardisation organisation or national standardisation body intends to prepare or amend, which it is preparing or amending and which it has adopted in the period of the preceding work programme, unless these are identical or equivalent transpositions of international or European standards.
2. The work programme shall indicate, in respect of each standard and European standardisation deliverable:
(a)
the subject matter;
(b)
the stage attained in the development of the standards and European standardisation deliverables;
(c)
the references of any international standards taken as a basis.
3. Each European standardisation organisation and national standardisation body shall make its work programme available on its website or any other publicly available website, as well as make a notice of the existence of the work programme available in a national or, where appropriate, European publication of standardisation activities.
4. No later than at the time of publication of its work programme, each European standardisation organisation and national standardisation body shall notify the existence thereof to the other European standardisation organisations and national standardisation bodies and to the Commission. The Commission shall make that information available to the Member States via the committee referred to in Article 22.
5. National standardisation bodies may not object to a subject for standardisation in their work programme being considered at European level in accordance with the rules laid down by the European standardisation organisations and may not undertake any action which could prejudice a decision in this regard.
6. During the preparation of a harmonised standard or after its approval, national standardisation bodies shall not take any action which could prejudice the harmonisation intended and, in particular, shall not publish in the field in question a new or revised national standard which is not completely in line with an existing harmonised standard. After publication of a new harmonised standard, all conflicting national standards shall be withdrawn within a reasonable deadline.
Article 4
Transparency of standards
1. Each European standardisation organisation and national standardisation body shall send at least in electronic form any draft national standard, European standard or European standardisation deliverable to other European standardisation organisations, national standardisation bodies or the Commission, upon their request.
2. Each European standardisation organisation and national standardisation body shall within three months reply to, and take due account of, any comments received from any other European standardisation organisation, national standardisation body or the Commission with respect to any draft referred to in paragraph 1.
3. When a national standardisation body receives comments indicating that the draft standard would have a negative impact on the internal market, it shall consult the European standardisation organisations and the Commission before adopting it.
4. National standardisation bodies shall:
(a)
ensure access to draft national standards in such a way that all relevant parties in particular those established in other Member States have the opportunity to submit comments;
(b)
allow other national standardisation bodies to be involved passively or actively, by sending an observer, in the planned activities.
Article 5
Stakeholder participation in European standardisation
1. European standardisation organisations shall encourage and facilitate an appropriate representation and effective participation of all relevant stakeholders, including SMEs, consumer organisations and environmental and social stakeholders in their standardisation activities. They shall in particular encourage and facilitate such representation and participation through the European stakeholder organisations receiving Union financing in accordance with this Regulation at the policy development level and at the following stages of the development of European standards or European standardisation deliverables:
(a)
the proposal and acceptance of new work items;
(b)
the technical discussion on proposals;
(c)
the submission of comments on drafts;
(d)
the revision of existing European standards or European standardisation deliverables;
(e)
the dissemination of information of, and awareness-building about, adopted European standards or European standardisation deliverables.
2. In addition to the collaboration with market surveillance authorities in the Member States, research facilities of the Commission and the European stakeholder organisations receiving Union financing in accordance with this Regulation, European standardisation organisations shall encourage and facilitate appropriate representation, at technical level, of undertakings, research centres, universities and other legal entities, in standardisation activities concerning an emerging area with significant policy or technical innovation implications, if the legal entities concerned participated in a project that is related to that area and that is funded by the Union under a multiannual framework programme for activities in the area of research, innovation and technological development, adopted pursuant to Article 182 TFEU.
Article 6
Access of SMEs to standards
1. National standardisation bodies shall encourage and facilitate the access of SMEs to standards and standards development processes in order to reach a higher level of participation in the standardisation system, for instance by:
(a)
identifying, in their annual work programmes, the standardisation projects, which are of particular interests to SMEs;
(b)
giving access to standardisation activities without obliging SMEs to become a member of a national standardisation body;
(c)
providing free access or special rates to participate in standardisation activities;
(d)
providing free access to draft standards;
(e)
making available free of charge on their website abstracts of standards;
(f)
applying special rates for the provision of standards or providing bundles of standards at a reduced price.
2. National standardisation bodies shall exchange best practices aiming to enhance the participation of SMEs in standardisation activities and to increase and facilitate the use of standards by SMEs.
3. National standardisation bodies shall send annual reports to the European standardisation organisations with regards to their activities in paragraphs 1 and 2 and all other measures to improve conditions for SMEs to use standards and to participate in the standards development process. The national standardisation bodies shall publish those reports on their websites.
Article 7
Participation of public authorities in European standardisation
Member States shall, where appropriate, encourage participation of public authorities, including market surveillance authorities, in national standardisation activities aimed at the development or revision of standards requested by the Commission in accordance with Article 10.
CHAPTER III
EUROPEAN STANDARDS AND EUROPEAN STANDARDISATION DELIVERABLES IN SUPPORT OF UNION LEGISLATION AND POLICIES
Article 8
The annual Union work programme for European standardisation
1. The Commission shall adopt an annual Union work programme for European standardisation which shall identify strategic priorities for European standardisation, taking into account Union long-term strategies for growth. It shall indicate the European standards and European standardisation deliverables that the Commission intends to request from the European standardisation organisations in accordance with Article 10.
2. The annual Union work programme for European standardisation shall define the specific objectives and policies for the European standards and European standardisation deliverables that the Commission intends to request from the European standardisation organisations in accordance with Article 10. In cases of urgency the Commission can issue requests without prior indication.
3. The annual Union work programme for European standardisation shall also include objectives for the international dimension of European standardisation, in support of Union legislation and policies.
4. The annual Union work programme for European standardisation shall be adopted after having conducted a broad consultation of relevant stakeholders, including European standardisation organisations and European stakeholder organisations receiving Union financing in accordance with this Regulation, and Member States via the committee referred to in Article 22 of this Regulation.
5. After its adoption, the Commission shall make the annual Union work programme for European standardisation available on its website.
Article 9
Cooperation with research facilities
The Commission’s research facilities shall contribute to the preparation of the annual Union work programme for European standardisation referred to in Article 8 and provide European standardisation organisations with scientific input, in their areas of expertise, to ensure that European standards take into account economic competitiveness and societal needs such as environmental sustainability and safety and security concerns.
Article 10
Standardisation requests to European standardisation organisations
1. The Commission may within the limitations of the competences laid down in the Treaties, request one or several European standardisation organisations to draft a European standard or European standardisation deliverable within a set deadline. European standards and European standardisation deliverables shall be market-driven, take into account the public interest as well as the policy objectives clearly stated in the Commission’s request and based on consensus. The Commission shall determine the requirements as to the content to be met by the requested document and a deadline for its adoption.
2. The decisions referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 22(3) after consultation of the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation as well as the committee set up by the corresponding Union legislation, when such a committee exists, or after other forms of consultation of sectoral experts.
3. The relevant European standardisation organisation shall indicate, within one month following its receipt, if it accepts the request referred to in paragraph 1.
4. Where a request for funding is made, the Commission shall inform the relevant European standardisation organisations, within two months following the receipt of the acceptance referred to in paragraph 3, about the award of a grant for drafting a European standard or a European standardisation deliverable.
5. The European standardisation organisations shall inform the Commission about the activities undertaken for the development of the documents referred to in paragraph 1. The Commission together with the European standardisation organisations shall assess the compliance of the documents drafted by the European standardisation organisations with its initial request.
6. Where a harmonised standard satisfies the requirements which it aims to cover and which are set out in the corresponding Union harmonisation legislation, the Commission shall publish a reference of such harmonised standard without delay in the Official Journal of the European Union or by other means in accordance with the conditions laid down in the corresponding act of Union harmonisation legislation.
Article 11
Formal objections to harmonised standards
1. When a Member State or the European Parliament considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it shall inform the Commission thereof with a detailed explanation and the Commission shall, after consulting the committee set up by the corresponding Union harmonisation legislation, if it exists, or after other forms of consultation of sectoral experts, decide:
(a)
to publish, not to publish or to publish with restriction the references to the harmonised standard concerned in the Official Journal of the European Union;
(b)
to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union.
2. The Commission shall publish information on its website on the harmonised standards that have been subject to the decision referred to in paragraph 1.
3. The Commission shall inform the European standardisation organisation concerned of the decision referred to in paragraph 1 and, if necessary, request the revision of the harmonised standards concerned.
4. The decision referred to in point (a) of paragraph 1 of this Article shall be adopted in accordance with the advisory procedure referred to in Article 22(2).
5. The decision referred to in point (b) of paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 22(3).
Article 12
Notification of stakeholder organisations
The Commission shall establish a notification system for all stakeholders, including European standardisation organisations and European stakeholder organisations receiving Union financing in accordance with this Regulation in order to ensure proper consultation and market relevance prior to:
(a)
adopting the annual Union work programme for European standardisation referred to in Article 8(1);
(b)
adopting standardisation requests referred to in Article 10;
(c)
taking a decision on formal objections to harmonised standards, as referred to in Article 11(1);
(d)
taking a decision on identifications of ICT technical specifications referred to in Article 13;
(e)
adopting delegated acts referred to in Article 20.
CHAPTER IV
ICT TECHNICAL SPECIFICATIONS
Article 13
Identification of ICT technical specifications eligible for referencing
1. Either on proposal from a Member State or on its own initiative the Commission may decide to identify ICT technical specifications that are not national, European or international standards, but meet the requirements set out in Annex II, which may be referenced, primarily to enable interoperability, in public procurement.
2. Either on proposal from a Member State or on its own initiative, when an ICT technical specification identified in accordance with paragraph 1 is modified, withdrawn or no longer meets the requirements set out in Annex II, the Commission may decide to identify the modified ICT technical specification or to withdraw the identification.
3. The decisions provided for in paragraphs 1 and 2 shall be adopted after consultation of the European multi-stakeholder platform on ICT standardisation, which includes European standardisation organisations, Member States and relevant stakeholders, and after consultation of the committee set up by the corresponding Union legislation, if it exists, or after other forms of consultation of sectoral experts, if such a committee does not exist.
Article 14
Use of ICT technical specifications in public procurement
The ICT technical specifications referred to in Article 13 of this Regulation shall constitute common technical specifications referred to in Directives 2004/17/EC, 2004/18/EC and 2009/81/EC, and Regulation (EC, Euratom) No 2342/2002.
CHAPTER V
FINANCING OF EUROPEAN STANDARDISATION
Article 15
Financing of standardisation organisations by the Union
1. The financing by the Union may be granted to the European standardisation organisations for the following standardisation activities:
(a)
the development and revision of European standards or European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies;
(b)
the verification of the quality, and conformity to the corresponding Union legislation and policies, of European standards or European standardisation deliverables;
(c)
the performance of preliminary or ancillary work in connection with European standardisation, including studies, cooperation activities, including international cooperation, seminars, evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests, conformity evaluation work and measures to ensure that the periods for the development and the revision of European standards or European standardisation deliverables are shortened without prejudice to the founding principles, especially the principles of openness, quality, transparency and consensus among all stakeholders;
(d)
the activities of the central secretariats of the European standardisation organisations, including policy development, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties;
(e)
the translation of European standards or European standardisation deliverables used in support of Union legislation and policies into the official Union languages other than the working languages of the European standardisation organisations or, in duly justified cases into languages other than the official Union languages;
(f)
the drawing up of information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, abstracts of standards, best practice information and awareness-building actions, strategies and training programmes;
(g)
activities seeking to carry out programmes of technical assistance, cooperation with third countries and the promotion and enhancement of the European standardisation system and of European standards and European standardisation deliverables among interested parties in the Union and at international level.
2. The financing by the Union may also be granted to:
(a)
national standardisation bodies for the standardisation activities referred to in paragraph 1, which they jointly undertake with the European standardisation organisations;
(b)
other bodies which have been entrusted with contributing to the activities referred to in point (a) of paragraph 1, or carrying out the activities referred to in points (c) and (g) of paragraph 1, in cooperation with the European standardisation organisations.
Article 16
Financing of other European organisations by the Union
The financing by the Union may be granted to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation for the following activities:
(a)
the functioning of these organisations and of their activities relating to European and international standardisation, including the processing of technical work and the provision of information to members and other interested parties;
(b)
the provision of legal and technical expertise, including studies, in relation to assessment of the need for, and the development of, European standards and European standardisation deliverables and training of experts;
(c)
the participation in the technical work with respect to the development and revision of European standards and European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies;
(d)
the promotion of European standards and European standardisation deliverables, and the information on, and use of, standards among interested parties, including SMEs and consumers.
Article 17
Financing arrangements
1. Financing by the Union shall be provided in the form of:
(a)
grants without a call for proposals, or contracts after public procurement procedures, to:
(i)
European standardisation organisations and national standardisation bodies to carry out the activities referred to in Article 15(1);
(ii)
bodies identified by a basic act, within the meaning of Article 49 of Regulation (EC, Euratom) No 1605/2002, to carry out, in collaboration with the European standardisation organisations the activities referred to in point (c) of Article 15(1) of this Regulation;
(b)
grants after a call for proposals, or contracts after public procurement procedures, to other bodies referred to in point (b) of Article 15(2):
(i)
for contributing to the development and revision of European standards or European standardisation deliverables referred to in point (a) of Article 15(1);
(ii)
for carrying out the preliminary or ancillary work referred to in point (c) of Article 15(1);
(iii)
for carrying out the activities referred to in point (g) of Article 15(1);
(c)
grants after a call for proposals to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation to carry out the activities referred to in Article 16.
2. The activities of the bodies referred to in paragraph 1 may be financed by:
(a)
grants for actions;
(b)
operating grants for the European standardisation organisations and the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation in accordance with the rules set out in Regulation (EC, Euratom) No 1605/2002. In the event of renewal, operating grants shall not be automatically decreased.
3. The Commission shall decide on the financing arrangements referred to in paragraphs 1 and 2, on the amounts of the grants and, where necessary, on the maximum percentage of financing by type of activity.
4. Except in duly justified cases, grants awarded for the standardisation activities referred to in points (a) and (b) of Article 15(1) shall take the form of lump sums and for the standardisation activities referred to in point (a) of Article 15(1) shall be paid upon fulfilment of the following conditions:
(a)
European standards or European standardisation deliverables requested by the Commission in accordance with Article 10 are adopted or revised within a period not exceeding the period specified in the request referred to in that Article;
(b)
SMEs, consumer organisations and environmental and social stakeholders are appropriately represented and can participate in European standardisation activities, as referred to in Article 5(1).
5. The common cooperation objectives and the administrative and financial conditions relating to the grants awarded to European standardisation organisations and the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation shall be defined in the framework partnership agreements between the Commission and those standardisation and stakeholder organisations, in accordance with Regulations (EC, Euratom) No 1605/2002 and (EC, Euratom) No 2342/2002. The Commission shall inform the European Parliament and the Council of the conclusion of those agreements.
Article 18
Management
The appropriations determined by the budgetary authority for the financing of standardisation activities may also cover the administrative expenses relating to the preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the purposes of implementing Articles 15, 16 and 17, including studies, meetings, information and publication activities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for standardisation activities.
Article 19
Protection of the financial interests of the Union
1. The Commission shall ensure that, when the activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and other illegal activities, by effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective, proportionate and dissuasive penalties, in accordance with Regulations (EC, Euratom) No 2988/95, (Euratom, EC) No 2185/96 and (EC) No 1073/1999.
2. For the Union activities financed pursuant to this Regulation, the notion of irregularity defined in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Union law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the Union or budgets managed by it by an unjustified item of expenditure.
3. Any agreements and contracts resulting from this Regulation shall provide for monitoring and financial control by the Commission or any representative which it authorises and for audits by the European Court of Auditors, which if necessary may be conducted on the spot.
CHAPTER VI
DELEGATED ACTS, COMMITTEE AND REPORTING
Article 20
Delegated acts
The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning amendments to the Annexes, in order to:
(a)
update the list of European standardisation organisations set out in Annex I to take into account changes in their name or structure;
(b)
adapt the criteria for European stakeholder organisations set out in Annex III to this Regulation to further developments as regards their non-profit making nature and representativity. Such adaptations shall not have the effect of creating any new criteria or abolishing any existing criteria or category of organisation.
Article 21
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 20 shall be conferred on the Commission for a period of five years from 1 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 22
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.
Article 23
Committee cooperation with standardisation organisations and stakeholders
The committee referred to in Article 22(1) shall work in cooperation with the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation.
Article 24
Reports
1. The European standardisation organisations shall send an annual report on the implementation of this Regulation to the Commission. It shall contain detailed information on the following:
(a)
the application of Articles 4, 5, 10, 15 and 17;
(b)
the representation of SMEs, consumer organisations and environmental and social stakeholders in national standardisation bodies;
(c)
the representation of SMEs on the basis of the annual reports referred to in Article 6(3);
(d)
the use of ICT in the standardisation system;
(e)
cooperation between the national standardisation bodies and European standardisation organisations.
2. The European stakeholder organisations that received Union financing in accordance with this Regulation shall send an annual report on their activities to the Commission. This report shall contain in particular detailed information about the membership of these organisations and the activities referred to in Article 16.
3. By 31 December 2015 and every five years thereafter, the Commission shall present a report to the European Parliament and to the Council on the implementation of this Regulation. This report shall contain an analysis of the annual reports referred to in paragraphs 1 and 2, an evaluation of the relevance of the standardisation activities receiving Union financing in the light of the requirements of Union legislation and policies as well as an assessment of potential new measures to simplify the financing of European standardisation and to reduce the administrative burden for the European standardisation organisations.
Article 25
Review
By 2 January 2015, the Commission shall evaluate the impact of the procedure established by Article 10 of this Regulation on the timeframe for issuing standardisation requests. The Commission shall present its conclusions in a report to the European Parliament and to the Council. Where appropriate, that report shall be accompanied by a legislative proposal to amend this Regulation.
CHAPTER VII
FINAL PROVISIONS
Article 26
Amendments
1. The following provisions are deleted:
(a)
Article 6(1) of Directive 89/686/EEC;
(b)
Article 5 of Directive 93/15/EEC;
(c)
Article 6(1) of Directive 94/9/EC;
(d)
Article 6(1) of Directive 94/25/EC;
(e)
Article 6(1) of Directive 95/16/EC;
(f)
Article 6 of Directive 97/23/EC;
(g)
Article 14 of Directive 2004/22/EC;
(h)
Article 8(4) of Directive 2007/23/EC;
(i)
Article 7 of Directive 2009/23/EC;
(j)
Article 6 of Directive 2009/105/EC.
References to those deleted provisions shall be construed as references to Article 11 of this Regulation.
2. Directive 98/34/EC is hereby amended as follows:
(a)
in Article 1, paragraphs 6 to 10 are deleted;
(b)
Articles 2, 3 and 4 are deleted;
(c)
in Article 6(1), the words ‘with the representatives of the standards institutions referred to in Annexes I and II’ are deleted;
(d)
in Article 6(3), the first indent is deleted;
(e)
in Article 6(4), points (a), (b) and (e) are deleted;
(f)
Article 7 is replaced by the following:
‘Article 7
Member States shall communicate to the Commission, in accordance with Article 8(1), all requests made to standards institutions to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products as draft technical regulations, and shall state the grounds for their enactment.’;
(g)
in Article 11, the second sentence is replaced by the following sentence:
‘The Commission shall publish annual statistics on the notifications received in the Official Journal of the European Union.’;
(h)
Annexes I and II are deleted.
References to those deleted provisions shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV to this Regulation.
Article 27
National standardisation bodies
Member States shall inform the Commission of their standardisation bodies.
The Commission shall publish a list of national standardisation bodies and any updates to that list in the Official Journal of the European Union.
Article 28
Transitional provisions
In Union acts that provide for a presumption of conformity with essential requirements through the application of harmonised standards adopted in accordance with Directive 98/34/EC, references to Directive 98/34/EC shall be construed as references to this Regulation, except references to the committee set up by Article 5 of Directive 98/34/EC regarding technical regulations.
Where a Union act provides for a procedure for objection to harmonised standards, Article 11 of this Regulation shall not apply to that act.
Article 29
Repeal
Decision No 1673/2006/EC and Decision 87/95/EEC are hereby repealed.
References to the repealed Decisions shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV to this Regulation.
Article 30
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 25 October 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. D. MAVROYIANNIS
(1) OJ C 376, 22.12.2011, p. 69.
(2) Position of the European Parliament of 11 September 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012.
(3) OJ L 204, 21.7.1998, p. 37.
(4) OJ L 315, 15.11.2006, p. 9.
(5) OJ L 36, 7.2.1987, p. 31.
(6) OJ C 70 E, 8.3.2012, p. 56.
(7) OJ L 376, 27.12.2006, p. 36.
(8) OJ L 255, 30.9.2005, p. 22.
(9) Approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994)
(OJ L 336, 23.12.1994, p. 1).
(10) Approved by Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p. 35).
(11) OJ L 399, 30.12.1989, p. 18.
(12) OJ L 121, 15.5.1993, p. 20.
(13) OJ L 100, 19.4.1994, p. 1.
(14) OJ L 164, 30.6.1994, p. 15.
(15) OJ L 213, 7.9.1995, p. 1.
(16) OJ L 181, 9.7.1997, p. 1.
(17) OJ L 135, 30.4.2004, p. 1.
(18) OJ L 154, 14.6.2007, p. 1.
(19) OJ L 122, 16.5.2009, p. 6.
(20) OJ L 264, 8.10.2009, p. 12.
(21) OJ L 218, 13.8.2008, p. 82.
(22) OJ L 134, 30.4.2004, p. 1.
(23) OJ L 134, 30.4.2004, p. 114.
(24) OJ L 216, 20.8.2009, p. 76.
(25) OJ L 357, 31.12.2002, p. 1.
(26) OJ L 260, 3.10.2009, p. 20.
(27) OJ L 108, 24.4.2002, p. 33.
(28) OJ C 349, 30.11.2011, p. 4.
(29) OJ L 248, 16.9.2002, p. 1.
(30) OJ L 310, 9.11.2006, p. 15.
(31) OJ L 404, 30.12.2006, p. 39.
(32) OJ L 149, 9.6.2007, p. 1.
(33) OJ L 312, 23.12.1995, p. 1.
(34) OJ L 292, 15.11.1996, p. 2.
(35) OJ L 136, 31.5.1999, p. 1.
(36) OJ L 55, 28.2.2011, p. 13.
(37) OJ L 88, 4.4.2011, p. 5.
ANNEX I
EUROPEAN STANDARDISATION ORGANISATIONS
1. CEN— European Committee for Standardisation
2. Cenelec— European Committee for Electrotechnical Standardisation
3. ETSI— European Telecommunications Standards Institute
ANNEX II
REQUIREMENTS FOR THE IDENTIFICATION OF ICT TECHNICAL SPECIFICATIONS
1.
The technical specifications have market acceptance and their implementations do not hamper interoperability with the implementations of existing European or international standards. Market acceptance can be demonstrated by operational examples of compliant implementations from different vendors.
2.
The technical specifications are coherent as they do not conflict with European standards, that is to say they cover domains where the adoption of new European standards is not foreseen within a reasonable period, where existing standards have not gained market uptake or where these standards have become obsolete, and where the transposition of the technical specifications into European standardisation deliverables is not foreseen within a reasonable period.
3.
The technical specifications were developed by a non-profit making organisation which is a professional society, industry or trade association or any other membership organisation that within its area of expertise develops ICT technical specifications and which is not a European standardisation organisation, national or international standardisation body, through processes which fulfil the following criteria:
(a)
openness:
the technical specifications were developed on the basis of open decision-making accessible to all interested parties in the market or markets affected by those technical specifications;
(b)
consensus:
the decision-making process was collaborative and consensus based and did not favour any particular stakeholder. Consensus means a general agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. Consensus does not imply unanimity;
(c)
transparency:
(i)
all information concerning technical discussions and decision making was archived and identified;
(ii)
information on new standardisation activities was publicly and widely announced through suitable and accessible means;
(iii)
participation of all relevant categories of interested parties was sought with a view to achieving balance;
(iv)
consideration and response were given to comments by interested parties.
4.
The technical specifications meet the following requirements:
(a)
maintenance: ongoing support and maintenance of published specifications are guaranteed over a long period;
(b)
availability: specifications are publicly available for implementation and use on reasonable terms (including for a reasonable fee or free of charge);
(c)
intellectual property rights essential to the implementation of specifications are licensed to applicants on a (fair) reasonable and non-discriminatory basis ((F)RAND), which includes, at the discretion of the intellectual property right-holder, licensing essential intellectual property without compensation;
(d)
relevance:
(i)
the specifications are effective and relevant;
(ii)
specifications need to respond to market needs and regulatory requirements;
(e)
neutrality and stability:
(i)
specifications whenever possible are performance oriented rather than based on design or descriptive characteristics;
(ii)
specifications do not distort the market or limit the possibilities for implementers to develop competition and innovation based upon them;
(iii)
specifications are based on advanced scientific and technological developments;
(f)
quality:
(i)
the quality and level of detail are sufficient to permit the development of a variety of competing implementations of interoperable products and services;
(ii)
standardised interfaces are not hidden or controlled by anyone other than the organisations that adopted the technical specifications.
ANNEX III
EUROPEAN STAKEHOLDER ORGANISATIONS ELIGIBLE FOR UNION FINANCING
1.
A European organisation representing SMEs in European standardisation activities which:
(a)
is non-governmental and non-profit-making;
(b)
has as its statutory objectives and activities to represent the interests of SMEs in the standardisation process at European level, to raise their awareness for standardisation and to motivate them to become involved in the standardisation process;
(c)
has been mandated by non-profit organisations representing SMEs in at least two thirds of the Member States, to represent the interests of SMEs in the standardisation process at European level.
2.
A European organisation representing consumers in European standardisation activities which:
(a)
is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;
(b)
has as its statutory objectives and activities to represent consumer interests in the standardisation process at European level;
(c)
has been mandated by national non-profit consumer organisations in at least two thirds of the Member States, to represent the interests of consumers in the standardisation process at European level.
3.
A European organisation representing environmental interests in European standardisation activities which:
(a)
is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;
(b)
has as its statutory objectives and activities to represent environmental interests in the standardisation process at European level;
(c)
has been mandated by national non-profit environmental organisations in at least two thirds of the Member States, to represent environmental interests in the standardisation process at European level.
4.
A European organisation representing social interests in European standardisation activities which:
(a)
is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;
(b)
has as its statutory objectives and activities to represent social interests in the standardisation process at European level;
(c)
has been mandated by national non-profit social organisations in at least two thirds of the Member States, to represent social interests in the standardisation process at European level.
ANNEX IV
CORRELATION TABLE
Directive 98/34/EC
This Regulation
Article 1, first paragraph, point (6)
Article 2(1)
Article 1, first paragraph, point (7)
—
Article 1, first paragraph, point (8)
Article 2(3)
Article 1, first paragraph, point (9)
Article 2(8)
Article 1, first paragraph, point (10)
Article 2(10)
Article 2(1)
Article 3(1)
Article 2(2)
Article 3(2)
Article 2(3)
Article 3(3) and (4)
Article 2(4)
Article 27
Article 2(5)
Article 20(a)
Article 3
Article 4(1)
Article 4(1)
Article 3(3) and (5) and Article 4(4)
Article 4(2)
—
Article 6(3), first indent
—
Article 6(4)(a)
Article 20(a)
Article 6(4)(b)
—
Article 6(4)(e)
Article 10(2)
Annex I
Annex I
Annex II
Article 27
Decision No 1673/2006/EC
This Regulation
Article 1
Article 1
Articles 2 and 3
Article 15
Article 4
—
Article 5
Article 17
Article 6(1)
Article 18
Article 6(2)
Article 24(3)
Article 7
Article 19
Decision 87/95/EEC
This Regulation
Article 1
Article 2
Article 2
Article 3
Article 3
Article 13
Article 4
Article 8
Article 5
Article 14
Article 6
—
Article 7
—
Article 8
Article 24(3)
Article 9
—
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European standardisation
European standardisation
SUMMARY OF:
Regulation (EU) No 1025/2012 on European standardisation
WHAT IS THE AIM OF THE REGULATION?
It aims to modernise and improve standardisation, which plays a leading role in the EU’s Single Market by outlining how: the EU standards-setting process operates; andthe various organisations involved in this process (both at EU and national level) work together.
It seeks to simplify and adapt the legislative framework to reflect the latest developments and future challenges.
Standards support market competition, reduce costs, improve safety, and enhance competition, protecting health, safety, security, and the environment.
KEY POINTS
The regulation introduces rules governing:
cooperation between standardisation organisations, national standardisation bodies, EU countries and the European Commission;
establishing market-driven European standards for products and services in line with EU legislation and policies;
how information and communication technology technical specifications can support this process;
financing standardisation activities, normally in the form of grants or calls for proposals in line with EU legislation and policies;
stakeholder participation.
The regulation covers standards for services as well as for products, and environmental and public health protection must also be included among the required characteristics of a product or service.
Broad participation in the standards setting process
European standardisation organisations must facilitate the effective participation of all relevant stakeholders, including small- and medium-sized enterprises, consumer organisations and environmental and social stakeholders in their standardisation work.
National standardisation bodies must facilitate the access of SMEs to the standards and their development processes, sharing best practices to improve participation.
EU countries will, where appropriate, encourage participation of public authorities, including market surveillance authorities, in national standardisation activities to develop or revise standards.
Standardisation requests to European standardisation organisations
The Commission may request one or several European standardisation organisations to draft a European standard, which must be market-driven, and take into account the public interest as well as EU policy objectives. The Commission determines the requirements and deadlines to be met. EU countries will communicate to the Commission all requests made to standards institutions to draw up technical specifications or a specific product standard so that a draft technical regulations can be drawn up.
Recognition and use of technical specifications
Public authorities should use the full range of relevant technical specifications when procuring hardware, software and information technology services. The technical specifications have market acceptance and do not hamper interoperability with existing EU or international standards.
Annual work programme, and objections to harmonised standards
The annual work programme sets out strategic priorities taking into account EU long-term growth strategies.The Commission will set up a notification system for all stakeholders to ensure proper consultation and market relevance before adopting the annual work programme or standardisation requests, or making decisions on any objections to harmonised standards brought by EU countries or the European Parliament.
Reporting
The European standardisation organisations will send an annual report on the implementation of this regulation to the Commission.
Amendments since publication
The regulation has been amended since it was issued to explicitly cover the following specific standards:
pyrotechnic articles;
recreational craft and personal watercraft;
explosives for civil uses;
simple pressure vessels;
non-automatic weighing instruments;
measuring instruments;
lifts and safety components for lifts;
equipment used in potentially explosive atmospheres; and
pressure equipment.
FROM WHEN DOES THIS REGULATION APPLY?
It has applied since 1 January 2013.
BACKGROUND
See also:
Standardisation policy (European Commission)
Independent review of the European standardisation system (European Commission).
MAIN DOCUMENT
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, pp. 12-33).
Successive amendments to Regulation (EU) No 1025/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Communication from the Commission to the European Parliament, the Council and the Economic and Social Committee — A strategic vision for European standards: Moving forward to enhance and accelerate the sustainable growth of the European economy by 2020 (COM(2011) 311 final, 1.6.2011)
last update 22.05.2019
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32012R0531
|
30.6.2012
EN
Official Journal of the European Union
L 172/10
REGULATION (EU) No 531/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 June 2012
on roaming on public mobile communications networks within the Union
(recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
Regulation (EC) No 717/2007 of the European Parliament and of the Council of 27 June 2007 on roaming on public mobile communications networks within the Community (3) has been substantially amended (4). Since further amendments are to be made, it should be recast in the interests of clarity.
(2)
The objective of reducing the difference between national and roaming tariffs, which was included in the Commission’s Benchmarking Framework 2011-2015, endorsed by the i2010 High Level Group in November 2009, and included in the Commission Communication entitled ‘A Digital Agenda for Europe’, should also remain the goal of this Regulation. The envisaged separate sale of roaming services and domestic services should increase competition and therefore lower the prices for customers and create an internal market for roaming services in the Union with no significant differentiation between national and roaming tariffs. Union-wide roaming services can stimulate the development of an internal telecommunications market in the Union.
(3)
An internal telecommunications market cannot be said to exist while there are significant differences between domestic and roaming prices. Therefore the ultimate aim should be to eliminate the difference between domestic charges and roaming charges, thus establishing an internal market for mobile communication services.
(4)
The high level of voice, SMS and data roaming prices payable by users of public mobile communication networks, such as students, business travellers and tourists, acts as an obstacle to using their mobile devices when travelling abroad within the Union and is a matter of concern for consumers, national regulatory authorities, and the Union institutions, constituting a significant barrier to the internal market. The excessive retail charges are resulting from high wholesale charges levied by the foreign host network operator and also, in many cases, from high retail mark-ups charged by the customer’s own network operator. Due to a lack of competition, reductions in wholesale charges are often not passed on to the retail customer. Although some operators have recently introduced tariff schemes that offer customers more favourable conditions and somewhat lower prices, there is still evidence that the relationship between costs and prices is far from what would prevail in competitive markets.
(5)
High roaming charges constitute an impediment to the Union’s efforts to develop into a knowledge-based economy and to the realisation of an internal market of 500 million consumers. Mobile data traffic is facilitated by allocating sufficient radio spectrum in order for consumers and businesses to use voice, SMS and data services anywhere in the Union. By providing for the allocation of sufficient and appropriate spectrum in a timely manner to support Union policy objectives and to best meet the increasing demands for wireless data traffic, the multiannual radio spectrum policy programme established by Decision No 243/2012/EU of the European Parliament and of the Council (5) will pave the way for a development that will allow the Union to take the global lead on broadband speeds, mobility, coverage and capacity, facilitating the emergence of new business models and technologies, thereby contributing to reducing the structural problems at roaming wholesale level.
(6)
The widespread use of internet-enabled mobile devices means that data roaming is of great economic significance. This is a decisive criterion for both users and providers of applications and content. In order to stimulate the development of this market, charges for data transport should not impede growth.
(7)
The Commission noted in its Communication entitled ‘On the interim report on the state of development of roaming services within the European Union’ that technological developments and/or the alternatives to roaming services, such as availability of Voice over Internet Protocol (VoIP) or Wi-Fi, may render the internal market for roaming services in the Union more competitive. While these alternatives, in particular VoIP services, are increasingly being used at the domestic level, there have been no significant developments in their use when roaming.
(8)
Given the rapid development of mobile data traffic and the increasing amount of customers using voice, SMS and data roaming services abroad, there is a need to increase the competitive pressure, to develop new business models and technologies. The regulation of roaming charges should be designed in a way that does not discourage competition towards lower price levels.
(9)
The creation of a European social, educational, cultural and entrepreneurial area based on the mobility of individuals and digital data should facilitate communication between people in order to build a real ‘Europe for Citizens’.
(10)
Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (6), Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (7), Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (8), Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive) (9) and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (10) (hereinafter together referred to as ‘the 2002 regulatory framework for electronic communications’) aim to create an internal market for electronic communications within the Union while ensuring a high level of consumer protection through enhanced competition.
(11)
Regulation (EC) No 717/2007 is not an isolated measure, but complements and supports, insofar as Union-wide roaming is concerned, the rules provided for by the 2002 regulatory framework for electronic communications. That framework has not provided national regulatory authorities with sufficient tools to take effective and decisive action with regard to the pricing of roaming services within the Union and thus fails to ensure the smooth functioning of the internal market for roaming services. Regulation (EC) No 717/2007 was an appropriate means of correcting this situation.
(12)
The 2002 regulatory framework for electronic communications draws on the principle that ex-ante regulatory obligations should only be imposed where there is not effective competition, providing for a process of periodic market analysis and review of obligations by national regulatory authorities, leading to the imposition of ex-ante obligations on operators designated as having significant market power. The elements constituting this process include the definition of relevant markets in accordance with the Commission’s Recommendation on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation in accordance with Directive 2002/21/EC (11) (hereinafter referred to as ‘the Recommendation’), the analysis of the defined markets in accordance with the Commission’s guidelines on market analysis and the assessment of significant market power under the Union regulatory framework for electronic communications networks and services (12), the designation of operators with significant market power and the imposition of ex-ante obligations on operators so designated.
(13)
The Recommendation identified as a relevant market susceptible to ex-ante regulation the wholesale national market for international roaming on public mobile networks. However, the work undertaken by the national regulatory authorities, both individually and within the European Regulators Group (ERG) and its successor the Body of European Regulators for Electronic Communications (BEREC) established by Regulation (EC) No 1211/2009 of the European Parliament and of the Council (13), in analysing the wholesale national markets for international roaming has demonstrated that it has not yet been possible for a national regulatory authority to address effectively the high level of wholesale Union-wide roaming charges because of the difficulty in identifying undertakings with significant market power in view of the specific circumstances of international roaming, including its cross-border nature. Following the entry into force of Regulation (EC) No 717/2007, the roaming market was withdrawn from the revised Recommendation (14).
(14)
In addition, the national regulatory authorities responsible for safeguarding and promoting the interests of mobile customers normally resident within their territory are not able to control the behaviour of the visited network operators, situated in other Member States, on whom those customers depend when using international roaming services. This obstacle could also diminish the effectiveness of measures taken by Member States based on their residual competence to adopt consumer protection rules.
(15)
Accordingly, there is pressure for Member States to take measures to address the level of international roaming charges, but the mechanism for ex-ante regulatory intervention by national regulatory authorities provided by the 2002 regulatory framework for electronic communications has not proved sufficient to enable those authorities to act decisively in the consumers’ interest in this specific area.
(16)
Furthermore, the European Parliament resolution on European electronic communications regulation and markets (15) called on the Commission to develop new initiatives to reduce the high costs of cross-border mobile telephone traffic, while the European Council of 23 and 24 March 2006 concluded that focused, effective and integrated information and communication technology (ICT) policies both at Union and national level are essential to achieving the goals of economic growth and productivity and noted in this context the importance for competitiveness of reducing roaming charges.
(17)
The 2002 regulatory framework for electronic communications, on the basis of considerations apparent at that time, was aimed at removing all barriers to trade between Member States in the area that it harmonised, inter alia, measures which affect roaming charges. However, this should not prevent the adaptation of harmonised rules in step with other considerations in order to find the most effective means of enhancing competition in the internal market for roaming services and achieving a high level of consumer protection.
(18)
This Regulation should therefore allow for a departure from the rules otherwise applicable under the 2002 regulatory framework for electronic communications, in particular the Framework Directive, namely that prices for service offerings should be determined by commercial agreement in the absence of significant market power, and to thereby accommodate the introduction of complementary regulatory obligations which reflect the specific characteristics of Union-wide roaming services.
(19)
The retail and wholesale roaming markets exhibit unique characteristics which justify exceptional measures which go beyond the mechanisms otherwise available under the 2002 regulatory framework for electronic communications.
(20)
A common, harmonised approach should be employed for ensuring that users of terrestrial public mobile communication networks when travelling within the Union do not pay excessive prices for Union-wide roaming services, thereby enhancing competition concerning roaming services between roaming providers, achieving a high level of consumer protection and preserving both incentives for innovation and consumer choice. In view of the cross-border nature of the services concerned, this common approach is needed so that roaming providers can operate within a single coherent regulatory framework based on objectively established criteria.
(21)
Regulation (EC) No 717/2007 is to expire on 30 June 2012. Prior to its expiry, the Commission has carried out a review in accordance with Article 11 thereof, where it was required to evaluate whether the objectives of that Regulation had been achieved and to review developments in wholesale and retail charges for the provision to roaming customers of voice, SMS and data communications services. In its report to the European Parliament and the Council of 6 July 2011 on the outcome of the review of the functioning of Regulation (EC) No 717/2007, the Commission concluded that it was appropriate to extend the applicability of Regulation (EC) No 717/2007 beyond 30 June 2012.
(22)
Data on the development of prices for Union-wide voice, SMS and data roaming services since the entry into force of Regulation (EC) No 717/2007, including in particular those collected on a quarterly basis by national regulatory authorities and reported through the medium of the BEREC, do not provide evidence to suggest that competition at the retail or wholesale levels has reasonably developed and is likely to be sustainable from June 2012 onwards in the absence of regulatory measures. Such data indicates that retail and wholesale roaming prices are still much higher than domestic prices and continue to cluster at or close to the limits set by Regulation (EC) No 717/2007, with only limited competition below those limits.
(23)
The expiry on 30 June 2012 of the regulatory safeguards which apply to Union-wide roaming services at wholesale and retail levels by virtue of Regulation (EC) No 717/2007 would therefore give rise to a significant risk that the underlying lack of competitive pressures in the internal market for roaming services and the incentive for roaming providers to maximise their roaming revenues would result in retail and wholesale prices for Union-wide roaming that do not constitute a reasonable reflection of the underlying costs involved in the provision of the service, thereby jeopardising the objectives of that Regulation. Regulatory intervention in the market for mobile roaming services should therefore be extended beyond 30 June 2012 in order to ensure the smooth functioning of the internal market by allowing competition to develop, while at the same time guaranteeing that consumers continue to benefit from the assurance that they will not be charged an excessive price, in comparison with competitive national prices.
(24)
The policy objective laid down in Article 8 of the Framework Directive concerning end users’ ability to access and distribute information or run applications and services of their choice should be promoted by national regulatory authorities.
(25)
In order to allow for the development of a more efficient, integrated and competitive market for roaming services, there should be no restrictions that prevent undertakings from effectively negotiating wholesale access for the purpose of providing roaming services. Obstacles to access to such wholesale roaming services, due to differences in negotiating power and in the degree of infrastructure ownership of undertakings should be removed. Mobile virtual network operators (MVNOs) and resellers of mobile communication services without their own network infrastructure typically provide roaming services based on commercial wholesale roaming agreements with their host mobile network operators in the same Member State. Commercial negotiations, however, may not leave enough margin to MVNOs and resellers for stimulating competition through lower prices. The removal of those obstacles and balancing the negotiation power between MVNOs/resellers and mobile network operators by an access obligation and wholesale caps should facilitate the development of alternative, innovative and Union-wide roaming services and offers for customers. The rules of the 2002 regulatory framework for electronic communications, in particular of the Framework Directive and Access Directive, do not allow this problem to be addressed via the imposition of obligations on operators with significant market powers.
(26)
Therefore rules should be introduced to lay down the obligation to meet reasonable requests for wholesale access to public mobile communications networks for the purpose of providing roaming services. Such access should be in line with the needs of those seeking access. Access should be refused only on the basis of objective criteria, such as technical feasibility and the need to maintain network integrity. Where access is refused, the aggrieved party should be able to submit the case for dispute resolution in accordance with the procedure set out in this Regulation. In order to ensure a level playing field, wholesale access for the purpose of providing roaming services should be granted in accordance with the regulatory obligations laid down in this Regulation applicable at the wholesale level and should take into account the different cost elements necessary for the provision of such access. A consistent regulatory approach to the wholesale access for the provision of roaming services should contribute to avoiding distortions between Member States. BEREC should, in coordination with the Commission and in collaboration with the relevant stakeholders, issue guidelines for wholesale access for the purpose of providing roaming services.
(27)
A wholesale roaming access obligation should include the provision of direct wholesale roaming services as well as the provision of roaming services on a wholesale basis for resale by third parties. The wholesale roaming access obligation should also cover mobile network operator’s obligation to enable MVNOs and resellers to purchase regulated wholesale roaming services from wholesale aggregators which provide a single point of access and a standardised platform to roaming agreements all over the Union. In order to ensure that operators provide access to all facilities necessary for direct wholesale roaming access and wholesale roaming resale access to roaming providers within a reasonable period of time, a reference offer should be published containing the standard conditions for direct wholesale roaming access and wholesale roaming resale access. The publication of the reference offer should not prevent commercial negotiations between access seeker and access provider on the price level of the final wholesale agreement or on additional wholesale access services that go beyond those necessary for direct wholesale roaming access and wholesale roaming resale access.
(28)
A wholesale roaming access obligation should cover access to all the components necessary to enable the provision of roaming services, such as: network elements and associated facilities; relevant software systems including operational support systems; information systems or databases for pre-ordering, provisioning, ordering, maintaining and repair requests, and billing; number translation or systems offering equivalent functionality; mobile networks and virtual network services.
(29)
If access seekers for wholesale roaming resale request access to facilities or services in addition to what is necessary for the provision of retail roaming services, mobile network operators may recover fair and reasonable charges for those facilities or services. Those additional facilities or services could, inter alia, be value-added services, additional software and information systems or billing arrangements.
(30)
Mobile communications services are sold in bundles including both domestic and roaming services, which limits customer choice for roaming services. Such bundles reduce transparency concerning roaming services, since it is difficult to compare individual items within the bundles. Consequently, competition among operators on the basis of the roaming element in the mobile bundle is not yet apparent. Facilitating the availability of roaming as a stand-alone service would address structural problems by raising consumer awareness of roaming prices, allowing distinct consumer choice concerning roaming services and thus increasing competitive pressure on the demand side. This will therefore contribute to the smooth functioning of the internal market for roaming services.
(31)
Consumer and business demand for mobile data services has increased significantly in recent years. However, due to high data roaming charges, the use of those services is severely constrained for consumers and businesses operating across borders in the Union. Given the infancy of the market and the rapidly increasing consumer demand for data roaming, regulated retail charges might only keep prices around the proposed maximum charges themselves, as experienced in relation to Regulation (EC) No 717/2007, instead of pushing them down further, which therefore confirms the need for further structural measures.
(32)
Customers should be able to switch easily, within the shortest possible time depending on the technical solution, without penalty and free of charge to an alternative roaming provider or between alternative roaming providers. Customers should be informed in a clear, understandable and easily accessible form about this possibility.
(33)
Consumers should have the right to opt, in a consumer-friendly way, for the separate sale of roaming services from their domestic mobile package. There are currently several ways in which the separate sale of regulated retail roaming services could be technically implemented, including dual International Mobile Subscriber Identity (IMSI) (two separate IMSI on the same SIM card), single IMSI (the sharing of one IMSI between the domestic and roaming providers) and combinations of dual or single IMSI together with the technical modality that does not prevent the customer from accessing regulated data roaming services provided directly on a visited network, by means of arrangements between the home network operator and the visited network operator.
(34)
High data roaming prices are deterring customers from using mobile data services when travelling in the Union. Given the increasing demand and importance of data roaming services, there should be no obstacles to using alternative data roaming services, provided directly on a visited network, temporarily or permanently, regardless of existing roaming contracts or arrangements with domestic providers and without any additional charge levied by them. When it is required, in order to offer data roaming services, provided directly on a visited network, domestic providers and providers of data roaming services should collaborate in order not to prevent customers from accessing and using those services and to ensure service continuity of other roaming services.
(35)
While this Regulation should not lay down any particular technical modalities for the separate sale of roaming services, but instead pave the way for the most effective and efficient solution, including a combined solution, to be developed by the Commission based on input from BEREC, criteria should be laid down with regard to the technical characteristics which should be met by the technical solution for the separate sale of roaming services. Those criteria should include, inter alia, the introduction of the solution in a coordinated and harmonised manner across the Union and should ensure that consumers are able to quickly and easily choose a different provider for roaming services without changing their number. Furthermore, roaming outside the Union or by third-country customers inside the Union should not be impeded.
(36)
Increased cooperation and coordination among mobile network operators should be established to technically enable a coordinated and sound technical evolution of the provision of separate roaming services, and not preventing access to data roaming services provided directly on a visited network. Therefore, the relevant basic principles and methodologies should be elaborated, in order to allow a rapid adaptation to changed circumstances and technological advancement. BEREC should, in collaboration with the relevant stakeholders, assist the Commission to develop technical elements in order to enable the separate sale of roaming services and in order not to prevent access to data roaming services provided directly on a visited network. If necessary, the Commission should give a mandate to a European standardisation body for the amendment of the relevant standards that are necessary for the harmonised implementation of the separate sale of regulated retail roaming services.
(37)
In order to ensure uniform conditions for the implementation of the provisions of this Regulation, implementing powers should be conferred on the Commission in respect of detailed rules on information obligations of domestic providers and on a technical solution for the separate sale of roaming services. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (16).
(38)
BEREC should be allowed, taking into account this Regulation and the implementing acts adopted pursuant hereto, to provide on its own initiative specific technical guidance on the separate sale of regulated retail roaming services or on other matters covered by this Regulation.
(39)
It is considered that, for the separate sale of regulated retail roaming services to be fully effective, such sale needs to be combined with the wholesale access obligation for the provision of roaming services to facilitate market entry by new or existing players including cross-border roaming services providers. That solution would avoid distortions between Member States by ensuring a consistent regulatory approach thereby contributing to the development of the internal market. However, the implementation of the separate sale of regulated retail roaming services will require a reasonable period for operators to adapt at the technical level, and therefore the structural measures will only result in a genuine internal market with sufficient competition after a certain period of time. For this reason, maximum wholesale charges for voice, SMS and data roaming services as well as safeguard caps for those services at the retail level should be maintained on a temporary basis at an appropriate level to ensure that the existing consumer benefits are preserved during a transitional period of implementation of such structural measures.
(40)
With regard to the continuation of temporary price regulation, regulatory obligations should be imposed at both retail and wholesale levels to protect the interests of roaming customers, since experience has shown that reductions in wholesale prices for Union-wide roaming services may not be reflected in lower retail prices for roaming owing to the absence of incentives for this to happen. On the other hand, action to reduce the level of retail prices without addressing the level of the wholesale costs associated with the provision of these services could risk disrupting the orderly functioning of the internal market for roaming services and would not allow a higher degree of competition.
(41)
Until the structural measures have brought sufficient competition in the internal market for roaming services which would lead to reductions in wholesale costs which in turn would be passed on to consumers, the most effective and proportionate approach to regulating the level of prices for making and receiving intra-Union roaming calls is the setting at Union level of a maximum average per-minute charge at wholesale level and the limiting of charges at retail level through the Eurotariff introduced by Regulation (EC) No 717/2007, which was extended by the euro-SMS tariff provided for in Regulation (EC) No 544/2009 of the European Parliament and of the Council (17) and should be extended by the euro-data tariff provided for in this Regulation. The average wholesale charge should apply between any pair of operators within the Union over a specified period.
(42)
The transitory euro-voice, euro-SMS and euro-data tariffs should be set at a safeguard level which, whilst ensuring that consumer benefits are not only preserved but even increased during a transitional period of implementing the structural measures, guarantees a sufficient margin to roaming providers and encourages competitive roaming offerings at lower rates. During the period concerned, roaming providers should actively bring to the attention of the customers information about the Eurotariffs and offer them to all their roaming customers, free of charge, and in a clear and transparent manner.
(43)
The transitory euro-voice, euro-SMS and euro-data tariffs to be offered to roaming customers should reflect a reasonable margin over the wholesale cost of providing a roaming service, whilst allowing roaming providers the freedom to compete by differentiating their offerings and adapting their pricing structures to market conditions and consumer preferences. Such safeguard caps should be set at levels which do not distort the competitive benefits of structural measures and could be removed once the structural measures have had an opportunity to deliver concrete gains for customers. This regulatory approach should not apply to the part of the tariff that is charged for the provision of value-added services but only to the tariffs for the connection to such services.
(44)
This regulatory approach should be simple to implement and monitor in order to minimise the administrative burden both for the operators and roaming providers which are affected by its requirements and for the national regulatory authorities charged with its supervision and enforcement. It should also be transparent and immediately understandable to all mobile customers within the Union. Furthermore it should provide certainty and predictability to operators providing wholesale and retail roaming services. The level in monetary terms of the maximum per-minute charges at wholesale and retail level should therefore be specified in this Regulation.
(45)
The maximum average per-minute charge at wholesale level so specified should take account of the different elements involved in the making of a Union-wide roaming call, in particular the cost of originating and terminating calls over mobile networks and including overheads, signalling and transit. The most appropriate benchmark for call origination and for call termination is the average mobile termination rate for mobile network operators in the Union, based on information provided by the national regulatory authorities and published by the Commission. The maximum average per-minute charge established by this Regulation should therefore be determined taking into account the average mobile termination rate, which offers a benchmark for the costs involved. The maximum average per-minute charge at wholesale level should decrease annually to take account of reductions in mobile termination rates imposed by national regulatory authorities from time to time.
(46)
The transitory euro-voice tariff applicable at retail level should provide roaming customers with the assurance that they will not be charged an excessive price when making or receiving a regulated roaming call, whilst leaving the roaming provider sufficient margin to differentiate the products they offer to customers.
(47)
During the transitional period of safeguard caps, all consumers should be informed about, and have the option of choosing without additional charges or preconditions, a simple roaming tariff which will not exceed maximum charges. A reasonable margin between wholesale costs and retail prices should ensure that roaming providers cover all their specific roaming costs at retail level including appropriate shares of marketing costs and handset subsidies and are left with an adequate residual to yield a reasonable return. Transitory euro-voice, euro-SMS and euro-data tariffs are an appropriate means to provide both the consumer with protection and the roaming provider with flexibility. In line with the wholesale level, the maximum levels of the euro-voice, euro-SMS and euro-data tariffs should decrease annually.
(48)
During the transitional period of safeguard caps, new roaming customers should be fully informed in a clear and understandable manner of the range of tariffs that exist for roaming within the Union, including the tariffs which are compliant with the transitory euro-voice, euro-SMS and euro-data tariffs. Existing roaming customers should be given the opportunity to choose a new tariff compliant with the transitory euro-voice, euro-SMS and euro-data tariffs or any other roaming tariffs within a certain time frame. For existing roaming customers who have not made their choice within this time frame, it is appropriate to distinguish between those who had already opted for a specific roaming tariff or package before the entry into force of this Regulation and those who had not. The latter should be automatically accorded a tariff that complies with this Regulation. Roaming customers who already benefit from specific roaming tariffs or packages which suit their individual requirements and which they have chosen on that basis should remain on their previously selected tariff or package if, after having been reminded of their current tariff conditions and of the applicable Eurotariffs, they express the choice to their roaming provider to remain on that tariff. Such specific roaming tariffs or packages could include, for example, roaming flat-rates, non-public tariffs, tariffs with additional fixed roaming charges, tariffs with per-minute charges lower than the maximum euro-voice, euro-SMS and euro-data tariffs or tariffs with set-up charges.
(49)
Since this Regulation should constitute a specific measure within the meaning of Article 1(5) of the Framework Directive, and since providers of Union-wide roaming services may be required by this Regulation to make changes to their retail roaming tariffs in order to comply with the requirements of this Regulation, such changes should not trigger for mobile customers any right under national laws transposing the 2002 regulatory framework for electronic communications to withdraw from their contracts.
(50)
This Regulation should not prejudice innovative offers to consumers which are more advantageous than the transitory euro-voice, euro-SMS and euro-data tariffs as defined in this Regulation, but rather should encourage innovative offers to roaming customers at lower rates in particular in response to the additional competitive pressure created by the structural provisions of this Regulation. This Regulation does not require roaming charges to be reintroduced in cases where they have been abolished altogether, nor does it require existing roaming charges to be increased to the level of the transitory safeguard limits set out in this Regulation.
(51)
Where maximum charges are not denominated in euro, the applicable initial limits and the revised values of those limits should be determined in the relevant currency by applying the reference exchange rates published in the Official Journal of the European Union on the date specified in this Regulation. Where there is no publication on the date specified, the applicable reference exchange rates should be those published in the first Official Journal of the European Union following that date and containing such reference exchange rates. To protect consumers against increasing retail prices for regulated roaming services (regulated voice, SMS or data roaming services) due to fluctuations in the reference exchange rate of currencies other than the euro, a Member State whose currency is not the euro should use an average of several reference exchange rates over time for determining the maximum retail charges in its currency.
(52)
The practice by some mobile network operators of billing for the provision of wholesale roaming calls on the basis of minimum charging periods of up to 60 seconds, as opposed to the per-second basis normally applied for other wholesale interconnection charges, creates a distortion of competition between those operators and those applying different billing methods, and undermines the consistent application of the maximum wholesale charges introduced by this Regulation. Moreover it represents an additional charge which, by increasing wholesale costs, has negative consequences for the pricing of voice roaming services at retail level. Mobile network operators should therefore be required to bill for the wholesale provision of regulated roaming calls on a per-second basis.
(53)
The ERG, the predecessor of the BEREC, estimated that the practice of mobile operators of using charging intervals of more than one second when billing for roaming services at retail level has added 24 % to a typical euro-voice tariff bill for calls made and 19 % for calls received. They also stated that these increases represent a form of hidden charge since they are not transparent to most consumers. For this reason, the ERG recommended urgent action to address the different billing practices at retail level applied to the euro-voice tariff.
(54)
While Regulation (EC) No 717/2007, by introducing a Eurotariff in the Union, established a common approach to ensuring that roaming customers are not charged excessive prices for regulated roaming calls, the different billing unitisation practices employed by mobile operators seriously undermines its consistent application. This also means that, despite the cross-border nature of Union-wide roaming services, there are divergent approaches in relation to the billing of regulated roaming calls which distort competitive conditions in the internal market.
(55)
A common set of rules regarding unitisation of euro-voice tariff bills at retail level should therefore be introduced in order to further strengthen the internal market and provide throughout the Union the same high level of protection to consumers of Union-wide roaming services.
(56)
Providers of regulated roaming calls at the retail level should therefore be required to bill their customers on a per-second basis for all calls subject to a euro-voice tariff subject only to the possibility to apply a minimum initial charging period of no more than 30 seconds for calls made. This will enable roaming providers to cover any reasonable set-up costs and to provide flexibility to compete by offering shorter minimum charging periods. No minimum initial charging period is justified in the case of euro-voice tariff calls received, as the underlying wholesale cost is charged on a per-second basis and any specific set-up costs are already covered by mobile termination rates.
(57)
Customers should not have to pay for receiving voice mail messages in a visited network, as they cannot control the duration of such messages. This should be without prejudice to other applicable voice mail charges, for example charges for listening to such messages.
(58)
Customers living in border regions should not receive unnecessarily high bills due to inadvertent roaming. Roaming providers should therefore take reasonable steps to protect customers against incurring roaming charges while they are located in their Member State. This should include adequate information measures in order to empower customers to actively prevent such instances of inadvertent roaming. National regulatory authorities should be alert to situations in which customers face problems with paying roaming charges while they are still located in their Member State and should take appropriate steps to mitigate the problem.
(59)
With regard to SMS roaming services, as is the case for voice roaming calls, there is a significant risk that imposing wholesale pricing obligations alone would not result automatically in lower rates for retail customers. On the other hand, action to reduce the level of retail prices without addressing the level of the wholesale costs associated with the provision of these services could prejudice the position of some roaming providers, in particular smaller roaming providers, by increasing the risk of price squeeze.
(60)
Furthermore, because of the particular structure of the market for roaming services and its cross-border nature, the 2002 regulatory framework for electronic communications has not provided national regulatory authorities with suitable tools to address effectively the competitive problems underlying the high level of wholesale and retail prices for regulated roaming SMS services. This fails to ensure the smooth functioning of the internal market and should be corrected.
(61)
Regulatory obligations should therefore be imposed with regard to regulated roaming SMS services at wholesale level, in order to establish a more reasonable relationship between wholesale charges and the underlying costs of provision, and at retail level for a transitional period to protect the interests of roaming customers until the structural measures become effective.
(62)
Until the structural measures have brought sufficient competition in the market for roaming services, the most effective and proportionate approach to regulating the level of prices for regulated roaming SMS messages at wholesale level is the setting at Union level of a maximum average charge per SMS sent from a visited network. The average wholesale charge should apply between any pair of operators within the Union over a specified period.
(63)
The maximum wholesale charge for regulated roaming SMS services should include all costs incurred by the provider of the wholesale service, including, inter alia, origination, transit and the unrecovered cost of termination of roaming SMS messages on the visited network. Wholesale providers of regulated roaming SMS services should therefore be prohibited from introducing a separate charge for the termination of roaming SMS messages on their network, in order to ensure the consistent application of the rules established by this Regulation.
(64)
In order to ensure that the maximum charges for wholesale roaming SMS services are closer to levels reflecting underlying costs of provision and that competition can develop at the retail level, the maximum wholesale charges for regulated SMS should follow subsequent reductions.
(65)
Regulation (EC) No 544/2009 considered that, in the absence of structural elements introducing competition in the market for roaming services, the most effective and proportionate approach to regulating the level of prices for Union-wide roaming SMS messages at the retail level was the introduction of a requirement for mobile operators to offer their roaming customers a euro-SMS tariff which does not exceed a specified maximum charge.
(66)
Until the structural measures become effective, the transitory euro-SMS tariff should be retained at a safeguard level which, whilst ensuring that the existing consumer benefits are preserved, guarantees a sufficient margin to roaming providers while also more reasonably reflecting the underlying costs of provision.
(67)
The transitory euro-SMS tariff that may be offered to roaming customers should therefore reflect a reasonable margin over the costs of providing a regulated roaming SMS service, whilst allowing roaming providers the freedom to compete by differentiating their offerings and adapting their pricing structures to market conditions and consumer preferences. Such a safeguard cap should be set at a level which does not distort the competitive benefits of structural measures and could be removed once the structural measures become effective. This regulatory approach should not apply to value-added SMS services.
(68)
Roaming customers should not be required to pay any additional charge for receiving a regulated roaming SMS or voicemail message while roaming on a visited network, since such termination costs are already compensated by the retail charge levied for the sending of a roaming SMS or voicemail message.
(69)
A euro-SMS tariff should automatically apply to any new or existing roaming customer who has not deliberately chosen or does not deliberately choose a special SMS roaming tariff or a package for roaming services including regulated roaming SMS services.
(70)
An SMS message is a Short Message Service text message and is clearly distinct from other messages such as MMS messages or e-mails. In order to ensure that this Regulation is not deprived of its effectiveness and that its objectives are fully met, any changes to the technical parameters of a roaming SMS message which would differentiate it from a domestic SMS message should be prohibited.
(71)
Data collected by national regulatory authorities indicate that high prices for average wholesale charges for data roaming services levied by visited network operators on roaming customers’ roaming providers persist. Even if these wholesale charges appear to be on a downward trend, they are still very high in relation to underlying cost.
(72)
The persistence of high wholesale charges for data roaming services is primarily attributable to high wholesale prices charged by operators of non-preferred networks. Such charges are caused by traffic-steering limitations which leave operators with no incentive to reduce their standard wholesale prices unilaterally since the traffic will be received irrespective of the price charged. This results in an extreme variation in wholesale costs. In some cases the wholesale data roaming charges applicable to non-preferred networks are six times higher than those applied to the preferred network. These excessively high wholesale charges for data roaming services lead to appreciable distortions of competitive conditions between mobile operators within the Union which undermine the smooth functioning of the internal market. They also constrain the ability of roaming providers to predict their wholesale costs and therefore to provide their customers with transparent and competitive retail pricing packages. In view of the limitations on the ability of national regulatory authorities to deal with these problems effectively at national level, a maximum wholesale charge on data roaming services should apply. Regulatory obligations should therefore be imposed with regard to regulated data roaming services at wholesale level, in order to establish a more reasonable relationship between wholesale charges and the underlying costs of provision, and at retail level to protect the interests of roaming customers.
(73)
Roaming providers should not charge the roaming customer for any regulated data roaming service, unless and until the roaming customer accepts the provision of the service.
(74)
The scope of this Regulation should cover the provision of Union-wide retail data roaming services. The special characteristics exhibited by the markets for roaming services, which justified the adoption of Regulation (EC) No 717/2007 and the imposition of obligations on mobile operators with regard to the provision of Union-wide voice roaming calls and SMS messages, apply equally to the provision of Union-wide retail data roaming services. Like voice and SMS roaming services, data roaming services are not purchased independently at national level but constitute only part of a broader retail package purchased by customers from their roaming provider, thereby limiting the competitive forces at play. Likewise, because of the cross-border nature of the services concerned, national regulatory authorities which are responsible for safeguarding and promoting the interests of mobile customers resident within their territory are not able to control the behaviour of the operators of the visited network, situated in other Member States.
(75)
As with the regulatory measures already in place for voice and SMS services, until the structural measures bring sufficient competition, the most effective and proportionate approach to regulating the level of prices for Union-wide retail data roaming services for a transitional period is the introduction of a requirement for roaming providers to offer their roaming customers a transitory euro-data tariff which does not exceed a specified maximum charge. The euro-data tariff should be set at a safeguard level which, whilst ensuring consumer protection until the structural measures become effective, guarantees a sufficient margin to roaming providers while also more reasonably reflecting the underlying costs of provision.
(76)
The transitory euro-data tariff that may be offered to roaming customers should therefore reflect a reasonable margin over the costs of providing a regulated data roaming service, whilst allowing roaming providers the freedom to compete by differentiating their offerings and adapting their pricing structures to market conditions and consumer preferences. Such a safeguard cap should be set at a level which does not distort the competitive benefits of structural measures and could be removed once the structural measures have had an opportunity to deliver concrete and lasting gains for customers. Similar to the approach followed for voice and SMS roaming services, given the reductions foreseen in the underlying costs for the provision of retail data roaming services, the maximum regulated charges for the transitory euro-data tariff should follow a declining glide path.
(77)
A transitory euro-data tariff should automatically apply to any new or existing roaming customer who has not deliberately chosen or does not deliberately choose a special data roaming tariff or a package for roaming services including regulated data roaming services.
(78)
In order to ensure that consumers pay for the data services they actually consume and to avoid the problems observed with voice services after the introduction of Regulation (EC) No 717/2007 of the hidden charges for the consumer due to the charging mechanisms applied by operators, the transitory euro-data tariff should be billed on a per-kilobyte basis. Such charging is consistent with the charging mechanism already applicable at the wholesale level.
(79)
Roaming providers may offer a fair-use, all-inclusive, monthly flat-rate to which no maximum charges apply and which could cover all Union-wide roaming services.
(80)
To ensure that all users of mobile voice telephony may benefit from the provisions of this Regulation, the transitory retail pricing requirements should apply regardless of whether roaming customers have a pre-paid or a post-paid contract with their roaming provider, and regardless of whether the roaming provider has its own network, is a mobile virtual network operator or is a reseller of mobile voice telephony services.
(81)
Where Union providers of mobile telephony services find the benefits of interoperability and end-to-end connectivity for their customers jeopardised by the termination, or threat of termination, of their roaming arrangements with mobile network operators in other Member States, or are unable to provide their customers with service in another Member State as a result of a lack of agreement with at least one wholesale network provider, national regulatory authorities should make use, where necessary, of the powers under Article 5 of the Access Directive to ensure adequate access and interconnection in order to guarantee such end-to-end connectivity and the interoperability of services, taking into account the objectives of Article 8 of the Framework Directive, in particular the creation of a fully functioning internal market for electronic communications services.
(82)
In order to improve the transparency of retail prices for roaming services and to help roaming customers make decisions on the use of their mobile devices while abroad, providers of mobile communication services should supply their roaming customers with information free of charge on the roaming charges applicable to them when using roaming services in a visited Member State. Since certain customer groups might be well informed about roaming charges, roaming providers should provide a possibility to easily opt-out from this automatic message service. Moreover, providers should actively give their customers, provided that the latter are located in the Union, on request and free of charge, additional information on the per-minute, per-SMS or per-megabyte data charges (including VAT) for the making or receiving of voice calls and also for the sending and receiving of SMS, MMS and other data communication services in the visited Member State.
(83)
Transparency also requires that providers furnish information on roaming charges, in particular on the euro-voice, euro-SMS and euro-data tariffs and the all-inclusive flat-rate should they offer one, when subscriptions are taken out and each time there is a change in roaming charges. Roaming providers should provide information on roaming charges by appropriate means such as invoices, the internet, TV advertisements or direct mail. All information and offers should be clear, understandable, permit comparison and be transparent with regard to prices and service characteristics. Advertising of roaming offers and marketing to consumers should fully comply with consumer protection legislation, in particular with Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (Unfair Commercial Practices Directive) (18). Roaming providers should ensure that all their roaming customers are aware of the availability of regulated tariffs for the period concerned and should send a clear and unbiased communication to these customers in writing describing the conditions of the euro-voice, euro-SMS and euro-data tariffs and the right to switch to and from them.
(84)
Moreover, measures should be introduced to improve the transparency of retail charges for all data roaming services, in particular to eliminate the problem of ‘bill shock’ which constitutes a barrier to the smooth functioning of the internal market, and to provide roaming customers with the tools they need to monitor and control their expenditure on data roaming services. Equally, there should be no obstacles to the emergence of applications or technologies which can be a substitute for, or alternative to, roaming services, such as Wi-Fi.
(85)
In particular, roaming providers should provide their roaming customers, free of charge, with personalised tariff information on the charges applicable to those customers for data roaming services every time they initiate a data roaming service on entering another country. This information should be delivered to their mobile device in the manner best suited to its easy receipt and comprehension, and in such a manner as to enable easy access to it at a later date.
(86)
In order to facilitate customers’ understanding of the financial consequences of the use of data roaming services and to permit them to monitor and control their expenditure, roaming providers should, both before and after the conclusion of a contract, keep their customers adequately informed of charges for regulated data roaming services. Such information could include examples of the approximate amount of data used by, for example, sending an e-mail, sending a picture, web-browsing and using mobile applications.
(87)
In addition, in order to avoid bill shocks, roaming providers should define one or more maximum financial and/or volume limits for their outstanding charges for data roaming services, expressed in the currency in which the roaming customer is billed, and which they should offer to all their roaming customers, free of charge, with an appropriate notification, in a media format that can be consulted again subsequently, when this limit is being approached. Upon reaching this maximum limit, customers should no longer receive or be charged for those services unless they specifically request continued provision of those services in accordance with the terms and conditions set out in the notification. In such a case, they should receive free confirmation, in a media format that can be consulted again subsequently. Roaming customers should be given the opportunity to opt for any of these maximum financial or volume limits within a reasonable period or to choose not to have such a limit. Unless customers state otherwise, they should be put on a default limit system.
(88)
These transparency measures should be seen as minimum safeguards for roaming customers, and should not preclude roaming providers from offering their customers a range of other facilities which help them to predict and control their expenditure on data roaming services. For example, many roaming providers are developing new retail flat-rate roaming offers which permit data roaming for a specified price over a specified period up to a ‘fair use’ volume limit. Likewise roaming providers are developing systems to enable their roaming customers to be updated on a real-time basis on their accumulated outstanding data roaming charges. To ensure the smooth functioning of the internal market, these developments on the domestic markets should be reflected in the harmonised rules.
(89)
Customers under pre-paid tariffs may also suffer from bill shocks for the use of data roaming services. For this reason the provisions on the cut-off limit should also apply to those customers.
(90)
There are considerable disparities between regulated roaming tariffs within the Union and roaming tariffs incurred by customers when they are travelling outside the Union, which are significantly higher than prices within the Union. Due to the absence of a consistent approach to transparency and safeguard measures concerning roaming outside the Union, consumers are not confident about their rights and are therefore often deterred from using mobile services while abroad. Transparent information provided to consumers could not only assist them in the decision as to how to use their mobile devices while travelling abroad (both within and outside the Union), but could also assist them in the choice between roaming providers. It is therefore necessary to address the problem of the lack of transparency and consumer protection by applying certain transparency and safeguard measures also to roaming services provided outside the Union. Those measures would facilitate competition and improve the functioning of the internal market.
(91)
If the visited network operator in the visited country outside the Union does not allow the roaming provider to monitor its customers’ usage on a real-time basis, the roaming provider should not be obliged to provide the maximum financial or volume limits for safeguarding customers.
(92)
The national regulatory authorities which are responsible for carrying out tasks under the 2002 regulatory framework for electronic communications should have the powers needed to supervise and enforce the obligations under this Regulation within their territory. They should also monitor developments in the pricing of voice and data services for roaming customers within the Union including, where appropriate, the specific costs related to roaming calls made and received in the outermost regions of the Union and the need to ensure that these costs can be adequately recovered on the wholesale market, and that traffic-steering techniques are not used to limit choice to the detriment of customers. They should ensure that up-to-date information on the application of this Regulation is made available to interested parties and publish the results of such monitoring every six months. Information should be provided on corporate, post-paid and pre-paid customers separately.
(93)
In-country roaming in the outermost regions of the Union where mobile telephony licences are distinct from those issued in respect of the rest of the national territory could benefit from rate reductions equivalent to those practised on the internal market for roaming services. The implementation of this Regulation should not give rise to less favourable pricing treatment for customers using in-country roaming services as opposed to customers using Union-wide roaming services. To this end, the national authorities may take additional measures consistent with Union law.
(94)
When laying down the rules on penalties applicable to infringements of this Regulation, Member States should, inter alia, take into account the possibility for roaming providers to compensate customers for any delay or hindrance to the switch to an alternative roaming provider, in accordance with their national law.
(95)
Since the objectives of this Regulation, namely to establish a common approach to ensure that users of public mobile communication networks when travelling within the Union do not pay excessive prices for Union-wide roaming services, thereby achieving a high level of consumer protection by enhancing competition between roaming providers, cannot be sufficiently achieved by the Member States in a secure, harmonised and timely manner and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(96)
Regulatory obligations on wholesale charges for voice, SMS and data roaming services should be maintained until the structural measures have become effective and competition in the wholesale markets has developed sufficiently. In addition, market trends currently show that data services will progressively become the most relevant segment of mobile services, and wholesale data roaming services currently exhibit the highest level of dynamism, with prices reasonably below the current regulated rates.
(97)
Retail safeguard caps should be set at sufficiently high levels which do not distort the potential competitive benefits of structural measures and could be removed completely once those measures become effective and have enabled the development of a genuine internal market. Therefore, retail safeguard caps should follow a downward trend and subsequently expire.
(98)
The Commission should review the effectiveness of this Regulation in light of its objectives and the contribution to the implementation of the 2002 regulatory framework for electronic communications and the smooth functioning of the internal market. In this context, the Commission should consider the impact on the competitive position of mobile communications providers of different sizes and from different parts of the Union, the developments, trends and transparency in retail and wholesale charges, their relation to actual costs, the extent to which the assumptions made in the impact assessment that accompanied this Regulation have been confirmed, the costs of compliance and the impact on the investments. The Commission should also, in the light of technological developments, consider the availability and quality of services which are an alternative to roaming (such as access through Wi-Fi).
(99)
Regulatory obligations on wholesale and retail charges for voice, SMS and data roaming services should be maintained to safeguard consumers as long as competition at the retail or wholesale level is not fully developed. To this end, the Commission should, by 30 June 2016, assess whether the objectives of this Regulation have been achieved, including whether the structural measures have been fully implemented and competition is sufficiently developed in the internal market for roaming services. If the Commission concludes that competition has not developed sufficiently, the Commission should make appropriate proposals to the European Parliament and the Council to ensure that consumers are adequately safeguarded as from 2017.
(100)
After the abovementioned review, and in order to ensure the continuous monitoring of roaming services in the Union, the Commission should prepare a report to the European Parliament and the Council every two years which includes a general summary of the latest trends in roaming services and an intermediary assessment of the progress towards achieving the objectives of this Regulation and of the possible alternative options for achieving these objectives,
HAVE ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1. This Regulation introduces a common approach to ensuring that users of public mobile communications networks, when travelling within the Union, do not pay excessive prices for Union-wide roaming services in comparison with competitive national prices, when making calls and receiving calls, when sending and receiving SMS messages and when using packet switched data communication services, thereby contributing to the smooth functioning of the internal market while achieving a high level of consumer protection, fostering competition and transparency in the market and offering both incentives for innovation and consumer choice.
It lays down rules to enable the separate sale of regulated roaming services from domestic mobile communications services and sets out the conditions for wholesale access to public mobile communications networks for the purpose of providing regulated roaming services. It also lays down transitory rules on the charges that may be levied by roaming providers for the provision of regulated roaming services for voice calls and SMS messages originating and terminating within the Union and for packet switched data communication services used by roaming customers while roaming on a mobile communications network within the Union. It applies both to charges levied by network operators at wholesale level and to charges levied by roaming providers at retail level.
2. The separate sale of regulated roaming services from domestic mobile communications services is a necessary intermediate step to increase competition so as to lower roaming tariffs for customers in order to achieve an internal market for mobile communication services and ultimately for there to be no differentiation between national and roaming tariffs.
3. This Regulation also lays down rules aimed at increasing price transparency and improving the provision of information on charges to users of roaming services.
4. This Regulation constitutes a specific measure within the meaning of Article 1(5) of the Framework Directive.
5. The maximum charges set out in this Regulation are expressed in euro.
6. Where maximum charges under Articles 7, 9 and 12 are denominated in currencies other than the euro, the initial limits pursuant to those Articles shall be determined in those currencies by applying the reference exchange rates published on 1 May 2012 by the European Central Bank in the Official Journal of the European Union.
For the purposes of the subsequent limits provided for in Article 7(2), Article 9(1), and Article 12(1), the revised values shall be determined by applying the reference exchange rates so published on 1 May of the relevant calendar year. For the maximum charges under Article 7(2), Article 9(1) and Article 12(1), the limits in currencies other than the euro shall be revised annually as from 2015. The annually revised limits in those currencies shall apply from 1 July using the reference exchange rates published on 1 May of the same year.
7. Where maximum charges under Articles 8, 10 and 13 are denominated in currencies other than the euro, the initial limits pursuant to those Articles shall be determined in those currencies by applying the average of the reference exchange rates published on 1 March, 1 April and 1 May 2012 by the European Central Bank in the Official Journal of the European Union.
For the purposes of the subsequent limits provided for in Article 8(2), Article 10(2) and Article 13(2), the revised values shall be determined by applying the average of the reference exchange rates so published on 1 March, 1 April and 1 May of the relevant calendar year. For the maximum charges under Article 8(2), Article 10(2) and Article 13(2), the limits in currencies other than euro shall be revised annually as from 2015. The annually revised limits in those currencies shall apply from 1 July using the average of the reference exchange rates published on 1 March, 1 April and 1 May of the same year.
Article 2
Definitions
1. For the purposes of this Regulation, the definitions set out in Article 2 of the Access Directive, Article 2 of the Framework Directive, and Article 2 of the Universal Service Directive shall apply.
2. In addition to the definitions referred to in paragraph 1, the following definitions shall apply:
(a)
‘roaming provider’ means an undertaking that provides a roaming customer with regulated retail roaming services;
(b)
‘domestic provider’ means an undertaking that provides a roaming customer with domestic mobile communications services;
(c)
‘alternative roaming provider’ means a roaming provider different from the domestic provider;
(d)
‘home network’ means a public communications network located within a Member State and used by the roaming provider for the provision of regulated retail roaming services to a roaming customer;
(e)
‘visited network’ means a terrestrial public mobile communications network situated in a Member State other than that of the roaming customer’s domestic provider that permits a roaming customer to make or receive calls, to send or receive SMS messages or to use packet switched data communications, by means of arrangements with the home network operator;
(f)
‘Union-wide roaming’ means the use of a mobile device by a roaming customer to make or receive intra-Union calls, to send or receive intra-Union SMS messages, or to use packet switched data communications, while in a Member State other than that in which the network of the domestic provider is located, by means of arrangements between the home network operator and the visited network operator;
(g)
‘roaming customer’ means a customer of a roaming provider of regulated roaming services, by means of a terrestrial public mobile communications network situated in the Union, whose contract or arrangement with that roaming provider permits Union-wide roaming;
(h)
‘regulated roaming call’ means a mobile voice telephony call made by a roaming customer, originating on a visited network and terminating on a public communications network within the Union or received by a roaming customer, originating on a public communications network within the Union and terminating on a visited network;
(i)
‘euro-voice tariff’ means any tariff not exceeding the maximum charge provided for in Article 8, which a roaming provider may levy for the provision of regulated roaming calls in accordance with that Article;
(j)
‘SMS message’ means a Short Message Service text message, composed principally of alphabetical and/or numerical characters, capable of being sent between mobile and/or fixed numbers assigned in accordance with national numbering plans;
(k)
‘regulated roaming SMS message’ means an SMS message sent by a roaming customer, originating on a visited network and terminating on a public communications network within the Union or received by a roaming customer, originating on a public communications network within the Union and terminating on a visited network;
(l)
‘euro-SMS tariff’ means any tariff not exceeding the maximum charge provided for in Article 10, which a roaming provider may levy for the provision of regulated roaming SMS messages in accordance with that Article;
(m)
‘regulated data roaming service’ means a roaming service enabling the use of packet switched data communications by a roaming customer by means of his mobile device while it is connected to a visited network. A regulated data roaming service does not include the transmission or receipt of regulated roaming calls or SMS messages, but does include the transmission and receipt of MMS messages;
(n)
‘euro-data tariff’ means any tariff not exceeding the maximum charge provided for in Article 13, which a roaming provider may levy for the provision of regulated data roaming services in accordance with that Article;
(o)
‘wholesale roaming access’ means direct wholesale roaming access or wholesale roaming resale access;
(p)
‘direct wholesale roaming access’ means the making available of facilities and/or services by a mobile network operator to another undertaking, under defined conditions, for the purpose of that other undertaking providing regulated roaming services to roaming customers;
(q)
‘wholesale roaming resale access’ means the provision of roaming services on a wholesale basis by a mobile network operator different from the visited network operator to another undertaking for the purpose of that other undertaking providing regulated roaming services to roaming customers.
Article 3
Wholesale roaming access
1. Mobile network operators shall meet all reasonable requests for wholesale roaming access.
2. Mobile network operators may refuse requests for wholesale roaming access only on the basis of objective criteria.
3. Wholesale roaming access shall cover access to all network elements and associated facilities, relevant services, software and information systems, necessary for the provision of regulated roaming services to customers.
4. Rules on regulated wholesale roaming charges laid down in Articles 7, 9 and 12 shall apply to the provision of access to all components of wholesale roaming access referred to in paragraph 3.
Without prejudice to the first subparagraph, in the case of wholesale roaming resale access, mobile network operators may charge fair and reasonable prices for components not covered by paragraph 3.
5. Mobile network operators shall publish a reference offer, taking into account the BEREC guidelines referred to in paragraph 8, and make it available to an undertaking requesting wholesale roaming access. Mobile network operators shall provide the undertaking requesting access with a draft contract, complying with this Article, for such access at the latest one month after the initial receipt of the request by the mobile network operator. The wholesale roaming access shall be granted within a reasonable period of time not exceeding three months from the conclusion of the contract. Mobile network operators receiving a wholesale roaming access request and undertakings requesting access shall negotiate in good faith.
6. The reference offer referred to in paragraph 5 shall be sufficiently detailed and shall include all components necessary for wholesale roaming access as referred to in paragraph 3, providing a description of the offerings relevant for direct wholesale roaming access and wholesale roaming resale access, and the associated terms and conditions. If necessary, national regulatory authorities shall impose changes to reference offers to give effect to obligations laid down in this Article.
7. Where the undertaking requesting the access desires to enter into commercial negotiations to also include components not covered by the reference offer, the mobile network operators shall respond to such a request within a reasonable period of time not exceeding two months from its initial receipt. For the purposes of this paragraph, paragraphs 2 and 5 shall not apply.
8. By 30 September 2012, and in order to contribute to the consistent application of this Article, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, lay down guidelines for wholesale roaming access.
9. Paragraphs 5 to 7 shall apply from 1 January 2013.
Article 4
Separate sale of regulated retail roaming services
1. Domestic providers shall enable their customers to access regulated voice, SMS and data roaming services, provided as a bundle by any alternative roaming provider.
Neither domestic nor roaming providers shall prevent customers from accessing regulated data roaming services provided directly on a visited network by an alternative roaming provider.
2. Roaming customers shall have the right to switch roaming provider at any time. Where a roaming customer chooses to switch roaming provider, the switch shall be carried out without undue delay, and in any case within the shortest possible period of time depending on the technical solution chosen for the implementation of the separate sale of regulated retail roaming services, but under no circumstances exceeding three working days from the conclusion of the agreement with the new roaming provider.
3. The switch to an alternative roaming provider or between roaming providers shall be free of charge for customers and shall be possible under any tariff plan. It shall not entail any associated subscription or additional fixed or recurring charges, pertaining to elements of the subscription other than roaming, as compared to the conditions prevailing before the switch.
4. Domestic providers shall inform all their roaming customers in a clear, understandable and easily accessible form about the possibility to opt for services referred to in the first subparagraph of paragraph 1.
In particular, at the time of making or renewing a contract on mobile communication services, domestic providers shall provide all their customers individually with full information on the possibility to choose an alternative roaming provider and shall not hinder the conclusion of a contract with an alternative roaming provider. Customers concluding a contract with a domestic provider for regulated roaming services shall explicitly confirm that they have been informed of such possibility. A domestic provider shall not prevent, dissuade or discourage retailers serving as the domestic provider’s points of sale from offering contracts for separate roaming services with alternative roaming providers.
5. The technical characteristics of regulated roaming services shall not be altered in such a way as to make them differ from the technical characteristics of the regulated roaming services, including the quality parameters, as provided to the customer before the switch. Where the switch does not concern all regulated roaming services, those services which have not been switched shall continue to be provided at the same price and, to the fullest extent possible, with the same technical characteristics, including quality parameters.
6. This Article shall apply from 1 July 2014.
Article 5
Implementation of separate sale of regulated retail roaming services
1. Domestic providers shall implement the separate sale of regulated retail roaming services as provided for in Article 4 so that customers can use domestic mobile communication services and separate regulated roaming services. Domestic providers shall meet all reasonable requests for access to facilities and related support services relevant for the separate sale of regulated retail roaming services. Access to those facilities and support services that are necessary for the separate sale of regulated roaming services, including user authentication services, shall be free of charge and shall not entail any direct charges to customers.
2. In order to ensure consistent and simultaneous implementation across the Union of the separate sale of regulated retail roaming services, the Commission shall, by means of implementing acts and after having consulted BEREC, adopt, by 31 December 2012, detailed rules on the information obligations laid down in Article 4(4) and on a technical solution for the implementation of the separate sale of regulated retail roaming services. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 6(2), and shall apply from 1 July 2014.
3. The technical solution to implement the separate sale of regulated retail roaming services shall meet the following criteria:
(a)
consumer friendliness, in particular allowing consumers to easily and quickly switch to an alternative roaming provider while keeping their existing mobile phone number and while using the same mobile device;
(b)
ability to serve all categories of consumer demand on competitive terms, including intensive usage of data services;
(c)
ability to effectively foster competition, taking also into account the scope for operators to exploit their infrastructure assets or commercial arrangements;
(d)
cost-effectiveness, taking into account the division of costs between domestic providers and alternative roaming providers;
(e)
ability to give effect to the obligations referred to in Article 4(1) in an efficient manner;
(f)
allowing a maximum degree of interoperability;
(g)
user friendliness, in particular in respect of the customers’ technical handling of the mobile device when changing networks;
(h)
ensuring that roaming by Union customers in third countries or by third country customers in the Union is not impeded;
(i)
ensuring that the rules on protection of privacy, personal data, security and integrity of networks and transparency required by the Framework Directive and the Specific Directives are respected;
(j)
taking into account the promotion by national regulatory authorities of the ability of end users to access and distribute information or run applications and services of their choice, in accordance with point (g) of Article 8(4) of the Framework Directive;
(k)
ensuring that providers apply equivalent conditions in equivalent circumstances.
4. The technical solution may combine one or several technical modalities for the purposes of meeting the criteria set out in paragraph 3.
5. If necessary, the Commission shall give a mandate to a European standardisation body for the adaptation of the relevant standards that are necessary for the harmonised implementation of the separate sale of regulated retail roaming services.
6. Paragraphs 1, 3, 4 and 5 of this Article shall apply from 1 July 2014.
Article 6
Committee procedure
1. The Commission shall be assisted by the Communications Committee established by Article 22 of the Framework Directive. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 7
Wholesale charges for the making of regulated roaming calls
1. The average wholesale charge that the visited network operator may levy on the customer’s roaming provider for the provision of a regulated roaming call originating on that visited network, inclusive, inter alia, of origination, transit and termination costs, shall not exceed EUR 0,14 per minute as of 1 July 2012.
2. The average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a 12-month period or any such shorter period as may remain before the end of the period of application of a maximum average wholesale charge as provided for in this paragraph or before 30 June 2022. The maximum average wholesale charge shall decrease to EUR 0,10 on 1 July 2013 and to EUR 0,05 on 1 July 2014 and shall, without prejudice to Article 19, remain at EUR 0,05 until 30 June 2022.
3. The average wholesale charge referred to in paragraph 1 shall be calculated by dividing the total wholesale roaming revenue received by the total number of wholesale roaming minutes actually used for the provision of wholesale roaming calls within the Union by the relevant operator over the relevant period, aggregated on a per-second basis adjusted to take account of the possibility for the operator of the visited network to apply an initial minimum charging period not exceeding 30 seconds.
Article 8
Retail charges for regulated roaming calls
1. Roaming providers shall make available and actively offer to all their roaming customers, clearly and transparently, a euro-voice tariff as provided for in paragraph 2. That tariff shall not entail any associated subscription or other fixed or recurring charges and may be combined with any retail tariff.
When making this offer, roaming providers shall remind any of their roaming customers who had chosen a specific roaming tariff or package of the conditions applicable to that tariff or package.
2. With effect from 1 July 2012, the retail charge (excluding VAT) for a euro-voice tariff which a roaming provider may levy on its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed EUR 0,29 per minute for any call made or EUR 0,08 per minute for any call received. The maximum retail charge for calls made shall decrease to EUR 0,24 on 1 July 2013 and to EUR 0,19 on 1 July 2014 and the maximum retail charge for calls received shall decrease to EUR 0,07 on 1 July 2013 and to EUR 0,05 on 1 July 2014. Without prejudice to Article 19 those maximum retail charges for the euro-voice tariff shall remain valid until 30 June 2017.
Roaming providers shall not levy any charge on their roaming customers for the receipt by them of a roaming voicemail message. This shall be without prejudice to other applicable charges such as those for listening to such messages.
Every roaming provider shall charge its roaming customers for the provision of any regulated roaming call to which a euro-voice tariff applies, whether made or received, on a per-second basis.
The roaming provider may apply an initial minimum charging period not exceeding 30 seconds to calls made which are subject to a euro-voice tariff.
3. Roaming providers shall apply a euro-voice tariff to all existing roaming customers automatically with the exception of such roaming customers who have already made a deliberate choice of a specific roaming tariff or package by virtue of which they benefit from a different tariff for regulated roaming calls than they would have been accorded in the absence of such a choice.
4. Roaming providers shall apply a euro-voice tariff to all new roaming customers who do not make a deliberate choice to select a different roaming tariff or a tariff package for roaming services which includes a different tariff for regulated roaming calls.
5. Any roaming customer may request to switch to or from a euro-voice tariff. Any switch shall be made within one working day of receipt of the request, shall be free of charge and shall not entail conditions or restrictions pertaining to other elements of the subscription, save that where a roaming customer who has subscribed to a special roaming package which includes more than one regulated roaming service wishes to switch to a euro-voice tariff, the roaming provider may require the switching customer to forego the benefits of the other elements of that package. A roaming provider may delay a switch until the previous roaming tariff has been effective for a minimum specified period not exceeding two months. A euro-voice tariff may always be combined with a euro-SMS tariff and a euro-data tariff.
Article 9
Wholesale charges for regulated roaming SMS messages
1. With effect from 1 July 2012, the average wholesale charge that the visited network operator may levy for the provision of a regulated roaming SMS message originating on that visited network shall not exceed EUR 0,03 per SMS message. The maximum average wholesale charge shall decrease to EUR 0,02 on 1 July 2013 and shall, without prejudice to Article 19, remain at EUR 0,02 until 30 June 2022.
2. The average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a 12-month period or any such shorter period as may remain before 30 June 2022.
3. The average wholesale charge referred to in paragraph 1 shall be calculated by dividing the total wholesale revenue received by the visited network operator or home network operator for the origination and transmission of regulated roaming SMS messages within the Union in the relevant period by the total number of such SMS messages originated and transmitted on behalf of the relevant roaming provider or home network operator within that period.
4. The visited network operator shall not levy any charge on a roaming customer’s roaming provider or home network operator, separate from the charge referred to in paragraph 1, for the termination of a regulated roaming SMS message sent to a roaming customer while roaming on its visited network.
Article 10
Retail charges for regulated roaming SMS messages
1. Roaming providers shall make available and actively offer to all their roaming customers, clearly and transparently, a euro-SMS tariff as provided for in paragraph 2. The euro-SMS tariff shall not entail any associated subscription or other fixed or recurring charges and may be combined with any retail tariff, subject to the other provisions of this Article.
2. With effect from 1 July 2012, the retail charge (excluding VAT) for a euro-SMS tariff which a roaming provider may levy on its roaming customer for a regulated roaming SMS message sent by that roaming customer may vary for any regulated roaming SMS message but shall not exceed EUR 0,09. That maximum charge shall decrease to EUR 0,08 on 1 July 2013 and to EUR 0,06 on 1 July 2014 and shall, without prejudice to Article 19, remain at EUR 0,06 until 30 June 2017.
3. Roaming providers shall not levy any charge on their roaming customers for the receipt by them of a regulated roaming SMS message.
4. Roaming providers shall apply a euro-SMS tariff to all existing roaming customers automatically, with the exception of such roaming customers who have already made a deliberate choice of a specific roaming tariff or package by virtue of which they benefit from a different tariff for regulated roaming SMS messages than they would have been accorded in the absence of such a choice.
5. Roaming providers shall apply a euro-SMS tariff to all new roaming customers who do not make a deliberate choice to select a different roaming SMS tariff or a tariff package for roaming services which includes a different tariff for regulated roaming SMS messages.
6. Any roaming customer may request to switch to or from a euro-SMS tariff at any time. Any switch shall be made within one working day of receipt of the request, shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than roaming. A roaming provider may delay such a switch until the previous roaming tariff has been effective for a minimum specified period not exceeding two months. A euro-SMS tariff may always be combined with a euro-voice tariff and a euro-data tariff.
Article 11
Technical characteristics of regulated roaming SMS messages
No roaming provider, domestic provider, home network operator or visited network operator shall alter the technical characteristics of regulated roaming SMS messages in such a way as to make them differ from the technical characteristics of SMS messages provided within its domestic market.
Article 12
Wholesale charges for regulated data roaming services
1. With effect from 1 July 2012, the average wholesale charge that the visited network operator may levy on the roaming customer’s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of EUR 0,25 per megabyte of data transmitted. The safeguard limit shall decrease to EUR 0,15 per megabyte of data transmitted on 1 July 2013 and to EUR 0,05 per megabyte of data transmitted on 1 July 2014 and shall, without prejudice to Article 19, remain at EUR 0,05 per megabyte of data transmitted until 30 June 2022.
2. The average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a 12-month period or any such shorter period as may remain before 30 June 2022.
3. The average wholesale charge referred to in paragraph 1 shall be calculated by dividing the total wholesale revenue received by the visited network or home network operator for the provision of regulated data roaming services in the relevant period by the total number of megabytes of data actually consumed by the provision of those services within that period, aggregated on a per-kilobyte basis on behalf of the relevant roaming provider or home network operator within that period.
Article 13
Retail charges for regulated data roaming services
1. Roaming providers shall make available and actively offer to all their roaming customers, clearly and transparently, a euro-data tariff as provided for in paragraph 2. This euro-data tariff shall not entail any associated subscription or other fixed or recurring charges and may be combined with any retail tariff.
When making this offer, roaming providers shall remind those roaming customers who have already chosen a specific roaming tariff or package of the conditions applicable to that tariff or package.
2. With effect from 1 July 2012, the retail charge (excluding VAT) of a euro-data tariff which a roaming provider may levy on its roaming customer for the provision of a regulated data roaming service shall not exceed EUR 0,70 per megabyte used. The maximum retail charge for data used shall decrease to EUR 0,45 per megabyte used on 1 July 2013 and to EUR 0,20 per megabyte used on 1 July 2014 and shall, without prejudice to Article 19, remain at EUR 0,20 per megabyte used until 30 June 2017.
Every roaming provider shall charge its roaming customers for the provision of any regulated roaming data service to which a euro-data tariff applies on a per-kilobyte basis, except for Multimedia Messaging Service (MMS) messages which may be charged on a per-unit basis. In such a case, the retail charge which a roaming provider may levy on its roaming customer for the transmission or receipt of a roaming MMS message shall not exceed the maximum retail charge set in the first subparagraph.
3. From 1 July 2012 roaming providers shall apply a euro-data tariff to all existing roaming customers automatically, with the exception of such roaming customers who have already made a choice of a specific roaming tariff, or who are already on a tariff which is demonstrably lower than the euro-data tariff or who have already made a choice of a package by virtue of which they benefit from a different tariff for regulated data roaming services than they would have been accorded in the absence of such choice.
4. From 1 July 2012 roaming providers shall apply a euro-data tariff to all new roaming customers who have not made a deliberate choice to select a different roaming data tariff or a tariff package for roaming services which includes a different tariff for regulated roaming data services.
5. Any roaming customer may request to switch to or from a euro-data tariff, respecting their contractual conditions, at any point in time. Any switch shall be made within one working day of receipt of the request, shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than Union-wide roaming. A roaming provider may delay such a switch until the previous roaming tariff has been effective for a minimum specified period not exceeding two months. A euro-data tariff may always be combined with a euro-SMS tariff and a euro-voice tariff.
6. By 30 June 2012 roaming providers shall inform all their roaming customers individually, in a clear and understandable manner and on a durable medium, about the euro-data tariff, that it will apply from 1 July 2012 at the latest to all roaming customers who have not made a deliberate choice of a special tariff or package applicable to regulated data roaming services, and about their right to switch to and from it in accordance with paragraph 5.
Article 14
Transparency of retail charges for roaming calls and SMS messages
1. To alert roaming customers to the fact that they will be subject to roaming charges when making or receiving a call or when sending an SMS message, each roaming provider shall, except when the customer has notified the roaming provider that he does not require this service, provide the customer, automatically by means of a Message Service, without undue delay and free of charge, when he enters a Member State other than that of his domestic provider, with basic personalised pricing information on the roaming charges (including VAT) that apply to the making and receiving of calls and to the sending of SMS messages by that customer in the visited Member State.
That basic personalised pricing information shall include the maximum charges (in the currency of the home bill provided by the customer’s domestic provider) to which the customer may be subject under his tariff scheme for:
(a)
making regulated roaming calls within the visited Member State and back to the Member State of his domestic provider, as well as for regulated roaming calls received; and
(b)
sending regulated roaming SMS messages while in the visited Member State.
It shall also include the free-of-charge number referred to in paragraph 2 for obtaining more detailed information and information on the possibility of accessing emergency services by dialling the European emergency number 112 free of charge.
On the occasion of each message, a customer shall have the opportunity to give notice to the roaming provider, free of charge and in an easy manner, that he does not require the automatic Message Service. A customer who has given notice that he does not require the automatic Message Service shall have the right at any time and free of charge to require the roaming provider to provide the service again.
Roaming providers shall provide blind or partially-sighted customers with the basic personalised pricing information referred to in the first subparagraph automatically, by voice call, free of charge, if they so request.
The first, second, fourth and fifth subparagraphs shall also apply to voice and SMS roaming services used by roaming customers travelling outside the Union and provided by a roaming provider.
2. In addition to paragraph 1, customers shall have the right to request and receive, free of charge, and irrespective of their location within the Union, more detailed personalised pricing information on the roaming charges that apply in the visited network to voice calls and SMS, and information on the transparency measures applicable by virtue of this Regulation, by means of a mobile voice call or by SMS. Such a request shall be to a free-of-charge number designated for this purpose by the roaming provider. Obligations provided for in paragraph 1 shall not apply to devices which do not support SMS functionality.
3. Roaming providers shall provide all users with full information on applicable roaming charges, in particular on the euro-voice tariff and the euro-SMS tariff, when subscriptions are taken out. They shall also provide their roaming customers with updates on applicable roaming charges without undue delay each time there is a change in these charges.
Roaming providers shall take the necessary steps to secure awareness by all their roaming customers of the availability of the euro-voice tariff and the euro-SMS tariff. They shall in particular communicate to all roaming customers the conditions relating to the euro-voice tariff and the conditions relating to the euro-SMS tariff, in each case in a clear and unbiased manner. They shall send a reminder at reasonable intervals thereafter to all customers who have opted for another tariff.
The information provided shall be sufficiently detailed for customers to judge whether or not it is beneficial for them to switch to a Eurotariff.
4. Roaming providers shall make available information to their customers on how to avoid inadvertent roaming in border regions. Roaming providers shall take reasonable steps to protect their customers from paying roaming charges for inadvertently accessed roaming services while situated in their home Member State.
Article 15
Transparency and safeguard mechanisms for retail data roaming services
1. Roaming providers shall ensure that their roaming customers, both before and after the conclusion of a contract, are kept adequately informed of the charges which apply to their use of regulated data roaming services, in ways which facilitate customers’ understanding of the financial consequences of such use and permit them to monitor and control their expenditure on regulated data roaming services in accordance with paragraphs 2 and 3.
Where appropriate, roaming providers shall inform their customers, before the conclusion of a contract and on a regular basis thereafter, of the risk of automatic and uncontrolled data roaming connection and download. Furthermore, roaming providers shall notify to their customers, free of charge and in a clear and easily understandable manner, how to switch off these automatic data roaming connections in order to avoid uncontrolled consumption of data roaming services.
2. An automatic message from the roaming provider shall inform the roaming customer that the latter is roaming and provide basic personalised tariff information on the charges (in the currency of the home bill provided by the customer’s domestic provider), expressed in price per megabyte, applicable to the provision of regulated data roaming services to that roaming customer in the Member State concerned, except where the customer has notified the roaming provider that he does not require that information.
Such basic personalised tariff information shall be delivered to the roaming customer’s mobile device, for example by an SMS message, an e-mail or a pop-up window on the mobile device, every time the roaming customer enters a Member State other than that of his domestic provider and initiates for the first time a data roaming service in that particular Member State. It shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service, by an appropriate means adapted to facilitate its receipt and easy comprehension.
A customer who has notified his roaming provider that he does not require the automatic tariff information shall have the right at any time and free of charge to require the roaming provider to provide this service again.
3. Each roaming provider shall grant to all their roaming customers the opportunity to opt deliberately and free of charge for a facility which provides information on the accumulated consumption expressed in volume or in the currency in which the roaming customer is billed for regulated data roaming services and which guarantees that, without the customer’s explicit consent, the accumulated expenditure for regulated data roaming services over a specified period of use, excluding MMS billed on a per-unit basis, does not exceed a specified financial limit.
To this end, the roaming provider shall make available one or more maximum financial limits for specified periods of use, provided that the customer is informed in advance of the corresponding volume amounts. One of those limits (the default financial limit) shall be close to, but not exceed, EUR 50 of outstanding charges per monthly billing period (excluding VAT).
Alternatively, the roaming provider may establish limits expressed in volume, provided that the customer is informed in advance of the corresponding financial amounts. One of those limits (the default volume limit) shall have a corresponding financial amount not exceeding EUR 50 of outstanding charges per monthly billing period (excluding VAT).
In addition, the roaming provider may offer to its roaming customers other limits with different, that is, higher or lower, maximum monthly financial limits.
The default limits referred to in the second and third subparagraphs shall be applicable to all customers who have not opted for another limit.
Each roaming provider shall also ensure that an appropriate notification is sent to the roaming customer’s mobile device, for example by an SMS message, an e-mail or a pop-up window on the computer, when the data roaming services have reached 80 % of the agreed financial or volume limit. Each customer shall have the right to require the roaming provider to stop sending such notifications and shall have the right, at any time and free of charge, to require the provider to provide the service again.
When the financial or volume limit would otherwise be exceeded, a notification shall be sent to the roaming customer’s mobile device. That notification shall indicate the procedure to be followed if the customer wishes to continue provision of those services and the cost associated with each additional unit to be consumed. If the roaming customer does not respond as prompted in the notification received, the roaming provider shall immediately cease to provide and to charge the roaming customer for regulated data roaming services, unless and until the roaming customer requests the continued or renewed provision of those services.
Whenever a roaming customer requests to opt for or to remove a financial or volume limit facility, the change shall be made within one working day of receipt of the request, shall be free of charge, and shall not entail conditions or restrictions pertaining to other elements of the subscription.
4. Paragraphs 2 and 3 shall not apply to machine-to-machine devices that use mobile data communication.
5. Roaming providers shall take reasonable steps to protect their customers from paying roaming charges for inadvertently accessed roaming services while situated in their home Member State. This shall include informing customers on how to avoid inadvertent roaming in border regions.
6. This Article, with the exception of paragraph 5, and subject to the second and third subparagraph of this paragraph, shall also apply to data roaming services used by roaming customers travelling outside the Union and provided by a roaming provider.
Where the customer opts for the facility referred to in the first subparagraph of paragraph 3, the requirements provided in paragraph 3 shall not apply if the visited network operator in the visited country outside the Union does not allow the roaming provider to monitor its customers’ usage on a real-time basis.
In such a case the customer shall be notified by an SMS message when entering such a country, without undue delay and free of charge, that information on accumulated consumption and the guarantee not to exceed a specified financial limit are not available.
Article 16
Supervision and enforcement
1. National regulatory authorities shall monitor and supervise compliance with this Regulation within their territory.
2. National regulatory authorities shall make up-to-date information on the application of this Regulation, in particular Articles 7, 8, 9, 10, 12 and 13, publicly available in a manner that enables interested parties to have easy access to it.
3. National regulatory authorities shall, in preparation for the review provided for in Article 19, monitor developments in wholesale and retail charges for the provision to roaming customers of voice and data communications services, including SMS and MMS, including in the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union. National regulatory authorities shall also be alert to the particular case of inadvertent roaming in the border regions of neighbouring Member States and monitor whether traffic-steering techniques are used to the disadvantage of customers.
National regulatory authorities shall monitor and collect information on inadvertent roaming and take appropriate measures.
4. National regulatory authorities shall have the power to require undertakings subject to obligations under this Regulation to supply all information relevant to the implementation and enforcement of this Regulation. Those undertakings shall provide such information promptly on request and in accordance with time limits and level of detail required by the national regulatory authority.
5. National regulatory authorities may intervene on their own initiative in order to ensure compliance with this Regulation. In particular, they shall, where necessary, make use of the powers under Article 5 of the Access Directive to ensure adequate access and interconnection in order to guarantee the end-to-end connectivity and interoperability of roaming services, for example where customers are unable to exchange regulated roaming SMS messages with customers of a terrestrial public mobile communications network in another Member State as a result of the absence of an agreement enabling the delivery of those messages.
6. Where a national regulatory authority finds that a breach of the obligations set out in this Regulation has occurred, it shall have the power to require the immediate cessation of such a breach.
Article 17
Dispute resolution
1. In the event of a dispute in connection with the obligations laid down in this Regulation between undertakings providing electronic communications networks or services in a Member State, the dispute resolution procedures laid down in Articles 20 and 21 of the Framework Directive shall apply.
2. In the event of an unresolved dispute involving a consumer or end-user and concerning an issue falling within the scope of this Regulation, the Member States shall ensure that the out-of-court dispute resolution procedures laid down in Article 34 of the Universal Service Directive are available.
Article 18
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 30 June 2013 and shall notify it without delay of any subsequent amendment affecting them.
Article 19
Review
1. The Commission shall review the functioning of this Regulation and, after a public consultation, shall report to the European Parliament and the Council by 30 June 2016. The Commission shall evaluate in particular whether the objectives of this Regulation have been achieved. In so doing, the Commission shall review, inter alia:
(a)
whether competition has sufficiently developed in order to justify the expiry of maximum retail charges;
(b)
whether competition will be sufficient for the removal of maximum wholesale charges;
(c)
the developments and expected future trends in wholesale and retail charges for the provision to roaming customers of voice, SMS and data communication services, in comparison to the charges for mobile communications services at domestic level in the Member States, both for pre-paid and post-paid customers separately, and in the quality and speed of these services;
(d)
the availability and quality of services including those which are an alternative to voice, SMS and data roaming services, in particular in the light of technological developments;
(e)
the extent to which consumers have benefited through real reductions in the price of roaming services, the variety of tariffs and products which are available to consumers with different calling patterns, and the difference between roaming and national tariffs, including the availability of offers providing a single tariff for national and roaming services;
(f)
the degree of competition in both the retail and wholesale markets, in particular the competitive situation of smaller, independent or newly started operators, including the competition effects of commercial agreements and the degree of interconnection between operators;
(g)
the extent to which the implementation of the structural measures provided for in Articles 3 and 4 has produced results in developing competition in the internal market for roaming services to the extent that the difference between roaming and national tariffs has approached zero;
(h)
the extent to which the level of wholesale and retail maximum charges has provided adequate safeguards against excessive prices for consumers while allowing the development of competition in the internal market for roaming services.
2. If the report shows that the structural measures provided for by this Regulation have not been sufficient to promote competition in the internal market for roaming services for the benefit of all European consumers or that the differences between roaming tariffs and national tariffs have not approached zero, the Commission shall make appropriate proposals to the European Parliament and the Council to address this situation and thus achieve an internal market for mobile communication services, ultimately with there being no difference between national and roaming tariffs. The Commission shall examine, in particular, whether it is necessary:
(a)
to lay down additional technical and structural measures;
(b)
to modify the structural measures;
(c)
to extend the duration and possibly revise the level of the maximum retail charges provided for in Articles 8, 10 and 13;
(d)
to change the duration or revise the level of maximum wholesale charges provided for in Articles 7, 9 and 12;
(e)
to introduce any other necessary requirements, including non-differentiation of roaming and national tariffs.
3. In addition, the Commission shall submit a report to the European Parliament and the Council every two years after the report referred to in paragraph 1. Each report shall include a summary of the monitoring of the provision of roaming services in the Union and an assessment of the progress towards achieving the objectives of this Regulation, including by reference to the matters referred to in paragraphs 1 and 2.
4. In order to assess the competitive developments in the Union-wide roaming markets, BEREC shall regularly collect data from national regulatory authorities on the development of retail and wholesale charges for voice, SMS and data roaming services. Those data shall be notified to the Commission at least twice a year. The Commission shall make them public.
BEREC shall also annually collect information from national regulatory authorities on transparency and comparability of different tariffs offered by operators to their customers. The Commission shall make those data and findings public.
Article 20
Notification requirements
Member States shall notify to the Commission the identity of the national regulatory authorities responsible for carrying out tasks under this Regulation.
Article 21
Repeal
Regulation (EC) No 717/2007 is repealed in accordance with Annex I with effect from 1 July 2012.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.
Article 22
Entry into force and expiry
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union and its provisions shall apply from that day save as otherwise provided for in specific Articles.
It shall expire on 30 June 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 13 June 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
N. WAMMEN
(1) OJ C 24, 28.1.2012, p. 131.
(2) Position of the European Parliament of 10 May 2012 (not yet published in the Official Journal) and decision of the Council of 30 May 2012.
(3) OJ L 171, 29.6.2007, p. 32.
(4) See Annex I.
(5) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7).
(6) OJ L 108, 24.4.2002, p. 7.
(7) OJ L 108, 24.4.2002, p. 21.
(8) OJ L 108, 24.4.2002, p. 33.
(9) OJ L 108, 24.4.2002, p. 51.
(10) OJ L 201, 31.7.2002, p. 37.
(11) OJ L 114, 8.5.2003, p. 45.
(12) OJ C 165, 11.7.2002, p. 6.
(13) Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office (OJ L 337, 18.12.2009, p. 1).
(14) Commission Recommendation of 17 December 2007 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation in accordance with Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services (OJ L 344, 28.12.2007, p. 65).
(15) OJ C 285 E, 22.11.2006, p. 143.
(16) OJ L 55, 28.2.2011, p. 13.
(17) Regulation (EC) No 544/2009 of the European Parliament and of the Council of 18 June 2009 amending Regulation (EC) No 717/2007 on roaming on public mobile telephone networks within the Community and Directive 2002/21/EC on a common regulatory framework for electronic communications networks and services (OJ L 167, 29.6.2009, p. 12).
(18) OJ L 149, 11.6.2005, p. 22.
ANNEX I
Repealed Regulation with its amendment
(referred to in Article 21)
Regulation (EC) No 717/2007 of the European Parliament and of the Council (OJ L 171, 29.6.2007, p. 32).
Regulation (EC) No 544/2009 of the European Parliament and of the Council (OJ L 167, 29.6.2009, p. 12).
only Article 1
ANNEX II
Correlation Table
Regulation (EC) No 717/2007
This Regulation
Article 1
Article 1
—
Article 1(2)
Article 1(2)
Article 1(3)
Article 1(3)
Article 1(4)
Article 1(4) first subparagraph, first sentence
Article 1(5)
Article 1(4) first subparagraph, second sentence
Article 1(6) first subparagraph
Article 1(7) first subparagraph
Article 1(4) second subparagraph, first sentence
Article 1(6) second subparagraph, first sentence
Article 1(7) second subparagraph, first sentence
Article 1(4) second subparagraph, second sentence
Article 1(6) second subparagraph, second and third sentences
Article 1(7) second subparagraph, second and third sentences
Article 2(1)
Article 2(1)
Article 2(2), introductory words
Article 2(2), introductory words
Article 2(2), point (a)
Article 2(2), point (i)
Article 2(2), point (b)
Article 2(2), point (a)
—
Article 2(2), point (b)
—
Article 2(2), point (c)
Article 2(2), point (c)
Article 2(2), point (d)
Article 2(2), point (g)
Article 2(2), point (e)
Article 2(2), point (d)
Article 2(2), point (f)
Article 2(2), point (f)
Article 2(2), point (g)
Article 2(2), point (e)
Article 2(2), point (h)
Article 2(2), point (i)
Article 2(2), point (j)
Article 2(2), point (j)
Article 2(2), point (k)
Article 2(2), point (h)
Article 2(2), point (l)
Article 2(2), point (k)
Article 2(2), point (m)
—
Article 2(2), point (n)
—
Article 2(2), point (o)
—
Article 2(2), point (p)
—
Article 2(2), point (q)
—
Articles 3, 4, 5 and 6
Article 3(1)
Article 7(1)
Article 3(2)
Article 7(2)
Article 3(3), first subparagraph
—
Article 3(3), second subparagraph
Article 7(3)
Article 4(1)
Article 8(1)
Article 4(2)
Article 8(2)
Article 4(3), first subparagraph
—
Article 4(3), second subparagraph
Article 8(3)
Article 4(3), third subparagraph
Article 8(4)
Article 4(4)
Article 8(5)
Article 4a
Article 9
Article 4b
Article 10
Article 4b(7)
—
Article 4c
Article 11
—
Article 12
—
Article 13
Article 6(1) first to fifth subparagraphs
Article 14(1) first to fifth subparagraphs
—
Article 14(1) sixth subparagraph
Article 6(2)
Article 14(2)
Article 6(3) first and second subparagraphs
Article 14(3) first and second subparagraphs
—
Article 14(3) third subparagraph
—
Article 14(4)
Article 6a
Article 15
—
Article 15(4)
—
Article 15(5)
—
Article 15(6)
Article 6a(4)
—
Article 7
Article 16
—
Article 16(3) second subparagraph
Article 8
Article 17
Article 9
Article 18
Article 10
—
Article 11(1) introductory words
Article 19(1) introductory words
—
Article 19(1), points (a) and (b)
Article 11(1) first subparagraph, first to fourth indent
Article 19(1), points (c) to (f)
—
Article 19(1), points (g) and (h)
Article 11(1) second subparagraph
—
—
Article 19(2)
Article 11(2)
Article 19(3)
—
Article 19(4)
Article 12
Article 20
—
Article 21
Article 13
Article 22
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Roaming charges within the European Union
Roaming charges within the European Union
SUMMARY OF:
Regulation (EU) No 531/2012 — roaming on public mobile communications networks within the EU
WHAT IS THE AIM OF THE REGULATION?
It aims to end roaming charges while travelling within the EU. This means that EU citizens travelling within the EU can make calls, send text messages and access the internet on their mobile phones for the same price as in their own countries.
It also sets out safeguards to ensure that mobile telephone operators are protected against abuses and can sustain the new roaming rules without increasing domestic prices.
Regulation (EU) 2017/920 amends Regulation (EU) No 531/2012 with effect from 15 June 2017. It introduces rules that limit the amount that mobile telephone operators may charge one another for roaming (i.e. wholesale roaming) in the EU.
KEY POINTS
Call, text and data costs incurred while travelling in another EU country will be deducted from the user’s domestic volume.
Operators do not have to offer roaming services; however, if they do, they must observe the ‘roam like at home’ principle and charge users only the domestic rate.
The regulation is not intended to permit ‘permanent roaming’, where a subscriber identity module (SIM) card from another EU country is used on a permanent basis. Operators can detect abuses of the principle by analysing roaming and domestic calls and use of mobile services over a 4-month period.If a customer spends a majority of their time abroad and uses their mobile phone more abroad than at home, the operator can ask the customer to clarify the situation within 14 days.This check is designed to target those who stay abroad for long periods, not those who log on to their national network regularly, such as frontier workers.
If a user remains permanently outside the country where the SIM card was issued, the operator can apply a surcharge: maximum €0.032 per minute of voice call;maximum €0.01 per short message service (SMS);maximum €7.70 per gigabyte of data from 15 June 2017 to 31 December 2017, decreasing on 1 January each year as follows: €6 in 2018, €4.50 in 2019, €3.50 in 2020, €3 in 2021 and €2.50 in 2022.
In case of domestic ‘open data bundles’ (i.e. unlimited data, or data at a very low unit price), the operator may apply a limit to roaming data without surcharge. This limit must be above a threshold based on the price of the domestic bundle and is large enough to cover most customers’ roaming needs. Beyond this limit, the customer can continue data roaming with a surcharge as indicated above.
The national regulator may authorise an exception to the ‘roam like at home’ principle in cases where an operator can show, based on evidence, that it cannot provide ‘roam like at home’ services without increasing its domestic prices.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 July 2012.
BACKGROUND
For more information, see:
Questions and Answers — Roaming (European Commission)
End of roaming charges in the EU: Joint statement by 3 EU institutions (European Commission)
Roaming charges — What has the European Commission done so far? (European Commission).
MAIN DOCUMENT
Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (recast) (OJ L 172, 30.6.2012, pp. 10-35)
Successive amendments to Regulation (EU) No 531/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Implementing Regulation (EU) 2016/2286 of 15 December 2016 laying down detailed rules on the application of fair use policy and on the methodology for assessing the sustainability of the abolition of retail roaming surcharges and on the application to be submitted by a roaming provider for the purposes of that assessment (OJ L 344, 17.12.2016, pp. 46-62)
Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users’ rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, pp. 1-18)
last update 08.02.2018
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32012R0648
|
27.7.2012
EN
Official Journal of the European Union
L 201/1
REGULATION (EU) No 648/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 July 2012
on OTC derivatives, central counterparties and trade repositories
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Central Bank (1),
Having regard to the opinion of the European Economic and Social Committee (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
At the request of the Commission, a report was published on 25 February 2009 by a High-Level Group chaired by Jacques de Larosière and concluded that the supervisory framework of the financial sector of the Union needed to be strengthened to reduce the risk and severity of future financial crises and recommended far-reaching reforms to the structure of supervision of that sector, including the creation of a European System of Financial Supervisors, comprising three European supervisory authorities, one each for the banking, the insurance and occupational pensions and the securities and markets sectors, and the creation of a European Systemic Risk Council.
(2)
The Commission Communication of 4 March 2009, entitled ‘Driving European Recovery’, proposed to strengthen the Union’s regulatory framework for financial services. In its Communication of 3 July 2009 entitled ‘Ensuring efficient, safe and sound derivatives markets’, the Commission assessed the role of derivatives in the financial crisis, and in its Communication of 20 October 2009 entitled ‘Ensuring efficient, safe and sound derivative markets: Future policy actions’, the Commission outlined the actions it intends to take to reduce the risks associated with derivatives.
(3)
On 23 September 2009, the Commission adopted proposals for three regulations establishing the European System of Financial Supervision, including the creation of three European Supervisory Authorities (ESAs) to contribute to a consistent application of Union legislation and to the establishment of high-quality common regulatory and supervisory standards and practices. The ESAs comprise the European Supervisory Authority (European Banking Authority) (EBA) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (4), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (EIOPA) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (5), and the European Supervisory Authority (European Securities and Markets Authority) (ESMA) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (6). The ESAs have a crucial role to play in safeguarding the stability of the financial sector. It is therefore essential to ensure continuously that the development of their work is a matter of high political priority and that they are adequately resourced.
(4)
Over-the-counter derivatives (‘OTC derivative contracts’) lack transparency as they are privately negotiated contracts and any information concerning them is usually only available to the contracting parties. They create a complex web of interdependence which can make it difficult to identify the nature and level of risks involved. The financial crisis has demonstrated that such characteristics increase uncertainty in times of market stress and, accordingly, pose risks to financial stability. This Regulation lays down conditions for mitigating those risks and improving the transparency of derivative contracts.
(5)
At the 26 September 2009 summit in Pittsburgh, G20 leaders agreed that all standardised OTC derivative contracts should be cleared through a central counterparty (CCP) by the end of 2012 and that OTC derivative contracts should be reported to trade repositories. In June 2010, G20 leaders in Toronto reaffirmed their commitment and also committed to accelerate the implementation of strong measures to improve transparency and regulatory oversight of OTC derivative contracts in an internationally consistent and non-discriminatory way.
(6)
The Commission will monitor and endeavour to ensure that those commitments are implemented in a similar way by the Union’s international partners. The Commission should cooperate with third-country authorities in order to explore mutually supportive solutions to ensure consistency between this Regulation and the requirements established by third countries and thus avoid any possible overlapping in this respect. With the assistance of ESMA, the Commission should monitor and prepare reports to the European Parliament and the Council on the international application of principles laid down in this Regulation. In order to avoid potential duplicate or conflicting requirements, the Commission might adopt decisions on equivalence of the legal, supervisory and enforcement framework in third countries, if a number of conditions are met. The assessment which forms the basis of such decisions should not prejudice the right of a CCP established in a third country and recognised by ESMA to provide clearing services to clearing members or trading venues established in the Union, as the recognition decision should be independent of this assessment. Similarly, neither an equivalence decision nor the assessment should prejudice the right of a trade repository established in a third country and recognised by ESMA to provide services to entities established in the Union.
(7)
With regard to the recognition of third-country CCPs, and in accordance with the Union’s international obligations under the agreement establishing the World Trade Organisation, including the General Agreement on Trade in Services, decisions determining third-country legal regimes as equivalent to the legal regime of the Union should be adopted only if the legal regime of the third country provides for an effective equivalent system for the recognition of CCPs authorised under foreign legal regimes in accordance with the general regulatory goals and standards set out by the G20 in September 2009 of improving transparency in the derivatives markets, mitigating systemic risk, and protecting against market abuse. Such a system should be considered equivalent if it ensures that the substantial result of the applicable regulatory regime is similar to Union requirements and should be considered effective if those rules are being applied in a consistent manner.
(8)
It is appropriate and necessary in this context, taking account of the characteristics of derivative markets and the functioning of CCPs, to verify the effective equivalence of foreign regulatory systems in meeting G20 goals and standards in order to improve transparency in derivatives markets, mitigate systemic risk and protect against market abuse. The very special situation of CCPs requires that the provisions relating to third countries are organised and function in accordance with arrangements that are specific to these market structure entities. Therefore this approach does not constitute a precedent for other legislation.
(9)
The European Council, in its Conclusions of 2 December 2009, agreed that there was a need to substantially improve the mitigation of counterparty credit risk and that it was important to improve transparency, efficiency and integrity for derivative transactions. The European Parliament resolution of 15 June 2010 on ‘Derivatives markets: future policy actions’ called for mandatory clearing and reporting of OTC derivative contracts.
(10)
ESMA should act within the scope of this Regulation by safeguarding the stability of financial markets in emergency situations, ensuring the consistent application of Union rules by national supervisory authorities and settling disagreements between them. It is also entrusted with developing draft regulatory and implementing technical standards and has a central role in the authorisation and monitoring of CCPs and trade repositories.
(11)
One of the basic tasks to be carried out through the European System of Central Banks (ESCB) is to promote the smooth operation of payment systems. In this respect, the members of the ESCB execute oversight by ensuring efficient and sound clearing and payment systems, including CCPs. The members of the ESCB are thus closely involved in the authorisation and monitoring of CCPs, recognition of third-country CCPs and the approval of interoperability arrangements. In addition, they are closely involved in respect of the setting of regulatory technical standards as well as guidelines and recommendations. This Regulation is without prejudice to the responsibilities of the European Central Bank (ECB) and the national central banks (NCBs) to ensure efficient and sound clearing and payment systems within the Union and with other countries. Consequently, and in order to prevent the possible creation of parallel sets of rules, ESMA and the ESCB should cooperate closely when preparing the relevant draft technical standards. Further, the access to information by the ECB and the NCBs is crucial when fulfilling their tasks relating to the oversight of clearing and payment systems as well as to the functions of a central bank of issue.
(12)
Uniform rules are required for derivative contracts set out in Annex I, Section C, points (4) to (10) of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (7).
(13)
Incentives to promote the use of CCPs have not proven to be sufficient to ensure that standardised OTC derivative contracts are in fact cleared centrally. Mandatory CCP clearing requirements for those OTC derivative contracts that can be cleared centrally are therefore necessary.
(14)
It is likely that Member States will adopt divergent national measures which could create obstacles to the smooth functioning of the internal market and be to the detriment of market participants and financial stability. A uniform application of the clearing obligation in the Union is also necessary to ensure a high level of investor protection and to create a level playing field between market participants.
(15)
Ensuring that the clearing obligation reduces systemic risk requires a process of identification of classes of derivatives that should be subject to that obligation. That process should take into account the fact that not all CCP-cleared OTC derivative contracts can be considered suitable for mandatory CCP clearing.
(16)
This Regulation sets out the criteria for determining whether or not different classes of OTC derivative contracts should be subject to a clearing obligation. On the basis of draft regulatory technical standards developed by ESMA, the Commission should decide whether a class of OTC derivative contract is to be subject to a clearing obligation, and from when the clearing obligation takes effect including, where appropriate, phased-in implementation and the minimum remaining maturity of contracts entered into or novated before the date on which the clearing obligation takes effect, in accordance with this Regulation. A phased-in implementation of the clearing obligation could be in terms of the types of market participants that must comply with the clearing obligation. In determining which classes of OTC derivative contracts are to be subject to the clearing obligation, ESMA should take into account the specific nature of OTC derivative contracts which are concluded with covered bond issuers or with cover pools for covered bonds.
(17)
When determining which classes of OTC derivative contracts are to be subject to the clearing obligation, ESMA should also pay due regard to other relevant considerations, most importantly the interconnectedness between counterparties using the relevant classes of OTC derivative contracts and the impact on the levels of counterparty credit risk as well as promote equal conditions of competition within the internal market as referred to in Article 1(5)(d) of Regulation (EU) No 1095/2010.
(18)
Where ESMA has identified that an OTC derivative product is standardised and suitable for clearing but no CCP is willing to clear that product, ESMA should investigate the reason for this.
(19)
In determining which classes of OTC derivative contracts are to be subject to the clearing obligation, due account should be taken of the specific nature of the relevant classes of OTC derivative contracts. The predominant risk for transactions in some classes of OTC derivative contracts may relate to settlement risk, which is addressed through separate infrastructure arrangements, and may distinguish certain classes of OTC derivative contracts (such as foreign exchange) from other classes. CCP clearing specifically addresses counterparty credit risk, and may not be the optimal solution for dealing with settlement risk. The regime for such contracts should rely, in particular, on preliminary international convergence and mutual recognition of the relevant infrastructure.
(20)
In order to ensure a uniform and coherent application of this Regulation and a level playing field for market participants when a class of OTC derivative contract is declared subject to the clearing obligation, this obligation should also apply to all contracts pertaining to that class of OTC derivative contract entered into on or after the date of notification of a CCP authorisation for the purpose of the clearing obligation received by ESMA but before the date from which the clearing obligation takes effect, provided that those contracts have a remaining maturity above the minimum determined by the Commission.
(21)
In determining whether a class of OTC derivative contract is to be subject to clearing requirements, ESMA should aim for a reduction in systemic risk. This includes taking into account in the assessment factors such as the level of contractual and operational standardisation of contracts, the volume and the liquidity of the relevant class of OTC derivative contract as well as the availability of fair, reliable and generally accepted pricing information in the relevant class of OTC derivative contract.
(22)
For an OTC derivative contract to be cleared, both parties to that contract must be subject to a clearing obligation or must consent. Exemptions to the clearing obligation should be narrowly tailored as they would reduce the effectiveness of the obligation and the benefits of CCP clearing and may lead to regulatory arbitrage between groups of market participants.
(23)
In order to foster financial stability within the Union, it might be necessary also to subject the transactions entered into by entities established in third countries to the clearing and risk-mitigation techniques obligations, provided that the transactions concerned have a direct, substantial and foreseeable effect within the Union or where such obligations are necessary or appropriate to prevent the evasion of any provisions of this Regulation.
(24)
OTC derivative contracts that are not considered suitable for CCP clearing entail counterparty credit and operational risk and therefore, rules should be established to manage that risk. To mitigate counterparty credit risk, market participants that are subject to the clearing obligation should have risk-management procedures that require the timely, accurate and appropriately segregated exchange of collateral. When preparing draft regulatory technical standards specifying those risk-management procedures, ESMA should take into account the proposals of the international standard setting bodies on margining requirements for non-centrally cleared derivatives. When developing draft regulatory technical standards to specify the arrangements required for the accurate and appropriate exchange of collateral to manage risks associated with uncleared trades, ESMA should take due account of impediments faced by covered bond issuers or cover pools in providing collateral in a number of Union jurisdictions. ESMA should also take into account the fact that preferential claims given to covered bond issuers counterparties on the covered bond issuer’s assets provides equivalent protection against counterparty credit risk.
(25)
Rules on clearing OTC derivative contracts, reporting on derivative transactions and risk-mitigation techniques for OTC derivative contracts not cleared by a CCP should apply to financial counterparties, namely investment firms as authorised in accordance with Directive 2004/39/EC, credit institutions as authorised in accordance with Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (8), insurance undertakings as authorised in accordance with First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, Regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life insurance (9), assurance undertakings as authorised in accordance with Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (10), reinsurance undertakings as authorised in accordance with Directive 2005/68/EC of the European Parliament and of the Council of 16 November 2005 on reinsurance (11), undertakings for collective investments in transferable securities (UCITS) and, where relevant, their management companies, as authorised in accordance with Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (12), institutions for occupational retirement provision as defined in Directive 2003/41/EC of the European Parliament and of the Council of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision (13) and alternative investment funds managed by alternative investment fund managers (AIFM) as authorised or registered in accordance with Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers (14).
(26)
Entities operating pension scheme arrangements, the primary purpose of which is to provide benefits upon retirement, usually in the form of payments for life, but also as payments made for a temporary period or as a lump sum, typically minimise their allocation to cash in order to maximise the efficiency and the return for their policy holders. Hence, requiring such entities to clear OTC derivative contracts centrally would lead to divesting a significant proportion of their assets for cash in order for them to meet the ongoing margin requirements of CCPs. To avoid a likely negative impact of such a requirement on the retirement income of future pensioners, the clearing obligation should not apply to pension schemes until a suitable technical solution for the transfer of non-cash collateral as variation margins is developed by CCPs to address this problem. Such a technical solution should take into account the special role of pension scheme arrangements and avoid materially adverse effects on pensioners. During a transitional period, OTC derivative contracts entered into with a view to decreasing investment risks directly relating to the financial solvency of pension scheme arrangements should be subject not only to the reporting obligation, but also to bilateral collateralisation requirements. The ultimate aim, however, is central clearing as soon as this is tenable.
(27)
It is important to ensure that only appropriate entities and arrangements receive special treatment as well as to take into account the diversity of pension systems across the Union, while also to provide for a level playing field for all pension scheme arrangements. Therefore, the temporary derogation should apply to institutions for occupational retirement provision registered in accordance with Directive 2003/41/EC, including any authorised entity responsible for managing such an institution and acting on its behalf as referred to in Article 2(1) of that Directive as well as any legal entity set up for the purpose of investment by such institutions, acting solely and exclusively in their interest, and to occupational retirement provision businesses of institutions referred to in Article 3 of Directive 2003/41/EC.
(28)
The temporary derogation should also apply to occupational retirement provision businesses of life insurance undertakings provided that all corresponding assets and liabilities are ring-fenced, managed and organised separately, without any possibility of transfer. It should also apply to any other authorised and supervised entities operating on a national basis only or arrangements that are provided mainly in the territory of one Member State, only if both of them are recognised by national law and their primary purpose is to provide benefits upon retirement. The entities and arrangements referred to in this recital should be subject to the decision of the relevant competent authority and in order to ensure consistency, remove possible misalignments and avoid any abuse, the opinion of ESMA, after consulting EIOPA. This could include entities and arrangements that are not necessarily linked to an employer pension programme but still have the primary purpose of providing income at retirement, either on a compulsory or on a voluntary basis. Examples could include legal entities operating pension schemes on a funded basis under national law, provided that they invest in accordance with the ‘prudent person’ principle, and pension arrangements taken up by individuals directly, which may also be provided by life insurers. The exemption in the case of pension arrangements taken up by individuals directly should not cover OTC derivative contracts relating to other life insurance products of the insurer which do not have the primary purpose of providing an income at retirement.
Further examples might be retirement provision businesses of insurance undertakings covered by Directive 2002/83/EC, provided that all assets corresponding to the businesses are included in a special register in accordance with the Annex to Directive 2001/17/EC of the European Parliament and of the Council of 19 March 2001 on the reorganisation and winding-up of insurance undertakings (15) as well as occupational retirement provision arrangements of insurance undertakings based on collective bargaining agreements. Institutions established for the purpose of providing compensation to members of pension scheme arrangements in the case of a default should also be treated as a pension scheme for the purpose of this Regulation.
(29)
Where appropriate, rules applicable to financial counterparties, should also apply to non-financial counterparties. It is recognised that non-financial counterparties use OTC derivative contracts in order to cover themselves against commercial risks directly linked to their commercial or treasury financing activities. Consequently, in determining whether a non-financial counterparty should be subject to the clearing obligation, consideration should be given to the purpose for which that non-financial counterparty uses OTC derivative contracts and to the size of the exposures that it has in those instruments. In order to ensure that non-financial institutions have the opportunity to state their views on the clearing thresholds, ESMA should, when preparing the relevant regulatory technical standards, conduct an open public consultation ensuring the participation of non-financial institutions. ESMA should also consult all relevant authorities, for example the Agency for the Cooperation of Energy Regulators, in order to ensure that the particularities of those sectors are fully taken into account. Moreover, by 17 August 2015, the Commission should assess the systemic importance of the transactions of non-financial firms in OTC derivative contracts in different sectors, including in the energy sector.
(30)
In determining whether an OTC derivative contract reduces risks directly relating to the commercial activities and treasury activities of a non-financial counterparty, due account should be taken of that non-financial counterparty’s overall hedging and risk-mitigation strategies. In particular, consideration should be given to whether an OTC derivative contract is economically appropriate for the reduction of risks in the conduct and management of a non-financial counterparty, where the risks relate to fluctuations in interest rates, foreign exchange rates, inflation rates or commodity prices.
(31)
The clearing threshold is a very important figure for all non-financial counterparties. When the clearing threshold is set, the systemic relevance of the sum of net positions and exposures per counterparty and per class of OTC derivative contract should be taken into account. In that connection, appropriate efforts should be made to recognise the methods of risk mitigation used by non-financial counterparties in the context of their normal business activity.
(32)
Members of the ESCB and other Member States’ bodies performing similar functions, other Union public bodies charged with or intervening in the management of the public debt, and the Bank for International Settlements should be excluded from the scope of this Regulation in order to avoid limiting their power to perform their tasks of common interest.
(33)
As not all market participants that are subject to the clearing obligation are able to become clearing members of the CCP, they should have the possibility to access CCPs as clients or indirect clients subject to certain conditions.
(34)
The introduction of a clearing obligation along with a process to establish which CCPs can be used for the purpose of this obligation may lead to unintended competitive distortions of the OTC derivatives market. For example, a CCP could refuse to clear transactions executed on certain trading venues because the CCP is owned by a competing trading venue. In order to avoid such discriminatory practices, CCPs should agree to clear transactions executed in different trading venues, to the extent that those trading venues comply with the operational and technical requirements established by the CCP, without reference to the contractual documents on the basis of which the parties concluded the relevant OTC derivative transaction, provided that those documents are consistent with market standards. Trading venues should provide the CCPs with trade feeds on a transparent and non-discriminatory basis. The right of access of a CCP to a trading venue should allow for arrangements whereby multiple CCPs use trade feeds of the same trading venue. However, this should not lead to interoperability for derivatives clearing or create liquidity fragmentation.
(35)
This Regulation should not block fair and open access between trading venues and CCPs in the internal market, subject to the conditions laid down in this Regulation and in the regulatory technical standards developed by ESMA and adopted by the Commission. The Commission should continue to monitor closely the evolution of the OTC derivatives market and should, where necessary, intervene in order to prevent competitive distortions from occurring in the internal market with the aim of ensuring a level playing field in the financial markets.
(36)
In certain areas within financial services and trading of derivative contracts, commercial and intellectual property rights may also exist. In instances where such property rights relate to products or services which have become, or impact upon, industry standards, licences should be available on proportionate, fair, reasonable and non-discriminatory terms.
(37)
In order to identify the relevant classes of OTC derivative contracts that should be subject to the clearing obligation, the thresholds and systemically relevant non-financial counterparties, reliable data is needed. Therefore, for regulatory purposes, it is important that a uniform derivatives data reporting requirement is established at Union level. Moreover, a retrospective reporting obligation is needed, to the largest possible extent, for both financial counterparties and non-financial counterparties, in order to provide comparative data, including to ESMA and the relevant competent authorities.
(38)
An intragroup transaction is a transaction between two undertakings which are included in the same consolidation on a full basis and are subject to appropriate centralised risk evaluation, measurement and control procedures. They are part of the same institutional protection scheme as referred to in Article 80(8) of Directive 2006/48/EC or, in the case of credit institutions affiliated to the same central body, as referred to in Article 3(1) of that Directive, both are credit institutions or one is a credit institution and the other is a central body. OTC derivative contracts may be recognised within non-financial or financial groups, as well as within groups composed of both financial and non-financial undertakings, and if such a contract is considered an intragroup transaction in respect of one counterparty, then it should also be considered an intragroup transaction in respect of the other counterparty to that contract. It is recognised that intragroup transactions may be necessary for aggregating risks within a group structure and that intragroup risks are therefore specific. Since the submission of those transactions to the clearing obligation may limit the efficiency of those intragroup risk-management processes, an exemption of intragroup transactions from the clearing obligation may be beneficial, provided that this exemption does not increase systemic risk. As a result, adequate exchange of collateral should be substituted to the CCP clearing those transactions, where that is appropriate to mitigate intragroup counterparty risks.
(39)
However, some intragroup transactions could be exempted, in some cases on the basis of the decision of the competent authorities, from the collateralisation requirement provided that their risk-management procedures are adequately sound, robust and consistent with the level of complexity of the transaction and there is no impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties. Those criteria as well as the procedures for the counterparties and the relevant competent authorities to be followed while applying exemptions should be specified in regulatory technical standards adopted in accordance with the relevant regulations establishing the ESAs. Before developing such draft regulatory technical standards, the ESAs should prepare an impact assessment of their potential impact on the internal market as well as on financial market participants and in particular on the operations and the structure of groups concerned. All the technical standards applicable to the collateral exchanged in intragroup transactions, including criteria for the exemption, should take into account the prevailing specificities of those transactions and existing differences between non-financial and financial counterparties as well as their purpose and methods of using derivatives.
(40)
Counterparties should be considered to be included in the same consolidation at least where they are both included in a consolidation in accordance with Council Directive 83/349/EEC (16) or International Financial Reporting Standards (IFRS) adopted pursuant to Regulation (EC) No 1606/2002 of the European Parliament and of the Council (17) or, in relation to a group the parent undertaking of which has its head office in a third country, in accordance with generally accepted accounting principles of a third country determined to be equivalent to IFRS in accordance with Commission Regulation (EC) No 1569/2007 (18) (or accounting standards of a third country the use of which is permitted in accordance with Article 4 of Regulation (EC) No 1569/2007), or where they are both covered by the same consolidated supervision in accordance with Directive 2006/48/EC or with Directive 2006/49/EC of the European Parliament and of the Council (19) or, in relation to a group the parent undertaking of which has its head office in a third country, the same consolidated supervision by a third country competent authority verified as equivalent to that governed by the principles laid down in Article 143 of Directive 2006/48/EC or in Article 2 of Directive 2006/49/EC.
(41)
It is important that market participants report all details regarding derivative contracts they have entered into to trade repositories. As a result, information on the risks inherent in derivatives markets will be centrally stored and easily accessible, inter alia, to ESMA, the relevant competent authorities, the European Systemic Risk Board (ESRB) and the relevant central banks of the ESCB.
(42)
The provision of trade repository services is characterised by economies of scale, which may hamper competition in this particular field. At the same time, the imposition of a comprehensive reporting requirement on market participants may increase the value of the information maintained by trade repositories also for third parties providing ancillary services such as trade confirmation, trade matching, credit event servicing, portfolio reconciliation or portfolio compression. It is appropriate to ensure that a level playing field in the post-trade sector more generally is not compromised by a possible natural monopoly in the provision of trade repository services. Therefore, trade repositories should be required to provide access to the information held in the repository on fair, reasonable and non-discriminatory terms, subject to necessary precautions on data protection.
(43)
In order to allow for a comprehensive overview of the market and for assessing systemic risk, both CCP-cleared and non-CCP-cleared derivative contracts should be reported to trade repositories.
(44)
The ESAs should be provided with adequate resources in order to perform the tasks they are given in this Regulation effectively.
(45)
Counterparties and CCPs that conclude, modify, or terminate a derivative contract should ensure that the details of that contract are reported to a trade repository. They should be able to delegate the reporting of the contract to another entity. An entity or its employees that report the details of a derivative contract to a trade repository on behalf of a counterparty, in accordance with this Regulation, should not be in breach of any restriction on disclosure. When preparing the draft regulatory technical standards regarding reporting, ESMA should take into account the progress made in the development of a unique contract identifier and the list of required reporting data in Annex I, Table 1 of Commission Regulation (EC) No 1287/2006 (20) implementing Directive 2004/39/EC and consult other relevant authorities such as the Agency for the Cooperation of Energy Regulators.
(46)
Taking into consideration the principles set out in the Commission’s Communication on reinforcing sanctioning regimes in the financial services sector and legal acts of the Union adopted as a follow-up to that Communication, Member States should lay down rules on penalties applicable to infringements of this Regulation. Member States should enforce those penalties in a manner that does not reduce the effectiveness of those rules. Those penalties should be effective, proportionate and dissuasive. They should be based on guidelines adopted by ESMA to promote convergence and cross-sector consistency of penalty regimes in the financial sector. Member States should ensure that the penalties imposed are publicly disclosed, where appropriate, and that assessment reports on the effectiveness of existing rules are published at regular intervals.
(47)
A CCP might be established in accordance with this Regulation in any Member State. No Member State or group of Member States should be discriminated against, directly or indirectly, as a venue for clearing services. Nothing in this Regulation should attempt to restrict or impede a CCP in one jurisdiction from clearing a product denominated in the currency of another Member State or in the currency of a third country.
(48)
Authorisation of a CCP should be conditional on a minimum amount of initial capital. Capital, including retained earnings and reserves of a CCP, should be proportionate to the risk stemming from the activities of the CCP at all times in order to ensure that it is adequately capitalised against credit, counterparty, market, operational, legal and business risks which are not already covered by specific financial resources and that it is able to conduct an orderly winding-up or restructuring of its operations if necessary.
(49)
As this Regulation introduces a legal obligation to clear through specific CCPs for regulatory purposes, it is essential to ensure that those CCPs are safe and sound and comply at all times with the stringent organisational, business conduct, and prudential requirements established by this Regulation. In order to ensure uniform application of this Regulation, those requirements should apply to the clearing of all financial instruments in which the CCPs deal.
(50)
It is therefore necessary, for regulatory and harmonisation purposes, to ensure that counterparties only use CCPs which comply with the requirements laid down in this Regulation. Those requirements should not prevent Member States from adopting or continuing to apply additional requirements in respect of CCPs established in their territory including certain authorisation requirements under Directive 2006/48/EC. However, imposing such additional requirements should not influence the right of CCPs authorised in other Member States or recognised, in accordance with this Regulation, to provide clearing services to clearing members and their clients established in the Member State introducing additional requirements, since those CCPs are not subject to those additional requirements and do not need to comply with them. By 30 September 2014, ESMA should draft a report on the impact of the application of additional requirements by Member States.
(51)
Direct rules regarding the authorisation and supervision of CCPs are an essential corollary to the obligation to clear OTC derivative contracts. It is appropriate that competent authorities retain responsibility for all aspects of the authorisation and the supervision of CCPs, including the responsibility for verifying that the applicant CCP complies with this Regulation and with Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (21), in view of the fact that those national competent authorities remain best placed to examine how the CCPs operate on a daily basis, to carry out regular reviews and to take appropriate action, where necessary.
(52)
Where a CCP risks insolvency, fiscal responsibility may lie predominantly with the Member State in which that CCP is established. It follows that authorisation and supervision of that CCP should be exercised by the relevant competent authority of that Member State. However, since a CCP’s clearing members may be established in different Member States and they will be the first to be impacted by the CCP’s default, it is imperative that all relevant competent authorities and ESMA be involved in the authorisation and supervisory process. This will avoid divergent national measures or practices and obstacles to the proper functioning of the internal market. Furthermore, no proposal or policy of any member of a college of supervisors should, directly or indirectly, discriminate against any Member State or group of Member States as a venue for clearing services in any currency. ESMA should be a participant in every college in order to ensure the consistent and correct application of this Regulation. ESMA should involve other competent authorities in the Member States concerned in the work of preparing recommendations and decisions.
(53)
In light of the role assigned to colleges, it is important that all the relevant competent authorities as well as members of the ESCB are involved in performing their tasks. The college should consist not only of the competent authorities supervising the CCP but also of the supervisors of the entities on which the operations of that CCP might have an impact, namely selected clearing members, trading venues, interoperable CCPs and central securities depositories. Members of the ESCB that are responsible for the oversight of the CCP and interoperable CCPs as well as those responsible for the issue of the currencies of the financial instruments cleared by the CCP, should be able to participate in the college. As the supervised or overseen entities would be established in a limited range of Member States in which the CCP operates, a single competent authority or member of the ESCB could be responsible for supervision or oversight of a number of those entities. In order to ensure smooth cooperation between all the members of the college, appropriate procedures and mechanisms should be put in place.
(54)
Since the establishment and functioning of the college is assumed to be based on a written agreement between all of its members, it is appropriate to confer upon them the power to determine the college’s decision-making procedures, given the sensitivity of the issue. Therefore, detailed rules on voting procedures should be laid down in a written agreement between the members of the college. However, in order to balance the interests of all the relevant market participants and Member States appropriately, the college should vote in accordance with the general principle whereby each member has one vote, irrespective of the number of functions it performs in accordance with this Regulation. For colleges with up to and including 12 members, a maximum of two college members belonging to the same Member State should have a vote and each voting member should have one vote. For colleges with more than 12 members, a maximum of three college members belonging to the same Member State should have a vote and each voting member should have one vote.
(55)
The very particular situation of CCPs requires that colleges are organised and function in accordance with arrangements that are specific to the supervision of CCPs.
(56)
The arrangements provided for in this Regulation do not constitute a precedent for other legislation on the supervision and oversight of financial market infrastructures, in particular with regard to the voting modalities for referrals to ESMA.
(57)
A CCP should not be authorised where all the members of the college, excluding the competent authorities of the Member State where the CCP is established, reach a joint opinion by mutual agreement that the CCP should not be authorised. If, however, a sufficient majority of the college has expressed a negative opinion and any of the competent authorities concerned, based on that majority of two-thirds of the college, has referred the matter to ESMA, the competent authority of the Member State where the CCP is established should defer its decision on the authorisation and await any decision that ESMA may take regarding conformity with Union law. The competent authority of the Member State where the CCP is established should take its decision in accordance with such a decision by ESMA. Where all the members of the college, excluding the authorities of the Member State where the CCP is established, reach a joint opinion to the effect that they consider that the requirements are not met and that the CCP should not receive authorisation, the competent authority of the Member State where the CCP is established should be able to refer the matter to ESMA to decide on conformity with Union law.
(58)
It is necessary to reinforce provisions on exchange of information between competent authorities, ESMA and other relevant authorities and to strengthen the duties of assistance and cooperation between them. Due to increasing cross-border activity, those authorities should provide each other with the relevant information for the exercise of their functions so as to ensure the effective enforcement of this Regulation, including in situations where infringements or suspected infringements may be of concern to authorities in two or more Member States. For the exchange of information, strict professional secrecy is needed. It is essential, due to the wide impact of OTC derivative contracts, that other relevant authorities, such as tax authorities and energy regulators, have access to information necessary to the exercise of their functions.
(59)
In view of the global nature of financial markets, ESMA should be directly responsible for recognising CCPs established in third countries and thus allowing them to provide clearing services within the Union, provided that the Commission has recognised the legal and supervisory framework of that third country as equivalent to the Union framework and that certain other conditions are met. Therefore, a CCP established in a third country, providing clearing services to clearing members or trading venues established in the Union should be recognised by ESMA. However, in order not to hamper the further development of cross-border investment management business in the Union, a third-country CCP providing services to clients established in the Union through a clearing member established in a third country should not have to be recognised by ESMA. In this context, agreements with the Union’s major international partners will be of particular importance in order to ensure a global level playing field and financial stability.
(60)
On 16 September 2010, the European Council agreed on the need for the Union to promote its interest and values more assertively and, in a spirit of reciprocity and mutual benefit, in the context of the Union’s external relations and to take steps, inter alia, to secure greater market access for European business and deepen regulatory cooperation with major trade partners.
(61)
A CCP should have robust governance arrangements, senior management of good repute and independent members on its board, irrespective of its ownership structure. At least one-third, and no less than two, members of its board should be independent. However, different governance arrangements and ownership structures may influence a CCP’s willingness or ability to clear certain products. It is thus appropriate that the independent members of the board and the risk committee to be established by the CCP address any potential conflict of interests within a CCP. Clearing members and clients need to be adequately represented as decisions taken by the CCP may have an impact on them.
(62)
A CCP may outsource functions. The CCP’s risk committee should advise on such outsourcing. Major activities linked to risk management should not be outsourced unless this is approved by the competent authority.
(63)
The participation requirements for a CCP should be transparent, proportionate, and non-discriminatory and should allow for remote access to the extent that this does not expose the CCP to additional risks.
(64)
Clients of clearing members that clear their OTC derivative contracts with CCPs should be granted a high level of protection. The actual level of protection depends on the level of segregation that those clients choose. Intermediaries should segregate their assets from those of their clients. For this reason, CCPs should keep updated and easily identifiable records, in order to facilitate the transfer of the positions and assets of a defaulting clearing member’s clients to a solvent clearing member or, as the case may be, the orderly liquidation of the clients’ positions and the return of excess collateral to the clients. The requirements laid down in this Regulation on the segregation and portability of clients’ positions and assets should therefore prevail over any conflicting laws, regulations and administrative provisions of the Member States that prevent the parties from fulfilling them.
(65)
A CCP should have a sound risk-management framework to manage credit risks, liquidity risks, operational and other risks, including the risks that it bears or poses to other entities as a result of interdependencies. A CCP should have adequate procedures and mechanisms in place to deal with the default of a clearing member. In order to minimise the contagion risk of such a default, the CCP should have in place stringent participation requirements, collect appropriate initial margins, maintain a default fund and other financial resources to cover potential losses. In order to ensure that it benefits from sufficient resources on an ongoing basis, the CCP should establish a minimum amount below which the size of the default fund is not generally to fall. This should not, however, limit the CCP’s ability to use the entirety of the default fund to cover the losses caused by a clearing member’s default.
(66)
When defining a sound risk-management framework, a CCP should take into account its potential risk and economic impact on the clearing members and their clients. Although the development of a highly robust risk management should remain its primary objective, a CCP may adapt its features to the specific activities and risk profiles of the clients of the clearing members, and if deemed appropriate on the basis of the criteria specified in the regulatory technical standards to be developed by ESMA, may include in the scope of the highly liquid assets accepted as collateral, at least cash, government bonds, covered bonds in accordance with Directive 2006/48/EC subject to adequate haircuts, guarantees callable on first demand granted by a member of the ESCB, commercial bank guarantees under strict conditions, in particular relating to the creditworthiness of the guarantor, and the guarantor’s capital links with CCP’s clearing members. Where appropriate, ESMA may also consider gold as an asset acceptable as collateral. CCPs should be able to accept, under strict risk-management conditions, commercial bank guarantees from non-financial counterparties acting as clearing members.
(67)
CCPs’ risk-management strategies should be sufficiently sound so as to avoid risks for the taxpayer.
(68)
Margin calls and haircuts on collateral may have procyclical effects. CCPs, competent authorities and ESMA should therefore adopt measures to prevent and control possible procyclical effects in risk-management practices adopted by CCPs, to the extent that a CCP’s soundness and financial security is not negatively affected.
(69)
Exposure management is an essential part of the clearing process. Access to, and use of, the relevant pricing sources should be granted to provide clearing services in general. Such pricing sources should include those relating to indices that are used as references to derivatives or other financial instruments.
(70)
Margins are the primary line of defence for a CCP. Although CCPs should invest the margins received in a safe and prudent manner, they should make particular efforts to ensure adequate protection of margins to guarantee that they are returned in a timely manner to the non-defaulting clearing members or to an interoperable CCP where the CCP collecting these margins defaults.
(71)
Access to adequate liquidity resources is essential for a CCP. It is possible for such liquidity to derive from access to central bank liquidity, creditworthy and reliable commercial bank liquidity, or a combination of both. Access to liquidity could result from an authorisation granted in accordance with Article 6 of Directive 2006/48/EC or other appropriate arrangements. In assessing the adequacy of liquidity resources, especially in stress situations, a CCP should take into consideration the risks of obtaining the liquidity by only relying on commercial banks credit lines.
(72)
The ‘European Code of Conduct for Clearing and Settlement’ of 7 November 2006 established a voluntary framework for establishing links between CCPs. However, the post-trade sector remains fragmented along national lines, making cross-border trades more costly and hindering harmonisation. It is therefore necessary to lay down the conditions for the establishment of interoperability arrangements between CCPs to the extent these do not expose the relevant CCPs to risks that are not appropriately managed.
(73)
Interoperability arrangements are important for greater integration of the post-trading market within the Union and regulation should be provided for. However, as interoperability arrangements may expose CCPs to additional risks, CCPs should have been, for three years, authorised to clear or recognised in accordance with this Regulation, or authorised under a pre-existing national authorisation regime, before competent authorities grant approval of such interoperability arrangements. In addition, given the additional complexities involved in an interoperability arrangement between CCPs clearing OTC derivative contracts, it is appropriate at this stage to restrict the scope of interoperability arrangements to transferable securities and money-market instruments. However, by 30 September 2014, ESMA should submit a report to the Commission on whether an extension of that scope to other financial instruments would be appropriate.
(74)
Trade repositories collect data for regulatory purposes that are relevant to authorities in all Member States. ESMA should assume responsibility for the registration, withdrawal of registration and supervision of trade repositories.
(75)
Given that regulators, CCPs and other market participants rely on the data maintained by trade repositories, it is necessary to ensure that those trade repositories are subject to strict operational, record-keeping and data-management requirements.
(76)
Transparency of prices, fees and risk-management models associated with the services provided by CCPs, their members and trade repositories is necessary to enable market participants to make an informed choice.
(77)
In order to carry out its duties effectively, ESMA should be able to require, by simple request or by decision, all necessary information from trade repositories, related third parties and third parties to which the trade repositories have outsourced operational functions or activities. If ESMA requires such information by simple request, the addressee is not obliged to provide the information but, in the event that it does so voluntarily, the information provided should not be incorrect or misleading. Such information should be made available without delay.
(78)
Without prejudice to cases covered by criminal or tax law, the competent authorities, ESMA, bodies or natural or legal persons other than the competent authorities, which receive confidential information should use it only in the performance of their duties and for the exercise of their functions. However, this should not prevent the exercise, in accordance with national law, of the functions of national bodies responsible for the prevention, investigation or correction of cases of maladministration.
(79)
In order to exercise its supervisory powers effectively, ESMA should be able to conduct investigations and on-site inspections.
(80)
ESMA should be able to delegate specific supervisory tasks to the competent authority of a Member State, for instance where a supervisory task requires knowledge and experience with respect to local conditions, which are more easily available at national level. ESMA should be able to delegate the carrying out of specific investigatory tasks and on-site inspections. Prior to the delegation of tasks, ESMA should consult the relevant competent authority about the detailed conditions relating to such delegation of tasks, including the scope of the task to be delegated, the timetable for the performance of the task, and the transmission of necessary information by and to ESMA. ESMA should compensate the competent authorities for carrying out a delegated task in accordance with a regulation on fees to be adopted by the Commission by means of a delegated act. ESMA should not be able to delegate the power to adopt decisions on registration.
(81)
It is necessary to ensure that competent authorities are able to request that ESMA examine whether the conditions for the withdrawal of a trade repository’s registration are met. ESMA should assess such requests and take any appropriate measures.
(82)
ESMA should be able to impose periodic penalty payments to compel trade repositories to put an end to an infringement, to supply complete and correct information required by ESMA or to submit to an investigation or an on-site inspection.
(83)
ESMA should also be able to impose fines on trade repositories where it finds that they have committed, intentionally or negligently, an infringement of this Regulation. Fines should be imposed according to the level of seriousness of the infringement. Infringements should be divided into different groups for which specific fines should be allocated. In order to calculate the fine relating to a particular infringement, ESMA should use a two-step methodology consisting of setting a basic amount and adjusting that basic amount, if necessary, by certain coefficients. The basic amount should be established by taking into account the annual turnover of the trade repository concerned and the adjustments should be made by increasing or decreasing the basic amount through the application of the relevant coefficients in accordance with this Regulation.
(84)
This Regulation should establish coefficients linked to aggravating and mitigating circumstances in order to give the necessary tools to ESMA to decide on a fine which is proportionate to the seriousness of the infringement committed by a trade repository, taking into account the circumstances under which that infringement has been committed.
(85)
Before taking a decision to impose fines or periodic penalty payments, ESMA should give the persons subject to the proceedings the opportunity to be heard in order to respect their rights of defence.
(86)
ESMA should refrain from imposing fines or periodic penalty payments where a prior acquittal or conviction arising from identical facts, or from facts which are substantially the same, has acquired the force of res judicata as a result of criminal proceedings under national law.
(87)
ESMA’s decisions imposing fines and periodic penalty payments should be enforceable and their enforcement should be subject to the rules of civil procedure which are in force in the State in the territory of which it is carried out. Rules of civil procedure should not include criminal procedural rules but could include administrative procedural rules.
(88)
In the case of an infringement committed by a trade repository, ESMA should be empowered to take a range of supervisory measures, including requiring the trade repository to bring the infringement to an end, and, as a last resort, withdrawing the registration where the trade repository has seriously or repeatedly infringed this Regulation. The supervisory measures should be applied by ESMA taking into account the nature and seriousness of the infringement and should respect the principle of proportionality. Before taking a decision on supervisory measures, ESMA should give the persons subject to the proceedings an opportunity to be heard in order to comply with their rights of defence.
(89)
It is essential that Member States and ESMA protect the right to privacy of natural persons when processing personal data, in accordance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (22) and with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and of the free movement of such data (23).
(90)
It is important to ensure international convergence of requirements for CCPs and trade repositories. This Regulation follows the existing recommendations developed by the Committee on Payment and Settlement Systems (CPSS) and International Organization of Securities Commissions (IOSCO) noting that the CPSS-IOSCO principles for financial market infrastructure, including CCPs, were established on 16 April 2012. It creates a Union framework in which CCPs can operate safely. ESMA should consider these existing standards and their future developments when drawing up or proposing to revise the regulatory technical standards as well as the guidelines and recommendations foreseen in this Regulation.
(91)
The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amendments to the list of entities exempt from this Regulation, further rules of procedure relating to the imposition of fines or periodic penalty payments, including provisions on the rights of the defence, time limits, the collection of fines or periodic penalty payments and the limitation periods for the imposition and enforcement of penalty payments or fines; measures to amend Annex II in order to take account of developments in the financial markets; the further specification of the type of fees, the matters for which fees are due, the amount of the fees and the manner in which they are to be paid. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(92)
In order to ensure consistent harmonisation, power should be delegated to the Commission to adopt the ESAs’ draft regulatory technical standards in accordance with Articles 10 to 14 of Regulations (EU) No 1093/2010, (EU) No 1094/2010 and (EU) No 1095/2010 for the application, for the purposes of this Regulation, of points (4) to (10) of Section C of Annex I to Directive 2004/39/EC and in order to specify: the OTC derivative contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation; the types of indirect contractual arrangements that meet the conditions set out in this Regulation; the classes of OTC derivative contracts that should be subject to the clearing obligation, the date or dates from which the clearing obligation is to take effect, including any phase-in, the categories of counterparties to which the clearing obligation applies, and the minimum remaining maturity of the OTC derivative contracts entered into or novated before the date on which the clearing obligation takes effect; the details to be included in a competent authority’s notification to ESMA of its authorisation of a CCP to clear a class of OTC derivative contract; particular classes of OTC derivative contracts, the degree of standardisation of the contractual terms and operational processes, the volume and the liquidity, and the availability of fair, reliable and generally accepted pricing information; the details to be included in ESMA’s register of classes of OTC derivative contracts subject to the clearing obligation; the details and type of the reports for the different classes of derivatives; criteria to determine which OTC derivative contracts are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity and values of the clearing thresholds, the procedures and the arrangements in regard to risk-mitigation techniques for OTC derivative contracts not cleared by a CCP; the risk-management procedures, including the required levels and type of collateral and segregation arrangements and the required level of capital; the notion of liquidity fragmentation; requirements regarding the capital, retained earnings and reserves of CCPs; the minimum content of the rules and governance arrangements for CCPs; the details of the records and information to be retained by CCPs; the minimum content and requirements for CCPs’ business continuity policies and disaster recovery plans; the appropriate percentage and time horizons for the liquidation period and the calculation of historical volatility to be considered for the different classes of financial instruments taking into account the objective to limit pro-cyclicality and the conditions under which portfolio margining practices can be implemented; the framework for defining extreme but plausible market conditions which should be used when defining the size of the default fund and the resources of CCPs; the methodology for calculating and maintaining the amount of CCPs’ own resources; the type of collateral that could be considered highly liquid, such as cash, gold, government and high-quality corporate bonds, covered bonds and the haircuts and the conditions under which commercial bank guarantees can be accepted as collateral; the financial instruments that can be considered highly liquid, bearing minimal credit and market risk, highly secured arrangements and concentration limits; the type of stress tests to be undertaken by CCPs for different classes of financial instruments and portfolios, the involvement of clearing members or other parties in the tests, the frequency and timing of the tests and the key information that the CCP is to disclose on its risk-management model and assumptions adopted to perform the stress tests; the details of the application by trade repositories for registration with ESMA; the frequency and the detail in which trade repositories are to disclose information relating to aggregate positions by class of OTC derivative contract; and the operational standards required in order to aggregate and compare data across repositories.
(93)
Any obligation imposed by this Regulation which is to be further developed by means of delegated or implementing acts adopted under Article 290 or 291 TFEU should be understood as applying only from the date on which those acts take effect.
(94)
As a part of its development of technical guidelines and regulatory technical standards, and in particular when setting the clearing threshold for non-financial counterparties under this Regulation, ESMA should organise public hearings of market participants.
(95)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (24).
(96)
The Commission should monitor and assess the need for any appropriate measures to ensure the consistent and effective application and development of regulations, standards and practices falling within the scope of this Regulation, taking into consideration the outcome of the work performed by relevant international forums.
(97)
In view of the rules regarding interoperable systems, it was deemed appropriate to amend Directive 98/26/EC to protect the rights of a system operator that provides collateral security to a receiving system operator in the event of insolvency proceedings against that receiving system operator.
(98)
In order to facilitate efficient clearing, recording, settlement and payment, CCPs and trade repositories should accommodate in their communication procedures with participants and with the market infrastructures they interface with, the relevant international communication procedures and standards for messaging and reference data.
(99)
Since the objectives of this Regulation, namely to lay down uniform requirements for OTC derivative contracts and for the performance of activities of CCPs and trade repositories, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
HAVE ADOPTED THIS REGULATION:
TITLE I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation lays down clearing and bilateral risk-management requirements for over-the-counter (‘OTC’) derivative contracts, reporting requirements for derivative contracts and uniform requirements for the performance of activities of central counterparties (‘CCPs’) and trade repositories.
2. This Regulation shall apply to CCPs and their clearing members, to financial counterparties and to trade repositories. It shall apply to non-financial counterparties and trading venues where so provided.
3. Title V of this Regulation shall apply only to transferable securities and money-market instruments, as defined in point (18)(a) and (b) and point (19) of Article 4(1) of Directive 2004/39/EC.
4. This Regulation shall not apply to:
(a)
the members of the ESCB and other Member States’ bodies performing similar functions and other Union public bodies charged with or intervening in the management of the public debt;
(b)
the Bank for International Settlements.
5. With the exception of the reporting obligation under Article 9, this Regulation shall not apply to the following entities:
(a)
multilateral development banks, as listed under Section 4.2 of Part 1 of Annex VI to Directive 2006/48/EC;
(b)
public sector entities within the meaning of point (18) of Article 4 of Directive 2006/48/EC where they are owned by central governments and have explicit guarantee arrangements provided by central governments;
(c)
the European Financial Stability Facility and the European Stability Mechanism.
6. The Commission shall be empowered to adopt delegated acts in accordance with Article 82 to amend the list set out in paragraph 4 of this Article.
To that end, by 17 November 2012 the Commission shall present to the European Parliament and the Council a report assessing the international treatment of public bodies charged with or intervening in the management of the public debt and central banks.
The report shall include a comparative analysis of the treatment of those bodies and of central banks within the legal framework of a significant number of third countries, including at least the three most important jurisdictions as regards volumes of contracts traded, and the risk-management standards applicable to the derivative transactions entered into by those bodies and by central banks in those jurisdictions. If the report concludes, in particular in regard to the comparative analysis, that the exemption of the monetary responsibilities of those third-country central banks from the clearing and reporting obligation is necessary, the Commission shall add them to the list set out in paragraph 4.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)
‘CCP’ means a legal person that interposes itself between the counterparties to the contracts traded on one or more financial markets, becoming the buyer to every seller and the seller to every buyer;
(2)
‘trade repository’ means a legal person that centrally collects and maintains the records of derivatives;
(3)
‘clearing’ means the process of establishing positions, including the calculation of net obligations, and ensuring that financial instruments, cash, or both, are available to secure the exposures arising from those positions;
(4)
‘trading venue’ means a system operated by an investment firm or a market operator within the meaning of Article 4(1)(1) and 4(1)(13) of Directive 2004/39/EC other than a systematic internaliser within the meaning of Article 4(1)(7) thereof, which brings together buying or selling interests in financial instruments in the system, in a way that results in a contract in accordance with Title II or III of that Directive;
(5)
‘derivative’ or ‘derivative contract’ means a financial instrument as set out in points (4) to (10) of Section C of Annex I to Directive 2004/39/EC as implemented by Article 38 and 39 of Regulation (EC) No 1287/2006;
(6)
‘class of derivatives’ means a subset of derivatives sharing common and essential characteristics including at least the relationship with the underlying asset, the type of underlying asset, and currency of notional amount. Derivatives belonging to the same class may have different maturities;
(7)
‘OTC derivative’ or ‘OTC derivative contract’ means a derivative contract the execution of which does not take place on a regulated market as within the meaning of Article 4(1)(14) of Directive 2004/39/EC or on a third-country market considered as equivalent to a regulated market in accordance with Article 19(6) of Directive 2004/39/EC;
(8)
‘financial counterparty’ means an investment firm authorised in accordance with Directive 2004/39/EC, a credit institution authorised in accordance with Directive 2006/48/EC, an insurance undertaking authorised in accordance with Directive 73/239/EEC, an assurance undertaking authorised in accordance with Directive 2002/83/EC, a reinsurance undertaking authorised in accordance with Directive 2005/68/EC, a UCITS and, where relevant, its management company, authorised in accordance with Directive 2009/65/EC, an institution for occupational retirement provision within the meaning of Article 6(a) of Directive 2003/41/EC and an alternative investment fund managed by AIFMs authorised or registered in accordance with Directive 2011/61/EU;
(9)
‘non-financial counterparty’ means an undertaking established in the Union other than the entities referred to in points (1) and (8);
(10)
‘pension scheme arrangement’ means:
(a)
institutions for occupational retirement provision within the meaning of Article 6(a) of Directive 2003/41/EC, including any authorised entity responsible for managing such an institution and acting on its behalf as referred to in Article 2(1) of that Directive as well as any legal entity set up for the purpose of investment of such institutions, acting solely and exclusively in their interest;
(b)
occupational retirement provision businesses of institutions referred to in Article 3 of Directive 2003/41/EC;
(c)
occupational retirement provision businesses of life insurance undertakings covered by Directive 2002/83/EC, provided that all assets and liabilities corresponding to the business are ring-fenced, managed and organised separately from the other activities of the insurance undertaking, without any possibility of transfer;
(d)
any other authorised and supervised entities, or arrangements, operating on a national basis, provided that:
(i)
they are recognised under national law; and
(ii)
their primary purpose is to provide retirement benefits;
(11)
‘counterparty credit risk’ means the risk that the counterparty to a transaction defaults before the final settlement of the transaction’s cash flows;
(12)
‘interoperability arrangement’ means an arrangement between two or more CCPs that involves a cross-system execution of transactions;
(13)
‘competent authority’ means the competent authority referred to in the legislation referred to in point (8) of this Article, the competent authority referred to in Article 10(5) or the authority designated by each Member State in accordance with Article 22;
(14)
‘clearing member’ means an undertaking which participates in a CCP and which is responsible for discharging the financial obligations arising from that participation;
(15)
‘client’ means an undertaking with a contractual relationship with a clearing member of a CCP which enables that undertaking to clear its transactions with that CCP;
(16)
‘group’ means the group of undertakings consisting of a parent undertaking and its subsidiaries within the meaning of Articles 1 and 2 of Directive 83/349/EEC or the group of undertakings referred to in Article 3(1) and Article 80(7) and (8) of Directive 2006/48/EC;
(17)
‘financial institution’ means an undertaking other than a credit institution, the principal activity of which is to acquire holdings or to carry on one or more of the activities listed in points (2) to (12) of Annex I to Directive 2006/48/EC;
(18)
‘financial holding company’ means a financial institution, the subsidiary undertakings of which are either exclusively or mainly credit institutions or financial institutions, at least one of such subsidiary undertakings being a credit institution, and which is not a mixed financial holding company within the meaning of Article 2(15) of Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (25);
(19)
‘ancillary services undertaking’ means an undertaking the principal activity of which consists in owning or managing property, managing data-processing services, or a similar activity which is ancillary to the principal activity of one or more credit institution;
(20)
‘qualifying holding’ means any direct or indirect holding in a CCP or trade repository which represents at least 10 % of the capital or of the voting rights, as set out in Articles 9 and 10 of Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market (26), taking into account the conditions regarding aggregation thereof laid down in Article 12(4) and (5) of that Directive, or which makes it possible to exercise a significant influence over the management of the CCP or trade repository in which that holding subsists;
(21)
‘parent undertaking’ means a parent undertaking as described in Articles 1 and 2 of Directive 83/349/EEC;
(22)
‘subsidiary’ means a subsidiary undertaking as described in Articles 1 and 2 of Directive 83/349/EEC, including a subsidiary of a subsidiary undertaking of an ultimate parent undertaking;
(23)
‘control’ means the relationship between a parent undertaking and a subsidiary, as described in Article 1 of Directive 83/349/EEC;
(24)
‘close links’ means a situation in which two or more natural or legal persons are linked by:
(a)
participation, by way of direct ownership or control, of 20 % or more of the voting rights or capital of an undertaking; or
(b)
control or a similar relationship between any natural or legal person and an undertaking or a subsidiary of a subsidiary also being considered a subsidiary of the parent undertaking which is at the head of those undertakings.
A situation in which two or more natural or legal persons are permanently linked to one and the same person by a control relationship shall also be regarded as constituting a close link between such persons.
(25)
‘capital’ means subscribed capital within the meaning of Article 22 of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (27) in so far it has been paid up, plus the related share premium accounts, it fully absorbs losses in going concern situations, and, in the event of bankruptcy or liquidation, it ranks after all other claims;
(26)
‘reserves’ means reserves as set out in Article 9 of Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3)(g) of the Treaty on the annual accounts of certain types of companies (28) and profits and losses brought forward as a result of the application of the final profit or loss;
(27)
‘board’ means administrative or supervisory board, or both, in accordance with national company law;
(28)
‘independent member’ of the board means a member of the board who has no business, family or other relationship that raises a conflict of interests regarding the CCP concerned or its controlling shareholders, its management or its clearing members, and who has had no such relationship during the five years preceding his membership of the board;
(29)
‘senior management’ means the person or persons who effectively direct the business of the CCP or the trade repository, and the executive member or members of the board.
Article 3
Intragroup transactions
1. In relation to a non-financial counterparty, an intragroup transaction is an OTC derivative contract entered into with another counterparty which is part of the same group provided that both counterparties are included in the same consolidation on a full basis and they are subject to an appropriate centralised risk evaluation, measurement and control procedures and that counterparty is established in the Union or, if it is established in a third country, the Commission has adopted an implementing act under Article 13(2) in respect of that third country.
2. In relation to a financial counterparty, an intragroup transaction is any of the following:
(a)
an OTC derivative contract entered into with another counterparty which is part of the same group, provided that the following conditions are met:
(i)
the financial counterparty is established in the Union or, if it is established in a third country, the Commission has adopted an implementing act under Article 13(2) in respect of that third country;
(ii)
the other counterparty is a financial counterparty, a financial holding company, a financial institution or an ancillary services undertaking subject to appropriate prudential requirements;
(iii)
both counterparties are included in the same consolidation on a full basis; and
(iv)
both counterparties are subject to appropriate centralised risk evaluation, measurement and control procedures;
(b)
an OTC derivative contract entered into with another counterparty where both counterparties are part of the same institutional protection scheme, referred to in Article 80(8) of Directive 2006/48/EC, provided that the condition set out in point (a)(ii) of this paragraph is met;
(c)
an OTC derivative contract entered into between credit institutions affiliated to the same central body or between such credit institution and the central body, as referred to in Article 3(1) of Directive 2006/48/EC; or
(d)
an OTC derivative contract entered into with a non-financial counterparty which is part of the same group provided that both counterparties are included in the same consolidation on a full basis and they are subject to an appropriate centralised risk evaluation, measurement and control procedures and that counterparty is established in the Union or in a third-country jurisdiction for which the Commission has adopted an implementing act as referred to in Article 13(2) in respect of that third country.
3. For the purposes of this Article, counterparties shall be considered to be included in the same consolidation when they are both either:
(a)
included in a consolidation in accordance with Directive 83/349/EEC or International Financial Reporting Standards (IFRS) adopted pursuant to Regulation (EC) No 1606/2002 or, in relation to a group the parent undertaking of which has its head office in a third country, in accordance with generally accepted accounting principles of a third country determined to be equivalent to IFRS in accordance with Regulation (EC) No 1569/2007 (or accounting standards of a third country the use of which is permitted in accordance with Article 4 of that Regulation); or
(b)
covered by the same consolidated supervision in accordance with Directive 2006/48/EC or Directive 2006/49/EC or, in relation to a group the parent undertaking of which has its head office in a third country, the same consolidated supervision by a third-country competent authority verified as equivalent to that governed by the principles laid down in Article 143 of Directive 2006/48/EC or in Article 2 of Directive 2006/49/EC.
TITLE II
CLEARING, REPORTING AND RISK MITIGATION OF OTC DERIVATIVES
Article 4
Clearing obligation
1. Counterparties shall clear all OTC derivative contracts pertaining to a class of OTC derivatives that has been declared subject to the clearing obligation in accordance with Article 5(2), if those contracts fulfil both of the following conditions:
(a)
they have been concluded in one of the following ways:
(i)
between two financial counterparties;
(ii)
between a financial counterparty and a non-financial counterparty that meets the conditions referred to in Article 10(1)(b);
(iii)
between two non-financial counterparties that meet the conditions referred to in Article 10(1)(b);
(iv)
between a financial counterparty or a non-financial counterparty meeting the conditions referred to in Article 10(1)(b) and an entity established in a third country that would be subject to the clearing obligation if it were established in the Union; or
(v)
between two entities established in one or more third countries that would be subject to the clearing obligation if they were established in the Union, provided that the contract has a direct, substantial and foreseeable effect within the Union or where such an obligation is necessary or appropriate to prevent the evasion of any provisions of this Regulation; and
(b)
they are entered into or novated either:
(i)
on or after the date from which the clearing obligation takes effect; or
(ii)
on or after notification as referred to in Article 5(1) but before the date from which the clearing obligation takes effect if the contracts have a remaining maturity higher than the minimum remaining maturity determined by the Commission in accordance with Article 5(2)(c).
2. Without prejudice to risk-mitigation techniques under Article 11, OTC derivative contracts that are intragroup transactions as described in Article 3 shall not be subject to the clearing obligation.
The exemption set out in the first subparagraph shall apply only:
(a)
where two counterparties established in the Union belonging to the same group have first notified their respective competent authorities in writing that they intend to make use of the exemption for the OTC derivative contracts concluded between each other. The notification shall be made not less than 30 calendar days before the use of the exemption. Within 30 calendar days after receipt of that notification, the competent authorities may object to the use of this exemption if the transactions between the counterparties do not meet the conditions laid down in Article 3, without prejudice to the right of the competent authorities to object after that period of 30 calendar days has expired where those conditions are no longer met. If there is disagreement between the competent authorities, ESMA may assist those authorities in reaching an agreement in accordance with its powers under Article 19 of Regulation (EU) No 1095/2010;
(b)
to OTC derivative contracts between two counterparties belonging to the same group which are established in a Member State and in a third country, where the counterparty established in the Union has been authorised to apply the exemption by its competent authority within 30 calendar days after it has been notified by the counterparty established in the Union, provided that the conditions laid down in Article 3 are met. The competent authority shall notify ESMA of that decision.
3. The OTC derivative contracts that are subject to the clearing obligation pursuant to paragraph 1 shall be cleared in a CCP authorised under Article 14 or recognised under Article 25 to clear that class of OTC derivatives and listed in the register in accordance with Article 6(2)(b).
For that purpose a counterparty shall become a clearing member, a client, or shall establish indirect clearing arrangements with a clearing member, provided that those arrangements do not increase counterparty risk and ensure that the assets and positions of the counterparty benefit from protection with equivalent effect to that referred to in Articles 39 and 48.
4. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation as referred to in paragraph 1(a)(v), and the types of indirect contractual arrangements that meet the conditions referred to in the second subparagraph of paragraph 3.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 5
Clearing obligation procedure
1. Where a competent authority authorises a CCP to clear a class of OTC derivatives under Article 14 or 15, it shall immediately notify ESMA of that authorisation.
In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details to be included in the notifications referred to in the first subparagraph.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
2. Within six months of receiving notification in accordance with paragraph 1 or accomplishing a procedure for recognition set out in Article 25, ESMA shall, after conducting a public consultation and after consulting the ESRB and, where appropriate, the competent authorities of third countries, develop and submit to the Commission for endorsement draft regulatory technical standards specifying the following:
(a)
the class of OTC derivatives that should be subject to the clearing obligation referred to in Article 4;
(b)
the date or dates from which the clearing obligation takes effect, including any phase in and the categories of counterparties to which the obligation applies; and
(c)
the minimum remaining maturity of the OTC derivative contracts referred to in Article 4(1)(b)(ii).
Power is delegated to the Commission to adopt regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
3. ESMA shall, on its own initiative, after conducting a public consultation and after consulting the ESRB and, where appropriate, the competent authorities of third countries, identify, in accordance with the criteria set out in points (a), (b) and (c) of paragraph 4 and notify to the Commission the classes of derivatives that should be subject to the clearing obligation provided in Article 4, but for which no CCP has yet received authorisation.
Following the notification, ESMA shall publish a call for a development of proposals for the clearing of those classes of derivatives.
4. With the overarching aim of reducing systemic risk, the draft regulatory technical standards for the part referred to in paragraph 2(a) shall take into consideration the following criteria:
(a)
the degree of standardisation of the contractual terms and operational processes of the relevant class of OTC derivatives;
(b)
the volume and liquidity of the relevant class of OTC derivatives;
(c)
the availability of fair, reliable and generally accepted pricing information in the relevant class of OTC derivatives.
In preparing those draft regulatory technical standards, ESMA may take into consideration the interconnectedness between counterparties using the relevant classes of OTC derivatives, the anticipated impact on the levels of counterparty credit risk between counterparties as well as the impact on competition across the Union.
In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards further specifying the criteria referred to in points (a), (b) and (c) of the first subparagraph.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt regulatory technical standards referred to in the third subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
5. The draft regulatory technical standards for the part referred to in paragraph 2(b) shall take into consideration the following criteria:
(a)
the expected volume of the relevant class of OTC derivatives;
(b)
whether more than one CCP already clear the same class of OTC derivatives;
(c)
the ability of the relevant CCPs to handle the expected volume and to manage the risk arising from the clearing of the relevant class of OTC derivatives;
(d)
the type and number of counterparties active, and expected to be active within the market for the relevant class of OTC derivatives;
(e)
the period of time a counterparty subject to the clearing obligation needs in order to put in place arrangements to clear its OTC derivative contracts through a CCP;
(f)
the risk management and the legal and operational capacity of the range of counterparties that are active in the market for the relevant class of OTC derivatives and that would be captured by the clearing obligation pursuant to Article 4(1).
6. If a class of OTC derivative contracts no longer has a CCP which is authorised or recognised to clear those contracts under this Regulation, it shall cease to be subject to the clearing obligation referred to in Article 4, and paragraph 3 of this Article shall apply.
Article 6
Public register
1. ESMA shall establish, maintain and keep up to date a public register in order to identify the classes of OTC derivatives subject to the clearing obligation correctly and unequivocally. The public register shall be available on ESMA’s website.
2. The register shall include:
(a)
the classes of OTC derivatives that are subject to the clearing obligation pursuant to Article 4;
(b)
the CCPs that are authorised or recognised for the purpose of the clearing obligation;
(c)
the dates from which the clearing obligation takes effect, including any phased-in implementation;
(d)
the classes of OTC derivatives identified by ESMA in accordance with Article 5(3);
(e)
the minimum remaining maturity of the derivative contracts referred to in Article 4(1)(b)(ii);
(f)
the CCPs that have been notified to ESMA by the competent authority for the purpose of the clearing obligation and the date of notification of each of them.
3. Where a CCP is no longer authorised or recognised in accordance with this Regulation to clear a given class of derivatives, ESMA shall immediately remove it from the public register in relation to that class of OTC derivatives.
4. In order to ensure consistent application of this Article, ESMA may develop draft regulatory technical standards specifying the details to be included in the public register referred to in paragraph 1.
ESMA shall submit any such draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 7
Access to a CCP
1. A CCP that has been authorised to clear OTC derivative contracts shall accept clearing such contracts on a non-discriminatory and transparent basis, regardless of the trading venue.
A CCP may require that a trading venue comply with the operational and technical requirements established by the CCP, including the risk-management requirements.
2. A CCP shall accede to or refuse a formal request for access by a trading venue within three months of such a request.
3. Where a CCP refuses access under paragraph 2, it shall provide the trading venue with full reasons for such refusal.
4. Save where the competent authority of the trading venue and that of the CCP refuse access, the CCP shall, subject to the second subparagraph, grant access within three months of a decision acceding to the trading venue’s formal request in accordance with paragraph 2.
The competent authority of the trading venue and that of the CCP may refuse access to the CCP following a formal request by the trading venue only where such access would threaten the smooth and orderly functioning of the markets or would adversely affect systemic risk.
5. ESMA shall settle any dispute arising from a disagreement between competent authorities in accordance with its powers under Article 19 of Regulation (EU) No 1095/2010.
Article 8
Access to a trading venue
1. A trading venue shall provide trade feeds on a non-discriminatory and transparent basis to any CCP that has been authorised to clear OTC derivative contracts traded on that trading venue upon request by the CCP.
2. Where a request to access a trading venue has been formally submitted to a trading venue by a CCP, the trading venue shall respond to the CCP within three months.
3. Where access is refused by a trading venue, it shall notify the CCP accordingly, providing full reasons.
4. Without prejudice to the decision by competent authorities of the trading venue and of the CCP, access shall be made possible by the trading venue within three months of a positive response to a request for access.
Access of the CCP to the trading venue shall be granted only where such access would not require interoperability or threaten the smooth and orderly functioning of markets in particular due to liquidity fragmentation and the trading venue has put in place adequate mechanisms to prevent such fragmentation.
5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the notion of liquidity fragmentation.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 9
Reporting obligation
1. Counterparties and CCPs shall ensure that the details of any derivative contract they have concluded and of any modification or termination of the contract are reported to a trade repository registered in accordance with Article 55 or recognised in accordance with Article 77. The details shall be reported no later than the working day following the conclusion, modification or termination of the contract.
The reporting obligation shall apply to derivative contracts which:
(a)
were entered into before 16 August 2012 and remain outstanding on that date;
(b)
are entered into on or after 16 August 2012.
A counterparty or a CCP which is subject to the reporting obligation may delegate the reporting of the details of the derivative contract.
Counterparties and CCPs shall ensure that the details of their derivative contracts are reported without duplication.
2. Counterparties shall keep a record of any derivative contract they have concluded and any modification for at least five years following the termination of the contract.
3. Where a trade repository is not available to record the details of a derivative contract, counterparties and CCPs shall ensure that such details are reported to ESMA.
In this case ESMA shall ensure that all the relevant entities referred to in Article 81(3) have access to all the details of derivative contracts they need to fulfil their respective responsibilities and mandates.
4. A counterparty or a CCP that reports the details of a derivative contract to a trade repository or to ESMA, or an entity that reports such details on behalf of a counterparty or a CCP shall not be considered in breach of any restriction on disclosure of information imposed by that contract or by any legislative, regulatory or administrative provision.
No liability resulting from that disclosure shall lie with the reporting entity or its directors or employees.
5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details and type of the reports referred to in paragraphs 1 and 3 for the different classes of derivatives.
The reports referred to in paragraphs 1 and 3 shall specify at least:
(a)
the parties to the derivative contract and, where different, the beneficiary of the rights and obligations arising from it;
(b)
the main characteristics of the derivative contracts, including their type, underlying maturity, notional value, price, and settlement date.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
6. In order to ensure uniform conditions of application of paragraphs 1 and 3, ESMA shall develop draft implementing technical standards specifying:
(a)
the format and frequency of the reports referred to in paragraphs 1 and 3 for the different classes of derivatives;
(b)
the date by which derivative contracts are to be reported, including any phase-in for contracts entered into before the reporting obligation applies.
ESMA shall submit those draft implementing technical standards to the Commission by 30 September 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 10
Non-financial counterparties
1. Where a non-financial counterparty takes positions in OTC derivative contracts and those positions exceed the clearing threshold as specified under paragraph 3, that non-financial counterparty shall:
(a)
immediately notify ESMA and the competent authority referred to in paragraph 5 thereof;
(b)
become subject to the clearing obligation for future contracts in accordance with Article 4 if the rolling average position over 30 working days exceeds the threshold; and
(c)
clear all relevant future contracts within four months of becoming subject to the clearing obligation.
2. A non-financial counterparty that has become subject to the clearing obligation in accordance with paragraph 1(b) and that subsequently demonstrates to the authority designated in accordance with paragraph 5 that its rolling average position over 30 working days does not exceed the clearing threshold, shall no longer be subject to the clearing obligation set out in Article 4.
3. In calculating the positions referred to in paragraph 1, the non-financial counterparty shall include all the OTC derivative contracts entered into by the non-financial counterparty or by other non-financial entities within the group to which the non-financial counterparty belongs, which are not objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity of the non-financial counterparty or of that group.
4. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards, after consulting the ESRB and other relevant authorities, specifying:
(a)
criteria for establishing which OTC derivative contracts are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity referred to in paragraph 3; and
(b)
values of the clearing thresholds, which are determined taking into account the systemic relevance of the sum of net positions and exposures per counterparty and per class of OTC derivatives.
After conducting an open public consultation, ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
After consulting the ESRB and other relevant authorities, ESMA shall periodically review the thresholds and, where necessary, propose regulatory technical standards to amend them.
5. Each Member State shall designate an authority responsible for ensuring that the obligation under paragraph 1 is met.
Article 11
Risk-mitigation techniques for OTC derivative contracts not cleared by a CCP
1. Financial counterparties and non-financial counterparties that enter into an OTC derivative contract not cleared by a CCP, shall ensure, exercising due diligence, that appropriate procedures and arrangements are in place to measure, monitor and mitigate operational risk and counterparty credit risk, including at least:
(a)
the timely confirmation, where available, by electronic means, of the terms of the relevant OTC derivative contract;
(b)
formalised processes which are robust, resilient and auditable in order to reconcile portfolios, to manage the associated risk and to identify disputes between parties early and resolve them, and to monitor the value of outstanding contracts.
2. Financial counterparties and non-financial counterparties referred to in Article 10 shall mark-to-market on a daily basis the value of outstanding contracts. Where market conditions prevent marking-to-market, reliable and prudent marking-to-model shall be used.
3. Financial counterparties shall have risk-management procedures that require the timely, accurate and appropriately segregated exchange of collateral with respect to OTC derivative contracts that are entered into on or after 16 August 2012. Non-financial counterparties referred to in Article 10 shall have risk-management procedures that require the timely, accurate and appropriately segregated exchange of collateral with respect to OTC derivative contracts that are entered into on or after the clearing threshold is exceeded.
4. Financial counterparties shall hold an appropriate and proportionate amount of capital to manage the risk not covered by appropriate exchange of collateral.
5. The requirement laid down in paragraph 3 of this Article shall not apply to an intragroup transaction referred to in Article 3 that is entered into by counterparties which are established in the same Member State provided that there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between counterparties.
6. An intragroup transaction referred to in Article 3(2)(a), (b) or (c) that is entered into by counterparties which are established in different Member States shall be exempt totally or partially from the requirement laid down in paragraph 3 of this Article, on the basis of a positive decision of both the relevant competent authorities, provided that the following conditions are fulfilled:
(a)
the risk-management procedures of the counterparties are adequately sound, robust and consistent with the level of complexity of the derivative transaction;
(b)
there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties.
If the competent authorities fail to reach a positive decision within 30 calendar days of receipt of the application for exemption, ESMA may assist those authorities in reaching agreement in accordance with its powers under Article 19 of Regulation (EU) No 1095/2010.
7. An intragroup transaction referred to in Article 3(1) that is entered into by non-financial counterparties which are established in different Member States shall be exempt from the requirement laid down in paragraph 3 of this Article, provided that the following conditions are fulfilled:
(a)
the risk-management procedures of the counterparties are adequately sound, robust and consistent with the level of complexity of the derivative transaction;
(b)
there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties.
The non-financial counterparties shall notify their intention to apply the exemption to the competent authorities referred to in Article 10(5). The exemption shall be valid unless either of the notified competent authorities does not agree upon fulfilment of the conditions referred to in point (a) or (b) of the first subparagraph within three months of the date of the notification.
8. An intragroup transaction referred to in Article 3(2)(a) to (d) that is entered into by a counterparty which is established in the Union and a counterparty which is established in a third-country jurisdiction shall be exempt totally or partially from the requirement laid down in paragraph 3 of this Article, on the basis of a positive decision of the relevant competent authority responsible for supervision of the counterparty which is established in the Union, provided that the following conditions are fulfilled:
(a)
the risk-management procedures of the counterparties are adequately sound, robust and consistent with the level of complexity of the derivative transaction;
(b)
there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties.
9. An intragroup transaction referred to in Article 3(1) that is entered into by a non-financial counterparty which is established in the Union and a counterparty which is established in a third-country jurisdiction shall be exempt from the requirement laid down in paragraph 3 of this Article, provided that the following conditions are fulfilled:
(a)
the risk-management procedures of the counterparties are adequately sound, robust and consistent with the level of complexity of the derivative transaction;
(b)
there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties.
The non-financial counterparty shall notify its intention to apply the exemption to the competent authority referred to in Article 10(5). The exemption shall be valid unless the notified competent authority does not agree upon fulfilment of the conditions referred to in point (a) or (b) of the first subparagraph within three months of the date of notification.
10. An intragroup transaction referred to in Article 3(1) that is entered into by a non-financial counterparty and a financial counterparty which are established in different Member States shall be exempt totally or partially from the requirement laid down in paragraph 3 of this Article, on the basis of a positive decision of the relevant competent authority responsible for supervision of the financial counterparty, provided that the following conditions are fulfilled:
(a)
the risk-management procedures of the counterparties are adequately sound, robust and consistent with the level of complexity of the derivative transaction;
(b)
there is no current or foreseen practical or legal impediment to the prompt transfer of own funds or repayment of liabilities between the counterparties.
The relevant competent authority responsible for supervision of the financial counterparty shall notify any such decision to the competent authority referred to in Article 10(5). The exemption is valid unless the notified competent authority does not agree upon fulfilment of the conditions referred to in point (a) or (b) of the first subparagraph. If there is disagreement between the competent authorities, ESMA may assist those authorities in reaching an agreement in accordance with its powers under Article 19 of Regulation (EU) No 1095/2010.
11. The counterparty of an intragroup transaction which has been exempted from the requirement laid down in paragraph 3 shall publicly disclose information on the exemption.
A competent authority shall notify ESMA of any decision adopted pursuant to paragraph 6, 8 or 10, or any notification received pursuant to paragraph 7, 9 or 10, and shall provide ESMA with the details of the intragroup transaction concerned.
12. The obligations set out in paragraphs 1 to 11 shall apply to OTC derivative contracts entered into between third country entities that would be subject to those obligations if they were established in the Union, provided that those contracts have a direct, substantial and foreseeable effect within the Union or where such obligation is necessary or appropriate to prevent the evasion of any provision of this Regulation.
13. ESMA shall regularly monitor the activity in derivatives not eligible for clearing in order to identify cases where a particular class of derivatives may pose systemic risk and to prevent regulatory arbitrage between cleared and non-cleared derivative transactions. In particular, ESMA shall, after consulting the ESRB, take action in accordance with Article 5(3) or review the regulatory technical standards on margin requirements laid down in paragraph 14 of this Article and in Article 41.
14. In order to ensure consistent application of this Article, ESMA shall draft regulatory technical standards specifying:
(a)
the procedures and arrangements referred to in paragraph 1;
(b)
the market conditions that prevent marking-to-market and the criteria for using marking-to-model referred to in paragraph 2;
(c)
the details of the exempted intragroup transactions to be included in the notification referred to in paragraphs 7, 9 and 10;
(d)
the details of the information on exempted intragroup transactions referred to in paragraph 11;
(e)
the contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation as referred to in paragraph 12;
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
15. In order to ensure consistent application of this Article, the ESAs shall develop common draft regulatory technical standards specifying:
(a)
the risk-management procedures, including the levels and type of collateral and segregation arrangements, required for compliance with paragraph 3;
(b)
the level of capital required for compliance with paragraph 4;
(c)
the procedures for the counterparties and the relevant competent authorities to be followed when applying exemptions under paragraphs 6 to 10;
(d)
the applicable criteria referred to in paragraphs 5 to 10 including in particular what should be considered as practical or legal impediment to the prompt transfer of own funds and repayment of liabilities between the counterparties.
The ESAs shall submit those common draft regulatory technical standards to the Commission by 30 September 2012.
Depending on the legal nature of the counterparty, power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with either Articles 10 to 14 of Regulations (EU) No 1093/2010, (EU) No 1094/2010 or (EU) No 1095/2010.
Article 12
Penalties
1. Member States shall lay down the rules on penalties applicable to infringements of the rules under this Title and shall take all measures necessary to ensure that they are implemented. Those penalties shall include at least administrative fines. The penalties provided for shall be effective, proportionate and dissuasive.
2. Member States shall ensure that the competent authorities responsible for the supervision of financial, and, where appropriate, non-financial counterparties disclose every penalty that has been imposed for infringements of Articles 4, 5 and 7 to 11 to the public, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved. Member States shall, at regular intervals, publish assessment reports on the effectiveness of the penalty rules being applied. Such disclosure and publication shall not contain personal data within the meaning of Article 2(a) of Directive 95/46/EC.
By 17 February 2013, the Member States shall notify the rules referred to in paragraph 1 to the Commission. They shall notify the Commission of any subsequent amendment thereto without delay.
3. An infringement of the rules under this Title shall not affect the validity of an OTC derivative contract or the possibility for the parties to enforce the provisions of an OTC derivative contract. An infringement of the rules under this Title shall not give rise to any right to compensation from a party to an OTC derivative contract.
Article 13
Mechanism to avoid duplicative or conflicting rules
1. The Commission shall be assisted by ESMA in monitoring and preparing reports to the European Parliament and to the Council on the international application of principles laid down in Articles 4, 9, 10 and 11, in particular with regard to potential duplicative or conflicting requirements on market participants, and recommend possible action.
2. The Commission may adopt implementing acts declaring that the legal, supervisory and enforcement arrangements of a third country:
(a)
are equivalent to the requirements laid down in this Regulation under Articles 4, 9, 10 and 11;
(b)
ensure protection of professional secrecy that is equivalent to that set out in this Regulation; and
(c)
are being effectively applied and enforced in an equitable and non-distortive manner so as to ensure effective supervision and enforcement in that third country.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 86(2).
3. An implementing act on equivalence as referred to in paragraph 2 shall imply that counterparties entering into a transaction subject to this Regulation shall be deemed to have fulfilled the obligations contained in Articles 4, 9, 10 and 11 where at least one of the counterparties is established in that third country.
4. The Commission shall, in cooperation with ESMA, monitor the effective implementation by third countries, for which an implementing act on equivalence has been adopted, of the requirements equivalent to those laid down in Articles 4, 9, 10 and 11 and regularly report, at least on an annual basis, to the European Parliament and the Council. Where the report reveals an insufficient or inconsistent application of the equivalent requirements by third country authorities, the Commission shall, within 30 calendar days of the presentation of the report, withdraw the recognition as equivalent of the third country legal framework in question. Where an implementing act on equivalence is withdrawn, counterparties shall automatically be subject again to all requirements laid down in this Regulation.
TITLE III
AUTHORISATION AND SUPERVISION OF CCPs
CHAPTER 1
Conditions and procedures for the authorisation of a CCP
Article 14
Authorisation of a CCP
1. Where a legal person established in the Union intends to provide clearing services as a CCP, it shall apply for authorisation to the competent authority of the Member State where it is established (the CCP’s competent authority), in accordance with the procedure set out in Article 17.
2. Once authorisation has been granted in accordance with Article 17, it shall be effective for the entire territory of the Union.
3. Authorisation referred to in paragraph 1 shall be granted only for activities linked to clearing and shall specify the services or activities which the CCP is authorised to provide or perform including the classes of financial instruments covered by such authorisation.
4. A CCP shall comply at all times with the conditions necessary for authorisation.
A CCP shall, without undue delay, notify the competent authority of any material changes affecting the conditions for authorisation.
5. Authorisation referred to in paragraph 1 shall not prevent Member States from adopting or continuing to apply, in respect of CCPs established in their territory, additional requirements including certain requirements for authorisation under Directive 2006/48/EC.
Article 15
Extension of activities and services
1. A CCP wishing to extend its business to additional services or activities not covered by the initial authorisation shall submit a request for extension to the CCP’s competent authority. The offering of clearing services for which the CCP has not already been authorised shall be considered to be an extension of that authorisation.
The extension of authorisation shall be made in accordance with the procedure set out under Article 17.
2. Where a CCP wishes to extend its business into a Member State other than that where it is established, the CCP’s competent authority shall immediately notify the competent authority of that other Member State.
Article 16
Capital requirements
1. A CCP shall have a permanent and available initial capital of at least EUR 7,5 million to be authorised pursuant to Article 14.
2. A CCP’s capital, including retained earnings and reserves, shall be proportionate to the risk stemming from the activities of the CCP. It shall at all times be sufficient to ensure an orderly winding-down or restructuring of the activities over an appropriate time span and an adequate protection of the CCP against credit, counterparty, market, operational, legal and business risks which are not already covered by specific financial resources as referred to in Articles 41 to 44.
3. In order to ensure consistent application of this Article, EBA shall, in close cooperation with the ESCB and after consulting ESMA, develop draft regulatory technical standards specifying requirements regarding the capital, retained earnings and reserves of a CCP referred to in paragraph 2.
EBA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010.
Article 17
Procedure for granting and refusing authorisation
1. The applicant CCP shall submit an application for authorisation to the competent authority of the Member State where it is established.
2. The applicant CCP shall provide all information necessary to satisfy the competent authority that the applicant CCP has established, at the time of authorisation, all the necessary arrangements to meet the requirements laid down in this Regulation. The competent authority shall immediately transmit all the information received from the applicant CCP to ESMA and the college referred to in Article 18(1).
3. Within 30 working days of receipt of the application, the competent authority shall assess whether the application is complete. If the application is not complete, the competent authority shall set a deadline by which the applicant CCP has to provide additional information. After assessing that an application is complete, the competent authority shall notify the applicant CCP and the members of the college established in accordance with Article 18(1) and ESMA accordingly.
4. The competent authority shall grant authorisation only where it is fully satisfied that the applicant CCP complies with all the requirements laid down in this Regulation and that the CCP is notified as a system pursuant to Directive 98/26/EC.
The competent authority shall duly consider the opinion of the college reached in accordance with Article 19. Where the CCP’s competent authority does not agree with a positive opinion of the college, its decision shall contain full reasons and an explanation of any significant deviation from that positive opinion.
The CCP shall not be authorised where all the members of the college, excluding the authorities of the Member State where the CCP is established, reach a joint opinion by mutual agreement, pursuant to Article 19(1), that the CCP not be authorised. That opinion shall state in writing the full and detailed reasons why the college consider that the requirements laid down in this Regulation or other Union law are not met.
Where a joint opinion by mutual agreement as referred to in the third subparagraph has not been reached and a majority of two-thirds of the college have expressed a negative opinion, any of the competent authorities concerned, based on that majority of two-thirds of the college, may, within 30 calendar days of the adoption of that negative opinion, refer the matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010.
The referral decision shall state in writing the full and detailed reasons why the relevant members of the college consider that the requirements laid down in this Regulation or other parts of Union law are not met. In that case the CCP’s competent authority shall defer its decision on authorisation and await any decision on authorisation that ESMA may take in accordance with Article 19(3) of Regulation (EU) No 1095/2010, The competent authority shall take its decision in conformity with ESMA’s decision. The matter shall not be referred to ESMA after the end of the 30-day period referred to in the fourth subparagraph.
Where all the members of the college, excluding the authorities of the Member State where the CCP is established, reach a joint opinion by mutual agreement, pursuant to Article 19(1), that the CCP not be authorised, the CCP’s competent authority may refer the matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010.
The competent authority of the Member State where the CCP is established shall transmit the decision to the other competent authorities concerned.
5. ESMA shall act in accordance with Article 17 of Regulation (EU) No 1095/2010 in the event that the CCP’s competent authority has not applied the provisions of this Regulation, or has applied them in a way which appears to be in breach of Union law.
ESMA may investigate an alleged breach or non-application of Union law upon request from any member of the college or on its own initiative, after having informed the competent authority.
6. While performing their duties, any action taken by any member of the college shall not, directly or indirectly, discriminate against any Member State or group of Member States as a venue for clearing services in any currency.
7. Within six months of the submission of a complete application, the competent authority shall inform the applicant CCP in writing, with a fully reasoned explanation, whether authorisation has been granted or refused.
Article 18
College
1. Within 30 calendar days of the submission of a complete application in accordance with Article 17, the CCP’s competent authority shall establish, manage and chair a college to facilitate the exercise of the tasks referred to in Articles 15, 17, 49, 51 and 54.
2. The college shall consist of:
(a)
ESMA;
(b)
the CCP’s competent authority;
(c)
the competent authorities responsible for the supervision of the clearing members of the CCP that are established in the three Member States with the largest contributions to the default fund of the CCP referred to in Article 42 on an aggregate basis over a one-year period;
(d)
the competent authorities responsible for the supervision of trading venues served by the CCP;
(e)
the competent authorities supervising CCPs with which interoperability arrangements have been established;
(f)
the competent authorities supervising central securities depositories to which the CCP is linked;
(g)
the relevant members of the ESCB responsible for the oversight of the CCP and the relevant members of the ESCB responsible for the oversight of the CCPs with which interoperability arrangements have been established;
(h)
the central banks of issue of the most relevant Union currencies of the financial instruments cleared.
3. The competent authority of a Member State which is not a member of the college may request from the college any information relevant for the performance of its supervisory duties.
4. The college shall, without prejudice to the responsibilities of competent authorities under this Regulation, ensure:
(a)
the preparation of the opinion referred to in Article 19;
(b)
the exchange of information, including requests for information pursuant to Article 84;
(c)
agreement on the voluntary entrustment of tasks among its members;
(d)
the coordination of supervisory examination programmes based on a risk assessment of the CCP; and
(e)
the determination of procedures and contingency plans to address emergency situations, as referred to in Article 24.
5. The establishment and functioning of the college shall be based on a written agreement between all its members.
That agreement shall determine the practical arrangements for the functioning of the college, including detailed rules on voting procedures as referred to in Article 19(3), and may determine tasks to be entrusted to the CCP’s competent authority or another member of the college.
6. In order to ensure the consistent and coherent functioning of colleges across the Union, ESMA shall develop draft regulatory technical standards specifying the conditions under which the Union currencies referred to in paragraph 2(h) are to be considered as the most relevant and the details of the practical arrangements referred to in paragraph 5.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 19
Opinion of the college
1. Within four months of the submission of a complete application by the CCP in accordance with Article 17, the CCP’s competent authority shall conduct a risk assessment of the CCP and submit a report to the college.
Within 30 calendar days of receipt, and on the basis of the findings in, that report, the college shall reach a joint opinion determining whether the applicant CCP complies with all the requirements laid down in this Regulation.
Without prejudice to the fourth subparagraph of Article 17(4) and if no joint opinion is reached in accordance with the second subparagraph, the college shall adopt a majority opinion within the same period.
2. ESMA shall facilitate the adoption of the joint opinion in accordance with its general coordination function under Article 31 of Regulation (EU) No 1095/2010.
3. A majority opinion of the college shall be adopted on the basis of a simple majority of its members. For colleges up to and including 12 members, a maximum of two college members belonging to the same Member State shall have a vote and each voting member shall have one vote. For colleges with more than 12 members, a maximum of three members belonging to the same Member State shall have a vote and each voting member shall have one vote. ESMA shall have no voting rights on the opinions of the college.
Article 20
Withdrawal of authorisation
1. Without prejudice to Article 22(3), the CCP’s competent authority shall withdraw authorisation where the CCP:
(a)
has not made use of the authorisation within 12 months, expressly renounces the authorisation or has provided no services or performed no activity for the preceding six months;
(b)
has obtained authorisation by making false statements or by any other irregular means;
(c)
is no longer in compliance with the conditions under which authorisation was granted and has not taken the remedial action requested by the CCP’s competent authority within a set time frame;
(d)
has seriously and systematically infringed any of the requirements laid down in this Regulation.
2. Where the CCP’s competent authority considers that one of the circumstances referred to in paragraph 1 applies, it shall, within five working days, notify ESMA and the members of college accordingly.
3. The CCP’s competent authority shall consult the members of the college on the necessity to withdraw the authorisation of the CCP, except where a decision is required urgently.
4. Any member of the college may, at any time, request that the CCP’s competent authority examine whether the CCP remains in compliance with the conditions under which authorisation was granted.
5. The CCP’s competent authority may limit the withdrawal to a particular service, activity, or class of financial instruments.
6. The CCP’s competent authority shall send ESMA and the members of the college its fully reasoned decision, which shall take into account the reservations of the members of the college.
7. The decision on the withdrawal of authorisation shall take effect throughout the Union.
Article 21
Review and evaluation
1. Without prejudice to the role of the college, the competent authorities referred to in Article 22 shall review the arrangements, strategies, processes and mechanisms implemented by CCPs to comply with this Regulation and evaluate the risks to which CCPs are, or might be, exposed.
2. The review and evaluation referred to in paragraph 1 shall cover all the requirements on CCPs laid down in this Regulation.
3. The competent authorities shall establish the frequency and depth of the review and evaluation referred to in paragraph 1 having regard to the size, systemic importance, nature, scale and complexity of the activities of the CCPs concerned. The review and evaluation shall be updated at least on an annual basis.
The CCPs shall be subject to on-site inspections.
4. The competent authorities shall regularly, and at least annually, inform the college of the results of the review and evaluation as referred to in paragraph 1, including any remedial action taken or penalty imposed.
5. The competent authorities shall require any CCP that does not meet the requirements laid down in this Regulation to take the necessary action or steps at an early stage to address the situation.
6. ESMA shall fulfil a coordination role between competent authorities and across colleges with a view to building a common supervisory culture and consistent supervisory practices, ensuring uniform procedures and consistent approaches, and strengthening consistency in supervisory outcomes.
For the purposes of the first subparagraph, ESMA shall, at least annually:
(a)
conduct a peer review analysis of the supervisory activities of all competent authorities in relation to the authorisation and the supervision of CCPs in accordance with Article 30 of Regulation (EU) No 1095/2010; and
(b)
initiate and coordinate Union-wide assessments of the resilience of CCPs to adverse market developments in accordance with Article 32(2) of Regulation (EU) No 1095/2010.
Where an assessment referred to in point (b) of the second subparagraph exposes shortcomings in the resilience of one or more CCPs, ESMA shall issue the necessary recommendations pursuant to Article 16 of Regulation (EU) No 1095/2010.
CHAPTER 2
Supervision and oversight of CCPs
Article 22
Competent authority
1. Each Member State shall designate the competent authority responsible for carrying out the duties resulting from this Regulation for the authorisation and supervision of CCPs established in its territory and shall inform the Commission and ESMA thereof.
Where a Member State designates more than one competent authority, it shall clearly determine the respective roles and shall designate a single authority to be responsible for coordinating cooperation and the exchange of information with the Commission, ESMA, other Member States’ competent authorities, EBA and the relevant members of the ESCB, in accordance with Articles 23, 24, 83 and 84.
2. Each Member State shall ensure that the competent authority has the supervisory and investigatory powers necessary for the exercise of its functions.
3. Each Member State shall ensure that appropriate administrative measures, in conformity with national law, can be taken or imposed against the natural or legal persons responsible for non-compliance with this Regulation.
Those measures shall be effective, proportionate and dissuasive and may include requests for remedial action within a set time frame.
4. ESMA shall publish on its website a list of the competent authorities designated in accordance with paragraph 1.
CHAPTER 3
Cooperation
Article 23
Cooperation between authorities
1. Competent authorities shall cooperate closely with each other, with ESMA and, if necessary, with the ESCB.
2. Competent authorities shall, in the exercise of their general duties, duly consider the potential impact of their decisions on the stability of the financial system in all other Member States concerned, in particular the emergency situations referred to in Article 24, based on the available information at the time.
Article 24
Emergency situations
The CCP’s competent authority or any other authority shall inform ESMA, the college, the relevant members of the ESCB and other relevant authorities without undue delay of any emergency situation relating to a CCP, including developments in financial markets, which may have an adverse effect on market liquidity and the stability of the financial system in any of the Member States where the CCP or one of its clearing members are established.
CHAPTER 4
Relations with third countries
Article 25
Recognition of a third-country CCP
1. A CCP established in a third country may provide clearing services to clearing members or trading venues established in the Union only where that CCP is recognised by ESMA.
2. ESMA, after consulting the authorities referred to in paragraph 3, may recognise a CCP established in a third country that has applied for recognition to provide certain clearing services or activities where:
(a)
the Commission has adopted an implementing act in accordance with paragraph 6;
(b)
the CCP is authorised in the relevant third country, and is subject to effective supervision and enforcement ensuring full compliance with the prudential requirements applicable in that third country;
(c)
cooperation arrangements have been established pursuant to paragraph 7;
(d)
the CCP is established or authorised in a third country that is considered as having equivalent systems for anti-money-laundering and combating the financing of terrorism to those of the Union in accordance with the criteria set out in the common understanding between Member States on third-country equivalence under Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (29).
3. When assessing whether the conditions referred to in paragraph 2 are met, ESMA shall consult:
(a)
the competent authority of a Member State in which the CCP provides or intends to provide clearing services and which has been selected by the CCP;
(b)
the competent authorities responsible for the supervision of the clearing members of the CCP that are established in the three Member States which make or are anticipated by the CCP to make the largest contributions to the default fund of the CCP referred to in Article 42 on an aggregate basis over a one-year period;
(c)
the competent authorities responsible for the supervision of trading venues located in the Union, served or to be served by the CCP;
(d)
the competent authorities supervising CCPs established in the Union with which interoperability arrangements have been established;
(e)
the relevant members of the ESCB of the Member States in which the CCP provides or intends to provide clearing services and the relevant members of the ESCB responsible for the oversight of the CCPs with which interoperability arrangements have been established;
(f)
the central banks of issue of the most relevant Union currencies of the financial instruments cleared or to be cleared.
4. The CCP referred to in paragraph 1 shall submit its application to ESMA.
The applicant CCP shall provide ESMA with all information necessary for its recognition. Within 30 working days of receipt, ESMA shall assess whether the application is complete. If the application is not complete, ESMA shall set a deadline by which the applicant CCP has to provide additional information.
The recognition decision shall be based on the conditions set out in paragraph 2 and shall be independent of any assessment as the basis for the equivalence decision as referred to in Article 13(3).
ESMA shall consult the authorities and entities referred to in paragraph 3 prior to taking its decision.
Within 180 working days of the submission of a complete application, ESMA shall inform the applicant CCP in writing, with a fully reasoned explanation, whether the recognition has been granted or refused.
ESMA shall publish on its website a list of the CCPs recognised in accordance with this Regulation.
5. ESMA shall, after consulting the authorities and entities referred to in paragraph 3, review the recognition of the CCP established in a third country where that CCP has extended the range of its activities and services in the Union. That review shall be conducted in accordance with paragraphs 2, 3 and 4. ESMA may withdraw the recognition of that CCP where the conditions set out in paragraph 2 are no longer met and in the same circumstances as those described in Article 20.
6. The Commission may adopt an implementing act under Article 5 of Regulation (EU) No 182/2011, determining that the legal and supervisory arrangements of a third country ensure that CCPs authorised in that third country comply with legally binding requirements which are equivalent to the requirements laid down in Title IV of this Regulation, that those CCPs are subject to effective supervision and enforcement in that third country on an ongoing basis and that the legal framework of that third country provides for an effective equivalent system for the recognition of CCPs authorised under third-country legal regimes.
7. ESMA shall establish cooperation arrangements with the relevant competent authorities of third countries whose legal and supervisory frameworks have been recognised as equivalent to this Regulation in accordance with paragraph 6. Such arrangements shall specify at least:
(a)
the mechanism for the exchange of information between ESMA and the competent authorities of the third countries concerned, including access to all information requested by ESMA regarding CCPs authorised in third countries;
(b)
the mechanism for prompt notification to ESMA where a third-country competent authority deems a CCP it is supervising to be in breach of the conditions of its authorisation or of other law to which it is subject;
(c)
the mechanism for prompt notification to ESMA by a third-country competent authority where a CCP it is supervising has been granted the right to provide clearing services to clearing members or clients established in the Union;
(d)
the procedures concerning the coordination of supervisory activities including, where appropriate, on-site inspections.
8. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the information that the applicant CCP shall provide ESMA in its application for recognition.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
TITLE IV
REQUIREMENTS FOR CCPs
CHAPTER 1
Organisational requirements
Article 26
General provisions
1. A CCP shall have robust governance arrangements, which include a clear organisational structure with well-defined, transparent and consistent lines of responsibility, effective processes to identify, manage, monitor and report the risks to which it is or might be exposed, and adequate internal control mechanisms, including sound administrative and accounting procedures.
2. A CCP shall adopt policies and procedures which are sufficiently effective so as to ensure compliance with this Regulation, including compliance of its managers and employees with all the provisions of this Regulation.
3. A CCP shall maintain and operate an organisational structure that ensures continuity and orderly functioning in the performance of its services and activities. It shall employ appropriate and proportionate systems, resources and procedures.
4. A CCP shall maintain a clear separation between the reporting lines for risk management and those for the other operations of the CCP.
5. A CCP shall adopt, implement and maintain a remuneration policy which promotes sound and effective risk management and which does not create incentives to relax risk standards.
6. A CCP shall maintain information technology systems adequate to deal with the complexity, variety and type of services and activities performed so as to ensure high standards of security and the integrity and confidentiality of the information maintained.
7. A CCP shall make its governance arrangements, the rules governing the CCP, and its admission criteria for clearing membership, available publicly free of charge.
8. The CCP shall be subject to frequent and independent audits. The results of those audits shall be communicated to the board and shall be made available to the competent authority.
9. In order to ensure consistent application of this Article, ESMA, after consulting the members of the ESCB, shall develop draft regulatory technical standards specifying the minimum content of the rules and governance arrangements referred to in paragraphs 1 to 8.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 27
Senior management and the board
1. The senior management of a CCP shall be of sufficiently good repute and shall have sufficient experience so as to ensure the sound and prudent management of the CCP.
2. A CCP shall have a board. At least one third, but no less than two, of the members of that board shall be independent. Representatives of the clients of clearing members shall be invited to board meetings for matters relevant to Articles 38 and 39. The compensation of the independent and other non-executive members of the board shall not be linked to the business performance of the CCP.
The members of a CCP’s board, including its independent members, shall be of sufficiently good repute and shall have adequate expertise in financial services, risk management and clearing services.
3. A CCP shall clearly determine the roles and responsibilities of the board and shall make the minutes of the board meetings available to the competent authority and auditors.
Article 28
Risk committee
1. A CCP shall establish a risk committee, which shall be composed of representatives of its clearing members, independent members of the board and representatives of its clients. The risk committee may invite employees of the CCP and external independent experts to attend risk-committee meetings in a non-voting capacity. Competent authorities may request to attend risk-committee meetings in a non-voting capacity and to be duly informed of the activities and decisions of the risk committee. The advice of the risk committee shall be independent of any direct influence by the management of the CCP. None of the groups of representatives shall have a majority in the risk committee.
2. A CCP shall clearly determine the mandate, the governance arrangements to ensure its independence, the operational procedures, the admission criteria and the election mechanism for risk-committee members. The governance arrangements shall be publicly available and shall, at least, determine that the risk committee is chaired by an independent member of the board, reports directly to the board and holds regular meetings.
3. The risk committee shall advise the board on any arrangements that may impact the risk management of the CCP, such as a significant change in its risk model, the default procedures, the criteria for accepting clearing members, the clearing of new classes of instruments, or the outsourcing of functions. The advice of the risk committee is not required for the daily operations of the CCP. Reasonable efforts shall be made to consult the risk committee on developments impacting the risk management of the CCP in emergency situations.
4. Without prejudice to the right of competent authorities to be duly informed, the members of the risk committee shall be bound by confidentiality. Where the chairman of the risk committee determines that a member has an actual or potential conflict of interest on a particular matter, that member shall not be allowed to vote on that matter.
5. A CCP shall promptly inform the competent authority of any decision in which the board decides not to follow the advice of the risk committee.
Article 29
Record keeping
1. A CCP shall maintain, for a period of at least 10 years, all the records on the services and activity provided so as to enable the competent authority to monitor the CCP’s compliance with this Regulation.
2. A CCP shall maintain, for a period of at least 10 years following the termination of a contract, all information on all contracts it has processed. That information shall at least enable the identification of the original terms of a transaction before clearing by that CCP.
3. A CCP shall make the records and information referred to in paragraphs 1 and 2 and all information on the positions of cleared contracts, irrespective of the venue where the transactions were executed, available upon request to the competent authority, to ESMA and to the relevant members of the ESCB.
4. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the records and information to be retained as referred to in paragraphs 1 to 3.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
5. In order to ensure uniform conditions of application of paragraphs 1 and 2, ESMA shall develop draft implementing technical standards specifying the format of the records and information to be retained.
ESMA shall submit those draft implementing technical standards to the Commission by 30 September 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 30
Shareholders and members with qualifying holdings
1. The competent authority shall not authorise a CCP unless it has been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and of the amounts of those holdings.
2. The competent authority shall refuse to authorise a CCP where it is not satisfied as to the suitability of the shareholders or members that have qualifying holdings in the CCP, taking into account the need to ensure the sound and prudent management of a CCP.
3. Where close links exist between the CCP and other natural or legal persons, the competent authority shall grant authorisation only where those links do not prevent the effective exercise of the supervisory functions of the competent authority.
4. Where the persons referred to in paragraph 1 exercise an influence which is likely to be prejudicial to the sound and prudent management of the CCP, the competent authority shall take appropriate measures to terminate that situation, which may include the withdrawal of the authorisation of the CCP.
5. The competent authority shall refuse authorisation where the laws, regulations or administrative provisions of a third country governing one or more natural or legal persons with which the CCP has close links, or difficulties involved in their enforcement, prevent the effective exercise of the supervisory functions of the competent authority.
Article 31
Information to competent authorities
1. A CCP shall notify its competent authority of any changes to its management, and shall provide the competent authority with all the information necessary to assess compliance with Article 27(1) and the second subparagraph of Article 27(2).
Where the conduct of a member of the board is likely to be prejudicial to the sound and prudent management of the CCP, the competent authority shall take appropriate measures, which may include removing that member from the board.
2. Any natural or legal person or such persons acting in concert (the ‘proposed acquirer’), who have taken a decision either to acquire, directly or indirectly, a qualifying holding in a CCP or to further increase, directly or indirectly, such a qualifying holding in a CCP as a result of which the proportion of the voting rights or of the capital held would reach or exceed 10 %, 20 %, 30 % or 50 % or so that the CCP would become its subsidiary (the ‘proposed acquisition’), shall first notify in writing the competent authority of the CCP in which they are seeking to acquire or increase a qualifying holding, indicating the size of the intended holding and relevant information, as referred to in Article 32(4).
Any natural or legal person who has taken a decision to dispose, directly or indirectly, of a qualifying holding in a CCP (the ‘proposed vendor’) shall first notify the competent authority in writing thereof, indicating the size of such holding. Such a person shall likewise notify the competent authority where it has taken a decision to reduce a qualifying holding so that the proportion of the voting rights or of the capital held would fall below 10 %, 20 %, 30 % or 50 % or so that the CCP would cease to be that person’s subsidiary.
The competent authority shall, promptly and in any event within two working days of receipt of the notification referred to in this paragraph and of the information referred to in paragraph 3, acknowledge receipt in writing thereof to the proposed acquirer or vendor.
The competent authority shall have a maximum of 60 working days as from the date of the written acknowledgement of receipt of the notification and all documents required to be attached to the notification on the basis of the list referred to in Article 32(4) (the assessment period), to carry out the assessment provided for in Article 32(1) (the assessment).
The competent authority shall inform the proposed acquirer or vendor of the date of the expiry of the assessment period at the time of acknowledging receipt.
3. The competent authority may, during the assessment period, where necessary, but no later than on the 50th working day of the assessment period, request any further information that is necessary to complete the assessment. Such request shall be made in writing and shall specify the additional information needed.
The assessment period shall be interrupted for the period between the date of request for information by the competent authority and the receipt of a response thereto by the proposed acquirer. The interruption shall not exceed 20 working days. Any further requests by the competent authority for completion or clarification of the information shall be at its discretion but may not result in an interruption of the assessment period.
4. The competent authority may extend the interruption referred to in the second subparagraph of paragraph 3 up to 30 working days where the proposed acquirer or vendor is either:
(a)
situated or regulated outside the Union;
(b)
a natural or legal person not subject to supervision under this Regulation or Directive 73/239/EEC, Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance (30) or Directives 2002/83/EC, 2003/41/EC, 2004/39/EC, 2005/68/EC, 2006/48/EC, 2009/65/EC or 2011/61/EU.
5. Where the competent authority, upon completion of the assessment, decides to oppose the proposed acquisition, it shall, within two working days, and not exceeding the assessment period, inform the proposed acquirer in writing and provide the reasons for that decision. The competent authority shall notify the college referred to in Article 18 accordingly. Subject to national law, an appropriate statement of the reasons for the decision may be made accessible to the public at the request of the proposed acquirer. However, Member States may allow a competent authority to make such disclosure in the absence of a request by the proposed acquirer.
6. Where the competent authority does not oppose the proposed acquisition within the assessment period, it shall be deemed to be approved.
7. The competent authority may fix a maximum period for concluding the proposed acquisition and extend it where appropriate.
8. Member States shall not impose requirements for notification to, and approval by, the competent authority of direct or indirect acquisitions of voting rights or capital that are more stringent than those set out in this Regulation.
Article 32
Assessment
1. Where assessing the notification provided for in Article 31(2) and the information referred to in Article 31(3), the competent authority shall, in order to ensure the sound and prudent management of the CCP in which an acquisition is proposed, and having regard to the likely influence of the proposed acquirer on the CCP, appraise the suitability of the proposed acquirer and the financial soundness of the proposed acquisition against all of the following:
(a)
the reputation and financial soundness of the proposed acquirer;
(b)
the reputation and experience of any person who will direct the business of the CCP as a result of the proposed acquisition;
(c)
whether the CCP will be able to comply and continue to comply with this Regulation;
(d)
whether there are reasonable grounds to suspect that, in connection with the proposed acquisition, money laundering or terrorist financing within the meaning of Article 1 of Directive 2005/60/EC is being or has been committed or attempted, or that the proposed acquisition could increase the risk thereof.
Where assessing the financial soundness of the proposed acquirer, the competent authority shall pay particular attention to the type of business pursued and envisaged in the CCP in which the acquisition is proposed.
Where assessing the CCP’s ability to comply with this Regulation, the competent authority shall pay particular attention to whether the group of which it will become a part has a structure that makes it possible to exercise effective supervision, to effectively exchange information among the competent authorities and to determine the allocation of responsibilities among the competent authorities.
2. The competent authorities may oppose the proposed acquisition only where there are reasonable grounds for doing so on the basis of the criteria set out in paragraph 1 or where the information provided by the proposed acquirer is incomplete.
3. Member States shall neither impose any prior conditions in respect of the level of holding that shall be acquired nor allow their competent authorities to examine the proposed acquisition in terms of the economic needs of the market.
4. Member States shall make publicly available a list specifying the information that is necessary to carry out the assessment and that shall be provided to the competent authorities at the time of notification referred to in Article 31(2). The information required shall be proportionate and shall be adapted to the nature of the proposed acquirer and the proposed acquisition. Member States shall not require information that is not relevant for a prudential assessment.
5. Notwithstanding Article 31(2), (3) and (4), where two or more proposals to acquire or increase qualifying holdings in the same CCP have been notified to the competent authority, the latter shall treat the proposed acquirers in a non-discriminatory manner.
6. The relevant competent authorities shall cooperate closely with each other when carrying out the assessment where the proposed acquirer is one of the following:
(a)
another CCP, a credit institution, assurance undertaking, insurance undertaking, reinsurance undertaking, investment firm, market operator, an operator of a securities settlement system, a UCITS management company or an AIFM authorised in another Member State;
(b)
the parent undertaking of another CCP, a credit institution, assurance undertaking, insurance undertaking, reinsurance undertaking, investment firm, market operator, an operator of a securities settlement system, a UCITS management company or an AIFM authorised in another Member State;
(c)
a natural or legal person controlling another CCP, a credit institution, assurance undertaking, insurance undertaking, reinsurance undertaking, investment firm, market operator, an operator of a securities settlement system, a UCITS management company or an AIFM authorised in another Member State.
7. The competent authorities shall, without undue delay, provide each other with any information which is essential or relevant for the assessment. The competent authorities shall, upon request, communicate all relevant information to each other and shall communicate all essential information at their own initiative. A decision by the competent authority that has authorised the CCP in which the acquisition is proposed shall indicate any views or reservations expressed by the competent authority responsible for the proposed acquirer.
Article 33
Conflicts of interest
1. A CCP shall maintain and operate effective written organisational and administrative arrangements to identify and manage any potential conflicts of interest between itself, including its managers, employees, or any person with direct or indirect control or close links, and its clearing members or their clients known to the CCP. It shall maintain and implement adequate procedures aiming at resolving possible conflicts of interest.
2. Where the organisational or administrative arrangements of a CCP to manage conflicts of interest are not sufficient to ensure, with reasonable confidence, that risks of damage to the interests of a clearing member or client are prevented, it shall clearly disclose the general nature or sources of conflicts of interest to the clearing member before accepting new transactions from that clearing member. Where the client is known to the CCP, the CCP shall inform the client and the clearing member whose client is concerned.
3. Where the CCP is a parent undertaking or a subsidiary, the written arrangements shall also take into account any circumstances, of which the CCP is or should be aware, which may give rise to a conflict of interest arising as a result of the structure and business activities of other undertakings with which it has a parent undertaking or a subsidiary relationship.
4. The written arrangements established in accordance with paragraph 1 shall include the following:
(a)
the circumstances which constitute or may give rise to a conflict of interest entailing a material risk of damage to the interests of one or more clearing members or clients;
(b)
procedures to be followed and measures to be adopted in order to manage such conflict.
5. A CCP shall take all reasonable steps to prevent any misuse of the information held in its systems and shall prevent the use of that information for other business activities. A natural person who has a close link to a CCP or a legal person that has a parent undertaking or a subsidiary relationship with a CCP shall not use confidential information recorded in that CCP for any commercial purposes without the prior written consent of the client to whom such confidential information belongs.
Article 34
Business continuity
1. A CCP shall establish, implement and maintain an adequate business continuity policy and disaster recovery plan aiming at ensuring the preservation of its functions, the timely recovery of operations and the fulfilment of the CCP’s obligations. Such a plan shall at least allow for the recovery of all transactions at the time of disruption to allow the CCP to continue to operate with certainty and to complete settlement on the scheduled date.
2. A CCP shall establish, implement and maintain an adequate procedure ensuring the timely and orderly settlement or transfer of the assets and positions of clients and clearing members in the event of a withdrawal of authorisation pursuant to a decision under Article 20.
3. In order to ensure consistent application of this Article, ESMA shall, after consulting the members of the ESCB, develop draft regulatory technical standards specifying the minimum content and requirements of the business continuity policy and of the disaster recovery plan.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 35
Outsourcing
1. Where a CCP outsources operational functions, services or activities, it shall remain fully responsible for discharging all of its obligations under this Regulation and shall ensure at all times that:
(a)
outsourcing does not result in the delegation of its responsibility;
(b)
the relationship and obligations of the CCP towards its clearing members or, where relevant, towards their clients are not altered;
(c)
the conditions for authorisation of the CCP do not effectively change;
(d)
outsourcing does not prevent the exercise of supervisory and oversight functions, including on-site access to acquire any relevant information needed to fulfil those mandates;
(e)
outsourcing does not result in depriving the CCP from the necessary systems and controls to manage the risks it faces;
(f)
the service provider implements equivalent business continuity requirements to those that the CCP must fulfil under this Regulation;
(g)
the CCP retains the necessary expertise and resources to evaluate the quality of the services provided and the organisational and capital adequacy of the service provider, and to supervise the outsourced functions effectively and manage the risks associated with the outsourcing and supervises those functions and manages those risks on an ongoing basis;
(h)
the CCP has direct access to the relevant information of the outsourced functions;
(i)
the service provider cooperates with the competent authority in connection with the outsourced activities;
(j)
the service provider protects any confidential information relating to the CCP and its clearing members and clients or, where that service provider is established in a third country, ensures that the data protection standards of that third country, or those set out in the agreement between the parties concerned, are comparable to the data protection standards in effect in the Union.
A CCP shall not outsource major activities linked to risk management unless such outsourcing is approved by the competent authority.
2. The competent authority shall require the CCP to allocate and set out its rights and obligations, and those of the service provider, clearly in a written agreement.
3. A CCP shall make all information necessary to enable the competent authority to assess the compliance of the performance of the outsourced activities with this Regulation available on request.
CHAPTER 2
Conduct of business rules
Article 36
General provisions
1. When providing services to its clearing members, and where relevant, to their clients, a CCP shall act fairly and professionally in accordance with the best interests of such clearing members and clients and sound risk management.
2. A CCP shall have accessible, transparent and fair rules for the prompt handling of complaints.
Article 37
Participation requirements
1. A CCP shall establish, where relevant per type of product cleared, the categories of admissible clearing members and the admission criteria, upon the advice of the risk committee pursuant to Article 28(3). Such criteria shall be non-discriminatory, transparent and objective so as to ensure fair and open access to the CCP and shall ensure that clearing members have sufficient financial resources and operational capacity to meet the obligations arising from participation in a CCP. Criteria that restrict access shall be permitted only to the extent that their objective is to control the risk for the CCP.
2. A CCP shall ensure that the application of the criteria referred to in paragraph 1 is met on an ongoing basis and shall have timely access to the information relevant for such assessment. A CCP shall conduct, at least once a year, a comprehensive review of compliance with this Article by its clearing members.
3. Clearing members that clear transactions on behalf of their clients shall have the necessary additional financial resources and operational capacity to perform this activity. The CCP’s rules for clearing members shall allow it to gather relevant basic information to identify, monitor and manage relevant concentrations of risk relating to the provision of services to clients. Clearing members shall, upon request, inform the CCP about the criteria and arrangements they adopt to allow their clients to access the services of the CCP. Responsibility for ensuring that clients comply with their obligations shall remain with clearing members.
4. A CCP shall have objective and transparent procedures for the suspension and orderly exit of clearing members that no longer meet the criteria referred to in paragraph 1.
5. A CCP may only deny access to clearing members meeting the criteria referred to in paragraph 1 where duly justified in writing and based on a comprehensive risk analysis.
6. A CCP may impose specific additional obligations on clearing members, such as the participation in auctions of a defaulting clearing member’s position. Such additional obligations shall be proportional to the risk brought by the clearing member and shall not restrict participation to certain categories of clearing members.
Article 38
Transparency
1. A CCP and its clearing members shall publicly disclose the prices and fees associated with the services provided. They shall disclose the prices and fees of each service provided separately, including discounts and rebates and the conditions to benefit from those reductions. A CCP shall allow its clearing members and, where relevant, their clients separate access to the specific services provided.
A CCP shall account separately for costs and revenues of the services provided and shall disclose that information to the competent authority.
2. A CCP shall disclose to clearing members and clients the risks associated with the services provided.
3. A CCP shall disclose to its clearing members and to its competent authority the price information used to calculate its end-of-day exposures to its clearing members.
A CCP shall publicly disclose the volumes of the cleared transactions for each class of instruments cleared by the CCP on an aggregated basis.
4. A CCP shall publicly disclose the operational and technical requirements relating to the communication protocols covering content and message formats it uses to interact with third parties, including the operational and technical requirements referred to in Article 7.
5. A CCP shall publicly disclose any breaches by clearing members of the criteria referred to in Article 37(1) and the requirements laid down in paragraph 1 of this Article, except where the competent authority, after consulting ESMA, considers that such disclosure would constitute a threat to financial stability or to market confidence or would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved.
Article 39
Segregation and portability
1. A CCP shall keep separate records and accounts that shall enable it, at any time and without delay, to distinguish in accounts with the CCP the assets and positions held for the account of one clearing member from the assets and positions held for the account of any other clearing member and from its own assets.
2. A CCP shall offer to keep separate records and accounts enabling each clearing member to distinguish in accounts with the CCP the assets and positions of that clearing member from those held for the accounts of its clients (‘omnibus client segregation’).
3. A CCP shall offer to keep separate records and accounts enabling each clearing member to distinguish in accounts with the CCP the assets and positions held for the account of a client from those held for the account of other clients (‘individual client segregation’). Upon request, the CCP shall offer clearing members the possibility to open more accounts in their own name or for the account of their clients.
4. A clearing member shall keep separate records and accounts that enable it to distinguish both in accounts held with the CCP and in its own accounts its assets and positions from the assets and positions held for the account of its clients at the CCP.
5. A clearing member shall offer its clients, at least, the choice between omnibus client segregation and individual client segregation and inform them of the costs and level of protection referred to in paragraph 7 associated with each option. The client shall confirm its choice in writing.
6. When a client opts for individual client segregation, any margin in excess of the client’s requirement shall also be posted to the CCP and distinguished from the margins of other clients or clearing members and shall not be exposed to losses connected to positions recorded in another account.
7. CCPs and clearing members shall publicly disclose the levels of protection and the costs associated with the different levels of segregation that they provide and shall offer those services on reasonable commercial terms. Details of the different levels of segregation shall include a description of the main legal implications of the respective levels of segregation offered including information on the insolvency law applicable in the relevant jurisdictions.
8. A CCP shall have a right of use relating to the margins or default fund contributions collected via a security financial collateral arrangement, within the meaning of Article 2(1)(c) of Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (31) provided that the use of such arrangements is provided for in its operating rules. The clearing member shall confirm its acceptance of the operating rules in writing. The CCP shall publicly disclose that right of use, which shall be exercised in accordance with Article 47.
9. The requirement to distinguish assets and positions with the CCP in accounts is satisfied where:
(a)
the assets and positions are recorded in separate accounts;
(b)
the netting of positions recorded on different accounts is prevented;
(c)
the assets covering the positions recorded in an account are not exposed to losses connected to positions recorded in another account.
10. Assets refer to collateral held to cover positions and include the right to the transfer of assets equivalent to that collateral or the proceeds of the realisation of any collateral, but does not include default fund contributions.
CHAPTER 3
Prudential requirements
Article 40
Exposure management
A CCP shall measure and assess its liquidity and credit exposures to each clearing member and, where relevant, to another CCP with which it has concluded an interoperability arrangement, on a near to real-time basis. A CCP shall have access in a timely manner and on a non-discriminatory basis to the relevant pricing sources to effectively measure its exposures. This shall be done on a reasonable cost basis.
Article 41
Margin requirements
1. A CCP shall impose, call and collect margins to limit its credit exposures from its clearing members and, where relevant, from CCPs with which it has interoperability arrangements. Such margins shall be sufficient to cover potential exposures that the CCP estimates will occur until the liquidation of the relevant positions. They shall also be sufficient to cover losses that result from at least 99 % of the exposures movements over an appropriate time horizon and they shall ensure that a CCP fully collateralises its exposures with all its clearing members, and, where relevant, with CCPs with which it has interoperability arrangements, at least on a daily basis. A CCP shall regularly monitor and, if necessary, revise the level of its margins to reflect current market conditions taking into account any potentially procyclical effects of such revisions.
2. A CCP shall adopt models and parameters in setting its margin requirements that capture the risk characteristics of the products cleared and take into account the interval between margin collections, market liquidity and the possibility of changes over the duration of the transaction. The models and parameters shall be validated by the competent authority and subject to an opinion in accordance with Article 19.
3. A CCP shall call and collect margins on an intraday basis, at least when predefined thresholds are exceeded.
4. A CCP shall call and collect margins that are adequate to cover the risk stemming from the positions registered in each account kept in accordance with Article 39 with respect to specific financial instruments. A CCP may calculate margins with respect to a portfolio of financial instruments provided that the methodology used is prudent and robust.
5. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA and the ESCB, develop draft regulatory technical standards specifying the appropriate percentage and time horizons for the liquidation period and the calculation of historical volatility, as referred to in paragraph 1, to be considered for the different classes of financial instruments, taking into account the objective to limit procyclicality, and the conditions under which portfolio margining practices referred to in paragraph 4 can be implemented.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 42
Default fund
1. To limit its credit exposures to its clearing members further, a CCP shall maintain a pre-funded default fund to cover losses that exceed the losses to be covered by margin requirements laid down in Article 41, arising from the default, including the opening of an insolvency procedure, of one or more clearing members.
The CCP shall establish a minimum amount below which the size of the default fund is not to fall under any circumstances.
2. A CCP shall establish the minimum size of contributions to the default fund and the criteria to calculate the contributions of the single clearing members. The contributions shall be proportional to the exposures of each clearing member.
3. The default fund shall at least enable the CCP to withstand, under extreme but plausible market conditions, the default of the clearing member to which it has the largest exposures or of the second and third largest clearing members, if the sum of their exposures is larger. A CCP shall develop scenarios of extreme but plausible market conditions. The scenarios shall include the most volatile periods that have been experienced by the markets for which the CCP provides its services and a range of potential future scenarios. They shall take into account sudden sales of financial resources and rapid reductions in market liquidity.
4. A CCP may establish more than one default fund for the different classes of instrument that it clears.
5. In order to ensure consistent application of this Article, ESMA shall, in close cooperation with the ESCB and after consulting EBA, develop draft regulatory technical standards specifying the framework for defining extreme but plausible market conditions referred to in paragraph 3, that should be used when defining the size of the default fund and the other financial resources referred to in Article 43.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 43
Other financial resources
1. A CCP shall maintain sufficient pre-funded available financial resources to cover potential losses that exceed the losses to be covered by margin requirements laid down in Article 41 and the default fund as referred to in Article 42. Such pre-funded financial resources shall include dedicated resources of the CCP, shall be freely available to the CCP and shall not be used to meet the capital required under Article 16.
2. The default fund referred to in Article 42 and the other financial resources referred to in paragraph 1 of this Article shall at all times enable the CCP to withstand the default of at least the two clearing members to which it has the largest exposures under extreme but plausible market conditions.
3. A CCP may require non-defaulting clearing members to provide additional funds in the event of a default of another clearing member. The clearing members of a CCP shall have limited exposures toward the CCP.
Article 44
Liquidity risk controls
1. A CCP shall at all times have access to adequate liquidity to perform its services and activities. To that end, it shall obtain the necessary credit lines or similar arrangements to cover its liquidity needs in case the financial resources at its disposal are not immediately available. A clearing member, parent undertaking or subsidiary of that clearing member together shall not provide more than 25 % of the credit lines needed by the CCP.
A CCP shall measure, on a daily basis, its potential liquidity needs. It shall take into account the liquidity risk generated by the default of at least the two clearing members to which it has the largest exposures.
2. In order to ensure consistent application of this Article, ESMA shall, after consulting the relevant authorities and the members of the ESCB, develop draft regulatory technical standards specifying the framework for managing the liquidity risk that CCPs are to withstand in accordance with paragraph 1.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 45
Default waterfall
1. A CCP shall use the margins posted by a defaulting clearing member prior to other financial resources in covering losses.
2. Where the margins posted by the defaulting clearing member are not sufficient to cover the losses incurred by the CCP, the CCP shall use the default fund contribution of the defaulting member to cover those losses.
3. A CCP shall use contributions to the default fund of the non-defaulting clearing members and any other financial resources referred to in Article 43(1) only after having exhausted the contributions of the defaulting clearing member.
4. A CCP shall use dedicated own resources before using the default fund contributions of non-defaulting clearing members. A CCP shall not use the margins posted by non-defaulting clearing members to cover the losses resulting from the default of another clearing member.
5. In order to ensure consistent application of this Article, ESMA, shall, after consulting the relevant competent authorities and the members of the ESCB, develop draft regulatory technical standards specifying the methodology for calculation and maintenance of the amount of the CCP’s own resources to be used in accordance with paragraph 4.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 46
Collateral requirements
1. A CCP shall accept highly liquid collateral with minimal credit and market risk to cover its initial and ongoing exposure to its clearing members. For non-financial counterparties, a CCP may accept bank guarantees, taking such guarantees into account when calculating its exposure to a bank that is a clearing member. It shall apply adequate haircuts to asset values that reflect the potential for their value to decline over the interval between their last revaluation and the time by which they can reasonably be assumed to be liquidated. It shall take into account the liquidity risk following the default of a market participant and the concentration risk on certain assets that may result in establishing the acceptable collateral and the relevant haircuts.
2. A CCP may accept, where appropriate and sufficiently prudent, the underlying of the derivative contract or the financial instrument that originates the CCP exposure as collateral to cover its margin requirements.
3. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA, the ESRB and the ESCB, develop draft regulatory technical standards specifying:
(a)
the type of collateral that could be considered highly liquid, such as cash, gold, government and high-quality corporate bonds and covered bonds;
(b)
the haircuts referred to in paragraph 1; and
(c)
the conditions under which commercial bank guarantees may be accepted as collateral under paragraph 1.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 47
Investment policy
1. A CCP shall invest its financial resources only in cash or in highly liquid financial instruments with minimal market and credit risk. A CCP’s investments shall be capable of being liquidated rapidly with minimal adverse price effect.
2. The amount of capital, including retained earnings and reserves of a CCP which are not invested in accordance with paragraph 1, shall not be taken into account for the purposes of Article 16(2) or Article 45(4).
3. Financial instruments posted as margins or as default fund contributions shall, where available, be deposited with operators of securities settlement systems that ensure the full protection of those financial instruments. Alternatively, other highly secure arrangements with authorised financial institutions may be used.
4. Cash deposits of a CCP shall be performed through highly secure arrangements with authorised financial institutions or, alternatively, through the use of the standing deposit facilities of central banks or other comparable means provided for by central banks.
5. Where a CCP deposits assets with a third party, it shall ensure that the assets belonging to the clearing members are identifiable separately from the assets belonging to the CCP and from assets belonging to that third party by means of differently titled accounts on the books of the third party or any other equivalent measures that achieve the same level of protection. A CCP shall have prompt access to the financial instruments when required.
6. A CCP shall not invest its capital or the sums arising from the requirements laid down in Article 41, 42, 43 or 44 in its own securities or those of its parent undertaking or its subsidiary.
7. A CCP shall take into account its overall credit risk exposures to individual obligors in making its investment decisions and shall ensure that its overall risk exposure to any individual obligor remains within acceptable concentration limits.
8. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA and the ESCB, develop draft regulatory technical standards specifying the financial instruments that can be considered highly liquid, bearing minimal credit and market risk as referred to in paragraph 1, the highly secured arrangements referred to in paragraphs 3 and 4 and the concentration limits referred to in paragraph 7.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 48
Default procedures
1. A CCP shall have detailed procedures in place to be followed where a clearing member does not comply with the participation requirements of the CCP laid down in Article 37 within the time limit and in accordance with the procedures established by the CCP. The CCP shall set out in detail the procedures to be followed in the event the default of a clearing member is not declared by the CCP. Those procedures shall be reviewed annually.
2. A CCP shall take prompt action to contain losses and liquidity pressures resulting from defaults and shall ensure that the closing out of any clearing member’s positions does not disrupt its operations or expose the non-defaulting clearing members to losses that they cannot anticipate or control.
3. Where a CCP considers that the clearing member will not be able to meet its future obligations, it shall promptly inform the competent authority before the default procedure is declared or triggered. The competent authority shall promptly communicate that information to ESMA, to the relevant members of the ESCB and to the authority responsible for the supervision of the defaulting clearing member.
4. A CCP shall verify that its default procedures are enforceable. It shall take all reasonable steps to ensure that it has the legal powers to liquidate the proprietary positions of the defaulting clearing member and to transfer or liquidate the clients’ positions of the defaulting clearing member.
5. Where assets and positions are recorded in the records and accounts of a CCP as being held for the account of a defaulting clearing member’s clients in accordance with Article 39(2), the CCP shall, at least, contractually commit itself to trigger the procedures for the transfer of the assets and positions held by the defaulting clearing member for the account of its clients to another clearing member designated by all of those clients, on their request and without the consent of the defaulting clearing member. That other clearing member shall be obliged to accept those assets and positions only where it has previously entered into a contractual relationship with the clients by which it has committed itself to do so. If the transfer to that other clearing member has not taken place for any reason within a predefined transfer period specified in its operating rules, the CCP may take all steps permitted by its rules to actively manage its risks in relation to those positions, including liquidating the assets and positions held by the defaulting clearing member for the account of its clients.
6. Where assets and positions are recorded in the records and accounts of a CCP as being held for the account of a defaulting clearing member’s client in accordance with Article 39(3), the CCP shall, at least, contractually commit itself to trigger the procedures for the transfer of the assets and positions held by the defaulting clearing member for the account of the client to another clearing member designated by the client, on the client’s request and without the consent of the defaulting clearing member. That other clearing member shall be obliged to accept these assets and positions only where it has previously entered into a contractual relationship with the client by which it has committed itself to do so. If the transfer to that other clearing member has not taken place for any reason within a predefined transfer period specified in its operating rules, the CCP may take all steps permitted by its rules to actively manage its risks in relation to those positions, including liquidating the assets and positions held by the defaulting clearing member for the account of the client.
7. Clients’ collateral distinguished in accordance with Article 39(2) and (3) shall be used exclusively to cover the positions held for their account. Any balance owed by the CCP after the completion of the clearing member’s default management process by the CCP shall be readily returned to those clients when they are known to the CCP or, if they are not, to the clearing member for the account of its clients.
Article 49
Review of models, stress testing and back testing
1. A CCP shall regularly review the models and parameters adopted to calculate its margin requirements, default fund contributions, collateral requirements and other risk control mechanisms. It shall subject the models to rigorous and frequent stress tests to assess their resilience in extreme but plausible market conditions and shall perform back tests to assess the reliability of the methodology adopted. The CCP shall obtain independent validation, shall inform its competent authority and ESMA of the results of the tests performed and shall obtain their validation before adopting any significant change to the models and parameters.
The adopted models and parameters, including any significant change thereto, shall be subject to an opinion of the college pursuant to Article 19.
ESMA shall ensure that information on the results of the stress tests is passed on to the ESAs to enable them to assess the exposure of financial undertakings to the default of CCPs.
2. A CCP shall regularly test the key aspects of its default procedures and take all reasonable steps to ensure that all clearing members understand them and have appropriate arrangements in place to respond to a default event.
3. A CCP shall publicly disclose key information on its risk-management model and assumptions adopted to perform the stress tests referred to in paragraph 1.
4. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA, other relevant competent authorities and the members of the ESCB, develop draft regulatory technical standards specifying:
(a)
the type of tests to be undertaken for different classes of financial instruments and portfolios;
(b)
the involvement of clearing members or other parties in the tests;
(c)
the frequency of the tests;
(d)
the time horizons of the tests;
(e)
the key information referred to in paragraph 3.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 50
Settlement
1. A CCP shall, where practical and available, use central bank money to settle its transactions. Where central bank money is not used, steps shall be taken to strictly limit cash settlement risks.
2. A CCP shall clearly state its obligations with respect to deliveries of financial instruments, including whether it has an obligation to make or receive delivery of a financial instrument or whether it indemnifies participants for losses incurred in the delivery process.
3. Where a CCP has an obligation to make or receive deliveries of financial instruments, it shall eliminate principal risk through the use of delivery-versus-payment mechanisms to the extent possible.
TITLE V
INTEROPERABILITY ARRANGEMENTS
Article 51
Interoperability arrangements
1. A CCP may enter into an interoperability arrangement with another CCP where the requirements laid down in Articles 52, 53 and 54 are fulfilled.
2. When establishing an interoperability arrangement with another CCP for the purpose of providing services to a particular trading venue, the CCP shall have non-discriminatory access, both to the data that it needs for the performance of its functions from that particular trading venue, to the extent that the CCP complies with the operational and technical requirements established by the trading venue, and to the relevant settlement system.
3. Entering into an interoperability arrangement or accessing a data feed or a settlement system referred to in paragraphs 1 and 2 shall be rejected or restricted, directly or indirectly, only in order to control any risk arising from that arrangement or access.
Article 52
Risk management
1. CCPs that enter into an interoperability arrangement shall:
(a)
put in place adequate policies, procedures and systems to effectively identify, monitor and manage the risks arising from the arrangement so that they can meet their obligations in a timely manner;
(b)
agree on their respective rights and obligations, including the applicable law governing their relationships;
(c)
identify, monitor and effectively manage credit and liquidity risks so that a default of a clearing member of one CCP does not affect an interoperable CCP;
(d)
identify, monitor and address potential interdependences and correlations that arise from an interoperability arrangement that may affect credit and liquidity risks relating to clearing member concentrations, and pooled financial resources.
For the purposes of point (b) of the first subparagraph, CCPs shall use the same rules concerning the moment of entry of transfer orders into their respective systems and the moment of irrevocability as set out in Directive 98/26/EC, where relevant.
For the purposes of point (c) of the first subparagraph, the terms of the arrangement shall outline the process for managing the consequences of the default where one of the CCPs with which an interoperability arrangement has been concluded is in default.
For the purposes of point (d) of the first subparagraph, CCPs shall have robust controls over the re-use of clearing members’ collateral under the arrangement, if permitted by their competent authorities. The arrangement shall outline how those risks have been addressed taking into account sufficient coverage and need to limit contagion.
2. Where the risk-management models used by the CCPs to cover their exposure to their clearing members or their reciprocal exposures are different, the CCPs shall identify those differences, assess risks that may arise therefrom and take measures, including securing additional financial resources, that limit their impact on the interoperability arrangement as well as their potential consequences in terms of contagion risks and ensure that these differences do not affect each CCP’s ability to manage the consequences of the default of a clearing member.
3. Any associated costs that arise from paragraphs 1 and 2 shall be borne by the CCP requesting interoperability or access, unless otherwise agreed between the parties.
Article 53
Provision of margins among CCPs
1. A CCP shall distinguish in accounts the assets and positions held for the account of CCPs with whom it has entered into an interoperability arrangement.
2. If a CCP that enters into an interoperability arrangement with another CCP only provides initial margins to that CCP under a security financial collateral arrangement, the receiving CCP shall have no right of use over the margins provided by the other CCP.
3. Collateral received in the form of financial instruments shall be deposited with operators of securities settlement systems notified under Directive 98/26/EC.
4. The assets referred to in paragraphs 1 and 2 shall be available to the receiving CCP only in case of default of the CCP which has provided the collateral in the context of an interoperability arrangement.
5. In case of default of the CCP which has received the collateral in the context of an interoperability arrangement, the collateral referred to in paragraphs 1 and 2 shall be readily returned to the providing CCP.
Article 54
Approval of interoperability arrangements
1. An interoperability arrangement shall be subject to the prior approval of the competent authorities of the CCPs involved. The procedure under Article 17 shall apply.
2. The competent authorities shall grant approval of the interoperability arrangement only where the CCPs involved have been authorised to clear under Article 17 or recognised under Article 25 or authorised under a pre-existing national authorisation regime for a period of at least three years, the requirements laid down in Article 52 are met and the technical conditions for clearing transactions under the terms of the arrangement allow for a smooth and orderly functioning of financial markets and the arrangement does not undermine the effectiveness of supervision.
3. Where a competent authority considers that the requirements laid down in paragraph 2 are not met, it shall provide explanations in writing regarding its risk considerations to the other competent authorities and the CCPs involved. It shall also notify ESMA, which shall issue an opinion on the effective validity of the risk considerations as grounds for denial of the interoperability arrangement. ESMA’s opinion shall be made available to all the CCPs involved. Where ESMA’s opinion differs from the assessment of the relevant competent authority, that competent authority shall reconsider its position, taking into account ESMA’s opinion.
4. By 31 December 2012, ESMA shall issue guidelines or recommendations with a view to establishing consistent, efficient and effective assessments of interoperability arrangements, in accordance with the procedure laid down in Article 16 of Regulation (EU) No 1095/2010.
ESMA shall develop drafts of those guidelines or recommendations after consulting the members of the ESCB.
TITLE VI
REGISTRATION AND SUPERVISION OF TRADE REPOSITORIES
CHAPTER 1
Conditions and procedures for registration of a trade repository
Article 55
Registration of a trade repository
1. A trade repository shall register with ESMA for the purposes of Article 9.
2. To be eligible to be registered under this Article, a trade repository shall be a legal person established in the Union and meet the requirements laid down in Title VII.
3. The registration of a trade repository shall be effective for the entire territory of the Union.
4. A registered trade repository shall comply at all times with the conditions for registration. A trade repository shall, without undue delay, notify ESMA of any material changes to the conditions for registration.
Article 56
Application for registration
1. A trade repository shall submit an application for registration to ESMA.
2. ESMA shall assess whether the application is complete within 20 working days of receipt of the application.
Where the application is not complete, ESMA shall set a deadline by which the trade repository is to provide additional information.
After assessing an application as complete, ESMA shall notify the trade repository accordingly.
3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the application for registration referred to in paragraph 1.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
4. In order to ensure uniform conditions of application of paragraph 1, ESMA shall develop draft implementing technical standards specifying the format of the application for registration to ESMA.
ESMA shall submit those draft implementing technical standards to the Commission by 30 September 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 57
Notification of and consultation with competent authorities prior to registration
1. If a trade repository which is applying for registration is an entity which is authorised or registered by a competent authority in the Member State where it is established, ESMA shall, without undue delay, notify and consult that competent authority prior to the registration of the trade repository.
2. ESMA and the relevant competent authority shall exchange all information that is necessary for the registration of the trade repository as well as for the supervision of the entity’s compliance with the conditions of its registration or authorisation in the Member State where it is established.
Article 58
Examination of the application
1. ESMA shall, within 40 working days from the notification referred to in the third subparagraph of Article 56(2), examine the application for registration based on the compliance of the trade repository with Articles 78 to 81 and shall adopt a fully reasoned registration decision or decision refusing registration.
2. A decision issued by ESMA pursuant to paragraph 1 shall take effect on the fifth working day following its adoption.
Article 59
Notification of ESMA decisions relating to registration
1. Where ESMA adopts a registration decision or a decision refusing or withdrawing registration, it shall notify the trade repository within five working days with a fully reasoned explanation of its decision.
ESMA shall, without undue delay, notify the relevant competent authority referred to in Article 57(1) of its decision.
2. ESMA shall communicate any decision taken in accordance with paragraph 1 to the Commission.
3. ESMA shall publish on its website a list of trade repositories registered in accordance with this Regulation. That list shall be updated within five working days following the adoption of a decision under paragraph 1.
Article 60
Exercise of the powers referred to in Articles 61 to 63
The powers conferred on ESMA or any official of or other person authorised by ESMA by Articles 61 to 63 shall not be used to require the disclosure of information or documents which are subject to legal privilege.
Article 61
Request for information
1. ESMA may by simple request or by decision require trade repositories and related third parties to whom the trade repositories have outsourced operational functions or activities to provide all information that is necessary in order to carry out its duties under this Regulation.
2. When sending a simple request for information under paragraph 1, ESMA shall:
(a)
refer to this Article as the legal basis of the request;
(b)
state the purpose of the request;
(c)
specify what information is required;
(d)
set a time limit within which the information is to be provided;
(e)
inform the person from whom the information is requested that he is not obliged to provide the information but that in case of a voluntary reply to the request the information provided must not be incorrect and misleading; and
(f)
indicate the fine provided for in Article 65 in conjunction with point (a) of Section IV of Annex I where the answers to questions asked are incorrect or misleading.
3. When requiring to supply information under paragraph 1 by decision, ESMA shall:
(a)
refer to this Article as the legal basis of the request;
(b)
state the purpose of the request;
(c)
specify what information is required;
(d)
set a time limit within which the information is to be provided;
(e)
indicate the periodic penalty payments provided for in Article 66 where the production of the required information is incomplete;
(f)
indicate the fine provided for in Article 65 in conjunction with point (a) of Section IV of Annex I, where the answers to questions asked are incorrect or misleading; and
(g)
indicate the right to appeal the decision before ESMA’s Board of Appeal and to have the decision reviewed by the Court of Justice of the European Union (‘Court of Justice’) in accordance with Articles 60 and 61 of Regulation (EU) No 1095/2010.
4. The persons referred to in paragraph 1 or their representatives and, in the case of legal persons or associations having no legal personality, the persons authorised to represent them by law or by their constitution shall supply the information requested. Lawyers duly authorised to act may supply the information on behalf of their clients. The latter shall remain fully responsible if the information supplied is incomplete, incorrect or misleading.
5. ESMA shall, without delay, send a copy of the simple request or of its decision to the competent authority of the Member State where the persons referred to in paragraph 1 concerned by the request for information are domiciled or established.
Article 62
General investigations
1. In order to carry out its duties under this Regulation, ESMA may conduct necessary investigations of persons referred to in Article 61(1). To that end, the officials and other persons authorised by ESMA shall be empowered to:
(a)
examine any records, data, procedures and any other material relevant to the execution of its tasks irrespective of the medium on which they are stored;
(b)
take or obtain certified copies of or extracts from such records, data, procedures and other material;
(c)
summon and ask any person referred to in Article 61(1) or their representatives or staff for oral or written explanations on facts or documents relating to the subject matter and purpose of the inspection and to record the answers;
(d)
interview any other natural or legal person who consents to be interviewed for the purpose of collecting information relating to the subject matter of an investigation;
(e)
request records of telephone and data traffic.
2. The officials and other persons authorised by ESMA for the purposes of the investigations referred to in paragraph 1 shall exercise their powers upon production of a written authorisation specifying the subject matter and purpose of the investigation. That authorisation shall also indicate the periodic penalty payments provided for in Article 66 where the production of the required records, data, procedures or any other material, or the answers to questions asked to persons referred to in Article 61(1) are not provided or are incomplete, and the fines provided for in Article 65 in conjunction with point (b) of Section IV of Annex I, where the answers to questions asked to persons referred to in Article 61(1) are incorrect or misleading.
3. The persons referred to in Article 61(1) are required to submit to investigations launched on the basis of a decision of ESMA. The decision shall specify the subject matter and purpose of the investigation, the periodic penalty payments provided for in Article 66, the legal remedies available under Regulation (EU) No 1095/2010 and the right to have the decision reviewed by the Court of Justice.
4. In good time before the investigation, ESMA shall inform the competent authority of the Member State where the investigation is to be carried out of the investigation and of the identity of the authorised persons. Officials of the competent authority concerned shall, upon the request of ESMA, assist those authorised persons in carrying out their duties. Officials of the competent authority concerned may also attend the investigations upon request.
5. If a request for records of telephone or data traffic referred to in point (e) of paragraph 1 requires authorisation from a judicial authority according to national rules, such authorisation shall be applied for. Such authorisation may also be applied for as a precautionary measure.
6. Where authorisation as referred to in paragraph 5 is applied for, the national judicial authority shall control that the decision of ESMA is authentic and that the coercive measures envisaged are neither arbitrary nor excessive having regard to the subject matter of the investigations. In its control of the proportionality of the coercive measures, the national judicial authority may ask ESMA for detailed explanations, in particular relating to the grounds ESMA has for suspecting that an infringement of this Regulation has taken place and the seriousness of the suspected infringement and the nature of the involvement of the person subject to the coercive measures. However, the national judicial authority shall not review the necessity for the investigation or demand that it be provided with the information on ESMA’s file. The lawfulness of ESMA’s decision shall be subject to review only by the Court of Justice following the procedure set out in Regulation (EU) No 1095/2010.
Article 63
On-site inspections
1. In order to carry out its duties under this Regulation, ESMA may conduct all necessary on-site inspections at any business premises or land of the legal persons referred to in Article 61(1). Where the proper conduct and efficiency of the inspection so require, ESMA may carry out the on-site inspection without prior announcement.
2. The officials and other persons authorised by ESMA to conduct an on-site inspection may enter any business premises or land of the legal persons subject to an investigation decision adopted by ESMA and shall have all the powers stipulated in Article 62(1). They shall also have the power to seal any business premises and books or records for the period of, and to the extent necessary for, the inspection.
3. The officials and other persons authorised by ESMA to conduct an on-site inspection shall exercise their powers upon production of a written authorisation specifying the subject matter and purpose of the inspection and the periodic penalty payments provided for in Article 66 where the persons concerned do not submit to the inspection. In good time before the inspection, ESMA shall give notice of the inspection to the competent authority of the Member State where the inspection is to be conducted.
4. The persons referred to in Article 61(1) shall submit to on-site inspections ordered by decision of ESMA. The decision shall specify the subject matter and purpose of the inspection, appoint the date on which it is to begin and indicate the periodic penalty payments provided for in Article 66, the legal remedies available under Regulation (EU) No 1095/2010 as well as the right to have the decision reviewed by the Court of Justice. ESMA shall take such decisions after consulting the competent authority of the Member State where the inspection is to be conducted.
5. Officials of, as well as those authorised or appointed by, the competent authority of the Member State where the inspection is to be conducted shall, at the request of ESMA, actively assist the officials and other persons authorised by ESMA. To that end, they shall enjoy the powers set out in paragraph 2. Officials of the competent authority of the Member State concerned may also attend the on-site inspections on request.
6. ESMA may also require competent authorities to carry out specific investigatory tasks and on-site inspections as provided for in this Article and in Article 62(1) on its behalf. To that end, competent authorities shall enjoy the same powers as ESMA as set out in this Article and in Article 62(1).
7. Where the officials and other accompanying persons authorised by ESMA find that a person opposes an inspection ordered pursuant to this Article, the competent authority of the Member State concerned shall afford them the necessary assistance, requesting, where appropriate, the assistance of the police or of an equivalent enforcement authority, so as to enable them to conduct their on-site inspection.
8. If the on-site inspection provided for in paragraph 1 or the assistance provided for in paragraph 7 requires authorisation by a judicial authority according to national law, such authorisation shall be applied for. Such authorisation may also be applied for as a precautionary measure.
9. Where authorisation as referred to in paragraph 8 is applied for, the national judicial authority shall verify that ESMA’s decision is authentic and that the coercive measures envisaged are neither arbitrary nor excessive having regard to the subject matter of the inspection. In its control of the proportionality of the coercive measures, the national judicial authority may ask ESMA for detailed explanations. Such a request for detailed explanations may in particular relate to the grounds ESMA has for suspecting that an infringement of this Regulation has taken place, as well as to the seriousness of the suspected infringement and the nature of the involvement of the person who is subjected to the coercive measures. However, the national judicial authority may not review the necessity for the inspection or demand to be provided with the information on ESMA’s file. The lawfulness of ESMA’s decision shall be subject to review only by the Court of Justice following the procedure set out in Regulation (EU) No 1095/2010.
Article 64
Procedural rules for taking supervisory measures and imposing fines
1. Where, in carrying out its duties under this Regulation, ESMA finds that there are serious indications of the possible existence of facts liable to constitute one or more of the infringements listed in Annex I, ESMA shall appoint an independent investigation officer within ESMA to investigate the matter. The appointed officer shall not be involved or have been directly or indirectly involved in the supervision or the registration process of the trade repository concerned and shall perform his functions independently from ESMA.
2. The investigation officer shall investigate the alleged infringements, taking into account any comments submitted by the persons who are subject to the investigations, and shall submit a complete file with his findings to ESMA.
In order to carry out his tasks, the investigation officer may exercise the power to request information in accordance with Article 61 and to conduct investigations and on-site inspections in accordance with Articles 62 and 63. When using those powers, the investigation officer shall comply with Article 60.
Where carrying out his tasks, the investigation officer shall have access to all documents and information gathered by ESMA in its supervisory activities.
3. Upon completion of his investigation and before submitting the file with his findings to ESMA, the investigation officer shall give the persons subject to the investigations the opportunity to be heard on the matters being investigated. The investigation officer shall base his findings only on facts on which the persons concerned have had the opportunity to comment.
The rights of the defence of the persons concerned shall be fully respected during investigations under this Article.
4. When submitting the file with his findings to ESMA, the investigation officer shall notify that fact to the persons who are subject to the investigations. The persons subject to the investigations shall be entitled to have access to the file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information affecting third parties.
5. On the basis of the file containing the investigation officer’s findings and, when requested by the persons concerned, after having heard the persons subject to the investigations in accordance with Article 67, ESMA shall decide if one or more of the infringements listed in Annex I has been committed by the persons who have been subject to the investigations and, in such a case, shall take a supervisory measure in accordance with Article 73 and impose a fine in accordance with Article 65.
6. The investigation officer shall not participate in ESMA’s deliberations or in any other way intervene in ESMA’s decision-making process.
7. The Commission shall adopt further rules of procedure for the exercise of the power to impose fines or periodic penalty payments, including provisions on the rights of the defence, temporal provisions, and the collection of fines or periodic penalty payments, and shall adopt detailed rules on the limitation periods for the imposition and enforcement of penalties.
The rules referred to in the first subparagraph shall be adopted by means of delegated acts in accordance with Article 82.
8. ESMA shall refer matters for criminal prosecution to the relevant national authorities where, in carrying out its duties under this Regulation, it finds that there are serious indications of the possible existence of facts liable to constitute criminal offences. In addition, ESMA shall refrain from imposing fines or periodic penalty payments where a prior acquittal or conviction arising from identical fact or facts which are substantially the same has already acquired the force of res judicata as the result of criminal proceedings under national law.
Article 65
Fines
1. Where, in accordance with Article 64(5), ESMA finds that a trade repository has, intentionally or negligently, committed one of the infringements listed in Annex I, it shall adopt a decision imposing a fine in accordance with paragraph 2 of this Article.
An infringement by a trade repository shall be considered to have been committed intentionally if ESMA finds objective factors which demonstrate that the trade repository or its senior management acted deliberately to commit the infringement.
2. The basic amounts of the fines referred to in paragraph 1 shall be included within the following limits:
(a)
for the infringements referred to in point (c) of Section I of Annex I and in points (c) to (g) of Section II of Annex I, and in points (a) and (b) of Section III of Annex I the amounts of the fines shall be at least EUR 10 000 and shall not exceed EUR 20 000;
(b)
for the infringements referred to in points (a), (b) and (d) to (h) of Section I of Annex I, and in points (a), (b) and (h) of Section II of Annex I, the amounts of the fines shall be at least EUR 5 000 and shall not exceed EUR 10 000.
In order to decide whether the basic amount of the fines should be at the lower, the middle or the higher end of the limits set out in the first subparagraph, ESMA shall have regard to the annual turnover of the preceding business year of the trade repository concerned. The basic amount shall be at the lower end of the limit for trade repositories whose annual turnover is below EUR 1 million, the middle of the limit for the trade repository whose turnover is between EUR 1 and 5 million and the higher end of the limit for the trade repository whose annual turnover is higher than EUR 5 million.
3. The basic amounts set out in paragraph 2 shall be adjusted, if need be, by taking into account aggravating or mitigating factors in accordance with the relevant coefficients set out in Annex II.
The relevant aggravating coefficients shall be applied one by one to the basic amount. If more than one aggravating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual aggravating coefficient shall be added to the basic amount.
The relevant mitigating coefficients shall be applied one by one to the basic amount. If more than one mitigating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual mitigating coefficient shall be subtracted from the basic amount.
4. Notwithstanding paragraphs 2 and 3, the amount of the fine shall not exceed 20 % of the annual turnover of the trade repository concerned in the preceding business year but, where the trade repository has directly or indirectly benefited financially from the infringement, the amount of the fine shall be at least equal to that benefit.
Where an act or omission of a trade repository constitutes more than one infringement listed in Annex I, only the higher fine calculated in accordance with paragraphs 2 and 3 and relating to one of those infringements shall apply.
Article 66
Periodic penalty payments
1. ESMA shall, by decision, impose periodic penalty payments in order to compel:
(a)
a trade repository to put an end to an infringement in accordance with a decision taken pursuant to Article 73(1)(a); or
(b)
a person referred to in Article 61(1):
(i)
to supply complete information which has been requested by a decision pursuant to Article 61;
(ii)
to submit to an investigation and in particular to produce complete records, data, procedures or any other material required and to complete and correct other information provided in an investigation launched by a decision pursuant to Article 62; or
(iii)
to submit to an on-site inspection ordered by a decision taken pursuant to Article 63.
2. A periodic penalty payment shall be effective and proportionate. The periodic penalty payment shall be imposed for each day of delay.
3. Notwithstanding paragraph 2, the amount of the periodic penalty payments shall be 3 % of the average daily turnover in the preceding business year, or, in the case of natural persons, 2 % of the average daily income in the preceding calendar year. It shall be calculated from the date stipulated in the decision imposing the periodic penalty payment.
4. A periodic penalty payment shall be imposed for a maximum period of six months following the notification of ESMA’s decision. Following the end of the period, ESMA shall review the measure.
Article 67
Hearing of the persons concerned
1. Before taking any decision on a fine or periodic penalty payment under Articles 65 and 66, ESMA shall give the persons subject to the proceedings the opportunity to be heard on its findings. ESMA shall base its decisions only on findings on which the persons subject to the proceedings have had an opportunity to comment.
2. The rights of the defence of the persons subject to the proceedings shall be fully respected in the proceedings. They shall be entitled to have access to ESMA’s file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information or ESMA’s internal preparatory documents.
Article 68
Disclosure, nature, enforcement and allocation of fines and periodic penalty payments
1. ESMA shall disclose to the public every fine and periodic penalty payment that has been imposed pursuant to Articles 65 and 66 unless such disclosure to the public would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved. Such disclosure shall not contain personal data within the meaning of Regulation (EC) No 45/2001.
2. Fines and periodic penalty payments imposed pursuant to Articles 65 and 66 shall be of an administrative nature.
3. Where ESMA decides to impose no fines or penalty payments, it shall inform the European Parliament, the Council, the Commission, and the competent authorities of the Member State concerned accordingly and shall set out the reasons for its decision.
4. Fines and periodic penalty payments imposed pursuant to Articles 65 and 66 shall be enforceable.
Enforcement shall be governed by the rules of civil procedure in force in the State in the territory of which it is carried out. The order for its enforcement shall be appended to the decision without other formality than verification of the authenticity of the decision by the authority which the government of each Member State shall designate for that purpose and shall make known to ESMA and to the Court of Justice.
When those formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent body.
Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the Member State concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner.
5. The amounts of the fines and periodic penalty payments shall be allocated to the general budget of the European Union.
Article 69
Review by the Court of Justice
The Court of Justice shall have unlimited jurisdiction to review decisions whereby ESMA has imposed a fine or a periodic penalty payment. It may annul, reduce or increase the fine or periodic penalty payment imposed.
Article 70
Amendments to Annex II
In order to take account of developments on financial markets the Commission shall be empowered to adopt delegated acts in accordance with Article 82 concerning measures to amend Annex II.
Article 71
Withdrawal of registration
1. Without prejudice to Article 73, ESMA shall withdraw the registration of a trade repository where the trade repository:
(a)
expressly renounces the registration or has provided no services for the preceding six months;
(b)
obtained the registration by making false statements or by any other irregular means;
(c)
no longer meets the conditions under which it was registered.
2. ESMA shall, without undue delay, notify the relevant competent authority referred to in Article 57(1) of a decision to withdraw the registration of a trade repository.
3. The competent authority of a Member State in which the trade repository performs its services and activities and which considers that one of the conditions referred to in paragraph 1 has been met, may request ESMA to examine whether the conditions for the withdrawal of registration of the trade repository concerned are met. Where ESMA decides not to withdraw the registration of the trade repository concerned, it shall provide full reasons.
4. The competent authority referred to in paragraph 3 shall be the authority designated under Article 22.
Article 72
Supervisory fees
1. ESMA shall charge fees to the trade repositories in accordance with this Regulation and in accordance with the delegated acts adopted pursuant to paragraph 3. Those fees shall fully cover ESMA’s necessary expenditure relating to the registration and supervision of trade repositories and the reimbursement of any costs that the competent authorities may incur carrying out work pursuant to this Regulation in particular as a result of any delegation of tasks in accordance with Article 74.
2. The amount of a fee charged to a trade repository shall cover all administrative costs incurred by ESMA for its registration and supervision activities and be proportionate to the turnover of the trade repository concerned.
3. The Commission shall adopt a delegated act in accordance with Article 82 to specify further the type of fees, the matters for which fees are due, the amount of the fees and the manner in which they are to be paid.
Article 73
Supervisory measures by ESMA
1. Where, in accordance with Article 64(5), ESMA finds that a trade repository has committed one of the infringements listed in Annex I, it shall take one or more of the following decisions:
(a)
requiring the trade repository to bring the infringement to an end;
(b)
imposing fines under Article 65;
(c)
issuing public notices;
(d)
as a last resort, withdrawing the registration of the trade repository.
2. When taking the decisions referred to in paragraph 1, ESMA shall take into account the nature and seriousness of the infringement, having regard to the following criteria:
(a)
the duration and frequency of the infringement;
(b)
whether the infringement has revealed serious or systemic weaknesses in the undertaking’s procedures or in its management systems or internal controls;
(c)
whether financial crime has been occasioned, facilitated or otherwise attributable to the infringement;
(d)
whether the infringement has been committed intentionally or negligently.
3. Without undue delay, ESMA shall notify any decision adopted pursuant to paragraph 1 to the trade repository concerned, and shall communicate it to the competent authorities of the Member States and to the Commission. It shall publicly disclose any such decision on its website within 10 working days from the date when it was adopted.
When making public its decision as referred to in the first subparagraph, ESMA shall also make public the right of the trade repository concerned to appeal the decision, the fact, where relevant, that such an appeal has been lodged, specifying that such an appeal does not have suspensive effect, and the fact that it is possible for ESMA’s Board of Appeal to suspend the application of the contested decision in accordance with Article 60(3) of Regulation (EU) No 1095/2010.
Article 74
Delegation of tasks by ESMA to competent authorities
1. Where necessary for the proper performance of a supervisory task, ESMA may delegate specific supervisory tasks to the competent authority of a Member State in accordance with the guidelines issued by ESMA pursuant to Article 16 of Regulation (EU) No 1095/2010. Such specific supervisory tasks may, in particular, include the power to carry out requests for information in accordance with Article 61 and to conduct investigations and on-site inspections in accordance with Article 62 and Article 63(6).
2. Prior to delegation of a task, ESMA shall consult the relevant competent authority. Such consultation shall concern:
(a)
the scope of the task to be delegated;
(b)
the timetable for the performance of the task; and
(c)
the transmission of necessary information by and to ESMA.
3. In accordance with the regulation on fees adopted by the Commission pursuant to Article 72(3), ESMA shall reimburse a competent authority for costs incurred as a result of carrying out delegated tasks.
4. ESMA shall review the decision referred to in paragraph 1 at appropriate intervals. A delegation may be revoked at any time.
5. A delegation of tasks shall not affect the responsibility of ESMA and shall not limit ESMA’s ability to conduct and oversee the delegated activity. Supervisory responsibilities under this Regulation, including registration decisions, final assessments and follow-up decisions concerning infringements, shall not be delegated.
CHAPTER 2
Relations with third countries
Article 75
Equivalence and international agreements
1. The Commission may adopt an implementing act determining that the legal and supervisory arrangements of a third country ensure that:
(a)
trade repositories authorised in that third country comply with legally binding requirements which are equivalent to those laid down in this Regulation;
(b)
effective supervision and enforcement of trade repositories takes place in that third country on an ongoing basis; and
(c)
guarantees of professional secrecy exist, including the protection of business secrets shared with third parties by the authorities, and they are at least equivalent to those set out in this Regulation.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 86(2).
2. Where appropriate, and in any case after adopting an implementing act as referred to in paragraph 1, the Commission shall submit recommendations to the Council for the negotiation of international agreements with the relevant third countries regarding mutual access to, and exchange of information on, derivative contracts held in trade repositories which are established in that third country, in a way that ensures that Union authorities, including ESMA, have immediate and continuous access to all the information needed for the exercise of their duties.
3. After conclusion of the agreements referred to in paragraph 2, and in accordance with them, ESMA shall establish cooperation arrangements with the competent authorities of the relevant third countries. Those arrangements shall specify at least:
(a)
a mechanism for the exchange of information between ESMA and any other Union authorities that exercise responsibilities in accordance with this Regulation on the one hand and the relevant competent authorities of third countries concerned on the other; and
(b)
procedures concerning the coordination of supervisory activities.
4. ESMA shall apply Regulation (EC) No 45/2001 with regard to the transfer of personal data to a third country.
Article 76
Cooperation arrangements
Relevant authorities of third countries that do not have any trade repository established in their jurisdiction may contact ESMA with a view to establishing cooperation arrangements to access information on derivatives contracts held in Union trade repositories.
ESMA may establish cooperation arrangements with those relevant authorities regarding access to information on derivatives contracts held in Union trade repositories that these authorities need to fulfil their respective responsibilities and mandates, provided that guarantees of professional secrecy exist, including the protection of business secrets shared by the authorities with third parties.
Article 77
Recognition of trade repositories
1. A trade repository established in a third country may provide its services and activities to entities established in the Union for the purposes of Article 9 only after its recognition by ESMA in accordance with paragraph 2.
2. A trade repository referred to in paragraph 1 shall submit to ESMA its application for recognition together with all necessary information, including at least the information necessary to verify that the trade repository is authorised and subject to effective supervision in a third country which:
(a)
has been recognised by the Commission, by means of an implementing act pursuant to Article 75(1), as having an equivalent and enforceable regulatory and supervisory framework;
(b)
has entered into an international agreement with the Union pursuant to Article 75(2); and
(c)
has entered into cooperation arrangements pursuant to Article 75(3) to ensure that Union authorities, including ESMA, have immediate and continuous access to all the necessary information.
Within 30 working days of receipt of the application, ESMA shall assess whether the application is complete. If the application is not complete, ESMA shall set a deadline by which the applicant trade repository has to provide additional information.
Within 180 working days of the submission of a complete application, ESMA shall inform the applicant trade repository in writing with a fully reasoned explanation whether the recognition has been granted or refused.
ESMA shall publish on its website a list of the trade repositories recognised in accordance with this Regulation.
TITLE VII
REQUIREMENTS FOR TRADE REPOSITORIES
Article 78
General requirements
1. A trade repository shall have robust governance arrangements, which include a clear organisational structure with well defined, transparent and consistent lines of responsibility and adequate internal control mechanisms, including sound administrative and accounting procedures, which prevent any disclosure of confidential information.
2. A trade repository shall maintain and operate effective written organisational and administrative arrangements to identify and manage any potential conflicts of interest concerning its managers, employees, or any person directly or indirectly linked to them by close links.
3. A trade repository shall establish adequate policies and procedures sufficient to ensure its compliance, including of its managers and employees, with all the provisions of this Regulation.
4. A trade repository shall maintain and operate an adequate organisational structure to ensure continuity and orderly functioning of the trade repository in the performance of its services and activities. It shall employ appropriate and proportionate systems, resources and procedures.
5. Where a trade repository offers ancillary services such as trade confirmation, trade matching, credit event servicing, portfolio reconciliation or portfolio compression services, the trade repository shall maintain those ancillary services operationally separate from the trade repository’s function of centrally collecting and maintaining records of derivatives.
6. The senior management and members of the board of a trade repository shall be of sufficiently good repute and experience so as to ensure the sound and prudent management of the trade repository.
7. A trade repository shall have objective, non-discriminatory and publicly disclosed requirements for access by undertakings subject to the reporting obligation under Article 9. A trade repository shall grant service providers non-discriminatory access to information maintained by the trade repository, on condition that the relevant counterparties have provided their consent. Criteria that restrict access shall only be permitted to the extent that their objective is to control the risk to the data maintained by a trade repository.
8. A trade repository shall publicly disclose the prices and fees associated with services provided under this Regulation. It shall disclose the prices and fees of each service provided separately, including discounts and rebates and the conditions to benefit from those reductions. It shall allow reporting entities to access specific services separately. The prices and fees charged by a trade repository shall be cost-related.
Article 79
Operational reliability
1. A trade repository shall identify sources of operational risk and minimise them through the development of appropriate systems, controls and procedures. Such systems shall be reliable and secure and have adequate capacity to handle the information received.
2. A trade repository shall establish, implement and maintain an adequate business continuity policy and disaster recovery plan aiming at ensuring the maintenance of its functions, the timely recovery of operations and the fulfilment of the trade repository’s obligations. Such a plan shall at least provide for the establishment of backup facilities.
3. A trade repository from which registration has been withdrawn shall ensure orderly substitution including the transfer of data to other trade repositories and the redirection of reporting flows to other trade repositories.
Article 80
Safeguarding and recording
1. A trade repository shall ensure the confidentiality, integrity and protection of the information received under Article 9.
2. A trade repository may only use the data it receives under this Regulation for commercial purposes if the relevant counterparties have provided their consent.
3. A trade repository shall promptly record the information received under Article 9 and shall maintain it for at least 10 years following the termination of the relevant contracts. It shall employ timely and efficient record keeping procedures to document changes to recorded information.
4. A trade repository shall calculate the positions by class of derivatives and by reporting entity based on the details of the derivative contracts reported in accordance with Article 9.
5. A trade repository shall allow the parties to a contract to access and correct the information on that contract in a timely manner.
6. A trade repository shall take all reasonable steps to prevent any misuse of the information maintained in its systems.
A natural person who has a close link with a trade repository or a legal person that has a parent undertaking or a subsidiary relationship with the trade repository shall not use confidential information recorded in a trade repository for commercial purposes.
Article 81
Transparency and data availability
1. A trade repository shall regularly, and in an easily accessible way, publish aggregate positions by class of derivatives on the contracts reported to it.
2. A trade repository shall collect and maintain data and shall ensure that the entities referred to in paragraph 3 have direct and immediate access to the details of derivatives contracts they need to fulfil their respective responsibilities and mandates.
3. A trade repository shall make the necessary information available to the following entities to enable them to fulfil their respective responsibilities and mandates:
(a)
ESMA;
(b)
the ESRB;
(c)
the competent authority supervising CCPs accessing the trade repository;
(d)
the competent authority supervising the trading venues of the reported contracts;
(e)
the relevant members of the ESCB;
(f)
the relevant authorities of a third country that has entered into an international agreement with the Union as referred to in Article 75;
(g)
supervisory authorities appointed under Article 4 of Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (32);
(h)
the relevant Union securities and market authorities;
(i)
the relevant authorities of a third country that have entered into a cooperation arrangement with ESMA as referred to in Article 76;
(j)
the Agency for the Cooperation of Energy Regulators.
4. ESMA shall share the information necessary for the exercise of their duties with other relevant Union authorities.
5. In order to ensure consistent application of this Article, ESMA shall, after consulting the members of the ESCB, develop draft regulatory technical standards specifying the frequency and the details of the information referred to in paragraphs 1 and 3 as well as operational standards required in order to aggregate and compare data across repositories and for the entities referred to in paragraph 3 to have access to information as necessary. Those draft regulatory technical standards shall aim to ensure that the information published under paragraph 1 is not capable of identifying a party to any contract.
ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 82
Exercise of the delegation
1. The power to adopt delegated acts is conferred to the Commission subject to the conditions laid down in this Article.
2. The delegation of power referred to in Article 1(6), Article 64(7), Article 70, Article 72(3) and Article 85(2) shall be conferred to the Commission for an indeterminate period of time.
3. Before adopting a delegated act, the Commission shall endeavour to consult ESMA.
4. A delegation of power referred to in Article 1(6), Article 64(7), Article 70, Article 72(3) and Article 85(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. The decision to revoke shall take effect on the day following that of its publication in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 1(6), Article 64(7), Article 70, Article 72(3) and Article 85(2) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of the act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament or the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
TITLE VIII
COMMON PROVISIONS
Article 83
Professional secrecy
1. The obligation of professional secrecy shall apply to all persons who work or have worked for the competent authorities designated in accordance with Article 22 and the authorities referred to in Article 81(3), for ESMA, or for auditors and experts instructed by the competent authorities or ESMA. No confidential information that those persons receive in the course of their duties shall be divulged to any person or authority, except in summary or aggregate form such that an individual CCP, trade repository or any other person cannot be identified, without prejudice to cases covered by criminal or tax law or to this Regulation.
2. Where a CCP has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties may be divulged in civil or commercial proceedings where necessary for carrying out the proceeding.
3. Without prejudice to cases covered by criminal or tax law, the competent authorities, ESMA, bodies or natural or legal persons other than competent authorities which receive confidential information pursuant to this Regulation may use it only in the performance of their duties and for the exercise of their functions, in the case of the competent authorities, within the scope of this Regulation or, in the case of other authorities, bodies or natural or legal persons, for the purpose for which such information was provided to them or in the context of administrative or judicial proceedings specifically relating to the exercise of those functions, or both. Where ESMA, the competent authority or another authority, body or person communicating information consents thereto, the authority receiving the information may use it for other non-commercial purposes.
4. Any confidential information received, exchanged or transmitted pursuant to this Regulation shall be subject to the conditions of professional secrecy laid down in paragraphs 1, 2 and 3. However, those conditions shall not prevent ESMA, the competent authorities or the relevant central banks from exchanging or transmitting confidential information in accordance with this Regulation and with other legislation applicable to investment firms, credit institutions, pension funds, UCITS, AIFMs, insurance and reinsurance intermediaries, insurance undertakings, regulated markets or market operators or otherwise with the consent of the competent authority or other authority or body or natural or legal person that communicated the information.
5. Paragraphs 1, 2 and 3 shall not prevent the competent authorities from exchanging or transmitting confidential information, in accordance with national law, that has not been received from a competent authority of another Member State.
Article 84
Exchange of information
1. Competent authorities, ESMA, and other relevant authorities shall, without undue delay, provide one another with the information required for the purposes of carrying out their duties.
2. Competent authorities, ESMA, other relevant authorities and other bodies or natural and legal persons receiving confidential information in the exercise of their duties under this Regulation shall use it only in the course of their duties.
3. Competent authorities shall communicate information to the relevant members of the ESCB where such information is relevant for the exercise of their duties.
TITLE IX
TRANSITIONAL AND FINAL PROVISIONS
Article 85
Reports and review
1. By 17 August 2015, the Commission shall review and prepare a general report on this Regulation. The Commission shall submit the report to the European Parliament and the Council, together with any appropriate proposals.
The Commission shall in particular:
(a)
assess, in cooperation with the members of the ESCB, the need for any measure to facilitate the access of CCPs to central bank liquidity facilities;
(b)
assess, in coordination with ESMA and the relevant sectoral authorities, the systemic importance of the transactions of non-financial firms in OTC derivatives and, in particular, the impact of this Regulation on the use of OTC derivatives by non-financial firms;
(c)
assess, in the light of experience, the functioning of the supervisory framework for CCPs, including the effectiveness of supervisory colleges, the respective voting modalities laid down in Article 19(3), and the role of ESMA, in particular during the authorisation process for CCPs;
(d)
assess, in cooperation with ESMA and ESRB, the efficiency of margining requirements to limit procyclicality and the need to define additional intervention capacity in this area;
(e)
assess in cooperation with ESMA the evolution of CCP’s policies on collateral margining and securing requirements and their adaptation to the specific activities and risk profiles of their users.
The assessment referred to in point (a) of the first subparagraph shall take into account any result of ongoing work between central banks at Union and international level. The assessment shall also take into account the principle of independence of central banks and their right to provide access to liquidity facilities at their own discretion as well as the potential unintended effect on the behaviour of the CCPs or the internal market. Any accompanying proposals shall not, either directly or indirectly, discriminate against any Member State or group of Member States as a venue for clearing services.
2. By 17 August 2014, the Commission shall prepare a report, after consulting ESMA and EIOPA, assessing the progress and effort made by CCPs in developing technical solutions for the transfer by pension scheme arrangements of non-cash collateral as variation margins, as well as the need for any measures to facilitate such solution. If the Commission considers that the necessary effort to develop appropriate technical solutions has not been made and that the adverse effect of centrally clearing derivative contracts on the retirement benefits of future pensioners remain unchanged, it shall be empowered to adopt delegated acts in accordance with Article 82 to extend the three-year period referred to in Article 89(1) once by two years and once by one year.
3. ESMA shall submit to the Commission reports:
(a)
on the application of the clearing obligation under Title II and in particular the absence of clearing obligation for OTC derivative contracts entered into before the date of entry into force of this Regulation;
(b)
on the application of the identification procedure under Article 5(3);
(c)
on the application of the segregation requirements laid down in Article 39;
(d)
on the extension of the scope of interoperability arrangements under Title V to transactions in classes of financial instruments other than transferable securities and money-market instruments;
(e)
on the access of CCPs to trading venues, the effects on competitiveness of certain practices, and the impact on liquidity fragmentation;
(f)
on ESMA’s staffing and resources needs arising from the assumption of its powers and duties in accordance with this Regulation;
(g)
on the impact of the application of additional requirements by Member States pursuant to Article 14(5).
Those reports shall be communicated to the Commission by 30 September 2014 for the purposes of paragraph 1. They shall also be submitted to the European Parliament and the Council.
4. The Commission shall, in cooperation with the Member States and ESMA, and after requesting the assessment of the ESRB, draw up an annual report assessing any possible systemic risk and cost implications of interoperability arrangements.
The report shall focus at least on the number and complexity of such arrangements, and the adequacy of risk-management systems and models. The Commission shall submit the report to the European Parliament and the Council, together with any appropriate proposals.
The ESRB shall provide the Commission with its assessment of any possible systemic risk implications of interoperability arrangements.
5. ESMA shall present an annual report to the European Parliament, the Council and the Commission on the penalties imposed by competent authorities, including supervisory measures, fines and periodic penalty payments.
Article 86
Committee procedure
1. The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC (33). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 87
Amendment to Directive 98/26/EC
1. In Article 9(1) of Directive 98/26/EC, the following subparagraph is added:
‘Where a system operator has provided collateral security to another system operator in connection with an interoperable system, the rights of the providing system operator to that collateral security shall not be affected by insolvency proceedings against the receiving system operator.’.
2. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with point (1) by 17 August 2014. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to Directive 98/26/EC or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 88
Websites
1. ESMA shall maintain a website which provides details of the following:
(a)
contracts eligible for the clearing obligation under Article 5;
(b)
penalties imposed for breaches of Articles 4, 5 and 7 to 11;
(c)
CCPs authorised to offer services or activities in the Union that are established in the Union, and the services or activities which they are authorised to provide or perform, including the classes of financial instruments covered by their authorisation;
(d)
penalties imposed for breaches of Titles IV and V;
(e)
CCPs authorised to offer services or activities in the Union established in a third country, and the services or activities which they are authorised to provide or perform, including the classes of financial instruments covered by their authorisation;
(f)
trade repositories authorised to offer services or activities in the Union;
(g)
fines and periodic penalty payments imposed in accordance with Articles 65 and 66;
(h)
the public register referred to in Article 6.
2. For the purposes of points (b), (c) and (d) of paragraph 1, competent authorities shall maintain websites, which shall be linked to the ESMA website.
3. All websites referred to in this Article shall be publicly accessible and regularly updated, and shall provide information in a clear format.
Article 89
Transitional provisions
1. For three years after the entry into force of this Regulation, the clearing obligation set out in Article 4 shall not apply to OTC derivative contracts that are objectively measurable as reducing investment risks directly relating to the financial solvency of pension scheme arrangements as defined in Article 2(10). The transitional period shall also apply to entities established for the purpose of providing compensation to members of pension scheme arrangements in case of a default.
The OTC derivative contracts, which would otherwise be subject to the clearing obligation under Article 4, entered into by those entities during this period shall be subject to the requirements laid down in Article 11.
2. In relation to pension scheme arrangements referred to in Article 2(10)(c) and (d) the exemption referred to in paragraph 1 of this Article shall be granted by the relevant competent authority for types of entities or types of arrangements. After receiving the request, the competent authority shall notify ESMA and EIOPA. Within 30 calendar days of receipt of the notification ESMA, after consulting EIOPA, shall issue an opinion assessing compliance of the type of entities or the type of arrangements with Article 2(10)(c) or (d) as well as the reasons why an exemption is justified due to difficulties in meeting the variation margin requirements. The competent authority shall only grant an exemption where it is fully satisfied that the type of entities or the type of arrangements complies with Article 2(10)(c) or (d) and that they encounter difficulties in meeting the variation margin requirements. The competent authority shall adopt a decision within ten working days of receipt of ESMA’s opinion, taking due account of that opinion. If the competent authority does not agree with ESMA’s opinion, it shall give full reasons in its decision and shall explain any significant deviation therefrom.
ESMA shall publish on its website a list of types of entities and types of arrangements referred to in Article 2(10)(c) and (d) which has been granted an exemption in accordance with the first subparagraph. To further strengthen consistency in supervisory outcomes, ESMA shall conduct a peer review of the entities included on the list every year in accordance with Article 30 of Regulation (EU) No 1095/2010.
3. A CCP that has been authorised in its Member State of establishment to provide clearing services in accordance with the national law of that Member State before all the regulatory technical standards under Articles 4, 5, 8 to 11, 16, 18, 25, 26, 29, 34, 41, 42, 44, 45, 46, 47, 49, 56 and 81 are adopted by the Commission, shall apply for authorisation under Article 14 for the purposes of this Regulation within six months of the date of entry into force of all the regulatory technical standards under Articles 16, 25, 26, 29, 34, 41, 42, 44, 45, 47 and 49.
A CCP established in a third country, which has been recognised to provide clearing services in a Member State in accordance with the national law of that Member State before all the regulatory technical standards under Articles 16, 26, 29, 34, 41, 42, 44, 45, 47 and 49 are adopted by the Commission, shall apply for recognition under Article 25 for the purposes of this Regulation within six months of the date of entry into force of all the regulatory technical standards under Articles 16, 26, 29, 34, 41, 42, 44, 45, 47 and 49.
4. Until a decision is made under this Regulation on the authorisation or recognition of a CCP, the respective national rules on authorisation and recognition of CCPs shall continue to apply and the CCP shall continue to be supervised by the competent authority of its Member State of establishment or recognition.
5. Where a competent authority authorised a CCP to clear a given class of derivatives in accordance with the national law of its Member State before all the regulatory technical standards under Articles 16, 26, 29, 34, 41, 42, 45, 47 and 49 are adopted by the Commission, the competent authority of that Member State shall notify ESMA of that authorisation within one month of the date of entry into force of the regulatory technical standards under Article 5(1).
Where a competent authority recognised a CCP established in a third country to provide clearing services in accordance with the national law of its Member State before all the regulatory technical standards under Articles 16, 26, 29, 34, 41, 42, 45, 47 and 49 are adopted by the Commission, the competent authority of that Member State shall notify ESMA of that recognition within one month of the date of entry into force of the regulatory technical standards under Article 5(1).
6. A trade repository that has been authorised or registered in its Member State of establishment to collect and maintain the records of derivatives in accordance with the national law of that Member State before all the regulatory and implementing technical standards under Articles 9, 56 and 81 are adopted by the Commission, shall apply for registration under Article 55 within six months of the date of entry into force of those regulatory and implementing technical standards.
A trade repository established in a third country, which is allowed to collect and maintain the records of derivatives in a Member State in accordance with the national law of that Member State before all the regulatory and implementing technical standards under Articles 9, 56 and 81 are adopted by the Commission, shall apply for recognition under Article 77 within six months of the date of entry into force of those regulatory and implementing technical standards.
7. Until a decision is made under this Regulation on the registration or recognition of a trade repository, the respective national rules on authorisation, registration and recognition of trade repositories shall continue to apply and the trade repository shall continue to be supervised by the competent authority of its Member State of establishment or recognition.
8. A trade repository that has been authorised or registered in its Member State of establishment to collect and maintain the records of derivatives in accordance with the national law of that Member State before the regulatory and implementing technical standards under Articles 56 and 81 are adopted by the Commission, can be used to meet the reporting requirement under Article 9 until the time a decision is made on the registration of the trade repository under this Regulation.
A trade repository established in a third country which has been allowed to collect and maintain the records of derivatives in accordance with the national law of a Member State before all the regulatory and implementing technical standards under Articles 56 and 81 are adopted by the Commission, can be used to meet the reporting requirement under Article 9 until the time a decision is made on the recognition of the trade repository under this Regulation.
9. Notwithstanding Article 81(3)(f), where no international agreement is in place between a third country and the Union as referred to in Article 75, a trade repository may make the necessary information available to the relevant authorities of that third country until 17 August 2013 provided that it notifies ESMA.
Article 90
Staff and resources of ESMA
By 31 December 2012, ESMA shall assess the staffing and resources needs arising from the assumption of its powers and duties in accordance with this Regulation and submit a report to the European Parliament, the Council and the Commission.
Article 91
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 4 July 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. D. MAVROYIANNIS
(1) OJ C 57, 23.2.2011, p. 1.
(2) OJ C 54, 19.2.2011, p. 44.
(3) Position of the European Parliament of 29 March 2012 (not yet published in the Official Journal) and decision of the Council of 4 July 2012.
(4) OJ L 331, 15.12.2010, p. 12.
(5) OJ L 331, 15.12.2010, p. 48.
(6) OJ L 331, 15.12.2010, p. 84.
(7) OJ L 145, 30.4.2004, p. 1.
(8) OJ L 177, 30.6.2006, p. 1.
(9) OJ L 228, 16.8.1973, p. 3.
(10) OJ L 345, 19.12.2002, p. 1.
(11) OJ L 323, 9.12.2005, p. 1.
(12) OJ L 302, 17.11.2009, p. 32.
(13) OJ L 235, 23.9.2003, p. 10.
(14) OJ L 174, 1.7.2011, p. 1.
(15) OJ L 110, 20.4.2001, p. 28.
(16) Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 54(3)(g) of the Treaty on consolidated accounts (OJ L 193, 18.7.1983, p. 1).
(17) Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (OJ L 243, 11.9.2002, p. 1).
(18) Commission Regulation (EC) No 1569/2007 of 21 December 2007 establishing a mechanism for the determination of equivalence of accounting standards applied by third country issuers of securities pursuant to Directives 2003/71/EC and 2004/109/EC of the European Parliament and of the Council (OJ L 340, 22.12.2007, p. 66).
(19) Directive 2006/49/EC of the European Parliament and of the Council of 14 June 2006 on the capital adequacy of investment firms and credit institutions (OJ L 177, 30.6.2006, p. 201).
(20) OJ L 241, 2.9.2006, p. 1.
(21) OJ L 166, 11.6.1998, p. 45.
(22) OJ L 281, 23.11.1995, p. 31.
(23) OJ L 8, 12.1.2001, p. 1.
(24) OJ L 55, 28.2.2011, p. 13.
(25) OJ L 35, 11.2.2003, p. 1.
(26) OJ L 390, 31.12.2004, p. 38.
(27) OJ L 372, 31.12.1986, p. 1.
(28) OJ L 222, 14.8.1978, p. 11.
(29) OJ L 309, 25.11.2005, p. 15.
(30) OJ L 228, 11.8.1992, p. 1.
(31) OJ L 168, 27.6.2002, p. 43.
(32) OJ L 142, 30.4.2004, p. 12.
(33) OJ L 191, 13.7.2001, p. 45.
ANNEX I
List of infringements referred to in Article 65(1)
I.
Infringements relating to organisational requirements or conflicts of interest:
(a)
a trade repository infringes Article 78(1) by not having robust governance arrangements which include a clear organisational structure with well-defined, transparent and consistent lines of responsibility and adequate internal control mechanisms, including sound administrative and accounting procedures, which prevent the disclosure of confidential information;
(b)
a trade repository infringes Article 78(2) by not maintaining or operating effective written organisational and administrative arrangements to identify and manage any potential conflicts of interest concerning its managers, its employees, and any person directly or indirectly linked to them by close links;
(c)
a trade repository infringes Article 78(3) by not establishing adequate policies and procedures sufficient to ensure compliance, including that of its managers and employees, with all the provisions of this Regulation;
(d)
a trade repository infringes Article 78(4) by not maintaining or operating an adequate organisational structure to ensure continuity and orderly functioning of the trade repository in the performance of its services and activities;
(e)
a trade repository infringes Article 78(5) by not separating operationally its ancillary services from its function of centrally collecting and maintaining records of derivatives;
(f)
a trade repository infringes Article 78(6) by not ensuring that its senior management and the members of the board are of sufficiently good repute and experience so as to ensure the sound and prudent management of the trade repository;
(g)
a trade repository infringes Article 78(7) by not having objective non-discriminatory and publicly disclosed requirements for access by services providers and undertakings subject to the reporting obligation under Article 9;
(h)
a trade repository infringes Article 78(8) by not publicly disclosing the prices and fees associated with services provided under this Regulation, by not allowing reporting entities to access specific services separately or by charging prices and fees that are not cost related.
II.
Infringements relating to operational requirements:
(a)
a trade repository infringes Article 79(1) by not identifying sources of operational risk or by not minimising those risks through the development of appropriate systems, controls and procedures;
(b)
a trade repository infringes Article 79(2) by not establishing, implementing or maintaining an adequate business continuity policy and disaster recovery plan aimed at ensuring the maintenance of its functions, the timely recovery of operations and the fulfilment of the trade repository’s obligations;
(c)
a trade repository infringes Article 80(1) by not ensuring the confidentiality, integrity or protection of the information received under Article 9;
(d)
a trade repository infringes Article 80(2) by using the data that it receives under this Regulation for commercial purposes without the relevant counterparties having provided their consent;
(e)
a trade repository infringes Article 80(3) by not promptly recording the information received under Article 9 or by not maintaining it for at least 10 years following the termination of the relevant contracts or by not employing timely and efficient record-keeping procedures to document changes to recorded information;
(f)
a trade repository infringes Article 80(4) by not calculating the positions by class of derivatives and by reporting entity based on the details of the derivative contracts reported in accordance with Article 9;
(g)
a trade repository infringes Article 80(5) by not allowing the parties to a contract to access and correct the information on that contract in a timely manner;
(h)
a trade repository infringes Article 80(6) by not taking all reasonable steps to prevent any misuse of the information maintained in its systems.
III.
Infringements relating to transparency and the availability of information:
(a)
a trade repository infringes Article 81(1) by not regularly publishing, in an easily accessible way, aggregate positions by class of derivatives on the contracts reported to it;
(b)
a trade repository infringes Article 81(2) by not allowing the entities referred to in Article 81(3) direct and immediate access to the details of derivatives contracts they need to fulfil their respective responsibilities and mandates.
IV.
Infringements relating to obstacles to the supervisory activities:
(a)
a trade repository infringes Article 61(1) by providing incorrect or misleading information in response to a simple request for information by ESMA in accordance with Article 61(2) or in response to a decision by ESMA requiring information in accordance with Article 61(3);
(b)
a trade repository provides incorrect or misleading answers to questions asked pursuant to Article 62(1)(c);
(c)
a trade repository does not comply in due time with a supervisory measure adopted by ESMA pursuant to Article 73.
ANNEX II
List of the coefficients linked to aggravating and mitigating factors for the application of Article 65(3)
The following coefficients shall be applicable, cumulatively, to the basic amounts referred to in Article 65(2):
I.
Adjustment coefficients linked to aggravating factors:
(a)
if the infringement has been committed repeatedly, for every time it has been repeated, an additional coefficient of 1,1 shall apply;
(b)
if the infringement has been committed for more than six months, a coefficient of 1,5 shall apply;
(c)
if the infringement has revealed systemic weaknesses in the organisation of the trade repository, in particular in its procedures, management systems or internal controls, a coefficient of 2,2 shall apply;
(d)
if the infringement has a negative impact on the quality of the data it maintains, a coefficient of 1,5 shall apply;
(e)
if the infringement has been committed intentionally, a coefficient of 2 shall apply;
(f)
if no remedial action has been taken since the breach has been identified, a coefficient of 1,7 shall apply;
(g)
if the trade repository’s senior management has not cooperated with ESMA in carrying out its investigations, a coefficient of 1,5 shall apply.
II.
Adjustment coefficients linked to mitigating factors:
(a)
if the infringement has been committed for less than 10 working days, a coefficient of 0,9 shall apply;
(b)
if the trade repository’s senior management can demonstrate to have taken all the necessary measures to prevent the infringement, a coefficient of 0,7 shall apply;
(c)
if the trade repository has brought quickly, effectively and completely the infringement to ESMA’s attention, a coefficient of 0,4 shall apply;
(d)
if the trade repository has voluntarily taken measures to ensure that a similar infringement cannot be committed in the future, a coefficient of 0,6 shall apply.
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EU rules on over-the-counter derivatives contracts, central counterparties and trade repositories
EU rules on over-the-counter derivatives contracts, central counterparties and trade repositories
SUMMARY OF:
Regulation (EU) No 648/2012 on OTC derivatives, central counterparties and trade repositories
WHAT IS THE AIM OF THE REGULATION?
The European market infrastructure regulation (EMIR), lays down rules regarding over-the-counter (OTC) derivative* contracts, central counterparties (CCPs)* and trade repositories*, in line with the G20 commitments made in Pittsburgh, United States, in September 2009.
EMIR aims to reduce systemic risk, increase transparency in the OTC market and preserve financial stability.
KEY POINTS
To increase transparency, EMIR requires that all information on all European derivative contracts is reported to trade repositories and made accessible to supervisory authorities, including the European Securities and Markets Authority (ESMA).
To reduce counterparty credit risk*, EMIR sets out strict organisational, business conduct and prudential obligations for CCPs. Standard derivative contracts must be cleared through CCPs (see clearing*).
To reduce operational risk* for OTC derivative contracts that are not centrally cleared, EMIR requires the counterparties to have robust procedures in place for the timely confirmation of the terms of contracts, to identify and resolve disputes early and to mark-to-market* on a daily basis the value of outstanding contracts. Moreover, the counterparties must exchange collateral and ensure that they have sufficient capital to manage the risk not covered by the collateral.
The clearing and reporting obligations apply to firms that have large holdings in OTC derivatives, including: financial firms, such as banks and insurance firms; ornon-financial firms, such as energy companies and airlines.
Exemptions
Intra-group transactions are exempted from central clearing, reporting and the obligation to exchange margins on non-centrally cleared OTC derivatives under certain conditions.
Pension scheme arrangements have been temporarily exempted since no viable solution has yet been developed to allow the participation of pension scheme arrangements in central clearing.
Certain public entities and international institutions are exempt from the scope of EMIR (with the exemption for reporting depending on the entity).
A suspension of the clearing obligation for certain OTC derivative contracts or certain counterparties is possible under certain circumstances.
The European Securities and Markets Authority’s responsibilities
ESMA is responsible for identifying contracts that should be subject to the clearing obligation, that is, those that are standardised and must be cleared by CCPs.
ESMA play an important role in ensuring further European Union (EU) harmonisation and cooperation between EU Member State authorities responsible for the supervision of EU CCPs.
ESMA is responsible for the recognition of non-EU-country CCPs that want to offer clearing services in the EU, and supervises non-EU-country CCPs that are systemically important for financial stability in the EU or one or more of its Member States (Tier 2 CCPs).
ESMA also supervises trade repositories.
Competences
EMIR sets out the competences of: national competent authorities, colleges of supervisors and ESMA – for the authorisation and supervision of CCPs established in the EU;ESMA, the non-EU-country CCP college and the central banks of issue of EU currencies – for the recognition of non-EU-country CCPs and the ongoing supervision of the compliance of Tier 2 CCPs with EMIR.
The European Commission has adopted a number of delegated regulations, including technical standards on the basis of ESMA drafts, to supplement the terms of the regulation. The technical standards developed by ESMA cover a range of topics including: capital requirements of CCPs;the minimum data to be reported to trade repositories;supervisory reporting of institutions of the liquidity coverage requirement.
It also has the power to adopt delegated regulations on a variety of aspects, including: amendments to the list of entities exempt from the regulation;rules of procedure relating to the imposition of fines or periodic penalty payments;measures to amend Annex II to take account of developments in the financial markets;the further specification of the type of fees, the matters for which fees are due, the amount of the fees and the manner in which they are to be paid.
It has adopted implementing decisions on a number of aspects including the ‘equivalence’ of the regulation regimes for CCPs in certain non-EU countries.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 16 August 2012.
BACKGROUND
OTC derivatives are generally negotiated privately. The information concerning them is consequently only available to the contracting parties, which can make it difficult to identify the nature and level of risks involved.
For further information, see:
Derivatives/EMIR (European Commission)
Financial stability: new Commission rules on central clearing for interest rate derivatives – press release (European Commission).
KEY TERMS
Over-the-counter (OTC) derivative. A derivative is a financial contract linked to the future value or status of an underlying entity such as an asset, index or interest rate. An OTC derivative is a derivative that is not traded on an exchange or on an equivalent non-EU market but is instead privately negotiated between two counterparties, for example, a bank and a manufacturer.
Central counterparty (CCP). A body that acts between the two counterparties to a transaction, acting as the buyer to every seller and the seller to every buyer. A CCP’s main purpose is to manage the risk of a counterparty being unable to make the required payments when they are due and defaulting on the deal.
Trade repository. A central data centre where details of derivatives transactions are reported. Trade repositories are commercial firms. There are global trade repositories for credit, interest rate and equity OTC derivatives (a particular class of derivative such as options or futures).
Counterparty credit risk. A risk that a counterparty, i.e. the other party in a financial transaction, will default on payment.
Clearing. All activities from the time a commitment is made for a transaction until it is settled.
Operational risk. A risk of loss resulting from inadequate or failed internal processes or external events, for example, fraud, human error or terrorism.
Mark-to-market. Assigning a value to an asset equal to the current market price of the asset or one calculated based on related standardised assets for which there is a market.
MAIN DOCUMENT
Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, pp. 1–59).
Successive amendments to Regulation (EU) No 648/2012 have been incorporated in the original text. This consolidated version is of documentary value only.
last update 29.11.2021
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32012R0260
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30.3.2012
EN
Official Journal of the European Union
L 94/22
REGULATION (EU) No 260/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 March 2012
establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Central Bank (1),
Having regard to the opinion of the European Economic and Social Committee (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
The creation of an integrated market for electronic payments in euro, with no distinction between national and cross-border payments is necessary for the proper functioning of the internal market. To that end, the single euro payments area (SEPA) project aims to develop common Union-wide payment services to replace current national payment services. As a result of the introduction of open, common payment standards, rules and practices, and through integrated payment processing, SEPA should provide Union citizens and businesses with secure, competitively priced, user-friendly, and reliable payment services in euro. This should apply to SEPA payments within and across national boundaries under the same basic conditions and in accordance with the same rights and obligations, regardless of location within the Union. SEPA should be completed in a way that facilitates access for new market entrants and the development of new products, and creates favourable conditions for increased competition in payment services and for the unhindered development and swift, Union-wide implementation of innovations relating to payments. Consequently, improved economies of scale, increased operating efficiency and strengthened competition should lead to downward price pressure in electronic payment services in euro on a ‘best-of-breed’ basis. The effects of this should be significant, in particular in Member States where payments are relatively expensive compared to other Member States. The transition to SEPA should therefore not be accompanied by overall price increases for payment service users (PSUs) in general and for consumers in particular. Instead, where the PSU is a consumer, the principle of not levying higher charges should be encouraged. The Commission will continue to monitor price developments in the payment sector and is invited to provide an annual analysis thereof.
(2)
The success of SEPA is very important economically and politically. SEPA is fully in line with the Europe 2020 strategy which aims at a smarter economy in which prosperity results from innovation and from the more efficient use of available resources. Both the European Parliament, through its resolutions of 12 March 2009 (4) and of 10 March 2010 (5) on the implementation of SEPA, and the Council in its conclusions adopted on 2 December 2009, have underlined the importance of achieving rapid migration to SEPA.
(3)
Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market (6) provides a modern legal foundation for the creation of an internal market for payments, of which SEPA is a fundamental element.
(4)
Regulation (EC) No 924/2009 of the European Parliament and of the Council of 16 September 2009 on cross-border payments in the Community (7) also provides a number of facilitating measures for the success of SEPA such as the extension of the principle of equal charges to cross-border direct debits and reachability for direct debits.
(5)
Self-regulatory efforts of the European banking sector through the SEPA initiative have not proven sufficient to drive forward concerted migration to Union-wide schemes for credit transfers and direct debits on both the supply and the demand side. In particular, consumer and other user interests have not been taken into account in a sufficient and transparent way. The voice of all relevant stakeholders should be heard. Moreover, that self-regulatory process has not been subject to appropriate governance mechanisms, which may partly explain the slow uptake on the demand side. While the recent establishment of the SEPA Council represents a significant improvement of the governance of the SEPA project, fundamentally and formally governance still remains very much in the hands of the European Payments Council (EPC). The Commission should therefore review the governance arrangements of the whole SEPA project before the end of 2012 and, where necessary, make a proposal. That review should examine, inter alia, the composition of the EPC, the interaction between the EPC and an overarching governance structure, such as the SEPA Council, and the role of that overarching structure.
(6)
Only rapid and comprehensive migration to Union-wide credit transfers and direct debits will generate the full benefits of an integrated payments market, so that the high costs of running both ‘legacy’ and SEPA products in parallel can be eliminated. Rules should therefore be laid down to cover the execution of all credit transfer and direct debit transactions denominated in euro within the Union. However, card transactions should not be covered at this stage, since common standards for Union card payments are still under development. Money remittance, internally processed payments, large-value payment transactions, payments between payment service providers (PSPs) for their own account and payments via mobile phone or any other means of telecommunication or digital or IT device should not fall within the scope of those rules since those payment services are not comparable to credit transfers or direct debits. Where a payment card at the point of sale or some other device such as a mobile phone is used as the means to initiate a payment transaction, either at the point of sale or remotely, which directly results in a credit transfer or a direct debit to and from a payment account identified by the existing national basic bank account number (BBAN) or the international bank account number (IBAN), that payment transaction should, however, be included. In addition, given the specific characteristics of payments processed through large-value payment systems, namely their high priority, urgency, and primarily large amount, it is not appropriate to cover such payments under this Regulation. That exclusion should not include direct debit payments, unless the payer has explicitly requested the payment be routed via a large-value payment system.
(7)
Several payment services currently exist, mostly for payments through the internet, which also use IBAN and the business identifier code (BIC) and are based on credit transfers or direct debits but have additional features. Those services are expected to extend beyond their current national borders and could fulfil a consumer demand for innovative, safe and cheap payment services. In order not to foreclose such services from the market, the regulation of the end-dates for credit transfers and direct debits provided for in this Regulation should apply only to the credit transfer or direct debit underlying those transactions.
(8)
In the vast majority of payment transactions in the Union, it is possible to identify a unique payment account using only IBAN without additionally specifying BIC. Reflecting this reality, banks in a number of Member States have already established a directory, database or other technical means to identify the BIC corresponding to a specific IBAN. BIC is required only in a very small, residual number of cases. It seems unjustified and excessively burdensome to oblige all payers and payees throughout the Union always to provide BIC in addition to IBAN for the small number of cases where this is currently necessary. A much simpler approach would be for PSPs and other parties to solve and eliminate those cases where a payment account cannot be identified unambiguously by a given IBAN. Therefore the necessary technical means should be developed to enable all users to identify unambiguously a payment account by IBAN alone.
(9)
For a credit transfer to be executed, the payee’s payment account must be reachable. Therefore, in order to encourage the successful take-up of Union-wide credit transfer and direct debit services, a reachability obligation should be established across the Union. To improve transparency, it is furthermore appropriate to consolidate that obligation and the reachability obligation for direct debits already established under Regulation (EC) No 924/2009 in a single act. All payee payment accounts reachable for a national credit transfer should also be reachable via a Union-wide credit transfer scheme. All payers’ payment accounts reachable for a national direct debit should also be reachable via a Union-wide direct debit scheme. This should apply whether or not a PSP decides to participate in a particular credit transfer or direct debit scheme.
(10)
Technical interoperability is a prerequisite for competition. In order to create an integrated market for electronic payments systems in euro, it is essential that the processing of credit transfers and direct debits is not hindered by business rules or technical obstacles such as compulsory adherence to more than one system for settling cross-border payments. Credit transfers and direct debits should be carried out under a scheme, the basic rules of which are adhered to by PSPs representing a majority of PSPs within a majority of the Member States and constituting a majority of PSPs within the Union, and which are the same both for cross-border and for purely national credit transfer and direct debit transactions. Where there is more than one payment system for the processing of such payments, those payment systems should be interoperable through the use of Union-wide and international standards so that all PSUs and all PSPs can enjoy the benefits of seamless retail euro payments across the Union.
(11)
Given the specific characteristics of the business market, whilst business-to-business credit transfer or direct debit schemes need to comply with all other provisions in this Regulation, including having the same rules for cross-border and national transactions, the requirement that participants represent a majority of PSPs within the majority of Member States should apply only to the extent that PSPs providing business-to-business credit transfer or direct debit services represent a majority of PSPs in the majority of Member States where such services are available, and constitute a majority of PSPs providing such services within the Union.
(12)
It is crucial to identify technical requirements unambiguously determining the features which Union-wide payment schemes to be developed under appropriate governance arrangements have to respect in order to ensure interoperability between payment systems. Such technical requirements should not restrict flexibility and innovation but should be open to and neutral towards potential new developments and improvements in the payments market. Technical requirements should be designed taking into account the special characteristics of credit transfers and direct debits, in particular with regard to the data elements contained in the payment message.
(13)
It is important to take measures to strengthen the confidence of PSUs in the use of such services, especially for direct debits. Such measures should allow payers to instruct their PSPs to limit direct debit collection to a certain amount or a certain periodicity and to establish specific positive or negative lists of payees. Within the framework of the establishment of Union-wide direct debit schemes, it is appropriate that consumers are able to benefit from such checks. Nevertheless for the practical implementation of such checks on payees, it is important that PSPs are able to check on the basis of IBAN, and, for a transitional period, but only where necessary, BIC, or some other unique creditor identifier of specified payees. Other relevant rights of users are already established in Directive 2007/64/EC and should be fully ensured.
(14)
Technical standardisation is a cornerstone for the integration of networks, such as the Union payments market. The use of standards developed by international or European standardisation bodies should be mandatory as from a given date for all relevant transactions. In the payment context, such mandatory standards are IBAN, BIC, and the financial services messaging standard ‘ISO 20022 XML’. The use of those standards by all PSPs is therefore a requirement for full interoperability throughout the Union. In particular, the mandatory use of IBAN and BIC where necessary should be promoted through comprehensive communication and facilitating measures in Member States in order to allow a smooth and easy transition to Union-wide credit transfers and direct debits, in particular for consumers. PSPs should be able to agree, bilaterally or multilaterally, on the expansion of the basic Latin character set to support regional variations of SEPA standard messages.
(15)
It is absolutely crucial that all actors, and particularly Union citizens, are properly informed, in a timely manner, so that they are fully prepared for the changes brought about by SEPA. Key stakeholders such as PSPs, public administrations and national central banks as well as other heavy users of regular payments should therefore carry out specific and extensive information campaigns, proportionate to the need and tailored to their audience as may be necessary, in order to raise public awareness and prepare citizens for SEPA migration. In particular, there is a need to familiarise citizens with migration from BBAN to IBAN. National SEPA coordination committees are best placed to coordinate such information campaigns.
(16)
In order to allow a concerted transition process in the interests of clarity and simplicity for consumers, it is appropriate to set a single migration deadline by which all credit transfers and direct debit transactions should comply with those technical requirements, while leaving the market open for further development and innovation.
(17)
For a transitional period, Member States should be able to permit PSPs to allow consumers to continue using BBAN for national payment transactions on condition that interoperability is ensured by converting BBAN technically and securely into the respective unique payment account identifier by the PSP concerned. The PSP should not levy any direct or indirect charges or other fees linked to that service.
(18)
Although the level of development of credit transfer and direct debit services differs from one Member State to another, a common deadline at the end of an adequate period for implementation, which allows for all the necessary processes to take place would contribute to a coordinated, coherent and integrated migration to SEPA and would help prevent a two-speed SEPA, which would cause greater confusion among consumers.
(19)
PSPs and PSUs should have sufficient time to adapt to the technical requirements. However, the adaptation period should not unnecessarily delay the benefits to consumers or penalise the efforts of proactive operators that have already moved towards SEPA. For national payment and cross-border payment transactions, the PSPs should provide their retail customers with the necessary technical services in order to ensure a smooth and secure conversion to the technical requirements laid down in this Regulation.
(20)
It is important to provide legal certainty to the payments industry on business models for direct debits. Regulation of multilateral interchange fees (MIFs) for direct debits is essential to create neutral conditions of competition between PSPs and so to permit the development of a single market for direct debits. Such fees for transactions which are rejected, refused, returned or reversed because they cannot be properly executed or result in exception processing (so-called ‘R-transactions’ where the letter ‘R’ can signify ‘reject’, ‘refusal’, ‘return’, ‘reversal’, ‘revocation’ or ‘request for cancellation’), could help to allocate costs efficiently within the internal market. Therefore, it would appear beneficial for the creation of an effective European direct debit market to prohibit per transaction MIF. Nevertheless, R-transaction fees should be allowed, provided that they comply with certain conditions. PSPs must provide clear and understandable information to consumers on R-transaction fees in the interests of transparency and consumer protection. In any event, the R-transaction rules are without prejudice to the application of Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU). Furthermore, it should be noted that in general direct debits and card payments have different characteristics, in particular in terms of the higher potential for payees to provide incentives for the use of a direct debit by payers through a pre-existing contract between the payee and the payer, whilst for card payments no such prior contract exists and the payment transaction is often an isolated and irregular event. Therefore, the provisions on MIFs for direct debits are without prejudice to the analysis under Union competition rules of MIFs for payment card transactions. Additional optional services are not covered by the prohibition under this Regulation where they are clearly and unequivocally distinct from the core direct debit services and where PSPs and PSUs are completely at liberty to offer or use such services. Nevertheless they remain subject to Union and national competition rules.
(21)
Therefore, the possibility to apply per transaction MIF for national and cross-border direct debits should be limited in time and general conditions should be laid down for the application of interchange fees for R-transactions.
(22)
The Commission should monitor the level of R-transaction fees across the Union. R-transaction fees in the internal market should converge over time so that they do not vary across Member States to an extent to threaten the level playing field.
(23)
In some Member States, there are certain legacy payment services which are credit transfers or direct debits but which have very specific functionalities, often due to historical or legal reasons. The transaction volume of such services is usually marginal. Such services could therefore be classified as niche products. A transitional period for such niche products, sufficiently long to minimise the impact of migration on PSUs, should help both sides of the market to focus first on the migration of the bulk of credit transfers and direct debits, thereby allowing the majority of the potential benefits of an integrated payments market in the Union to be reaped earlier. In some Member States, specific direct debit instruments exist which seem very similar to payment card transactions in that the payer uses a card at the point of sale to initiate the payment transaction but the underlying payment transaction is a direct debit. In such payment transactions the card is used only for a read-out in order to facilitate the electronic generation of the mandate, which has to be signed by the payer at the point of sale. Although such payment services cannot be classified as a niche product, there is a need for a transitional period in relation to such payment services because of the substantial transaction volume involved. In order to enable the stakeholders to implement an adequate SEPA substitute, that transitional period should be of sufficient length.
(24)
For the proper functioning of the internal market for payments it is essential to ensure that payers such as consumers, businesses or public authorities are able to send credit transfers to payment accounts held by the payees with PSPs which are located in other Member States and which are reachable in accordance with this Regulation.
(25)
In order to secure a smooth transition to SEPA, a valid payee authorisation to collect recurring direct debits in a legacy scheme should remain valid after the migration deadline established in this Regulation. Such an authorisation should be considered as representing consent to the payer’s PSP to execute the recurring direct debits collected by the payee in compliance with this Regulation, in the absence of national law relating to the continued validity of the mandate or customer agreements changing direct debit mandates to allow their continuation. However, consumer rights must be protected and where existing direct debit mandates have unconditional refund rights, such rights should be maintained.
(26)
Competent authorities should be empowered to fulfil their monitoring duties efficiently and to take all necessary measures including considering complaints to ensure that PSPs comply with this Regulation. Also, Member States should ensure that complaints against PSUs for not complying with this Regulation can be filed and that this Regulation can be enforced in an effective and efficient manner by administrative or judicial means. To foster compliance with this Regulation the competent authorities of different Member States should cooperate with each other and, where appropriate, with the European Central Bank (ECB) and the national central banks of the Member States and other relevant competent authorities, such as the European Supervisory Authority (European Banking Authority) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (8) (EBA), designated under Union or national legislation applicable to PSPs.
(27)
Member States should lay down rules on the penalties applicable to infringements of this Regulation and should ensure that those penalties are effective, proportionate and dissuasive and that they are applied. Those penalties should not be applied to consumers.
(28)
In order to ensure that redress is possible where this Regulation has been incorrectly applied, or where disputes occur between PSUs and PSPs concerning rights and obligations arising under this Regulation, Member States should establish adequate and effective out-of-court complaint and redress procedures. Member States should be able to decide that those procedures apply only to consumers or only to consumers and microenterprises.
(29)
The Commission should submit a report to the European Parliament, the Council, the European Economic and Social Committee, EBA and the ECB on the application of this Regulation. The report should be accompanied, where necessary, by a proposal for the amendment of this Regulation.
(30)
In order to ensure that the technical requirements for credit transfers and direct debits in euro remain up to date, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of those technical requirements. In the Declaration (No 39) on Article 290 TFEU, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. It is of particular importance that the Commission carry out appropriate and transparent consultation during its preparatory work, including with the ECB and all relevant stakeholders. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council.
(31)
Since PSPs located in Member States whose currency is not the euro would need to undertake special preparatory work outside the payments market for their national currency, such PSPs should be allowed to defer the application of the technical requirements for a certain period. Member States whose currency is not the euro should, however, comply with the technical requirements to create a true European payments area, which will strengthen the internal market.
(32)
In order to ensure broad public support for SEPA, a high level of protection for payers is essential, particularly for direct debit transactions. The current and only pan-European direct debit scheme for consumers developed by the EPC provides for a ‘no-questions-asked’, unconditional refund right for authorised payments during a period of 8 weeks from the date on which the funds were debited, while that refund right is subject to several conditions under Articles 62 and 63 of Directive 2007/64/EC. In the light of the prevailing market situation and of the necessity to ensure a high level of consumer protection, the impact of those provisions should be assessed in the report that, in accordance with Article 87 of Directive 2007/64/EC, the Commission shall, no later than 1 November 2012, present to the European Parliament, the Council, the European Economic and Social Committee and the ECB accompanied, where appropriate, by a proposal for its revision.
(33)
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (9) governs the processing of personal data carried out pursuant to this Regulation. Migration to SEPA and the introduction of common standards and rules for payments should be based on compliance with national law on the protection of sensitive personal data in Member States and should safeguard the interests of Union citizens.
(34)
Financial messages relating to payments and transfers in the SEPA are outside the scope of the Agreement between the European Union and the United States of America of 28 June 2010 on the processing and transfer of Financial Messaging Data from the European Union to the United States for the purposes of the Terrorist Finance Tracking Program (10).
(35)
Since the objective of this Regulation, namely establishing technical and business requirements for credit transfers and direct debits in euro, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale or effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(36)
Pursuant to Article 5(1) of Regulation (EC) No 924/2009, Member States are to remove settlement-based national reporting obligations on PSPs for balance of payments statistics relating to payment transactions of their customers of up to EUR 50 000. The collection of balance-of-payments statistics based on settlements emerged after the end of foreign exchange controls and until now, constitutes a major data source alongside others such as direct surveys, contributing to good quality statistics. From the beginning of the 1990s some Member States opted to rely more on information reported directly by companies and households than on data reported through banks on behalf of their customers. Although settlement-based reporting represents a solution that, in terms of society as a whole, reduces the cost of balance-of-payments compilation while assuring good-quality statistics, in strict terms of cross-border payments the maintenance of such reporting in some Member States might diminish efficiency and increases costs. Since one aim of SEPA is to reduce the costs of cross-border payments, settlement-based balance-of-payments reporting should be abolished completely.
(37)
In order to enhance legal certainty it is appropriate to align the deadlines for interchange fees set out in Article 7 of Regulation (EC) No 924/2009 with the provisions laid down in this Regulation.
(38)
Regulation (EC) No 924/2009 should therefore be amended accordingly,
HAVE ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1. This Regulation lays down rules for credit transfer and direct debit transactions denominated in euro within the Union where both the payer’s payment service provider and the payee’s payment service provider are located in the Union, or where the sole payment service provider (PSP) involved in the payment transaction is located in the Union.
2. This Regulation does not apply to the following:
(a)
payment transactions carried out between and within PSPs, including their agents or branches, for their own account;
(b)
payment transactions processed and settled through large-value payment systems, excluding direct debit payment transactions which the payer has not explicitly requested be routed via a large-value payment system;
(c)
payment transactions through a payment card or similar device, including cash withdrawals, unless the payment card or similar device is used only to generate the information required to directly make a credit transfer or direct debit to and from a payment account identified by BBAN or IBAN;
(d)
payment transactions by means of any telecommunication, digital or IT device, if such payment transactions do not result in a credit transfer or direct debit to and from a payment account identified by BBAN or IBAN;
(e)
transactions of money remittance as defined in point (13) of Article 4 of Directive 2007/64/EC;
(f)
payment transactions transferring electronic money as defined in point (2) of Article 2 of Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions (11), unless such transactions result in a credit transfer or direct debit to and from a payment account identified by BBAN or IBAN.
3. Where payment schemes are based on payment transactions by credit transfers or direct debits but have additional optional features or services, this Regulation applies only to the underlying credit transfers or direct debits.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘credit transfer’ means a national or cross-border payment service for crediting a payee’s payment account with a payment transaction or a series of payment transactions from a payer’s payment account by the PSP which holds the payer’s payment account, based on an instruction given by the payer;
(2)
‘direct debit’ means a national or cross-border payment service for debiting a payer’s payment account, where a payment transaction is initiated by the payee on the basis of the payer’s consent;
(3)
‘payer’ means a natural or legal person who holds a payment account and allows a payment order from that payment account or, where there is no payer’s payment account, a natural or legal person who makes a payment order to a payee’s payment account;
(4)
‘payee’ means a natural or legal person who holds a payment account and who is the intended recipient of funds which have been the subject of a payment transaction;
(5)
‘payment account’ means an account held in the name of one or more payment service users which is used for the execution of payment transactions;
(6)
‘payment system’ means a funds transfer system with formal and standardised arrangements and common rules for the processing, clearing or settlement of payment transactions;
(7)
‘payment scheme’ means a single set of rules, practices, standards and/or implementation guidelines agreed between PSPs for the execution of payment transactions across the Union and within Member States, and which is separated from any infrastructure or payment system that supports its operation;
(8)
‘PSP’ means a payment service provider falling under any of the categories referred to in Article 1(1) of Directive 2007/64/EC and the legal and natural persons referred to in Article 26 of Directive 2007/64/EC, but excludes the bodies listed in Article 2 of Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (12) benefiting from a waiver under Article 2(3) of Directive 2007/64/EC;
(9)
‘PSU’ means a natural or legal person making use of a payment service in the capacity of payer or payee;
(10)
‘payment transaction’ means an act, initiated by the payer or by the payee of transferring funds between payment accounts in the Union, irrespective of any underlying obligations between the payer and the payee;
(11)
‘payment order’ means an instruction by a payer or payee to his PSP requesting the execution of a payment transaction;
(12)
‘interchange fee’ means a fee paid between the payer’s PSP and the payee’s PSP for direct debit transactions;
(13)
‘MIF’ means a multilateral interchange fee which is subject to an arrangement between more than two PSPs;
(14)
‘BBAN’ means a payment account number identifier, which unambiguously identifies an individual payment account with a PSP in a Member State and which can only be used for national payment transactions while the same payment account is identified by IBAN for cross-border payment transactions;
(15)
‘IBAN’ means an international payment account number identifier, which unambiguously identifies an individual payment account in a Member State, the elements of which are specified by the International Organisation for Standardisation (ISO);
(16)
‘BIC’ means a business identifier code that unambiguously identifies a PSP, the elements of which are specified by the ISO;
(17)
‘ISO 20022 XML standard’ means a standard for the development of electronic financial messages as defined by the ISO, encompassing the physical representation of the payment transactions in XML syntax, in accordance with business rules and implementation guidelines of Union-wide schemes for payment transactions falling within the scope of this Regulation;
(18)
‘large-value payment system’ means a payment system the main purpose of which is to process, clear or settle single payment transactions of high priority and urgency, and primarily of large amount;
(19)
‘settlement date’ means a date on which obligations with respect to the transfer of funds are discharged between the payer’s PSP and the payee’s PSP;
(20)
‘collection’ means a part of a direct debit transaction starting from its initiation by the payee until its end through the normal debiting of the payer’s payment account;
(21)
‘mandate’ means the expression of consent and authorisation given by the payer to the payee and (directly or indirectly via the payee) to the payer’s PSP to allow the payee to initiate a collection for debiting the payer’s specified payment account and to allow the payer’s PSP to comply with such instructions;
(22)
‘retail payment system’ means a payment system the main purpose of which is to process, clear or settle credit transfers or direct debits, which are generally bundled together for transmission and are primarily of small amount and low priority, and that is not a large-value payment system;
(23)
‘microenterprise’ means an enterprise, which at the time of conclusion of the payment service contract, is an enterprise as defined in Article 1 and Article 2(1) and (3) of the Annex to Commission Recommendation 2003/361/EC (13);
(24)
‘consumer’ means a natural person acting for purposes other than trade, business or profession in payment service contracts;
(25)
‘R-transaction’ means a payment transaction which cannot be properly executed by a PSP or which results in exception processing, inter alia, because of a lack of funds, revocation, a wrong amount or a wrong date, a lack of mandate or wrong or closed account;
(26)
‘cross-border payment transaction’ means a payment transaction initiated by a payer or by a payee where the payer’s PSP and the payee’s PSP are located in different Member States;
(27)
‘national payment transaction’ means a payment transaction initiated by a payer or by a payee, where the payer’s PSP and the payee’s PSP are located in the same Member State;
(28)
‘reference party’ means a natural or legal person on behalf of whom a payer makes a payment or a payee receives a payment.
Article 3
Reachability
1. A payee’s PSP which is reachable for a national credit transfer under a payment scheme shall be reachable, in accordance with the rules of a Union-wide payment scheme, for credit transfers initiated by a payer through a PSP located in any Member State.
2. A payer’s PSP which is reachable for a national direct debit under a payment scheme shall be reachable, in accordance with the rules of a Union-wide payment scheme, for direct debits initiated by a payee through a PSP located in any Member State.
3. Paragraph 2 shall apply only to direct debits which are available to consumers as payers under the payment scheme.
Article 4
Interoperability
1. Payment schemes to be used by PSPs for the purposes of carrying out credit transfers and direct debits shall comply with the following conditions:
(a)
their rules are the same for national and cross-border credit transfer transactions within the Union and similarly for national and cross-border direct debit transactions within the Union; and
(b)
the participants in the payment scheme represent a majority of PSPs within a majority of Member States, and constitute a majority of PSPs within the Union, taking into account only PSPs that provide credit transfers or direct debits respectively.
For the purposes of point (b) of the first subparagraph, where neither the payer nor the payee is a consumer, only Member States where such services are made available by PSPs and only PSPs providing such services shall be taken into account.
2. The operator or, in the absence of a formal operator, the participants of a retail payment system within the Union shall ensure that their payment system is technically interoperable with other retail payment systems within the Union through the use of standards developed by international or European standardisation bodies. In addition, they shall not adopt business rules that restrict interoperability with other retail payment systems within the Union. Payment systems designated under Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (14) shall only be obliged to ensure technical interoperability with other payment systems designated under the same Directive.
3. The processing of credit transfers and direct debits shall not be hindered by technical obstacles.
4. The payment scheme owner or, where there is no formal payment scheme owner, the leading participant of a new entrant retail payment scheme which has participants in at least eight Member States, may apply to the competent authorities in the Member State where the payment scheme owner or leading participant is located for a temporary exemption from the conditions set out in point (b) of the first subparagraph of paragraph 1. Those competent authorities may grant, after consulting the competent authorities in the other Member States where the new entrant payment scheme has a participant, the Commission and the ECB, such an exemption for a maximum of 3 years. Those competent authorities shall base their decision on the potential of the new entrant payment scheme to develop into a fully fledged pan-European payment scheme and its contribution to improving competition or promoting innovation.
5. With the exception of payment services benefiting from a waiver under Article 16(4), this Article shall be effective by 1 February 2014.
Article 5
Requirements for credit transfer and direct debit transactions
1. PSPs shall carry out credit transfer and direct debit transactions in accordance with the following requirements:
(a)
they must use the payment account identifier specified in point (1)(a) of the Annex for the identification of payment accounts regardless of the location of the PSPs concerned;
(b)
they must use the message formats specified in point (1)(b) of the Annex, when transmitting payment transactions to another PSP or via a retail payment system;
(c)
they must ensure that PSUs use the payment account identifier specified in point (1)(a) of the Annex for the identification of payment accounts, whether the payer’s PSP and the payee’s PSP or the sole PSP in the payment transaction are located in the same Member State or in different Member States;
(d)
they must ensure that where a PSU that is not a consumer or a microenterprise, initiates or receives individual credit transfers or individual direct debits which are not transmitted individually, but are bundled together for transmission, the message formats specified in point (1)(b) of the Annex are used.
Without prejudice to point (b) of the first subparagraph, PSPs shall, upon the specific request of a PSU, use the message formats specified in point (1)(b) of the Annex in relation to that PSU.
2. PSPs shall carry out credit transfers in accordance with the following requirements, subject to any obligation laid down in the national law implementing Directive 95/46/EC:
(a)
the payer’s PSP must ensure that the payer provides the data elements specified in point (2)(a) of the Annex;
(b)
the payer’s PSP must provide the data elements specified in point (2)(b) of the Annex to the payee’s PSP;
(c)
the payee’s PSP must provide or make available to the payee the data elements specified in point (2)(d) of the Annex.
3. PSPs shall carry out direct debits in accordance with the following requirements, subject to any obligation laid down in national law implementing Directive 95/46/EC:
(a)
the payee’s PSP must ensure that:
(i)
the payee provides the data elements specified in point (3)(a) of the Annex with the first direct debit and one-off direct debit and with each subsequent payment transaction,
(ii)
the payer gives consent both to the payee and to the payer’s PSP (directly or indirectly via the payee), the mandates, together with later modifications or cancellation, are stored by the payee or by a third party on behalf of the payee and the payee is informed of this obligation by the PSP in accordance with Articles 41 and 42 of Directive 2007/64/EC;
(b)
the payee’s PSP must provide the payer’s PSP with the data elements specified in point (3)(b) of the Annex;
(c)
the payer’s PSP must provide or make available to the payer the data elements specified in point (3)(c) of the Annex;
(d)
the payer must have the right to instruct its PSP:
(i)
to limit a direct debit collection to a certain amount or periodicity or both,
(ii)
where a mandate under a payment scheme does not provide for the right to a refund, to verify each direct debit transaction, and to check whether the amount and periodicity of the submitted direct debit transaction is equal to the amount and periodicity agreed in the mandate, before debiting their payment account, based on the mandate-related information,
(iii)
to block any direct debits to the payer’s payment account or to block any direct debits initiated by one or more specified payees or to authorise direct debits only initiated by one or more specified payees;
Where neither the payer nor the payee is a consumer, PSPs shall not be required to comply with point (d)(i), (ii) or (iii).
The payer’s PSP shall inform the payer of the rights referred to in point (d) in accordance with Articles 41 and 42 of Directive 2007/64/EC.
Upon the first direct debit transaction or a one-off direct debit transaction and upon each subsequent direct debit transaction, the payee shall send the mandate-related information to his or her PSP and the payee’s PSP shall transmit that mandate-related information to the payer’s PSP with each direct debit transaction.
4. In addition to the requirements referred to in paragraph 1, the payee accepting credit transfers shall communicate its payment account identifier specified in point (1)(a) of the Annex and, until 1 February 2014 for national payment transactions and until 1 February 2016 for cross-border payment transactions, but only where necessary, its PSP’s BIC to its payers, when a credit transfer is requested.
5. Before the first direct debit transaction, a payer shall communicate its payment account identifier specified in point (1)(a) of the Annex. The BIC of a payer’s PSP shall be communicated until 1 February 2014 for national payment transactions and until 1 February 2016 for cross-border payment transactions by the payer but only where necessary.
6. Where the framework agreement between the payer and the payer’s PSP does not provide for the right to a refund, the payer’s PSP shall, without prejudice to paragraph (3)(a)(ii), verify each direct debit transaction to check whether the amount of the submitted direct debit transaction is equal to the amount and periodicity agreed in the mandate before debiting the payer’s payment account, based on the mandate-related information.
7. After 1 February 2014 for national payment transactions and after 1 February 2016 for cross-border payment transactions PSPs shall not require PSUs to indicate the BIC of the PSP of a payer or of the PSP of a payee.
8. The payer’s PSP and the payee’s PSP shall not levy additional charges or other fees on the read-out process to automatically generate a mandate for those payment transactions initiated through or by means of a payment card at the point of sale, which result in direct debit.
Article 6
End-dates
1. By 1 February 2014, credit transfers shall be carried out in accordance with the technical requirements set out in Article 5(1), (2) and (4) and points 1 and 2 of the Annex.
2. By 1 February 2014, direct debits shall be carried out in accordance with Article 8(2) and (3) and with the requirements set out in Article 5(1), (3), (5), (6) and (8) and points 1 and 3 of the Annex.
3. Without prejudice to Article 3, direct debits shall be carried out in accordance with the requirements set out in Article 8(1) by 1 February 2017 for national payments and by 1 November 2012 for cross-border payments.
4. For national payment transactions a Member State or, with the approval of the Member State concerned, the PSPs of a Member State may, after taking into account and evaluating the state of preparedness and readiness of their citizens, set earlier dates than those referred to in paragraphs 1 and 2.
Article 7
Validity of mandates and right to a refund
1. A valid payee authorisation to collect recurring direct debits in a legacy scheme prior to 1 February 2014 shall continue to remain valid after that date and shall be considered as representing the consent to the payer’s PSP to execute the recurring direct debits collected by that payee in compliance with this Regulation in the absence of national law or customer agreements continuing the validity of direct debit mandates.
2. Mandates as referred to in paragraph 1 shall allow for unconditional refunds and refunds backdated to the date of the refunded payment where such refunds have been provided for within the framework of the existing mandate.
Article 8
Interchange fees for direct debit transactions
1. Without prejudice to paragraph 2, no MIF per direct debit transaction or other agreed remuneration with an equivalent object or effect shall apply to direct debit transactions.
2. For R-transactions a MIF may be applied provided that the following conditions are complied with:
(a)
the arrangement aims at efficiently allocating costs to the PSP which, or the PSU of which, has caused the R-transaction, as appropriate, while taking into account the existence of transaction costs and ensures that the payer is not automatically charged and the PSP is prohibited from charging PSUs in respect of a given type of R-transaction fees that exceed the cost borne by the PSP for such transactions;
(b)
the fees are strictly cost based;
(c)
the level of the fees does not exceed the actual costs of handling an R-transaction by the most cost-efficient comparable PSP that is a representative party to the arrangement in terms of volume of transactions and nature of services;
(d)
the application of the fees in accordance with points (a), (b) and (c) prevent the PSP from charging additional fees relating to the costs covered by those interchange fees to their respective PSUs;
(e)
there is no practical and economically viable alternative to the arrangement which would lead to an equally or more efficient handling of R-transactions at equal or lower cost to consumers.
For the purposes of the first subparagraph, only cost categories directly and unequivocally relevant to the handling of the R-transaction shall be considered in the calculation of the R-transaction fees. Those costs shall be precisely determined. The breakdown of the amount of the costs, including separate identification of each of its components, shall be part of the arrangement to allow for easy verification and monitoring.
3. Paragraphs 1 and 2 shall apply mutatis mutandis to unilateral arrangements by a PSP and to bilateral arrangements between PSPs that have an object or effect equivalent to that of a multilateral arrangement.
Article 9
Payment accessibility
1. A payer making a credit transfer to a payee holding a payment account located within the Union shall not specify the Member State in which that payment account is to be located, provided that the payment account is reachable in accordance with Article 3.
2. A payee accepting a credit transfer or using a direct debit to collect funds from a payer holding a payment account located within the Union shall not specify the Member State in which that payment account is to be located, provided that the payment account is reachable in accordance with Article 3.
Article 10
Competent authorities
1. Member States shall designate as the competent authorities responsible for ensuring compliance with this Regulation public authorities, bodies recognised by national law or public authorities expressly empowered for that purpose by national law, including national central banks. Member States may designate existing bodies to act as competent authorities.
2. Member States shall notify the Commission of the competent authorities designated under paragraph 1 by 1 February 2013. They shall notify the Commission and the European Supervisory Authority (European Banking Authority) (EBA) without delay of any subsequent change concerning those authorities.
3. Member States shall ensure that the competent authorities referred to in paragraph 1 have all the powers necessary for the performance of their duties. Where there is more than one competent authority for matters covered by this Regulation on its territory, Member States shall ensure that those authorities cooperate closely so that they can discharge their respective duties effectively.
4. The competent authorities shall monitor compliance by PSPs with this Regulation effectively and take all necessary measures to ensure such compliance. They shall cooperate with each other in accordance with Article 24 of Directive 2007/64/EC and with Article 31 of Regulation (EU) No 1093/2010.
Article 11
Penalties
1. Member States shall, by 1 February 2013, lay down rules on the penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. Such penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by 1 August 2013 and shall notify it without delay of any subsequent amendment affecting them.
2. The penalties referred to in paragraph 1 shall not be applied to consumers.
Article 12
Out-of-court complaint and redress procedures
1. Member States shall establish adequate and effective out-of-court complaint and redress procedures for the settlement of disputes concerning rights and obligations arising from this Regulation between PSUs and their PSPs. For those purposes, Member States shall designate existing bodies or where appropriate, set up new bodies.
2. Member States shall notify the Commission of the bodies referred to in paragraph 1 by 1 February 2013. They shall notify the Commission without delay of any subsequent change concerning those bodies.
3. Member States may provide for this Article to apply only to PSUs that are consumers or only to those that are consumers and microenterprises. Member States shall inform the Commission of any such provision by 1 August 2013.
Article 13
Delegation of power
The Commission shall be empowered to adopt delegated acts in accordance with Article 14 to amend the Annex, in order to take account of technical progress and market developments.
Article 14
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of 5 years from 31 March 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 3 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or the Council.
Article 15
Review
By 1 February 2017, the Commission shall present to the European Parliament, the Council, the European Economic and Social Committee, ECB and EBA a report on the application of this Regulation accompanied, if appropriate, by a proposal.
Article 16
Transitional provisions
1. By way of derogation from Article 6(1) and (2), Member States may allow PSPs to provide PSUs, until 1 February 2016, with conversion services for national payment transactions enabling PSUs that are consumers to continue using BBAN instead of the payment account identifier specified in point (1)(a) of the Annex on condition that interoperability is ensured by converting the payer’s and the payee’s BBAN technically and securely into the respective payment account identifier specified in point (1)(a) of the Annex. That payment account identifier shall be delivered to the initiating PSU, where appropriate before the payment is executed. In such a case PSPs shall not levy any charges or other fees on the PSU directly or indirectly linked to those conversion services.
2. PSPs that offer payment services denominated in euro and that are located in a Member State which does not have the euro as its currency shall comply with Article 3 when offering payment services denominated in euro by 31 October 2016. If, however, the euro is introduced as the currency of any such Member State before 31 October 2015, the PSP located in that Member State shall comply with Article 3 within 1 year of the date on which the Member State concerned joined the euro area.
3. Member States may allow their competent authorities to waive all or some of the requirements referred to in Article 6(1) and (2) for those credit transfer or direct debit transactions with a cumulative market share, based on the official payment statistics published annually by the ECB, of less than 10 % of the total number of credit transfers or direct debit transactions respectively, in that Member State until 1 February 2016.
4. Member States may allow their competent authorities to waive all or some of the requirements referred to in Article 6(1) and (2) for those payment transactions generated using a payment card at the point of sale which result in direct debit to and from a payment account identified by BBAN or IBAN until 1 February 2016.
5. By way of derogation from Article 6(1) and (2), Member States may allow their competent authorities, until 1 February 2016, to waive the specific requirement to use the message formats specified in point (1)(b) of the Annex set out in Article 5(1)(d) for PSUs which initiate or receive individual credit transfers or direct debits that are bundled together for transmission. Notwithstanding a possible waiver, PSPs shall fulfil the requirements set out in Article 5(1)(d) where a PSU requests such a service.
6. By way of derogation from Article 6(1) and (2), Member States may defer the requirements relating to provision of BIC for national payment transactions in Article 5(4), (5) and (7) until 1 February 2016.
7. Where a Member State intends to make use of a derogation as provided for in paragraph 1, 3, 4, 5 or 6, that Member State shall notify the Commission accordingly by 1 February 2013, and shall subsequently allow its competent authority to waive, as relevant, some or all of the requirements set out in Article 5, Article 6(1) or (2) and the Annex, for the relevant payment transactions as referred to in the respective paragraphs or subparagraphs and for a period not exceeding that of the derogation. Member States shall notify the Commission of the payment transactions subject to the derogation and of any subsequent change.
8. PSPs located in, and PSUs making use of a payment service in a Member State which does not have the euro as its currency shall comply with the requirements of Articles 4 and 5 by 31 October 2016. Operators of retail payment systems for a Member State which does not have the euro as its currency shall comply with the requirements of Article 4(2) by 31 October 2016.
If, however, the euro is introduced as the currency of any such Member State before 31 October 2015, the PSPs or where relevant operators of retail payment systems located and PSUs making use of a payment service, in that Member State shall comply with the respective provisions within 1 year of the date on which the Member State concerned joined the euro area, but not earlier than the respective dates specified for the Member States having the euro as their own currency on 31 March 2012.
Article 17
Amendments to Regulation (EC) No 924/2009
Regulation (EC) No 924/2009 is hereby amended as follows:
(1)
in Article 2, point (10) is replaced by the following:
‘10.
“funds” means banknotes and coins, scriptural money and electronic money as defined in Article 2(2) of Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions (15).
(2)
in Article 3, paragraph 1 is replaced by the following:
‘1. Charges levied by a payment service provider on a payment service user in respect of cross-border payments shall be the same as the charges levied by that payment service provider on payment service users for corresponding national payments of the same value and in the same currency.’;
(3)
Article 4 is amended as follows:
(a)
paragraph 2 is deleted;
(b)
paragraph 3 is replaced by the following:
‘3. The payment service provider may levy charges additional to those levied in accordance with Article 3(1) on the payment service user where that user instructs the payment service provider to execute the cross-border payment without communicating IBAN and, where appropriate and in accordance with Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 (16), the related BIC for the payment account in the other Member State. Those charges shall be appropriate and in line with the costs. They shall be agreed between the payment service provider and the payment service user. The payment service provider shall inform the payment service user of the amount of the additional charges in good time before the payment service user is bound by such an agreement.
(4)
in Article 5, paragraph 1 is replaced by the following:
‘1. With effect from 1 February 2016, Member States shall remove settlement-based national reporting obligations on payment service providers for balance of payments statistics relating to payment transactions of their customers.’;
(5)
Article 7 is amended as follows:
(a)
in paragraph 1, the date ‘1 November 2012’ is replaced by ‘1 February 2017’;
(b)
in paragraph 2, the date ‘1 November 2012’ is replaced by ‘1 February 2017’;
(c)
in paragraph 3, the date ‘1 November 2012’ is replaced by ‘1 February 2017’;
(6)
Article 8 is deleted.
Article 18
Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 14 March 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
N. WAMMEN
(1) OJ C 155, 25.5.2011, p. 1.
(2) OJ C 218, 23.7.2011, p. 74.
(3) Position of the European Parliament of 14 February 2012 (not yet published in the Official Journal) and Council decision of 28 February 2012.
(4) OJ C 87 E, 1.4.2010, p. 166.
(5) OJ C 349 E, 22.12.2010, p. 43.
(6) OJ L 319, 5.12.2007, p. 1.
(7) OJ L 266, 9.10.2009, p. 11.
(8) OJ L 331, 15.12.2010, p. 12.
(9) OJ L 281, 23.11.1995, p. 31.
(10) OJ L 195, 27.7.2010, p. 5.
(11) OJ L 267, 10.10.2009, p. 7.
(12) OJ L 177, 30.6.2006, p. 1.
(13) OJ L 124, 20.5.2003, p. 36.
(14) OJ L 166, 11.6.1998, p. 45.
(15) OJ L 267, 10.10.2009, p. 7.’;
(16) OJ L 94, 30.3.2012 p. 22.’;
ANNEX
TECHNICAL REQUIREMENTS (ARTICLE 5)
(1)
In addition to the essential requirements set out in Article 5, the following technical requirements shall apply to credit transfers and direct debit transactions:
(a)
The payment account identifier referred to in Article 5(1)(a) and (c) must be IBAN.
(b)
The standard for message format referred to in Article 5(1)(b) and (d) must be the ISO 20022 XML standard.
(c)
The remittance data field must allow for 140 characters. Payment schemes may allow for a higher number of characters, except if the device used to remit information has technical limitations relating to the number of characters, in which case the technical limit of the device applies.
(d)
Remittance reference information and all the other data elements provided in accordance with points (2) and (3) of this Annex must be passed in full and without alteration between PSPs in the payment chain.
(e)
Once the required data is available in electronic form payment transactions must allow for a fully automated, electronic processing in all process stages throughout the payment chain (end-to-end straight through processing), enabling the entire payment process to be conducted electronically without the need for re-keying or manual intervention. This must also apply to exceptional handling of credit transfers and direct debit transactions, whenever possible.
(f)
Payment schemes must set no minimum threshold for the amount of the payment transaction allowing for credit transfers and direct debits but are not required to process payment transactions with zero amount.
(g)
Payment schemes are not obliged to carry out credit transfers and direct debits exceeding the amount of EUR 999 999 999,99.
(2)
In addition to the requirements referred to in point (1), the following requirements shall apply to credit transfer transactions:
(a)
The data elements referred to in Article 5(2)(a) are the following:
(i)
the payer’s name and/or the IBAN of the payer’s payment account,
(ii)
the amount of the credit transfer,
(iii)
the IBAN of the payee’s payment account,
(iv)
where available, the payee’s name,
(v)
any remittance information.
(b)
The data elements referred to in Article 5(2)(b) are the following:
(i)
the payer’s name,
(ii)
the IBAN of the payer’s payment account,
(iii)
the amount of the credit transfer,
(iv)
the IBAN of the payee’s payment account,
(v)
any remittance information,
(vi)
any payee identification code,
(vii)
the name of any payee reference party,
(viii)
any purpose of the credit transfer,
(ix)
any category of the purpose of the credit transfer.
(c)
In addition, the following mandatory data elements are to be provided by the payer’s PSP to the payee’s PSP:
(i)
the BIC of the payer’s PSP (if not agreed otherwise by the PSPs involved in the payment transaction),
(ii)
the BIC of the payee’s PSP (if not agreed otherwise by the PSPs involved in the payment transaction),
(iii)
the identification code of the payment scheme,
(iv)
the settlement date of the credit transfer,
(v)
the reference number of the credit transfer message of the payer’s PSP,
(d)
The data elements referred to in Article 5(2)(c) are the following:
(i)
the payer’s name,
(ii)
the amount of the credit transfer,
(iii)
any remittance information.
(3)
In addition to the requirements referred to in point (1), the following requirements shall apply to direct debit transactions:
(a)
The data elements referred to in Article 5(3)(a)(i) are the following:
(i)
the type of direct debit (recurrent, one-off, first, last or reversal),
(ii)
the payee’s name,
(iii)
the IBAN of the payee’s payment account to be credited for the collection,
(iv)
where available, the payer’s name,
(v)
the IBAN of the payer’s payment account to be debited for the collection,
(vi)
the unique mandate reference,
(vii)
where the payer’s mandate is given after 31 March 2012, the date on which it was signed,
(viii)
the amount of the collection,
(ix)
where the mandate has been taken over by a payee other than the payee who issued the mandate, the unique mandate reference as given by the original payee who issued the mandate,
(x)
the payee’s identifier,
(xi)
where the mandate has been taken over by a payee other than the payee who issued the mandate, the identifier of the original payee who issued the mandate,
(xii)
any remittance information from the payee to the payer,
(xiii)
any purpose of the collection,
(xiv)
any category of the purpose of the collection.
(b)
The data elements referred to in Article 5(3)(b) are the following:
(i)
the BIC of the payee’s PSP (if not agreed otherwise by the PSPs involved in the payment transaction),
(ii)
the BIC of the payer’s PSP (if not agreed otherwise by the PSPs involved in the payment transaction),
(iii)
the payer reference party’s name (if present in dematerialised mandate),
(iv)
the payer reference party’s identification code (if present in dematerialised mandate),
(v)
the payee reference party’s name (if present in the dematerialised mandate),
(vi)
the payee reference party’s identification code (if present in dematerialised mandate),
(vii)
the identification code of the payment scheme,
(viii)
the settlement date of the collection,
(ix)
the payee’s PSP’s reference for the collection,
(x)
the type of mandate,
(xi)
the type of direct debit (recurrent, one-off, first, last or reversal),
(xii)
the payee’s name,
(xiii)
the IBAN of the payee’s payment account to be credited for the collection,
(xiv)
where available, the payer’s name,
(xv)
the IBAN of the payer’s payment account to be debited for the collection,
(xvi)
the unique mandate reference,
(xvii)
the date of signing of the mandate if the mandate is given by the payer after 31 March 2012,
(xviii)
the amount of the collection,
(xix)
the unique mandate reference as given by the original payee who issued the mandate (if the mandate has been taken over by another payee than the payee who issued the mandate),
(xx)
the payee’s identifier,
(xxi)
the identifier of the original payee who issued the mandate (if the mandate has been taken over by a payee other than the payee who issued the mandate),
(xxii)
any remittance information from the payee to the payer.
(c)
The data elements referred to in Article 5(3)(c) are the following:
(i)
the unique mandate reference,
(ii)
the payee’s identifier,
(iii)
the payee’s name,
(iv)
the amount of the collection,
(v)
any remittance information,
(vi)
the identification code of the payment scheme.
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Single Euro Payments Area Regulation
Single Euro Payments Area Regulation
SUMMARY OF:
Regulation (EU) No 260/2012 — technical and business requirements for credit transfers and direct debits in euro
WHAT IS THE AIM OF THE REGULATION?
It sets out the rules and technical requirements for credit transfers and direct debit transactions in euro within the single euro payments area (SEPA).
KEY POINTS
National accounts used for credit transfers and direct debits within each country should also be accessible EU-wide. This is known as ‘reachability’.
The same rules apply to both national and cross-border operations.
Payment systems should be interoperable with each other.
Credit transfers and direct debit transactions must meet certain conditions, including: the use of international bank account numbers, bank identifier codes and a financial messaging standard for all payments in euro;the right of payers to issue specific instructions, such as the amount and frequency of a direct debit.
The legislation set the following entry dates: from 1 February 2014 (later postponed to August 2014), all credit transfers and direct debits in euro to be made under the same format in EU countries with the euro as national currency;from 31 October 2016, all credit transfers and direct debits in euro to be made under the same format also in non-euro EU countries;from 1 February 2017, abolition of multilateral interchange fees* for direct debits;from 1 February 2016, an end to compulsory use of the business identifier code (BIC).
EU countries had to: appoint a national authority with the necessary powers to ensure the legislation is fully implemented;lay down, by 1 February 2013, rules on penalties for any violations of the legislation;establish adequate and effective out-of-court complaint and redress procedures.
The European Commission: was given the five-year renewable power from 31 March 2012 to adopt delegated acts;had to present a report by 1 February 2017 on implementation of the legislation.
Regulation (EU) No 248/2014 amended Regulation (EU) No 260/2012, introducing certain transitional arrangements. These ended on 1 February 2016.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 31 March 2012.
BACKGROUND
The single euro payments area harmonises the way cashless euro payments are made across the EU. It makes them as easy as national payments.
SEPA covers payments in euro in the EU and Iceland, Norway, Switzerland, Liechtenstein, Andorra, Monaco, San Marino and the Vatican City.
For more information, see: Single euro payments area (SEPA) (European Commission).
KEY TERMS
Multilateral interchange fees: fees which the sellers of goods and services pay for the cross-border payments they receive by consumer debit and credit cards.
MAIN DOCUMENT
Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 (OJ L 94, 30.3.2012, pp. 22-37)
Successive amendments to Regulation (EU) No 260/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENT
Regulation (EC) No 924/2009 of the European Parliament and of the Council of 16 September 2009 on cross-border payments in the Community and repealing Regulation (EC) No 2560/2001 (OJ L 266, 9.10.2009, pp. 11-18)
See consolidated version.
last update 14.05.2019
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32014R0912
|
28.8.2014
EN
Official Journal of the European Union
L 257/121
REGULATION (EU) No 912/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 July 2014
establishing a framework for managing financial responsibility linked to investor-to-state dispute settlement tribunals established by international agreements to which the European Union is party
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Acting in accordance with the ordinary legislative procedure (1),
Whereas:
(1)
With the entry into force of the Treaty of Lisbon foreign direct investment is included in the list of matters falling under the common commercial policy. In accordance with point (e) of Article 3(1) of the Treaty on the Functioning of the European Union (TFEU), the Union has exclusive competence with respect to the common commercial policy and may be a party to international agreements covering provisions on foreign direct investment.
(2)
Agreements providing for investment protection may include an investor-to-state dispute settlement mechanism, which allows an investor from a third country to bring a claim against a state in which it has made an investment. Investor-to-state dispute settlement can result in awards for monetary compensation. Furthermore, significant costs for administering the arbitration as well as costs relating to the defence of a case will inevitably be incurred in any such case.
(3)
International responsibility for treatment subject to dispute settlement follows the division of competences between the Union and the Member States. As a consequence, the Union will in principle be responsible for defending any claims alleging a violation of rules included in an agreement which fall within the Union’s exclusive competence, irrespective of whether the treatment at issue is afforded by the Union itself or by a Member State.
(4)
Union agreements should afford foreign investors the same high level of protection as Union law and the general principles common to the laws of the Member States grant to investors from within the Union, but not a higher level of protection. Union agreements should ensure that the Union’s legislative powers and right to regulate are respected and safeguarded.
(5)
Where the Union, as an entity having legal personality, has international responsibility for the treatment afforded, it will be expected, as a matter of international law, to pay any adverse award and bear the costs of any dispute. However, an adverse award may potentially flow either from treatment afforded by the Union itself or from treatment afforded by a Member State. It would as a consequence be inequitable if awards and the costs of arbitration were to be paid from the budget of the Union where the treatment was afforded by a Member State, unless the treatment in question is required by Union law. It is therefore necessary that financial responsibility be allocated, as a matter of Union law, between the Union itself and the Member State responsible for the treatment afforded on the basis of criteria established by this Regulation.
(6)
In its resolution of 6 April 2011 on the future European international investment policy, the European Parliament explicitly called for the creation of the mechanism provided for in this Regulation. Furthermore, in its Conclusions of 25 October 2010 on a Comprehensive international investment policy, the Council requested the Commission to study the matter.
(7)
Financial responsibility should be allocated to the entity responsible for the treatment found to be inconsistent with the relevant provisions of the agreement. Therefore the Union itself should bear the financial responsibility where the treatment concerned is afforded by an institution, body, office or agency of the Union. The Member State concerned should bear the financial responsibility where the treatment concerned is afforded by that Member State. However, where the Member State acts in a manner required by Union law, for example in transposing a directive adopted by the Union, the Union itself should bear financial responsibility in so far as the treatment concerned is required by Union law. This Regulation should also provide for the possibility that individual cases concern both treatment afforded by a Member State and treatment required by Union law and should cover all actions taken by Member States and by the Union. In such cases, the Member States and the Union should bear financial responsibility for the specific treatment afforded by either of them.
(8)
The Union should always act as the respondent where a dispute exclusively concerns treatment afforded by the institutions, bodies, offices or agencies of the Union, so that the Union bears the potential financial responsibility arising from the dispute in accordance with the above criteria.
(9)
Where a Member State would bear the potential financial responsibility arising from a dispute, it is equitable and appropriate that such Member State acts as a respondent in order to defend the treatment which it has afforded to the investor. The arrangements laid down in this Regulation are aimed at ensuring that the budget of the Union and Union non-financial resources are not burdened, even temporarily, by either the costs of litigation or any award made against the Member State concerned.
(10)
Member States may, nevertheless, prefer that the Union act as the respondent in this type of dispute, for example for reasons of technical expertise. Member States should, therefore, have the possibility to decline to act as the respondent, without prejudice to their financial responsibility.
(11)
In order to ensure that the interests of the Union can be appropriately safeguarded, it is essential that, in exceptional circumstances, the Union itself act as the respondent in disputes involving treatment afforded by a Member State. Those circumstances are limited to cases where the dispute also involves treatment afforded by the Union, where it appears that the treatment afforded by a Member State is required by Union law and where similar treatment is being challenged in a related claim against the Union in the World Trade Organisation (WTO), where a panel has been established and the claim concerns the same specific legal issue and where it is necessary to ensure a consistent argumentation in the WTO case.
(12)
Where the Union acts as the respondent in cases involving Member State measures, the Commission should conduct its defence in a manner which protects the financial interests of the Member State concerned.
(13)
Decisions on whether the Union or a Member State should act as the respondent should be taken within the framework laid down in this Regulation. It is appropriate that the Commission immediately informs the European Parliament and the Council about the manner in which this framework is applied.
(14)
This Regulation should provide for some practical arrangements for the conduct of arbitration proceedings in disputes concerning treatment afforded by a Member State. Those arrangements should aim for the best possible management of the dispute whilst ensuring compliance with the duty of sincere cooperation referred to in Article 4(3) of the Treaty on European Union (TEU) and the defence and protection of the interests of the Member State concerned.
(15)
Where the Union acts as the respondent such arrangements should provide for very close cooperation including the prompt notification of any significant procedural steps, the provision of relevant documents, frequent consultations and participation in the delegation to the proceedings.
(16)
Where a Member State acts as the respondent, it is appropriate that, in accordance with the duty of sincere cooperation referred to in Article 4(3) of the TEU, it keeps the Commission informed of developments in the case and in particular ensures timely information of any significant procedural steps, the provision of relevant documents, frequent consultations and participation in the delegation to the proceedings. It is also appropriate that the Commission is provided with adequate opportunity to identify any point of law or any other element of Union interest raised by the dispute.
(17)
Without prejudice to the outcome of the arbitration proceedings, a Member State should be able at any time to accept that it would be financially responsible in the event that compensation is to be paid. In such a case, the Member State and the Commission should be able to enter into arrangements for the periodic payment of costs and for the payment of any compensation. Such acceptance does not imply that the Member State accepts that the claim under dispute is well founded. The Commission should be able in such a case to adopt a decision requiring the Member State to make provision for such costs. In the event that the tribunal awards costs to the Union, the Commission should ensure that any advance payment of costs is immediately reimbursed to the Member State concerned.
(18)
In some cases, it may be appropriate to reach a settlement in order to avoid costly and unnecessary arbitration. It is necessary to lay down a procedure for making such settlements. Such a procedure should permit the Commission, acting in accordance with the examination procedure, to settle a case involving the financial responsibility of the Union, where this would be in the interests of the Union. Where the case also concerns treatment afforded by a Member State, it is appropriate that the Union would only be able to settle a dispute if the settlement would not have any financial or budgetary implications for the Member State concerned. In such cases, it is appropriate that there should be close cooperation and consultations between the Commission and the Member State concerned. The Member State should remain free to settle the case at all times, provided that it accepts full financial responsibility and that any such settlement is consistent with Union law.
(19)
Where an award has been rendered against the Union, that award should be paid without delay. The Commission should make arrangements for the payment of such awards, unless a Member State has already accepted financial responsibility.
(20)
The Commission should consult closely with the Member State concerned in order to reach agreement on the apportionment of financial responsibility. Where the Commission determines that a Member State is responsible, and the Member State does not accept that determination, the Commission should pay the award, but should also address a decision to the Member State requesting it to provide the amounts concerned to the budget of the Union, together with applicable interest. The interest payable should be that laid down pursuant to Article 78(4) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (2). Article 263 TFEU is available in cases where a Member State considers that the decision falls short of the criteria set out in this Regulation.
(21)
The budget of the Union should provide coverage of the expenditure resulting from agreements covering provisions on foreign direct investment to which the Union is a party and which provide for investor-to-state dispute settlement. Where Member States have financial responsibility pursuant to this Regulation, the Union should be able to either accumulate the contributions of the Member State concerned first before implementing the relevant expenditure or implement the relevant expenditure first and be reimbursed by the Member State concerned after. Use of both of these mechanisms of budgetary treatment should be possible, depending on what is feasible, in particular in terms of timing. For both mechanisms, the contributions or reimbursements paid by the Member State concerned should be treated as internal assigned revenue of the budget of the Union. The appropriations arising from this internal assigned revenue should not only cover the relevant expenditure but they should also be eligible for replenishment of other parts of the budget of the Union which provided the initial appropriations to implement the relevant expenditure under the second mechanism.
(22)
In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission.
(23)
The implementing powers relating to Article 9(2) and (3), Article 13(1), Article 14(8), Article 15(3) and Article 16(3) should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (3).
(24)
The advisory procedure should be used for the adoption of decisions providing that the Union act as the respondent pursuant to Article 9(2), given that it is necessary for the Union to take over the defence in such cases, but that this should still be subject to control by the Member States. The advisory procedure should be used for the adoption of decisions on settlement of disputes pursuant to Article 15(3) given that those decisions will have at most a merely temporary impact on the budget of the Union, since the Member State concerned will be required to assume any financial responsibility arising from the dispute, and because of the detailed criteria laid down in this Regulation for acceptability of such settlements,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
1. Without prejudice to the division of competences established by the TFEU, this Regulation applies to investor-to-state dispute settlement conducted pursuant to an agreement to which the Union is party, or the Union and its Member States are parties, and initiated by a claimant of a third country. In particular, the adoption and application of this Regulation shall not affect the delimitation of competences established by the Treaties, including in relation to the treatment afforded by the Member States or the Union and challenged by a claimant in investor-to-state dispute settlement conducted pursuant to an agreement.
2. For information purposes, the Commission shall publish in the Official Journal of the European Union and keep up to date a list of the agreements falling within the scope of this Regulation.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(a)
‘agreement’ means any international agreement covering provisions on foreign direct investment to which the Union is party, or the Union and its Member States are parties, and which provides for investor-to-state dispute settlement;
(b)
‘costs arising from the arbitration’ means the fees and costs of the arbitration tribunal and the arbitration institution, and the costs of representation and expenses awarded to the claimant by the arbitration tribunal, such as costs of translation, costs of legal and economic analysis and other relevant costs with respect to the arbitration proceedings;
(c)
‘dispute’ means a claim brought by a claimant against the Union or a Member State pursuant to an agreement and on which an arbitration tribunal will rule;
(d)
‘investor-to-state dispute settlement’ means a mechanism provided for by an agreement by which a claimant may initiate claims against the Union or a Member State;
(e)
‘Member State’ means one or more Member States of the European Union;
(f)
‘Member State concerned’ means the Member State which has afforded the treatment alleged to be inconsistent with the agreement;
(g)
‘financial responsibility’ means an obligation to pay a sum of money awarded by an arbitration tribunal or agreed as part of a settlement and including the costs arising from the arbitration;
(h)
‘settlement’ means any agreement between the Union or a Member State, or both, of the one part, and a claimant, of the other, whereby the claimant agrees not to pursue its claims in exchange for the payment of a sum of money or action other than the payment of money, including where the settlement is recorded in an award of an arbitration tribunal;
(i)
‘arbitration tribunal’ means any person or body designated under an agreement to rule on an investor-to-state dispute;
(j)
‘claimant’ means any natural or legal person which may bring a claim to investor-to-state dispute settlement pursuant to an agreement or any natural or legal person to whom the claims of the claimant under the agreement have been lawfully assigned;
(k)
‘Union law’ means the TFEU and the TEU, as well as any legal acts of the Union referred to in the second, third and fourth paragraphs of Article 288 TFEU and any international agreements to which the Union is party or the Union and its Member States are parties; for the sole purposes of this Regulation ‘Union law’ shall not mean the investment protection provisions in the agreement;
(l)
‘required by Union law’ refers to treatment where the Member State concerned could only have avoided the alleged breach of the agreement by disregarding an obligation under Union law such as where it has no discretion or margin of appreciation as to the result to be achieved.
CHAPTER II
APPORTIONMENT OF FINANCIAL RESPONSIBILITY
Article 3
Apportionment criteria
1. Financial responsibility arising from a dispute under an agreement shall be apportioned in accordance with the following criteria:
(a)
the Union shall bear the financial responsibility arising from treatment afforded by the institutions, bodies, offices or agencies of the Union;
(b)
the Member State concerned shall bear the financial responsibility arising from treatment afforded by that Member State;
(c)
by way of exception to point (b), the Union shall bear the financial responsibility arising from treatment afforded by a Member State where such treatment was required by Union law.
Notwithstanding point (c) of the first subparagraph, where the Member State concerned is required to act pursuant to Union law in order to remedy the inconsistency with Union law of a prior act, that Member State shall be financially responsible unless such prior act was required by Union law.
2. Where provided for in this Regulation, the Commission shall adopt a decision determining the financial responsibility of the Member State concerned in accordance with the criteria laid down in paragraph 1. The European Parliament and the Council shall be informed of such a decision.
3. Notwithstanding paragraph 1 of this Article, the Member State concerned shall bear the financial responsibility where:
(a)
it has accepted potential financial responsibility pursuant to Article 12; or
(b)
it enters into a settlement, pursuant to Article 15.
4. Notwithstanding paragraph 1 of this Article, the Union shall bear the financial responsibility where the Union acts as the respondent pursuant to Article 4.
CHAPTER III
CONDUCT OF DISPUTES
SECTION 1
conduct of disputes concerning treatment afforded by the union
Article 4
Treatment afforded by the Union
1. The Union shall act as the respondent where the dispute concerns treatment afforded by the institutions, bodies, offices or agencies of the Union.
2. Where the Commission receives a request for consultations from a claimant or a notice by which a claimant states its intention to initiate arbitration proceedings in accordance with an agreement, it shall immediately notify the European Parliament and the Council.
SECTION 2
conduct of disputes concerning treatment afforded by a Member State
Article 5
Treatment afforded by a Member State
This Section shall apply in disputes concerning, fully or partially, treatment afforded by a Member State.
Article 6
Cooperation and consultations between the Commission and the Member State concerned
1. In accordance with the principle of sincere cooperation referred to in Article 4(3) TEU, the Commission and the Member State concerned shall take all necessary steps to defend and protect the interests of the Union and of the Member State concerned.
2. The Commission and the Member State concerned shall enter into consultations on the management of disputes pursuant to this Regulation, bearing in mind any deadlines laid down in this Regulation and in the agreement concerned, and shall share with each other information where relevant to the conduct of disputes.
Article 7
Request for consultations
1. Where the Commission receives a request for consultations from a claimant in accordance with an agreement, it shall immediately notify the Member State concerned. Where a Member State has been made aware of or has received a request for consultations, it shall immediately inform the Commission.
2. Representatives of the Member State concerned and of the Commission shall form part of the Union’s delegation to the consultations.
3. The Member State concerned and the Commission shall immediately provide to each other relevant information for the case.
4. The Commission shall inform the European Parliament and the Council of any such requests for consultations.
Article 8
Notice of intention to initiate arbitration proceedings
1. Where the Commission receives notice by which a claimant states its intention to initiate arbitration proceedings, in accordance with an agreement, it shall immediately notify the Member State concerned. When a claimant states its intention to initiate arbitration proceedings against the Union or a Member State, the Commission shall inform the European Parliament and the Council, within 15 working days of receiving the notice, of the name of the claimant, the provisions of the agreement alleged to have been breached, the economic sector involved, the treatment alleged to be in breach of the agreement and the amount of damages claimed.
2. Where a Member State receives notice by which a claimant states its intention to initiate arbitration proceedings, it shall immediately notify the Commission.
3. The Commission shall inform the European Parliament and the Council of any such notices of intention to initiate arbitration proceedings.
Article 9
Respondent status
1. The Member State concerned shall act as the respondent except where either of the following situations arise:
(a)
the Commission, following consultations pursuant to Article 6, has taken a decision pursuant to paragraph 2 or 3 of this Article within 45 days of receiving the notice or notification referred to in Article 8; or
(b)
the Member State, following consultations pursuant to Article 6, has confirmed to the Commission in writing that it does not intend to act as the respondent within 45 days of receiving the notice or notification referred to in Article 8.
If either of the situations referred to in point (a) or (b) arise, the Union shall act as the respondent.
2. The Commission may decide by means of implementing acts, based on a full and balanced factual analysis and legal reasoning provided to the Member States, in accordance with the advisory procedure referred to in Article 22(2), that the Union is to act as the respondent where one or more of the following circumstances arise:
(a)
the Union would bear all or at least part of the potential financial responsibility arising from the dispute in accordance with the criteria laid down in Article 3; or
(b)
the dispute also concerns treatment afforded by the institutions, bodies, offices or agencies of the Union.
3. The Commission may decide by means of implementing acts, based on a full and balanced factual analysis and legal reasoning provided to the Member States in accordance with the examination procedure referred to in Article 22(3), that the Union is to act as the respondent where similar treatment is being challenged in a related claim against the Union in the WTO, where a panel has been established and the claim concerns the same specific legal issue, and where it is necessary to ensure a consistent argumentation in the WTO case.
4. In acting pursuant to this Article, the Commission shall ensure that the Union’s defence protects the financial interests of the Member State concerned.
5. The Commission and the Member State concerned shall immediately after receiving the notice or notification referred to in Article 8 enter into consultations pursuant to Article 6 on the management of the case pursuant to this Article. The Commission and the Member State concerned shall ensure that any deadlines set down in the agreement are respected.
6. When the Union acts as the respondent in accordance with paragraphs 2 and 5, the Commission shall consult the Member State concerned on any pleading or observation prior to the finalisation and submission thereof. Representatives of the Member State concerned shall, at the Member State’s request and at its expense, form part of the Union’s delegation to any hearing and the Commission shall take due account of the Member State’s interest.
7. The Commission shall immediately inform the European Parliament and the Council of any dispute in which this Article is applied and the manner in which it has been applied.
Article 10
Conduct of arbitration proceedings by a Member State
1. Where a Member State acts as the respondent, in all phases of the dispute, including possible annulment, appeal or review, the Member State pursuant to Article 6 shall:
(a)
provide the Commission in a timely manner with relevant documents relating to the proceeding;
(b)
inform the Commission in a timely manner of all significant procedural steps, and upon request enter into consultations with the Commission with a view to taking into due consideration any point of law or any other element of Union interest raised by the dispute and identified by the Commission in a non-binding written analysis provided to the Member State concerned; and
(c)
permit representatives of the Commission, at its request and its own expense to form part of the delegation representing the Member State.
2. The Commission shall provide the Member State with relevant documents relating to the proceedings, so as to ensure as effective a defence as possible.
3. As soon as an award is rendered, the Member State shall inform the Commission. The Commission shall inform the European Parliament and the Council.
Article 11
Conduct of arbitration proceedings by the Union
1. Pursuant to Article 6, the following provisions shall apply throughout arbitration proceedings, where the Union acts as the respondent in any disputes in which a Member State would be liable to bear all or part of the potential financial responsibility:
(a)
the Commission shall take all necessary measures to defend and protect the interests of the Member State concerned;
(b)
the Member State concerned shall provide all necessary assistance to the Commission;
(c)
the Commission shall provide the Member State concerned with relevant documents relating to the proceeding, keep the Member State informed of all significant procedural steps and enter into consultations with the Member State in any event when requested by the Member State concerned, so as to ensure as effective a defence as possible;
(d)
the Commission and the Member State concerned shall prepare the defence in close cooperation with each other; and,
(e)
the Union’s delegation to the proceedings shall comprise the Commission and representatives of the Member State concerned, unless the Member State concerned informs the Commission that it intends not to form part of the Union’s delegation to the proceedings.
2. The Commission shall regularly inform the European Parliament and the Council of developments in the arbitration proceedings referred to in paragraph 1.
Article 12
Acceptance by the Member State concerned of potential financial responsibility where the Union is the respondent
Where the Union acts as the respondent in any disputes in which a Member State would be liable to bear all or part of the potential financial responsibility, the Member State concerned may, at any time, accept any potential financial responsibility arising from the arbitration. To this end, the Member State concerned and the Commission may enter into arrangements dealing with, inter alia:
(a)
mechanisms for the periodic payment of costs arising from the arbitration;
(b)
mechanisms for the payment of any awards made against the Union.
CHAPTER IV
SETTLEMENT OF DISPUTES WHERE THE UNION IS THE RESPONDENT
Article 13
Settlement of disputes concerning treatment afforded by the Union
1. If the Commission considers that a settlement of a dispute concerning treatment exclusively afforded by the Union would be in the interests of the Union, it may adopt an implementing act to approve the settlement. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 22(3).
2. Should a settlement potentially involve action other than the payment of a monetary sum, the relevant procedures for such action shall apply.
Article 14
Settlement of disputes concerning treatment afforded in full or in part by a Member State where the Union wishes to settle
1. Where the Union is the respondent in a dispute concerning treatment afforded, whether fully or in part, by a Member State, and the Commission considers that the settlement of the dispute would be in the financial interests of the Union, the Commission shall first consult with the Member State concerned pursuant to Article 6. The Member State may also initiate such consultations with the Commission.
2. If the Commission and the Member State concerned agree to settle the dispute, the Member State concerned shall endeavour to enter into an arrangement with the Commission setting out the necessary elements for the negotiation and implementation of the settlement.
3. Where the Union is the respondent in a dispute pursuant to which a Member State would incur financial responsibility and where no Union financial responsibility is involved, only the Member State concerned may settle the dispute, pursuant to Article 15.
4. Where the Union is the respondent pursuant to point (b) of Article 9(1), the Commission may, following consultations pursuant to Article 6(1), decide to settle the dispute where the settlement is in the financial interests of the Union. In so deciding, the Commission shall provide a full and balanced factual analysis and legal reasoning demonstrating the financial interests of the Union.
5. Where the Union is the respondent in a dispute pursuant to Article 9(2) which solely involves the financial responsibility of the Union and where no Member State financial responsibility is involved, the Commission may decide to settle the dispute.
6. Where the Union is the respondent in a dispute pursuant to Article 9(2) which involves the financial responsibility of the Union and of a Member State, the Commission may not settle the dispute without the agreement of the Member State concerned. The Member State concerned may submit a full analysis of the impact of the proposed settlement on its financial interests. Where the Member State does not agree to settle the dispute, the Commission may nonetheless decide to settle provided that such settlement does not have any financial or budgetary implications for the Member State concerned on the basis of a full and balanced factual analysis and legal reasoning, taking account of the Member State’s analysis and demonstrating the financial interests of the Union and of the Member State concerned. In that case Article 19 shall not apply.
7. The terms of settlement under paragraphs 4, 5 and 6 shall not include actions on the part of the Member State concerned other than the payment of a monetary sum.
8. Any settlements under this Article shall be subject to approval by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(3).
Article 15
Settlement of disputes concerning treatment afforded exclusively by a Member State where the Member State wishes to settle
1. Where the Union is the respondent in a dispute exclusively concerning treatment afforded by a Member State, the Member State concerned may propose to settle a dispute where:
(a)
the Member State concerned accepts any potential financial responsibility arising from the settlement;
(b)
any settlement arrangement is enforceable only against the Member State concerned; and
(c)
the terms of the settlement are compatible with Union law.
2. The Commission and the Member State concerned shall enter into consultations to evaluate a Member State’s intention to settle a dispute.
3. The Member State concerned shall notify the Commission of the draft settlement arrangement. The Commission shall be deemed to have accepted the draft settlement arrangement unless, within 90 days following the notification of the draft settlement by the Member State, it decides otherwise by means of an implementing act adopted in accordance with the advisory procedure referred to in Article 22(2), on the grounds that the draft settlement does not meet all of the conditions set out in paragraph 1 of this Article. When the draft settlement is accepted, the Commission shall take all necessary steps to make the settlement arrangements effective.
Article 16
Settlement of disputes concerning treatment afforded in part by a Member State where that Member State wishes to settle
1. Where the Union is the respondent in a dispute concerning treatment afforded in part by a Member State, and the Member State considers that the settlement of the dispute would be in its financial interest, it shall first consult with the Commission pursuant to Article 6.
2. If the Commission and the Member State concerned agree to settle the dispute, the Member State concerned shall endeavour to enter into an arrangement with the Commission setting out the necessary elements for the negotiation and implementation of the settlement.
3. In the event that the Commission does not consent to the settlement of the dispute, the Commission may decide to refuse to settle, based on a full and balanced factual analysis and legal reasoning provided to Member States, by means of an implementing act. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 22(3).
CHAPTER V
PAYMENT OF FINAL AWARDS OR SETTLEMENTS
Article 17
Scope
This Chapter shall apply where the Union acts as the respondent in a dispute.
Article 18
Procedure for the payment of awards or settlements
1. A claimant having obtained a final award pursuant to an agreement may present a request to the Commission for payment of that award. The Commission shall pay any such award, except where the Member State concerned has accepted financial responsibility pursuant to Article 12, in which case the Member State shall pay the award.
2. Where a settlement pursuant to Article 13 or 14 is not recorded in an award, a claimant may present a request to the Commission for payment of the settlement. The Commission shall pay any such settlement within any relevant time periods set down in the settlement agreement.
Article 19
Procedure where there is no agreement as to financial responsibility
1. Where the Union acts as the respondent pursuant to Article 9, and the Commission considers that the award or settlement or costs arising from the arbitration in question should be paid, in part or in full, by the Member State concerned on the basis of the criteria laid down in Article 3(1), the procedure set out in paragraphs 2 to 5 of this Article shall apply.
2. The Commission and the Member State concerned shall immediately enter into consultations to seek agreement on the financial responsibility of the Member State concerned, and the Union where applicable.
3. Within three months of receipt by the Commission of the request for payment of the award or settlement or costs arising from the arbitration, the Commission shall adopt a decision addressed to the Member State concerned, determining the amount to be paid by that Member State. The Commission shall inform the European Parliament and the Council of such decision and its financial reasoning.
4. Unless the Member State concerned objects to the Commission’s determination within two months of the entry into force of the decision referred to in paragraph 3, the Member State concerned shall compensate the budget of the Union for the payment of the award or settlement or costs arising from the arbitration within six months of the entry into force of the Commission’s decision. The Member State concerned shall be liable for any interest due at the rate applicable to other monies owed to the budget of the Union.
5. If the Member State concerned objects and the Commission disagrees with the Member State’s objection, the Commission shall adopt a decision within six months of receipt of the Member State’s objection, requiring the Member State concerned to reimburse the amount paid by the Commission, together with interest at the rate applicable to other monies owed to the budget of the Union.
6. The Commission’s decisions pursuant to paragraphs 3 and 5 shall be published in the Official Journal of the European Union.
Article 20
Advance payment of costs arising from the arbitration
1. The Commission may adopt a decision requiring the Member State concerned to advance financial contributions to the budget of the Union in respect of foreseeable or incurred costs arising from the arbitration. Such a decision on financial contributions shall be proportionate, taking into account the criteria set down in Article 3.
2. To the extent that the costs arising from the arbitration are awarded to the Union by the arbitration tribunal, and the Member State concerned has made periodic payment of costs arising from the arbitration, the Commission shall ensure that they are transferred to the Member State which has paid them in advance, together with interest at the rate applicable to other monies owed to the budget of the Union.
Article 21
Payment by a Member State
A Member State’s reimbursement or payment to the budget of the Union, for the payment of an award or a settlement or costs arising from the arbitration, including those referred to in Article 20(1) of this Regulation, shall be considered as internal assigned revenue in the sense of Article 21(4) of Regulation (EU, Euratom) No 966/2012. It may be used to cover expenditure resulting from agreements concluded pursuant to Article 218 TFEU providing for investor-to-state dispute settlement or to replenish appropriations initially provided to cover the payment of an award or a settlement or costs arising from the arbitration.
CHAPTER VI
FINAL PROVISIONS
Article 22
Committee procedure
1. The Commission shall be assisted by the Committee for Investment Agreements established by Regulation (EU) No 1219/2012 of the European Parliament and of the Council (4). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 23
Report and review
1. The Commission shall submit a detailed report on the operation of this Regulation to the European Parliament and to the Council at regular intervals. That report shall contain all relevant information including the listing of the claims made against the Union or the Member States, related proceedings and rulings, and the financial impact on the budget of the Union. The first report shall be submitted by 18 September 2019. Subsequent reports shall be submitted every three years thereafter.
2. The Commission shall annually submit to the European Parliament and to the Council a list of requests for consultations from claimants, claims and arbitration rulings.
3. The Commission may also submit, together with the report referred to in paragraph 1 and based on the Commission’s findings, a proposal to the European Parliament and to the Council for the amendment of this Regulation.
Article 24
Disputes under agreements concluded before the entry into force of this Regulation
With regard to disputes under agreements covered under Article 1 and concluded before 17 September 2014, this Regulation shall apply only in respect of disputes where the submission of a claim to arbitration has been lodged after 17 September 2014, and that concern treatment afforded after 17 September 2014.
Article 25
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 July 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
S. GOZI
(1) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 23 July 2014.
(2) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).
(3) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(4) Regulation (EU) No 1219/2012 of the European Parliament and of the Council of 12 December 2012 establishing transitional arrangements for bilateral investment agreements between Member States and third countries (OJ L 351 20.12.2012, p. 40).
Joint declaration by the European Parliament, the Council and the Commission
The adoption and application of this Regulation are without prejudice to the division of competences established by the Treaties and shall not be interpreted as an exercise of shared competence by the Union in areas where the Union’s competence has not been exercised.
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Disputes between foreign investors and EU governments
Disputes between foreign investors and EU governments
The regulation clarifies the financial responsibility between the European Union and its member countries when an investor from a non-EU country brings a claim for breach of an international agreement to which the EU is party.
ACT
Regulation (EU) No 912/2014 of the European Parliament and of the Council of 23 July 2014 establishing a framework for managing financial responsibility linked to investor-to-state dispute settlement tribunals established by international agreements to which the European Union is party.
SUMMARY
WHAT DOES THIS REGULATION DO?
Under the Lisbon Treaty, foreign direct investment became part of the EU’s trade policy, for which the EU has exclusive competence. This means that the European Commission negotiates on behalf of the EU countries the investment part of trade agreements concluded with non-EU countries. These agreements may include an investor-state dispute settlement mechanism (ISDS). This is a protective measure that gives the right to investors from non-EU countries concerned to take legal action against an EU country in which it has invested money. Claims are about alleged breach of the international agreements.
The new rules determine whether it is the EU, represented by the Commission, or the European governments that have to bear the financial costs, including compensation, arising from the disputes.
KEY POINTS
Criteria clarifying the division of financial responsibility
1.The EU bears the financial costs when the claim brought by an investor is about a measure taken by an EU institution, body or agency.
2.The EU country concerned bears the financial costs when the claim brought by an investor is about a measure it has taken.
3.If a measure is taken by an EU country but is required by EU law, the EU is financially responsible.
Procedure
Cooperation and consultations: the Commission and the EU country concerned by a dispute must cooperate, enter into consultation and share information. The regulation also provides for rules of conduct when arbitration proceedings (proceedings to resolve the dispute) are conducted by the EU and the EU country concerned.
Disagreement over the financial responsibility: where the EU is the respondent in the dispute, and the Commission considers that the EU country concerned is actually responsible for the costs arising from the arbitration, they have to reach an agreement with each other.
If the EU country disagrees with this, the Commission can then adopt a decision that forces the country in question to reimburse the amount paid.
WHEN DOES THE REGULATION APPLY?
The regulation applies from 17 September 2014.
Further information is available from the European Commission’s Directorate-General for Trade website.
REFERENCES
Act
Entry into force
Deadline for transposition in the Member States
Official Journal
Regulation (EU) No 912/2014
17.9.2014
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OJ L 257, 28.8.2014, p. 121-134
last update 03.12.2014
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32014R1143
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4.11.2014
EN
Official Journal of the European Union
L 317/35
REGULATION (EU) No 1143/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 October 2014
on the prevention and management of the introduction and spread of invasive alien species
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
The appearance of alien species, whether of animals, plants, fungi or micro-organisms, in new locations is not always a cause for concern. However, a significant subset of alien species can become invasive and have serious adverse impact on biodiversity and related ecosystem services, as well as have other social and economic impact, which should be prevented. Some 12 000 species in the environment of the Union and in other European countries are alien, of which roughly 10 to 15 % are estimated to be invasive.
(2)
Invasive alien species represent one of the main threats to biodiversity and related ecosystem services, especially in geographically and evolutionarily isolated ecosystems, such as small islands. The risks such species pose may intensify due to increased global trade, transport, tourism and climate change.
(3)
The threat to biodiversity and related ecosystem services that invasive alien species pose takes different forms, including severe impacts on native species and the structure and functioning of ecosystems through the alteration of habitats, predation, competition, the transmission of diseases, the replacement of native species throughout a significant proportion of range and through genetic effects by hybridisation. Furthermore, invasive alien species can also have a significant adverse impact on human health and the economy. Only live specimens, and parts that can reproduce, represent a threat to biodiversity and related ecosystem services, human health or the economy, and therefore, only those should be subject to the restrictions under this Regulation.
(4)
The Union, as a party to the Convention on Biological Diversity, approved by Council Decision 93/626/EEC (3), is bound by Article 8(h) of that Convention, according to which the Parties shall, as far as possible and as appropriate, 'prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species'.
(5)
The Union, as a Party to the Convention on the Conservation of European Wildlife and Natural Habitats, approved by Council Decision 82/72/EEC (4), has undertaken to take all appropriate measures to ensure the conservation of the habitats of the wild flora and fauna species.
(6)
To support the achievement of the objectives of Directives 2000/60/EC (5), 2008/56/EC (6) and 2009/147/EC (7) of the European Parliament and of the Council and Council Directive 92/43/EEC (8), this Regulation should establish rules to prevent, minimise and mitigate the adverse effects of invasive alien species on biodiversity and related ecosystem services, and on human health and safety as well as to reduce their social and economic impact.
(7)
Some species migrate naturally in response to environmental changes. They should not be considered as alien species in their new environment and should be excluded from the scope of this Regulation. This Regulation should focus only on species introduced into the Union as a consequence of human intervention.
(8)
There are currently over 40 Union legislative acts on animal health which include provisions on animal diseases. Moreover, Council Directive 2000/29/EC (9) includes provisions on organisms which are harmful to plants or plant products, and Directive 2001/18/EC of the European Parliament and of the Council (10) sets out the regime applicable to genetically modified organisms. Therefore, any new rules on invasive alien species should be aligned with and not overlap with those legislative acts of the Union and should not apply to the organisms targeted by those legislative acts.
(9)
Regulations (EC) No 1107/2009 (11) and (EU) No 528/2012 (12) of the European Parliament and of the Council and Council Regulation (EC) No 708/2007 (13) provide for rules concerning the authorisation for the use of certain alien species for particular purposes. The use of certain species has already been authorised under those regimes at the time of entry into force of this Regulation. To ensure a coherent legal framework, species used for those purposes should thus be excluded from the scope of this Regulation.
(10)
As invasive alien species are numerous, it is important to ensure that priority is given to addressing the subset of invasive alien species considered to be of Union concern. A list of such invasive alien species considered to be of Union concern ("the Union list") should therefore be established and regularly updated. An invasive alien species should be considered to be of Union concern if the damage that it causes in affected Member States is so significant that it justifies the adoption of dedicated measures applicable across the Union, including in the Member States that are not yet affected or are even unlikely to be affected. To ensure that the identification of invasive alien species of Union concern remains proportionate, the Union list should be established and updated gradually and be focused on species whose inclusion on the Union list would effectively prevent, minimise or mitigate the adverse impact of those species in a cost efficient manner. As species within the same taxonomic group often have similar ecological requirements and may pose similar risks, the inclusion of taxonomic groups of species on the Union list should be allowed, where appropriate.
(11)
The criteria for inclusion on the Union list are the core instrument of application of this Regulation. To ensure the effective use of resources, those criteria should ensure that among the potential invasive alien species currently known, those that have the most significant adverse impact will be listed. The Commission should submit to the committee established by this Regulation a proposal for a Union list based on those criteria within one year of the entry into force of this Regulation. When proposing the Union list, the Commission should inform that committee on how it took those criteria into account. The criteria should include a risk assessment pursuant to the applicable provisions under the relevant Agreements of the World Trade Organisation (WTO) on placing trade restrictions on species.
(12)
To avoid disproportionate or excessive costs for any Member State and to safeguard the added value of Union action through this Regulation, when proposing the Union list and consequential measures, the Commission should take into consideration the implementation cost for Member States, the cost of inaction, the cost-effectiveness and the socio-economic aspects. In this context, in selecting the invasive alien species to be included on the Union list, special attention should be given to species that are widely used and provide significant social and economic benefits in a Member State, without compromising the objectives of this Regulation.
(13)
To ensure compliance with the rules under the relevant Agreements of the WTO and the coherent application of this Regulation, common criteria should be established to carry out the risk assessment. Where appropriate, those criteria should be based on existing national and international standards and should encompass different aspects of the characteristics of the species, the risk and modes of introduction into the Union, the adverse social, economic and biodiversity impact of the species, the potential benefits of uses and the costs of mitigation to weigh them against the adverse impact, as well as on an assessment of the potential costs of environmental, social and economic damage demonstrating the significance for the Union, so as to further justify action. In order to develop the system progressively and build upon the experience gained, the overall approach should be assessed by 1 June 2021.
(14)
Some invasive alien species are included in Annex B to Council Regulation (EC) No 338/97 (14), and their importation into the Union is prohibited because their invasive character has been recognised and their introduction into the Union has an adverse impact on native species. Those species are: Callosciurus erythraeus, Sciurus carolinensis, Oxyura jamaicensis, Lithobates (Rana) catesbeianus, Sciurus niger, Chrysemys picta and Trachemys scripta elegans. To ensure a coherent legal framework and uniform rules on invasive alien species at Union level, the listing of those invasive alien species as invasive alien species of Union concern should be considered as a matter of priority.
(15)
Prevention is generally more environmentally desirable and cost-effective than reaction after the fact, and should be prioritised. Therefore, priority should be given to the listing of invasive alien species that are not yet present in the Union or are at an early stage of invasion and of invasive alien species that are likely to have the most significant adverse impact. As new invasive alien species can be introduced continuously into the Union and alien species present are spreading and expanding their range, it is necessary to ensure that the Union list is constantly reviewed and kept up-to-date.
(16)
Regional cooperation should be explored between Member States concerned with the same species that are not able to establish a viable population in a large part of the Union. Where the objectives of this Regulation are better achieved by measures at Union level, those species could also be included on the Union list.
(17)
In pursuing the objectives of this Regulation, it is appropriate to take account of the specific situation of the outermost regions, and in particular their remoteness, insularity and the uniqueness of their respective biodiversities. Therefore, the requirements under this Regulation to take restrictive and preventive measures relating to invasive alien species of Union concern should be adapted to the specificities of the outermost regions, as defined by the Treaty on the Functioning of the European Union (TFEU), taking into account European Council Decisions 2010/718/EU (15) and 2012/419/EU (16).
(18)
The risks and concerns associated with invasive alien species represent a cross-border challenge affecting the whole of the Union. It is therefore essential to adopt a ban at Union level on intentionally or negligently bringing into the Union, reproducing, growing, transporting, buying, selling, using, exchanging, keeping and releasing invasive alien species of Union concern in order to ensure that early and consistent action is taken across the Union to avoid distortions of the internal market and to prevent situations where action taken in one Member State is undermined by inaction in another Member State.
(19)
With a view to enabling scientific research and ex-situ conservation activities, it is necessary to provide specific rules for the invasive alien species of Union concern subject to those activities. Those activities should be carried out in closed establishments where the organisms are in contained holding and with all the necessary measures taken to avoid the escape or unlawful release of invasive alien species of Union concern. Where authorised by the Commission in duly motivated exceptional cases of compelling public interest it should be possible for those rules to apply also to certain other activities, including commercial activities. In implementing those rules, particular attention should be paid to avoiding any adverse impact on protected species and habitats, in accordance with relevant Union law.
(20)
There may be cases where alien species not yet recognised as invasive alien species of Union concern appear at the Union borders or are detected in the territory of the Union. Member States should therefore be granted the possibility to adopt certain emergency measures on the basis of available scientific evidence. Such emergency measures would allow immediate reaction against invasive alien species which could pose risks related to their introduction, establishment and spread in those countries, while Member States assess the actual risks posed by them, in line with the applicable provisions of the relevant Agreements of the WTO, in particular with a view to having those species recognised as invasive alien species of Union concern. There is a need to couple national emergency measures with the possibility of adopting emergency measures at Union level to comply with the provisions of the relevant Agreements of the WTO. Furthermore, emergency measures at Union level would equip the Union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle.
(21)
A large proportion of invasive alien species are introduced unintentionally into the Union. It is therefore crucial to manage the pathways of unintentional introduction more effectively. Action in this area should be gradual, given the relatively limited experience in this field. Action should include voluntary measures, such as the actions proposed by the International Maritime Organisation's Guidelines for the Control and Management of Ships' Biofouling, and mandatory measures. Action should build on the experience gained in the Union and in Member States in managing certain pathways, including measures established through the International Convention for the Control and Management of Ships Ballast Water and Sediments adopted in 2004. Accordingly, the Commission should take all appropriate steps to encourage Member States to ratify that Convention.
(22)
To develop an adequate knowledge base to address the problems raised by invasive alien species, it is important that Member States undertake research, monitoring and surveillance of such species. As surveillance systems offer the most appropriate means for early detection of new invasive alien species and for the determination of the distribution of already established species, those systems should include both targeted and general surveys and benefit from the involvement of different sectors and stakeholders, including regional and local communities. Surveillance systems should imply paying continuous attention to any new invasive alien species anywhere in the Union and aim to provide an effective and complete picture at Union level. In the interest of efficiency and cost-effectiveness, existing systems of customs control, surveillance and monitoring already established by Union law should be applied, in particular those set out in Directives 92/43/EEC, 2000/60/EC, 2008/56/EC and 2009/147/EC.
(23)
Official controls on animals and plants should be carried out to prevent the intentional introduction of invasive alien species. Live animals and plants should only enter the Union through border control entities in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council (17), and Council Directives 91/496/EEC (18) and 97/78/EC (19) or points of entry in accordance with Directive 2000/29/EC. To ensure efficiency gains and avoid creating parallel systems of customs controls, competent authorities should verify whether those species are invasive alien species of Union concern at the first border control entity or point of entry.
(24)
After the introduction of an invasive alien species, early detection and rapid eradication measures are crucial to prevent their establishment and spread. The most effective and cost efficient response is often to eradicate the population as soon as possible while the number of specimens is still limited. In the event that eradication is not feasible or the costs of eradication outweigh the environmental, social and economic benefits in the long term, containment and control measures should be applied. Management measures should be proportional to the impact on the environment and take due consideration of the biogeographic and climatic conditions of the Member State concerned.
(25)
Management measures should avoid any adverse impact on the environment as well as on human health. Eradicating and managing some animal invasive alien species, while necessary in some cases, may induce pain, distress, fear or other forms of suffering to the animals, even when using the best available technical means. For that reason, Member States and any operator involved in the eradication, control or containment of invasive alien species should take the necessary measures to spare avoidable pain, distress and suffering of animals during the process, taking into account as far as possible the best practices in the field, for example the Guiding Principles on Animal Welfare developed by the World Organisation for Animal Health. Non-lethal methods should be considered and any action taken should minimise the impact on non-targeted species.
(26)
Invasive alien species generally cause damage to ecosystems and reduce the resilience of those ecosystems. Therefore proportionate restoration measures should be undertaken to strengthen the ecosystems' resilience towards invasions, to repair the damage caused and to enhance the conservation status of species and their habitats in accordance with Directives 92/43/EEC and 2009/147/EC, the ecological status of inland surface waters, transitional waters, coastal waters and groundwater in accordance with Directive 2000/60/EC, and the environmental status of marine waters in accordance with Directive 2008/56/EC. The costs of such restoration measures should be recovered in accordance with the polluter pays principle.
(27)
Cross-border cooperation, particularly with neighbouring countries, and coordination between Member States, particularly within the same biogeographical region of the Union, should be fostered to contribute to the effective application of this Regulation.
(28)
A system to address invasive alien species should be underpinned by a centralised information system collating the existing information on alien species in the Union and allowing access to information on the presence of species, their spread, their ecology, invasion history and all other information necessary to underpin policy and management decisions and allowing also the exchange of best practices.
(29)
Directive 2003/35/EC of the European Parliament and of the Council (20) has established a framework for public consultation in environment related decisions. In defining action in the field of invasive alien species, effective public participation should enable the public to express, and the decision-maker to take account of, opinions and concerns which may be relevant to those decisions. That should increase the accountability and transparency of the decision-making process and contribute to public awareness of environmental issues and support for the decisions taken.
(30)
The participation of the scientific community is important to provide an adequate knowledge base to address the problems raised by invasive alien species. A dedicated scientific forum should be set up to provide advice on the scientific aspects related to the application of this Regulation, in particular as regards establishing and updating the Union list, risk assessments, emergency measures and rapid eradication measures.
(31)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the adoption and updating of the Union list, the format of the documents serving as evidence for permits, the adoption of emergency measures at Union level, the requirement to apply certain provisions in the Member States concerned in the case of enhanced regional cooperation, the rejection of the Member States' decisions not to apply eradication measures and the technical formats for reporting to the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (21).
(32)
In order to take into account the latest scientific developments in the environmental field, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of determining how it may be concluded that invasive alien species are capable of establishing viable populations and of spreading, as well as for setting out the common elements for the development of risk assessments. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(33)
To guarantee compliance with this Regulation, it is important that Member States impose effective, proportionate and dissuasive sanctions for infringements, taking into account the nature and gravity of the infringement, the principle of recovery of the costs and the polluter pays principle.
(34)
Through measures taken under this Regulation, Member States may impose obligations on holders or users of alien species as well as owners and tenants of the land concerned.
(35)
To enable non-commercial owners to keep their companion animals that belong to species included on the Union list until the end of the animal's natural life, it is necessary to provide transitional measures, on condition that all measures are put in place to avoid reproduction or escape.
(36)
To enable commercial operators, who may have legitimate expectations, for instance those who have received an authorisation in accordance with Regulation (EC) No 708/2007, to exhaust their stock of invasive alien species of Union concern following the entry into force of this Regulation, it is justified to allow them two years to slaughter, humanely cull, sell or, where relevant, hand over the specimens to research or ex-situ conservation establishments.
(37)
Since the objectives of this Regulation, namely to prevent, minimise and mitigate the adverse impact on biodiversity of the introduction and spread of invasive alien species within the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(38)
It should be possible for Member States to maintain or adopt rules on invasive alien species of Union concern that are more stringent than those laid down in this Regulation and to apply provisions such as those set out in this Regulation for invasive alien species of Union concern to invasive alien species of Member State concern. Any such measures should be compatible with the TFEU and be notified to the Commission in accordance with Union law,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation sets out rules to prevent, minimise and mitigate the adverse impact on biodiversity of the introduction and spread within the Union, both intentional and unintentional, of invasive alien species.
Article 2
Scope
1. This Regulation applies to all invasive alien species.
2. This Regulation does not apply to:
(a)
species changing their natural range without human intervention, in response to changing ecological conditions and climate change;
(b)
genetically modified organisms as defined in point 2 of Article 2 of Directive 2001/18/EC;
(c)
pathogens that cause animal diseases; for the purpose of this Regulation, animal disease means the occurrence of infections and infestations in animals, caused by one or more pathogens transmissible to animals or to humans;
(d)
harmful organisms listed in Annex I or Annex II to Directive 2000/29/EC, and harmful organisms for which measures have been adopted in accordance with Article 16(3) of that Directive;
(e)
species listed in Annex IV to Regulation (EC) No 708/2007 when used in aquaculture;
(f)
micro-organisms manufactured or imported for use in plant protection products already authorised or for which an assessment is ongoing under Regulation (EC) No 1107/2009; or
(g)
micro-organisms manufactured or imported for use in biocidal products already authorised or for which an assessment is ongoing under Regulation (EU) No 528/2012.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
'alien species' means any live specimen of a species, subspecies or lower taxon of animals, plants, fungi or micro-organisms introduced outside its natural range; it includes any part, gametes, seeds, eggs or propagules of such species, as well as any hybrids, varieties or breeds that might survive and subsequently reproduce;
(2)
'invasive alien species' means an alien species whose introduction or spread has been found to threaten or adversely impact upon biodiversity and related ecosystem services;
(3)
'invasive alien species of Union concern' means an invasive alien species whose adverse impact has been deemed such as to require concerted action at Union level pursuant to Article 4(3);
(4)
'invasive alien species of Member State concern' means an invasive alien species other than an invasive alien species of Union concern, for which a Member State considers on the basis of scientific evidence that the adverse impact of its release and spread, even where not fully ascertained, is of significance for its territory, or part of it, and requires action at the level of that Member State;
(5)
'biodiversity' means the variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems;
(6)
'ecosystem services' means the direct and indirect contributions of ecosystems to human wellbeing;
(7)
'introduction' means the movement, as a consequence of human intervention, of a species outside its natural range;
(8)
'research' means descriptive or experimental work, undertaken under regulated conditions to obtain new scientific findings or to develop new products, including the initial phases of identification, characterisation and isolation of genetic features, other than those features which make a species invasive, of invasive alien species only insofar as essential to enable the breeding of those features into non-invasive species;
(9)
'contained holding' means keeping an organism in closed facilities from which escape or spread is not possible;
(10)
'ex-situ conservation' means the conservation of components of biological diversity outside their natural habitat;
(11)
'pathways' means the routes and mechanisms of the introduction and spread of invasive alien species;
(12)
'early detection' means the confirmation of the presence of a specimen or specimens of an invasive alien species in the environment before it has become widely spread;
(13)
'eradication' means the complete and permanent removal of a population of invasive alien species by lethal or non-lethal means;
(14)
'population control' means any lethal or non-lethal action applied to a population of invasive alien species, while also minimising the impact on non-targeted species and their habitats, with the aim of keeping the number of individuals as low as possible, so that, while not being able to eradicate the species, its invasive capacity and adverse impact on biodiversity, the related ecosystem services, on human health or the economy, are minimised;
(15)
'containment' means any action aimed at creating barriers which minimises the risk of a population of an invasive alien species dispersing and spreading beyond the invaded area;
(16)
'widely spread' means an invasive alien species whose population has gone beyond the naturalisation stage, in which a population is self-sustaining, and has spread to colonise a large part of the potential range where it can survive and reproduce;
(17)
'management' means any lethal or non-lethal action aimed at the eradication, population control or containment of a population of an invasive alien species, while also minimising the impact on non-targeted species and their habitats.
Article 4
List of invasive alien species of Union concern
1. The Commission shall adopt, by means of implementing acts, a list of invasive alien species of Union concern ('the Union list'), on the basis of the criteria laid down in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). The draft implementing acts shall be submitted to the Committee referred to in Article 27(1) by 2 January 2016.
2. The Commission shall undertake a comprehensive review of the Union list at least every six years and shall, in the meantime, update it, as appropriate, in accordance with the procedure referred to in paragraph 1 with:
(a)
the addition of new invasive alien species;
(b)
the removal of listed species if they no longer meet one or more of the criteria laid down in paragraph 3.
3. Invasive alien species shall only be included on the Union list if they meet all of the following criteria:
(a)
they are found, based on available scientific evidence, to be alien to the territory of the Union excluding the outermost regions;
(b)
they are found, based on available scientific evidence, to be capable of establishing a viable population and spreading in the environment under current conditions and in foreseeable climate change conditions in one biogeographical region shared by more than two Member States or one marine subregion excluding their outermost regions;
(c)
they are, based on available scientific evidence, likely to have a significant adverse impact on biodiversity or the related ecosystem services, and may also have an adverse impact on human health or the economy;
(d)
it is demonstrated by a risk assessment carried out pursuant to Article 5(1) that concerted action at Union level is required to prevent their introduction, establishment or spread;
(e)
it is likely that the inclusion on the Union list will effectively prevent, minimise or mitigate their adverse impact.
4. Member States may submit to the Commission requests for the inclusion of invasive alien species on the Union list. Those requests shall include all of the following:
(a)
the name of the species;
(b)
a risk assessment carried out in accordance with Article 5(1);
(c)
evidence that the criteria set out in paragraph 3 of this Article are met.
5. The Union list shall make reference, where relevant, to the goods with which the invasive alien species are generally associated and their Combined Nomenclature codes as provided by Council Regulation (EEC) No 2658/87 (22), indicating the categories of goods that shall be subject to official controls pursuant to Article 15 of this Regulation.
6. When adopting or updating the Union list, the Commission shall apply the criteria set out in paragraph 3 with due consideration to the implementation cost for Member States, the cost of inaction, the cost-effectiveness and the socio-economic aspects. The Union list shall include as a priority those invasive alien species that:
(a)
are not yet present in the Union or are at an early stage of invasion and are most likely to have a significant adverse impact;
(b)
are already established in the Union and have the most significant adverse impact.
7. When proposing the Union list, the Commission shall also justify that the objectives of this Regulation are better achieved by measures at Union level.
Article 5
Risk assessment
1. For the purposes of Article 4, a risk assessment shall be carried out in relation to the current and potential range of invasive alien species, having regard to the following elements:
(a)
a description of the species with its taxonomic identity, its history, and its natural and potential range;
(b)
a description of its reproduction and spread patterns and dynamics including an assessment of whether the environmental conditions necessary for its reproduction and spread exist;
(c)
a description of the potential pathways of introduction and spread of the species, both intentional and unintentional, including where relevant the commodities with which the species is generally associated;
(d)
a thorough assessment of the risk of introduction, establishment and spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions;
(e)
a description of the current distribution of the species, including whether the species is already present in the Union or in neighbouring countries, and a projection of its likely future distribution;
(f)
a description of the adverse impact on biodiversity and related ecosystem services, including on native species, protected sites, endangered habitats, as well as on human health, safety, and the economy including an assessment of the potential future impact having regard to available scientific knowledge;
(g)
an assessment of the potential costs of damage;
(h)
a description of the known uses for the species and social and economic benefits deriving from those uses.
2. When proposing species for listing as invasive alien species of Union concern, the Commission shall carry out the risk assessment referred to in paragraph 1.
Whenever a Member State submits a request for the inclusion of a species on the Union list it shall be responsible for carrying out the risk assessment referred to in paragraph 1. Where necessary, the Commission may assist the Member States in the development of such risk assessments in so far as it relates to their European dimension.
3. The Commission shall be empowered to adopt delegated acts, in accordance with Article 29, to further specify the type of evidence acceptable for the purposes of point (b) of Article 4(3) and provide a detailed description of the application of points (a) to (h) of paragraph 1 of this Article. The detailed description shall include the methodology to be applied in the risk assessments, taking into account relevant national and international standards and the need to prioritise action against invasive alien species associated with, or that have the potential to cause, a significant adverse impact on biodiversity or related ecosystem services, as well as on human health or the economy, such adverse impact being considered as an aggravating factor. It is of particular importance that the Commission follow its usual practice and carry out consultations with experts, including Member States' experts, before adopting those delegated acts.
Article 6
Provisions for the outermost regions
1. Invasive alien species of Union concern shall not be subject to Article 7 or Articles 13 to 20 in the outermost regions.
2. By 2 January 2017, each Member State with outermost regions shall adopt for each of those regions a list of invasive alien species of concern, in consultation with those regions.
3. As regards the invasive alien species included on the lists referred to in paragraph 2 of this Article, Member States may, within the respective outermost regions, apply the measures as provided for in Articles 7 to 9, 13 to 17, 19 and 20, as appropriate. Those measures shall be compatible with the TFEU and be notified to the Commission in accordance with Union law.
4. Member States shall immediately notify the Commission and shall inform the other Member States of the lists referred to in paragraph 2 and of any update to those lists.
CHAPTER II
PREVENTION
Article 7
Restrictions
1. Invasive alien species of Union concern shall not be intentionally:
(a)
brought into the territory of the Union, including transit under customs supervision;
(b)
kept, including in contained holding;
(c)
bred, including in contained holding;
(d)
transported to, from or within the Union, except for the transportation of species to facilities in the context of eradication;
(e)
placed on the market;
(f)
used or exchanged;
(g)
permitted to reproduce, grown or cultivated, including in contained holding; or
(h)
released into the environment.
2. Member States shall take all necessary steps to prevent the unintentional introduction or spread, including, where applicable, by gross negligence, of invasive alien species of Union concern.
Article 8
Permits
1. By way of derogation from the restrictions set out in points (a), (b), (c), (d), (f) and (g) of Article 7(1), and subject to paragraph 2 of this Article, Member States shall establish a permit system allowing establishments to carry out research on, or ex-situ conservation of, invasive alien species of Union concern. Where the use of products derived from invasive alien species of Union concern is unavoidable to advance human health, Member States may also include scientific production and subsequent medicinal use within their permit system.
2. Member States shall empower their competent authorities to issue the permits referred to in paragraph 1 for activities carried out in contained holding that fulfil all of the following conditions:
(a)
the invasive alien species of Union concern is kept in and handled in contained holding in accordance with paragraph 3;
(b)
the activity is to be carried out by appropriately qualified personnel as laid down by the competent authorities;
(c)
transport to and from contained holding is carried out under conditions that exclude escape of the invasive alien species as established by the permit;
(d)
in the case of invasive alien species of Union concern that are animals, they are marked or otherwise effectively identified where appropriate, using methods that do not cause avoidable pain, distress or suffering;
(e)
the risk of escape or spread or removal is effectively managed, taking into account the identity, biology and means of dispersal of the species, the activity and the contained holding envisaged, the interaction with the environment and other relevant factors;
(f)
a continuous surveillance system and a contingency plan covering possible escape or spread is drawn up by the applicant, including an eradication plan. The contingency plan shall be approved by the competent authority. If an escape or spread occurs, the contingency plan shall be implemented immediately and the permit may be withdrawn, temporarily or permanently.
The permit referred to in paragraph 1 shall be limited to a number of invasive alien species and specimens that does not exceed the capacity of the contained holding. It shall include the restrictions necessary to mitigate the risk of escape or spread of the species concerned. It shall accompany the invasive alien species to which it refers at all times when those species are kept, brought into and transported within the Union.
3. Specimens shall be considered to be kept in contained holding if the following conditions are fulfilled:
(a)
the specimens are physically isolated and they cannot escape or spread or be removed by unauthorised persons from the holdings where they are kept;
(b)
cleaning, waste handling and maintenance protocols ensure that no specimens or reproducible parts can escape, spread or be removed by unauthorised persons;
(c)
the removal of the specimens from the holdings, disposal or destruction or humane cull is done in such way as to exclude propagation or reproduction outside of the holdings.
4. When applying for a permit, the applicant shall provide all necessary evidence to allow the competent authority to assess whether the conditions set out in paragraphs 2 and 3 are fulfilled.
5. Member States shall empower their competent authorities to withdraw the permit at any point in time, temporarily or permanently, if unforeseen events with an adverse impact on biodiversity or related ecosystem services occur. Any withdrawal of a permit shall be justified on scientific grounds and, where scientific information is insufficient, on the grounds of the precautionary principle and having due regard to national administrative rules.
6. The Commission shall adopt, by means of implementing acts, the format of the document serving as evidence for the permit issued by the competent authorities of a Member State. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). Member States shall use that format for a document accompanying the permit.
7. For all permits issued in accordance with paragraph 1 of this Article, Member States, shall, without delay, make publicly available on the internet at least the following:
(a)
the scientific and common names of the invasive alien species of Union concern for which the permit has been issued;
(b)
the number or the volume of specimens concerned;
(c)
the purpose for which the permit has been issued; and
(d)
the codes of Combined Nomenclature as provided by Regulation (EEC) No 2658/87.
8. Member States shall ensure that inspections are carried out by their competent authorities to ensure that the establishments comply with the conditions set out in those permits issued.
Article 9
Authorisations
1. In exceptional cases, for reasons of compelling public interest, including those of a social or economic nature, Member States may issue permits allowing establishments to carry out activities other than those set out in Article 8(1) subject to authorisation by the Commission, in accordance with the procedure laid down in this Article and subject to the conditions set out in Article 8(2) and (3).
2. The Commission shall set up and operate an electronic authorisation system and shall decide on applications for authorisation within 60 days of receipt of an application.
3. Applications for authorisation shall be submitted by Member States using the system referred to in paragraph 2.
4. An application for an authorisation shall include the following:
(a)
details of the establishment or groups of establishments including their name and address;
(b)
the scientific and common names of the invasive alien species of Union concern for which an authorisation is requested;
(c)
the codes of Combined Nomenclature as provided by Regulation (EEC) No 2658/87;
(d)
the number or the volume of specimens concerned;
(e)
the reasons for the requested authorisation;
(f)
a detailed description of the envisaged measures to ensure that escape or spread are not possible from contained holding facilities in which the invasive alien species of Union concern is to be kept in and handled, as well as of the measures to ensure that any transport of the species that may be necessary is carried out under conditions that exclude escape;
(g)
an assessment of the risk of escape of the invasive alien species of Union concern for which an authorisation is requested, accompanied by a description of the risk mitigation measures to be put in place;
(h)
a description of the surveillance system planned and of the contingency plan drawn to cater for possible escape or spread, including an eradication plan where necessary;
(i)
a description of relevant national law applicable to those establishments.
5. Authorisations granted by the Commission shall be notified to the competent authority of the Member State concerned. An authorisation shall be specific to an individual establishment, irrespective of the application procedure followed in accordance with point (a) of paragraph 4, and shall include the information referred to in paragraph 4 and the duration of the authorisation. An authorisation shall also include provisions regarding the supply to the establishment of additional or replacement specimens for use in the activity for which that authorisation is requested.
6. Following an authorisation by the Commission, the competent authority may issue the permit referred to in paragraph 1 of this Article in accordance with Article 8(4) to (8). The permit shall include all provisions specified in the authorisation issued by the Commission.
7. The Commission shall reject an application for an authorisation if any relevant obligations set out in this Regulation are not complied with.
8. The Commission shall, as soon as possible, inform the Member State concerned of any rejection of an application pursuant to paragraph 7 and shall specify the reason for the rejection.
Article 10
Emergency measures
1. Where a Member State has evidence concerning the presence in, or imminent risk of introduction into its territory of an invasive alien species, which is not included on the Union list but which the competent authorities have found, on the basis of preliminary scientific evidence, to be likely to meet the criteria set out in Article 4(3), it may immediately take emergency measures, consisting of any of the restrictions set out in Article 7(1).
2. The Member State introducing emergency measures in its national territory which include the application of points (a), (d) or (e) of Article 7(1) shall immediately notify the Commission and all other Member States of the measures taken and the evidence justifying those measures.
3. The Member State concerned shall without delay carry out a risk assessment pursuant to Article 5 for the invasive alien species subject to the emergency measures, given the available technical and scientific information, and in any case within 24 months from the date of the adoption of the decision to introduce emergency measures, with a view to include that species on the Union list.
4. Where the Commission receives the notification referred to in paragraph 2 of this Article or has other evidence concerning the presence in or imminent risk of introduction into the Union of an invasive alien species which is not included on the Union list, but is likely to meet the criteria set out in Article 4(3), it shall, by means of implementing acts, conclude, on the basis of preliminary scientific evidence, whether the species is likely to meet those criteria and adopt emergency measures for the Union consisting of any of the restrictions set out in Article 7(1) for a limited time as regards the risks posed by that species, where it concludes that the criteria set out in Article 4(3) are likely to be fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2).
5. Where the Commission adopts an implementing act referred to in paragraph 4, Member States shall repeal or amend, as appropriate, any emergency measures which they have taken.
6. Where the Commission includes the invasive alien species on the Union list, Member States shall also repeal or amend their emergency measures.
7. When, following the risk assessment carried out pursuant to paragraph 3 of this Article, the Commission does not include the invasive alien species on the Union list, Member States shall repeal their emergency measures taken pursuant to paragraph 1 of this Article and may include that species on a national list of invasive alien species of Member State concern, pursuant to Article 12(1), and consider enhanced regional cooperation in accordance with Article 11.
Article 11
Invasive alien species of regional concern and species native to the Union
1. Member States may identify, from their national list of invasive alien species of Member State concern established in accordance with Article 12, species native or non-native to the Union that require enhanced regional cooperation.
2. At the request of the Member States involved, the Commission shall act to facilitate the cooperation and coordination among those Member States involved, in accordance with Article 22(1). Where necessary, based on the impact of certain invasive alien species on biodiversity and related ecosystem services as well as on human health and the economy and provided that it is thoroughly substantiated by a comprehensive analysis of the justification for an enhanced regional cooperation carried out by the requesting Member States, the Commission may require, by means of implementing acts, that the Member States concerned apply, mutatis mutandis, in their territory or part of it, Articles 13, 14 and 16, Article 17 notwithstanding Article 18, as well as apply Articles 19 and 20, as appropriate. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2).
3. Invasive alien species of regional concern which are native to a Member State shall not be subject to the provisions of Articles 13, 14, 16, 17, 19, 20 and 24 in the territory of that Member State. Member States to which those species are native, shall cooperate with the Member States concerned for the assessment of the pathways in accordance with Article 13 and, in consultation with the other Member States, may adopt relevant measures to avoid further spread of those species in accordance with the procedure referred to in Article 22(1).
Article 12
Invasive alien species of Member State concern
1. Member States may establish a national list of invasive alien species of Member State concern. For those invasive alien species, Member States may apply, in their territory, measures such as those provided for in Articles 7, 8, 13 to 17, 19 and 20, as appropriate. Those measures shall be compatible with the TFEU and be notified to the Commission in accordance with Union law.
2. Member States shall inform the Commission and the other Member States of the species they consider to be invasive alien species of Member State concern and of the measures applied in accordance with paragraph 1.
Article 13
Action plans on the pathways of invasive alien species
1. Member States shall, within 18 months of the adoption of the Union list carry out a comprehensive analysis of the pathways of unintentional introduction and spread of invasive alien species of Union concern at least in their territory, as well as in their marine waters as defined in point (1) of Article 3 of Directive 2008/56/EC, and identify the pathways which require priority action ('priority pathways') because of the volume of species or of the potential damage caused by the species entering the Union through those pathways.
2. Within three years of the adoption of the Union list, each Member State shall establish and implement one single action plan or a set of action plans to address the priority pathways it has identified pursuant to paragraph 1. Action plans shall include timetables for action and shall describe the measures to be adopted and, as appropriate, voluntary actions and codes of good practice, to address the priority pathways and to prevent the unintentional introduction and spread of invasive alien species into or within the Union.
3. Member States shall ensure coordination with the aim of establishing one single action plan or a set of action plans coordinated at the appropriate regional level in accordance with Article 22(1). Where such regional action plans are not established, Member States shall establish and implement action plans for their territory and as far as possible coordinated at the appropriate regional level.
4. The action plans referred to in paragraph 2 of this Article shall include, in particular, measures based on an analysis of costs and benefits, in order to:
(a)
raise awareness;
(b)
minimise contamination of goods, commodities, vehicles and equipment by specimens of invasive alien species, including measures to tackle transportation of invasive alien species from third countries;
(c)
ensure appropriate checks at the Union borders, other than the official controls pursuant to Article 15.
5. The action plans established in accordance with paragraph 2 shall be transmitted to the Commission without delay. Member States shall review their action plans and transmit them to the Commission at least every six years.
CHAPTER III
EARLY DETECTION AND RAPID ERADICATION
Article 14
Surveillance system
1. Within 18 months of the adoption of the Union list, Member States shall establish a surveillance system of invasive alien species of Union concern, or include it in their existing system, which collects and records data on the occurrence in the environment of invasive alien species by survey, monitoring or other procedures to prevent the spread of invasive alien species into or within the Union.
2. The surveillance system referred to in paragraph 1 of this Article shall:
(a)
cover the territory, including marine territorial waters, of the Member States to determine the presence and distribution of new as well as already established invasive alien species of Union concern;
(b)
be sufficiently dynamic to detect rapidly the appearance in the environment of the territory or part of the territory of a Member State of any invasive alien species of Union concern, whose presence was previously unknown;
(c)
build upon, be compatible with, and avoid duplication of relevant provisions for assessment and monitoring laid down by Union law or under international agreements and make use of the information provided by the existing systems of surveillance and monitoring set out in Article 11 of Directive 92/43/EEC, Article 8 of Directive 2000/60/EC and Article 11 of Directive 2008/56/EC;
(d)
take into account the relevant transboundary impact and transboundary features, to the extent possible.
Article 15
Official controls
1. By 2 January 2016, Member States shall have in place fully functioning structures to carry out the official controls necessary to prevent the intentional introduction into the Union of invasive alien species of Union concern. Those official controls shall apply to the categories of goods falling within the Combined Nomenclature codes to which a reference is made in the Union list, pursuant to Article 4(5).
2. Competent authorities shall carry out the appropriate risk-based controls to the goods mentioned in paragraph 1 of this Article verifying that:
(a)
they are not on the Union list; or
(b)
they are covered by a valid permit as referred to in Article 8.
3. The controls referred to in paragraph 2 of this Article, consisting of documentary, identity and where necessary, physical checks, shall take place when goods referred to in paragraph 1 of this Article are brought into the Union. Where Union law on official controls already provides for specific official controls at border entities in accordance with Regulation (EC) No 882/2004 and Directives 91/496/EEC and 97/78/EC or at points of entry in accordance with Directive 2000/29/EC, for categories of goods referred to in paragraph 1 of this Article, Member States shall confer the responsibility of carrying out the controls referred to in paragraph 2 of this Article to the competent authorities tasked with those controls in accordance with Article 4 of Regulation (EC) No 882/2004 or with point (g) of Article 2(1) of Directive 2000/29/EC.
4. The handling in free zones or free warehouses and the placing of goods referred to in paragraph 1 under the customs procedures of release for free circulation, transit, customs warehousing, inward processing, processing under customs control and temporary admission shall be subject to the declaration to the customs authorities of:
(a)
the relevant entry document duly completed by the competent authorities referred to in paragraph 3 of this Article attesting that the conditions referred to in paragraph 2 of this Article are met, in cases where the controls have been carried out at border entities in accordance with Regulation (EC) No 882/2004 and Directives 91/496/EEC and 97/78/EC or at points of entry in accordance with point (j) of Article 2(1) of Directive 2000/29/EC. The customs procedure indicated therein shall be followed; or
(b)
where goods are not subject to official controls according to Union law, other documentary evidence that the controls have been carried out with satisfactory results and the subsequent entry document.
Those documents may also be submitted electronically.
5. If the controls establish non-compliance with this Regulation:
(a)
customs authorities shall suspend the placing under a customs procedure or detain the goods;
(b)
competent authorities referred to in paragraph 3 shall detain the goods.
Where goods are detained, they shall be entrusted to the competent authority in charge of applying this Regulation. That authority shall act in accordance with national legislation. Member States may delegate specific functions to other authorities.
6. Costs incurred while the verification is carried out and those arising from any non-compliance shall be at the expense of the natural or legal person within the Union who brought the goods into the Union, except where the Member State concerned determines otherwise.
7. Member States shall put in place procedures to ensure the exchange of relevant information and the efficient and effective coordination and cooperation between all authorities involved for the verification referred to in paragraph 2.
8. Based on best practices, the Commission, together with all Member States, shall develop guidelines and training programmes to facilitate the identification and detection of invasive alien species of Union concern and the performance of efficient and effective controls.
9. Where permits have been issued in accordance with Article 8, reference to a valid permit covering the declared goods shall be made in the customs declaration or relevant notifications to the border entity.
Article 16
Early detection notifications
1. Member States shall use the surveillance system established in accordance with Article 14 and the information collected at official controls provided for by Article 15 to confirm early detection of the introduction or presence of invasive alien species of Union concern.
2. Member States shall without delay notify the Commission, in writing, of the early detection of the introduction or presence of invasive alien species of Union concern and inform the other Member States, in particular of:
(a)
the appearance on their territory or part of their territory of any species included on the Union list whose presence was previously unknown in their territory or in part of their territory;
(b)
the re-appearance on their territory or part of their territory of any species included on the Union list after it has been reported as eradicated.
Article 17
Rapid eradication at an early stage of invasion
1. After early detection and within three months after the transmission of the early detection notification referred to in Article 16, Member States shall apply eradication measures and notify those measures to the Commission and inform the other Member States.
2. When applying eradication measures, Member States shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned, with due regard to human health and the environment, especially non-targeted species and their habitats, and ensuring that animals are spared any avoidable pain, distress or suffering.
3. Member States shall monitor the effectiveness of the eradication. Member States may use the surveillance system provided for in Article 14 to this effect. The monitoring shall also assess the impact on non-targeted species, as appropriate.
4. Member States shall inform the Commission of the effectiveness of the measures taken and notify the Commission when a population of an invasive alien species of Union concern has been eradicated. They shall also provide that information to other Member States.
Article 18
Derogations from the obligation of rapid eradication
1. A Member State may, based on robust scientific evidence, decide, within two months of the detection of an invasive alien species referred to in Article 16, not to apply eradication measures if at least one of the following conditions is met:
(a)
eradication is demonstrated to be technically unfeasible because the eradication methods available cannot be applied in the environment where the invasive alien species is established;
(b)
a cost-benefit analysis demonstrates on the basis of the available data with reasonable certainty that the costs will, in the long term, be exceptionally high and disproportionate to the benefits of eradication;
(c)
eradication methods are not available or are available but have very serious adverse impact on human health, the environment or other species.
The Member State concerned shall without delay notify the Commission of its decision in writing. The notification shall be accompanied by all the evidence referred to in points (a), (b) and (c) of the first subparagraph.
2. The Commission may decide, by means of implementing acts, to reject the decision notified in accordance with the second subparagraph of paragraph 1 where the conditions set out therein are not met.
3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). The draft implementing acts shall be submitted to the Committee referred to in Article 27(1) within two months of receipt of the Member State's notification.
4. Member States shall ensure that containment measures are in place to avoid further spread of the invasive alien species to other Member States when, pursuant to paragraph 1, no eradication measures are applied.
5. Where the Commission rejects a decision notified in accordance with the second subparagraph of paragraph 1 of this Article, the Member State concerned shall apply the eradication measures referred to in Article 17 without delay.
6. Where the Commission does not reject a decision notified in accordance with the second subparagraph of paragraph 1 of this Article, the invasive alien species shall be subject to the management measures referred to in Article 19.
CHAPTER IV
MANAGEMENT OF INVASIVE ALIEN SPECIES THAT ARE WIDELY SPREAD
Article 19
Management measures
1. Within 18 months of an invasive alien species being included on the Union list, Member States shall have in place effective management measures for those invasive alien species of Union concern which the Member States have found to be widely spread on their territory, so that their impact on biodiversity, the related ecosystem services, and, where applicable, on human health or the economy are minimised.
Those management measures shall be proportionate to the impact on the environment and appropriate to the specific circumstances of the Member States, be based on an analysis of costs and benefits and also include, as far as is feasible, the restoration measures referred to in Article 20. They shall be prioritised based on the risk evaluation and their cost effectiveness.
2. The management measures shall consist of lethal or non-lethal physical, chemical or biological actions aimed at the eradication, population control or containment of a population of an invasive alien species. Where appropriate, management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions. The commercial use of already established invasive alien species may be temporarily allowed as part of the management measures aimed at their eradication, population control or containment, under strict justification and provided that all appropriate controls are in place to avoid any further spread.
3. When applying management measures and selecting methods to be used, Member States shall have due regard to human health and the environment, especially non-targeted species and their habitats, and shall ensure that, when animals are targeted, they are spared any avoidable pain, distress or suffering, without compromising the effectiveness of the management measures.
4. The surveillance system provided for in Article 14 shall be designed and used to monitor the effectiveness of eradication, population control or containment measures in minimising the impact on biodiversity, the related ecosystems services and, where applicable, on human health or the economy. The monitoring shall also assess the impact on non-targeted species, as appropriate.
5. Where there is a significant risk that an invasive alien species of Union concern will spread to another Member State, the Member States in which that species is present shall immediately notify the other Member States and the Commission. Where appropriate, the Member States concerned shall establish jointly agreed management measures. Where third countries may also be affected by the spread, the Member State affected shall endeavour to inform the third countries concerned.
Article 20
Restoration of the damaged ecosystems
1. Member States shall carry out appropriate restoration measures to assist the recovery of an ecosystem that has been degraded, damaged, or destroyed by invasive alien species of Union concern unless a cost-benefit analysis demonstrates, on the basis of the available data and with reasonable certainty, that the costs of those measures will be high and disproportionate to the benefits of restoration.
2. The restoration measures referred to in paragraph 1 shall include at least the following:
(a)
measures to increase the ability of an ecosystem exposed to disturbance caused by the presence of invasive alien species of Union concern to resist, absorb, accommodate to and recover from the effects of disturbance;
(b)
measures to support the prevention of reinvasion following an eradication campaign.
CHAPTER V
HORIZONTAL PROVISIONS
Article 21
Costs recovery
In accordance with the polluter pays principle and without prejudice to Directive 2004/35/EC of the European Parliament and of the Council (23), Member States shall aim to recover the costs of the measures needed to prevent, minimise or mitigate the adverse impact of invasive alien species, including environmental and resources costs as well as the restoration cost.
Article 22
Cooperation and coordination
1. Member States shall, when complying with their obligations under this Regulation, make every effort to ensure close coordination with all Member States concerned and, where practical and appropriate, use existing structures arising from regional or international agreements. In particular, Member States concerned shall endeavour to ensure coordination with other Member States that share:
(a)
the same marine subregions in accordance with Article 4(2) of Directive 2008/56/EC, regarding marine species;
(b)
the same biogeographical region in accordance with point (iii) of point (c) of Article 1 of Directive 92/43/EEC, regarding non-marine species;
(c)
the same borders;
(d)
the same river basin in accordance with point (13) of Article 2 of Directive 2000/60/EC, regarding fresh water species; or
(e)
any other common concern.
At the request of the Member States involved, the Commission shall act to facilitate the coordination.
2. Member States shall, when complying with their obligations under this Regulation, endeavour to cooperate with third countries, as appropriate, including by using existing structures arising from regional or international agreements, for the purpose of meeting the objectives of this Regulation.
3. Member States may also apply provisions, such as those referred to in paragraph 1 of this Article, to ensure coordination and cooperation with other relevant Member States as regards invasive alien species of Member State concern identified in national lists adopted in accordance with Article 12(1). Member States may also establish mechanisms for cooperation at the appropriate level for those invasive alien species. Such mechanisms may include exchange of information and data, action plans on pathways and exchange of best practice on management, control and eradication of invasive alien species, early warning systems and programmes related to public awareness or education.
Article 23
More stringent national rules
Member States may maintain or lay down more stringent national rules with the aim of preventing the introduction, establishment and spread of invasive alien species. Those measures shall be compatible with the TFEU and be notified to the Commission in accordance with Union law.
CHAPTER VI
FINAL PROVISIONS
Article 24
Reporting and review
1. By 1 June 2019, and every six years thereafter, Member States shall update and transmit to the Commission the following:
(a)
a description, or an updated version thereof, of the surveillance system pursuant to Article 14 and of the official control system on alien species entering the Union pursuant to Article 15;
(b)
the distribution of the invasive alien species of Union concern or regional concern in accordance with Article 11(2) present in their territory, including information regarding migratory or reproductive patterns;
(c)
information about the species considered as invasive alien species of Member State concern pursuant to Article 12(2);
(d)
the action plans referred to in Article 13(2);
(e)
aggregated information covering the entire national territory on the eradication measures taken in accordance with Article 17, the management measures undertaken in accordance with Article 19, their effectiveness, and their impact on non-targeted species;
(f)
the number of the permits referred to in Article 8 and the purpose for which they were issued;
(g)
measures taken to inform the public about the presence of an invasive alien species and any actions that citizens have been requested to take;
(h)
the inspections required under Article 8(8); and
(i)
information on the cost of action undertaken to comply with this Regulation, when available.
2. By 5 November 2015, Member States shall notify the Commission and inform the other Member States of the competent authorities in charge of applying this Regulation.
3. By 1 June 2021, the Commission shall review the application of this Regulation including the Union list, the action plans referred to in Article 13(2), the surveillance system, customs controls, eradication obligation and management obligations, and submit a report to the European Parliament and to the Council, which may be accompanied by legislative proposals for the amendment of this Regulation, including changes to the Union list. That review shall also examine the effectiveness of the implementing provisions on invasive alien species of regional concern, the need for and the feasibility of, including species native to the Union in the Union list and whether further harmonisation is needed to increase the effectiveness of the action plans and measures undertaken by the Member States.
4. The Commission shall, by means of implementing acts, specify the technical formats for reporting in order to simplify and streamline reporting obligations for the Member States in relation to the information pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2).
Article 25
Information support system
1. The Commission shall progressively establish an information support system necessary to facilitate the application of this Regulation.
2. By 2 January 2016 that system shall include a data support mechanism interconnecting existing data systems on invasive alien species, paying particular attention to information on the invasive alien species of Union concern, so as to facilitate the reporting pursuant to Article 24.
The data support mechanism referred to in the first subparagraph shall become a tool to assist the Commission and the Member States in handling the relevant notifications required by Article 16(2).
3. By 2 January 2019, the data support mechanism referred to in paragraph 2 shall become a mechanism for exchanging information on other aspects of the application of this Regulation.
It may also include information on invasive alien species of Member State concern, and on pathways, risk assessment, management and eradication measures, when available.
Article 26
Public participation
Where action plans are being established pursuant to Article 13 of this Regulation and where management measures are put in place pursuant to Article 19 of this Regulation, Member States shall ensure that the public is given early and effective opportunities to participate in their preparation, modification or review, using the arrangements already determined by the Member States in accordance with the second subparagraph of Article 2(3) of Directive 2003/35/EC.
Article 27
Committee
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 and may be assisted in its tasks by the scientific forum referred to in Article 28.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 28
Scientific forum
The Commission shall ensure the participation of representatives of the scientific community appointed by the Member States in providing advice on any scientific question related to the application of this Regulation, in particular as regards Articles 4, 5, 10 and 18. Those representatives shall meet in a scientific forum. The rules of procedure of that forum shall be established by the Commission.
Article 29
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 5(3) shall be conferred on the Commission for a period of five years from 1 January 2015. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Article 5(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 5(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 30
Penalties
1. Member States shall lay down the provisions on penalties applicable to infringements of this Regulation. Member States shall take all the necessary measures to ensure that they are applied.
2. The penalties provided for shall be effective, proportionate and dissuasive.
3. The penalties provided may include, inter alia:
(a)
fines;
(b)
seizure of the non-compliant invasive alien species of Union concern;
(c)
immediate suspension or withdrawal of a permit issued in accordance with Article 8.
4. By 2 January 2016, Member States shall communicate to the Commission the provisions referred to in paragraph 1, and any subsequent amendments without delay.
Article 31
Transitional provisions for non-commercial owners
1. By way of derogation from points (b) and (d) of Article 7(1), owners of companion animals not kept for commercial purposes that belong to the invasive alien species included on the Union list shall be allowed to keep them until the end of the animals' natural life, provided the following conditions are met:
(a)
the animals were kept before their inclusion on the Union list;
(b)
the animals are kept in contained holding and all appropriate measures are put in place to ensure that reproduction or escape are not possible.
2. Competent authorities shall take all reasonable steps to inform non-commercial owners of the risks posed by keeping the animals referred to in paragraph 1 and of the measures to be taken to minimise the risk of reproducing and escaping through awareness-raising and education programmes organised by Member States.
3. Non-commercial owners who cannot ensure that the conditions set out in paragraph 1 are met, shall not be permitted to keep the animals concerned. Member States may offer them the possibility of having their animals taken from them. Where this occurs, due regard to animal welfare shall be given.
4. The animals referred to in paragraph 3 of this Article may be kept by the establishments referred to in Article 8 or in facilities established by Member States for that purpose.
Article 32
Transitional provisions for commercial stocks
1. Keepers of a commercial stock of specimens of invasive alien species acquired before their inclusion on the Union list shall be allowed up to two years after inclusion of the species on that list to keep and transport live specimens or reproducible parts of those species in order to sell or transfer them to the research or ex-situ conservation establishments and for the purposes of medicinal activities referred to in Article 8, provided that the specimens are kept and transported in contained holding and all appropriate measures are put in place to ensure that reproduction or escape are not possible; or in order to slaughter or humanely cull those specimens to exhaust their stock.
2. The sale or transfer of live specimens to non-commercial users shall be allowed for one year after inclusion of the species on the Union list provided that the specimens are kept and transported in contained holding and all appropriate measures are put in place to ensure that reproduction or escape are not possible.
3. Where a permit has been issued in accordance with Article 6 of Regulation (EC) No 708/2007 for an aquaculture species that is subsequently included on the Union list, and the duration of the permit exceeds the period referred to in paragraph 1 of this Article, the Member State shall withdraw the permit in accordance with Article 12 of Regulation (EC) No 708/2007 by the end of the period referred to in paragraph 1 of this Article.
Article 33
Entry into force
This Regulation shall enter into force on 1 January 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 22 October 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
B. DELLA VEDOVA
(1) OJ C 177, 11.6.2014, p. 84.
(2) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 29 September 2014.
(3) Council Decision 93/626/EEC of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity (OJ L 309, 13.12.1993, p. 1).
(4) Council Decision 82/72/EEC of 3 December 1981 concerning the conclusion of the Convention on the conservation of European wildlife and natural habitats (OJ L 38, 10.2.1982, p. 1).
(5) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
(6) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19).
(7) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
(8) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
(9) Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1).
(10) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(11) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(12) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
(13) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1).
(14) Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (OJ L 61, 3.3.1997, p. 1).
(15) European Council Decision 2010/718/EU of 29 October 2010 amending the status with regard to the European Union of the island of Saint-Barthélemy (OJ L 325, 9.12.2010, p. 4).
(16) European Council Decision 2012/419/EU of 11 July 2012 amending the status of Mayotte with regard to the European Union (OJ L 204, 31.7.2012, p. 131).
(17) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
(18) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56).
(19) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).
(20) Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC (OJ L 156, 25.6.2003, p. 17).
(21) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(22) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
(23) Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56).
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Protecting biodiversity from invasive alien species
Protecting biodiversity from invasive alien species
SUMMARY OF:
Regulation (EU) No 1143/2014 on the prevention and management of the introduction and spread of invasive alien species
WHAT IS THE AIM OF THE REGULATION?
It sets out rules to prevent, minimise and mitigate the adverse impact on biodiversity and related ecosystem services caused by the introduction and spread of invasive alien species (IAS)* in the European Union (EU). IAS can also have a significant adverse impact on human health and the economy.
KEY POINTS
List of invasive alien species of Union concern
On 13 July 2016, the European Commission adopted its first list of IAS of ‘Union concern’. It entered into force on 3 August 2016. A first and a second update of the list entered into force on 2 August 2017 and on 15 August 2019, respectively. The list, which is developed on the basis of scientific risk assessments, is updated regularly and reviewed at least every 6 years. The most recent list dates from 2019.
Species on this list may not be intentionally brought into the EU’s territory. Nor may they be kept, bred, transported to, from or within the EU, sold, grown or released into the environment.
Permits
EU Member States may issue permits to allow research, off-site conservation and medicinal use of the species listed as IAS of Union concern. For any other uses, Member States wishing to issue permits first need to seek the Commission’s authorisation.
The IAS in question must be kept and handled in contained holding and transported under conditions that prevent their escape.
National action plans
Within 3 years of the listing of species, Member States have to establish and implement action plans to deal with the main routes of spread of IAS in their territory. This is to prevent the unintentional introduction and spread of IAS of Union concern in their territory.
IAS of regional concern and native IAS
IAS may originate in one EU region and create problems in another EU region. Here, at the request of the Member States involved, the Commission may play a role in ensuring that the affected Member States work together to deal with the problem.
Surveillance systems
Within 18 months of the adoption of the list of IAS of Union concern, Member States must establish surveillance systems that collect and record data on the occurrence of IAS in the environment.
Official controls
By 2 January 2016, Member States need to have established fully functioning structures to carry out the official controls necessary to prevent the intentional introduction into the EU of IAS of Union concern. Those official controls apply to the categories of goods falling within the Combined Nomenclature codes to which a reference is made in the Union list.
Early detection and rapid eradication of newly established IAS
After any new observation (first observation or first observation after eradication) of a listed IAS in a Member State or in part of its territory it must be rapidly eradicated. Eradication can be achieved by lethal or non-lethal measures.
Management of widely-spread IAS
Within 18 months of the listing of species, Member States need to establish management measures for IAS that have already widely spread in their territory, in order to minimise adverse effects.
These measures may be lethal or non lethal and should remain proportionate to their impact on the environment and appropriate to the specific circumstances in the Member State.
Restoring damaged ecosystems
Member States should carry out measures to assist in the recovery of an ecosystem that has been degraded, damaged or destroyed by an IAS of Union concern.
Transitional measures
Individuals may keep their pets (‘companion animals’ that belong to IAS) on the condition that: they were acquired before the list was drafted; andall appropriate measures are put in place to ensure that they cannot reproduce or escape.
In the first year after it was listed, a business or other commercial enterprise may continue selling a species until stock is exhausted. However, in the second year following listing, a species could be sold or transferred to an establishment holding a permit, or culled humanely. These transactions are allowed on the condition that all appropriate steps are taken to ensure that the species cannot escape or reproduce.
Implementing and delegated acts
Regulation (EU) No 1143/2014 grants the Commission implementing and delegated powers.
Delegated Regulation (EU) 2018/968 supplements Regulation (EU) No 1143/2014 with regard to risk assessments in relation to IAS. it describes in detail the methodology to be applied in the risk assessments, taking into account relevant national and international standards and the need to prioritise action against invasive alien species associated with, or that have the potential to cause, a significant adverse impact on biodiversity or related ecosystem services, as well as on human health or the economy, such adverse impact being considered as an aggravating factor.
In addition to implementing acts updating the lists of IAS, the Commission has adopted 2 other implementing acts: Implementing Regulation (EU) 2016/145 on the format of the document serving as evidence for the permit issued by the Member States allowing establishments to carry out certain activities concerning invasive alien species of Union concern;Implementing Regulation (EU) 2017/1454 specifying the technical formats for reporting by the Member States.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2015.
BACKGROUND
For more information, see:
Invasive alien species (European Commission).
KEY TERMS
Invasive alien species (IAS): plants or animals that have been transported outside their natural ecological range by humans (whether intentionally or unintentionally) into a new environment. While many of these species do not survive, some do and, due to their invasiveness, cause significant ecological and economic damage.
MAIN DOCUMENT
Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, pp. 35-55)
Successive amendments to Regulation (EU) No 1143/2014 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Delegated Regulation (EU) 2018/968 of 30 April 2018 supplementing Regulation (EU) No 1143/2014 of the European Parliament and of the Council with regard to risk assessments in relation to invasive alien species (OJ L 174, 10.7.2018, pp. 5-11)
Commission Implementing Regulation (EU) 2017/1454 of 10 August 2017 specifying the technical formats for reporting by the Member States pursuant to Regulation (EU) No 1143/2014 of the European Parliament and of the Council (OJ L 208, 11.8.2017, pp. 15-27)
Commission Implementing Regulation (EU) 2016/1141 of 13 July 2016 adopting a list of invasive alien species of Union concern pursuant to Regulation (EU) No 1143/2014 of the European Parliament and of the Council (OJ L 189, 14.7.2016, pp. 4-8)
See consolidated version.
Commission Implementing Regulation (EU) 2016/145 of 4 February 2016 adopting the format of the document serving as evidence for the permit issued by the competent authorities of Member States allowing establishments to carry out certain activities concerning invasive alien species of Union concern pursuant to Regulation (EU) No 1143/2014 of the European Parliament and of the Council (OJ L 30, 5.2.2016, pp. 1-6)
last update 10.09.2021
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32014R0517
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20.5.2014
EN
Official Journal of the European Union
L 150/195
REGULATION (EU) No 517/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 April 2014
on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
The Fourth Assessment Report of the Intergovernmental Panel on Climate Change (‘IPCC’) of the United Nations Framework Convention on Climate Change (‘UNFCCC’), to which the Union is party (3), stated that, on the basis of existing scientific data, developed countries would need to reduce greenhouse gas emissions by 80 % to 95 % below 1990 levels by 2050 to limit global climate change to a temperature increase of 2 °C and thus prevent undesirable climate effects.
(2)
To reach this target, the Commission adopted a Roadmap for moving to a competitive low carbon economy in 2050, which was noted by the Council in its Conclusions of 17 May 2011, and endorsed by the European Parliament in its Resolution of 15 March 2012. In that Roadmap, the Commission laid out a cost-effective way of achieving the necessary overall emission reductions in the Union by 2050. That roadmap establishes the sectoral contributions needed in six areas. Non-CO2 emissions, including fluorinated greenhouse gases but excluding non-CO2 emissions from agriculture, should be reduced by 72 % to 73 % by 2030 and by 70 % to 78 % by 2050, compared to 1990 levels. If based on the reference year 2005, a reduction in non-CO2 emissions, except those from agriculture, of 60 % to 61 % by 2030 is required. Fluorinated greenhouse gas emissions were estimated at 90 million tonnes (Mt) of CO2 equivalent in 2005. A 60 % reduction means that emissions would have to be reduced to approximately 35 Mt of CO2 equivalent by 2030. Given estimated emissions of 104 Mt of CO2 equivalent in 2030 based on the full application of current Union legislation, a further decrease of approximately 70 Mt of CO2 equivalent is required.
(3)
The Commission report of 26 September 2011 on the application, effects and adequacy of Regulation (EC) No 842/2006 of the European Parliament and of the Council (4) concluded that the current containment measures, if fully applied, have the potential to reduce emissions of fluorinated greenhouse gases. Those measures should therefore be maintained and clarified on the basis of the experience gained in implementing them. Certain measures should also be extended to other appliances in which substantial quantities of fluorinated greenhouse gases are used, such as refrigerated trucks and trailers. The obligation to establish and maintain records of equipment that contains such gases should also cover electrical switchgear. Given the importance of containment measures at the end of life of products and equipment containing fluorinated greenhouse gases, Member States should take account of the value of producer responsibility schemes and encourage their establishment, based on existing best practices.
(4)
That report also concluded that more can be done to reduce emissions of fluorinated greenhouse gases in the Union, in particular by avoiding the use of such gases where there are safe and energy-efficient alternative technologies with no impact or a lower impact on the climate. A decrease of up to two thirds of the 2010 emissions by 2030 is cost-effective because proven and tested alternatives are available in many sectors.
(5)
The European Parliament Resolution of 14 September 2011 on a comprehensive approach to non-CO2 climate-relevant anthropogenic emissions welcomed the Union’s commitment to support action on hydrofluorocarbons under the Montreal Protocol on substances that deplete the ozone layer (‘Montreal Protocol’) as a prime example of a non-market based approach to reducing greenhouse gas emissions. That Resolution also called for the exploration of ways to promote an immediate phase down of hydrofluorocarbons at international level through the Montreal Protocol.
(6)
To encourage the use of technologies with no impact or lower impact on the climate, the training of natural persons who carry out activities involving fluorinated greenhouse gases should cover information on technologies that serve to replace and reduce the use of fluorinated greenhouse gases. Given that some alternatives to fluorinated greenhouse gases used in products and equipment to replace and reduce the use of fluorinated greenhouse gases can be toxic, flammable or highly pressurised, the Commission should examine existing Union legislation covering the training of natural persons for the safe-handling of alternative refrigerants and, if appropriate, should submit a legislative proposal to the European Parliament and to the Council to amend the relevant Union legislation.
(7)
Certification and training programmes should be established or adapted taking account of those established under Regulation (EC) No 842/2006 and may be integrated into the vocational training systems.
(8)
To ensure coherence with monitoring and reporting requirements under the UNFCCC and with Decision 4/CMP.7 of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol to the UNFCCC, adopted by the seventh Conference of the Parties of the UNFCCC meeting in Durban on 11 December 2011, global warming potentials should be calculated in terms of the 100-year global warming potential of one kilogram of a gas relative to one kilogram of CO2. The calculation should, where possible, be based on the Fourth Assessment Report adopted by the IPCC.
(9)
Effective monitoring of fluorinated greenhouse gas emissions is critical for tracking progress towards the achievement of emission reduction targets and for assessing the impact of this Regulation. The use of consistent, high-quality data to report on fluorinated greenhouse gas emissions is essential to ensuring the quality of emissions reporting. The establishment of reporting systems by Member States of emissions of fluorinated greenhouse gases would provide coherence with Regulation (EU) No 525/2013 of the European Parliament and of the Council (5). Data on leakage of fluorinated greenhouse gases from equipment collected by companies under this Regulation could significantly improve those emission reporting systems. In that way, it should be possible to check the consistency of the data used to derive emissions and to improve approximations based on calculations, leading to a better estimation of emissions of fluorinated greenhouse gases in the national greenhouse gases inventories.
(10)
Given that there are suitable alternatives available, the current ban on using sulphur hexafluoride in magnesium die-casting and the recycling of magnesium die-casting alloys should be extended to facilities that use less than 850 kg of sulphur hexafluoride per year. Similarly, with an appropriate transitional period, the use of refrigerants with a very high global warming potential of 2 500 or more to service or maintain refrigeration equipment with a charge size of 40 tonnes of CO2 equivalent or more should be banned.
(11)
Where suitable alternatives to the use of specific fluorinated greenhouse gases are available, bans on the placing on the market of new equipment for refrigeration, air-conditioning and fire protection that contains, or whose functioning relies upon, those substances should be introduced. Where alternatives are not available or cannot be used for technical or safety reasons, or where the use of such alternatives would entail disproportionate costs, it should be possible for the Commission to authorise an exemption to allow the placing on the market of such products and equipment for a limited period. In the light of future technical developments, the Commission should further assess bans on the placing on the market of new equipment for medium-voltage secondary switchgear and new small single split air-conditioning systems.
(12)
Equipment containing fluorinated greenhouse gases should be allowed to be placed on the market if the overall greenhouse gas emissions of that equipment, taking into account realistic leakage and recovery rates, are lower, during its lifecycle, than those that would result from equivalent equipment without fluorinated greenhouse gases, which has the maximum allowed energy consumption set out in relevant implementing measures adopted under Directive 2009/125/EC of the European Parliament and of the Council (6). The regular and timely review of those implementing measures, in accordance with that Directive would help to ensure that those implementing measures continue to be effective and appropriate.
(13)
Gradually reducing the quantities of hydrofluorocarbons that can be placed on the market has been identified as the most effective and cost-efficient way of reducing emissions of those substances in the long term.
(14)
To implement the gradual reduction of the quantities of hydrofluorocarbons that can be placed on the Union market, the Commission should allocate quotas to individual producers and importers for the placing of hydrofluorocarbons on the market in order that the overall quantitative limit for the placing hydrofluorocarbons on the market is not exceeded. To protect the integrity of the gradual reduction of the quantities of hydrofluorocarbons placed on the market, hydrofluorocarbons contained in equipment should be accounted for under the Union quota system. Where hydrofluorocarbons contained in equipment have not been placed on the market prior to the charging of the equipment, a declaration of conformity should be required to prove that those hydrofluorocarbons are accounted for under the Union quota system.
(15)
Initially, the calculation of reference values and the allocation of quotas to individual producers and importers should be based on the quantities of hydrofluorocarbons that they reported as having been placed on the marked during the reference period from 2009 to 2012. However, in order not to exclude small undertakings, eleven per cent of the overall quantitative limit should be reserved for importers and producers who have not placed on the market 1 tonne or more of fluorinated greenhouse gases in the reference period.
(16)
By regularly recalculating the reference values and quotas, the Commission should ensure that undertakings are allowed to continue their activities on the basis of the average volumes they placed on the market in recent years.
(17)
The manufacturing process for some fluorinated gases can result in significant emissions of other fluorinated greenhouse gases produced as by-products. Such by-product emissions should be destroyed or recovered for subsequent use as a condition for the placing of fluorinated greenhouse gases on the market.
(18)
The Commission should ensure that a central electronic registry is in place to manage quotas, for the placing of hydrofluorocarbons on the market, and the reporting, including the reporting on equipment placed on the market, in particular where the equipment is pre-charged with hydrofluorocarbons that have not been placed on the market prior to the charging, thus requiring verification, through a declaration of conformity and subsequent third party verification, that the quantities of hydrofluorocarbons are accounted for under the Union quota system.
(19)
To maintain the flexibility of the market in bulk hydrofluorocarbons, it should be possible to transfer quotas allocated on the basis of reference values to another producer or importer in the Union or to another producer or importer which is represented in the Union by an only representative.
(20)
To enable the monitoring of the effectiveness of this Regulation, the scope of the current reporting obligations should be extended to cover other fluorinated substances that have significant global warming potential or that are likely to replace the fluorinated greenhouse gases listed in Annex I. For the same reason the destruction of fluorinated greenhouse gases and the importation into the Union of those gases when contained in products and equipment should also be reported. De minimis thresholds should be set to avoid disproportionate administrative burden, in particular for small and medium-sized enterprises and micro-enterprises.
(21)
The Commission should continuously monitor the effects of reducing the quantities of hydrofluorocarbons placed on the market, including its effects on the supply for equipment where the use of hydrofluorocarbons would result in lower life-cycle emissions than if an alternative technology was used. The Commission should produce a report on the availability of hydrofluorocarbons on the Union market by the end of 2020. A comprehensive review should be carried out by the Commission by the end of 2022 in time to adapt the provisions of this Regulation, in the light of its implementation and of new developments and international commitments, and to propose, if appropriate, further reduction measures.
(22)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (7).
(23)
In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (‘TFEU’) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(24)
Since it is adopted pursuant to Article 192(1) TFEU, this Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with the TFEU. Pursuant to Article 193 TFEU, Member States are to notify the Commission of any such measures.
(25)
This Regulation amends and complements the subject matter of Regulation (EC) No 842/2006, which should therefore be repealed. However, in order to ensure a smooth transition from the old regime to the new regime, it is appropriate to provide that Commission Regulations (EC) No 1493/2007 (8), (EC) No 1494/2007 (9), (EC) No 1497/2007 (10), (EC) No 1516/2007 (11), (EC) No 303/2008 (12), (EC) No 304/2008 (13), (EC) No 305/2008 (14), (EC) No 306/2008 (15), (EC) No 307/2008 (16) and (EC) No 308/2008 (17) should remain in force and continue to apply unless and until repealed by delegated or implementing acts adopted by the Commission pursuant to this Regulation.
(26)
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the transboundary nature of the environmental problem addressed and the effects of this Regulation on the intra-Union and external trade, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject-matter
The objective of this Regulation is to protect the environment by reducing emissions of fluorinated greenhouse gases. Accordingly, this Regulation:
(a)
establishes rules on containment, use, recovery and destruction of fluorinated greenhouse gases, and on related ancillary measures;
(b)
imposes conditions on the placing on the market of specific products and equipment that contain, or whose functioning relies upon, fluorinated greenhouse gases;
(c)
imposes conditions on specific uses of fluorinated greenhouse gases; and
(d)
establishes quantitative limits for the placing on the market of hydrofluorocarbons.
Article 2
Definitions
For the purposes of this Regulation the following definitions apply:
(1)
‘fluorinated greenhouse gases’ means the hydrofluorocarbons, perfluorocarbons, sulphur hexafluoride and other greenhouse gases that contain fluorine, listed in Annex I, or mixtures containing any of those substances;
(2)
‘hydrofluorocarbons’ or ‘HFCs’ means the substances listed in section 1 of Annex I, or mixtures containing any of those substances;
(3)
‘perfluorocarbons’ or ‘PFCs’ means the substances listed in section 2 of Annex I, or mixtures containing any of those substances;
(4)
‘sulphur hexafluoride’ or ‘SF6’ means the substance listed in section 3 of Annex I, or mixtures containing that substance;
(5)
‘mixture’ means a fluid composed of two or more substances, at least one of which is a substance listed in Annex I or in Annex II;
(6)
‘global warming potential’ or ‘GWP’ means the climatic warming potential of a greenhouse gas relative to that of carbon dioxide (‘CO2’), calculated in terms of the 100-year warming potential of one kilogram of a greenhouse gas relative to one kilogram of CO2, as set out in Annexes I, II and IV or in the case of mixtures, calculated in accordance with Annex IV;
(7)
‘tonne(s) of CO2 equivalent’ means a quantity of greenhouse gases„ expressed as the product of the weight of the greenhouse gases in metric tonnes and of their global warming potential;
(8)
‘operator’ means the natural or legal person exercising actual power over the technical functioning of products and equipment covered by this Regulation; a Member State may, in defined, specific situations, designate the owner as being responsible for the operator’s obligations;
(9)
‘use’ means the utilisation of fluorinated greenhouse gases in the production, maintenance or servicing, including the refilling, of products and equipment, or in other processes referred to in this Regulation;
(10)
‘placing on the market’ means supplying or making available to another party in the Union for the first time, for payment or free of charge, or using for its own account in the case of a producer, and includes customs release for free circulation in the Union;
(11)
‘hermetically sealed equipment’ means equipment in which all fluorinated greenhouse gas containing parts are made tight by welding, brazing or a similar permanent connection, which may include capped valves or capped service ports that allow proper repair or disposal, and which have a tested leakage rate of less than 3 grams per year under a pressure of at least a quarter of the maximum allowable pressure;
(12)
‘container’ means a product which is designed primarily for transporting or storing fluorinated greenhouse gases;
(13)
‘a non-refillable container’ means a container which cannot be refilled without being adapted for that purpose or is placed on the market without provision having been made for its return for refilling;
(14)
‘recovery’ means the collection and storage of fluorinated greenhouse gases from products, including containers, and equipment during maintenance or servicing or prior to the disposal of the products or equipment;
(15)
‘recycling’ means the reuse of a recovered fluorinated greenhouse gas following a basic cleaning process;
(16)
‘reclamation’ means the reprocessing of a recovered fluorinated greenhouse gas in order to match the equivalent performance of a virgin substance, taking into account its intended use;
(17)
‘destruction’ means the process of permanently transforming or decomposing all or most of a fluorinated greenhouse gas into one or more stable substances that are not fluorinated greenhouse gases;
(18)
‘decommissioning’ means the final shut-down and removal from operation or usage of a product or piece of equipment containing fluorinated greenhouse gases;
(19)
‘repair’ means the restoration of damaged or leaking products or equipment that contain, or whose functioning relies upon, fluorinated greenhouse gases, involving a part containing or designed to contain such gases;
(20)
‘installation’ means joining two or more pieces of equipment or circuits containing or designed to contain fluorinated greenhouse gases, with a view to assembling a system in the location where it will be operated, that entails joining together gas carrying conductors of a system to complete a circuit irrespective of the need to charge the system after assembly;
(21)
‘maintenance or servicing’ means all activities, excluding recovery in accordance with Article 8 and leak checks in accordance with Article 4 and point (b) of Article 10(1) of this Regulation, that entail breaking into the circuits containing or designed to contain fluorinated greenhouse gases, in particular supplying the system with fluorinated greenhouse gases, removing one or more pieces of circuit or equipment, reassembling two or more pieces of circuit or equipment, as well as repairing leaks;
(22)
‘virgin substance’ means a substance which has not previously been used;
(23)
‘stationary’ means not normally in transit during operation and includes moveable room air-conditioning appliances;
(24)
‘mobile’ means normally in transit during operation;
(25)
‘one-component foam’ means a foam composition contained in a single aerosol dispenser in unreacted or partly reacted liquid state and that expands and hardens when it leaves the dispenser;
(26)
‘refrigerated truck’ means a motor vehicle with a mass of more than 3,5 tonnes that is designed and constructed primarily to carry goods and that is equipped with a refrigeration unit;
(27)
‘refrigerated trailer’ means a vehicle that is designed and constructed to be towed by a truck or a tractor, primarily to carry goods and that is equipped with a refrigeration unit;
(28)
‘technical aerosol’ means an aerosol dispenser used in maintaining, repairing, cleaning, testing, disinsecting and manufacturing products and equipment, installing equipment, and in other applications;
(29)
‘leakage detection system’ means a calibrated mechanical, electrical or electronic device for detecting leakage of fluorinated greenhouse gases which, on detection, alerts the operator;
(30)
‘undertaking’ means any natural or legal person who:
(a)
produces, uses, recovers, collects, recycles, reclaims, or destroys fluorinated greenhouse gases;
(b)
imports or exports fluorinated greenhouse gases or products and equipment that contain such gases;
(c)
places on the market fluorinated greenhouse gases or products and equipment that contain, or whose functioning relies upon, such gases;
(d)
installs, services, maintains, repairs, checks for leaks or decommissions equipment that contains, or whose functioning relies upon, fluorinated greenhouse gases;
(e)
is the operator of equipment that contains, or whose functioning relies upon, fluorinated greenhouse gases;
(f)
produces, imports, exports, places on the market or destroys gases listed in Annex II;
(g)
places on the market products or equipment containing gases listed in Annex II;
(31)
‘feedstock’ means any fluorinated greenhouse gas, or substance listed in Annex II, that undergoes chemical transformation in a process in which it is entirely converted from its original composition and its emissions are insignificant;
(32)
‘commercial use’ means used for the storage, display or dispensing of products, for sale to end users, in retail and food services;
(33)
‘fire protection equipment’ means the equipment and systems utilised in fire prevention or suppression applications and includes fire extinguishers;
(34)
‘organic Rankine cycle’ means a cycle containing condensable fluorinated greenhouse gas converting heat from a heat source into power for the generation of electric or mechanical energy;
(35)
‘military equipment’ mean arms, munitions and war material intended specifically for military purposes which are necessary for the protection of the essential interests of the security of Member States;
(36)
‘electrical switchgear’ means switching devices and their combination with associated control, measuring, protective and regulating equipment, and assemblies of such devices and equipment with associated interconnections, accessories, enclosures and supporting structures, intended for usage in connection with the generation, transmission, distribution and conversion of electric energy;
(37)
‘multipack centralised refrigeration systems’ means systems with two or more compressors operated in parallel, which are connected to one or more common condensers and to a number of cooling devices such as display cases, cabinets, freezers or to chilled store rooms;
(38)
‘primary refrigerant circuit of cascade systems’ means the primary circuit in indirect medium temperature systems where a combination of two or more separate refrigeration circuits are connected in series such that the primary circuit absorbs the condenser heat from a secondary circuit for the medium temperature;
(39)
‘single split air conditioning systems’ means systems for room air conditioning that consist of one outdoor unit and one indoor unit linked by refrigerant piping, needing installation at the site of usage.
CHAPTER II
CONTAINMENT
Article 3
Prevention of emissions of fluorinated greenhouse gases
1. The intentional release of fluorinated greenhouse gases into the atmosphere shall be prohibited where the release is not technically necessary for the intended use.
2. Operators of equipment that contains fluorinated greenhouse gases shall take precautions to prevent the unintentional release (‘leakage’) of those gases. They shall take all measures which are technically and economically feasible to minimise leakage of fluorinated greenhouse gases.
3. Where a leakage of fluorinated greenhouse gases is detected, the operators shall ensure that the equipment is repaired without undue delay.
Where the equipment is subject to leak checks under Article 4(1), and a leak in the equipment has been repaired, the operators shall ensure that the equipment is checked by a certified natural person within one month after the repair to verify that the repair has been effective.
4. Natural persons carrying out the tasks referred to in points (a) to (c) of Article 10(1) shall be certified in accordance with Article 10(4) and (7) and shall take precautionary measures to prevent leakage of fluorinated greenhouse gases.
Undertakings carrying out the installation, servicing, maintenance, repair or decommissioning of the equipment listed in points (a) to (d) of the Article 4(2) shall be certified in accordance with Article 10(6) and (7) and shall take precautionary measures to prevent leakage of fluorinated greenhouse gases.
Article 4
Leak checks
1. Operators of equipment that contains fluorinated greenhouse gases in quantities of 5 tonnes of CO2 equivalent or more and not contained in foams shall ensure that the equipment is checked for leaks.
Hermetically sealed equipment that contains fluorinated greenhouse gases in quantities of less than 10 tonnes of CO2 equivalent, shall not be subject to leak checks under this Article, provided the equipment is labelled as hermetically sealed.
Electrical switchgear shall not be subject to leak checks under this Article provided it complies with one of the following conditions:
(a)
it has a tested leakage rate of less than 0,1 % per year as set out in the technical specification of the manufacturer and is labelled accordingly;
(b)
it is equipped with a pressure or density monitoring device; or
(c)
it contains less than 6 kg of fluorinated greenhouse gases.
2. Paragraph 1 applies to operators of the following equipment that contains fluorinated greenhouse gases:
(a)
stationary refrigeration equipment;
(b)
stationary air-conditioning equipment;
(c)
stationary heat pumps;
(d)
stationary fire protection equipment;
(e)
refrigeration units of refrigerated trucks and trailers;
(f)
electrical switchgear;
(g)
organic Rankine cycles.
As regards the equipment referred to in points (a) to (e) of the first subparagraph, the checks shall be carried out by natural persons certified in accordance with the rules provided for in Article 10.
By way of derogation from the first subparagraph of paragraph 1, until 31 December 2016, equipment that contains less than 3 kg of fluorinated greenhouse gases or hermetically sealed equipment, which is labelled accordingly and contains less than 6 kg of fluorinated greenhouse gases shall not be subject to leak checks.
3. The leak checks pursuant to paragraph 1 shall be carried out with the following frequency:
(a)
for equipment that contains fluorinated greenhouse gases in quantities of 5 tonnes of CO2 equivalent or more, but of less than 50 tonnes of CO2 equivalent: at least every 12 months; or where a leakage detection system is installed, at least every 24 months;
(b)
for equipment that contains fluorinated greenhouse gases in quantities of 50 tonnes of CO2 equivalent or more, but of less than 500 tonnes of CO2 equivalent: at least every six months or, where a leakage detection system is installed, at least every 12 months;
(c)
for equipment that contains fluorinated greenhouse gases in quantities of 500 tonnes of CO2 equivalent or more: at least every three months or, where a leakage detection system is installed, at least every six months.
4. Obligations of paragraph 1 for fire protection equipment as referred to in point (d) of paragraph 2 shall be considered to be fulfilled provided the following two conditions are met:
(a)
the existing inspection regime meets ISO 14520 or EN 15004 standards; and
(b)
the fire protection equipment is inspected as often as is required under paragraph 3.
5. The Commission may, by means of implementing acts, specify requirements for the leak checks to be carried out in accordance with paragraph 1 of this Article for each type of equipment referred to in that paragraph, identify those parts of the equipment most likely to leak and repeal acts adopted pursuant to Article 3(7) of Regulation (EC) No 842/2006. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
Article 5
Leakage detection systems
1. Operators of the equipment listed in points (a) to (d) of Article 4(2) and containing fluorinated greenhouse gases in quantities of 500 tonnes of CO2 equivalent or more, shall ensure that the equipment is provided with a leakage detection system which alerts the operator or a service company of any leakage.
2. Operators of the equipment listed in points (f) and (g) of Article 4(2) and containing fluorinated greenhouse gases in quantities of 500 tonnes of CO2 equivalent or more and installed from 1 January 2017, shall ensure that this equipment is provided with a leakage detection system which alerts the operator or a service company of any leakage.
3. Operators of the equipment listed in points (a) to (d) and (g) of Article 4(2) that is subject to paragraph 1 or 2 of this Article shall ensure that leakage detection systems are checked at least once every 12 months to ensure their proper functioning.
4. Operators of the equipment listed in point (f) of Article 4(2) that is subject to paragraph 2 of this Article shall ensure that leakage detection systems are checked at least once every 6 years to ensure their proper functioning.
Article 6
Record keeping
1. Operators of equipment which is required to be checked for leaks pursuant to Article 4(1), shall establish and maintain records for each piece of such equipment specifying the following information:
(a)
the quantity and type of fluorinated greenhouse gases installed;
(b)
the quantities of fluorinated greenhouse gases added during installation, maintenance or servicing or due to leakage;
(c)
whether the quantities of installed fluorinated greenhouse gases have been recycled or reclaimed, including the name and address of the recycling or reclamation facility and, where applicable, the certificate number;
(d)
the quantity of fluorinated greenhouse gases recovered;
(e)
the identity of the undertaking which installed, serviced, maintained and where applicable repaired or decommissioned the equipment, including, where applicable, the number of its certificate;
(f)
the dates and results of the checks carried out under Article 4(1) to (3);
(g)
if the equipment was decommissioned, the measures taken to recover and dispose of the fluorinated greenhouse gases.
2. Unless the records referred to in paragraph 1 are stored in a database set up by the competent authorities of the Member States the following rules apply:
(a)
the operators referred to in paragraph 1 shall keep the records referred to in that paragraph for at least five years;
(b)
undertakings carrying out the activities referred to in point (e) of paragraph 1 for operators shall keep copies of the records referred to in paragraph 1 for at least five years.
The records referred to in paragraph 1 shall be made available, on request, to the competent authority of the Member State concerned or to the Commission. To the extent that such records contain environmental information, Directive 2003/4/EC of the European Parliament and of the Council (18) or Regulation (EC) No 1367/2006 of the European Parliament and of the Council (19) shall apply as appropriate.
3. For the purpose of Article 11(4), undertakings supplying fluorinated greenhouse gases shall establish records of relevant information on the purchasers of fluorinated greenhouse gases including the following details:
(a)
the numbers of certificates of the purchasers; and
(b)
the respective quantities of fluorinated greenhouse gases purchased.
The undertakings supplying fluorinated greenhouse gases shall maintain those records for at least five years.
The undertakings supplying fluorinated greenhouse gases shall make such records available, on request, to the competent authority of the Member State concerned or to the Commission. To the extent that the records contain environmental information, Directive 2003/4/EC or Regulation (EC) No 1367/2006 shall apply as appropriate.
4. The Commission may, by means of an implementing act, determine the format of the records referred to in paragraphs 1 and 3 of this Article and specify how they should be established and maintained. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24.
Article 7
Emissions of fluorinated greenhouse gases in relation to production
1. Producers of fluorinated compounds shall take all necessary precautions to limit emissions of fluorinated greenhouse gases to the greatest extent possible during:
(a)
production;
(b)
transport; and
(c)
storage.
This Article also applies where fluorinated greenhouse gases are produced as by-products.
2. Without prejudice to Article 11(1), the placing on the market of fluorinated greenhouse gases and gases listed in Annex II shall be prohibited unless, where relevant, producers or importers provide evidence, at the time of such placing, that trifluoromethane, produced as a by-product during the manufacturing process, including during the manufacturing of feedstocks for their production, has been destroyed or recovered for subsequent use, in line with best available techniques.
This requirement shall apply from 11 June 2015.
Article 8
Recovery
1. Operators of stationary equipment or of refrigeration units of refrigerated trucks and trailers that contain fluorinated greenhouse gases not contained in foams shall ensure that the recovery of those gases is carried out by natural persons that hold the relevant certificates provided for by Article 10, so that those gases are recycled, reclaimed or destroyed.
This obligation applies to operators of any of the following equipment:
(a)
the cooling circuits of stationary refrigeration, stationary air-conditioning and stationary heat pump equipment;
(b)
the cooling circuits of refrigeration units of refrigerated trucks and trailers;
(c)
stationary equipment that contains fluorinated greenhouse gas-based solvents;
(d)
stationary fire protection equipment;
(e)
stationary electrical switchgear.
2. The undertaking that uses a fluorinated greenhouse gas container immediately prior to its disposal shall arrange for the recovery of any residual gases to make sure they are recycled, reclaimed or destroyed.
3. Operators of products and equipment not listed in paragraph 1, including mobile equipment, that contain fluorinated greenhouse gases shall arrange for the recovery of the gases, to the extent that it is technically feasible and does not entail disproportionate costs, by appropriately qualified natural persons, so that they are recycled, reclaimed or destroyed or shall arrange for their destruction without prior recovery.
The recovery of fluorinated greenhouse gases from air-conditioning equipment in road vehicles outside the scope of Directive 2006/40/EC of the European Parliament and of the Council (20) shall be carried out by appropriately qualified natural persons.
For the recovery of fluorinated greenhouse gases from air-conditioning equipment in motor vehicles falling within the scope of Directive 2006/40/EC only natural persons holding at least a training attestation in accordance with Article 10(2) shall be considered appropriately qualified.
Article 9
Producer responsibility schemes
Without prejudice to existing Union legislation, Member States shall encourage the development of producer responsibility schemes for the recovery of fluorinated greenhouse gases and their recycling, reclamation or destruction.
Member States shall provide information to the Commission on the actions undertaken under the first paragraph.
Article 10
Training and certification
1. Member States shall, on the basis of the minimum requirements referred to in paragraph 5, establish or adapt certification programmes, including evaluation processes. Member States shall ensure that training is available for natural persons carrying out the following tasks:
(a)
installation, servicing, maintenance, repair or decommissioning of the equipment listed in the points (a) to (f) of Article 4(2);
(b)
leak checks of the equipment referred to in points (a) to (e) of Article 4(2), as provided for in Article 4(1);
(c)
recovery of fluorinated greenhouse gases as provided for in Article 8(1).
2. Member States shall ensure that training programmes for natural persons recovering fluorinated greenhouse gases from air-conditioning equipment in motor vehicles falling within the scope of Directive 2006/40/EC are available, on the basis of the minimum requirements referred to in paragraph 5.
3. The certification programmes and training provided for in paragraphs 1 and 2 shall cover the following:
(a)
applicable regulations and technical standards;
(b)
emission prevention;
(c)
recovery of fluorinated greenhouse gases;
(d)
safe handling of equipment of the type and size covered by the certificate;
(e)
information on relevant technologies to replace or to reduce the use of fluorinated greenhouse gases and their safe handling.
4. Certificates under the certification programmes provided for in paragraph 1 shall be subject to the condition that the applicant has successfully completed an evaluation process established in accordance with paragraphs 1, 3 and 5.
5. The minimum requirements for certification programmes are those laid down in Regulations (EC) No 303/2008 to (EC) No 306/2008 and under paragraph 12. The minimum requirements for training attestations are those laid down in Regulation (EC) No 307/2008 and under paragraph 12. Those minimum requirements shall specify, for each type of equipment referred to in paragraphs 1 and 2, the required practical skills and theoretical knowledge, where appropriate, differentiating between different activities to be covered, as well as the conditions for mutual recognition of certificates and training attestations.
6. Member States shall establish or adapt certification programmes on the basis of the minimum requirements referred to in paragraph 5 for undertakings carrying out installation, servicing, maintenance, repair or decommissioning of the equipment listed in points (a) to (d) of Article 4(2) for other parties.
7. Existing certificates and training attestations issued in accordance with Regulation (EC) No 842/2006 shall remain valid, in accordance with the conditions under which they were originally issued.
8. Member States shall ensure that all natural persons holding certificates under certification programmes provided for in paragraphs 1 and 7 have access to information regarding each of the following:
(a)
technologies referred to point (e) of paragraph 3; and
(b)
existing regulatory requirements for working with equipment containing alternative refrigerants to fluorinated greenhouse gases.
9. Member States shall ensure the availability of training for natural persons who wish to update their knowledge in relation to the matters referred to in paragraph 3.
10. By 1 January 2017 Member States shall notify the Commission of certification and training programmes.
Member States shall recognise certificates and training attestations issued in another Member State in accordance with this Article. They shall not restrict the freedom to provide services or the freedom of establishment because a certificate was issued in another Member State.
11. Any undertaking which assigns a task referred to in paragraph 1 to another undertaking shall take reasonable steps to ascertain that the latter holds the necessary certificates for the required tasks pursuant to this Article.
12. In the event that it appears necessary for the purposes of the application of this Article, to provide for a more harmonised approach to training and certification, the Commission shall, by means of implementing acts, adapt and update the minimum requirements as to the skills and knowledge to be covered, specify the modalities of the certification or attestation and the conditions for mutual recognition and repeal acts adopted pursuant to Article 5(1) of Regulation (EC) No 842/2006. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24. When exercising the power conferred on it by this paragraph, the Commission shall take into account relevant existing qualification or certification schemes.
13. The Commission may, by means of implementing acts, determine the format of the notification referred to in paragraph 10 of this Article and may repeal acts adopted pursuant to Article 5(5) of Regulation (EC) No 842/2006. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
14. Where the obligations under this Article relating to the provision of certification and training would impose disproportionate burdens on a Member State because of the small size of its population and the consequent lack of demand for such training and certification, compliance may be achieved through the recognition of certificates issued in other Member States.
Member States applying this paragraph shall inform the Commission who shall inform other Member States.
15. Nothing in this Article shall prevent Member States from setting up further certification and training programmes in respect of equipment other than that referred to in paragraph 1.
CHAPTER III
PLACING ON THE MARKET AND CONTROL OF USE
Article 11
Restrictions on the placing on the market
1. The placing on the market of products and equipment listed in Annex III, with an exemption for military equipment, shall be prohibited from the date specified in that Annex, differentiating, where applicable, according to the type or global warming potential of the fluorinated greenhouse gas contained.
2. The prohibition set out in paragraph 1 shall not apply to equipment for which it has been established in ecodesign requirements adopted under Directive 2009/125/EC that due to higher energy efficiency during its operation, its lifecycle CO2 equivalent emissions would be lower than those of equivalent equipment which meets relevant ecodesign requirements and does not contain hydrofluorocarbons.
3. Following a substantiated request by a competent authority of a Member State and taking into account the objectives of this Regulation, the Commission may, exceptionally, by means of implementing acts, authorise an exemption for up to four years to allow the placing on the market of products and equipment listed in Annex III containing, or whose functioning relies upon, fluorinated greenhouse gases, where it is demonstrated that:
(a)
for a specific product or a piece of equipment, or for a specific category of products or equipment, alternatives are not available, or cannot be used for technical or safety reasons; or
(b)
the use of technically feasible and safe alternatives would entail disproportionate costs.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
4. For the purposes of carrying out the installation, servicing, maintenance or repair of the equipment that contains fluorinated greenhouse gases or whose functioning relies upon those gases for which certification or attestation is required under Article 10, fluorinated greenhouse gases shall only be sold to and purchased by undertakings that hold the relevant certificates or attestations in accordance with Article 10 or undertakings that employ persons holding a certificate or a training attestation in accordance with Article 10(2) and (5). This paragraph shall not prevent non-certified undertakings, who do not carry out the activities referred to in the first sentence of this paragraph, from collecting, transporting or delivering fluorinated greenhouse gases.
5. Non-hermetically sealed equipment charged with fluorinated greenhouse gases shall only be sold to the end user where evidence is provided that the installation is to be carried out by an undertaking certified in accordance with Article 10.
6. The Commission shall collect, on the basis of available data from Member States, information on national codes, standards or legislation of Member States with respect to replacement technologies using alternatives to fluorinated greenhouse gases in refrigeration, air-conditioning and heat pump equipment and in foams.
The Commission shall publish a synthesis report on the information collected under the first subparagraph by 1 January 2017.
Article 12
Labelling and product and equipment information
1. Products and equipment that contain, or whose functioning relies upon, fluorinated greenhouse gases shall not be placed on the market unless they are labelled. This only applies to:
(a)
refrigeration equipment;
(b)
air-conditioning equipment;
(c)
heat pumps;
(d)
fire protection equipment;
(e)
electrical switchgear;
(f)
aerosol dispenser that contain fluorinated greenhouse gases, with the exception of metered dose inhalers for the delivery of pharmaceutical ingredients;
(g)
all fluorinated greenhouse gas containers;
(h)
fluorinated greenhouse gas-based solvents;
(i)
organic Rankine cycles.
2. Products or equipment subject to an exemption under Article 11(3) shall be labelled accordingly and shall include a reference that those products or equipment may only be used for the purpose for which an exemption under that Article was granted.
3. The label required pursuant to paragraph 1 shall indicate the following information:
(a)
a reference that the product or equipment contains fluorinated greenhouse gases or that its functioning relies upon such gases;
(b)
the accepted industry designation for the fluorinated greenhouse gases concerned or, if no such designation is available, the chemical name;
(c)
from 1 January 2017, the quantity expressed in weight and in CO2 equivalent of fluorinated greenhouse gases contained in the product or equipment, or the quantity of fluorinated greenhouse gases for which the equipment is designed, and the global warming potential of those gases.
The label required pursuant to paragraph 1 shall indicate the following information, where applicable:
(a)
a reference that the fluorinated greenhouse gases are contained in hermetically sealed equipment;
(b)
a reference that the electrical switchgear has a tested leakage rate of less than 0,1 % per year as set out in the technical specification of the manufacturer.
4. The label shall be clearly readable and indelible and shall be placed either:
(a)
adjacent to the service ports for charging or recovering the fluorinated greenhouse gas; or
(b)
on that part of the product or equipment that contains the fluorinated greenhouse gas.
The label shall be in the official languages of the Member State in which it is to be placed on the market.
5. Foams and pre-blended polyols that contain fluorinated greenhouse gases shall not be placed on the market unless the fluorinated greenhouse gases are identified with a label using the accepted industry designation or, if no such designation is available, the chemical name. The label shall clearly indicate that the foam or pre-blended polyol contains fluorinated greenhouse gases. In the case of foam boards, this information shall be clearly and indelibly stated on the boards.
6. Reclaimed or recycled fluorinated greenhouse gases shall be labelled with an indication that the substance has been reclaimed or recycled, information on the batch number and the name and address of the reclamation or recycling facility.
7. Fluorinated greenhouse gases placed on the market for destruction shall be labelled with an indication that the contents of the container may only be destroyed.
8. Fluorinated greenhouse gases placed on the market for direct export shall be labelled with an indication that the contents of the container may only be directly exported.
9. Fluorinated greenhouse gases placed on the market for the use in military equipment shall be labelled with an indication that the contents of the container may only be used for that purpose.
10. Fluorinated greenhouse gases placed on the market for the etching of semiconductor material or the cleaning of chemicals vapour deposition chambers within the semiconductor manufacturing sector shall be labelled with an indication that the contents of the container may only be used for that purpose.
11. Fluorinated greenhouse gases placed on the market for feedstock use shall be labelled with an indication that the contents of the container may only be used as feedstock.
12. Fluorinated greenhouse gases placed on the market for producing metered dose inhalers for the delivery of pharmaceutical ingredients shall be labelled with an indication that the contents of the container may only be used for that purpose.
13. The information referred to in paragraphs 3 and 5 shall be included in instruction manuals for the products and equipment concerned.
In the case of products and equipment that contain fluorinated greenhouse gases with a global warming potential of 150 or more this information shall also be included in descriptions used for advertising.
14. The Commission may, by means of implementing acts, determine the format of the labels referred to in paragraph 1 and paragraphs 4 to 12 and may repeal acts adopted pursuant to Article 7(3) of Regulation (EC) No 842/2006. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
15. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 amending the labelling requirements set out in paragraphs 4 to 12 where appropriate in view of commercial or technological development.
Article 13
Control of use
1. The use of sulphur hexafluoride in magnesium die-casting and in the recycling of magnesium die-casting alloys shall be prohibited.
As regards installations using a quantity of sulphur hexafluoride below 850 kg per year, in respect of magnesium die-casting and in the recycling of magnesium die-casting alloys, this prohibition shall only apply from 1 January 2018.
2. The use of sulphur hexafluoride to fill vehicle tyres shall be prohibited.
3. From 1 January 2020, the use of fluorinated greenhouse gases, with a global warming potential of 2 500 or more, to service or maintain refrigeration equipment with a charge size of 40 tonnes of CO2 equivalent or more, shall be prohibited.
This paragraph shall not apply to military equipment or equipment intended for applications designed to cool products to temperatures below – 50 °C.
The prohibition referred to in the first subparagraph shall not apply to the following categories of fluorinated greenhouse gases until 1 January 2030:
(a)
reclaimed fluorinated greenhouse gases with a global warming potential of 2 500 or more used for the maintenance or servicing of existing refrigeration equipment, provided that they have been labelled in accordance with Article 12(6);
(b)
recycled fluorinated greenhouse gases with a global warming potential of 2 500 or more used for the maintenance or servicing of existing refrigeration equipment provided they have been recovered from such equipment. Such recycled gases may only be used by the undertaking which carried out their recovery as part of maintenance or servicing or the undertaking for which the recovery was carried out as part of maintenance or servicing.
The prohibition referred to in the first subparagraph shall not apply to refrigeration equipment for which an exemption has been authorised pursuant to Article 11(3).
Article 14
Pre-charging of equipment with hydrofluorocarbons
1. From 1 January 2017 refrigeration, air conditioning and heat pump equipment charged with hydrofluorocarbons shall not be placed on the market unless hydrofluorocarbons charged into the equipment are accounted for within the quota system referred to in Chapter IV.
2. When placing pre-charged equipment as referred to in paragraph 1 on the market, manufacturers and importers of equipment shall ensure that compliance with paragraph 1 is fully documented and shall draw up a declaration of conformity in this respect.
From 1 January 2018, where hydrofluorocarbons contained in the equipment have not been placed on the market prior to the charging of the equipment, importers of that equipment shall ensure that by 31 March every year the accuracy of the documentation and declaration of conformity is verified, for the preceding calendar year, by an independent auditor. The auditor shall be either:
(a)
accredited pursuant to Directive 2003/87/EC of the European Parliament and of the Council (21); or
(b)
accredited to verify financial statements in accordance with the legislation of the Member State concerned.
Manufacturers and importers of equipment referred to in paragraph 1 shall keep the documentation and declaration of conformity for a period of at least five years after the placing on the market of that equipment. Importers of equipment placing on the market pre-charged equipment where hydrofluorocarbons contained in that equipment have not been placed on the market prior to the charging of the equipment shall ensure they are registered pursuant to point (e) of Article 17(1).
3. By drawing up the declaration of conformity, manufacturers and importers of equipment referred to in paragraph 1 shall assume responsibility for compliance with paragraphs 1 and 2.
4. The Commission shall, by means of implementing acts, determine the detailed arrangements relating to the declaration of conformity and the verification by the independent auditor referred to in the second subparagraph of paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
CHAPTER IV
REDUCTION OF THE QUANTITY OF HYDROFLUOROCARBONS PLACED ON THE MARKET
Article 15
Reduction of the quantity of hydrofluorocarbons placed on the market
1. The Commission shall ensure that the quantity of hydrofluorocarbons that producers and importers are entitled to place on the market in the Union each year does not exceed the maximum quantity for the year in question calculated in accordance with Annex V.
Producers and importers shall ensure that the quantity of hydrofluorocarbons calculated in accordance with Annex V that that each of them places on the market does not exceed their respective quota allocated pursuant to Article 16(5) or transferred pursuant to Article 18.
2. This Article shall not apply to producers or importers of less than 100 tonnes of CO2 equivalent of hydrofluorocarbons per year.
This Article shall also not apply to the following categories of hydrofluorocarbons:
(a)
hydrofluorocarbons imported into the Union for destruction;
(b)
hydrofluorocarbons used by a producer in feedstock applications or supplied directly by a producer or an importer to undertakings for use in feedstock applications;
(c)
hydrofluorocarbons supplied directly by a producer or an importer to undertakings, for export out of the Union, where those hydrofluorcarbons are not subsequently made available to any other party within the Union, prior to export;
(d)
hydrofluorocarbons supplied directly by a producer or an importer for use in military equipment;
(e)
hydrofluorocarbons supplied directly by a producer or an importer to an undertaking using it for the etching of semiconductor material or the cleaning of chemicals vapour deposition chambers within the semiconductor manufacturing sector;
(f)
from 1 January 2018 onwards, hydrofluorocarbons supplied directly by a producer or an importer to an undertaking producing metered dose inhalers for the delivery of pharmaceutical ingredients.
3. This Article and Articles 16, 18, 19 and 25 shall also apply to hydrofluorocarbons contained in pre-blended polyols.
4. Following a substantiated request by a competent authority of a Member State and taking into account the objectives of this Regulation, the Commission may, exceptionally, by means of implementing acts, authorise an exemption for up to four years to exclude from the quota requirement laid down in paragraph 1 hydrofluorocarbons for use in specific applications, or specific categories of products or equipment, where it is demonstrated that:
(a)
for those particular applications, products or equipment, alternatives are not available, or cannot be used for technical or safety reasons; and
(b)
a sufficient supply of hydrofluorcarbons cannot be ensured without entailing disproportionate costs.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
Article 16
Allocation of quotas for placing hydrofluorocarbons on the market
1. By 31 October 2014 the Commission shall, by means of implementing acts, determine for each producer or importer, having reported data under Article 6 of Regulation (EC) No 842/2006, a reference value based on the annual average of the quantities of hydrofluorocarbons the producer or importer reported to have placed on the market from 2009 to 2012. The reference values shall be calculated in accordance with Annex V to this Regulation.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
2. Producers and importers that have not reported placing on the market hydrofluorocarbons under Article 6 of Regulation (EC) No 842/2006 for the reference period referred to in paragraph 1 may declare their intention to place hydrofluorocarbons on the market in the following year.
The declaration shall be addressed to the Commission, specifying the types of hydrofluorocarbons and the quantities that are expected to be placed on the market.
The Commission shall issue a notice of the time-limit for submitting those declarations. Before submitting a declaration pursuant to paragraphs 2 and 4 of this Article, undertakings shall register in the registry provided for in Article 17.
3. By 31 October 2017 and every three years thereafter, the Commission shall recalculate the reference values for the producers and importers referred to in paragraphs 1 and 2 of this Article on the basis of the annual average of the quantities of hydrofluorocarbons lawfully placed on the market from 1 January 2015 as reported under Article 19 for the years available. The Commission shall determine those reference values by means of implementing acts.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
4. Producers and importers for which reference values have been determined may declare additional anticipated quantities following the procedure set out in paragraph 2.
5. The Commission shall allocate quotas for placing hydrofluorocarbons on the market for each producer and importer for each year beginning with the year 2015, applying the allocation mechanism laid down in Annex VI.
Quotas shall only be allocated to producers or importers which are established within the Union, or which have mandated an only representative established within the Union for the purpose of compliance with the requirements of this Regulation. The only representative may be the same as the one mandated pursuant to Article 8 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (22).
The only representative shall comply with all obligations of producers and importers under this Regulation.
Article 17
Registry
1. By 1 January 2015, the Commission shall set up and ensure the operation of an electronic registry for quotas for placing hydrofluorocarbons on the market (‘the registry’).
Registration in the registry shall be compulsory for the following:
(a)
producers and importers to which a quota for the placing on the market of hydrofluorocarbons has been allocated in accordance with Article 16(5);
(b)
undertakings to which a quota is transferred in accordance with Article 18;
(c)
producers and importers declaring their intention to submit a declaration pursuant to Article 16(2);
(d)
producers and importers supplying, or undertakings in receipt of hydrofluorocarbons for the purposes listed in points (a) to (f) of the second subparagraph of Article 15(2);
(e)
importers of equipment placing pre-charged equipment on the market where the hydrofluorocarbons contained in the equipment have not been placed on the market prior to the charging of that equipment in accordance with Article 14.
Registration shall be effected by means of application to the Commission in accordance with procedures to be set out by the Commission.
2. The Commission may, to the extent necessary, by means of implementing acts, ensure the smooth functioning of the registry. Those implementing acts shall be adopted in accordance with the examination procedure in Article 24.
3. The Commission shall ensure that registered producers and importers are informed via the registry about the quota allocated and about any changes to it during the allocation period.
4. The competent authorities, including customs authorities, of the Member States shall have access, for information purposes, to the registry.
Article 18
Transfer of quotas and authorisation to use quotas for the placing on the market of hydrofluorocarbons in imported equipment
1. Any producer or importer for whom a reference value has been determined pursuant to Article 16(1) or (3) and who has been allocated a quota in accordance with Article 16(5), may transfer in the registry referred to in Article 17(1) that quota for all or any quantities to another producer or importer in the Union or to another producer or importer which is represented in the Union by an only representative referred to in the second and third subparagraph of Article 16(5).
2. Any producer or importer having received its quota pursuant to Article 16(1) and (3) or to whom a quota has been transferred pursuant to paragraph 1 of this Article may authorise another undertaking to use its quota for the purpose of Article 14.
Any producer or importer having received its quota exclusively on the basis of a declaration pursuant to Article 16(2), may only authorise another undertaking to use its quota for the purpose of Article 14 provided that the corresponding quantities of hydrofluorocarbons are physically supplied by the authorising producer or importer.
For the purpose of Articles 15, 16 and 19(1) and (6) the respective quantities of hydrofluorocarbons shall be deemed to be placed on the market by the authorising producer or importer at the moment of the authorisation. The Commission may require from the authorising producer or importer evidence that it is active in the supply of hydrofluorocarbons.
CHAPTER V
REPORTING
Article 19
Reporting on production, import, export, feedstock use and destruction of the substances listed in Annexes I or II
1. By 31 March 2015 and every year thereafter, each producer, importer and exporter that produced, imported or exported one metric tonne or 100 tonnes of CO2 equivalent or more of fluorinated greenhouse gases and gases listed in Annex II during the preceding calendar year shall report to the Commission the data specified in Annex VII on each of those substances for that calendar year. This paragraph shall also apply to undertakings receiving quotas pursuant to Article 18(1).
2. By 31 March 2015 and every year thereafter, each undertaking that destroyed 1 metric tonne or 1 000 tonnes of CO2 equivalent or more of fluorinated greenhouse gases and gases listed in Annex II during the preceding calendar year shall report to the Commission the data specified in Annex VII on each of those substances for that calendar year.
3. By 31 March 2015 and every year thereafter, each undertaking that used 1 000 tonnes of CO2 equivalent or more of fluorinated greenhouse gases as feedstock during the preceding calendar year shall report to the Commission the data specified in Annex VII on each of those substances for that calendar year.
4. By 31 March 2015 and every year thereafter, each undertaking that placed 500 tonnes of CO2 equivalent or more of fluorinated greenhouse gases and gases listed in Annex II contained in products or equipment on the market during the preceding calendar year shall report to the Commission the data specified in Annex VII on each of those substances for that calendar year.
5. Each importer of equipment that place on the market pre-charged equipment where hydrofluorocarbons contained in this equipment have not been placed on the market prior to the charging of the equipment shall submit to the Commission a verification document issued pursuant to Article 14(2).
6. By 30 June 2015 and every year thereafter, each undertaking which under paragraph 1 reports on the placing on the market 10 000 tonnes of CO2 equivalent or more of hydrofluorocarbons during the preceding calendar year shall, in addition, ensure that the accuracy of the data is verified by an independent auditor. The auditor shall be either:
(a)
accredited pursuant to Directive 2003/87/EC; or
(b)
accredited to verify financial statements in accordance with the legislation of the Member State concerned.
The undertaking shall keep the verification report for at least five years. The verification report shall be made available, on request, to the competent authority of the Member State concerned and to the Commission.
7. The Commission may, by means of implementing acts, determine the format and means of submitting the reports referred to in this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24.
8. The Commission shall take appropriate measures to protect the confidentiality of the information submitted to it in accordance with this Article.
Article 20
Collection of emissions data
Member States shall establish reporting systems for the relevant sectors referred to in this Regulation, with the objective of acquiring, to the extent possible, emissions data.
CHAPTER VI
FINAL PROVISIONS
Article 21
Review
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 concerning the updating of Annexes I, II and IV on the basis of new Assessment Reports adopted by the Intergovernmental Panel on Climate Change or new reports of the Scientific Assessment Panel (SAP) of the Montreal Protocol on the global warming potential of the listed substances.
2. On the basis of information on the placing on the market of the gases listed in Annexes I and II, reported in accordance with Article 19, and on emissions of fluorinated greenhouse gases made available in accordance with Article 20 and on the basis of any relevant information received from Member States, the Commission shall monitor the application and effects of this Regulation.
No later than 31 December 2020, the Commission shall publish a report on the availability of hydrofluorocarbons on the Union market.
No later than 31 December 2022, it shall publish a comprehensive report on the effects of this Regulation, including in particular:
(a)
a forecast of the continued demand for hydrofluorocarbons up to and beyond 2030;
(b)
an assessment of the need for further action by the Union and its Member States in light of existing and new international commitments regarding the reduction of fluorinated greenhouse gas emissions;
(c)
an overview of European and international standards, national safety legislation and building codes in Member States in relation to the transition to alternative refrigerants;
(d)
a review of the availability of technically feasible and cost-effective alternatives to products and equipment containing fluorinated greenhouse gases for products and equipment not listed in Annex III, taking into account energy efficiency.
3. No later than 1 July 2017, the Commission shall publish a report assessing the prohibition pursuant to point 13 of Annex III, considering in particular, the availability of cost-effective, technically feasible, energy-efficient and reliable alternatives to multipack centralised refrigeration systems referred to in that provision. In light of that report, the Commission shall submit, if appropriate, a legislative proposal to the European Parliament and to the Council with a view to amending the provision pursuant to point 13 of Annex III.
4. No later than 1 July 2020, the Commission shall publish a report assessing whether cost-effective, technically feasible, energy-efficient and reliable alternatives exist, which make the replacement of fluorinated greenhouse gases possible in new medium-voltage secondary switchgear and new small single split air-conditioning systems and shall submit, if appropriate, a legislative proposal to the European Parliament and to the Council to amend the list set out in Annex III.
5. No later than 1 July 2017, the Commission shall publish a report assessing the quota allocation method, including the impact of allocating quotas for free, and the costs of implementing this Regulation in Member States and of a possible international agreement on hydrofluorocarbons, if applicable. In light of that report the Commission shall submit, if appropriate, a legislative proposal to the European Parliament and to the Council with a view to:
(a)
amending the quota allocation method;
(b)
establishing an appropriate method of distributing any possible revenues.
6. No later than 1 January 2017, the Commission shall publish a report examining Union legislation with respect to the training of natural persons for the safe handling of alternative refrigerants to replace or reduce the use of fluorinated greenhouse gases and shall submit, if appropriate, a legislative proposal to the European Parliament and to the Council to amend the relevant Union legislation.
Article 22
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 12(15) and 21(1) shall be conferred on the Commission for period of five years from 10 June 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for further periods of five years, unless the European Parliament or the Council opposes such extension not later than three months before the end of each such period.
3. The delegation of power referred to in Articles 12(15) and 21(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 12(15) and 21(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 23
Consultation Forum
In implementing this Regulation, the Commission shall ensure a balanced participation of Member States’ representatives and representatives of civil society, including environmental organisations, representatives of manufacturers, operators and certified persons. To that end, it shall establish a Consultation Forum for those parties to meet and provide advice and expertise to the Commission in relation to the implementation of this Regulation, in particular with regard to the availability of alternatives to fluorinated greenhouse gases, including the environmental, technical, economic and safety aspects of their use. The rules of procedure of the Consultation Forum shall be established by the Commission and shall be published.
Article 24
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 25
Penalties
1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
Member States shall notify those provisions to the Commission by 1 January 2017 at the latest and shall notify it without delay of any subsequent amendment affecting them.
2. In addition to the penalties referred to in paragraph 1, undertakings that have exceeded their quota for placing hydrofluorocarbons on the market, allocated in accordance with Article 16(5) or transferred to them in accordance with Article 18, may only be allocated a reduced quota allocation for the allocation period after the excess has been detected.
The amount of reduction shall be calculated as 200 % of the amount by which the quota was exceeded. If the amount of the reduction is higher than the amount to be allocated in accordance with Article 16(5) as a quota for the allocation period after the excess has been detected, no quota shall be allocated for that allocation period and the quota for the following allocation periods shall be reduced likewise until the full amount has been deducted.
Article 26
Repeal
Regulation (EC) No 842/2006 shall be repealed with effect from 1 January 2015, without prejudice to compliance with the requirements of that Regulation in accordance with the timetable set out therein.
However, Regulations (EC) No 1493/2007, (EC) No 1494/2007, (EC) No 1497/2007, (EC) No 1516/2007, (EC) No 303/2008, (EC) No 304/2008, (EC) No 305/2008, (EC) No 306/2008, (EC) No 307/2008 and (EC) No 308/2008 shall remain in force and continue to apply unless and until repealed by delegated or implementing acts adopted by the Commission pursuant to this Regulation.
References to Regulation (EC) No 842/2006 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII.
Article 27
Entry into force and date of application
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 16 April 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
D. KOURKOULAS
(1) OJ C 271, 19.9.2013, p. 138.
(2) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014.
(3) Council Decision 94/69/EC of 15 December 1993 concerning the conclusion of the United Nations Framework Convention on Climate Change (OJ L 33, 7.2.1994, p. 11).
(4) Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17 May 2006 on certain fluorinated greenhouse gases (OJ L 161, 14.6.2006, p. 1).
(5) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13).
(6) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10).
(7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(8) Commission Regulation (EC) No 1493/2007 of 17 December 2007 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, the format for the report to be submitted by producers, importers and exporters of certain fluorinated greenhouse gases (OJ L 332, 18.12.2007, p. 7).
(9) Commission Regulation (EC) No 1494/2007 of 17 December 2007 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, the form of labels and additional labelling requirements as regards products and equipment containing certain fluorinated greenhouse gases (OJ L 332, 18.12.2007, p. 25).
(10) Commission Regulation (EC) No 1497/2007 of 18 December 2007 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, standard leakage checking requirements for stationary fire protection systems containing certain fluorinated greenhouse gases (OJ L 333, 19.12.2007, p. 4).
(11) Commission Regulation (EC) No 1516/2007 of 19 December 2007 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, standard leakage checking requirements for stationary refrigeration, air conditioning and heat pump equipment containing certain fluorinated greenhouse gases (OJ L 335, 20.12.2007, p. 10).
(12) Commission Regulation (EC) No 303/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, minimum requirements and the conditions for mutual recognition for the certification of companies and personnel as regards stationary refrigeration, air conditioning and heat pump equipment containing certain fluorinated greenhouse gases (OJ L 92, 3.4.2008, p. 3).
(13) Commission Regulation (EC) No 304/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, minimum requirements and the conditions for mutual recognition for the certification of companies and personnel as regards stationary fire protection systems and fire extinguishers containing certain fluorinated greenhouse gases (OJ L 92, 3.4.2008, p. 12).
(14) Commission Regulation (EC) No 305/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, minimum requirements and the conditions for mutual recognition for the certification of personnel recovering certain fluorinated greenhouse gases from high-voltage switchgear (OJ L 92, 3.4.2008, p. 17).
(15) Commission Regulation (EC) No 306/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, minimum requirements and the conditions for mutual recognition for the certification of personnel recovering certain fluorinated greenhouse gas-based solvents from equipment (OJ L 92, 3.4.2008, p. 21).
(16) Commission Regulation (EC) No 307/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, minimum requirements for training programmes and the conditions for mutual recognition of training attestations for personnel as regards air-conditioning systems in certain motor vehicles containing certain fluorinated greenhouse gases (OJ L 92, 3.4.2008, p. 25).
(17) Commission Regulation (EC) No 308/2008 of 2 April 2008 establishing, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council, the format for notification of the training and certification programmes of the Member States (OJ L 92, 3.4.2008, p. 28).
(18) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).
(19) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).
(20) Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12).
(21) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
(22) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
ANNEX I
FLUORINATED GREENHOUSE GASES REFERRED TO IN POINT 1 OF ARTICLE 2
Substance
GWP (1)
Industrial designation
Chemical name
(Common name)
Chemical formula
Section 1: Hydrofluorocarbons (HFCs)
HFC-23
trifluoromethane
(fluoroform)
CHF3
14 800
HFC-32
difluoromethane
CH2F2
675
HFC-41
fluoromethane
(methyl fluoride)
CH3F
92
HFC-125
pentafluoroethane
CHF2CF3
3 500
HFC-134
1,1,2,2-tetrafluoroethane
CHF2CHF2
1 100
HFC-134a
1,1,1,2-tetrafluoroethane
CH2FCF3
1 430
HFC-143
1,1,2-trifluoroethane
CH2FCHF2
353
HFC-143a
1,1,1-trifluoroethane
CH3CF3
4 470
HFC-152
1,2-difluoroethane
CH2FCH2F
53
HFC-152a
1,1-difluoroethane
CH3CHF2
124
HFC-161
fluoroethane
(ethyl fluoride)
CH3CH2F
12
HFC-227ea
1,1,1,2,3,3,3-heptafluoropropane
CF3CHFCF3
3 220
HFC-236cb
1,1,1,2,2,3-hexafluoropropane
CH2FCF2CF3
1 340
HFC-236ea
1,1,1,2,3,3-hexafluoropropane
CHF2CHFCF3
1 370
HFC-236fa
1,1,1,3,3,3-hexafluoropropane
CF3CH2CF3
9 810
HFC-245ca
1,1,2,2,3-pentafluoropropane
CH2FCF2CHF2
693
HFC-245fa
1,1,1,3,3-pentafluoropropane
CHF2CH2CF3
1 030
HFC-365 mfc
1,1,1,3,3-pentafluorobutane
CF3CH2CF2CH3
794
HFC-43-10 mee
1,1,1,2,2,3,4,5,5,5-decafluoropentane
CF3CHFCHFCF2CF3
1 640
Section 2: Perfluorocarbons (PFCs)
PFC-14
tetrafluoromethane
(perfluoromethane, carbon tetrafluoride)
CF4
7 390
PFC-116
hexafluoroethane
(perfluoroethane)
C2F6
12 200
PFC-218
octafluoropropane
(perfluoropropane)
C3F8
8 830
PFC-3-1-10
(R-31-10)
decafluorobutane
(perfluorobutane)
C4F10
8 860
PFC-4-1-12
(R-41-12)
dodecafluoropentane
(perfluoropentane)
C5F12
9 160
PFC-5-1-14
(R-51-14)
tetradecafluorohexane
(perfluorohexane)
C6F14
9 300
PFC-c-318
octafluorocyclobutane
(perfluorocyclobutane)
c-C4F8
10 300
Section 3: Other perfluorinated compounds
sulphur hexafluoride
SF6
22 800
(1) Based on the Fourth Assessment Report adopted by the Intergovernmental Panel on Climate Change, unless otherwise indicated.
ANNEX II
OTHER FLUORINATED GREENHOUSE GASES SUBJECT TO REPORTING IN ACCORDANCE WITH ARTICLE 19
Substance
GWP (1)
Common name/industrial designation
Chemical formula
Section 1: Unsaturated hydro(chloro)fluorocarbons
HFC-1234yf
CF3CF = CH2
4 Fn
(2)
HFC-1234ze
trans — CHF = CHCF3
7 Fn 2
HFC-1336mzz
CF3CH = CHCF3
9
HCFC-1233zd
C3H2ClF3
4,5
HCFC-1233xf
C3H2ClF3
1 Fn
(3)
Section 2: Fluorinated ethers and alcohols
HFE-125
CHF2OCF3
14 900
HFE-134 (HG-00)
CHF2OCHF2
6 320
HFE-143a
CH3OCF3
756
HCFE-235da2 (isofluorane)
CHF2OCHClCF3
350
HFE-245cb2
CH3OCF2CF3
708
HFE-245fa2
CHF2OCH2CF3
659
HFE-254cb2
CH3OCF2CHF2
359
HFE-347 mcc3 (HFE-7000)
CH3OCF2CF2CF3
575
HFE-347pcf2
CHF2CF2OCH2CF3
580
HFE-356pcc3
CH3OCF2CF2CHF2
110
HFE-449sl (HFE-7100)
C4F9OCH3
297
HFE-569sf2 (HFE-7200)
C4F9OC2H5
59
HFE-43-10pccc124 (H-Galden 1040x) HG-11
CHF2OCF2OC2F4OCHF2
1 870
HFE-236ca12 (HG-10)
CHF2OCF2OCHF2
2 800
HFE-338pcc13 (HG-01)
CHF2OCF2CF2OCHF2
1 500
HFE-347mmy1
(CF3)2CFOCH3
343
2,2,3,3,3-pentafluoropropanol
CF3CF2CH2OH
42
bis(trifluoromethyl)-methanol
(CF3)2CHOH
195
HFE-227ea
CF3CHFOCF3
1 540
HFE-236ea2 (desfluoran)
CHF2OCHFCF3
989
HFE-236fa
CF3CH2OCF3
487
HFE-245fa1
CHF2CH2OCF3
286
HFE 263fb2
CF3CH2OCH3
11
HFE-329 mcc2
CHF2CF2OCF2CF3
919
HFE-338 mcf2
CF3CH2OCF2CF3
552
HFE-338mmz1
(CF3)2CHOCHF2
380
HFE-347 mcf2
CHF2CH2OCF2CF3
374
HFE-356 mec3
CH3OCF2CHFCF3
101
HFE-356mm1
(CF3)2CHOCH3
27
HFE-356pcf2
CHF2CH2OCF2CHF2
265
HFE-356pcf3
CHF2OCH2CF2CHF2
502
HFE 365 mcf3
CF3CF2CH2OCH3
11
HFE-374pc2
CHF2CF2OCH2CH3
557
- (CF2)4CH (OH)-
73
Section 3: Other perfluorinated compounds
perfluoropolymethylisopropyl-ether (PFPMIE)
CF3OCF(CF3)CF2OCF2OCF3
10 300
nitrogen trifluoride
NF3
17 200
trifluoromethyl sulphur pentafluoride
SF5CF3
17 700
perfluorocyclopropane
c-C3F6
17 340Fn
(4)
(1) Based on the Fourth Assessment Report adopted by the Intergovernmental Panel on Climate Change, unless otherwise indicated.
(2) GWP according to the Report of the 2010 Assessment of the Scientific Assessment Panel (SAP) of the Montreal Protocol, Tables 1-11, citing two peer-reviewed scientific references. http://ozone.unep.org/Assessment_Panels/SAP/Scientific_Assessment_2010/index.shtml
(3) Default value, global warming potential not yet available.
(4) Minimum value according to the Fourth Assessment Report adopted by the Intergovernmental Panel on Climate Change.
ANNEX III
PLACING ON THE MARKET PROHIBITIONS REFERRED TO IN ARTICLE 11(1)
Products and equipment
Where relevant, the GWP of mixtures containing fluorinated greenhouse gases shall be calculated in accordance with Annex IV, as provided for in point 6 of Article 2
Date of prohibition
1.
Non-refillable containers for fluorinated greenhouse gases used to service, maintain or fill refrigeration, air-conditioning or heat-pump equipment, fire protection systems or switchgear, or for use as solvents
4 July 2007
2.
Non-confined direct evaporation systems that contain HFCs and PFCs as refrigerants
4 July 2007
3.
Fire protection equipment
that contain PFCs
4 July 2007
that contain HFC-23
1 January 2016
4.
Windows for domestic use that contain fluorinated greenhouse gases
4 July 2007
5.
Other windows that contain fluorinated greenhouse gases
4 July 2008
6.
Footwear that contains fluorinated greenhouse gases
4 July 2006
7.
Tyres that contain fluorinated greenhouse gases
4 July 2007
8.
One-component foams, except when required to meet national safety standards, that contain fluorinated greenhouse gases with GWP of 150 or more
4 July 2008
9.
Aerosol generators marketed and intended for sale to the general public for entertainment and decorative purposes, as listed in point 40 of Annex XVII to Regulation (EC) No 1907/2006, and signal horns, that contain HFCs with GWP of 150 or more
4 July 2009
10.
Domestic refrigerators and freezers that contain HFCs with GWP of 150 or more
1 January 2015
11.
Refrigerators and freezers for commercial use (hermetically sealed equipment)
that contain HFCs with GWP of 2 500 or more
1 January 2020
that contain HFCs with GWP of 150 or more
1 January 2022
12.
Stationary refrigeration equipment, that contains, or whose functioning relies upon, HFCs with GWP of 2 500 or more except equipment intended for application designed to cool products to temperatures below – 50 °C
1 January 2020
13.
Multipack centralised refrigeration systems for commercial use with a rated capacity of 40 kW or more that contain, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 150 or more, except in the primary refrigerant circuit of cascade systems where fluorinated greenhouse gases with a GWP of less than 1 500 may be used
1 January 2022
14.
Movable room air-conditioning equipment (hermetically sealed equipment which is movable between rooms by the end user) that contain HFCs with GWP of 150 or more
1 January 2020
15.
Single split air-conditioning systems containing less than 3 kg of fluorinated greenhouse gases, that contain, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 750 or more
1 January 2025
16.
Foams that contain HFCs with GWP of 150 or more except when required to meet national safety standards
Extruded polystyrene (XPS)
1 January 2020
Other foams
1 January 2023
17.
Technical aerosols that contain HFCs with GWP of 150 or more, except when required to meet national safety standards or when used for medical applications
1 January 2018
ANNEX IV
METHOD OF CALCULATING THE TOTAL GWP OF A MIXTURE
The GWP of a mixture is calculated as a weighted average, derived from the sum of the weight fractions of the individual substances multiplied by their GWP, unless otherwise specified, including substances that are not fluorinated greenhouse gases.
,
where % is the contribution by weight with a weight tolerance of +/– 1 %.
For example: applying the formula to a blend of gases consisting of 60 % dimethyl ether, 10 % HFC-152a and 30 % isobutane:
→ Total GWP = 13,9
The GWP of the following non-fluorinated substances are used to calculate the GWP of mixtures. For other substances not listed in this annex a default value of 0 applies.
Substance
GWP (1)
Common name
Industrial designation
Chemical Formula
methane
CH4
25
nitrous oxide
N2O
298
dimethyl ether
CH3OCH3
1
methylene chloride
CH2Cl2
9
methyl chloride
CH3Cl
13
chloroform
CHCl3
31
ethane
R-170
CH3CH3
6
propane
R-290
CH3CH2CH3
3
butane
R-600
CH3CH2CH2CH3
4
isobutane
R-600a
CH(CH3)2CH3
3
pentane
R-601
CH3CH2CH2CH2CH3
5 (2)
isopentane
R-601a
(CH3)2CHCH2CH3
5 (2)
ethoxyethane (diethyl ether)
R-610
CH3CH2OCH2CH3
4
methyl formate
R-611
HCOOCH3
25
hydrogen
R-702
H2
6
ammonia
R-717
NH3
0
ethylene
R-1150
C2H4
4
propylene
R-1270
C3H6
2
cyclopentane
C5H10
5 (2)
(1) Based on the Fourth Assessment Report adopted by the Intergovernmental Panel on Climate Change, unless otherwise indicated.
(2) Substance not listed in the Fourth Assessment Report adopted by the Intergovernmental Panel on Climate Change, default value on the basis of the GWPs of other hydrocarbons.
ANNEX V
CALCULATION OF THE MAXIMUM QUANTITY, REFERENCE VALUES AND QUOTAS FOR PLACING HYDROFLUOROCARBONS ON THE MARKET
The maximum quantity referred to in Article 15(1) shall be calculated by applying the following percentages to the annual average of the total quantity placed on the market into the Union during the period from 2009 to 2012. From 2018 onwards, the maximum quantity referred to in Article 15(1) shall be calculated by applying the following percentages to the annual average of the total quantity placed on the market into the Union during period 2009 to 2012, and subsequently subtracting the amounts for exempted uses according to Article 15(2), on the basis of available data.
Years
Percentage to calculate the maximum quantity of hydrofluorocarbons to be placed on the market and corresponding quotas
2015
100 %
2016–17
93 %
2018–20
63 %
2021–23
45 %
2024–26
31 %
2027–29
24 %
2030
21 %
The maximum quantity, reference values and quotas for placing hydrofluorocarbons on the market referred to in Articles 15 and 16 shall be calculated as the aggregated quantities of all types of hydrofluorocarbons, expressed in tonne(s) of CO2 equivalent.
The calculation of reference values and quotas for placing hydrofluorocarbons on the market referred to in Articles 15 and 16 shall be based on the quantities of hydrofluorocarbons producers and importers have placed on the market in the Union during the reference or allocation period but excluding quantities of hydrofluorocarbons for the usage referred to in Article 15(2) during the same period, on the basis of available data.
Transactions referred to in point (c) of Article 15(2) shall be verified in accordance with Article 19(6) regardless of the quantities involved.
ANNEX VI
ALLOCATION MECHANISM REFERRED TO IN ARTICLE 16
1. Determination of the quantity to be allocated to undertakings for which a reference value has been established under Article 16(1) and (3)
Each undertaking for which a reference value has been established receives a quota corresponding to 89 % of the reference value multiplied by the percentage indicated in Annex V for the respective year.
2. Determination of the quantity to be allocated to undertakings that have submitted a declaration under Article 16(2)
The sum of the quotas allocated under point 1 is subtracted from the maximum quantity for the given year set out in Annex V to determine the quantity to be allocated to undertakings for which no reference value has been established and which have submitted a declaration under Article 16(2) (quantity to be allocated in step 1 of the calculation).
2.1. Step 1 of the calculation
Each undertaking receives an allocation corresponding to the quantity requested in its declaration, but no more than a pro-rata share of the quantity to be allocated in step 1.
The pro-rata share is calculated by dividing 100 by the number of undertakings that have submitted a declaration. The sum of the quotas allocated in step 1 is subtracted from the quantity to be allocated in step 1 to determine the quantity to be allocated in step 2.
2.2. Step 2 of the calculation
Each undertaking that has not obtained 100 % of the quantity requested in its declaration in step 1 receives an additional allocation corresponding to the difference between the quantity requested and the quantity obtained in step 1. However, this must not exceed the pro-rata share of the quantity to be allocated in step 2.
The pro-rata share is calculated by dividing 100 by the number of undertakings eligible for an allocation in step 2. The sum of the quotas allocated in step 2 is subtracted from the quantity to be allocated in step 2 to determine the quantity to be allocated in step 3.
2.3. Step 3 of the calculation
Step 2 is repeated until all requests are satisfied or the remaining quantity to be allocated in the next phase is less than 500 tonnes of CO2 equivalent.
3. Determination of the quantity to be allocated to undertakings that have submitted a declaration under Article 16(4)
For the allocation of quotas for 2015 to 2017 the sum of the quotas allocated under points 1 and 2 is subtracted from the maximum quantity for the given year set out in Annex V to determine the quantity to be allocated to undertakings for which a reference value has been established and that have submitted a declaration under Article 16(4).
The allocation mechanism set out under points 2.1 and 2.2 applies.
For the allocation of quotas for 2018 and every year thereafter, undertakings that have submitted a declaration under Article 16(4) shall be treated in the same way as undertakings that have submitted a declaration under Article 16(2).
ANNEX VII
DATA TO BE REPORTED PURSUANT TO ARTICLE 19
1.
Each producer referred to in Article 19(1) shall report on:
(a)
the total quantity of each substance listed in Annexes I and II it has produced in the Union, identifying the main categories of application in which the substance is used;
(b)
the quantities of each substance listed in Annex I and, where applicable, Annex II it has placed on the market in the Union, specifying separately quantities placed on the market for feedstock uses, direct exports, producing metered dose inhalers for the delivery of pharmaceutical ingredients, use in military equipment and use in the etching of semiconductor material or the cleaning of chemical vapour deposition chambers within the semiconductor manufacturing sector;
(c)
the quantities of each substance listed in Annexes I and II that have been recycled, reclaimed and destroyed, respectively;
(d)
any stocks held at the beginning and the end of the reporting period;
(e)
any authorisation to use quota, specifying relevant quantities, for the purpose of Article 14.
2.
Each importer referred to in Article 19(1) shall report on:
(a)
the quantity of each substance listed in Annex I and, where applicable, Annex II it has imported into the Union, identifying the main categories of application in which the substance is used, specifying separately quantities placed on the market for destruction, feedstock uses, direct exports, producing metered dose inhalers for the delivery of pharmaceutical ingredients, use in military equipment and use in the etching of semiconductor material or the cleaning of chemical vapour deposition chambers within the semiconductor manufacturing sector;
(b)
the quantities of each substance listed in Annexes I and II that have been recycled, reclaimed and destroyed, respectively;
(c)
any authorisation to use quota, specifying relevant quantities, for the purpose of Article 14;
(d)
any stocks held at the beginning and the end of the reporting period.
3.
Each exporter referred to in Article 19(1) shall report on:
(a)
the quantities of each substance listed in Annexes I and II that it has exported from the Union other than to be recycled, reclaimed or destroyed;
(b)
any quantities of each substance listed in Annexes I and II that it has exported from the Union to be recycled, reclaimed and destroyed, respectively.
4.
Each undertaking referred to in Article 19(2) shall report on:
(a)
the quantities of each substance listed in Annexes I and II destroyed, including the quantities of those substances contained in products or equipment;
(b)
any stocks of each substance listed in Annexes I and II waiting to be destroyed, including the quantities of those substances contained in products or equipment;
(c)
the technology used for the destruction of the substances listed in Annexes I and II.
5.
Each undertaking referred to in Article 19(3) shall report on the quantities of each substance listed in Annex I used as feedstock.
6.
Each undertaking referred to in Article 19(4) shall report on:
(a)
the categories of the products or equipment containing substances listed in Annexes I and II;
(b)
the number of units;
(c)
any quantities of each substance listed in Annexes I and II contained in the products or equipment.
ANNEX VIII
CORRELATION TABLE
Regulation (EC) No 842/2006
This Regulation
Article 1
Article 1
Article 2
Article 2
Article 3(1)
Article 3(2) and (3)
Article 3(2), first subparagraph
Article 4(1), (2) and (3)
Article 3(2), second subparagraph
Article 3(3), second subparagraph
Article 3(2), third subparagraph
—
Article 3(3)
Article 5(1)
Article 3(4)
Article 4(3)
Article 3(5)
Article 4(4)
Article 3(6)
Article 6(1) and (2)
Article 3(7)
Article 4(5)
Article 4(1)
Article 8(1)
Article 4(2)
Article 8(2)
Article 4(3)
Article 8(3)
Article 4(4)
—
Article 5(1)
Article 10(5) and (12)
Article 5(2), first sentence
Article 10(1), (2) and (6)
Article 5(2), second sentence
Article 10(10), first subparagraph
Article 5(2), third sentence
Article 10(10), second subparagraph
Article 5(3)
Article 3(4), first subparagraph and Article 10(3)
Article 5(4)
Article 11(4)
Article 5(5)
Article 10(13)
Article 6(1)
Article 19(1) and Annex VII
Article 6(2)
Article 19(7)
Article 6(3)
Article 19(8)
Article 6(4)
Article 20 and Article 6(2)
Article 7(1), first subparagraph, first sentence
Article 12(1) first sentence
Article 7(1), first subparagraph, second and third sentence
Article 12(2), (3) and (4)
Article 7(1), second subparagraph
Article 12(13)
Article 7(2)
Article 12(1), second sentence
Article 7(3), first sentence
Article 12(14)
Article 7(3), second sentence
Article 12(15)
Article 8(1)
Article 13(1)
Article 8(2)
Article 13(2)
Article 9(1)
Article 11(1)
Article 9(2)
—
Article 9(3)
—
Article 10
21(2)
Article 11
—
Article 12
Article 24
Article 13(1)
Article 25(1), first subparagraph
Article 13(2)
Article 25(1), second subparagraph
Article 14
—
Article 15
Article 27
Annex I — Part 1
Annex I
Annex I — Part 2
Annex IV
Annex II
Annex III
|
Reducing human-made greenhouse gases (fluorinated gases)
Reducing human-made greenhouse gases (fluorinated gases)
SUMMARY OF:
Regulation (EU) No 517/2014 on fluorinated greenhouse gases
WHAT IS THE AIM OF THE REGULATION?
It is designed to mitigate climate change and protect the environment by reducing emissions of fluorinated greenhouse gases (F-gases) which are human-made greenhouse gases with a global warming effect up to 23,000 times that of carbon dioxide.
It aims to cut the F-gas emissions of the European Union (EU) by two thirds by 2030 compared with 2014 levels.
KEY POINTS
The regulation:
covers hydrofluorocarbons (HFCs)*, perfluorocarbons (PFCs)* and sulphur hexafluorides (SF6)*;
lays down rules on the containment, use, recovery and destruction of F-gases;
sets an overall yearly limit on the climate impact of HFCs, to be gradually reduced between 2015 and 2030.
It also lays down the following obligations.
Intentional release of F-gases is prohibited, unless technically necessary for the intended use of a product. Manufacturers must do their utmost to limit emissions during the production, transport and storage of F-gases.
Operators of equipment containing F-gases must take every precaution to avoid any leakage. They must ensure the equipment is regularly checked for leaks. The requirements vary according to the potential climate impact or whether the equipment is hermetically sealed.
The European Commission must report on the impact of the regulation by 31 December 2022.
Certification and training programmes
National authorities are responsible for setting up certification and training programmes for businesses and people involved in installing, servicing, maintaining, repairing or decommissioning F-gases equipment and in recovering F-gases.
Bans on products containing F-gases
The regulation phases in bans from 2015 to 2025 on the sale of new items such as certain categories of fridges and freezers, air-conditioning systems, foams and aerosols containing F-gases where safer, more climate-friendly alternatives exist.
Annual limits for HFCs
The regulation seeks to reduce the climate impact of the use of HFCs over time. The annual limit for HFCs on the market in 2030 is 21% of 2009–2012 levels.
To ensure the limits are met, the Commission allocates annual quotas to producers and importers. These must not be exceeded.
Reporting
Producers, importers, exporters, users of feedstock and businesses that destroy F-gases must report annually to the Commission.
Importers of F-gases equipment must do the same and, from 2017, have had to provide evidence that the quantities of HFCs in their imported equipment are accounted for.
Kigali Amendment to the Montreal Protocol
The regulation also ensures that the EU complies with its international obligations under the Kigali Amendment to the Montreal Protocol.
The Kigali Amendment added HFCs to the list of controlled substances under the Montreal Protocol (see summary). It entered into force on 1 January 2019. The phase-down of HFCs is expected to save around 80 gigatonnes of CO2 equivalents until 2050 and make a significant contribution to fighting climate change.
All 198 Montreal Protocol parties agreed to take steps to gradually reduce their production and use of HFCs. The first reduction step was to be taken by the EU and other developed countries in 2019. Most developing countries will start their phase-down in 2024.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2015.
BACKGROUND
F-gases account for 2% of EU greenhouse gas emissions. F-gases are often replaceable by more climate-friendly alternatives.
For further information, see: EU legislation to control F-gases (European Commission).
KEY TERMS
HFCs. Used as refrigerants, cleaning solvents and foam-blowing agents (such as fire extinguishers).
PFCs. Used to manufacture semiconductors, as cleaning solvents and as foam-blowing agents.
SF6. Used in high-voltage switch gear and magnesium production.
MAIN DOCUMENT
Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, pp. 195–230).
RELATED DOCUMENTS
Council Decision (EU) 2017/1541 of 17 July 2017 on the conclusion, on behalf of the European Union, of the Kigali Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 236, 14.9.2017, pp. 1–2).
Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 236, 14.9.2017, pp. 3–13).
last update 09.11.2021
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32014R0515
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20.5.2014
EN
Official Journal of the European Union
L 150/143
REGULATION (EU) No 515/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 April 2014
establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
The Union’s objective of ensuring a high level of security within an area of freedom, security and justice pursuant to Article 67(3) of the Treaty on the Functioning of the Union (TFEU) should be achieved, inter alia, through common measures on the crossing of internal borders by persons and on border controls at external borders and the common visa policy as part of a convergent multi-layer system, which would allow the exchange of data and a complete situation awareness and which aims to facilitate legitimate travel and to tackle illegal immigration.
(2)
The Union needs a more coherent approach to the internal and external aspects of migration management and internal security, and should establish a correlation between the fight against illegal immigration and the improvement of the security of the external borders of the Union, and better cooperation and dialogue with third countries for the purposes of dealing with illegal immigration and promoting legal migration.
(3)
It is necessary to develop an integrated approach to issues arising from the pressure of migration and asylum applications and for the management of the external borders of the Union, and to provide a budget and adequate resources to cope with emergencies in a spirit of respect for human rights and solidarity between all Member States, while remaining aware of national responsibilities and ensuring a clear division of tasks.
(4)
The Internal Security Strategy for the European Union (the ‘Internal Security Strategy’), adopted by the Council in February 2010, constitutes a shared agenda for tackling these common security challenges. The Commission Communication of November 2010, entitled ‘The EU Internal Security Strategy in Action’, translates the strategy’s principles and guidelines into concrete actions by identifying five strategic objectives: to disrupt international crime networks, to prevent terrorism and address radicalisation and recruitment, to raise levels of security for citizens and businesses in cyberspace, to strengthen security through border management and to increase Europe’s resilience in the face of crises and disasters.
(5)
According to the Internal Security Strategy, freedom, security and justice are objectives that should be pursued in parallel, and in order to achieve freedom and justice, security should always be pursued in accordance with the principles of the Treaties, the rule of law and the Union’s fundamental rights obligations.
(6)
Solidarity among Member States, clarity about the division of tasks, respect for fundamental freedoms and human rights and the rule of law, a strong focus on the global perspective and the link with external security, and consistency and coherence with the Union foreign policy objectives, as laid down in Article 21 of the Treaty on European Union (TEU), should be key principles guiding the implementation of the Internal Security Strategy.
(7)
To promote the implementation of the Internal Security Strategy and to ensure that it becomes an operational reality, Member States should be provided with adequate Union financial support by setting up an Internal Security Fund (‘the Fund’).
(8)
Due to the legal particularities applicable to Title V TFEU, it is not legally possible to establish the Fund as a single financial instrument. The Fund should therefore be established as a comprehensive framework for Union financial support in the field of internal security comprising the instrument for financial support for external borders and visa (‘the Instrument’) established by this Regulation as well as the instrument for financial support for police cooperation, preventing and combating crime, and crisis management established by Regulation (EU) No 513/2014 of the European Parliament and of the Council (4). This comprehensive framework should be complemented by Regulation (EU) No 514/2014 of the European Parliament and of the Council (5) to which this Regulation should refer as regards rules on programming, financial management, management and control, clearance of accounts, closure of programmes and reporting and evaluation.
(9)
The new two-pillar structure of funding in the field of home affairs should contribute to the simplification, rationalisation, consolidation and transparency of funding in that field. Synergies, consistency and complementarity should be sought with other funds and programmes, including with a view to allocating funding to common objectives. However, overlap between the different funding instruments should be avoided.
(10)
The Fund should reflect the need for increased flexibility and simplification while respecting requirements in terms of predictability, and ensuring a fair and transparent distribution of resources to meet the general and specific objectives laid down in this Regulation.
(11)
Efficiency of measures and quality of spending constitute guiding principles in the implementation of the Fund. Furthermore, the Fund should also be implemented in the most effective and user-friendly manner possible.
(12)
The Fund should take special account of those Member States which are facing disproportionate burdens from migratory flows due to their geographical location.
(13)
Solidarity and responsibility-sharing between Member States and the Union is a fundamental component of the common policy for the management of the external borders.
(14)
The Fund should express solidarity through financial assistance to those Member States that fully apply the Schengen provisions on external borders as well as to those which are preparing for full participation in Schengen, and should be used by the Member States in the interests of the Union’s common policy for the management of the external borders.
(15)
In order to contribute to the achievement of the general objective of the Fund, Member States should ensure that their national programmes address the specific objectives of the Instrument and that the allocation of resources between objectives is proportionate to the challenges and needs and ensures that the objectives can be met. Where a national programme does not address one of the specific objectives or the allocation is below the minimum percentages for some objectives of the national programmes set in this Regulation, the Member State concerned should provide a justification within the programme.
(16)
In order to measure the achievements of the Fund, common indicators should be established in relation to each specific objective of the Instrument. The measurement of the achievement of the specific objectives by means of common indicators does not render the implementation of actions related to those indicators mandatory.
(17)
Participation by a Member State should not coincide with its participation in a temporary financial instrument of the Union which supports the beneficiary Member States to finance, inter alia, actions at new external borders of the Union for the implementation of the Schengen acquis on borders and visas and external border control.
(18)
The Instrument should build on the capacity-building process developed with the assistance of the External Borders Fund for the period 2007-2013, established by Decision No 574/2007/EC of the European Parliament and of the Council (6), and should extend it to take into account new developments.
(19)
When executing tasks at external borders and consulates in accordance with the Schengen acquis on borders and visas, Member States carry out activities in the interests of and on behalf of all other Member States in the Schengen area, thus performing a public service for the Union. The Instrument should contribute to supporting operating costs related to border control and visa policy and enable Member States to maintain capabilities which are crucial for that service for all. Such support consists of full reimbursement of a choice of specific costs related to the objectives under the Instrument and should form an integral part of the national programmes.
(20)
The Instrument should complement and reinforce the activities undertaken to develop operational cooperation under the aegis of the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (‘the Frontex Agency’) as established by Council Regulation (EC) No 2007/2004 (7), including the new activities resulting from the amendments introduced by Regulation (EU) No 1168/2011 of the European Parliament and of the Council (8), and thereby further reinforce solidarity between those Member States controlling external borders in the interests and on behalf of the Schengen area as a whole. This means, inter alia, that, when drawing up their national programmes, Member States should take into account the analytical tools and operational and technical guidelines developed by the Frontex Agency as well as the training curricula developed, namely the common core curricula for the training of border guards, including its components with regard to fundamental rights and access to international protection. In order to develop complementarity between its mission and the responsibilities of the Member States for the control and surveillance of external borders as well as to ensure consistency and to avoid cost inefficiency, the Frontex Agency should be consulted by the Commission on draft national programmes submitted by the Member States, and in particular on the activities financed under the operating support.
(21)
The Instrument should be implemented in full compliance with the rights and principles enshrined in the Charter of Fundamental Rights of the European Union and with the Union’s international obligations, and without prejudice to the application of special provisions concerning the right to asylum and to international protection.
(22)
Uniform and high-quality external border control is essential for strengthening the area of freedom, security and justice. In accordance with common Union standards, the Instrument should support measures relating to the management of external borders, to be implemented in accordance with the four-tier access control model which comprises measures in third countries, cooperation with neighbouring countries, border control measures and control measures within the area of free movement in order to prevent illegal immigration and cross-border crime inside the Schengen area.
(23)
Pursuant to Article 3 TEU, the Instrument should support activities which ensure the protection of children at risk of harm at the external borders. In particular, when implementing actions in relation to the identification, immediate assistance and referral to protection services, Member States should, wherever possible, give special attention to vulnerable persons, in particular children and unaccompanied minors.
(24)
To ensure a uniform and high-quality external border control and to facilitate legitimate travel across external borders within the framework of the Internal Security Strategy, the Instrument should contribute to the development of a European common integrated border management system. That system includes all the measures involving policy, law, systematic cooperation, burden sharing, assessment of the situation and changing circumstances regarding crossing points for irregular migrants, personnel, equipment and technology taken at different levels by the competent authorities of the Member States, acting in cooperation with the Frontex Agency, with third countries and, where necessary, with other actors, in particular Europol and the Agency for the Operational Management of Large-Scale IT-Systems, utilising, inter alia, the four-tier border security model and integrated risk analysis of the Union.
(25)
In accordance with Protocol No 5 to the 2003 Act of Accession on the transit of persons by land between the region of Kaliningrad and other parts of the Russian Federation, the Instrument should bear any additional cost incurred in implementing the specific provisions of the Union acquis covering such transit, i.e. Council Regulation (EC) No 693/2003 (9) and Council Regulation (EC) No 694/2003 (10). The need for continued financial support for foregone fees, however, should be dependent upon the visa regime of the Union in force with the Russian Federation.
(26)
The Instrument should include support for national measures and cooperation between Member States in the area of visa policy and other pre-frontier activities that take place prior to external border controls and should make full use of the Visa Information System (VIS). The efficient management of activities organised by the services of the Member States in third countries is in the interests of the common visa policy as part of a multi-layered system aimed at facilitating legitimate travel and tackling illegal immigration into the Union, and constitutes an integral part of the common integrated border management system.
(27)
Moreover, the Instrument should support measures in the territory of the Schengen countries as part of the development of a common integrated border management system which strengthens the overall functioning of the Schengen area.
(28)
The Instrument should also support the development by the Union of IT systems, based on existing and/or new IT systems, which would equip Member States with the tools to manage the movement of third-country nationals across borders more efficiently and to ensure a better identification and verification of travellers, thereby facilitating travel and enhancing border security. To that end, a programme, in keeping with the Information Management Strategy for EU internal security, should be established with the aim of covering costs for the development of both the central and national components of such systems, ensuring technical consistency, interoperability with other Union IT systems, cost savings and a smooth implementation in the Member States. Those IT systems should comply with fundamental rights, including the protection of personal data.
(29)
Member States should devote the necessary funding to the European Border Surveillance System (Eurosur), established by Regulation (EU) No 1052/2013 of the European Parliament and the Council (11), in order to ensure the good functioning of that system.
(30)
To address immediately unforeseen migratory pressure and risks to border security, it should be possible to provide emergency assistance in accordance with the framework set out in Regulation (EU) No 514/2014.
(31)
Moreover, in the interests of enhanced solidarity in the Schengen area as a whole, where weaknesses or possible risks are identified, in particular following a Schengen evaluation, the Member State concerned should follow the matter up adequately by using resources under its national programme by priority, where applicable, complementing emergency assistance measures.
(32)
To reinforce solidarity and responsibility-sharing, Member States should be encouraged to use part of the resources available under their national programmes for specific priorities defined by the Union, such as the purchase of technical equipment needed by the Frontex Agency and the development of consular cooperation for the Union. There is a need to maximise the impact of Union funding by mobilising, pooling and leveraging public and private financial resources. Utmost transparency, accountability and democratic scrutiny should be ensured for innovative financial instruments and mechanisms that involve the Union budget.
(33)
To safeguard the application of the Schengen acquis throughout the Schengen area, the implementation of Council Regulation (EU) No 1053/2013 (12) should also be supported under the Instrument, as an essential tool to facilitate the implementation of Union policies in the area of freedom, justice and security by ensuring a high level of external border protection and the absence of border controls within the Schengen area.
(34)
In light of the experience gained with the External Borders Fund and the development of the SIS II and VIS, it is considered appropriate to allow for a certain degree of flexibility regarding possible transfers of resources between the different means of implementation of the objectives pursued under the Instrument, without prejudice to the principle of ensuring from the start a critical mass and financial stability for the programmes and the operating support for Member States and without prejudice to the scrutiny by the European Parliament and the Council.
(35)
In the same vein, the scope of the actions and the ceiling for resources which remain available to the Union (‘Union actions’) should be increased to enhance the capacity of the Union to carry out, in a given budget year, multiple activities for the management of external borders and the common visa policy in the interests of the Union as a whole, when and insofar as the needs arise. Such Union actions include studies and pilot projects to further the management of external borders and the common visa policy and their application, the training of border guards in the protection of human rights, measures or arrangements in third countries addressing migratory pressures from those countries in the interests of an optimal management of migration flows into the Union and of an efficient organisation of the related tasks at external borders and consulates.
(36)
Measures in, and in relation to, third countries supported through the Instrument should be taken in synergy and coherence with other actions outside the Union, supported through geographic and thematic Union external assistance instruments. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of the Union’s external action and foreign policy related to the country or region in question. They should not be intended to support actions which are directly development-oriented and they should complement, when appropriate, the financial assistance provided through external aid instruments. Coherence will also be sought with the Union’s humanitarian policy, in particular as regards the implementation of emergency measures.
(37)
Funding from the Union budget should concentrate on activities where Union intervention can bring added value compared with action by Member States alone. As the Union is in a better position than Member States to provide a framework for expressing Union solidarity in border control, visa policy and the management of migration flows, and to provide a platform for the development of common IT systems underpinning those policies, financial support provided under this Regulation will contribute in particular to strengthening national and Union capabilities in those areas.
(38)
This Regulation should establish the allocation of basic amounts to Member States. The basic amount for each Member State should be calculated on the basis of the External Borders Fund allocations for each Member State in the years 2010-2012 and by dividing the figure obtained by the total of the appropriations available for shared management for those three years. The calculations were made in accordance with the distribution criteria laid down in Decision No 574/2007/EC.
(39)
The Commission should monitor the implementation of the Instrument, in accordance with the relevant provisions of Regulation (EU) No 514/2014, with the aid of key indicators for evaluating results and impacts. The indicators, including relevant baselines, should provide the minimum basis for evaluating the extent to which the objectives of the Instrument have been achieved.
(40)
In order to supplement or amend provisions in this Regulation regarding the definition of specific actions under the national programmes, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(41)
In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from all Member States.
(42)
In order to ensure a uniform, efficient and timely application of the provisions on operating support laid down in this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (13).
(43)
Since the objective of this Regulation, namely to provide for solidarity and responsibility sharing between Member States and the Union in the management of external borders and visa policy, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(44)
Decision No 574/2007/EC should be repealed, subject to the transitional provisions set out in this Regulation.
(45)
As regards Iceland and Norway, this Regulation constitutes a development of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters’ association with the implementation, application and development of the Schengen acquis
(14) which falls within the areas referred to in Article 1, Points A and B of Council Decision 1999/437/EC (15).
(46)
As regards Switzerland, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis
(16) which fall within the area referred to in Article 1, Points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (17).
(47)
As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen (18) which fall within the area referred to in Article 1, Points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (19).
(48)
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to TEU and TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement this Regulation in its national law.
(49)
This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (20); the United Kingdom is therefore not taking part in its adoption and is not bound by it or subject to its application.
(50)
This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (21). Ireland is therefore not taking part in its adoption and is not bound by it or subject to its application.
(51)
It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) No 1311/2013 (22). Therefore, this Regulation should apply as from 1 January 2014,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Purpose and scope
1. This Regulation establishes the Instrument for financial support for the management of external borders and the common visa policy (‘the Instrument’) as part of the Internal Security Fund (‘the Fund’).
Jointly with Regulation (EU) 513/2014, this Regulation establishes the Fund for the period from 1 January 2014 to 31 December 2020.
2. This Regulation lays down:
(a)
the objectives of financial support and the eligible actions;
(b)
the general framework for the implementation of the eligible actions;
(c)
the resources made available under the Instrument from 1 January 2014 to 31 December 2020 and their distribution;
(d)
the scope and purpose of the different specific means through which the expenditure for the management of the external borders and the common visa policy is financed.
3. This Regulation provides for the application of the rules set out in Regulation (EU) No 514/2014.
Article 2
Definitions
For the purposes of this Regulation the following definitions shall apply:
(a)
‘external borders’ means the land borders of the Member States, including river and lake borders, sea borders and their airports, river ports, sea ports and lake ports to which the provisions of Union law on the crossing of external borders apply, whether the borders are temporary or not;
(b)
‘common Union standards’ means the application of operational measures in a common and unfragmented manner to obtain a high and uniform level of security in the field of border control and visas in accordance with Regulation (EC) No 562/2006 of the European Parliament and of the Council (23), Regulation (EC) No 810/2009 of the European Parliament and of the Council (24), Regulation (EC) No 767/2008 of the European Parliament and of the Council (25), Regulation (EC) No 2007/2004, Regulation (EC) No 1931/2006 of the European Parliament and of the Council (26), the Schengen catalogue for external border control, the Practical Handbook for border guards, the Handbook on visas, the Eurosur Handbook and any other Regulations and guidelines to be adopted at the Union level on border control and visas;
(c)
‘temporary external borders’ means:
(i)
the common border between a Member State fully implementing the Schengen acquis and a Member State bound to apply the Schengen acquis in full, in conformity with its Act of Accession, but for which the relevant Council Decision authorising it to fully apply that acquis has not entered into force;
(ii)
the common border between two Member States bound to apply the Schengen acquis in full, in conformity with their respective Acts of Accession, but for which the relevant Council Decision authorising them to fully apply that acquis has not yet entered into force;
(d)
‘border crossing point’ means any crossing point authorised by the competent authorities for the crossing of external borders as notified in accordance with Article 34(2) of Regulation (EC) No 562/2006;
(e)
‘Schengen evaluation and monitoring mechanism’ means the verification of the correct application of the Schengen acquis as laid down in Regulation (EU) No 1053/2013;
(f)
‘emergency situation’ means a situation resulting from an urgent and exceptional pressure where a large or disproportionate number of third-country nationals are crossing or are expected to cross the external border of one or more Member States or any other duly substantiated emergency situation requiring urgent action at the external borders;
(g)
‘external borders section’ means the whole or a part of the external land or sea border of a Member State as defined by national law or as determined by the national coordination centre or any other responsible national authority for the purpose of the implementation of Regulation (EU) No 1052/2013.
Article 3
Objectives
1. The general objective of the Instrument shall be to contribute to ensuring a high level of security in the Union while facilitating legitimate travel, through a uniform and high level of control of the external borders and the effective processing of Schengen visas, in compliance with the Union’s commitment to fundamental freedoms and human rights.
2. Within the general objective set out in paragraph 1, the Instrument shall contribute — in accordance with the priorities identified in relevant Union strategies, programmes, threat assessments and risk assessments — to meeting the following specific objectives:
(a)
supporting a common visa policy to facilitate legitimate travel, provide a high quality of service to visa applicants, ensure equal treatment of third-country nationals and tackle illegal immigration;
(b)
supporting integrated border management, including promoting further harmonisation of border management-related measures in accordance with common Union standards and through the sharing of information between Member States and between Member States and the Frontex Agency, to ensure, on one hand, a uniform and high level of control and protection of the external borders, including by the tackling of illegal immigration and, on the other hand, the smooth crossing of the external borders in conformity with the Schengen acquis, while guaranteeing access to international protection for those needing it, in accordance with the obligations contracted by the Member States in the field of human rights, including the principle of non-refoulement.
The achievement of the specific objectives of the Instrument shall be evaluated in accordance with Article 55(2) of Regulation (EU) No 514/2014 using common indicators, as set out in Annex IV to this Regulation and programme-specific indicators included in national programmes.
3. To achieve the objectives referred to in paragraphs 1 and 2, the Instrument shall contribute to the following operational objectives:
(a)
promoting the development, implementation and enforcement of policies with a view to ensuring the absence of any controls on persons, whatever their nationality, when crossing the internal borders, and to carrying out checks on persons and monitoring efficiently the crossing of external borders;
(b)
gradually establishing an integrated management system for external borders, based on solidarity and responsibility, in particular by means of:
(i)
the reinforcement of external border checks and surveillance systems and of inter-agency cooperation between border guards, customs, migration, asylum and law enforcement authorities of Member States at the external borders, including in the maritime border area;
(ii)
measures within the territory relating to the management of external borders and the necessary flanking measures on document security, identity management and the interoperability of acquired technical equipment;
(iii)
any measures also contributing to the prevention and fight against cross-border crime at external borders relating to the movement of persons, including trafficking in human beings and human smuggling;
(c)
promoting the development and implementation of the common policy on visas and other short-stay residence permits, and of different forms of consular cooperation in order to ensure better consular coverage and harmonised practices on visa issuing;
(d)
setting up and running IT systems, their communication infrastructure and equipment that support the common visa policy, border checks and border surveillance at the external borders and fully respect personal data protection law;
(e)
reinforcing situational awareness at the external borders and the reaction capabilities of Member States;
(f)
ensuring the efficient and uniform application of the Union’s acquis on borders and visas, including the effective functioning of the Schengen evaluation and monitoring mechanism;
(g)
reinforcing actions by the Member States contributing to enhancing the cooperation between Member States operating in third countries as regards the flows of third-country nationals into the territory of Member States, including prevention and tackling of illegal immigration, as well as the cooperation with third countries in that respect in full coherence with the objectives and principles of Union external action and humanitarian policy.
4. Actions funded under the Instrument shall be implemented in full compliance with fundamental rights and respect for human dignity. In particular, actions shall comply with the provisions of the Charter of Fundamental Rights of the European Union, Union data protection law, the European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR), the principle of fair treatment of third-country nationals, the right to asylum and international protection, the principle of non-refoulement and the international obligations of the Union and Member States arising from international instruments to which they are signatory such as the Geneva Convention Relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967.
In particular, wherever possible, special attention shall be given by Member States when implementing actions to the identification, immediate assistance and referral to protection services of vulnerable persons, in particular children and unaccompanied minors.
5. When implementing actions funded under the Instrument which are related to maritime border surveillance, Member States shall pay special attention to their obligations under international maritime law to render assistance to persons in distress. In that regard, equipment and systems supported under the Instrument may be used to address search and rescue situations which may arise during a border surveillance operation at sea, thereby contributing to ensuring the protection and saving the lives of migrants.
6. The Instrument shall also contribute to the financing of technical assistance at the initiative of the Member States and the Commission.
Article 4
Eligible actions
1. Within the objectives referred to in Article 3 of this Regulation, and in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014 and in accordance with the objectives of the national programme referred to in Article 9 of this Regulation, the Instrument shall support actions in or by Member States, in particular the following:
(a)
infrastructures, buildings and systems required at border crossing points and for surveillance between border crossing points to prevent and tackle unauthorised border crossings, illegal immigration and cross-border criminality as well as to guarantee smooth travel flows;
(b)
operating equipment, means of transport and communication systems required for effective and secure border control and the detection of persons;
(c)
IT and communication systems for the efficient management of migration flows across borders, including investment in existing and future systems;
(d)
infrastructures, buildings, communication and IT systems and operating equipment required for the processing of visa applications and consular cooperation, as well as other actions aimed at improving the quality of service for visa applicants;
(e)
training in the use of the equipment and systems referred to in points (b), (c) and (d) and the promotion of quality management standards and training of border guards, including where appropriate in third countries, with respect to the performance of their surveillance, advisory and control tasks in compliance with international human rights law, including the identification of victims of human trafficking and people smuggling;
(f)
secondment of immigration liaisons officers and document advisers in third countries and the exchange and secondment of border guards between Member States or between a Member State and a third country;
(g)
studies, training, pilot projects and other actions gradually establishing an integrated management system for external borders as referred to in Article 3(3), including actions aiming to foster interagency cooperation either within Member States or between Member States and actions relating to the interoperability and harmonisation of border management systems;
(h)
studies, pilot projects and actions aiming to implement the recommendations, operational standards and best practices resulting from the operational cooperation between Member States and Union agencies.
2. Within the objectives referred to in Article 3 of this Regulation, and in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014 and in accordance with the objectives of the national programme referred to in Article 9 of this Regulation, the Instrument shall support actions in relation to and in third countries and in particular the following:
(a)
information systems, tools or equipment for sharing information between Member States and third countries;
(b)
actions relating to operational cooperation between Member States and third countries, including joint operations;
(c)
projects in third countries aimed at improving surveillance systems to ensure cooperation with Eurosur;
(d)
studies, seminars, workshops, conferences, training, equipment and pilot projects to provide ad hoc technical and operational expertise to third countries;
(e)
studies, seminars, workshops, conferences, training, equipment and pilot projects implementing specific recommendations, operational standards and best practices resulting from operational cooperation between Member States and Union agencies in third countries.
The Commission and the Member States, together with the European External Action Service, shall ensure coordination as regards actions in and in relation to third countries, as set out in Article 3(5) of Regulation (EU) No 514/2014.
3. The actions referred to in point (a) of paragraph 1 shall not be eligible at temporary external borders.
4. The actions related to the temporary and exceptional reintroduction of border control at internal borders as referred to in the Schengen Borders Code shall not be eligible.
5. The actions of which the exclusive aim or effect is the control of goods shall not be eligible.
CHAPTER II
FINANCIAL AND IMPLEMENTATION FRAMEWORK
Article 5
Global resources and implementation
1. The global resources for the implementation of the Instrument shall be EUR 2 760 million in current prices.
2. Annual appropriations shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework.
3. The global resources shall be implemented through the following means:
(a)
national programmes, in accordance with Articles 9 and 12;
(b)
operating support, within the framework of the national programmes and under the conditions laid down in Article 10;
(c)
the Special Transit Scheme, in accordance with Article 11;
(d)
Union actions, in accordance with Article 13;
(e)
emergency assistance, in accordance with Article 14;
(f)
the implementation of a programme for setting up IT systems supporting the management of migration flows across the external borders under the conditions laid down in Article 15;
(g)
technical assistance in accordance with Article 16.
4. The budget allocated under the Instrument to Union actions referred to in Article 13 of this Regulation, to the emergency assistance referred to in Article 14 of this Regulation and to the technical assistance referred to in Article 16(1) of this Regulation shall be implemented under direct management in accordance with point (a) of Article 58(1) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (27) and, where appropriate, under indirect management in accordance with point (c) of Article 58(1) of Regulation (EU, Euratom) No 966/2012.
The budget allocated to the national programmes referred to in Article 9, to the operating support referred to in Article 10 and to the functioning of the Special Transit Scheme referred to in Article 11 shall be implemented under shared management in accordance with point (b) of Article 58(1) of Regulation (EU, Euratom) No 966/2012.
The budget allocated to countries associated with the implementation, application and development of the Schengen acquis referred to in paragraph 7 of this Article shall be implemented under indirect management in accordance with point (c)(i) of Article 58(1) of Regulation (EU, Euratom) No 966/2012.
The method(s) of implementation of the budget for the programme on the development of IT systems, based on existing and/or new IT systems, shall be set out in the relevant Union legislative acts subject to their adoption.
5. The global resources shall be used as follows:
(a)
EUR 1 551 million for the national programmes of Member States;
(b)
EUR 791 million for developing IT systems, based on existing and/or new IT systems, supporting the management of migration flows across the external borders, subject to the adoption of the relevant Union legislative acts;
Where that amount is not allocated or spent, the Commission shall, by means of a delegated act in accordance with Article 17, re-allocate it to one or more of the activities referred to in points (b) and (c) of Article 6(1)and point (d) of this paragraph. That delegated act shall include an assessment of the evolution of the relevant IT systems including the implementation of the budget and expected unspent amounts. That re-allocation may take place following the adoption of the relevant legislative acts or on the occasion of the mid-term review referred to in Article 8.
(c)
EUR 154 million for the Special Transit Scheme;
(d)
EUR 264 million for Union actions, emergency assistance and technical assistance at the initiative of the Commission, of which at least 30 % shall be used for Union actions.
6. Jointly with the global resources established for Regulation (EU) No 513/2014, the global resources available for the Instrument, as established in paragraph 1, constitute the financial envelope for the Fund and serve as the prime reference, within the meaning of point 17 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (28), for the European Parliament and the Council during the annual budgetary procedure.
7. The countries associated with the implementation, application and development of the Schengen acquis shall participate in the Instrument in accordance with this Regulation.
Arrangements shall be concluded on the financial contributions by those countries to the Instrument and the supplementary rules necessary for such participation, including provisions ensuring the protection of the Union’s financial interests and the power of audit of the Court of Auditors.
The financial contributions from those countries shall be added to the global resources available from the Union budget referred to in paragraph 1.
Article 6
Resources for eligible actions in the Member States
1. EUR 1 551 million shall be allocated to the Member States indicatively as follows:
(a)
EUR 1 276 million, as indicated in Annex I;
(b)
EUR 147 million, based on the results of the mechanism referred to in Article 7;
(c)
in the framework of the mid-term review referred to in Article 8 and for the period as of budget year 2018, EUR 128 million, the remainder of the available appropriations under this Article or another amount, as determined pursuant to paragraph 4, based on the results of the risk analysis and the mid-term review.
2. Each Member State shall allocate the basic amounts for national programmes indicated in Annex I as follows:
(a)
at least 10 % for actions relating to point (a) of Article 9(2);
(b)
at least 25 % for actions relating to point (b) of Article 9(2);
(c)
at least 5 % for actions relating to points (c), (d), (e) and (f) of Article 9(2).
Member States may depart from those minimum percentages provided that an explanation is included in the national programme as to why allocating resources below those minima does not jeopardise the achievement of the relevant objective. That explanation will be assessed by the Commission in the context of its approval of national programmes as referred to in Article 9(2).
3. Member States shall devote the necessary funding to Eurosur in order to ensure its good functioning.
4. To address properly the objectives of the Instrument in the event of unforeseen or new circumstances and/or to ensure the effective implementation of funding available under the Instrument, the Commission shall be empowered to adopt delegated acts in accordance with Article 17 to adjust the indicative amount laid down in point (c) of paragraph 1 of this Article.
5. Member States which accede to the Union in the period 2012-2020 shall not benefit from allocations for national programmes under the Instrument as long as they benefit from a temporary instrument of the Union which supports the beneficiary Member States to finance actions at new external borders for the implementation of the Schengen acquis on borders and visas and external border control.
Article 7
Resources for specific actions
1. Member States may, in addition to their allocation calculated in accordance with point (a) of Article 6(1), receive an additional amount, provided that it is earmarked as such in the national programme and is to be used to achieve specific actions listed in Annex II.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 17 for the revision of the specific actions listed in Annex II, if deemed appropriate, including in the context of the mid-term review. On the basis of the new specific actions, Member States may receive an additional amount as laid down in paragraph 1 of this Article, subject to available resources.
3. The additional amounts under this Article shall be allocated to the Member States concerned in the individual financing decision approving or revising their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014.
Article 8
Resources in the framework of the mid-term review
1. In order to allocate the amount indicated in point (c) of Article 6(1), by 1 June 2017 the Commission shall take into account the burden of Member States in border management, including search and rescue activities which may arise during border surveillance operations at sea and assessment reports drawn up as part of the Schengen evaluation and monitoring mechanism, and threat levels at the external borders for the period 2017-2020, as well as factors that affected security at the external borders in 2014-2016. That amount shall be distributed between Member States on the basis of the weighing of the following categories of borders, taking into account paragraph 6 of this Article:
(a)
45 % for external maritime borders;
(b)
38 % for external land borders;
(c)
17 % for airports.
2. For the external maritime and land borders the calculation of the amount shall be based on the length of sections of the external border multiplied by a threat level (minimum, normal, medium, high) for each border section, as follows:
(a)
coefficient 0,5 for minimum threat;
(b)
coefficient 1 for normal threat;
(c)
coefficient 3 for medium threat;
(d)
coefficient 5 for high threat.
3. For the airports, the allocation shall be calculated for each Member State as follows:
(a)
50 % on the basis of the number of persons crossing the external borders;
(b)
50 % on the basis of the number of third-country nationals refused entry at the external borders.
4. In accordance with the Frontex Agency’s risk analysis report and in consultation with the Frontex Agency, and, where relevant, other Union agencies, the Commission shall determine threat levels for each external border section of the Member States for the period 2017-2020. The threat levels shall be based on the following factors:
(a)
burden in border management at the external borders;
(b)
factors that affected security at the external borders of the Member States in the period 2014-2016;
(c)
changes in Union policies, for example visa policies;
(d)
possible future trends in migratory flows and risks of unlawful activities related to the irregular crossing of persons of the external borders; and
(e)
likely political, economic and social developments in third countries, and in particular, neighbouring countries.
Before issuing its report determining the threat levels, the Commission shall hold an exchange of views with the Member States.
5. For the purpose of the distribution of resources under paragraph 1:
(a)
the line between the areas referred to in Article 1 of Council Regulation (EC) No 866/2004 (29), but not the maritime border north of that line, shall be taken into account even though it does not constitute an external land border for as long as Article 1 of Protocol No 10 on Cyprus to the 2003 Act of Accession remains applicable;
(b)
the expression ‘external maritime borders’ shall mean the outer limit of the territorial sea of the Member States as defined in accordance with Articles 4 to 16 of the United Nations Convention on the Law of the Sea. However, in cases where long range operations are required on a regular basis in order to prevent unauthorised border crossings, that expression shall mean the outer limit of high threat areas. Those outer limits shall be determined by taking into account the relevant data on these operations in 2014-2016 as provided by the Member States in question.
6. Moreover, following invitation from the Commission by 1 June 2017, Member States may receive an additional allocation, provided that it is earmarked as such in the national programme and is to be used to achieve specific actions to be established in the light of the priorities of the Union at that time.
7. The additional amounts under this Article shall be allocated to the Member States concerned in an individual financing decision approving or revising their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014.
Article 9
National programmes
1. The national programme to be prepared, taking into account the outcome of the policy dialogue referred to in Article 13 of Regulation (EU) No 514/2014, under the Instrument and the one to be prepared under Regulation (EU) No 513/2014 shall be proposed to the Commission as one single national programme for the Fund and in accordance with Article 14 of Regulation (EU) No 514/2014.
2. Under the national programmes to be examined and approved by the Commission pursuant to Article 14 of Regulation (EU) No 514/2014, Member States shall, within the objectives referred to in Article 3 of this Regulation and taking into account the outcome of the policy dialogue referred to in Article 13 of Regulation (EU) No 514/2014, pursue in particular objectives from the following:
(a)
developing Eurosur in accordance with Union law and guidelines;
(b)
supporting and expanding the existing capacity at national level in visa policy and in the management of the external borders, as well as supporting and expanding measures within the area of free movement relating to the management of external borders, bearing in mind in particular, new technology, developments and/or standards in relation to the management of migration flows;
(c)
supporting the further development of the management of migration flows by consular and other services of the Member States in third countries, including the setting up of consular cooperation mechanisms with a view to facilitating legitimate travel in accordance with Union law or the law of the Member State concerned and preventing illegal immigration into the Union;
(d)
reinforcing integrated border management by testing and introducing new tools, interoperable systems and working methods which aim to enhance information exchange within the Member State or to improve inter-agency cooperation;
(e)
developing projects with a view to ensuring a uniform and high level of control of the external border in accordance with common Union standards and aiming at increased interoperability of border management systems between Member States;
(f)
supporting actions, after consulting the Frontex Agency, aimed at promoting further harmonisation of border management and in particular technological capabilities, in accordance with common Union standards;
(g)
ensuring the correct and uniform application of the Union acquis on border control and visas in response to weaknesses identified at Union level, as shown by results established in the framework of the Schengen evaluation and monitoring mechanism;
(h)
building the capacity to face upcoming challenges, including present and future threats and pressures at the external borders, taking into account in particular the analyses carried out by relevant Union agencies.
3. In pursuit of the objectives referred to in paragraph 2, Member States may support actions in, and in relation to, third countries under their national programmes, including through information-sharing and operational cooperation.
4. The Commission shall consult the Frontex Agency on draft national programmes, in particular on the activities financed under the operating support, submitted by the Member States in order to develop complementarity between the mission of the Frontex Agency and the responsibilities of the Member States for the control and surveillance of external borders as well as to ensure consistency and to avoid cost inefficiency.
Article 10
Operating support under the national programmes of the Member States
1. A Member State may use up to 40 % of the amount allocated under the Instrument to its national programme to finance operating support to the public authorities responsible for accomplishing the tasks and services which constitute a public service for the Union.
2. Operating support shall be provided when the following conditions are met by the Member State concerned:
(a)
compliance with the Union acquis on borders and visas;
(b)
compliance with the objectives of the national programme;
(c)
compliance with common Union standards in order to enhance coordination between Member States and avoid duplication, fragmentation and cost inefficiency in the border control domain.
3. To that end, before the approval of the national programme, the Commission shall assess the baseline situation in Member States which have indicated their intention to request operating support, taking into account, where relevant, the Schengen evaluation reports.
The findings of the Commission shall be the subject of an exchange of views with the Member State concerned.
Following the exchange of views, the acceptance by the Commission of budget support within the national programme of a Member State may be made conditional upon the programming and completion of a number of actions aiming to ensure that the conditions laid down in paragraph 2 are fully met by the time the budget support is provided.
4. Operating support shall be concentrated on specific tasks and/or services and shall be focused on the objectives as laid down in Annex III. It shall entail full reimbursement of the expenditure incurred to accomplish the tasks and/or services defined in the national programme, within the financial limits set by the programme and the ceiling laid down in paragraph 1.
5. Operating support shall be the subject of monitoring and exchange of information between the Commission and the Member State concerned in relation to the baseline situation in that Member State, the objectives and targets to be accomplished and the indicators to measure progress.
6. The Commission shall set out, by means of implementing acts, reporting procedures on the application of this provision and any other practical arrangements to be made between Member States and the Commission to comply with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).
Article 11
Operating support for the Special Transit Scheme
1. The Instrument shall provide support to compensate for foregone fees from visas issued for the purpose of transit and additional costs incurred in implementing the Facilitated Transit Document (FTD) and the Facilitated Rail Transit Document (FRTD) scheme in accordance with Regulation (EC) No 693/2003 and Regulation (EC) No 694/2003.
2. The resources allocated to Lithuania pursuant to paragraph 1 shall not exceed EUR 154 million for the period 2014-2020 and shall be made available as additional specific operating support for Lithuania.
3. For the purpose of paragraph 1, additional costs means costs which result directly from the specific requirements of implementing the operation of the Special Transit Scheme and which are not generated as a result of the issuing of visas for the purpose of transit or other purposes.
The following types of additional cost shall be eligible for financing:
(a)
investment in infrastructures;
(b)
training of staff implementing the special transit scheme;
(c)
additional operational costs, including salaries of staff specifically implementing the special transit scheme.
4. The foregone fees referred to in paragraph 1 of this Article shall be calculated on the basis of the level of visa fees and the visa fee waivers established by the Agreement between the European Community and the Russian Federation on the facilitation of the issuance of visas to the citizens of the European Union and the Russian Federation (30), within the financial framework set out in paragraph 2 of this Article.
5. The Commission and Lithuania shall review the application of this Article in the event of changes which have an impact on the existence and/or functioning of the Special Transit Scheme.
6. The Commission shall set out, by means of implementing acts, reporting procedures on the application of this provision and any financial and other practical arrangements to be made between Lithuania and the Commission to comply with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).
7. To ensure the smooth functioning of the Special Transit Scheme the Commission may make specific interim payment arrangements which derogate from the provisions of Regulation (EU) No 514/2014.
Article 12
Programming in line with the outcomes of the Schengen evaluation and monitoring mechanism
Following a Schengen evaluation report, as adopted in accordance with Regulation (EU) No 1053/2013, the Member State concerned shall examine, together with the Commission and the Frontex Agency, how to address the findings, including any deficiencies, and implement the recommendations within the framework of its national programme.
Where necessary, a Member State shall revise its national programme in accordance with Article 14(9) of Regulation (EU) No 514/2014 to take into account those findings and recommendations.
The financing of corrective actions shall be a priority. In dialogue with the Commission and the Frontex Agency, the Member State concerned shall reallocate resources under its programme, including those programmed for operating support, and/or introduce or amend actions aiming to remedy the weaknesses in accordance with the findings and recommendations of the Schengen evaluation report.
Article 13
Union actions
1. At the Commission’s initiative, the Instrument may be used to finance transnational actions or actions of particular interest to the Union (‘Union actions’) concerning the general, specific and operational objectives referred to in Article 3.
2. To be eligible for funding, Union actions shall in particular pursue the following objectives:
(a)
to support preparatory, monitoring, administrative and technical activities, required to implement external borders and visa policies, including to strengthen the governance of the Schengen area by developing and implementing the evaluation mechanism as established by Regulation (EU) No 1053/2013 to verify the application of the Schengen acquis and the Schengen Borders Code, in particular mission expenditure for experts of the Commission and the Member States participating in on site visits;
(b)
to improve the knowledge and understanding of the situation prevailing in the Member States and third countries through the analysis, evaluation and close monitoring of policies;
(c)
to support the development of statistical tools, including common statistical tools, methods and common indicators;
(d)
to support and monitor the implementation of Union law and Union policy objectives in the Member States, and assess their effectiveness and impact, including with regard to respect for human rights and fundamental freedoms, as far as the scope of the Instrument is concerned;
(e)
to promote networking, mutual learning, identification and dissemination of best practices and innovative approaches amongst different stakeholders at European level;
(f)
to promote projects aiming at harmonisation and interoperability of border management-related measures in accordance with common Union standards with a view to developing an integrated European border management system;
(g)
to enhance awareness of Union policies and objectives among stakeholders and the general public, including corporate communication on the political priorities of the Union;
(h)
to boost the capacity of European networks to assess, promote, support and further develop Union policies and objectives;
(i)
to support particularly innovative projects developing new methods and/or technologies with a potential for transferability to other Member States, especially projects which aim to test and validate research projects;
(j)
to support actions in relation to and in third countries as referred to in Article 4(2).
3. Union actions shall be implemented in accordance with Article 6 of Regulation (EU) No 514/2014.
Article 14
Emergency assistance
1. The Instrument shall provide financial assistance to address urgent and specific needs in the event of an emergency situation as defined in point (f) of Article 2.
2. Emergency assistance shall be implemented in accordance with Articles 6 and 7 of Regulation (EU) No 514/2014.
Article 15
Establishing a programme on the development of IT systems
The programme on the development of the IT systems, based on existing and/or new IT systems, shall be implemented subject to adoption of the Union legislative acts defining those IT systems and their communication infrastructure with the aim, in particular, of improving the management and control of travel flows at the external borders by reinforcing checks while speeding up border crossings for regular travellers. Where appropriate, synergies with existing IT systems shall be sought in order to avoid double-spending.
The breakdown of the amount referred to in point (b) of Article 5(5) shall be made either in the relevant Union legislative acts or, following the adoption of those legislative acts, through a delegated act in accordance with Article 17.
The Commission shall inform the European Parliament and the Council of progress in developing those IT systems at least once a year and whenever appropriate.
Article 16
Technical assistance
1. At the initiative and/or on behalf of the Commission, the Instrument may contribute up to EUR 1,7 million annually for technical assistance to the Fund in accordance with Article 9 of Regulation (EU) No 514/2014.
2. At the initiative of a Member State, the Instrument may finance technical assistance activities, in accordance with Article 20 of Regulation (EU) No 514/2014. The amount set aside for technical assistance shall not exceed, for the period 2014–2020, 5 % of the total amount allocated to a Member State plus EUR 500 000.
CHAPTER III
FINAL PROVISIONS
Article 17
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in point (b) of Article 5(5) and Articles 6(4), 7(2) and 15 shall be conferred on the Commission for a period of seven years from 21 May 2014. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the seven year period. The delegation of power shall be tacitly extended for a period of three years, unless the European Parliament or the Council opposes such extension not later than three months before the end of the seven-year period.
3. The delegation of power referred to in point (b) of Article 5(5) and Articles 6(4), 7(2) and 15 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to point (b) of Article 5(5) and Articles 6(4), 7(2) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 18
Committee procedure
1. The Commission shall be assisted by the ‘Asylum, Migration and Integration and Internal Security Funds Committee’ established by Article 59(1) of Regulation EU No 514/2014.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 19
Applicability of Regulation (EU) No 514/2014
The provisions of Regulation (EU) No 514/2014 shall apply to the Instrument.
Article 20
Repeal
Decision No 574/2007/EC shall be repealed with effect from 1 January 2014.
Article 21
Transitional provisions
1. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of the projects and annual programmes until their closure or the financial assistance approved by the Commission on the basis of Decision No 574/2007/EC or any other legislation applying to that assistance on 31 December 2013.
2. When adopting decisions on co-financing under the Instrument, the Commission shall take account of measures adopted on the basis of Decision No 574/2007/EC before 20 May 2014 which have financial repercussions during the period covered by that co-financing.
3. Sums committed for co-financing approved by the Commission between 1 January 2011 and 31 December 2014 for which the documents required for closure of the actions have not been sent to the Commission by the deadline for submitting the final report shall be automatically decommitted by the Commission by 31 December 2017, giving rise to the repayment of amounts unduly paid.
4. Amounts relating to actions which have been suspended due to legal proceedings or administrative appeals having suspensive effect shall be disregarded in calculating the amount to be automatically decommitted.
5. Member States shall submit to the Commission by 30 June 2015 the evaluation report on the results and impact of actions co-financed under the Decision No 574/2007/EC concerning the period 2011–2013.
6. The Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions by 31 December 2015 the ex-post evaluation report under Decision No 574/2007/EC concerning the period 2011-2013.
Article 22
Review
The European Parliament and the Council shall, on the basis of a proposal of the Commission, review this Regulation by 30 June 2020.
Article 23
Entry into force and application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Strasbourg, 16 April 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
D. KOURKOULAS
(1) OJ C 299, 4.10.2012, p. 108.
(2) OJ C 277, 13.9.2012, p. 23.
(3) Position of the European Parliament of 13 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014.
(4) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (see page 93 of this Official Journal).
(5) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (see page 112 of this Official Journal).
(6) Decision No 574/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the External Borders Fund for the period 2007 to 2013 as part of the General programme ‘Solidarity and Management of Migration Flows’ (OJ L 144, 6.6.2007, p. 22).
(7) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1).
(8) Regulation (EU) No 1168/2011 of the European Parliament and of the Council of 25 October 2011 amending Council Regulation (EC) No 2007/2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 304, 22.11.2011, p. 1).
(9) Council Regulation (EC) No 693/2003 of 14 April 2003 establishing a specific Facilitated Transit Document (FTD), a Facilitated Rail Transit Document (FRTD) and amending the Common Consular Instructions and the Common Manual (OJ L 99, 17.4.2003, p. 8).
(10) Council Regulation (EC) No 694/2003 of 14 April 2003 on uniform formats for Facilitated Transit Documents (FTD) and Facilitated Rail Transit Documents (FRTD) provided for in Regulation (EC) No 693/2003 (OJ L 99, 17.4.2003, p. 15).
(11) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, p. 11).
(12) Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27).
(13) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers
(OJ L 55, 28.2.2011, p. 13).
(14) OJ L 176, 10.7.1999, p. 36.
(15) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen (OJ L 176, 10.7.1999, p. 31).
(16) OJ L 53, 27.2.2008, p. 52.
(17) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1).
(18) OJ L 160, 18.6.2011, p. 21.
(19) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19).
(20) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43).
(21) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).
(22) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884).
(23) Regulation (EC) No 562/2006 of the European Parliament and of the Council of 15 March 2006 establishing a Community Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 105, 13.4.2006, p. 1).
(24) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).
(25) Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, p. 60).
(26) Regulation (EC) No 1931/2006 of the European Parliament and of the Council of 20 December 2006 laying down rules on local border traffic at the external land borders of the Member States and amending the provisions of the Schengen Convention (OJ L 405, 30.12.2006, p. 1).
(27) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).
(28) OJ C 373, 20.12.2013, p. 1.
(29) Council Regulation (EC) No 866/2004 of 29 April 2004 on a regime under Article 2 of Protocol No 10 to the Act of Accession (OJ L 161, 30.4.2004, p. 128).
(30) OJ L 129, 17.5.2007, p. 27.
ANNEX I
Amounts constituting the basis for the national programmes of Member States (in EUR)
Member State/associated state
Minimum amount
Fixed part distributed on basis of 2010-2012 average
% 2010-2012 with Croatia
TOTAL
AT
5 000 000
9 162 727
0,828 %
14 162 727
BE
5 000 000
12 519 321
1,131 %
17 519 321
BG
5 000 000
35 366 130
3,196 %
40 366 130
CH
5 000 000
13 920 284
1,258 %
18 920 284
CY
15 000 000
19 507 030
1,763 %
34 507 030
CZ
5 000 000
9 381 484
0,848 %
14 381 484
DE
5 000 000
46 753 437
4,225 %
51 753 437
DK
5 000 000
5 322 133
0,481 %
10 322 133
EE
5 000 000
16 781 752
1,516 %
21 781 752
ES
5 000 000
190 366 875
17,201 %
195 366 875
FI
5 000 000
31 934 528
2,886 %
36 934 528
FR
5 000 000
79 999 342
7,229 %
84 999 342
GR
5 000 000
161 814 388
14,621 %
166 814 388
HR
4 285 714
31 324 057
2,830 %
35 609 771
HU
5 000 000
35 829 197
3,237 %
40 829 197
IE
IS
5 000 000
326 980
0,030 %
5 326 980
IT
5 000 000
151 306 897
13,672 %
156 306 897
LI
5 000 000
0
0,000 %
5 000 000
LT
5 000 000
19 704 873
1,780 %
24 704 873
LU
5 000 000
400 129
0,036 %
5 400 129
LV
5 000 000
10 521 704
0,951 %
15 521 704
MT
15 000 000
38 098 597
3,442 %
53 098 597
NL
5 000 000
25 609 543
2,314 %
30 609 543
NO
5 000 000
9 317 819
0,842 %
14 317 819
PL
5 000 000
44 113 133
3,986 %
49 113 133
PT
5 000 000
13 900 023
1,256 %
18 900 023
RO
5 000 000
56 151 568
5,074 %
61 151 568
SE
5 000 000
6 518 706
0,589 %
11 518 706
SI
5 000 000
25 669 103
2,319 %
30 669 103
SK
5 000 000
5 092 525
0,460 %
10 092 525
UK
TOTAL
169 285 714
1 106 714 286
100,00 %
1 276 000 000
ANNEX II
List of specific actions
1.
Setting up consular cooperation mechanisms between at least two Member States resulting in economies of scale as regards the processing of applications and the issuing of visas at consulates in accordance with the principles on cooperation laid down in the Visa Code, including common visa application centres.
2.
Purchasing means of transport and operating equipment that are considered necessary for the deployment during joint operations by the Frontex Agency and which shall be put at the disposal of the Frontex Agency in accordance with the second and third subparagraph of Article 7(5) of Regulation (EC) No 2007/2004.
ANNEX III
Objectives for operating support within the national programmes
Objective 1: promoting the development and implementation of policies ensuring the absence of any controls on persons, whatever their nationality, when crossing the internal borders, carrying out checks on persons and monitoring efficiently the crossing of external borders
—
operations
—
staff costs, including for training
—
service costs, such as maintenance and repair
—
upgrading/replacement of equipment
—
real estate (depreciation, refurbishment)
Objective 2: promoting the development and implementation of the common policy on visas and other short-stay residence permits, including consular cooperation
—
operations staff costs, including for training
—
service costs, maintenance and repair
—
upgrading/replacement of equipment
—
real estate (depreciation, refurbishment)
Objective 3: setting up and running secure IT systems, their communication infrastructure and equipment supporting the management of migration flows, including surveillance, across the external borders of the Union
—
operational management of SIS, VIS and new systems to be set up
—
staff costs, including for training
—
service costs, such as maintenance and repair
—
communication infrastructure and security as well as data protection related matters
—
upgrading/replacement of equipment
—
rental of secure premises and/or refurbishment
ANNEX IV
List of common indicators for the measurement of the specific objectives
(a)
Supporting a common visa policy to facilitate legitimate travel, ensure equal treatment of third-country nationals and tackle illegal immigration
(i)
Number of consular cooperation activities developed with the help of the Instrument
For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as:
—
co-locations,
—
common application centres,
—
representations,
—
others.
(ii)
Number of staff trained and number of training courses in aspects related to the common visa policy with the help of the Instrument
(iii)
Number of specialised posts in third countries supported by the Instrument
For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as:
—
immigration liaison officers,
—
others.
(iv)
Percentage and number of consulates developed or upgraded with the help of the Instrument out of the total number of consulates
(b)
Supporting borders management, including through sharing information between Member States and between Member States and the Frontex Agency, to ensure, on one hand, a high level of protection of the external borders, including by the tackling of illegal immigration and, on the other hand, the smooth crossing of the external borders in conformity with the Schengen acquis
(i)
Number of staff trained and number of training courses in aspects related to border management with the help of the Instrument
(ii)
Number of border control (checks and surveillance) infrastructure and means developed or upgraded with the help of the Instrument
For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as:
—
infrastructure,
—
fleet (air, land, sea borders),
—
equipment,
—
others.
(iii)
Number of border crossings of the external borders through ABC gates supported from the Instrument out of the total number of border crossings
(iv)
Number of national border surveillance infrastructure established/further developed in the framework of Eurosur
For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as:
—
National Coordination Centres,
—
Regional Coordination Centres,
—
Local Coordination Centres,
—
other types of coordination centres.
(v)
Number of incidents reported by Member States to the European Situational Picture
For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as:
—
illegal immigration, including incidents relating to a risk to the lives of migrants,
—
cross-border crime,
—
crisis situations.
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Financial support for EU’s external borders and the common visa policy: Internal Security Fund
Financial support for EU’s external borders and the common visa policy: Internal Security Fund
SUMMARY OF:
Regulation (EU) No 515/2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa policy
WHAT IS THE AIM OF THE REGULATION?
The regulation, known as the ISF-Borders and Visa Regulation, creates a funding instrument and lays down the objectives, the budget and procedures for implementing the eligible actions for the period 2014-2020.
The general objective of the instrument is to contribute to a high level of security in the EU while facilitating legitimate travel by ensuring the efficient management of the EU’s external borders and the effective processing of visas for the Schengen area (a border-free area comprising 22 EU countries and 4 associated countries — Iceland, Liechtenstein, Norway and Switzerland).
KEY POINTS
The ISF-Borders Fund aims to support:
the common visa policy to make legitimate travel easier by ensuring a high-quality service for visa applicants and equal treatment of nationals from outside the Schengen area, as well as to tackle illegal migration;
integrated border management, including the use of common standards and information exchange between Schengen countries and with the European Border and Coast Guard Agency (EBCG agency, commonly referred to as Frontex) to ensure;a high level of control and protection of the external borders;smooth crossing of the external borders in conformity with the Schengen acquis; andguaranteeing access to international protection for those needing it.
The instrument funds actions to:
strengthen external border checks to monitor the crossing of external borders;
gradually establish an integrated management system for external borders, based on solidarity and responsibility, through for example;external border surveillance systems; andcooperation (including in the maritime border area) between border guards, customs, migration, asylum and law enforcement authorities;
promote the common policy on visas and other short-stay residence permits and consular cooperation mechanisms;
set up and run IT systems supporting the common visa policy and border control, and improve awareness of the situation at external borders;
prevent and tackle illegal immigration in cooperation with non-EU countries.
Examples of eligible actions include:
infrastructures, IT systems and operating equipment, including means of transport, for border control and processing of visa applications;
studies, training and pilot projects on operational standards and best practices in the field;
actions relating to operational cooperation between EU and non EU-countries, including joint operations;
The implementation of the fund is mainly entrusted to the participating 26 EU countries (all EU countries, except Ireland and UK) and the 4 Schengen Associated countries (Iceland, Liechtenstein, Norway, and Switzerland). The national programmes define the funding priorities by addressing the fund’s objectives.
The allocation of resources is based on a number of criteria relating to the type of external border (maritime, land and international airports), taking into account the travel flows and the level of risks and threats. The allocation of funds to specific objectives under the national programmes relate to the challenges and needs of participating countries.
A table setting out the amounts constituting the basis for participating countries’ national programmes is included in the regulation’s annex I. During the implementation period, such amounts have increased following the allocation of additional funds to national programmes in the framework of the mid-term review conducted in 2018, and specifically for the development of IT systems and for the implementation of the specific actions.
A part of the fund is managed centrally by the Commission in the form of Union actions which includes assistance to address urgent and specific needs in the event of an emergency situation (emergency assistance).
The fund is complemented by the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (ISF-Police Fund), set up by Regulation (EU) No 513/2014.
Budget
The total initial allocation for ISF-Borders and Visa (2014-20) was €2.76 billion (in current prices).
Implementation
The so-called ‘Horizontal Regulation’ (Regulation (EU) No 514/2014 — see relevant summary) contains the general rules and procedures for implementing this instrument.
Extension of the fund to the Schengen associated countries
Agreements have been negotiated between the EU and the 4 Schengen Associated Countries allowing their participation in the ISF-Borders and Visa.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2014.
BACKGROUND
For more information, see:
Internal Security Fund — borders and visa (European Commission).
MAIN DOCUMENT
Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, pp. 143-167).
The successive amendments to Regulation (EU) No 515/2014 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, crisis management and repealing Council Decision 2007/125/JHA (OJ L 150, 20.5.2014, pp. 93-111)
Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, pp. 112-142)
Swiss Confederation
Council Decision (EU) 2018/929 of 25 June 2018 on the conclusion, on behalf of the Union, of the Agreement between the European Union and the Swiss Confederation on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 165, 2.7.2018, pp. 1-2)
Council Decision (EU) 2018/404 of 13 March 2018 on the signing, on behalf of the Union, of the Agreement between the European Union and the Swiss Confederation on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 74, 16.3.2018, pp. 1-2)
Agreement between the European Union and the Swiss Confederation on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 165, 2.7.2018, pp. 3-11)
Iceland
Council Decision (EU) 2018/948 of 25 June 2018 on the conclusion on behalf of the European Union of the Agreement between the European Union and Iceland on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 167, 4.7.2018, pp. 1-2).
Council Decision (EU) 2018/398 of 12 June 2017 on the signing, on behalf of the European Union, and provisional application of the Agreement between the European Union and Iceland on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 72, 15.3.2018, pp. 1-2)
Agreement between the European Union and Iceland on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund, for the period 2014 to 2020 (OJ L 72, 15.3.2018, pp. 3-11)
Kingdom of Norway
Council Decision (EU) 2017/1249 of 16 June 2017 on the conclusion on behalf of the Union of the Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 179, 12.7.2017, pp. 1-2)
Council Decision (EU) 2017/479 of 8 December 2016 on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 75, 21.3.2017, pp. 1-2)
Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 75, 21.3.2017, pp. 3-11)
Information relating to the entry into force of the Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 68, 12.3.2018, p. 1)
Principality of Liechtenstein
Council Decision (EU) 2017/657 of 3 April 2017 on the conclusion on behalf of the European Union of the Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 94, 7.4.2017, pp. 1-2)
Council Decision (EU) 2017/47 of 8 November 2016 on the signing, on behalf of the European Union, and provisional application of the Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 7, 12.1.2017, pp. 2-3)
Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (OJ L 7, 12.1.2017, pp. 4-13)
last update 26.06.2019
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32014R0223
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12.3.2014
EN
Official Journal of the European Union
L 72/1
REGULATION (EU) No 223/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 March 2014
on the Fund for European Aid to the Most Deprived
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 175(3) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
In line with the conclusions of the European Council of 17 June 2010, whereby the Union strategy for smart, sustainable and inclusive growth ('Europe 2020 strategy') was adopted, the Union and the Member States have set themselves the objective of having at least 20 million fewer people at risk of poverty and social exclusion by 2020. Nonetheless, in 2011, nearly one quarter of people living in the Union (119,82 million) were at risk of poverty or social exclusion, approximately 4 million people more than in the previous year. However, poverty and social exclusion are not uniform across the Union and their gravity varies between the Member States.
(2)
The number of persons suffering from material, or even severe material, deprivation in the Union is increasing and in 2011 nearly 8,8 % of Union citizens lived in conditions of severe material deprivation. In addition, those persons are often too excluded to benefit from the activation measures of Regulation (EU) No 1303/2013 of the European Parliament and of the Council (4), and, in particular of Regulation (EU) No 1304/2013 of the European Parliament and of the Council (5).
(3)
Member States and the Commission should take appropriate steps to prevent any discrimination and should ensure equality between men and women and the coherent integration of the gender perspective at all stages of the preparation, the programming, management and implementation, the monitoring and the evaluation of the a Fund for European Aid to the Most Deprived (the 'Fund'), as well as in information and awareness raising campaigns and the exchange of best practices.
(4)
Article 2 of the Treaty on European Union (TEU) emphasises that the Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities.
(5)
Article 6 TEU emphasises that the Union recognises the rights, freedoms and principles set out in the Charter of Fundamental Rights of the European Union.
(6)
Article 174 of the Treaty on the Functioning of the European Union (TFEU) provides that in order to promote its overall harmonious development, the Union is to develop and pursue actions leading to the strengthening of its economic, social and territorial cohesion.
(7)
The Fund should strengthen social cohesion by contributing to the reduction of poverty, and ultimately the eradication of the worst forms of poverty, in the Union by supporting national schemes that provide non-financial assistance to alleviate food and severe material deprivation and/or contribute to the social inclusion of the most deprived persons. The Fund should alleviate the forms of extreme poverty with the greatest social exclusion impact, such as homelessness, child poverty and food deprivation.
(8)
The Fund is not meant to replace public policies undertaken by the Member States to fight poverty and social exclusion, in particular policies which are necessary to prevent the marginalisation of vulnerable and low-income groups and to avert the increased risk of poverty and social exclusion.
(9)
Under Article 317 TFEU, and in the context of shared management, the conditions allowing the Commission to exercise its responsibilities for implementation of the general budget of the Union should be specified and the responsibilities in terms of cooperation by the Member States clarified. Those conditions should enable the Commission to obtain assurance that Member States are using the Fund in a legal and regular manner and in accordance with the principle of sound financial management within the meaning of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6) ('the Financial Regulation').
(10)
Those provisions also ensure that the operations supported shall comply with applicable Union and related national law which directly or indirectly implements this Regulation, as well as policies, in particular as regards the safety of food and/or basic material assistance distributed to the most deprived persons.
(11)
The allocation of the appropriations of the Fund between the Member States for the 2014-2020 period takes into account in equal measure the following indicators assessed on the basis of data from Eurostat on the population suffering from severe material deprivation and the population living in households with very low work intensity. Furthermore, the allocation also takes into account the different ways of assisting the most deprived persons in the Member States. However, each Member State should be allocated the minimum amount of 3 500 000 EUR for the 2014-2020 programming period in order to set an operational programme with a meaningful level of resources.
(12)
The Member State's allocation for the Fund should be deducted from the Member State Structural Funds allocation.
(13)
The operational programmes of Member States should identify and justify the forms of food and/or material deprivation to be addressed and/or social inclusion activities to be supported, and should describe features of the assistance to the most deprived persons that will be provided through the Fund's support for national schemes. It should also include elements necessary to ensure the effective and efficient implementation of the operational programmes.
(14)
Severe food deprivation in the Union coincides with significant food wastage. In this respect, the Fund should facilitate food donations, where appropriate. However, this is without prejudging the need to remove existing obstacles in order to encourage donations of excess food for the purposes of combating food deprivation.
(15)
With a view to ensuring the effective and efficient implementation of the measures financed from the Fund, Member States should, where appropriate, promote cooperation between regional and local authorities and bodies representing civil society and the participation by all those involved in drawing up and implementing activities financed from the Fund.
(16)
In order to maximise the effectiveness of the Fund, in particular as regards possible changes in the national circumstances, it is appropriate to establish a procedure to amend an operational programme.
(17)
The partnership principle should apply in order to respond in the most effective and adequate manner to the various needs and to better reach out to the most deprived persons.
(18)
Exchanges of experience and best practices have a significant added value because they facilitate mutual learning. The Commission should facilitate and promote their dissemination, while seeking synergies with the exchange of best practices in the context of related Funds, in particular the European Social Fund (ESF).
(19)
In order to monitor the progress of implementation of operational programmes, Member States should draw up and provide to the Commission annual and final implementation reports. This should ensure the availability of essential and up-to-date information for those operational programmes. For the same purposes, the Commission and each Member State should meet every year to carry out a review, unless they agree otherwise. Relevant stakeholders should be involved in the monitoring in an appropriate way.
(20)
In order to improve the quality and design of each operational programme and evaluate the effectiveness and efficiency of the Fund, ex ante and ex post evaluations should be carried out. Those evaluations should be based upon relevant data and supplemented, where relevant, by surveys on the most deprived persons who have benefited from the operational programme and, if necessary, by evaluations during the programming period. Those evaluations should also respect the privacy of end recipients and be carried out in such a way as not to stigmatise the most deprived persons. The responsibilities of Member States and the Commission in this respect should be specified.
(21)
In evaluating the Fund and in developing the evaluation methodology it should be borne in mind that deprivation is a complex concept of a multi-dimensional nature.
(22)
Citizens have the right to know how the Union's financial resources are invested and to what effect. For the purpose of ensuring wide dissemination of information about the achievements of the Fund and to ensure accessibility and transparency of funding opportunities, detailed rules about information and communication, especially in relation to the responsibilities of the beneficiaries, the Member States and, where relevant, local and regional authorities should be established.
(23)
Union law concerning the protection of individuals with regard to the processing of personal data and on the free movement of such data, in particular Directive 95/46/EC of the European Parliament and of the Council (7) is applicable.
(24)
It is necessary to establish a maximum level of co-financing from the Fund to the operational programmes to provide for a multiplier effect of Union resources. In addition the situation of Member States facing temporary budget difficulties should be addressed.
(25)
Uniform, simple and equitable rules on the eligibility period, operations and expenditures for the Fund should be applied across the Union. The conditions of eligibility should reflect the specific nature of the Fund's objectives and target populations, in particular through adequate and simplified conditions of eligibility of the operations as well as forms of support and rules and conditions of reimbursement.
(26)
Taking into account the date by which invitations to tender have to be issued, the time limits for adoption of this Regulation and the time needed for the preparation of operational programmes, rules should be put in place to permit a smooth transition so that there is no interruption in the supply of food aid. To this end, it is appropriate to allow eligibility of expenditure from 1 December 2013.
(27)
Regulation (EU) No 1308/2013 of the European Parliament and of the Council (8) provides that products bought under public intervention may be disposed of by making them available for the scheme for food distribution to the most deprived in the Union if that scheme so provides. Given that, depending on the circumstances, obtaining food from the use, processing or sale of those products is the most economically favourable option, it is appropriate to provide for such a possibility in this Regulation. The amounts derived from a transaction concerning such products should be used for the benefit of the most deprived persons. Those amounts should not be applied so as to diminish the obligation of the Member States to co-finance the programme. To ensure the most efficient possible use of those products and their proceeds, the Commission should adopt implementing acts in accordance with Regulation (EU) No 1308/2013 establishing procedures by which those products may be used, processed or sold for the purposes of the most deprived persons programme.
(28)
It is necessary to specify the types of actions that can be undertaken at the initiative of the Commission and of the Member States as technical assistance supported by the Fund. The Commission should consult the Member States and representatives of partner organisations at Union level for this purpose.
(29)
In accordance with the principle of shared management, Member States and the Commission should be responsible for the management and control of programmes. Member States should have the primary responsibility, through their management and control system, for the implementation and control of their operational programme.
(30)
Member States should adopt adequate measures to guarantee the proper set up and functioning of their management and control systems to give assurance on the legal and regular use of the Fund. The obligations of Member States as regards the management and control systems of their operational programmes, and in relation to the prevention, detection and correction of irregularities and breaches of Union law should therefore be specified.
(31)
Member States should fulfil the management, control and audit obligations and assume the responsibilities as laid down in the rules on shared management set out in this Regulation and in the Financial Regulation. Member States should ensure that, in accordance with the conditions set out in this Regulation, effective arrangements for the examination of complaints in relation to the Fund are in place. In accordance with the principle of subsidiarity, Member States should, upon request of the Commission, examine complaints submitted to the Commission falling within the scope of their arrangements and should inform the Commission of the results of examinations upon request.
(32)
Member States should designate a managing authority, a certifying authority and a functionally independent auditing authority for each operational programme. To provide flexibility for Member States in setting up control systems, it is appropriate to provide for the option for the functions of the certifying authority to be carried out by the managing authority. Member States should also be allowed to designate intermediate bodies to carry out certain tasks of the managing authority or the certifying authority. Member States should in that case lay down clearly their respective responsibilities and functions.
(33)
The managing authority bears the main responsibility for the effective and efficient implementation of the Fund and thus fulfils a substantial number of functions related to operational programme management and monitoring, financial management and controls as well as project selection. Accordingly, the managing authority's responsibilities and functions should be set out in this Regulation.
(34)
The certifying authority should draw up and submit to the Commission payment applications. It should draw up the accounts, certifying their completeness, accuracy and veracity and that the expenditure entered in the accounts complies with applicable Union and national rules. The certifying authority's responsibilities and functions should be set out in this Regulation.
(35)
The audit authority should ensure that audits are carried out on the management and control systems, on an appropriate sample of operations and on the accounts. The audit authority's responsibilities and functions should be set out in this Regulation. Audits of declared expenditure should be carried out on a representative sample of operations in order to enable the results to be extrapolated. As a general rule, a statistical sampling method should be used in order to provide a reliable representative sample. Nevertheless, audit authorities should be able to use in duly justified circumstances a non-statistical sampling method or substantive testing, provided that the conditions laid down in this Regulation are complied with.
(36)
In order to take account of the specific organisation of the management and control systems for the Fund and the need to ensure a proportionate approach, specific provisions should be laid down in relation to the designation of the managing authority and the certifying authority. In order to avoid an unnecessary administrative burden, the ex ante verification of compliance with the designation criteria indicated in this Regulation should be limited to the managing and certifying authority. There should be no requirement to approve the designation by the Commission. The monitoring of compliance with the designation criteria carried out on the basis of audit and control arrangements should, where results show non-compliance with the criteria, give rise to remedial actions, and possibly to the ending of the designation.
(37)
Without prejudice to the Commission's powers as regards financial control, cooperation between the Member States and the Commission in the framework of this Regulation should be ensured and criteria should be established which allow the Commission to determine, in the context of its strategy of control of national systems, the level of assurance it should obtain from national audit bodies.
(38)
The powers and responsibilities of the Commission with regard to verifying the effective functioning of the management and control systems, and to require Member State action, should be laid down. The Commission should also have the power to carry out on-the-spot audits focused on issues relating to sound financial management in order to draw conclusions on the performance of the Fund.
(39)
Budget commitments of the Union should be effected annually. In order to ensure effective programme management, it is necessary to lay down simple rules for pre-financing, interim requests for payment and the final balance.
(40)
With a view to ensuring reasonable assurance for the Commission prior to the acceptance of accounts, applications for interim payment should be reimbursed at a rate of 90 % of the amount resulting from applying the co-financing rate laid down in the decision adopting the operational programme, to the eligible expenditure. The outstanding amounts due should be paid to the Member States upon acceptance of accounts, provided that the Commission is able to conclude that the accounts are complete, accurate and true.
(41)
A pre-financing payment at the start of the operational programme should ensure that the Member State has the means to provide support to the beneficiaries in the implementation of the operations starting from the adoption of the operational programme. This pre-financing should be used exclusively for this purpose and so that beneficiaries should receive enough funding to start up an operation upon its selection.
(42)
Beneficiaries should receive the support in full no later than 90 days from the date of submission of the payment claim by the beneficiary, subject to the availability of funding from pre-financing and interim payments. The managing authority should be able to interrupt the deadline where supporting documents are incomplete or there is evidence of irregularity requiring further investigation.
(43)
In order to safeguard the Union's financial interests, measures should be provided for that are limited in time that allow the authorising officer by delegation to interrupt payments where there is clear evidence to suggest a significant deficiency in the functioning of the management and control system, evidence of irregularities linked to a request for payment, or a failure to submit documents for the purpose of the examination and acceptance of accounts. The duration of the interruption period should be for a period of up to six months, with a possible extension of that period up to nine months with the agreement of the Member State, to allow sufficient time to resolve the causes of the interruption thereby avoiding the application of suspensions.
(44)
In order to safeguard the Union's financial interests and provide the means to ensure effective programme implementation, provisions should be laid down allowing for the suspension by the Commission of payments.
(45)
In order to apply the requirements of the Financial Regulation to the financial management of the Fund, it is necessary to set out simple procedures for the preparation, examination and acceptance of accounts which should ensure a clear basis and legal certainty for these arrangements. In addition, in order to allow a Member State properly to fulfil its responsibilities, it should be possible for the Member State to exclude amounts which are the subject of an ongoing assessment of legality and regularity.
(46)
To reduce the risk of irregular expenditure being declared, it should be possible for a certifying authority, without any need for additional justification, to include the amounts which require further verification in an interim payment application after the accounting year in which they were entered into its accounting system.
(47)
In order to reduce the administrative burden on beneficiaries, specific time limits should be set out during which the managing authorities are obliged to ensure the availability of documents for operations following submission of expenditure or completion of an operation. In accordance with the principle of proportionality, the period for keeping the documents should be differentiated depending on the total eligible expenditure of an operation.
(48)
As accounts are verified and accepted every year, the closure procedure should be simple. The final closure of the programme should therefore be based only on the documents relating to the final accounting year and the final implementation report or the last annual implementation report, without any need to provide any additional documents.
(49)
In order to safeguard the budget of the Union, it is possible that it would be necessary for the Commission to make financial corrections. To ensure legal certainty for the Member States, it is important to define the circumstances under which breaches of the applicable Union law or national law related to its application can lead to financial corrections by the Commission. In order to ensure that any financial corrections which the Commission imposes on Member States are related to the protection of the Union's financial interests, such corrections should be confined to cases where the breach of applicable Union law or national law related to applying relevant Union law concerns the eligibility, regularity, management or control of operations and the corresponding expenditure declared to the Commission. To ensure proportionality it is important that the Commission considers the nature and the gravity of the breach and the related financial implications for the budget of the Union when deciding on a financial correction.
(50)
It is necessary to establish a legal framework which provides robust management and control systems and an appropriate division of roles and responsibilities in the context of shared management. The role of the Commission should therefore be specified and clarified and proportionate rules set out for the application of financial corrections by the Commission.
(51)
The frequency of audits on operations should be proportionate to the extent of the Union's support from the Fund. In particular, the number of audits carried out should be reduced where the total eligible expenditure for an operation does not exceed EUR 150 000. Nevertheless, it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud, or following closure of a completed operation, as part of an audit sample. The Commission should be able to review the audit trail of the audit authority or take part in on-the-spot audits of the audit authority. Where the Commission does not obtain the necessary assurance as to the effective functioning of the audit authority by those means, the Commission should be able to carry out a re-performance of the audit activity where this is in accordance with internationally accepted audit standards. In order that the level of auditing by the Commission is proportionate to the risk, the Commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on. In order to reduce the administrative burden on beneficiaries, specific rules should be introduced to reduce the risk of overlap between audits of the same operations by various institutions, namely the European Court of Auditors, the Commission and the audit authority. In addition, the scope of audits should take fully into account the objective and the features of the target populations of the Fund, as well as the voluntary character of many beneficiaries.
(52)
In order to ensure financial discipline, it is appropriate to define the arrangements for de-commitment of any part of the budget commitment in an operational programme, in particular where an amount may be excluded from de-commitment, in particular where delays in implementation result from circumstances which are independent of the party concerned, abnormal or unforeseeable and whose consequences cannot be avoided despite the diligence shown, as well as in a situation in which a request for payment has been made but for which the payment deadline has been interrupted or the payment suspended.
(53)
In order to supplement and amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the content of the annual and final implementation reports, including the list of common indicators, the criteria for determining the cases of irregularity to be reported, the data to be provided and the recovery of sums unduly paid, the rules specifying the information in relation to the data to be recorded and stored in computerised form within the monitoring systems established by managing authorities, the minimum requirements for audit trails, the scope and content of national audits and methodology for sampling, the detailed rules on the use of data collected during audits, and the criteria for determining serious deficiencies in the effective functioning of management and control systems, for establishing the level of financial correction to be applied and for applying flat-rates or extrapolated financial corrections. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
(54)
The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council
(55)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards decisions on annual plans of actions to be financed from technical assistance at the initiative of the Commission, adopting and amending operational programmes, decisions suspending interim payments, decisions on the non-acceptance of the accounts and the amount chargeable, if the accounts were not accepted, decisions on financial corrections decisions setting out the annual breakdown of the commitment appropriations to the Member States, and, in the case of decommitment, decisions to amend decisions adopting programmes.
(56)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the template for the structured survey on end recipients, the frequency of reporting of irregularities and the reporting format to be used, the terms and conditions for the electronic data exchange system for management and control, the technical specifications of recording and data-storing in relation to the management and control system, the model for the management declaration, the models for the audit strategy, audit opinion and control report, the model for the report and opinion of the independent audit body and description of the functions and procedures in place for the management authority and, where appropriate, the certifying authority, the model for payment applications, and the model for accounts. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (9).
(57)
For certain implementing acts to be adopted in accordance with the examination procedure laid down in Article 5 of Regulation (EU) No 182/2011 the potential impact and implications are of such a high significance to Member States that an exception from the general rule is justified. Accordingly, where no opinion is delivered by the committee, the Commission should not adopt the draft implementing act. Those implementing acts relate to laying down technical specifications of recording and data storing in relation to the management and control system. The third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 should therefore apply to those implementing acts.
(58)
This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, including respect for human dignity and for private and family life, the right to the protection of personal data, the rights of the child, the rights of the elderly, equality between men and women, and the prohibition of discrimination. This Regulation should be applied according to those rights and principles.
(59)
Since the objectives of this Regulation, namely to improve social cohesion in the Union and contribute to the fight against poverty and social exclusion, cannot be sufficiently achieved by Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives.
(60)
It should be ensured that the Fund complements actions that are funded under the ESF as social inclusion activities, while exclusively supporting the most deprived persons.
(61)
In order to allow for the prompt adoption of the delegated acts provided for in this Regulation, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,
HAVE ADOPTED THIS REGULATION:
TITLE I
GENERAL PROVISIONS
Article 1
Subject matter and purpose
This Regulation establishes the Fund for European Aid to the Most Deprived ('the Fund') for the period from 1 January 2014 to 31 December 2020 and determines the objectives of the Fund, the scope of its support, the financial resources available and their allocation for each Member State, and lays down the rules necessary to ensure the effectiveness and efficiency of the Fund.
Article 2
Definitions
The following definitions apply:
(1)
'basic material assistance' means basic consumer goods of a limited value and for the personal use of the most deprived persons for example clothing, footwear, hygiene goods, school material and sleeping bags;
(2)
'most deprived persons' means natural persons, whether individuals, families, households or groups composed of such persons, whose need for assistance has been established according to the objective criteria set by the national competent authorities in consultation with relevant stakeholders, while avoiding conflicts of interest, or defined by the partner organisations and which are approved by those national competent authorities and which may include elements that allow the targeting of the most deprived persons in certain geographical areas;
(3)
'partner organisations' means public bodies and/or non- profit organisations that deliver food and/or basic material assistance, where applicable, combined with accompanying measures directly or through other partner organisations, or that undertake activities aiming directly at the social inclusion of the most deprived persons, and whose operations have been selected by the managing authority in accordance with point (b) of Article 32(3);
(4)
'national schemes' means any scheme having, at least partly, the same objectives as the Fund and which is being implemented at national, regional or local level by public bodies or non-profit organisations;
(5)
'food and/or basic material assistance operational programme' (also referred to as 'OP I') means an operational programme supporting the distribution of food and/or basic material assistance to the most deprived persons, combined where applicable with accompanying measures, aimed at alleviating the social exclusion of most deprived persons;
(6)
'social inclusion of the most deprived persons operational programme' (also referred to as 'OP II') means an operational programme supporting the activities outside active labour market measures, consisting in non-financial, non-material assistance, aimed at the social inclusion of the most deprived persons;
(7)
'operation' means a project, contract or action selected by the managing authority of the operational programme concerned, or under its responsibility, contributing to the objectives of the operational programme to which it relates;
(8)
'completed operation' means an operation that has been physically completed or fully implemented and in respect of which all related payments have been made by beneficiaries and the support from the corresponding operational programme has been paid to the beneficiaries;
(9)
'beneficiary' means a public or private body responsible for initiating or initiating and implementing operations;
(10)
'end recipient' means the most deprived person or persons receiving support as defined in Article 4 of this Regulation;
(11)
'accompanying measures' means activities provided in addition to the distribution of food and/or basic material assistance with the aim of alleviating social exclusion and/or tackling social emergencies in a more empowering and sustainable way, for example guidance on a balanced diet and budget management advice;
(12)
'public expenditure' means a public contribution to the financing of operations the source of which is the budget of national, regional or local public authorities, the budget of the Union related to the Fund, the budget of public law bodies or the budget of associations of public authorities or any body governed by public law within the meaning of Article 1(9) of Directive 2004/18/EC of the European Parliament and of the Council (10);
(13)
'intermediate body' means any public or private body which acts under the responsibility of a managing or certifying authority, or which carries out duties on behalf of such an authority in relation to beneficiaries' implementing operations;
(14)
'accounting year', means the period from 1 July to 30 June, except for the first accounting year of the programming period, in respect of which it means the period from the start date for eligibility of expenditure until 30 June 2015. The final accounting year shall be from 1 July 2023 to 30 June 2024;
(15)
'financial year' means the period from 1 January to 31 December;
(16)
'irregularity' means any breach of Union law or of national law relating to its application, resulting from an act or omission by an economic operator involved in the implementation of the Fund, which has, or would have, the effect of prejudicing the budget of the Union by charging an unjustified item of expenditure to the budget of the Union;
(17)
'economic operator' means any natural or legal person or other entity taking part in the implementation of assistance from the Fund, with the exception of a Member State exercising its prerogatives as a public authority;
(18)
'systemic irregularity' means any irregularity, that may be of a recurring nature, with a high probability of occurrence in similar types of operations, which results from a serious deficiency in the effective functioning of a management and control system, including a failure to establish appropriate procedures in accordance with this Regulation;
(19)
'serious deficiency in the effective functioning of a management and control system' means a deficiency for which substantial improvements in the system are required, which exposes the Fund to significant risk of irregularities, and the existence of which is incompatible with an unqualified audit opinion on the functioning of the management and control system.
Article 3
Objectives
1. The Fund shall promote social cohesion, enhance social inclusion and therefore ultimately contribute to the objective of eradicating poverty in the Union by contributing to achieving the poverty reduction target of at least 20 million of the number of persons at risk of poverty and social exclusion in accordance with the Europe 2020 strategy, whilst complementing the Structural Funds. The Fund shall contribute to achieving the specific objective of alleviating the worst forms of poverty, by providing non-financial assistance to the most deprived persons by food and/or basic material assistance, and social inclusion activities aiming at the social integration of the most deprived persons.
This objective and the results of the implementation of the Fund shall be qualitatively and quantitatively assessed.
2. The Fund shall complement sustainable national poverty eradication and social inclusion policies, which remain the responsibility of Member States.
Article 4
Scope of support
1. The Fund shall support national schemes whereby food and/or basic material assistance, are distributed to the most deprived persons through partner organisations selected by Member States.
With the view to augmenting and diversifying the supply of food for the most deprived persons, as well as reducing and preventing food wastage, the Fund may support activities related to the collection, transport, storage and distribution of food donations.
The Fund may also support accompanying measures, complementing the provision of food and/or basic material assistance.
2. The Fund shall support activities contributing to the social inclusion of the most deprived persons.
3. The Fund shall promote, at Union level, mutual learning, networking and dissemination of good practices in the area of non-financial assistance to the most deprived persons.
Article 5
Principles
1. The part of the budget of the Union allocated to the Fund shall be implemented within the framework of shared management between the Member States and the Commission, in accordance with point (b) of Article 58(1) of the Financial Regulation, with the exception of technical assistance at the initiative of the Commission, which shall be implemented in the framework of direct management in accordance with point (a) of Article 58(1) of the Financial Regulation.
2. The Commission and the Member States shall ensure, taking account of the specific context of each Member State, that support from the Fund is consistent with the relevant policies and priorities of the Union and complementary to other instruments of the Union.
3. Support from the Fund shall be implemented in close co-operation between the Commission and the Member States in accordance with the principle of subsidiarity.
4. Member States and the bodies designated by them for that purpose, shall be responsible for implementing the operational programmes and carrying out their tasks under this Regulation in accordance with the institutional, legal and financial framework of the Member State and subject to compliance with this Regulation.
5. Arrangements for the implementation and use of the Fund, and in particular the financial and administrative resources required in relation to reporting, evaluation, management and control shall take into account the principle of proportionality having regard to the level of support allocated and the limited administrative capacity of the organisations that function thanks mainly to volunteers.
6. In accordance with their respective responsibilities, and to prevent double funding, the Commission and the Member States shall ensure coordination with the ESF, and with other relevant Union policies, strategies and instruments, in particular Union initiatives in the field of public health and against food waste.
7. The Commission and the Member States and the beneficiaries shall apply the principle of sound financial management in accordance with Article 30 of the Financial Regulation.
8. The Commission and the Member States shall ensure the effectiveness of the Fund, in particular through monitoring, reporting and evaluation.
9. The Member States and the Commission shall ensure that the operational programmes are prepared, programmed, implemented, monitored and evaluated, respecting the partnership principle, when carrying out the consultations of relevant stakeholders as set out in this Regulation.
10. The Commission and the Member States shall take action to ensure the effectiveness of the Fund, and shall carry out their respective roles in relation to the Fund with the aim of reducing the administrative burden for beneficiaries.
11. The Commission and the Member States shall ensure that equality between men and women and the integration of the gender perspective are taken into account and promoted during the various stages of the preparation, programming, management and implementation, monitoring and evaluation of the Fund, as well as in information and awareness raising campaigns and exchanges of best practices. The Commission and the Member States shall use data broken down by gender, where available.
The Commission and the Member States shall take appropriate steps to prevent any discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation in obtaining access to the Fund, and to programmes and operations supported by the Fund.
12. Operations supported by the Fund shall comply with applicable Union law and national law relating to its application ('applicable law'). In particular, the Fund may only be used to support the distribution of food or goods that are in conformity with the Union law on consumer product safety.
13. Member States and beneficiaries shall choose the food and/or the basic material assistance on the basis of objective criteria related to the needs of the most deprived persons. The selection criteria for the food products, and where appropriate for goods, shall also take into consideration climatic and environmental aspects, in particular with a view to reduction of food waste. Where appropriate, the choice of the type of food products to be distributed shall be made having considered their contribution to the balanced diet of the most deprived persons.
14. The Commission and the Member States shall ensure that aid provided in the framework of this Fund respects the dignity of the most deprived persons.
TITLE II
RESOURCES AND PROGRAMMING
Article 6
Global resources
1. The resources for the Fund available for budgetary commitment for the period 2014 - 2020 shall be EUR 3 395 684 880 in 2011 prices, in accordance with the annual breakdown set out in Annex II.
2. The allocation of the Fund for the period 2014–2020 for every Member State is set out in Annex III. The minimum amount for each Member State is EUR 3 500 000 for the whole period.
3. For the purpose of programming and subsequent inclusion in the general budget of the Union, the amount of resources shall be indexed at 2 % per year.
4. 0,35 % of the global resources shall be allocated to technical assistance at the initiative of the Commission.
Article 7
Operational programmes
1. Each Member State shall submit to the Commission, within six months of the entry into force of this Regulation, an OP I and/or an OP II, covering the period from 1 January 2014 to 31 December 2020.
2. An OP I shall set out:
(a)
an identification of and a justification for selecting the type or types of material deprivation to be addressed under the operational programme and, for each type of material deprivation addressed, a description of the main characteristics of the distribution of food and/or basic material assistance and, where appropriate, of the accompanying measures to be provided, having regard to the results of the ex ante evaluation carried out in accordance with Article 16;
(b)
a description of the corresponding national scheme or schemes for each type of material deprivation addressed;
(c)
a description of the mechanism setting the eligibility criteria for the most deprived persons, differentiated where necessary by type of material deprivation addressed;
(d)
the criteria for the selection of operations and a description of the selection mechanism differentiated where necessary by type of material deprivation addressed;
(e)
the criteria for the selection of the partner organisations differentiated where necessary by type of material deprivation addressed;
(f)
a description of the mechanism used to ensure complementarity with the ESF;
(g)
a financing plan containing a table specifying, for the whole programming period, the amount of the total financial appropriation in respect of support from the operational programme, indicatively broken down by type of material deprivation addressed as well as the corresponding accompanying measures.
3. An OP II shall set out:
(a)
a strategy for the programme contribution to the promotion of social cohesion and poverty reduction in accordance with the Europe 2020 strategy, including a justification for the choice of assistance priority;
(b)
the specific objectives of the operational programme based on an identification of national needs, having regard to the results of the ex ante evaluation carried out in accordance with Article 16. The ex ante evaluation shall be submitted to the Commission at the same time as the operational programme;
(c)
a financing plan containing a table specifying, for the whole programming period, the amount of the total financial appropriation in respect of support from the operational programme, indicatively broken down by type of action;
(d)
the identification of the most deprived persons to be targetted;
(e)
the financial indicators relating to the corresponding expenditure allocated;
(f)
the expected results for the specific objectives and the corresponding programme specific output and result indicators with a base line and target values;
(g)
a description of the type and examples of actions to be supported and their expected contribution to the specific objectives referred to in point (b) including the guiding principles for the selection of operations and, where appropriate, the identification of the types of beneficiaries;
(h)
a description of the mechanism to ensure complementarity with the ESF, as well as to prevent overlap and double-financing of operations.
4. In addition, each operational programme shall set out:
(a)
the identification of the managing authority, the certifying authority where applicable, the audit authority and the body to which payments are to be made by the Commission and a description of the monitoring procedure;
(b)
a description of the measures taken to involve all relevant stakeholders as well as, where appropriate, the competent regional, local and other public authorities in the preparation of the operational programme;
(c)
a description of the planned use of technical assistance in accordance with Article 27(4), including actions to reinforce the administrative capacity of the beneficiaries in relation to the implementation of the operational programme;
(d)
a financing plan containing a table specifying for each year in accordance with Article 20 the amount of the financial appropriation envisaged for support from the Fund and the co-financing in accordance with Article 20.
The partner organisations referred to in point (e) of Article 7(2) that deliver directly the food and/or basic material assistance shall themselves or in cooperation with other organisations undertake activities, where appropriate consisting of a re-orientation towards competent services, that complement the provision of material assistance, aiming at the social inclusion of the most deprived persons, whether or not these activities are supported by the Fund. However, such accompanying measures shall not be compulsory in cases where the food and/or basic material assistance is provided solely to most deprived children in childcare or comparable facilities.
5. Member States or any authority designated by them shall draw up operational programmes. They shall cooperate with all relevant stakeholders as well as, where appropriate, the competent regional, local and other public authorities. Member States shall ensure that the operational programmes are closely linked to national social inclusion policies.
6. Member States shall draft their operational programmes in accordance with the templates set out in Annex I as appropriate.
Article 8
Adoption of operational programmes
1. The Commission shall assess the consistency of each operational programme with this Regulation and its contribution to the objectives of the Fund, taking into account the ex ante evaluation carried out in accordance with Article 16. The Commission shall ensure that there is no overlap with any operational programme financed by the ESF in the Member State.
2. The Commission may make observations within three months of the date of submission of the operational programme. The Member State shall provide to the Commission all necessary additional information and, where appropriate, revise the proposed operational programme.
3. Provided that any observations made by the Commission in accordance with paragraph 2 have been adequately taken into account, the Commission shall, by means of implementing acts, approve each operational programme no later than six months after its submission by the Member State.
Article 9
Amendment of operational programmes
1. A Member State may submit a request for amendment of an operational programme. The request shall be accompanied by the revised operational programme and the justification for the amendment.
2. The Commission shall assess the information provided in accordance with paragraph 1, taking account of the justification provided by the Member State. The Commission may make observations and the Member State shall provide to the Commission all necessary additional information.
3. The Commission shall, by means of implementing acts, approve the amendment of an operational programme no later than four months after its submission by the Member State provided that any observations made by the Commission have been adequately taken into account.
Article 10
Exchange of good practices
The Commission shall facilitate, including by means of a website, the exchange of experience, capacity building and networking, as well as dissemination of relevant outcomes in the area of non-financial assistance to the most deprived persons.
Relevant organisations that do not make use of the Fund may also be included.
In addition, the Commission shall consult, at least once a year, the organisations which represent the partner organisations at Union level on the implementation of support from the Fund and, following such consultation, shall report back to the European Parliament and to the Council in due course.
The Commission shall also facilitate the online dissemination of relevant outcomes, reports and information in relation to the Fund.
TITLE III
MONITORING AND EVALUATION, INFORMATION AND COMMUNICATION
Article 11
Monitoring committee for an OP II
1. Within three months of the date of notification to the Member State of the decision adopting an OP II, the Member State shall set up or appoint a committee, in accordance with the institutional, legal and financial framework of the Member State concerned to monitor the implementation of the programme, in agreement with the managing authority.
2. Each monitoring committee shall draw up and adopt its rules of procedure in accordance with the institutional, legal and financial framework of the Member State concerned.
3. The composition of the monitoring committee shall be decided by the Member State, provided that the monitoring committee is composed of representatives of the relevant Member State authorities and intermediate bodies and of all relevant stakeholders as well as where appropriate of representatives of the competent regional, local and other public authorities. Representatives of the competent regional, local and other public authorities as well as of relevant stakeholders shall be delegated to be part of the monitoring committee by the respective organisation through transparent processes. Each member of the monitoring committee may have a voting right. The list of members of the monitoring committee shall be published.
4. The Commission shall participate in the work of the monitoring committee in an advisory capacity.
5. The monitoring committee shall be chaired by a representative of the Member State or of the managing authority.
Article 12
Functions of the monitoring committee for an OP II
1. The monitoring committee shall meet at least once a year and shall review implementation of the programme and progress made towards achieving its specific objectives. In doing so, it shall have regard to the financial data, common and programme -specific indicators, including changes in the value of result indicators and progress towards quantified target values, and, where relevant, the results of qualitative analyses.
2. The monitoring committee shall examine all issues that affect the performance of the programme. It shall examine in particular:
(a)
progress made towards achieving the specific targets of the operational programme on the basis of the documents submitted by the managing authority, including evaluation findings;
(b)
implementation of the information and communication actions;
(c)
actions, which take into account and promote equality between men and women, equal opportunities and non-discrimination.
3. The monitoring committee shall examine and approve:
(a)
the methodology and criteria for selection of operations in line with the guiding principles as set out in point (f) of Article 7(3);
(b)
the annual and final implementation reports;
(c)
any proposal by the managing authority for an amendment to the operational programme.
4. The monitoring committee may make observations to the managing authority regarding implementation of the programme and its evaluation.
It shall monitor actions taken as a result of its observations.
Article 13
Implementation reports and indicators
1. From 2015 to 2023, the Member States shall submit to the Commission, by 30 June of each year, an annual implementation report for the operational programme implemented in the previous financial year.
2. The Member States shall draft the annual implementation report in accordance with the delegated act referred to in paragraph 6, including the list of common indicators, and for the social inclusion operational programmes, of the programme specific indicators.
The Member States shall consult the relevant stakeholders, while avoiding conflicts of interest, on the implementation reports of OP I. A summary of the comments of those relevant stakeholders shall be annexed to the report.
3. The annual implementation reports shall be admissible where they contain all the information required in accordance with the delegated act referred to in paragraph 6. The Commission shall inform the Member State concerned within 15 working days from the date of receipt of the annual implementation report if it is not admissible. Where the Commission has not informed the Member State within the time limit, the report shall be deemed admissible.
4. The Commission shall examine the annual implementation report and inform the Member State of its observations within two months of the receipt of the annual implementation report.
Where the Commission does not provide observations to the Member State within this time limit, the reports shall be deemed to be accepted.
5. The Member State shall submit a final report on implementation of the operational programme by 30 September 2024.
The Member States shall draft the final implementation report in accordance with the delegated acts referred to in paragraph 6.
The Commission shall examine the final implementation report and inform the Member State of its observations within five months of receipt of the final report.
Where the Commission does not provide observations to the Member State within that time limit, the reports shall be deemed to have been accepted.
6. The Commission shall be empowered to adopt delegated acts, in accordance with Article 62, laying down the content of the annual and final implementation reports, including the list of common indicators, by 17 July 2014.
7. The Commission may address observations to a Member State concerning the implementation of the operational programme. The managing authority shall within three months inform the Commission of the corrective measures taken.
8. The managing authority shall make public a summary of the contents of each annual and final implementation report.
9. The Commission shall present a summary of the annual implementation reports and the final implementation reports to the European Parliament and to the Council in due course.
10. The procedure concerning implementation reports shall not be excessive in comparison to the resources allocated and to the nature of the support and shall not cause unnecessary administrative burdens.
Article 14
Review meetings
1. The Commission and the Member States shall meet every year from 2014 to 2023, unless otherwise agreed, to review the progress made in implementing the operational programme, taking account of the annual implementation report and the Commission's observations referred to in Article 13(7), where applicable.
2. The review meeting shall be chaired by the Commission. The relevant stakeholders shall be invited to participate in review meetings of OP I except for the parts of that meeting when their participation would lead to conflicts of interest or breach of confidentiality related to audit matters.
3. The Member State shall ensure that appropriate follow-up is given to any comments of the Commission following the review meeting and shall refer to that follow-up in the implementation report of the following financial year or, as appropriate, years.
Article 15
General provisions on evaluation
1. Member States shall provide the resources necessary for carrying out evaluations, and shall ensure that procedures are in place to produce and collect the data necessary for evaluations, including data related to the common indicators referred to in Article 13.
2. Evaluations shall be carried out by experts that are functionally independent of the authorities responsible for operational programme implementation. All evaluations shall be made public in their entirety but shall under no circumstances include information regarding the identity of end recipients.
3. The evaluations shall not be excessive in comparison to the resources allocated or to the nature of the support and shall not cause unnecessary administrative burdens.
Article 16
Ex ante evaluation
1. Member States shall carry out an ex ante evaluation of each operational programme.
2. Ex ante evaluation shall be carried out under the responsibility of the authority responsible for preparing the operational programme. It shall be submitted to the Commission at the same time as the operational programme, together with an executive summary.
3. Ex ante evaluations of OP I shall appraise the following elements:
(a)
the contribution to the Union objective of at least 20 million fewer people living in poverty or at risk of poverty and social exclusion by 2020, having regard to the selected type of material deprivation to be addressed and taking into account national circumstances in terms of poverty and social exclusion and material deprivation;
(b)
the internal coherence of the proposed operational programme and its relation with other relevant financial instruments;
(c)
the consistency of the allocation of budgetary resources with the objectives of the operational programme;
(d)
the contribution of the expected outputs to the results and thus to the objectives of the Fund;
(e)
the involvement of relevant stakeholders;
(f)
the suitability of the procedures for monitoring the operational programme and for collecting the data necessary to carry out evaluations.
4. Ex ante evaluations of OP II shall appraise the following elements:
(a)
the contribution to the promotion of social cohesion and poverty reduction in accordance with the Europe 2020 strategy, taking into account national needs;
(b)
the internal coherence of the proposed programme and its relation with other relevant instruments, in particular the ESF;
(c)
the consistency of the allocation of budgetary resources with the objectives of the programme;
(d)
the relevance and clarity of the proposed programme specific indicators;
(e)
how the expected outputs will contribute to results;
(f)
whether the quantified target values for indicators are realistic, having regard to the support from the Fund envisaged;
(g)
the rationale for the form of support proposed;
(h)
the adequacy of human resources and administrative capacity for management of the programme;
(i)
the suitability of the procedures for monitoring the programme and for collecting the data necessary to carry out evaluations;
(j)
the adequacy of planned measures to promote equal opportunities between men and women and to prevent any discrimination.
Article 17
Evaluation during the programming period
1. The Commission shall present a mid-term evaluation of the Fund to the European Parliament and to the Council by 31 December 2018.
2. The Commission may, at its own initiative, evaluate operational programmes.
3. During the programming period, the managing authority of an OP I may evaluate the effectiveness and efficiency of the operational programme.
4. The managing authority of an OP I shall carry out a structured survey on end recipients in 2017 and 2022, in accordance with the template adopted by the Commission. The Commission shall adopt implementing acts establishing the template after the consultation of relevant stakeholders. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 63(2).
5. The managing authority of an OP II shall carry out at least one evaluation before 31 December 2022. The evaluation shall assess the effectiveness, efficiency and impact of the operations supported. Appropriate follow up shall be ensured.
Article 18
Ex post evaluation
At its own initiative and in close cooperation with the Member States, the Commission shall carry out, with the assistance of external experts, an ex-post evaluation, to assess the effectiveness and efficiency of the Fund and the sustainability of results obtained, as well as to measure the added value of the Fund. This ex post evaluation shall be completed by 31 December 2024.
Article 19
Information and communication
1. The Commission and the Member States shall provide information on and promote the actions supported by the Fund. The information shall, in particular, be addressed to the most deprived persons, as well as to the wider public and the media. It shall highlight the role of the Union and ensure that the contribution from the Fund, the Member States and the partner organisations regarding the Union's social cohesion objectives is visible without stigmatising end recipients.
2. The managing authority shall, in order to ensure transparency in the support of the Fund, maintain a list of operations supported by the Fund in a spread sheet data format, which allows the data to be sorted, searched, extracted, compared and easily published on the internet. The list of operations shall include at least the following information:
(a)
the name and address of the beneficiary;
(b)
the allocated amount of Union funding;
(c)
for OP I, the type of material deprivation addressed.
The managing authority shall update the list of operations at least every twelve months.
3. During the implementation of an operation, the beneficiaries and partner organisations shall inform the public about the support obtained from the Fund by placing either at least one poster with information about the operation (minimum size A3), including about the financial support from Union or a Union emblem of reasonable size, at a location readily visible to the public. This requirement shall be fulfilled, without stigmatising end-recipients, at each place of delivery of OP I and/or OP II, unless this is not possible due to the circumstances of the distribution.
Beneficiaries and partner organisations which have websites shall also provide a short description of the operation on their website, including its aims and results, and highlighting the financial support from the Union.
4. All information and communication measures undertaken by the beneficiary and the partner organisations shall acknowledge support from the Fund to the operation by displaying the emblem of the Union together with a reference to the Union and the Fund.
5. The managing authority shall inform beneficiaries of publication of the list of operations in accordance with paragraph 2. The managing authority shall provide information and communication tools, including templates in electronic format, to help beneficiaries and partner organisations to meet their obligations as set out in paragraph 3.
6. In the case of OP II:
(a)
the Member State or the managing authority shall be responsible for organising:
(i)
a main information activity to publicise the launch of the operational programme; and
(ii)
at least one main information activity a year to promote the funding opportunities and the strategies pursued and/or present the achievements of the operational programme, including, where relevant, examples of operations;
(b)
during implementation of an operation, the beneficiary shall inform the public about the support obtained from the Fund by ensuring that those taking part in the operation have been informed of the support from the Fund;
(c)
any document, including any attendance or other certificate, concerning an operation shall include a statement to the effect that the operational programme was supported by the Fund;
(d)
the managing authority shall ensure that potential beneficiaries have access to the relevant information on the funding opportunities, the launching of application calls and conditions thereof and the criteria for selecting the operations to be supported.
7. In processing personal data pursuant to Articles 15 to 19 of this Regulation, the managing authority as well as the beneficiaries and partner organisations shall comply with Directive 95/46/EC.
TITLE IV
FINANCIAL SUPPORT FROM THE FUND
Article 20
Co-financing
1. The co-financing rate at the level of the operational programme amounts up to 85 % of the eligible public expenditure. It may be increased in the cases described in Article 21(1). Member States shall be free to support the Fund's initiatives with additional national resources.
2. The Commission decision adopting an operational programme shall fix the co-financing rate applicable to the operational programme and the maximum amount of support from the Fund.
3. The technical assistance measures implemented at the initiative of, or on behalf of, the Commission may be financed at the rate of 100 %.
Article 21
Increase in payments for Member States with temporary budgetary difficulties
1. At the request of a Member State, interim payments and payments of the final balance may be increased by 10 percentage points above the co-financing rate applicable to the operational programme. The increased rate, which can not exceed 100 %, shall apply to requests for payment relating to the accounting period in which the Member State has submitted its request and subsequent accounting periods during which the Member State meets one of the following conditions:
(a)
where the Member State concerned has adopted the euro, it receives macro-financial assistance from the Union in accordance with Council Regulation (EU) No 407/2010 (11);
(b)
where the Member State concerned has not adopted the euro, it receives medium-term financial assistance in accordance with Council Regulation (EC) No 332/2002 (12);
(c)
financial assistance is made available to it in accordance with the Treaty establishing the European Stability Mechanism.
2. Notwithstanding paragraph 1, Union support through interim payments and payments of the final balance shall not be higher than the public support and the maximum amount of support from the Fund, as laid down in the Commission decision approving the operational programme.
Article 22
Eligibility period
1. This Article shall be without prejudice to the rules on eligibility of technical assistance at the initiative of the Commission as set out in Article 27.
2. Expenditure shall be eligible for a support from an operational programme if it is incurred by a beneficiary and paid between 1 December 2013 and 31 December 2023.
3. Operations shall not be selected for support by an operational programme where they have been physically completed or fully implemented before the application for funding under the operational programme has been submitted by the beneficiary to the managing authority, irrespective of whether all related payments have been made by the beneficiary.
4. In the case of amendment of an operational programme, expenditure that becomes eligible because of the amendment to the operational programme shall only be eligible from the date of submission of the request for amendment by the Member State to the Commission.
Article 23
Eligibility of operations
1. Operations supported by an operational programme shall be located in the Member State covered by the operational programme.
2. Operations may receive support from an operational programme provided that they have been selected in accordance with a fair and transparent procedure and on the basis of either of the criteria laid down in the operational programme or approved by the monitoring committee as appropriate.
3. The selection criteria and lists of operations selected for support from an OP II shall be communicated upon adoption to the monitoring committees of the operational programmes co-financed by the ESF.
4. The food and/or basic material assistance for the most deprived persons may be purchased by the partner organisations themselves.
The food and/or basic material assistance for the most deprived persons may also be purchased by a public body and made available free of charge to the partner organisations. In that case, the food may be obtained from the use, processing or sale of the products disposed of in accordance with Article 16(2)of Regulation (EU) No 1308/2013, provided that this is economically the most favourable option and does not unduly delay the delivery of the food products to the partner organisations. Any amount derived from such a transaction shall be used for the benefit of the most deprived persons, and shall not be applied so as to diminish the obligation of the Member States, provided in Article 20 of this Regulation, to co-finance the programme.
The Commission shall apply the procedures adopted pursuant to point (i) of Article 20 of Regulation (EU) No 1308/2013 by which the products referred to therein may be used, processed or sold for the purposes of this Regulation, in order to ensure their maximum efficiency.
5. That food and/or basic material assistance shall be distributed free of charge to the most deprived persons.
6. An operation supported by the Fund shall not receive support from more than one operational programme co-financed by the Fund or from another Union instrument in order to avoid double funding.
Article 24
Forms of support
The Fund shall be used by Member States to provide support in the forms of grants, procurement or a combination thereof. However, that support shall not take the form of aid falling under Article 107(1) TFEU.
Article 25
Forms of grants
1. Grants may take the following forms:
(a)
reimbursement of eligible costs actually incurred and paid;
(b)
reimbursement on the basis of unit costs;
(c)
lump sums not exceeding EUR 100 000 of public support;
(d)
flat-rate financing, determined by the application of a percentage to one or several defined categories of costs.
2. The options referred to in paragraph 1 may be combined in respect of a single operation only where each option is applied to different categories of costs or where they are used for successive phases thereof.
3. The amounts referred to in points (b), (c) and (d) of paragraph 1 shall be established on the basis of:
(a)
a fair, equitable and verifiable calculation method based on one of the following:
(i)
statistical data or other objective information;
(ii)
the verified historical data of individual beneficiaries or the application of their usual cost accounting practices;
(b)
methods and corresponding unit costs, lump sums and flat-rate financing applied under schemes for grants funded entirely by the Member State concerned for a similar type of operation and beneficiary;
(c)
rates established by this Regulation;
(d)
a case-by-case basis by reference to a draft budget agreed ex ante by the managing authority, where public support does not exceed EUR 100 000.
4. The amounts calculated in the forms of grants referred to in points (b), (c) and (d) of paragraph 1 shall be regarded as eligible expenditure incurred and paid by the beneficiary for the purpose of applying Title VI.
5. The document setting out the conditions for support for each operation shall set out the method to be applied for determining the costs of the operation and the conditions for payment of the grant.
Article 26
Eligibility of expenditure
1. The eligibility of expenditure shall be determined on the basis of national rules, except where specific rules are laid down in or on the basis of this Regulation.
2. Notwithstanding paragraph 1, the costs eligible for a support from OP I shall be:
(a)
the costs of purchasing food and/or basic material assistance;
(b)
where a public body purchases the food or basic material assistance and provides them to partner organisations, the costs of transporting food or basic material assistance to the storage depots of the partner organisations and storage costs at a flat-rate of 1 % of the costs referred to in point (a) or, in duly justified cases, costs actually incurred and paid;
(c)
the administrative, transport and storage costs borne by the partner organisations at a flat-rate of 5 % of the costs referred to in point (a); or 5 % of the value of the food products disposed of in accordance with Article 16 of Regulation (EU) No 1308/2013;
(d)
the cost of collection, transport, storage and distribution of food donations and directly related awareness raising activities, incurred and paid for by partner organisations;
(e)
the costs of accompanying measures undertaken and declared by the partner organisations delivering directly or under cooperation agreements the food and/or basic material assistance to the most deprived persons at a flat-rate of 5 % of the costs referred to in point (a).
3. Notwithstanding paragraph 1, the costs eligible for support from an operational programme shall be the costs incurred pursuant to Article 27(4) or, for indirect costs incurred pursuant to Article 27(4), a flat-rate of up to 15 % of eligible direct staff costs.
4. The following costs shall not be eligible for a support from the operational programme:
(a)
interest on debt;
(b)
provision of infrastructure;
(c)
costs of second-hand goods;
(d)
value added tax except where it is non-recoverable under national VAT legislation.
Article 27
Technical assistance
1. At the initiative of, or on behalf of the Commission, and subject to a ceiling of 0,35 % of its annual allocation, the Fund may finance preparation, monitoring, administrative and technical assistance, audit, information, control and evaluation measures necessary for implementing this Regulation as well as for activities pursuant to Article 10.
2. The Commission shall consult the Member States and the organisations which represent the partner organisations at Union level on the planned use of technical assistance.
3. The Commission shall set out each year its plans on the type of actions related to the measures listed in paragraph 1, when a contribution from the Fund is envisaged, by means of implementing acts.
4. At the initiative of the Member States, and subject to a ceiling of 5 % of the Fund allocation, the operational programme may finance preparation, management, monitoring, administrative and technical assistance, audit, information, control and evaluation measures necessary for implementing this Regulation. It may also finance technical assistance and capacity building of partner organisations.
TITLE V
MANAGEMENT AND CONTROL
Article 28
General principles of management and control systems
Management and control systems shall, in accordance with Article 5(7), provide for:
(a)
a description of the functions of each body involved in management and control, and the allocation of functions within each body;
(b)
compliance with the principle of separation of functions between and within such bodies;
(c)
procedures for ensuring the correctness and regularity of expenditure declared;
(d)
computerised systems for accounting, for the storage and transmission of financial data and data on indicators, for monitoring and for reporting;
(e)
systems for reporting and monitoring where the body responsible entrusts execution of tasks to another body;
(f)
arrangements for auditing the functioning of the management and control systems;
(g)
systems and procedures to ensure an adequate audit trail;
(h)
the prevention, detection and correction of irregularities, including fraud, and the recovery of amounts unduly paid, together with any interest on late payments.
Article 29
Responsibilities under shared management
In accordance with the principle of shared management, Member States and the Commission shall be responsible for the management and control of programmes in accordance with their respective responsibilities laid down in this Regulation.
Article 30
Responsibilities of Member States
1. Member States shall fulfil the management, control and audit obligations and assume the resulting responsibilities, which are laid down in the rules on shared management set out in the Financial Regulation and this Regulation.
2. Member States shall prevent, detect and correct irregularities and shall recover amounts unduly paid, together with any interest on late payments. They shall notify the Commission of irregularities that exceed EUR 10 000 in contribution from the Fund and shall keep it informed of significant progress in related administrative and legal proceedings.
The Member States shall not notify the Commission of irregularities in relation to the following cases:
(a)
where the irregularity consists solely of the failure to execute, in whole or in part, an operation included in the co-financed operational programme owing to the bankruptcy of the beneficiary;
(b)
those brought to the attention of the managing authority or certifying authority by the beneficiary voluntarily and before detection by either authority, whether before or after the payment of the public contribution;
(c)
those which are detected and corrected by the managing authority or certifying authority before inclusion of the expenditure concerned in a statement of expenditure submitted to the Commission.
In all other cases, in particular those preceding a bankruptcy or in cases of suspected fraud, the detected irregularities and the associated preventive and corrective measures shall be reported to the Commission.
When amounts unduly paid to a beneficiary cannot be recovered and this is as a result of fault or negligence on the part of a Member State, the Member State shall be responsible for reimbursing the amounts concerned to the budget of the Union. Member States may decide not to recover an amount unduly paid if the amount to be recovered from the beneficiary, not including interest, does not exceed EUR 250 in contribution from the Fund.
The Commission shall be empowered to adopt delegated acts in accordance with Article 62 laying down additional detailed rules on the criteria for determining the cases of irregularity to be reported, the data to be provided and on the conditions and procedures to be applied to determine whether amounts which are irrecoverable shall be reimbursed by Member States.
The Commission shall adopt implementing acts in accordance with the advisory procedure under Article 63(2) setting out the frequency of the reporting and the reporting format to be used.
3. Member States shall ensure that effective arrangements for the examination of complaints concerning the Fund are in place. The scope, rules and procedures concerning such arrangements shall be the responsibility of Member States in accordance with their institutional and legal framework. Member States shall, upon request by the Commission, examine complaints submitted to the Commission falling within the scope of their arrangements. Member States shall inform the Commission, upon request, of the results of those examinations.
4. All official exchanges of information between the Member State and the Commission shall be carried out using an electronic data exchange system. The Commission shall adopt implementing acts in order to establish the terms and conditions with which that electronic data exchange system is to comply. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(3).
Article 31
Designation of authorities
1. Each Member State shall designate, for each operational programme, a national public authority or body as managing authority. The same managing authority may be designated for two operational programmes.
2. The Member State shall designate, for each operational programme, a national public authority or body as a certifying authority, without prejudice to paragraph 3. The same certifying authority may be designated for two operational programmes.
3. The Member State may designate, for an operational programme, a managing authority to carry out in addition the functions of the certifying authority.
4. The Member State shall designate, for each operational programme, a national public authority or body, functionally independent from the managing authority and the certifying authority, as audit authority. The same audit authority may be designated for two operational programmes.
5. Provided that the principle of separation of functions is respected, the managing authority, the certifying authority for OP I and, for OP II for which the total amount of support from the Fund does not exceed EUR 250 000 000, the audit authority may be part of the same public authority or body.
6. The Member State may designate one or more intermediate bodies to carry out certain tasks of the managing authority or the certifying authority under the responsibility of that authority. The relevant arrangements between the managing authority or certifying authority and the intermediate bodies shall be formally recorded in writing.
7. The Member State or the managing authority may entrust the management of part of an operational programme to an intermediate body by way of an agreement in writing between the intermediate body and the Member State or managing authority. The intermediate body shall provide guarantees of its solvency and competence in the domain concerned, as well as of its administrative and financial management capacity.
8. The Member State shall lay down in writing rules governing its relationship with the managing authorities, certifying authorities and audit authorities, the relations between such authorities, and the relations of such authorities with the Commission
Article 32
Functions of the managing authority
1. The managing authority shall be responsible for managing the operational programme in accordance with the principle of sound financial management.
2. As regards the management of the operational programme, the managing authority shall:
(a)
where relevant, support the work of the monitoring committee referred to in Article 11 and provide it with the information it requires to carry out its tasks, in particular the data relating to the progress of the operational programme in achieving its objectives, financial data and data relating to indicators;
(b)
draw up and, after consultation of the relevant stakeholders, while avoiding conflicts of interests, for OP I, or after approval the monitoring committee referred to in Article 11 for OP II, submit to the Commission annual and final implementation reports referred to in Article 13;
(c)
make available to intermediate bodies and beneficiaries information that is relevant to the execution of their tasks and the implementation of operations respectively;
(d)
establish a system to record and store in computerised form data on each operation necessary for monitoring, evaluation, financial management, verification and audit, including data on individual participants in operations co-financed by OP II;
(e)
ensure that the data referred to in point (d) is collected, entered and stored in the system, referred to in point (d) in compliance with the provisions of Directive 95/46/CE and where available, broken down by gender.
3. As regards the selection of operations, the managing authority shall:
(a)
draw up and, where relevant once approved, apply appropriate selection procedures and/or criteria, that are non-discriminatory and transparent;
(b)
ensure that the selected operation:
(i)
falls within the scope of the Fund and the operational programme;
(ii)
fulfils the criteria set out in the operational programme and in Articles 22, 23 and 26;
(iii)
takes into account, where relevant, the principles set out in Article 5(11), (12), (13) and (14);
(c)
ensure that the beneficiary is provided with a document setting out the conditions for support for each operation including the specific requirements concerning the products or services to be delivered under the operation, the financing plan, and the time-limit for execution;
(d)
satisfy itself that the beneficiary has the administrative, financial and operational capacity to fulfil the conditions referred to in point (c) before approval of the operation;
(e)
satisfy itself that, where the operation has started before the submission of an application for funding to the managing authority, applicable law relevant for the operation has been complied with;
(f)
determine the type of material assistance for OP I and the type of action for OP II to which the expenditure of an operation shall be attributed.
4. As regards the financial management and control of the operational programme, the managing authority shall:
(a)
verify that the co-financed products and services have been delivered and that expenditure declared by the beneficiaries has been paid and that it complies with applicable law, the operational programme and the conditions for support of the operation;
(b)
ensure that beneficiaries involved in the implementation of operations reimbursed on the basis of eligible costs actually incurred maintain either a separate accounting system or an adequate accounting code for all transactions relating to an operation;
(c)
put in place effective and proportionate anti-fraud measures taking into account the risks identified;
(d)
set up procedures to ensure that all documents regarding expenditure and audits required to ensure an adequate audit trail are held in accordance with the requirements of point (g) of Article 28;
(e)
draw up the management declaration and annual summary referred to in point (a) and (b) of the first subparagraph of Article 59(5) of the Financial Regulation.
5. Verifications pursuant to point (a) of paragraph 4 shall include the following procedures:
(a)
administrative verifications in respect of each application for reimbursement by beneficiaries;
(b)
on-the-spot verifications of operations.
The frequency and coverage of the on-the-spot verifications shall be proportionate to the amount of public support to an operation and to the level of risk identified by such verifications and audits by the audit authority for the management and control system as a whole.
6. On-the-spot verifications of individual operations pursuant to point (b) of the first subparagraph of paragraph 5 may be carried out on a sample basis.
7. Where the managing authority is also a beneficiary under the operational programme, arrangements for the verifications referred to in point (a) of paragraph 4 shall ensure adequate separation of functions.
8. The Commission shall be empowered to adopt delegated acts, in accordance with Article 62, laying down rules specifying the information in relation to the data to be recorded and stored in computerised form within the monitoring system established under point (d) of paragraph 2 of this Article.
The Commission shall adopt implementing acts laying down the technical specifications of the system established under point (d) of paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(3).
9. The Commission shall be empowered to adopt delegated acts, in accordance with Article 62, laying down the detailed minimum requirements for the audit trail referred to in point (d) of paragraph 4 of this Article in respect of the accounting records to be maintained and the supporting documents to be held at the level of the certifying authority, managing authority, intermediate bodies and beneficiaries.
10. The Commission shall, in order to ensure uniform conditions on the implementation of this Article, adopt implementing acts concerning the model for the management declaration referred to in point (e) of paragraph 4. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 63(2).
Article 33
Functions of the certifying authority
The certifying authority of an operational programme shall be responsible in particular for:
(a)
drawing up and submitting payment applications to the Commission and certifying that they result from reliable accounting systems, are based on verifiable supporting documents and have been subject to verifications by the managing authority;
(b)
drawing up the accounts referred to in point (a) of the first subparagraph of Article 59(5) of the Financial Regulation;
(c)
certifying the completeness, accuracy and veracity of the accounts and that the expenditure entered in them complies with applicable law and has been incurred in respect of operations selected for funding in accordance with the criteria applicable to the operational programme and complying with applicable law;
(d)
ensuring that there is a system which records and stores, in computerised form, accounting records for each operation, and which supports all the data required for drawing up payment applications and accounts, including records of amounts recoverable, amounts recovered and amounts withdrawn following cancellation of all or part of the contribution for an operation or an operational programme;
(e)
ensuring for the purposes of drawing up and submitting payment applications that it has received adequate information from the managing authority on the procedures and verifications carried out in relation to expenditure;
(f)
taking account, when drawing up and submitting payment applications, of the results of all audits carried out by or under the responsibility of the audit authority;
(g)
maintaining, in a computerised form, accounting records of expenditure declared to the Commission and of the corresponding public contribution paid to beneficiaries;
(h)
keeping an account of amounts recoverable and of amounts withdrawn following cancellation of all or part of the contribution for an operation. Amounts recovered shall be repaid to the budget of the Union prior to the closure of the operational programme by deducting them from the subsequent statement of expenditure.
Article 34
Functions of the audit authority
1. The audit authority shall ensure that audits are carried out on the proper functioning of the management and control system of the operational programme and on an appropriate sample of operations on the basis of the declared expenditure.
The declared expenditure shall be audited based on a representative sample or, where appropriate, on substantive testing and, as a general rule, on statistical sampling methods.
A non- statistical sampling method may be used on the professional judgement of the audit authority, in duly justified cases, in accordance with internationally accepted audit standards and in any case where the number of operations for an accounting year is insufficient to allow the use of a statistical method.
In such cases, the size of the sample shall be sufficient to enable the audit authority to draw up a valid audit opinion in accordance with point (b) of the first subparagraph of Article 59(5) of the Financial Regulation.
The non-statistical sample method shall cover a minimum of 5 % of operations for which expenditure has been declared to the Commission during an accounting year and 10 % of the expenditure which has been declared to the Commission during an accounting year.
Where the total amount of support from the Fund to an OP I does not exceed EUR 35 000 000, the audit authority shall be allowed to limit the audit activities to an annual system audit that includes substantive testing on a combination of random and risk-based testing of operations. The audit work shall be carried out in accordance with internationally accepted audit standards and shall quantify annually the level of error included in the declarations of expenditure certified to the Commission.
2. Where audits are carried out by a body other than the audit authority, the audit authority shall ensure that any such body has the necessary functional independence.
3. The audit authority shall ensure that audit work takes account of internationally accepted audit standards.
4. The audit authority shall, within eight months of adoption of an operational programme, prepare an audit strategy for the performance of audits. The audit strategy shall set out the audit methodology, the sampling or, where appropriate, substantive testing method for audits on operations and the planning of audits in relation to the current accounting year and the two subsequent accounting years. The audit strategy shall be updated annually from 2016 until and including 2024. Where a common management and control system applies to two operational programmes, a single audit strategy may be prepared for the operational programmes concerned. The audit authority shall submit the audit strategy to the Commission upon request.
5. The audit authority shall draw up:
(a)
an audit opinion in accordance with point (b) of the first subparagraph of Article 59(5) of the Financial Regulation;
(b)
a control report setting out the main findings of the audits carried out in accordance with paragraph 1, including findings with regard to deficiencies found in the management and control systems, and the proposed and implemented corrective actions.
Where a common management and control system applies to two operational programmes, the information required under point (b) of the first subparagraph may be grouped in a single report.
6. The Commission shall, in order to ensure uniform conditions for the implementation of this Article, adopt implementing acts laying down models for the audit strategy, the audit opinion and the control report. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 63(2).
7. The Commission shall be empowered to adopt delegated acts, in accordance with Article 62, to set out the scope and content of audits of operations and audits of the accounts and the methodology for the selection of the sample of operations referred to in paragraph 1 of this Article.
8. The Commission shall be empowered to adopt delegated acts, in accordance with Article 62, laying down detailed rules on the use of data collected during audits carried out by Commission officials or authorised Commission representatives.
Article 35
Procedure for the designation of the managing authority and the certifying authority
1. The Member State shall notify the Commission of the date and form of the designations, which shall be carried out at an appropriate level, of the managing authority and, where appropriate, of the certifying authority, prior to the submission of the first application for interim payment to the Commission.
2. The designations referred to in paragraph 1 shall be based on a report and an opinion of an independent audit body that assesses the fulfilment by the authorities of the criteria relating to the internal control environment, risk management, management and control activities, and monitoring set out in Annex IV.
The independent audit body shall be the audit authority, or another public or private law body with the necessary audit capacity, which is independent of the managing authority and, where applicable, of the certifying authority, and which shall carry out its work taking account of internationally accepted audit standards.
3. Member States may decide that a managing authority or a certifying authority which has been designated in relation to an ESF co-financed operational programme pursuant to Regulation (EU) No 1303/2013 is deemed to be designated for the purposes of this Regulation.
4. The Commission may request, within one month of notification of the designations referred to in paragraph 1, the report and the opinion of the independent audit body referred to in paragraph 2 and the description of the functions and procedures in place for the managing authority or, where appropriate, the certifying authority. The Commission shall decide whether to request those documents on the basis of its risk assessment.
The Commission may make observations within two months of receipt of the documents referred to in the first subparagraph.
Without prejudice to Article 46, the examination of those documents shall not interrupt the treatment of applications for interim payments.
5. Where existing audit and control results show that the designated authority no longer fulfils the criteria referred to in paragraph 2, the Member State shall, at an appropriate level, fix, according to the severity of the problem, a period of probation, during which the necessary remedial action shall be taken.
Where the designated authority fails to implement the required remedial action within the period of probation determined by the Member State, the Member State, at an appropriate level, shall end its designation.
The Member State shall notify the Commission without delay when a designated authority is put under probation, providing information on the respective period of probation, when following implementation of remedial actions the probation is ended, as well as when the designation of an authority is ended. The notification that a designated body is put on probation by the Member State, without prejudice to the application of Article 46, shall not interrupt the treatment of applications for interim payments.
6. Where the designation of a managing authority or a certifying authority is ended, Member States shall designate, in accordance with the procedure provided for in paragraph 2, a new body to take over the functions of the managing authority or of the certifying authority, and shall notify the Commission thereof.
7. The Commission shall, in order to ensure uniform conditions for the implementation of this Article, adopt implementing acts concerning the model for the report and opinion of the independent audit body and the description of the functions and procedures in place for the managing authority and, where appropriate, the certifying authority. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(3).
Article 36
Commission powers and responsibilities
1. The Commission shall satisfy itself on the basis of available information, including information on the designation of bodies responsible for the management and control, the documents provided each year, in accordance with Article 59(5) of the Financial Regulation, by those designated bodies, control reports, annual implementation reports and audits carried out by national and Union bodies, that the Member States have set up management and control systems that comply with this Regulation and that those systems function effectively during the implementation of operational programmes.
2. Commission officials or authorised Commission representatives may carry out on-the-spot audits or checks subject to giving at least 12 working days' notice to the competent national authority, except in urgent cases. The Commission shall respect the principle of proportionality by taking into account the need to avoid unjustified duplication of audits or checks carried out by Member States, the level of risk to the budget of the Union and the need to minimise the administrative burden on beneficiaries in accordance with this Regulation. The scope of such audits or checks may include, in particular, verification of the effective functioning of management and control systems in a programme or a part thereof, in operations and assessment of the sound financial management of operations or programmes. Officials or authorised representatives of the Member State may take part in such audits or checks.
Commission officials or authorised Commission representatives, duly empowered to carry out on-the-spot audits or checks, shall have access to all necessary records, documents and metadata, irrespective of the medium in which they are stored, relating to operations supported by the Fund or to management and control systems. Member States shall provide copies of such records, documents and metadata to the Commission upon request.
The powers set out in this paragraph shall not affect the application of national provisions which reserve certain acts for agents specifically designated by national legislation. Commission officials and authorised representatives shall not take part, inter alia, in home visits or the formal questioning of persons within the framework of national legislation. However, such officials and representatives shall have access to the information thus obtained without prejudice to the competences of national courts and in full respect of the fundamental rights of the legal subjects concerned.
3. The Commission may require a Member State to take the actions necessary to ensure the effective functioning of their management and control systems or to verify the correctness of expenditure in accordance with this Regulation.
Article 37
Cooperation with audit authorities
1. The Commission shall cooperate with audit authorities to coordinate their audit plans and methods and shall immediately exchange with those authorities the results of audits carried out on management and control systems.
2. To facilitate this cooperation in cases where a Member State designates more than one audit authority, the Member State may designate a coordination body.
3. The Commission, the audit authorities and any coordination body shall meet on a regular basis and, as a general rule, at least once a year, unless otherwise agreed, to examine the annual control report, the audit opinion and the audit strategy, and to exchange views on issues relating to improvement of the management and control systems.
TITLE VI
FINANCIAL MANAGEMENT, EXAMINATION AND ACCEPTANCE OF ACCOUNTS, FINANCIAL CORRECTIONS AND DECOMMITMENTS
CHAPTER 1
Financial management
Article 38
Budget commitments
The budget commitments of the Union in respect of each operational programme shall be made in annual instalments during the period between 1 January 2014 and 31 December 2020. The decision of the Commission adopting an operational programme shall constitute a financing decision within the meaning of Article 84 of the Financial Regulation and once notified to the Member State concerned, a legal commitment within the meaning of that Regulation.
For each operational programme, the budget commitment for the first instalment shall follow the adoption of the operational programme by the Commission.
The budget commitments for subsequent instalments shall be made by the Commission before 1 May of each year, on the basis of the decision referred to in the second paragraph, except where Article 16 of the Financial Regulation applies.
Article 39
Payments by the Commission
1. Payments by the Commission of the contribution from the Fund to each operational programme shall be made in accordance with budget appropriations and subject to available funding. Each payment shall be posted to the earliest open budget commitment of the Fund.
2. Payments shall take the form of pre-financing, interim payments and payment of the final balance.
Article 40
Interim payments and payment of the final balance by the Commission
1. The Commission shall reimburse as interim payments 90 % of the amount resulting from applying the co-financing rate laid down in the decision adopting the operational programme to the eligible public expenditure included in the payment application. The Commission shall determine the remaining amounts to be reimbursed as interim payments or recovered in accordance with Article 50.
2. Notwithstanding Article 21, the contribution from the Fund through the interim payments and the payment of the final balance shall not be higher than the maximum amount of contribution from the Fund as laid down in the decision of the Commission approving the operational programme.
Article 41
Payment applications
1. The payment application to be submitted to the Commission shall provide all the information necessary for the Commission to produce accounts in accordance with Article 68(3) of the Financial Regulation.
2. Payment applications shall include for the operational programme as a whole and for technical assistance referred to in Article 27(4):
(a)
the total amount of eligible public expenditure incurred by beneficiaries and paid in implementing operations, as entered in the accounting system of the certifying authority;
(b)
the total amount of public expenditure incurred in implementing operations as entered in the accounting system of the certifying authority.
3. Eligible expenditure included in a payment application shall be supported by receipted invoices or accounting documents of equivalent probative value, except for forms of support under points (b), (c) and (d) of Article 25(1). For those forms of grants, the amounts included in a payment application shall be the costs calculated on the applicable basis.
4. The Commission shall, in order to ensure uniform conditions for the implementation of this Article, adopt, implementing acts, laying down the model for payment applications. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(3).
Article 42
Payments to beneficiaries
1. The managing authority shall ensure that, in the case of grants to partner organisations, beneficiaries are provided with a float that is sufficient to ensure proper implementation of the operations.
2. Subject to the availability of funding from pre-financing and interim payments, the managing authority shall ensure that a beneficiary receives the total amount of eligible public expenditure due in full and no later than 90 days from the date of submission of the payment claim by the beneficiary. No amount shall be deducted or withheld and no specific charge or other charge with equivalent effect shall be levied that would reduce amounts due to beneficiaries.
3. The payment deadline referred to in paragraph 2 may be interrupted by the managing authority in either of the following duly justified cases:
(a)
the amount of the payment claim is not due or the appropriate supporting documents, including the documents necessary for management verifications under point (a) of Article 32(4), have not been provided;
(b)
an investigation has been initiated in relation to a possible irregularity affecting the expenditure concerned.
The beneficiary concerned shall be informed in writing of the interruption and the reasons for it.
Article 43
Use of the euro
1. Amounts set out in operational programmes submitted by Member States, statements of expenditure, requests for payment, accounts and expenditure mentioned in the annual and final implementation reports shall be denominated in euro.
2. Member States which have not adopted the euro as their currency on the date of an application for payment shall convert the amounts of expenditure incurred in national currency into euro. Those amounts shall be converted into euro using the monthly accounting exchange rate of the Commission in the month during which the expenditure was registered in the accounts of the certifying authority of the operational programme concerned. The exchange rate shall be published electronically by the Commission each month.
3. When the euro becomes the currency of a Member State, the conversion procedure set out in paragraph 2 shall continue to apply to all expenditure recorded in the accounts by the certifying authority before the date of entry into force of the fixed conversion rate between the national currency and the euro.
Article 44
Payment and clearance of pre-financing
1. Following the Commission decision adopting the operational programme, a pre-financing amount of 11 % of the Fund's overall contribution to the operational programme concerned shall be paid by the Commission.
2. Pre-financing shall be used only for payments to beneficiaries in the implementation of the operational programme. It shall be made available without delay to the responsible body for this purpose.
3. The total amount paid as pre-financing shall be reimbursed to the Commission if no payment application for the operational programme concerned is sent within 24 months of the date on which the Commission pays the first pre-financing amount. The Union contribution to the operational programme concerned shall not be affected by such reimbursement.
4. The amount paid as pre-financing shall be totally cleared from the Commission accounts at the latest when the operational programme is closed.
Article 45
Deadline for presentation of interim payment applications and for their payment
1. The certifying authority shall submit on a regular basis an application for interim payment in accordance with Article 41(2) covering amounts entered in its accounting system in the accounting year. However, the certifying authority, where it considers it to be necessary, may include such amounts in payment applications submitted in subsequent accounting years.
2. The certifying authority shall submit the final application for an interim payment by 31 July following the end of the previous accounting year and, in any event, before the first application for interim payment for the next accounting year.
3. The first application for interim payment shall not be made before the notification to the Commission of the designation of the managing authority and the certifying authority in accordance with Article 35.
4. Interim payments shall not be made for an operational programme unless the annual implementation report has been sent to the Commission in accordance with Article 13.
5. Subject to available funding, the Commission shall make the interim payment no later than 60 days after the date on which a payment application is registered with the Commission.
Article 46
Interruption of the payment deadline
1. The payment deadline for an interim payment claim may be interrupted by the authorising officer by delegation within the meaning of the Financial Regulation for a maximum period of six months if:
(a)
following information provided by a national or Union audit body, there is clear evidence to suggest a significant deficiency in the functioning of the management and control system;
(b)
the authorising officer by delegation has to carry out additional verifications following information that has come to that officer's attention alerting him or her that expenditure in a request for payment is linked to an irregularity having serious financial consequences;
(c)
there is a failure to submit one of the documents required under Article 59(5) of the Financial Regulation.
The Member State may agree to an extension of the interruption period for another three months.
2. The authorising officer by delegation shall limit the interruption to the part of the expenditure covered by the payment claim affected by the elements referred to in the first subparagraph of paragraph 1, unless it is not possible to identify the part of the expenditure affected. The authorising officer by delegation shall inform the Member State and the managing authority in writing immediately of the reason for interruption and shall ask them to remedy the situation. The interruption shall be ended by the authorising officer by delegation as soon as the necessary measures have been taken.
Article 47
Suspension of payments
1. All or part of the interim payments may be suspended by the Commission if one or more of the following conditions are met:
(a)
there is a serious deficiency in the effective functioning of the management and control system of the operational programme, which has put at risk the Union contribution to the operational programme and for which corrective measures have not been taken;
(b)
expenditure in a statement of expenditure is linked to an irregularity having serious financial consequences which has not been corrected;
(c)
the Member State has failed to take the necessary action to remedy the situation giving rise to an interruption under Article 46;
(d)
there is a serious deficiency in the quality and reliability of the monitoring system or of the data on indicators.
2. The Commission may decide, by means of implementing acts, to suspend all or part of interim payments, after having given the Member State the opportunity to present its observations.
3. The Commission shall end suspension of all or part of interim payments where the Member State has taken the necessary measures to enable the suspension to be lifted.
CHAPTER 2
Preparation, examination and acceptance of accounts and closure of operational programmes
Article 48
Submission of information
For each year from 2016 until and including 2025, Member States shall submit to the Commission by the deadline set out in Article 59(5) of the Financial Regulation, the following documents referred to in that Article, namely:
(a)
the accounts referred to in Article 49(1) of this Regulation, for the preceding accounting year;
(b)
the management declaration and the annual summary referred to in point (e) of Article 32(4) of this Regulation, for the preceding accounting year;
(c)
the audit opinion and the control report referred to in points (a) and (b) of Article 34(5) of this Regulation for the preceding accounting year.
Article 49
Preparation of the accounts
1. The accounts referred to in point (a) of the first subparagraph of Article 59(5) of the Financial Regulation shall be submitted to the Commission for each operational programme. The accounts shall cover the accounting year and shall include the following:
(a)
the total amount of eligible public expenditure entered into the accounting systems of the certifying authority which has been included in payment applications submitted to the Commission, in accordance with Article 41 and Article 45(2), by 31 July following the end of the accounting year, the total amount of the corresponding eligible public expenditure incurred in implementing operations, and the total amount of corresponding payments made to beneficiaries under Article 42(2);
(b)
the amounts withdrawn and recovered during the accounting year, the amounts to be recovered as at the end of the accounting year and the irrecoverable amounts;
(c)
a reconciliation between the expenditure stated pursuant to point (a) and the expenditure declared in respect of the same accounting year in payment applications, accompanied by an explanation of any differences.
2. Where expenditure previously included in an application for interim payment for the accounting year is excluded by a Member State from its accounts, due to an ongoing assessment of that expenditure's legality and regularity, any or all of that expenditure subsequently found to be legal and regular may be included in an application for interim payment relating to subsequent accounting years.
3. The Commission shall, in order to lay down uniform conditions for the implementation of this Article, adopt implementing acts setting out the model for the accounts referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(3).
Article 50
Examination and acceptance of accounts
1. By 31 May of the year following the end of the accounting period, the Commission shall, in accordance with Article 59(6) of the Financial Regulation, carry out an examination of the documents submitted by the Member State under Article 48 of this Regulation.
Upon request by the Commission, the Member State shall provide all necessary additional information to enable the Commission to determine whether the accounts are complete, accurate and true by the deadline set out in the first subparagraph of this paragraph.
2. The Commission shall accept the accounts where it is able to conclude that the accounts are complete, accurate and true. The Commission shall reach such a conclusion where the audit authority has provided an unqualified audit opinion regarding the completeness, accuracy and veracity of the accounts unless the Commission has specific evidence that the audit opinion on the accounts is unreliable.
3. The Commission shall inform the Member State by the deadline set out in paragraph 1 whether it is able to accept the accounts.
4. If for reasons attributable to Member State, the Commission is unable to accept the accounts by the deadline set out in paragraph 1 the Commission shall notify the Member States specifying the reasons in accordance with paragraph 2 and the actions which are required to be undertaken and the time period for their completion. At the end of that period the Commission shall inform the Member State whether it is able to accept the accounts.
5. Issues related to legality and regularity of the underlying transactions concerning expenditure entered in the accounts shall not be taken into account for the purposes of acceptance of the accounts by the Commission. The procedure for examination and acceptance of the accounts shall not interrupt the treatment of applications for interim payments and shall not lead to suspension of payments, without prejudice to Articles 46 and 47.
6. On the basis of the accepted accounts the Commission shall calculate the amount chargeable to the Fund for the accounting year and the consequent adjustments in relation to the payments to the Member State. The Commission shall take into account:
(i)
the amounts in the accounts referred to in point (a) of Article 49(1), and to which the co-financing rate defined in Article 20 is to be applied;
(ii)
the total amount of payments made by the Commission during that accounting year, consisting of the amount of interim payments paid by the Commission in accordance with Article 21 and Article 40(1).
7. After the calculation carried out under paragraph 6 of this Article, the Commission shall pay any additional amount due within 30 days of the acceptance of the accounts. Where there is an amount recoverable from the Member State, it shall be subject to a recovery order issued by the Commission which shall be executed, where possible, by offsetting against amounts due to the Member State under subsequent payments to the same operational programme. Such recovery shall not constitute a financial correction and shall not reduce support from the Fund to the operational programme. The amount recovered shall constitute assigned revenue in accordance with Article 177(3) of the Financial Regulation.
8. Where after applying the procedure set out in paragraph 4, the Commission is unable to accept the accounts, the Commission shall determine, on the basis of the available information and in accordance with paragraph 6, the amount chargeable to the Fund for the accounting year, and shall inform the Member State. Where the Member State notifies the Commission of its agreement within two months of the transmission by the Commission of the information, paragraph 7 shall apply. In the absence of such agreement, the Commission shall adopt a decision, by means of implementing acts, setting out the amount chargeable to the Fund for the accounting year. Such decision shall not constitute a financial correction and shall not reduce support from the Fund to the operational programme. On the basis of the decision, the Commission shall apply the adjustments to the payments to the Member State in accordance with paragraph 7.
9. The acceptance of the accounts by the Commission, or a decision by the Commission under paragraph 8, shall be without prejudice to the application of corrections under Articles 55 and 56.
10. Member States may replace irregular amounts which are detected after the submission of the accounts by making the corresponding adjustments in the accounts for the accounting year in which the irregularity is detected, without prejudice to Articles 55 and 56.
Article 51
Availability of documents
1. The managing authority shall ensure that all supporting documents regarding expenditure supported by the Fund on operations for which the total eligible public expenditure is less than EUR 1 000 000, are made available to the Commission and the European Court of Auditors upon request for a period of three years from 31 December following the submission of the accounts in which the expenditure of the operation is included.
In the case of operations other than those referred to in the first subparagraph, all supporting documents shall be made available for a two year period from 31 December following the submission of the accounts in which the final expenditure of the completed operation is included.
A managing authority may decide to apply to operations for which the total eligible expenditure is less than EUR 1 000 000 the rule referred to in second subparagraph.
The time period referred to in the first subparagraph shall be interrupted either in the case of legal proceedings or by a duly justified request of the Commission.
2. The managing authority shall inform beneficiaries of the start date of the period referred to in paragraph 1.
3. The documents shall be kept either in the form of the originals, or certified true copies of the originals, or on commonly accepted data carriers including electronic versions of original documents or documents existing in electronic version only.
4. The documents shall be kept in a form which permits the identification of data subjects for no longer than is necessary for the purposes for which the data were collected or for which they are further processed.
5. The procedure for certification of conformity of documents held on commonly accepted data carriers with the original document shall be laid down by the national authorities and shall ensure that the versions held comply with national legal requirements and can be relied on for audit purposes.
6. Where documents exist in electronic form only, the computer systems used shall meet accepted security standards that ensure that the documents held comply with national legal requirements and can be relied on for audit purposes.
Article 52
Submission of closure documents and payment of the final balance
1. In addition to the documents referred to in Article 48, for the final accounting year from 1 July 2023 to 30 June 2024, Member States shall submit a final implementation report for the operational programme.
2. The final balance shall be paid no later than three months after the date of acceptance of accounts of the final accounting year or one month after the date of acceptance of the final implementation report, whichever date is later.
CHAPTER 3
Financial corrections and recoveries
Article 53
Financial corrections by Member States
1. The Member States shall in the first instance be responsible for investigating irregularities and for making the financial corrections required and pursuing recoveries. In the case of a systemic irregularity, the Member State shall extend its investigation to cover all operations potentially affected.
2. The Member States shall make the financial corrections required in connection with individual or systemic irregularities detected in operations or operational programmes. Financial corrections shall consist of cancelling all or part of the public contribution to an operation or operational programme. The Member State shall take into account the nature and gravity of the irregularities and the financial loss to the Fund and shall apply a proportionate correction. Financial corrections shall be recorded in the accounts by the managing authority for the accounting year in which the cancellation is decided.
3. The contribution from the Fund cancelled in accordance with paragraph 2 may be reused by the Member State within the operational programme concerned, subject to paragraph 4.
4. The contribution cancelled in accordance with paragraph 2 may not be reused for any operation that was the subject of the correction or, where a financial correction is made for a systemic irregularity, for any operation affected by the systemic irregularity.
5. A financial correction shall not prejudice the Member States' obligation to pursue recoveries under this Article.
Article 54
Financial corrections by the Commission
1. The Commission shall make financial corrections, by means of implementing acts, by cancelling all or part of the Union contribution to an operational programme and effecting recovery from the Member State in order to exclude from Union financing expenditure which is in breach of applicable law.
2. A breach of applicable law shall lead to a financial correction only in relation to expenditure which has been declared to the Commission and where one of the following conditions is met:
(a)
the breach has affected the selection of an operation by the body responsible for support from the Fund or in cases where, due to the nature of the breach, it is not possible to establish that impact but there is a substantiated risk that the breach has had such an effect;
(b)
the breach has affected the amount of expenditure declared for reimbursement by the budget of the Union or in cases where, due to the nature of the breach, it is not possible to quantify its financial impact but there is a substantiated risk that the breach has had such an effect.
3. When deciding on a financial correction under paragraph 1, the Commission shall respect the principle of proportionality by taking account of the nature and gravity of the breach of applicable law and its financial implications for the budget of the Union. The Commission shall keep the European Parliament and the Council informed of decisions taken to apply financial corrections.
Article 55
Criteria for financial corrections by the Commission
1. The Commission shall make financial corrections by means of implementing acts by cancelling all or part of the Union contribution to an operational programme in accordance with Article 54 where, after carrying out the necessary examination, it concludes that:
(a)
there is a serious deficiency in the effective functioning of the management and control system of the operational programme which has put at risk the Union contribution already paid to the operational programme;
(b)
the Member State has not complied with its obligations under Article 53 prior to the opening of the correction procedure under this paragraph;
(c)
expenditure contained in a payment application is irregular and has not been corrected by the Member State prior to the opening of the correction procedure under this paragraph.
The Commission shall base its financial corrections on individual cases of identified irregularity and shall take account of whether an irregularity is systemic. Where it is not possible to quantify precisely the amount of irregular expenditure charged to the Fund, the Commission shall apply a flat-rate or extrapolated financial correction.
2. The Commission shall, when deciding on a correction under paragraph 1, respect the principle of proportionality by taking account of the nature and gravity of the irregularity and the extent and financial implications of the deficiencies in management and control systems found in the operational programme.
3. Where the Commission bases its position on reports of auditors other than those of its own services, it shall draw its own conclusions regarding the financial consequences after examining the measures taken by the Member State concerned under Article 53(2), the notifications sent under Article 30(2), and any replies from the Member State.
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 62, laying down detailed rules concerning the criteria for determining serious deficiencies in the effective functioning of management and control systems, including the main types of such deficiencies, the criteria for establishing the level of financial correction to be applied and the criteria for applying flat-rates or extrapolated financial corrections.
Article 56
Procedure for financial corrections by the Commission
1. Before taking a decision on a financial correction, the Commission shall launch the procedure by informing the Member State of the provisional conclusions of its examination and requesting the Member State to submit its comments within two months.
2. Where the Commission proposes a financial correction on the basis of extrapolation or a flat-rate, the Member State shall be given the opportunity to demonstrate, through an examination of the documentation concerned, that the actual extent of irregularity is less than the Commission's assessment. In agreement with the Commission, the Member State may limit the scope of that examination to an appropriate proportion or sample of the documentation concerned. Except in duly justified cases, the time allowed for this examination shall not exceed a further period of two months after the two-month period referred to in paragraph 1.
3. The Commission shall take account of any evidence provided by the Member State within the time limits set out in paragraphs 1 and 2.
4. Where the Member State does not accept the provisional conclusions of the Commission, the Member State shall be invited to a hearing by the Commission, in order to ensure that all relevant information and observations are available as a basis for conclusions by the Commission on the application of the financial correction.
5. In the event of an agreement, and without prejudice to paragraph 7 of this Article, the Member State may reuse the Fund in accordance with Article 53(3).
6. In order to apply financial corrections the Commission shall take a decision, by means of implementing acts, within six months of the date of the hearing, or of the date of receipt of additional information where the Member State agrees to submit such additional information following the hearing. The Commission shall take account of all information and observations submitted during the course of the procedure. If no hearing takes place, the six month period shall begin to run two months after the date of the letter of invitation to the hearing sent by the Commission.
7. Where the Commission in carrying out its responsibilities under Article 36, or the European Court of Auditors, detects irregularities demonstrating a serious deficiency in the effective functioning of the management and control systems, the resulting financial correction shall reduce support from the Fund to the operational programme.
The first subparagraph shall not apply in the case of a serious deficiency in the effective functioning of a management and control system which, prior to the date of detection by the Commission or the European Court of Auditors:
(a)
had been identified in the management declaration, annual control report or the audit opinion submitted to the Commission in accordance with Article 59(5) of the Financial Regulation, or in other audit reports of the audit authority submitted to the Commission and appropriate measures taken; or
(b)
had been the subject of appropriate remedial measures by the Member State.
The assessment of serious deficiencies in the effective functioning of a management and control system shall be based on the applicable law when the relevant management declarations, annual control reports and audit opinions were submitted.
When deciding on a financial correction the Commission shall:
(a)
respect the principle of proportionality by taking account of the nature and gravity of the serious deficiency in the effective functioning of a management and control system and its financial implications for the budget of the Union;
(b)
for the purpose of applying a flat-rate or extrapolated correction, exclude irregular expenditure previously detected by the Member State which has been the subject of an adjustment in the accounts in accordance with Article 50(10), and expenditure subject to an ongoing assessment of its legality and regularity under Article 49(2);
(c)
take into account flat-rate or extrapolated corrections applied to the expenditure by the Member State for other serious deficiencies detected by the Member State when determining the residual risk for the budget of the Union.
Article 57
Repayment
1. Any repayment due to be made to the budget of the Union shall be effected before the due date indicated in the order for recovery drawn up in accordance with Article 73 of the Financial Regulation. The due date shall be the last day of the second month following the issuing of the order.
2. Any delay in effecting repayment shall give rise to interest on account of late payment, starting on the due date and ending on the date of actual payment. The rate of such interest shall be one-and-a-half percentage points above the rate applied by the European Central Bank in its main refinancing operations on the first working day of the month in which the due date falls.
Article 58
Proportional control of operational programmes
1. Operations for which the total eligible expenditure does not exceed EUR 150 000 shall not be subject to more than one audit by either the audit authority or the Commission prior to the submission of the accounts for the accounting year in which the operation is completed. Other operations shall not be subject to more than one audit per accounting year either by the audit authority or the Commission prior to the submission of the accounts for the accounting year in which the operation is completed. Operations shall not be subject to an audit by the Commission or the audit authority in any year if there has already been an audit in that year by the European Court of Auditors, provided that the results of the audit work performed by the European Court of Auditors for such operations can be used by the audit authority or the Commission for the purpose of fulfilling their respective tasks.
2. The audit of an operation supported by an OP I may cover all stages of its implementation and all levels of the distribution chain, with the sole exception of control of the end recipients, unless a risk assessment establishes a specific risk of irregularity or fraud.
3. For operational programmes for which the most recent audit opinion indicates that there are no significant deficiencies, the Commission may agree with the audit authority in the subsequent meeting referred to in Article 37(2) that the level of audit work required may be reduced so that it is proportionate to the risk established. In such cases, the Commission shall not carry out its own on-the-spot audits unless there is evidence suggesting deficiencies in the management and control system affecting expenditure declared to the Commission in an accounting year for which the accounts have been accepted by the Commission.
4. For operational programmes for which the Commission concludes that the opinion of the audit authority is reliable, it may agree with the audit authority to limit the Commission's own on-the-spot audits to audit the work of the audit authority unless there is evidence of deficiencies in the work of the audit authority work for an accounting year for which the accounts have been accepted by the Commission.
5. Notwithstanding paragraph 1, the audit authority and the Commission may carry out audits of operations in the event that a risk assessment or an audit by the European Court of Auditors establishes a specific risk of irregularity or fraud, in the case of evidence of serious deficiencies in the effective functioning of the management and control system of the operational programme concerned, and, during the period referred to in Article 51(1). The Commission may, for the purpose of assessing the work of an audit authority, review the audit trail of the audit authority or take part in the on-the-spot audits of the audit authority and, where, in accordance with internationally accepted audit standards, it is necessary for the purpose of obtaining assurance as to the effective functioning of the audit authority, the Commission may carry out audits of operations.
CHAPTER 4
Decommitment
Article 59
Decommitment
1. The Commission shall decommit any part of the amount in an operational programme that has not been used for payment of the pre-financing and interim payments by 31 December of the third financial year following the year of budget commitment under the operational programme or for which a payment application drawn up in accordance with Article 41 has not been submitted in accordance with Article 45, including any payment application for which all or part is subject to an interruption of the payment deadline or suspension of payments.
2. That part of commitments still open on 31 December 2023 shall be decommitted if any of the documents required under Article 52(1) has not been submitted to the Commission by the deadline set out in Article 52(1).
Article 60
Exception to the decommitment
1. The amount concerned by decommitment shall be reduced by the amounts equivalent to that part of the budget commitment for which:
(a)
the operations are suspended by a legal proceeding or by an administrative appeal having suspensory effect; or
(b)
it has not been possible to make a request for payment for reasons of force majeure seriously affecting implementation of all or part of the operational programme.
The national authorities claiming force majeure under point (b) of the first subparagraph shall demonstrate the direct consequences of the force majeure on the implementation of all or part of the operational programme.
For the purpose of points (a) and (b) of the first subparagraph, the reduction may be requested once, if the suspension or force majeure lasted no longer than one year, or a number of times that corresponds to the duration of the force majeure or the number of years between the date of the legal or administrative decision suspending the implementation of the operation and the date of the final legal or administrative decision.
2. By 31 January, the Member State shall send to the Commission information on the exceptions referred to in points (a) and (b) of the first subparagraph of paragraph 1 for the amount to be declared by the end of the preceding year.
Article 61
Procedure
1. The Commission shall inform the Member State and the managing authority in good time whenever there is a risk of application of the decommitment rule under Article 59.
2. On the basis of the information it received as of 31 January, the Commission shall inform the Member State and the managing authority of the amount of the decommitment resulting from that information.
3. The Member State shall have two months to agree to the amount to be decommitted or to submit its observations.
4. By 30 June, the Member State shall submit to the Commission a revised financing plan reflecting, for the financial year concerned, the reduced amount of support of the operational programme. Failing such submission, the Commission shall revise the financing plan by reducing the contribution from the Fund for the financial year concerned.
5. The Commission shall amend the decision adopting the operational programme, by means of implementing acts, no later than 30 September.
TITLE VII
DELEGATIONS OF POWER, IMPLEMENTING AND FINAL PROVISIONS
Article 62
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The delegations of power referred to in Article 13(6), the fifth subparagraph of Article 30(2), the first subparagraph of Article 32(8), Article 32(9), Article 34(7), Article 34(8) and Article 55(4) shall be conferred for an indeterminate period of time from the date of entry into force of this Regulation.
3. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
4. The delegated acts shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
If the European Parliament or the Council objects to a delegated act, the act shall not enter into force. The institution that objects to the delegated act shall state the reasons for its objections.
Article 63
Committee Procedure
1. The Commission shall be assisted by a Committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in the second subparagraph of Article 32(8) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 64
Entry into force
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 11 March 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
D. KOURKOULAS
(1) OJ C 133, 9.5.2013, p. 62
(2) OJ C 139, 17.5.2013, p. 59.
(3) Position of the European Parliament of 25 February 2014 (not yet published in the Official Journal) and decision of the Council of 10 March 2014.
(4) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, p. 320).
(5) Regulation (EU) No 1304/2013 of the European Parliament and of the Council of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 (OJ L 347, 20.12.2013, p. 470).
(6) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).
(7) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(8) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).
(9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(10) Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of the procedures for the award of public works contracts, public supply contracts and public service contracts (OJ L 134, 30.4.2004, p. 114).
(11) Council Regulation (EU) No 407/2010 of 11 May 2010 establishing a European financial stabilisation mechanism (OJ L 118, 12.5.2010, p. 1).
(12) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States' balances of payments (OJ L 53, 23.2.2002, p. 1).
ANNEX I
OPERATIONAL PROGRAMME TEMPLATES
1. Template for Operational Programme OP I
Chapter
Section
Sub-section
Description / Observations
Size
(characters)
1.
IDENTIFICATION
The purpose of this section is to identify only the programme concerned. This section shall clearly state the following:
Member State
Name of the Operational Programme
CCI
200
2.
PROGRAMME FORMULATION
2.1.
Situation
An identification and a justification of the material deprivation(s) to be addressed
4 000
Indication of the type of material deprivation(s) retained for the OP.
200
2.2.
Material deprivation addressed
One section (and the corresponding sub-sections) shall be provided for each type of material deprivation to be addressed.
2.2.1.
Description
Description of the main characteristics of the distribution of food or basic material assistance to be provided and the corresponding accompanying measures.
4 000
2.2.2.
National schemes
Description of the national schemes to be supported
2 000
2.3.
Other
Any other information deemed necessary
4 000
3.
IMPLEMENTATION
3.1.
Identification of most deprived persons
Description of the mechanism setting the eligible criteria of the most deprived persons, differentiated if necessary by type of material deprivation addressed.
2 000
3.2.
Selection of operations
Criteria for the selection of operations and the description of the selection mechanism, differentiated if necessary by type of material deprivation addressed.
2 000
3.3.
Selection of partner organisations
Criteria for the selection of partner organisations, differentiated if necessary by type of material deprivation addressed.
2 000
3.4.
Complementarity with ESF
Description of the mechanism to ensure complementarity with the ESF
4 000
3.5.
Institutional set-up
The identification of the managing authority, the certifying authority where applicable, the audit authority and the body to which payments will be made by the Commission
2 000
3.6.
Monitoring and evaluation
Description of how the programme implementation will be monitored.
4 000
3.7.
Technical assistance
The description of the planned use of technical assistance pursuant to Article 27(4), including actions to reinforce the administrative capacity of the beneficiaries in relation to sound financial management of operations
4 000
4.
INVOLVEMENT OF STAKEHOLDERS
A description of the measures taken to involve all relevant stakeholders as well as, where appropriate, the competent regional, local and other public authorities in the preparation of the operational programme.
2 000
5.
FINANCIAL PLAN
This section shall contain:
5.1.
a table specifying for each year in accordance with Article 20 the amount of the financial appropriation envisaged for support from the Fund and the co-financing;
5.2.
a table specifying, for the whole programming period, the amount of the total financial appropriation of the support from the operational programme for each type of material deprivation addressed as well as the corresponding accompanying measures.
Text: 1 000
Data in CSV or XLS format
Format for financial data (section 5):
5.1.
Financing plan of the operational programme giving the annual commitment of the Fund and corresponding national co-financing in the operational programme (in EUR)
Total
2014
2015
….
2020
Fund (a)
National co-financing (b)
public expenditure
(c) = (a) + (b)
Co-financing rate
(d) = (a) / (c)
5.2.
Financing plan giving the amount of the total financial appropriations of the support from the operational programme for each type of material deprivation addressed as well as the corresponding accompanying measures (in EUR)
Type of material assistance
Public expenditure
Total
Technical assistance
Type of material assistance 1
of which, accompanying measures
Type of material assistance 2
of which, accompanying measures
Type of material assistance n
of which, accompanying measures
2. Template for Operational Programme OP II
Chapter
Section
Sub-section
Description / Observations
Size
(characters)
1.
IDENTIFICATION
The purpose of this section is only to identify the programme concerned. This section shall clearly state the following:
Member State
Name of the Operational Programme
CCI
200
2.
PROGRAMME FORMULATION
2.1.
Strategy
Description of strategy for the programme contribution to the promotion of social cohesion and poverty reduction in accordance with the Europe 2020 strategy, including a justification of the choice of assistance priority;
20 000
2.2.
Intervention logic
Identification of the national needs
3 500
Specific objectives of the operational programme
7 000
Expected results and corresponding output and results indicators, with a baseline and a target value (for each specific objective)
3 500
Identification of the most deprived persons to be targetted
3 500
Financial indicators
2 000
2.3.
Other
Any other information deemed necessary
3 500
3
IMPLEMENTATION
3.1.
Actions
Description of the types and examples of actions to be supported and their contribution to the specific objectives
7 000
3.2.
Selection of operations
Guiding principles for the selection of operations, differentiated, if necessary, by type of actions
3 500
3.3.
Beneficiaries
Identification of types of beneficiaries (where appropriate), differentiated, if necessary by type of actions
3 500
3.4.
Complementarity with ESF
Description of the mechanism to ensure complementarity with the ESF and prevention of overlap and double funding
4 000
3.5.
Institutional set-up
The identification of the managing authority, the certifying authority where applicable, the audit authority and the body to which payments will be made by the Commission
2 000
3.6.
Monitoring and evaluation
This sub-section shall describe how the programme implementation will be monitored. There is, in particular, a need to explain how indicators will be used to track programme implementation. The indicators shall include financial indicators relating to expenditures allocated and programme specific output indicators relating to the operations supported and programme specific result indicators in relation to each specific objective.
4 000
3.7.
Technical assistance
The description of the planned use of technical assistance pursuant to Article 27(4), including actions to reinforce the administrative capacity of the beneficiaries in relation to sound financial management of operations
4 000
4.
INVOLVEMENT OF STAKEHOLDERS
A description of the measures taken to involve all relevant stakeholders as well as, where appropriate, the competent regional, local and other public authorities in the preparation of the operational programme;
2 000
5.
FINANCIAL PLAN
This section shall contain:
5.1.
a table specifying for each year in accordance with Article 20 the amount of the financial appropriation envisaged for support from the Fund and the co-financing;
5.2.
a table specifying, for the whole programming period, the amount of the total financial appropriation of the support from the operational programme for each type of action supported
Text: 1 000
Data in CSV or XLS format
Format for financial data (section 5):
5.1.
Financing plan of the operational programme giving the annual commitment of the Fund and corresponding national co-financing in the operational programme (in EUR)
Total
2014
2015
….
2020
Fund (a)
National co-financing (b)
public expenditure
(c) = (a) + (b)
Co-financing rate (1)
(d) = (a) / (c)
5.2.
Financing plan giving the amount of the total financial appropriations of the support from the Operational programme for each type of action (in EUR)
Intervention area
Public expenditure
Total
Technical Assistance
Type of action 1
Type of action 2
…
Type of action n
(1) This rate may be rounded to the nearest whole number in the table. The precise rate used to reimburse expenditure is the ratio (d).
ANNEX II
Annual breakdown of commitment appropriation for 2014 to 2020 (in 2011 prices)
2014
EUR
485 097 840
2015
EUR
485 097 840
2016
EUR
485 097 840
2017
EUR
485 097 840
2018
EUR
485 097 840
2019
EUR
485 097 840
2020
EUR
485 097 840
Total
EUR
3 395 684 880
ANNEX III
The allocation of the Fund for the period 2014–2020 per Member State (in 2011 prices)
Member States
EUR
Belgium
65 500 000
Bulgaria
93 000 000
Czech Republic
20 700 000
Denmark
3 500 000
Germany
70 000 000
Estonia
7 100 000
Ireland
20 200 000
Greece
249 300 000
Spain
499 900 000
France
443 000 000
Croatia
32 500 000
Italy
595 000 000
Cyprus
3 500 000
Latvia
36 400 000
Lithuania
68 500 000
Luxembourg
3 500 000
Hungary
83 300 000
Malta
3 500 000
Netherlands
3 500 000
Austria
16 000 000
Poland
420 000 000
Portugal
157 000 000
Romania
391 300 000
Slovenia
18 200 000
Slovakia
48 900 000
Finland
20 000 000
Sweden
7 000 000
United Kingdom
3 500 000
Total
3 383 800 000
ANNEX IV
Designation Criteria for the managing authority and the certifying authority
1. Internal control environment
(i)
existence of an organisational structure covering the functions of managing and certifying authorities and the allocation of functions within each of them, ensuring that the principle of separation of functions, where appropriate, is respected;
(ii)
framework for ensuring, in case of delegation of tasks to intermediate bodies, the definition of their respective responsibilities and obligations, verification of their capacities to carry out delegated tasks and the existence of reporting procedures;
(iii)
reporting and monitoring procedures for irregularities and for the recovery of amounts unduly paid;
(iv)
Plan for allocation of appropriate human resources with necessary technical skills, at different levels and for different functions in the organisation.
2. Risk management
Taking into account the principle of proportionality, a framework for ensuring that an appropriate risk management exercise is conducted when necessary, and in particular, in the event of major modifications to the activities.
3. Management and control activities
A. Managing authority
(i)
procedures regarding grant applications, appraisal of applications, selection for funding, including instructions and guidance ensuring the contribution of operations to achieving the specific objectives and results of the operational programme in accordance with the provisions of point (b) of Article 32(3) of this Regulation;
(ii)
procedures for management verifications including administrative verifications in respect of each application for reimbursement by beneficiaries and the on-the-spot verifications of operations;
(iii)
procedures for treatment of applications for reimbursement by beneficiaries and authorisation of payments;
(iv)
procedures for a system to collect, record and store in computerised form data on each operation, including, where appropriate, data on individual participants and a breakdown of data on indicators by gender when required, and to ensure that systems security is in line with internationally accepted standards;
(v)
procedures established by the managing authority to ensure that beneficiaries maintain either a separate accounting system or an adequate accounting code for all transactions relating to an operation;
(vi)
procedures for putting in place effective and proportionate anti-fraud measures;
(vii)
procedures to ensure an adequate audit trail and archiving system;
(viii)
procedures to draw up the management declaration of assurance, report on the controls carried out and weaknesses identified, and the annual summary of final audits and controls;
(ix)
procedures to ensure the provision to the beneficiary of a document setting out the conditions for support for each operation.
B. Certifying authority
(i)
procedures for certifying interim payment applications to the Commission;
(ii)
procedures for drawing up the accounts and certifying that they are true, complete and accurate and that the expenditure complies with applicable law taking into account the results of all audits;
(iii)
procedures for ensuring an adequate audit trail by maintaining accounting records including amounts recoverable, recovered and withdrawn for each operation in computerised form;
(iv)
procedures, where appropriate, to ensure that it receives adequate information from the managing authority on the verifications carried out, and the results of the audits carried out by or under the responsibility of the audit authority.
4. Monitoring
A. Managing authority
(i)
where relevant, procedures to support the work of the monitoring committee;
(ii)
procedures to draw up and submit to the Commission annual and final implementation reports.
B. Certifying authority
Procedures on the fulfilment of its responsibilities for monitoring the results of the management verifications and the results of the audits carried out by or under the responsibility of the audit authority before submitting payment applications to the Commission.
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Fund for European Aid to the Most Deprived (FEAD)
Fund for European Aid to the Most Deprived (FEAD)
SUMMARY OF:
Regulation (EU) No 223/2014 on the Fund for European Aid to the Most Deprived
WHAT IS THE AIM OF THE REGULATION?
It sets up FEAD, which aims to complement national poverty eradication programmes and social inclusion policies. FEAD follows on from the EU food aid programme.
Its specific aim is to help alleviate the most severe forms of poverty.
Its main focus is to provide basic material assistance and/or food to the most deprived people, together with other related measures, or to provide dedicated social inclusion support.
In taking care of people’s most basic needs, it complements the European Social Fund, which can provide further social inclusion support with a view to integrating people into the labour market.
KEY POINTS
Approval of national programmes by the European Commission
The management of the fund is shared between the Commission and the EU Member States, in the same way as the European Structural and Investment Funds.
National authorities submit a national programme for the 2014-2020 period for the Commission’s approval. It contains all the information concerning, for example, what action(s) that Member State is proposing to take, the type of assistance planned and how that country is going to manage the programme.
Member States can choose what type of assistance they will provide (food, basic goods or a combination, as well as social inclusion support — for example, activities to help the inclusion of elderly people or children) and how to procure and distribute these goods.
Partner organisations at national level
To implement the programme on the ground, each Member State selects partner organisations — either public bodies or non-governmental organisations (NGOs) — using objective and transparent criteria that are defined at national level.
Implementation
The Commission has adopted implementing acts (see related documents below) which lay down rules for submitting, implementing and monitoring of programmes financed by the FEAD. These implementing acts mainly aim to: set out the conditions of the use of the System for Fund Management in the European Union (SFC2014). The SFC2014 is an electronic data-exchange system between the Member States and the Commission for the implementation of EU funds;create a computerised system to store data on the financial management and the evaluation of the programmes financed by FEAD;set up specific models for the management and the payment of each operational programme implemented under FEAD;set out the frequency and the format of the reporting of irregularities;set out models for the management declaration, the audit strategy, the audit opinion and the annual control report.
The Commission has also adopted delegated acts, among other things, introducing specific rules on the reporting of irregularities (Regulation (EU) 2015/1972) and laying down the content of the annual and final implementation reports, including the list of common indicators (Regulation (EU) No 1255/2014).
Budget
Over €3.8 billion is allocated for FEAD for 2014-2020 (in current prices).
In addition, Member States must contribute at least 15% in national co-financing to their national programme.
Revision of the Financial Regulation (Omnibus Regulation): first amendment to the regulation
Regulation (EU, Euratom) 2018/1046 (see summary) amends Regulation (EU) No 223/2014 to simplify the implementation of the fund, notably by:
extending the possibility for Member States to use simplified cost options;
simplifying the procedures for amending certain elements of operational programmes;
setting up safeguards for partner organisations in case the body purchasing the food or other basic goods fails to comply with the applicable law.
COVID-19 pandemic: second amendment to the regulation
Regulation (EU) 2020/559 amends Regulation (EU) No 223/2014 to enable Member States to respond to the COVID-19 outbreak and introduces measures to ensure that the most deprived people can continue to receive assistance under FEAD in a safe environment.
It gives Member States sufficient flexibility and liquidity to adjust their support schemes to the situation based on consultations with partner organisations, including by: providing more flexibility to Member States to purchase personal protective equipment (PPE) for partner organisations;allowing alternative schemes of delivery, such as through vouchers or cards in electronic or other form;allowing Member States to amend certain elements of the operational programme without the need for a Commission decision;allowing expenditure in relation to operations providing a response to the COVID-19 outbreak to be eligible as from 1 February 2020 and by alleviating certain requirements on monitoring, control and audit.
COVID-19 pandemic: third amendment to the regulation
Amending Regulation (EU) 2021/177 allows Member States to use additional funds made available for post-COVID-19 recovery under the REACT-EU initiative in 2021 and 2022.
To ensure Member States have sufficient financial means to swiftly implement measures to assist the most deprived, they may benefit from a co-financing rate of up to 100%. This alleviates the burden on Member States’ public budgets and provides some relief to organisations responding to the COVID-19 emergency in enabling the continuity of their aid provision.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2014.
BACKGROUND
In 2012, according to Eurostat, close to 125 million people — almost a quarter of the EU’s population — were at risk of poverty or social exclusion. Almost 50 million were suffering severe material deprivation.
For more information, see: Fund for European Aid to the Most Deprived (FEAD) (European Commission).
MAIN DOCUMENT
Regulation (EU) No 223/2014 of the European Parliament and of the Council of 11 March 2014 on the Fund for European Aid to the Most Deprived (OJ L 72, 12.3.2014, pp. 1-41)
Successive amendments to Regulation (EU) No 223/2014 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Implementing Regulation (EU) 2016/594 of 18 April 2016 establishing a template for the structured survey on end recipients of food and/or basic material assistance operational programmes of the Fund for European Aid to the Most Deprived pursuant to Regulation (EU) No 223/2014 of the European Parliament and of the Council (OJ L 103, 19.4.2016, pp. 13-21)
Commission Delegated Regulation (EU) 2015/1972 of 8 July 2015 supplementing Regulation (EU) No 223/2014 of the European Parliament and of the Council with specific provisions on the reporting of irregularities concerning the Fund for European Aid to the Most Deprived (OJ L 293, 10.11.2015, pp. 11-14)
Commission Implementing Regulation (EU) 2015/1976 of 8 July 2015 setting out the frequency and the format of the reporting of irregularities concerning the Fund for European Aid to the Most Deprived, under Regulation (EU) No 223/2014 of the European Parliament and of the Council (OJ L 293, 10.11.2015, pp. 26-28)
Commission Implementing Regulation (EU) 2015/1386 of 12 August 2015 laying down detailed rules implementing Regulation (EU) No 223/2014 of the European Parliament and of the Council as regards the models for the management declaration, the audit strategy, the audit opinion and the annual control report (OJ L 214, 13.8.2015, pp. 9-23)
Commission Implementing Regulation (EU) 2015/341 of 20 February 2015 laying down detailed rules for implementing Regulation (EU) No 223/2014 of the European Parliament and of the Council as regards the models for submission of certain information to the Commission (OJ L 60, 4.3.2015, pp. 1-30)
Commission Implementing Regulation (EU) 2015/212 of 11 February 2015 laying down rules for the application of Regulation (EU) No 223/2014 of the European Parliament and of the Council as regards the technical specifications of the system to record and store data on each operation necessary for monitoring, evaluation, financial management, verification and audit, including data on individual participants in operations co-financed by OP II (OJ L 36, 12.2.2015, pp. 1-3)
Commission Delegated Regulation (EU) No 1255/2014 of 17 July 2014 supplementing Regulation (EU) No 223/2014 of the European Parliament and of the Council on the Fund for European Aid to the Most Deprived by laying down the content of the annual and final implementation reports, including the list of common indicators (OJ L 337, 25.11.2014, pp. 46-50)
Commission Delegated Regulation (EU) No 532/2014 of 13 March 2014 supplementing Regulation (EU) No 223/2014 of the European Parliament and of the Council on the Fund for European Aid to the Most Deprived (OJ L 148, 20.5.2014, pp. 54-69)
Commission Implementing Regulation (EU) No 463/2014 of 5 May 2014 laying down pursuant to Regulation (EU) No 223/2014 of the European Parliament and of the Council on the Fund for European Aid to the Most Deprived, the terms and conditions applicable to the electronic data exchange system between the Member States and the Commission (OJ L 134, 7.5.2014, pp. 32-36)
last update 29.03.2021
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32012R0649
|
27.7.2012
EN
Official Journal of the European Union
L 201/60
REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 July 2012
concerning the export and import of hazardous chemicals
(recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) and Article 207 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (3) has been substantially amended several times. Since further amendments are to be made, Regulation (EC) No 689/2008 should be recast in the interest of clarity.
(2)
Regulation (EC) No 689/2008 implements the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (4) (the ‘Convention’), which entered into force on 24 February 2004, and replaces Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals (5).
(3)
For reasons of clarity and consistency with other relevant Union legislation, certain definitions should be introduced or clarified and terminology should be aligned with that used in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (6), on the one hand, and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (7) on the other hand. It is appropriate to ensure that this Regulation reflects the transitional provisions of Regulation (EC) No 1272/2008, in order to avoid any inconsistencies between the timetable of application of that Regulation and this Regulation.
(4)
The Convention allows Parties the right to take action that is more stringently protective of human health and the environment than that called for in the Convention, provided that such action is consistent with the provisions of the Convention and is in accordance with international law. It is necessary and appropriate, in order to ensure a higher level of protection of the environment and the general public of importing countries, to go further than the provisions of the Convention in certain respects.
(5)
As regards the participation of the Union in the Convention, it is essential to have a single contact point for Union interaction with the Secretariat of the Convention (the ‘Secretariat’) and other Parties to the Convention as well as with other countries. The Commission should act as that contact point.
(6)
There is a need to ensure the effective coordination and management of technical and administrative aspects of this Regulation at Union level. The Member States and the European Chemicals Agency established by Regulation (EC) No 1907/2006 (the ‘Agency’) have the competence and experience in implementing Union legislation on chemicals and international agreements on chemicals. The Member States and the Agency should, therefore, carry out tasks with regard to the administrative, technical and scientific aspects of the implementation of the Convention through this Regulation, as well as the exchange of information. In addition, the Commission, the Member States and the Agency should cooperate in order to implement the Union’s international obligations under the Convention effectively.
(7)
Given that certain tasks of the Commission should be transferred to the Agency, the European Database on Export and Import of Dangerous Chemicals initially established by the Commission should be further developed and maintained by the Agency.
(8)
Exports of hazardous chemicals that are banned or severely restricted within the Union should continue to be subject to a common export notification procedure. Accordingly, hazardous chemicals, whether in the form of substances on their own or in mixtures or in articles, which have been banned or severely restricted by the Union as plant protection products, as other forms of pesticides, or as industrial chemicals for use by professional users or by the public, should be subject to export notification rules similar to those applicable to such chemicals when they are banned or severely restricted within either or both of the use categories laid down in the Convention, namely as pesticides or chemicals for industrial use. In addition, chemicals subject to the international prior informed consent (PIC) procedure (the ‘PIC procedure’) should also be subject to the same export notification rules. That common export notification procedure should apply to Union exports to all third countries, whether or not they are Parties to the Convention or participate in its procedures. Member States should be permitted to charge administrative fees, in order to cover their costs in carrying out this procedure.
(9)
Exporters and importers should be obliged to provide information concerning the quantities of chemicals in international trade covered by this Regulation so that the impact and effectiveness of the arrangements laid down therein can be monitored and assessed.
(10)
Notifications to the Secretariat of Union or Member State final regulatory actions banning or severely restricting chemicals, with a view to their inclusion in the PIC procedure, should be submitted by the Commission in cases where the criteria laid down in the Convention in this regard are met. Additional information to support such notifications should be sought where necessary.
(11)
In cases where Union or Member State final regulatory actions do not qualify for notification because they do not meet the criteria laid down in the Convention, information concerning the actions should nevertheless be conveyed to the Secretariat and other Parties to the Convention in the interests of exchange of information.
(12)
It is also necessary to ensure that the Union takes decisions with regard to the import into the Union of chemicals that are subject to the PIC procedure. These decisions should be based on applicable Union legislation and take into account bans or severe restrictions imposed by Member States. Where justified, amendments to Union legislation should be proposed.
(13)
Arrangements are needed to ensure that Member States and exporters are aware of the decisions of importing countries as regards chemicals that are subject to the PIC procedure, and that exporters comply with those decisions. Furthermore, in order to prevent undesired exports, no chemicals banned or severely restricted within the Union that meet the criteria for notification under the Convention or that are subject to the PIC procedure should be exported unless the explicit consent of the importing country concerned has been sought and obtained, whether or not that country is a Party to the Convention. At the same time, an exemption from this obligation is appropriate in relation to exports of certain chemicals to countries that are members of the Organisation for Economic Cooperation and Development (OECD) provided that certain conditions are met. Furthermore, a procedure is needed to deal with cases in which, despite all reasonable efforts, no response is obtained from the importing country, so that exports of certain chemicals may proceed on a temporary basis under specified conditions. It is also necessary to provide for periodic review of all such cases as well as those in which explicit consent is obtained.
(14)
It is also important that all chemicals exported have an adequate shelf-life so that they may be used effectively and safely. As regards pesticides, in particular those exported to developing countries, it is essential that information about appropriate storage conditions be provided and that suitable packaging and sizes of containers be used to avoid creating obsolete stocks.
(15)
Articles containing chemicals do not fall within the scope of the Convention. Nevertheless, it seems appropriate that articles, as defined in this Regulation, containing chemicals that could be released under certain conditions of use or disposal and that are banned or severely restricted in the Union within one or more of the use categories laid down in the Convention or are subject to the PIC procedure should also be subject to the export notification rules. Furthermore, certain chemicals and articles containing specific chemicals falling outside the scope of the Convention but giving rise to particular concern should not be exported at all.
(16)
In accordance with the Convention, information on transit movements of chemicals subject to the PIC procedure should be provided to Parties to the Convention who request such information.
(17)
Union rules on packaging and labelling and other safety information should apply to all chemicals when intended for export to Parties and other countries unless those provisions would conflict with any specific requirements of those countries, taking into account relevant international standards. Since Regulation (EC) No 1272/2008 established new provisions on classification, labelling and packaging of substances and mixtures, a reference to that Regulation should be included in this Regulation.
(18)
In order to ensure effective control and enforcement, Member States should designate authorities such as customs authorities that should have the responsibility of controlling imports and exports of chemicals covered by this Regulation. The Commission, supported by the Agency, and the Member States have a key role to play and should act in a targeted and coordinated way. Member States should provide for appropriate penalties in the event of infringements.
(19)
In order to facilitate customs control and to reduce the administrative burden for both exporters and authorities, a system of codes to be used in export declarations should be established. Special codes should also be used, as appropriate, for chemicals exported for the purpose of research or analysis in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10 kg from each exporter to each importing country per calendar year.
(20)
Exchange of information, shared responsibility and cooperative efforts between the Union and the Member States and third countries should be promoted with a view to ensuring sound management of chemicals, whether or not those third countries are Parties to the Convention. In particular, technical assistance to developing countries and countries with economies in transition should be provided directly by the Commission and the Member States, or indirectly via support for projects by non-governmental organisations, especially assistance seeking to enable those countries to implement the Convention, thereby contributing to the prevention of harmful effects of chemicals on human health and the environment.
(21)
There should be regular monitoring of the operation of the procedures if they are to be effective. To this end, Member States and the Agency should regularly submit reports in standardised form to the Commission, which should in turn regularly report to the European Parliament and the Council.
(22)
Technical notes for guidance should be drawn up by the Agency to assist the designated authorities, including such authorities as customs authorities controlling exports, exporters and importers, in the application of this Regulation.
(23)
In order to adapt this Regulation to technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of inclusion of chemicals in Part 1 or 2 of Annex I and other amendments to that Annex, inclusion of chemicals in Part 1 or 2 of Annex V and other amendments to that Annex, and amendments to Annexes II, III, IV and VI. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(24)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (8).
(25)
Since the objectives of this Regulation, namely to ensure coherent and effective implementation of the Union’s obligations under the Convention, cannot be sufficiently achieved by the Member States and can therefore, by reason of the necessity to harmonise the rules concerning imports and exports of hazardous chemicals, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(26)
Regulation (EC) No 689/2008 should be repealed.
(27)
It is appropriate to provide for the deferred application of this Regulation so as to allow the Agency sufficient time to prepare for its new role and allowing industry to familiarise itself with the new procedures,
HAVE ADOPTED THIS REGULATION:
Article 1
Objectives
1. The objectives of this Regulation are to:
(a)
implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the ‘Convention’);
(b)
promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm;
(c)
contribute to the environmentally sound use of hazardous chemicals.
The objectives set out in the first subparagraph shall be achieved by facilitating the exchange of information concerning the characteristics of hazardous chemicals, by providing for a decision-making process within the Union on their import and export and by disseminating decisions to Parties and other countries as appropriate.
2. In addition to the objectives set out in paragraph 1, this Regulation shall ensure that the provisions of Regulation (EC) No 1272/2008 relating to classification, labelling and packaging apply to all chemicals when they are exported from the Member States to other Parties or other countries, unless those provisions would conflict with any specific requirements of those Parties or other countries.
Article 2
Scope
1. This Regulation shall apply to:
(a)
certain hazardous chemicals that are subject to the prior informed consent procedure under the Convention (the ‘PIC procedure’);
(b)
certain hazardous chemicals that are banned or severely restricted within the Union or a Member State;
(c)
chemicals when exported in so far as their classification, labelling and packaging are concerned.
2. This Regulation shall not apply to any of the following:
(a)
narcotic drugs and psychotropic substances covered by Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (9);
(b)
radioactive materials and substances covered by Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (10);
(c)
wastes covered by Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (11);
(d)
chemical weapons covered by Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items (12);
(e)
food and food additives covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (13);
(f)
feedingstuffs covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (14), including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
(g)
genetically modified organisms covered by Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (15);
(h)
save to the extent covered by Article 3(5)(b) of this Regulation, proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (16) and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (17) respectively.
3. This Regulation shall not apply to chemicals exported for the purpose of research or analysis in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10 kg from each exporter to each importing country per calendar year.
Notwithstanding the first subparagraph, exporters of the chemicals referred to therein shall obtain a special reference identification number using the Database referred to in Article 6(1)(a) and provide that reference identification number in their export declaration.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)
‘chemical’ means a substance, whether by itself or in a mixture, or a mixture, whether manufactured or obtained from nature, but does not include living organisms, which belongs to either of the following categories:
(a)
pesticides, including severely hazardous pesticide formulations;
(b)
industrial chemicals;
(2)
‘substance’ means any chemical element and its compounds as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;
(3)
‘mixture’ means a mixture or a solution as defined in point 8 of Article 2 of Regulation (EC) No 1272/2008;
(4)
‘article’ means a finished product containing or including a chemical, the use of which has been banned or severely restricted by Union legislation in that particular product where that product does not fall under point 2 or 3;
(5)
‘pesticides’ means chemicals in either of the following subcategories:
(a)
pesticides used as plant protection products covered by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (18);
(b)
other pesticides, such as:
(i)
biocidal products under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (19); and
(ii)
disinfectants, insecticides and parasiticides covered by Directives 2001/82/EC and 2001/83/EC;
(6)
‘industrial chemicals’ means chemicals in either of the following subcategories:
(a)
chemicals for use by professionals;
(b)
chemicals for use by the public;
(7)
‘chemical subject to export notification’ means any chemical that is banned or severely restricted within the Union within one or more categories or subcategories, and any chemical listed in Part 1 of Annex I that is subject to the PIC procedure;
(8)
‘chemical qualifying for PIC notification’ means any chemical that is banned or severely restricted within the Union or a Member State within one or more categories. Chemicals banned or severely restricted in the Union within one or more categories are listed in Part 2 of Annex I;
(9)
‘chemical subject to the PIC procedure’ means any chemical listed in Annex III to the Convention and in Part 3 of Annex I to this Regulation;
(10)
‘banned chemical’ means either of the following:
(a)
a chemical all uses of which within one or more categories or subcategories have been prohibited by final regulatory action by the Union in order to protect human health or the environment;
(b)
a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the Union market or from further consideration in a notification, registration or approval process and where there is evidence that the chemical raises concern for human health or the environment;
(11)
‘severely restricted chemical’ means either of the following:
(a)
a chemical, virtually all use of which within one or more categories or subcategories has been prohibited by final regulatory action by the Union in order to protect human health or the environment, but for which certain specific uses remain allowed;
(b)
a chemical that has, for virtually all uses, been refused for approval or been withdrawn by industry either from the Union market or from further consideration in a notification, registration or approval process, and where there is evidence that the chemical raises concern for human health or the environment;
(12)
‘chemical banned or severely restricted by a Member State’ means any chemical that is banned or severely restricted by national final regulatory action of a Member State;
(13)
‘final regulatory action’ means a legally binding act the purpose of which is to ban or severely restrict a chemical;
(14)
‘severely hazardous pesticide formulation’ means a chemical formulated for use as a pesticide that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use;
(15)
‘customs territory of the Union’ means the territory as determined in Article 3 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (20);
(16)
‘export’ means the following:
(a)
the permanent or temporary export of a chemical meeting the conditions of Article 28(2) TFEU;
(b)
the re-export of a chemical not meeting the conditions of Article 28(2) TFEU which is placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union;
(17)
‘import’ means the physical introduction into the customs territory of the Union of a chemical that is placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union;
(18)
‘exporter’ means any of the following persons, whether natural or legal:
(a)
the person on whose behalf an export declaration is made, that is to say the person who, at the time the declaration is accepted, holds the contract with the consignee in a Party or other country and has the power to determine that the chemical be sent out of the customs territory of the Union;
(b)
where no export contract has been concluded or where the holder of the contract does not act on its own behalf, the person who has the power to determine that the chemical be sent out of the customs territory of the Union;
(c)
where the benefit of a right to dispose of the chemical belongs to a person established outside the Union pursuant to the contract on which the export is based, the contracting party established in the Union;
(19)
‘importer’ means any natural or legal person who at the time of import into the customs territory of the Union is the consignee for the chemical;
(20)
‘Party to the Convention’ or ‘Party’ means a State or a regional economic integration organisation that has consented to be bound by the Convention and for which the Convention is in force;
(21)
‘other country’ means any country that is not a Party;
(22)
‘Agency’ means the European Chemicals Agency established under Regulation (EC) No 1907/2006;
(23)
‘Secretariat’ means the Secretariat of the Convention, unless otherwise specified in this Regulation.
Article 4
Designated national authorities of the Member States
Each Member State shall designate the authority or authorities (the ‘designated national authority’ or the ‘designated national authorities’) to carry out the administrative functions required by this Regulation, unless it has already done so before the entry into force of this Regulation.
It shall inform the Commission of such designation by 17 November 2012, unless that information has been already provided before entry into force of this Regulation, and shall also inform the Commission of any change of designated national authority.
Article 5
Participation of the Union in the Convention
1. Participation in the Convention shall be a joint responsibility of the Commission and the Member States, in particular as regards technical assistance, the exchange of information and matters relating to dispute settlement, participation in subsidiary bodies and voting.
2. The Commission shall act as a common designated authority for the administrative functions of the Convention with reference to the PIC procedure on behalf of and in close cooperation and consultation with all the designated national authorities of the Member States.
The Commission shall, in particular, be responsible for the following:
(a)
the transmission of Union export notifications to Parties and other countries pursuant to Article 8;
(b)
the submission to the Secretariat of notifications of relevant final regulatory actions concerning chemicals qualifying for PIC notification pursuant to Article 11;
(c)
the transmission of information concerning other final regulatory actions involving chemicals not qualifying for PIC notification in accordance with Article 12;
(d)
the receiving of information from the Secretariat more generally.
The Commission shall also provide the Secretariat with Union import responses for chemicals subject to the PIC procedure pursuant to Article 13.
In addition, the Commission shall coordinate the Union input on all technical issues relating to the following:
(a)
the Convention;
(b)
the preparation of the Conference of the Parties established by Article 18(1) of the Convention;
(c)
the Chemical Review Committee established in accordance with Article 18(6) of the Convention (the ‘Chemical Review Committee’);
(d)
other subsidiary bodies of the Conference of the Parties.
3. The Commission and the Member States shall take the necessary initiatives to ensure appropriate representation of the Union in the various bodies implementing the Convention.
Article 6
Tasks of the Agency
1. The Agency shall, in addition to the tasks allocated to it under Articles 7, 8, 9, 10, 11, 13, 14, 15, 18, 19, 20, 21, 22 and 25, carry out the following tasks:
(a)
maintain, further develop and regularly update a database on export and import of hazardous chemicals (the ‘Database’);
(b)
make the Database publicly available on its website;
(c)
where appropriate, provide, with the agreement of the Commission and after consultations with Member States, assistance and technical and scientific guidance and tools for the industry in order to ensure the effective application of this Regulation;
(d)
provide, with the agreement of the Commission, the designated national authorities of the Member States with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation;
(e)
at the request of Member State or Commission experts of the Chemical Review Committee, and within the available resources, provide input in drafting of decision guidance documents referred to in Article 7 of the Convention and other technical documents related to the implementation of the Convention;
(f)
upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation;
(g)
upon request, provide the Commission with technical and scientific input and assist it in exercising its role as the common designated authority of the Union.
2. The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation.
Article 7
Chemicals subject to export notification, chemicals qualifying for PIC notification, and chemicals subject to the PIC procedure
1. The chemicals subject to export notification, the chemicals qualifying for PIC notification and the chemicals subject to the PIC procedure shall be as listed in Annex I.
2. Chemicals listed in Annex I shall be assigned to one or more of three groups of chemicals, set out as Parts 1, 2 and 3 of that Annex.
The chemicals listed in Part 1 of Annex I shall be subject to the export notification procedure laid down in Article 8, with detailed information being given on the identity of the substance, on the use category and/or subcategory subject to restriction, the type of restriction and, where appropriate, additional information, in particular on exemptions to requirements for export notification.
The chemicals listed in Part 2 of Annex I shall, in addition to being subject to the export notification procedure laid down in Article 8, qualify for the PIC notification procedure set out in Article 11, with detailed information being given on the identity of the substance and on the use category.
The chemicals listed in Part 3 of Annex I shall be subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification.
3. The lists set out in Annex I shall be made publicly available by means of the Database.
Article 8
Export notifications forwarded to Parties and other countries
1. In the case of substances listed in Part 1 of Annex I or mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances, paragraphs 2 to 8 of this Article shall apply regardless of the intended use of the chemical in the importing Party or other country.
2. When an exporter is due to export a chemical referred to in paragraph 1 from the Union to a Party or other country for the first time on or after the date on which it becomes subject to this Regulation, the exporter shall notify the designated national authority of the Member State in which he is established (the ‘exporter’s Member State’), no later than 35 days before the expected date of export. Thereafter the exporter shall notify that designated national authority of the first export of the chemical each calendar year no later than 35 days before the export takes place. The notifications shall comply with the information requirements laid down in Annex II and shall be made available to the Commission and to the Member States by means of the Database.
The designated national authority of the exporter’s Member State shall check compliance of the information with Annex II and if the notification is complete forward it to the Agency no later than 25 days before the expected date of export.
The Agency shall, on behalf of the Commission, transmit the notification to the designated national authority of the importing Party or the appropriate authority of the importing other country and take the measures necessary to ensure that they receive that notification no later than 15 days before the first intended export of the chemical and thereafter no later than 15 days before the first export in any subsequent calendar year.
The Agency shall register each export notification and assign it a reference identification number in the Database. The Agency shall also make available to the public and the designated national authorities of the Member States, as appropriate, an updated list of the chemicals concerned and the importing Parties and other countries for each calendar year by means of the Database.
3. If the Agency does not receive from the importing Party or other country an acknowledgement of receipt of the first export notification made after the chemical is included in Part 1 of Annex I within 30 days of the dispatch of such notification, it shall, on behalf of the Commission, submit a second notification. The Agency shall, on behalf of the Commission, make reasonable efforts to ensure that the designated national authority of the importing Party or the appropriate authority of the importing other country receives the second notification.
4. A new export notification shall be made in accordance with paragraph 2 for exports which take place subsequent to the entry into force of amendments to Union legislation concerning the marketing, use or labelling of the substances in question or whenever the composition of the mixture in question changes so that the labelling of such mixture is altered. The new notification shall comply with the information requirements laid down in Annex II and shall indicate that it is a revision of a previous notification.
5. Where the export of a chemical relates to an emergency situation in which any delay may endanger public health or the environment in the importing Party or other country, an exemption from the obligations set out in paragraphs 2, 3 and 4 in whole or in part may be granted at the reasoned request of the exporter or the importing Party or other country and at the discretion of the designated national authority of the exporter’s Member State, in consultation with the Commission assisted by the Agency. A decision on the request shall be considered to have been made in consultation with the Commission if there is no dissenting response from the Commission within 10 days of the designated national authority of the Member State sending it details of the request.
6. Without prejudice to the obligations set out in Article 19(2), the obligations set out in paragraphs 2, 3 and 4 of this Article shall cease when all of the following conditions are fulfilled:
(a)
the chemical has become a chemical subject to the PIC procedure;
(b)
the importing country is a Party to the Convention and has provided the Secretariat with a response in accordance with Article 10(2) of the Convention indicating whether or not it consents to import of the chemical; and
(c)
the Commission has been informed of that response by the Secretariat and has forwarded that information to the Member States and the Agency.
Notwithstanding the first subparagraph of this paragraph, the obligations set out in paragraphs 2, 3 and 4 of this Article shall not cease where an importing country is a Party to the Convention and explicitly requires continued export notification by exporting Parties, for example through its import decision or otherwise.
Without prejudice to the obligations set out in Article 19(2), the obligations set out in paragraphs 2, 3 and 4 of this Article shall also cease when both of the following conditions are fulfilled:
(a)
the designated national authority of the importing Party or the appropriate authority of the importing other country has waived the requirement to be notified before the export of the chemical; and
(b)
the Commission has received the information from the Secretariat or from the designated national authority of the importing Party or the appropriate authority of the importing other country and has forwarded it to the Member States and the Agency, which has made it available by means of the Database.
7. The Commission, the relevant designated national authorities of the Member States, the Agency and the exporters shall, on request, provide importing Parties and other countries with available additional information concerning the exported chemicals.
8. Member States may establish, in a transparent manner, systems obliging exporters to pay an administrative fee for each export notification made and for each request for explicit consent made, corresponding to the costs they incur in carrying out the procedures set out in paragraphs 2 and 4 of this Article and in Article 14(6) and (7).
Article 9
Export notifications received from Parties and other countries
1. Export notifications received by the Agency from the designated national authorities of Parties or the appropriate authorities of other countries concerning the export to the Union of a chemical the manufacture, use, handling, consumption, transport or sale of which is subject to prohibition or severe restriction under that Party’s or other country’s legislation shall be made available by means of the Database within 15 days of the Agency’s receipt of such notification.
The Agency shall, on behalf of the Commission, acknowledge receipt of the first export notification received for each chemical from each Party or other country.
The designated national authority of the Member State receiving that import shall receive a copy of any notification received by the Agency, within 10 days of its receipt, together with all available information. Other Member States shall be entitled to receive copies on request.
2. Where the Commission or the designated national authorities of the Member States receive any export notifications either directly or indirectly from the designated national authorities of Parties or the appropriate authorities of other countries, they shall immediately forward those notifications to the Agency together with all available information.
Article 10
Information on export and import of chemicals
1. Each exporter of one or more of the following:
(a)
substances listed in Annex I;
(b)
mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances; or
(c)
articles containing substances listed in Part 2 or 3 of Annex I in unreacted form or mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances;
shall, during the first quarter of each year, inform the designated national authority of the exporter’s Member State regarding the quantity of the chemical, as a substance and as contained in mixtures or in articles, shipped to each Party or other country during the preceding year. That information shall be given together with a list of the names and addresses of each natural or legal person importing the chemical into a Party or other country to which shipment took place during the same period. That information shall list separately exports pursuant to Article 14(7).
Each importer within the Union shall provide the equivalent information for the quantities imported into the Union.
2. At the request of the Commission, assisted by the Agency, or the designated national authority of its Member State, the exporter or importer shall provide any additional information relating to chemicals that is necessary to implement this Regulation.
3. Each Member State shall provide the Agency each year with aggregated information in accordance with Annex III. The Agency shall summarise that information at Union level and shall make the non-confidential information publicly available by means of the Database.
Article 11
Notification of banned or severely restricted chemicals under the Convention
1. The Commission shall notify the Secretariat in writing of the chemicals listed in Part 2 of Annex I, which qualify for PIC notification.
2. Whenever further chemicals are added to Part 2 of Annex I pursuant to the second subparagraph of Article 23(2), the Commission shall notify those chemicals to the Secretariat. That PIC notification shall be submitted as soon as possible after adoption of the relevant final regulatory action at Union level banning or severely restricting the chemical, and no later than 90 days after the date on which the final regulatory action is to be applied.
3. The PIC notification shall provide all relevant information required in Annex IV.
4. In determining priorities for notifications, the Commission shall take into account whether the chemical is already listed in Part 3 of Annex I, the extent to which the information requirements laid down in Annex IV can be met, and the severity of the risks presented by the chemical, in particular for developing countries.
Where a chemical qualifies for PIC notification, but the information is insufficient to meet the requirements of Annex IV, identified exporters or importers shall, upon request by the Commission, provide all relevant information available to them, including that from other national or international chemical control programmes, within 60 days of the request.
5. The Commission shall notify the Secretariat in writing when a final regulatory action notified under paragraphs 1 or 2 is amended as soon as possible after adoption of the new final regulatory action, and no later than 60 days after the date on which the new final regulatory action is to be applied.
The Commission shall provide all relevant information that was not available at the time the initial notification was made under paragraphs 1 or 2 respectively.
6. At the request of any Party or the Secretariat, the Commission shall provide additional information concerning the chemical or the final regulatory action, as far as practicable.
The Member States and the Agency shall, upon request, assist the Commission as necessary in compiling that information.
7. The Commission shall forward immediately to the Member States and the Agency information that it receives from the Secretariat regarding chemicals notified as banned or severely restricted by other Parties.
Where appropriate, the Commission shall evaluate, in close cooperation with the Member States and the Agency, the need to propose measures at Union level in order to prevent any unacceptable risks to human health or the environment within the Union.
8. Where a Member State takes national final regulatory action in accordance with the relevant Union legislation to ban or severely restrict a chemical, it shall provide the Commission with relevant information. The Commission shall make that information available to the Member States. Within four weeks of that information having been made available, Member States may send comments on a possible PIC notification, including, in particular, relevant information about their national regulatory position in respect of the chemical to the Commission and to the Member State which submitted the national final regulatory action. After consideration of the comments, the submitting Member State shall inform the Commission whether the latter has to:
(a)
make a PIC notification to the Secretariat, pursuant to this Article; or
(b)
provide the information to the Secretariat, pursuant to Article 12.
Article 12
Information to be transmitted to the Secretariat concerning banned or severely restricted chemicals not qualifying for PIC notification
In the case of chemicals listed only in Part 1 of Annex I or following receipt of information from a Member State pursuant to point (b) of Article 11(8), the Commission shall provide the Secretariat with information concerning the relevant final regulatory actions, so that the information can be disseminated to other Parties to the Convention as appropriate.
Article 13
Obligations in relation to import of chemicals
1. The Commission shall immediately forward to the Member States and the Agency any decision guidance documents which it receives from the Secretariat.
The Commission shall, by means of an implementing act, adopt an import decision in the form of a final or interim import response on behalf of the Union concerning the future import of the chemical concerned. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 27(2). The Commission shall communicate the decision to the Secretariat as soon as possible, and no later than nine months after the date of dispatch of the decision guidance document by the Secretariat.
Where a chemical becomes subject to additional or amended restrictions under Union legislation, the Commission shall, by means of an implementing act, adopt a revised import decision. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 27(2). The Commission shall communicate the revised import decision to the Secretariat.
2. In the case of a chemical banned or severely restricted by one or more Member States, the Commission shall, at the written request of the Member States concerned, take the information into account in its import decision.
3. An import decision under paragraph 1 shall relate to the category or categories specified for the chemical in the decision guidance document.
4. When communicating the import decision to the Secretariat, the Commission shall provide a description of the legislative or administrative measure upon which it is based.
5. Each designated national authority of the Member States shall make the import decisions under paragraph 1 available to those concerned within its competence, in accordance with its legislative or administrative measures. The Agency shall make the import decisions under paragraph 1 publicly available by means of the Database.
6. Where appropriate, the Commission shall evaluate, in close cooperation with the Member States and the Agency, the need to propose measures at Union level in order to prevent any unacceptable risks to human health or the environment within the Union, taking into account the information given in the decision guidance document.
Article 14
Obligations in relation to export of chemicals other than export notification
1. The Commission shall immediately forward to the Member States, the Agency and European industry associations the information which it receives, whether in the form of circulars or otherwise, from the Secretariat regarding chemicals subject to the PIC procedure and the decisions of importing Parties regarding import conditions applicable to those chemicals. It shall also immediately forward to the Member States and the Agency information concerning any cases of failure to transmit a response in accordance with Article 10(2) of the Convention. The Agency shall assign each import decision a reference identification number and keep all information regarding such decisions publicly available by means of the Database, and provide anyone with that information upon request.
2. The Commission shall assign each chemical listed in Annex I a classification in the European Union’s Combined Nomenclature. Those classifications shall be revised as necessary in the light of any changes made in the World Customs Organisation’s Harmonised System Nomenclature or in the European Union’s Combined Nomenclature for the chemicals concerned.
3. Each Member State shall communicate the information and decisions forwarded by the Commission under paragraph 1 to those concerned within its jurisdiction.
4. Exporters shall comply with decisions in each import response no later than six months after the Secretariat first informs the Commission of such decisions under paragraph 1.
5. The Commission, assisted by the Agency, and the Member States shall advise and assist importing Parties, upon request and as appropriate, in obtaining further information needed to prepare a response to the Secretariat concerning the import of a given chemical.
6. Substances listed in Part 2 or 3 of Annex I or mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances shall, regardless of their intended use in the importing Party or other country, not be exported unless either of the following conditions is fulfilled:
(a)
explicit consent to import has been sought and received by the exporter through the designated national authority of the exporter’s Member State in consultation with the Commission, assisted by the Agency, and the designated national authority of the importing Party or an appropriate authority in an importing other country;
(b)
in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the Secretariat pursuant to paragraph 1 indicates that the importing Party has given consent to import.
In the case of chemicals listed in Part 2 of Annex I that are to be exported to OECD countries, the designated national authority of the exporter’s Member State may, at the request of the exporter, in consultation with the Commission and on a case-by-case basis, decide that no explicit consent is required if the chemical, at the time of importation into the OECD country concerned, is licensed, registered or authorised in that OECD country.
Where explicit consent has been sought pursuant to point (a) of the first subparagraph, if the Agency has not received a response to the request within 30 days, the Agency shall, on behalf of the Commission, send a reminder unless the Commission or the designated national authority of the exporter’s Member State received a response and forwarded it to the Agency. Where appropriate, if there is still no response within a further 30 days, the Agency may send further reminders as necessary.
7. In the case of chemicals listed in Part 2 or 3 of Annex I, the designated national authority of the exporter’s Member State may, in consultation with the Commission assisted by the Agency, on a case-by-case basis and subject to the second subparagraph, decide that the export may proceed, if no evidence from official sources of final regulatory action to ban or severely restrict the use of the chemical taken by the importing Party or other country exists and if, after all reasonable efforts, no response to a request for explicit consent pursuant to point (a) of paragraph 6 has been received within 60 days and where one of the following conditions is met:
(a)
there is evidence from official sources in the importing Party or other country that the chemical is licensed, registered or authorised; or
(b)
the intended use declared in the export notification and confirmed in writing by the natural or legal person importing the chemical into a Party or other country, is not in a category for which the chemical is listed in Part 2 or 3 of Annex I, and there is evidence from official sources that the chemical has in the last five years been used in or imported into the importing Party or other country concerned.
In the case of chemicals listed in Part 3 of Annex I, an export based on the fulfilment of the condition under point (b) may not proceed if the chemical has been classified in accordance with Regulation (EC) No 1272/2008 as carcinogenic category 1A or 1B, or mutagenic category 1A or 1B, or toxic for reproduction category 1A or 1B or the chemical fulfils the criteria of Annex XIII to Regulation (EC) No 1907/2006 for being persistent, bioaccumulative and toxic or very persistent and very bioaccumulative.
When deciding on the export of chemicals listed in Part 3 of Annex I, the designated national authority of the exporter’s Member State shall, in consultation with the Commission assisted by the Agency, consider the possible impact on human health or the environment of the use of the chemical in the importing Party or other country, and submit relevant documentation to the Agency, to be made available by means of the Database.
8. The validity of each explicit consent obtained pursuant to point (a) of paragraph 6 or decision to proceed with export in the absence of explicit consent pursuant to paragraph 7 shall be subject to periodic review by the Commission in consultation with the Member States concerned as follows:
(a)
for each explicit consent obtained pursuant to point (a) of paragraph 6 a new explicit consent shall be required by the end of the third calendar year after the consent was given, unless the terms of that consent require otherwise;
(b)
unless a response to a request has been received in the meantime, each decision to proceed without explicit consent pursuant to paragraph 7 shall be valid for a maximum period of 12 months, upon expiry of which explicit consent shall be required.
In the cases referred to in point (a) of the first subparagraph, exports may, however, continue after the end of the relevant period, pending a response to a new request for explicit consent, for an additional period of 12 months.
9. The Agency shall register all requests for explicit consent, responses obtained and decisions to proceed without explicit consent, including the documentation referred to in the third subparagraph of paragraph 7, in the Database. Each explicit consent obtained or decision to proceed without explicit consent shall be assigned a reference identification number and shall be listed with all relevant information concerning any conditions attached, such as validity dates. The non-confidential information shall be made publicly available by means of the Database.
10. No chemical shall be exported later than six months before its expiry date, where such a date exists or can be inferred from the production date, unless the intrinsic properties of the chemical render that impracticable. In particular, in the case of pesticides, exporters shall ensure that the size and packaging of containers is optimised so as to minimise the risk of creating obsolete stocks.
11. When exporting pesticides, exporters shall ensure that the label contains specific information about storage conditions and storage stability under the climatic conditions of the importing Party or other country. In addition, they shall ensure that the pesticides exported comply with the purity specification laid down in Union legislation.
Article 15
Export of certain chemicals and articles
1. Articles shall be subject to the export notification procedure laid down in Article 8 if they contain any of the following:
(a)
substances listed in Part 2 or 3 of Annex I in unreacted form;
(b)
mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances.
2. Chemicals and articles the use of which is prohibited in the Union for the protection of human health or the environment, as listed in Annex V, shall not be exported.
Article 16
Information on transit movements
1. Parties to the Convention requiring information concerning transit movements of chemicals subject to the PIC procedure, together with the information requested by each Party to the Convention through the Secretariat, shall be as listed in Annex VI.
2. Where a chemical listed in Part 3 of Annex I is transported through the territory of a Party to the Convention listed in Annex VI, the exporter shall, as far as practicable, provide the designated national authority of the exporter’s Member State with the information required by the Party to the Convention in accordance with Annex VI no later than 30 days before the first transit movement takes place and no later than eight days before each subsequent transit movement.
3. The designated national authority of the exporter’s Member State shall forward to the Commission with a copy to the Agency, the information received from the exporter under paragraph 2 together with any additional information available.
4. The Commission shall forward the information received under paragraph 3 to the designated national authorities of Parties to the Convention which requested that information, together with any additional information available, no later than 15 days before the first transit movement and prior to any subsequent transit movement.
Article 17
Information to accompany exported chemicals
1. Chemicals that are intended for export shall be subject to the provisions on packaging and labelling established in, or pursuant to, Regulation (EC) No 1107/2009, Directive 98/8/EC and Regulation (EC) No 1272/2008, or any other relevant Union legislation.
The first subparagraph shall apply unless those provisions would conflict with any specific requirements of the importing Parties or other countries.
2. Where appropriate, the expiry date and the production date of chemicals referred to in paragraph 1 or listed in Annex I shall be indicated on the label, and if necessary such expiry dates shall be given for different climate zones.
3. A safety data sheet in accordance with Regulation (EC) No 1907/2006 shall accompany chemicals referred to in paragraph 1 when exported. The exporter shall send such a safety data sheet to each natural or legal person importing the chemical into a Party or other country.
4. The information on the label and on the safety data sheet shall as far as practicable be given in the official languages, or in one or more of the principal languages, of the country of destination or of the area of intended use.
Article 18
Obligations of the authorities of the Member States for controlling import and export
1. Each Member State shall designate authorities such as customs authorities that shall have the responsibility of controlling the import and export of chemicals listed in Annex I, unless it has already done so before the entry into force of this Regulation.
The Commission, supported by the Agency, and the Member States shall act in a targeted and coordinated way in monitoring exporters’ compliance with this Regulation.
2. The Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006 shall be used to coordinate a network of the Member States’ authorities responsible for enforcement of this Regulation.
3. Each Member State shall, in its regular reports on the operation of procedures pursuant to Article 22(1), include details of the activities of its authorities in that regard.
Article 19
Further obligations of exporters
1. Exporters of chemicals subject to the obligations set out in Article 8(2) and (4) shall provide the applicable reference identification numbers in their export declaration (box 44 of the Single Administrative Documents or corresponding data element in an electronic export declaration) as referred to in Article 161(5) of Regulation (EEC) No 2913/92.
2. Exporters of chemicals exempted by Article 8(5) from the obligations set out in paragraphs 2 and 4 of that Article or of chemicals for which those obligations have ceased in accordance with Article 8(6) shall obtain a special reference identification number using the Database and provide that reference identification number in their export declaration.
3. Where requested by the Agency, exporters shall use the Database for the submission of information required for the fulfilment of their obligations under this Regulation.
Article 20
Exchange of information
1. The Commission, assisted by the Agency, and the Member States shall, as appropriate, facilitate the provision of scientific, technical, economic and legal information concerning chemicals subject to this Regulation, including toxicological, ecotoxicological and safety information.
The Commission, with the support of the Member States and the Agency as necessary, shall, as appropriate, ensure the following:
(a)
the provision of publicly available information concerning regulatory actions relevant to the objectives of the Convention;
(b)
the provision of information for Parties and other countries directly or through the Secretariat concerning those actions which substantially restrict one or more uses of a chemical.
2. The Commission, the Member States and the Agency shall protect any confidential information received from a Party or other country as mutually agreed.
3. As regards the transmission of information under this Regulation, and without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (21), the following information at least shall not be regarded as confidential:
(a)
the information specified in Annex II and Annex IV;
(b)
the information contained in safety data sheets referred to in Article 17(3);
(c)
the expiry date of a chemical;
(d)
the production date of a chemical;
(e)
information concerning precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice;
(f)
the summary results of toxicological and ecotoxicological tests;
(g)
information concerning handling packaging after chemicals have been removed.
4. A compilation of the information transmitted shall be prepared every two years by the Agency.
Article 21
Technical assistance
The Commission, the designated national authorities of the Member States and the Agency shall, taking into account in particular the needs of developing countries and countries with economies in transition, cooperate in promoting technical assistance, including training, for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their lifecycles.
In particular, and with a view to enabling those countries to implement the Convention, technical assistance shall be promoted by means of the provision of technical information concerning chemicals, the promotion of the exchange of experts, support for the establishment or maintenance of designated national authorities and the provision of technical expertise for the identification of hazardous pesticide formulations and for the preparation of notifications to the Secretariat.
The Commission and the Member States shall actively participate in international activities in capacity-building in chemicals management, by providing information concerning the projects they are supporting or financing to improve the management of chemicals in developing countries and countries with economies in transition. The Commission and the Member States shall also consider giving support to non-governmental organisations.
Article 22
Monitoring and reporting
1. Member States and the Agency shall forward information to the Commission every three years concerning the operation of the procedures provided for in this Regulation, including customs controls, infringements, penalties and remedial action, as appropriate. The Commission shall adopt an implementing act laying down in advance a common format for reporting. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 27(2).
2. The Commission shall compile a report every three years on the performance of the functions provided for in this Regulation for which it is responsible and shall incorporate it in a synthesis report integrating the information provided by the Member States and the Agency under paragraph 1. A summary of that report, which shall be published on the internet, shall be forwarded to the European Parliament and to the Council.
3. As regards the information supplied pursuant to paragraphs 1 and 2, the Commission, the Member States and the Agency shall comply with relevant obligations to protect the confidentiality and ownership of data.
Article 23
Updating annexes
1. The list of chemicals in Annex I shall be reviewed by the Commission at least every year, on the basis of developments in Union law and under the Convention.
2. When determining whether a final regulatory action at Union level constitutes a ban or a severe restriction, the effect of that action shall be assessed at the level of the subcategories within the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within any one of the subcategories it shall be included in Part 1 of Annex I.
When determining whether a final regulatory action at Union level constitutes a ban or a severe restriction such that the chemical concerned qualifies for PIC notification under Article 11, the effect of that action shall be assessed at the level of the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within either of the categories it shall also be included in Part 2 of Annex I.
3. The decision to include chemicals in Annex I, or to modify their entry where appropriate, shall be taken without undue delay.
4. In order to adapt this Regulation to technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 concerning the following measures:
(a)
inclusion of a chemical in Part 1 or 2 of Annex I pursuant to paragraph 2 of this Article following final regulatory action at Union level, and other amendments of Annex I, including modifications to existing entries;
(b)
inclusion of a chemical that is subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (22) in Part 1 of Annex V;
(c)
inclusion of a chemical already subject to an export ban at Union level in Part 2 of Annex V;
(d)
modifications to existing entries in Annex V;
(e)
amendments of Annexes II, III, IV and VI.
Article 24
The budget of the Agency
1. For the purposes of this Regulation, the revenues of the Agency shall consist of:
(a)
a subsidy from the Union, entered in the general budget of the Union (Commission Section);
(b)
any voluntary contribution from the Member States.
2. Revenues and expenditure for activities under this Regulation and those relating to activities under other Regulations shall be dealt with separately, through different sections in the Agency’s budget.
The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation.
3. The Commission shall examine whether it is appropriate for the Agency to charge a fee for the services provided to exporters within five years of 1 March 2014 and, if necessary, submit a relevant proposal.
Article 25
Formats and software for submission of information to the Agency
The Agency shall specify formats and software packages and make them available free of charge on its website for any submission of information to the Agency. Member States and other parties subject to this Regulation shall use those formats and packages in their submissions to the Agency pursuant to this Regulation.
Article 26
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 23(4) shall be conferred on the Commission for a period of five years from 1 March 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period.
3. The delegation of power referred to in Article 23(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 23(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 27
Committee procedure
1. The Commission shall be assisted by the committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Article 28
Penalties
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure correct implementation of these provisions. The penalties provided for must be effective, proportionate and dissuasive. If they have not already done so before the entry into force of this Regulation, Member States shall notify those provisions to the Commission by 1 March 2014 and shall notify it without delay of any subsequent amendment affecting them.
Article 29
Transitional period on the classification, labelling and packaging of chemicals
References in this Regulation to Regulation (EC) No 1272/2008 shall be construed, where appropriate, as references to the Union legislation which applies by virtue of Article 61 of that Regulation and in accordance with the timetable set out therein.
Article 30
Repeal
Regulation (EC) No 689/2008 shall be repealed with effect from 1 March 2014.
References to Regulation (EC) No 689/2008 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.
Article 31
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 March 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 4 July 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. D. MAVROYIANNIS
(1) OJ C 318, 29.10.2011, p. 163.
(2) Position of the European Parliament of 10 May 2012 (not yet published in the Official Journal) and decision of the Council of 26 June 2012.
(3) OJ L 204, 31.7.2008, p. 1.
(4) OJ L 63, 6.3.2003, p. 29.
(5) OJ L 63, 6.3.2003, p. 1.
(6) OJ L 396, 30.12.2006, p. 1.
(7) OJ L 353, 31.12.2008, p. 1.
(8) OJ L 55, 28.2.2011, p. 13.
(9) OJ L 22, 26.1.2005, p. 1.
(10) OJ L 159, 29.6.1996, p. 1.
(11) OJ L 312, 22.11.2008, p. 3.
(12) OJ L 134, 29.5.2009, p. 1.
(13) OJ L 165, 30.4.2004, p. 1.
(14) OJ L 31, 1.2.2002, p. 1.
(15) OJ L 106, 17.4.2001, p. 1.
(16) OJ L 311, 28.11.2001, p. 67.
(17) OJ L 311, 28.11.2001, p. 1.
(18) OJ L 309, 24.11.2009, p. 1.
(19) OJ L 123, 24.4.1998, p. 1.
(20) OJ L 302, 19.10.1992, p. 1.
(21) OJ L 41, 14.2.2003, p. 26.
(22) OJ L 158, 30.4.2004, p. 7.
ANNEX I
LIST OF CHEMICALS
(referred to in Article 7)
PART 1
List of chemicals subject to export notification procedure
(referred to in Article 8)
It should be noted that where chemicals listed in this part of the Annex are subject to the PIC procedure, the export notification obligations set out in Article 8(2), (3) and (4) shall not apply provided that the conditions laid down in points (b) and (c) of the first subparagraph of Article 8(6) have been fulfilled. Such chemicals, which are identified by the symbol ‘#’ in the list below, are listed again in Part 3 of this Annex for ease of reference.
It should also be noted that where the chemicals listed in this part of the Annex qualify for PIC notification because of the nature of the Union’s final regulatory action, those chemicals are also listed in Part 2 of this Annex. Such chemicals are identified by the symbol ‘+’ in the list below.
Chemical
CAS No
Einecs No
CN code
Subcategory (1)
Use limitation (2)
Countries for which no notification is required
1,1,1-Trichloroethane
71-55-6
200-756-3
2903 19 10
i(2)
b
1,2-Dibromoethane (Ethylene dibromide) (6)
106-93-4
203-444-5
2903 31 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
1,2-Dichloroethane (ethylene dichloride) (6)
107-06-2
203-458-1
2903 15 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
i(2)
b
Cis- 1,3-dichloropropene ((1Z)-1,3-dichloroprop-1-ene)
10061-01-5
233-195-8
2903 29 00
p(1)-p(2)
b-b
1,3-dichloropropene (3)
(7)
542-75-6
208-826-5
2903 29 00
p(1)
b
2-aminobutane
13952-84-6
237-732-7
2921 19 80
p(1)-p(2)
b-b
2-Naphthylamine (naphthalen-2-amine) and its salts (7)
91-59-8, 553-00-4, 612-52-2 and others
202-080-4, 209-030-0, 210-313-6 and others
2921 45 00
i(1)
b
i(2)
b
2-Naphthyloxyacetic acid
120-23-0
204-380-0
2918 99 90
p(1)
b
2,4,5-T and its salts and esters (6)
93-76-5 and others
202-273-3 and others
2918 91 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
4-Aminobiphenyl (biphenyl-4-amine) and its salts (7)
92-67-1, 2113-61-3 and others
202-177-1 and others
2921 49 80
i(1)
b
i(2)
b
4-Nitrobiphenyl (7)
92-93-3
202-204-7
2904 20 00
i(1)
b
i(2)
b
Acephate (7)
30560-19-1
250-241-2
2930 90 85
p(1)-p(2)
b-b
Acifluorfen
50594-66-6
256-634-5
2916 39 00
p(1)-p(2)
b-b
Alachlor (7)
15972-60-8
240-110-8
2924 29 95
p(1)
b
Aldicarb (7)
116-06-3
204-123-2
2930 90 85
p(1)-p(2)
sr-b
Ametryn
834-12-8
212-634-7
2933 69 80
p(1)-p(2)
b-b
Amitraz (7)
33089-61-1
251-375-4
2925 29 00
p(1)-p(2)
b-b
Anthraquinone (7)
84-65-1
201-549-0
2914 61 00
p(1)-p(2)
b-b
Arsenic compounds
p(2)
sr
Asbestos Fibres (7):
1332-21-4 and others
Please refer to PIC circular at www.pic.int/
Crocidolite (6)
12001-28-4
2524 10 00
i
b
Amosite (6)
12172-73-5
2524 90 00
i
b
Antophyllite (6)
77536-67-5
2524 90 00
i
b
Actinolite (6)
77536-66-4
2524 90 00
i
b
Tremolite (6)
77536-68-6
2524 90 00
i
b
Chrysotile (7)
12001-29-5 or 132207-32-0
2524 90 00
i
b
Atrazine (7)
1912-24-9
217-617-8
2933 69 10
p(1)
b
Azinphos-ethyl
2642-71-9
220-147-6
2933 99 90
p(1)-p(2)
b-b
Azinphos-methyl (7)
86-50-0
201-676-1
2933 99 90
p(1)
b
Benfuracarb (7)
82560-54-1
2932 99 00
p(1)
b
Bensultap
17606-31-4
2930 90 85
p(1)-p(2)
b-b
Benzene (5)
71-43-2
200-753-7
2902 20 00
i(2)
sr
Benzidine and its salts (7)
Benzidine derivatives (7)
92-87-5, 36341-27-2 and others
202-199-1, 252-984-8 and others
2921 59 90
i(1)-i(2)
sr-b
i(2)
b
Bifenthrin
82657-04-3
2916 20 00
p(1)
b
Binapacryl (6)
485-31-4
207-612-9
2916 19 50
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
i(2)
b
Butralin (7)
33629-47-9
251-607-4
2921 49 00
p(1)
b
Cadmium and its compounds
7440-43-9 and others
231-152-8 and others
81073206 49 30 and others
i(1)
sr
Cadusafos (7)
95465-99-9
n.a.
2930 90 85
p(1)
b
Calciferol
50-14-6
200-014-9
2936 29 90
p(1)
b
Captafol (6)
2425-06-1
219-363-3
2930 50 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Carbaryl (7)
63-25-2
200-555-0
2924 29 95
p(1)-p(2)
b–b
Carbofuran (7)
1563-66-2
216-353-0
2932 99 85
p(1)
b
Carbon tetrachloride
56-23-5
200-262-8
2903 14 00
i(2)
b
Carbosulfan (7)
55285-14-8
259-565-9
2932 99 85
p(1)
b
Cartap
15263-53-3
2930 20 00
p(1)-p(2)
b-b
Chinomethionat
2439-01-2
219-455-3
2934 99 90
p(1)-p(2)
b-b
Chlorate (7)
7775-09-9
231-887-4
2829 11 00
p(1)
b
10137-74-3
233-378-2
2829 19 00
Chlordimeform (6)
6164-98-3
228-200-5
2925 21 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Chlorfenapyr (7)
122453-73-0
2933 99 90
p(1)
b
Chlorfenvinphos
470-90-6
207-432-0
2919 90 90
p(1)-p(2)
b-b
Chlormephos
24934-91-6
246-538-1
2930 90 85
p(1)-p(2)
b-b
Chlorobenzilate (6)
510-15-6
208-110-2
2918 18 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Chloroform
67-66-3
200-663-8
2903 13 00
i(2)
b
Chlorthal-dimethyl (7)
1861-32-1
217-464-7
2917 39 95
p(1)
b
Chlozolinate (7)
84332-86-5
282-714-4
2934 99 90
p(1)-p(2)
b-b
Cholecalciferol
67-97-0
200-673-2
2936 29 90
p(1)
b
Coumafuryl
117-52-2
204-195-5
2932 29 85
p(1)-p(2)
b-b
Creosote and creosote related substances
8001-58-9
232-287-5
2707 91 00
61789-28-4
263-047-8
84650-04-4
283-484-8
3807 00 90
90640-84-9
292-605-3
65996-91-0
266-026-1
i(2)
b
90640-80-5
292-602-7
65996-85-2
266-019-3
8021-39-4
232-419-1
122384-78-5
310-191-5
Crimidine
535-89-7
208-622-6
2933 59 95
p(1)
b
Cyanamide (7)
420-04-2
206-992-3
2853 00 90
p(1)
b
Cyanazine
21725-46-2
244-544-9
2933 69 80
p(1)-p(2)
b-b
Cyhalothrine
68085-85-8
268-450-2
2926 90 95
p(1)
b
DBB (Di-μ-oxo-di-n-butylstannio-hydroxyborane/dioxastannaboretan-4-ol)
75113-37-0
401-040-5
2931 00 95
i(1)
b
Diazinon (7)
333-41-5
206-373-8
2933 59 10
p(1)
b
Dichlobenil (7)
1194-65-6
214-787-5
2926 90 95
p(1)
b
Dicloran (7)
99-30-9
202-746-4
2921 42 00
p(1)
b
Dichlorvos (7)
62-73-7
200-547-7
2919 90 90
p(1)
b
Dicofol (7)
115-32-2
204-082-0
2906 29 00
p(1)-p(2)
b-b
Dicofol containing < 78 % p, p′-Dicofol or 1 g/kg of DDT and DDT related compounds (7)
115-32-2
204-082-0
2906 29 00
p(1)-p(2)
b-b
Dimethenamid (7)
87674-68-8
n.a.
2934 99 90
p(1)
b
Diniconazole-M (7)
83657-18-5
n.a.
2933 99 80
p(1)
b
Dinitro-ortho-cresol (DNOC) and its salts (such as ammonium salt, potassium salt and sodium salt) (6)
534-52-1
208-601-1
2908 99 90
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
2980-64-5
221-037-0
5787-96-2
—
2312-76-7
219-007-7
Dinobuton
973-21-7
213-546-1
2920 90 10
p(1)-p(2)
b-b
Dinoseb and its salts and esters (6)
88-85-7 and others
201-861-7 and others
2908 91 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
2915 36 00
i(2)
b
Dinoterb (7)
1420-07-1
215-813-8
2908 99 90
p(1)-p(2)
b-b
Diphenylamine
122-39-4
204-539-4
2921 44 00
p(1)
b
Dustable powder formulations containing a combination of:
3808 99 90
Please refer to PIC circular at www.pic.int/
Benomyl at or above 7 %
17804-35-2
241-775-7
2933 99 90
p(1)
b
Carbofuran at or above 10 %
1563-66-2
216-353-0
2932 99 85
p(2)
b
and Thiram at or above 15 % (6)
137-26-8
205-286-2
2930 30 00
Endosulfan (7)
115-29-7
204-079-4
2920 90 85
p(1)
b
Ethalfluralin (7)
55283-68-6
259-564-3
2921 43 00
p(1)
b
Ethion
563-12-2
209-242-3
2930 90 85
p(1)-p(2)
b-b
Ethoxyquin (7)
91-53-2
202-075-7
2933 49 90
p(1)
b
Ethylene oxide (Oxirane) (6)
75-21-8
200-849-9
2910 10 00
p(1)
b
Please refer to PIC circular at www.pic.int/
Fenarimol (7)
60168-88-9
262-095-7
2933 59 95
p(1)
b
Fenitrothion (7)
122-14-5
204-524-2
2920 19 00
p(1)
b
Fenpropathrin
39515-41-8
254-485-0
2926 90 95
p(1)-p(2)
b-b
Fenthion (7)
55-38-9
200-231-9
2930 90 85
p(1)
sr
Fentin acetate (7)
900-95-8
212-984-0
2931 00 95
p(1)-p(2)
b-b
Fentin hydroxide (7)
76-87-9
200-990-6
2931 00 95
p(1)-p(2)
b-b
Fenvalerate
51630-58-1
257-326-3
2926 90 95
p(1)
b
Ferbam
14484-64-1
238-484-2
2930 20 00
p(1)-p(2)
b-b
Fluoroacetamide (6)
640-19-7
211-363-1
2924 12 00
p(1)
b
Please refer to PIC circular at www.pic.int/
Flurenol
467-69-6
207-397-1
2918 19 85
p(1)-p(2)
b-b
Flurprimidol (7)
56425-91-3
n.a.
2933 59 95
p(1)
b
Furathiocarb
65907-30-4
265-974-3
2932 99 85
p(1)-p(2)
b-b
Guazatine (7)
108173-90-6
115044-19-4
236-855-3
3808 99 90
p(1)-p(2)
b-b
Hexachloroethane
67-72-1
200-666-4
2903 19 80
i(1)
sr
Hexazinone
51235-04-2
257-074-4
2933 69 80
p(1)-p(2)
b-b
Iminoctadine
13516-27-3
236-855-3
2925 29 00
p(1)-p(2)
b-b
Indolylacetic acid (7)
87-51-4
201-748-2
2933 99 80
p(1)
b
Isoxathion
18854-01-8
242-624-8
2934 99 90
p(1)
b
Malathion
121-75-5
204-497-7
2930 90 99
p(2)
b
(a)
Maleic hydrazide, and its salts, other than choline, potassium and sodium salts
123-33-1
204-619-9
2933 99 90
p(1)
b
(b)
Choline, potassium and sodium salts of maleic hydrazide containing more than 1 mg/kg of free hydrazine expressed on the basis of the acid equivalent
61167-10-0, 51542-52-0, 28330-26-9
257-261-0, 248-972-7
2933 99 90
Mercury compounds, including inorganic mercury compounds, alkyl mercury compounds and alkyloxyalkyl and aryl mercury compounds except mercury compounds listed in Annex V (6)
62-38-4, 26545-49-3 and others
200-532-5, 247-783-7 and others
2852 00 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Metam
144-54-7
205-632-2
2930 20 00
p(1)
b
137-42-8
205-239-0
Methamidophos (4)
(7)
10265-92-6
233-606-0
2930 50 00
p(1)
b
Methamidophos (Soluble liquid formulations of the substance that exceed 600 g active ingredient/l) (6)
10265-92-6
233-606-0
2930 50 00
3808 50 00
p(2)
b
Please refer to PIC circular at www.pic.int/
Methidathion
950-37-8
213-449-4
2934 99 90
p(1)-p(2)
b-b
Methomyl
16752-77-5
240-815-0
2930 90 99
p(2)
b
Methyl bromide (7)
74-83-9
200-813-2
2903 39 11
p(1)-p(2)
b-b
Methyl-parathion (7)
(6)
298-00-0
206-050-1
2920 11 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Metoxuron
19937-59-8
243-433-2
2924 21 90
p(1)-p(2)
b-b
Monocrotophos (6)
6923-22-4
230-042-7
2924 12 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Monolinuron
1746-81-2
217-129-5
2928 00 90
p(1)
b
Monomethyl-dibromo-diphenyl methane
Tradename: DBBT (7)
99688-47-8
402-210-1
2903 69 90
i(1)
b
Monomethyl-Dichloro-Diphenyl methane;
Tradename: Ugilec 121 or Ugilec 21 (7)
—
400-140-6
2903 69 90
i(1)-i(2)
b-b
Monomethyl-Tetrachlorodiphenyl methane;
Tradename: Ugilec 141 (7)
76253-60-6
278-404-3
2903 69 90
i(1)-i(2)
b-b
Monuron
150-68-5
205-766-1
2924 21 90
p(1)
b
Nicotine (7)
54-11-5
200-193-3
2939 99 00
p(1)
b
Nitrofen (7)
1836-75-5
217-406-0
2909 30 90
p(1)-p(2)
b-b
Nonylphenols C6H4(OH)C9H19
(7)
25154-52-3 (phenol, nonyl-),
246-672-0
2907 13 00
i(1)
sr
84852-15-3 (phenol, 4-nonyl-, branched)
284-325-5
11066-49-2 (isononylphenol),
234-284-4
90481-04-2, (phenol, nonyl-, branched),
291-844-0
104-40-5(p-nonylphenol) and others
203-199-4 and others
Nonylphenol ethoxylates (C2H4O)nC15H24O (7)
9016-45-9, 26027-38-3, 68412-54-4, 37205-87-1, 127087-87-0 and others
3402 13 00
i(1)
sr
p(1)-p(2)
b-b
Octabromodiphenyl ether (7)
32536-52-0
251-087-9
2909 30 38
i(1)
sr
Omethoate
1113-02-6
214-197-8
2930 90 85
p(1)-p(2)
b-b
Oxydemeton-methyl (7)
301-12-2
206-110-7
2930 90 85
p(1)
b
Paraquat (7)
4685-14-7
225-141-7
2933 39 99
p(1)
b
1910-42-5
217-615-7
2074-50-2
218-196-3
Parathion (6)
56-38-2
200-271-7
2920 11 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Pebulate
1114-71-2
214-215-4
2930 20 00
p(1)-p(2)
b-b
Pentachlorophenol and its salts and esters (6)
87-86-5 and others
201-778-6 and others
2908 11 00
2908 19 00 and others
p(1)-p(2)
b-sr
Please refer to PIC circular at www.pic.int/
Perfluorooctane sulfonates
1763-23-1
n.a.
2904 90 20
i(1)
sr
(PFOS)
2795-39-3
2904 90 20
C8F17SO2X
and others
and others
(X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) (7)
Permethrin
52645-53-1
258-067-9
2916 20 00
p(1)
b
Phosalone (7)
2310-17-0
218-996-2
2934 99 90
p(1)
b
Phosphamidon (soluble liquid formulations of the substance that exceed 1 000 g active ingredient/l) (6)
13171-21-6 (mixture, (E) & (Z) isomers)
23783-98-4 ((Z)-isomer)
297-99-4 ((E)-isomer)
236-116-5
2924 12 00
3808 50 00
p(1)-p(2)
b-b
Please refer to PIC circular at www.pic.int/
Polybrominated biphenyls (PBB) except hexabromo-biphenyl (6)
13654-09-6, 27858-07-7 and others
237-137-2, 248-696-7 and others
2903 69 90
i(1)
sr
Please refer to PIC circular at www.pic.int/
Polychlorinated terphenyls (PCT) (6)
61788-33-8
262-968-2
2903 69 90
i(1)
b
Please refer to PIC circular at www.pic.int/
Procymidone (7)
32809-16-8
251-233-1
2925 19 95
p(1)
b
Propachlor (7)
1918-16-7
217-638-2
2924 29 98
p(1)
b
Propanil
709-98-8
211-914-6
2924 29 98
p(1)
b
Propham
122-42-9
204-542-0
2924 29 95
p(1)
b
Propisochlor (7)
86763-47-5
n.a.
2924 29 98
p(1)
b
Pyrazophos (7)
13457-18-6
236-656-1
2933 59 95
p(1)-p(2)
b-b
Quintozene (7)
82-68-8
201-435-0
2904 90 85
p(1)-p(2)
b-b
Scilliroside
507-60-8
208-077-4
2938 90 90
p(1)
b
Simazine (7)
122-34-9
204-535-2
2933 69 10
p(1)-p(2)
b-b
Strychnine
57-24-9
200-319-7
2939 99 00
p(1)
b
Tecnazene (7)
117-18-0
204-178-2
2904 90 85
p(1)-p(2)
b-b
Terbufos
13071-79-9
235-963-8
2930 90 85
p(1)-p(2)
b-b
Tetraethyl lead (6)
78-00-2
201-075-4
2931 00 95
i(1)
sr
Please refer to PIC circular at www.pic.int/
Tetramethyl lead (6)
75-74-1
200-897-0
2931 00 95
i(1)
sr
Please refer to PIC circular at www.pic.int/
Thallium sulphate
7446-18-6
231-201-3
2833 29 90
p(1)
b
Thiobencarb (7)
28249-77-6
248-924-5
2930 20 00
p(1)
b
Thiocyclam
31895-22-4
250-859-2
2934 99 90
p(1)-p(2)
b-b
Thiodicarb (7)
59669-26-0
261-848-7
2930 90 85
p(1)
b
Tolylfluanid (7)
731-27-1
211-986-9
2930 90 85
p(1)
b
Triazophos
24017-47-8
245-986-5
2933 99 90
p(1)-p(2)
b-b
All tributyltin compounds, including:
2931 00 95
p(2)
b
Please refer to PIC circular at www.pic.int/
Tributyltin oxide
56-35-9
200-268-0
2931 00 95
Tributyltin fluoride
1983-10-4
217-847-9
2931 00 95
Tributyltin methacrylate
2155-70-6
218-452-4
2931 00 95
Tributyltin benzoate
4342-36-3
224-399-8
2931 00 95
Tributyltin chloride
1461-22-9
215-958-7
2931 00 95
Tributyltin linoleate
24124-25-2
246-024-7
2931 00 95
Tributyltin naphthenate (6)
85409-17-2
287-083-9
2931 00 95
Trichlorfon (7)
52-68-6
200-149-3
2931 00 95
p(1)-p(2)
b-b
Tricyclazole (7)
41814-78-2
255-559-5
2934 99 90
p(1)
b
Tridemorph
24602-86-6
246-347-3
2934 99 90
p(1)-p(2)
b-b
Trifluralin (7)
1582-09-8
216-428-8
2921 43 00
p(1)
b
Triorganostannic compounds other than tributyltin compounds (7)
—
—
2931 00 95 and others
p(2)
sr
i(2)
sr
Tris (2,3-Dibromopropyl) phosphate (6)
126-72-7
204-799-9
2919 10 00
i(1)
sr
Please refer to PIC circular at www.pic.int/
Tris-aziridinyl-phosphinoxide (1,1′,1′-phosphoryltriaziridine) (7)
545-55-1
208-892-5
2933 99 90
i(1)
sr
Vamidothion
2275-23-2
218-894-8
2930 90 85
p(1)-p(2)
b-b
Vinclozolin (7)
50471-44-8
256-599-6
2934 99 90
p(1)
b
Zineb
12122-67-7
235-180-1
2930 20 00 or 3824 90 97
p(1)
b
PART 2
List of chemicals qualifying for PIC notification
(referred to in Article 11)
This list comprises chemicals qualifying for PIC notification. It does not include chemicals that are already subject to the PIC procedure, which are listed in Part 3 of this Annex.
Chemical
CAS No
Einecs No
CN code
Category (8)
Use limitation (9)
1,3-dichloropropene
542-75-6
208-826-5
2903 29 00
p
b
2-Naphthylamine (naphthalen-2-amine) and its salts
91-59-8, 553-00-4, 612-52-2 and others
202-080-4, 209-030-0, 210-313-6 and others
2921 45 00
i
b
4-Aminobiphenyl (biphenyl-4-amine) and its salts
92-67-1, 2113-61-3 and others
202-177-1 and others
2921 49 80
i
b
4-Nitrobiphenyl
92-92-3
202-204-7
2904 20 00
i
b
Acephate
30560-19-1
250-241-2
2930 90 85
p
b
Alachlor
15972-60-8
240-110-8
2924 29 95
p
b
Aldicarb
116-06-3
204-123-2
2930 90 85
p
sr
Amitraz
33089-61-1
251-375-4
2925 29 00
p
b
Anthraquinone
84-65-1
201-549-0
2914 61 00
p
b
Asbestos fibres: Chrysotile
12001-29-5 or 132207-32-0
2524 90 00
i
b
Atrazine
1912-24-9
217-617-8
2933 69 10
p
b
Azinphos-methyl
86-50-0
201-676-1
2933 99 80
p
b
Benfuracarb
82560-54-1
n.a.
2932 99 00
p
b
Benzidine and its salts
92-87-5, 36341-27-2 and others
202-199-1, 252-984-8 and others
2921 59 90
i
sr
Benzidine derivatives
—
—
Butralin
33629-47-9
251-607-4
2921 49 00
p
b
Cadusafos
95465-99-9
n.a.
2930 90 99
p
b
Carbaryl
63-25-2
200-555-0
2924 29 95
p
b
Carbofuran
1563-66-2
216-353-0
2932 99 00
p
b
Carbosulfan
55285-14-8
259-565-9
2932 99 00
p
b
Chlorate
7775-09-9
231-887-4
2829 11 00
p
b
10137-74-3
233-378-2
2829 19 00
Chlorfenapyr
122453-73-0
2933 99 90
p
sr
Chlorthal-dimethyl
1861-32-1
217-464-7
2917 39 95
p
b
Chlozolinate
84332-86-5
282-714-4
2934 99 90
p
b
Cyanamide
420-04-2
206-992-3
2853 00 90
p
sr
Diazinon
333-41-5
206-373-8
2933 59 10
p
sr
Dichlobenil
1194-65-6
214-787-5
2926 90 95
p
b
Dicloran
99-30-9
202-746-4
2921 42 00
p
b
Dichlorvos
62-73-7
200-547-7
2919 90 00
p
sr
Dicofol
115-32-2
204-082-0
2906 29 00
p
b
Dicofol containing < 78 % p, p′-Dicofol or 1 g/kg of DDT and DDT related compounds
115-32-3
204-082-0
2906 29 00
p
b
Dimethenamid
87674-68-8
n.a.
2934 99 90
p
b
Diniconazole-M
83657-18-5
n.a.
2933 99 80
p
b
Dinoterb
1420-07-1
215-813-8
2908 99 90
p
b
Endosulfan
115-29-7
204-079-4
2920 90 85
p
b
Ethalfluralin
55283-68-6
259-564-3
2921 43 00
p
b
Ethoxyquin
91-53-2
202-075-7
2933 49 90
p
b
Fenarimol
60168-88-9
262-095-7
2933 59 95
p
b
Fenitrothion
122-14-5
204-524-2
2920 19 00
p
sr
Fenthion
55-38-9
200-231-9
2930 90 85
p
sr
Fentin acetate
900-95-8
212-984-0
2931 00 95
p
b
Fentin hydroxide
76-87-9
200-990-6
2931 00 95
p
b
Flurprimidol
56425-91-3
n.a.
2933 59 95
p
b
Guazatine
108173-90-6
115044-19-4
236-855-3
3808 99 90
p
b
Indolylacetic acid
87-51-4
201-748-2
2933 99 80
p
b
Methamidophos (10)
10265-92-6
233-606-0
2930 50 00
p
b
Methyl bromide
74-83-9
200-813-2
2903 39 11
p
b
Methyl parathion (11)
298-00-0
206-050-1
2920 11 00
p
b
Monomethyl-dibromo-diphenyl methane
Tradename: DBBT
99688-47-8
401-210-1
2903 69 90
i
b
Monomethyl-Dichloro-Diphenyl methane;
Tradename: Ugilec 121 or Ugilec 21
—
400-140-6
2903 69 90
i
b
Monomethyl-Tetrachlorodiphenyl methane;
Tradename: Ugilec 141
76253-60-6
278-404-3
2903 69 90
i
b
Nicotine
54-11-5
200-193-3
2939 99 00
p
b
Nitrofen
1836-75-5
217-406-0
2909 30 90
p
b
Nonylphenols C6H4(OH)C9H19
25154-52-3 (phenol, nonyl-),
246-672-0
2907 13 00
i
sr
84852-15-3 (phenol, 4-nonyl-, branched),
284-325-5
11066-49-2 (isononylphenol),
234-284-4
90481-04-2, (phenol, nonyl-, branched),
291-844-0
104-40-5 (P-nonylphenol) and others
203-199-4 and others
Nonylphenol ethoxylates (C2H4O)nC15H24O
9016-45-9, 26027-38-3, 68412-54-4, 37205-87-1, 127087-87-0 and others
3402 13 00
i
sr
p
b
Octabromodiphenyl ether
32536-52-0
251-087-9
2909 30 38
i
sr
Oxydemeton-methyl
301-12-2
206-110-7
2930 90 85
p
b
Paraquat
4685-14-7
225-141-7
2933 39 99
p
b
1910-42-5
217-615-7
2074-50-2
218-196-3
Perfluorooctane sulfonates
1763-23-1
n.a.
2904 90 20
i
sr
(PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers)
2795-39-3 and others
2904 90 20 and others
Phosalone
2310-17-0
218-996-2
2934 99 90
p
b
Procymidone
32809-16-8
251-233-1
2925 19 95
p
b
Propachlor
1918-16-7
217-638-2
2924 29 98
p
b
Propisochlor
86763-47-5
n.a.
2924 29 98
p
b
Pyrazophos
13457-18-6
236-656-1
2933 59 95
p
b
Quintozene
82-68-8
201-435-0
2904 90 85
p
b
Simazine
122-34-9
204-535-2
2933 69 10
p
b
Tecnazene
117-18-0
204-178-2
2904 90 85
p
b
Thiobencarb
28249-77-6
248-924-5
2930 20 00
p
b
Thiodicarb
59669-26-0
261-848-7
2930 90 85
p
b
Tolylfluanid
731-27-1
211-986-9
2930 90 85
p
sr
Trichlorfon
52-68-6
200-149-3
2931 00 95
p
b
Tricyclazole
41814-78-2
255-559-5
2934 99 90
p
b
Trifluralin
1582-09-8
216-428-8
2921 43 00
p
b
Triorganostannic compounds other than tributyltin compounds
—
—
2931 00 95 and others
p
sr
Vinclozolin
50471-44-8
256-599-6
2934 99 90
p
b
PART 3
List of chemicals subject to the PIC procedure
(referred to in Articles 13 and 14)
(The categories shown are those referred to in the Convention)
Chemical
Relevant CAS number(s)
HS code
Pure substance
HS code
Mixtures containing substance
Category
2,4,5-T and its salts and esters
93-76-5 (13)
2918.91
3808.50
Pesticide
Aldrin (12)
309-00-2
2903.52
3808.50
Pesticide
Binapacryl
485-31-4
2916.19
3808.50
Pesticide
Captafol
2425-06-1
2930.50
3808.50
Pesticide
Chlordane (12)
57-74-9
2903.52
3808.50
Pesticide
Chlordimeform
6164-98-3
2925.21
3808.50
Pesticide
Chlorobenzilate
510-15-6
2918.18
3808.50
Pesticide
DDT (12)
50-29-3
2903.62
3808.50
Pesticide
Dieldrin (12)
60-57-1
2910.40
3808.50
Pesticide
Dinitro-ortho-cresol (DNOC) and its salts (such as ammonium salt, potassium salt and sodium salt)
534-52-1, 2980-64-5, 5787-96-2, 2312-76-7
2908.99
3808.91
3808.92
3808.93
Pesticide
Dinoseb and its salts and esters
88-85-7 (13)
2908.91
3808.50
Pesticide
1,2-dibromoethane (EDB)
106-93-4
2903.31
3808.50
Pesticide
Ethylene dichloride (1,2-dichloroethane)
107-06-2
2903.15
3808.50
Pesticide
Ethylene oxide
75-21-8
2910.10
3808.50
3824.81
Pesticide
Fluoroacetamide
640-19-7
2924.12
3808.50
Pesticide
HCH (mixed isomers) (12)
608-73-1
2903.51
3808.50
Pesticide
Heptachlor (12)
76-44-8
2903.52
3808.50
Pesticide
Hexachlorobenzene (12)
118-74-1
2903.62
3808.50
Pesticide
Lindane (12)
58-89-9
2903.51
3808.50
Pesticide
Mercury compounds, including inorganic mercury compounds, alkyl mercury compounds and alkyloxyalkyl and aryl mercury compounds
10112-91-1, 21908-53-2 and others
See also: www.pic.int/
2852.00
3808.50
Pesticide
Monocrotophos
6923-22-4
2924.12
3808.50
Pesticide
Parathion
56-38-2
2920.11
3808.50
Pesticide
Pentachlorophenol and its salts and esters
87-86-5 (13)
2908.11
2908.19
3808.50
3808.91
3808.92
3808.93
3808.94
3808.99
Pesticide
Toxaphene (12)
8001-35-2
—
3808.50
Pesticide
Dustable powder formulations containing a combination of: Benomyl at or above 7 %, Carbofuran at or above 10 % and Thiram at or above 15 %
17804-35-2
1563-66-2
137-26-8
—
3808.92
Severely hazardous pesticide formulation
Methamidophos (soluble liquid formulations of the substance that exceed 600 g active ingredient/l)
10265-92-6
2930.50
3808.50
Severely hazardous pesticide formulation
Methyl-parathion (emulsifiable concentrates (EC) at or above 19,5 % active ingredient and dusts at or above 1,5 % active ingredient)
298-00-0
2920.11
3808.50
Severely hazardous pesticide formulation
Phosphamidon (soluble liquid formulations of the substance that exceed 1 000 g active ingredient/l)
2924.12
3808.50
Severely hazardous pesticide formulation
Mixture (E) & (Z) isomers
13171-21-6
(Z)-isomer
23783-98-4
(E)-isomer
297-99-4
Asbestos fibres:
2524.10
2524.90
6811.40
6812.80
6812.91
6812.92
6812.93
6812.99
6813.20
Industrial
Crocidolite
12001-28-4
2524.10
Actinolite
77536-66-4
2524.90
Anthophyllite
77536-67-5
2524.90
Amosite
12172-73-5
2524.90
Tremolite
77536-68-6
2524.90
Polybrominated biphenyls (PBB)
—
(hexa-) (12)
36355-01-8
—
3824.82
Industrial
—
(octa-)
27858-07-7
—
(deca-)
13654-09-6
Polychlorinated biphenyls (PCB) (12)
1336-36-3
—
3824.82
Industrial
Polychlorinated terphenyls (PCT)
61788-33-8
—
3824.82
Industrial
Tetraethyl lead
78-00-2
2931.00
3811.11
Industrial
Tetramethyl lead
75-74-1
2931.00
3811.11
Industrial
All tributyltin compounds, including:
2931.00
3808.99
Pesticide
Tributyltin oxide
56-35-9
2931.00
3808.99
Tributyltin fluoride
1983-10-4
2931.00
3808.99
Tributyltin methacrylate
2155-70-6
2931.00
3808.99
Tributyltin benzoate
4342-36-3
2931.00
3808.99
Tributyltin chloride
1461-22-9
2931.00
3808.99
Tributyltin linoleate
24124-25-2
2931.00
3808.99
Tributyltin naphthenate
85409-17-2
2931.00
3808.99
Tris (2,3-dibromopropyl) phosphate
126-72-7
2919.10
3824.83
Industrial
(1) Sub-category: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for public use.
(2) Use limitation: sr — severe restriction, b — ban (for the sub-category or sub-categories concerned) according to Union legislation.
(3) This entry does not affect the existing entry for cis-1,3-dichloropropene (CAS No 10061-01-5).
(4) This entry does not affect the existing entry for soluble liquid formulations of methamidophos that exceed 600 g active ingredient/l.
(5) Except motor fuels subject to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels (OJ L 350, 28.12.1998, p. 58).
CAS No= Chemical Abstracts Service Registry Number.
(6)
(#)
Chemical subject or partially subject to the PIC procedure.
(7)
(+)
Chemical qualifying for PIC notification.
(8) Category: p — pesticides; i — industrial chemical.
(9) Use limitation: sr — severe restriction, b — ban (for the category or categories concerned).CAS No = Chemical Abstracts Service Registry Number.
(10) This entry does not affect the entry in Annex I Part 3 for soluble liquid formulations of methamidophos that exceed 600 g active ingredient/l.
(11)
(#)
Chemical subject or partially subject to the PIC procedure.
(12) These substances are subject to an export ban in accordance with Article 15(2) of and Annex V to this Regulation.
(13)
(#)
Only the CAS numbers of parent compounds are listed.
ANNEX II
EXPORT NOTIFICATION
The following information is required pursuant to Article 8:
1.
Identity of the substance to be exported:
(a)
name in nomenclature of the International Union of Pure and Applied Chemistry;
(b)
other names (e.g. ISO name, usual names, trade names, and abbreviations);
(c)
European Inventory of Existing Chemical Substances (Einecs) number and Chemical Abstracts Services (CAS) number;
(d)
CUS number (European Customs Inventory of Chemical Substances) and Combined Nomenclature code;
(e)
main impurities of the substance, when particularly relevant.
2.
Identity of the mixture to be exported:
(a)
trade name and/or designation of the mixture;
(b)
for each substance listed in Annex I, percentage and details as specified under point 1;
(c)
CUS number (European Customs Inventory of Chemical Substances) and Combined Nomenclature code.
3.
Identity of the article to be exported:
(a)
trade name and/or designation of the article;
(b)
for each substance listed in Annex I, percentage and details as specified under point 1.
4.
Information on the export:
(a)
country of destination;
(b)
country of origin;
(c)
expected date of first export this year;
(d)
estimated amount of the chemical to be exported to the country concerned this year;
(e)
intended use in the country of destination, if known, including information on the category(ies) under the Convention under which the use falls;
(f)
name, address and other relevant particulars of the natural or legal importing person;
(g)
name, address and other relevant particulars of the exporter.
5.
Designated national authorities:
(a)
the name, address, telephone and telex, fax number or e-mail of the designated authority in the Union from which further information may be obtained;
(b)
the name, address, telephone and telex, fax number or e-mail of the designated authority in the importing country.
6.
Information on precautions to be taken, including category of danger and risk and safety advice.
7.
A summary on physicochemical, toxicological and ecotoxicological properties.
8.
Use of the chemical in the Union:
(a)
uses, category(ies) under the Convention and Union subcategory(ies) subject to control measure (ban or severe restriction);
(b)
uses for which the chemical is not severely restricted or banned (use categories and subcategories as defined in Annex I of the Regulation);
(c)
estimation, where available, of quantities of the chemical produced, imported, exported and used.
9.
Information on precautionary measures to reduce exposure to, and emission of, the chemical.
10.
Summary of regulatory restrictions and reasons for them.
11.
Summary of information specified in points 2(a), (c) and (d) of Annex IV.
12.
Additional information provided by the exporting Party because considered of concern or further information specified in Annex IV when requested by the importing Party.
ANNEX III
Information to be supplied to the Commission by the designated national authorities of the Member States in accordance with Article 10
1.
Summary of quantities of chemicals (in the form of substances, mixtures and articles) subject to Annex I exported during the previous year.
(a)
Year in which exports took place.
(b)
Table summarising quantities of exported chemicals (in the form of substances, mixtures and articles) as outlined below.
Chemical
Importing country
Quantity of substance
2.
List of natural or legal persons importing chemicals into a Party or other country
Chemical
Importing country
Importing person
Address and other relevant particulars of the importing person
ANNEX IV
Notification to the Secretariat of the Convention of a banned or severely restricted chemical
INFORMATION REQUIREMENTS FOR NOTIFICATIONS PURSUANT TO ARTICLE 11
Notifications shall include:
1.
properties, identification and uses
(a)
common name;
(b)
chemical name according to an internationally recognised nomenclature (for example International Union of Pure and Applied Chemistry (IUPAC)), where such nomenclature exists;
(c)
trade names and names of mixtures;
(d)
code numbers: Chemical Abstracts Service (CAS) number, Harmonised System Customs Code and other numbers;
(e)
information on hazard classification, where the chemical is subject to classification requirements;
(f)
use or uses of the chemical:
—
in the Union,
—
elsewhere (if known);
(g)
the physicochemical, toxicological and ecotoxicological properties;
2.
final regulatory action
(a)
information specific to the final regulatory action:
(i)
summary of the final regulatory action;
(ii)
reference to the regulatory document;
(iii)
date of entry into force of the final regulatory action;
(iv)
indication of whether the final regulatory action was taken on the basis of a risk or hazard evaluation and, if so, information on such an evaluation, covering a reference to the relevant documentation;
(v)
reasons for the final regulatory action relevant to human health, including the health of consumers and workers, or the environment;
(vi)
summary of the hazards and risks presented by the chemical to human health, including the health of consumers and workers, or the environment and the expected effect of the final regulatory action;
(b)
category or categories where the final regulatory action has been taken, and for each category:
(i)
use or uses prohibited by the final regulatory action;
(ii)
use or uses that remain allowed;
(iii)
estimation, where available, of quantities of the chemical produced, imported, exported and used;
(c)
an indication, to the extent possible, of the likely relevance of the final regulatory action to other States and regions;
(d)
other relevant information that may cover:
(i)
assessment of socioeconomic effects of the final regulatory action;
(ii)
information on alternatives and their relative risks, where available, such as:
—
integrated pest management strategies,
—
industrial practices and processes, including cleaner technology.
ANNEX V
Chemicals and articles subject to export ban
(referred to in Article 15)
PART 1
Persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants (1) according to the provisions thereof.
Description of chemicals/article(s) subject to export ban
Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)
Aldrin
EC No 206-215-8,
CAS No 309-00-2,
CN code 2903 52 00
Chlordane
EC No 200-349-0,
CAS No 57-74-9,
CN code 2903 52 00
Chlordecone
EC No 205-601-3
CAS No 143-50-0
CN code 2914 70 00
Dieldrin
EC No 200-484-5,
CAS No 60-57-1,
CN code 2910 40 00
DDT (1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane
EC No 200-024-3,
CAS No 50-29-3,
CN code 2903 62 00
Endrin
EC No 200-775-7,
CAS No 72-20-8,
CN code 2910 90 00
Heptabromodiphenyl ether C12H3Br7O
EC No 273-031-2
CAS No 68928-80-3 and others
CN code 2909 30 38
Heptachlor
EC No 200-962-3,
CAS No 76-44-8,
CN code 2903 52 00
Hexabromobiphenyl
EC No 252-994-2
CAS No 36355-01-8
CN code 2903 69 90
Hexabromodiphenyl ether C12H4Br6O
EC No 253-058-6
CAS No 36483-60-0 and others
CN code 2909 30 38
Hexachlorobenzene
EC No 200-273-9,
CAS No 118-74-1,
CN code 2903 62 00
Hexachlorocyclohexanes, including lindane
EC No 200-401-2, 206-270-8, 206-271-3, 210-168-9
CAS No 58-89-9, 319-84-6, 319-85-7, 608-73-1
CN code 2903 51 00
Mirex
EC No 219-196-6,
CAS No 2385-85-5,
CN code 2903 59 80
Pentabromodiphenyl ether C12H5Br5O
EC No 251-084-2 and others
CAS No 32534-81-9 and others
CN code 2909 30 31
Pentachlorobenzene
EC No 210-172-5
CAS No 608-93-5
CN code 2903 69 90
Polychlorinated biphenyls (PCBs)
EC No 215-648-1 and others,
CAS No 1336-36-3 and others,
CN code 2903 69 90
Tetrabromodiphenyl ether C12H6Br4O
EC No 254-787-2 and others
CAS No 40088-47-9 and others
CN code 2909 30 38
Toxaphene (camphechlor)
EC No 232-283-3,
CAS No 8001-35-2,
CN code 3808 50 00
PART 2
Chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants according to the provisions thereof.
Description of chemicals/article(s) subject to export ban
Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)
Cosmetic soaps containing mercury
CN codes 3401 11 00, 3401 19 00, 3401 20 10, 3401 20 90, 3401 30 00
Mercury compounds except compounds exported for research and development, medical or analysis purposes
Cinnabar ore, mercury (I) chloride (Hg2Cl2, CAS No 10112-91-1), mercury (II) oxide (HgO, CAS No 21908-53-2); CN code 2852 00 00
Metallic mercury and mixtures of metallic mercury with other substances, including alloys of mercury, with a mercury concentration of at least 95 % weight by weight
CAS No 7439-97-6
CN code 2805 40
(1) OJ L 209, 31.7.2006, p. 3.
ANNEX VI
List of Parties to the Convention requiring information concerning transit movements of chemicals subject to the PIC procedure
(referred to in Article 16)
Country
Required information
ANNEX VII
Correlation table
Regulation (EC) No 689/2008
This Regulation
—
Article 1
Article 1(1)
1(1)
Article 1(2)
1(2)
—
Article 2
Article 2(1)
2(1)
Article 2(2)
2(2)
—
2(3)
Article 3
Article 3
Article 4
Article 4
—
Article 5
Article 5(1)
5(1)
Article 5(2)
5(2)
Article 5(3)
5(3)
—
Article 6
—
6(1)
—
6(2)
—
Article 7
Article 6(1)
7(1)
Article 6(2)
7(2)
Article 6(3)
7(3)
—
Article 8
Article 7(1)
8(1)
Article 7(2)
8(2)
Article 7(3)
8(3)
Article 7(4)
8(4)
Article 7(5)
8(5)
Article 7(6)
8(6)
Article 7(7)
8(7)
Article 7(8)
8(8)
—
Article 9
Article 8(1)
9(1)
Article 8(2)
9(2)
—
Article 10
Article 9(1)
10(1)
Article 9(2)
10(2)
Article 9(3)
10(3)
—
Article 11
Article 10(1)
11(1)
Article 10(2)
11(2)
Article 10(3)
11(3)
Article 10(4)
11(4)
Article 10(5)
11(5)
Article 10(6)
11(6)
Article 10(7)
11(7)
Article 10(8)
11(8)
Article 11
Article 12
—
Article 13
Article 12(1)
13(1)
Article 12(2)
13(2)
Article 12(3)
13(3)
Article 12(4)
13(4)
Article 12(5)
13(5)
Article 12(6)
13(6)
—
Article 14
Article 13(1)
14(1)
Article 13(2)
14(2)
Article 13(3)
14(3)
Article 13(4)
14(4)
Article 13(5)
14(5)
Article 13(6)
14(6)
Article 13(7)
14(7)
Article 13(8)
14(8)
Article 13(9)
14(9)
Article 13(10)
14(10)
Article 13(11)
14(11)
—
Article 15
Article 14(1)
15(1)
Article 14(2)
15(2)
—
Article 16
Article 15(1)
16(1)
Article 15(2)
16(2)
Article 15(3)
16(3)
Article 15(4)
16(4)
—
Article 17
Article 16(1)
17(1)
Article 16(2)
17(2)
Article 16(3)
17(3)
Article 16(4)
17(4)
—
Article 18
Article 17(1)
18(1)
—
18(2)
Article 17(1)
18(3)
—
Article 19
Article 17(2)
19(1)
—
19(2)
—
19(3)
—
Article 20
Article 19(1)
20(1)
Article 19(2)
20(2)
Article 19(3)
20(3)
Article 19(3)
20(4)
Article 20
Article 21
—
Article 22
Article 21(1)
22(1)
Article 21(2)
22(2)
Article 21(3)
22(3)
—
Article 23
Article 22(1)
23(1)
Article 22(2)
23(2)
Article 22(3)
23(3)
Article 22(4)
23(4)
—
Article 24
—
24(1)
—
24(2)
—
24(3)
—
Article 25
—
Article 26
—
26(1)
—
26(2)
—
26(3)
—
26(4)
—
26(5)
—
Article 27
Article 24(1)
27(1)
Article 24(2)
27(2)
Article 18
Article 28
—
Article 29
Article 25
Article 30
Article 26
Article 31
Annex I
Annex I
Annex II
Annex II
Annex III
Annex III
Annex IV
Annex IV
Annex V
Annex V
Annex VI
Annex VI
|
Hazardous chemicals — rules on export and import
Hazardous chemicals — rules on export and import
SUMMARY OF:
Regulation (EU) No 649/2012 — export and import of hazardous chemicals
WHAT IS THE AIM OF THE REGULATION?
It implements in the European Union (EU) the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade.
It ensures that countries receiving certain chemicals from the EU are: informed about the export;asked whether they agree to the export;informed about the safe handling of chemicals to protect human health and the environment from potential harm.
KEY POINTS
Scope
The regulation applies to: hazardous chemicals listed under the Rotterdam Convention;chemicals that are banned or severely restricted within the EU;chemicals that are exported.
It does not cover: narcotics;radioactive materials;waste;chemical weapons;food and food additives;feed;genetically modified organisms and some medicines;chemicals exported for research or analysis in quantities unlikely to affect human health or the environment.
The regulation requires proper labelling and packaging of chemicals when they are exported from an EU Member State.
242 chemicals (pesticides and industrial chemicals) are listed in Annex I and are subject to certain obligations when exported. Hazardous chemicals can either be exported on their own or blended into a mixture or article.
This regulation recasts and replaces Regulation (EC) No 689/2008 and updates some procedures and terminology that needed to be brought into line with other EU rules. In addition, it involves the European Chemicals Agency established by Regulation (EC) No 1907/2006 (see summary) in implementing the legal requirements.
How it works
The regulation implements the two main procedures of the convention, i.e. the prior informed consent procedure and information exchange. It includes export notification in order to inform countries on the trade in certain chemicals, but it also goes further than the convention, for example by applying the export procedures to all countries, irrespective of whether they are parties to the convention.
The prior informed consent procedure allows importing parties to the convention to inform exporting parties on whether they agree to imports of the hazardous chemicals listed in the convention. The regulation requires the explicit consent of the importing country for more chemicals than those listed in the convention.
Each chemical listed in the convention has a decision guidance document to help governments make a more informed decision. All parties are required to take a decision on allowing imports — known as an import response — and the regulation ensures that import responses are respected for EU exports.
Under the information exchange mechanism, each party must notify the convention’s Secretariat when banning a chemical, and must notify the importing parties when it is exported. The regulation establishes the export notification procedure for EU exports of such chemicals to all importing countries.
All chemicals intended for export must be labelled and packed according to certain standards and accompanied by basic safety information on a safety data sheet.
Each EU Member State must set up a designated national authority to be responsible for implementing the regulation.
The European Commission and Member States share responsibility within the convention, in particular with regard to: technical assistance;information sharing;matters relating to dispute settlement.
Implementation of Regulation (EU) No 649/2012
In 2018, the Commission published a report and a staff working document on the operation of Regulation (EU) No 649/2012. The report concluded that the procedures established by the regulation had worked well and contributed to achieving its objectives.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 March 2014. Regulation (EU) No 649/2012 revised and replaced Regulation (EC) No 689/2008 and its subsequent amendments.
BACKGROUND
For more information, see:
Regulation on export and import (European Commission)
Understanding prior informed consent (European Chemicals Agency).
MAIN DOCUMENT
Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) (OJ L 201, 27.7.2012, pp. 60–106).
Successive amendments to Regulation (EU) No 649/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — Summary of the synthesis report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals (COM(2018) 697 final, 17.10.2018).
Commission Staff Working Document — Synthesis report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals — accompanying the document Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — Summary of the synthesis report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals (SWD(2018) 438 final, 17.10.2018).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1–849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3–280).
See consolidated version.
Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L 299, 28.10.2006, pp. 23–25).
last update 20.10.2021
|
32013R0604
|
29.6.2013
EN
Official Journal of the European Union
L 180/31
REGULATION (EU) No 604/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 26 June 2013
establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (recast)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 78(2)(e) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
A number of substantive changes are to be made to Council Regulation (EC) No 343/2003 of 18 February 2003 establishing the criteria and mechanisms for determining the Member State responsible for examining an asylum application lodged in one of the Member States by a third-country national (4). In the interests of clarity, that Regulation should be recast.
(2)
A common policy on asylum, including a Common European Asylum System (CEAS), is a constituent part of the European Union’s objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Union.
(3)
The European Council, at its special meeting in Tampere on 15 and 16 October 1999, agreed to work towards establishing the CEAS, based on the full and inclusive application of the Geneva Convention Relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967 (‘the Geneva Convention’), thus ensuring that nobody is sent back to persecution, i.e. maintaining the principle of non-refoulement. In this respect, and without the responsibility criteria laid down in this Regulation being affected, Member States, all respecting the principle of non-refoulement, are considered as safe countries for third-country nationals.
(4)
The Tampere conclusions also stated that the CEAS should include, in the short-term, a clear and workable method for determining the Member State responsible for the examination of an asylum application.
(5)
Such a method should be based on objective, fair criteria both for the Member States and for the persons concerned. It should, in particular, make it possible to determine rapidly the Member State responsible, so as to guarantee effective access to the procedures for granting international protection and not to compromise the objective of the rapid processing of applications for international protection.
(6)
The first phase in the creation of a CEAS that should lead, in the longer term, to a common procedure and a uniform status, valid throughout the Union, for those granted international protection, has now been completed. The European Council of 4 November 2004 adopted The Hague Programme which set the objectives to be implemented in the area of freedom, security and justice in the period 2005-2010. In this respect, The Hague Programme invited the European Commission to conclude the evaluation of the first-phase legal instruments and to submit the second-phase instruments and measures to the European Parliament and to the Council with a view to their adoption before 2010.
(7)
In the Stockholm Programme, the European Council reiterated its commitment to the objective of establishing a common area of protection and solidarity in accordance with Article 78 of the Treaty on the Functioning of the European Union (TFEU), for those granted international protection, by 2012 at the latest. Furthermore it emphasised that the Dublin system remains a cornerstone in building the CEAS, as it clearly allocates responsibility among Member States for the examination of applications for international protection.
(8)
The resources of the European Asylum Support Office (EASO), established by Regulation (EU) No 439/2010 of the European Parliament and of the Council (5), should be available to provide adequate support to the relevant services of the Member States responsible for implementing this Regulation. In particular, EASO should provide solidarity measures, such as the Asylum Intervention Pool with asylum support teams, to assist those Member States which are faced with particular pressure and where applicants for international protection (‘applicants’) cannot benefit from adequate standards, in particular as regards reception and protection.
(9)
In the light of the results of the evaluations undertaken of the implementation of the first-phase instruments, it is appropriate, at this stage, to confirm the principles underlying Regulation (EC) No 343/2003, while making the necessary improvements, in the light of experience, to the effectiveness of the Dublin system and the protection granted to applicants under that system. Given that a well-functioning Dublin system is essential for the CEAS, its principles and functioning should be reviewed as other components of the CEAS and Union solidarity tools are built up. A comprehensive ‘fitness check’ should be foreseen by conducting an evidence-based review covering the legal, economic and social effects of the Dublin system, including its effects on fundamental rights.
(10)
In order to ensure equal treatment for all applicants and beneficiaries of international protection, and consistency with the current Union asylum acquis, in particular with Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (6), the scope of this Regulation encompasses applicants for subsidiary protection and persons eligible for subsidiary protection.
(11)
Directive 2013/33/EU of the European Parliament and of the Council of 26 June 2013 laying down standards for the reception of applicants for international protection (7) should apply to the procedure for the determination of the Member State responsible as regulated under this Regulation, subject to the limitations in the application of that Directive.
(12)
Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (8) should apply in addition and without prejudice to the provisions concerning the procedural safeguards regulated under this Regulation, subject to the limitations in the application of that Directive.
(13)
In accordance with the 1989 United Nations Convention on the Rights of the Child and with the Charter of Fundamental Rights of the European Union, the best interests of the child should be a primary consideration of Member States when applying this Regulation. In assessing the best interests of the child, Member States should, in particular, take due account of the minor’s well-being and social development, safety and security considerations and the views of the minor in accordance with his or her age and maturity, including his or her background. In addition, specific procedural guarantees for unaccompanied minors should be laid down on account of their particular vulnerability.
(14)
In accordance with the European Convention for the Protection of Human Rights and Fundamental Freedoms and with the Charter of Fundamental Rights of the European Union, respect for family life should be a primary consideration of Member States when applying this Regulation.
(15)
The processing together of the applications for international protection of the members of one family by a single Member State makes it possible to ensure that the applications are examined thoroughly, the decisions taken in respect of them are consistent and the members of one family are not separated.
(16)
In order to ensure full respect for the principle of family unity and for the best interests of the child, the existence of a relationship of dependency between an applicant and his or her child, sibling or parent on account of the applicant’s pregnancy or maternity, state of health or old age, should become a binding responsibility criterion. When the applicant is an unaccompanied minor, the presence of a family member or relative on the territory of another Member State who can take care of him or her should also become a binding responsibility criterion.
(17)
Any Member State should be able to derogate from the responsibility criteria, in particular on humanitarian and compassionate grounds, in order to bring together family members, relatives or any other family relations and examine an application for international protection lodged with it or with another Member State, even if such examination is not its responsibility under the binding criteria laid down in this Regulation.
(18)
A personal interview with the applicant should be organised in order to facilitate the determination of the Member State responsible for examining an application for international protection. As soon as the application for international protection is lodged, the applicant should be informed of the application of this Regulation and of the possibility, during the interview, of providing information regarding the presence of family members, relatives or any other family relations in the Member States, in order to facilitate the procedure for determining the Member State responsible.
(19)
In order to guarantee effective protection of the rights of the persons concerned, legal safeguards and the right to an effective remedy in respect of decisions regarding transfers to the Member State responsible should be established, in accordance, in particular, with Article 47 of the Charter of Fundamental Rights of the European Union. In order to ensure that international law is respected, an effective remedy against such decisions should cover both the examination of the application of this Regulation and of the legal and factual situation in the Member State to which the applicant is transferred.
(20)
The detention of applicants should be applied in accordance with the underlying principle that a person should not be held in detention for the sole reason that he or she is seeking international protection. Detention should be for as short a period as possible and subject to the principles of necessity and proportionality. In particular, the detention of applicants must be in accordance with Article 31 of the Geneva Convention. The procedures provided for under this Regulation in respect of a detained person should be applied as a matter of priority, within the shortest possible deadlines. As regards the general guarantees governing detention, as well as detention conditions, where appropriate, Member States should apply the provisions of Directive 2013/33/EU also to persons detained on the basis of this Regulation.
(21)
Deficiencies in, or the collapse of, asylum systems, often aggravated or contributed to by particular pressures on them, can jeopardise the smooth functioning of the system put in place under this Regulation, which could lead to a risk of a violation of the rights of applicants as set out in the Union asylum acquis and the Charter of Fundamental Rights of the European Union, other international human rights and refugee rights.
(22)
A process for early warning, preparedness and management of asylum crises serving to prevent a deterioration in, or the collapse of, asylum systems, with EASO playing a key role using its powers under Regulation (EU) No 439/2010, should be established in order to ensure robust cooperation within the framework of this Regulation and to develop mutual trust among Member States with respect to asylum policy. Such a process should ensure that the Union is alerted as soon as possible when there is a concern that the smooth functioning of the system set up by this Regulation is being jeopardised as a result of particular pressure on, and/or deficiencies in, the asylum systems of one or more Member States. Such a process would allow the Union to promote preventive measures at an early stage and pay the appropriate political attention to such situations. Solidarity, which is a pivotal element in the CEAS, goes hand in hand with mutual trust. By enhancing such trust, the process for early warning, preparedness and management of asylum crises could improve the steering of concrete measures of genuine and practical solidarity towards Member States, in order to assist the affected Member States in general and the applicants in particular. In accordance with Article 80 TFEU, Union acts should, whenever necessary, contain appropriate measures to give effect to the principle of solidarity, and the process should be accompanied by such measures. The conclusions on a Common Framework for genuine and practical solidarity towards Member States facing particular pressures on their asylum systems, including through mixed migration flows, adopted by the Council on 8 March 2012, provide for a ‘tool box’ of existing and potential new measures, which should be taken into account in the context of a mechanism for early warning, preparedness and crisis management.
(23)
Member States should collaborate with EASO in the gathering of information concerning their ability to manage particular pressure on their asylum and reception systems, in particular within the framework of the application of this Regulation. EASO should regularly report on the information gathered in accordance with Regulation (EU) No 439/2010.
(24)
In accordance with Commission Regulation (EC) No 1560/2003 (9), transfers to the Member State responsible for examining an application for international protection may be carried out on a voluntary basis, by supervised departure or under escort. Member States should promote voluntary transfers by providing adequate information to the applicant and should ensure that supervised or escorted transfers are undertaken in a humane manner, in full compliance with fundamental rights and respect for human dignity, as well as the best interests of the child and taking utmost account of developments in the relevant case law, in particular as regards transfers on humanitarian grounds.
(25)
The progressive creation of an area without internal frontiers in which free movement of persons is guaranteed in accordance with the TFEU and the establishment of Union policies regarding the conditions of entry and stay of third-country nationals, including common efforts towards the management of external borders, makes it necessary to strike a balance between responsibility criteria in a spirit of solidarity.
(26)
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (10) applies to the processing of personal data by the Member States under this Regulation.
(27)
The exchange of an applicant’s personal data, including sensitive data on his or her health, prior to a transfer, will ensure that the competent asylum authorities are in a position to provide applicants with adequate assistance and to ensure continuity in the protection and rights afforded to them. Special provisions should be made to ensure the protection of data relating to applicants involved in that situation, in accordance with Directive 95/46/EC.
(28)
The application of this Regulation can be facilitated, and its effectiveness increased, by bilateral arrangements between Member States for improving communication between competent departments, reducing time limits for procedures or simplifying the processing of requests to take charge or take back, or establishing procedures for the performance of transfers.
(29)
Continuity between the system for determining the Member State responsible established by Regulation (EC) No 343/2003 and the system established by this Regulation should be ensured. Similarly, consistency should be ensured between this Regulation and Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of ‘Eurodac’ for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparisons with Eurodac data by Member States’ law enforcement authorities and Europol for law enforcement purposes (11).
(30)
The operation of the Eurodac system, as established by Regulation (EU) No 603/2013, should facilitate the application of this Regulation.
(31)
The operation of the Visa Information System, as established by Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (12), and in particular the implementation of Articles 21 and 22 thereof, should facilitate the application of this Regulation.
(32)
With respect to the treatment of persons falling within the scope of this Regulation, Member States are bound by their obligations under instruments of international law, including the relevant case-law of the European Court of Human Rights.
(33)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (13).
(34)
The examination procedure should be used for the adoption of a common leaflet on Dublin/Eurodac, as well as a specific leaflet for unaccompanied minors; of a standard form for the exchange of relevant information on unaccompanied minors; of uniform conditions for the consultation and exchange of information on minors and dependent persons; of uniform conditions on the preparation and submission of take charge and take back requests; of two lists of relevant elements of proof and circumstantial evidence, and the periodical revision thereof; of a laissez passer; of uniform conditions for the consultation and exchange of information regarding transfers; of a standard form for the exchange of data before a transfer; of a common health certificate; of uniform conditions and practical arrangements for the exchange of information on a person’s health data before a transfer, and of secure electronic transmission channels for the transmission of requests.
(35)
In order to provide for supplementary rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification of family members, siblings or relatives of an unaccompanied minor; the criteria for establishing the existence of proven family links; the criteria for assessing the capacity of a relative to take care of an unaccompanied minor, including where family members, siblings or relatives of the unaccompanied minor stay in more than one Member State; the elements for assessing a dependency link; the criteria for assessing the capacity of a person to take care of a dependent person and the elements to be taken into account in order to assess the inability to travel for a significant period of time. In exercising its powers to adopt delegated acts, the Commission shall not exceed the scope of the best interests of the child as provided for under Article 6(3) of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(36)
In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from, among others, all relevant national authorities.
(37)
Detailed rules for the application of Regulation (EC) No 343/2003 have been laid down by Regulation (EC) No 1560/2003. Certain provisions of Regulation (EC) No 1560/2003 should be incorporated into this Regulation, either for reasons of clarity or because they can serve a general objective. In particular, it is important, both for the Member States and the applicants concerned, that there should be a general mechanism for finding a solution in cases where Member States differ over the application of a provision of this Regulation. It is therefore justified to incorporate the mechanism provided for in Regulation (EC) No 1560/2003 for the settling of disputes on the humanitarian clause into this Regulation and to extend its scope to the entirety of this Regulation.
(38)
The effective monitoring of the application of this Regulation requires that it be evaluated at regular intervals.
(39)
This Regulation respects the fundamental rights and observes the principles which are acknowledged, in particular, in the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full observance of the right to asylum guaranteed by Article 18 of the Charter as well as the rights recognised under Articles 1, 4, 7, 24 and 47 thereof. This Regulation should therefore be applied accordingly.
(40)
Since the objective of this Regulation, namely the establishment of criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(41)
In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the TFEU, those Member States have notified their wish to take part in the adoption and application of this Regulation.
(42)
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (‘the Member State responsible’).
Article 2
Definitions
For the purposes of this Regulation:
(a)
‘third-country national’ means any person who is not a citizen of the Union within the meaning of Article 20(1) TFEU and who is not national of a State which participates in this Regulation by virtue of an agreement with the European Union;
(b)
‘application for international protection’ means an application for international protection as defined in Article 2(h) of Directive 2011/95/EU;
(c)
‘applicant’ means a third-country national or a stateless person who has made an application for international protection in respect of which a final decision has not yet been taken;
(d)
‘examination of an application for international protection’ means any examination of, or decision or ruling concerning, an application for international protection by the competent authorities in accordance with Directive 2013/32/EU and Directive 2011/95/EU, except for procedures for determining the Member State responsible in accordance with this Regulation;
(e)
‘withdrawal of an application for international protection’ means the actions by which the applicant terminates the procedures initiated by the submission of his or her application for international protection, in accordance with Directive 2013/32/EU, either explicitly or tacitly;
(f)
‘beneficiary of international protection’ means a third-country national or a stateless person who has been granted international protection as defined in Article 2(a) of Directive 2011/95/EU;
(g)
‘family members’ means, insofar as the family already existed in the country of origin, the following members of the applicant’s family who are present on the territory of the Member States:
—
the spouse of the applicant or his or her unmarried partner in a stable relationship, where the law or practice of the Member State concerned treats unmarried couples in a way comparable to married couples under its law relating to third-country nationals,
—
the minor children of couples referred to in the first indent or of the applicant, on condition that they are unmarried and regardless of whether they were born in or out of wedlock or adopted as defined under national law,
—
when the applicant is a minor and unmarried, the father, mother or another adult responsible for the applicant, whether by law or by the practice of the Member State where the adult is present,
—
when the beneficiary of international protection is a minor and unmarried, the father, mother or another adult responsible for him or her whether by law or by the practice of the Member State where the beneficiary is present;
(h)
‘relative’ means the applicant’s adult aunt or uncle or grandparent who is present in the territory of a Member State, regardless of whether the applicant was born in or out of wedlock or adopted as defined under national law;
(i)
‘minor’ means a third-country national or a stateless person below the age of 18 years;
(j)
‘unaccompanied minor’ means a minor who arrives on the territory of the Member States unaccompanied by an adult responsible for him or her, whether by law or by the practice of the Member State concerned, and for as long as he or she is not effectively taken into the care of such an adult; it includes a minor who is left unaccompanied after he or she has entered the territory of Member States;
(k)
‘representative’ means a person or an organisation appointed by the competent bodies in order to assist and represent an unaccompanied minor in procedures provided for in this Regulation with a view to ensuring the best interests of the child and exercising legal capacity for the minor where necessary. Where an organisation is appointed as a representative, it shall designate a person responsible for carrying out its duties in respect of the minor, in accordance with this Regulation;
(l)
‘residence document’ means any authorisation issued by the authorities of a Member State authorising a third-country national or a stateless person to stay on its territory, including the documents substantiating the authorisation to remain on the territory under temporary protection arrangements or until the circumstances preventing a removal order from being carried out no longer apply, with the exception of visas and residence authorisations issued during the period required to determine the Member State responsible as established in this Regulation or during the examination of an application for international protection or an application for a residence permit;
(m)
‘visa’ means the authorisation or decision of a Member State required for transit or entry for an intended stay in that Member State or in several Member States. The nature of the visa shall be determined in accordance with the following definitions:
—
‘long-stay visa’ means an authorisation or decision issued by one of the Member States in accordance with its national law or Union law required for entry for an intended stay in that Member State of more than three months,
—
‘short-stay visa’ means an authorisation or decision of a Member State with a view to transit through or an intended stay on the territory of one or more or all the Member States of a duration of no more than three months in any six-month period beginning on the date of first entry on the territory of the Member States,
—
‘airport transit visa’ means a visa valid for transit through the international transit areas of one or more airports of the Member States;
(n)
‘risk of absconding’ means the existence of reasons in an individual case, which are based on objective criteria defined by law, to believe that an applicant or a third-country national or a stateless person who is subject to a transfer procedure may abscond.
CHAPTER II
GENERAL PRINCIPLES AND SAFEGUARDS
Article 3
Access to the procedure for examining an application for international protection
1. Member States shall examine any application for international protection by a third-country national or a stateless person who applies on the territory of any one of them, including at the border or in the transit zones. The application shall be examined by a single Member State, which shall be the one which the criteria set out in Chapter III indicate is responsible.
2. Where no Member State responsible can be designated on the basis of the criteria listed in this Regulation, the first Member State in which the application for international protection was lodged shall be responsible for examining it.
Where it is impossible to transfer an applicant to the Member State primarily designated as responsible because there are substantial grounds for believing that there are systemic flaws in the asylum procedure and in the reception conditions for applicants in that Member State, resulting in a risk of inhuman or degrading treatment within the meaning of Article 4 of the Charter of Fundamental Rights of the European Union, the determining Member State shall continue to examine the criteria set out in Chapter III in order to establish whether another Member State can be designated as responsible.
Where the transfer cannot be made pursuant to this paragraph to any Member State designated on the basis of the criteria set out in Chapter III or to the first Member State with which the application was lodged, the determining Member State shall become the Member State responsible.
3. Any Member State shall retain the right to send an applicant to a safe third country, subject to the rules and safeguards laid down in Directive 2013/32/EU.
Article 4
Right to information
1. As soon as an application for international protection is lodged within the meaning of Article 20(2) in a Member State, its competent authorities shall inform the applicant of the application of this Regulation, and in particular of:
(a)
the objectives of this Regulation and the consequences of making another application in a different Member State as well as the consequences of moving from one Member State to another during the phases in which the Member State responsible under this Regulation is being determined and the application for international protection is being examined;
(b)
the criteria for determining the Member State responsible, the hierarchy of such criteria in the different steps of the procedure and their duration, including the fact that an application for international protection lodged in one Member State can result in that Member State becoming responsible under this Regulation even if such responsibility is not based on those criteria;
(c)
the personal interview pursuant to Article 5 and the possibility of submitting information regarding the presence of family members, relatives or any other family relations in the Member States, including the means by which the applicant can submit such information;
(d)
the possibility to challenge a transfer decision and, where applicable, to apply for a suspension of the transfer;
(e)
the fact that the competent authorities of Member States can exchange data on him or her for the sole purpose of implementing their obligations arising under this Regulation;
(f)
the right of access to data relating to him or her and the right to request that such data be corrected if inaccurate or be deleted if unlawfully processed, as well as the procedures for exercising those rights, including the contact details of the authorities referred to in Article 35 and of the national data protection authorities responsible for hearing claims concerning the protection of personal data.
2. The information referred to in paragraph 1 shall be provided in writing in a language that the applicant understands or is reasonably supposed to understand. Member States shall use the common leaflet drawn up pursuant to paragraph 3 for that purpose.
Where necessary for the proper understanding of the applicant, the information shall also be supplied orally, for example in connection with the personal interview as referred to in Article 5.
3. The Commission shall, by means of implementing acts, draw up a common leaflet, as well as a specific leaflet for unaccompanied minors, containing at least the information referred to in paragraph 1 of this Article. This common leaflet shall also include information regarding the application of Regulation (EU) No 603/2013 and, in particular, the purpose for which the data of an applicant may be processed within Eurodac. The common leaflet shall be established in such a manner as to enable Member States to complete it with additional Member State-specific information. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2) of this Regulation.
Article 5
Personal interview
1. In order to facilitate the process of determining the Member State responsible, the determining Member State shall conduct a personal interview with the applicant. The interview shall also allow the proper understanding of the information supplied to the applicant in accordance with Article 4.
2. The personal interview may be omitted if:
(a)
the applicant has absconded; or
(b)
after having received the information referred to in Article 4, the applicant has already provided the information relevant to determine the Member State responsible by other means. The Member State omitting the interview shall give the applicant the opportunity to present all further information which is relevant to correctly determine the Member State responsible before a decision is taken to transfer the applicant to the Member State responsible pursuant to Article 26(1).
3. The personal interview shall take place in a timely manner and, in any event, before any decision is taken to transfer the applicant to the Member State responsible pursuant to Article 26(1).
4. The personal interview shall be conducted in a language that the applicant understands or is reasonably supposed to understand and in which he or she is able to communicate. Where necessary, Member States shall have recourse to an interpreter who is able to ensure appropriate communication between the applicant and the person conducting the personal interview.
5. The personal interview shall take place under conditions which ensure appropriate confidentiality. It shall be conducted by a qualified person under national law.
6. The Member State conducting the personal interview shall make a written summary thereof which shall contain at least the main information supplied by the applicant at the interview. This summary may either take the form of a report or a standard form. The Member State shall ensure that the applicant and/or the legal advisor or other counsellor who is representing the applicant have timely access to the summary.
Article 6
Guarantees for minors
1. The best interests of the child shall be a primary consideration for Member States with respect to all procedures provided for in this Regulation.
2. Member States shall ensure that a representative represents and/or assists an unaccompanied minor with respect to all procedures provided for in this Regulation. The representative shall have the qualifications and expertise to ensure that the best interests of the minor are taken into consideration during the procedures carried out under this Regulation. Such representative shall have access to the content of the relevant documents in the applicant’s file including the specific leaflet for unaccompanied minors.
This paragraph shall be without prejudice to the relevant provisions in Article 25 of Directive 2013/32/EU.
3. In assessing the best interests of the child, Member States shall closely cooperate with each other and shall, in particular, take due account of the following factors:
(a)
family reunification possibilities;
(b)
the minor’s well-being and social development;
(c)
safety and security considerations, in particular where there is a risk of the minor being a victim of human trafficking;
(d)
the views of the minor, in accordance with his or her age and maturity.
4. For the purpose of applying Article 8, the Member State where the unaccompanied minor lodged an application for international protection shall, as soon as possible, take appropriate action to identify the family members, siblings or relatives of the unaccompanied minor on the territory of Member States, whilst protecting the best interests of the child.
To that end, that Member State may call for the assistance of international or other relevant organisations, and may facilitate the minor’s access to the tracing services of such organisations.
The staff of the competent authorities referred to in Article 35 who deal with requests concerning unaccompanied minors shall have received, and shall continue to receive, appropriate training concerning the specific needs of minors.
5. With a view to facilitating the appropriate action to identify the family members, siblings or relatives of the unaccompanied minor living in the territory of another Member State pursuant to paragraph 4 of this Article, the Commission shall adopt implementing acts including a standard form for the exchange of relevant information between Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
CHAPTER III
CRITERIA FOR DETERMINING THE MEMBER STATE RESPONSIBLE
Article 7
Hierarchy of criteria
1. The criteria for determining the Member State responsible shall be applied in the order in which they are set out in this Chapter.
2. The Member State responsible in accordance with the criteria set out in this Chapter shall be determined on the basis of the situation obtaining when the applicant first lodged his or her application for international protection with a Member State.
3. In view of the application of the criteria referred to in Articles 8, 10 and 16, Member States shall take into consideration any available evidence regarding the presence, on the territory of a Member State, of family members, relatives or any other family relations of the applicant, on condition that such evidence is produced before another Member State accepts the request to take charge or take back the person concerned, pursuant to Articles 22 and 25 respectively, and that the previous applications for international protection of the applicant have not yet been the subject of a first decision regarding the substance.
Article 8
Minors
1. Where the applicant is an unaccompanied minor, the Member State responsible shall be that where a family member or a sibling of the unaccompanied minor is legally present, provided that it is in the best interests of the minor. Where the applicant is a married minor whose spouse is not legally present on the territory of the Member States, the Member State responsible shall be the Member State where the father, mother or other adult responsible for the minor, whether by law or by the practice of that Member State, or sibling is legally present.
2. Where the applicant is an unaccompanied minor who has a relative who is legally present in another Member State and where it is established, based on an individual examination, that the relative can take care of him or her, that Member State shall unite the minor with his or her relative and shall be the Member State responsible, provided that it is in the best interests of the minor.
3. Where family members, siblings or relatives as referred to in paragraphs 1 and 2, stay in more than one Member State, the Member State responsible shall be decided on the basis of what is in the best interests of the unaccompanied minor.
4. In the absence of a family member, a sibling or a relative as referred to in paragraphs 1 and 2, the Member State responsible shall be that where the unaccompanied minor has lodged his or her application for international protection, provided that it is in the best interests of the minor.
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 45 concerning the identification of family members, siblings or relatives of the unaccompanied minor; the criteria for establishing the existence of proven family links; the criteria for assessing the capacity of a relative to take care of the unaccompanied minor, including where family members, siblings or relatives of the unaccompanied minor stay in more than one Member State. In exercising its powers to adopt delegated acts, the Commission shall not exceed the scope of the best interests of the child as provided for under Article 6(3).
6. The Commission shall, by means of implementing acts, establish uniform conditions for the consultation and the exchange of information between Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 9
Family members who are beneficiaries of international protection
Where the applicant has a family member, regardless of whether the family was previously formed in the country of origin, who has been allowed to reside as a beneficiary of international protection in a Member State, that Member State shall be responsible for examining the application for international protection, provided that the persons concerned expressed their desire in writing.
Article 10
Family members who are applicants for international protection
If the applicant has a family member in a Member State whose application for international protection in that Member State has not yet been the subject of a first decision regarding the substance, that Member State shall be responsible for examining the application for international protection, provided that the persons concerned expressed their desire in writing.
Article 11
Family procedure
Where several family members and/or minor unmarried siblings submit applications for international protection in the same Member State simultaneously, or on dates close enough for the procedures for determining the Member State responsible to be conducted together, and where the application of the criteria set out in this Regulation would lead to their being separated, the Member State responsible shall be determined on the basis of the following provisions:
(a)
responsibility for examining the applications for international protection of all the family members and/or minor unmarried siblings shall lie with the Member State which the criteria indicate is responsible for taking charge of the largest number of them;
(b)
failing this, responsibility shall lie with the Member State which the criteria indicate is responsible for examining the application of the oldest of them.
Article 12
Issue of residence documents or visas
1. Where the applicant is in possession of a valid residence document, the Member State which issued the document shall be responsible for examining the application for international protection.
2. Where the applicant is in possession of a valid visa, the Member State which issued the visa shall be responsible for examining the application for international protection, unless the visa was issued on behalf of another Member State under a representation arrangement as provided for in Article 8 of Regulation (EC) No 810/2009 of the European Parliament and of the Council, of 13 July 2009, establishing a Community Code on Visas (14). In such a case, the represented Member State shall be responsible for examining the application for international protection.
3. Where the applicant is in possession of more than one valid residence document or visa issued by different Member States, the responsibility for examining the application for international protection shall be assumed by the Member States in the following order:
(a)
the Member State which issued the residence document conferring the right to the longest period of residency or, where the periods of validity are identical, the Member State which issued the residence document having the latest expiry date;
(b)
the Member State which issued the visa having the latest expiry date where the various visas are of the same type;
(c)
where visas are of different kinds, the Member State which issued the visa having the longest period of validity or, where the periods of validity are identical, the Member State which issued the visa having the latest expiry date.
4. Where the applicant is in possession only of one or more residence documents which have expired less than two years previously or one or more visas which have expired less than six months previously and which enabled him or her actually to enter the territory of a Member State, paragraphs 1, 2 and 3 shall apply for such time as the applicant has not left the territories of the Member States.
Where the applicant is in possession of one or more residence documents which have expired more than two years previously or one or more visas which have expired more than six months previously and enabled him or her actually to enter the territory of a Member State and where he has not left the territories of the Member States, the Member State in which the application for international protection is lodged shall be responsible.
5. The fact that the residence document or visa was issued on the basis of a false or assumed identity or on submission of forged, counterfeit or invalid documents shall not prevent responsibility being allocated to the Member State which issued it. However, the Member State issuing the residence document or visa shall not be responsible if it can establish that a fraud was committed after the document or visa had been issued.
Article 13
Entry and/or stay
1. Where it is established, on the basis of proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) of this Regulation, including the data referred to in Regulation (EU) No 603/2013, that an applicant has irregularly crossed the border into a Member State by land, sea or air having come from a third country, the Member State thus entered shall be responsible for examining the application for international protection. That responsibility shall cease 12 months after the date on which the irregular border crossing took place.
2. When a Member State cannot or can no longer be held responsible in accordance with paragraph 1 of this Article and where it is established, on the basis of proof or circumstantial evidence as described in the two lists mentioned in Article 22(3), that the applicant — who has entered the territories of the Member States irregularly or whose circumstances of entry cannot be established — has been living for a continuous period of at least five months in a Member State before lodging the application for international protection, that Member State shall be responsible for examining the application for international protection.
If the applicant has been living for periods of time of at least five months in several Member States, the Member State where he or she has been living most recently shall be responsible for examining the application for international protection.
Article 14
Visa waived entry
1. If a third-country national or a stateless person enters into the territory of a Member State in which the need for him or her to have a visa is waived, that Member State shall be responsible for examining his or her application for international protection.
2. The principle set out in paragraph 1 shall not apply if the third-country national or the stateless person lodges his or her application for international protection in another Member State in which the need for him or her to have a visa for entry into the territory is also waived. In that case, that other Member State shall be responsible for examining the application for international protection.
Article 15
Application in an international transit area of an airport
Where the application for international protection is made in the international transit area of an airport of a Member State by a third-country national or a stateless person, that Member State shall be responsible for examining the application.
CHAPTER IV
DEPENDENT PERSONS AND DISCRETIONARY CLAUSES
Article 16
Dependent persons
1. Where, on account of pregnancy, a new-born child, serious illness, severe disability or old age, an applicant is dependent on the assistance of his or her child, sibling or parent legally resident in one of the Member States, or his or her child, sibling or parent legally resident in one of the Member States is dependent on the assistance of the applicant, Member States shall normally keep or bring together the applicant with that child, sibling or parent, provided that family ties existed in the country of origin, that the child, sibling or parent or the applicant is able to take care of the dependent person and that the persons concerned expressed their desire in writing.
2. Where the child, sibling or parent referred to in paragraph 1 is legally resident in a Member State other than the one where the applicant is present, the Member State responsible shall be the one where the child, sibling or parent is legally resident unless the applicant’s health prevents him or her from travelling to that Member State for a significant period of time. In such a case, the Member State responsible shall be the one where the applicant is present. Such Member State shall not be subject to the obligation to bring the child, sibling or parent of the applicant to its territory.
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 45 concerning the elements to be taken into account in order to assess the dependency link, the criteria for establishing the existence of proven family links, the criteria for assessing the capacity of the person concerned to take care of the dependent person and the elements to be taken into account in order to assess the inability to travel for a significant period of time.
4. The Commission shall, by means of implementing acts, establish uniform conditions for the consultation and exchange of information between Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 17
Discretionary clauses
1. By way of derogation from Article 3(1), each Member State may decide to examine an application for international protection lodged with it by a third-country national or a stateless person, even if such examination is not its responsibility under the criteria laid down in this Regulation.
The Member State which decides to examine an application for international protection pursuant to this paragraph shall become the Member State responsible and shall assume the obligations associated with that responsibility. Where applicable, it shall inform, using the ‘DubliNet’ electronic communication network set up under Article 18 of Regulation (EC) No 1560/2003, the Member State previously responsible, the Member State conducting a procedure for determining the Member State responsible or the Member State which has been requested to take charge of, or to take back, the applicant.
The Member State which becomes responsible pursuant to this paragraph shall forthwith indicate it in Eurodac in accordance with Regulation (EU) No 603/2013 by adding the date when the decision to examine the application was taken.
2. The Member State in which an application for international protection is made and which is carrying out the process of determining the Member State responsible, or the Member State responsible, may, at any time before a first decision regarding the substance is taken, request another Member State to take charge of an applicant in order to bring together any family relations, on humanitarian grounds based in particular on family or cultural considerations, even where that other Member State is not responsible under the criteria laid down in Articles 8 to 11 and 16. The persons concerned must express their consent in writing.
The request to take charge shall contain all the material in the possession of the requesting Member State to allow the requested Member State to assess the situation.
The requested Member State shall carry out any necessary checks to examine the humanitarian grounds cited, and shall reply to the requesting Member State within two months of receipt of the request using the ‘DubliNet’ electronic communication network set up under Article 18 of Regulation (EC) No 1560/2003. A reply refusing the request shall state the reasons on which the refusal is based.
Where the requested Member State accepts the request, responsibility for examining the application shall be transferred to it.
CHAPTER V
OBLIGATIONS OF THE MEMBER STATE RESPONSIBLE
Article 18
Obligations of the Member State responsible
1. The Member State responsible under this Regulation shall be obliged to:
(a)
take charge, under the conditions laid down in Articles 21, 22 and 29, of an applicant who has lodged an application in a different Member State;
(b)
take back, under the conditions laid down in Articles 23, 24, 25 and 29, an applicant whose application is under examination and who made an application in another Member State or who is on the territory of another Member State without a residence document;
(c)
take back, under the conditions laid down in Articles 23, 24, 25 and 29, a third-country national or a stateless person who has withdrawn the application under examination and made an application in another Member State or who is on the territory of another Member State without a residence document;
(d)
take back, under the conditions laid down in Articles 23, 24, 25 and 29, a third-country national or a stateless person whose application has been rejected and who made an application in another Member State or who is on the territory of another Member State without a residence document.
2. In the cases falling within the scope of paragraph 1(a) and (b), the Member State responsible shall examine or complete the examination of the application for international protection made by the applicant.
In the cases falling within the scope of paragraph 1(c), when the Member State responsible had discontinued the examination of an application following its withdrawal by the applicant before a decision on the substance has been taken at first instance, that Member State shall ensure that the applicant is entitled to request that the examination of his or her application be completed or to lodge a new application for international protection, which shall not be treated as a subsequent application as provided for in Directive 2013/32/EU. In such cases, Member States shall ensure that the examination of the application is completed.
In the cases falling within the scope of paragraph 1(d), where the application has been rejected at first instance only, the Member State responsible shall ensure that the person concerned has or has had the opportunity to seek an effective remedy pursuant to Article 46 of Directive 2013/32/EU.
Article 19
Cessation of responsibilities
1. Where a Member State issues a residence document to the applicant, the obligations specified in Article 18(1) shall be transferred to that Member State.
2. The obligations specified in Article 18(1) shall cease where the Member State responsible can establish, when requested to take charge or take back an applicant or another person as referred to in Article 18(1)(c) or (d), that the person concerned has left the territory of the Member States for at least three months, unless the person concerned is in possession of a valid residence document issued by the Member State responsible.
An application lodged after the period of absence referred to in the first subparagraph shall be regarded as a new application giving rise to a new procedure for determining the Member State responsible.
3. The obligations specified in Article 18(1)(c) and (d) shall cease where the Member State responsible can establish, when requested to take back an applicant or another person as referred to in Article 18(1)(c) or (d), that the person concerned has left the territory of the Member States in compliance with a return decision or removal order issued following the withdrawal or rejection of the application.
An application lodged after an effective removal has taken place shall be regarded as a new application giving rise to a new procedure for determining the Member State responsible.
CHAPTER VI
PROCEDURES FOR TAKING CHARGE AND TAKING BACK
SECTION I
Start of the procedure
Article 20
Start of the procedure
1. The process of determining the Member State responsible shall start as soon as an application for international protection is first lodged with a Member State.
2. An application for international protection shall be deemed to have been lodged once a form submitted by the applicant or a report prepared by the authorities has reached the competent authorities of the Member State concerned. Where an application is not made in writing, the time elapsing between the statement of intention and the preparation of a report should be as short as possible.
3. For the purposes of this Regulation, the situation of a minor who is accompanying the applicant and meets the definition of family member shall be indissociable from that of his or her family member and shall be a matter for the Member State responsible for examining the application for international protection of that family member, even if the minor is not individually an applicant, provided that it is in the minor’s best interests. The same treatment shall be applied to children born after the applicant arrives on the territory of the Member States, without the need to initiate a new procedure for taking charge of them.
4. Where an application for international protection is lodged with the competent authorities of a Member State by an applicant who is on the territory of another Member State, the determination of the Member State responsible shall be made by the Member State in whose territory the applicant is present. The latter Member State shall be informed without delay by the Member State which received the application and shall then, for the purposes of this Regulation, be regarded as the Member State with which the application for international protection was lodged.
The applicant shall be informed in writing of this change in the determining Member State and of the date on which it took place.
5. An applicant who is present in another Member State without a residence document or who there lodges an application for international protection after withdrawing his or her first application made in a different Member State during the process of determining the Member State responsible shall be taken back, under the conditions laid down in Articles 23, 24, 25 and 29, by the Member State with which that application for international protection was first lodged, with a view to completing the process of determining the Member State responsible.
That obligation shall cease where the Member State requested to complete the process of determining the Member State responsible can establish that the applicant has in the meantime left the territory of the Member States for a period of at least three months or has obtained a residence document from another Member State.
An application lodged after the period of absence referred to in the second subparagraph shall be regarded as a new application giving rise to a new procedure for determining the Member State responsible.
SECTION II
Procedures for take charge requests
Article 21
Submitting a take charge request
1. Where a Member State with which an application for international protection has been lodged considers that another Member State is responsible for examining the application, it may, as quickly as possible and in any event within three months of the date on which the application was lodged within the meaning of Article 20(2), request that other Member State to take charge of the applicant.
Notwithstanding the first subparagraph, in the case of a Eurodac hit with data recorded pursuant to Article 14 of Regulation (EU) No 603/2013, the request shall be sent within two months of receiving that hit pursuant to Article 15(2) of that Regulation.
Where the request to take charge of an applicant is not made within the periods laid down in the first and second subparagraphs, responsibility for examining the application for international protection shall lie with the Member State in which the application was lodged.
2. The requesting Member State may ask for an urgent reply in cases where the application for international protection was lodged after leave to enter or remain was refused, after an arrest for an unlawful stay or after the service or execution of a removal order.
The request shall state the reasons warranting an urgent reply and the period within which a reply is expected. That period shall be at least one week.
3. In the cases referred to in paragraphs 1 and 2, the request that charge be taken by another Member State shall be made using a standard form and including proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) and/or relevant elements from the applicant’s statement, enabling the authorities of the requested Member State to check whether it is responsible on the basis of the criteria laid down in this Regulation.
The Commission shall, by means of implementing acts, adopt uniform conditions on the preparation and submission of take charge requests. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 22
Replying to a take charge request
1. The requested Member State shall make the necessary checks, and shall give a decision on the request to take charge of an applicant within two months of receipt of the request.
2. In the procedure for determining the Member State responsible elements of proof and circumstantial evidence shall be used.
3. The Commission shall, by means of implementing acts, establish, and review periodically, two lists, indicating the relevant elements of proof and circumstantial evidence in accordance with the criteria set out in points (a) and (b) of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
(a)
Proof:
(i)
this refers to formal proof which determines responsibility pursuant to this Regulation, as long as it is not refuted by proof to the contrary;
(ii)
the Member States shall provide the Committee provided for in Article 44 with models of the different types of administrative documents, in accordance with the typology established in the list of formal proofs;
(b)
Circumstantial evidence:
(i)
this refers to indicative elements which while being refutable may be sufficient, in certain cases, according to the evidentiary value attributed to them;
(ii)
their evidentiary value, in relation to the responsibility for examining the application for international protection shall be assessed on a case-by-case basis.
4. The requirement of proof should not exceed what is necessary for the proper application of this Regulation.
5. If there is no formal proof, the requested Member State shall acknowledge its responsibility if the circumstantial evidence is coherent, verifiable and sufficiently detailed to establish responsibility.
6. Where the requesting Member State has pleaded urgency in accordance with the provisions of Article 21(2), the requested Member State shall make every effort to comply with the time limit requested. In exceptional cases, where it can be demonstrated that the examination of a request for taking charge of an applicant is particularly complex, the requested Member State may give its reply after the time limit requested, but in any event within one month. In such situations the requested Member State must communicate its decision to postpone a reply to the requesting Member State within the time limit originally requested.
7. Failure to act within the two-month period mentioned in paragraph 1 and the one-month period mentioned in paragraph 6 shall be tantamount to accepting the request, and entail the obligation to take charge of the person, including the obligation to provide for proper arrangements for arrival.
SECTION III
Procedures for take back requests
Article 23
Submitting a take back request when a new application has been lodged in the requesting Member State
1. Where a Member State with which a person as referred to in Article 18(1)(b), (c) or (d) has lodged a new application for international protection considers that another Member State is responsible in accordance with Article 20(5) and Article 18(1)(b), (c) or (d), it may request that other Member State to take back that person.
2. A take back request shall be made as quickly as possible and in any event within two months of receiving the Eurodac hit, pursuant to Article 9(5) of Regulation (EU) No 603/2013.
If the take back request is based on evidence other than data obtained from the Eurodac system, it shall be sent to the requested Member State within three months of the date on which the application for international protection was lodged within the meaning of Article 20(2).
3. Where the take back request is not made within the periods laid down in paragraph 2, responsibility for examining the application for international protection shall lie with the Member State in which the new application was lodged.
4. A take back request shall be made using a standard form and shall include proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) and/or relevant elements from the statements of the person concerned, enabling the authorities of the requested Member State to check whether it is responsible on the basis of the criteria laid down in this Regulation.
The Commission shall, by means of implementing acts, adopt uniform conditions for the preparation and submission of take back requests. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 24
Submitting a take back request when no new application has been lodged in the requesting Member State
1. Where a Member State on whose territory a person as referred to in Article 18(1)(b), (c) or (d) is staying without a residence document and with which no new application for international protection has been lodged considers that another Member State is responsible in accordance with Article 20(5) and Article 18(1)(b), (c) or (d), it may request that other Member State to take back that person.
2. By way of derogation from Article 6(2) of Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (15), where a Member State on whose territory a person is staying without a residence document decides to search the Eurodac system in accordance with Article 17 of Regulation (EU) No 603/2013, the request to take back a person as referred to in Article 18(1)(b) or (c) of this Regulation, or a person as referred to in its Article 18(1)(d) whose application for international protection has not been rejected by a final decision, shall be made as quickly as possible and in any event within two months of receipt of the Eurodac hit, pursuant to Article 17(5) of Regulation (EU) No 603/2013.
If the take back request is based on evidence other than data obtained from the Eurodac system, it shall be sent to the requested Member State within three months of the date on which the requesting Member State becomes aware that another Member State may be responsible for the person concerned.
3. Where the take back request is not made within the periods laid down in paragraph 2, the Member State on whose territory the person concerned is staying without a residence document shall give that person the opportunity to lodge a new application.
4. Where a person as referred to in Article 18(1)(d) of this Regulation whose application for international protection has been rejected by a final decision in one Member State is on the territory of another Member State without a residence document, the latter Member State may either request the former Member State to take back the person concerned or carry out a return procedure in accordance with Directive 2008/115/EC.
When the latter Member State decides to request the former Member State to take back the person concerned, the rules laid down in Directive 2008/115/EC shall not apply.
5. The request for the person referred to in Article 18(1)(b), (c) or (d) to be taken back shall be made using a standard form and shall include proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) and/or relevant elements from the person’s statements, enabling the authorities of the requested Member State to check whether it is responsible on the basis of the criteria laid down in this Regulation.
The Commission shall, by means of implementing acts, establish and review periodically two lists indicating the relevant elements of proof and circumstantial evidence in accordance with the criteria set out in Article 22(3)(a) and (b), and shall adopt uniform conditions for the preparation and submission of take back requests. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 25
Replying to a take back request
1. The requested Member State shall make the necessary checks and shall give a decision on the request to take back the person concerned as quickly as possible and in any event no later than one month from the date on which the request was received. When the request is based on data obtained from the Eurodac system, that time limit shall be reduced to two weeks.
2. Failure to act within the one month period or the two weeks period mentioned in paragraph 1 shall be tantamount to accepting the request, and shall entail the obligation to take back the person concerned, including the obligation to provide for proper arrangements for arrival.
SECTION IV
Procedural safeguards
Article 26
Notification of a transfer decision
1. Where the requested Member State accepts to take charge of or to take back an applicant or other person as referred to in Article 18(1)(c) or (d), the requesting Member State shall notify the person concerned of the decision to transfer him or her to the Member State responsible and, where applicable, of not examining his or her application for international protection. If a legal advisor or other counsellor is representing the person concerned, Member States may choose to notify the decision to such legal advisor or counsellor instead of to the person concerned and, where applicable, communicate the decision to the person concerned.
2. The decision referred to in paragraph 1 shall contain information on the legal remedies available, including on the right to apply for suspensive effect, where applicable, and on the time limits applicable for seeking such remedies and for carrying out the transfer, and shall, if necessary, contain information on the place where, and the date on which, the person concerned should appear, if that person is travelling to the Member State responsible by his or her own means.
Member States shall ensure that information on persons or entities that may provide legal assistance to the person concerned is communicated to the person concerned together with the decision referred to in paragraph 1, when that information has not been already communicated.
3. When the person concerned is not assisted or represented by a legal advisor or other counsellor, Member States shall inform him or her of the main elements of the decision, which shall always include information on the legal remedies available and the time limits applicable for seeking such remedies, in a language that the person concerned understands or is reasonably supposed to understand.
Article 27
Remedies
1. The applicant or another person as referred to in Article 18(1)(c) or (d) shall have the right to an effective remedy, in the form of an appeal or a review, in fact and in law, against a transfer decision, before a court or tribunal.
2. Member States shall provide for a reasonable period of time within which the person concerned may exercise his or her right to an effective remedy pursuant to paragraph 1.
3. For the purposes of appeals against, or reviews of, transfer decisions, Member States shall provide in their national law that:
(a)
the appeal or review confers upon the person concerned the right to remain in the Member State concerned pending the outcome of the appeal or review; or
(b)
the transfer is automatically suspended and such suspension lapses after a certain reasonable period of time, during which a court or a tribunal, after a close and rigorous scrutiny, shall have taken a decision whether to grant suspensive effect to an appeal or review; or
(c)
the person concerned has the opportunity to request within a reasonable period of time a court or tribunal to suspend the implementation of the transfer decision pending the outcome of his or her appeal or review. Member States shall ensure that an effective remedy is in place by suspending the transfer until the decision on the first suspension request is taken. Any decision on whether to suspend the implementation of the transfer decision shall be taken within a reasonable period of time, while permitting a close and rigorous scrutiny of the suspension request. A decision not to suspend the implementation of the transfer decision shall state the reasons on which it is based.
4. Member States may provide that the competent authorities may decide, acting ex officio, to suspend the implementation of the transfer decision pending the outcome of the appeal or review.
5. Member States shall ensure that the person concerned has access to legal assistance and, where necessary, to linguistic assistance.
6. Member States shall ensure that legal assistance is granted on request free of charge where the person concerned cannot afford the costs involved. Member States may provide that, as regards fees and other costs, the treatment of applicants shall not be more favourable than the treatment generally accorded to their nationals in matters pertaining to legal assistance.
Without arbitrarily restricting access to legal assistance, Member States may provide that free legal assistance and representation not be granted where the appeal or review is considered by the competent authority or a court or tribunal to have no tangible prospect of success.
Where a decision not to grant free legal assistance and representation pursuant to this paragraph is taken by an authority other than a court or tribunal, Member States shall provide the right to an effective remedy before a court or tribunal to challenge that decision.
In complying with the requirements set out in this paragraph, Member States shall ensure that legal assistance and representation is not arbitrarily restricted and that the applicant’s effective access to justice is not hindered.
Legal assistance shall include at least the preparation of the required procedural documents and representation before a court or tribunal and may be restricted to legal advisors or counsellors specifically designated by national law to provide assistance and representation.
Procedures for access to legal assistance shall be laid down in national law.
SECTION V
Detention for the purpose of transfer
Article 28
Detention
1. Member States shall not hold a person in detention for the sole reason that he or she is subject to the procedure established by this Regulation.
2. When there is a significant risk of absconding, Member States may detain the person concerned in order to secure transfer procedures in accordance with this Regulation, on the basis of an individual assessment and only in so far as detention is proportional and other less coercive alternative measures cannot be applied effectively.
3. Detention shall be for as short a period as possible and shall be for no longer than the time reasonably necessary to fulfil the required administrative procedures with due diligence until the transfer under this Regulation is carried out.
Where a person is detained pursuant to this Article, the period for submitting a take charge or take back request shall not exceed one month from the lodging of the application. The Member State carrying out the procedure in accordance with this Regulation shall ask for an urgent reply in such cases. Such reply shall be given within two weeks of receipt of the request. Failure to reply within the two-week period shall be tantamount to accepting the request and shall entail the obligation to take charge or take back the person, including the obligation to provide for proper arrangements for arrival.
Where a person is detained pursuant to this Article, the transfer of that person from the requesting Member State to the Member State responsible shall be carried out as soon as practically possible, and at the latest within six weeks of the implicit or explicit acceptance of the request by another Member State to take charge or to take back the person concerned or of the moment when the appeal or review no longer has a suspensive effect in accordance with Article 27(3).
When the requesting Member State fails to comply with the deadlines for submitting a take charge or take back request or where the transfer does not take place within the period of six weeks referred to in the third subparagraph, the person shall no longer be detained. Articles 21, 23, 24 and 29 shall continue to apply accordingly.
4. As regards the detention conditions and the guarantees applicable to persons detained, in order to secure the transfer procedures to the Member State responsible, Articles 9, 10 and 11 of Directive 2013/33/EU shall apply.
SECTION VI
Transfers
Article 29
Modalities and time limits
1. The transfer of the applicant or of another person as referred to in Article 18(1)(c) or (d) from the requesting Member State to the Member State responsible shall be carried out in accordance with the national law of the requesting Member State, after consultation between the Member States concerned, as soon as practically possible, and at the latest within six months of acceptance of the request by another Member State to take charge or to take back the person concerned or of the final decision on an appeal or review where there is a suspensive effect in accordance with Article 27(3).
If transfers to the Member State responsible are carried out by supervised departure or under escort, Member States shall ensure that they are carried out in a humane manner and with full respect for fundamental rights and human dignity.
If necessary, the applicant shall be supplied by the requesting Member State with a laissez passer. The Commission shall, by means of implementing acts, establish the design of the laissez passer. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
The Member State responsible shall inform the requesting Member State, as appropriate, of the safe arrival of the person concerned or of the fact that he or she did not appear within the set time limit.
2. Where the transfer does not take place within the six months’ time limit, the Member State responsible shall be relieved of its obligations to take charge or to take back the person concerned and responsibility shall then be transferred to the requesting Member State. This time limit may be extended up to a maximum of one year if the transfer could not be carried out due to imprisonment of the person concerned or up to a maximum of eighteen months if the person concerned absconds.
3. If a person has been transferred erroneously or a decision to transfer is overturned on appeal or review after the transfer has been carried out, the Member State which carried out the transfer shall promptly accept that person back.
4. The Commission shall, by means of implementing acts, establish uniform conditions for the consultation and exchange of information between Member States, in particular in the event of postponed or delayed transfers, transfers following acceptance by default, transfers of minors or dependent persons, and supervised transfers. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 30
Costs of transfer
1. The costs necessary to transfer an applicant or another person as referred to in Article 18(1)(c) or (d) to the Member State responsible shall be met by the transferring Member State.
2. Where the person concerned has to be transferred back to a Member State as a result of an erroneous transfer or of a transfer decision that has been overturned on appeal or review after the transfer has been carried out, the Member State which initially carried out the transfer shall be responsible for the costs of transferring the person concerned back to its territory.
3. Persons to be transferred pursuant to this Regulation shall not be required to meet the costs of such transfers.
Article 31
Exchange of relevant information before a transfer is carried out
1. The Member State carrying out the transfer of an applicant or of another person as referred to in Article 18(1)(c) or (d) shall communicate to the Member State responsible such personal data concerning the person to be transferred as is appropriate, relevant and non-excessive for the sole purposes of ensuring that the competent authorities, in accordance with national law in the Member State responsible, are in a position to provide that person with adequate assistance, including the provision of immediate health care required in order to protect his or her vital interests, and to ensure continuity in the protection and rights afforded by this Regulation and by other relevant asylum legal instruments. Those data shall be communicated to the Member State responsible within a reasonable period of time before a transfer is carried out, in order to ensure that its competent authorities in accordance with national law have sufficient time to take the necessary measures.
2. The transferring Member State shall, in so far as such information is available to the competent authority in accordance with national law, transmit to the Member State responsible any information that is essential in order to safeguard the rights and immediate special needs of the person to be transferred, and in particular:
(a)
any immediate measures which the Member State responsible is required to take in order to ensure that the special needs of the person to be transferred are adequately addressed, including any immediate health care that may be required;
(b)
contact details of family members, relatives or any other family relations in the receiving Member State, where applicable;
(c)
in the case of minors, information on their education;
(d)
an assessment of the age of an applicant.
3. The exchange of information under this Article shall only take place between the authorities notified to the Commission in accordance with Article 35 of this Regulation using the ‘DubliNet’ electronic communication network set-up under Article 18 of Regulation (EC) No 1560/2003. The information exchanged shall only be used for the purposes set out in paragraph 1 of this Article and shall not be further processed.
4. With a view to facilitating the exchange of information between Member States, the Commission shall, by means of implementing acts, draw up a standard form for the transfer of the data required pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure laid down in Article 44(2).
5. The rules laid down in Article 34(8) to (12) shall apply to the exchange of information pursuant to this Article.
Article 32
Exchange of health data before a transfer is carried out
1. For the sole purpose of the provision of medical care or treatment, in particular concerning disabled persons, elderly people, pregnant women, minors and persons who have been subject to torture, rape or other serious forms of psychological, physical and sexual violence, the transferring Member State shall, in so far as it is available to the competent authority in accordance with national law, transmit to the Member State responsible information on any special needs of the person to be transferred, which in specific cases may include information on that person’s physical or mental health. That information shall be transferred in a common health certificate with the necessary documents attached. The Member State responsible shall ensure that those special needs are adequately addressed, including in particular any essential medical care that may be required.
The Commission shall, by means of implementing acts, draw up the common health certificate. Those implementing acts shall be adopted in accordance with the examination procedure laid down in Article 44(2).
2. The transferring Member State shall only transmit the information referred to in paragraph 1 to the Member State responsible after having obtained the explicit consent of the applicant and/or of his or her representative or, if the applicant is physically or legally incapable of giving his or her consent, when such transmission is necessary to protect the vital interests of the applicant or of another person. The lack of consent, including a refusal to consent, shall not constitute an obstacle to the transfer.
3. The processing of personal health data referred to in paragraph 1 shall only be carried out by a health professional who is subject, under national law or rules established by national competent bodies, to the obligation of professional secrecy or by another person subject to an equivalent obligation of professional secrecy.
4. The exchange of information under this Article shall only take place between the health professionals or other persons referred to in paragraph 3. The information exchanged shall only be used for the purposes set out in paragraph 1 and shall not be further processed.
5. The Commission shall, by means of implementing acts, adopt uniform conditions and practical arrangements for exchanging the information referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure laid down in Article 44(2).
6. The rules laid down in Article 34(8) to (12) shall apply to the exchange of information pursuant to this Article.
Article 33
A mechanism for early warning, preparedness and crisis management
1. Where, on the basis of, in particular, the information gathered by EASO pursuant to Regulation (EU) No 439/2010, the Commission establishes that the application of this Regulation may be jeopardised due either to a substantiated risk of particular pressure being placed on a Member State’s asylum system and/or to problems in the functioning of the asylum system of a Member State, it shall, in cooperation with EASO, make recommendations to that Member State, inviting it to draw up a preventive action plan.
The Member State concerned shall inform the Council and the Commission whether it intends to present a preventive action plan in order to overcome the pressure and/or problems in the functioning of its asylum system whilst ensuring the protection of the fundamental rights of applicants for international protection.
A Member State may, at its own discretion and initiative, draw up a preventive action plan and subsequent revisions thereof. When drawing up a preventive action plan, the Member State may call for the assistance of the Commission, other Member States, EASO and other relevant Union agencies.
2. Where a preventive action plan is drawn up, the Member State concerned shall submit it and shall regularly report on its implementation to the Council and to the Commission. The Commission shall subsequently inform the European Parliament of the key elements of the preventive action plan. The Commission shall submit reports on its implementation to the Council and transmit reports on its implementation to the European Parliament.
The Member State concerned shall take all appropriate measures to deal with the situation of particular pressure on its asylum system or to ensure that the deficiencies identified are addressed before the situation deteriorates. Where the preventive action plan includes measures aimed at addressing particular pressure on a Member State’s asylum system which may jeopardise the application of this Regulation, the Commission shall seek the advice of EASO before reporting to the European Parliament and to the Council.
3. Where the Commission establishes, on the basis of EASO’s analysis, that the implementation of the preventive action plan has not remedied the deficiencies identified or where there is a serious risk that the asylum situation in the Member State concerned develops into a crisis which is unlikely to be remedied by a preventive action plan, the Commission, in cooperation with EASO as applicable, may request the Member State concerned to draw up a crisis management action plan and, where necessary, revisions thereof. The crisis management action plan shall ensure, throughout the entire process, compliance with the asylum acquis of the Union, in particular with the fundamental rights of applicants for international protection.
Following the request to draw up a crisis management action plan, the Member State concerned shall, in cooperation with the Commission and EASO, do so promptly, and at the latest within three months of the request.
The Member State concerned shall submit its crisis management action plan and shall report, at least every three months, on its implementation to the Commission and other relevant stakeholders, such as EASO, as appropriate.
The Commission shall inform the European Parliament and the Council of the crisis management action plan, possible revisions and the implementation thereof. In those reports, the Member State concerned shall report on data to monitor compliance with the crisis management action plan, such as the length of the procedure, the detention conditions and the reception capacity in relation to the inflow of applicants.
4. Throughout the entire process for early warning, preparedness and crisis management established in this Article, the Council shall closely monitor the situation and may request further information and provide political guidance, in particular as regards the urgency and severity of the situation and thus the need for a Member State to draw up either a preventive action plan or, if necessary, a crisis management action plan. The European Parliament and the Council may, throughout the entire process, discuss and provide guidance on any solidarity measures as they deem appropriate.
CHAPTER VII
ADMINISTRATIVE COOPERATION
Article 34
Information sharing
1. Each Member State shall communicate to any Member State that so requests such personal data concerning the applicant as is appropriate, relevant and non-excessive for:
(a)
determining the Member State responsible;
(b)
examining the application for international protection;
(c)
implementing any obligation arising under this Regulation.
2. The information referred to in paragraph 1 may only cover:
(a)
personal details of the applicant, and, where appropriate, his or her family members, relatives or any other family relations (full name and where appropriate, former name; nicknames or pseudonyms; nationality, present and former; date and place of birth);
(b)
identity and travel papers (references, validity, date of issue, issuing authority, place of issue, etc.);
(c)
other information necessary for establishing the identity of the applicant, including fingerprints processed in accordance with Regulation (EU) No 603/2013;
(d)
places of residence and routes travelled;
(e)
residence documents or visas issued by a Member State;
(f)
the place where the application was lodged;
(g)
the date on which any previous application for international protection was lodged, the date on which the present application was lodged, the stage reached in the proceedings and the decision taken, if any.
3. Furthermore, provided it is necessary for the examination of the application for international protection, the Member State responsible may request another Member State to let it know on what grounds the applicant bases his or her application and, where applicable, the grounds for any decisions taken concerning the applicant. The other Member State may refuse to respond to the request submitted to it, if the communication of such information is likely to harm its essential interests or the protection of the liberties and fundamental rights of the person concerned or of others. In any event, communication of the information requested shall be subject to the written approval of the applicant for international protection, obtained by the requesting Member State. In that case, the applicant must know for what specific information he or she is giving his or her approval.
4. Any request for information shall only be sent in the context of an individual application for international protection. It shall set out the grounds on which it is based and, where its purpose is to check whether there is a criterion that is likely to entail the responsibility of the requested Member State, shall state on what evidence, including relevant information from reliable sources on the ways and means by which applicants enter the territories of the Member States, or on what specific and verifiable part of the applicant’s statements it is based. It is understood that such relevant information from reliable sources is not in itself sufficient to determine the responsibility and the competence of a Member State under this Regulation, but it may contribute to the evaluation of other indications relating to an individual applicant.
5. The requested Member State shall be obliged to reply within five weeks. Any delays in the reply shall be duly justified. Non-compliance with the five week time limit shall not relieve the requested Member State of the obligation to reply. If the research carried out by the requested Member State which did not respect the maximum time limit withholds information which shows that it is responsible, that Member State may not invoke the expiry of the time limits provided for in Articles 21, 23 and 24 as a reason for refusing to comply with a request to take charge or take back. In that case, the time limits provided for in Articles 21, 23 and 24 for submitting a request to take charge or take back shall be extended by a period of time which shall be equivalent to the delay in the reply by the requested Member State.
6. The exchange of information shall be effected at the request of a Member State and may only take place between authorities whose designation by each Member State has been communicated to the Commission in accordance with Article 35(1).
7. The information exchanged may only be used for the purposes set out in paragraph 1. In each Member State such information may, depending on its type and the powers of the recipient authority, only be communicated to the authorities and courts and tribunals entrusted with:
(a)
determining the Member State responsible;
(b)
examining the application for international protection;
(c)
implementing any obligation arising under this Regulation.
8. The Member State which forwards the information shall ensure that it is accurate and up-to-date. If it transpires that it has forwarded information which is inaccurate or which should not have been forwarded, the recipient Member States shall be informed thereof immediately. They shall be obliged to correct such information or to have it erased.
9. The applicant shall have the right to be informed, on request, of any data that is processed concerning him or her.
If the applicant finds that the data have been processed in breach of this Regulation or of Directive 95/46/EC, in particular because they are incomplete or inaccurate, he or she shall be entitled to have them corrected or erased.
The authority correcting or erasing the data shall inform, as appropriate, the Member State transmitting or receiving the information.
The applicant shall have the right to bring an action or a complaint before the competent authorities or courts or tribunals of the Member State which refused the right of access to or the right of correction or erasure of data relating to him or her.
10. In each Member State concerned, a record shall be kept, in the individual file for the person concerned and/or in a register, of the transmission and receipt of information exchanged.
11. The data exchanged shall be kept for a period not exceeding that which is necessary for the purposes for which they are exchanged.
12. Where the data are not processed automatically or are not contained, or intended to be entered, in a file, each Member State shall take appropriate measures to ensure compliance with this Article through effective checks.
Article 35
Competent authorities and resources
1. Each Member State shall notify the Commission without delay of the specific authorities responsible for fulfilling the obligations arising under this Regulation, and any amendments thereto. The Member States shall ensure that those authorities have the necessary resources for carrying out their tasks and in particular for replying within the prescribed time limits to requests for information, requests to take charge of and requests to take back applicants.
2. The Commission shall publish a consolidated list of the authorities referred to in paragraph 1 in the Official Journal of the European Union. Where there are amendments thereto, the Commission shall publish once a year an updated consolidated list.
3. The authorities referred to in paragraph 1 shall receive the necessary training with respect to the application of this Regulation.
4. The Commission shall, by means of implementing acts, establish secure electronic transmission channels between the authorities referred to in paragraph 1 for transmitting requests, replies and all written correspondence and for ensuring that senders automatically receive an electronic proof of delivery. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(2).
Article 36
Administrative arrangements
1. Member States may, on a bilateral basis, establish administrative arrangements between themselves concerning the practical details of the implementation of this Regulation, in order to facilitate its application and increase its effectiveness. Such arrangements may relate to:
(a)
exchanges of liaison officers;
(b)
simplification of the procedures and shortening of the time limits relating to transmission and the examination of requests to take charge of or take back applicants.
2. Member States may also maintain the administrative arrangements concluded under Regulation (EC) No 343/2003. To the extent that such arrangements are not compatible with this Regulation, the Member States concerned shall amend the arrangements in such a way as to eliminate any incompatibilities observed.
3. Before concluding or amending any arrangement referred to in paragraph 1(b), the Member States concerned shall consult the Commission as to the compatibility of the arrangement with this Regulation.
4. If the Commission considers the arrangements referred to in paragraph 1(b) to be incompatible with this Regulation, it shall, within a reasonable period, notify the Member States concerned. The Member States shall take all appropriate steps to amend the arrangement concerned within a reasonable time in such a way as to eliminate any incompatibilities observed.
5. Member States shall notify the Commission of all arrangements referred to in paragraph 1, and of any denunciation thereof, or amendment thereto.
CHAPTER VIII
CONCILIATION
Article 37
Conciliation
1. Where the Member States cannot resolve a dispute on any matter related to the application of this Regulation, they may have recourse to the conciliation procedure provided for in paragraph 2.
2. The conciliation procedure shall be initiated by a request from one of the Member States in dispute to the Chairman of the Committee set up by Article 44. By agreeing to use the conciliation procedure, the Member States concerned undertake to take the utmost account of the solution proposed.
The Chairman of the Committee shall appoint three members of the Committee representing three Member States not connected with the matter. They shall receive the arguments of the parties either in writing or orally and, after deliberation, shall propose a solution within one month, where necessary after a vote.
The Chairman of the Committee, or his or her deputy, shall chair the discussion. He or she may put forward his or her point of view but may not vote.
Whether it is adopted or rejected by the parties, the solution proposed shall be final and irrevocable.
CHAPTER IX
TRANSITIONAL PROVISIONS AND FINAL PROVISIONS
Article 38
Data security and data protection
Member States shall take all appropriate measures to ensure the security of transmitted personal data and in particular to avoid unlawful or unauthorised access or disclosure, alteration or loss of personal data processed.
Each Member State shall provide that the national supervisory authority or authorities designated pursuant to Article 28(1) of Directive 95/46/EC shall monitor independently, in accordance with its respective national law, the lawfulness of the processing, in accordance with this Regulation, of personal data by the Member State in question.
Article 39
Confidentiality
Member States shall ensure that the authorities referred to in Article 35 are bound by the confidentiality rules provided for in national law, in relation to any information they obtain in the course of their work.
Article 40
Penalties
Member States shall take the necessary measures to ensure that any misuse of data processed in accordance with this Regulation is punishable by penalties, including administrative and/or criminal penalties in accordance with national law, that are effective, proportionate and dissuasive.
Article 41
Transitional measures
Where an application has been lodged after the date mentioned in the second paragraph of Article 49, the events that are likely to entail the responsibility of a Member State under this Regulation shall be taken into consideration, even if they precede that date, with the exception of the events mentioned in Article 13(2).
Article 42
Calculation of time limits
Any period of time prescribed in this Regulation shall be calculated as follows:
(a)
where a period expressed in days, weeks or months is to be calculated from the moment at which an event occurs or an action takes place, the day during which that event occurs or that action takes place shall not be counted as falling within the period in question;
(b)
a period expressed in weeks or months shall end with the expiry of whichever day in the last week or month is the same day of the week or falls on the same date as the day during which the event or action from which the period is to be calculated occurred or took place. If, in a period expressed in months, the day on which it should expire does not occur in the last month, the period shall end with the expiry of the last day of that month;
(c)
time limits shall include Saturdays, Sundays and official holidays in any of the Member States concerned.
Article 43
Territorial scope
As far as the French Republic is concerned, this Regulation shall apply only to its European territory.
Article 44
Committee
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 45
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 8(5) and 16(3) shall be conferred on the Commission for a period of 5 years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Articles 8(5) and 16(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 8(5) and 16(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of four months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 46
Monitoring and evaluation
By 21 July 2016, the Commission shall report to the European Parliament and to the Council on the application of this Regulation and, where appropriate, shall propose the necessary amendments. Member States shall forward to the Commission all information appropriate for the preparation of that report, at the latest six months before that time limit expires.
After having submitted that report, the Commission shall report to the European Parliament and to the Council on the application of this Regulation at the same time as it submits reports on the implementation of the Eurodac system provided for by Article 40 of Regulation (EU) No 603/2013.
Article 47
Statistics
In accordance with Article 4(4) of Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection (16), Member States shall communicate to the Commission (Eurostat), statistics concerning the application of this Regulation and of Regulation (EC) No 1560/2003.
Article 48
Repeal
Regulation (EC) No 343/2003 is repealed.
Articles 11(1), 13, 14 and 17 of Regulation (EC) No 1560/2003 are repealed.
References to the repealed Regulation or Articles shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.
Article 49
Entry into force and applicability
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply to applications for international protection lodged as from the first day of the sixth month following its entry into force and, from that date, it will apply to any request to take charge of or take back applicants, irrespective of the date on which the application was made. The Member State responsible for the examination of an application for international protection submitted before that date shall be determined in accordance with the criteria set out in Regulation (EC) No 343/2003.
References in this Regulation to Regulation (EU) No 603/2013, Directive 2013/32/EU and Directive 2013/33/EU shall be construed, until the dates of their application, as references to Regulation (EC) No 2725/2000 (17), Directive 2003/9/EC (18) and Directive 2005/85/EC (19) respectively.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Brussels, 26 June 2013.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. SHATTER
(1) OJ C 317, 23.12.2009, p. 115.
(2) OJ C 79, 27.3.2010, p. 58.
(3) Position of the European Parliament of 7 May 2009 (OJ C 212 E, 5.8.2010, p. 370) and position of the Council at first reading of 6 June 2013 (not yet published in the Official Journal). Position of the European Parliament of 10 June 2013 (not yet published in the Official Journal).
(4) OJ L 50, 25.2.2003, p. 1.
(5) OJ L 132, 29.5.2010, p. 11.
(6) OJ L 337, 20.12.2011, p. 9.
(7) See page 96 of this Official Journal.
(8) See page 60 of this Official Journal.
(9) OJ L 222, 5.9.2003, p. 3.
(10) OJ L 281, 23.11.1995, p. 31.
(11) See page 1 of this Official Journal.
(12) OJ L 218, 13.8.2008, p. 60.
(13) OJ L 55, 28.2.2011, p. 13.
(14) OJ L 243, 15.9.2009, p. 1.
(15) OJ L 348, 24.12.2008, p. 98.
(16) OJ L 199, 31.7.2007, p. 23.
(17) Council Regulation (EC) No 2725/2000 of 11 December 2000 concerning the establishment of ‘Eurodac’ for the comparison of fingerprints for the effective application of the Dublin Convention (OJ L 316, 15.12.2000, p. 1).
(18) Council Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the reception of asylum seekers (OJ L 31, 6.2.2003, p. 18).
(19) Council Directive 2005/85/EC of 1 December 2005 on minimum standards on procedures for granting and withdrawing refugee status (OJ L 326, 13.12.2005, p. 13).
ANNEX I
Repealed Regulations (referred to in Article 48)
Council Regulation (EC) No 343/2003
(OJ L 50, 25.2.2003, p. 1)
Commission Regulation (EC) No 1560/2003 only Articles 11(1), 13, 14 and 17
(OJ L 222, 5.9.2003, p. 3)
ANNEX II
Correlation table
Regulation (EC) No 343/2003
This Regulation
Article 1
Article 1
Article 2(a)
Article 2(a)
Article 2(b)
—
Article 2(c)
Article 2(b)
Article 2(d)
Article 2(c)
Article 2(e)
Article 2(d)
Article 2(f)
Article 2(e)
Article 2(g)
Article 2(f)
—
Article 2(h)
—
Article 2(i)
Article 2(h)
Article 2(j)
Article 2(i)
Article 2(g)
—
Article 2(k)
Article 2(j) and (k)
Article 2(l) and (m)
—
Article 2(n)
Article 3(1)
Article 3(1)
Article 3(2)
Article 17(1)
Article 3(3)
Article 3(3)
Article 3(4)
Article 4(1), introductory wording
—
Article 4(1)(a) to (f)
—
Article 4(2) and (3)
Article 4(1) to (5)
Article 20(1) to (5)
—
Article 20(5), third subparagraph
—
Article 5
—
Article 6
Article 5(1)
Article 7(1)
Article 5(2)
Article 7(2)
—
Article 7(3)
Article 6, first paragraph
Article 8(1)
—
Article 8(3)
Article 6, second paragraph
Article 8(4)
Article 7
Article 9
Article 8
Article 10
Article 9
Article 12
Article 10
Article 13
Article 11
Article 14
Article 12
Article 15
—
Article 16
Article 13
Article 3(2)
Article 14
Article 11
Article 15(1)
Article 17(2), first subparagraph
Article 15(2)
Article 16(1)
Article 15(3)
Article 8(2)
Article 15(4)
Article 17(2), fourth subparagraph
Article 15(5)
Articles 8(5) and (6) and Article 16(2)
Article 16(1)(a)
Article 18(1)(a)
Article 16(1)(b)
Article 18(2)
Article 16(1)(c)
Article 18(1)(b)
Article 16(1)(d)
Article 18(1)(c)
Article 16(1)(e)
Article 18(1)(d)
Article 16(2)
Article 19(1)
Article 16(3)
Article 19(2), first subparagraph
—
Article 19(2), second subparagraph
Article 16(4)
Article 19(3)
—
Article 19(3), second subparagraph
Article 17
Article 21
Article 18
Article 22
Article 19(1)
Article 26(1)
Article 19(2)
Article 26(2) and Article 27(1)
—
Article 27(2) to (6)
Article 19(3)
Article 29(1)
Article 19(4)
Article 29(2)
—
Article 29(3)
Article 19(5)
Article 29(4)
Article 20(1), introductory wording
Article 23(1)
—
Article 23(2)
—
Article 23(3)
—
Article 23(4)
Article 20(1)(a)
Article 23(5), first subparagraph
—
Article 24
Article 20(1)(b)
Article 25(1)
Article 20(1)(c)
Article 25(2)
Article 20(1)(d)
Article 29(1), first subparagraph
Article 20(1)(e)
Article 26(1), (2), Article 27(1), Article 29(1), second and third subparagraphs
Article 20(2)
Article 29(2)
Article 20(3)
Article 23(5), second subparagraph
Article 20(4)
Article 29(4)
—
Article 28
—
Article 30
—
Article 31
—
Article 32
—
Article 33
Article 21(1) to (9)
Article 34(1) to (9), first to third subparagraphs
—
Article 34(9), fourth subparagraph
Article 21(10) to (12)
Article 34(10) to (12)
Article 22(1)
Article 35(1)
—
Article 35(2)
—
Article 35(3)
Article 22(2)
Article 35(4)
Article 23
Article 36
—
Article 37
—
Article 40
Article 24(1)
—
Article 24(2)
Article 41
Article 24(3)
—
Article 25(1)
Article 42
Article 25(2)
—
Article 26
Article 43
Article 27(1), (2)
Article 44(1), (2)
Article 27(3)
—
—
Article 45
Article 28
Article 46
—
Article 47
—
Article 48
Article 29
Article 49
Regulation (EC) No 1560/2003
This Regulation
Article 11(1)
—
Article 13(1)
Article 17(2), first subparagraph
Article 13(2)
Article 17(2), second subparagraph
Article 13(3)
Article 17(2), third subparagraph
Article 13(4)
Article 17(2), first subparagraph
Article 14
Article 37
Article 17(1)
Articles 9, 10, 17(2), first subparagraph
Article 17(2)
Article 34(3)
STATEMENT BY THE COUNCIL, THE EUROPEAN PARLIAMENT AND THE COMMISSION
The Council and the European Parliament invite the Commission to consider, without prejudice to its right of initiative, a revision of Article 8(4) of the Recast of the Dublin Regulation once the Court of Justice rules on case C-648/11 MA and Others vs. Secretary of State for the Home Department and at the latest by the time limits set in Article 46 of the Dublin Regulation. The European Parliament and the Council will then both exercise their legislative competences, taking into account the best interests of the child.
The Commission, in a spirit of compromise and in order to ensure the immediate adoption of the proposal, accepts to consider this invitation, which it understands as being limited to these specific circumstances and not creating a precedent.
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EU asylum policy: EU country responsible for examining applications
EU asylum policy: EU country responsible for examining applications
Regulation (EU) No 604/2013 (Dublin III Regulation), replacing Council Regulation (EC) No 343/2003 (Dublin II Regulation), lays down the criteria and mechanisms for determining which EU country is responsible for examining an asylum application.
ACT
Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person.
SUMMARY
Regulation (EU) No 604/2013 (Dublin III Regulation), replacing Council Regulation (EC) No 343/2003 (Dublin II Regulation), lays down the criteria and mechanisms for determining which EU country is responsible for examining an asylum application.
WHAT DOES THIS REGULATION DO?
The Dublin III Regulation establishes the EU country responsible for examining an asylum application. It affords applicants better protection until their status is established. It also creates a new system for detecting early problems in national asylum or reception systems and tackling their root causes before they develop into full-blown crises.
KEY POINTS
Principle and criteria for determining responsibility
These include, in order of importance:
family considerations;
recent possession of a visa or a residence permit in an EU country;
whether the applicant entered the EU irregularly or regularly.
More guarantees for applicants
The regulation contains more protective guarantees for applicants, such as:
the right to information;
personal interviews;
more guarantees for minors, prioritising children’s best interests throughout the procedure;
increased protection for applicants’ children, family members, dependent persons and relatives;
the option of free legal aid, upon request;
the right to appeal against a transfer decision to another EU country, including the option of granting suspensive effect.
A new 2014 proposal lays down rules for deciding who is responsible for examining unaccompanied minors’ applications.
Detention
As a general principle, applicants must not be held in detention merely because they are seeking asylum. However, the regulation provides for applicants’ detention if there is a risk of absconding (e.g. they are being transferred to another EU country).
A mechanism for early warning, preparedness and crisis management
The Dublin III Regulation makes the system more efficient by introducing an early warning, preparedness and crisis management mechanism designed to:
tackle malfunctions in national asylum systems; or
help EU countries facing high numbers of applicants for international protection at their borders.
WHEN DOES THE REGULATION APPLY?
The new regulation, which applies from 1 January 2014, replaces Council Regulation (EC) No 343/2003 (repealed).
BACKGROUND
The EU has been working to set up a common European asylum system (CEAS). Since 2011, various new texts have been adopted to improve the workings of the CEAS.
Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted: Communication from the Commission COVID-19: Guidance on the implementation of relevant EU provisions in the area of asylum and return procedures and on resettlement
REFERENCES
Act
Entry into force
Deadline for transposition in the Member States
Official Journal
Regulation (EU) No 604/2013
1.1.2014
-
OJ L 180 of 29.6.2013, pp. 31-59
RELATED ACTS
Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (Official Journal L 337 of 20.12.2011, pp. 9-26).
Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (Official Journal L 180 of 29.6.2013, pp. 60-95).
Directive 2013/33/EU of the European Parliament and of the Council of 26 June 2013 laying down standards for the reception of applicants for international protection (Official Journal L 180 of 29.6.2013, pp. 96-116).
Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of ‘Eurodac’ for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (Official Journal L 180 of 29.6.2013, pp. 1-30).
Commission Regulation (EC) No 1560/2003 of 2 September 2003 laying down detailed rules for the application of Council Regulation (EC) No 343/2003 establishing the criteria and mechanisms for determining the Member State responsible for examining an asylum application lodged in one of the Member States by a third-country national (Official Journal L 222 of 5.9.2003, pp. 3-23).
Commission Implementing Regulation (EU) No 118/2014 of 30 January 2014 amending Regulation (EC) No 1560/2003 laying down detailed rules for the application of Council Regulation (EC) No 343/2003 establishing the criteria and mechanisms for determining the Member State responsible for examining an asylum application lodged in one of the Member States by a third-country national (Official Journal L 39, 8.2.2014, pp. 1-43).
last update 25.05.2020
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32012R1215
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20.12.2012
EN
Official Journal of the European Union
L 351/1
REGULATION (EU) No 1215/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 December 2012
on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters
(recast)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 67(4) and points (a), (c) and (e) of Article 81(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
On 21 April 2009, the Commission adopted a report on the application of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (3). The report concluded that, in general, the operation of that Regulation is satisfactory, but that it is desirable to improve the application of certain of its provisions, to further facilitate the free circulation of judgments and to further enhance access to justice. Since a number of amendments are to be made to that Regulation it should, in the interests of clarity, be recast.
(2)
At its meeting in Brussels on 10 and 11 December 2009, the European Council adopted a new multiannual programme entitled ‘The Stockholm Programme – an open and secure Europe serving and protecting citizens’ (4). In the Stockholm Programme the European Council considered that the process of abolishing all intermediate measures (the exequatur) should be continued during the period covered by that Programme. At the same time the abolition of the exequatur should also be accompanied by a series of safeguards.
(3)
The Union has set itself the objective of maintaining and developing an area of freedom, security and justice, inter alia, by facilitating access to justice, in particular through the principle of mutual recognition of judicial and extra-judicial decisions in civil matters. For the gradual establishment of such an area, the Union is to adopt measures relating to judicial cooperation in civil matters having cross-border implications, particularly when necessary for the proper functioning of the internal market.
(4)
Certain differences between national rules governing jurisdiction and recognition of judgments hamper the sound operation of the internal market. Provisions to unify the rules of conflict of jurisdiction in civil and commercial matters, and to ensure rapid and simple recognition and enforcement of judgments given in a Member State, are essential.
(5)
Such provisions fall within the area of judicial cooperation in civil matters within the meaning of Article 81 of the Treaty on the Functioning of the European Union (TFEU).
(6)
In order to attain the objective of free circulation of judgments in civil and commercial matters, it is necessary and appropriate that the rules governing jurisdiction and the recognition and enforcement of judgments be governed by a legal instrument of the Union which is binding and directly applicable.
(7)
On 27 September 1968, the then Member States of the European Communities, acting under Article 220, fourth indent, of the Treaty establishing the European Economic Community, concluded the Brussels Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters, subsequently amended by conventions on the accession to that Convention of new Member States (5) (‘the 1968 Brussels Convention’). On 16 September 1988, the then Member States of the European Communities and certain EFTA States concluded the Lugano Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (6) (‘the 1988 Lugano Convention’), which is a parallel convention to the 1968 Brussels Convention. The 1988 Lugano Convention became applicable to Poland on 1 February 2000.
(8)
On 22 December 2000, the Council adopted Regulation (EC) No 44/2001, which replaces the 1968 Brussels Convention with regard to the territories of the Member States covered by the TFEU, as between the Member States except Denmark. By Council Decision 2006/325/EC (7), the Community concluded an agreement with Denmark ensuring the application of the provisions of Regulation (EC) No 44/2001 in Denmark. The 1988 Lugano Convention was revised by the Convention on Jurisdiction and the Recognition and Enforcement of Judgments in Civil and Commercial Matters (8), signed at Lugano on 30 October 2007 by the Community, Denmark, Iceland, Norway and Switzerland (‘the 2007 Lugano Convention’).
(9)
The 1968 Brussels Convention continues to apply to the territories of the Member States which fall within the territorial scope of that Convention and which are excluded from this Regulation pursuant to Article 355 of the TFEU.
(10)
The scope of this Regulation should cover all the main civil and commercial matters apart from certain well-defined matters, in particular maintenance obligations, which should be excluded from the scope of this Regulation following the adoption of Council Regulation (EC) No 4/2009 of 18 December 2008 on jurisdiction, applicable law, recognition and enforcement of decisions and cooperation in matters relating to maintenance obligations (9).
(11)
For the purposes of this Regulation, courts or tribunals of the Member States should include courts or tribunals common to several Member States, such as the Benelux Court of Justice when it exercises jurisdiction on matters falling within the scope of this Regulation. Therefore, judgments given by such courts should be recognised and enforced in accordance with this Regulation.
(12)
This Regulation should not apply to arbitration. Nothing in this Regulation should prevent the courts of a Member State, when seised of an action in a matter in respect of which the parties have entered into an arbitration agreement, from referring the parties to arbitration, from staying or dismissing the proceedings, or from examining whether the arbitration agreement is null and void, inoperative or incapable of being performed, in accordance with their national law.
A ruling given by a court of a Member State as to whether or not an arbitration agreement is null and void, inoperative or incapable of being performed should not be subject to the rules of recognition and enforcement laid down in this Regulation, regardless of whether the court decided on this as a principal issue or as an incidental question.
On the other hand, where a court of a Member State, exercising jurisdiction under this Regulation or under national law, has determined that an arbitration agreement is null and void, inoperative or incapable of being performed, this should not preclude that court’s judgment on the substance of the matter from being recognised or, as the case may be, enforced in accordance with this Regulation. This should be without prejudice to the competence of the courts of the Member States to decide on the recognition and enforcement of arbitral awards in accordance with the Convention on the Recognition and Enforcement of Foreign Arbitral Awards, done at New York on 10 June 1958 (‘the 1958 New York Convention’), which takes precedence over this Regulation.
This Regulation should not apply to any action or ancillary proceedings relating to, in particular, the establishment of an arbitral tribunal, the powers of arbitrators, the conduct of an arbitration procedure or any other aspects of such a procedure, nor to any action or judgment concerning the annulment, review, appeal, recognition or enforcement of an arbitral award.
(13)
There must be a connection between proceedings to which this Regulation applies and the territory of the Member States. Accordingly, common rules of jurisdiction should, in principle, apply when the defendant is domiciled in a Member State.
(14)
A defendant not domiciled in a Member State should in general be subject to the national rules of jurisdiction applicable in the territory of the Member State of the court seised.
However, in order to ensure the protection of consumers and employees, to safeguard the jurisdiction of the courts of the Member States in situations where they have exclusive jurisdiction and to respect the autonomy of the parties, certain rules of jurisdiction in this Regulation should apply regardless of the defendant’s domicile.
(15)
The rules of jurisdiction should be highly predictable and founded on the principle that jurisdiction is generally based on the defendant’s domicile. Jurisdiction should always be available on this ground save in a few well-defined situations in which the subject-matter of the dispute or the autonomy of the parties warrants a different connecting factor. The domicile of a legal person must be defined autonomously so as to make the common rules more transparent and avoid conflicts of jurisdiction.
(16)
In addition to the defendant’s domicile, there should be alternative grounds of jurisdiction based on a close connection between the court and the action or in order to facilitate the sound administration of justice. The existence of a close connection should ensure legal certainty and avoid the possibility of the defendant being sued in a court of a Member State which he could not reasonably have foreseen. This is important, particularly in disputes concerning non-contractual obligations arising out of violations of privacy and rights relating to personality, including defamation.
(17)
The owner of a cultural object as defined in Article 1(1) of Council Directive 93/7/EEC of 15 March 1993 on the return of cultural objects unlawfully removed from the territory of a Member State (10) should be able under this Regulation to initiate proceedings as regards a civil claim for the recovery, based on ownership, of such a cultural object in the courts for the place where the cultural object is situated at the time the court is seised. Such proceedings should be without prejudice to proceedings initiated under Directive 93/7/EEC.
(18)
In relation to insurance, consumer and employment contracts, the weaker party should be protected by rules of jurisdiction more favourable to his interests than the general rules.
(19)
The autonomy of the parties to a contract, other than an insurance, consumer or employment contract, where only limited autonomy to determine the courts having jurisdiction is allowed, should be respected subject to the exclusive grounds of jurisdiction laid down in this Regulation.
(20)
Where a question arises as to whether a choice-of-court agreement in favour of a court or the courts of a Member State is null and void as to its substantive validity, that question should be decided in accordance with the law of the Member State of the court or courts designated in the agreement, including the conflict-of-laws rules of that Member State.
(21)
In the interests of the harmonious administration of justice it is necessary to minimise the possibility of concurrent proceedings and to ensure that irreconcilable judgments will not be given in different Member States. There should be a clear and effective mechanism for resolving cases of lis pendens and related actions, and for obviating problems flowing from national differences as to the determination of the time when a case is regarded as pending. For the purposes of this Regulation, that time should be defined autonomously.
(22)
However, in order to enhance the effectiveness of exclusive choice-of-court agreements and to avoid abusive litigation tactics, it is necessary to provide for an exception to the general lis pendens rule in order to deal satisfactorily with a particular situation in which concurrent proceedings may arise. This is the situation where a court not designated in an exclusive choice-of-court agreement has been seised of proceedings and the designated court is seised subsequently of proceedings involving the same cause of action and between the same parties. In such a case, the court first seised should be required to stay its proceedings as soon as the designated court has been seised and until such time as the latter court declares that it has no jurisdiction under the exclusive choice-of-court agreement. This is to ensure that, in such a situation, the designated court has priority to decide on the validity of the agreement and on the extent to which the agreement applies to the dispute pending before it. The designated court should be able to proceed irrespective of whether the non-designated court has already decided on the stay of proceedings.
This exception should not cover situations where the parties have entered into conflicting exclusive choice-of-court agreements or where a court designated in an exclusive choice-of-court agreement has been seised first. In such cases, the general lis pendens rule of this Regulation should apply.
(23)
This Regulation should provide for a flexible mechanism allowing the courts of the Member States to take into account proceedings pending before the courts of third States, considering in particular whether a judgment of a third State will be capable of recognition and enforcement in the Member State concerned under the law of that Member State and the proper administration of justice.
(24)
When taking into account the proper administration of justice, the court of the Member State concerned should assess all the circumstances of the case before it. Such circumstances may include connections between the facts of the case and the parties and the third State concerned, the stage to which the proceedings in the third State have progressed by the time proceedings are initiated in the court of the Member State and whether or not the court of the third State can be expected to give a judgment within a reasonable time.
That assessment may also include consideration of the question whether the court of the third State has exclusive jurisdiction in the particular case in circumstances where a court of a Member State would have exclusive jurisdiction.
(25)
The notion of provisional, including protective, measures should include, for example, protective orders aimed at obtaining information or preserving evidence as referred to in Articles 6 and 7 of Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (11). It should not include measures which are not of a protective nature, such as measures ordering the hearing of a witness. This should be without prejudice to the application of Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (12).
(26)
Mutual trust in the administration of justice in the Union justifies the principle that judgments given in a Member State should be recognised in all Member States without the need for any special procedure. In addition, the aim of making cross-border litigation less time-consuming and costly justifies the abolition of the declaration of enforceability prior to enforcement in the Member State addressed. As a result, a judgment given by the courts of a Member State should be treated as if it had been given in the Member State addressed.
(27)
For the purposes of the free circulation of judgments, a judgment given in a Member State should be recognised and enforced in another Member State even if it is given against a person not domiciled in a Member State.
(28)
Where a judgment contains a measure or order which is not known in the law of the Member State addressed, that measure or order, including any right indicated therein, should, to the extent possible, be adapted to one which, under the law of that Member State, has equivalent effects attached to it and pursues similar aims. How, and by whom, the adaptation is to be carried out should be determined by each Member State.
(29)
The direct enforcement in the Member State addressed of a judgment given in another Member State without a declaration of enforceability should not jeopardise respect for the rights of the defence. Therefore, the person against whom enforcement is sought should be able to apply for refusal of the recognition or enforcement of a judgment if he considers one of the grounds for refusal of recognition to be present. This should include the ground that he had not had the opportunity to arrange for his defence where the judgment was given in default of appearance in a civil action linked to criminal proceedings. It should also include the grounds which could be invoked on the basis of an agreement between the Member State addressed and a third State concluded pursuant to Article 59 of the 1968 Brussels Convention.
(30)
A party challenging the enforcement of a judgment given in another Member State should, to the extent possible and in accordance with the legal system of the Member State addressed, be able to invoke, in the same procedure, in addition to the grounds for refusal provided for in this Regulation, the grounds for refusal available under national law and within the time-limits laid down in that law.
The recognition of a judgment should, however, be refused only if one or more of the grounds for refusal provided for in this Regulation are present.
(31)
Pending a challenge to the enforcement of a judgment, it should be possible for the courts in the Member State addressed, during the entire proceedings relating to such a challenge, including any appeal, to allow the enforcement to proceed subject to a limitation of the enforcement or to the provision of security.
(32)
In order to inform the person against whom enforcement is sought of the enforcement of a judgment given in another Member State, the certificate established under this Regulation, if necessary accompanied by the judgment, should be served on that person in reasonable time before the first enforcement measure. In this context, the first enforcement measure should mean the first enforcement measure after such service.
(33)
Where provisional, including protective, measures are ordered by a court having jurisdiction as to the substance of the matter, their free circulation should be ensured under this Regulation. However, provisional, including protective, measures which were ordered by such a court without the defendant being summoned to appear should not be recognised and enforced under this Regulation unless the judgment containing the measure is served on the defendant prior to enforcement. This should not preclude the recognition and enforcement of such measures under national law. Where provisional, including protective, measures are ordered by a court of a Member State not having jurisdiction as to the substance of the matter, the effect of such measures should be confined, under this Regulation, to the territory of that Member State.
(34)
Continuity between the 1968 Brussels Convention, Regulation (EC) No 44/2001 and this Regulation should be ensured, and transitional provisions should be laid down to that end. The same need for continuity applies as regards the interpretation by the Court of Justice of the European Union of the 1968 Brussels Convention and of the Regulations replacing it.
(35)
Respect for international commitments entered into by the Member States means that this Regulation should not affect conventions relating to specific matters to which the Member States are parties.
(36)
Without prejudice to the obligations of the Member States under the Treaties, this Regulation should not affect the application of bilateral conventions and agreements between a third State and a Member State concluded before the date of entry into force of Regulation (EC) No 44/2001 which concern matters governed by this Regulation.
(37)
In order to ensure that the certificates to be used in connection with the recognition or enforcement of judgments, authentic instruments and court settlements under this Regulation are kept up-to-date, the power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in respect of amendments to Annexes I and II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(38)
This Regulation respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union, in particular the right to an effective remedy and to a fair trial guaranteed in Article 47 of the Charter.
(39)
Since the objective of this Regulation cannot be sufficiently achieved by the Member States and can be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(40)
The United Kingdom and Ireland, in accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the TEU and to the then Treaty establishing the European Community, took part in the adoption and application of Regulation (EC) No 44/2001. In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, the United Kingdom and Ireland have notified their wish to take part in the adoption and application of this Regulation.
(41)
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application, without prejudice to the possibility for Denmark of applying the amendments to Regulation (EC) No 44/2001 pursuant to Article 3 of the Agreement of 19 October 2005 between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (13),
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
1. This Regulation shall apply in civil and commercial matters whatever the nature of the court or tribunal. It shall not extend, in particular, to revenue, customs or administrative matters or to the liability of the State for acts and omissions in the exercise of State authority (acta iure imperii).
2. This Regulation shall not apply to:
(a)
the status or legal capacity of natural persons, rights in property arising out of a matrimonial relationship or out of a relationship deemed by the law applicable to such relationship to have comparable effects to marriage;
(b)
bankruptcy, proceedings relating to the winding-up of insolvent companies or other legal persons, judicial arrangements, compositions and analogous proceedings;
(c)
social security;
(d)
arbitration;
(e)
maintenance obligations arising from a family relationship, parentage, marriage or affinity;
(f)
wills and succession, including maintenance obligations arising by reason of death.
Article 2
For the purposes of this Regulation:
(a)
‘judgment’ means any judgment given by a court or tribunal of a Member State, whatever the judgment may be called, including a decree, order, decision or writ of execution, as well as a decision on the determination of costs or expenses by an officer of the court.
For the purposes of Chapter III, ‘judgment’ includes provisional, including protective, measures ordered by a court or tribunal which by virtue of this Regulation has jurisdiction as to the substance of the matter. It does not include a provisional, including protective, measure which is ordered by such a court or tribunal without the defendant being summoned to appear, unless the judgment containing the measure is served on the defendant prior to enforcement;
(b)
‘court settlement’ means a settlement which has been approved by a court of a Member State or concluded before a court of a Member State in the course of proceedings;
(c)
‘authentic instrument’ means a document which has been formally drawn up or registered as an authentic instrument in the Member State of origin and the authenticity of which:
(i)
relates to the signature and the content of the instrument; and
(ii)
has been established by a public authority or other authority empowered for that purpose;
(d)
‘Member State of origin’ means the Member State in which, as the case may be, the judgment has been given, the court settlement has been approved or concluded, or the authentic instrument has been formally drawn up or registered;
(e)
‘Member State addressed’ means the Member State in which the recognition of the judgment is invoked or in which the enforcement of the judgment, the court settlement or the authentic instrument is sought;
(f)
‘court of origin’ means the court which has given the judgment the recognition of which is invoked or the enforcement of which is sought.
Article 3
For the purposes of this Regulation, ‘court’ includes the following authorities to the extent that they have jurisdiction in matters falling within the scope of this Regulation:
(a)
in Hungary, in summary proceedings concerning orders to pay (fizetési meghagyásos eljárás), the notary (közjegyző);
(b)
in Sweden, in summary proceedings concerning orders to pay (betalningsföreläggande) and assistance (handräckning), the Enforcement Authority (Kronofogdemyndigheten).
CHAPTER II
JURISDICTION
SECTION 1
General provisions
Article 4
1. Subject to this Regulation, persons domiciled in a Member State shall, whatever their nationality, be sued in the courts of that Member State.
2. Persons who are not nationals of the Member State in which they are domiciled shall be governed by the rules of jurisdiction applicable to nationals of that Member State.
Article 5
1. Persons domiciled in a Member State may be sued in the courts of another Member State only by virtue of the rules set out in Sections 2 to 7 of this Chapter.
2. In particular, the rules of national jurisdiction of which the Member States are to notify the Commission pursuant to point (a) of Article 76(1) shall not be applicable as against the persons referred to in paragraph 1.
Article 6
1. If the defendant is not domiciled in a Member State, the jurisdiction of the courts of each Member State shall, subject to Article 18(1), Article 21(2) and Articles 24 and 25, be determined by the law of that Member State.
2. As against such a defendant, any person domiciled in a Member State may, whatever his nationality, avail himself in that Member State of the rules of jurisdiction there in force, and in particular those of which the Member States are to notify the Commission pursuant to point (a) of Article 76(1), in the same way as nationals of that Member State.
SECTION 2
Special jurisdiction
Article 7
A person domiciled in a Member State may be sued in another Member State:
(1)
(a)
in matters relating to a contract, in the courts for the place of performance of the obligation in question;
(b)
for the purpose of this provision and unless otherwise agreed, the place of performance of the obligation in question shall be:
—
in the case of the sale of goods, the place in a Member State where, under the contract, the goods were delivered or should have been delivered,
—
in the case of the provision of services, the place in a Member State where, under the contract, the services were provided or should have been provided;
(c)
if point (b) does not apply then point (a) applies;
(2)
in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred or may occur;
(3)
as regards a civil claim for damages or restitution which is based on an act giving rise to criminal proceedings, in the court seised of those proceedings, to the extent that that court has jurisdiction under its own law to entertain civil proceedings;
(4)
as regards a civil claim for the recovery, based on ownership, of a cultural object as defined in point 1 of Article 1 of Directive 93/7/EEC initiated by the person claiming the right to recover such an object, in the courts for the place where the cultural object is situated at the time when the court is seised;
(5)
as regards a dispute arising out of the operations of a branch, agency or other establishment, in the courts for the place where the branch, agency or other establishment is situated;
(6)
as regards a dispute brought against a settlor, trustee or beneficiary of a trust created by the operation of a statute, or by a written instrument, or created orally and evidenced in writing, in the courts of the Member State in which the trust is domiciled;
(7)
as regards a dispute concerning the payment of remuneration claimed in respect of the salvage of a cargo or freight, in the court under the authority of which the cargo or freight in question:
(a)
has been arrested to secure such payment; or
(b)
could have been so arrested, but bail or other security has been given;
provided that this provision shall apply only if it is claimed that the defendant has an interest in the cargo or freight or had such an interest at the time of salvage.
Article 8
A person domiciled in a Member State may also be sued:
(1)
where he is one of a number of defendants, in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings;
(2)
as a third party in an action on a warranty or guarantee or in any other third-party proceedings, in the court seised of the original proceedings, unless these were instituted solely with the object of removing him from the jurisdiction of the court which would be competent in his case;
(3)
on a counter-claim arising from the same contract or facts on which the original claim was based, in the court in which the original claim is pending;
(4)
in matters relating to a contract, if the action may be combined with an action against the same defendant in matters relating to rights in rem in immovable property, in the court of the Member State in which the property is situated.
Article 9
Where by virtue of this Regulation a court of a Member State has jurisdiction in actions relating to liability from the use or operation of a ship, that court, or any other court substituted for this purpose by the internal law of that Member State, shall also have jurisdiction over claims for limitation of such liability.
SECTION 3
Jurisdiction in matters relating to insurance
Article 10
In matters relating to insurance, jurisdiction shall be determined by this Section, without prejudice to Article 6 and point 5 of Article 7.
Article 11
1. An insurer domiciled in a Member State may be sued:
(a)
in the courts of the Member State in which he is domiciled;
(b)
in another Member State, in the case of actions brought by the policyholder, the insured or a beneficiary, in the courts for the place where the claimant is domiciled; or
(c)
if he is a co-insurer, in the courts of a Member State in which proceedings are brought against the leading insurer.
2. An insurer who is not domiciled in a Member State but has a branch, agency or other establishment in one of the Member States shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that Member State.
Article 12
In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred. The same applies if movable and immovable property are covered by the same insurance policy and both are adversely affected by the same contingency.
Article 13
1. In respect of liability insurance, the insurer may also, if the law of the court permits it, be joined in proceedings which the injured party has brought against the insured.
2. Articles 10, 11 and 12 shall apply to actions brought by the injured party directly against the insurer, where such direct actions are permitted.
3. If the law governing such direct actions provides that the policyholder or the insured may be joined as a party to the action, the same court shall have jurisdiction over them.
Article 14
1. Without prejudice to Article 13(3), an insurer may bring proceedings only in the courts of the Member State in which the defendant is domiciled, irrespective of whether he is the policyholder, the insured or a beneficiary.
2. The provisions of this Section shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending.
Article 15
The provisions of this Section may be departed from only by an agreement:
(1)
which is entered into after the dispute has arisen;
(2)
which allows the policyholder, the insured or a beneficiary to bring proceedings in courts other than those indicated in this Section;
(3)
which is concluded between a policyholder and an insurer, both of whom are at the time of conclusion of the contract domiciled or habitually resident in the same Member State, and which has the effect of conferring jurisdiction on the courts of that Member State even if the harmful event were to occur abroad, provided that such an agreement is not contrary to the law of that Member State;
(4)
which is concluded with a policyholder who is not domiciled in a Member State, except in so far as the insurance is compulsory or relates to immovable property in a Member State; or
(5)
which relates to a contract of insurance in so far as it covers one or more of the risks set out in Article 16.
Article 16
The following are the risks referred to in point 5 of Article 15:
(1)
any loss of or damage to:
(a)
seagoing ships, installations situated offshore or on the high seas, or aircraft, arising from perils which relate to their use for commercial purposes;
(b)
goods in transit other than passengers’ baggage where the transit consists of or includes carriage by such ships or aircraft;
(2)
any liability, other than for bodily injury to passengers or loss of or damage to their baggage:
(a)
arising out of the use or operation of ships, installations or aircraft as referred to in point 1(a) in so far as, in respect of the latter, the law of the Member State in which such aircraft are registered does not prohibit agreements on jurisdiction regarding insurance of such risks;
(b)
for loss or damage caused by goods in transit as described in point 1(b);
(3)
any financial loss connected with the use or operation of ships, installations or aircraft as referred to in point 1(a), in particular loss of freight or charter-hire;
(4)
any risk or interest connected with any of those referred to in points 1 to 3;
(5)
notwithstanding points 1 to 4, all ‘large risks’ as defined in Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (14).
SECTION 4
Jurisdiction over consumer contracts
Article 17
1. In matters relating to a contract concluded by a person, the consumer, for a purpose which can be regarded as being outside his trade or profession, jurisdiction shall be determined by this Section, without prejudice to Article 6 and point 5 of Article 7, if:
(a)
it is a contract for the sale of goods on instalment credit terms;
(b)
it is a contract for a loan repayable by instalments, or for any other form of credit, made to finance the sale of goods; or
(c)
in all other cases, the contract has been concluded with a person who pursues commercial or professional activities in the Member State of the consumer’s domicile or, by any means, directs such activities to that Member State or to several States including that Member State, and the contract falls within the scope of such activities.
2. Where a consumer enters into a contract with a party who is not domiciled in a Member State but has a branch, agency or other establishment in one of the Member States, that party shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that Member State.
3. This Section shall not apply to a contract of transport other than a contract which, for an inclusive price, provides for a combination of travel and accommodation.
Article 18
1. A consumer may bring proceedings against the other party to a contract either in the courts of the Member State in which that party is domiciled or, regardless of the domicile of the other party, in the courts for the place where the consumer is domiciled.
2. Proceedings may be brought against a consumer by the other party to the contract only in the courts of the Member State in which the consumer is domiciled.
3. This Article shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending.
Article 19
The provisions of this Section may be departed from only by an agreement:
(1)
which is entered into after the dispute has arisen;
(2)
which allows the consumer to bring proceedings in courts other than those indicated in this Section; or
(3)
which is entered into by the consumer and the other party to the contract, both of whom are at the time of conclusion of the contract domiciled or habitually resident in the same Member State, and which confers jurisdiction on the courts of that Member State, provided that such an agreement is not contrary to the law of that Member State.
SECTION 5
Jurisdiction over individual contracts of employment
Article 20
1. In matters relating to individual contracts of employment, jurisdiction shall be determined by this Section, without prejudice to Article 6, point 5 of Article 7 and, in the case of proceedings brought against an employer, point 1 of Article 8.
2. Where an employee enters into an individual contract of employment with an employer who is not domiciled in a Member State but has a branch, agency or other establishment in one of the Member States, the employer shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that Member State.
Article 21
1. An employer domiciled in a Member State may be sued:
(a)
in the courts of the Member State in which he is domiciled; or
(b)
in another Member State:
(i)
in the courts for the place where or from where the employee habitually carries out his work or in the courts for the last place where he did so; or
(ii)
if the employee does not or did not habitually carry out his work in any one country, in the courts for the place where the business which engaged the employee is or was situated.
2. An employer not domiciled in a Member State may be sued in a court of a Member State in accordance with point (b) of paragraph 1.
Article 22
1. An employer may bring proceedings only in the courts of the Member State in which the employee is domiciled.
2. The provisions of this Section shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending.
Article 23
The provisions of this Section may be departed from only by an agreement:
(1)
which is entered into after the dispute has arisen; or
(2)
which allows the employee to bring proceedings in courts other than those indicated in this Section.
SECTION 6
Exclusive jurisdiction
Article 24
The following courts of a Member State shall have exclusive jurisdiction, regardless of the domicile of the parties:
(1)
in proceedings which have as their object rights in rem in immovable property or tenancies of immovable property, the courts of the Member State in which the property is situated.
However, in proceedings which have as their object tenancies of immovable property concluded for temporary private use for a maximum period of six consecutive months, the courts of the Member State in which the defendant is domiciled shall also have jurisdiction, provided that the tenant is a natural person and that the landlord and the tenant are domiciled in the same Member State;
(2)
in proceedings which have as their object the validity of the constitution, the nullity or the dissolution of companies or other legal persons or associations of natural or legal persons, or the validity of the decisions of their organs, the courts of the Member State in which the company, legal person or association has its seat. In order to determine that seat, the court shall apply its rules of private international law;
(3)
in proceedings which have as their object the validity of entries in public registers, the courts of the Member State in which the register is kept;
(4)
in proceedings concerned with the registration or validity of patents, trade marks, designs, or other similar rights required to be deposited or registered, irrespective of whether the issue is raised by way of an action or as a defence, the courts of the Member State in which the deposit or registration has been applied for, has taken place or is under the terms of an instrument of the Union or an international convention deemed to have taken place.
Without prejudice to the jurisdiction of the European Patent Office under the Convention on the Grant of European Patents, signed at Munich on 5 October 1973, the courts of each Member State shall have exclusive jurisdiction in proceedings concerned with the registration or validity of any European patent granted for that Member State;
(5)
in proceedings concerned with the enforcement of judgments, the courts of the Member State in which the judgment has been or is to be enforced.
SECTION 7
Prorogation of jurisdiction
Article 25
1. If the parties, regardless of their domicile, have agreed that a court or the courts of a Member State are to have jurisdiction to settle any disputes which have arisen or which may arise in connection with a particular legal relationship, that court or those courts shall have jurisdiction, unless the agreement is null and void as to its substantive validity under the law of that Member State. Such jurisdiction shall be exclusive unless the parties have agreed otherwise. The agreement conferring jurisdiction shall be either:
(a)
in writing or evidenced in writing;
(b)
in a form which accords with practices which the parties have established between themselves; or
(c)
in international trade or commerce, in a form which accords with a usage of which the parties are or ought to have been aware and which in such trade or commerce is widely known to, and regularly observed by, parties to contracts of the type involved in the particular trade or commerce concerned.
2. Any communication by electronic means which provides a durable record of the agreement shall be equivalent to ‘writing’.
3. The court or courts of a Member State on which a trust instrument has conferred jurisdiction shall have exclusive jurisdiction in any proceedings brought against a settlor, trustee or beneficiary, if relations between those persons or their rights or obligations under the trust are involved.
4. Agreements or provisions of a trust instrument conferring jurisdiction shall have no legal force if they are contrary to Articles 15, 19 or 23, or if the courts whose jurisdiction they purport to exclude have exclusive jurisdiction by virtue of Article 24.
5. An agreement conferring jurisdiction which forms part of a contract shall be treated as an agreement independent of the other terms of the contract.
The validity of the agreement conferring jurisdiction cannot be contested solely on the ground that the contract is not valid.
Article 26
1. Apart from jurisdiction derived from other provisions of this Regulation, a court of a Member State before which a defendant enters an appearance shall have jurisdiction. This rule shall not apply where appearance was entered to contest the jurisdiction, or where another court has exclusive jurisdiction by virtue of Article 24.
2. In matters referred to in Sections 3, 4 or 5 where the policyholder, the insured, a beneficiary of the insurance contract, the injured party, the consumer or the employee is the defendant, the court shall, before assuming jurisdiction under paragraph 1, ensure that the defendant is informed of his right to contest the jurisdiction of the court and of the consequences of entering or not entering an appearance.
SECTION 8
Examination as to jurisdiction and admissibility
Article 27
Where a court of a Member State is seised of a claim which is principally concerned with a matter over which the courts of another Member State have exclusive jurisdiction by virtue of Article 24, it shall declare of its own motion that it has no jurisdiction.
Article 28
1. Where a defendant domiciled in one Member State is sued in a court of another Member State and does not enter an appearance, the court shall declare of its own motion that it has no jurisdiction unless its jurisdiction is derived from the provisions of this Regulation.
2. The court shall stay the proceedings so long as it is not shown that the defendant has been able to receive the document instituting the proceedings or an equivalent document in sufficient time to enable him to arrange for his defence, or that all necessary steps have been taken to this end.
3. Article 19 of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents) (15) shall apply instead of paragraph 2 of this Article if the document instituting the proceedings or an equivalent document had to be transmitted from one Member State to another pursuant to that Regulation.
4. Where Regulation (EC) No 1393/2007 is not applicable, Article 15 of the Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters shall apply if the document instituting the proceedings or an equivalent document had to be transmitted abroad pursuant to that Convention.
SECTION 9
Lis pendens — related actions
Article 29
1. Without prejudice to Article 31(2), where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established.
2. In cases referred to in paragraph 1, upon request by a court seised of the dispute, any other court seised shall without delay inform the former court of the date when it was seised in accordance with Article 32.
3. Where the jurisdiction of the court first seised is established, any court other than the court first seised shall decline jurisdiction in favour of that court.
Article 30
1. Where related actions are pending in the courts of different Member States, any court other than the court first seised may stay its proceedings.
2. Where the action in the court first seised is pending at first instance, any other court may also, on the application of one of the parties, decline jurisdiction if the court first seised has jurisdiction over the actions in question and its law permits the consolidation thereof.
3. For the purposes of this Article, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings.
Article 31
1. Where actions come within the exclusive jurisdiction of several courts, any court other than the court first seised shall decline jurisdiction in favour of that court.
2. Without prejudice to Article 26, where a court of a Member State on which an agreement as referred to in Article 25 confers exclusive jurisdiction is seised, any court of another Member State shall stay the proceedings until such time as the court seised on the basis of the agreement declares that it has no jurisdiction under the agreement.
3. Where the court designated in the agreement has established jurisdiction in accordance with the agreement, any court of another Member State shall decline jurisdiction in favour of that court.
4. Paragraphs 2 and 3 shall not apply to matters referred to in Sections 3, 4 or 5 where the policyholder, the insured, a beneficiary of the insurance contract, the injured party, the consumer or the employee is the claimant and the agreement is not valid under a provision contained within those Sections.
Article 32
1. For the purposes of this Section, a court shall be deemed to be seised:
(a)
at the time when the document instituting the proceedings or an equivalent document is lodged with the court, provided that the claimant has not subsequently failed to take the steps he was required to take to have service effected on the defendant; or
(b)
if the document has to be served before being lodged with the court, at the time when it is received by the authority responsible for service, provided that the claimant has not subsequently failed to take the steps he was required to take to have the document lodged with the court.
The authority responsible for service referred to in point (b) shall be the first authority receiving the documents to be served.
2. The court, or the authority responsible for service, referred to in paragraph 1, shall note, respectively, the date of the lodging of the document instituting the proceedings or the equivalent document, or the date of receipt of the documents to be served.
Article 33
1. Where jurisdiction is based on Article 4 or on Articles 7, 8 or 9 and proceedings are pending before a court of a third State at the time when a court in a Member State is seised of an action involving the same cause of action and between the same parties as the proceedings in the court of the third State, the court of the Member State may stay the proceedings if:
(a)
it is expected that the court of the third State will give a judgment capable of recognition and, where applicable, of enforcement in that Member State; and
(b)
the court of the Member State is satisfied that a stay is necessary for the proper administration of justice.
2. The court of the Member State may continue the proceedings at any time if:
(a)
the proceedings in the court of the third State are themselves stayed or discontinued;
(b)
it appears to the court of the Member State that the proceedings in the court of the third State are unlikely to be concluded within a reasonable time; or
(c)
the continuation of the proceedings is required for the proper administration of justice.
3. The court of the Member State shall dismiss the proceedings if the proceedings in the court of the third State are concluded and have resulted in a judgment capable of recognition and, where applicable, of enforcement in that Member State.
4. The court of the Member State shall apply this Article on the application of one of the parties or, where possible under national law, of its own motion.
Article 34
1. Where jurisdiction is based on Article 4 or on Articles 7, 8 or 9 and an action is pending before a court of a third State at the time when a court in a Member State is seised of an action which is related to the action in the court of the third State, the court of the Member State may stay the proceedings if:
(a)
it is expedient to hear and determine the related actions together to avoid the risk of irreconcilable judgments resulting from separate proceedings;
(b)
it is expected that the court of the third State will give a judgment capable of recognition and, where applicable, of enforcement in that Member State; and
(c)
the court of the Member State is satisfied that a stay is necessary for the proper administration of justice.
2. The court of the Member State may continue the proceedings at any time if:
(a)
it appears to the court of the Member State that there is no longer a risk of irreconcilable judgments;
(b)
the proceedings in the court of the third State are themselves stayed or discontinued;
(c)
it appears to the court of the Member State that the proceedings in the court of the third State are unlikely to be concluded within a reasonable time; or
(d)
the continuation of the proceedings is required for the proper administration of justice.
3. The court of the Member State may dismiss the proceedings if the proceedings in the court of the third State are concluded and have resulted in a judgment capable of recognition and, where applicable, of enforcement in that Member State.
4. The court of the Member State shall apply this Article on the application of one of the parties or, where possible under national law, of its own motion.
SECTION 10
Provisional, including protective, measures
Article 35
Application may be made to the courts of a Member State for such provisional, including protective, measures as may be available under the law of that Member State, even if the courts of another Member State have jurisdiction as to the substance of the matter.
CHAPTER III
RECOGNITION AND ENFORCEMENT
SECTION 1
Recognition
Article 36
1. A judgment given in a Member State shall be recognised in the other Member States without any special procedure being required.
2. Any interested party may, in accordance with the procedure provided for in Subsection 2 of Section 3, apply for a decision that there are no grounds for refusal of recognition as referred to in Article 45.
3. If the outcome of proceedings in a court of a Member State depends on the determination of an incidental question of refusal of recognition, that court shall have jurisdiction over that question.
Article 37
1. A party who wishes to invoke in a Member State a judgment given in another Member State shall produce:
(a)
a copy of the judgment which satisfies the conditions necessary to establish its authenticity; and
(b)
the certificate issued pursuant to Article 53.
2. The court or authority before which a judgment given in another Member State is invoked may, where necessary, require the party invoking it to provide, in accordance with Article 57, a translation or a transliteration of the contents of the certificate referred to in point (b) of paragraph 1. The court or authority may require the party to provide a translation of the judgment instead of a translation of the contents of the certificate if it is unable to proceed without such a translation.
Article 38
The court or authority before which a judgment given in another Member State is invoked may suspend the proceedings, in whole or in part, if:
(a)
the judgment is challenged in the Member State of origin; or
(b)
an application has been submitted for a decision that there are no grounds for refusal of recognition as referred to in Article 45 or for a decision that the recognition is to be refused on the basis of one of those grounds.
SECTION 2
Enforcement
Article 39
A judgment given in a Member State which is enforceable in that Member State shall be enforceable in the other Member States without any declaration of enforceability being required.
Article 40
An enforceable judgment shall carry with it by operation of law the power to proceed to any protective measures which exist under the law of the Member State addressed.
Article 41
1. Subject to the provisions of this Section, the procedure for the enforcement of judgments given in another Member State shall be governed by the law of the Member State addressed. A judgment given in a Member State which is enforceable in the Member State addressed shall be enforced there under the same conditions as a judgment given in the Member State addressed.
2. Notwithstanding paragraph 1, the grounds for refusal or of suspension of enforcement under the law of the Member State addressed shall apply in so far as they are not incompatible with the grounds referred to in Article 45.
3. The party seeking the enforcement of a judgment given in another Member State shall not be required to have a postal address in the Member State addressed. Nor shall that party be required to have an authorised representative in the Member State addressed unless such a representative is mandatory irrespective of the nationality or the domicile of the parties.
Article 42
1. For the purposes of enforcement in a Member State of a judgment given in another Member State, the applicant shall provide the competent enforcement authority with:
(a)
a copy of the judgment which satisfies the conditions necessary to establish its authenticity; and
(b)
the certificate issued pursuant to Article 53, certifying that the judgment is enforceable and containing an extract of the judgment as well as, where appropriate, relevant information on the recoverable costs of the proceedings and the calculation of interest.
2. For the purposes of enforcement in a Member State of a judgment given in another Member State ordering a provisional, including a protective, measure, the applicant shall provide the competent enforcement authority with:
(a)
a copy of the judgment which satisfies the conditions necessary to establish its authenticity;
(b)
the certificate issued pursuant to Article 53, containing a description of the measure and certifying that:
(i)
the court has jurisdiction as to the substance of the matter;
(ii)
the judgment is enforceable in the Member State of origin; and
(c)
where the measure was ordered without the defendant being summoned to appear, proof of service of the judgment.
3. The competent enforcement authority may, where necessary, require the applicant to provide, in accordance with Article 57, a translation or a transliteration of the contents of the certificate.
4. The competent enforcement authority may require the applicant to provide a translation of the judgment only if it is unable to proceed without such a translation.
Article 43
1. Where enforcement is sought of a judgment given in another Member State, the certificate issued pursuant to Article 53 shall be served on the person against whom the enforcement is sought prior to the first enforcement measure. The certificate shall be accompanied by the judgment, if not already served on that person.
2. Where the person against whom enforcement is sought is domiciled in a Member State other than the Member State of origin, he may request a translation of the judgment in order to contest the enforcement if the judgment is not written in or accompanied by a translation into either of the following languages:
(a)
a language which he understands; or
(b)
the official language of the Member State in which he is domiciled or, where there are several official languages in that Member State, the official language or one of the official languages of the place where he is domiciled.
Where a translation of the judgment is requested under the first subparagraph, no measures of enforcement may be taken other than protective measures until that translation has been provided to the person against whom enforcement is sought.
This paragraph shall not apply if the judgment has already been served on the person against whom enforcement is sought in one of the languages referred to in the first subparagraph or is accompanied by a translation into one of those languages.
3. This Article shall not apply to the enforcement of a protective measure in a judgment or where the person seeking enforcement proceeds to protective measures in accordance with Article 40.
Article 44
1. In the event of an application for refusal of enforcement of a judgment pursuant to Subsection 2 of Section 3, the court in the Member State addressed may, on the application of the person against whom enforcement is sought:
(a)
limit the enforcement proceedings to protective measures;
(b)
make enforcement conditional on the provision of such security as it shall determine; or
(c)
suspend, either wholly or in part, the enforcement proceedings.
2. The competent authority in the Member State addressed shall, on the application of the person against whom enforcement is sought, suspend the enforcement proceedings where the enforceability of the judgment is suspended in the Member State of origin.
SECTION 3
Refusal of recognition and enforcement
Subsection 1
Refusal of recognition
Article 45
1. On the application of any interested party, the recognition of a judgment shall be refused:
(a)
if such recognition is manifestly contrary to public policy (ordre public) in the Member State addressed;
(b)
where the judgment was given in default of appearance, if the defendant was not served with the document which instituted the proceedings or with an equivalent document in sufficient time and in such a way as to enable him to arrange for his defence, unless the defendant failed to commence proceedings to challenge the judgment when it was possible for him to do so;
(c)
if the judgment is irreconcilable with a judgment given between the same parties in the Member State addressed;
(d)
if the judgment is irreconcilable with an earlier judgment given in another Member State or in a third State involving the same cause of action and between the same parties, provided that the earlier judgment fulfils the conditions necessary for its recognition in the Member State addressed; or
(e)
if the judgment conflicts with:
(i)
Sections 3, 4 or 5 of Chapter II where the policyholder, the insured, a beneficiary of the insurance contract, the injured party, the consumer or the employee was the defendant; or
(ii)
Section 6 of Chapter II.
2. In its examination of the grounds of jurisdiction referred to in point (e) of paragraph 1, the court to which the application was submitted shall be bound by the findings of fact on which the court of origin based its jurisdiction.
3. Without prejudice to point (e) of paragraph 1, the jurisdiction of the court of origin may not be reviewed. The test of public policy referred to in point (a) of paragraph 1 may not be applied to the rules relating to jurisdiction.
4. The application for refusal of recognition shall be made in accordance with the procedures provided for in Subsection 2 and, where appropriate, Section 4.
Subsection 2
Refusal of enforcement
Article 46
On the application of the person against whom enforcement is sought, the enforcement of a judgment shall be refused where one of the grounds referred to in Article 45 is found to exist.
Article 47
1. The application for refusal of enforcement shall be submitted to the court which the Member State concerned has communicated to the Commission pursuant to point (a) of Article 75 as the court to which the application is to be submitted.
2. The procedure for refusal of enforcement shall, in so far as it is not covered by this Regulation, be governed by the law of the Member State addressed.
3. The applicant shall provide the court with a copy of the judgment and, where necessary, a translation or transliteration of it.
The court may dispense with the production of the documents referred to in the first subparagraph if it already possesses them or if it considers it unreasonable to require the applicant to provide them. In the latter case, the court may require the other party to provide those documents.
4. The party seeking the refusal of enforcement of a judgment given in another Member State shall not be required to have a postal address in the Member State addressed. Nor shall that party be required to have an authorised representative in the Member State addressed unless such a representative is mandatory irrespective of the nationality or the domicile of the parties.
Article 48
The court shall decide on the application for refusal of enforcement without delay.
Article 49
1. The decision on the application for refusal of enforcement may be appealed against by either party.
2. The appeal is to be lodged with the court which the Member State concerned has communicated to the Commission pursuant to point (b) of Article 75 as the court with which such an appeal is to be lodged.
Article 50
The decision given on the appeal may only be contested by an appeal where the courts with which any further appeal is to be lodged have been communicated by the Member State concerned to the Commission pursuant to point (c) of Article 75.
Article 51
1. The court to which an application for refusal of enforcement is submitted or the court which hears an appeal lodged under Article 49 or Article 50 may stay the proceedings if an ordinary appeal has been lodged against the judgment in the Member State of origin or if the time for such an appeal has not yet expired. In the latter case, the court may specify the time within which such an appeal is to be lodged.
2. Where the judgment was given in Ireland, Cyprus or the United Kingdom, any form of appeal available in the Member State of origin shall be treated as an ordinary appeal for the purposes of paragraph 1.
SECTION 4
Common provisions
Article 52
Under no circumstances may a judgment given in a Member State be reviewed as to its substance in the Member State addressed.
Article 53
The court of origin shall, at the request of any interested party, issue the certificate using the form set out in Annex I.
Article 54
1. If a judgment contains a measure or an order which is not known in the law of the Member State addressed, that measure or order shall, to the extent possible, be adapted to a measure or an order known in the law of that Member State which has equivalent effects attached to it and which pursues similar aims and interests.
Such adaptation shall not result in effects going beyond those provided for in the law of the Member State of origin.
2. Any party may challenge the adaptation of the measure or order before a court.
3. If necessary, the party invoking the judgment or seeking its enforcement may be required to provide a translation or a transliteration of the judgment.
Article 55
A judgment given in a Member State which orders a payment by way of a penalty shall be enforceable in the Member State addressed only if the amount of the payment has been finally determined by the court of origin.
Article 56
No security, bond or deposit, however described, shall be required of a party who in one Member State applies for the enforcement of a judgment given in another Member State on the ground that he is a foreign national or that he is not domiciled or resident in the Member State addressed.
Article 57
1. When a translation or a transliteration is required under this Regulation, such translation or transliteration shall be into the official language of the Member State concerned or, where there are several official languages in that Member State, into the official language or one of the official languages of court proceedings of the place where a judgment given in another Member State is invoked or an application is made, in accordance with the law of that Member State.
2. For the purposes of the forms referred to in Articles 53 and 60, translations or transliterations may also be into any other official language or languages of the institutions of the Union that the Member State concerned has indicated it can accept.
3. Any translation made under this Regulation shall be done by a person qualified to do translations in one of the Member States.
CHAPTER IV
AUTHENTIC INSTRUMENTS AND COURT SETTLEMENTS
Article 58
1. An authentic instrument which is enforceable in the Member State of origin shall be enforceable in the other Member States without any declaration of enforceability being required. Enforcement of the authentic instrument may be refused only if such enforcement is manifestly contrary to public policy (ordre public) in the Member State addressed.
The provisions of Section 2, Subsection 2 of Section 3, and Section 4 of Chapter III shall apply as appropriate to authentic instruments.
2. The authentic instrument produced must satisfy the conditions necessary to establish its authenticity in the Member State of origin.
Article 59
A court settlement which is enforceable in the Member State of origin shall be enforced in the other Member States under the same conditions as authentic instruments.
Article 60
The competent authority or court of the Member State of origin shall, at the request of any interested party, issue the certificate using the form set out in Annex II containing a summary of the enforceable obligation recorded in the authentic instrument or of the agreement between the parties recorded in the court settlement.
CHAPTER V
GENERAL PROVISIONS
Article 61
No legalisation or other similar formality shall be required for documents issued in a Member State in the context of this Regulation.
Article 62
1. In order to determine whether a party is domiciled in the Member State whose courts are seised of a matter, the court shall apply its internal law.
2. If a party is not domiciled in the Member State whose courts are seised of the matter, then, in order to determine whether the party is domiciled in another Member State, the court shall apply the law of that Member State.
Article 63
1. For the purposes of this Regulation, a company or other legal person or association of natural or legal persons is domiciled at the place where it has its:
(a)
statutory seat;
(b)
central administration; or
(c)
principal place of business.
2. For the purposes of Ireland, Cyprus and the United Kingdom, ‘statutory seat’ means the registered office or, where there is no such office anywhere, the place of incorporation or, where there is no such place anywhere, the place under the law of which the formation took place.
3. In order to determine whether a trust is domiciled in the Member State whose courts are seised of the matter, the court shall apply its rules of private international law.
Article 64
Without prejudice to any more favourable provisions of national laws, persons domiciled in a Member State who are being prosecuted in the criminal courts of another Member State of which they are not nationals for an offence which was not intentionally committed may be defended by persons qualified to do so, even if they do not appear in person. However, the court seised of the matter may order appearance in person; in the case of failure to appear, a judgment given in the civil action without the person concerned having had the opportunity to arrange for his defence need not be recognised or enforced in the other Member States.
Article 65
1. The jurisdiction specified in point 2 of Article 8 and Article 13 in actions on a warranty or guarantee or in any other third-party proceedings may be resorted to in the Member States included in the list established by the Commission pursuant to point (b) of Article 76(1) and Article 76(2) only in so far as permitted under national law. A person domiciled in another Member State may be invited to join the proceedings before the courts of those Member States pursuant to the rules on third-party notice referred to in that list.
2. Judgments given in a Member State by virtue of point 2 of Article 8 or Article 13 shall be recognised and enforced in accordance with Chapter III in any other Member State. Any effects which judgments given in the Member States included in the list referred to in paragraph 1 may have, in accordance with the law of those Member States, on third parties by application of paragraph 1 shall be recognised in all Member States.
3. The Member States included in the list referred to in paragraph 1 shall, within the framework of the European Judicial Network in civil and commercial matters established by Council Decision 2001/470/EC (16) (‘the European Judicial Network’) provide information on how to determine, in accordance with their national law, the effects of the judgments referred to in the second sentence of paragraph 2.
CHAPTER VI
TRANSITIONAL PROVISIONS
Article 66
1. This Regulation shall apply only to legal proceedings instituted, to authentic instruments formally drawn up or registered and to court settlements approved or concluded on or after 10 January 2015.
2. Notwithstanding Article 80, Regulation (EC) No 44/2001 shall continue to apply to judgments given in legal proceedings instituted, to authentic instruments formally drawn up or registered and to court settlements approved or concluded before 10 January 2015 which fall within the scope of that Regulation.
CHAPTER VII
RELATIONSHIP WITH OTHER INSTRUMENTS
Article 67
This Regulation shall not prejudice the application of provisions governing jurisdiction and the recognition and enforcement of judgments in specific matters which are contained in instruments of the Union or in national legislation harmonised pursuant to such instruments.
Article 68
1. This Regulation shall, as between the Member States, supersede the 1968 Brussels Convention, except as regards the territories of the Member States which fall within the territorial scope of that Convention and which are excluded from this Regulation pursuant to Article 355 of the TFEU.
2. In so far as this Regulation replaces the provisions of the 1968 Brussels Convention between the Member States, any reference to that Convention shall be understood as a reference to this Regulation.
Article 69
Subject to Articles 70 and 71, this Regulation shall, as between the Member States, supersede the conventions that cover the same matters as those to which this Regulation applies. In particular, the conventions included in the list established by the Commission pursuant to point (c) of Article 76(1) and Article 76(2) shall be superseded.
Article 70
1. The conventions referred to in Article 69 shall continue to have effect in relation to matters to which this Regulation does not apply.
2. They shall continue to have effect in respect of judgments given, authentic instruments formally drawn up or registered and court settlements approved or concluded before the date of entry into force of Regulation (EC) No 44/2001.
Article 71
1. This Regulation shall not affect any conventions to which the Member States are parties and which, in relation to particular matters, govern jurisdiction or the recognition or enforcement of judgments.
2. With a view to its uniform interpretation, paragraph 1 shall be applied in the following manner:
(a)
this Regulation shall not prevent a court of a Member State which is party to a convention on a particular matter from assuming jurisdiction in accordance with that convention, even where the defendant is domiciled in another Member State which is not party to that convention. The court hearing the action shall, in any event, apply Article 28 of this Regulation;
(b)
judgments given in a Member State by a court in the exercise of jurisdiction provided for in a convention on a particular matter shall be recognised and enforced in the other Member States in accordance with this Regulation.
Where a convention on a particular matter to which both the Member State of origin and the Member State addressed are parties lays down conditions for the recognition or enforcement of judgments, those conditions shall apply. In any event, the provisions of this Regulation on recognition and enforcement of judgments may be applied.
Article 72
This Regulation shall not affect agreements by which Member States, prior to the entry into force of Regulation (EC) No 44/2001, undertook pursuant to Article 59 of the 1968 Brussels Convention not to recognise judgments given, in particular in other Contracting States to that Convention, against defendants domiciled or habitually resident in a third State where, in cases provided for in Article 4 of that Convention, the judgment could only be founded on a ground of jurisdiction specified in the second paragraph of Article 3 of that Convention.
Article 73
1. This Regulation shall not affect the application of the 2007 Lugano Convention.
2. This Regulation shall not affect the application of the 1958 New York Convention.
3. This Regulation shall not affect the application of bilateral conventions and agreements between a third State and a Member State concluded before the date of entry into force of Regulation (EC) No 44/2001 which concern matters governed by this Regulation.
CHAPTER VIII
FINAL PROVISIONS
Article 74
The Member States shall provide, within the framework of the European Judicial Network and with a view to making the information available to the public, a description of national rules and procedures concerning enforcement, including authorities competent for enforcement, and information on any limitations on enforcement, in particular debtor protection rules and limitation or prescription periods.
The Member States shall keep this information permanently updated.
Article 75
By 10 January 2014, the Member States shall communicate to the Commission:
(a)
the courts to which the application for refusal of enforcement is to be submitted pursuant to Article 47(1);
(b)
the courts with which an appeal against the decision on the application for refusal of enforcement is to be lodged pursuant to Article 49(2);
(c)
the courts with which any further appeal is to be lodged pursuant to Article 50; and
(d)
the languages accepted for translations of the forms as referred to in Article 57(2).
The Commission shall make the information publicly available through any appropriate means, in particular through the European Judicial Network.
Article 76
1. The Member States shall notify the Commission of:
(a)
the rules of jurisdiction referred to in Articles 5(2) and 6(2);
(b)
the rules on third-party notice referred to in Article 65; and
(c)
the conventions referred to in Article 69.
2. The Commission shall, on the basis of the notifications by the Member States referred to in paragraph 1, establish the corresponding lists.
3. The Member States shall notify the Commission of any subsequent amendments required to be made to those lists. The Commission shall amend those lists accordingly.
4. The Commission shall publish the lists and any subsequent amendments made to them in the Official Journal of the European Union.
5. The Commission shall make all information notified pursuant to paragraphs 1 and 3 publicly available through any other appropriate means, in particular through the European Judicial Network.
Article 77
The Commission shall be empowered to adopt delegated acts in accordance with Article 78 concerning the amendment of Annexes I and II.
Article 78
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 77 shall be conferred on the Commission for an indeterminate period of time from 9 January 2013.
3. The delegation of power referred to in Article 77 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 77 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 79
By 11 January 2022 the Commission shall present a report to the European Parliament, to the Council and to the European Economic and Social Committee on the application of this Regulation. That report shall include an evaluation of the possible need for a further extension of the rules on jurisdiction to defendants not domiciled in a Member State, taking into account the operation of this Regulation and possible developments at international level. Where appropriate, the report shall be accompanied by a proposal for amendment of this Regulation.
Article 80
This Regulation shall repeal Regulation (EC) No 44/2001. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex III.
Article 81
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 10 January 2015, with the exception of Articles 75 and 76, which shall apply from 10 January 2014.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Strasbourg, 12 December 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. D. MAVROYIANNIS
(1) OJ C 218, 23.7.2011, p. 78.
(2) Position of the European Parliament of 20 November 2012 (not yet published in the Official Journal) and decision of the Council of 6 December 2012.
(3) OJ L 12, 16.1.2001, p. 1.
(4) OJ C 115, 4.5.2010, p. 1.
(5) OJ L 299, 31.12.1972, p. 32, OJ L 304, 30.10.1978, p. 1, OJ L 388, 31.12.1982, p. 1, OJ L 285, 3.10.1989, p. 1, OJ C 15, 15.1.1997, p. 1. For a consolidated text, see OJ C 27, 26.1.1998, p. 1.
(6) OJ L 319, 25.11.1988, p. 9.
(7) OJ L 120, 5.5.2006, p. 22.
(8) OJ L 147, 10.6.2009, p. 5.
(9) OJ L 7, 10.1.2009, p. 1.
(10) OJ L 74, 27.3.1993, p. 74.
(11) OJ L 157, 30.4.2004, p. 45.
(12) OJ L 174, 27.6.2001, p. 1.
(13) OJ L 299, 16.11.2005, p. 62.
(14) OJ L 335, 17.12.2009, p. 1.
(15) OJ L 324, 10.12.2007, p. 79.
(16) OJ L 174, 27.6.2001, p. 25.
ANNEX I
ANNEX II
ANNEX III
CORRELATION TABLE
Regulation (EC) No 44/2001
This Regulation
Article 1(1)
Article 1(1)
Article 1(2), introductory words
Article 1(2), introductory words
Article 1(2) point (a)
Article 1(2), points (a) and (f)
Article 1(2), points (b) to (d)
Article 1(2), points (b) to (d)
—
Article 1(2), point (e)
Article 1(3)
—
—
Article 2
Article 2
Article 4
Article 3
Article 5
Article 4
Article 6
Article 5, introductory words
Article 7, introductory words
Article 5, point (1)
Article 7, point (1)
Article 5, point (2)
—
Article 5, points (3) and (4)
Article 7, points (2) and (3)
—
Article 7, point (4)
Article 5, points (5) to (7)
Article 7, points (5) to (7)
Article 6
Article 8
Article 7
Article 9
Article 8
Article 10
Article 9
Article 11
Article 10
Article 12
Article 11
Article 13
Article 12
Article 14
Article 13
Article 15
Article 14
Article 16
Article 15
Article 17
Article 16
Article 18
Article 17
Article 19
Article 18
Article 20
Article 19, points (1) and (2)
Article 21(1)
—
Article 21(2)
Article 20
Article 22
Article 21
Article 23
Article 22
Article 24
Article 23(1) and (2)
Article 25(1) and (2)
Article 23(3)
—
Article 23(4) and (5)
Article 25(3) and (4)
—
Article 25(5)
Article 24
Article 26(1)
—
Article 26(2)
Article 25
Article 27
Article 26
Article 28
Article 27(1)
Article 29(1)
—
Article 29(2)
Article 27(2)
Article 29(3)
Article 28
Article 30
Article 29
Article 31(1)
—
Article 31(2)
—
Article 31(3)
—
Article 31(4)
Article 30
Article 32(1), points (a) and (b)
—
Article 32(1), second subparagraph
—
Article 32(2)
—
Article 33
—
Article 34
Article 31
Article 35
Article 32
Article 2, point (a)
Article 33
Article 36
—
Article 37
—
Article 39
—
Article 40
—
Article 41
—
Article 42
—
Article 43
—
Article 44
Article 34
Article 45(1), points (a) to (d)
Article 35(1)
Article 45(1), point (e)
Article 35(2)
Article 45(2)
Article 35(3)
Article 45(3)
—
Article 45(4)
Article 36
Article 52
Article 37(1)
Article 38, point (a)
Article 38
—
Article 39
—
Article 40
—
Article 41
—
Article 42
—
Article 43
—
Article 44
—
Article 45
—
Article 46
—
Article 47
—
Article 48
—
—
Article 46
—
Article 47
—
Article 48
—
Article 49
—
Article 50
—
Article 51
—
Article 54
Article 49
Article 55
Article 50
—
Article 51
Article 56
Article 52
—
Article 53
—
Article 54
Article 53
Article 55(1)
—
Article 55(2)
Article 37(2), Article 47(3) and Article 57
Article 56
Article 61
Article 57(1)
Article 58(1)
Article 57(2)
—
Article 57(3)
Article 58(2)
Article 57(4)
Article 60
Article 58
Article 59 and Article 60
Article 59
Article 62
Article 60
Article 63
Article 61
Article 64
Article 62
Article 3
Article 63
—
Article 64
—
Article 65
Article 65(1) and (2)
—
Article 65(3)
Article 66
Article 66
Article 67
Article 67
Article 68
Article 68
Article 69
Article 69
Article 70
Article 70
Article 71
Article 71
Article 72
Article 72
—
Article 73
Article 73
Article 79
Article 74(1)
Article 75, first paragraph, points (a), (b) and (c), and Article 76(1), point (a)
Article 74(2)
Article 77
—
Article 78
—
Article 80
Article 75
—
Article 76
Article 81
Annex I
Article 76(1), point (a)
Annex II
Article 75, point (a)
Annex III
Article 75, point (b)
Annex IV
Article 75, point (c)
Annex V
Annex I and Annex II
Annex VI
Annex II
—
Annex III
|
Court jurisdiction in legal cases involving different EU countries
Court jurisdiction in legal cases involving different EU countries
SUMMARY OF:
Regulation (EU) No 1215/2012 - jurisdiction and the recognition and enforcement of judgments in civil and commercial matters
SUMMARY
WHAT DOES THE REGULATION DO?
It updates a previous EU law on the jurisdiction, the recognition and enforcement of judgments in civil and commercial matters (known as the ‘
Brussels I regulation
’). It aims to make the circulation of judgments in civil and commercial cases easier and faster within the EU, in line with the principle of mutual recognition and the Stockholm programme guidelines.
KEY POINTS
The regulation applies in civil and commercial matters. It does not apply, however, to family law, bankruptcy, inheritance questions and other specific matters listed in the regulation, such as social security or arbitration.
Under the new law, what was known as the
exequatur
procedure under the Brussels I regulation has been abolished. This means that a judgment given in one EU country is recognised in the other EU countries without the need for any special procedure. If it is enforceable in the country of origin, it is enforceable in the other EU countries without requiring any declaration of enforceability.
The person against whom enforcement is sought must be informed of this by means of a certificate concerning a judgment in civil and commercial matters. This is drawn up at the request of any interested party (a model is provided in the regulation). The certificate must be accompanied by the judgment (if it has not already been served). It must be served on the person in reasonable time prior to enforcing the judgment.
In certain cases, the person against whom enforcement is sought may apply for refusal of the recognition or enforcement of the judgment. This can arise when he or she considers one of the grounds for refusal of recognition stipulated in the regulation to be present (e.g. where the recognition of a judgment is manifestly contrary to public policy). EU countries must notify to the Commission the competent courts to which the application has to be submitted.
Common rules of jurisdiction
There has to be a connection between proceedings falling within the scope of this law and the territory of the EU countries. Common rules of jurisdiction should, in principle, apply when the defendant is domiciled in an EU country. A defendant not domiciled in an EU country (i.e. whose permanent home is not in an EU country) should be subject to the national rules of jurisdiction applicable in the territory of the country of the court seised (the court where the proceedings are initiated).
However, certain rules of jurisdiction apply, regardless of the defendant’s domicile, in order:
to ensure that consumers and employees are protected,
to safeguard the jurisdiction of the courts of EU countries when they have exclusive jurisdiction (e.g. in the case of real estate), and
to respect the autonomy of the parties.
The rules of jurisdiction may also, under certain circumstances, apply to parties domiciled outside the EU. This may arise, for example, where those parties have agreed that the courts of an EU country should have jurisdiction.
Enhancing the respect of the choice of court agreements
The law improves the effectiveness of choice of court agreements where the parties have designated a particular court or courts to resolve their dispute. It gives priority to the chosen court to decide on its jurisdiction, regardless of whether it is first or second seised. Any other court has to suspend proceedings until the chosen court has established or - where the agreement is invalid - declined jurisdiction.
The United Kingdom (1) and Ireland took part in the adoption and application of this regulation. Denmark applies the regulation in line with the agreement of 19 October 2005 between the European Community and Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters.
Application of Brussels I rules by the Unified Patent Court and the Benelux Court of Justice
Regulation (EU) No 542/2014 introduces new rules on the relationship between proceedings before certain courts that are common to several EU countries (such as the Unified Patent Court and the Benelux Court of Justice) on the one hand and the courts of the EU countries under the Brussels I Regulation on the other. This means that judgments handed down by these courts should be recognised and enforced in line with Regulation (EU) No 1215/2012.
ACT
Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters
REFERENCES
Act
Entry into force
Deadline for transposition in the Member States
Official Journal
Regulation (EU) No 1215/2012
9.1.2013
Application from 10.1.2015
-
OJ L 351 of 20.12.2012, pp. 1-32
Amending acts
Entry into force
Deadline for transposition in the Member States
Official Journal
Regulation (EU) No 542/2014 o
30.5.2014
-
OJ L 163, 29.5.2014, pp. 1-4
Regulation (EU) 2015/281
26.2.2015
-
OJ L 54, 25.2.2015, pp. 1-9
RELATED ACTS
Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (Official Journal L 79, 21.3.2013, pp. 4-4)
last update 24.09.2015(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020.
|
32012R0650
|
27.7.2012
EN
Official Journal of the European Union
L 201/107
REGULATION (EU) No 650/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 July 2012
on jurisdiction, applicable law, recognition and enforcement of decisions and acceptance and enforcement of authentic instruments in matters of succession and on the creation of a European Certificate of Succession
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 81(2) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
The Union has set itself the objective of maintaining and developing an area of freedom, security and justice in which the free movement of persons is ensured. For the gradual establishment of such an area, the Union is to adopt measures relating to judicial cooperation in civil matters having cross-border implications, particularly when necessary for the proper functioning of the internal market.
(2)
In accordance with point (c) of Article 81(2) of the Treaty on the Functioning of the European Union, such measures may include measures aimed at ensuring the compatibility of the rules applicable in the Member States concerning conflict of laws and of jurisdiction.
(3)
The European Council meeting in Tampere on 15 and 16 October 1999 endorsed the principle of mutual recognition of judgments and other decisions of judicial authorities as the cornerstone of judicial cooperation in civil matters and invited the Council and the Commission to adopt a programme of measures to implement that principle.
(4)
A programme of measures for implementation of the principle of mutual recognition of decisions in civil and commercial matters (3), common to the Commission and to the Council, was adopted on 30 November 2000. That programme identifies measures relating to the harmonisation of conflict-of-laws rules as measures facilitating the mutual recognition of decisions, and provides for the drawing-up of an instrument relating to wills and succession.
(5)
The European Council meeting in Brussels on 4 and 5 November 2004 adopted a new programme called ‘The Hague Programme: strengthening freedom, security and justice in the European Union’ (4). That programme underlines the need to adopt an instrument in matters of succession dealing, in particular, with the questions of conflict of laws, jurisdiction, mutual recognition and enforcement of decisions in the area of succession and a European Certificate of Succession.
(6)
At its meeting in Brussels on 10 and 11 December 2009 the European Council adopted a new multiannual programme called ‘The Stockholm Programme – An open and secure Europe serving and protecting citizens’ (5). In that programme the European Council considered that mutual recognition should be extended to fields that are not yet covered but are essential to everyday life, for example succession and wills, while taking into consideration Member States’ legal systems, including public policy (ordre public), and national traditions in this area.
(7)
The proper functioning of the internal market should be facilitated by removing the obstacles to the free movement of persons who currently face difficulties in asserting their rights in the context of a succession having cross-border implications. In the European area of justice, citizens must be able to organise their succession in advance. The rights of heirs and legatees, of other persons close to the deceased and of creditors of the succession must be effectively guaranteed.
(8)
In order to achieve those objectives, this Regulation should bring together provisions on jurisdiction, on applicable law, on recognition or, as the case may be, acceptance, enforceability and enforcement of decisions, authentic instruments and court settlements and on the creation of a European Certificate of Succession.
(9)
The scope of this Regulation should include all civil-law aspects of succession to the estate of a deceased person, namely all forms of transfer of assets, rights and obligations by reason of death, whether by way of a voluntary transfer under a disposition of property upon death or a transfer through intestate succession.
(10)
This Regulation should not apply to revenue matters or to administrative matters of a public-law nature. It should therefore be for national law to determine, for instance, how taxes and other liabilities of a public-law nature are calculated and paid, whether these be taxes payable by the deceased at the time of death or any type of succession-related tax to be paid by the estate or the beneficiaries. It should also be for national law to determine whether the release of succession property to beneficiaries under this Regulation or the recording of succession property in a register may be made subject to the payment of taxes.
(11)
This Regulation should not apply to areas of civil law other than succession. For reasons of clarity, a number of questions which could be seen as having a link with matters of succession should be explicitly excluded from the scope of this Regulation.
(12)
Accordingly, this Regulation should not apply to questions relating to matrimonial property regimes, including marriage settlements as known in some legal systems to the extent that such settlements do not deal with succession matters, and property regimes of relationships deemed to have comparable effects to marriage. The authorities dealing with a given succession under this Regulation should nevertheless, depending on the situation, take into account the winding-up of the matrimonial property regime or similar property regime of the deceased when determining the estate of the deceased and the respective shares of the beneficiaries.
(13)
Questions relating to the creation, administration and dissolution of trusts should also be excluded from the scope of this Regulation. This should not be understood as a general exclusion of trusts. Where a trust is created under a will or under statute in connection with intestate succession the law applicable to the succession under this Regulation should apply with respect to the devolution of the assets and the determination of the beneficiaries.
(14)
Property rights, interests and assets created or transferred otherwise than by succession, for instance by way of gifts, should also be excluded from the scope of this Regulation. However, it should be the law specified by this Regulation as the law applicable to the succession which determines whether gifts or other forms of dispositions inter vivos giving rise to a right in rem prior to death should be restored or accounted for for the purposes of determining the shares of the beneficiaries in accordance with the law applicable to the succession.
(15)
This Regulation should allow for the creation or the transfer by succession of a right in immovable or movable property as provided for in the law applicable to the succession. It should, however, not affect the limited number (‘numerus clausus’) of rights in rem known in the national law of some Member States. A Member State should not be required to recognise a right in rem relating to property located in that Member State if the right in rem in question is not known in its law.
(16)
However, in order to allow the beneficiaries to enjoy in another Member State the rights which have been created or transferred to them by succession, this Regulation should provide for the adaptation of an unknown right in rem to the closest equivalent right in rem under the law of that other Member State. In the context of such an adaptation, account should be taken of the aims and the interests pursued by the specific right in rem and the effects attached to it. For the purposes of determining the closest equivalent national right in rem, the authorities or competent persons of the State whose law applied to the succession may be contacted for further information on the nature and the effects of the right. To that end, the existing networks in the area of judicial cooperation in civil and commercial matters could be used, as well as any other available means facilitating the understanding of foreign law.
(17)
The adaptation of unknown rights in rem as explicitly provided for by this Regulation should not preclude other forms of adaptation in the context of the application of this Regulation.
(18)
The requirements for the recording in a register of a right in immovable or movable property should be excluded from the scope of this Regulation. It should therefore be the law of the Member State in which the register is kept (for immovable property, the lex rei sitae) which determines under what legal conditions and how the recording must be carried out and which authorities, such as land registers or notaries, are in charge of checking that all requirements are met and that the documentation presented or established is sufficient or contains the necessary information. In particular, the authorities may check that the right of the deceased to the succession property mentioned in the document presented for registration is a right which is recorded as such in the register or which is otherwise demonstrated in accordance with the law of the Member State in which the register is kept. In order to avoid duplication of documents, the registration authorities should accept such documents drawn up in another Member State by the competent authorities whose circulation is provided for by this Regulation. In particular, the European Certificate of Succession issued under this Regulation should constitute a valid document for the recording of succession property in a register of a Member State. This should not preclude the authorities involved in the registration from asking the person applying for registration to provide such additional information, or to present such additional documents, as are required under the law of the Member State in which the register is kept, for instance information or documents relating to the payment of revenue. The competent authority may indicate to the person applying for registration how the missing information or documents can be provided.
(19)
The effects of the recording of a right in a register should also be excluded from the scope of this Regulation. It should therefore be the law of the Member State in which the register is kept which determines whether the recording is, for instance, declaratory or constitutive in effect. Thus, where, for example, the acquisition of a right in immovable property requires a recording in a register under the law of the Member State in which the register is kept in order to ensure the erga omnes effect of registers or to protect legal transactions, the moment of such acquisition should be governed by the law of that Member State.
(20)
This Regulation should respect the different systems for dealing with matters of succession applied in the Member States. For the purposes of this Regulation, the term ‘court’ should therefore be given a broad meaning so as to cover not only courts in the true sense of the word, exercising judicial functions, but also the notaries or registry offices in some Member States who or which, in certain matters of succession, exercise judicial functions like courts, and the notaries and legal professionals who, in some Member States, exercise judicial functions in a given succession by delegation of power by a court. All courts as defined in this Regulation should be bound by the rules of jurisdiction set out in this Regulation. Conversely, the term ‘court’ should not cover non-judicial authorities of a Member State empowered under national law to deal with matters of succession, such as the notaries in most Member States where, as is usually the case, they are not exercising judicial functions.
(21)
This Regulation should allow all notaries who have competence in matters of succession in the Member States to exercise such competence. Whether or not the notaries in a given Member State are bound by the rules of jurisdiction set out in this Regulation should depend on whether or not they are covered by the term ‘court’ for the purposes of this Regulation.
(22)
Acts issued by notaries in matters of succession in the Member States should circulate under this Regulation. When notaries exercise judicial functions they are bound by the rules of jurisdiction, and the decisions they give should circulate in accordance with the provisions on recognition, enforceability and enforcement of decisions. When notaries do not exercise judicial functions they are not bound by the rules of jurisdiction, and the authentic instruments they issue should circulate in accordance with the provisions on authentic instruments.
(23)
In view of the increasing mobility of citizens and in order to ensure the proper administration of justice within the Union and to ensure that a genuine connecting factor exists between the succession and the Member State in which jurisdiction is exercised, this Regulation should provide that the general connecting factor for the purposes of determining both jurisdiction and the applicable law should be the habitual residence of the deceased at the time of death. In order to determine the habitual residence, the authority dealing with the succession should make an overall assessment of the circumstances of the life of the deceased during the years preceding his death and at the time of his death, taking account of all relevant factual elements, in particular the duration and regularity of the deceased’s presence in the State concerned and the conditions and reasons for that presence. The habitual residence thus determined should reveal a close and stable connection with the State concerned taking into account the specific aims of this Regulation.
(24)
In certain cases, determining the deceased’s habitual residence may prove complex. Such a case may arise, in particular, where the deceased for professional or economic reasons had gone to live abroad to work there, sometimes for a long time, but had maintained a close and stable connection with his State of origin. In such a case, the deceased could, depending on the circumstances of the case, be considered still to have his habitual residence in his State of origin in which the centre of interests of his family and his social life was located. Other complex cases may arise where the deceased lived in several States alternately or travelled from one State to another without settling permanently in any of them. If the deceased was a national of one of those States or had all his main assets in one of those States, his nationality or the location of those assets could be a special factor in the overall assessment of all the factual circumstances.
(25)
With regard to the determination of the law applicable to the succession the authority dealing with the succession may in exceptional cases – where, for instance, the deceased had moved to the State of his habitual residence fairly recently before his death and all the circumstances of the case indicate that he was manifestly more closely connected with another State – arrive at the conclusion that the law applicable to the succession should not be the law of the State of the habitual residence of the deceased but rather the law of the State with which the deceased was manifestly more closely connected. That manifestly closest connection should, however, not be resorted to as a subsidiary connecting factor whenever the determination of the habitual residence of the deceased at the time of death proves complex.
(26)
Nothing in this Regulation should prevent a court from applying mechanisms designed to tackle the evasion of the law, such as fraude à la loi in the context of private international law.
(27)
The rules of this Regulation are devised so as to ensure that the authority dealing with the succession will, in most situations, be applying its own law. This Regulation therefore provides for a series of mechanisms which would come into play where the deceased had chosen as the law to govern his succession the law of a Member State of which he was a national.
(28)
One such mechanism should be to allow the parties concerned to conclude a choice-of-court agreement in favour of the courts of the Member State of the chosen law. It would have to be determined on a case-by-case basis, depending in particular on the issue covered by the choice-of-court agreement, whether the agreement would have to be concluded between all parties concerned by the succession or whether some of them could agree to bring a specific issue before the chosen court in a situation where the decision by that court on that issue would not affect the rights of the other parties to the succession.
(29)
If succession proceedings are opened by a court of its own motion, as is the case in certain Member States, that court should close the proceedings if the parties agree to settle the succession amicably out of court in the Member State of the chosen law. Where succession proceedings are not opened by a court of its own motion, this Regulation should not prevent the parties from settling the succession amicably out of court, for instance before a notary, in a Member State of their choice where this is possible under the law of that Member State. This should be the case even if the law applicable to the succession is not the law of that Member State.
(30)
In order to ensure that the courts of all Member States may, on the same grounds, exercise jurisdiction in relation to the succession of persons not habitually resident in a Member State at the time of death, this Regulation should list exhaustively, in a hierarchical order, the grounds on which such subsidiary jurisdiction may be exercised.
(31)
In order to remedy, in particular, situations of denial of justice, this Regulation should provide a forum necessitatis allowing a court of a Member State, on an exceptional basis, to rule on a succession which is closely connected with a third State. Such an exceptional basis may be deemed to exist when proceedings prove impossible in the third State in question, for example because of civil war, or when a beneficiary cannot reasonably be expected to initiate or conduct proceedings in that State. Jurisdiction based on forum necessitatis should, however, be exercised only if the case has a sufficient connection with the Member State of the court seised.
(32)
In order to simplify the lives of heirs and legatees habitually resident in a Member State other than that in which the succession is being or will be dealt with, this Regulation should allow any person entitled under the law applicable to the succession to make declarations concerning the acceptance or waiver of the succession, of a legacy or of a reserved share, or concerning the limitation of his liability for the debts under the succession, to make such declarations in the form provided for by the law of the Member State of his habitual residence before the courts of that Member State. This should not preclude such declarations being made before other authorities in that Member State which are competent to receive declarations under national law. Persons choosing to avail themselves of the possibility to make declarations in the Member State of their habitual residence should themselves inform the court or authority which is or will be dealing with the succession of the existence of such declarations within any time limit set by the law applicable to the succession.
(33)
It should not be possible for a person who wishes to limit his liability for the debts under the succession to do so by a mere declaration to that effect before the courts or other competent authorities of the Member State of his habitual residence where the law applicable to the succession requires him to initiate specific legal proceedings, for instance inventory proceedings, before the competent court. A declaration made in such circumstances by a person in the Member State of his habitual residence in the form provided for by the law of that Member State should therefore not be formally valid for the purposes of this Regulation. Nor should the documents instituting the legal proceedings be regarded as declarations for the purposes of this Regulation.
(34)
In the interests of the harmonious functioning of justice, the giving of irreconcilable decisions in different Member States should be avoided. To that end, this Regulation should provide for general procedural rules similar to those of other Union instruments in the area of judicial cooperation in civil matters.
(35)
One such procedural rule is a lis pendens rule which will come into play if the same succession case is brought before different courts in different Member States. That rule will then determine which court should proceed to deal with the succession case.
(36)
Given that succession matters in some Member States may be dealt with by non-judicial authorities, such as notaries, who are not bound by the rules of jurisdiction under this Regulation, it cannot be excluded that an amicable out-of-court settlement and court proceedings relating to the same succession, or two amicable out-of-court settlements relating to the same succession, may be initiated in parallel in different Member States. In such a situation, it should be for the parties involved, once they become aware of the parallel proceedings, to agree among themselves how to proceed. If they cannot agree, the succession would have to be dealt with and decided upon by the courts having jurisdiction under this Regulation.
(37)
In order to allow citizens to avail themselves, with all legal certainty, of the benefits offered by the internal market, this Regulation should enable them to know in advance which law will apply to their succession. Harmonised conflict-of-laws rules should be introduced in order to avoid contradictory results. The main rule should ensure that the succession is governed by a predictable law with which it is closely connected. For reasons of legal certainty and in order to avoid the fragmentation of the succession, that law should govern the succession as a whole, that is to say, all of the property forming part of the estate, irrespective of the nature of the assets and regardless of whether the assets are located in another Member State or in a third State.
(38)
This Regulation should enable citizens to organise their succession in advance by choosing the law applicable to their succession. That choice should be limited to the law of a State of their nationality in order to ensure a connection between the deceased and the law chosen and to avoid a law being chosen with the intention of frustrating the legitimate expectations of persons entitled to a reserved share.
(39)
A choice of law should be made expressly in a declaration in the form of a disposition of property upon death or be demonstrated by the terms of such a disposition. A choice of law could be regarded as demonstrated by a disposition of property upon death where, for instance, the deceased had referred in his disposition to specific provisions of the law of the State of his nationality or where he had otherwise mentioned that law.
(40)
A choice of law under this Regulation should be valid even if the chosen law does not provide for a choice of law in matters of succession. It should however be for the chosen law to determine the substantive validity of the act of making the choice, that is to say, whether the person making the choice may be considered to have understood and consented to what he was doing. The same should apply to the act of modifying or revoking a choice of law.
(41)
For the purposes of the application of this Regulation, the determination of the nationality or the multiple nationalities of a person should be resolved as a preliminary question. The issue of considering a person as a national of a State falls outside the scope of this Regulation and is subject to national law, including, where applicable, international Conventions, in full observance of the general principles of the European Union.
(42)
The law determined as the law applicable to the succession should govern the succession from the opening of the succession to the transfer of ownership of the assets forming part of the estate to the beneficiaries as determined by that law. It should include questions relating to the administration of the estate and to liability for the debts under the succession. The payment of the debts under the succession may, depending, in particular, on the law applicable to the succession, include the taking into account of a specific ranking of the creditors.
(43)
The rules of jurisdiction laid down by this Regulation may, in certain cases, lead to a situation where the court having jurisdiction to rule on the succession will not be applying its own law. When that situation occurs in a Member State whose law provides for the mandatory appointment of an administrator of the estate, this Regulation should allow the courts of that Member State, when seised, to appoint one or more such administrators under their own law. This should be without prejudice to any choice made by the parties to settle the succession amicably out of court in another Member State where this is possible under the law of that Member State. In order to ensure a smooth coordination between the law applicable to the succession and the law of the Member State of the appointing court, the court should appoint the person(s) who would be entitled to administer the estate under the law applicable to the succession, such as for instance the executor of the will of the deceased or the heirs themselves or, if the law applicable to the succession so requires, a third-party administrator. The courts may, however, in specific cases where their law so requires, appoint a third party as administrator even if this is not provided for in the law applicable to the succession. If the deceased had appointed an executor of the will, that person may not be deprived of his powers unless the law applicable to the succession allows for the termination of his mandate.
(44)
The powers exercised by the administrators appointed in the Member State of the court seised should be the powers of administration which they may exercise under the law applicable to the succession. Thus, if, for instance, the heir is appointed as administrator he should have the powers to administer the estate which an heir would have under that law. Where the powers of administration which may be exercised under the law applicable to the succession are not sufficient to preserve the assets of the estate or to protect the rights of the creditors or of other persons having guaranteed the debts of the deceased, the administrator(s) appointed in the Member State of the court seised may, on a residual basis, exercise powers of administration to that end provided for by the law of that Member State. Such residual powers could include, for instance, establishing a list of the assets of the estate and the debts under the succession, informing creditors of the opening of the succession and inviting them to make their claims known, and taking any provisional, including protective, measures intended to preserve the assets of the estate. The acts performed by an administrator in exercise of the residual powers should respect the law applicable to the succession as regards the transfer of ownership of succession property, including any transaction entered into by the beneficiaries prior to the appointment of the administrator, liability for the debts under the succession and the rights of the beneficiaries, including, where applicable, the right to accept or to waive the succession. Such acts could, for instance, only entail the alienation of assets or the payment of debts where this would be allowed under the law applicable to the succession. Where under the law applicable to the succession the appointment of a third-party administrator changes the liability of the heirs, such a change of liability should be respected.
(45)
This Regulation should not preclude creditors, for instance through a representative, from taking such further steps as may be available under national law, where applicable, in accordance with the relevant Union instruments, in order to safeguard their rights.
(46)
This Regulation should allow for potential creditors in other Member States where assets are located to be informed of the opening of the succession. In the context of the application of this Regulation, consideration should therefore be given to the possibility of establishing a mechanism, if appropriate by way of the e-Justice portal, to enable potential creditors in other Member States to access the relevant information so that they can make their claims known.
(47)
The law applicable to the succession should determine who the beneficiaries are in any given succession. Under most laws, the term ‘beneficiaries’ would cover heirs and legatees and persons entitled to a reserved share although, for instance, the legal position of legatees is not the same under all laws. Under some laws, the legatee may receive a direct share in the estate whereas under other laws the legatee may acquire only a claim against the heirs.
(48)
In order to ensure legal certainty for persons wishing to plan their succession in advance, this Regulation should lay down a specific conflict-of-laws rule concerning the admissibility and substantive validity of dispositions of property upon death. To ensure the uniform application of that rule, this Regulation should list which elements should be considered as elements pertaining to substantive validity. The examination of the substantive validity of a disposition of property upon death may lead to the conclusion that that disposition is without legal existence.
(49)
An agreement as to succession is a type of disposition of property upon death the admissibility and acceptance of which vary among the Member States. In order to make it easier for succession rights acquired as a result of an agreement as to succession to be accepted in the Member States, this Regulation should determine which law is to govern the admissibility of such agreements, their substantive validity and their binding effects between the parties, including the conditions for their dissolution.
(50)
The law which, under this Regulation, will govern the admissibility and substantive validity of a disposition of property upon death and, as regards agreements as to succession, the binding effects of such an agreement as between the parties, should be without prejudice to the rights of any person who, under the law applicable to the succession, has a right to a reserved share or another right of which he cannot be deprived by the person whose estate is involved.
(51)
Where reference is made in this Regulation to the law which would have been applicable to the succession of the person making a disposition of property upon death if he had died on the day on which the disposition was, as the case may be, made, modified or revoked, such reference should be understood as a reference to either the law of the State of the habitual residence of the person concerned on that day or, if he had made a choice of law under this Regulation, the law of the State of his nationality on that day.
(52)
This Regulation should regulate the validity as to form of all dispositions of property upon death made in writing by way of rules which are consistent with those of the Hague Convention of 5 October 1961 on the Conflicts of Laws Relating to the Form of Testamentary Dispositions. When determining whether a given disposition of property upon death is formally valid under this Regulation, the competent authority should disregard the fraudulent creation of an international element to circumvent the rules on formal validity.
(53)
For the purposes of this Regulation, any provision of law limiting the permitted forms of dispositions of property upon death by reference to certain personal qualifications of the person making the disposition, such as, for instance, his age, should be deemed to pertain to matters of form. This should not be interpreted as meaning that the law applicable to the formal validity of a disposition of property upon death under this Regulation should determine whether or not a minor has the capacity to make a disposition of property upon death. That law should only determine whether a personal qualification such as, for instance, minority should bar a person from making a disposition of property upon death in a certain form.
(54)
For economic, family or social considerations, certain immovable property, certain enterprises and other special categories of assets are subject to special rules in the Member State in which they are located imposing restrictions concerning or affecting the succession in respect of those assets. This Regulation should ensure the application of such special rules. However, this exception to the application of the law applicable to the succession requires a strict interpretation in order to remain compatible with the general objective of this Regulation. Therefore, neither conflict-of-laws rules subjecting immovable property to a law different from that applicable to movable property nor provisions providing for a reserved share of the estate greater than that provided for in the law applicable to the succession under this Regulation may be regarded as constituting special rules imposing restrictions concerning or affecting the succession in respect of certain assets.
(55)
To ensure uniform handling of a situation in which it is uncertain in what order two or more persons whose succession would be governed by different laws died, this Regulation should lay down a rule providing that none of the deceased persons is to have any rights in the succession of the other or others.
(56)
In some situations an estate may be left without a claimant. Different laws provide differently for such situations. Under some laws, the State will be able to claim the vacant estate as an heir irrespective of where the assets are located. Under some other laws, the State will be able to appropriate only the assets located on its territory. This Regulation should therefore lay down a rule providing that the application of the law applicable to the succession should not preclude a Member State from appropriating under its own law the assets located on its territory. However, to ensure that this rule is not detrimental to the creditors of the estate, a proviso should be added enabling the creditors to seek satisfaction of their claims out of all the assets of the estate, irrespective of their location.
(57)
The conflict-of-laws rules laid down in this Regulation may lead to the application of the law of a third State. In such cases regard should be had to the private international law rules of that State. If those rules provide for renvoi either to the law of a Member State or to the law of a third State which would apply its own law to the succession, such renvoi should be accepted in order to ensure international consistency. Renvoi should, however, be excluded in situations where the deceased had made a choice of law in favour of the law of a third State.
(58)
Considerations of public interest should allow courts and other competent authorities dealing with matters of succession in the Member States to disregard, in exceptional circumstances, certain provisions of a foreign law where, in a given case, applying such provisions would be manifestly incompatible with the public policy (ordre public) of the Member State concerned. However, the courts or other competent authorities should not be able to apply the public-policy exception in order to set aside the law of another State or to refuse to recognise or, as the case may be, accept or enforce a decision, an authentic instrument or a court settlement from another Member State when doing so would be contrary to the Charter of Fundamental Rights of the European Union, and in particular Article 21 thereof, which prohibits all forms of discrimination.
(59)
In the light of its general objective, which is the mutual recognition of decisions given in the Member States in matters of succession, irrespective of whether such decisions were given in contentious or non-contentious proceedings, this Regulation should lay down rules relating to the recognition, enforceability and enforcement of decisions similar to those of other Union instruments in the area of judicial cooperation in civil matters.
(60)
In order to take into account the different systems for dealing with matters of succession in the Member States, this Regulation should guarantee the acceptance and enforceability in all Member States of authentic instruments in matters of succession.
(61)
Authentic instruments should have the same evidentiary effects in another Member State as they have in the Member State of origin, or the most comparable effects. When determining the evidentiary effects of a given authentic instrument in another Member State or the most comparable effects, reference should be made to the nature and the scope of the evidentiary effects of the authentic instrument in the Member State of origin. The evidentiary effects which a given authentic instrument should have in another Member State will therefore depend on the law of the Member State of origin.
(62)
The ‘authenticity’ of an authentic instrument should be an autonomous concept covering elements such as the genuineness of the instrument, the formal prerequisites of the instrument, the powers of the authority drawing up the instrument and the procedure under which the instrument is drawn up. It should also cover the factual elements recorded in the authentic instrument by the authority concerned, such as the fact that the parties indicated appeared before that authority on the date indicated and that they made the declarations indicated. A party wishing to challenge the authenticity of an authentic instrument should do so before the competent court in the Member State of origin of the authentic instrument under the law of that Member State.
(63)
The term ‘the legal acts or legal relationships recorded in an authentic instrument’ should be interpreted as referring to the contents as to substance recorded in the authentic instrument. The legal acts recorded in an authentic instrument could be, for instance, the agreement between the parties on the sharing-out or the distribution of the estate, or a will or an agreement as to succession, or another declaration of intent. The legal relationships could be, for instance, the determination of the heirs and other beneficiaries as established under the law applicable to the succession, their respective shares and the existence of a reserved share, or any other element established under the law applicable to the succession. A party wishing to challenge the legal acts or legal relationships recorded in an authentic instrument should do so before the courts having jurisdiction under this Regulation, which should decide on the challenge in accordance with the law applicable to the succession.
(64)
If a question relating to the legal acts or legal relationships recorded in an authentic instrument is raised as an incidental question in proceedings before a court of a Member State, that court should have jurisdiction over that question.
(65)
An authentic instrument which is being challenged should not produce any evidentiary effects in a Member State other than the Member State of origin as long as the challenge is pending. If the challenge concerns only a specific matter relating to the legal acts or legal relationships recorded in the authentic instrument, the authentic instrument in question should not produce any evidentiary effects in a Member State other than the Member State of origin with regard to the matter being challenged as long as the challenge is pending. An authentic instrument which has been declared invalid as a result of a challenge should cease to produce any evidentiary effects.
(66)
Should an authority, in the application of this Regulation, be presented with two incompatible authentic instruments, it should assess the question as to which authentic instrument, if any, should be given priority, taking into account the circumstances of the particular case. Where it is not clear from those circumstances which authentic instrument, if any, should be given priority, the question should be determined by the courts having jurisdiction under this Regulation, or, where the question is raised as an incidental question in the course of proceedings, by the court seised of those proceedings. In the event of incompatibility between an authentic instrument and a decision, regard should be had to the grounds of non-recognition of decisions under this Regulation.
(67)
In order for a succession with cross-border implications within the Union to be settled speedily, smoothly and efficiently, the heirs, legatees, executors of the will or administrators of the estate should be able to demonstrate easily their status and/or rights and powers in another Member State, for instance in a Member State in which succession property is located. To enable them to do so, this Regulation should provide for the creation of a uniform certificate, the European Certificate of Succession (hereinafter referred to as ‘the Certificate’), to be issued for use in another Member State. In order to respect the principle of subsidiarity, the Certificate should not take the place of internal documents which may exist for similar purposes in the Member States.
(68)
The authority which issues the Certificate should have regard to the formalities required for the registration of immovable property in the Member State in which the register is kept. For that purpose, this Regulation should provide for an exchange of information on such formalities between the Member States.
(69)
The use of the Certificate should not be mandatory. This means that persons entitled to apply for a Certificate should be under no obligation to do so but should be free to use the other instruments available under this Regulation (decisions, authentic instruments and court settlements). However, no authority or person presented with a Certificate issued in another Member State should be entitled to request that a decision, authentic instrument or court settlement be presented instead of the Certificate.
(70)
The Certificate should be issued in the Member State whose courts have jurisdiction under this Regulation. It should be for each Member State to determine in its internal legislation which authorities are to have competence to issue the Certificate, whether they be courts as defined for the purposes of this Regulation or other authorities with competence in matters of succession, such as, for instance, notaries. It should also be for each Member State to determine in its internal legislation whether the issuing authority may involve other competent bodies in the issuing process, for instance bodies competent to receive statutory declarations in lieu of an oath. The Member States should communicate to the Commission the relevant information concerning their issuing authorities in order for that information to be made publicly available.
(71)
The Certificate should produce the same effects in all Member States. It should not be an enforceable title in its own right but should have an evidentiary effect and should be presumed to demonstrate accurately elements which have been established under the law applicable to the succession or under any other law applicable to specific elements, such as the substantive validity of dispositions of property upon death. The evidentiary effect of the Certificate should not extend to elements which are not governed by this Regulation, such as questions of affiliation or the question whether or not a particular asset belonged to the deceased. Any person who makes payments or passes on succession property to a person indicated in the Certificate as being entitled to accept such payment or property as an heir or legatee should be afforded appropriate protection if he acted in good faith relying on the accuracy of the information certified in the Certificate. The same protection should be afforded to any person who, relying on the accuracy of the information certified in the Certificate, buys or receives succession property from a person indicated in the Certificate as being entitled to dispose of such property. The protection should be ensured if certified copies which are still valid are presented. Whether or not such an acquisition of property by a third person is effective should not be determined by this Regulation.
(72)
The competent authority should issue the Certificate upon request. The original of the Certificate should remain with the issuing authority, which should issue one or more certified copies of the Certificate to the applicant and to any other person demonstrating a legitimate interest. This should not preclude a Member State, in accordance with its national rules on public access to documents, from allowing copies of the Certificate to be disclosed to members of the public. This Regulation should provide for redress against decisions of the issuing authority, including decisions to refuse the issue of a Certificate. Where the Certificate is rectified, modified or withdrawn, the issuing authority should inform the persons to whom certified copies have been issued so as to avoid wrongful use of such copies.
(73)
Respect for international commitments entered into by the Member States means that this Regulation should not affect the application of international conventions to which one or more Member States are party at the time when this Regulation is adopted. In particular, the Member States which are Contracting Parties to the Hague Convention of 5 October 1961 on the Conflicts of Laws Relating to the Form of Testamentary Dispositions should be able to continue to apply the provisions of that Convention instead of the provisions of this Regulation with regard to the formal validity of wills and joint wills. Consistency with the general objectives of this Regulation requires, however, that this Regulation take precedence, as between Member States, over conventions concluded exclusively between two or more Member States in so far as such conventions concern matters governed by this Regulation.
(74)
This Regulation should not preclude Member States which are parties to the Convention of 19 November 1934 between Denmark, Finland, Iceland, Norway and Sweden comprising private international law provisions on succession, wills and estate administration from continuing to apply certain provisions of that Convention, as revised by the intergovernmental agreement between the States parties thereto.
(75)
In order to facilitate the application of this Regulation, provision should be made for an obligation requiring the Member States to communicate certain information regarding their legislation and procedures relating to succession within the framework of the European Judicial Network in civil and commercial matters established by Council Decision 2001/470/EC (6). In order to allow for the timely publication in the Official Journal of the European Union of all information of relevance for the practical application of this Regulation, the Member States should also communicate such information to the Commission before this Regulation starts to apply.
(76)
Equally, to facilitate the application of this Regulation and to allow for the use of modern communication technologies, standard forms should be prescribed for the attestations to be provided in connection with the application for a declaration of enforceability of a decision, authentic instrument or court settlement and for the application for a European Certificate of Succession, as well as for the Certificate itself.
(77)
In calculating the periods and time limits provided for in this Regulation, Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (7) should apply.
(78)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to the establishment and subsequent amendment of the attestations and forms pertaining to the declaration of enforceability of decisions, court settlements and authentic instruments and to the European Certificate of Succession. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (8).
(79)
The advisory procedure should be used for the adoption of implementing acts establishing and subsequently amending the attestations and forms provided for in this Regulation in accordance with the procedure laid down in Article 4 of Regulation (EU) No 182/2011.
(80)
Since the objectives of this Regulation, namely the free movement of persons, the organisation in advance by citizens of their succession in a Union context and the protection of the rights of heirs and legatees and of persons close to the deceased, as well as of the creditors of the succession, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(81)
This Regulation respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union. This Regulation must be applied by the courts and other competent authorities of the Member States in observance of those rights and principles.
(82)
In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, those Member States are not taking part in the adoption of this Regulation and are not bound by it or subject to its application. This is, however, without prejudice to the possibility for the United Kingdom and Ireland of notifying their intention of accepting this Regulation after its adoption in accordance with Article 4 of the said Protocol.
(83)
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Scope
1. This Regulation shall apply to succession to the estates of deceased persons. It shall not apply to revenue, customs or administrative matters.
2. The following shall be excluded from the scope of this Regulation:
(a)
the status of natural persons, as well as family relationships and relationships deemed by the law applicable to such relationships to have comparable effects;
(b)
the legal capacity of natural persons, without prejudice to point (c) of Article 23(2) and to Article 26;
(c)
questions relating to the disappearance, absence or presumed death of a natural person;
(d)
questions relating to matrimonial property regimes and property regimes of relationships deemed by the law applicable to such relationships to have comparable effects to marriage;
(e)
maintenance obligations other than those arising by reason of death;
(f)
the formal validity of dispositions of property upon death made orally;
(g)
property rights, interests and assets created or transferred otherwise than by succession, for instance by way of gifts, joint ownership with a right of survivorship, pension plans, insurance contracts and arrangements of a similar nature, without prejudice to point (i) of Article 23(2);
(h)
questions governed by the law of companies and other bodies, corporate or unincorporated, such as clauses in the memoranda of association and articles of association of companies and other bodies, corporate or unincorporated, which determine what will happen to the shares upon the death of the members;
(i)
the dissolution, extinction and merger of companies and other bodies, corporate or unincorporated;
(j)
the creation, administration and dissolution of trusts;
(k)
the nature of rights in rem; and
(l)
any recording in a register of rights in immovable or movable property, including the legal requirements for such recording, and the effects of recording or failing to record such rights in a register.
Article 2
Competence in matters of succession within the Member States
This Regulation shall not affect the competence of the authorities of the Member States to deal with matters of succession.
Article 3
Definitions
1. For the purposes of this Regulation:
(a)
‘succession’ means succession to the estate of a deceased person and covers all forms of transfer of assets, rights and obligations by reason of death, whether by way of a voluntary transfer under a disposition of property upon death or a transfer through intestate succession;
(b)
‘agreement as to succession’ means an agreement, including an agreement resulting from mutual wills, which, with or without consideration, creates, modifies or terminates rights to the future estate or estates of one or more persons party to the agreement;
(c)
‘joint will’ means a will drawn up in one instrument by two or more persons;
(d)
‘disposition of property upon death’ means a will, a joint will or an agreement as to succession;
(e)
‘Member State of origin’ means the Member State in which the decision has been given, the court settlement approved or concluded, the authentic instrument established or the European Certificate of Succession issued;
(f)
‘Member State of enforcement’ means the Member State in which the declaration of enforceability or the enforcement of the decision, court settlement or authentic instrument is sought;
(g)
‘decision’ means any decision in a matter of succession given by a court of a Member State, whatever the decision may be called, including a decision on the determination of costs or expenses by an officer of the court;
(h)
‘court settlement’ means a settlement in a matter of succession which has been approved by a court or concluded before a court in the course of proceedings;
(i)
‘authentic instrument’ means a document in a matter of succession which has been formally drawn up or registered as an authentic instrument in a Member State and the authenticity of which:
(i)
relates to the signature and the content of the authentic instrument; and
(ii)
has been established by a public authority or other authority empowered for that purpose by the Member State of origin.
2. For the purposes of this Regulation, the term ‘court’ means any judicial authority and all other authorities and legal professionals with competence in matters of succession which exercise judicial functions or act pursuant to a delegation of power by a judicial authority or act under the control of a judicial authority, provided that such other authorities and legal professionals offer guarantees with regard to impartiality and the right of all parties to be heard and provided that their decisions under the law of the Member State in which they operate:
(a)
may be made the subject of an appeal to or review by a judicial authority; and
(b)
have a similar force and effect as a decision of a judicial authority on the same matter.
The Member States shall notify the Commission of the other authorities and legal professionals referred to in the first subparagraph in accordance with Article 79.
CHAPTER II
JURISDICTION
Article 4
General jurisdiction
The courts of the Member State in which the deceased had his habitual residence at the time of death shall have jurisdiction to rule on the succession as a whole.
Article 5
Choice-of-court agreement
1. Where the law chosen by the deceased to govern his succession pursuant to Article 22 is the law of a Member State, the parties concerned may agree that a court or the courts of that Member State are to have exclusive jurisdiction to rule on any succession matter.
2. Such a choice-of-court agreement shall be expressed in writing, dated and signed by the parties concerned. Any communication by electronic means which provides a durable record of the agreement shall be deemed equivalent to writing.
Article 6
Declining of jurisdiction in the event of a choice of law
Where the law chosen by the deceased to govern his succession pursuant to Article 22 is the law of a Member State, the court seised pursuant to Article 4 or Article 10:
(a)
may, at the request of one of the parties to the proceedings, decline jurisdiction if it considers that the courts of the Member State of the chosen law are better placed to rule on the succession, taking into account the practical circumstances of the succession, such as the habitual residence of the parties and the location of the assets; or
(b)
shall decline jurisdiction if the parties to the proceedings have agreed, in accordance with Article 5, to confer jurisdiction on a court or the courts of the Member State of the chosen law.
Article 7
Jurisdiction in the event of a choice of law
The courts of a Member State whose law had been chosen by the deceased pursuant to Article 22 shall have jurisdiction to rule on the succession if:
(a)
a court previously seised has declined jurisdiction in the same case pursuant to Article 6;
(b)
the parties to the proceedings have agreed, in accordance with Article 5, to confer jurisdiction on a court or the courts of that Member State; or
(c)
the parties to the proceedings have expressly accepted the jurisdiction of the court seised.
Article 8
Closing of own-motion proceedings in the event of a choice of law
A court which has opened succession proceedings of its own motion under Article 4 or Article 10 shall close the proceedings if the parties to the proceedings have agreed to settle the succession amicably out of court in the Member State whose law had been chosen by the deceased pursuant to Article 22.
Article 9
Jurisdiction based on appearance
1. Where, in the course of proceedings before a court of a Member State exercising jurisdiction pursuant to Article 7, it appears that not all the parties to those proceedings were party to the choice-of-court agreement, the court shall continue to exercise jurisdiction if the parties to the proceedings who were not party to the agreement enter an appearance without contesting the jurisdiction of the court.
2. If the jurisdiction of the court referred to in paragraph 1 is contested by parties to the proceedings who were not party to the agreement, the court shall decline jurisdiction.
In that event, jurisdiction to rule on the succession shall lie with the courts having jurisdiction pursuant to Article 4 or Article 10.
Article 10
Subsidiary jurisdiction
1. Where the habitual residence of the deceased at the time of death is not located in a Member State, the courts of a Member State in which assets of the estate are located shall nevertheless have jurisdiction to rule on the succession as a whole in so far as:
(a)
the deceased had the nationality of that Member State at the time of death; or, failing that,
(b)
the deceased had his previous habitual residence in that Member State, provided that, at the time the court is seised, a period of not more than five years has elapsed since that habitual residence changed.
2. Where no court in a Member State has jurisdiction pursuant to paragraph 1, the courts of the Member State in which assets of the estate are located shall nevertheless have jurisdiction to rule on those assets.
Article 11
Forum necessitatis
Where no court of a Member State has jurisdiction pursuant to other provisions of this Regulation, the courts of a Member State may, on an exceptional basis, rule on the succession if proceedings cannot reasonably be brought or conducted or would be impossible in a third State with which the case is closely connected.
The case must have a sufficient connection with the Member State of the court seised.
Article 12
Limitation of proceedings
1. Where the estate of the deceased comprises assets located in a third State, the court seised to rule on the succession may, at the request of one of the parties, decide not to rule on one or more of such assets if it may be expected that its decision in respect of those assets will not be recognised and, where applicable, declared enforceable in that third State.
2. Paragraph 1 shall not affect the right of the parties to limit the scope of the proceedings under the law of the Member State of the court seised.
Article 13
Acceptance or waiver of the succession, of a legacy or of a reserved share
In addition to the court having jurisdiction to rule on the succession pursuant to this Regulation, the courts of the Member State of the habitual residence of any person who, under the law applicable to the succession, may make, before a court, a declaration concerning the acceptance or waiver of the succession, of a legacy or of a reserved share, or a declaration designed to limit the liability of the person concerned in respect of the liabilities under the succession, shall have jurisdiction to receive such declarations where, under the law of that Member State, such declarations may be made before a court.
Article 14
Seising of a court
For the purposes of this Chapter, a court shall be deemed to be seised:
(a)
at the time when the document instituting the proceedings or an equivalent document is lodged with the court, provided that the applicant has not subsequently failed to take the steps he was required to take to have service effected on the defendant;
(b)
if the document has to be served before being lodged with the court, at the time when it is received by the authority responsible for service, provided that the applicant has not subsequently failed to take the steps he was required to take to have the document lodged with the court; or
(c)
if the proceedings are opened of the court’s own motion, at the time when the decision to open the proceedings is taken by the court, or, where such a decision is not required, at the time when the case is registered by the court.
Article 15
Examination as to jurisdiction
Where a court of a Member State is seised of a succession matter over which it has no jurisdiction under this Regulation, it shall declare of its own motion that it has no jurisdiction.
Article 16
Examination as to admissibility
1. Where a defendant habitually resident in a State other than the Member State where the action was brought does not enter an appearance, the court having jurisdiction shall stay the proceedings so long as it is not shown that the defendant has been able to receive the document instituting the proceedings or an equivalent document in time to arrange for his defence, or that all necessary steps have been taken to that end.
2. Article 19 of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents) (9) shall apply instead of paragraph 1 of this Article if the document instituting the proceedings or an equivalent document had to be transmitted from one Member State to another pursuant to that Regulation.
3. Where Regulation (EC) No 1393/2007 is not applicable, Article 15 of the Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters shall apply if the document instituting the proceedings or an equivalent document had to be transmitted abroad pursuant to that Convention.
Article 17
Lis pendens
1. Where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established.
2. Where the jurisdiction of the court first seised is established, any court other than the court first seised shall decline jurisdiction in favour of that court.
Article 18
Related actions
1. Where related actions are pending in the courts of different Member States, any court other than the court first seised may stay its proceedings.
2. Where those actions are pending at first instance, any court other than the court first seised may also, on the application of one of the parties, decline jurisdiction if the court first seised has jurisdiction over the actions in question and its law permits the consolidation thereof.
3. For the purposes of this Article, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable decisions resulting from separate proceedings.
Article 19
Provisional, including protective, measures
Application may be made to the courts of a Member State for such provisional, including protective, measures as may be available under the law of that State, even if, under this Regulation, the courts of another Member State have jurisdiction as to the substance of the matter.
CHAPTER III
APPLICABLE LAW
Article 20
Universal application
Any law specified by this Regulation shall be applied whether or not it is the law of a Member State.
Article 21
General rule
1. Unless otherwise provided for in this Regulation, the law applicable to the succession as a whole shall be the law of the State in which the deceased had his habitual residence at the time of death.
2. Where, by way of exception, it is clear from all the circumstances of the case that, at the time of death, the deceased was manifestly more closely connected with a State other than the State whose law would be applicable under paragraph 1, the law applicable to the succession shall be the law of that other State.
Article 22
Choice of law
1. A person may choose as the law to govern his succession as a whole the law of the State whose nationality he possesses at the time of making the choice or at the time of death.
A person possessing multiple nationalities may choose the law of any of the States whose nationality he possesses at the time of making the choice or at the time of death.
2. The choice shall be made expressly in a declaration in the form of a disposition of property upon death or shall be demonstrated by the terms of such a disposition.
3. The substantive validity of the act whereby the choice of law was made shall be governed by the chosen law.
4. Any modification or revocation of the choice of law shall meet the requirements as to form for the modification or revocation of a disposition of property upon death.
Article 23
The scope of the applicable law
1. The law determined pursuant to Article 21 or Article 22 shall govern the succession as a whole.
2. That law shall govern in particular:
(a)
the causes, time and place of the opening of the succession;
(b)
the determination of the beneficiaries, of their respective shares and of the obligations which may be imposed on them by the deceased, and the determination of other succession rights, including the succession rights of the surviving spouse or partner;
(c)
the capacity to inherit;
(d)
disinheritance and disqualification by conduct;
(e)
the transfer to the heirs and, as the case may be, to the legatees of the assets, rights and obligations forming part of the estate, including the conditions and effects of the acceptance or waiver of the succession or of a legacy;
(f)
the powers of the heirs, the executors of the wills and other administrators of the estate, in particular as regards the sale of property and the payment of creditors, without prejudice to the powers referred to in Article 29(2) and (3);
(g)
liability for the debts under the succession;
(h)
the disposable part of the estate, the reserved shares and other restrictions on the disposal of property upon death as well as claims which persons close to the deceased may have against the estate or the heirs;
(i)
any obligation to restore or account for gifts, advancements or legacies when determining the shares of the different beneficiaries; and
(j)
the sharing-out of the estate.
Article 24
Dispositions of property upon death other than agreements as to succession
1. A disposition of property upon death other than an agreement as to succession shall be governed, as regards its admissibility and substantive validity, by the law which, under this Regulation, would have been applicable to the succession of the person who made the disposition if he had died on the day on which the disposition was made.
2. Notwithstanding paragraph 1, a person may choose as the law to govern his disposition of property upon death, as regards its admissibility and substantive validity, the law which that person could have chosen in accordance with Article 22 on the conditions set out therein.
3. Paragraph 1 shall apply, as appropriate, to the modification or revocation of a disposition of property upon death other than an agreement as to succession. In the event of a choice of law in accordance with paragraph 2, the modification or revocation shall be governed by the chosen law.
Article 25
Agreements as to succession
1. An agreement as to succession regarding the succession of one person shall be governed, as regards its admissibility, its substantive validity and its binding effects between the parties, including the conditions for its dissolution, by the law which, under this Regulation, would have been applicable to the succession of that person if he had died on the day on which the agreement was concluded.
2. An agreement as to succession regarding the succession of several persons shall be admissible only if it is admissible under all the laws which, under this Regulation, would have governed the succession of all the persons involved if they had died on the day on which the agreement was concluded.
An agreement as to succession which is admissible pursuant to the first subparagraph shall be governed, as regards its substantive validity and its binding effects between the parties, including the conditions for its dissolution, by the law, from among those referred to in the first subparagraph, with which it has the closest connection.
3. Notwithstanding paragraphs 1 and 2, the parties may choose as the law to govern their agreement as to succession, as regards its admissibility, its substantive validity and its binding effects between the parties, including the conditions for its dissolution, the law which the person or one of the persons whose estate is involved could have chosen in accordance with Article 22 on the conditions set out therein.
Article 26
Substantive validity of dispositions of property upon death
1. For the purposes of Articles 24 and 25 the following elements shall pertain to substantive validity:
(a)
the capacity of the person making the disposition of property upon death to make such a disposition;
(b)
the particular causes which bar the person making the disposition from disposing in favour of certain persons or which bar a person from receiving succession property from the person making the disposition;
(c)
the admissibility of representation for the purposes of making a disposition of property upon death;
(d)
the interpretation of the disposition;
(e)
fraud, duress, mistake and any other questions relating to the consent or intention of the person making the disposition.
2. Where a person has the capacity to make a disposition of property upon death under the law applicable pursuant to Article 24 or Article 25, a subsequent change of the law applicable shall not affect his capacity to modify or revoke such a disposition.
Article 27
Formal validity of dispositions of property upon death made in writing
1. A disposition of property upon death made in writing shall be valid as regards form if its form complies with the law:
(a)
of the State in which the disposition was made or the agreement as to succession concluded;
(b)
of a State whose nationality the testator or at least one of the persons whose succession is concerned by an agreement as to succession possessed, either at the time when the disposition was made or the agreement concluded, or at the time of death;
(c)
of a State in which the testator or at least one of the persons whose succession is concerned by an agreement as to succession had his domicile, either at the time when the disposition was made or the agreement concluded, or at the time of death;
(d)
of the State in which the testator or at least one of the persons whose succession is concerned by an agreement as to succession had his habitual residence, either at the time when the disposition was made or the agreement concluded, or at the time of death; or
(e)
in so far as immovable property is concerned, of the State in which that property is located.
The determination of the question whether or not the testator or any person whose succession is concerned by the agreement as to succession had his domicile in a particular State shall be governed by the law of that State.
2. Paragraph 1 shall also apply to dispositions of property upon death modifying or revoking an earlier disposition. The modification or revocation shall also be valid as regards form if it complies with any one of the laws according to the terms of which, under paragraph 1, the disposition of property upon death which has been modified or revoked was valid.
3. For the purposes of this Article, any provision of law which limits the permitted forms of dispositions of property upon death by reference to the age, nationality or other personal conditions of the testator or of the persons whose succession is concerned by an agreement as to succession shall be deemed to pertain to matters of form. The same rule shall apply to the qualifications to be possessed by any witnesses required for the validity of a disposition of property upon death.
Article 28
Validity as to form of a declaration concerning acceptance or waiver
A declaration concerning the acceptance or waiver of the succession, of a legacy or of a reserved share, or a declaration designed to limit the liability of the person making the declaration, shall be valid as to form where it meets the requirements of:
(a)
the law applicable to the succession pursuant to Article 21 or Article 22; or
(b)
the law of the State in which the person making the declaration has his habitual residence.
Article 29
Special rules on the appointment and powers of an administrator of the estate in certain situations
1. Where the appointment of an administrator is mandatory or mandatory upon request under the law of the Member State whose courts have jurisdiction to rule on the succession pursuant to this Regulation and the law applicable to the succession is a foreign law, the courts of that Member State may, when seised, appoint one or more administrators of the estate under their own law, subject to the conditions laid down in this Article.
The administrator(s) appointed pursuant to this paragraph shall be the person(s) entitled to execute the will of the deceased and/or to administer the estate under the law applicable to the succession. Where that law does not provide for the administration of the estate by a person who is not a beneficiary, the courts of the Member State in which the administrator is to be appointed may appoint a third-party administrator under their own law if that law so requires and there is a serious conflict of interests between the beneficiaries or between the beneficiaries and the creditors or other persons having guaranteed the debts of the deceased, a disagreement amongst the beneficiaries on the administration of the estate or a complex estate to administer due to the nature of the assets.
The administrator(s) appointed pursuant to this paragraph shall be the only person(s) entitled to exercise the powers referred to in paragraph 2 or 3.
2. The person(s) appointed as administrator(s) pursuant to paragraph 1 shall exercise the powers to administer the estate which he or they may exercise under the law applicable to the succession. The appointing court may, in its decision, lay down specific conditions for the exercise of such powers in accordance with the law applicable to the succession.
Where the law applicable to the succession does not provide for sufficient powers to preserve the assets of the estate or to protect the rights of the creditors or of other persons having guaranteed the debts of the deceased, the appointing court may decide to allow the administrator(s) to exercise, on a residual basis, the powers provided for to that end by its own law and may, in its decision, lay down specific conditions for the exercise of such powers in accordance with that law.
When exercising such residual powers, however, the administrator(s) shall respect the law applicable to the succession as regards the transfer of ownership of succession property, liability for the debts under the succession, the rights of the beneficiaries, including, where applicable, the right to accept or to waive the succession, and, where applicable, the powers of the executor of the will of the deceased.
3. Notwithstanding paragraph 2, the court appointing one or more administrators pursuant to paragraph 1 may, by way of exception, where the law applicable to the succession is the law of a third State, decide to vest in those administrators all the powers of administration provided for by the law of the Member State in which they are appointed.
When exercising such powers, however, the administrators shall respect, in particular, the determination of the beneficiaries and their succession rights, including their rights to a reserved share or claim against the estate or the heirs under the law applicable to the succession.
Article 30
Special rules imposing restrictions concerning or affecting the succession in respect of certain assets
Where the law of the State in which certain immovable property, certain enterprises or other special categories of assets are located contains special rules which, for economic, family or social considerations, impose restrictions concerning or affecting the succession in respect of those assets, those special rules shall apply to the succession in so far as, under the law of that State, they are applicable irrespective of the law applicable to the succession.
Article 31
Adaptation of rights in rem
Where a person invokes a right in rem to which he is entitled under the law applicable to the succession and the law of the Member State in which the right is invoked does not know the right in rem in question, that right shall, if necessary and to the extent possible, be adapted to the closest equivalent right in rem under the law of that State, taking into account the aims and the interests pursued by the specific right in rem and the effects attached to it.
Article 32
Commorientes
Where two or more persons whose successions are governed by different laws die in circumstances in which it is uncertain in what order their deaths occurred, and where those laws provide differently for that situation or make no provision for it at all, none of the deceased persons shall have any rights to the succession of the other or others.
Article 33
Estate without a claimant
To the extent that, under the law applicable to the succession pursuant to this Regulation, there is no heir or legatee for any assets under a disposition of property upon death and no natural person is an heir by operation of law, the application of the law so determined shall not preclude the right of a Member State or of an entity appointed for that purpose by that Member State to appropriate under its own law the assets of the estate located on its territory, provided that the creditors are entitled to seek satisfaction of their claims out of the assets of the estate as a whole.
Article 34
Renvoi
1. The application of the law of any third State specified by this Regulation shall mean the application of the rules of law in force in that State, including its rules of private international law in so far as those rules make a renvoi:
(a)
to the law of a Member State; or
(b)
to the law of another third State which would apply its own law.
2. No renvoi shall apply with respect to the laws referred to in Article 21(2), Article 22, Article 27, point (b) of Article 28 and Article 30.
Article 35
Public policy (ordre public)
The application of a provision of the law of any State specified by this Regulation may be refused only if such application is manifestly incompatible with the public policy (ordre public) of the forum.
Article 36
States with more than one legal system – territorial conflicts of laws
1. Where the law specified by this Regulation is that of a State which comprises several territorial units each of which has its own rules of law in respect of succession, the internal conflict-of-laws rules of that State shall determine the relevant territorial unit whose rules of law are to apply.
2. In the absence of such internal conflict-of-laws rules:
(a)
any reference to the law of the State referred to in paragraph 1 shall, for the purposes of determining the law applicable pursuant to provisions referring to the habitual residence of the deceased, be construed as referring to the law of the territorial unit in which the deceased had his habitual residence at the time of death;
(b)
any reference to the law of the State referred to in paragraph 1 shall, for the purposes of determining the law applicable pursuant to provisions referring to the nationality of the deceased, be construed as referring to the law of the territorial unit with which the deceased had the closest connection;
(c)
any reference to the law of the State referred to in paragraph 1 shall, for the purposes of determining the law applicable pursuant to any other provisions referring to other elements as connecting factors, be construed as referring to the law of the territorial unit in which the relevant element is located.
3. Notwithstanding paragraph 2, any reference to the law of the State referred to in paragraph 1 shall, for the purposes of determining the relevant law pursuant to Article 27, in the absence of internal conflict-of-laws rules in that State, be construed as referring to the law of the territorial unit with which the testator or the persons whose succession is concerned by the agreement as to succession had the closest connection.
Article 37
States with more than one legal system – inter-personal conflicts of laws
In relation to a State which has two or more systems of law or sets of rules applicable to different categories of persons in respect of succession, any reference to the law of that State shall be construed as referring to the system of law or set of rules determined by the rules in force in that State. In the absence of such rules, the system of law or the set of rules with which the deceased had the closest connection shall apply.
Article 38
Non-application of this Regulation to internal conflicts of laws
A Member State which comprises several territorial units each of which has its own rules of law in respect of succession shall not be required to apply this Regulation to conflicts of laws arising between such units only.
CHAPTER IV
RECOGNITION, ENFORCEABILITY AND ENFORCEMENT OF DECISIONS
Article 39
Recognition
1. A decision given in a Member State shall be recognised in the other Member States without any special procedure being required.
2. Any interested party who raises the recognition of a decision as the principal issue in a dispute may, in accordance with the procedure provided for in Articles 45 to 58, apply for that decision to be recognised.
3. If the outcome of the proceedings in a court of a Member State depends on the determination of an incidental question of recognition, that court shall have jurisdiction over that question.
Article 40
Grounds of non-recognition
A decision shall not be recognised:
(a)
if such recognition is manifestly contrary to public policy (ordre public) in the Member State in which recognition is sought;
(b)
where it was given in default of appearance, if the defendant was not served with the document which instituted the proceedings or with an equivalent document in sufficient time and in such a way as to enable him to arrange for his defence, unless the defendant failed to commence proceedings to challenge the decision when it was possible for him to do so;
(c)
if it is irreconcilable with a decision given in proceedings between the same parties in the Member State in which recognition is sought;
(d)
if it is irreconcilable with an earlier decision given in another Member State or in a third State in proceedings involving the same cause of action and between the same parties, provided that the earlier decision fulfils the conditions necessary for its recognition in the Member State in which recognition is sought.
Article 41
No review as to the substance
Under no circumstances may a decision given in a Member State be reviewed as to its substance.
Article 42
Staying of recognition proceedings
A court of a Member State in which recognition is sought of a decision given in another Member State may stay the proceedings if an ordinary appeal against the decision has been lodged in the Member State of origin.
Article 43
Enforceability
Decisions given in a Member State and enforceable in that State shall be enforceable in another Member State when, on the application of any interested party, they have been declared enforceable there in accordance with the procedure provided for in Articles 45 to 58.
Article 44
Determination of domicile
To determine whether, for the purposes of the procedure provided for in Articles 45 to 58, a party is domiciled in the Member State of enforcement, the court seised shall apply the internal law of that Member State.
Article 45
Jurisdiction of local courts
1. The application for a declaration of enforceability shall be submitted to the court or competent authority of the Member State of enforcement communicated by that Member State to the Commission in accordance with Article 78.
2. The local jurisdiction shall be determined by reference to the place of domicile of the party against whom enforcement is sought, or to the place of enforcement.
Article 46
Procedure
1. The application procedure shall be governed by the law of the Member State of enforcement.
2. The applicant shall not be required to have a postal address or an authorised representative in the Member State of enforcement.
3. The application shall be accompanied by the following documents:
(a)
a copy of the decision which satisfies the conditions necessary to establish its authenticity;
(b)
the attestation issued by the court or competent authority of the Member State of origin using the form established in accordance with the advisory procedure referred to in Article 81(2), without prejudice to Article 47.
Article 47
Non-production of the attestation
1. If the attestation referred to in point (b) of Article 46(3) is not produced, the court or competent authority may specify a time for its production or accept an equivalent document or, if it considers that it has sufficient information before it, dispense with its production.
2. If the court or competent authority so requires, a translation of the documents shall be produced. The translation shall be done by a person qualified to do translations in one of the Member States.
Article 48
Declaration of enforceability
The decision shall be declared enforceable immediately on completion of the formalities in Article 46 without any review under Article 40. The party against whom enforcement is sought shall not at this stage of the proceedings be entitled to make any submissions on the application.
Article 49
Notice of the decision on the application for a declaration of enforceability
1. The decision on the application for a declaration of enforceability shall forthwith be brought to the notice of the applicant in accordance with the procedure laid down by the law of the Member State of enforcement.
2. The declaration of enforceability shall be served on the party against whom enforcement is sought, accompanied by the decision, if not already served on that party.
Article 50
Appeal against the decision on the application for a declaration of enforceability
1. The decision on the application for a declaration of enforceability may be appealed against by either party.
2. The appeal shall be lodged with the court communicated by the Member State concerned to the Commission in accordance with Article 78.
3. The appeal shall be dealt with in accordance with the rules governing procedure in contradictory matters.
4. If the party against whom enforcement is sought fails to appear before the appellate court in proceedings concerning an appeal brought by the applicant, Article 16 shall apply even where the party against whom enforcement is sought is not domiciled in any of the Member States.
5. An appeal against the declaration of enforceability shall be lodged within 30 days of service thereof. If the party against whom enforcement is sought is domiciled in a Member State other than that in which the declaration of enforceability was given, the time for appealing shall be 60 days and shall run from the date of service, either on him in person or at his residence. No extension may be granted on account of distance.
Article 51
Procedure to contest the decision given on appeal
The decision given on the appeal may be contested only by the procedure communicated by the Member State concerned to the Commission in accordance with Article 78.
Article 52
Refusal or revocation of a declaration of enforceability
The court with which an appeal is lodged under Article 50 or Article 51 shall refuse or revoke a declaration of enforceability only on one of the grounds specified in Article 40. It shall give its decision without delay.
Article 53
Staying of proceedings
The court with which an appeal is lodged under Article 50 or Article 51 shall, on the application of the party against whom enforcement is sought, stay the proceedings if the enforceability of the decision is suspended in the Member State of origin by reason of an appeal.
Article 54
Provisional, including protective, measures
1. When a decision must be recognised in accordance with this Chapter, nothing shall prevent the applicant from availing himself of provisional, including protective, measures in accordance with the law of the Member State of enforcement without a declaration of enforceability under Article 48 being required.
2. The declaration of enforceability shall carry with it by operation of law the power to proceed to any protective measures.
3. During the time specified for an appeal pursuant to Article 50(5) against the declaration of enforceability and until any such appeal has been determined, no measures of enforcement may be taken other than protective measures against the property of the party against whom enforcement is sought.
Article 55
Partial enforceability
1. Where a decision has been given in respect of several matters and the declaration of enforceability cannot be given for all of them, the court or competent authority shall give it for one or more of them.
2. An applicant may request a declaration of enforceability limited to parts of a decision.
Article 56
Legal aid
An applicant who, in the Member State of origin, has benefited from complete or partial legal aid or exemption from costs or expenses shall be entitled, in any proceedings for a declaration of enforceability, to benefit from the most favourable legal aid or the most extensive exemption from costs or expenses provided for by the law of the Member State of enforcement.
Article 57
No security, bond or deposit
No security, bond or deposit, however described, shall be required of a party who in one Member State applies for recognition, enforceability or enforcement of a decision given in another Member State on the ground that he is a foreign national or that he is not domiciled or resident in the Member State of enforcement.
Article 58
No charge, duty or fee
In proceedings for the issue of a declaration of enforceability, no charge, duty or fee calculated by reference to the value of the matter at issue may be levied in the Member State of enforcement.
CHAPTER V
AUTHENTIC INSTRUMENTS AND COURT SETTLEMENTS
Article 59
Acceptance of authentic instruments
1. An authentic instrument established in a Member State shall have the same evidentiary effects in another Member State as it has in the Member State of origin, or the most comparable effects, provided that this is not manifestly contrary to public policy (ordre public) in the Member State concerned.
A person wishing to use an authentic instrument in another Member State may ask the authority establishing the authentic instrument in the Member State of origin to fill in the form established in accordance with the advisory procedure referred to in Article 81(2) describing the evidentiary effects which the authentic instrument produces in the Member State of origin.
2. Any challenge relating to the authenticity of an authentic instrument shall be made before the courts of the Member State of origin and shall be decided upon under the law of that State. The authentic instrument challenged shall not produce any evidentiary effect in another Member State as long as the challenge is pending before the competent court.
3. Any challenge relating to the legal acts or legal relationships recorded in an authentic instrument shall be made before the courts having jurisdiction under this Regulation and shall be decided upon under the law applicable pursuant to Chapter III. The authentic instrument challenged shall not produce any evidentiary effect in a Member State other than the Member State of origin as regards the matter being challenged as long as the challenge is pending before the competent court.
4. If the outcome of proceedings in a court of a Member State depends on the determination of an incidental question relating to the legal acts or legal relationships recorded in an authentic instrument in matters of succession, that court shall have jurisdiction over that question.
Article 60
Enforceability of authentic instruments
1. An authentic instrument which is enforceable in the Member State of origin shall be declared enforceable in another Member State on the application of any interested party in accordance with the procedure provided for in Articles 45 to 58.
2. For the purposes of point (b) of Article 46(3), the authority which established the authentic instrument shall, on the application of any interested party, issue an attestation using the form established in accordance with the advisory procedure referred to in Article 81(2).
3. The court with which an appeal is lodged under Article 50 or Article 51 shall refuse or revoke a declaration of enforceability only if enforcement of the authentic instrument is manifestly contrary to public policy (ordre public) in the Member State of enforcement.
Article 61
Enforceability of court settlements
1. Court settlements which are enforceable in the Member State of origin shall be declared enforceable in another Member State on the application of any interested party in accordance with the procedure provided for in Articles 45 to 58.
2. For the purposes of point (b) of Article 46(3), the court which approved the settlement or before which it was concluded shall, on the application of any interested party, issue an attestation using the form established in accordance with the advisory procedure referred to in Article 81(2).
3. The court with which an appeal is lodged under Article 50 or Article 51 shall refuse or revoke a declaration of enforceability only if enforcement of the court settlement is manifestly contrary to public policy (ordre public) in the Member State of enforcement.
CHAPTER VI
EUROPEAN CERTIFICATE OF SUCCESSION
Article 62
Creation of a European Certificate of Succession
1. This Regulation creates a European Certificate of Succession (hereinafter referred to as ‘the Certificate’) which shall be issued for use in another Member State and shall produce the effects listed in Article 69.
2. The use of the Certificate shall not be mandatory.
3. The Certificate shall not take the place of internal documents used for similar purposes in the Member States. However, once issued for use in another Member State, the Certificate shall also produce the effects listed in Article 69 in the Member State whose authorities issued it in accordance with this Chapter.
Article 63
Purpose of the Certificate
1. The Certificate is for use by heirs, legatees having direct rights in the succession and executors of wills or administrators of the estate who, in another Member State, need to invoke their status or to exercise respectively their rights as heirs or legatees and/or their powers as executors of wills or administrators of the estate.
2. The Certificate may be used, in particular, to demonstrate one or more of the following:
(a)
the status and/or the rights of each heir or, as the case may be, each legatee mentioned in the Certificate and their respective shares of the estate;
(b)
the attribution of a specific asset or specific assets forming part of the estate to the heir(s) or, as the case may be, the legatee(s) mentioned in the Certificate;
(c)
the powers of the person mentioned in the Certificate to execute the will or administer the estate.
Article 64
Competence to issue the Certificate
The Certificate shall be issued in the Member State whose courts have jurisdiction under Article 4, Article 7, Article 10 or Article 11. The issuing authority shall be:
(a)
a court as defined in Article 3(2); or
(b)
another authority which, under national law, has competence to deal with matters of succession.
Article 65
Application for a Certificate
1. The Certificate shall be issued upon application by any person referred to in Article 63(1) (hereinafter referred to as ‘the applicant’).
2. For the purposes of submitting an application, the applicant may use the form established in accordance with the advisory procedure referred to in Article 81(2).
3. The application shall contain the information listed below, to the extent that such information is within the applicant’s knowledge and is necessary in order to enable the issuing authority to certify the elements which the applicant wants certified, and shall be accompanied by all relevant documents either in the original or by way of copies which satisfy the conditions necessary to establish their authenticity, without prejudice to Article 66(2):
(a)
details concerning the deceased: surname (if applicable, surname at birth), given name(s), sex, date and place of birth, civil status, nationality, identification number (if applicable), address at the time of death, date and place of death;
(b)
details concerning the applicant: surname (if applicable, surname at birth), given name(s), sex, date and place of birth, civil status, nationality, identification number (if applicable), address and relationship to the deceased, if any;
(c)
details concerning the representative of the applicant, if any: surname (if applicable, surname at birth), given name(s), address and representative capacity;
(d)
details of the spouse or partner of the deceased and, if applicable, ex-spouse(s) or ex-partner(s): surname (if applicable, surname at birth), given name(s), sex, date and place of birth, civil status, nationality, identification number (if applicable) and address;
(e)
details of other possible beneficiaries under a disposition of property upon death and/or by operation of law: surname and given name(s) or organisation name, identification number (if applicable) and address;
(f)
the intended purpose of the Certificate in accordance with Article 63;
(g)
the contact details of the court or other competent authority which is dealing with or has dealt with the succession as such, if applicable;
(h)
the elements on which the applicant founds, as appropriate, his claimed right to succession property as a beneficiary and/or his right to execute the will of the deceased and/or to administer the estate of the deceased;
(i)
an indication of whether the deceased had made a disposition of property upon death; if neither the original nor a copy is appended, an indication regarding the location of the original;
(j)
an indication of whether the deceased had entered into a marriage contract or into a contract regarding a relationship which may have comparable effects to marriage; if neither the original nor a copy of the contract is appended, an indication regarding the location of the original;
(k)
an indication of whether any of the beneficiaries has made a declaration concerning acceptance or waiver of the succession;
(l)
a declaration stating that, to the applicant’s best knowledge, no dispute is pending relating to the elements to be certified;
(m)
any other information which the applicant deems useful for the purposes of the issue of the Certificate.
Article 66
Examination of the application
1. Upon receipt of the application the issuing authority shall verify the information and declarations and the documents and other evidence provided by the applicant. It shall carry out the enquiries necessary for that verification of its own motion where this is provided for or authorised by its own law, or shall invite the applicant to provide any further evidence which it deems necessary.
2. Where the applicant has been unable to produce copies of the relevant documents which satisfy the conditions necessary to establish their authenticity, the issuing authority may decide to accept other forms of evidence.
3. Where this is provided for by its own law and subject to the conditions laid down therein, the issuing authority may require that declarations be made on oath or by a statutory declaration in lieu of an oath.
4. The issuing authority shall take all necessary steps to inform the beneficiaries of the application for a Certificate. It shall, if necessary for the establishment of the elements to be certified, hear any person involved and any executor or administrator and make public announcements aimed at giving other possible beneficiaries the opportunity to invoke their rights.
5. For the purposes of this Article, the competent authority of a Member State shall, upon request, provide the issuing authority of another Member State with information held, in particular, in the land registers, the civil status registers and registers recording documents and facts of relevance for the succession or for the matrimonial property regime or an equivalent property regime of the deceased, where that competent authority would be authorised, under national law, to provide another national authority with such information.
Article 67
Issue of the Certificate
1. The issuing authority shall issue the Certificate without delay in accordance with the procedure laid down in this Chapter when the elements to be certified have been established under the law applicable to the succession or under any other law applicable to specific elements. It shall use the form established in accordance with the advisory procedure referred to in Article 81(2).
The issuing authority shall not issue the Certificate in particular if:
(a)
the elements to be certified are being challenged; or
(b)
the Certificate would not be in conformity with a decision covering the same elements.
2. The issuing authority shall take all necessary steps to inform the beneficiaries of the issue of the Certificate.
Article 68
Contents of the Certificate
The Certificate shall contain the following information, to the extent required for the purpose for which it is issued:
(a)
the name and address of the issuing authority;
(b)
the reference number of the file;
(c)
the elements on the basis of which the issuing authority considers itself competent to issue the Certificate;
(d)
the date of issue;
(e)
details concerning the applicant: surname (if applicable, surname at birth), given name(s), sex, date and place of birth, civil status, nationality, identification number (if applicable), address and relationship to the deceased, if any;
(f)
details concerning the deceased: surname (if applicable, surname at birth), given name(s), sex, date and place of birth, civil status, nationality, identification number (if applicable), address at the time of death, date and place of death;
(g)
details concerning the beneficiaries: surname (if applicable, surname at birth), given name(s) and identification number (if applicable);
(h)
information concerning a marriage contract entered into by the deceased or, if applicable, a contract entered into by the deceased in the context of a relationship deemed by the law applicable to such a relationship to have comparable effects to marriage, and information concerning the matrimonial property regime or equivalent property regime;
(i)
the law applicable to the succession and the elements on the basis of which that law has been determined;
(j)
information as to whether the succession is testate or intestate, including information concerning the elements giving rise to the rights and/or powers of the heirs, legatees, executors of wills or administrators of the estate;
(k)
if applicable, information in respect of each beneficiary concerning the nature of the acceptance or waiver of the succession;
(l)
the share for each heir and, if applicable, the list of rights and/or assets for any given heir;
(m)
the list of rights and/or assets for any given legatee;
(n)
the restrictions on the rights of the heir(s) and, as appropriate, legatee(s) under the law applicable to the succession and/or under the disposition of property upon death;
(o)
the powers of the executor of the will and/or the administrator of the estate and the restrictions on those powers under the law applicable to the succession and/or under the disposition of property upon death.
Article 69
Effects of the Certificate
1. The Certificate shall produce its effects in all Member States, without any special procedure being required.
2. The Certificate shall be presumed to accurately demonstrate elements which have been established under the law applicable to the succession or under any other law applicable to specific elements. The person mentioned in the Certificate as the heir, legatee, executor of the will or administrator of the estate shall be presumed to have the status mentioned in the Certificate and/or to hold the rights or the powers stated in the Certificate, with no conditions and/or restrictions being attached to those rights or powers other than those stated in the Certificate.
3. Any person who, acting on the basis of the information certified in a Certificate, makes payments or passes on property to a person mentioned in the Certificate as authorised to accept payment or property shall be considered to have transacted with a person with authority to accept payment or property, unless he knows that the contents of the Certificate are not accurate or is unaware of such inaccuracy due to gross negligence.
4. Where a person mentioned in the Certificate as authorised to dispose of succession property disposes of such property in favour of another person, that other person shall, if acting on the basis of the information certified in the Certificate, be considered to have transacted with a person with authority to dispose of the property concerned, unless he knows that the contents of the Certificate are not accurate or is unaware of such inaccuracy due to gross negligence.
5. The Certificate shall constitute a valid document for the recording of succession property in the relevant register of a Member State, without prejudice to points (k) and (l) of Article 1(2).
Article 70
Certified copies of the Certificate
1. The issuing authority shall keep the original of the Certificate and shall issue one or more certified copies to the applicant and to any person demonstrating a legitimate interest.
2. The issuing authority shall, for the purposes of Articles 71(3) and 73(2), keep a list of persons to whom certified copies have been issued pursuant to paragraph 1.
3. The certified copies issued shall be valid for a limited period of six months, to be indicated in the certified copy by way of an expiry date. In exceptional, duly justified cases, the issuing authority may, by way of derogation, decide that the period of validity is to be longer. Once this period has elapsed, any person in possession of a certified copy must, in order to be able to use the Certificate for the purposes indicated in Article 63, apply for an extension of the period of validity of the certified copy or request a new certified copy from the issuing authority.
Article 71
Rectification, modification or withdrawal of the Certificate
1. The issuing authority shall, at the request of any person demonstrating a legitimate interest or of its own motion, rectify the Certificate in the event of a clerical error.
2. The issuing authority shall, at the request of any person demonstrating a legitimate interest or, where this is possible under national law, of its own motion, modify or withdraw the Certificate where it has been established that the Certificate or individual elements thereof are not accurate.
3. The issuing authority shall without delay inform all persons to whom certified copies of the Certificate have been issued pursuant to Article 70(1) of any rectification, modification or withdrawal thereof.
Article 72
Redress procedures
1. Decisions taken by the issuing authority pursuant to Article 67 may be challenged by any person entitled to apply for a Certificate.
Decisions taken by the issuing authority pursuant to Article 71 and point (a) of Article 73(1) may be challenged by any person demonstrating a legitimate interest.
The challenge shall be lodged before a judicial authority in the Member State of the issuing authority in accordance with the law of that State.
2. If, as a result of a challenge as referred to in paragraph 1, it is established that the Certificate issued is not accurate, the competent judicial authority shall rectify, modify or withdraw the Certificate or ensure that it is rectified, modified or withdrawn by the issuing authority.
If, as a result of a challenge as referred to in paragraph 1, it is established that the refusal to issue the Certificate was unjustified, the competent judicial authority shall issue the Certificate or ensure that the issuing authority re-assesses the case and makes a fresh decision.
Article 73
Suspension of the effects of the Certificate
1. The effects of the Certificate may be suspended by:
(a)
the issuing authority, at the request of any person demonstrating a legitimate interest, pending a modification or withdrawal of the Certificate pursuant to Article 71; or
(b)
the judicial authority, at the request of any person entitled to challenge a decision taken by the issuing authority pursuant to Article 72, pending such a challenge.
2. The issuing authority or, as the case may be, the judicial authority shall without delay inform all persons to whom certified copies of the Certificate have been issued pursuant to Article 70(1) of any suspension of the effects of the Certificate.
During the suspension of the effects of the Certificate no further certified copies of the Certificate may be issued.
CHAPTER VII
GENERAL AND FINAL PROVISIONS
Article 74
Legalisation and other similar formalities
No legalisation or other similar formality shall be required in respect of documents issued in a Member State in the context of this Regulation.
Article 75
Relationship with existing international conventions
1. This Regulation shall not affect the application of international conventions to which one or more Member States are party at the time of adoption of this Regulation and which concern matters covered by this Regulation.
In particular, Member States which are Contracting Parties to the Hague Convention of 5 October 1961 on the Conflicts of Laws Relating to the Form of Testamentary Dispositions shall continue to apply the provisions of that Convention instead of Article 27 of this Regulation with regard to the formal validity of wills and joint wills.
2. Notwithstanding paragraph 1, this Regulation shall, as between Member States, take precedence over conventions concluded exclusively between two or more of them in so far as such conventions concern matters governed by this Regulation.
3. This Regulation shall not preclude the application of the Convention of 19 November 1934 between Denmark, Finland, Iceland, Norway and Sweden comprising private international law provisions on succession, wills and estate administration, as revised by the intergovernmental agreement between those States of 1 June 2012, by the Member States which are parties thereto, in so far as it provides for:
(a)
rules on the procedural aspects of estate administration as defined by the Convention and assistance in that regard by the authorities of the States Contracting Parties to the Convention; and
(b)
simplified and more expeditious procedures for the recognition and enforcement of decisions in matters of succession.
Article 76
Relationship with Council Regulation (EC) No 1346/2000
This Regulation shall not affect the application of Council Regulation (EC) No 1346/2000 of 29 May 2000 on insolvency proceedings (10).
Article 77
Information made available to the public
The Member States shall, with a view to making the information available to the public within the framework of the European Judicial Network in civil and commercial matters, provide the Commission with a short summary of their national legislation and procedures relating to succession, including information on the type of authority which has competence in matters of succession and information on the type of authority competent to receive declarations of acceptance or waiver of the succession, of a legacy or of a reserved share.
The Member States shall also provide fact sheets listing all the documents and/or information usually required for the purposes of registration of immovable property located on their territory.
The Member States shall keep the information permanently updated.
Article 78
Information on contact details and procedures
1. By 16 January 2014, the Member States shall communicate to the Commission:
(a)
the names and contact details of the courts or authorities with competence to deal with applications for a declaration of enforceability in accordance with Article 45(1) and with appeals against decisions on such applications in accordance with Article 50(2);
(b)
the procedures to contest the decision given on appeal referred to in Article 51;
(c)
the relevant information regarding the authorities competent to issue the Certificate pursuant to Article 64; and
(d)
the redress procedures referred to in Article 72.
The Member States shall apprise the Commission of any subsequent changes to that information.
2. The Commission shall publish the information communicated in accordance with paragraph 1 in the Official Journal of the European Union, with the exception of the addresses and other contact details of the courts and authorities referred to in point (a) of paragraph 1.
3. The Commission shall make all information communicated in accordance with paragraph 1 publicly available through any other appropriate means, in particular through the European Judicial Network in civil and commercial matters.
Article 79
Establishment and subsequent amendment of the list containing the information referred to in Article 3(2)
1. The Commission shall, on the basis of the notifications by the Member States, establish the list of the other authorities and legal professionals referred to in Article 3(2).
2. The Member States shall notify the Commission of any subsequent changes to the information contained in that list. The Commission shall amend the list accordingly.
3. The Commission shall publish the list and any subsequent amendments in the Official Journal of the European Union.
4. The Commission shall make all information notified in accordance with paragraphs 1 and 2 publicly available through any other appropriate means, in particular through the European Judicial Network in civil and commercial matters.
Article 80
Establishment and subsequent amendment of the attestations and forms referred to in Articles 46, 59, 60, 61, 65 and 67
The Commission shall adopt implementing acts establishing and subsequently amending the attestations and forms referred to in Articles 46, 59, 60, 61, 65 and 67. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 81(2).
Article 81
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Article 82
Review
By 18 August 2025 the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation, including an evaluation of any practical problems encountered in relation to parallel out-of-court settlements of succession cases in different Member States or an out-of-court settlement in one Member State effected in parallel with a settlement before a court in another Member State. The report shall be accompanied, where appropriate, by proposals for amendments.
Article 83
Transitional provisions
1. This Regulation shall apply to the succession of persons who die on or after 17 August 2015.
2. Where the deceased had chosen the law applicable to his succession prior to 17 August 2015, that choice shall be valid if it meets the conditions laid down in Chapter III or if it is valid in application of the rules of private international law which were in force, at the time the choice was made, in the State in which the deceased had his habitual residence or in any of the States whose nationality he possessed.
3. A disposition of property upon death made prior to 17 August 2015 shall be admissible and valid in substantive terms and as regards form if it meets the conditions laid down in Chapter III or if it is admissible and valid in substantive terms and as regards form in application of the rules of private international law which were in force, at the time the disposition was made, in the State in which the deceased had his habitual residence or in any of the States whose nationality he possessed or in the Member State of the authority dealing with the succession.
4. If a disposition of property upon death was made prior to 17 August 2015 in accordance with the law which the deceased could have chosen in accordance with this Regulation, that law shall be deemed to have been chosen as the law applicable to the succession.
Article 84
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 17 August 2015, except for Articles 77 and 78, which shall apply from 16 January 2014, and Articles 79, 80 and 81, which shall apply from 5 July 2012.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Strasbourg, 4 July 2012.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. D. MAVROYIANNIS
(1) OJ C 44, 11.2.2011, p. 148.
(2) Position of the European Parliament of 13 March 2012 (not yet published in the Official Journal) and decision of the Council of 7 June 2012.
(3) OJ C 12, 15.1.2001, p. 1.
(4) OJ C 53, 3.3.2005, p. 1.
(5) OJ C 115, 4.5.2010, p. 1.
(6) OJ L 174, 27.6.2001, p. 25.
(7) OJ L 124, 8.6.1971, p. 1.
(8) OJ L 55, 28.2.2011, p. 13.
(9) OJ L 324, 10.12.2007, p. 79.
(10) OJ L 160, 30.6.2000, p. 1.
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Jurisdiction and applicable law in succession matters and European Certificate of Succession
Jurisdiction and applicable law in succession matters and European Certificate of Succession
SUMMARY OF:
Regulation (EU) No 650/2012 on matters of succession and on the creation of a European Certificate of Succession
SUMMARY
WHAT DOES THE REGULATION DO?
It provides legal certainty to beneficiaries of international successions, avoids conflicting decisions and simplifies proceedings. It thus makes it easier for beneficiaries in another EU country to enjoy the rights which have been granted or transferred to them by succession.
It establishes EU-wide rules on jurisdiction and on the applicable law governing succession matters in the EU, as well as rules on recognition and enforcement of decisions given in an EU country and the acceptance and the enforcement of formal legal documents issued in an EU country.
It also introduces a European Certificate of Succession to be used by heirs, legatees, executors of wills or administrators of the estate to demonstrate their status and/or exercise their rights or powers in another EU country.
It applies to all EU countries, except the UK (1), Ireland and Denmark which will continue to apply their national law to international successions. The other EU countries will apply their national rules on recognition and enforcement to decisions given in these 3 countries.
It applies to deaths on or after 17 August 2015.
KEY POINTS
Scope
The regulation applies to all civil aspects of the succession to the estates of deceased people.
It does not apply to:
revenue (for example, tax matters);
customs;
or administrative matters.
Areas of civil law other than succession, such as matrimonial property regimes, gifts and pension plans are not covered by the regulation.
Jurisdiction and applicable law
The courts of the EU country in which the deceased was usually living at the time of death will have jurisdiction to rule on the succession as a whole.
As a rule, the law applicable to the succession is the law of the country in which the deceased was usually living at their time of death. It can be the law of either an EU or non-EU country.
However, before their death, a person can instead choose that the applicable law should be the law of their country of nationality. If this person is a national of an EU country, the parties concerned by the succession may agree that the courts of that EU country should deal with the succession rather than the one in which the deceased was usually living.
The same law applies to the whole succession, irrespective of either the type of assets (moveable or immoveable) concerned or the country of their location.
The applicable law will govern, for example:
the determination of the beneficiaries and their respective shares;
the capacity to inherit;
the powers of the heirs, the executors of the wills and the administrators of the estate;
the liability for the debts under the succession;
the sharing-out of the estate.
Recognition and enforcement
The application of a single law by a single authority to an international succession avoids parallel proceedings, with possibly conflicting judicial decisions. It also ensures that decisions given in an EU country are recognised throughout the EU without need for any special procedure. Decisions enforceable in the EU country where they have been given are enforceable in another EU country when, on the application of an interested party, they have been declared enforceable there by the local court.
European Certificate of Succession
The European Certificate of Succession (ECS) is an optional document issued by the authority dealing with the succession.
It is for use by heirs, legatees, executors of wills or administrators of the estate who, in another EU country, need to demonstrate their status and/or exercise their rights as heirs or legatees or their powers as executors of wills or administrators of the estate.
Once issued, the ECS will be recognised in all EU countries without any special procedure being required.
In contrast with national certificates of succession, which have different effects depending on the EU country of issue, the ECS will have the same effects, set out in the regulation, in all EU countries.
Regulation (EU) No 1329/2014 sets out the forms to be used to accompany this Regulation, in particular the ECS.
FROM WHEN DOES THE REGULATION APPLY?
It entered into force on 5 July 2012.
BACKGROUND
For more information, see the e-Justice Portal
ACT
Regulation (EU) No 650/2012 of the European Parliament and of the Council of 4 July 2012 on jurisdiction, applicable law, recognition and enforcement of decisions and acceptance and enforcement of authentic instruments in matters of succession and on the creation of a European Certificate of Succession (OJ L 201, 27.7.2012, pp. 107-134)
Successive amendments to Regulation (EU) No 650/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED ACTS
Commission Implementing Regulation (EU) No 1329/2014 of 9 December 2014 establishing the Forms referred to in Regulation (EU) No 650/2012 of the European Parliament and of the Council on jurisdiction, applicable law, recognition and enforcement of decisions and acceptance and enforcement of authentic instruments in matters of succession and on the creation of a European Certificate of Succession (OJ L 359, 16.12.2014, pp. 30-84). See consolidated version.
last update 25.01.2016(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020.
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32010R1093
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15.12.2010
EN
Official Journal of the European Union
L 331/12
REGULATION (EU) No 1093/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 24 November 2010
establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Central Bank (1),
Having regard to the opinion of the European Economic and Social Committee (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
The financial crisis in 2007 and 2008 exposed important shortcomings in financial supervision, both in particular cases and in relation to the financial system as a whole. Nationally based supervisory models have lagged behind financial globalisation and the integrated and interconnected reality of European financial markets, in which many financial institutions operate across borders. The crisis exposed shortcomings in the areas of cooperation, coordination, consistent application of Union law and trust between national supervisors.
(2)
Before and during the financial crisis, the European Parliament has called for a move towards more integrated European supervision in order to ensure a true level playing field for all actors at the level of the Union and to reflect the increasing integration of financial markets in the Union (in its resolutions of 13 April 2000 on the Commission communication on implementing the framework for financial markets: Action Plan (4), of 21 November 2002 on prudential supervision rules in the European Union (5), of 11 July 2007 on financial services policy (2005 to 2010) – White Paper (6), of 23 September 2008 with recommendations to the Commission on hedge funds and private equity (7) and of 9 October 2008 with recommendations to the Commission on Lamfalussy follow-up: future structure of supervision (8), and in its positions of 22 April 2009 on the amended proposal for a directive of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (9) and of 23 April 2009 on the proposal for a regulation of the European Parliament and of the Council on Credit Rating Agencies (10)).
(3)
In November 2008, the Commission mandated a High-Level Group chaired by Jacques de Larosière to make recommendations on how to strengthen European supervisory arrangements with a view to better protecting the citizen and rebuilding trust in the financial system. In its final report presented on 25 February 2009 (the ‘de Larosière Report’), the High-Level Group recommended that the supervisory framework be strengthened to reduce the risk and severity of future financial crises. It recommended reforms to the structure of supervision of the financial sector in the Union. The group also concluded that a European System of Financial Supervisors should be created, comprising three European Supervisory Authorities, one for the banking sector, one for the securities sector and one for the insurance and occupational pensions sector, and recommended the creation of a European Systemic Risk Council. The report represented the reforms the experts considered were needed and on which work had to begin immediately.
(4)
In its Communication of 4 March 2009 entitled ‘Driving European Recovery’, the Commission proposed to put forward draft legislation creating a European system of financial supervision and a European systemic risk board. In its Communication of 27 May 2009 entitled ‘European Financial Supervision’, it provided more detail about the possible architecture of such a new supervisory framework reflecting the main thrust of the de Larosière Report.
(5)
The European Council, in its conclusions of 19 June 2009, confirmed that a European System of Financial Supervisors, comprising three new European Supervisory Authorities, should be established. The system should be aimed at upgrading the quality and consistency of national supervision, strengthening oversight of cross-border groups and establishing a European single rule book applicable to all financial institutions in the internal market. It emphasised that the European Supervisory Authorities should also have supervisory powers in relation to credit rating agencies and invited the Commission to prepare concrete proposals on how the European System of Financial Supervisors could play a strong role in crisis situations, while stressing that decisions taken by the European Supervisory Authorities should not impinge on the fiscal responsibilities of Member States.
(6)
On 17 June 2010, the European Council agreed that ‘Member States should introduce systems of levies and taxes on financial institutions to ensure fair burden-sharing and to set incentives to contain systemic risk. Such levies or taxes should be part of a credible resolution framework. Further work is urgently required on their main features and issues of level playing field and cumulative impacts of various regulatory measures should be carefully assessed’.
(7)
The financial and economic crisis has created real and serious risks to the stability of the financial system and the functioning of the internal market. Restoring and maintaining a stable and reliable financial system is an absolute prerequisite to preserving trust and coherence in the internal market, and thereby to preserve and improve the conditions for the establishment of a fully integrated and functioning internal market in the field of financial services. Moreover, deeper and more integrated financial markets offer better opportunities for financing and risk diversification, and thus help to improve the capacity of the economies to absorb shocks.
(8)
The Union has reached the limits of what can be done with the present status of the Committees of European Supervisors. The Union cannot remain in a situation where there is no mechanism to ensure that national supervisors arrive at the best possible supervisory decisions for cross-border financial institutions; where there is insufficient cooperation and information exchange between national supervisors; where joint action by national authorities requires complicated arrangements to take account of the patchwork of regulatory and supervisory requirements; where national solutions are most often the only feasible option in responding to problems at the level of the Union, and where different interpretations of the same legal text exist. The European System of Financial Supervision (hereinafter ‘the ESFS’) should be designed to overcome those deficiencies and provide a system that is in line with the objective of a stable and single Union financial market for financial services, linking national supervisors within a strong Union network.
(9)
The ESFS should be an integrated network of national and Union supervisory authorities, leaving day-to-day supervision to the national level. Greater harmonisation and the coherent application of rules for financial institutions and markets across the Union should also be achieved. In addition to the European Supervisory Authority (European Banking Authority) (hereinafter ‘the Authority’), a European Supervisory Authority (European Insurance and Occupational Pensions Authority) and a European Supervisory Authority (European Securities and Markets Authority) as well as a Joint Committee of the European Supervisory Authorities (hereinafter ‘the Joint Committee’) should be established. A European Systemic Risk Board (hereinafter ‘the ESRB’) should form part of the ESFS for the purposes of the tasks as specified in this Regulation and in Regulation (EU) No 1092/2010 of the European Parliament and of the Council (11).
(10)
The European Supervisory Authorities (hereinafter collectively referred to as the ‘ESAs’) should replace the Committee of European Banking Supervisors established by Commission Decision 2009/78/EC (12), the Committee of European Insurance and Occupational Pensions Supervisors established by Commission Decision 2009/79/EC (13) and the Committee of European Securities Regulators established by Commission Decision 2009/77/EC (14), and should assume all of the tasks and competences of those committees including the continuation of ongoing work and projects, where appropriate. The scope of each European Supervisory Authority’s action should be clearly defined. The ESAs should be accountable to the European Parliament and the Council. When that accountability relates to cross-sectoral issues that have been coordinated through the Joint Committee, the ESAs should be accountable, through the Joint Committee, for such coordination.
(11)
The Authority should act with a view to improving the functioning of the internal market, in particular by ensuring a high, effective and consistent level of regulation and supervision taking account of the varying interests of all Member States and the different nature of financial institutions. The Authority should protect public values such as the stability of the financial system, the transparency of markets and financial products, and the protection of depositors and investors. The Authority should also prevent regulatory arbitrage and guarantee a level playing field, and strengthen international supervisory coordination, for the benefit of the economy at large, including financial institutions and other stakeholders, consumers and employees. Its tasks should also include promoting supervisory convergence and providing advice to the Union institutions in the areas of banking, payments, e-money regulation and supervision, and related corporate governance, auditing and financial reporting issues. The Authority should also be entrusted with certain responsibilities for existing and new financial activities.
(12)
The Authority should also be able to temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in this Regulation. If required to make such temporary prohibition in the case of an emergency situation, the Authority should do so in accordance with and under the conditions laid down in this Regulation. In cases where a temporary prohibition or restriction of certain financial activities has a cross-sectoral impact, sectoral legislation should provide that the Authority should consult and coordinate its action with, where relevant, the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and with the European Supervisory Authority (European Securities and Markets Authority), through the Joint Committee.
(13)
The Authority should take due account of the impact of its activities on competition and innovation within the internal market, on the Union’s global competitiveness, on financial inclusion, and on the Union’s new strategy for jobs and growth.
(14)
In order to fulfil its objectives, the Authority should have legal personality as well as administrative and financial autonomy.
(15)
Based on the work of international bodies, systemic risk should be defined as a risk of disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructures may be potentially systemically important to some degree.
(16)
Cross-border risk includes all risks caused by economic imbalances or financial failures in all or parts of the Union that have the potential to have significant negative consequences for the transactions between economic operators of two or more Member States, for the functioning of the internal market or for the public finances of the Union or any of its Member States.
(17)
The Court of Justice of the European Union in its judgment of 2 May 2006 in Case C-217/04 (United Kingdom of Great Britain and Northern Ireland v. European Parliament and Council of the European Union) held that ‘nothing in the wording of Article 95 EC [now Article 114 of the Treaty on the Functioning of the European Union (TFEU)] implies that the addressees of the measures adopted by the Community legislature on the basis of that provision can only be the individual Member States. The legislature may deem it necessary to provide for the establishment of a Community body responsible for contributing to the implementation of a process of harmonisation in situations where, in order to facilitate the uniform implementation and application of acts based on that provision, the adoption of non-binding supporting and framework measures seems appropriate’ (15). The purpose and tasks of the Authority – assisting competent national supervisory authorities in the consistent interpretation and application of Union rules and contributing to financial stability necessary for financial integration – are closely linked to the objectives of the Union acquis concerning the internal market for financial services. The Authority should therefore be established on the basis of Article 114 TFEU.
(18)
The following legislative acts lay down the tasks for the competent authorities of Member States, including cooperating with each other and with the Commission: Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (16), Directive 2006/49/EC of the European Parliament and of the Council of 14 June 2006 on the capital adequacy of investment firms and credit institutions (17) and Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes (18).
(19)
Existing Union legislation regulating the field covered by this Regulation also includes Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (19), Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group (20), Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (21), Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions (22), and the relevant parts of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (23), of Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (24) and of Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market (25).
(20)
It is desirable that the Authority promote a consistent approach in the area of deposit guarantees to ensure a level playing field and the equitable treatment of depositors across the Union. As deposit guarantee schemes are subject to oversight in their Member States rather than regulatory supervision, the Authority should be able to exercise its powers under this Regulation in relation to the deposit guarantee scheme itself and its operator.
(21)
In accordance with the Declaration (No 39) on Article 290 of the Treaty on the Functioning of the European Union (TFEU), annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the elaboration of regulatory technical standards requires assistance of technical expertise in a form which is specific to the financial services area. It is necessary to allow the Authority to provide such expertise also on standards or parts of standards that are not based on a draft technical standard that it has elaborated.
(22)
There is a need to introduce an effective instrument to establish harmonised regulatory technical standards in financial services to ensure, also through a single rulebook, a level playing field and adequate protection of depositors, investors and consumers across the Union. As a body with highly specialised expertise, it is efficient and appropriate to entrust the Authority, in areas defined by Union law, with the elaboration of draft regulatory technical standards, which do not involve policy choices.
(23)
The Commission should endorse those draft regulatory technical standards by means of delegated acts pursuant to Article 290 TFEU in order to give them binding legal effect. They should be subject to amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission’s decision to endorse draft regulatory technical standards should be subject to a time limit.
(24)
Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission’s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority.
(25)
The Commission should also be empowered to adopt implementing technical standards by means of implementing acts pursuant to Article 291 TFEU.
(26)
In areas not covered by regulatory or implementing technical standards, the Authority should have the power to issue guidelines and recommendations on the application of Union law. In order to ensure transparency and to strengthen compliance by national supervisory authorities with those guidelines and recommendations, it should be possible for the Authority to publish the reasons for supervisory authorities’ non-compliance with those guidelines and recommendations.
(27)
Ensuring the correct and full application of Union law is a core prerequisite for the integrity, transparency, efficiency and orderly functioning of financial markets, the stability of the financial system, and for neutral conditions of competition for financial institutions in the Union. A mechanism should therefore be established whereby the Authority addresses instances of non-application or incorrect application of Union law amounting to a breach thereof. That mechanism should apply in areas where Union law defines clear and unconditional obligations.
(28)
To allow for a proportionate response to instances of incorrect or insufficient application of Union law, a three-step mechanism should apply. First, the Authority should be empowered to investigate alleged incorrect or insufficient application of Union law obligations by national authorities in their supervisory practice, concluded by a recommendation. Second, where the competent national authority does not follow the recommendation, the Commission should be empowered to issue a formal opinion taking into account the Authority’s recommendation, requiring the competent authority to take the actions necessary to ensure compliance with Union law.
(29)
Third, to overcome exceptional situations of persistent inaction by the competent authority concerned, the Authority should be empowered, as a last resort, to adopt decisions addressed to individual financial institutions. That power should be limited to exceptional circumstances in which a competent authority does not comply with the formal opinion addressed to it and in which Union law is directly applicable to financial institutions by virtue of existing or future Union regulations.
(30)
Serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the Union require a swift and concerted response at Union level. The Authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation. The power to determine the existence of an emergency situation should be conferred on the Council, following a request by any of the ESAs, the Commission or the ESRB.
(31)
The Authority should be able to require national supervisory authorities to take specific action to remedy an emergency situation. The action undertaken by the Authority in this respect should be without prejudice to the Commission’s powers pursuant to Article 258 TFEU to initiate infringement proceedings against the Member State of that supervisory authority for its failure to take such action, and without prejudice to the Commission’s right in such circumstances to seek interim measures in accordance with the rules of procedure of the Court of Justice of the European Union. Furthermore, it should be without prejudice to any liability that that Member State might incur in accordance with the case law of the Court of Justice of the European Union if its supervisory authorities fail to take the action required by the Authority.
(32)
In order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different Member States, the Authority should be able to settle disagreements in cross-border situations between those competent authorities with binding effect, including within colleges of supervisors. A conciliation phase should be provided for during which the competent authorities may reach an agreement. The Authority’s competence should cover disagreements on the procedure or content of an action or inaction by a competent authority of a Member State in cases specified in the legally binding Union acts referred to in this Regulation. In such a situation, one of the supervisors involved should be entitled to refer the issue to the Authority, which should act in accordance with this Regulation. The Authority should be empowered to require the competent authorities concerned to take specific action or to refrain from action in order to settle the matter in order to ensure compliance with Union law, with binding effects for the competent authorities concerned. If a competent authority does not comply with the settlement decision addressed to it, the Authority should be empowered to adopt decisions directly addressed to financial institutions in areas of Union law directly applicable to them. The power to adopt such decisions should apply only as a last resort and then only to ensure the correct and consistent application of Union law. In cases where the relevant Union legislation confers discretion on Member States’ competent authorities, decisions taken by the Authority cannot replace the exercise in compliance with Union law of that discretion.
(33)
The crisis has proven that the current system of cooperation between national authorities whose powers are limited to individual Member States is insufficient as regards financial institutions that operate across borders.
(34)
Expert Groups set up by Member States to examine the causes of the crisis and make suggestions to improve the regulation and supervision of the financial sector have confirmed that the current arrangements are not a sound basis for the future regulation and supervision of cross-border financial institutions across the Union.
(35)
As the de Larosière Report indicates, ‘[i]n essence, we have two alternatives: the first “chacun pour soi” beggar-thy-neighbour solutions; or the second – enhanced, pragmatic, sensible European cooperation for the benefit of all to preserve an open world economy. This will bring undoubted economic gains’.
(36)
Colleges of supervisors play an important role in the efficient, effective and consistent supervision of financial institutions operating across borders. The Authority should contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors and, in that respect, have a leading role in ensuring the consistent and coherent functioning of colleges of supervisors for cross-border financial institutions across the Union. The Authority should therefore have full participation rights in colleges of supervisors with a view to streamlining the functioning of and the information exchange process in the colleges of supervisors and to foster convergence and consistency across colleges in the application of Union law. As the de Larosière Report states, ‘competition distortions and regulatory arbitrage stemming from different supervisory practices must be avoided, because they have the potential of undermining financial stability – inter alia by encouraging a shift of financial activity to countries with lax supervision. The supervisory system has to be perceived as fair and balanced’.
(37)
Convergence in the fields of crisis prevention, management and resolution, including funding mechanisms, is necessary in order to ensure the internalisation of costs by the financial system and the ability of public authorities to resolve failing financial institutions whilst minimising the impact of failures on the financial system, reliance on taxpayer funds to bail out banks and the use of public sector resources, limiting damage to the economy, and coordinating the application of national resolution measures. In this regard it is imperative to develop a common set of rules on a complete set of tools for the prevention and resolution of failing banks, to deal in particular with the crisis of large, cross-border or interconnected institutions, and the need to confer additional relevant powers to the Authority should be assessed as well as how banks and savings institutions could prioritise the protection of savers.
(38)
In the current review of Directive 94/19/EC and Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (26), the Commission’s intention to pay special attention to the need to ensure further harmonisation throughout the Union is noted. In the insurance sector, the Commission’s intention to examine the possibility of introducing Union rules protecting insurance policy holders in case of a failing insurance company is also noted. The ESAs should play an important role in those areas and appropriate powers concerning the European guarantee scheme systems should be conferred upon them.
(39)
The delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks, to foster cooperation and thereby streamline the supervisory process, as well as to reduce the burden imposed on financial institutions. This Regulation should therefore provide a clear legal basis for such delegation. Whilst respecting the general rule that delegation should be allowed, Member States should be able to introduce specific conditions for the delegation of responsibilities, for example, regarding information about, and the notification of, delegation arrangements. Delegation of tasks means that tasks are carried out by the Authority or by a national supervisory authority other than the responsible authority, while the responsibility for supervisory decisions remains with the delegating authority. By the delegation of responsibilities, the Authority or a national supervisory authority (the delegate) should be able to decide upon a certain supervisory matter in its own name in lieu of the delegating authority. Delegations should be governed by the principle of allocating supervisory competence to a supervisor which is best placed to take action in the subject matter. A reallocation of responsibilities would be appropriate, for example, for reasons of economies of scale or scope, of coherence in group supervision, and of optimal use of technical expertise among national supervisory authorities. Decisions by the delegate should be recognised by the delegating authority and by other competent authorities as determinative if those decisions are within the scope of the delegation. Relevant Union legislation could further specify the principles for the reallocation of responsibilities upon agreement. The Authority should facilitate and monitor delegation agreements between national supervisory authorities by all appropriate means.
It should be informed in advance of intended delegation agreements, in order to be able to express an opinion where appropriate. It should centralise the publication of such agreements to ensure timely, transparent and easily accessible information about agreements for all parties concerned. It should identify and disseminate best practices regarding delegation and delegation agreements.
(40)
The Authority should actively foster supervisory convergence across the Union with the aim of establishing a common supervisory culture.
(41)
Peer reviews are an efficient and effective tool for fostering consistency within the network of financial supervisors. The Authority should therefore develop the methodological framework for such reviews and conduct them on a regular basis. Reviews should focus not only on the convergence of supervisory practices, but also on the capacity of supervisors to achieve high-quality supervisory outcomes, as well as on the independence of those competent authorities. The outcome of peer reviews should be made public with the agreement of the competent authority subject to the review. Best practices should also be identified and made public.
(42)
The Authority should actively promote a coordinated Union supervisory response, in particular to ensure the orderly functioning and integrity of financial markets and the stability of the financial system in the Union. In addition to its powers for action in emergency situations, the Authority should therefore be entrusted with a general coordination function within the ESFS. The smooth flow of all relevant information between competent authorities should be a particular focus of the Authority’s actions.
(43)
In order to safeguard financial stability it is necessary to identify, at an early stage, trends, potential risks and vulnerabilities stemming from the micro-prudential level, across borders and across sectors. The Authority should monitor and assess such developments in the area of its competence and, where necessary, inform the European Parliament, the Council, the Commission, the other European Supervisory Authorities and the ESRB on a regular and, as necessary, on an ad hoc basis. The Authority should also, in cooperation with the ESRB, initiate and coordinate Union-wide stress tests to assess the resilience of financial institutions to adverse market developments, and it should ensure that an as consistent as possible methodology is applied at the national level to such tests. In order to perform its functions properly, the Authority should conduct economic analyses of the markets and the impact of potential market developments.
(44)
Given the globalisation of financial services and the increased importance of international standards, the Authority should foster dialogue and cooperation with supervisors outside the Union. It should be empowered to develop contacts and enter into administrative arrangements with the supervisory authorities and administrations of third countries and with international organisations, while fully respecting the existing roles and respective competences of the Member States and the Union institutions. Participation in the work of the Authority should be open to countries which have concluded agreements with the Union whereby they have adopted and are applying Union law, and the Authority should be able to cooperate with third countries which apply legislation that has been recognised as equivalent to that of the Union.
(45)
The Authority should serve as an independent advisory body to the European Parliament, the Council, and the Commission in the area of its competence. Without prejudice to the competencies of the competent authorities concerned, the Authority should be able to provide its opinion on the prudential assessment of mergers and acquisitions under Directive 2006/48/EC, as amended by Directive 2007/44/EC (27) in those cases in which that Directive requires consultation between competent authorities from two or more Member States.
(46)
In order to carry out its duties effectively, the Authority should have the right to request all necessary information. To avoid the duplication of reporting obligations for financial institutions, that information should normally be provided by the national supervisory authorities which are closest to the financial markets and institutions and should take into account already existing statistics. However, as a last resort, the Authority should be able to address a duly justified and reasoned request for information directly to a financial institution where a national competent authority does not or cannot provide such information in a timely fashion. Member States’ authorities should be obliged to assist the Authority in enforcing such direct requests. In that context, the work on common reporting formats is essential. The measures for the collection of information should be without prejudice to the legal framework of the European Statistical System and the European System of Central Banks in the field of statistics. This Regulation should therefore be without prejudice both to Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (28) and to Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (29).
(47)
Close cooperation between the Authority and the ESRB is essential to give full effectiveness to the functioning of the ESRB and the follow-up to its warnings and recommendations. The Authority and the ESRB should share any relevant information with each other. Data related to individual undertakings should be provided only upon reasoned request. Upon receipt of warnings or recommendations addressed by the ESRB to the Authority or a national supervisory authority, the Authority should ensure follow-up as appropriate.
(48)
The Authority should consult interested parties on regulatory or implementing technical standards, guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures. Before adopting draft regulatory or implementing technical standards, guidelines and recommendations, the Authority should carry out an impact study. For reasons of efficiency, a Banking Stakeholder Group should be used for that purpose, and should represent, in balanced proportions, Union credit and investment institutions, representing the diverse models and sizes of financial institutions and businesses, including, as appropriate, institutional investors and other financial institutions which themselves use financial services; small and medium-sized enterprises (SMEs); trade unions; academics; consumers; and other retail users of banking services. The Banking Stakeholder Group should work as an interface with other user groups in the financial services area established by the Commission or by Union legislation.
(49)
Members of the Banking Stakeholder Group representing non-profit organisations or academics should receive adequate compensation in order to allow persons that are neither well-funded nor industry representatives to take part fully in the debate on financial regulation.
(50)
Member States have a core responsibility for ensuring coordinated crisis management and preserving financial stability in crisis situations, in particular with regard to stabilising and resolving individual failing financial institutions. Decisions by the Authority in emergency or settlement situations affecting the stability of a financial institution should not impinge on the fiscal responsibilities of Member States. A mechanism should be established whereby Member States may invoke this safeguard and ultimately bring the matter before the Council for a decision. However, that safeguard mechanism should not be abused, in particular in relation to a decision taken by the Authority which does not have a significant or material fiscal impact, such as a reduction of income linked to the temporary prohibition of specific activities or products for consumer protection purposes. When taking decisions under the safeguard mechanism, the Council should vote in accordance with the principle where each member has one vote. It is appropriate to confer on the Council a role in this matter given the particular responsibilities of the Member States in this respect. Given the sensitivity of the issue, strict confidentiality arrangements should be ensured.
(51)
In its decision-making procedures, the Authority should be bound by Union rules and general principles on due process and transparency. The right of the addressees of the Authority’s decisions to be heard should be fully respected. The Authority’s acts should form an integral part of Union law.
(52)
A Board of Supervisors composed of the heads of the relevant competent authorities in each Member State, and chaired by the Chairperson of the Authority, should be the principal decision-making organ of the Authority. Representatives of the Commission, the ESRB, the European Central Bank, the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) should participate as observers. Members of the Board of Supervisors should act independently and only in the Union’s interest.
(53)
As a general rule, the Board of Supervisors should take its decisions by simple majority in accordance with the principle where each member has one vote. However, for acts of a general nature, including those relating to regulatory and implementing technical standards, guidelines and recommendations, for budgetary matters as well as in respect of requests by a Member State to reconsider a decision by the Authority to temporarily prohibit or restrict certain financial activities, it is appropriate to apply the rules of qualified majority voting as laid down in Article 16(4) of the Treaty on European Union and in the Protocol (No 36) on transitional provisions annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union. Cases concerning the settlement of disagreements between national supervisory authorities should be examined by a restricted, objective panel, composed of members who neither are representatives of the competent authorities which are party to the disagreement nor have any interest in the conflict or direct links to the competent authorities concerned. The composition of the panel should be appropriately balanced. The decision taken by the panel should be approved by the Board of Supervisors by simple majority in accordance with the principle where each member has one vote. However, with regard to decisions taken by the consolidating supervisor, the decision proposed by the panel could be rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
(54)
A Management Board, composed of the Chairperson of the Authority, of representatives of national supervisory authorities and of the Commission, should ensure that the Authority carries out its mission and performs the tasks assigned to it. The Management Board should be entrusted with the necessary powers, inter alia, to propose the annual and multi-annual work programme, to exercise certain budgetary powers, to adopt the Authority’s staff policy plan, to adopt special provisions on the right to access to documents and to propose the annual report.
(55)
The Authority should be represented by a full-time Chairperson, appointed by the Board of Supervisors, on the basis of merit, skills, knowledge of financial institutions and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure organised and managed by the Board of Supervisors assisted by the Commission. For the designation of the first Chairperson of the Authority, the Commission should, inter alia, draw up a shortlist of candidates on the basis of merit, skills, knowledge of financial institutions and markets, and experience relevant to financial supervision and regulation. For the subsequent designations, the opportunity of having a shortlist drawn up by the Commission should be reviewed in a report to be established pursuant to this Regulation. Before the selected person takes up his duties, and up to 1 month after his selection by the Board of Supervisors, the European Parliament should be entitled, after having heard the person selected, to object to his designation.
(56)
The management of the Authority should be entrusted to an Executive Director, who should have the right to participate in meetings of the Board of Supervisors and the Management Board without the right to vote.
(57)
In order to ensure cross-sectoral consistency in the activities of the ESAs, they should coordinate closely through a Joint Committee and reach common positions where appropriate. The Joint Committee should coordinate the functions of the ESAs in relation to financial conglomerates and other cross-sectoral matters. Where relevant, acts also falling within the area of competence of the European Supervisory Authority (European Insurance and Occupational Pensions Authority) or the European Supervisory Authority (European Securities and Markets Authority) should be adopted in parallel by the European Supervisory Authorities concerned. The Joint Committee should be chaired for a 12-month term on a rotating basis by the Chairpersons of the ESAs. The Chairperson of the Joint Committee should be a Vice-Chair of the ESRB. The Joint Committee should have dedicated staff provided by the ESAs to allow for informal information sharing and the development of a common supervisory culture approach across the ESAs.
(58)
It is necessary to ensure that the parties affected by decisions adopted by the Authority may have recourse to the necessary remedies. To protect effectively the rights of parties, and for reasons of procedural economy, where the Authority has decision-making powers, parties should be granted a right of appeal to a Board of Appeal. For reasons of efficiency and consistency, the Board of Appeal should be a joint body of the ESAs, independent from their administrative and regulatory structures. The decisions of the Board of Appeal should be subject to appeal before the Court of Justice of the European Union.
(59)
In order to guarantee its full autonomy and independence, the Authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the General Budget of the European Union. Union financing of the Authority is subject to an agreement by the budgetary authority in accordance with Point 47 of the Interinstitutional Agreement between the European Parliament, the Council and the Commission of 17 May 2006 on budgetary discipline and sound financial management (30). The Union budgetary procedure should be applicable. The auditing of accounts should be undertaken by the Court of Auditors. The overall budget is subject to the discharge procedure.
(60)
Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (31) should apply to the Authority. The Authority should also accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (32).
(61)
In order to ensure open and transparent employment conditions and equal treatment of staff, the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities (33) should apply to the staff of the Authority.
(62)
It is essential that business secrets and other confidential information be protected. The confidentiality of information made available to the Authority and exchanged in the network should be subject to stringent and effective confidentiality rules.
(63)
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (34) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (35) are fully applicable to the processing of personal data for the purposes of this Regulation.
(64)
In order to ensure the transparent operation of the Authority, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (36) should apply to the Authority.
(65)
Third countries should be allowed to participate in the work of the Authority in accordance with appropriate agreements to be concluded by the Union.
(66)
Since the objectives of this Regulation, namely improving the functioning of the internal market by means of ensuring a high, effective and consistent level of prudential regulation and supervision, protecting depositors and investors, protecting the integrity, efficiency and orderly functioning of financial markets, maintaining the stability of the financial system, and strengthening international supervisory coordination, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(67)
The Authority should assume all current tasks and powers of the Committee of European Banking Supervisors. Commission Decision 2009/78/EC should therefore be repealed on the date of the establishment of the Authority and Decision No 716/2009/EC of the European Parliament and of the Council of 16 September 2009 establishing a Community programme to support specific activities in the field of financial services, financial reporting and auditing (37) should be amended accordingly. Given the existing structures and operations of the Committee of European Banking Supervisors, it is important to ensure very close cooperation between the Committee of European Banking Supervisors and the Commission when establishing appropriate transitional arrangements, to ensure that the period during which the Commission is responsible for the administrative establishment and initial administrative operation of the Authority be as limited as possible.
(68)
It is appropriate to set a time limit for the application of this Regulation in order to ensure that the Authority is adequately prepared to begin operations and a smooth transition from the Committee of European Banking Supervisors. The Authority should be appropriately financed. At least initially, it should be financed 40 % from Union funds and 60 % through contributions from Member States, made in accordance with the weighting of votes set out in Article 3(3) of the Protocol (No 36) on transitional provisions.
(69)
In order to enable the Authority to be established on 1 January 2011, this Regulation should enter into force on the day following its publication in the Official Journal of the European Union,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
ESTABLISHMENT AND LEGAL STATUS
Article 1
Establishment and scope of action
1. This Regulation establishes a European Supervisory Authority (European Banking Authority) (hereinafter ‘the Authority’).
2. The Authority shall act within the powers conferred by this Regulation and within the scope of Directive 2006/48/EC, Directive 2006/49/EC, Directive 2002/87/EC, Regulation (EC) No 1781/2006, Directive 94/19/EC and, to the extent that those acts apply to credit and financial institutions and the competent authorities that supervise them, within the relevant parts of Directive 2005/60/EC, Directive 2002/65/EC, Directive 2007/64/EC and Directive 2009/110/EC, including all directives, regulations, and decisions based on those acts, and of any further legally binding Union act which confers tasks on the Authority.
3. The Authority shall also act in the field of activities of credit institutions, financial conglomerates, investment firms, payment institutions and e-money institutions in relation to issues not directly covered in the acts referred to in paragraph 2, including matters of corporate governance, auditing and financial reporting, provided that such actions by the Authority are necessary to ensure the effective and consistent application of those acts.
4. The provisions of this Regulation are without prejudice to the powers of the Commission, in particular pursuant to Article 258 TFEU, to ensure compliance with Union law.
5. The objective of the Authority shall be to protect the public interest by contributing to the short, medium and long-term stability and effectiveness of the financial system, for the Union economy, its citizens and businesses. The Authority shall contribute to:
(a)
improving the functioning of the internal market, including, in particular, a sound, effective and consistent level of regulation and supervision;
(b)
ensuring the integrity, transparency, efficiency and orderly functioning of financial markets;
(c)
strengthening international supervisory coordination;
(d)
preventing regulatory arbitrage and promoting equal conditions of competition;
(e)
ensuring the taking of credit and other risks are appropriately regulated and supervised; and
(f)
enhancing customer protection.
For those purposes, the Authority shall contribute to ensuring the consistent, efficient and effective application of the acts referred to in paragraph 2, foster supervisory convergence, provide opinions to the European Parliament, the Council, and the Commission and undertake economic analyses of the markets to promote the achievement of the Authority’s objective.
In the exercise of the tasks conferred upon it by this Regulation, the Authority shall pay particular attention to any systemic risk posed by financial institutions, the failure of which may impair the operation of the financial system or the real economy.
When carrying out its tasks, the Authority shall act independently and objectively and in the interest of the Union alone.
Article 2
European System of Financial Supervision
1. The Authority shall form part of a European System of Financial Supervision (ESFS). The main objective of the ESFS shall be to ensure that the rules applicable to the financial sector are adequately implemented to preserve financial stability and to ensure confidence in the financial system as a whole and sufficient protection for the customers of financial services.
2. The ESFS shall comprise the following:
(a)
the European Systemic Risk Board (ESRB), for the purposes of the tasks as specified in Regulation (EU) No 1092/2010 and this Regulation;
(b)
the Authority;
(c)
the European Supervisory Authority (European Insurance and Occupational Pensions Authority) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (38);
(d)
the European Supervisory Authority (European Securities and Markets Authority) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (39);
(e)
the Joint Committee of the European Supervisory Authorities (Joint Committee) for the purposes of carrying out the tasks as specified in Articles 54 to 57 of this Regulation, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010;
(f)
the competent or supervisory authorities in the Member States as specified in the Union acts referred to in Article 1(2) of this Regulation, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010.
3. The Authority shall cooperate regularly and closely with the ESRB as well as with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) through the Joint Committee, ensuring cross-sectoral consistency of work and reaching joint positions in the area of supervision of financial conglomerates and on other cross-sectoral issues.
4. In accordance with the principle of sincere cooperation pursuant to Article 4(3) of the Treaty on European Union, the parties to the ESFS shall cooperate with trust and full mutual respect, in particular in ensuring the flow of appropriate and reliable information between them.
5. Those supervisory authorities that are party to the ESFS shall be obliged to supervise financial institutions operating in the Union in accordance with the acts referred to in Article 1(2).
Article 3
Accountability of the Authorities
The Authorities referred to in Article 2(2)(a) to (d) shall be accountable to the European Parliament and the Council.
Article 4
Definitions
For the purposes of this Regulation the following definitions apply:
(1)
‘financial institutions’ means ‘credit institutions’ as defined in Article 4(1) of Directive 2006/48/EC, ‘investment firms’ as defined in Article 3(1)(b) of Directive 2006/49/EC, and ‘financial conglomerates’ as defined in Article 2(14) of Directive 2002/87/EC, save that, with regard to Directive 2005/60/EC, ‘financial institutions’ means credit institutions and financial institutions as defined in Article 3(1) and (2) of that Directive;
(2)
‘competent authorities’ means:
(i)
competent authorities as defined in Directives 2006/48/EC, 2006/49/EC and 2007/64/EC and as referred to in Directive 2009/110/EC;
(ii)
with regard to Directives 2002/65/EC and 2005/60/EC, the authorities competent for ensuring compliance with the requirements of those Directives by credit and financial institutions; and
(iii)
with regard to deposit guarantee schemes, bodies which administer deposit-guarantee schemes pursuant to Directive 94/19/EC, or, where the operation of the deposit-guarantee scheme is administered by a private company, the public authority supervising those schemes pursuant to that Directive.
Article 5
Legal status
1. The Authority shall be a Union body with legal personality.
2. In each Member State, the Authority shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings.
3. The Authority shall be represented by its Chairperson.
Article 6
Composition
The Authority shall comprise:
(1)
a Board of Supervisors, which shall exercise the tasks set out in Article 43;
(2)
a Management Board, which shall exercise the tasks set out in Article 47;
(3)
a Chairperson, who shall exercise the tasks set out in Article 48;
(4)
an Executive Director, who shall exercise the tasks set out in Article 53;
(5)
a Board of Appeal, which shall exercise the tasks set out in Article 60.
Article 7
Seat
The Authority shall have its seat in London.
CHAPTER II
TASKS AND POWERS OF THE AUTHORITY
Article 8
Tasks and powers of the Authority
1. The Authority shall have the following tasks:
(a)
to contribute to the establishment of high-quality common regulatory and supervisory standards and practices, in particular by providing opinions to the Union institutions and by developing guidelines, recommendations, and draft regulatory and implementing technical standards which shall be based on the legislative acts referred to in Article 1(2);
(b)
to contribute to the consistent application of legally binding Union acts, in particular by contributing to a common supervisory culture, ensuring consistent, efficient and effective application of the acts referred to in Article 1(2), preventing regulatory arbitrage, mediating and settling disagreements between competent authorities, ensuring effective and consistent supervision of financial institutions, ensuring a coherent functioning of colleges of supervisors and taking actions, inter alia, in emergency situations;
(c)
to stimulate and facilitate the delegation of tasks and responsibilities among competent authorities;
(d)
to cooperate closely with the ESRB, in particular by providing the ESRB with the necessary information for the achievement of its tasks and by ensuring a proper follow up to the warnings and recommendations of the ESRB;
(e)
to organise and conduct peer review analyses of competent authorities, including issuing guidelines and recommendations and identifying best practices, in order to strengthen consistency in supervisory outcomes;
(f)
to monitor and assess market developments in the area of its competence, including where appropriate trends in credit, in particular, to households and SMEs;
(g)
to undertake economic analyses of markets to inform the discharge of the Authority’s functions;
(h)
to foster depositor and investor protection;
(i)
to contribute to the consistent and coherent functioning of colleges of supervisors, the monitoring, assessment and measurement of systemic risk, the development and coordination of recovery and resolution plans, providing a high level of protection to depositors and investors throughout the Union and developing methods for the resolution of failing financial institutions and an assessment of the need for appropriate financing instruments, in accordance with Articles 21 to 26;
(j)
to fulfil any other specific tasks set out in this Regulation or in other legislative acts;
(k)
to publish on its website, and to update regularly, information relating to its field of activities, in particular, within the area of its competence, on registered financial institutions, in order to ensure information is easily accessible by the public;
(l)
to take over, as appropriate, all existing and ongoing tasks from the Committee of European Banking Supervisors (CEBS).
2. To achieve the tasks set out in paragraph 1, the Authority shall have the powers set out in this Regulation, in particular to:
(a)
develop draft regulatory technical standards in the specific cases referred to in Article 10;
(b)
develop draft implementing technical standards in the specific cases referred to in Article 15;
(c)
issue guidelines and recommendations, as laid down in Article 16;
(d)
issue recommendations in specific cases, as referred to in Article 17(3);
(e)
take individual decisions addressed to competent authorities in the specific cases referred to in Articles 18(3) and 19(3);
(f)
in cases concerning directly applicable Union law, take individual decisions addressed to financial institutions, in the specific cases referred to in Article 17(6), 18(4) and 19(4);
(g)
issue opinions to the European Parliament, the Council, or the Commission as provided for in Article 34;
(h)
collect the necessary information concerning financial institutions as provided for in Article 35;
(i)
develop common methodologies for assessing the effect of product characteristics and distribution processes on the financial position of institutions and on consumer protection;
(j)
provide a centrally accessible database of registered financial institutions in the area of its competence where specified in the acts referred to in Article 1(2).
Article 9
Tasks related to consumer protection and financial activities
1. The Authority shall take a leading role in promoting transparency, simplicity and fairness in the market for consumer financial products or services across the internal market, including by:
(a)
collecting, analysing and reporting on consumer trends;
(b)
reviewing and coordinating financial literacy and education initiatives by the competent authorities;
(c)
developing training standards for the industry; and
(d)
contributing to the development of common disclosure rules.
2. The Authority shall monitor new and existing financial activities and may adopt guidelines and recommendations with a view to promoting the safety and soundness of markets and convergence of regulatory practice.
3. The Authority may also issue warnings in the event that a financial activity poses a serious threat to the objectives laid down in Article 1(5).
4. The Authority shall establish, as an integral part of the Authority, a Committee on financial innovation, which brings together all relevant competent national supervisory authorities with a view to achieving a coordinated approach to the regulatory and supervisory treatment of new or innovative financial activities and providing advice for the Authority to present to the European Parliament, the Council and the Commission.
5. The Authority may temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in Article 1(2) or, if so required, in the case of an emergency situation in accordance with and under the conditions laid down in Article 18.
The Authority shall review the decision referred to in the first subparagraph at appropriate intervals and at least every 3 months. If the decision is not renewed after a 3-month period, it shall automatically expire.
A Member State may request the Authority to reconsider its decision. In that case, the Authority shall decide, in accordance with the procedure set out in the second subparagraph of Article 44(1), whether it maintains its decision.
The Authority may also assess the need to prohibit or restrict certain types of financial activity and, where there is such a need, inform the Commission in order to facilitate the adoption of any such prohibition or restriction.
Article 10
Regulatory technical standards
1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts pursuant to Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement.
Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based.
Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the Banking Stakeholder Group referred to in Article 37.
Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council.
Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union’s interests so require.
Where the Commission intends not to endorse a draft regulatory technical standard or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant, or reject it.
The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
2. Where the Authority has not submitted a draft regulatory technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.
3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority.
The Commission shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the Banking Stakeholder Group referred to in Article 37.
The Commission shall immediately forward the draft regulatory technical standard to the European Parliament and the Council.
The Commission shall send its draft regulatory technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft regulatory technical standard, the Commission may adopt the regulatory technical standard.
If the Authority has submitted an amended draft regulatory technical standard within the six-week period, the Commission may amend the draft regulatory technical standard on the basis of the Authority’s proposed amendments or adopt the regulatory technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
4. The regulatory technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
Article 11
Exercise of the delegation
1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of 4 years from 16 December 2010. The Commission shall draw up a report in respect of the delegated power not later than 6 months before the end of the 4-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14.
2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council.
3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14.
Article 12
Revocation of the delegation
1. The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council.
2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.
3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union.
Article 13
Objections to regulatory technical standards
1. The European Parliament or the Council may object to a regulatory technical standard within a period of 3 months from the date of notification of the regulatory technical standard adopted by the Commission. At the initiative of the European Parliament or the Council that period shall be extended by 3 months.
Where the Commission adopts a regulatory technical standard which is the same as the draft regulatory technical standard submitted by the Authority, the period during which the European Parliament and the Council may object shall be 1 month from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 1 month.
2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the regulatory technical standard, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
The regulatory technical standard may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
3. If either the European Parliament or the Council objects to a regulatory technical standard within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the regulatory technical standard.
Article 14
Non-endorsement or amendment of draft regulatory technical standards
1. In the event that the Commission does not endorse a draft regulatory technical standard or amends it as provided for in Article 10, the Commission shall inform the Authority, the European Parliament and the Council, stating its reasons.
2. Where appropriate, the European Parliament or the Council may invite the responsible Commissioner, together with the Chairperson of the Authority, within 1 month of the notice referred to in paragraph 1, for an ad hoc meeting of the competent committee of the European Parliament or the Council to present and explain their differences.
Article 15
Implementing technical standards
1. The Authority may develop implementing technical standards, by means of implementing acts pursuant to Article 291 TFEU, in the areas specifically set out in the legislative acts referred to in Article 1(2). Implementing technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be to determine the conditions of application of those acts. The Authority shall submit its draft implementing technical standards to the Commission for endorsement.
Before submitting draft implementing technical standards to the Commission, the Authority shall conduct open public consultations and shall analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the Banking Stakeholder Group referred to in Article 37.
Where the Authority submits a draft implementing technical standard, the Commission shall immediately forward it to the European Parliament and the Council.
Within 3 months of receipt of a draft implementing technical standard, the Commission shall decide whether to endorse it. The Commission may extend that period by 1 month. The Commission may endorse the draft implementing technical standard in part only, or with amendments, where the Union’s interests so require.
Where the Commission intends not to endorse a draft implementing technical standard or intends to endorse it in part or with amendments, it shall send it back to the Authority explaining why it does not intend to endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of the six-week period referred to in the fifth subparagraph, the Authority has not submitted an amended draft implementing technical standard, or has submitted a draft implementing technical standard that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing technical standard with the amendments it considers relevant or reject it.
The Commission shall not change the content of a draft implementing technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
2. In cases where the Authority has not submitted a draft implementing technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.
3. Only where the Authority does not submit a draft implementing technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt an implementing technical standard by means of an implementing act without a draft from the Authority.
The Commission shall conduct open public consultations on draft implementing technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the Banking Stakeholder Group referred to in Article 37.
The Commission shall immediately forward the draft implementing technical standard to the European Parliament and the Council.
The Commission shall send the draft implementing technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft implementing technical standard, the Commission may adopt the implementing technical standard.
If the Authority has submitted an amended draft implementing technical standard within that six-week period, the Commission may amend the draft implementing technical standard on the basis of the Authority’s proposed amendments or adopt the implementing technical standard with the amendments it considers relevant.
The Commission shall not change the content of the draft implementing technical standards prepared by the Authority without prior coordination with the Authority, as set out in this Article.
4. The implementing technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
Article 16
Guidelines and recommendations
1. The Authority shall, with a view to establishing consistent, efficient and effective supervisory practices within the ESFS, and to ensuring the common, uniform and consistent application of Union law, issue guidelines and recommendations addressed to competent authorities or financial institutions.
2. The Authority shall, where appropriate, conduct open public consultations regarding the guidelines and recommendations and analyse the related potential costs and benefits. Such consultations and analyses shall be proportionate in relation to the scope, nature and impact of the guidelines or recommendations. The Authority shall, where appropriate, also request opinions or advice from the Banking Stakeholder Group referred to in Article 37.
3. The competent authorities and financial institutions shall make every effort to comply with those guidelines and recommendations.
Within 2 months of the issuance of a guideline or recommendation, each competent authority shall confirm whether it complies or intends to comply with that guideline or recommendation. In the event that a competent authority does not comply or does not intend to comply, it shall inform the Authority, stating its reasons.
The Authority shall publish the fact that a competent authority does not comply or does not intend to comply with that guideline or recommendation. The Authority may also decide, on a case-by-case basis, to publish the reasons provided by the competent authority for not complying with that guideline or recommendation. The competent authority shall receive advanced notice of such publication.
If required by that guideline or recommendation, financial institutions shall report, in a clear and detailed way, whether they comply with that guideline or recommendation.
4. In the report referred to in Article 43(5) the Authority shall inform the European Parliament, the Council and the Commission of the guidelines and recommendations that have been issued, stating which competent authority has not complied with them, and outlining how the Authority intends to ensure that the competent authority concerned follow its recommendations and guidelines in the future.
Article 17
Breach of Union law
1. Where a competent authority has not applied the acts referred to in Article 1(2), or has applied them in a way which appears to be a breach of Union law, including the regulatory technical standards and implementing technical standards established in accordance with Articles 10 to 15, in particular by failing to ensure that a financial institution satisfies the requirements laid down in those acts, the Authority shall act in accordance with the powers set out in paragraphs 2, 3 and 6 of this Article.
2. Upon a request from one or more competent authorities, the European Parliament, the Council, the Commission or the Banking Stakeholder Group, or on its own initiative, and after having informed the competent authority concerned, the Authority may investigate the alleged breach or non-application of Union law.
Without prejudice to the powers laid down in Article 35, the competent authority shall, without delay, provide the Authority with all information which the Authority considers necessary for its investigation.
3. The Authority may, not later than 2 months from initiating its investigation, address a recommendation to the competent authority concerned setting out the action necessary to comply with Union law.
The competent authority shall, within 10 working days of receipt of the recommendation, inform the Authority of the steps it has taken or intends to take to ensure compliance with Union law.
4. Where the competent authority has not complied with Union law within 1 month from receipt of the Authority’s recommendation, the Commission may, after having been informed by the Authority, or on its own initiative, issue a formal opinion requiring the competent authority to take the action necessary to comply with Union law. The Commission’s formal opinion shall take into account the Authority’s recommendation.
The Commission shall issue such a formal opinion no later than 3 months after the adoption of the recommendation. The Commission may extend this period by 1 month.
The Authority and the competent authorities shall provide the Commission with all necessary information.
5. The competent authority shall, within 10 working days of receipt of the formal opinion referred to in paragraph 4, inform the Commission and the Authority of the steps it has taken or intends to take to comply with that formal opinion.
6. Without prejudice to the powers of the Commission pursuant to Article 258 TFEU, where a competent authority does not comply with the formal opinion referred to in paragraph 4 within the period of time specified therein, and where it is necessary to remedy in a timely manner such non-compliance in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system, the Authority may, where the relevant requirements of the acts referred to in Article 1(2) are directly applicable to financial institutions, adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under Union law including the cessation of any practice.
The decision of the Authority shall be in conformity with the formal opinion issued by the Commission pursuant to paragraph 4.
7. Decisions adopted under paragraph 6 shall prevail over any previous decision adopted by the competent authorities on the same matter.
When taking action in relation to issues which are subject to a formal opinion pursuant to paragraph 4 or a decision pursuant to paragraph 6, competent authorities shall comply with the formal opinion or the decision, as the case may be.
8. In the report referred to in Article 43(5), the Authority shall set out which competent authorities and financial institutions have not complied with the formal opinions or decisions referred to in paragraphs 4 and 6 of this Article.
Article 18
Action in emergency situations
1. In the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority shall actively facilitate and, where deemed necessary, coordinate any actions undertaken by the relevant national competent supervisory authorities.
In order to be able to perform that facilitating and coordinating role, the Authority shall be fully informed of any relevant developments, and shall be invited to participate as an observer in any relevant gathering by the relevant national competent supervisory authorities.
2. The Council, in consultation with the Commission and the ESRB and, where appropriate, the ESAs, may adopt a decision addressed to the Authority, determining the existence of an emergency situation for the purposes of this Regulation, following a request by the Authority, the Commission or the ESRB. The Council shall review that decision at appropriate intervals and at least once a month. If the decision is not renewed at the end of a 1-month period, it shall automatically expire. The Council may declare the discontinuation of the emergency situation at any time.
Where the ESRB or the Authority considers that an emergency situation may arise, it shall issue a confidential recommendation addressed to the Council and provide it with an assessment of the situation. The Council shall then assess the need for a meeting. In that process, due care of confidentiality shall be guaranteed.
If the Council determines the existence of an emergency situation, it shall duly inform the European Parliament and the Commission without delay.
3. Where the Council has adopted a decision pursuant to paragraph 2, and in exceptional circumstances where coordinated action by national authorities is necessary to respond to adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in Article 1(2) to address any such developments by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation.
4. Without prejudice to the powers of the Commission pursuant to Article 258 TFEU, where a competent authority does not comply with the decision of the Authority referred to in paragraph 3 within the period laid down in that decision, the Authority may, where the relevant requirements laid down in the legislative acts referred to in Article 1(2) including in regulatory technical standards and implementing technical standards adopted in accordance with those acts are directly applicable to financial institutions, adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under that legislation, including the cessation of any practice. This shall apply only in situations in which a competent authority does not apply the legislative acts referred to in Article 1(2), including regulatory technical standards and implementing technical standards adopted in accordance with those acts, or applies them in a way which appears to be a manifest breach of those acts, and where urgent remedying is necessary to restore the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union.
5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter.
Any action by the competent authorities in relation to issues which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions.
Article 19
Settlement of disagreements between competent authorities in cross-border situations
1. Without prejudice to the powers laid down in Article 17, where a competent authority disagrees about the procedure or content of an action or inaction of a competent authority of another Member State in cases specified in the acts referred to in Article 1(2), the Authority, at the request of one or more of the competent authorities concerned, may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4 of this Article.
In cases specified in the legislation referred to in Article 1(2), and where on the basis of objective criteria, disagreement between competent authorities from different Member States can be determined, the Authority may, on its own initiative, assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4.
2. The Authority shall set a time limit for conciliation between the competent authorities taking into account any relevant time periods specified in the acts referred to in Article 1(2) and the complexity and urgency of the matter. At that stage the Authority shall act as a mediator.
3. If the competent authorities concerned fail to reach an agreement within the conciliation phase referred to in paragraph 2, the Authority may, in accordance with the procedure set out in the third and fourth subparagraph of Article 44(1) take a decision requiring them to take specific action or to refrain from action in order to settle the matter, with binding effects for the competent authorities concerned, in order to ensure compliance with Union law.
4. Without prejudice to the powers of the Commission pursuant to Article 258 TFEU, where a competent authority does not comply with the decision of the Authority, and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the acts referred to in Article 1(2), the Authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under Union law, including the cessation of any practice.
5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter. Any action by the competent authorities in relation to facts which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions.
6. In the report referred to in Article 50(2), the Chairperson of the Authority shall set out the nature and type of disagreements between competent authorities, the agreements reached and the decisions taken to settle such disagreements.
Article 20
Settlement of disagreements between competent authorities across sectors
The Joint Committee shall, in accordance with the procedure laid down in Articles 19 and 56, settle cross-sectoral disagreements that may arise between competent authorities as defined in Article 4(2) of this Regulation, of Regulation (EU) 1094/2010 and of Regulation (EU)1095/2010 respectively.
Article 21
Colleges of supervisors
1. The Authority shall contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors referred to in Directive 2006/48/EC and foster the coherence of the application of Union law among the colleges of supervisors. With the objective of converging supervisory best practices, staff from the Authority shall be able to participate in the activities of the colleges of supervisors, including on-site examinations, carried out jointly by two or more competent authorities.
2. The Authority shall lead in ensuring a consistent and coherent functioning of colleges of supervisors for cross-border institutions across the Union, taking account of the systemic risk posed by financial institutions referred to in Article 23.
For the purpose of this paragraph and of paragraph 1 of this Article, the Authority shall be considered a ‘competent authority’ within the meaning of the relevant legislation.
The Authority may:
(a)
collect and share all relevant information in cooperation with the competent authorities in order to facilitate the work of the college and establish and manage a central system to make such information accessible to the competent authorities in the college;
(b)
initiate and coordinate Union-wide stress tests in accordance with Article 32 to assess the resilience of financial institutions, in particular the systemic risk posed by financial institutions as referred to in Article 23, to adverse market developments, and evaluate the potential for systemic risk to increase in situations of stress, ensuring that a consistent methodology is applied at the national level to such tests and, where appropriate, address a recommendation to the competent authority to correct issues identified in the stress test;
(c)
promote effective and efficient supervisory activities, including evaluating the risks to which financial institutions are or might be exposed as determined under the supervisory review process or in stress situations;
(d)
oversee, in accordance with the tasks and powers specified in this Regulation, the tasks carried out by the competent authorities; and
(e)
request further deliberations of a college in any cases where it considers that the decision would result in an incorrect application of Union law or would not contribute to the objective of convergence of supervisory practices. It may also require the consolidating supervisor to schedule a meeting of the college or add a point to the agenda of a meeting.
3. The Authority may develop draft regulatory and implementing technical standards to ensure uniform conditions of application with respect to the provisions regarding the operational functioning of colleges of supervisors and issue guidelines and recommendations adopted pursuant to Article 16 to promote convergence in supervisory functioning and best practices adopted by the colleges of supervisors.
4. The Authority shall have a legally binding mediation role to resolve disputes between competent authorities in accordance with the procedure set out in Article 19. The Authority may take supervisory decisions directly applicable to the institution concerned in accordance with Article 19.
Article 22
General provisions
1. The Authority shall duly consider systemic risk as defined by Regulation (EU) No 1092/2010. It shall address any risk of disruption in financial services that:
(a)
is caused by an impairment of all or parts of the financial system; and
(b)
has the potential to have serious negative consequences for internal market and the real economy.
The Authority shall consider, where appropriate, the monitoring and assessment of systemic risk as developed by the ESRB and the Authority and respond to warnings and recommendations by the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010.
2. The Authority shall, in collaboration with the ESRB, develop a common set of quantitative and qualitative indicators (risk dashboard) to identify and measure systemic risk.
The Authority shall also develop an adequate stress-testing regime to help identifying those institutions that may pose systemic risk. These institutions shall be subject to strengthened supervision, and where necessary, to the recovery and resolution procedures referred to in Article 25.
3. Without prejudice to the acts referred to in Article 1(2), the Authority shall draw up, as necessary, additional guidelines and recommendations for financial institutions, to take account of the systemic risk posed by them.
The Authority shall ensure that the systemic risk posed by financial institutions is taken into account when developing draft regulatory and implementing technical standards in the areas laid down in the legislative acts referred to in Article 1(2).
4. Upon a request from one or more competent authorities, the European Parliament, the Council or the Commission, or on its own initiative, the Authority may conduct an inquiry into a particular type of financial institution or type of product or type of conduct in order to assess potential threats to the stability of the financial system and make appropriate recommendations for action to the competent authorities concerned.
For those purposes, the Authority may use the powers conferred on it under this Regulation, including Article 35.
5. The Joint Committee shall ensure overall and cross-sectoral coordination of the activities carried out in accordance with this Article.
Article 23
Identification and measurement of systemic risk
1. The Authority shall, in consultation with the ESRB, develop criteria for the identification and measurement of systemic risk and an adequate stress-testing regime which includes an evaluation of the potential for systemic risk posed by financial institutions to increase in situations of stress. The financial institutions that may pose a systemic risk shall be subject to strengthened supervision, and where necessary, the recovery and resolution procedures referred to in Article 25.
2. The Authority shall take fully into account the relevant international approaches when developing the criteria for the identification and measurement of systemic risk posed by financial institutions, including those established by the Financial Stability Board, the International Monetary Fund and the Bank for International Settlements.
Article 24
Permanent capacity to respond to systemic risks
1. The Authority shall ensure it has specialised and ongoing capacity to respond effectively to the materialisation of systemic risks as referred to in Articles 22 and 23, in particular, with respect to institutions that pose a systemic risk.
2. The Authority shall fulfil the tasks conferred upon it in this Regulation and in the legislation referred to in Article 1(2), and shall contribute to ensuring a coherent and coordinated crisis management and resolution regime in the Union.
Article 25
Recovery and resolution procedures
1. The Authority shall contribute to and participate actively in the development and coordination of effective and consistent recovery and resolution plans, procedures in emergency situations and preventive measures to minimise the systemic impact of any failure.
2. The Authority may identify best practices aimed at facilitating the resolution of failing institutions and, in particular, cross-border groups, in ways which avoid contagion, ensuring that appropriate tools, including sufficient resources, are available and allow the institution or the group to be resolved in an orderly, cost-efficient and timely manner.
3. The Authority may develop regulatory and implementing technical standards as specified in the legislative acts referred to in Article 1(2) in accordance with the procedure laid down in Articles 10 to 15.
Article 26
European system of deposit guarantee schemes
1. The Authority shall contribute to strengthening the European system of national deposit guarantee schemes by acting under the powers conferred to it in this Regulation to ensure the correct application of Directive 94/19/EC with the aim of ensuring that national deposit guarantee schemes are adequately funded by contributions from financial institutions including from those financial institutions established and taking deposits within the Union but headquartered outside the Union as provided for in Directive 94/19/EC and provide a high level of protection to all depositors in a harmonised framework throughout the Union, which leaves the stabilising safeguard role of mutual guarantee schemes intact, provided they comply with Union legislation.
2. Article 16 concerning the Authority’s powers to adopt guidelines and recommendations shall apply to deposit guarantee schemes.
3. The Authority may develop regulatory and implementing technical standards as specified in the legislative acts referred to in Article 1(2) in accordance with the procedure laid down in Articles 10 to 15.
4. The review of this Regulation provided for in Article 81 shall, in particular, examine the convergence of the European system of national deposit guarantee schemes.
Article 27
European system of bank resolution and funding arrangements
1. The Authority shall contribute to developing methods for the resolution of failing financial institutions, in particular those that may pose a systemic risk, in ways which avoid contagion and allow them to be wound down in an orderly and timely manner, including, where applicable, coherent and robust funding mechanisms as appropriate.
2. The Authority shall contribute to the assessment of the need for a system of coherent, robust and credible funding mechanisms, with appropriate financing instruments linked to a set of coordinated national crisis management arrangements.
The Authority shall contribute to the work on the level playing field issues and cumulative impacts of any systems of levies and contributions on financial institutions that may be introduced to ensure fair burden sharing and incentives to contain systemic risk as a part of a coherent and credible resolution framework.
The review of this Regulation provided for in Article 81 shall, in particular, examine the possible enhancement of the role of the Authority in a framework of crisis prevention, management and resolution, and, if necessary, the creation of a European resolution fund.
Article 28
Delegation of tasks and responsibilities
1. Competent authorities may, with the consent of the delegate, delegate tasks and responsibilities to the Authority or other competent authorities subject to the conditions set out in this Article. Member States may set out specific arrangements regarding the delegation of responsibilities that have to be complied with before their competent authorities enter into such delegation agreements, and may limit the scope of delegation to what is necessary for the effective supervision of cross-border financial institutions or groups.
2. The Authority shall stimulate and facilitate the delegation of tasks and responsibilities between competent authorities by identifying those tasks and responsibilities that can be delegated or jointly exercised and by promoting best practices.
3. The delegation of responsibilities shall result in the reallocation of competences laid down in the acts referred to in Article 1(2). The law of the delegate authority shall govern the procedure, enforcement and administrative and judicial review relating to the delegated responsibilities.
4. The competent authorities shall inform the Authority of delegation agreements into which they intend to enter. They shall put the agreements into effect at the earliest 1 month after informing the Authority.
The Authority may give an opinion on the intended agreement within 1 month of being informed.
The Authority shall publish, by appropriate means, any delegation agreement as concluded by the competent authorities, in order to ensure that all parties concerned are informed appropriately.
Article 29
Common supervisory culture
1. The Authority shall play an active role in building a common Union supervisory culture and consistent supervisory practices, as well as in ensuring uniform procedures and consistent approaches throughout the Union. The Authority shall carry out, at a minimum, the following activities:
(a)
providing opinions to competent authorities;
(b)
promoting an effective bilateral and multilateral exchange of information between competent authorities, with full respect for the applicable confidentiality and data protection provisions provided for in the relevant Union legislation;
(c)
contributing to developing high-quality and uniform supervisory standards, including reporting standards, and international accounting standards in accordance with Article 1(3);
(d)
reviewing the application of the relevant regulatory and implementing technical standards adopted by the Commission, and of the guidelines and recommendations issued by the Authority and proposing amendments where appropriate; and
(e)
establishing sectoral and cross-sectoral training programmes, facilitating personnel exchanges and encouraging competent authorities to intensify the use of secondment schemes and other tools.
2. The Authority may, as appropriate, develop new practical instruments and convergence tools to promote common supervisory approaches and practices.
Article 30
Peer reviews of competent authorities
1. The Authority shall periodically organise and conduct peer reviews of some or all of the activities of competent authorities, to further strengthen consistency in supervisory outcomes. To that end, the Authority shall develop methods to allow for objective assessment and comparison between the authorities reviewed. When conducting peer reviews, existing information and evaluations already made with regard to the competent authority concerned shall be taken into account.
2. The peer review shall include an assessment of, but shall not be limited to:
(a)
the adequacy of resources and governance arrangements of the competent authority, with particular regard to the effective application of the regulatory technical standards and implementing technical standards referred to in Articles 10 to 15 and of the acts referred to in Article 1(2) and the capacity to respond to market developments;
(b)
the degree of convergence reached in the application of Union law and in supervisory practice, including regulatory technical standards and implementing technical standards, guidelines and recommendations adopted pursuant to Articles 10 to 16, and the extent to which the supervisory practice achieves the objectives set out in Union law;
(c)
best practices developed by some competent authorities which might be of benefit for other competent authorities to adopt;
(d)
the effectiveness and the degree of convergence reached with regard to the enforcement of the provisions adopted in the implementation of Union law, including the administrative measures and sanctions imposed against persons responsible where those provisions have not been complied with.
3. On the basis of a peer review, the Authority may issue guidelines and recommendations pursuant to Article 16. In accordance with Article 16(3), the competent authorities shall endeavour to follow those guidelines and recommendations. The Authority shall take into account the outcome of the peer review when developing draft regulatory technical or implementing technical standards in accordance with Articles 10 to 15.
4. The Authority shall make the best practices that can be identified from those peer reviews publicly available. In addition, all other results of peer reviews may be disclosed publicly, subject to the agreement of the competent authority that is the subject of the peer review.
Article 31
Coordination function
The Authority shall fulfil a general coordination role between competent authorities, in particular in situations where adverse developments could potentially jeopardise the orderly functioning and integrity of financial markets or the stability of the financial system in the Union.
The Authority shall promote a coordinated Union response, inter alia, by:
(a)
facilitating the exchange of information between the competent authorities;
(b)
determining the scope and, where possible and appropriate, verifying the reliability of information that should be made available to all the competent authorities concerned;
(c)
without prejudice to Article 19, carrying out non-binding mediation upon a request from the competent authorities or on its own initiative;
(d)
notifying the ESRB of any potential emergency situations without delay;
(e)
taking all appropriate measures in case of developments which may jeopardise the functioning of the financial markets with a view to facilitating the coordination of actions undertaken by relevant competent authorities;
(f)
centralising information received from competent authorities in accordance with Articles 21 and 35 as the result of the regulatory reporting obligations for institutions active in more than one Member State. The Authority shall share that information with the other competent authorities concerned.
Article 32
Assessment of market developments
1. The Authority shall monitor and assess market developments in the area of its competence and, where necessary, inform the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority), the ESRB and the European Parliament, the Council and the Commission about the relevant micro-prudential trends, potential risks and vulnerabilities. The Authority shall include in its assessments an economic analysis of the markets in which financial institutions operate and an assessment of the impact of potential market developments on such institutions.
2. The Authority shall, in cooperation with the ESRB, initiate and coordinate Union-wide assessments of the resilience of financial institutions to adverse market developments. To that end, it shall develop the following, for application by the competent authorities:
(a)
common methodologies for assessing the effect of economic scenarios on an institution’s financial position;
(b)
common approaches to communication on the outcomes of these assessments of the resilience of financial institutions;
(c)
common methodologies for assessing the effect of particular products or distribution processes on an institution’s financial position and on depositors, investors and customer information.
3. Without prejudice to the tasks of the ESRB set out in Regulation (EU) No 1092/2010, the Authority shall, at least once a year, and more frequently as necessary, provide assessments to the European Parliament, the Council, the Commission and the ESRB of trends, potential risks and vulnerabilities in its area of competence.
The Authority shall include a classification of the main risks and vulnerabilities in these assessments and, where necessary, recommend preventative or remedial actions.
4. The Authority shall ensure an adequate coverage of cross-sectoral developments, risks and vulnerabilities by closely cooperating with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) through the Joint Committee.
Article 33
International relations
1. Without prejudice to the respective competences of the Member States and the Union institutions, the Authority may develop contacts and enter into administrative arrangements with supervisory authorities, international organisations and the administrations of third countries. Those arrangements shall not create legal obligations in respect of the Union and its Member States nor shall they prevent Member States and their competent authorities from concluding bilateral or multilateral arrangements with those third countries.
2. The Authority shall assist in preparing equivalence decisions pertaining to supervisory regimes in third countries in accordance with the acts referred to in Article 1(2).
3. In the report referred to in Article 43(5), the Authority shall set out the administrative arrangements agreed upon with international organisations or administrations in third countries and the assistance provided in preparing equivalence decisions.
Article 34
Other tasks
1. The Authority may, upon a request from the European Parliament, the Council or the Commission, or on its own initiative, provide opinions to the European Parliament, the Council and the Commission on all issues related to its area of competence.
2. With regard to prudential assessments of mergers and acquisitions falling within the scope of Directive 2006/48/EC, as amended by Directive 2007/44/EC, and which according to that Directive require consultation between competent authorities from two or more Member States, the Authority may, on application of one of the competent authorities concerned, issue and publish an opinion on a prudential assessment, except in relation to the criteria in Article 19a(1)(e) of Directive 2006/48/EC. The opinion shall be issued promptly and in any event before the end of the assessment period in accordance with Directive 2006/48/EC, as amended by Directive 2007/44/EC. Article 35 shall apply to the areas in respect of which the Authority may issue an opinion.
Article 35
Collection of information
1. At the request of the Authority, the competent authorities of the Member States shall provide the Authority with all the necessary information to carry out the duties assigned to it by this Regulation, provided that they have legal access to the relevant information and that the request for information is necessary in relation to the nature of the duty in question.
2. The Authority may also request information to be provided at recurring intervals and in specified formats. Such requests shall, where possible, be made using common reporting formats.
3. Upon a duly justified request from a competent authority of a Member State, the Authority may provide any information that is necessary to enable the competent authority to carry out its duties, in accordance with the professional secrecy obligations laid down in sectoral legislation and in Article 70.
4. Before requesting information in accordance with this Article and in order to avoid the duplication of reporting obligations, the Authority shall take account of any relevant existing statistics produced and disseminated by the European Statistical System and the European System of Central Banks.
5. Where information is not available or is not made available by the competent authorities in a timely fashion, the Authority may address a duly justified and reasoned request to other supervisory authorities, to the ministry responsible for finance where it has at its disposal prudential information, to the national central bank or to the statistical office of the Member State concerned.
6. Where information is not available or is not made available under paragraph 1 or 5 in a timely fashion, the Authority may address a duly justified and reasoned request directly to the relevant financial institutions. The reasoned request shall explain why the information concerning the respective individual financial institutions is necessary.
The Authority shall inform the relevant competent authorities of requests in accordance with this paragraph and with paragraph 5.
At the request of the Authority, the competent authorities shall assist the Authority in collecting the information.
7. The Authority may use confidential information received pursuant to this Article only for the purposes of carrying out the duties assigned to it by this Regulation.
Article 36
Relationship with the ESRB
1. The Authority shall cooperate closely and on a regular basis with the ESRB.
2. The Authority shall provide the ESRB with regular and timely information necessary for the achievement of its tasks. Any data necessary for the achievement of its tasks that are not in summary or aggregate form shall be provided, without delay, to the ESRB upon a reasoned request, as specified in Article 15 of Regulation (EU) No 1092/2010. The Authority, in cooperation with the ESRB, shall have in place adequate internal procedures for the transmission of confidential information, in particular information regarding individual financial institutions.
3. The Authority shall, in accordance with paragraphs 4 and 5, ensure a proper follow-up to ESRB warnings and recommendations referred to in Article 16 of Regulation (EU) No 1092/2010.
4. On receipt of a warning or recommendation from the ESRB addressed to the Authority, the Authority shall convene a meeting of the Board of Supervisors without delay and assess the implications of such a warning or recommendation for the fulfilment of its tasks.
It shall decide, by the relevant decision-making procedure, on any actions to be taken in accordance with the powers conferred upon it by this Regulation for addressing the issues identified in the warnings and recommendations.
If the Authority does not act on a recommendation, it shall explain to the ESRB and the Council its reasons for not doing so.
5. On receipt of a warning or recommendation from the ESRB addressed to a competent national supervisory authority, the Authority shall, where relevant, use the powers conferred upon it by this Regulation to ensure a timely follow-up.
Where the addressee intends not to follow the recommendation of the ESRB, it shall inform and discuss with the Board of Supervisors its reasons for not acting.
The competent authority shall take due account of the views of the Board of Supervisors when informing the Council and the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010.
6. In discharging the tasks set out in this Regulation, the Authority shall take the utmost account of the warnings and recommendations of the ESRB.
Article 37
Banking Stakeholder Group
1. To help facilitate consultation with stakeholders in areas relevant to the tasks of the Authority, a Banking Stakeholder Group shall be established. The Banking Stakeholder Group shall be consulted on actions taken in accordance with Articles 10 to 15 concerning regulatory technical standards and implementing technical standards and, to the extent that these do not concern individual financial institutions, Article 16 concerning guidelines and recommendations. If actions must be taken urgently and consultation becomes impossible, the Banking Stakeholder Group shall be informed as soon as possible.
The Banking Stakeholder Group shall meet at least four times a year.
2. The Banking Stakeholder Group shall be composed of 30 members, representing in balanced proportions credit and investment institutions operating in the Union, their employees’ representatives as well as consumers, users of banking services and representatives of SMEs. At least five of its members shall be independent top-ranking academics. Ten of its members shall represent financial institutions, three of whom shall represent cooperative and savings banks.
3. The members of the Banking Stakeholder Group shall be appointed by the Board of Supervisors, following proposals from the relevant stakeholders. In making its decision, the Board of Supervisors shall, to the extent possible, ensure an appropriate geographical and gender balance and representation of stakeholders across the Union.
4. The Authority shall provide all necessary information subject to professional secrecy as set out in Article 70 and ensure adequate secretarial support for the Banking Stakeholder Group. Adequate compensation shall be provided to members of the Banking Stakeholder Group representing non-profit organisations, excluding industry representatives. The Banking Stakeholder Group may establish working groups on technical issues. Members of the Banking Stakeholder Group shall serve for a period of 2 1/2 years, following which a new selection procedure shall take place.
The members of the Banking Stakeholder Group may serve two successive terms.
5. The Banking Stakeholder Group may submit opinions and advice to the Authority on any issue related to the tasks of the Authority with particular focus on the tasks set out in Articles 10 to 16 and Articles 29, 30 and 32.
6. The Banking Stakeholder Group shall adopt its rules of procedure by a majority of two-thirds of its members.
7. The Authority shall make public the opinions and advice of the Banking Stakeholder Group and the results of its consultations.
Article 38
Safeguards
1. The Authority shall ensure that no decision adopted pursuant to Article 18 or 19 impinges in any way on the fiscal responsibilities of Member States.
2. Where a Member State considers that a decision taken pursuant to Article 19(3) impinges on its fiscal responsibilities, it may notify the Authority and the Commission within 2 weeks after notification of the Authority’s decision to the competent authority that the decision will not be implemented by the competent authority.
In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities.
In the case of such notification, the decision of the Authority shall be suspended.
Within a period of 1 month from the notification by the Member State, the Authority shall inform the Member State as to whether it maintains its decision or whether it amends or revokes it. If the decision is maintained or amended, the Authority shall state that fiscal responsibilities are not affected.
Where the Authority maintains its decision, the Council shall take a decision, by a majority of the votes cast, at one of its meetings not later than 2 months after the Authority has informed the Member State as set out in the fourth subparagraph, as to whether the Authority’s decision is maintained.
Where the Council, after having considered the matter, does not take a decision to maintain the Authority’s decision in accordance with the fifth subparagraph, the Authority’s decision shall be terminated.
3. Where a Member State considers that a decision taken pursuant to Article 18(3) impinges on its fiscal responsibilities, it may notify the Authority, the Commission and the Council within 3 working days after notification of the Authority’s decision to the competent authority that the decision will not be implemented by the competent authority.
In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities.
In the case of such notification, the decision of the Authority shall be suspended.
The Council shall, within 10 working days, convene a meeting and take a decision, by a simple majority of its members, as to whether the Authority’s decision is revoked.
Where the Council, after having considered the matter, does not take a decision to revoke the Authority’s decision in accordance with the fourth subparagraph, the suspension of the Authority’s decision shall be terminated.
4. Where the Council has taken a decision in accordance with paragraph 3 not to revoke a decision of the Authority relating to Article 18(3), and the Member State concerned still considers that the decision of the Authority impinges upon its fiscal responsibilities, that Member State may notify the Commission and the Authority and request the Council to re-examine the matter. The Member State concerned shall clearly set out the reasons for its disagreement with the decision of the Council.
Within a period of 4 weeks after the notification referred to in the first subparagraph, the Council shall confirm its original decision or take a new decision in accordance with paragraph 3.
The period of 4 weeks may be extended by four additional weeks by the Council, if the particular circumstances of the case so require.
5. Any abuse of this Article, in particular in relation to a decision by the Authority which does not have a significant or material fiscal impact, shall be prohibited as incompatible with the internal market.
Article 39
Decision-making procedures
1. Before taking the decisions provided for in this Regulation, the Authority shall inform any named addressee of its intention to adopt the decision, setting a time limit within which the addressee may express its views on the matter, taking full account of the urgency, complexity and potential consequences of the matter. This applies mutatis mutandis to recommendations as referred to in Article 17(3).
2. The decisions of the Authority shall state the reasons on which they are based.
3. The addressees of decisions of the Authority shall be informed of the legal remedies available under this Regulation.
4. Where the Authority has taken a decision pursuant to Article 18(3) or (4), it shall review that decision at appropriate intervals.
5. The decisions which the Authority takes pursuant to Article 17, 18 or 19 shall be made public and shall state the identity of the competent authority or financial institution concerned and the main content of the decision, unless such publication is in conflict with the legitimate interests of financial institutions in the protection of their business secrets or could seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system of the Union.
CHAPTER III
ORGANISATION
SECTION 1
Board of Supervisors
Article 40
Composition
1. The Board of Supervisors shall be composed of:
(a)
the Chairperson, who shall be non-voting;
(b)
the head of the national public authority competent for the supervision of credit institutions in each Member State, who shall meet in person at least twice a year;
(c)
one representative of the Commission, who shall be non-voting;
(d)
one representative of the European Central Bank, who shall be non-voting;
(e)
one representative of the ESRB, who shall be non-voting;
(f)
one representative of each of the other two European Supervisory Authorities, who shall be non-voting.
2. The Board of Supervisors shall convene meetings with the Banking Stakeholder Group regularly, at least twice a year.
3. Each competent authority shall be responsible for nominating a high-level alternate from its authority, who may replace the member of the Board of Supervisors referred to in paragraph 1(b), where that person is prevented from attending.
4. Where the authority referred to in paragraph 1(b) is not a central bank, the member of the Board of Supervisors referred to in that point may decide to bring a representative from the Member State’s central bank, who shall be non-voting.
5. In Member States where more than one authority is responsible for the supervision according to this Regulation, those authorities shall agree on a common representative. Nevertheless, when an item to be discussed by the Board of Supervisors does not fall within the competence of the national authority being represented by the member referred to in paragraph 1(b), that member may bring a representative from the relevant national authority, who shall be non-voting.
6. For the purpose of acting within the scope of Directive 94/19/EC, the member of the Board of Supervisors referred to in paragraph 1(b) may, where appropriate, be accompanied by a representative from the relevant bodies which administer deposit-guarantee schemes in each Member State, who shall be non-voting.
7. The Board of Supervisors may decide to admit observers.
The Executive Director may participate in meetings of the Board of Supervisors, without the right to vote.
Article 41
Internal committees and panels
1. The Board of Supervisors may establish internal committees or panels for specific tasks attributed to the Board of Supervisors, and may provide for the delegation of certain clearly defined tasks and decisions to internal committees or panels, to the Management Board or to the Chairperson.
2. For the purposes of Article 19, the Board of Supervisors shall convoke an independent panel to facilitate an impartial settlement of the disagreement, consisting of the Chairperson and two of its members, who are not representatives of the competent authorities which are party to the disagreement and who have neither any interest in the conflict nor direct links to the competent authorities concerned.
3. Subject to Article 19(2), the panel shall propose a decision for final adoption by the Board of Supervisors, in accordance with the procedure set out in the third subparagraph of Article 44(1).
4. The Board of Supervisors shall adopt rules of procedure for the panel referred to in paragraph 2.
Article 42
Independence
When carrying out the tasks conferred upon it by this Regulation, the Chairperson and the voting members of the Board of Supervisors shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Board of Supervisors in the performance of their tasks.
Article 43
Tasks
1. The Board of Supervisors shall give guidance to the work of the Authority and shall be in charge of taking the decisions referred to in Chapter II.
2. The Board of Supervisors shall adopt the opinions, recommendations, and decisions, and issue the advice referred to in Chapter II.
3. The Board of Supervisors shall appoint the Chairperson.
4. The Board of Supervisors shall adopt, before 30 September of each year, on the basis of a proposal by the Management Board, the work programme of the Authority for the coming year, and shall transmit it for information to the European Parliament, the Council and the Commission.
The work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public.
5. The Board of Supervisors shall, on the basis of a proposal by the Management Board, adopt the annual report on the activities of the Authority, including on the performance of the Chairperson’s duties, on the basis of the draft report referred to in Article 53(7) and shall transmit that report to the European Parliament, the Council, the Commission, the Court of Auditors and the European Economic and Social Committee by 15 June each year. The report shall be made public.
6. The Board of Supervisors shall adopt the multi-annual work programme of the Authority, and shall transmit it for information to the European Parliament, the Council and the Commission.
The multi-annual work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public.
7. The Board of Supervisors shall adopt the budget in accordance with Article 63.
8. The Board of Supervisors shall exercise disciplinary authority over the Chairperson and the Executive Director and may remove them from office in accordance with Article 48(5) or 51(5) respectively.
Article 44
Decision-making
1. Decisions of the Board of Supervisors shall be taken by a simple majority of its members. Each member shall have one vote.
With regard to the acts specified in Articles 10 to 16 and measures and decisions adopted under the third subparagraph of Article 9(5) and Chapter VI and by way of derogation from the first subparagraph of this paragraph, the Board of Supervisors shall take decisions on the basis of a qualified majority of its members, as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
With regard to decisions in accordance with Article 19(3), for decisions taken by the consolidating supervisor, the decision proposed by the panel shall be considered as adopted, if approved by a simple majority, unless it is rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
For all other decisions in accordance with Article 19(3), the decision proposed by the panel shall be adopted by a simple majority of the members of the Board of Supervisors. Each member shall have one vote.
2. Meetings of the Board of Supervisors shall be convened by the Chairperson at his own initiative or at the request of one third of its members, and shall be chaired by the Chairperson.
3. The Board of Supervisors shall adopt and make public its rules of procedure.
4. The rules of procedure shall set out in detail the arrangements governing voting, including, where appropriate, the rules governing quorums. The non-voting members and the observers, with the exception of the Chairperson and the Executive Director, shall not attend any discussions within the Board of Supervisors relating to individual financial institutions, unless otherwise provided for in Article 75(3) or in the acts referred to in Article 1(2).
SECTION 2
Management Board
Article 45
Composition
1. The Management Board shall be composed of the Chairperson and six other members of the Board of Supervisors, elected by and from the voting members of the Board of Supervisors.
Other than the Chairperson, each member of the Management Board shall have an alternate, who may replace him if he is prevented from attending.
The term of office of the members elected by the Board of Supervisors shall be 2 1/2 years. That term may be extended once. The composition of the Management Board shall be balanced and proportionate and shall reflect the Union as a whole. Mandates shall be overlapping and an appropriate rotating arrangement shall apply.
2. Decisions by the Management Board shall be adopted on the basis of a majority of the members present. Each member shall have one vote.
The Executive Director and a representative of the Commission shall participate in meetings of the Management Board without the right to vote.
The representative of the Commission shall have the right to vote on matters referred to in Article 63.
The Management Board shall adopt and make public its rules of procedure.
3. Meetings of the Management Board shall be convened by the Chairperson at his own initiative or at the request of at least a third of its members, and shall be chaired by the Chairperson.
The Management Board shall meet prior to every meeting of the Board of Supervisors and as often as the Management Board deems necessary. It shall meet at least five times a year.
4. The members of the Management Board may, subject to the rules of procedure, be assisted by advisers or experts. The non-voting members, with the exception of the Executive Director, shall not attend any discussions within the Management Board relating to individual financial institutions.
Article 46
Independence
The members of the Management Board shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Management Board in the performance of their tasks.
Article 47
Tasks
1. The Management Board shall ensure that the Authority carries out its mission and performs the tasks assigned to it in accordance with this Regulation.
2. The Management Board shall propose, for adoption by the Board of Supervisors, an annual and multi-annual work programme.
3. The Management Board shall exercise its budgetary powers in accordance with Articles 63 and 64.
4. The Management Board shall adopt the Authority’s staff policy plan and, pursuant to Article 68(2), the necessary implementing measures of the Staff Regulations of Officials of the European Communities (hereinafter ‘the Staff Regulations’).
5. The Management Board shall adopt the special provisions on right of access to the documents of the Authority, in accordance with Article 72.
6. The Management Board shall propose an annual report on the activities of the Authority, including on the Chairperson’s duties, on the basis of the draft report referred to in Article 53(7) to the Board of Supervisors for approval.
7. The Management Board shall adopt and make public its rules of procedure.
8. The Management Board shall appoint and remove the members of the Board of Appeal in accordance with Article 58(3) and (5).
SECTION 3
Chairperson
Article 48
Appointment and tasks
1. The Authority shall be represented by a Chairperson, who shall be a full-time independent professional.
The Chairperson shall be responsible for preparing the work of the Board of Supervisors and shall chair the meetings of the Board of Supervisors and the Management Board.
2. The Chairperson shall be appointed by the Board of Supervisors on the basis of merit, skills, knowledge of financial institutions and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure.
Before taking up his duties, and up to 1 month after the selection by the Board of Supervisors, the European Parliament may, after having heard the candidate selected by the Board of Supervisors, object to the designation of the selected person.
The Board of Supervisors shall also elect, from among its members, an alternate who shall carry out the functions of the Chairperson in his absence. That alternate shall not be elected from among the members of the Management Board.
3. The Chairperson’s term of office shall be 5 years and may be extended once.
4. In the course of the 9 months preceding the end of the 5-year term of office of the Chairperson, the Board of Supervisors shall evaluate:
(a)
the results achieved in the first term of office and the way they were achieved;
(b)
the Authority’s duties and requirements in the coming years.
The Board of Supervisors, taking into account the evaluation, may extend the term of office of the Chairperson once subject to confirmation by the European Parliament.
5. The Chairperson may be removed from office only by the European Parliament following a decision of the Board of Supervisors.
The Chairperson shall not prevent the Board of Supervisors from discussing matters relating to the Chairperson, in particular the need for his removal, and shall not be involved in deliberations concerning such a matter.
Article 49
Independence
Without prejudice to the role of the Board of Supervisors in relation to the tasks of the Chairperson, the Chairperson shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the Chairperson in the performance of his tasks.
In accordance with the Staff Regulations referred to in Article 68, the Chairperson shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Article 50
Report
1. The European Parliament and the Council may invite the Chairperson or his alternate to make a statement, while fully respecting his independence. The Chairperson shall make a statement before the European Parliament and answer any questions put by its members, whenever so requested.
2. The Chairperson shall report in writing on the main activities of the Authority to the European Parliament when requested and at least 15 days before making the statement referred to in paragraph 1.
3. In addition to the information referred to in Articles 11 to 18 and Articles 20 and 33, the report shall also include any relevant information requested by the European Parliament on an ad-hoc basis.
SECTION 4
Executive Director
Article 51
Appointment
1. The Authority shall be managed by an Executive Director, who shall be a full-time independent professional.
2. The Executive Director shall be appointed by the Board of Supervisors, after confirmation by the European Parliament, on the basis of merit, skills, knowledge of financial institutions and markets, and experience relevant to financial supervision and regulation and managerial experience, following an open selection procedure.
3. The Executive Director’s term of office shall be 5 years and may be extended once.
4. In the course of the 9 months preceding the end of the Executive Director’s term of office, the Board of Supervisors shall evaluate in particular:
(a)
the results achieved in the first term of office and the way they were achieved;
(b)
the Authority’s duties and requirements in the coming years.
The Board of Supervisors, taking into account the evaluation referred to in the first subparagraph, may extend the term of office of the Executive Director once.
5. The Executive Director may be removed from office only upon a decision of the Board of Supervisors.
Article 52
Independence
Without prejudice to the respective roles of the Management Board and the Board of Supervisors in relation to the tasks of the Executive Director, the Executive Director shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the Executive Director in the performance of his tasks.
In accordance with the Staff Regulations referred to in Article 68, the Executive Director shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Article 53
Tasks
1. The Executive Director shall be in charge of the management of the Authority and shall prepare the work of the Management Board.
2. The Executive Director shall be responsible for implementing the annual work programme of the Authority under the guidance of the Board of Supervisors and under the control of the Management Board.
3. The Executive Director shall take the necessary measures, notably the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Authority, in accordance with this Regulation.
4. The Executive Director shall prepare a multi-annual work programme, as referred to in Article 47(2).
5. Each year, by 30 June, the Executive Director shall prepare a work programme for the following year, as referred to in Article 47(2).
6. The Executive Director shall draw up a preliminary draft budget of the Authority pursuant to Article 63 and shall implement the budget of the Authority pursuant to Article 64.
7. Each year the Executive Director shall prepare a draft report with a section on the regulatory and supervisory activities of the Authority and a section on financial and administrative matters.
8. The Executive Director shall exercise in respect to the Authority’s staff the powers laid down in Article 68 and manage staff matters.
CHAPTER IV
JOINT BODIES OF THE EUROPEAN SUPERVISORY AUTHORITIES
SECTION 1
Joint Committee of European Supervisory Authorities
Article 54
Establishment
1. The Joint Committee of the European Supervisory Authorities is hereby established.
2. The Joint Committee shall serve as a forum in which the Authority shall cooperate regularly and closely and ensure cross-sectoral consistency with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority), in particular regarding:
—
financial conglomerates,
—
accounting and auditing,
—
micro-prudential analyses of cross-sectoral developments, risks and vulnerabilities for financial stability,
—
retail investment products,
—
measures combating money laundering, and
—
information exchange with the ESRB and developing the relationship between the ESRB and the ESAs.
3. The Joint Committee shall have a dedicated staff provided by the ESAs that shall act as a secretariat. The Authority shall contribute adequate resources to administrative, infrastructure and operational expenses.
4. In the event that a financial institution reaches across different sectors, the Joint Committee shall resolve disagreements in accordance with Article 56.
Article 55
Composition
1. The Joint Committee shall be composed of the Chairpersons of the ESAs, and, where applicable, the Chairperson of any Sub-Committee established pursuant to Article 57.
2. The Executive Director, a representative of the Commission and the ESRB shall be invited to the meetings of the Joint Committee, as well as of any Sub-Committees referred to in Article 57, as observers.
3. The Chairperson of the Joint Committee shall be appointed on an annual rotational basis from among the Chairpersons of the ESAs. The Chairperson of the Joint Committee shall be a Vice-Chair of the ESRB.
4. The Joint Committee shall adopt and publish its own rules of procedure. The rules may specify further participants in the meetings of the Joint Committee.
The Joint Committee shall meet at least once every 2 months.
Article 56
Joint positions and common acts
Within the scope of its tasks in Chapter II, and in particular with respect to the implementation of Directive 2002/87/EC, where relevant, the Authority shall reach joint positions with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and with the European Supervisory Authority (European Securities and Markets Authority), as appropriate.
Acts pursuant to Articles 10 to 15, 17, 18 or 19 of this Regulation in relation to the application of Directive 2002/87/EC and of any other Union acts referred to in Article 1(2) that also fall within the area of competence of the European Supervisory Authority (European Insurance and Occupational Pensions Authority) or the European Supervisory Authority (European Securities and Markets Authority) shall be adopted, in parallel, by the Authority, the European Supervisory Authority (European Insurance and Occupational Pensions Authority), and the European Supervisory Authority (European Securities and Markets Authority), as appropriate.
Article 57
Sub-Committees
1. For the purposes of Article 56, a Sub-Committee on Financial Conglomerates to the Joint Committee shall be established.
2. The Sub-Committee shall be composed of the individuals referred to in Article 55(1), and one high-level representative from the current staff of the relevant competent authority from each Member State.
3. The Sub-Committee shall elect a Chairperson from among its members, who shall also be a member of the Joint Committee.
4. The Joint Committee may establish further Sub-Committees.
SECTION 2
Board of Appeal
Article 58
Composition and operation
1. The Board of Appeal shall be a joint body of the ESAs.
2. The Board of Appeal shall be composed of six members and six alternates, who shall be individuals of a high repute with a proven record of relevant knowledge and professional experience, including supervisory experience, to a sufficiently high level in the fields of banking, insurance, occupational pensions, securities markets or other financial services, excluding current staff of the competent authorities or other national or Union institutions involved in the activities of the Authority. The Board of Appeal shall have sufficient legal expertise to provide expert legal advice on the legality of the Authority’s exercise of its powers.
The Board of Appeal shall designate its President.
3. Two members of the Board of Appeal and two alternates shall be appointed by the Management Board of the Authority from a short-list proposed by the Commission, following a public call for expressions of interest published in the Official Journal of the European Union, and after consultation of the Board of Supervisors.
The other members shall be appointed in accordance with Regulation (EU) No 1094/2010 and Regulation (EU) No 1095/2010.
4. The term of office of the members of the Board of Appeal shall be 5 years. That term may be extended once.
5. A member of the Board of Appeal appointed by the Management Board of the Authority shall not be removed during his term of office, unless he has been found guilty of serious misconduct and the Management Board takes a decision to that effect after consulting the Board of Supervisors.
6. The decisions of the Board of Appeal shall be adopted on the basis of a majority of at least four of its six members. Where the appealed decision falls within the scope of this Regulation, the deciding majority shall include at least one of the two members of the Board of Appeal appointed by the Authority.
7. The Board of Appeal shall be convened by its President when necessary.
8. The ESAs shall ensure adequate operational and secretarial support for the Board of Appeal through the Joint Committee.
Article 59
Independence and impartiality
1. The members of the Board of Appeal shall be independent in making their decisions. They shall not be bound by any instructions. They shall not perform any other duties in relation to the Authority, its Management Board or its Board of Supervisors.
2. Members of the Board of Appeal shall not take part in any appeal proceedings in which they have any personal interest, if they have previously been involved as representatives of one of the parties to the proceedings, or if they have participated in the decision under appeal.
3. If, for one of the reasons referred to in paragraphs 1 and 2 or for any other reason, a member of a Board of Appeal considers that another member should not take part in any appeal proceedings, he shall inform the Board of Appeal accordingly.
4. Any party to the appeal proceedings may object to the participation of a member of the Board of Appeal on any of the grounds referred to in paragraphs 1 and 2, or if suspected of bias.
No objection may be based on the nationality of members nor shall it be admissible if, while being aware of a reason for objecting, the party to the appeal proceedings has nonetheless taken a procedural step other than objecting to the composition of the Board of Appeal.
5. The Board of Appeal shall decide on the action to be taken in the cases specified in paragraphs 1 and 2 without the participation of the member concerned.
For the purpose of taking that decision, the member concerned shall be replaced on the Board of Appeal by his alternate. Where the alternate is in a similar situation, the Chairperson shall designate a replacement from among the available alternates.
6. The members of the Board of Appeal shall undertake to act independently and in the public interest.
For that purpose, they shall make a declaration of commitments and a declaration of interests indicating either the absence of any interest which may be considered prejudicial to their independence or any direct or indirect interest which might be considered prejudicial to their independence.
Those declarations shall be made public, annually and in writing.
CHAPTER V
REMEDIES
Article 60
Appeals
1. Any natural or legal person, including competent authorities, may appeal against a decision of the Authority referred to in Articles 17, 18 and 19 and any other decision taken by the Authority in accordance with the Union acts referred to in Article 1(2) which is addressed to that person, or against a decision which, although in the form of a decision addressed to another person, is of direct and individual concern to that person.
2. The appeal, together with a statement of grounds, shall be filed in writing at the Authority within 2 months of the date of notification of the decision to the person concerned, or, in the absence of a notification, of the day on which the Authority published its decision.
The Board of Appeal shall decide upon the appeal within 2 months after the appeal has been lodged.
3. An appeal lodged pursuant to paragraph 1 shall not have suspensive effect.
However, the Board of Appeal may, if it considers that circumstances so require, suspend the application of the contested decision.
4. If the appeal is admissible, the Board of Appeal shall examine whether it is well-founded. It shall invite the parties to the appeal proceedings to file observations on its own notifications or on communications from the other parties to the appeal proceedings, within specified time limits. Parties to the appeal proceedings shall be entitled to make oral representations.
5. The Board of Appeal may confirm the decision taken by the competent body of the Authority, or remit the case to the competent body of the Authority. That body shall be bound by the decision of the Board of Appeal and that body shall adopt an amended decision regarding the case concerned.
6. The Board of Appeal shall adopt and make public its rules of procedure.
7. The decisions taken by the Board of Appeal shall be reasoned and shall be made public by the Authority.
Article 61
Actions before the Court of Justice of the European Union
1. Proceedings may be brought before the Court of Justice of the European Union, in accordance with Article 263 TFEU, contesting a decision taken by the Board of Appeal or, in cases where there is no right of appeal before the Board of Appeal, by the Authority.
2. Member States and the Union institutions, as well as any natural or legal person, may institute proceedings before the Court of Justice of the European Union against decisions of the Authority, in accordance with Article 263 TFEU.
3. In the event that the Authority has an obligation to act and fails to take a decision, proceedings for failure to act may be brought before the Court of Justice of the European Union in accordance with Article 265 TFEU.
4. The Authority shall be required to take the necessary measures to comply with the judgment of the Court of Justice of the European Union.
CHAPTER VI
FINANCIAL PROVISIONS
Article 62
Budget of the Authority
1. The revenues of the Authority, a European body in accordance with Article 185 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (40) (hereinafter the ‘Financial Regulation’), shall consist, in particular, of any combination of the following:
(a)
obligatory contributions from the national public authorities competent for the supervision of financial institutions, which shall be made in accordance with a formula based on the weighting of votes set out in Article 3(3) of Protocol (No 36) on transitional provisions. For the purposes of this Article, Article 3(3) of Protocol (No 36) on transitional provisions shall continue to apply beyond the deadline of 31 October 2014 therein established;
(b)
a subsidy from the Union, entered in the General Budget of the European Union (Commission Section);
(c)
any fees paid to the Authority in the cases specified in the relevant instruments of Union law.
2. The expenditure of the Authority shall include, at least, staff, remuneration, administrative, infrastructure, professional training and operational expenses.
3. Revenue and expenditure shall be in balance.
4. Estimates of all Authority revenue and expenditure shall be prepared for each financial year, corresponding to the calendar year, and shall be presented in the budget of the Authority.
Article 63
Establishment of the budget
1. By 15 February each year, the Executive Director shall draw up a draft statement of estimates of revenue and expenditure for the following financial year, and shall forward it to the Management Board and the Board of Supervisors, together with the establishment plan. Each year, the Board of Supervisors shall, on the basis of the draft statement drawn up by the Executive Director and approved by the Management Board, produce a statement of estimates of revenue and expenditure of the Authority for the following financial year. That statement of estimates, including a draft establishment plan, shall be transmitted by the Board of Supervisors to the Commission by 31 March. Prior to adoption of the statement of estimates, the draft prepared by the Executive Director shall be approved by the Management Board.
2. The statement of estimates shall be transmitted by the Commission to the European Parliament and to the Council (hereinafter referred to together as the ‘budgetary authority’), together with the draft budget of the European Union.
3. On the basis of the statement of estimates, the Commission shall enter in the draft budget of the European Union the estimates it deems necessary in respect of the establishment plan and the amount of the subsidy to be charged to the General Budget of the European Union in accordance with Articles 313 and 314 TFEU.
4. The budgetary authority shall adopt the establishment plan for the Authority. The budgetary authority shall authorise the appropriations for the subsidy to the Authority.
5. The budget of the Authority shall be adopted by the Board of Supervisors. It shall become final after the final adoption of the General Budget of the European Union. Where necessary, it shall be adjusted accordingly.
6. The Management Board shall, without delay, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any project relating to property, such as the rental or purchase of buildings. It shall inform the Commission thereof. If either branch of the budgetary authority intends to issue an opinion, it shall, within 2 weeks of receipt of the information on the project, notify the Authority of its intention to issue such an opinion. In the absence of a reply, the Authority may proceed with the planned operation.
7. For the first year of operation of the Authority, ending on 31 December 2011, the financing of the Authority by the Union is subject to an agreement by the budgetary authority as provided for in Point 47 of the Interinstitutional Agreement on budgetary discipline and sound financial management.
Article 64
Implementation and control of the budget
1. The Executive Director shall act as authorising officer and shall implement the Authority’s budget.
2. By 1 March following the completion of each financial year, the Authority’s accounting officer shall forward to the Commission’s accounting officer and to the Court of Auditors the provisional accounts, accompanied by the report on budgetary and financial management during the financial year. The Authority’s accounting officer shall also send the report on budgetary and financial management to the members of the Board of Supervisors, the European Parliament and the Council by 31 March of the following year.
The Commission’s accounting officer shall then consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation.
3. After receiving the observations of the Court of Auditors on the provisional accounts of the Authority in accordance with Article 129 of the Financial Regulation, the Executive Director, acting on his own responsibility, shall draw up the final accounts of the Authority and transmit them, for opinion, to the Management Board.
4. The Management Board shall deliver an opinion on the final accounts of the Authority.
5. The Executive Director shall transmit those final accounts, accompanied by the opinion of the Management Board, by 1 July following the completion of the financial year, to the Members of the Board of Supervisors, the European Parliament, the Council, the Commission and the Court of Auditors.
6. The final accounts shall be published.
7. The Executive Director shall send the Court of Auditors a reply to the latter’s observations by 30 September. He shall also send a copy of that reply to the Management Board and the Commission.
8. The Executive Director shall submit to the European Parliament, at the latter’s request and as provided for in Article 146(3) of the Financial Regulation, any information necessary for the smooth application of the discharge procedure for the financial year in question.
9. The European Parliament, following a recommendation from the Council acting by qualified majority, shall, before 15 May of the year N + 2, grant a discharge to the Authority for the implementation of the budget comprising revenue from the General Budget of the European Union and competent authorities for the financial year N.
Article 65
Financial rules
The financial rules applicable to the Authority shall be adopted by the Management Board after consulting the Commission. Those rules may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (41) unless the specific operational needs for the functioning of the Authority so require and only with the prior agreement of the Commission.
Article 66
Anti-fraud measures
1. For the purposes of combating fraud, corruption and any other illegal activity, Regulation (EC) No 1073/1999 shall apply to the Authority without any restriction.
2. The Authority shall accede to the Interinstitutional Agreement concerning internal investigations by OLAF and shall immediately adopt appropriate provisions for all staff of the Authority.
3. The funding decisions and the agreements and the implementing instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may, if need be, carry out on-the-spot checks on the beneficiaries of monies disbursed by the Authority as well as on the staff responsible for allocating these monies.
CHAPTER VII
GENERAL PROVISIONS
Article 67
Privileges and immunities
The Protocol (No 7) on the privileges and immunities of the European Union annexed to the Treaty on European Union and to the TFEU shall apply to the Authority and its staff.
Article 68
Staff
1. The Staff Regulations, the Conditions of Employment of Other Servants and the rules adopted jointly by the Union institutions for the purpose of applying them shall apply to the staff of the Authority, including its Executive Director and its Chairperson.
2. The Management Board, in agreement with the Commission, shall adopt the necessary implementing measures, in accordance with the arrangements provided for in Article 110 of the Staff Regulations.
3. In respect of its staff, the Authority shall exercise the powers conferred on the appointing authority by the Staff Regulations and on the authority entitled to conclude contracts by the Conditions of Employment of Other Servants.
4. The Management Board shall adopt provisions to allow national experts from Member States to be seconded to the Authority.
Article 69
Liability of the Authority
1. In the case of non-contractual liability, the Authority shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its staff in the performance of their duties. The Court of Justice of the European Union shall have jurisdiction in any dispute over the remedying of such damage.
2. The personal financial liability and disciplinary liability of Authority staff towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority.
Article 70
Obligation of professional secrecy
1. Members of the Board of Supervisors and the Management Board, the Executive Director, and members of the staff of the Authority including officials seconded by Member States on a temporary basis and all other persons carrying out tasks for the Authority on a contractual basis shall be subject to the requirements of professional secrecy pursuant to Article 339 TFEU and the relevant provisions in Union legislation, even after their duties have ceased.
Article 16 of the Staff Regulations shall apply to them.
In accordance with the Staff Regulations, the staff shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence staff members of the Authority in the performance of their tasks.
2. Without prejudice to cases covered by criminal law, any confidential information received by persons referred to in paragraph 1 whilst performing their duties may not be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual financial institutions cannot be identified.
Moreover, the obligation under paragraph 1 and the first subparagraph of this paragraph shall not prevent the Authority and the national supervisory authorities from using the information for the enforcement of the acts referred to in Article 1(2), and in particular for legal procedures for the adoption of decisions.
3. Paragraphs 1 and 2 shall not prevent the Authority from exchanging information with national supervisory authorities in accordance with this Regulation and other Union legislation applicable to financial institutions.
That information shall be subject to the conditions of professional secrecy referred to in paragraphs 1 and 2. The Authority shall lay down in its internal rules of procedure the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2.
4. The Authority shall apply Commission Decision 2001/844/EC/ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (42).
Article 71
Data protection
This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Directive 95/46/EC or the obligations of the Authority relating to its processing of personal data under Regulation (EC) No 45/2001 when fulfilling its responsibilities.
Article 72
Access to documents
1. Regulation (EC) No 1049/2001 shall apply to documents held by the Authority.
2. The Management Board shall, by 31 May 2011, adopt practical measures for applying Regulation (EC) No 1049/2001.
3. Decisions taken by the Authority pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or of proceedings before the Court of Justice of the European Union, following an appeal to the Board of Appeal, as appropriate, in accordance with the conditions laid down in Articles 228 and 263 TFEU respectively.
Article 73
Language arrangements
1. Council Regulation No 1 determining the languages to be used by the European Economic Community (43) shall apply to the Authority.
2. The Management Board shall decide on the internal language arrangements for the Authority.
3. The translation services required for the functioning of the Authority shall be provided by the Translation Centre for the Bodies of the European Union.
Article 74
Headquarters Agreement
The necessary arrangements concerning the accommodation to be provided for the Authority in the Member State where its seat is located and the facilities to be made available by that Member State, as well as the specific rules applicable in that Member State to the Executive Director, the members of the Management Board, the staff of the Authority and members of their families shall be laid down in a Headquarters Agreement between the Authority and that Member State concluded after obtaining the approval of the Management Board.
That Member State shall provide the best possible conditions to ensure the proper functioning of the Authority, including multilingual, European-oriented schooling and appropriate transport connections.
Article 75
Participation of third countries
1. Participation in the work of the Authority shall be open to third countries which have concluded agreements with the Union whereby they have adopted and are applying Union law in the areas of competence of the Authority as referred to in Article 1(2).
2. The Authority may cooperate with the countries referred to in paragraph 1, applying legislation which has been recognised as equivalent in the areas of competence of the Authority referred to in Article 1(2), as provided for in international agreements concluded by the Union in accordance with Article 216 TFEU.
3. Under the relevant provisions of the agreements referred to in paragraphs 1 and 2, arrangements shall be made specifying, in particular, the nature, scope and procedural aspects of the involvement of the countries referred to in paragraph 1 in the work of the Authority, including provisions relating to financial contributions and to staff. They may provide for representation, as an observer, on the Board of Supervisors, but shall ensure that those countries do not attend any discussions relating to individual financial institutions, except where there is a direct interest.
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 76
Preparatory actions
1. Following the entry into force of this Regulation, and before the establishment of the Authority, CEBS shall act in close cooperation with the Commission to prepare for the replacement of CEBS by the Authority.
2. Once the Authority has been established, the Commission shall be responsible for the administrative establishment and initial administrative operation of the Authority until the Authority has appointed an Executive Director.
For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Board of Supervisors in accordance with Article 51, the Commission may assign one official on an interim basis in order to fulfil the functions of the Executive Director. That period shall be limited to the time necessary for the appointment of an Executive Director of the Authority.
The interim Executive Director may authorise all payments covered by credits provided in the budget of the Authority, once approved by the Management Board and may conclude contracts, including staff contracts following the adoption of the Authority’s establishment plan.
3. Paragraphs 1 and 2 are without prejudice to the powers of the Board of Supervisors and the Management Board.
4. The Authority shall be considered the legal successor of CEBS. By the date of establishment of the Authority, all assets and liabilities and all pending operations of CEBS shall be automatically transferred to the Authority. CEBS shall establish a statement showing its closing asset and liability situation as of the date of that transfer. That statement shall be audited and approved by CEBS and by the Commission.
Article 77
Transitional staff provisions
1. By way of derogation from Article 68, all employment contracts and secondment agreements concluded by CEBS or its Secretariat and in force on 1 January 2011 shall be honoured until their expiry date. They may not be extended.
2. All members of staff under contracts referred to in paragraph 1 shall be offered the possibility of concluding temporary agent contracts pursuant to Article 2(a) of the Conditions of Employment of Other Servants at the various grades as set out in the Authority’s establishment plan.
An internal selection limited to staff who have contracts with CEBS or its Secretariat shall be carried out after the entry into force of this Regulation by the authority authorised to conclude contracts in order to check the ability, efficiency and integrity of those to be engaged. The internal selection procedure shall take full account of the skills and experience demonstrated by the individuals’ performance prior to the engagement.
3. Depending on the type and level of functions to be performed, successful applicants shall be offered temporary agents’ contracts of a duration corresponding at least to the time remaining under the prior contract.
4. The relevant national law relating to labour contracts and other relevant instruments shall continue to apply to staff members with prior contracts who choose not to apply for temporary agent’s contracts or who are not offered temporary agents contracts in accordance with paragraph 2.
Article 78
National provisions
The Member States shall make such provision as is appropriate to ensure the effective application of this Regulation.
Article 79
Amendments
Decision No 716/2009/EC is hereby amended in so far as CEBS is removed from the list of beneficiaries set out in Section B of the Annex to that Decision.
Article 80
Repeal
Commission Decision 2009/78/EC, establishing CEBS, is hereby repealed with effect from 1 January 2011.
Article 81
Review
1. By 2 January 2014, and every 3 years thereafter, the Commission shall publish a general report on the experience acquired as a result of the operation of the Authority and the procedures laid down in this Regulation. That report shall evaluate, inter alia:
(a)
the convergence in supervisory practices reached by competent authorities:
(i)
the convergence in functional independence of the competent authorities and in standards equivalent to corporate governance;
(ii)
the impartiality, objectivity and autonomy of the Authority;
(b)
the functioning of the colleges of supervisors;
(c)
the progress achieved towards convergence in the fields of crisis prevention, management and resolution, including Union funding mechanisms;
(d)
the role of the Authority as regards systemic risk;
(e)
the application of the safeguard clause established in Article 38;
(f)
the application of the binding mediation role established in Article 19.
2. The report referred to in paragraph 1 shall also examine whether:
(a)
it is appropriate to continue separate supervision of banking, insurance, occupational pensions, securities and financial markets;
(b)
it is appropriate to undertake prudential supervision and supervise the conduct of business separately or by the same supervisor;
(c)
it is appropriate to simplify and reinforce the architecture of the ESFS in order to increase the coherence between the macro and the micro levels and between the ESAs;
(d)
the evolution of the ESFS is consistent with that of the global evolution;
(e)
there is sufficient diversity and excellence within the ESFS;
(f)
accountability and transparency in relation to publication requirements are adequate;
(g)
the resources of the Authority are adequate to carry out its responsibilities;
(h)
it is appropriate for the seat of the Authority to be maintained or to move the ESAs to a single seat to enhance better coordination between them.
3. Concerning the issue of direct supervision of institutions or infrastructures of pan-European reach and taking account of market developments, the Commission shall draw up an annual report on the appropriateness of entrusting the Authority with further supervisory responsibilities in this area.
4. The report and any accompanying proposals, as appropriate, shall be forwarded to the European Parliament and to the Council.
Article 82
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2011, with the exception of Article 76 and Article 77(1) and (2), which shall apply as from the date of its entry into force.
The Authority shall be established on 1 January 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 24 November 2010.
For the European Parliament
The President
J. BUZEK
For the Council
The President
O. CHASTEL
(1) OJ C 13, 20.1.2010, p. 1.
(2) Opinion of 22 January 2010 (not yet published in the Official Journal).
(3) Position of the European Parliament of 22 September 2010 (not yet published in the Official Journal) and decision of the Council of 17 November 2010.
(4) OJ C 40, 7.2.2001, p. 453.
(5) OJ C 25 E, 29.1.2004, p. 394.
(6) OJ C 175 E, 10.7.2008, p. 392.
(7) OJ C 8 E, 14.1.2010, p. 26.
(8) OJ C 9 E, 15.1.2010, p. 48.
(9) OJ C 184 E, 8.7.2010, p. 214.
(10) OJ C 184 E, 8.7.2010, p. 292.
(11) See page 1 of this Official Journal.
(12) OJ L 25, 29.1.2009, p. 23.
(13) OJ L 25, 29.1.2009, p. 28.
(14) OJ L 25, 29.1.2009, p. 18.
(15) European Court Reports 2006 Page I-03771, para. 44.
(16) OJ L 177, 30.6.2006, p. 1.
(17) OJ L 177, 30.6.2006, p. 201.
(18) OJ L 135, 31.5.1994, p. 5.
(19) OJ L 35, 11.2.2003, p. 1.
(20) OJ L 330, 5.12.1998, p. 1.
(21) OJ L 345, 8.12.2006, p. 1.
(22) OJ L 267, 10.10.2009, p. 7.
(23) OJ L 309, 25.11.2005, p. 15.
(24) OJ L 271, 9.10.2002, p. 16.
(25) OJ L 319, 5.12.2007, p. 1.
(26) OJ L 84, 26.3.1997, p. 22.
(27) Directive 2007/44/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 92/49/EEC and Directives 2002/83/EC, 2004/39/EC, 2005/68/EC and 2006/48/EC as regards procedural rules and evaluation criteria for the prudential assessment of acquisitions and increase of holdings in the financial sector (OJ L 247, 21.9.2007, p. 1).
(28) OJ L 87, 31.3.2009, p. 164.
(29) OJ L 318, 27.11.1998, p. 8.
(30) OJ C 139, 14.6.2006, p. 1.
(31) OJ L 136, 31.5.1999, p. 1.
(32) OJ L 136, 31.5.1999, p. 15.
(33) OJ L 56, 4.3.1968, p. 1.
(34) OJ L 281, 23.11.1995, p. 31.
(35) OJ L 8, 12.1.2001, p. 1.
(36) OJ L 145, 31.5.2001, p. 43.
(37) OJ L 253, 25.9.2009, p. 8.
(38) See page 48 of this Official Journal.
(39) See page 84 of this Official Journal.
(40) OJ L 248, 16.9.2002, p. 1.
(41) OJ L 357, 31.12.2002, p. 72.
(42) OJ L 317, 3.12.2001, p. 1.
(43) OJ 17, 6.10.1958, p. 385.
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European Banking Authority (EBA)
European Banking Authority (EBA)
SUMMARY OF:
Regulation (EU) No 1093/2010 establishing the European Banking Authority
WHAT IS THE AIM OF THE REGULATION?
It sets up the European Banking Authority (EBA), a European Union (EU) agency that works to ensure effective and consistent prudential regulation and supervision across the European banking sector.
The EBA’s overall objectives are to maintain financial stability in the EU and to safeguard the integrity, efficiency and orderly functioning of the banking sector.
KEY POINTS
Consistent application of EU law
The EBA:
draws up regulatory technical standards to specify the banking legislation to be adopted by the European Commission, where the European Parliament and the Council of the European Union delegate this power to the Commission;
has the power to issue guidelines and recommendations on the application of the relevant EU legislation and, under amending Regulation (EU) 2019/2175, is granted more wide-ranging powers in relation to money laundering-related breaches.
Stress tests
The EBA has a prominent role in the EU-wide stress test exercise that examines banks’ resilience with regard to adverse market developments and any systemic risks in the EU financial system.
It initiates and coordinates stress tests in the EU with the national authorities responsible for supervising banks.
In cooperation with the European Systemic Risk Board (ESRB), the European Central Bank and the Commission, the EBA defines a common methodology for each edition of the stress test.
It also monitors and assesses market and credit trends.
Breaches of EU law
The EBA has the power to investigate the alleged incorrect application by a national supervisor of EU banking and financial legislation (in particular when it fails to ensure that a bank complies with the requirements laid down in that legislation).
The EBA may address a recommendation to the particular national supervisor. If the supervisor does not comply with this, the Commission can issue a formal opinion taking into account the EBA’s recommendation.
If a national supervisor persists in not complying with the law, the EBA can adopt decisions directly addressed to the bank. This power can only be used in exceptional circumstances.
Amending Regulation (EU) 2019/2175 gives the EBA power to take immediate action where anti-money laundering rules are broken at the national level (see below).
European financial supervision
The EBA is part of the European system of financial supervision created in 2010 which, in addition to the ESRB, comprises two other supervisory organisations:
the European Insurance and Occupational Pensions Authority
the European Securities and Markets Authority.
Amending Regulation (EU) 2019/2175 bolsters the mandates, governance and funding of the three European supervisory authorities and, in regard to the EBA, it:
reinforces its supervisory role and powers with a view to combating money laundering and terrorist financing and, in this regard, requires it to: collect information from the competent national authorities,develop new standards to improve the quality of supervision,carry out risk assessments,facilitate cooperation with non-EU countries on cross-border cases;
strengthens its powers in the area of consumer protection by promoting greater transparency and clarity regarding financial products and services by: monitoring trends in retail financial products’ costs and charges,developing retail risk indicators for consumers;
increases its resources to enable it to carry out its new tasks.
Payment services
In relation to payments services in the EU, amending Directive (EU) 2015/2366 strengthens the EBA’s role (see summary) and requires it to:
develop a publicly accessible central register of authorised payment institutions, which must be kept up to date by the national authorities;
assist in resolving disputes between national authorities;
develop and issue guidelines and draft regulatory technical standards on: strong customer authentication and secure communication channels with which all payment service providers must comply,cooperation and the exchange of information between supervisory authorities.
Headquarters
Under amending Regulation (EU) 2018/1717, in the context of the United Kingdom’s withdrawal from the EU, the seat of the EBA was relocated from London to Paris as of 30 March 2019.
FROM WHEN DOES THE REGULATION APPLY?
Regulation (EU) No 1093/2010 has applied since 1 January 2011.
Amending Directive (EU) 2015/2366 has applied since 12 January 2016 and had to become law in the Member States by 13 January 2018.
Amending Regulation (EU) 2019/2175 has applied since 1 January 2020.
BACKGROUND
For further information, see:
Missions and tasks (European Banking Authority)
Supervisory convergence (European Banking Authority).
MAIN DOCUMENT
Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, pp. 12–47).
Successive amendments to Regulation (EU) No 1093/2010 have been incorporated into the original document. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, pp. 349–496).
See consolidated version.
Council Regulation (EU) No 1096/2010 of 17 November 2010 conferring specific tasks upon the European Central Bank concerning the functioning of the European Systemic Risk Board (OJ L 331, 15.12.2010, pp. 162–164).
last update 29.11.2021
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32010R1095
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15.12.2010
EN
Official Journal of the European Union
L 331/84
REGULATION (EU) No 1095/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 24 November 2010
establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Central Bank (1),
Having regard to the opinion of the European Economic and Social Committee (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
The financial crisis in 2007 and 2008 exposed important shortcomings in financial supervision, both in particular cases and in relation to the financial system as a whole. Nationally based supervisory models have lagged behind financial globalisation and the integrated and interconnected reality of European financial markets, in which many financial institutions operate across borders. The crisis exposed shortcomings in the areas of cooperation, coordination, consistent application of Union law and trust between national supervisors.
(2)
Before and during the financial crisis, the European Parliament has called for a move towards more integrated European supervision in order to ensure a true level playing field for all actors at the level of the Union and to reflect the increasing integration of financial markets in the Union (in its resolutions of 13 April 2000 on the Commission communication on implementing the framework for financial markets: Action Plan (4), of 21 November 2002 on prudential supervision rules in the European Union (5), of 11 July 2007 on financial services policy (2005 to 2010) – White Paper (6), of 23 September 2008 with recommendations to the Commission on hedge funds and private equity (7) and of 9 October 2008 with recommendations to the Commission on Lamfalussy follow-up: future structure of supervision (8), and in its positions of 22 April 2009 on the amended proposal for a directive of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (9) and of 23 April 2009 on the proposal for a regulation of the European Parliament and of the Council on Credit Rating Agencies (10)).
(3)
In November 2008, the Commission mandated a High-Level Group chaired by Jacques de Larosière to make recommendations on how to strengthen European supervisory arrangements with a view to better protecting the citizen and rebuilding trust in the financial system. In its final report presented on 25 February 2009 (the ‘de Larosière Report’), the High-Level Group recommended that the supervisory framework be strengthened to reduce the risk and severity of future financial crises. It recommended reforms to the structure of supervision of the financial sector in the Union. The group also concluded that a European System of Financial Supervisors should be created, comprising three European Supervisory Authorities, one for the banking sector, one for the securities sector and one for the insurance and occupational pensions sector and recommended the creation of a European Systemic Risk Council. The report represented the reforms the experts considered were needed and on which work had to begin immediately.
(4)
In its Communication of 4 March 2009 entitled ‘Driving European Recovery’, the Commission proposed to put forward draft legislation creating a European system of financial supervision and a European systemic risk board. In its Communication of 27 May 2009 entitled ‘European Financial Supervision’, it provided more detail about the possible architecture of such a new supervisory framework reflecting the main thrust of the de Larosière Report.
(5)
The European Council, in its conclusions of 19 June 2009, confirmed that a European System of Financial Supervisors, comprising three new European Supervisory Authorities, should be established. The system should be aimed at upgrading the quality and consistency of national supervision, strengthening oversight of cross-border groups and establishing a European single rule book applicable to all financial market participants in the internal market. It emphasised that the European Supervisory Authorities should also have supervisory powers in relation to credit rating agencies and invited the Commission to prepare concrete proposals on how the European System of Financial Supervisors could play a strong role in crisis situations, while stressing that decisions taken by the European Supervisory Authorities should not impinge on the fiscal responsibilities of Member States. The Commission has presented a Proposal for a Regulation amending Regulation (EC) No 1060/2009 of the European Parliament and of the Council of 16 September 2009 on credit rating agencies (11). The European Parliament and the Council should consider that proposal in order to ensure that European Supervisory Authority (European Securities and Markets Authority) (hereinafter the Authority’) will have adequate supervisory powers over credit rating agencies, bearing in mind that the Authority should execute exclusive supervisory powers over Credit Rating Agencies entrusted to it in Regulation (EC) No 1060/2009. For that purpose, the Authority should have appropriate powers of investigation and enforcement as specified in the relevant legislation, as well as the possibility of charging fees.
(6)
On 17 June 2010, the European Council agreed that ‘Member States should introduce systems of levies and taxes on financial institutions to ensure fair burden-sharing and to set incentives to contain systemic risk. Such levies or taxes should be part of a credible resolution framework. Further work is urgently required on their main features and issues of level playing field and cumulative impacts of various regulatory measures should be carefully assessed’.
(7)
The financial and economic crisis has created real and serious risks to the stability of the financial system and the functioning of the internal market. Restoring and maintaining a stable and reliable financial system is an absolute prerequisite to preserving trust and coherence in the internal market, and thereby to preserve and improve the conditions for the establishment of a fully integrated and functioning internal market in the field of financial services. Moreover, deeper and more integrated financial markets offer better opportunities for financing and risk diversification, and thus help to improve the capacity of the economies to absorb shocks.
(8)
The Union has reached the limits of what can be done with the present status of the Committees of European Supervisors. The Union cannot remain in a situation where there is no mechanism to ensure that national supervisors arrive at the best possible supervisory decisions for cross-border financial market participants; where there is insufficient cooperation and information exchange between national supervisors; where joint action by national authorities requires complicated arrangements to take account of the patchwork of regulatory and supervisory requirements; where national solutions are most often the only feasible option in responding to problems at the level of the Union; and where different interpretations of the same legal text exist. The European System of Financial Supervision (hereinafter the ESFS’) should be designed to overcome those deficiencies and provide a system that is in line with the objective of a stable and single Union financial market for financial services, linking national supervisors within a strong Union network.
(9)
The ESFS should be an integrated network of national and Union supervisory authorities, leaving day-to-day supervision to the national level. Greater harmonisation and the coherent application of rules for financial market participants across the Union should also be achieved. In addition to the Authority, a European Supervisory Authority (European Banking Authority) and a European Supervisory Authority (European Insurance and Occupational Pensions Authority) as well as a Joint Committee of the European Supervisory Authorities (hereinafter the Joint Committee’) should be established. A European Systemic Risk Board (hereinafter the ESRB’) should form part of the ESFS for the purposes of the tasks as specified in this Regulation and in Regulation (EU) No 1092/2010 of the European Parliament and of the Council (12).
(10)
The European Supervisory Authorities (hereinafter collectively referred to as the ‘ESAs’) should replace the Committee of European Banking Supervisors established by Commission Decision 2009/78/EC (13), the Committee of European Insurance and Occupational Pensions Supervisors established by Commission Decision 2009/79/EC (14) and the Committee of European Securities Regulators established by Commission Decision 2009/77/EC (15), and should assume all of the tasks and competences of those committees including the continuation of ongoing work and projects, where appropriate. The scope of each European Supervisory Authority’s action should be clearly defined. The ESAs should be accountable to the European Parliament and the Council. When that accountability relates to cross-sectoral issues that have been coordinated through the Joint Committee, the ESAs should be accountable, through the Joint Committee, for such coordination.
(11)
The Authority should act with a view to improving the functioning of the internal market, in particular by ensuring a high, effective and consistent level of regulation and supervision taking account of the varying interests of all Member States and the different nature of financial market participants. The Authority should protect public values such as the integrity and stability of the financial system, the transparency of markets and financial products and the protection of investors. The Authority should also prevent regulatory arbitrage and guarantee a level playing field, and strengthen international supervisory coordination, for the benefit of the economy at large, including financial institutions and other stakeholders, consumers and employees. Its tasks should also include promoting supervisory convergence and providing advice to the Union institutions in the areas of its responsibility. The Authority should also be entrusted with certain responsibilities for existing and new financial activities.
(12)
The Authority should also be able to temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in this Regulation. If required to make such temporary prohibition in the case of an emergency situation, the Authority should do so in accordance with and under the conditions laid down in this Regulation. In cases where a temporary prohibition or restriction of certain financial activities has a cross-sectoral impact, sectoral legislation should provide that the Authority should consult and coordinate its action with, where relevant, the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority), through the Joint Committee.
(13)
The Authority should take due account of the impact of its activities on competition and innovation within the internal market, on the Union’s global competitiveness, on financial inclusion, and on the Union’s new strategy for jobs and growth.
(14)
In order to fulfil its objectives, the Authority should have legal personality as well as administrative and financial autonomy.
(15)
Based on the work of international bodies, systemic risk should be defined as a risk of disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructures may be potentially systemically important to some degree.
(16)
Cross-border risk includes all risks caused by economic imbalances or financial failures in all or parts of the Union that have the potential to have significant negative consequences for the transactions between economic operators of two or more Member States, for the functioning of the internal market or for the public finances of the Union or any of its Member States.
(17)
The Court of Justice of the European Union in its judgment of 2 May 2006 in Case C-217/04 (United Kingdom of Great Britain and Northern Ireland v. European Parliament and Council of the European Union) held that: ‘nothing in the wording of Article 95 EC [now Article 114 of the Treaty on the Functioning of the European Union (TFEU)] implies that the addressees of the measures adopted by the Community legislature on the basis of that provision can only be the individual Member States. The legislature may deem it necessary to provide for the establishment of a Community body responsible for contributing to the implementation of a process of harmonisation in situations where, in order to facilitate the uniform implementation and application of acts based on that provision, the adoption of non-binding supporting and framework measures seems appropriate’ (16). The purpose and tasks of the Authority – assisting competent national supervisory authorities in the consistent interpretation and application of Union rules and contributing to financial stability necessary for financial integration – are closely linked to the objectives of the Union acquis concerning the internal market for financial services. The Authority should therefore be established on the basis of Article 114 TFEU.
(18)
The following legislative acts lay down the tasks for competent authorities of Member States, including cooperating with each other and with the Commission: Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (17), Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (18), Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (19), Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (20), Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (21), Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (22), Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (23), Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market (24), Directive 2006/49/EC of the European Parliament and the Council of 14 June 2006 on the capital adequacy of investment firms and credit institutions (25), without prejudice to the competence of the European Supervisory Authority (European Banking Authority), as far as prudential supervision is concerned, Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (26), any future legislation in the area of Alternative Investment Fund Managers (AIFM) and Regulation (EC) No 1060/2009.
(19)
Existing Union legislation regulating the field covered by this Regulation also includes Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (27), Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group (28), Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (29), and the relevant parts of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (30) and of Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (31).
(20)
It is desirable that the Authority promote a consistent approach in the area of investor compensation schemes to ensure a level playing field and the equitable treatment of investors across the Union. As investor compensation schemes are subject to oversight in their Member States rather than regulatory supervision, the Authority should be able to exercise its powers under this Regulation in relation to the investor compensation scheme itself and its operator.
(21)
In accordance with the Declaration (No 39) on Article 290 of the Treaty on the Functioning of the European Union (TFEU), annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the elaboration of regulatory technical standards requires assistance of technical expertise in a form which is specific to the financial services area. It is necessary to allow the Authority to provide such expertise also on standards or parts of standards that are not based on a draft technical standard that it has elaborated.
(22)
There is a need to introduce an effective instrument to establish harmonised regulatory technical standards in financial services to ensure, also through a single rulebook, a level playing field and adequate protection of investors and consumers across the Union. As a body with highly specialised expertise, it is efficient and appropriate to entrust the Authority, in areas defined by Union law, with the elaboration of draft regulatory technical standards, which do not involve policy choices.
(23)
The Commission should endorse those draft regulatory technical standards by means of delegated acts under Article 290 TFEU in order to give them binding legal effect. They should be subject to amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission’s decision to endorse draft regulatory technical standards should be subject to a time limit.
(24)
Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission’s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority.
(25)
The Commission should also be empowered to adopt implementing technical standards by means of implementing acts under Article 291 TFEU.
(26)
In areas not covered by regulatory or implementing technical standards, the Authority should have the power to issue guidelines and recommendations on the application of Union law. In order to ensure transparency and to strengthen compliance by national supervisory authorities with those guidelines and recommendations, it should be possible for the Authority to publish the reasons for supervisory authorities’ non-compliance with those guidelines and recommendations.
(27)
Ensuring the correct and full application of Union law is a core prerequisite for the integrity, transparency, efficiency and orderly functioning of financial markets, the stability of the financial system, and for neutral conditions of competition for financial market participants in the Union. A mechanism should therefore be established whereby the Authority addresses instances of non-application or incorrect application of Union law amounting to a breach thereof. That mechanism should apply in areas where Union law defines clear and unconditional obligations.
(28)
To allow for a proportionate response to instances of incorrect or insufficient application of Union law, a three-step mechanism should apply. First, the Authority should be empowered to investigate alleged incorrect or insufficient application of Union law obligations by national authorities in their supervisory practice, concluded by a recommendation. Second, where the competent national authority does not follow the recommendation, the Commission should be empowered to issue a formal opinion taking into account the Authority’s recommendation, requiring the competent authority to take the actions necessary to ensure compliance with Union law.
(29)
Third, to overcome exceptional situations of persistent inaction by the competent authority concerned, the Authority should be empowered, as a last resort, to adopt decisions addressed to individual financial market participants. That power should be limited to exceptional circumstances in which a competent authority does not comply with the formal opinion addressed to it and in which Union law is directly applicable to financial market participants by virtue of existing or future Union regulations.
(30)
Serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the Union require a swift and concerted response at Union level. The Authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation. The power to determine the existence of an emergency situation should be conferred on the Council, following a request by any of the ESAs, the Commission or the ESRB.
(31)
The Authority should be able to require national supervisory authorities to take specific action to remedy an emergency situation. The action undertaken by the Authority in this respect should be without prejudice to the Commission’s powers under Article 258 TFEU to initiate infringement proceedings against the Member State of that supervisory authority for its failure to take such action, and without prejudice to the Commission’s right in such circumstances to seek interim measures in accordance with the rules of procedure of the Court of Justice of the European Union. Furthermore, it should be without prejudice to any liability that that Member State might incur in accordance with the case law of the Court of Justice of the European Union if its supervisory authorities fail to take the action required by the Authority.
(32)
In order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different Member States, the Authority should be able to settle disagreements in cross-border situations between those competent authorities with binding effect, including within colleges of supervisors. A conciliation phase should be provided for during which the competent authorities may reach an agreement. The Authority’s competence should cover disagreements on the procedure or content of an action or inaction by a competent authority of a Member State in cases specified in the legally binding Union acts referred to in this Regulation. In such a situation, one of the supervisors involved should be entitled to refer the issue to the Authority, which should act in accordance with this Regulation. The Authority should be empowered to require the competent authorities concerned to take specific action or to refrain from action in order to settle the matter in order to ensure compliance with Union law, with binding effects for the competent authorities concerned. If a competent authority does not comply with the settlement decision addressed to it, the Authority should be empowered to adopt decisions directly addressed to financial market participants in areas of Union law directly applicable to them. The power to adopt such decisions should apply only as a last resort and then only to ensure the correct and consistent application of Union law. In cases where the relevant Union legislation confers discretion on Member States’ competent authorities, decisions taken by the Authority cannot replace the exercise in compliance with Union law of that discretion.
(33)
The crisis has proven that the current system of cooperation between national authorities whose powers are limited to individual Member States is insufficient as regards financial institutions that operate across borders.
(34)
Expert Groups set up by Member States to examine the causes of the crisis and make suggestions to improve the regulation and supervision of the financial sector have confirmed that the current arrangements are not a sound basis for the future regulation and supervision of cross-border financial institutions across the Union.
(35)
As the de Larosière Report indicates, ‘[i]n essence, we have two alternatives: the first “chacun pour soi” beggar-thy-neighbour solutions; or the second – enhanced, pragmatic, sensible European cooperation for the benefit of all to preserve an open world economy. This will bring undoubted economic gains’.
(36)
Colleges of supervisors play an important role in the efficient, effective and consistent supervision of financial market participants operating across borders. The Authority should contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors and, in that respect, have a leading role in ensuring the consistent and coherent functioning of colleges of supervisors for cross-border financial institutions across the Union. The Authority should therefore have full participation rights in colleges of supervisors with a view to streamlining the functioning of and the information exchange process in the colleges of supervisors and to foster convergence and consistency across colleges in the application of Union law. As the de Larosière Report states, ‘competition distortions and regulatory arbitrage stemming from different supervisory practices must be avoided, because they have the potential of undermining financial stability – inter alia by encouraging a shift of financial activity to countries with lax supervision. The supervisory system has to be perceived as fair and balanced’.
(37)
In the areas of its competence, the Authority should contribute to, and participate actively in the development and coordination of effective and consistent recovery and resolution plans, procedures in emergency situations and preventive measures to ensure the internalisation of costs by the financial system, in order to minimise the systemic impact of any failure and the reliance on taxpayer funds to bail out financial market participants. It should contribute to developing methods for the resolution of failing key financial market participants in ways which avoid contagion, which allow them to be wound down in an orderly and timely manner, and which, where applicable, include coherent and credible funding mechanisms as appropriate.
(38)
In the current review of Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes (32) and Directive 97/9/EC, the Commission’s intention to pay special attention to the need to ensure further harmonisation throughout the Union is noted. In the insurance sector, the Commission’s intention to examine the possibility of introducing Union rules protecting insurance policy holders in case of a failing insurance company is also noted. The ESAs should play an important role in those areas and appropriate powers concerning the European guarantee scheme systems should be conferred upon them.
(39)
The delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks, to foster cooperation and thereby streamline the supervisory process, as well as to reduce the burden imposed on financial market participants. This Regulation should therefore provide a clear legal basis for such delegation. Whilst respecting the general rule that delegation should be allowed, Member States should be able to introduce specific conditions for the delegation of responsibilities, for example regarding information about, and the notification of, delegation arrangements. Delegation of tasks means that tasks are carried out by the Authority or by a national supervisory authority other than the responsible authority, while the responsibility for supervisory decisions remains with the delegating authority. By the delegation of responsibilities, the Authority or a national supervisory authority (the delegate) should be able to decide upon a certain supervisory matter in its own name in lieu of the delegating authority. Delegations should be governed by the principle of allocating supervisory competence to a supervisor which is best placed to take action in the subject matter. A reallocation of responsibilities would be appropriate, for example, for reasons of economies of scale or scope, of coherence in group supervision, and of optimal use of technical expertise among national supervisory authorities. Decisions by the delegate should be recognised by the delegating authority and by other competent authorities as determinative if those decisions are within the scope of the delegation. Relevant Union legislation could further specify the principles for the reallocation of responsibilities upon agreement. The Authority should facilitate and monitor delegation agreements between national supervisory authorities by all appropriate means.
It should be informed in advance of intended delegation agreements, in order to be able to express an opinion where appropriate. It should centralise the publication of such agreements to ensure timely, transparent and easily accessible information about agreements for all parties concerned. It should identify and disseminate best practices regarding delegation and delegation agreements.
(40)
The Authority should actively foster supervisory convergence across the Union with the aim of establishing a common supervisory culture.
(41)
Peer reviews are an efficient and effective tool for fostering consistency within the network of financial supervisors. The Authority should therefore develop the methodological framework for such reviews and conduct them on a regular basis. Reviews should focus not only on the convergence of supervisory practices but also on the capacity of supervisors to achieve high quality supervisory outcomes as well as on the independence of those competent authorities. The outcome of peer reviews should be made public with the agreement of the competent authority subject to the review. Best practices should also be identified and made public.
(42)
The Authority should actively promote a coordinated Union supervisory response, in particular to ensure the orderly functioning and integrity of financial markets and the stability of the financial system in the Union. In addition to its powers for action in emergency situations, the Authority should therefore be entrusted with a general coordination function within the ESFS. The smooth flow of all relevant information between competent authorities should be a particular focus of the Authority’s actions.
(43)
In order to safeguard financial stability it is necessary to identify, at an early stage, trends, potential risks and vulnerabilities stemming from the micro-prudential level, across borders and across sectors. The Authority should monitor and assess such developments in the area of its competence and, where necessary, inform the European Parliament, the Council, the Commission, the other European Supervisory Authorities and the ESRB on a regular and, as necessary, on an ad hoc basis. The Authority should also, in cooperation with the ESRB, initiate and coordinate Union-wide stress tests to assess the resilience of financial market participants to adverse market developments, and it should ensure that an as consistent as possible methodology is applied at the national level to such tests. In order to perform its functions properly, the Authority should conduct economic analyses of the markets and the impact of potential market developments.
(44)
Given the globalisation of financial services and the increased importance of international standards, the Authority should foster dialogue and cooperation with supervisors outside the Union. It should be empowered to develop contacts and enter into administrative arrangements with the supervisory authorities and administrations of third countries and with international organisations, while fully respecting the existing roles and respective competences of the Member States and the Union institutions. Participation in the work of the Authority should be open to countries which have concluded agreements with the Union whereby they have adopted and are applying Union law, and the Authority should be able to cooperate with third countries which apply legislation that has been recognised as equivalent to that of the Union.
(45)
The Authority should serve as an independent advisory body to the European Parliament, the Council, and the Commission in the area of its competence. Without prejudice to the competencies of the competent authorities concerned, the Authority should be able to provide its opinion on the prudential assessment of mergers and acquisitions under Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (23), as amended by Directive 2007/44/EC (33) in those cases in which that Directive requires consultation between competent authorities from two or more Member States.
(46)
In order to carry out its duties effectively, the Authority should have the right to request all necessary information. To avoid the duplication of reporting obligations for financial market participants, that information should normally be provided by the national supervisory authorities which are closest to the financial markets and financial market participants and should take into account already existing statistics. However, as a last resort, the Authority should be able to address a duly justified and reasoned request for information directly to a financial market participant where a national competent authority does not or cannot provide such information in a timely fashion. Member States’ authorities should be obliged to assist the Authority in enforcing such direct requests. In that context, the work on common reporting formats is essential. The measures for the collection of information should be without prejudice to the legal framework of the European Statistical System and the European System of Central Banks in the field of statistics. This Regulation should therefore be without prejudice both to Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (34) and to Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (35).
(47)
Close cooperation between the Authority and the ESRB is essential to give full effectiveness to the functioning of the ESRB and the follow-up to its warnings and recommendations. The Authority and the ESRB should share any relevant information with each other. Data related to individual undertakings should be provided only upon reasoned request. Upon receipt of warnings or recommendations addressed by the ESRB to the Authority or a national supervisory authority, the Authority should ensure follow-up as appropriate.
(48)
The Authority should consult interested parties on regulatory or implementing technical standards, guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures. Before adopting draft regulatory or implementing technical standards, guidelines and recommendations, the Authority should carry out an impact study. For reasons of efficiency, a Securities and Markets Stakeholder Group should be used for that purpose, and should represent, in balanced proportions, financial market participants, small and medium-sized enterprises (SMEs), academics and consumers and other retail users of financial services. The Securities and Markets Stakeholder Group should work as an interface with other user groups in the financial services area established by the Commission or by Union legislation.
(49)
Members of the Securities and Markets Stakeholder Group representing non-profit organisations or academics should receive adequate compensation in order to allow persons that are neither well-funded nor industry representatives to take part fully in the debate on financial regulation.
(50)
Member States have a core responsibility for ensuring coordinated crisis management and preserving financial stability in crisis situations, in particular with regard to stabilising and resolving individual failing financial market participants. Decisions by the Authority in emergency or settlement situations affecting the stability of a financial market participant should not impinge on the fiscal responsibilities of Member States. A mechanism should be established whereby Member States may invoke this safeguard and ultimately bring the matter before the Council for a decision. However, that safeguard mechanism should not be abused, in particular in relation to a decision taken by the Authority which does not have a significant or material fiscal impact, such as a reduction of income linked to the temporary prohibition of specific activities or products for consumer protection purposes. When taking decisions under the safeguard mechanism, the Council should vote, in accordance with the principle where each member has one vote. It is appropriate to confer on the Council a role in this matter given the particular responsibilities of the Member States in this respect. Given the sensitivity of the issue, strict confidentiality arrangements should be ensured.
(51)
In its decision-making procedures, the Authority should be bound by Union rules and general principles on due process and transparency. The right of the addressees of the Authority’s decisions to be heard should be fully respected. The Authority’s acts should form an integral part of Union law.
(52)
A Board of Supervisors composed of the heads of the relevant competent authorities in each Member State, and chaired by the Chairperson of the Authority, should be the principal decision-making organ of the Authority. Representatives of the Commission, the ESRB, the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Banking Authority) should participate as observers. Members of the Board of Supervisors should act independently and only in the Union’s interest.
(53)
As a general rule, the Board of Supervisors should take its decisions by simple majority in accordance with the principle where each member has one vote. However, for acts of a general nature, including those relating to regulatory and implementing technical standards, guidelines and recommendations, for budgetary matters as well as in respect of requests by a Member State to reconsider a decision by the Authority to temporarily prohibit or restrict certain financial activities, it is appropriate to apply the rules of qualified majority voting as laid down in Article 16(4) of the Treaty on European Union and in the Protocol (No 36) on transitional provisions annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union. Cases concerning the settlement of disagreements between national supervisory authorities should be examined by a restricted, objective panel, composed of members who neither are representatives of the competent authorities which are party to the disagreement nor have any interest in the conflict or direct links to the competent authorities concerned. The composition of the panel should be appropriately balanced. The decision taken by the panel should be approved by the Board of Supervisors by simple majority in accordance with the principle where each member has one vote. However, with regard to decisions taken by the consolidating supervisor, the decision proposed by the panel could be rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
(54)
A Management Board, composed of the Chairperson of the Authority, of representatives of national supervisory authorities and of the Commission, should ensure that the Authority carries out its mission and performs the tasks assigned to it. The Management Board should be entrusted with the necessary powers, inter alia, to propose the annual and multi-annual work programme, to exercise certain budgetary powers, to adopt the Authority’s staff policy plan, to adopt special provisions on the right to access to documents and to propose the annual report.
(55)
The Authority should be represented by a full time Chairperson, appointed by the Board of Supervisors on the basis of merit, skills, knowledge of financial institutions and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure organised and managed by the Board of Supervisors assisted by the Commission. For the designation of the first Chairperson of the Authority, the Commission should, inter alia, draw up a shortlist of candidates on the basis of merit, skills, knowledge of financial institutions and markets, and experience relevant to financial supervision and regulation. For the subsequent designations, the opportunity of having a shortlist drawn up by the Commission should be reviewed in a report to be established pursuant to this Regulation. Before the selected person takes up his duties, and up to 1 month after his selection by the Board of Supervisors, the European Parliament should be entitled, after having heard the person selected, to object to his designation.
(56)
The management of the Authority should be entrusted to an Executive Director, who should have the right to participate in meetings of the Board of Supervisors and the Management Board without the right to vote.
(57)
In order to ensure cross-sectoral consistency in the activities of the ESAs, they should coordinate closely through a Joint Committee and reach common positions where appropriate. The Joint Committee should coordinate the functions of the ESAs in relation to financial conglomerates and other cross sectoral matters. Where relevant, acts also falling within the area of competence of the European Supervisory Authority (European Insurance and Occupational Pensions Authority) or the European Supervisory Authority (European Banking Authority) should be adopted in parallel by the European Supervisory Authorities concerned. The Joint Committee should be chaired for a 12-month term on a rotating basis by the Chairpersons of the ESAs. The Chairperson of the Joint Committee should be a Vice-Chair of the ESRB. The Joint Committee should have dedicated staff provided by the ESAs to allow for informal information sharing and the development of a common supervisory culture approach across the ESAs.
(58)
It is necessary to ensure that the parties affected by decisions adopted by the Authority may have recourse to the necessary remedies. To protect effectively the rights of parties, and for reasons of procedural economy, where the Authority has decision-making powers, parties should be granted a right of appeal to a Board of Appeal. For reasons of efficiency and consistency, the Board of Appeal should be a joint body of the ESAs, independent from their administrative and regulatory structures. The decisions of the Board of Appeal should be subject to appeal before the Court of Justice of the European Union.
(59)
In order to guarantee its full autonomy and independence, the Authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the General Budget of the European Union. Union financing of the Authority is subject to an agreement by the budgetary authority in accordance with Point 47 of the Interinstitutional Agreement between the European Parliament, the Council and the Commission of 17 May 2006 on budgetary discipline and sound financial management (36). The Union budgetary procedure should be applicable. The auditing of accounts should be undertaken by the Court of Auditors. The overall budget is subject to the discharge procedure.
(60)
Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (37) should apply to the Authority. The Authority should also accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (38).
(61)
In order to ensure open and transparent employment conditions and equal treatment of staff, Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities (39) should apply to the staff of the Authority.
(62)
It is essential that business secrets and other confidential information be protected. The confidentiality of information made available to the Authority and exchanged in the network should be subject to stringent and effective confidentiality rules.
(63)
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (40) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (41) are fully applicable to the processing of personal data for the purposes of this Regulation.
(64)
In order to ensure the transparent operation of the Authority, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (42) should apply to the Authority.
(65)
Third countries should be allowed to participate in the work of the Authority in accordance with appropriate agreements to be concluded by the Union.
(66)
Since the objectives of this Regulation, namely improving the functioning of the internal market by means of ensuring a high, effective and consistent level of prudential regulation and supervision, protecting investors, protecting the integrity, efficiency and orderly functioning of financial markets, maintaining the stability of the financial system, and strengthening international supervisory coordination, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(67)
The Authority should assume all current tasks and powers of the Committee of European Securities Regulators. Commission Decision 2009/77/EC should therefore be repealed on the date of the establishment of the Authority and Decision No 716/2009/EC of the European Parliament and of the Council of 16 September 2009 establishing a Community programme to support specific activities in the field of financial services, financial reporting and auditing (43), should be amended accordingly. Given the existing structures and operations of the Committee of European Securities Regulators, it is important to ensure very close cooperation between the Committee of European Securities Regulators and the Commission when establishing appropriate transitional arrangements, to ensure that the period during which the Commission is responsible for the administrative establishment and initial administrative operation of the Authority be as limited as possible.
(68)
It is appropriate to set a time limit for the application of this Regulation in order to ensure that the Authority is adequately prepared to begin operations and a smooth transition from the Committee of European Securities Regulators. The Authority should be appropriately financed. At least initially, it should be financed 40 % from Union funds and 60 % through contributions from Member States, made in accordance with the weighting of votes set out in Article 3(3) of the Protocol (No 36) on transitional provisions.
(69)
In order to enable the Authority to be established on 1 January 2011, this Regulation should enter into force on the day following its publication in the Official Journal of the European Union,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
ESTABLISHMENT AND LEGAL STATUS
Article 1
Establishment and scope of action
1. This Regulation establishes a European Supervisory Authority (European Securities and Markets Authority) (hereinafter the Authority’).
2. The Authority shall act within the powers conferred by this Regulation and within the scope of Directive 97/9/EC, Directive 98/26/EC, Directive 2001/34/EC, Directive 2002/47/EC, Directive 2003/6/EC, Directive 2003/71/EC, Directive 2004/39/EC, Directive 2004/109/EC, Directive 2009/65/EC and to Directive 2006/49/EC, without prejudice to the competence of the European Supervisory Authority (European Banking Authority) in terms of prudential supervision, any future legislation in the area of Alternative Investment Fund Managers (AIFM), and Regulation (EC) No 1060/2009, and, to the extent that these acts apply to firms providing investment services or to collective investment undertakings marketing their units or shares and the competent authorities that supervise them, within the relevant parts of, Directive 2002/87/EC, Directive 2005/60/EC, Directive 2002/65/EC, including all directives, regulations, and decisions based on those acts, and of any further legally binding Union act which confers tasks on the Authority.
3. The Authority shall also act in the field of activities of market participants in relation to issues not directly covered in the acts referred to in paragraph 2, including matters of corporate governance, auditing and financial reporting, provided that such actions by the Authority are necessary to ensure the effective and consistent application of those acts. The Authority shall also take appropriate action in the context of take-over bids, clearing and settlement and derivative issues.
4. The provisions of this Regulation are without prejudice to the powers of the Commission, in particular under Article 258 TFEU, to ensure compliance with Union law.
5. The objective of the Authority shall be to protect the public interest by contributing to the short, medium and long-term stability and effectiveness of the financial system, for the Union economy, its citizens and businesses. The Authority shall contribute to:
(a)
improving the functioning of the internal market, including in particular a sound, effective and consistent level of regulation and supervision,
(b)
ensuring the integrity, transparency, efficiency and orderly functioning of financial markets,
(c)
strengthening international supervisory coordination,
(d)
preventing regulatory arbitrage and promoting equal conditions of competition,
(e)
ensuring the taking of investment and other risks are appropriately regulated and supervised, and
(f)
enhancing customer protection.
For those purposes, the Authority shall contribute to ensuring the consistent, efficient and effective application of the acts referred to in paragraph 2, foster supervisory convergence, provide opinions to the European Parliament, the Council, and the Commission and undertake economic analyses of the markets to promote the achievement of the Authority’s objective.
In the exercise of the tasks conferred upon it by this Regulation, the Authority shall pay particular attention to any systemic risk posed by financial market participants, the failure of which may impair the operation of the financial system or the real economy.
When carrying out its tasks, the Authority shall act independently and objectively and in the interest of the Union alone.
Article 2
European System of Financial Supervision
1. The Authority shall form part of a European System of Financial Supervision (ESFS). The main objective of the ESFS shall be to ensure that the rules applicable to the financial sector are adequately implemented to preserve financial stability and to ensure confidence in the financial system as a whole and sufficient protection for the customers of financial services.
2. The ESFS shall comprise the following:
(a)
the European Systemic Risk Board (ESRB), for the purposes of the tasks as specified in Regulation (EU) No 1092/2010 (44) and this Regulation;
(b)
the Authority;
(c)
the European Supervisory Authority (European Banking Authority) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (45);
(d)
the European Supervisory Authority (European Insurance and Occupational Pensions Authority) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (46);
(e)
the Joint Committee of the European Supervisory Authorities (‘Joint Committee’) for the purposes of carrying out the tasks as specified in Articles 54 to 57 of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1094/2010;
(f)
the competent or supervisory authorities in the Member States as specified in the Union acts referred to in Article 1(2) of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1094/2010.
3. The Authority shall cooperate regularly and closely with the ESRB as well as with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority) through the Joint Committee, ensuring cross-sectoral consistency of work and reaching joint positions in the area of supervision of financial conglomerates and on other cross-sectoral issues.
4. In accordance with the principle of sincere cooperation under Article 4(3) of the Treaty on European Union, the parties to the ESFS shall cooperate with trust and full mutual respect, in particular in ensuring the flow of appropriate and reliable information between them.
5. Those supervisory authorities that are party to the ESFS shall be obliged to supervise financial market participants operating in the Union in accordance with the acts referred to in Article 1(2).
Article 3
Accountability of the Authorities
The Authorities referred to in Article 2(2)(a) to (d) shall be accountable to the European Parliament and the Council.
Article 4
Definitions
For the purposes of this Regulation the following definitions apply:
(1)
‘financial market participant’ means any person in relation to whom a requirement in the legislation referred to in Article 1(2) or a national law implementing such legislation applies;
(2)
‘key financial market participant’ means a financial market participant whose regular activity or financial viability has or is likely to have a significant effect on the stability, integrity or efficiency of the financial markets in the Union;
(3)
‘competent authorities’ means:
(i)
competent authorities and/or supervisory authorities as defined in the legislation referred to in Article 1(2);
(ii)
with regard to Directives 2002/65/EC and 2005/60/EC, the authorities competent for ensuring compliance with the requirements of those Directives by firms providing investment services and by collective investment undertakings marketing their units or shares;
(iii)
with regard to investor compensation schemes, bodies which administer national compensation schemes pursuant to Directive 97/9/EC, or in the case where the operation of the investor compensation scheme is administered by a private company, the public authority supervising those schemes pursuant to that Directive.
Article 5
Legal status
1. The Authority shall be a Union body with legal personality.
2. In each Member State, the Authority shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings.
3. The Authority shall be represented by its Chairperson.
Article 6
Composition
The Authority shall comprise:
(1)
a Board of Supervisors, which shall exercise the tasks set out in Article 43;
(2)
a Management Board, which shall exercise the tasks set out in Article 47;
(3)
a Chairperson, who shall exercise the tasks set out in Article 48;
(4)
an Executive Director, who shall exercise the tasks set out in Article 53;
(5)
a Board of Appeal, which shall exercise the tasks set out in Article 60.
Article 7
Seat
The Authority shall have its seat in Paris.
CHAPTER II
TASKS AND POWERS OF THE AUTHORITY
Article 8
Tasks and powers of the Authority
1. The Authority shall have the following tasks:
(a)
to contribute to the establishment of high- quality common regulatory and supervisory standards and practices, in particular by providing opinions to the Union institutions and by developing guidelines, recommendations, and draft regulatory and implementing technical standards which shall be based on the legislative acts referred to in Article 1(2);
(b)
to contribute to the consistent application of legally binding Union acts, in particular by contributing to a common supervisory culture, ensuring consistent, efficient and effective application of the acts referred to in Article 1(2), preventing regulatory arbitrage, mediating and settling disagreements between competent authorities, ensuring effective and consistent supervision of financial market participants, ensuring a coherent functioning of colleges of supervisors and taking actions, inter alia, in emergency situations;
(c)
to stimulate and facilitate the delegation of tasks and responsibilities among competent authorities;
(d)
to cooperate closely with the ESRB, in particular by providing the ESRB with the necessary information for the achievement of its tasks and by ensuring a proper follow up to the warnings and recommendations of the ESRB;
(e)
to organise and conduct peer review analyses of competent authorities, including issuing guidelines and recommendations and identifying best practices, in order to strengthen consistency in supervisory outcomes;
(f)
to monitor and assess market developments in the area of its competence;
(g)
to undertake economic analyses of markets to inform the discharge of the Authority's functions;
(h)
to foster investor protection;
(i)
to contribute to the consistent and coherent functioning of colleges of supervisors, the monitoring, assessment and measurement of systemic risk, the development and coordination of recovery and resolution plans, providing a high level of protection to investors throughout the Union and developing methods for the resolution of failing financial market participants and an assessment of the need for appropriate financing instruments, in accordance with Articles 21 to 26;
(j)
to fulfil any other specific tasks set out in this Regulation or in other legislative acts;
(k)
to publish on its website, and to update regularly, information relating to its field of activities, in particular, within the area of its competence, on registered financial market participants, in order to ensure information is easily accessible by the public;
(l)
to take over, as appropriate, all existing and ongoing tasks from the Committee of European Securities Regulators (CESR).
2. To achieve the tasks set out in paragraph 1, the Authority shall have the powers set out in this Regulation, in particular to:
(a)
develop draft regulatory technical standards in the specific cases referred to in Article 10;
(b)
develop draft implementing technical standards in the specific cases referred to in Article 15;
(c)
issue guidelines and recommendations, as laid down in Article 16;
(d)
issue recommendations in specific cases, as referred to in Article 17(3);
(e)
take individual decisions addressed to competent authorities in the specific cases referred to in Articles 18(3) and 19(3);
(f)
in cases concerning directly applicable Union law, take individual decisions addressed to financial market participants, in the specific cases referred to in Article 17(6), in Article 18(4) and in Article 19(4);
(g)
issue opinions to the European Parliament, the Council, or the Commission as provided for in Article 34;
(h)
collect the necessary information concerning financial market participants as provided for in Article 35;
(i)
develop common methodologies for assessing the effect of product characteristics and distribution processes on the financial position of financial market participants and on consumer protection;
(j)
provide a centrally accessible database of registered financial market participants in the area of its competence where specified in the acts referred to in Article 1(2).
Article 9
Tasks related to consumer protection and financial activities
1. The Authority shall take a leading role in promoting transparency, simplicity and fairness in the market for consumer financial products or services across the internal market, including by:
(a)
collecting, analysing and reporting on consumer trends;
(b)
reviewing and coordinating financial literacy and education initiatives by the competent authorities;
(c)
developing training standards for the industry; and
(d)
contributing to the development of common disclosure rules.
2. The Authority shall monitor new and existing financial activities and may adopt guidelines and recommendations with a view to promoting the safety and soundness of markets and convergence of regulatory practice.
3. The Authority may also issue warnings in the event that a financial activity poses a serious threat to the objectives laid down in Article 1(5).
4. The Authority shall establish, as an integral part of the Authority, a Committee on financial innovation, which brings together all relevant competent national supervisory authorities with a view to achieving a coordinated approach to the regulatory and supervisory treatment of new or innovative financial activities and providing advice for the Authority to present to the European Parliament, the Council and the Commission.
5. The Authority may temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in Article 1(2) or if so required in the case of an emergency situation in accordance with and under the conditions laid down in Article 18.
The Authority shall review the decision referred to in the first subparagraph at appropriate intervals and at least every 3 months. If the decision is not renewed after a three-month period, it shall automatically expire.
A Member State may request the Authority to reconsider its decision. In that case, the Authority shall decide in accordance with the procedure set out in the second subparagraph of Article 44(1), whether it maintains its decision.
The Authority may also assess the need to prohibit or restrict certain types of financial activity and, where there is such a need, inform the Commission in order to facilitate the adoption of any such prohibition or restriction.
Article 10
Regulatory technical standards
1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts under Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement.
Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based.
Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the Securities and Markets Stakeholder Group referred to in Article 37.
Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council.
Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union’s interests so require.
Where the Commission intends not to endorse a draft regulatory technical standard or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant, or reject it.
The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
2. Where the Authority has not submitted a draft regulatory technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.
3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority.
The Commission shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the Securities and Markets Stakeholder Group referred to in Article 37.
The Commission shall immediately forward the draft regulatory technical standard to the European Parliament and the Council.
The Commission shall send its draft regulatory technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft regulatory technical standard, the Commission may adopt the regulatory technical standard.
If the Authority has submitted an amended draft regulatory technical standard within the six-week period, the Commission may amend the draft regulatory technical standard on the basis of the Authority’s proposed amendments or adopt the regulatory technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
4. The regulatory technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
Article 11
Exercise of the delegation
1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of 4 years from 16 December 2010. The Commission shall draw up a report in respect of the delegated power not later than 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14.
2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council.
3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14.
Article 12
Revocation of the delegation
1. The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council.
2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.
3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union.
Article 13
Objections to regulatory technical standards
1. The European Parliament or the Council may object to a regulatory technical standard within a period of 3 months from the date of notification of the regulatory technical standard adopted by the Commission. At the initiative of the European Parliament or the Council that period shall be extended by 3 months.
Where the Commission adopts a regulatory technical standard which is the same as the draft regulatory technical standard submitted by the Authority, the period during which the European Parliament and the Council may object shall be 1 month from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 1 month.
2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the regulatory technical standard, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
The regulatory technical standard may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
3. If either the European Parliament or the Council objects to a regulatory technical standard within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the regulatory technical standard.
Article 14
Non-endorsement or amendment of draft regulatory technical standards
1. In the event that the Commission does not endorse a draft regulatory technical standard or amends it as provided for in Article 10, the Commission shall inform the Authority, the European Parliament and the Council, stating its reasons.
2. Where appropriate, the European Parliament or the Council may invite the responsible Commissioner, together with the Chairperson of the Authority, within 1 month of the notice referred to in paragraph 1, for an ad hoc meeting of the competent committee of the European Parliament or the Council to present and explain their differences.
Article 15
Implementing technical standards
1. The Authority may develop implementing technical standards, by means of implementing acts under Article 291 TFEU, in the areas specifically set out in the legislative acts referred to in Article 1(2). Implementing technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be to determine the conditions of application of those acts. The Authority shall submit its draft implementing technical standards to the Commission for endorsement.
Before submitting draft implementing technical standards to the Commission, the Authority shall conduct open public consultations and shall analyse the potential, related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the Securities and Markets Stakeholder Group referred to in Article 37.
Where the Authority submits a draft implementing technical standard, the Commission shall immediately forward it to the European Parliament and the Council.
Within 3 months of receipt of a draft implementing technical standard, the Commission shall decide whether to endorse it. The Commission may extend that period by 1 month. The Commission may endorse the draft implementing technical standard in part only, or with amendments, where the Union’s interests so require.
Where the Commission intends not to endorse a draft implementing technical standard or intends to endorse it in part or with amendments, it shall send it back to the Authority explaining why it does not intend to endorse it, or as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of the six-week period referred to in the fifth subparagraph, the Authority has not submitted an amended draft implementing technical standard, or has submitted a draft implementing technical standard that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing technical standard with the amendments it considers relevant or reject it.
The Commission shall not change the content of a draft implementing technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article.
2. In cases where the Authority has not submitted a draft implementing technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.
3. Only where the Authority does not submit a draft implementing technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt an implementing technical standard by means of an implementing act without a draft from the Authority.
The Commission shall conduct open public consultations on draft implementing technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the Securities and Markets Stakeholder Group referred to in Article 37.
The Commission shall immediately forward the draft implementing technical standard to the European Parliament and the Council.
The Commission shall send the draft implementing technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council.
If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft implementing technical standard, the Commission may adopt the implementing technical standard.
If the Authority has submitted an amended draft implementing technical standard within that six-week period, the Commission may amend the draft implementing technical standard on the basis of the Authority’s proposed amendments or adopt the implementing technical standard with the amendments it considers relevant.
The Commission shall not change the content of the draft implementing technical standards prepared by the Authority without prior coordination with the Authority, as set out in this Article.
4. The implementing technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
Article 16
Guidelines and recommendations
1. The Authority shall, with a view to establishing consistent, efficient and effective supervisory practices within the ESFS, and to ensuring the common, uniform and consistent application of Union law, issue guidelines and recommendations addressed to competent authorities or financial market participants.
2. The Authority shall, where appropriate, conduct open public consultations regarding the guidelines and recommendations and analyse the related potential costs and benefits. Such consultations and analyses shall be proportionate in relation to the scope, nature and impact of the guidelines or recommendations. The Authority shall, where appropriate, also request opinions or advice from the Securities and Markets Stakeholder Group referred to in Article 37.
3. The competent authorities and financial market participants shall make every effort to comply with those guidelines and recommendations.
Within 2 months of the issuance of a guideline or recommendation, each competent authority shall confirm whether it complies or intends to comply with that guideline or recommendation. In the event that a competent authority does not comply or does not intend to comply, it shall inform the Authority, stating its reasons.
The Authority shall publish the fact that a competent authority does not comply or does not intend to comply with that guideline or recommendation. The Authority may also decide, on a case by case basis, to publish the reasons provided by the competent authority for not complying with that guideline or recommendation. The competent authority shall receive advanced notice of such publication.
If required by that guideline or recommendation, financial market participants shall report, in a clear and detailed way, whether they comply with that guideline or recommendation.
4. In the report referred to in Article 43(5) the Authority shall inform the European Parliament, the Council and the Commission of the guidelines and recommendations that have been issued, stating which competent authority has not complied with them, and outlining how the Authority intends to ensure that the competent authority concerned follow its recommendations and guidelines in the future.
Article 17
Breach of Union law
1. Where a competent authority has not applied the acts referred to in Article 1(2), or has applied them in a way which appears to be a breach of Union law, including the regulatory technical standards and implementing technical standards established in accordance with Articles 10 to 15, in particular by failing to ensure that a financial market participant satisfies the requirements laid down in those acts, the Authority shall act in accordance with the powers set out in paragraphs 2, 3 and 6 of this Article.
2. Upon a request from one or more competent authorities, the European Parliament, the Council, the Commission or the Securities and Markets Stakeholder Group, or on its own initiative, and after having informed the competent authority concerned, the Authority may investigate the alleged breach or non-application of Union law.
Without prejudice to the powers laid down in Article 35, the competent authority shall, without delay, provide the Authority with all information which the Authority considers necessary for its investigation.
3. The Authority may, not later than 2 months from initiating its investigation, address a recommendation to the competent authority concerned setting out the action necessary to comply with Union law.
The competent authority shall, within ten working days of receipt of the recommendation, inform the Authority of the steps it has taken or intends to take to ensure compliance with Union law.
4. Where the competent authority has not complied with Union law within 1 month from receipt of the Authority’s recommendation, the Commission may, after having been informed by the Authority or on its own initiative, issue a formal opinion requiring the competent authority to take the action necessary to comply with Union law. The Commission’s formal opinion shall take into account the Authority’s recommendation.
The Commission shall issue such a formal opinion no later than 3 months after the adoption of the recommendation. The Commission may extend this period by 1 month.
The Authority and the competent authorities shall provide the Commission with all necessary information.
5. The competent authority shall, within ten working days of receipt of the formal opinion referred to in paragraph 4, inform the Commission and the Authority of the steps it has taken or intends to take to comply with that formal opinion.
6. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the formal opinion referred to in paragraph 4 within the period of time specified therein, and where it is necessary to remedy in a timely manner such non compliance in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system, the Authority may, where the relevant requirements of the acts referred to in Article 1(2) are directly applicable to financial market participants, adopt an individual decision addressed to a financial market participant requiring the necessary action to comply with its obligations under Union law including the cessation of any practice.
The decision of the Authority shall be in conformity with the formal opinion issued by the Commission pursuant to paragraph 4.
7. Decisions adopted under paragraph 6 shall prevail over any previous decision adopted by the competent authorities on the same matter.
When taking action in relation to issues which are subject to a formal opinion pursuant to paragraph 4 or a decision pursuant to paragraph 6, competent authorities shall comply with the formal opinion or the decision, as the case may be.
8. In the report referred to in Article 43(5), the Authority shall set out which competent authorities and financial market participants have not complied with the formal opinions or decisions referred to in paragraphs 4 and 6 of this Article.
Article 18
Action in emergency situations
1. In the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority shall actively facilitate and, where deemed necessary, coordinate any actions undertaken by the relevant national competent supervisory authorities.
In order to be able to perform that facilitating and coordinating role, the Authority shall be fully informed of any relevant developments, and shall be invited to participate as an observer in any relevant gathering by the relevant national competent supervisory authorities.
2. The Council, in consultation with the Commission and the ESRB and, where appropriate, the ESAs, may adopt a decision addressed to the Authority, determining the existence of an emergency situation for the purposes of this Regulation, following a request by the Authority, the Commission or the ESRB. The Council shall review that decision at appropriate intervals and at least once a month. If the decision is not renewed at the end of a one-month period, it shall automatically expire. The Council may declare the discontinuation of the emergency situation at any time.
Where the ESRB or the Authority considers that an emergency situation may arise, it shall issue a confidential recommendation addressed to the Council and provide it with an assessment of the situation. The Council shall then assess the need for a meeting. In that process, due care of confidentiality shall be guaranteed.
If the Council determines the existence of an emergency situation, it shall duly inform the European Parliament and the Commission without delay.
3. Where the Council has adopted a decision pursuant to paragraph 2, and in exceptional circumstances where coordinated action by national authorities is necessary to respond to adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in Article 1(2) to address any such developments by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation.
4. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the decision of the Authority referred to in paragraph 3 within the period laid down in that decision, the Authority may, where the relevant requirements laid down in the legislative acts referred to in Article 1(2) including in regulatory technical standards and implementing technical standards adopted in accordance with those acts are directly applicable to financial market participants, adopt an individual decision addressed to a financial market participant requiring the necessary action to comply with its obligations under that legislation, including the cessation of any practice. This shall apply only in situations in which a competent authority does not apply the legislative acts referred to in Article 1(2), including regulatory technical standards and implementing technical standards adopted in accordance with those acts, or applies them in a way which appears to be a manifest breach of those acts, and where urgent remedying is necessary to restore the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union.
5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter.
Any action by the competent authorities in relation to issues which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions.
Article 19
Settlement of disagreements between competent authorities in cross-border situations
1. Without prejudice to the powers laid down in Article 17, where a competent authority disagrees about the procedure or content of an action or inaction of a competent authority of another Member State in cases specified in the acts referred to in Article 1(2), the Authority, at the request of one or more of the competent authorities concerned may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4 of this Article.
In cases specified in the legislation referred to in Article 1(2), and where on the basis of objective criteria, disagreement between competent authorities from different Member States can be determined, the Authority may, on its own initiative, assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4.
2. The Authority shall set a time limit for conciliation between the competent authorities taking into account any relevant time periods specified in the acts referred to in Article 1(2) and the complexity and urgency of the matter. At that stage the Authority shall act as a mediator.
3. If the competent authorities concerned fail to reach an agreement within the conciliation phase referred to in paragraph 2, the Authority may, in accordance with the procedure set out in the third and fourth subparagraph of Article 44(1) take a decision requiring them to take specific action or to refrain from action in order to settle the matter, with binding effects for the competent authorities concerned, in order to ensure compliance with Union law.
4. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the decision of the Authority, and thereby fails to ensure that a financial market participant complies with requirements directly applicable to it by virtue of the acts referred to in Article 1(2), the Authority may adopt an individual decision addressed to a financial market participant requiring the necessary action to comply with its obligations under Union law, including the cessation of any practice.
5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter. Any action by the competent authorities in relation to facts which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions.
6. In the report referred to in Article 50(2), the Chairperson of the Authority shall set out the nature and type of disagreements between competent authorities, the agreements reached and the decisions taken to settle such disagreements.
Article 20
Settlement of disagreements between competent authorities across sectors
The Joint Committee shall, in accordance with the procedure laid down in Article 19 and Article 56, settle cross-sectoral disagreements that may arise between competent authorities as defined in Article 4(2) of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1094/2010 respectively.
Article 21
Colleges of supervisors
1. The Authority shall contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors established in the legislative acts referred to in Article 1(2) and foster the coherence of the application of Union law among the colleges of supervisors. With the objective of converging supervisory best practices, staff from the Authority shall be able to participate in the activities of the colleges of supervisors, including on-site examinations, carried out jointly by two or more competent authorities.
2. The Authority shall lead in ensuring a consistent and coherent functioning of colleges of supervisors for cross-border institutions across the Union, taking account of the systemic risk posed by financial market participants referred to in Article 23.
For the purpose of this paragraph and of paragraph 1 of this Article, the Authority shall be considered a ‘competent authority’ within the meaning of the relevant legislation.
The Authority may:
(a)
collect and share all relevant information in cooperation with the competent authorities in order to facilitate the work of the college and establish and manage a central system to make such information accessible to the competent authorities in the college;
(b)
initiate and coordinate Union-wide stress tests in accordance with Article 32 to assess the resilience of financial market participants, in particular the systemic risk posed by key financial market participants as referred to in Article 23, to adverse market developments, and evaluate the potential for systemic risk posed by key financial market participants to increase in situations of stress, ensuring that a consistent methodology is applied at the national level to such tests and, where appropriate, address a recommendation to the competent authority to correct issues identified in the stress test;
(c)
promote effective and efficient supervisory activities, including evaluating the risks to which financial market participants are or might be exposed in stress situations;
(d)
oversee, in accordance with the tasks and powers specified in this Regulation, the tasks carried out by the competent authorities, and
(e)
request further deliberations of a college in any cases where it considers that the decision would result in an incorrect application of Union law or would not contribute to the objective of convergence of supervisory practices. It may also require to schedule a meeting of the college or add a point to the agenda of a meeting.
3. The Authority may develop draft regulatory and implementing technical standards to ensure uniform conditions of application with respect to the provisions regarding the operational functioning of colleges of supervisors and issue guidelines and recommendations adopted under Article 16 to promote convergence in supervisory functioning and best practices adopted by the colleges of supervisors.
4. The Authority shall have a legally binding mediation role to resolve disputes between competent authorities in accordance with the procedure set out in Article 19. The Authority may take supervisory decisions directly applicable to the financial market participant concerned in accordance with Article 19.
Article 22
General provisions
1. The Authority shall duly consider systemic risk as defined by Regulation (EU) No 1092/2010. It shall address any risk of disruption in financial services that:
(a)
is caused by an impairment of all or parts of the financial system; and
(b)
has the potential to have serious negative consequences for internal market and the real economy.
The Authority shall consider, where appropriate, the monitoring and assessment of systemic risk as developed by the ESRB and the Authority and respond to warnings and recommendations by the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010.
2. The Authority shall, in collaboration with the ESRB, and in accordance with Article 23 develop a common approach for the identification and measurement of systemic risk posed by key financial market participants, including quantitative and qualitative indicators as appropriate.
Those indicators shall be a critical element in the determination of appropriate supervisory actions. The Authority shall monitor the degree of convergence in the determinations made, with a view to promoting a common approach.
3. Without prejudice to the acts referred to in Article 1(2), the Authority shall draw up, as necessary, additional guidelines and recommendations for key financial market participants, to take account of the systemic risk posed by them.
The Authority shall ensure that the systemic risk posed by key financial market participants is taken into account when developing draft regulatory and implementing technical standards in the areas laid down in the legislative acts referred to in Article 1(2).
4. Upon a request from one or more competent authorities, the European Parliament, the Council or the Commission, or on its own initiative, the Authority may conduct an inquiry into a particular type of financial activity or type of product or type of conduct in order to assess potential threats to the integrity of financial markets or the stability of the financial system and make appropriate recommendations for action to the competent authorities concerned.
For those purposes, the Authority may use the powers conferred on it under this Regulation, including Article 35.
5. The Joint Committee shall ensure overall and cross-sectoral coordination of the activities carried out in accordance with this Article.
Article 23
Identification and measurement of systemic risk
1. The Authority shall, in consultation with the ESRB, develop criteria for the identification and measurement of systemic risk and an adequate stress testing regime which includes an evaluation of the potential for systemic risk posed by financial market participants to increase in situations of stress. The financial market participants that may pose a systemic risk shall be subject to strengthened supervision, and where necessary, the recovery and resolution procedures referred to in Article 25.
2. The Authority shall take fully into account the relevant international approaches when developing the criteria for the identification and measurement of systemic risk posed by financial market participants, including those established by the Financial Stability Board, the International Monetary Fund and the Bank for International Settlements.
Article 24
Permanent capacity to respond to systemic risks
1. The Authority shall ensure it has specialised and ongoing capacity to respond effectively to the materialisation of systemic risks as referred to in Articles 22 and 23, in particular with respect to institutions that pose a systemic risk.
2. The Authority shall fulfil the tasks conferred upon it in this Regulation and in the legislation referred to in Article 1(2), and shall contribute to ensuring a coherent and coordinated crisis management and resolution regime in the Union.
Article 25
Recovery and resolution procedures
1. The Authority shall contribute to and participate actively in the development and coordination of effective and consistent recovery and resolution plans, procedures in emergency situations and preventive measures to minimise the systemic impact of any failure.
2. The Authority may develop regulatory and implementing technical standards as specified in the legislative acts referred to in Article 1(2) in accordance with the procedure laid down in Articles 10 to 15.
Article 26
European system of national Investor Compensation Schemes
1. The Authority shall contribute to strengthening the European system of national Investor Compensation Schemes (ICS) by acting under the powers conferred to it in this Regulation to ensure the correct application of Directive 97/9/EC with the aim of ensuring that national Investor Compensation Schemes are adequately funded by contributions from the concerned financial market participants, including where appropriate financial market participants headquartered in third-countries, and provide a high level of protection to all investors in a harmonised framework throughout the Union.
2. Article 16 concerning the Authority’s powers to adopt guidelines and recommendations shall apply to Investor Compensation Schemes.
3. The Authority may develop regulatory and implementing technical standards as specified in the legislative acts referred to in Article 1(2) in accordance with the procedure laid down in Articles 10 to 15.
4. The review of this Regulation provided for in Article 81 shall in particular examine the convergence of the European system of national Investor Compensation Schemes.
Article 27
European system of resolution and funding arrangements
1. In the areas of its competence, the Authority shall contribute to developing methods for the resolution of failing key financial market participants in ways which avoid contagion, allow them to be wound down in an orderly and timely manner, and, where applicable, including coherent and credible funding mechanisms as appropriate.
2. The Authority shall contribute to the work on the level playing field issues and cumulative impacts of any systems of levies and contributions on financial institutions that may be introduced to ensure fair burden sharing and incentives to contain systemic risk as a part of a coherent and credible resolution framework.
The review of this Regulation provided for in Article 81 shall in particular examine the possible enhancement of the role of the Authority in a framework of crisis prevention, management and resolution.
Article 28
Delegation of tasks and responsibilities
1. Competent authorities may, with the consent of the delegate, delegate tasks and responsibilities to the Authority or other competent authorities subject to the conditions set out in this Article. Member States may set out specific arrangements regarding the delegation of responsibilities that have to be complied with before their competent authorities enter into such delegation agreements, and may limit the scope of delegation to what is necessary for the effective supervision of cross-border financial market participants or groups.
2. The Authority shall stimulate and facilitate the delegation of tasks and responsibilities between competent authorities by identifying those tasks and responsibilities that can be delegated or jointly exercised and by promoting best practices.
3. The delegation of responsibilities shall result in the reallocation of competences laid down in the acts referred to in Article 1(2). The law of the delegate authority shall govern the procedure, enforcement and administrative and judicial review relating to the delegated responsibilities.
4. The competent authorities shall inform the Authority of delegation agreements into which they intend to enter. They shall put the agreements into effect at the earliest 1 month after informing the Authority.
The Authority may give an opinion on the intended agreement within 1 month of being informed.
The Authority shall publish, by appropriate means, any delegation agreement as concluded by the competent authorities, in order to ensure that all parties concerned are informed appropriately.
Article 29
Common supervisory culture
1. The Authority shall play an active role in building a common Union supervisory culture and consistent supervisory practices, as well as in ensuring uniform procedures and consistent approaches throughout the Union. The Authority shall carry out, at a minimum, the following activities:
(a)
providing opinions to competent authorities;
(b)
promoting an effective bilateral and multilateral exchange of information between competent authorities, with full respect for the applicable confidentiality and data protection provisions provided for in the relevant Union legislation;
(c)
contributing to developing high-quality and uniform supervisory standards, including reporting standards, and international accounting standards in accordance with Article 1(3);
(d)
reviewing the application of the relevant regulatory and implementing technical standards adopted by the Commission, and of the guidelines and recommendations issued by the Authority and proposing amendments where appropriate; and
(e)
establishing sectoral and cross-sectoral training programmes, facilitating personnel exchanges and encouraging competent authorities to intensify the use of secondment schemes and other tools.
2. The Authority may, as appropriate, develop new practical instruments and convergence tools to promote common supervisory approaches and practices.
Article 30
Peer reviews of competent authorities
1. The Authority shall periodically organise and conduct peer reviews of some or all of the activities of competent authorities, to further strengthen consistency in supervisory outcomes. To that end, the Authority shall develop methods to allow for objective assessment and comparison between the authorities reviewed. When conducting peer reviews, existing information and evaluations already made with regard to the competent authority concerned shall be taken into account.
2. The peer review shall include an assessment of, but shall not be limited to:
(a)
the adequacy of resources and governance arrangements of the competent authority, with particular regard to the effective application of the regulatory technical standards and implementing technical standards referred to in Articles 10 to 15 and of the acts referred to in Article 1(2) and the capacity to respond to market developments;
(b)
the degree of convergence reached in the application of Union law and in supervisory practice, including regulatory technical standards and implementing technical standards, guidelines and recommendations adopted under Articles 10 to 16, and the extent to which the supervisory practice achieves the objectives set out in Union law;
(c)
best practices developed by some competent authorities which might be of benefit for other competent authorities to adopt;
(d)
the effectiveness and the degree of convergence reached with regard to the enforcement of the provisions adopted in the implementation of Union law, including the administrative measures and sanctions imposed against persons responsible where those provisions have not been complied with.
3. On the basis of a peer review, the Authority may issue guidelines and recommendations pursuant to Article 16. In accordance with Article 16(3), the competent authorities shall endeavour to follow those guidelines and recommendations. The Authority shall take into account the outcome of the peer review when developing draft regulatory technical or implementing technical standards in accordance with Articles 10 to 15.
4. The Authority shall make the best practices that can be identified from those peer reviews publicly available. In addition, all other results of peer reviews may be disclosed publicly, subject to the agreement of the competent authority that is the subject of the peer review.
Article 31
Coordination function
The Authority shall fulfil a general coordination role between competent authorities, in particular in situations where adverse developments could potentially jeopardise the orderly functioning and integrity of financial markets or the stability of the financial system in the Union.
The Authority shall promote a coordinated Union response, inter alia, by:
(a)
facilitating the exchange of information between the competent authorities;
(b)
determining the scope and, where possible and appropriate, verifying the reliability of information that should be made available to all the competent authorities concerned;
(c)
without prejudice to Article 19, carrying out non-binding mediation upon a request from the competent authorities or on its own initiative;
(d)
notifying the ESRB of any potential emergency situations without delay.
(e)
taking all appropriate measures in case of developments which may jeopardise the functioning of the financial markets with a view to facilitating the coordination of actions undertaken by relevant competent authorities;
(f)
centralising information received from competent authorities in accordance with Articles 21 and 35 as the result of the regulatory reporting obligations for financial market participants active in more than one Member State. The Authority shall share that information with the other competent authorities concerned.
Article 32
Assessment of market developments
1. The Authority shall monitor and assess market developments in the area of its competence and, where necessary, inform the European Supervisory Authority (European Banking Authority), and the European Supervisory Authority (European Insurance and Occupational Pensions Authority), the ESRB and the European Parliament, the Council and the Commission about the relevant micro-prudential trends, potential risks and vulnerabilities. The Authority shall include in its assessments an economic analysis of the markets in which financial market participants operate, and an assessment of the impact of potential market developments on such financial market participants.
2. The Authority shall, in cooperation with the ESRB, initiate and coordinate Union-wide assessments of the resilience of financial market participants to adverse market developments. To that end, it shall develop the following, for application by the competent authorities:
(a)
common methodologies for assessing the effect of economic scenarios on the financial position of a financial market participant;
(b)
common approaches to communication on the outcomes of these assessments of the resilience of financial market participants;
(c)
common methodologies for assessing the effect of particular products or distribution processes on the financial position of a financial market participant and on investors and customer information.
3. Without prejudice to the tasks of the ESRB set out in Regulation (EU) No 1092/2010, the Authority shall, at least once a year, and more frequently as necessary, provide assessments to the European Parliament, the Council, the Commission and the ESRB of trends, potential risks and vulnerabilities in its area of competence.
The Authority shall include a classification of the main risks and vulnerabilities in these assessments and, where necessary, recommend preventative or remedial actions.
4. The Authority shall ensure an adequate coverage of cross-sectoral developments, risks and vulnerabilities by closely cooperating with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority) through the Joint Committee.
Article 33
International relations
1. Without prejudice to the respective competences of the Member States and the Union institutions, the Authority may develop contacts and enter into administrative arrangements with supervisory authorities, international organisations and the administrations of third countries. Those arrangements shall not create legal obligations in respect of the Union and its Member States nor shall they prevent Member States and their competent authorities from concluding bilateral or multilateral arrangements with those third countries.
2. The Authority shall assist in preparing equivalence decisions pertaining to supervisory regimes in third countries in accordance with the acts referred to in Article 1(2).
3. In the report referred to in Article 43(5), the Authority shall set out the administrative arrangements agreed upon with international organisations or administrations in third countries and the assistance provided in preparing equivalence decisions.
Article 34
Other tasks
1. The Authority may, upon a request from the European Parliament, the Council or the Commission, or on its own initiative, provide opinions to the European Parliament, the Council and the Commission on all issues related to its area of competence.
2. With regard to prudential assessments of mergers and acquisitions falling within the scope of Directive 2004/39/EC, as amended by Directive 2007/44/EC, and which according to that Directive require consultation between competent authorities from two or more Member States, the Authority may, on application of one of the competent authorities concerned, issue and publish an opinion on a prudential assessment, except in relation to the criteria in Article 10b(e) of Directive 2004/39/EC. The opinion shall be issued promptly and in any event before the end of the assessment period in accordance with Directive 2004/39/EC, as amended by Directive 2007/44/EC. Article 35 shall apply to the areas in respect of which the Authority may issue an opinion.
Article 35
Collection of information
1. At the request of the Authority, the competent authorities of the Member States shall provide the Authority with all the necessary information to carry out the duties assigned to it by this Regulation, provided that they have legal access to the relevant information, and that the request for information is necessary in relation to the nature of the duty in question.
2. The Authority may also request information to be provided at recurring intervals and in specified formats. Such requests shall, where possible, be made using common reporting formats.
3. Upon a duly justified request from a competent authority of a Member State, the Authority may provide any information that is necessary to enable the competent authority to carry out its duties, in accordance with the professional secrecy obligations laid down in sectoral legislation and in Article 70.
4. Before requesting information in accordance with this Article and in order to avoid the duplication of reporting obligations, the Authority shall take account of any relevant existing statistics produced and disseminated by the European Statistical System and the European System of Central Banks.
5. Where information is not available or is not made available by the competent authorities in a timely fashion, the Authority may address a duly justified and reasoned request to other supervisory authorities, to the ministry responsible for finance where it has at its disposal prudential information, to the national central bank or to the statistical office of the Member State concerned.
6. Where information is not available or is not made available under paragraph 1 or 5 in a timely fashion, the Authority may address a duly justified and reasoned request directly to the relevant financial market participants. The reasoned request shall explain why the information concerning the respective individual financial market participants is necessary.
The Authority shall inform the relevant competent authorities of requests in accordance with this paragraph and with paragraph 5.
At the request of the Authority, the competent authorities shall assist the Authority in collecting the information.
7. The Authority may use confidential information received under this Article only for the purposes of carrying out the duties assigned to it by this Regulation.
Article 36
Relationship with the ESRB
1. The Authority shall cooperate closely and on a regular basis with the ESRB.
2. The Authority shall provide the ESRB with regular and timely information necessary for the achievement of its tasks. Any data necessary for the achievement of its tasks that are not in summary or aggregate form shall be provided, without delay, to the ESRB upon a reasoned request, as specified in Article 15 of Regulation (EU) No 1092/2010. The Authority, in cooperation with the ESRB, shall have in place adequate internal procedures for the transmission of confidential information, in particular information regarding individual financial market participants.
3. The Authority shall, in accordance with paragraphs 4 and 5, ensure a proper follow-up to ESRB warnings and recommendations referred to in Article 16 of Regulation (EU) No 1092/2010.
4. On receipt of a warning or recommendation from the ESRB addressed to the Authority, the Authority shall convene a meeting of the Board of Supervisors without delay and assess the implications of such a warning or recommendation for the fulfilment of its tasks.
It shall decide, by the relevant decision-making procedure, on any actions to be taken in accordance with the powers conferred upon it by this Regulation for addressing the issues identified in the warnings and recommendations.
If the Authority does not act on a recommendation, it shall explain to the ESRB and the Council its reasons for not doing so.
5. On receipt of a warning or recommendation from the ESRB addressed to a competent national supervisory authority, the Authority shall, where relevant, use the powers conferred upon it by this Regulation to ensure a timely follow-up.
Where the addressee intends not to follow the recommendation of the ESRB, it shall inform and discuss with the Board of Supervisors its reasons for not acting.
The competent authority shall take due account of the views of the Board of Supervisors when informing the Council and the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010.
6. In discharging the tasks set out in this Regulation, the Authority shall take the utmost account of the warnings and recommendations of the ESRB.
Article 37
Securities and Markets Stakeholder Group
1. To help facilitate consultation with stakeholders in areas relevant to the tasks of the Authority, a Securities and Markets Stakeholder Group shall be established. The Securities and Markets Stakeholder Group shall be consulted on actions taken in accordance with Articles 10 to 15 concerning regulatory technical standards and implementing technical standards and, to the extent that these do not concern individual financial market participants, Article 16 concerning guidelines and recommendations. If actions must be taken urgently and consultation becomes impossible, the Securities and Markets Stakeholder Group shall be informed as soon as possible.
The Securities and Markets Stakeholder Group shall meet at least four times a year.
2. The Securities and Markets Stakeholder Group shall be composed of 30 members, representing in balanced proportions financial market participants operating in the Union, their employees’ representatives as well as consumers, users of financial services and representatives of SMEs. At least five of its members shall be independent top-ranking academics. Ten of its members shall represent financial market participants.
3. The members of the Securities and Markets Stakeholder Group shall be appointed by the Board of Supervisors, following proposals from the relevant stakeholders. In making its decision, the Board of Supervisors shall, to the extent possible, ensure an appropriate geographical and gender balance and representation of stakeholders across the Union.
4. The Authority shall provide all necessary information, subject to professional secrecy, as set out in Article 70, and ensure adequate secretarial support for the Securities and Markets Stakeholder Group. Adequate compensation shall be provided to members of the Securities and Markets Stakeholder Group that are representing non-profit organisations, excluding industry representatives. The Securities and Markets Stakeholder Group may establish working groups on technical issues. Members of the Securities and Markets Stakeholder Group shall serve for a period of two-and-a-half years, following which a new selection procedure shall take place.
The members of the Securities and Markets Stakeholder Group may serve two successive terms.
5. The Securities and Markets Stakeholder Group may submit opinions and advice to the Authority on any issue related to the tasks of the Authority with particular focus on the tasks set out in Articles 10 to 16 and Articles 29, 30 and 32.
6. The Securities and Markets Stakeholder Group shall adopt its rules of procedure by a majority of two-thirds of its members.
7. The Authority shall make public the opinions and advice of the Securities and Markets Stakeholder Group and the results of its consultations.
Article 38
Safeguards
1. The Authority shall ensure that no decision adopted under Articles 18 or 19 impinges in any way on the fiscal responsibilities of Member States.
2. Where a Member State considers that a decision taken under Article 19(3) impinges on its fiscal responsibilities, it may notify the Authority and the Commission within 2 weeks after notification of the Authority’s decision to the competent authority that the decision will not be implemented by the competent authority.
In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities.
In the case of such notification, the decision of the Authority shall be suspended.
Within a period of 1 month from the notification by the Member State, the Authority shall inform the Member State as to whether it maintains its decision or whether it amends or revokes it. If the decision is maintained or amended, the Authority shall state that fiscal responsibilities are not affected.
Where the Authority maintains its decision, the Council shall take a decision, by a majority of the votes cast, at one of its meetings not later than 2 months after the Authority has informed the Member State as set out in the fourth subparagraph, as to whether the Authority’s decision is maintained.
Where the Council, after having considered the matter, does not take a decision to maintain the Authority’s decision in accordance with the fifth subparagraph, the Authority’s decision shall be terminated.
3. Where a Member State considers that a decision taken under Article 18(3) impinges on its fiscal responsibilities, it may notify the Authority, the Commission and the Council within three working days after notification of the Authority’s decision to the competent authority that the decision will not be implemented by the competent authority.
In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities.
In the event of such notification, the decision of the Authority shall be suspended.
The Council shall, within ten working days, convene a meeting and take a decision, by a simple majority of its members, as to whether the Authority’s decision is revoked.
Where the Council, after having considered the matter, does not take a decision to revoke the Authority’s decision in accordance with the fourth subparagraph, the suspension of the Authority’s decision shall be terminated.
4. Where the Council has taken a decision in accordance with paragraph 3 not to revoke a decision of the Authority relating to Article 18(3), and the Member State concerned still considers that the decision of the Authority impinges upon its fiscal responsibilities, that Member State may notify the Commission and the Authority and request the Council to re-examine the matter. The Member State concerned shall clearly set out the reasons for its disagreement with the decision of the Council.
Within a period of 4 weeks after the notification referred to in the first subparagraph, the Council shall confirm its original decision or take a new decision in accordance with paragraph 3.
The period of 4 weeks may be extended by four additional weeks by the Council, if the particular circumstances of the case so require.
5. Any abuse of this Article, in particular in relation to a decision by the Authority which does not have a significant or material fiscal impact, shall be prohibited as incompatible with the internal market.
Article 39
Decision-making procedures
1. Before taking the decisions provided for in this Regulation, the Authority shall inform any named addressee of its intention to adopt the decision, setting a time limit within which the addressee may express its views on the matter, taking full account of the urgency, complexity and potential consequences of the matter. This applies mutatis mutandis to recommendations as referred to in Article 17(3).
2. The decisions of the Authority shall state the reasons on which they are based.
3. The addressees of decisions of the Authority shall be informed of the legal remedies available under this Regulation.
4. Where the Authority has taken a decision pursuant to Article 18(3) or (4), it shall review that decision at appropriate intervals.
5. The decisions which the Authority takes pursuant to Articles 17, 18 or 19 shall be made public and shall state the identity of the competent authority or financial market participant concerned and the main content of the decision, unless such publication is in conflict with the legitimate interests of financial market participants in the protection of their business secrets or could seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system of the Union.
CHAPTER III
ORGANISATION
SECTION 1
Board of Supervisors
Article 40
Composition
1. The Board of Supervisors shall be composed of:
(a)
the Chairperson, who shall be non-voting;
(b)
the head of the national public authority competent for the supervision of financial market participants in each Member State, who shall meet in person at least twice a year;
(c)
one representative of the Commission, who shall be non-voting;
(d)
one representative of the ESRB, who shall be non-voting;
(e)
one representative of each of the other two European Supervisory Authorities who shall be non-voting;
2. The Board of Supervisors shall convene meetings with the Securities and Markets Stakeholder Group regularly, at least twice a year.
3. Each competent authority shall be responsible for nominating a high-level alternate from its authority, who may replace the member of the Board of Supervisors referred to in paragraph 1(b), where that person is prevented from attending.
4. In Member States where more than one authority is responsible for the supervision according to this Regulation, those authorities shall agree on a common representative. Nevertheless, when an item to be discussed by the Board of Supervisors does not fall within the competence of the national authority being represented by the member referred to in paragraph 1(b), that member may bring a representative from the relevant national authority, who shall be non-voting.
5. For the purpose of acting within the scope of Directive 97/9/EC, the member of the Board of Supervisors referred to in paragraph 1(b) may, where appropriate, be accompanied by a representative from the relevant bodies which administer investor compensation schemes in each Member State, who shall be non-voting.
6. The Board of Supervisors may decide to admit observers.
The Executive Director may participate in meetings of the Board of Supervisors without the right to vote.
Article 41
Internal committees and panels
1. The Board of Supervisors may establish internal committees or panels for specific tasks attributed to the Board of Supervisors, and may provide for the delegation of certain clearly defined tasks and decisions to internal committees or panels, to the Management Board or to the Chairperson.
2. For the purposes of Article 19, the Board of Supervisors shall convoke an independent panel to facilitate an impartial settlement of the disagreement, consisting of the Chairperson and two of its members, who are not representatives of the competent authorities which are party to the disagreement and who have neither any interest in the conflict nor direct links to the competent authorities concerned.
3. Subject to Article 19(2), the panel shall propose a decision for final adoption by the Board of Supervisors, in accordance with the procedure set out in the third subparagraph of Article 44(1).
4. The Board of Supervisors shall adopt rules of procedure for the panel referred to in paragraph 2.
Article 42
Independence
When carrying out the tasks conferred upon it by this Regulation, the Chairperson and the voting members of the Board of Supervisors shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Board of Supervisors in the performance of their tasks.
Article 43
Tasks
1. The Board of Supervisors shall give guidance to the work of the Authority and shall be in charge of taking the decisions referred to in Chapter II.
2. The Board of Supervisors shall adopt the opinions, recommendations, and decisions, and issue the advice referred to in Chapter II.
3. The Board of Supervisors shall appoint the Chairperson.
4. The Board of Supervisors shall adopt, before 30 September of each year, on the basis of a proposal by the Management Board, the work programme of the Authority for the coming year, and shall transmit it for information to the European Parliament, the Council and the Commission.
The work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public.
5. The Board of Supervisors shall, on the basis of a proposal by the Management Board, adopt the annual report on the activities of the Authority, including on the performance of the Chairperson’s duties, on the basis of the draft report referred to in Article 53(7) and shall transmit that report to the European Parliament, the Council, the Commission, the Court of Auditors and the European Economic and Social Committee by 15 June each year. The report shall be made public.
6. The Board of Supervisors shall adopt the multi-annual work programme of the Authority, and shall transmit it for information to the European Parliament, the Council and the Commission.
The multi-annual work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public.
7. The Board of Supervisors shall adopt the budget in accordance with Article 63.
8. The Board of Supervisors shall exercise disciplinary authority over the Chairperson and the Executive Director and may remove them from office in accordance with Article 48(5) or Article 51(5) respectively.
Article 44
Decision making
1. Decisions of the Board of Supervisors shall be taken by a simple majority of its members. Each member shall have one vote.
With regard to the acts specified in Articles 10 to 16 and measures and decisions adopted under the third subparagraph of Article 9(5) and Chapter VI and by way of derogation from the first subparagraph of this paragraph, the Board of Supervisors shall take decisions on the basis of a qualified majority of its members, as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
With regard to decisions in accordance with Article 19(3), for decisions taken by the consolidating supervisor, the decision proposed by the panel shall be considered as adopted, if approved by a simple majority, unless it is rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions.
For all other decisions in accordance with Article 19(3), the decision proposed by the panel shall be adopted by a simple majority of the members of the Board of Supervisors. Each member shall have one vote.
2. Meetings of the Board of Supervisors shall be convened by the Chairperson at his own initiative or at the request of one third of its members, and shall be chaired by the Chairperson.
3. The Board of Supervisors shall adopt and make public its rules of procedure.
4. The rules of procedure shall set out in detail the arrangements governing voting, including, where appropriate, the rules governing quorums. The non-voting members and the observers, with the exception of the Chairperson and the Executive Director, shall not attend any discussions within the Board of Supervisors relating to individual financial market participants, unless otherwise provided for in Article 75(3) or in the acts referred to in Article 1(2).
SECTION 2
Management Board
Article 45
Composition
1. The Management Board shall be composed of the Chairperson and six other members of the Board of Supervisors, elected by and from the voting members of the Board of Supervisors.
Other than the Chairperson, each member of the Management Board shall have an alternate, who may replace him if he is prevented from attending.
The term of office of the members elected by the Board of Supervisors shall be two-and-a-half years. That term may be extended once. The composition of the Management Board shall be balanced and proportionate and shall reflect the Union as a whole. Mandates shall be overlapping and an appropriate rotating arrangement shall apply.
2. Decisions by the Management Board shall be adopted on the basis of a majority of the members present. Each member shall have one vote.
The Executive Director and a representative of the Commission shall participate in meetings of the Management Board without the right to vote.
The representative of the Commission shall have the right to vote on matters referred to in Article 63.
The Management Board shall adopt and make public its rules of procedure.
3. Meetings of the Management Board shall be convened by the Chairperson at his own initiative or at the request of at least a third of its members, and shall be chaired by the Chairperson.
The Management Board shall meet prior to every meeting of the Board of Supervisors and as often as the Management Board deems necessary. It shall meet at least five times a year.
4. The members of the Management Board may, subject to the rules of procedure, be assisted by advisers or experts. The non-voting members, with the exception of the Executive Director, shall not attend any discussions within the Management Board relating to individual financial market participants.
Article 46
Independence
The members of the Management Board shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Management Board in the performance of their tasks.
Article 47
Tasks
1. The Management Board shall ensure that the Authority carries out its mission and performs the tasks assigned to it in accordance with this Regulation.
2. The Management Board shall propose, for adoption by the Board of Supervisors, an annual and multi-annual work programme.
3. The Management Board shall exercise its budgetary powers in accordance with Articles 63 and 64.
4. The Management Board shall adopt the Authority’s staff policy plan and, pursuant to Article 68(2), the necessary implementing measures of the Staff Regulations of Officials of the European Communities (hereinafter the Staff Regulations’).
5. The Management Board shall adopt the special provisions on right of access to the documents of the Authority, in accordance with Article 72.
6. The Management Board shall propose an annual report on the activities of the Authority, including on the Chairperson’s duties, on the basis of the draft report referred to in Article 53(7) to the Board of Supervisors for approval.
7. The Management Board shall adopt and make public its rules of procedure.
8. The Management Board shall appoint and remove the members of the Board of Appeal in accordance with Article 58(3) and (5).
SECTION 3
Chairperson
Article 48
Appointment and tasks
1. The Authority shall be represented by a Chairperson, who shall be a full-time independent professional.
The Chairperson shall be responsible for preparing the work of the Board of Supervisors and shall chair the meetings of the Board of Supervisors and the Management Board.
2. The Chairperson shall be appointed by the Board of Supervisors on the basis of merit, skills, knowledge of financial market participants and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure.
Before taking up his duties, and up to 1 month after the selection by the Board of Supervisors, the European Parliament may, after having heard the candidate selected by the Board of Supervisors, object to the designation of the selected person.
The Board of Supervisors shall also elect, from among its members, an alternate who shall carry out the functions of the Chairperson in his absence. That alternate shall not be elected from among the members of the Management Board.
3. The Chairperson’s term of office shall be 5 years and may be extended once.
4. In the course of the 9 months preceding the end of the five-year term of office of the Chairperson, the Board of Supervisors shall evaluate:
(a)
the results achieved in the first term of office and the way they were achieved;
(b)
the Authority’s duties and requirements in the coming years.
The Board of Supervisors, taking into account the evaluation may extend the term of office of the Chairperson once subject to confirmation by the European Parliament.
5. The Chairperson may be removed from office only by the European Parliament following a decision of the Board of Supervisors.
The Chairperson shall not prevent the Board of Supervisors from discussing matters relating to the Chairperson, in particular the need for his removal, and shall not be involved in deliberations concerning such a matter.
Article 49
Independence
Without prejudice to the role of the Board of Supervisors in relation to the tasks of the Chairperson, the Chairperson shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the Chairperson in the performance of his tasks.
In accordance with the Staff Regulations referred to in Article 68, the Chairperson shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Article 50
Report
1. The European Parliament and the Council may invite the Chairperson or his alternate to make a statement, while fully respecting his independence. The Chairperson shall, make a statement before the European Parliament and answer any questions put by its members, whenever so requested.
2. The Chairperson shall report in writing on the main activities of the Authority to the European Parliament when requested and at least 15 days before making the statement referred to in paragraph 1.
3. In addition to the information referred to in Articles 11 to 18 and Articles 20 and 33, the report shall also include any relevant information requested by the European Parliament on an ad-hoc basis.
SECTION 4
Executive Director
Article 51
Appointment
1. The Authority shall be managed by an Executive Director, who shall be a full-time independent professional.
2. The Executive Director shall be appointed by the Board of Supervisors, after confirmation by the European Parliament, on the basis of merit, skills, knowledge of financial market participants and markets, and experience relevant to financial supervision and regulation and managerial experience, following an open selection procedure.
3. The Executive Director’s term of office shall be 5 years and may be extended once.
4. In the course of the 9 months preceding the end of the Executive Director’s term of office, the Board of Supervisors shall evaluate in particular:
(a)
the results achieved in the first term of office and the way they were achieved;
(b)
the Authority’s duties and requirements in the coming years.
The Board of Supervisors, taking into account the evaluation referred to in the first subparagraph, may extend the term of office of the Executive Director once.
5. The Executive Director may be removed from office only upon a decision of the Board of Supervisors.
Article 52
Independence
Without prejudice to the respective roles of the Management Board and the Board of Supervisors in relation to the tasks of the Executive Director, the Executive Director shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the Executive Director in the performance of his tasks.
In accordance with the Staff Regulations referred to in Article 68, the Executive Director shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Article 53
Tasks
1. The Executive Director shall be in charge of the management of the Authority and shall prepare the work of the Management Board.
2. The Executive Director shall be responsible for implementing the annual work programme of the Authority under the guidance of the Board of Supervisors and under the control of the Management Board.
3. The Executive Director shall take the necessary measures, notably the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Authority, in accordance with this Regulation.
4. The Executive Director shall prepare a multi-annual work programme, as referred to in Article 47(2).
5. Each year by 30 June, the Executive Director shall prepare a work programme for the following year, as referred to in Article 47(2).
6. The Executive Director shall draw up a preliminary draft budget of the Authority pursuant to Article 63 and shall implement the budget of the Authority pursuant to Article 64.
7. Each year the Executive Director shall prepare a draft report with a section on the regulatory and supervisory activities of the Authority and a section on financial and administrative matters.
8. The Executive Director shall exercise in respect to the Authority’s staff the powers laid down in Article 68 and manage staff matters.
CHAPTER IV
JOINT BODIES OF THE EUROPEAN SUPERVISORY AUTHORITIES
SECTION 1
Joint Committee of European Supervisory Authorities
Article 54
Establishment
1. The Joint Committee of the European Supervisory Authorities is hereby established.
2. The Joint Committee shall serve as a forum in which the Authority shall cooperate regularly and closely and ensure cross-sectoral consistency with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority), in particular regarding:
—
financial conglomerates,
—
accounting and auditing,
—
micro-prudential analyses of cross-sectoral developments, risks and vulnerabilities for financial stability,
—
retail investment products,
—
measures combating money laundering; and,
—
information exchange with the ESRB and developing the relationship between the ESRB and the ESAs,
3. The Joint Committee shall have a dedicated staff provided by the ESAs that shall act as a secretariat. The Authority shall contribute adequate resources to administrative, infrastructure and operational expenses.
4. In the event that a financial market participant reaches across different sectors, the Joint Committee shall resolve disagreements in accordance with Article 56.
Article 55
Composition
1. The Joint Committee shall be composed of the Chairpersons of the ESAs, and, where applicable, the Chairperson of any Sub-Committee established under Article 57.
2. The Executive Director, a representative of the Commission and the ESRB shall be invited to the meetings of the Joint Committee, as well as of any Sub-Committees referred to in Article 57, as observers.
3. The Chairperson of the Joint Committee shall be appointed on an annual rotational basis from among the Chairpersons of the ESAs. The Chairperson of the Joint Committee shall be a Vice-Chair of the ESRB.
4. The Joint Committee shall adopt and publish its own rules of procedure. The rules may specify further participants in the meetings of the Joint Committee.
The Joint Committee shall meet at least once every 2 months.
Article 56
Joint positions and common acts
Within the scope of its tasks in Chapter II, and, in particular with respect to the implementation of Directive 2002/87/EC, where relevant, the Authority shall reach joint positions with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and with the European Supervisory Authority (European Banking Authority), as appropriate.
Acts under Articles 10 to 15, 17, 18 or 19 of this Regulation in relation to the application of Directive 2002/87/EC and of any other Union acts referred to in Article 1(2) that also fall within the area of competence of the European Supervisory Authority (European Banking Authority) or the European Supervisory Authority (European Insurance and Occupational Pensions Authority) shall be adopted, in parallel, by the Authority, the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority), as appropriate.
Article 57
Sub-Committees
1. For the purposes of Article 56, a Sub-Committee on Financial Conglomerates to the Joint Committee shall be established.
2. The Sub-Committee shall be composed of the individuals referred to in Article 55(1), and one high-level representative from the current staff of the relevant competent authority from each Member State.
3. The Sub-Committee shall elect a Chairperson from among its members, who shall also be a member of the Joint Committee.
4. The Joint Committee may establish further Sub Committees.
SECTION 2
Board of Appeal
Article 58
Composition and operation
1. The Board of Appeal shall be a joint body of the ESAs.
2. The Board of Appeal shall be composed of six members and six alternates, who shall be individuals of a high repute with a proven record of relevant knowledge and professional experience, including supervisory, experience to a sufficiently high level in the fields of banking, insurance, occupational pensions, securities markets or other financial services, excluding current staff of the competent authorities or other national or Union institutions involved in the activities of the Authority. The Board of Appeal shall have sufficient legal expertise to provide expert legal advice on the legality of the Authority’s exercise of its powers.
The Board of Appeal shall designate its President.
3. Two members of the Board of Appeal and two alternates shall be appointed by the Management Board of the Authority from a short-list proposed by the Commission, following a public call for expressions of interest published in the Official Journal of the European Union, and after consultation of the Board of Supervisors.
The other members shall be appointed in accordance with Regulation (EU) No 1093/2010 and Regulation (EU) No 1094/2010.
4. The term of office of the members of the Board of Appeal shall be 5 years. That term may be extended once.
5. A member of the Board of Appeal appointed by the Management Board of the Authority shall not be removed during his term of office, unless he has been found guilty of serious misconduct and the Management Board takes a decision to that effect after consulting the Board of Supervisors.
6. The decisions of the Board of Appeal shall be adopted on the basis of a majority of at least four of its six members. Where the appealed decision falls within the scope of this Regulation, the deciding majority shall include at least one of the two members of the Board of Appeal appointed by the Authority.
7. The Board of Appeal shall be convened by its President when necessary.
8. The ESAs shall ensure adequate operational and secretarial support for the Board of Appeal through the Joint Committee.
Article 59
Independence and impartiality
1. The members of the Board of Appeal shall be independent in making their decisions. They shall not be bound by any instructions. They shall not perform any other duties in relation to the Authority, its Management Board or its Board of Supervisors.
2. Members of the Board of Appeal shall not take part in any appeal proceedings in which they have any personal interest, if they have previously been involved as representatives of one of the parties to the proceedings, or if they have participated in the decision under appeal.
3. If, for one of the reasons referred to in paragraphs 1 and 2 or for any other reason, a member of a Board of Appeal considers that another member should not take part in any appeal proceedings, he shall inform the Board of Appeal accordingly.
4. Any party to the appeal proceedings may object to the participation of a member of the Board of Appeal on any of the grounds referred to in paragraphs 1 and 2, or if suspected of bias.
No objection may be based on the nationality of members nor shall it be admissible if, while being aware of a reason for objecting, the party to the appeal proceedings has nonetheless taken a procedural step other than objecting to the composition of the Board of Appeal.
5. The Board of Appeal shall decide on the action to be taken in the cases specified in paragraphs 1 and 2 without the participation of the member concerned.
For the purpose of taking that decision, the member concerned shall be replaced on the Board of Appeal by his alternate. Where the alternate is in a similar situation, the Chairperson shall designate a replacement from among the available alternates.
6. The members of the Board of Appeal shall undertake to act independently and in the public interest.
For that purpose, they shall make a declaration of commitments and a declaration of interests indicating either the absence of any interest which may be considered prejudicial to their independence or any direct or indirect interest which might be considered prejudicial to their independence.
Those declarations shall be made public, annually and in writing.
CHAPTER V
REMEDIES
Article 60
Appeals
1. Any natural or legal person, including competent authorities, may appeal against a decision of the Authority referred to in Articles 17, 18 and 19 and any other decision taken by the Authority in accordance with the Union acts referred to in Article 1(2) which is addressed to that person, or against a decision which, although in the form of a decision addressed to another person, is of direct and individual concern to that person.
2. The appeal, together with a statement of grounds, shall be filed in writing at the Authority within 2 months of the date of notification of the decision to the person concerned, or, in the absence of a notification, of the day on which the Authority published its decision.
The Board of Appeal shall decide upon the appeal within 2 months after the appeal has been lodged.
3. An appeal lodged pursuant to paragraph 1 shall not have suspensive effect.
However, the Board of Appeal may, if it considers that circumstances so require, suspend the application of the contested decision.
4. If the appeal is admissible, the Board of Appeal shall examine whether it is well-founded. It shall invite the parties to the appeal proceedings to file observations on its own notifications or on communications from the other parties to the appeal proceedings, within specified time limits. Parties to the appeal proceedings shall be entitled to make oral representations.
5. The Board of Appeal may confirm the decision taken by the competent body of the Authority, or remit the case to the competent body of the Authority. That body shall be bound by the decision of the Board of Appeal and that body shall adopt an amended decision regarding the case concerned.
6. The Board of Appeal shall adopt and make public its rules of procedure.
7. The decisions taken by the Board of Appeal shall be reasoned and shall be made public by the Authority.
Article 61
Actions before the Court of Justice of the European Union
1. Proceedings may be brought before the Court of Justice of the European Union, in accordance with Article 263 TFEU, contesting a decision taken by the Board of Appeal or, in cases where there is no right of appeal before the Board of Appeal, by the Authority.
2. Member States and the Union institutions, as well as any natural or legal person, may institute proceedings before the Court of Justice of the European Union against decisions of the Authority, in accordance with Article 263 TFEU.
3. In the event that the Authority has an obligation to act and fails to take a decision, proceedings for failure to act may be brought before the Court of Justice of the European Union in accordance with Article 265 TFEU.
4. The Authority shall be required to take the necessary measures to comply with the judgment of the Court of Justice of the European Union.
CHAPTER VI
FINANCIAL PROVISIONS
Article 62
Budget of the Authority
1. The revenues of the Authority, a European body in accordance with Article 185 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (47) (hereinafter the ‘Financial Regulation’), shall consist, in particular, of any combination of the following:
(a)
obligatory contributions from the national public authorities competent for the supervision of financial market participants which shall be made in accordance with a formula based on the weighting of votes set out in Article 3(3) of Protocol (No 36) on transitional provisions. For the purposes of this Article, Article 3(3) of Protocol (No 36) on transitional provisions shall continue to apply beyond the deadline of 31 October 2014 therein established;
(b)
a subsidy from the Union, entered in the General Budget of the European Union (Commission Section);
(c)
any fees paid to the Authority in the cases specified in the relevant instruments of Union law.
2. The expenditure of the Authority shall include, at least, staff, remuneration, administrative, infrastructure professional training and operational expenses.
3. Revenue and expenditure shall be in balance.
4. Estimates of all Authority revenue and expenditure shall be prepared for each financial year, corresponding to the calendar year, and shall be presented in the budget of the Authority.
Article 63
Establishment of the budget
1. By 15 February each year, the Executive Director shall draw up a draft statement of estimates of revenue and expenditure for the following financial year, and shall forward it to the Management Board and the Board of Supervisors, together with the establishment plan. Each year, the Board of Supervisors shall, on the basis of the draft statement drawn up by the Executive Director and approved by the Management Board, produce a statement of estimates of revenue and expenditure of the Authority for the following financial year. That statement of estimates, including a draft establishment plan, shall be transmitted by the Board of Supervisors to the Commission by 31 March. Prior to adoption of the statement of estimates, the draft prepared by the Executive Director shall be approved by the Management Board.
2. The statement of estimates shall be transmitted by the Commission to the European Parliament and to the Council (hereinafter referred to together as the ‘budgetary authority’), together with the draft budget of the European Union.
3. On the basis of the statement of estimates, the Commission shall enter in the draft budget of the European Union the estimates it deems necessary in respect of the establishment plan and the amount of the subsidy to be charged to the General Budget of the European Union in accordance with Articles 313 and 314 TFEU.
4. The budgetary authority shall adopt the establishment plan for the Authority. The budgetary authority shall authorise the appropriations for the subsidy to the Authority.
5. The budget of the Authority shall be adopted by the Board of Supervisors. It shall become final after the final adoption of the General Budget of the European Union. Where necessary, it shall be adjusted accordingly.
6. The Management Board shall, without delay, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any project relating to property, such as the rental or purchase of buildings. It shall inform the Commission thereof. If either branch of the budgetary authority intends to issue an opinion, it shall, within 2 weeks of receipt of the information on the project, notify the Authority of its intention to issue such an opinion. In the absence of a reply, the Authority may proceed with the planned operation.
7. For the first year of operation of the Authority, ending on 31 December 2011, the financing of the Authority by the Union is subject to an agreement by the budgetary authority as provided for in Point 47 of the Interinstitutional Agreement on budgetary discipline and sound financial management.
Article 64
Implementation and control of the budget
1. The Executive Director shall act as authorising officer and shall implement the Authority’s budget.
2. By 1 March following the completion of each financial year, the Authority’s accounting officer shall forward to the Commission’s accounting officer and to the Court of Auditors the provisional accounts, accompanied by the report on budgetary and financial management during the financial year. The Authority’s accounting officer shall also send the report on budgetary and financial management to the members of the Board of Supervisors, the European Parliament and the Council by 31 March of the following year.
The Commission’s accounting officer shall then consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation.
3. After receiving the observations of the Court of Auditors on the provisional accounts of the Authority in accordance with Article 129 of the Financial Regulation, the Executive Director, acting on his own responsibility, shall draw up the final accounts of the Authority and transmit them, for opinion, to the Management Board.
4. The Management Board shall deliver an opinion on the final accounts of the Authority.
5. The Executive Director shall transmit those final accounts, accompanied by the opinion of the Management Board, by 1 July following the completion of the financial year, to the Members of the Board of Supervisors, the European Parliament, the Council, the Commission and the Court of Auditors.
6. The final accounts shall be published.
7. The Executive Director shall send the Court of Auditors a reply to the latter’s observations by 30 September. He shall also send a copy of that reply to the Management Board and the Commission.
8. The Executive Director shall submit to the European Parliament, at the latter’s request and as provided for in Article 146(3) of the Financial Regulation, any information necessary for the smooth application of the discharge procedure for the financial year in question.
9. The European Parliament, following a recommendation from the Council acting by qualified majority, shall, before 15 May of the year N + 2, grant a discharge to the Authority for the implementation of the budget comprising revenue from the General Budget of the European Union and competent authorities for the financial year N.
Article 65
Financial rules
The financial rules applicable to the Authority shall be adopted by the Management Board after consulting the Commission. Those rules may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (48) unless the specific operational needs for the functioning of the Authority so require and only with the prior agreement of the Commission.
Article 66
Anti-fraud measures
1. For the purposes of combating fraud, corruption and any other illegal activity, Regulation (EC) No 1073/1999 shall apply to the Authority without any restriction.
2. The Authority shall accede to the Interinstitutional Agreement concerning internal investigations by OLAF and shall immediately adopt appropriate provisions for all staff of the Authority.
3. The funding decisions and the agreements and the implementing instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may, if need be, carry out on-the-spot checks on the beneficiaries of monies disbursed by the Authority as well as on the staff responsible for allocating these monies.
CHAPTER VII
GENERAL PROVISIONS
Article 67
Privileges and immunities
The Protocol (No 7) on the privileges and immunities of the European Union annexed to the Treaty on European Union and to the TFEU shall apply to the Authority and its staff.
Article 68
Staff
1. The Staff Regulations, the Conditions of Employment of Other Servants and the rules adopted jointly by the Union institutions for the purpose of applying them shall apply to the staff of the Authority, including its Executive Director and its Chairperson.
2. The Management Board, in agreement with the Commission, shall adopt the necessary implementing measures, in accordance with the arrangements provided for in Article 110 of the Staff Regulations.
3. In respect of its staff, the Authority shall exercise the powers conferred on the appointing authority by the Staff Regulations and on the authority entitled to conclude contracts by the Conditions of Employment of Other Servants.
4. The Management Board shall adopt provisions to allow national experts from Member States to be seconded to the Authority.
Article 69
Liability of the Authority
1. In the case of non-contractual liability, the Authority shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its staff in the performance of their duties. The Court of Justice of the European Union shall have jurisdiction in any dispute over the remedying of such damage.
2. The personal financial liability and disciplinary liability of Authority staff towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority.
Article 70
Obligation of professional secrecy
1. Members of the Board of Supervisors and the Management Board, the Executive Director, and members of the staff of the Authority including officials seconded by Member States on a temporary basis and all other persons carrying out tasks for the Authority on a contractual basis shall be subject to the requirements of professional secrecy pursuant to Article 339 TFEU and the relevant provisions in Union legislation, even after their duties have ceased.
Article 16 of the Staff Regulations shall apply to them.
In accordance with the Staff Regulations, the staff shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits.
Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence staff members of the Authority in the performance of their tasks.
2. Without prejudice to cases covered by criminal law, any confidential information received by persons referred to in paragraph 1 whilst performing their duties may not be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual financial market participants cannot be identified.
Moreover, the obligation under paragraph 1 and the first subparagraph of this paragraph shall not prevent the Authority and the national supervisory authorities from using the information for the enforcement of the acts referred to in Article 1(2), and in particular for legal procedures for the adoption of decisions.
3. Paragraphs 1 and 2 shall not prevent the Authority from exchanging information with national supervisory authorities in accordance with this Regulation and other Union legislation applicable to financial market participants.
That information shall be subject to the conditions of professional secrecy referred to in paragraphs 1 and 2. The Authority shall lay down in its internal rules of procedure the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2.
4. The Authority shall apply Commission Decision 2001/844/EC/ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (49).
Article 71
Data protection
This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Directive 95/46/EC or the obligations of the Authority relating to its processing of personal data under Regulation (EC) No 45/2001 when fulfilling its responsibilities.
Article 72
Access to documents
1. Regulation (EC) No 1049/2001 shall apply to documents held by the Authority.
2. The Management Board shall, by 31 May 2011, adopt practical measures for applying Regulation (EC) No 1049/2001.
3. Decisions taken by the Authority pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or of proceedings before the Court of Justice of the European Union, following an appeal to the Board of Appeal, as appropriate, in accordance with the conditions laid down in Articles 228 and 263 TFEU respectively.
Article 73
Language arrangements
1. Council Regulation No 1 determining the languages to be used by the European Economic Community (50) shall apply to the Authority.
2. The Management Board shall decide on the internal language arrangements for the Authority.
3. The translation services required for the functioning of the Authority shall be provided by the Translation Centre for the Bodies of the European Union.
Article 74
Headquarters Agreement
The necessary arrangements concerning the accommodation to be provided for the Authority in the Member State where its seat is located and the facilities to be made available by that Member State, as well as the specific rules applicable in that Member State to the Executive Director, the members of the Management Board, the staff of the Authority and members of their families shall be laid down in a Headquarters Agreement between the Authority and that Member State concluded after obtaining the approval of the Management Board.
That Member State shall provide the best possible conditions to ensure the proper functioning of the Authority, including multilingual, European-oriented schooling and appropriate transport connections.
Article 75
Participation of third countries
1. Participation in the work of the Authority shall be open to third countries which have concluded agreements with the Union whereby they have adopted and are applying Union law in the areas of competence of the Authority as referred to in Article 1(2).
2. The Authority may cooperate with the countries referred to in paragraph 1, applying legislation which has been recognised as equivalent in the areas of competence of the Authority referred to in Article 1(2), as provided for in international agreements concluded by the Union in accordance with Article 216 TFEU.
3. Under the relevant provisions of the agreements referred to in paragraphs 1 and 2, arrangements shall be made specifying, in particular, the nature, scope and procedural aspects of the involvement of the countries referred to in paragraph 1 in the work of the Authority, including provisions relating to financial contributions and to staff. They may provide for representation, as an observer, on the Board of Supervisors, but shall ensure that those countries do not attend any discussions relating to individual financial market participants, except where there is a direct interest.
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 76
Preparatory actions
1. Following the entry into force of this Regulation, and before the establishment of the Authority, CESR shall act in close cooperation with the Commission to prepare for the replacement of CESR by the Authority.
2. Once the Authority has been established, the Commission shall be responsible for the administrative establishment and initial administrative operation of the Authority until the Authority has appointed an Executive Director.
For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Board of Supervisors in accordance with Article 51, the Commission may assign one official on an interim basis in order to fulfil the functions of the Executive Director. That period shall be limited to the time necessary for the appointment of an Executive Director of the Authority.
The interim Executive Director may authorise all payments covered by credits provided in the budget of the Authority, once approved by the Management Board and may conclude contracts, including staff contracts following the adoption of the Authority’s establishment plan.
3. Paragraphs 1 and 2 are without prejudice to the powers of the Board of Supervisors and the Management Board.
4. The Authority shall be considered the legal successor of CESR. By the date of establishment of the Authority, all assets and liabilities and all pending operations of CESR shall be automatically transferred to the Authority. The CESR shall establish a statement showing its closing asset and liability situation as of the date of that transfer. That statement shall be audited and approved by CESR and by the Commission.
Article 77
Transitional staff provisions
1. By way of derogation from Article 68, all employment contracts and secondment agreements concluded by CESR or its Secretariat and in force on 1 January 2011 shall be honoured until their expiry date. They may not be extended.
2. All members of staff under contracts referred to in paragraph 1 shall be offered the possibility of concluding temporary agent contracts under Article 2(a) of the Conditions of Employment of Other Servants at the various grades as set out in the Authority’s establishment plan.
An internal selection limited to staff who have contracts with CESR or its Secretariat shall be carried out after the entry into force of this Regulation by the authority authorised to conclude contracts in order to check the ability, efficiency and integrity of those to be engaged. The internal selection procedure shall take full account of the skills and experience demonstrated by the individuals’ performance prior to the engagement.
3. Depending on the type and level of functions to be performed, successful applicants shall be offered temporary agents’ contracts of a duration corresponding at least to the time remaining under the prior contract.
4. The relevant national law relating to labour contracts and other relevant instruments shall continue to apply to staff members with prior contracts who choose not to apply for temporary agent’s contracts or who are not offered temporary agents contracts in accordance with paragraph 2.
Article 78
National provisions
The Member States shall make such provision as is appropriate to ensure the effective application of this Regulation.
Article 79
Amendments
Decision No 716/2009/EC is hereby amended in so far as CESR is removed from the list of beneficiaries set out in Section B of the Annex to that Decision.
Article 80
Repeal
Commission Decision 2009/77/EC, establishing CESR, is hereby repealed with effect from 1 January 2011.
Article 81
Review
1. By 2 January 2014 and every 3 years thereafter, the Commission shall publish a general report on the experience acquired as a result of the operation of the Authority and the procedures laid down in this Regulation. That report shall evaluate, inter alia:
(a)
the convergence in supervisory practices reached by competent authorities,
(i)
the convergence in functional independence of the competent authorities and in standards equivalent to corporate governance;
(ii)
the impartiality, objectivity and autonomy of the Authority;
(b)
the functioning of the colleges of supervisors;
(c)
the progress achieved towards convergence in the fields of crisis prevention, management and resolution, including Union funding mechanisms;
(d)
the role of the Authority as regards systemic risk;
(e)
the application of the safeguard clause established in Article 38;
(f)
the application of the binding mediation role established in Article 19.
2. The report referred to in paragraph 1 shall also examine whether:
(a)
it is appropriate to continue separate supervision of banking, insurance, occupational pensions, securities and financial markets;
(b)
it is appropriate to undertake prudential supervision and supervise the conduct of business separately or by the same supervisor;
(c)
it is appropriate to simplify and reinforce the architecture of the ESFS in order to increase the coherence between the macro and the micro levels and between the ESAs;
(d)
the evolution of the ESFS is consistent with that of the global evolution;
(e)
there is sufficient diversity and excellence within the ESFS;
(f)
accountability and transparency in relation to publication requirements are adequate;
(g)
the resources of the Authority are adequate to carry out its responsibilities;
(h)
it is appropriate for the seat of the Authority to be maintained or to move the ESAs to a single seat to enhance better coordination between them.
3. Concerning the issue of direct supervision of institutions or infrastructures of pan-European reach and taking account of market developments, the Commission shall draw up an annual report on the appropriateness of entrusting the Authority with further supervisory responsibilities in this area.
4. The report and any accompanying proposals, as appropriate, shall be forwarded to the European Parliament and to the Council.
Article 82
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2011, with the exception of Article 76 and Article 77(1) and (2), which shall apply as from the date of its entry into force.
The Authority shall be established on 1 January 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 24 November 2010.
For the European Parliament
The President
J. BUZEK
For the Council
The President
O. CHASTEL
(1) OJ C 13, 20.1.2010, p. 1.
(2) Opinion of 22 January 2010 (not yet published in the Official Journal).
(3) Position of the European Parliament of 22 September 2010 (not yet published in the Official Journal) and decision of the Council of 17 November 2010.
(4) OJ C 40, 7.2.2001, p. 453.
(5) OJ C 25 E, 29.1.2004, p. 394.
(6) OJ C 175 E, 10.7.2008, p. 392.
(7) OJ C 8 E, 14.1.2010, p. 26.
(8) OJ C 9 E, 15.1.2010, p. 48.
(9) OJ C 184 E, 8.7.2010, p. 214.
(10) OJ C 184 E, 8.7.2010, p. 292.
(11) OJ L 302, 17.11.2009, p. 1.
(12) See page 1 of this Official Journal.
(13) OJ L 25, 29.1.2009, p. 23.
(14) OJ L 25, 29.1.2009, p. 28.
(15) OJ L 25, 29.1.2009, p. 18.
(16) European Court Reports 2006 Page I-03771, para 44.
(17) OJ L 84, 26.3.1997, p. 22.
(18) OJ L 166, 11.6.1998, p. 45.
(19) OJ L 184, 6.7.2001, p. 1.
(20) OJ L 168, 27.6.2002, p. 43.
(21) OJ L 96, 12.4.2003, p. 16.
(22) OJ L 345, 31.12.2003, p. 64.
(23) OJ L 145, 30.4.2004, p. 1.
(24) OJ L 390, 31.12.2004, p. 38.
(25) OJ L 177, 30.6.2006, p. 201.
(26) OJ L 302, 17.11.2009, p. 32.
(27) OJ L 35, 11.2.2003, p. 1.
(28) OJ L 330, 5.12.1998, p. 1.
(29) OJ L 345, 8.12.2006, p. 1.
(30) OJ L 309, 25.11.2005, p. 15.
(31) OJ L 271, 9.10.2002, p. 16.
(32) OJ L 135, 31.5.1994, p. 5.
(33) Directive 2007/44/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 92/49/EEC and Directives 2002/83/EC, 2004/39/EC, 2005/68/EC and 2006/48/EC as regards procedural rules and evaluation criteria for the prudential assessment of acquisitions and increase of holdings in the financial sector (OJ L 247, 21.9.2007, p. 1).
(34) OJ L 87, 31.3.2009, p. 164.
(35) OJ L 318, 27.11.1998, p. 8.
(36) OJ C 139, 14.6.2006, p. 1.
(37) OJ L 136, 31.5.1999, p. 1.
(38) OJ L 136, 31.5.1999, p. 15.
(39) OJ L 56, 4.3.1968, p. 1.
(40) OJ L 281, 23.11.1995, p. 31.
(41) OJ L 8, 12.1.2001, p. 1.
(42) OJ L 145, 31.5.2001, p. 43.
(43) OJ L 253, 25.9.2009, p. 8.
(44) See page 1 of this Official Journal.
(45) See page 12 of this Official Journal.
(46) See page 48 of this Official Journal.
(47) OJ L 248, 16.9.2002, p. 1.
(48) OJ L 357, 31.12.2002, p. 72.
(49) OJ L 317, 3.12.2001, p. 1.
(50) OJ 17, 6.10.1958, p. 385.
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European Securities and Markets Authority (ESMA)
European Securities and Markets Authority (ESMA)
SUMMARY OF:
Regulation (EU) No 1095/2010 establishing the European Securities and Markets Authority
WHAT IS THE AIM OF THE REGULATION?
It creates the European Securities and Markets Authority (ESMA) — one of the three European supervisory authorities (ESAs) — which strengthens the coordination between national regulators of financial markets and ensures the consistent application of European Union (EU) financial legislation in EU Member States.
It was amended by Regulation (EU) 2019/2175 which gives all three of the ESAs greater responsibility for ensuring the convergence of financial market supervision in their respective fields.
KEY POINTS
Consistent application of law
ESMA draws up regulatory and technical standards based on EU financial legislation. It also has the power to issue guidelines and recommendations on the application of EU law.
Consumer protection and financial activities
ESMA promotes transparency, simplicity and fairness in the markets to protect consumers of financial products. It monitors financial activities and analyses consumer trends, along with other tasks. Under certain strict conditions, it can temporarily prohibit or restrict financial activities that pose a threat to the stability of the markets.
Breach of law
ESMA can investigate a breach of law by a national authority. This arises when the latter fails to ensure that a financial market participant complies with EU law.
Within 2 months, ESMA can issue a recommendation requiring the national authority to take the necessary action to comply with EU law. Then, the European Commission may issue a formal opinion. If the national authority’s non-compliance persists, ESMA may directly address a decision to a financial market participant under certain strict conditions. This decision prevails over previous decisions taken by the national authority.
Amending Regulation (EU) 2019/2175
This amending regulation grants ESMA direct supervisory powers over the administrators of critical benchmarks* and over providers of data communication services.
It transfers authorisation and supervisory powers in relation to data reporting services providers* from competent authorities to ESMA, except for those benefiting from a derogation because they have limited EU relevance. This will reduce fragmentation and costs and ensure the same quality and reliability of data across the EU.
ESMA gets a greater coordinating role in market abuse cases. Where certain orders, transactions or behaviours give rise to suspicions of market abuses and have cross-border implications for the integrity of financial markets or financial stability in the EU, ESMA is able to issue an opinion on the appropriate follow-up.
The regulation grants ESMA, in addition to the competent authorities, competences to directly gather data from market participants in relation to pre- and post-trade transparency requirements and to authorise and oversee data reporting services providers.
ESMA is able to conduct investigations and on-site inspections and can impose fines or periodic penalty payments to compel data reporting services providers to put an end to an infringement or to supply complete and correct information that it requires.
As the competent authority for recognising non-EU-country benchmark administrators, ESMA is the EU counterpart for supervisors in non-EU countries, making cross-border cooperation more efficient and effective.
FROM WHEN DOES THE REGULATION APPLY?
Regulation (EU) No 1095/2010 has applied since 1 January 2011.
Amending Regulation (EU) 2019/2175 (as far as amendments to Regulation (EU) No 1095/2010 are concerned) has applied since 1 January 2020.
BACKGROUND
Based in Paris, ESMA was created in 2010 to safeguard the stability of the EU’s financial markets and address shortcomings in financial supervision.
ESMA is part of the European system of financial supervision (ESFS), created in 2010, with two other supervisory organisations: the European Insurance and Occupational Pensions Authority, based in Frankfurt;the European Banking Authority, based in Paris.
The ESFS also comprises the European Systemic Risk Board of Financial Supervision and the Joint Committee of the European Supervisory Authorities and the national supervisory authorities.
For further information, see: European system of financial supervision (European Commission)ESMA in brief (ESMA).
KEY TERMS
Critical benchmarks. Indices or indicators used to price financial instruments and financial contracts or to measure the performance of an investment fund.
Data reporting services providers. Companies which enable the reporting of transactions in financial instruments to regulators and to the public.
MAIN DOCUMENT
Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, pp. 84–119).
Successive amendments to Regulation (EU) 1095/2010 have been incorporated in the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, pp. 349–496).
See consolidated version.
Directive 2014/51/EU of the European Parliament and of the Council of 16 April 2014 amending Directives 2003/71/EC and 2009/138/EC and Regulations (EC) No 1060/2009, (EU) No 1094/2010 and (EU) No 1095/2010 in respect of the powers of the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (OJ L 153 of 22.5.2014, pp. 1–61).
Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174 of 1.7.2011, pp. 1–73).
See consolidated version.
Council Regulation (EU) No 1096/2010 of 17 November 2010 conferring specific tasks upon the European Central Bank concerning the functioning of the European Systemic Risk Board (OJ L 331,15.12.2010, pp. 162–164).
last update 17.11.2021
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32009R1223
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22.12.2009
EN
Official Journal of the European Union
L 342/59
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 30 November 2009
on cosmetic products
(recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (3) has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity.
(2)
A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community.
(3)
This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.
(4)
This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.
(5)
The environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (4), which enables the assessment of environmental safety in a cross-sectoral manner.
(6)
This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. The delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use.
(7)
The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products and anti-wrinkle products.
(8)
The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation.
(9)
Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a risk-benefit reasoning should not justify a risk to human health.
(10)
The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (5).
(11)
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community.
(12)
Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators.
(13)
It is necessary to determine under which conditions a distributor is to be considered as the responsible person.
(14)
All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators.
(15)
The European cosmetics sector is one of the industrial activities affected by counterfeiting, which may increase risks to human health. Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (6) and Directive 2004/48/EC of the European parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (7). In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation.
(16)
To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice.
(17)
For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located.
(18)
In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.
(19)
It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.
(20)
To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.
(21)
The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation.
(22)
For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market.
(23)
In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end.
(24)
In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface.
(25)
In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application.
(26)
The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III. Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.
(27)
To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.
(28)
To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment (8) has been finalised. To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure.
(29)
The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.
(30)
At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.
(31)
The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.
(32)
Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (9), their use in cosmetic products should be prohibited. However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission in the Annexes to this Regulation. With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS. Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No 1272/2008. Such substances should be continuously reviewed by the SCCS.
(33)
A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources. At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates. In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for these substances.
(34)
The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.
(35)
The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products. These opinions should be based on full information being made available by the responsible person.
(36)
Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.
(37)
In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.
(38)
The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.
(39)
Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (10) established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory.
(40)
The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers.
(41)
The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.
(42)
It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition.
(43)
The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals. In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit.
(44)
Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research.
(45)
The recognition by third countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals.
(46)
Transparency is needed regarding the ingredients used in cosmetic products. Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging. Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.
(47)
A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. This glossary should not be intended to constitute a limitative list of substances used in cosmetic products.
(48)
In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.
(49)
A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.
(50)
In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.
(51)
The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (11) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.
(52)
It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the ‘non-animal testing’ producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between products on the basis of animal testing criteria.
(53)
In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices.
(54)
Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected. To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety.
(55)
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States.
(56)
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products.
(57)
In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary. This procedure should, where possible, build upon existing Community rules for unsafe goods.
(58)
In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced.
(59)
The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation.
(60)
In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated.
(61)
In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary. This concerns in particular mutual assistance in the verification of product information files located in another Member State.
(62)
The Commission should be assisted by the SCCS, an independent risk assessment body.
(63)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12).
(64)
In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(65)
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures relating to CMRs, nanomaterials and potential risks to human health.
(66)
Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(67)
Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period.
(68)
In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.
(69)
Directive 76/768/EEC should be repealed. However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and the information kept by the responsible person should remain available for the same period of time.
(70)
This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.
(71)
Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPE, DEFINITIONS
Article 1
Scope and objective
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.
Article 2
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a)
‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
(b)
‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
(c)
‘mixture’ means a mixture or solution composed of two or more substances;
(d)
‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
(e)
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;
(f)
‘end user’ means either a consumer or professional using the cosmetic product;
(g)
‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;
(h)
‘placing on the market’ means the first making available of a cosmetic product on the Community market;
(i)
‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;
(j)
‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (13) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;
(k)
‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;
(l)
‘preservatives’ means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;
(m)
‘colorants’ means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;
(n)
‘UV-filters’ means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;
(o)
‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;
(p)
‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death;
(q)
‘withdrawal’ means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain;
(r)
‘recall’ means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;
(s)
‘frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.
2. For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.
3. In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
CHAPTER II
SAFETY, RESPONSIBILITY, FREE MOVEMENT
Article 3
Safety
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:
(a)
presentation including conformity with Directive 87/357/EEC;
(b)
labelling;
(c)
instructions for use and disposal;
(d)
any other indication or information provided by the responsible person defined in Article 4.
The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.
Article 4
Responsible person
1. Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.
2. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
3. For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.
The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
4. Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
5. For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.
The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.
6. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
Article 5
Obligations of responsible persons
1. Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.
2. Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.
Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.
3. Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.
Article 6
Obligations of distributors
1. In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements.
2. Before making a cosmetic product available on the market distributors shall verify that:
—
the labelling information provided for in Article 19(1)(a), (e) and (g) and Article 19(3) and (4) is present,
—
the language requirements provided for in Article 19(5) are fulfilled,
—
the date of minimum durability specified, where applicable under Article 19(1), has not passed.
3. Where distributors consider or have reason to believe that:
—
a cosmetic product is not in conformity with the requirements laid down in this Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements,
—
a cosmetic product which they have made available on the market is not in conformity with this Regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken.
Furthermore, where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken.
4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.
5. Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market. In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2, in a language which can be easily understood by that authority.
Article 7
Identification within the supply chain
At the request of a competent authority:
—
responsible persons shall identify the distributors to whom they supply the cosmetic product,
—
the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.
This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.
Article 8
Good manufacturing practice
1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Article 9
Free movement
Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.
CHAPTER III
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
Article 10
Safety assessment
1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.
The responsible person shall ensure that:
(a)
the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
(b)
an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;
(c)
the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).
2. The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
3. Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product shall comply with Community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognised as being equivalent by the Commission or the ECHA.
Article 11
Product information file
1. When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
2. The product information file shall contain the following information and data which shall be updated as necessary:
(a)
a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
(b)
the cosmetic product safety report referred to in Article 10(1);
(c)
a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
(d)
where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(e)
data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.
The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.
4. The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
Article 12
Sampling and analysis
1. Sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.
2. In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Article 13
Notification
1. Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:
(a)
the category of cosmetic product and its name or names, enabling its specific identification;
(b)
the name and address of the responsible person where the product information file is made readily accessible;
(c)
the country of origin in the case of import;
(d)
the Member State in which the cosmetic product is to be placed on the market;
(e)
the contact details of a physical person to contact in the case of necessity;
(f)
the presence of substances in the form of nanomaterials and:
(i)
their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation;
(ii)
the reasonably foreseeable exposure conditions;
(g)
the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;
(h)
the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
The first subparagraph shall also apply to cosmetic products notified under Directive 76/768/EEC.
2. When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.
3. As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission:
(a)
the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;
(b)
the Member State in which the cosmetic product is made available;
(c)
his name and address;
(d)
the name and address of the responsible person where the product information file is made readily accessible..
4. Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate the following to the responsible person:
(a)
the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;
(b)
the Member State in which the cosmetic product is made available;
(c)
his name and address.
On the basis of that communication, the responsible person shall submit to the Commission, by electronic means, the information referred to in paragraph 1 of this Article, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.
5. The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.
That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
6. The Commission shall, without delay, make the information referred to in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.
That information may be used by those bodies only for the purposes of medical treatment.
7. Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.
8. The Commission may, taking into account technical and scientific progress and specific needs related to market surveillance, amend paragraphs 1 to 7 by adding requirements.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
CHAPTER IV
RESTRICTIONS FOR CERTAIN SUBSTANCES
Article 14
Restrictions for substances listed in the Annexes
1. Without prejudice to Article 3, cosmetic products shall not contain any of the following:
(a)
prohibited substances
—
prohibited substances listed in Annex II;
(b)
restricted substances
—
restricted substances which are not used in accordance with the restrictions laid down in Annex III;
(c)
colorants
(i)
colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;
(ii)
without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;
(d)
preservatives
(i)
preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;
(ii)
without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;
(e)
UV-filters
(i)
UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;
(ii)
without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.
2. Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair which are listed there but not used in accordance with the conditions laid down in that Annex.
The decision of the Commission referred to in the first subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Article 15
Substances classified as CMR substances
1. The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.
2. The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.
However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:
(a)
they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (14);
(b)
there are no suitable alternative substances available, as documented in an analysis of alternatives;
(c)
the application is made for a particular use of the product category with a known exposure; and
(d)
they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.
Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.
In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.
The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.
3. By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances. This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.
4. When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties.
Article 16
Nanomaterials
1. For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured.
2. The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.
3. In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013.
In the latter case, cosmetic products containing nanomaterials placed on the market shall be notified to the Commission by the responsible person between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13.
The first and the second subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.
The information notified to the Commission shall contain at least the following:
(a)
the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;
(b)
the specification of the nanomaterial including size of particles, physical and chemical properties;
(c)
an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;
(d)
the toxicological profile of the nanomaterial;
(e)
the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;
(f)
the reasonably foreseeable exposure conditions.
The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof.
The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d).
4. In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. The Commission shall make this information public. The SCCS shall deliver its opinion within six months of the Commission's request. Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.
5. The Commission may, at any time, invoke the procedure in paragraph 4 where it has any safety concerns, for example due to new information supplied by a third party.
6. Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.
7. The Commission may, taking into account technical and scientific progress, amend paragraph 3 by adding requirements.
8. The measures, referred to in paragraphs 6 and 7, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
9. On imperative grounds of urgency the Commission may use the procedure referred to in Article 32(4).
10. The following information shall be made available by the Commission:
(a)
By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions. This catalogue shall be regularly updated thereafter and be made publicly available.
(b)
The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community, including those used as colorants, UV-filters and preservatives in a separate section. The first report shall be presented by 11 July 2014 The report update shall summarise, in particular, the new nanomaterials in new categories of cosmetic products, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.
11. The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions.
The first review shall be undertaken by 11 July 2018.
Article 17
Traces of prohibited substances
The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.
CHAPTER V
ANIMAL TESTING
Article 18
Animal testing
1. Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:
(a)
the placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
(b)
the placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
(c)
the performance within the Community of animal testing of finished cosmetic products in order to meet the requirements of this Regulation;
(d)
the performance within the Community of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, after the date on which such tests are required to be replaced by one or more validated alternative methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (15) or in Annex VIII to this Regulation.
2. The Commission, after consulting the SCCS and the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, has established timetables for the implementation of the provisions under points (a), (b) and (d) of paragraph 1, including deadlines for the phasing-out of the various tests. The timetables were made available to the public on 1 October 2004 and sent to the European Parliament and the Council. The period for implementation was limited to 11 March 2009 in relation to points (a), (b) and (d) of paragraph 1.
In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to 11 March 2013.
The Commission shall study possible technical difficulties in complying with the ban in relation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration. Information about the provisional and final results of these studies forms part of the yearly reports presented pursuant to Article 35.
On the basis of these annual reports, the timetables established as referred to in the first subparagraph, could be adapted up to 11 March 2009 in relation to the first subparagraph and may be adapted up to 11 March 2013 in relation to the second subparagraph and after consultation of the entities referred to in the first subparagraph.
The Commission shall study progress and compliance with the deadlines as well as possible technical difficulties in complying with the ban. Information about the provisional and final results of the Commission studies forms part of the yearly reports presented pursuant to Article 35. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in the second subparagraph, that for technical reasons one or more tests referred to in that subparagraph will not be developed and validated before the expiry of the period referred to therein it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.
In exceptional circumstances, where serious concerns arise as regards the safety of an existing cosmetic ingredient, a Member State may request the Commission to grant a derogation from paragraph 1. The request shall contain an evaluation of the situation and indicate the measures necessary. On this basis, the Commission may, after consulting the SCCS and by means of a reasoned decision, authorise the derogation. That authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.
A derogation shall be granted only where:
(a)
the ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;
(b)
the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.
The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the annual report presented by the Commission in accordance with Article 35.
The measures referred to in the sixth subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
3. For the purposes of this Article and Article 20:
(a)
‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype;
(b)
‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.
CHAPTER VI
CONSUMER INFORMATION
Article 19
Labelling
1. Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:
(a)
the name or registered name and the address of the responsible person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted. The country of origin shall be specified for imported cosmetic products;
(b)
the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;
(c)
the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’).
The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.
The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.
Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);
(d)
particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use;
(e)
the batch number of manufacture or the reference for identifying the cosmetic product. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;
(f)
the function of the cosmetic product, unless it is clear from its presentation;
(g)
a list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.
For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing. The following shall not, however, be regarded as ingredients:
(i)
impurities in the raw materials used;
(ii)
subsidiary technical materials used in the mixture but not present in the final product.
Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.
The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.
Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.
2. Where it is impossible for practical reasons to label the information mentioned in points (d) and (g) of paragraph 1 as provided, the following applies:
—
the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card;
—
unless impracticable, this information shall be referred to by abbreviated information or the symbol given in point 1 of Annex VII, which must appear on the container or packaging for the information referred in point (d) of paragraph 1 and on packaging for the information referred in point (g) of paragraph 1.
3. In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information referred to in point (g) of paragraph 1 to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
4. For cosmetic products that are not pre-packaged, are packaged at the point of sale at the purchaser's request, or are pre-packaged for immediate sale, Member States shall adopt detailed rules for indication of the information referred to in paragraph 1.
5. The language of the information mentioned in points (b), (c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4) shall be determined by the law of the Member States in which the product is made available to the end user.
6. The information mentioned in point (g) of paragraph 1 shall be expressed by using the common ingredient name set out in the glossary provided for in Article 33. In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.
Article 20
Product claims
1. In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.
2. The Commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim.
After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation, taking into account the provisions of Directive 2005/29/EC.
By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the second subparagraph. If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States.
3. The responsible person may refer, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished cosmetic product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products.
Article 21
Access to information for the public
Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.
The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.
CHAPTER VII
MARKET SURVEILLANCE
Article 22
In-market control
Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.
Member States shall also monitor compliance with the principles of good manufacturing practices.
Member States shall entrust to market surveillance authorities the necessary powers, resources and knowledge in order for those authorities to properly perform their tasks.
Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.
Article 23
Communication of serious undesirable effects
1. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:
(a)
all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;
(b)
the name of the cosmetic product concerned, enabling its specific identification;
(c)
the corrective measures taken by him, if any.
2. Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.
3. Where distributors report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States and to the responsible person.
4. Where end users or health professionals report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information on the cosmetic product concerned to the competent authorities of the other Member States and to the responsible person.
5. Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
Article 24
Information on substances
In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance. The list shall indicate the concentration of this substance in the cosmetic products.
Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
CHAPTER VIII
NON-COMPLIANCE, SAFEGUARD CLAUSE
Article 25
Non-compliance by the responsible person
1. Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:
(a)
the good manufacturing practice referred to in Article 8;
(b)
the safety assessment referred to in Article 10;
(c)
the requirements for the product information file referred to in Article 11;
(d)
the provisions on sampling and analysis referred to in Article 12;
(e)
the notification requirements referred to in Articles 13 and 16;
(f)
the restrictions for substances referred to in Articles 14, 15 and 17;
(g)
the animal testing requirements referred to in Article 18;
(h)
the labelling requirements referred to in Article 19(1), (2), (5) and (6);
(i)
the requirements related to product claims set out in Article 20;
(j)
the access to information for the public referred to in Article 21;
(k)
the communication of serious undesirable effects referred to in Article 23;
(l)
the information requirements on substances referred to in Article 24.
2. Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.
3. The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.
4. In the case of serious risks to human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State in which the cosmetic product is made available on the market, it shall inform the Commission and the competent authorities of the other Member States of the measures which it has required the responsible person to take.
5. The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:
(a)
where an immediate action is necessary in the event of serious risk to human health; or
(b)
where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.
In the event of serious risks to human health, that competent authority shall inform the Commission and the competent authorities of the other Member States, without delay, of the measures taken.
6. In the absence of a serious risk to human health, in the event that the responsible person does not take all appropriate measures, the competent authority shall without delay inform the competent authority of the Member State in which the responsible person is established of the measures taken.
7. For the purposes of paragraphs 4 and 5 of this Article, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (16) shall be used.
Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (17) shall also apply.
Article 26
Non-compliance by distributors
Competent authorities shall require distributors to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within a given reasonable time limit, commensurate with the nature of the risk, where there is non-compliance with obligations laid down in Article 6.
Article 27
Safeguard clause
1. In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.
2. The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States the measures taken and any supporting data.
For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.
Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.
3. The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.
4. Where the provisional measures are justified, Article 31(1) shall apply.
5. Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.
Article 28
Good administrative practices
1. Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based. It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.
2. Except in the case where immediate action is necessary for reasons of serious risk to human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.
3. Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with regard to the distributor for any decisions taken pursuant to Articles 26 and 27.
CHAPTER IX
ADMINISTRATIVE COOPERATION
Article 29
Cooperation between competent authorities
1. The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure the proper application and due enforcement of this Regulation and shall transmit to each other all information necessary with a view to applying this Regulation uniformly.
2. The Commission shall provide for the organisation of an exchange of experience between the competent authorities in order to coordinate the uniform application of this Regulation.
3. Cooperation may be part of initiatives developed at international level.
Article 30
Cooperation regarding verification of product information files
The competent authority of any Member State where the cosmetic product is made available may request the competent authority of the Member State where the product information file is made readily accessible to verify whether the product information file satisfies the requirements referred to in Article 11(2) and whether the information set out therein provides evidence of the safety of the cosmetic product.
The requesting competent authority shall provide a motivation for the request.
Upon that request, the competent authority requested shall, without undue delay and taking into account the degree of urgency, carry out the verification and shall inform the requesting competent authority of its findings.
CHAPTER X
IMPLEMENTING MEASURES, FINAL PROVISIONS
Article 31
Amendment of the Annexes
1. Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4).
2. The Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
3. Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consulting the SCCS, amend Annex I.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Article 32
Committee procedure
1. The Commission shall be assisted by the Standing Committee on Cosmetic Products.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.
Article 33
Glossary of common ingredient names
The Commission shall compile and update a glossary of common ingredient names. To this end, the Commission shall take account of internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a list of the substances authorised for use in cosmetic products.
The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union.
Article 34
Competent authorities, poison control centres or assimilated entities
1. Member States shall designate their national competent authorities.
2. Member States shall communicate the details of authorities referred to in paragraph 1 and of the poison centres and similar bodies referred to in Article 13(6) to the Commission. They shall communicate an update of these details as necessary.
3. The Commission shall compile and update a list of the authorities and bodies referred to in paragraph 2 and make it available to the public.
Article 35
Annual report on animal testing
Every year the Commission shall present a report to the European Parliament and the Council on:
(1)
progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;
(2)
progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;
(3)
the manner in which the specific needs of small and medium-sized enterprises have been taken into account.
Article 36
Formal objection against harmonised standards
1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall deliver its opinion without delay.
2. In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.
3. The Commission shall inform the Member States and the European standardisation body concerned. It shall, if necessary, request the revision of the harmonised standards concerned.
Article 37
Penalties
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.
Article 38
Repeal
Directive 76/768/EEC is repealed with effect from 11 July 2013, with the exception of Article 4b which is repealed with effect from 1 December 2010.
References to the repealed Directive shall be understood as references to this Regulation.
This Regulation shall be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.
However, the competent authorities shall continue to keep available the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons shall continue to keep readily accessible the information collected pursuant to Article 7a of that Directive until 11 July 2020.
Article 39
Transitional provisions
By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.
As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.
Article 40
Entry into force and date of application
1. This Regulation shall enter into force on the [twentieth day after its publication in the Official Journal of the European Union
2. It shall apply from 11 July 2013, with the exception of:
—
Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and
—
Article 16(3) second subparagraph, which shall apply from 11 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 November 2009.
For the European Parliament
The President
J. BUZEK
For the Council
The President
B. ASK
(1) OJ C 27, 3.2.2009, p. 34.
(2) Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 20 November 2009.
(3) OJ L 262, 27.9.1976, p. 169.
(4) OJ L 396, 30.12.2006, p. 1.
(5) OJ L 192, 11.7.1987, p. 49.
(6) OJ L 196, 2.8.2003, p. 7.
(7) OJ L 157, 30.4.2004, p. 45.
(8) OJ L 241, 10.9.2008, p. 21.
(9) OJ L 353, 31.12.2008, p. 1.
(10) OJ L 358, 18.12.1986, p. 1.
(11) OJ L 149, 11.6.2005, p. 22.
(12) OJ L 184, 17.7.1999, p. 23.
(13) OJ L 204, 21.7.1998, p. 37.
(14) OJ L 31, 1.2.2002, p. 1.
(15) OJ L 142, 31.5.2008, p. 1.
(16) OJ L 11, 15.1.2002, p. 4.
(17) OJ L 218, 13.8.2008, p. 30.
ANNEX I
COSMETIC PRODUCT SAFETY REPORT
The cosmetic product safety report shall, as a minimum, contain the following:
PART A – Cosmetic product safety information
1. Quantitative and qualitative composition of the cosmetic product
The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.
2. Physical/chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
3. Microbiological quality
The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.
Results of preservation challenge test.
4. Impurities, traces, information about the packaging material
The purity of the substances and mixtures.
In the case of traces of prohibited substances, evidence for their technical unavoidability.
The relevant characteristics of packaging material, in particular purity and stability.
5. Normal and reasonably foreseeable use
The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.
6. Exposure to the cosmetic product
Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
1)
The site(s) of application;
2)
The surface area(s) of application;
3)
The amount of product applied;
4)
The duration and frequency of use;
5)
The normal and reasonably foreseeable exposure route(s);
6)
The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account.
The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).
Particular consideration shall be given to any possible impacts on exposure due to particle sizes.
7. Exposure to the substances
Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
8. Toxicological profile of the substances
Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.
All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.
Particular consideration shall be given to any possible impacts on the toxicological profile due to
—
particle sizes, including nanomaterials,
—
impurities of the substances and raw material used, and
—
interaction of substances.
Any read-across shall be duly substantiated and justified.
The source of information shall be clearly identified.
9. Undesirable effects and serious undesirable effects
All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.
10. Information on the cosmetic product
Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.
PART B – Cosmetic product safety assessment
1. Assessment conclusion
Statement on the safety of the cosmetic product in relation to Article 3.
2. Labelled warnings and instructions of use
Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).
3. Reasoning
Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.
There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.
Possible interactions of the substances contained in the cosmetic product shall be assessed.
The consideration and non-consideration of the different toxicological profiles shall be duly justified.
Impacts of the stability on the safety of the cosmetic product shall be duly considered.
4. Assessor's credentials and approval of part B
Name and address of the safety assessor.
Proof of qualification of safety assessor.
Date and signature of safety assessor.
Preamble to Annexes II to VI
(1)
For the purposes of the Annexes II to VI:
(a)
‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes;
(b)
‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes;
(c)
‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes;
(d)
‘Skin product’ means a cosmetic product which is intended to be applied on the skin;
(e)
‘Lip product’ means a cosmetic product which is intended to be applied on the lips;
(f)
‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;
(g)
‘Nail product’ means a cosmetic product which is intended to be applied on nails;
(h)
‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity;
(i)
‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes
—
of the oral cavity,
—
on the rim of the eyes,
—
or of the external genital organs;
(j)
‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;
(k)
‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity.
(2)
In order to facilitate substance identification, the following descriptors are used:
—
The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;
—
The Chemical Abstracts Service numbers (CAS);
—
The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances (EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration number given under Regulation (EC) No 1907/2006;
—
The XAN which is the name approved by specific country (X), e.g. USAN which correspond to the United State approved name;
—
The name in the glossary of common ingredient names referred to in Article 33 of this Regulation.
(3)
Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned.
ANNEX II
LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS
Reference number
Substance identification
Chemical name/INN
CAS number
EC number
a
b
c
d
1
N-(5-Chlorobenzoxazol-2-yl)acetamide
35783-57-4
2
(2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts
51-84-3
200-128-9
3
Deanol aceglumate (INN)
3342-61-8
222-085-5
4
Spironolactone (INN)
52-01-7
200-133-6
5
[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts
51-24-1
200-086-1
6
Methotrexate (INN)
59-05-2
200-413-8
7
Aminocaproic acid (INN) and its salts
60-32-2
200-469-3
8
Cinchophen (INN), its salts, derivatives and salts of these derivatives
132-60-5
205-067-1
9
Thyropropic acid (INN) and its salts
51-26-3
10
Trichloroacetic acid
76-03-9
200-927-2
11
Aconitum napellus L. (leaves, roots and galenical preparations)
84603-50-9
283-252-6
12
Aconitine (principal alkaloid of Aconitum napellus L.) and its salts
302-27-2
206-121-7
13
Adonis vernalis L. and its preparations
84649-73-0
283-458-6
14
Epinephrine (INN)
51-43-4
200-098-7
15
Rauwolfia serpentina L., alkaloids and their salts
90106-13-1
290-234-1
16
Alkyne alcohols, their esters, ethers and salts
17
Isoprenaline (INN)
7683-59-2
231-687-7
18
Allyl isothiocyanate
57-06-7
200-309-2
19
Alloclamide (INN) and its salts
5486-77-1
20
Nalorphine (INN), its salts and ethers
62-67-9
200-546-1
21
Sympathicomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe
300-62-9
206-096-2
22
Aniline, its salts and its halogenated and sulphonated derivatives
62-53-3
200-539-3
23
Betoxycaine (INN) and its salts
3818-62-0
24
Zoxazolamine (INN)
61-80-3
200-519-4
25
Procainamide (INN), its salts and derivatives
51-06-9
200-078-8
26
Benzidine
92-87-5
202-199-1
27
Tuaminoheptane (INN), its isomers and salts
123-82-0
204-655-5
28
Octodrine (INN) and its salts
543-82-8
208-851-1
29
2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts
530-34-7
30
1,3-Dimethylpentylamine and its salts
105-41-9
203-296-1
31
4-Aminosalicylic acid and its salts
65-49-6
200-613-5
32
Toluidines, their isomers, salts and halogenated and sulphonated derivatives
26915-12-8
248-105-2
33
Xylidines, their isomers, salts and halogenated and sulphonated derivatives
1300-73-8
215-091-4
34
Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)
482-44-0
207-581-1
35
Ammi majus L. and its galenical preparations
90320-46-0
291-072-4
36
2,3-Dichloro-2-methylbutane
507-45-9
37
Substances with androgenic effect
38
Anthracene oil
120-12-7
204-371-1
39
Antibiotics
40
Antimony and its compounds
7440-36-0
231-146-5
41
Apocynum cannabinum L. and its preparations
84603-51-0
283-253-1
42
Apomorphine ((R) 5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts
58-00-4
200-360-0
43
Arsenic and its compounds
7440-38-2
231-148-6
44
Atropa belladonna L. and its preparations
8007-93-0
232-365-9
45
Atropine, its salts and derivatives
51-55-8
200-104-8
46
Barium salts, with the exception of barium sulphide under the conditions laid down in Annex III, and of barium sulfate, lakes, salts and pigments prepared from colouring agents when listed in Annex IV
47
Benzene
71-43-2
200-753-7
48
Benzimidazol-2(3H)-one
615-16-7
210-412-4
49
Benzazepines and benzodiazepines
12794-10-4
50
1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts
644-26-8
211-411-1
51
2,2,6-Trimethyl-4-piperidyl benzoate (eucaine) and its salts
500-34-5
52
Isocarboxazid (INN)
59-63-2
200-438-4
53
Bendroflumethiazide (INN) and its derivatives
73-48-3
200-800-1
54
Beryllium and its compounds
7440-41-7
231-150-7
55
Bromine, elemental
7726-95-6
231-778-1
56
Bretylium tosilate (INN)
61-75-6
200-516-8
57
Carbromal (INN)
77-65-6
201-046-6
58
Bromisoval (INN)
496-67-3
207-825-7
59
Brompheniramine (INN) and its salts
86-22-6
201-657-8
60
Benzilonium bromide (INN)
1050-48-2
213-885-5
61
Tetrylammonium bromide (INN)
71-91-0
200-769-4
62
Brucine
357-57-3
206-614-7
63
Tetracaine (INN) and its salts
94-24-6
202-316-6
64
Mofebutazone (INN)
2210-63-1
218-641-1
65
Tolbutamide (INN)
64-77-7
200-594-3
66
Carbutamide (INN)
339-43-5
206-424-4
67
Phenylbutazone (INN)
50-33-9
200-029-0
68
Cadmium and its compounds
7440-43-9
231-152-8
69
Cantharides, Cantharis vesicatoria
92457-17-5
296-298-7
70
Cantharidine
56-25-7
200-263-3
71
Phenprobamate (INN)
673-31-4
211-606-1
72
Nitroderivatives of carbazole
73
Carbon disulphide
75-15-0
200-843-6
74
Catalase
9001-05-2
232-577-1
75
Cephaeline and its salts
483-17-0
207-591-6
76
Chenopodium ambrosioides L. (essential oil)
8006-99-3
77
2,2,2-Trichloroethane-1,1-diol
302-17-0
206-117-5
78
Chlorine
7782-50-5
231-959-5
79
Chlorpropamide (INN)
94-20-2
202-314-5
80
Moved or deleted
81
4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)
5909-04-6
82
Chlorzoxazone (INN)
95-25-0
202-403-9
83
2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)
535-89-7
208-622-6
84
Chlorprothixene (INN) and its salts
113-59-7
204-032-8
85
Clofenamide (INN)
671-95-4
211-588-5
86
N,N-bis(2-chloroethyl)methylamine N-oxide and its salts
126-85-2
87
Chlormethine (INN) and its salts
51-75-2
200-120-5
88
Cyclophosphamide (INN) and its salts
50-18-0
200-015-4
89
Mannomustine (INN) and its salts
576-68-1
209-404-3
90
Butanilicaine (INN) and its salts
3785-21-5
91
Chlormezanone (INN)
80-77-3
201-307-4
92
Triparanol (INN)
78-41-1
201-115-0
93
2-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione (chlorophacinone-ISO)
3691-35-8
223-003-0
94
Chlorphenoxamine (INN)
77-38-3
95
Phenaglycodol (INN)
79-93-6
201-235-3
96
Chloroethane
75-00-3
200-830-5
97
Chromium; chromic acid and its salts
7440-47-3
231-157-5
98
Claviceps purpurea Tul., its alkaloids and galenical preparations
84775-56-4
283-885-8
99
Conium maculatum L. (fruit, powder, galenical preparations)
85116-75-2
285-527-6
100
Glycyclamide (INN)
664-95-9
211-557-6
101
Cobalt benzenesulphonate
23384-69-2
102
Colchicine, its salts and derivatives
64-86-8
200-598-5
103
Colchicoside and its derivatives
477-29-2
207-513-0
104
Colchicum autumnale L. and its galenical preparations
84696-03-7
283-623-2
105
Convallatoxin
508-75-8
208-086-3
106
Anamirta cocculus L. (fruit)
107
Croton tiglium L. (oil)
8001-28-3
108
1-Butyl-3-(N-crotonoylsulphanilyl)urea
52964-42-8
109
Curare and curarine
8063-06-7/22260-42-0
232-511-1/244-880-6
110
Synthetic curarizants
111
Hydrogen cyanide and its salts
74-90-8
200-821-6
112
Feclemine (INN); 2-(alpha-Cyclohexylbenzyl)-N,N,N',N'-tetraethyl-1,3-propanediamine
3590-16-7
113
Cyclomenol (INN) and its salts
5591-47-9
227-002-6
114
Sodium hexacyclonate (INN)
7009-49-6
115
Hexapropymate (INN)
358-52-1
206-618-9
116
Moved or deleted
117
O,O'-Diacetyl-N-allyl-N-normorphine
2748-74-5
118
Pipazetate (INN) and its salts
2167-85-3
218-508-8
119
5-(α,β-Dibromophenethyl)-5-methylhydantoin
511-75-1
208-133-8
120
N,N'-Pentamethylenebis(trimethylammonium) salts, e. g. pentamethonium bromide (INN)
541-20-8
208-771-7
121
N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g. azamethonium bromide (INN)
306-53-6
206-186-1
122
Cyclarbamate (INN)
5779-54-4
227-302-7
123
Clofenotane (INN); DDT (ISO)
50-29-3
200-024-3
124
N,N'-Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide (INN)
55-97-0
200-249-7
125
Dichloroethanes (ethylene chlorides) e.g. 1,2-Dichloroethane
107-06-2
203-458-1
126
Dichloroethylenes (acetylene chlorides) e.g. Vinylidene chloride (1,1-Dichloroethylene)
75-35-4
200-864-0
127
Lysergide (INN) (LSD) and its salts
50-37-3
200-033-2
128
2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts
3572-52-9
222-686-2
129
Cinchocaine (INN) and its salts
85-79-0
201-632-1
130
3-Diethylaminopropyl cinnamate
538-66-9
131
O,O'-Diethyl-O-4-nitrophenyl phosphorothioate (Parathion - ISO)
56-38-2
200-271-7
132
[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts, e. g. ambenonium chloride (INN)
115-79-7
204-107-5
133
Methyprylon (INN) and its salts
125-64-4
204-745-4
134
Digitaline and all heterosides of Digitalis purpurea L.
752-61-4
212-036-6
135
7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)
2530-97-4
136
Dioxethedrin (INN) and its salts
497-75-6
207-849-8
137
Piprocurarium iodide (INN)
3562-55-8
222-627-0
138
Propyphenazone (INN)
479-92-5
207-539-2
139
Tetrabenazine (INN) and its salts
58-46-8
200-383-6
140
Captodiame (INN)
486-17-9
207-629-1
141
Mefeclorazine (INN) and its salts
1243-33-0
142
Dimethylamine
124-40-3
204-697-4
143
1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts
963-07-5
213-512-6
144
Methapyrilene (INN) and its salts
91-80-5
202-099-8
145
Metamfepramone (INN) and its salts
15351-09-4
239-384-1
146
Amitriptyline (INN) and its salts
50-48-6
200-041-6
147
Metformin (INN) and its salts
657-24-9
211-517-8
148
Isosorbide dinitrate (INN)
87-33-2
201-740-9
149
Malononitrile
109-77-3
203-703-2
150
Succinonitrile
110-61-2
203-783-9
151
Dinitrophenol isomers
51-28-5/329-71-5/573-56-8/25550-58-7
200-087-7/206-348-1/209-357-9/247-096-2
152
Inproquone (INN)
436-40-8
153
Dimevamide (INN) and its salts
60-46-8
200-479-8
154
Diphenylpyraline (INN) and its salts
147-20-6
205-686-7
155
Sulfinpyrazone (INN)
57-96-5
200-357-4
156
N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e. g. isopropamide iodide (INN)
71-81-8
200-766-8
157
Benactyzine (INN)
302-40-9
206-123-8
158
Benzatropine (INN) and its salts
86-13-5
159
Cyclizine (INN) and its salts
82-92-8
201-445-5
160
5,5-Diphenyl-4-imidazolidone (Doxenitoin (INN))
3254-93-1
221-851-6
161
Probenecid (INN)
57-66-9
200-344-3
162
Disulfiram (INN); thiram (INN)
97-77-8/137-26-8
202-607-8/205-286-2
163
Emetine, its salts and derivatives
483-18-1
207-592-1
164
Ephedrine and its salts
299-42-3
206-080-5
165
Oxanamide (INN) and its derivatives
126-93-2
166
Eserine or physostigmine and its salts
57-47-6
200-332-8
167
Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VI
168
Choline salts and their esters, e. g. choline chloride (INN)
67-48-1
200-655-4
169
Caramiphen (INN) and its salts
77-22-5
201-013-6
170
Diethyl 4-nitrophenyl phosphate (Paraoxon - ISO)
311-45-5
206-221-0
171
Metethoheptazine (INN) and its salts
509-84-2
172
Oxpheneridine (INN) and its salts
546-32-7
173
Ethoheptazine (INN) and its salts
77-15-6
201-007-3
174
Metheptazine (INN) and its salts
469-78-3
175
Methylphenidate (INN) and its salts
113-45-1
204-028-6
176
Doxylamine (INN) and its salts
469-21-6
207-414-2
177
Tolboxane (INN)
2430-46-8
178
4-Benzyloxyphenol and 4-ethoxyphenol
103-16-2/622-62-8
203-083-3/210-748-1
179
Parethoxycaine (INN) and its salts
94-23-5
205-246-4
180
Fenozolone (INN)
15302-16-6
239-339-6
181
Glutethimide (INN) and its salts
77-21-4
201-012-0
182
Ethylene oxide
75-21-8
200-849-9
183
Bemegride (INN) and its salts
64-65-3
200-588-0
184
Valnoctamide (INN)
4171-13-5
224-033-7
185
Haloperidol (INN)
52-86-8
200-155-6
186
Paramethasone (INN)
53-33-8
200-169-2
187
Fluanisone (INN)
1480-19-9
216-038-8
188
Trifluperidol (INN)
749-13-3
189
Fluoresone (INN)
2924-67-6
220-889-0
190
Fluorouracil (INN)
51-21-8
200-085-6
191
Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III
7664-39-3
231-634-8
192
Furfuryltrimethylammonium salts, e. g. furtrethonium iodide (INN)
541-64-0
208-789-5
193
Galantamine (INN)
357-70-0
194
Progestogens
195
1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)
58-89-9
200-401-2
196
(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethano-naphthalene (endrin-ISO)
72-20-8
200-775-7
197
Hexachloroethane
67-72-1
200-666-4
198
(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene (isodrin-ISO)
465-73-6
207-366-2
199
Hydrastine, hydrastinine and their salts
118-08-1/6592-85-4
204-233-0/229-533-9
200
Hydrazides and their salts e.g. Isoniazid (INN)
54-85-3
200-214-6
201
Hydrazine, its derivatives and their salts
302-01-2
206-114-9
202
Octamoxin (INN) and its salts
4684-87-1
203
Warfarin (INN) and its salts
81-81-2
201-377-6
204
Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid
548-00-5
208-940-5
205
Methocarbamol (INN)
532-03-6
208-524-3
206
Propatylnitrate (INN)
2921-92-8
220-866-5
207
4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin
208
Fenadiazole (INN)
1008-65-7
209
Nitroxoline (INN) and its salts
4008-48-4
223-662-4
210
Hyoscyamine, its salts and derivatives
101-31-5
202-933-0
211
Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)
84603-65-6
283-265-7
212
Pemoline (INN) and its salts
2152-34-3
218-438-8
213
Iodine
7553-56-2
231-442-4
214
Decamethylenebis(trimethylammonium) salts, e. g. decamethonium bromide (INN)
541-22-0
208-772-2
215
Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)
8012-96-2
232-385-8
216
(2-Isopropylpent4-enoyl)urea (apronalide)
528-92-7
208-443-3
217
α-Santonin [(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]
481-06-1
207-560-7
218
Lobelia inflata L. and its galenical preparations
84696-23-1
283-642-6
219
Lobeline (INN) and its salts
90-69-7
202-012-3
220
Barbiturates
221
Mercury and its compounds, except those special cases included in Annex V
7439-97-6
231-106-7
222
3,4,5-Trimethoxyphenethylamine (Mescaline) and its salts
54-04-6
200-190-7
223
Metaldehyde
9002-91-9
224
2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts
305-13-5
225
Coumetarol (INN)
4366-18-1
224-455-1
226
Dextromethorphan (INN) and its salts
125-71-3
204-752-2
227
2-Methylheptylamine and its salts
540-43-2
228
Isometheptene (INN) and its salts
503-01-5
207-959-6
229
Mecamylamine (INN)
60-40-2
200-476-1
230
Guaifenesin (INN)
93-14-1
202-222-5
231
Dicoumarol (INN)
66-76-2
200-632-9
232
Phenmetrazine (INN), its derivatives and salts
134-49-6
205-143-4
233
Thiamazole (INN)
60-56-0
200-482-4
234
3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)
518-20-7
208-248-3
235
Carisoprodol (INN)
78-44-4
201-118-7
236
Meprobamate (INN)
57-53-4
200-337-5
237
Tefazoline (INN) and its salts
1082-56-0
238
Arecoline
63-75-2
200-565-5
239
Poldine metilsulfate (INN)
545-80-2
208-894-6
240
Hydroxyzine (INN)
68-88-2
200-693-1
241
2-Naphthol
135-19-3
205-182-7
242
1-and 2-Naphthylamines and their salts
134-32-7/91-59-8
205-138-7/202-080-4
243
3-(1-Naphthyl)-4-hydroxycoumarin
39923-41-6
244
Naphazoline (INN) and its salts
835-31-4
212-641-5
245
Neostigmine and its salts e. g. neostigmine bromide (INN)
114-80-7
204-054-8
246
Nicotine and its salts
54-11-5
200-193-3
247
Amyl nitrites
110-46-3
203-770-8
248
Inorganic nitrites, with the exception of sodium nitrite
14797-65-0
249
Nitrobenzene
98-95-3
202-716-0
250
Nitrocresols and their alkali metal salts
12167-20-3
251
Nitrofurantoin (INN)
67-20-9
200-646-5
252
Furazolidone (INN)
67-45-8
200-653-3
253
Nitroglycerin; Propane-1,2,3-triyl trinitrate
55-63-0
200-240-8
254
Acenocoumarol (INN)
152-72-7
205-807-3
255
Alkali pentacyanonitrosylferrate (2-) e.g.
14402-89-2/13755-38-9
238-373-9 / -
256
Nitrostilbenes, their homologues and their derivatives
257
Noradrenaline and its salts
51-41-2
200-096-6
258
Noscapine (INN) and its salts
128-62-1
204-899-2
259
Guanethidine (INN) and its salts
55-65-2
200-241-3
260
Oestrogens
261
Oleandrin
465-16-7
207-361-5
262
Chlortalidone (INN)
77-36-1
201-022-5
263
Pelletierine and its salts
2858-66-4/4396-01-4
220-673-6/224-523-0
264
Pentachloroethane
76-01-7
200-925-1
265
Pentaerithrityl tetranitrate (INN)
78-11-5
201-084-3
266
Petrichloral (INN)
78-12-6
267
Octamylamine (INN) and its salts
502-59-0
207-947-0
268
Picric acid
88-89-1
201-865-9
269
Phenacemide (INN)
63-98-9
200-570-2
270
Difencloxazine (INN)
5617-26-5
271
2-Phenylindan-1,3-dione (phenindione (INN))
83-12-5
201-454-4
272
Ethylphenacemide (pheneturide (INN))
90-49-3
201-998-2
273
Phenprocoumon (INN)
435-97-2
207-108-9
274
Fenyramidol (INN)
553-69-5
209-044-7
275
Triamterene (INN) and its salts
396-01-0
206-904-3
276
Tetraethyl pyrophosphate (TEPP - ISO)
107-49-3
203-495-3
277
Tritolyl phosphate
1330-78-5
215-548-8
278
Psilocybine (INN)
520-52-5
208-294-4
279
Phosphorus and metal phosphides
7723-14-0
231-768-7
280
Thalidomide (INN) and its salts
50-35-1
200-031-1
281
Physostigma venenosum Balf.
89958-15-6
289-638-0
282
Picrotoxin
124-87-8
204-716-6
283
Pilocarpine and its salts
92-13-7
202-128-4
284
α-Piperidin-2-ylbenzyl acetate, laevorotatory threoform (levofacetoperane (INN)) and its salts
24558-01-8
285
Pipradrol (INN) and its salts
467-60-7
207-394-5
286
Azacyclonol (INN) and its salts
115-46-8
204-092-5
287
Bietamiverine (INN)
479-81-2
207-538-7
288
Butopiprine (INN) and its salts
55837-15-5
259-848-7
289
Lead and its compounds
7439-92-1
231-100-4
290
Coniine
458-88-8
207-282-6
291
Prunus laurocerasus L. (‘cherry laurel water’)
89997-54-6
289-689-9
292
Metyrapone (INN)
54-36-4
200-206-2
293
Radioactive substances, as defined by Directive 96/29/Euratom (1) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation
294
Juniperus sabina L. (leaves, essential oil and galenical preparations)
90046-04-1
289-971-1
295
Hyoscine, its salts and derivatives
51-34-3
200-090-3
296
Gold salts
297
Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III
7782-49-2
231-957-4
298
Solanum nigrum L. and its galenical preparations
84929-77-1
284-555-6
299
Sparteine (INN) and its salts
90-39-1
201-988-8
300
Glucocorticoids (Corticosteroids)
301
Datura stramonium L. and its galenical preparations
84696-08-2
283-627-4
302
Strophantines, their aglucones and their respective derivatives
11005-63-3
234-239-9
303
Strophantus species and their galenical preparations
304
Strychnine and its salts
57-24-9
200-319-7
305
Strychnos species and their galenical preparations
306
Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961
307
Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts
308
Sultiame (INN)
61-56-3
200-511-0
309
Neodymium and its salts
7440-00-8
231-109-3
310
Thiotepa (INN)
52-24-4
200-135-7
311
Pilocarpus jaborandi Holmes and its galenical preparations
84696-42-4
283-649-4
312
Tellurium and its compounds
13494-80-9
236-813-4
313
Xylometazoline (INN) and its salts
526-36-3
208-390-6
314
Tetrachloroethylene
127-18-4
204-825-9
315
Carbon tetrachloride
56-23-5
200-262-8
316
Hexaethyl tetraphosphate
757-58-4
212-057-0
317
Thallium and its compounds
7440-28-0
231-138-1
318
Thevetia neriifolia Juss., glycoside extract
90147-54-9
290-446-4
319
Ethionamide (INN)
536-33-4
208-628-9
320
Phenothiazine (INN) and its compounds
92-84-2
202-196-5
321
Thiourea and its derivatives, with the exception of the one listed in Annex III
62-56-6
200-543-5
322
Mephenesin (INN) and its esters
59-47-2
200-427-4
323
Vaccines, toxins or serums defined as immunological medicinal products pursuant to Article 1(4) of Directive 2001/83/EC
324
Tranylcypromine (INN) and its salts
155-09-9
205-841-9
325
Trichloronitromethane (chloropicrine)
76-06-2
200-930-9
326
2,2,2-Tribromoethanol (tribromoethyl alcohol)
75-80-9
200-903-1
327
Trichlormethine (INN) and its salts
817-09-4
212-442-3
328
Tretamine (INN)
51-18-3
200-083-5
329
Gallamine triethiodide (INN)
65-29-2
200-605-1
330
Urginea scilla Steinh. and its galenical preparations
84650-62-4
283-520-2
331
Veratrine, its salts and galenical preparations
8051-02-3
613-062-00-4
332
Schoenocaulon officinale Lind (seeds and galenical preparations)
84604-18-2
283-296-6
333
Veratrum spp. and their preparations
90131-91-2
290-407-1
334
Vinyl chloride monomer
75-01-4
200-831-0
335
Ergocalciferol (INN) and cholecalciferol (vitamins D2 and D3)
50-14-6/67-97-0
200-014-9/200-673-2
336
Salts of O-alkyldithiocarbonic acids (xanthates)
337
Yohimbine and its salts
146-48-5
205-672-0
338
Dimethyl sulfoxide (INN)
67-68-5
200-664-3
339
Diphenhydramine (INN) and its salts
58-73-1
200-396-7
340
4-tert-Butylphenol
98-54-4
202-679-0
341
4-tert-Butylpyrocatechol
98-29-3
202-653-9
342
Dihydrotachysterol (INN)
67-96-9
200-672-7
343
Dioxane
123-91-1
204-661-8
344
Morpholine and its salts
110-91-8
203-815-1
345.
Pyrethrum album L. and its galenical preparations
346
2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate (Mepyramine maleate; pyrilamine maleate)
59-33-6
200-422-7
347
Tripelennamine (INN)
91-81-6
202-100-1
348
Tetrachlorosalicylanilides
7426-07-5
349
Dichlorosalicylanilides
1147-98-4
350
Tetrabromosalicylanilides
351
Dibromosalicylanilides
352
Bithionol (INN)
97-18-7
202-565-0
353
Thiuram monosulphides
97-74-5
202-605-7
354
Moved or deleted
355
Dimethylformamide (N,N-Dimethylformamide)
68-12-2
200-679-5
356
4-Phenylbut-3-en-2-one (Benzylidene acetone)
122-57-6
204-555-1
357
Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (coniferyl alcohol) except for normal content in natural essences used
358
Furocoumarines (e. g. trioxysalen (INN), 8-methoxypsoralen, 5-methoxypsoralen) except for normal content in natural essences used.
In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg
3902-71-4/298-81-7/484-20-8
223-459-0/206-066-9/207-604-5
359
Oil from the seeds of Laurus nobilis L.
84603-73-6
283-272-5
360
Safrole except for normal content in the natural essences used and provided the concentration does not exceed:
100 ppm in the finished product, 50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children
94-59-7
202-345-4
361
5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite (thymol iodide)
552-22-7
209-007-5
362
3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen (AETT; Versalide)
88-29-9
201-817-7
363
o-Phenylenediamine and its salts
95-54-5
202-430-6
364
4-Methyl-m-phenylenediamine (Toluene-2,4-diamine) and its salts
95-80-7
202-453-1
365
Aristolochic acid and its salts; Aristolochia spp. and their preparations
475-80-9/313-67-7/15918-62-4
202-499-6/206-238-3/-
366
Chloroform
67-66-3
200-663-8
367
2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)
1746-01-6
217-122-7
368
2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)
828-00-2
212-579-9
369
Pyrithione sodium (INNM) (2)
3811-73-2
223-296-5
370
N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan - ISO)
133-06-2
205-087-0
371
2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (Hexachlorophene (INN))
70-30-4
200-733-8
372
6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (Minoxidil (INN)) and its salts
38304-91-5
253-874-2
373
3,4',5-Tribromosalicylanilide (Tribromsalan (INN))
87-10-5
201-723-6
374
Phytolacca spp. and their preparations
65497-07-6/60820-94-2
375
Tretinoin (INN) (retinoic acid and its salts)
302-79-4
206-129-0
376
1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) and its salts
615-05-4
210-406-1
377
1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and its salts
5307-02-8
226-161-9
378
Colouring agent CI 12140
3118-97-6
221-490-4
379
Colouring agent CI 26105 (Solvent Red 24)
85-83-6
201-635-8
380
Colouring agent CI 42555 (Basic Violet 3)
Colouring agent CI 42555:1
Colouring agent CI 42555:2
548-62-9
467-63-0
208-953-6
207-396-6
381
Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))
14779-78-3
238-849-6
383
2-Amino-4-nitrophenol
99-57-0
202-767-9
384
2-Amino-5-nitrophenol
121-88-0
204-503-8
385
11-α-Hydroxypregn-4-ene-3,20-dione and its esters
80-75-1
201-306-9
386
Colouring agent CI 42640 ([4-[[4-(Dimethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt)
1694-09-3
216-901-9
387
Colouring agent CI 13065
587-98-4
209-608-2
388
Colouring agent CI 42535 (Basic Violet 1)
8004-87-3
389
Colouring agent CI 61554 (Solvent Blue 35)
17354-14-2
241-379-4
390
Anti-androgens of steroidal structure
391
Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, and the zirconium lakes, pigments or salts of the colouring agents when listed in Annex IV
7440-67-7
231-176-9
392
Moved or deleted
393
Acetonitrile
75-05-8
200-835-2
394
Tetrahydrozoline (Tetryzoline (INN)) and its salts
84-22-0
201-522-3
395
Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III
148-24-3/134-31-6
205-711-1/205-137-1
396
Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)
43143-11-9
256-115-3
397
Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts
3468-63-1
222-429-4
398
Colouring agent CI 45170 and CI 45170:1 (Basic Violet 10)
81-88-9/509-34-2
201-383-9/208-096-8
399
Lidocaine (INN)
137-58-6
205-302-8
400
1,2-Epoxybutane
106-88-7
203-438-2
401
Colouring agent CI 15585
5160-02-1/2092-56-0
225-935-3/218-248-5
402
Strontium lactate
29870-99-3
249-915-9
403
Strontium nitrate
10042-76-9
233-131-9
404
Strontium polycarboxylate
405
Pramocaine (INN)
140-65-8
205-425-7
406
4-Ethoxy-m-phenylenediamine and its salts
5862-77-1
407
2,4-Diaminophenylethanol and its salts
14572-93-1
408
Pyrocatechol (Catechol)
120-80-9
204-427-5
409
Pyrogallol
87-66-1
201-762-9
410
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-Nitrosoimino)bisethanol
62-75-9/621-64-7/1116-54-7
200-549-8/210-698-0/214-237-4
411
Secondary alkyl- and alkanolamines and their salts
412
4-Amino-2-nitrophenol
119-34-6
204-316-1
413
2-Methyl-m-phenylenediamine (Toluene-2,6-diamine)
823-40-5
212-513-9
414
4-tert.-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)
83-66-9
201-493-7
415
Moved or deleted
416
Cells, tissues or products of human origin
417
3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))
77-09-8
201-004-7
418
3-Imidazol-4-ylacrylic acid (Urocanic acid) and its ethyl ester
104-98-3/27538-35-8
203-258-4/248-515-1
419
Category 1 material and Category 2 material as defined in Articles 4 and 5 respectively of Regulation (EC) No 1774/2002 of the European Parliament and of the Council (3), and ingredients derived therefrom
420
Crude and refined coal tars
8007-45-2
232-361-7
421
1,1,3,3,5-Pentamethyl-4,6-dinitroindane (Moskene)
116-66-5
204-149-4
422
5-tert.-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)
145-39-1
205-651-6
423
Alanroot oil (Inula helenium L.), when used as a fragrance ingredient
97676-35-2
424
Benzyl cyanide, when used as a fragrance ingredient
140-29-4
205-410-5
425
Cyclamen alcohol, when used as a fragrance ingredient
4756-19-8
225-289-2
426
Diethyl maleate, when used as a fragrance ingredient
141-05-9
205-451-9
427
3,4-Dihydrocoumarin, when used as a fragrance ingredient
119-84-6
204-354-9
428
2,4-Dihydroxy-3-methylbenzaldehyde, when used as a fragrance ingredient
6248-20-0
228-369-5
429
3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol), when used as a fragrance ingredient
40607-48-5
254-999-5
430
4,6-Dimethyl-8-tert-butylcoumarin, when used as a fragrance ingredient
17874-34-9
241-827-9
431
Dimethyl citraconate, when used as a fragrance ingredient
617-54-9
432
7,11-Dimethyl-4,6,10-dodecatrien-3-one (Pseudomethylionone), when used as a fragrance ingredient
26651-96-7
247-878-3
433
6,10-Dimethyl-3,5,9-undecatrien-2-one (Pseudoionone)(, when used as a fragrance ingredient
141-10-6
205-457-1
434
Diphenylamine, when used as a fragrance ingredient
122-39-4
204-539-4
435
Ethyl acrylate, when used as a fragrance ingredient
140-88-5
205-438-8
436
Fig leaf absolute (Ficus carica L.), when used as a fragrance ingredient
68916-52-9
437
trans-2-Heptenal, when used as a fragrance ingredient
18829-55-5
242-608-0
438
trans-2-Hexenal diethyl acetal, when used as a fragrance ingredient
67746-30-9
266-989-8
439
trans-2-Hexenal dimethyl acetal, when used as a fragrance ingredient
18318-83-7
242-204-4
440
Hydroabietyl alcohol, when used as a fragrance ingredient
13393-93-6
236-476-3
441
6-Isopropyl-2-decahydronaphthalenol, when used as a fragrance ingredient
34131-99-2
251-841-7
442
7-Methoxycoumarin, when used as a fragrance ingredient
531-59-9
208-513-3
443
4-(4-Methoxyphenyl)-3-butene-2-one (Anisylidene acetone), when used as a fragrance ingredient
943-88-4
213-404-9
444
1-(4-Methoxyphenyl)-1-penten-3-one (alpha-Methylanisylideneacetone), when used as a fragrance ingredient
104-27-8
203-190-5
445
Methyl trans-2-butenoate, when used as a fragrance ingredient
623-43-8
210-793-7
446
7-Methylcoumarin, when used as a fragrance ingredient
2445-83-2
219-499-3
447
5-Methyl-2,3-hexanedione (Acetyl isovaleryl), when used as a fragrance ingredient
13706-86-0
237-241-8
448
2-Pentylidenecyclohexanone, when used as a fragrance ingredient
25677-40-1
247-178-8
449
3,6,10-Trimethyl-3,5,9-undecatrien-2-one (Pseudo-Isomethyl ionone), when used as a fragrance ingredient
1117-41-5
214-245-8
450
Verbena oil (Lippia citriodora Kunth.), when used as a fragrance ingredient
8024-12-2
451
Moved or deleted
452
6-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane
37894-46-5
253-704-7
453
Cobalt dichloride
7646-79-9
231-589-4
454
Cobalt sulphate
10124-43-3
233-334-2
455
Nickel monoxide
1313-99-1
215-215-7
456
Dinickel trioxide
1314-06-3
215-217-8
457
Nickel dioxide
12035-36-8
234-823-3
458
Trinickel disulphide
12035-72-2
234-829-6
459
Tetracarbonylnickel
13463-39-3
236-669-2
460
Nickel sulphide
16812-54-7
240-841-2
461
Potassium bromate
7758-01-2
231-829-8
462
Carbon monoxide
630-08-0
211-128-3
463
Buta-1,3-diene, see also entries 464-611
106-99-0
203-450-8
464
Isobutane, if it contains ≥ 0,1 % w/w Butadiene
75-28-5
200-857-2
465
Butane, if it contains ≥ 0,1 % w/w Butadiene
106-97-8
203-448-7
466
Gases (petroleum), C3-4, if they contain > 0,1 % w/w Butadiene
68131-75-9
268-629-5
467
Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber, if it contains > 0,1 % w/w Butadiene
68307-98-2
269-617-2
468
Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene
68307-99-3
269-618-8
469
Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene
68308-00-9
269-619-3
470
Tail gas (petroleum), cracked distillate hydrotreater stripper, if it contains > 0,1 % w/w Butadiene
68308-01-0
269-620-9
471
Tail gas (petroleum), gas oil catalytic cracking absorber, if it contains > 0,1 % w/w Butadiene
68308-03-2
269-623-5
472
Tail gas (petroleum), gas recovery plant, if it contains > 0,1 % w/w Butadiene
68308-04-3
269-624-0
473
Tail gas (petroleum), gas recovery plant deethaniser, if it contains > 0,1 % w/w Butadiene
68308-05-4
269-625-6
474
Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised naphtha fractionator, acid-free, if it contains > 0,1 % w/w Butadiene
68308-06-5
269-626-1
475
Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene
68308-07-6
269-627-7
476
Tail gas (petroleum), isomerised naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene
68308-08-7
269-628-2
477
Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene
68308-09-8
269-629-8
478
Tail gas (petroleum), straight-run distillate hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene
68308-10-1
269-630-3
479
Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser, if it contains > 0,1 % w/w Butadiene
68308-11-2
269-631-9
480
Tail gas (petroleum), vacuum gas oil hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene
68308-12-3
269-632-4
481
Gases (petroleum), catalytic cracked overheads, if they contain > 0,1 % w/w Butadiene
68409-99-4
270-071-2
482
Alkanes, C1-2, if they contain > 0,1 % w/w Butadiene
68475-57-0
270-651-5
483
Alkanes, C2-3, if they contain > 0,1 % w/w Butadiene
68475-58-1
270-652-0
484
Alkanes, C3-4, if they contain > 0,1 % w/w Butadiene
68475-59-2
270-653-6
485
Alkanes, C4-5, if they contain > 0,1 % w/w Butadiene
68475-60-5
270-654-1
486
Fuel-gases, if they contain > 0,1 % w/w Butadiene
68476-26-6
270-667-2
487
Fuel gases, crude oil distillates, if they contain > 0,1 % w/w Butadiene
68476-29-9
270-670-9
488
Hydrocarbons, C3-4, if they contain > 0,1 % w/w Butadiene
68476-40-4
270-681-9
489
Hydrocarbons, C4-5, if they contain > 0,1 % w/w Butadiene
68476-42-6
270-682-4
490
Hydrocarbons, C2-4, C3-rich, if they contain > 0,1 % w/w Butadiene
68476-49-3
270-689-2
491
Petroleum gases, liquefied, if they contain > 0,1 % w/w Butadiene
68476-85-7
270-704-2
492
Petroleum gases, liquefied, sweetened, if they contain > 0,1 % w/w Butadiene
68476-86-8
270-705-8
493
Gases (petroleum), C3-4, isobutane-rich if they contain > 0,1 % w/w Butadiene
68477-33-8
270-724-1
494
Distillates (petroleum), C3-6, piperylene-rich, if they contain > 0,1 % w/w Butadiene
68477-35-0
270-726-2
495
Gases (petroleum), amine system feed, if they contain > 0,1 % w/w Butadiene
68477-65-6
270-746-1
496
Gases (petroleum), benzene unit hydrodesulfurised off, if they contain > 0,1 % w/w Butadiene
68477-66-7
270-747-7
497
Gases (petroleum), benzene unit recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68477-67-8
270-748-2
498
Gases (petroleum), blend oil, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene
68477-68-9
270-749-8
499
Gases (petroleum), butane splitter overheads, if they contain > 0,1 % w/w Butadiene
68477-69-0
270-750-3
500
Gases (petroleum), C2-3, if they contain > 0,1 % w/w Butadiene
68477-70-3
270-751-9
501
Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich acid-free, if they contain > 0,1 % w/w Butadiene
68477-71-4
270-752-4
502
Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-rich, if they contain > 0,1 % w/w Butadiene
68477-72-5
270-754-5
503
Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C3-rich acid-free, if they contain > 0,1 % w/w Butadiene
68477-73-6
270-755-0
504
Gases (petroleum), catalytic cracker, if they contain > 0,1 % w/w Butadiene
68477-74-7
270-756-6
505
Gases (petroleum), catalytic cracker, C1-5-rich, if they contain > 0,1 % w/w Butadiene
68477-75-8
270-757-1
506
Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich, if they contain > 0,1 % w/w Butadiene
68477-76-9
270-758-7
507
Gases (petroleum), catalytic reformed naphtha stripper overheads, if they contain > 0,1 % w/w Butadiene
68477-77-0
270-759-2
508
Gases (petroleum), catalytic reformer, C1-4-rich, if they contain > 0,1 % w/w Butadiene
68477-79-2
270-760-8
509
Gases (petroleum), C6-8 catalytic reformer recycle, if they contain > 0,1 % w/w Butadiene
68477-80-5
270-761-3
510
Gases (petroleum), C6-8 catalytic reformer, if they contain > 0,1 % w/w Butadiene
68477-81-6
270-762-9
511
Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68477-82-7
270-763-4
512
Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed, if they contain > 0,1 % w/w Butadiene
68477-83-8
270-765-5
513
Gases (petroleum), C2-return stream, if they contain > 0,1 % w/w Butadiene
68477-84-9
270-766-0
514
Gases (petroleum), C4-rich, if they contain > 0,1 % w/w Butadiene
68477-85-0
270-767-6
515
Gases (petroleum), deethaniser overheads, if they contain > 0,1 % w/w Butadiene
68477-86-1
270-768-1
516
Gases (petroleum), deisobutaniser tower overheads, if they contain > 0,1 % w/w Butadiene
68477-87-2
270-769-7
517
Gases (petroleum), depropaniser dry, propene-rich, if they contain > 0,1 % w/w Butadiene
68477-90-7
270-772-3
518
Gases (petroleum), depropaniser overheads, if they contain > 0,1 % w/w Butadiene
68477-91-8
270-773-9
519
Gases (petroleum), dry sour, gas-concn. -unit-off, if they contain > 0,1 % w/w Butadiene
68477-92-9
270-774-4
520
Gases (petroleum), gas concn. reabsorber distn., if they contain > 0,1 % w/w Butadiene
68477-93-0
270-776-5
521
Gases (petroleum), gas recovery plant depropaniser overheads, if they contain > 0,1 % w/w Butadiene
68477-94-1
270-777-0
522
Gases (petroleum), Girbatol unit feed, if they contain > 0,1 % w/w Butadiene
68477-95-2
270-778-6
523
Gases (petroleum), hydrogen absorber off, if they contain > 0,1 % w/w Butadiene
68477-96-3
270-779-1
524
Gases (petroleum), hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68477-97-4
270-780-7
525
Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene
68477-98-5
270-781-2
526
Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen sulfide-free, if they contain > 0,1 % w/w Butadiene
68477-99-6
270-782-8
527
Gases (petroleum), recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68478-00-2
270-783-3
528
Gases (petroleum), reformer make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68478-01-3
270-784-9
529
Gases (petroleum), reforming hydrotreater, if they contain > 0,1 % w/w Butadiene
68478-02-4
270-785-4
530
Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich, if they contain > 0,1 % w/w Butadiene
68478-03-5
270-787-5
531
Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene
68478-04-6
270-788-0
532
Gases (petroleum), thermal cracking distn., if they contain > 0,1 % w/w Butadiene
68478-05-7
270-789-6
533
Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum, if it contains > 0,1 % w/w Butadiene
68478-21-7
270-802-5
534
Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber, if it contains > 0,1 % w/w Butadiene
68478-22-8
270-803-0
535
Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurised combined fractionater, if it contains > 0,1 % w/w Butadiene
68478-24-0
270-804-6
536
Tail gas (petroleum), catalytic cracker refractionation absorber, if it contains > 0,1 % w/w Butadiene
68478-25-1
270-805-1
537
Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene
68478-26-2
270-806-7
538
Tail gas (petroleum), catalytic reformed naphtha separator, if it contains > 0,1 % w/w Butadiene
68478-27-3
270-807-2
539
Tail gas (petroleum), catalytic reformed naphtha stabiliser, if it contains > 0,1 % w/w Butadiene
68478-28-4
270-808-8
540
Tail gas (petroleum), cracked distillate hydrotreater separator, if it contains > 0,1 % w/w Butadiene
68478-29-5
270-809-3
541
Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator, if it contains > 0,1 % w/w Butadiene
68478-30-8
270-810-9
542
Tail gas (petroleum), saturate gas plant mixed stream, C4-rich, if it contains > 0,1 % w/w Butadiene
68478-32-0
270-813-5
543
Tail gas (petroleum), saturate gas recovery plant, C1-2-rich, if it contains > 0,1 % w/w Butadiene
68478-33-1
270-814-0
544
Tail gas (petroleum), vacuum residues thermal cracker, if it contains > 0,1 % w/w Butadiene
68478-34-2
270-815-6
545
Hydrocarbons, C3-4-rich, petroleum distillate, if they contain > 0,1 % w/w Butadiene
68512-91-4
270-990-9
546
Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads, if they contain > 0,1 % w/w Butadiene
68513-14-4
270-999-8
547
Gases (petroleum), full-range straight-run naphtha dehexaniser off, if they contain > 0,1 % w/w Butadiene
68513-15-5
271-000-8
548
Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich, if they contain > 0,1 % w/w Butadiene
68513-16-6
271-001-3
549
Gases (petroleum), light straight-run naphtha stabiliser off, if they contain > 0,1 % w/w Butadiene
68513-17-7
271-002-9
550
Gases (petroleum), reformer effluent high-pressure flash drum off, if they contain > 0,1 % w/w Butadiene
68513-18-8
271-003-4
551
Gases (petroleum), reformer effluent low-pressure flash drum off, if they contain > 0,1 % w/w Butadiene
68513-19-9
271-005-5
552
Residues (petroleum), alkylation splitter, C4-rich, if they contain > 0,1 % w/w Butadiene
68513-66-6
271-010-2
553
Hydrocarbons, C1-4, if they contain > 0,1 % w/w Butadiene
68514-31-8
271-032-2
554
Hydrocarbons, C1-4, sweetened, if they contain > 0,1 % w/w Butadiene
68514-36-3
271-038-5
555
Gases (petroleum), oil refinery gas distn. off, if they contain > 0,1 % w/w Butadiene
68527-15-1
271-258-1
556
Hydrocarbons, C1-3, if they contain > 0,1 % w/w Butadiene
68527-16-2
271-259-7
557
Hydrocarbons, C1-4, debutaniser fraction, if they contain > 0,1 % w/w Butadiene
68527-19-5
271-261-8
558
Gases (petroleum), benzene unit hydrotreater depentaniser overheads, if they contain > 0,1 % w/w Butadiene
68602-82-4
271-623-5
559
Gases (petroleum), C1-5, wet, if they contain > 0,1 % w/w Butadiene
68602-83-5
271-624-0
560
Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator, if they contain > 0,1 % w/w Butadiene
68602-84-6
271-625-6
561
Hydrocarbons, C2-4, if they contain > 0,1 % w/w Butadiene
68606-25-7
271-734-9
562
Hydrocarbons, C3, if they contain > 0,1 % w/w Butadiene
68606-26-8
271-735-4
563
Gases (petroleum), alkylation feed, if they contain > 0,1 % w/w Butadiene
68606-27-9
271-737-5
564
Gases (petroleum), depropaniser bottoms fractionation off, if they contain > 0,1 % w/w Butadiene
68606-34-8
271-742-2
565
Petroleum products, refinery gases, if they contain > 0,1 % w/w Butadiene
68607-11-4
271-750-6
566
Gases (petroleum), hydrocracking low-pressure separator, if they contain > 0,1 % w/w Butadiene
68783-06-2
272-182-1
567
Gases (petroleum), refinery blend, if they contain > 0,1 % w/w Butadiene
68783-07-3
272-183-7
568
Gases (petroleum), catalytic cracking, if they contain > 0,1 % w/w Butadiene
68783-64-2
272-203-4
569
Gases (petroleum), C2-4, sweetened, if they contain > 0,1 % w/w Butadiene
68783-65-3
272-205-5
570
Gases (petroleum), refinery, if they contain > 0,1 % w/w Butadiene
68814-67-5
272-338-9
571
Gases (petroleum), platformer products separator off, if they contain > 0,1 % w/w Butadiene
68814-90-4
272-343-6
572
Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off, if they contain > 0,1 % w/w Butadiene
68911-58-0
272-775-5
573
Gases (petroleum), hydrotreated sour kerosine flash drum, if they contain > 0,1 % w/w Butadiene
68911-59-1
272-776-0
574
Gases (petroleum), crude oil fractionation off, if they contain > 0,1 % w/w Butadiene
68918-99-0
272-871-7
575
Gases (petroleum), dehexaniser off, if they contain > 0,1 % w/w Butadiene
68919-00-6
272-872-2
576
Gases (petroleum), distillate unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene
68919-01-7
272-873-8
577
Gases (petroleum), fluidised catalytic cracker fractionation off if they contain > 0,1 % w/w Butadiene
68919-02-8
272-874-3
578
Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off, if they contain > 0,1 % w/w Butadiene
68919-03-9
272-875-9
579
Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene
68919-04-0
272-876-4
580
Gases (petroleum), light straight run gasoline fractionation stabiliser off, if they contain > 0,1 % w/w Butadiene
68919-05-1
272-878-5
581
Gases (petroleum), naphtha unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene
68919-06-2
272-879-0
582
Gases (petroleum), platformer stabiliser off, light ends fractionation, if they contain > 0,1 % w/w Butadiene
68919-07-3
272-880-6
583
Gases (petroleum), preflash tower off, crude distn., if they contain > 0,1 % w/w Butadiene
68919-08-4
272-881-1
584
Gases (petroleum), straight-run naphtha catalytic reforming off, if they contain > 0,1 % w/w Butadiene
68919-09-5
272-882-7
585
Gases (petroleum), straight-run stabiliser off, if they contain > 0,1 % w/w Butadiene
68919-10-8
272-883-2
586
Gases (petroleum), tar stripper off, if they contain > 0,1 % w/w Butadiene
68919-11-9
272-884-8
587
Gases (petroleum), unifiner stripper off, if they contain > 0,1 % w/w Butadiene
68919-12-0
272-885-3
588
Gases (petroleum), fluidised catalytic cracker splitter overheads, if they contain > 0,1 % w/w Butadiene
68919-20-0
272-893-7
589
Gases (petroleum), catalytic cracked naphtha debutaniser, if they contain > 0,1 % w/w Butadiene
68952-76-1
273-169-3
590
Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser, if it contains > 0,1 % w/w Butadiene
68952-77-2
273-170-9
591
Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator, if it contains > 0,1 % w/w Butadiene
68952-79-4
273-173-5
592
Tail gas (petroleum), straight-run naphtha hydrodesulfurised, if it contains > 0,1 % w/w Butadiene
68952-80-7
273-174-0
593
Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber, if it contains > 0,1 % w/w Butadiene
68952-81-8
273-175-6
594
Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking, if it contains > 0,1 % w/w Butadiene
68952-82-9
273-176-1
595
Gases (petroleum), light steam-cracked, butadiene conc., if they contain > 0,1 % w/w Butadiene
68955-28-2
273-265-5
596
Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulfuriser overhead fractionation, if they contain > 0,1 % w/w Butadiene
68955-33-9
273-269-7
597
Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead, if they contain > 0,1 % w/w Butadiene
68955-34-0
273-270-2
598
Gases (petroleum), crude distn. and catalytic cracking, if they contain > 0,1 % w/w Butadiene
68989-88-8
273-563-5
599
Hydrocarbons, C4, if they contain > 0,1 % w/w Butadiene
87741-01-3
289-339-5
600
Alkanes, C1-4, C3-rich, if they contain > 0,1 % w/w Butadiene
90622-55-2
292-456-4
601
Gases (petroleum), gas oil diethanolamine scrubber off, if they contain > 0,1 % w/w Butadiene
92045-15-3
295-397-2
602
Gases (petroleum), gas oil hydrodesulfurisation effluent, if they contain > 0,1 % w/w Butadiene
92045-16-4
295-398-8
603
Gases (petroleum), gas oil hydrodesulfurisation purge, if they contain > 0,1 % w/w Butadiene
92045-17-5
295-399-3
604
Gases (petroleum), hydrogenator effluent flash drum off, if they contain > 0,1 % w/w Butadiene
92045-18-6
295-400-7
605
Gases (petroleum), naphtha steam cracking high-pressure residual, if they contain > 0,1 % w/w Butadiene
92045-19-7
295-401-2
606
Gases (petroleum), residue visbreaking off, if they contain > 0,1 % w/w Butadiene
92045-20-0
295-402-8
607
Gases (petroleum), steam-cracker C3-rich, if they contain > 0,1 % w/w Butadiene
92045-22-2
295-404-9
608
Hydrocarbons, C4, steam-cracker distillate, if they contain > 0,1 % w/w Butadiene
92045-23-3
295-405-4
609
Petroleum gases, liquefied, sweetened, C4 fraction, if they contain > 0,1 % w/w Butadiene
92045-80-2
295-463-0
610
Hydrocarbons, C4, 1,3-butadiene- and isobutene-free, if they contain > 0,1 % w/w Butadiene
95465-89-7
306-004-1
611
Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free, if they contain > 0,1 % w/w Butadiene
97722-19-5
307-769-4
612
Benzo[def]chrysene (benzo[a]pyrene)
50-32-8
200-028-5
613
Pitch, coal tar-petroleum, if it contains > 0,005 % w/w benzo[a]pyrene
68187-57-5
269-109-0
614
Distillates (coal-petroleum), condensed-ring arom., if they contain > 0,005 % w/w benzo[a]pyrene
68188-48-7
269-159-3
615
Moved or deleted
616
Moved or deleted
617
Creosote oil, acenaphthene fraction, acenaphthene-free, if it contains > 0,005 % w/w benzo[a]pyrene
90640-85-0
292-606-9
618
Pitch, coal tar, low-temp., if it contains > 0,005 % w/w benzo[a]pyrene
90669-57-1
292-651-4
619
Pitch, coal tar, low-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene
90669-58-2
292-653-5
620
Pitch, coal tar, low-temp., oxidised, if it contains > 0,005 % w/w benzo[a]pyrene
90669-59-3
292-654-0
621
Extract residues (coal), brown, if they contain > 0,005 % w/w benzo[a]pyrene
91697-23-3
294-285-0
622
Paraffin waxes (coal), brown-coal high-temp. tar, if they contain > 0,005 % w/w benzo[a]pyrene
92045-71-1
295-454-1
623
Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated, if they contain > 0,005 % w/w benzo[a]pyrene
92045-72-2
295-455-7
624
Waste solids, coal-tar pitch coking, if they contain > 0,005 % w/w benzo[a]pyrene
92062-34-5
295-549-8
625
Pitch, coal tar, high-temp., secondary, if it contains > 0,005 % w/w benzo[a]pyrene
94114-13-3
302-650-3
626
Residues (coal), liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene
94114-46-2
302-681-2
627
Coal liquids, liq. solvent extn. soln., if they contain > 0,005 % w/w benzo[a]pyrene
94114-47-3
302-682-8
628
Coal liquids, liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene
94114-48-4
302-683-3
629
Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated, if they contain > 0,005 % w/w benzo[a]pyrene
97926-76-6
308-296-6
630
Paraffin waxes (coal), brown-coal high-temp tar, clay-treated, if they contain > 0,005 % w/w benzo[a]pyrene
97926-77-7
308-297-1
631
Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated, if they contain > 0,005 % w/w benzo[a]pyrene
97926-78-8
308-298-7
632
Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if they contain > 0,005 % w/w benzo[a]pyrene
101316-45-4
309-851-5
633
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene
101794-74-5
309-956-6
634
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene
101794-75-6
309-957-1
635
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene
101794-76-7
309-958-7
636
Pitch, coal tar, high-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene
121575-60-8
310-162-7
637
Dibenz[a,h]anthracene
53-70-3
200-181-8
638
Benz[a]anthracene
56-55-3
200-280-6
639
Benzo[e]pyrene
192-97-2
205-892-7
640
Benzo[j]fluoranthene
205-82-3
205-910-3
641
Benz(e)acephenanthrylene
205-99-2
205-911-9
642
Benzo(k)fluoranthene
207-08-9
205-916-6
643
Chrysene
218-01-9
205-923-4
644
2-Bromopropane
75-26-3
200-855-1
645
Trichloroethylene
79-01-6
201-167-4
646
1,2-Dibromo-3-chloropropane
96-12-8
202-479-3
647
2,3-Dibromopropan-1-ol
96-13-9
202-480-9
648
1,3-Dichloropropan-2-ol
96-23-1
202-491-9
649
α,α,α-Trichlorotoluene
98-07-7
202-634-5
650
α-Chlorotoluene (Benzyl chloride)
100-44-7
202-853-6
651
1,2-Dibromoethane
106-93-4
203-444-5
652
Hexachlorobenzene
118-74-1
204-273-9
653
Bromoethylene (Vinyl bromide)
593-60-2
209-800-6
654
1,4-Dichlorobut-2-ene
764-41-0
212-121-8
655
Methyloxirane (Propylene oxide)
75-56-9
200-879-2
656
(Epoxyethyl)benzene (Styrene oxide)
96-09-3
202-476-7
657
1-Chloro-2,3-epoxypropane (Epichlorohydrin)
106-89-8
203-439-8
658
R-1-Chloro-2,3-epoxypropane
51594-55-9
424-280-2
659
1,2-Epoxy-3-phenoxypropane (Phenylglycidyl ether)
122-60-1
204-557-2
660
2,3-Epoxypropan-1-ol (Glycidol)
556-52-5
209-128-3
661
R-2,3-Epoxy-1-propanol
57044-25-4
404-660-4
662
2,2′-Bioxirane (1,2:3,4-Diepoxybutane)
1464-53-5
215-979-1
663
(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; Epoxiconazole
133855-98-8
406-850-2
664
Chloromethyl methyl ether
107-30-2
203-480-1
665
2-Methoxyethanol and its acetate (2-Methoxyethyl acetate)
109-86-4/110-49-6
203-713-7/203-772-9
666
2-Ethoxyethanol and its acetate (2-Ethoxyethyl acetate)
110-80-5/111-15-9
203-804-1/203-839-2
667
Oxybis[chloromethane], bis (Chloromethyl) ether
542-88-1
208-832-8
668
2-Methoxypropanol
1589-47-5
216-455-5
669
Propiolactone
57-57-8
200-340-1
670
Dimethylcarbamoyl chloride
79-44-7
201-208-6
671
Urethane (Ethyl carbamate)
51-79-6
200-123-1
672
Moved or deleted
673
Moved or deleted
674
Methoxyacetic acid
625-45-6
210-894-6
675
Dibutyl phthalate
84-74-2
201-557-4
676
bis(2-Methoxyethyl) ether (Dimethoxydiglycol)
111-96-6
203-924-4
677
bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate)
117-81-7
204-211-0
678
bis(2-Methoxyethyl) phthalate
117-82-8
204-212-6
679
2-Methoxypropyl acetate
70657-70-4
274-724-2
680
2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-methyl]thio]acetate
80387-97-9
279-452-8
681
Acrylamide, unless regulated elsewhere in this Regulation
79-06-1
201-173-7
682
Acrylonitrile
107-13-1
203-466-5
683
2-Nitropropane
79-46-9
201-209-1
684
Dinoseb, its salts and esters with the exception of those specified elsewhere in this list
88-85-7
201-861-7
685
2-Nitroanisole
91-23-6
202-052-1
686
4-Nitrobiphenyl
92-93-3
202-204-7
687
2,4-Dinitrotoluene;
Dinitrotoluene, technical grade
121-14-2/25321-14-6
204-450-0/246-836-1
688
Binapacryl
485-31-4
207-612-9
689
2-Nitronaphthalene
581-89-5
209-474-5
690
2,3-Dinitrotoluene
602-01-7
210-013-5
691
5-Nitroacenaphthene
602-87-9
210-025-0
692
2,6-Dinitrotoluene
606-20-2
210-106-0
693
3,4-Dinitrotoluene
610-39-9
210-222-1
694
3,5-Dinitrotoluene
618-85-9
210-566-2
695
2,5-Dinitrotoluene
619-15-8
210-581-4
696
Dinoterb, its salts and esters
1420-07-1
215-813-8
697
Nitrofen
1836-75-5
217-406-0
698
Moved or deleted
699
Diazomethane
334-88-3
206-382-7
700
1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)
2475-45-8
219-603-7
701
Moved or deleted
702
1-Methyl-3-nitro-1-nitrosoguanidine
70-25-7
200-730-1
703
Moved or deleted
704
Moved or deleted
705
4,4′-Methylenedianiline
101-77-9
202-974-4
706
4,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride
569-61-9
209-321-2
707
4,4′-Methylenedi-o-toluidine
838-88-0
212-658-8
708
o-Anisidine
90-04-0
201-963-1
709
3,3′-Dimethoxybenzidine (ortho-Dianisidine) and its salts
119-90-4
204-355-4
710
Moved or deleted
711
o-Dianisidine based azo dyes
712
3,3′-Dichlorobenzidine
91-94-1
202-109-0
713
Benzidine dihydrochloride
531-85-1
208-519-6
714
[[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate
531-86-2
208-520-1
715
3,3′-Dichlorobenzidine dihydrochloride
612-83-9
210-323-0
716
Benzidine sulphate
21136-70-9
244-236-4
717
Benzidine acetate
36341-27-2
252-984-8
718
3,3′-Dichlorobenzidine dihydrogen bis(sulphate)
64969-34-2
265-293-1
719
3,3′-Dichlorobenzidine sulphate
74332-73-3
277-822-3
720
Benzidine based azo dyes
721
4,4′-Bi-o-toluidine (ortho-Tolidine)
119-93-7
204-358-0
722
4,4′-Bi-o-toluidine dihydrochloride
612-82-8
210-322-5
723
[3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogen sulphate)
64969-36-4
265-294-7
724
4,4′-Bi-o-toluidine sulphate
74753-18-7
277-985-0
725
o-Tolidine based dyes
611-030-00-4
726
Biphenyl-4-ylamine (4-Aminobiphenyl) and its salts
92-67-1
202-177-1
727
Azobenzene
103-33-3
203-102-5
728
(Methyl-ONN-azoxy)methyl acetate
592-62-1
209-765-7
729
Cycloheximide
66-81-9
200-636-0
730
2-Methylaziridine
75-55-8
200-878-7
731
Imidazolidine-2-thione (Ethylene thiourea)
96-45-7
202-506-9
732
Furan
110-00-9
203-727-3
733
Aziridine
151-56-4
205-793-9
734
Captafol
2425-06-1
219-363-3
735
Carbadox
6804-07-5
229-879-0
736
Flumioxazin
103361-09-7
613-166-00-X
737
Tridemorph
24602-86-6
246-347-3
738
Vinclozolin
50471-44-8
256-599-6
739
Fluazifop-butyl
69806-50-4
274-125-6
740
Flusilazole
85509-19-9
014-017-00-6
741
1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TGIC)
2451-62-9
219-514-3
742
Thioacetamide
62-55-5
200-541-4
743
Moved or deleted
744
Formamide
75-12-7
200-842-0
745
N-Methylacetamide
79-16-3
201-182-6
746
N-Methylformamide
123-39-7
204-624-6
747
N,N-Dimethylacetamide
127-19-5
204-826-4
748
Hexamethylphosphoric-triamide
680-31-9
211-653-8
749
Diethyl sulphate
64-67-5
200-589-6
750
Dimethyl sulphate
77-78-1
201-058-1
751
1,3-Propanesultone
1120-71-4
214-317-9
752
Dimethylsulphamoyl-chloride
13360-57-1
236-412-4
753
Sulfallate
95-06-7
202-388-9
754
A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole
403-250-2
755
(+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate
119738-06-6
607-373-00-4
756
6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile
85136-74-9-
400-340-3
757
(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate
108225-03-2
402-060-7
758
Trisodium [4′-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4″-(6-benzoylamino-3-Sulfonato-2-naphthylazo)-biphenyl-1,3′,3″,1‴-tetraolato-O,O′,O″,O‴]copper(II)
413-590-3
759
A mixture of: N-[3-Hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and N-[2,3-bis-(2-Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide and 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide
412-790-8
760
1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (Teroxirone)
59653-74-6
616-091-00-0
761
Erionite
12510-42-8
650-012-00-0
762
Asbestos
12001-28-4
650-013-00-6
763
Petroleum
8002-05-9
232-298-5
764
Distillates (petroleum), heavy hydrocracked, if they contain > 3 % w/w DMSO extract
64741-76-0
265-077-7
765
Distillates (petroleum), solvent-refined heavy paraffinic, if they contain > 3 % w/w DMSO extract
64741-88-4
265-090-8
766
Distillates (petroleum), solvent-refined light paraffinic, if they contain > 3 % w/w DMSO extract
64741-89-5
265-091-3
767
Residual oils (petroleum), solvent deasphalted, if they contain > 3 % w/w DMSO extract
64741-95-3
265-096-0
768
Distillates (petroleum), solvent-refined heavy naphthenic, if they contain > 3 % w/w DMSO extract
64741-96-4
265-097-6
769
Distillates (petroleum), solvent-refined light naphthenic, if they contain > 3 % w/w DMSO extract
64741-97-5
265-098-1
770
Residual oils (petroleum), solvent-refined, if they contain > 3 % w/w DMSO extract
64742-01-4
265-101-6
771
Distillates (petroleum), clay-treated heavy paraffinic, if they contain > 3 % w/w DMSO extract
64742-36-5
265-137-2
772
Distillates (petroleum), clay-treated light paraffinic, if they contain > 3 % w/w DMSO extract
64742-37-6
265-138-8
773
Residual oils (petroleum), clay-treated, if they contain > 3 % w/w DMSO extract
64742-41-2
265-143-5
774
Distillates (petroleum), clay-treated heavy naphthenic, if they contain > 3 % w/w DMSO extract
64742-44-5
265-146-1
775
Distillates (petroleum), clay-treated light naphthenic, if they contain > 3 % w/w DMSO extract
64742-45-6
265-147-7
776
Distillates (petroleum), hydrotreated heavy naphthenic, if they contain > 3 % w/w DMSO extract
64742-52-5
265-155-0
777
Distillates (petroleum), hydrotreated light naphthenic, if they contain > 3 % w/w DMSO extract
64742-53-6
265-156-6
778
Distillates (petroleum), hydrotreated heavy paraffinic, if they contain > 3 % w/w DMSO extract
64742-54-7
265-157-1
779
Distillates (petroleum), hydrotreated light paraffinic, if they contain > 3 % w/w DMSO extract
64742-55-8
265-158-7
780
Distillates (petroleum), solvent-dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract
64742-56-9
265-159-2
781
Residual oils (petroleum), hydrotreated, if they contain > 3 % w/w DMSO extract
64742-57-0
265-160-8
782
Residual oils (petroleum), solvent-dewaxed, if they contain > 3 % w/w DMSO extract
64742-62-7
265-166-0
783
Distillates (petroleum), solvent-dewaxed heavy naphthenic, if they contain > 3 % w/w DMSO extract
64742-63-8
265-167-6
784
Distillates (petroleum), solvent-dewaxed light naphthenic, if they contain > 3 % w/w DMSO extract
64742-64-9
265-168-1
785
Distillates (petroleum), solvent-dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract
64742-65-0
265-169-7
786
Foots oil (petroleum), if it contains > 3 % w/w DMSO extract
64742-67-2
265-171-8
787
Naphthenic oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract
64742-68-3
265-172-3
788
Naphthenic oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract
64742-69-4
265-173-9
789
Paraffin oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract
64742-70-7
265-174-4
790
Paraffin oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract
64742-71-8
265-176-5
791
Naphthenic oils (petroleum), complex dewaxed heavy, if they contain > 3 % w/w DMSO extract
64742-75-2
265-179-1
792
Naphthenic oils (petroleum), complex dewaxed light, if they contain > 3 % w/w DMSO extract
64742-76-3
265-180-7
793
Extracts (petroleum), heavy naphthenic distillate solvent, arom. Conc., if they contain > 3 % w/w DMSO extract
68783-00-6
272-175-3
794
Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract
68783-04-0
272-180-0
795
Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted, if they contain > 3 % w/w DMSO extract
68814-89-1
272-342-0
796
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity, if they contain > 3 % w/w DMSO extract
72623-85-9
276-736-3
797
Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract
72623- 86-0
276-737-9
798
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract
72623- 87-1
276-738-4
799
Lubricating oils, if they contain > 3 % w/w DMSO extract
74869-22-0
278-012-2
800
Distillates (petroleum), complex dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract
90640-91-8
292-613-7
801
Distillates (petroleum), complex dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract
90640-92-9
292-614-2
802
Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract
90640-94-1
292-616-3
803
Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract
90640-95-2
292-617-9
804
Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract
90640-96-3
292-618-4
805
Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract
90640-97-4
292-620-5
806
Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract
90641-07-9
292-631-5
807
Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract
90641-08-0
292-632-0
808
Extracts (petroleum), light paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract
90641-09-1
292-633-6
809
Residual oils (petroleum), hydrotreated solvent dewaxed, if they contain > 3 % w/w DMSO extract
90669-74-2
292-656-1
810
Residual oils (petroleum), catalytic dewaxed, if they contain > 3 % w/w DMSO extract
91770-57-9
294-843-3
811
Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract
91995-39-0
295-300-3
812
Distillates (petroleum), dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract
91995-40-3
295-301-9
813
Distillates (petroleum), hydrocracked solvent-refined, dewaxed, if they contain > 3 % w/w DMSO extract
91995-45-8
295-306-6
814
Distillates (petroleum), solvent-refined light naphthenic, hydrotreated, if they contain > 3 % w/w DMSO extract
91995-54-9
295-316-0
815
Extracts (petroleum), hydrotreated light paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract
91995- 73-2
295-335-4
816
Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract
91995-75-4
295-338-0
817
Extracts (petroleum), light paraffinic distillate solvent, acid-treated, if they contain > 3 % w/w DMSO extract
91995-76-5
295-339-6
818
Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract
91995-77-6
295-340-1
819
Extracts (petroleum), light vacuum gas oil solvent, hydrotreated, if they contain > 3 % w/w DMSO extract
91995-79-8
295-342-2
820
Foots oil (petroleum), hydrotreated, if it contains > 3 % w/w DMSO extract
92045-12-0
295-394-6
821
Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated, if they contain > 3 % w/w DMSO extract
92045-42-6
295-423-2
822
Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined, if they contain > 3 % w/w DMSO extract
92045-43-7
295-424-8
823
Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract
92061-86-4
295-499-7
824
Paraffin oils (petroleum), solvent-refined dewaxed heavy, if they contain > 3 % w/w DMSO extract
92129-09-4
295-810-6
825
Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract
92704-08-0
296-437-1
826
Lubricating oils (petroleum), base oils, paraffinic, if they contain > 3 % w/w DMSO extract
93572-43-1
297-474-6
827
Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract
93763-10-1
297-827-4
828
Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract
93763-11-2
297-829-5
829
Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed, if they contain > 3 % w/w DMSO extract
93763-38-3
297-857-8
830
Foots oil (petroleum), acid-treated, if it contains > 3 % w/w DMSO extract
93924-31-3
300-225-7
831
Foots oil (petroleum), clay-treated, if it contains > 3 % w/w DMSO extract
93924-32-4
300-226-2
832
Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate, if they contain > 3 % w/w DMSO extract
93924-61-9
300-257-1
833
Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated, if they contain > 3 % w/w DMSO extract
94733-08-1
305-588-5
834
Distillates (petroleum), solvent-refined hydrocracked light, if they contain > 3 % w/w DMSO extract
94733-09-2
305-589-0
835
Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based, if they contain > 3 % w/w DMSO extract
94733-15-0
305-594-8
836
Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based, if they contain > 3 % w/w DMSO extract
94733-16-1
305-595-3
837
Hydrocarbons, C13-30, arom. -rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract
95371-04-3
305-971-7
838
Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract
95371-05-4
305-972-2
839
Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues, if they contain > 3 % w/w DMSO extract
95371-07-6
305-974-3
840
Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues, if they contain > 3 % w/w DMSO extract
95371-08-7
305-975-9
841
Distillates (petroleum), hydrocracked solvent-refined light, if they contain > 3 % w/w DMSO extract
97488-73-8
307-010-7
842
Distillates (petroleum), solvent-refined hydrogenated heavy, if they contain > 3 % w/w DMSO extract
97488-74-9
307-011-2
843
Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed, if they contain > 3 % w/w DMSO extract
97488-95-4
307-034-8
844
Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights, if they contain > 3 % w/w DMSO extract
97675-87-1
307-661-7
845
Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights, if they contain > 3 % w/w DMSO extract
97722-06-0
307-755-8
846
Hydrocarbons, C13-27, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract
97722-09-3
307-758-4
847
Hydrocarbons, C14-29, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract
97722-10-6
307-760-5
848
Foots oil (petroleum), carbon-treated, if it contains > 3 % w/w DMSO extract
97862-76-5
308-126-0
849
Foots oil (petroleum), silicic acid-treated, if it contains > 3 % w/w DMSO extract
97862-77-6
308-127-6
850
Hydrocarbons, C27-42, dearomatised, if they contain > 3 % w/w DMSO extract
97862-81-2
308-131-8
851
Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights, if they contain > 3 % w/w DMSO extract
97862-82-3
308-132-3
852
Hydrocarbons, C27-45, naphthenic vacuum distn., if they contain > 3 % w/w DMSO extract
97862-83-4
308-133-9
853
Hydrocarbons, C27-45, dearomatised, if they contain > 3 % w/w DMSO extract
97926-68-6
308-287-7
854
Hydrocarbons, C20-58, hydrotreated, if they contain > 3 % w/w DMSO extract
97926-70-0
308-289-8
855
Hydrocarbons, C27-42, naphthenic, if they contain > 3 % w/w DMSO extract
97926-71-1
308-290-3
856
Extracts (petroleum), light paraffinic distillate solvent, carbon-treated, if they contain > 3 % w/w DMSO extract
100684-02-4
309-672-2
857
Extracts (petroleum), light paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract
100684- 03-5
309-673-8
858
Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated, if they contain > 3 % w/w DMSO extract
100684-04-6
309-674-3
859
Extracts (petroleum), light vacuum gas oil solvent, clay-treated, if they contain > 3 % w/w DMSO extract
100684-05-7
309-675-9
860
Residual oils (petroleum), carbon-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract
100684-37-5
309-710-8
861
Residual oils (petroleum), clay-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract
100684-38-6
309-711-3
862
Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract
101316-69-2
309-874-0
863
Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract
101316-70-5
309-875-6
864
Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract
101316-71-6
309-876-1
865
Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract
101316-72-7
309-877-7
866
Distillates (petroleum), sweetened middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64741-86-2
265-088-7
867
Gas oils (petroleum), solvent-refined, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64741-90-8
265-092-9
868
Distillates (petroleum), solvent-refined middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64741-91-9
265-093-4
869
Gas oils (petroleum), acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-12-7
265-112-6
870
Distillates (petroleum), acid-treated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-13-8
265-113-1
871
Distillates (petroleum), acid-treated light, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-14-9
265-114-7
872
Gas oils (petroleum), chemically neutralised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-29-6
265-129-9
873
Distillates (petroleum), chemically neutralised middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-30-9
265-130-4
874
Distillates (petroleum), clay-treated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-38-7
265-139-3
875
Distillates (petroleum), hydrotreated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-46-7
265-148-2
876
Gas oils (petroleum), hydrodesulfurised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-79-6
265-182-8
877
Distillates (petroleum), hydrodesulfurised middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-80-9
265-183-3
878
Distillates (petroleum), catalytic reformer fractionator residue, high-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
68477-29-2
270-719-4
879
Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
68477-30-5
270-721-5
880
Distillates (petroleum), catalytic reformer fractionator residue, low-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
68477-31-6
270-722-0
881
Alkanes, C12-26, branched and linear, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
90622-53-0
292-454-3
882
Distillates (petroleum), highly refined middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
90640-93-0
292-615-8
883
Distillates (petroleum), catalytic reformer, heavy arom. conc., except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
91995-34-5
295-294-2
884
Gas oils, paraffinic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
93924-33-5
300-227-8
885
Naphtha (petroleum), solvent-refined hydrodesulfurised heavy, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97488-96-5
307-035-3
886
Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97675- 85-9
307-659-6
887
Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97675-86-0
307-660-1
888
Hydrocarbons, C11-17, solvent-extd. light naphthenic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97722-08-2
307-757-9
889
Gas oils, hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97862-78-7
308-128-1
890
Distillates (petroleum), carbon-treated light paraffinic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
100683-97-4
309-667-5
891
Distillates (petroleum), intermediate paraffinic, carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
100683-98-5
309-668-0
892
Distillates (petroleum), intermediate paraffinic, clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
100683-99-6
309-669-6
893
Lubricating greases, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
74869-21-9
278-011-7
894
Slack wax (petroleum), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64742-61-6
265-165-5
895
Slack wax (petroleum), acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
90669-77-5
292-659-8
896
Slack wax (petroleum), clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
90669-78-6
292-660-3
897
Slack wax (petroleum), hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
92062-09-4
295-523-6
898
Slack wax (petroleum), low-melting, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
92062-10-7
295-524-1
899
Slack wax (petroleum), low-melting, hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
92062-11-8
295-525-7
900
Slack wax (petroleum), low-melting, carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97863-04-2
308-155-9
901
Slack wax (petroleum), low-melting, clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97863-05-3
308-156-4
902
Slack wax (petroleum), low-melting, silicic acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97863-06-4
308-158-5
903
Slack wax (petroleum), carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
100684-49-9
309-723-9
904
Petrolatum, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
8009-03-8
232-373-2
905
Petrolatum (petroleum), oxidised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
64743-01-7
265-206-7
906
Petrolatum (petroleum), alumina-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
85029-74-9
285-098-5
907
Petrolatum (petroleum), hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
92045-77-7
295-459-9
908
Petrolatum (petroleum), carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97862-97-0
308-149-6
909
Petrolatum (petroleum), silicic acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
97862-98-1
308-150-1
910
Petrolatum (petroleum), clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
100684-33-1
309-706-6
911
Distillates (petroleum), light catalytic cracked
64741-59-9
265-060-4
912
Distillates (petroleum), intermediate catalytic cracked
64741-60-2
265-062-5
913
Distillates (petroleum), light thermal cracked
64741-82-8
265-084-5
914
Distillates (petroleum), hydrodesulfurised light catalytic cracked
68333-25-5
269-781-5
915
Distillates (petroleum), light steam-cracked naphtha
68475-80-9
270-662-5
916
Distillates (petroleum), cracked steam-cracked petroleum distillates
68477-38-3
270-727-8
917
Gas oils (petroleum), steam-cracked
68527-18-4
271-260-2
918
Distillates (petroleum), hydrodesulfurised thermal cracked middle
85116-53-6
285-505-6
919
Gas oils (petroleum), thermal-cracked, hydrodesulfurised
92045-29-9
295-411-7
920
Residues (petroleum), hydrogenated steam-cracked naphtha
92062-00-5
295-514-7
921
Residues (petroleum), steam-cracked naphtha distn.
92062-04-9
295-517-3
922
Distillates (petroleum), light catalytic cracked, thermally degraded
92201-60-0
295-991-1
923
Residues (petroleum), steam-cracked heat-soaked naphtha
93763-85-0
297-905-8
924
Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised
97926-59-5
308-278-8
925
Distillates (petroleum), hydrodesulfurised middle coker
101316-59-0
309-865-1
926
Distillates (petroleum), heavy steam-cracked
101631-14-5
309-939-3
927
Residues (petroleum), atm. Tower
64741-45-3
265-045-2
928
Gas oils (petroleum), heavy vacuum
64741-57-7
265-058-3
929
Distillates (petroleum), heavy catalytic cracked
64741-61-3
265-063-0
930
Clarified oils (petroleum), catalytic cracked
64741-62-4
265-064-6
931
Residues (petroleum), catalytic reformer fractionator
64741-67-9
265-069-3
932
Residues (petroleum), hydrocracked
64741-75-9
265-076-1
933
Residues (petroleum), thermal cracked
64741-80-6
265-081-9
934
Distillates (petroleum), heavy thermal cracked
64741-81-7
265-082-4
935
Gas oils (petroleum), hydrotreated vacuum
64742-59-2
265-162-9
936
Residues (petroleum), hydrodesulfurised atmospheric tower
64742-78-5
265-181-2
937
Gas oils (petroleum), hydrodesulfurised heavy vacuum
64742-86-5
265-189-6
938
Residues (petroleum), steam-cracked
64742-90-1
265-193-8
939
Residues (petroleum), atmospheric
68333-22-2
269-777-3
940
Clarified oils (petroleum), hydrodesulfurised catalytic cracked
68333-26-6
269-782-0
941
Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked
68333-27-7
269-783-6
942
Distillates (petroleum), hydrodesulfurised heavy catalytic cracked
68333-28-8
269-784-1
943
Fuel oil, residues-straight-run gas oils, high-sulfur
68476-32-4
270-674-0
944
Fuel oil, residual
68476-33-5
270-675-6
945
Residues (petroleum), catalytic reformer fractionator residue distn.
68478-13-7
270-792-2
946
Residues (petroleum), heavy coker gas oil and vacuum gas oil
68478-17-1
270-796-4
947
Residues (petroleum), heavy coker and light vacuum
68512-61-8
270-983-0
948
Residues (petroleum), light vacuum
68512-62-9
270-984-6
949
Residues (petroleum), steam-cracked light
68513-69-9
271-013-9
950
Fuel oil, No 6
68553-00-4
271-384-7
951
Residues (petroleum), topping plant, low-sulfur
68607-30-7
271-763-7
952
Gas oils (petroleum), heavy atmospheric
68783-08-4
272-184-2
953
Residues (petroleum), coker scrubber, condensed-ring-arom. -contg
68783-13-1
272-187-9
954
Distillates (petroleum), petroleum residues vacuum
68955-27-1
273-263-4
955
Residues (petroleum), steam-cracked, resinous
68955-36-2
273-272-3
956
Distillates (petroleum), intermediate vacuum
70592-76-6
274-683-0
957
Distillates (petroleum), light vacuum
70592-77-7
274-684-6
958
Distillates (petroleum), vacuum
70592-78-8
274-685-1
959
Gas oils (petroleum), hydrodesulfurised coker heavy vacuum
85117-03-9
285-555-9
960
Residues (petroleum), steam-cracked, distillates
90669-75-3
292-657-7
961
Residues (petroleum), vacuum, light
90669-76-4
292-658-2
962
Fuel oil, heavy, high-sulfur
92045-14-2
295-396-7
963
Residues (petroleum), catalytic cracking
92061-97-7
295-511-0
964
Distillates (petroleum), intermediate catalytic cracked, thermally degraded
92201-59-7
295-990-6
965
Residual oils (petroleum)
93821-66-0
298-754-0
966
Residues, steam cracked, thermally treated
98219-64-8
308-733-0
967
Distillates (petroleum), hydrodesulfurised full-range middle
101316-57-8
309-863-0
968
Distillates (petroleum), light paraffinic
64741-50-0
265-051-5
969
Distillates (petroleum), heavy paraffinic
64741-51-1
265-052-0
970
Distillates (petroleum), light naphthenic
64741-52-2
265-053-6
971
Distillates (petroleum), heavy naphthenic
64741-53-3
265-054-1
972
Distillates (petroleum), acid-treated heavy naphthenic
64742-18-3
265-117-3
973
Distillates (petroleum), acid-treated light naphthenic
64742-19-4
265-118-9
974
Distillates (petroleum), acid-treated heavy paraffinic
64742-20-7
265-119-4
975
Distillates (petroleum), acid-treated light paraffinic
64742-21-8
265-121-5
976
Distillates (petroleum), chemically neutralised heavy paraffinic
64742-27-4
265-127-8
977
Distillates (petroleum), chemically neutralised light paraffinic
64742-28-5
265-128-3
978
Distillates (petroleum), chemically neutralised heavy naphthenic
64742-34-3
265-135-1
979
Distillates (petroleum), chemically neutralised light naphthenic
64742-35-4
265-136-7
980
Extracts (petroleum), light naphthenic distillate solvent
64742-03-6
265-102-1
981
Extracts (petroleum), heavy paraffinic distillate solvent
64742-04-7
265-103-7
982
Extracts (petroleum), light paraffinic distillate solvent
64742-05-8
265-104-2
983
Extracts (petroleum), heavy naphthenic distillate solvent
64742-11-6
265-111-0
984
Extracts (petroleum), light vacuum gas oil solvent
91995-78-7
295-341-7
985
Hydrocarbons, C26-55, arom. rich
97722-04-8
307-753-7
986
Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate)
573-58-0
209-358-4
987
Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
1937-37-7
217-710-3
988
Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]
2602-46-2
220-012-1
989
4-o-Tolylazo-o-toluidine
97-56-3
202-591-2
990
4-Aminoazobenzene
60-09-3
200-453-6
991
Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-)
16071-86-6
240-221-1
992
Resorcinol diglycidyl ether
101-90-6
202-987-5
993
1,3-Diphenylguanidine
102-06-7
203-002-1
994
Heptachlor-epoxide
1024-57-3
213-831-0
995
4-Nitrosophenol
104-91-6
203-251-6
996
Carbendazim
10605-21-7
234-232-0
997
Allyl glycidyl ether
106-92-3
203-442-4
998
Chloroacetaldehyde
107-20-0
203-472-8
999
Hexane
110-54-3
203-777-6
1000
2-(2-Methoxyethoxy)ethanol (Diethylene glycol monomethyl ether; DEGME)
111-77-3
203-906-6
1001
(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Tetraconazole - ISO)
112281-77-3
407-760-6
1002
4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone
114565-66-1
406-057-1
1003
5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone
115662-06-1
405-100-1
1004
tris(2-Chloroethyl) phosphate
115-96-8
204-118-5
1005
4′-Ethoxy-2-benzimidazoleanilide
120187-29-3
407-600-5
1006
Nickel dihydroxide
12054-48-7
235-008-5
1007
N,N-Dimethylaniline
121-69-7
204-493-5
1008
Simazine
122-34-9
204-535-2
1009
bis(Cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium
125051-32-3
412-000-1
1010
N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-diethyldiphenylmethane
130728-76-6
410-060-3
1011
Divanadium pentaoxide
1314-62-1
215-239-8
1012
Pentachlorophenol and its alkali salts
87-86-5/131-52-2/7778-73-6
201-778-6/205-025-2/231-911-3
1013
Phosphamidon
13171-21-6
236-116-5
1014
N-(Trichloromethylthio)phthalimide (Folpet - ISO)
133-07-3
205-088-6
1015
N-2-Naphthylaniline
135-88-6
205-223-9
1016
Ziram
137-30-4
205-288-3
1017
1-Bromo-3,4,5-trifluorobenzene
138526-69-9
418-480-9
1018
Propazine
139-40-2
205-359-9
1019
3-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
140-41-0
006-043-00-1
1020
Isoxaflutole
141112-29-0
606-054-00-7
1021
Kresoxim-methyl
143390-89-0
607-310-00-0
1022
Chlordecone
143-50-0
205-601-3
1023
9-Vinylcarbazole
1484-13-5
216-055-0
1024
2-Ethylhexanoic acid
149-57-5
205-743-6
1025
Monuron
150-68-5
205-766-1
1026
Morpholine-4-carbonyl chloride
15159-40-7
239-213-0
1027
Daminozide
1596-84-5
216-485-9
1028
Alachlor (ISO)
15972-60-8
240-110-8
1029
UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine
166242-53-1
422-720-8
1030
Ioxynil and Ioxynil octanoate (ISO)
1689-83-4/3861-47-0
216-881-1/223-375-4
1031
Bromoxynil (ISO) (3,5-Dibromo-4-hydroxybenzonitrile) and Bromoxynil heptanoate (ISO)
1689-84-5/56634-95-8
216-882-7/260-300-4
1032
2,6-Dibromo-4-cyanophenyl octanoate
1689-99-2
216-885-3
1033
Moved or deleted
1034
5-Chloro-1,3-dihydro-2H-indol-2-one
17630-75-0
412-200-9
1035
Benomyl
17804-35-2
241-775-7
1036
Chlorothalonil
1897-45-6
217-588-1
1037
N′-(4-Chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride
19750-95-9
243-269-1
1038
4,4′-Methylenebis(2-ethylaniline)
19900-65-3
243-420-1
1039
Valinamide
20108-78-5
402-840-7
1040
[(p-Tolyloxy)methyl]oxirane
2186-24-5
218-574-8
1041
[(m-Tolyloxy)methyl]oxirane
2186-25-6
218-575-3
1042
2,3-Epoxypropyl o-tolyl ether
2210-79-9
218-645-3
1043
[(Tolyloxy)methyl]oxirane, cresyl glycidyl ether
26447-14-3
247-711-4
1044
Di-allate
2303-16-4
218-961-1
1045
Benzyl 2,4-dibromobutanoate
23085-60-1
420-710-8
1046
Trifluoroiodomethane
2314-97-8
219-014-5
1047
Thiophanate-methyl
23564-05-8
245-740-7
1048
Dodecachloropentacyclo[5.2.1.02,6.03,905,8]decane (Mirex)
2385-85-5
219-196-6
1049
Propyzamide
23950-58-5
245-951-4
1050
Butyl glycidyl ether
2426-08-6
219-376-4
1051
2,3,4-Trichlorobut-1-ene
2431-50-7
219-397-9
1052
Chinomethionate
2439-01-2
219-455-3
1053
(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate
25383-07-7
418-570-8
1054
5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (Etridiazole - ISO)
2593-15-9
219-991-8
1055
Disperse Yellow 3
2832-40-8
220-600-8
1056
1,2,4-Triazole
288-88-0
206-022-9
1057
Aldrin (ISO)
309-00-2
206-215-8
1058
Diuron (ISO)
330-54-1
206-354-4
1059
Linuron (ISO)
330-55-2
206-356-5
1060
Nickel carbonate
3333-67-3
222-068-2
1061
3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon - ISO)
34123-59-6
251-835-4
1062
Iprodione
36734-19-7
253-178-9
1063
Moved or deleted
1064
5-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro-2-hydroxymethyltetrahydrofuran
41107-56-6
415-360-8
1065
Crotonaldehyde
4170-30-3
224-030-0
1066
Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide
418-350-1
1067
4,4′-Carbonimidoylbis[N,N-dimethylaniline] and its salts
492-80-8
207-762-5
1068
DNOC (ISO)
534-52-1
208-601-1
1069
Toluidinium chloride
540-23-8
208-740-8
1070
Toluidine sulphate (1:1)
540-25-0
208-741-3
1071
2-(4-tert.-Butylphenyl)ethanol
5406-86-0
410-020-5
1072
Fenthion
55-38-9
200-231-9
1073
Chlordane, pur
57-74-9
200-349-0
1074
Hexan-2-one (Methyl butyl ketone)
591-78-6
209-731-1
1075
Fenarimol
60168-88-9
262-095-7
1076
Acetamide
60-35-5
200-473-5
1077
N-Cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (Furmecyclox - ISO)
60568-05-0
262-302-0
1078
Dieldrin
60-57-1
200-484-5
1079
4,4′-Isobutylethylidenediphenol
6807-17-6
401-720-1
1080
Chlordimeform
6164-98-3
228-200-5
1081
Amitrole
61-82-5
200-521-5
1082
Carbaryl
63-25-2
200-555-0
1083
Distillates (petroleum), light hydrocracked
64741-77-1
265-078-2
1084
1-Ethyl-1-methylmorpholinium bromide
65756-41-4
612-182-00-4
1085
(3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone
66938-41-8
423-290-4
1086
Fuels, diesel, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
68334-30-5
269-822-7
1087
Fuel oil, no. 2
68476-30-2
270-671-4
1088
Fuel oil, no. 4
68476-31-3
270-673-5
1089
Fuels, diesel, no. 2
68476-34-6
270-676-1
1090
2,2-Dibromo-2-nitroethanol
69094-18-4
412-380-9
1091
1-Ethyl-1-methylpyrrolidinium bromide
69227-51-6
612-183-00-X
1092
Monocrotophos
6923-22-4
230-042-7
1093
Nickel
7440-02-0
231-111-4
1094
Bromomethane (Methyl bromide - ISO)
74-83-9
200-813-2
1095
Chloromethane (Methyl chloride)
74-87-3
200-817-4
1096
Iodomethane (Methyl iodide)
74-88-4
200-819-5
1097
Bromoethane (Ethyl bromide)
74-96-4
200-825-8
1098
Heptachlor
76-44-8
200-962-3
1099
Fentin hydroxide
76-87-9
200-990-6
1100
Nickel sulphate
7786-81-4
232-104-9
1101
3,5,5-Trimethylcyclohex-2-enone (Isophorone)
78-59-1
201-126-0
1102
2,3-Dichloropropene
78-88-6
201-153-8
1103
Fluazifop-P-butyl (ISO)
79241-46-6
607-305-00-3
1104
(S)-2,3-Dihydro-1H-indole-carboxylic acid
79815-20-6
410-860-2
1105
Toxaphene
8001-35-2
232-283-3
1106
(4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride
81880-96-8
406-090-1
1107
CI Solvent Yellow 14
842-07-9
212-668-2
1108
Chlozolinate
84332-86-5
282-714-4
1109
Alkanes, C10-13, monochloro
85535-84-8
287-476-5
1110
Moved or deleted
1111
2,4,6-Trichlorophenol
88-06-2
201-795-9
1112
Diethylcarbamoyl-chloride
88-10-8
201-798-5
1113
1-Vinyl-2-pyrrolidone
88-12-0
201-800-4
1114
Myclobutanil (ISO) (2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile)
88671-89-0
410-400-0
1115
Fentin acetate
900-95-8
212-984-0
1116
Biphenyl-2-ylamine
90-41-5
201-990-9
1117
Trans-4-cyclohexyl-L-proline monohydro-chloride
90657-55-9
419-160-1
1118
2-Methyl-m-phenylene diisocyanate (Toluene 2,6-diisocyanate)
91-08-7
202-039-0
1119
4-Methyl-m-phenylene diisocyanate (Toluene 2,4-diisocyanate)
584-84-9
209-544-5
1120
m-Tolylidene diisocyanate (Toluene diisocyanate)
26471-62-5
247-722-4
1121
Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated
94114-58-6
302-694-3
1122
Fuels, diesel, coal solvent extn., hydrocracked hydrogenated
94114-59-7
302-695-9
1123
Pitch, if it contains > 0,005 % w/w benzo[a]pyrene
61789-60-4
263-072-4
1124
2-Butanone oxime
96-29-7
202-496-6
1125
Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn. Residue
97675-88-2
307-662-2
1126
α,α-Dichlorotoluene
98-87-3
202-709-2
1127
Mineral wool, with the exception of those specified elsewhere in this Annex; [Man-made vitreous (silicate)fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O + K2O + CaO + MgO + BaO) content greater than 18 % by weight]
1128
Reaction product of acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid
406-230-1
1129
Moved or deleted
1130
Moved or deleted
1131
Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato-1-naphtholato)chromate(1-)
400-810-8
1132
A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)-phenoxy-2-hydroxypropyl-2-(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2- hydroxypropyl)-2-(2,3-epoxypropyl)phenoxy)phenol and 4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-2-(2,3-epoxypropyl)phenol
417-470-1
1133
Costus root oil (Saussurea lappa Clarke), when used as a fragrance ingredient
8023-88-9
1134
7-Ethoxy-4-methylcoumarin, when used as a fragrance ingredient
87-05-8
201-721-5
1135
Hexahydrocoumarin, when used as a fragrance ingredient
700-82-3
211-851-4
1136
Peru balsam (INCI name: Myroxylon pereirae), when used as a fragrance ingredient
8007-00-9
232-352-8
1137
Isobutyl nitrite
542-56-2
208-819-7
1138
Isoprene (stabilized); (2-methyl-1,3-butadiene)
78-79-5
201-143-3
1139
1-Bromopropane; n-Propyl bromide
106-94-5
203-445-0
1140
Chloroprene (stabilized); (2-Chlorobuta-1,3-diene)
126-99-8
204-818-0
1141
1,2,3-Trichloropropane
96-18-4
202-486-1
1142
Ethylene glycol dimethyl ether (EGDME)
110-71-4
203-794-9
1143
Dinocap (ISO)
39300-45-3
254-408-0
1144
Diaminotoluene, technical product -mixture of [4-methyl-m-phenylenediamine] (4) and [2-methyl-m-phenylenediamine] (5)
Methyl-phenylenediamine
25376-45-8
246-910-3
1145
p-Chlorobenzotrichloride
5216-25-1
226-009-1
1146
Diphenylether; octabromo derivate
32536-52-0
251-087-9
1147
1,2-bis(2-Methoxyethoxy)ethane; Triethylene glycol dimethyl ether (TEGDME)
112-49-2
203-977-3
1148
Tetrahydrothiopyran-3-carboxaldehyde
61571-06-0
407-330-8
1149
4,4′-bis(Dimethylamino)benzophenone (Michler's ketone)
90-94-8
202-027-5
1150
Oxiranemethanol, 4-methylbenzene-sulfonate, (S)-
70987-78-9
417-210-7
1151
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear [1]
84777-06-0 [1]
284-032-2
n-Pentyl-isopentylphthalate [2]-
[2]
di-n-Pentyl phthalate [3]
131-18-0 [3]
205-017-9
Diisopentylphthalate [4]
605-50-5 [4]
210-088-4
1152
Benzyl butyl phthalate (BBP)
85-68-7
201-622-7
1153
1,2-Benzenedicarboxylic acid, di-C7-11, branched and linear alkyl esters
68515-42-4
271-084-6
1154
A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl) pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate and trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate
402-660-9
1155
(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride dihydrochloride
401-500-5
1156
2-[2-Hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one
420-580-2
1157
Azafenidin
68049-83-2
1158
2,4,5-Trimethylaniline [1]
137-17-7 [1]
205-282-0
2,4,5-Trimethylaniline hydrochloride [2]
21436-97-5 [2]
1159
4,4′-Thiodianiline and its salts
139-65-1
205-370-9
1160
4,4′-Oxydianiline (p-Aminophenyl ether) and its salts
101-80-4
202-977-0
1161
N,N,N′,N′-Tetramethyl-4,4′-methylenedianiline
101-61-1
202-959-2
1162
6-Methoxy-m-toluidine; (p-Cresidine)
120-71-8
204-419-1
1163
3-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine
143860-04-2
421-150-7
1164
A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione and a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione
421-550-1
1165
2-Nitrotoluene
88-72-2
201-853-3
1166
Tributyl phosphate
126-73-8
204-800-2
1167
Naphthalene
91-20-3
202-049-5
1168
Nonylphenol [1]
25154-52-3 [1]
246-672-0
4-Nonylphenol, branched [2]
84852-15-3 [2]
284-325-5
1169
1,1,2-Trichloroethane
79-00-5
201-166-9
1170
Moved or deleted
1171
Moved or deleted
1172
allyl chloride; (3-Chloropropene)
107-05-1
203-457-6
1173
1,4-Dichlorobenzene; (p-Dichlorobenzene)
106-46-7
203-400-5
1174
bis(2-Chloroethyl) ether
111-44-4
203-870-1
1175
Phenol
108-95-2
203-632-7
1176
Bisphenol A (4,4′-Isopropylidenediphenol)
80-05-7
201-245-8
1177
Trioxymethylene (1,3,5-Trioxan)
110-88-3
203-812-5
1178
Propargite (ISO)
2312-35-8
219-006-1
1179
1-Chloro-4-nitrobenzene
100-00-5
202-809-6
1180
Molinate (ISO)
2212-67-1
218-661-0
1181
Fenpropimorph (ISO)
67564-91-4
266-719-9
1182
Moved or deleted
1183
Methyl isocyanate
624-83-9
210-866-3
1184
N,N-Dimethylanilinium tetrakis(pentafluorophenyl)borate
118612-00-3
422-050-6
1185
O,O′-(Ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]
421-870-1
1186
A 2:1 mixture of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)
140698-96-0
414-770-4
1187
A mixture of: reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) and reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3)
417-980-4
1188
Malachite green hydrochloride [1]
569-64-2 [1]
209-322-8
Malachite green oxalate [2]
18015-76-4 [2]
241-922-5
1189
1-(4-Chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
107534-96-3
403-640-2
1190
5-(3-Butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
138164-12-2
414-790-3
1191
trans-4-Phenyl-L-proline
96314-26-0
416-020-1
1192
Moved or deleted
1193
A mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid and 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid
163879-69-4
418-230-9
1194
2-{]4-(2-Ammoniopropylamino)-6-[}4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino{]-1,3,5-triazin-2-ylamino[}-2-aminopropyl formate
424-260-3
1195
5-Nitro-o-toluidine [1]
99-55-8 [1]
202-765-8
5-Nitro-o-toluidine hydrochloride [2]
51085-52-0 [2]
256-960-8
1196
1-(1-Naphthylmethyl)quinolinium chloride
65322-65-8
406-220-7
1197
(R)-5-Bromo-3-(1-methyl-2-pyrrolidinylmethyl)-1H-indole
143322-57-0
422-390-5
1198
Pymetrozine (ISO)
123312-89-0
613-202-00-4
1199
Oxadiargyl (ISO)
39807-15-3
254-637-6
1200
Chlorotoluron (3-(3-chloro-p-tolyl)-1,1-dimethylurea)
15545-48-9
239-592-2
1201
N-[2-(3-Acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]acetamide
416-860-9
1202
1,3-bis(Vinylsulfonylacetamido)propane
93629-90-4
428-350-3
1203
p-Phenetidine (4-Ethoxyaniline)
156-43-4
205-855-5
1204
m-Phenylenediamine and its salts
108-45-2
203-584-7
1205
Residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w benzo[a]pyrene
92061-93-3
295-506-3
1206
Creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
90640-84-9
292-605-3
1207
Creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene
61789-28-4
263-047-8
1208
Creosote, if it contains > 0,005 % w/w benzo[a]pyrene
8001-58-9
232-287-5
1209
Creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
70321-79-8
274-565-9
1210
Extract residues (coal), creosote oil acid, wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene
122384-77-4
310-189-4
1211
Creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
70321-80-1
274-566-4
1212
6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a substance in hair dye products
94166-62-8
303-358-9
1213
2,3-Naphthalenediol, when used as a substance in hair dye products
92-44-4
202-156-7
1214
2,4-Diaminodiphenylamine, when used as a substance in hair dye products
136-17-4
1215
2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when used as a substance in hair dye products
117907-42-3
1216
2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a substance in hair dye products
135043-65-1/29785-47-5
1217
4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a substance in hair dye products
20055-01-0/21616-59-1
1218
4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products
163183-00-4
1219
4-Chloro-2-Aminophenol, when used as a substance in hair dye products
95-85-2
202-458-9
1220
4-Hydroxyindole, when used as a substance in hair dye products
2380-94-1
219-177-2
1221
4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a substance in hair dye products
56496-88-9
1222
5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance in hair dye products
163183-01-5
1223
N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye products
91-68-9/68239-84-9
202-090-9/269-478-8
1224
N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a substance in hair dye products
—
1225
N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye products
104903-49-3
1226
N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used as a substance in hair dye products
72584-59-9/66566-48-1
276-723-2
1227
2,4-Diamino-5-methylphenetol and its HCl salt, when used as a substance in hair dye products
113715-25-6
1228
1,7-Naphthalenediol, when used as a substance in hair dye products
575-38-2
209-383-0
1229
3,4-Diaminobenzoic acid, when used as a substance in hair dye products
619-05-6
210-577-2
1230
2-Aminomethyl-p-aminophenol and its HCl salt, when used as a substance in hair dye products
79352-72-0
1231
Solvent Red 1 (CI 12150), when used as a substance in hair dye products
1229-55-6
214-968-9
1232
Acid Orange 24 (CI 20170), when used as a substance in hair dye products
1320-07-6
215-296-9
1233
Acid Red 73 (CI 27290), when used as a substance in hair dye products
5413-75-2
226-502-1
1234
PEG-3,2′,2′-di-p-Phenylenediamine
144644-13-3
1235
6-Nitro-o-Toluidine
570-24-1
209-329-6
1236
HC Yellow No 11
73388-54-2
1237
HC Orange No 3
81612-54-6
1238
HC Green No 1
52136-25-1
257-687-7
1239
HC Red No 8 and its salts
13556-29-1/97404-14-3
- / 306-778-0
1240
Tetrahydro-6-nitroquinoxaline and its salts
158006-54-3/41959-35-7/73855-45-5
1241
Disperse Red 15, except as impurity in Disperse Violet 1
116-85-8
204-163-0
1242
4-Amino-3-fluorophenol
399-95-1
402-230-0
1243
N,N′-dihexadecyl-N,N′-bis(2-hydroxyethyl)propanediamide
Bishydroxyethyl Biscetyl Malonamide
149591-38-8
422-560-9
1244
1-Methyl-2,4,5-trihydroxybenzene and its salts, when used as a substance in hair dye products
1124-09-0
214-390-7
1245
2,6-Dihydroxy-4-methylpyridine and its salts, when used as a substance in hair dye products
4664-16-8
225-108-7
1246
5-Hydroxy-1,4-benzodioxane and its salts, when used as a substance in hair dye products
10288-36-5
233-639-0
1247
3,4-Methylenedioxyphenol and its salts, when used as a substance in hair dye products
533-31-3
208-561-5
1248
3,4-Methylenedioxyaniline and its salts, when used as a substance in hair dye products
14268-66-7
238-161-6
1249
Hydroxypyridinone and its salts, when used as a substance in hair dye products
822-89-9
212-506-0
1250
3-Nitro-4-aminophenoxyethanol and its salts, when used as a substance in hair dye products
50982-74-6
1251
2-methoxy-4-nitrophenol (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
3251-56-7
221-839-0
1252
CI Acid Black 131 and its salts, when used as a substance in hair dye products
12219-01-1
1253
1,3,5-Trihydroxybenzene (Phloroglucinol) and its salts, when used as a substance in hair dye products
108-73-6
203-611-2
1254
1,2,4-Benzenetriacetate and its salts, when used as a substance in hair dye products
613-03-6
210-327-2
1255
Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (HC Blue No. 5) and its salts, when used as a substance in hair dye products
68478-64-8/158571-58-5
1256
N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (HC Blue No. 4) and its salts, when used as a substance in hair dye products
158571-57-4
1257
4-Aminobenzenesulfonic acid (Sulfanilic acid) and its salts, when used as a substance in hair dye products
121-57-3/515-74-2
204-482-5/208-208-5
1258
3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products
6373-79-1
228-922-0
1259
3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
89959-98-8/12221-69-1
289-660-0
1260
2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (Disperse Brown 1) and its salts, when used as a substance in hair dye products
23355-64-8
245-604-7
1261
Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl-, and its salts, when used as a substance in hair dye products
12270-13-2
235-546-0
1262
2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (Pigment Yellow 73) and its salts, when used as a substance in hair dye products
13515-40-7
236-852-7
1263
2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
6358-85-6
228-787-8
1264
2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products
2870-32-8
220-698-2
1265
2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (Solvent Black 3) and its salts, when used as a substance in hair dye products
4197-25-5
224-087-1
1266
3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products
3442-21-5/34977-63-4
222-351-0/252-305-5
1267
2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye products
2610-11-9
220-028-9
1268
(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
37279-54-2
253-441-8
1269
3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products
3441-14-3
222-348-4
1270
2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye products
2610-10-8/25188-41-4
220-027-3
1271
Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl-, and its salts, when used as a substance in hair dye products
2390-59-2
219-231-5
1272
3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products
54060-92-3
258-946-7
1273
3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products
4208-80-4
224-132-5
1274
Nigrosine spirit soluble (Solvent Black 5), when used as a substance in hair dye products
11099-03-9
1275
Phenoxazin-5-ium, 3,7-bis(diethylamino)-, and its salts, when used as a substance in hair dye products
47367-75-9/33203-82-6
251-403-5
1276
Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products
7057-57-0/966-62-1
230-338-6/213-524-1
1277
6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (Solvent Yellow 44) and its salts, when used as a substance in hair dye products
2478-20-8
219-607-9
1278
1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone and its salts, when used as a substance in hair dye products
67905-56-0/12217-43-5
267-677-4/235-398-7
1279
Laccaic Acid (CI Natural Red 25) and its salts, when used as a substance in hair dye products
60687-93-6
1280
Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, and its salts, when used as a substance in hair dye products
6373-74-6/15347-52-1
228-921-5/239-377-3
1281
4-[(4-Nitrophenyl)azo]aniline (Disperse Orange 3) and its salts, when used as a substance in hair dye products
730-40-5/70170-61-5
211-984-8
1282
4-Nitro-m-phenylenediamine and its salts, when used as a substance in hair dye products
5131-58-8
225-876-3
1283
1-Amino-4-(methylamino)-9,10-anthracenedione (Disperse Violet 4) and its salts, when used as a substance in hair dye products
1220-94-6
214-944-8
1284
N-Methyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products
2973-21-9
221-014-5
1285
N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (HC Yellow No. 5) and its salts, when used as a substance in hair dye products
56932-44-6
260-450-0
1286
N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (HC Yellow No. 3) and its salts, when used as a substance in hair dye products
56932-45-7
260-451-6
1287
2-Nitro-N-hydroxyethyl-p-anisidine and its salts, when used as a substance in hair dye products
57524-53-5
1288
N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products
10228-03-2
233-549-1
1289
3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol and its salts, when used as a substance in hair dye products
93633-79-5
403-440-5
1290
4-Ethylamino-3-nitrobenzoic acid (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products
2788-74-1
412-090-2
1291
(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17, when used as a substance in hair dye products
71134-97-9
275-216-3
1292
5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
12221-52-2
1293
m-Phenylenediamine, 4-(phenylazo)-, and its salts, when used as a substance in hair dye products
495-54-5
207-803-7
1294
1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products
4438-16-8
224-654-3
1295
2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)-, and its salts, when used as a substance in hair dye products
6441-93-6
229-231-7
1296
4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (Basic Brown 4) and its salts, when used as a substance in hair dye products
4482-25-1
224-764-1
1297
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products
83803-99-0
280-920-9
1298
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products
83803-98-9
280-919-3
1299
Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products
633-03-4
211-190-1
1300
9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)-, and its derivatives and salts, when used as a substance in hair dye products
2475-46-9/86722-66-9
219-604-2/289-276-3
1301
1,4-Diamino-2-methoxy-9,10-anthracenedione (Disperse Red 11) and its salts, when used as a substance in hair dye products
2872-48-2
220-703-8
1302
1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (Disperse Blue 7) and its salts, when used as a substance in hair dye products
3179-90-6
221-666-0
1303
1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products
22366-99-0
244-938-0
1304
N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (HC Yellow No. 8) and its salts, when used as a substance in hair dye products
66612-11-1
266-424-5
1305
[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (HC Red No. 9) and its salts, when used as a substance in hair dye products
56330-88-2
260-116-4
1306
Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, and its salts, when used as a substance in hair dye products
61-73-4
200-515-2
1307
4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products
94082-85-6
1308
5-Amino-2,6-Dimethoxy-3-Hydroxypyridine and its salts, when used as a substance in hair dye products
104333-03-1
1309
4,4'-Diaminodiphenylamine and its salts, when used as a substance in hair dye products
537-65-5
208-673-4
1310
4-Diethylamino-o-toluidine and its salts, when used as a substance in hair dye products
148-71-0/24828-38-4/2051-79-8
205-722-1/246-484-9/218-130-3
1311
N,N-Diethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products
93-05-0/6065-27-6/6283-63-2
202-214-1/227-995-6/228-500-6
1312
N,N-Dimethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products
99-98-9/6219-73-4
202-807-5/228-292-7
1313
Toluene-3,4-Diamine and its salts, when used as a substance in hair dye products
496-72-0
207-826-2
1314
2,4-Diamino-5-methylphenoxyethanol and its salts, when used as a substance in hair dye products
141614-05-3/113715-27-8
1315
6-Amino-o-cresol and its salts, when used as a substance in hair dye products
17672-22-9
1316
Hydroxyethylaminomethyl-p-aminophenol and its salts, when used as a substance in hair dye products
110952-46-0/135043-63-9
1317
2-Amino-3-nitrophenol and its salts, when used as a substance in hair dye products
603-85-0
210-060-1
1318
2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products
50610-28-1
256-652-3
1319
2-Nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products
5307-14-2/18266-52-9
226-164-5/242-144-9
1320
Hydroxyethyl-2,6-dinitro-p-anisidine and its salts, when used as a substance in hair dye products
122252-11-3
1321
6-Nitro-2,5-pyridinediamine and its salts, when used as a substance in hair dye products
69825-83-8
1322
Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl-, and its salts, when used as a substance in hair dye products
477-73-6
207-518-8
1323
3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid and its salts, when used as a substance in hair dye products
16279-54-2/5610-64-0
240-379-1/227-029-3
1324
3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (HC Yellow No. 6) and its salts, when used as a substance in hair dye products
104333-00-8
1325
2-[(4-chloro-2-nitrophenyl)amino]ethanol (HC Yellow No. 12) and its salts, when used as a substance in hair dye products
59320-13-7
1326
3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products
173994-75-7/102767-27-1
1327
3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products
114087-41-1/114087-42-2
1328
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, and its salts, when used as a substance in hair dye products
2390-60-5
219-232-0
(1) OJ L 159, 29.6.1996, p. 1
(2) Modified INNM-name.
(3) OJ L 273, 10.10.2002, p. 1.
(4) for the individual ingredient see reference number 364 in Annex II.
(5) for the individual ingredient see reference number 413 in Annex II.
ANNEX III
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
Reference number
Substance identification
Restrictions
Wording of conditions of use and warnings
Chemical name/INN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, body parts
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
1a
Boric acid, borates and tetraborates with the exception of substance No 1184 in Annex II
Boric acid
10043-35-3/11113-50-1
233-139-2/234-343-4
(a)
Talc
(a)
5 % (as boric acid)
(a)
Not to be used in products for children under 3 years of age
Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid)
(a)
Not to be used for children under 3 years of age
Not to be used on peeling or irritated skin
(b)
Oral products
(b)
0,1 % (as boric acid)
(b)
Not to be used in products for children under 3 years of age
(b)
Not to be swallowed
Not to be used for children under 3 years of age
(c)
Other products (excluding bath products and hair waving products)
(c)
3 % (as boric acid)
(c)
Not to be used in products for children under 3 years of age
Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid)
(c)
Not to be used for children under 3 years of age
Not to be used on peeling or irritated skin
1b
Tetraborates, see also 1a)
(a)
Bath products
(a)
18 % (as boric acid)
(a)
Not to be used in products for children under 3 years of age
(a)
Not to be used for children under 3 years of age
(b)
Hair products
(b)
8 % (as boric acid)
(b)
Rinse well
2a
Thioglycolic acid and its salts
Thioglycolic acid
68-11-1
200-677-4
(a)
Hair products
8 %
General use
ready for use pH 7 to 9,5
Conditions of use:
(a) (b) (c)
Avoid contact with eyes
In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice
(a) (c)
Wear suitable gloves
Warnings:
(a) (b) (c)
Contains thioglycolate
Follow the instructions
Keep out of reach of children
(a) For professional use only
11 %
Professional use
ready for use pH 7 to 9,5
(b)
Depilatories
5 %
ready for use pH 7 to 12,7
(c)
Hair rinse-off products
2 %
The abovementioned percentages are calculated as thioglycolic acid
ready for use pH 7 to 9,5
2b
Thioglycolic acid esters
Hair waving or straightening products
(a)
8 %
General use
ready for use pH 6 to 9,5
Conditions of use:
(a) (b)
May cause sensitization in the event of skin contact
Avoid contact with eyes
In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice
Wear suitable gloves
Warnings:
Contains thioglycolate
Follow the instructions
Keep out of reach of children
(b)
11 %
The abovementioned percentages are calculated as thioglycolic acid
Professional use
ready for use pH 6 to 9,5
(b)
For professional use only
3
Oxalic acid, its esters and alkaline salts
Oxalic acid
144-62-7
205-634-3
Hair products
5 %
Professional use
For professional use only
4
Ammonia
Ammonia
7664-41-7/1336-21-6
231-635-3/215-647-6
6 % (as NH3)
Above 2 %: Contains ammonia
5
Tosylchloramide sodium (INN)
Chloramine-T
127-65-1
204-854-7
0,2 %
6
Chlorates of alkali metals
Sodium chlorate
7775-09-9
231-887-4
(a)
Toothpaste
(b)
Other products
(a)
5 %
(b)
3 %
Potassium chlorate
3811-04-9
223-289-7
7
Dichloromethane
Dichloromethane
75-09-2
200-838-9
35 % (when mixed with 1,1,1-trichloro-ethane, total concentration must not exceed 35 %)
0,2 % as maximum impurity content
8
p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine (1), with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II
p-Phenylenediamine
106-50-3
203-404-7
Oxidising colouring agents for hair dyeing
6 % (as free base)
(a)
General use
Not to be used on eyebrows
(a)
Can cause an allergic reaction
Contains phenylenediamines
Do not use to dye eyelashes or eyebrows
(b)
Professional use
(b)
For professional use only
Contains phenylenediamines
Can cause an allergic reaction
Wear suitable gloves
9
Methylphenylenediamines, their N-substituted derivatives (1) and their salts with the exception of substances under reference numbers 364, 413, 1144, 1310 and 1313 in Annex II
Toluene-2,5-diamine
95-70-5
202-442-1
Oxidising colouring agents for hair dyeing
10 % (as free base)
(a)
General use
Not to be used on eyebrows
(a)
Can cause an allergic reaction
Contains phenylene-diamines
Do not use to dye eyelashes or eyebrows
(b)
Professional use
(b)
For professional use only
Contains phenylene-diamines
Can cause an allergic reaction
Wear suitable gloves
10
Diaminophenols (1)
Oxidising colouring agents for hair dyeing
10 % (as free base)
(a)
General use
Not to be used on eyebrows
(a)
Can cause an allergic reaction
Do not use to dye eyelashes or eyebrows
(b)
Professional use
(b)
For professional use only
Can cause an allergic reaction
Wear suitable gloves
11
Dichlorophen
Dichlorophen
97-23-4
202-567-1
0,5 %
Contains Dichlorophen
12
Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide
Hydrogen peroxide
7722-84-1
231-765-0
(a)
Hair- products
12 % H2O2 (40 volumes), present or released
(a)
Wear suitable gloves
(a) (b) (c):
Contains hydrogen peroxide
Avoid contact with eyes
Rinse eyes immediately if product comes into contact with them
(b)
Skin- products
4 % H2O2, present or released
(c)
Nail hardening products
2 % of H2O2, present or released
(d)
Oral products
0,1 % of H2O2, present or released
13
Formaldehyde (2)
Formaldehyde
50-00-0
200-001-8
Nail hardening products
5 % (as formaldehyde)
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
Protect cuticles with grease or oil
Contains formaldehyde (3)
14
Hydroquinone (4)
Hydroquinone
123-31-9
204-617-8
(a)
Oxidising colouring agent for hair dyeing
0,3 %
General use
Not to be used on eyebrows
Do not use to dye eyelashes or eyebrows
Rinse eyes immediately if the product comes into contact with them
Contains Hydroquinone
Professional use
For professional use only
Contains hydroquinone
Rinse eyes immediately if product comes into contact with them
(b)
Artificial nail systems
0,02 % (after mixing for use)
Professional use
(b)
For professional use only
Avoid skin contact
Read directions for use carefully
15a
Potassium or sodium hydroxide
Potassium hydroxide/sodium hydroxide
1310-58-3/1310-73-2
215-181-3/215-185-5
(a)
Nail cuticle solvent
(a)
5 % (5)
(a)
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
(b)
Hair straightener
2 % (5)
General use
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
4,5 % (5)
Professional use
For professional use only
Avoid contact with eyes
Can cause blindness
(c)
pH adjuster for depilatories
(c)
pH < 12,7
(c)
Keep out of reach of children
Avoid contact with eyes
(d)
Other uses as pH adjuster
(d)
pH < 11
15b
Lithium hydroxide
Lithium hydroxide
1310-65-2
215-183-4
(a)
Hair straighteners
2 % (6)
General use
(a)
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
4,5 % (6)
Professional use
Avoid contact with eyes
Can cause blindness
(b)
pH adjuster for depilatories
pH < 12,7
(b)
Contains alkali
Keep out of reach of children
Avoid contact with eyes
(c)
Other uses as pH adjuster (for rinse-off products only)
pH < 11
15c
Calcium hydroxide
Calcium hydroxide
1305-62-0
215-137-3
(a)
Hair straighteners containing two components: calcium hydroxide and a guanidine salt
(a)
7 % (as calcium hydroxide)
(a)
Contains alkali
Avoid contact with eyes
Keep out of reach of children
Can cause blindness
(b)
pH adjuster for depilatories
(b)
pH < 12,7
(b)
Contains alkali
Keep out of reach of children
Avoid contact with eyes
(c)
Other uses (e.g. pH adjuster, processing aid)
(c)
pH < 11
16
1-Naphthol and its salts
1-Naphtol
90-15-3
201-969-4
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Can cause an allergic reaction
17
Sodium nitrite
Sodium nitrite
7632-00-0
231-555-9
Rust inhibitor
0,2 %
Not to be used with secondary and/or tertiary amines or other substances forming nitrosamines
18
Nitromethane
Nitromethane
75-52-5
200-876-6
Rust inhibitor
0,3 %
19
Moved or deleted
20
Moved or deleted
21
Cinchonan-9-ol, 6'-methoxy-, (8.alpha., 9R)- and its salts
Quinine
130-95-0
205-003-2
(a)
Hair rinse-off products
(a)
0,5 % (as quinine base)
(b)
Hair leave-on products
(b)
0,2 % (as quinine base)
22
Resorcinol (4)
Resorcinol
108-46-3
203-585-2
(a)
Oxidising colouring agent for hair dyeing
5 %
General use
Not to be used on eyebrows
Contains resorcinol
Rinse hair well after application
Do not use to dye eyelashes or eyebrows
Rinse eyes immediately if product comes into contact with them
Professional use
For professional use only
Contains resorcinol
Rinse eyes immediately if product comes into contact with them
(b)
Hair lotions and shampoos
0,5 %
Contains resorcinol
23
(a)
Alkali sulphides
(a)
Depilatories
(a)
2 % (as sulphur)
pH ≤ 12,7
(a) (b)
Keep out of reach of children
Avoid contact with eyes
(b)
Alkaline earth sulphides
(b)
Depilatories
(b)
6 % (as sulphur)
24
Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8)
Zinc acetate, zinc chloride, zinc gluconate, zinc glutamate
1 % (as zinc)
25
Zinc 4-hydroxybenzene sulphonate
Zinc phenolsulfonate
127-82-2
204-867-8
Deodorants, antiperspirants and astringent lotions
6 % (as % anhydrous substance)
Avoid contact with eyes
26
Ammonium monofluorophosphate
Ammonium monofluorophosphate
20859-38-5/66115-19-3
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium monofluorophosphate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
27
Disodium fluorophosphate
Sodium monofluorophosphate
10163-15-2/7631-97-2
233-433-0/231-552-2
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium monofluorophosphate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
28
Dipotassium fluorophosphate
Potassium monofluorophosphate
14104-28-0
237-957-0
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium monofluorophosphate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
29
Calcium fluorophosphate
Calcium monofluorophosphate
7789-74-4
232-187-1
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains calcium monofluorophosphate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
30
Calcium fluoride
Calcium fluoride
7789-75-5
232-188-7
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains calcium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
31
Sodium fluoride
Sodium fluoride
7681-49-4
231-667-8
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
32
Potassium fluoride
Potassium fluoride
7789-23-3
232-151-5
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
33
Ammonium fluoride
Ammonium fluoride
12125-01-8
235-185-9
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
34
Aluminium fluoride
Aluminium fluoride
7784-18-1
232-051-1
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains aluminium-fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
35
Tin difluoride
Stannous fluoride
7783-47-3
231-999-3
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains stannous fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
36
Hexadecyl ammonium fluoride
Cetylamine hydrofluoride
3151-59-5
221-588-7
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains Cetylamine hydrofluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
37
3-(N-Hexadecyl-N-2-hydroxy-ethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride
—
—
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
38
N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
—
—
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
39
9-Octadecenamine, hydrofluoride
Octadecenyl-ammonium fluoride
2782-81-2
—
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains octadecenyl-ammonium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
40
Disodium hexafluorosilicate
Sodium fluorosilicate
16893-85-9
240-934-8
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium fluorosilicate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
41
Dipotassium hexafluorosilicate
Potassium fluorosilicate
16871-90-2
240-896-2
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium fluorosilicate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
42
Ammonium hexafluorosilicate
Ammonium fluorosilicate
16919-19-0
240-968-3
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium fluorosilicate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
43
Magnesium hexafluorosilicate
Magnesium fluorosilicate
16949-65-8
241-022-2
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains magnesium fluorosilicate
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
44
1,3-Bis (hydroxymethyl)imidazolidine-2-thione
Dimethylol ethylene thiourea
15534-95-9
239-579-1
(a)
Hair- products
(a)
2 %
(a)
Not to be used in aerosol dispensers (sprays)
Contains Dimethylol ethylene thiourea
(b)
Nail- products
(b)
2 %
(b)
pH < 4
45
Benzyl alcohol (7)
Benzyl alcohol
100-51-6
202-859-9
Solvents, perfumes and flavourings
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
46
6-Methylcoumarin
6-Methylcoumarin
92-48-8
202-158-8
Oral products
0,003 %
47
3-Pyridinemethanol, hydrofluoride
Nicomethanol hydrofluoride
62756-44-9
—
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains nicomethanol hydrofluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
48
Silver nitrate
Silver nitrate
7761-88-8
231-853-9
Only for colouring eyelashes and eyebrows
4 %
Contains silver nitrate
Rinse eyes immediately if product comes into contact with them
49
Selenium sulfide
Selenium disulphide
7488-56-4
231-303-8
Antidandruff shampoos
1 %
Contains selenium disulphide
Avoid contact with eyes or damaged skin
50
Aluminium zirconium chloride hydroxide complexes
AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes
Anti-perspirants
20 % (as anhydrous aluminium zirconium chloride hydroxide)
5,4 % (as zirconium)
1.
The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10
2.
The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1
3.
Not to be used in aerosol dispensers (sprays)
Do not apply to irritated or damaged skin
51
Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate
Oxyquinoline and oxyquinoline sulfate
148-24-3/134-31-6
205-711-1/205-137-1
Stabilizer for hydrogen peroxide in rinse-off hair- products
0,3 % (as base)
Stabilizer for hydrogen peroxide in leave-on hair products
0,03 % (as base)
52
Methanol
Methyl alcohol
67-56-1
200-659-6
Denaturant for ethanol and isopropyl alcohol
5 % (as a % ethanol and isopropyl alcohol)
53
(1-Hydroxyethylidene-diphosphonic acid) and its salts
Etidronic acid
2809-21-4
220-552-8
(a)
Hair- product
1,5 % (as etidronic acid)
(b)
Soap
0,2 % (as etidronic acid)
54
1-Phenoxypropan-2-ol (8)
Phenoxyisopropanol
770-35-4
212-222-7
Use only in rinse-off products
Not to be used in oral products
2 %
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
55
Moved or deleted
56
Magnesium fluoride
Magnesium fluoride
7783-40-6
231-995-1
Oral products
0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains magnesium fluoride
For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:
‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’
57
Strontium chloride hexahydrate
Strontium chloride
10476-85-4
233-971-6
(a)
Oral products
3,5 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 3,5 %
Contains strontium chloride
Frequent use by children is not advisable
(b)
Shampoo and face products
2,1 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 2,1 %
58
Strontium acetate hemihydrate
Strontium acetate
543-94-2
208-854-8
Oral products
3,5 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 3,5 %
Contains strontium acetate
Frequent use by children is not advisable
59
Talc: Hydrated magnesium silicate
Talc
14807-96-6
238-877-9
(a)
Powdery products intended to be used for children under 3 years of age
(b)
Other products
(a)
Keep powder away from children's nose and mouth
60
Fatty acid dialkylamides and dialkanolamides
Maximum secondary amine content: 0,5 %
—
Not to be used with nitrosating systems
—
Maximum secondary amine content: 5 % (applies to raw materials)
—
Maximum nitrosamine content: 50 μg/kg
—
Keep in nitrite-free containers
61
Monoalkylamines, monoalkanolamines and their salts
Maximum secondary amine content: 0,5 %
—
Not to be used with nitrosating systems- Minimum purity: 99 %
—
Maximum secondary amine content: 0,5 % (applies to raw materials)
—
Maximum nitrosamine content: 50 μg/kg
—
Keep in nitrite-free containers
62
Trialkylamines, trialkanolamines and their salts
(a)
Leave-on products
(b)
Rinse-off products
(a)
2,5 %
(a) (b)
—
Not to be used with nitrosating systems
—
Minimum purity: 99 %
—
Maximum secondary amine content: 0,5 % (applies to raw materials)
—
Maximum nitrosamine content: 50 μg/kg
—
Keep in nitrite-free containers
63
Strontium hydroxide
Strontium hydroxide
18480-07-4
242-367-1
pH adjuster for depilatories
3,5 % (as strontium)
pH ≤ 12,7
Keep out of reach of children
Avoid contact with eyes
64
Strontium peroxide
Strontium peroxide
1314-18-7
215-224-6
Rinse-off hair products
4,5 % (as strontium)
All products must meet the hydrogen peroxide release requirements
Professional use
Avoid contact with eyes
Rinse eyes immediately if product comes into contact with them
For professional use only
Wear suitable gloves
65
Benzalkonium chloride, bromide and saccharinate (9)
Benzalkonium bromide
91080-29-4
293-522-5
Rinse-off hair (head) products
3 % (as benzalkonium chloride)
In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0,1 % (as benzalkonium chloride)
Avoid contact with eyes
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
Benzalkonium chloride
63449-41-2/68391-01-5/68424-85-1/85409-22-9
264-151-6/269-919-4/270-325-2/287-089-1
Benzalkonium saccharinate
68989-01-5
273-545-7
66
Polyacrylamides
(a)
Body- leave-on products
(a)
Maximum residual acrylamide content 0,1 mg/kg
(b)
Other products
(b)
Maximum residual acrylamide content 0,5 mg/kg
67
2-Benzylideneheptanal
Amyl cinnamal
122-40-7
204-541-5
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
68
Benzyl alcohol
Benzyl alcohol
100-51-6
202-859-9
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
69
Cinnamyl alcohol
Cinnamyl alcohol
104-54-1
203-212-3
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
70
3,7-Dimethyl-2,6-octadienal
Citral
5392-40-5
226-394-6
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
71
Phenol, 2-methoxy-4-(2-propenyl)
Eugenol
97-53-0
202-589-1
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
72
7-Hydroxycitronellal
Hydroxycitronellal
107-75-5
203-518-7
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
73
Phenol, 2-methoxy-4-(1-propenyl)-
Isoeugenol
97-54-1
202-590-7
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
74
2-Pentyl-3-phenylprop-2-en-1-ol
Amylcinnamyl alcohol
101-85-9
202-982-8
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
75
Benzyl salicylate
Benzyl salicylate
118-58-1
204-262-9
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
76
2-Propenal, 3-phenyl-
Cinnamal
104-55-2
203-213-9
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
77
2H-1-Benzopyran-2-one
Coumarin
91-64-5
202-086-7
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
78
2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)-
Geraniol
106-24-1
203-377-1
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
79
3 and 4-(4-Hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
Hydroxyisohexyl 3-cyclohexene carboxaldehyde
51414-25-6/31906-04-4
257-187-9/250-863-4
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
80
4-Methoxybenzyl alcohol
Anise alcohol
105-13-5
203-273-6
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
81
2-Propenoic acid, 3-phenyl-, phenylmethyl ester
Benzyl cinnamate
103-41-3
203-109-3
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
82
2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-
Farnesol
4602-84-0
225-004-1
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
83
2-(4-tert-Butylbenzyl)propionaldehyde
Butylphenyl methylpropional
80-54-6
201-289-8
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
84
1,6-Octadien-3-ol, 3,7-dimethyl-
Linalool
78-70-6
201-134-4
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
85
Benzyl benzoate
Benzyl benzoate
120-51-4
204-402-9
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
86
Citronellol/(±) -3,7-dimethyloct-6-en-1-ol
Citronellol
106-22-9/26489-01-0
203-375-0/247-737-6
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
87
2-Benzylideneoctanal
Hexyl cinnamal
101-86-0
202-983-3
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
88
(4R)-1-Methyl-4-(1-methylethenyl)cyclohexene
Limonene
5989-27-5
227-813-5
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
89
Methyl heptin carbonate
Methyl 2-octynoate
111-12-6
203-836-6
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
90
3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
alpha-Isomethyl ionone
127-51-5
204-846-3
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
91
Oak moss extract
Evernia prunastri extract
90028-68-5
289-861-3
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
92
Treemoss extract
Evernia furfuracea extract
90028-67-4
289-860-8
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
93
2,4-Pyrimidinediamine, 3-oxide
Diaminopyrimidine oxide
74638-76-9
—
Hair products
1,5 %
94
Dibenzoyl peroxide
Benzoyl peroxide
94-36-0
202-327-6
Artificial nail systems
0,7 % (after mixing for use)
Professional use
For professional use only
Avoid skin contact
Read directions for use carefully
95
Hydroquinone methylether/Mequinol
p-Hydroxyanisol
150-76-5
205-769-8
Artificial nail systems
0,02 % (after mixing for use)
Professional use
For professional use only
Avoid skin contact
Read directions for use carefully
96
5-tert-Butyl-2,4,6-trinitro-m-xylene
Musk xylene
81-15-2
201-329-4
All cosmetic products, with the exception of oral products
(a)
1,0 % in fine fragrance
(b)
0,4 % in eau de toilette
(c)
0,03 % in other products
97
4'-tert-Butyl-2',6'-dimethyl-3',5'-dinitroacetophenone
Musk ketone
81-14-1
201-328-9
All cosmetic products, with the exception of oral products
(a)
1,4 % in fine fragrance
(b)
0,56 % in eau de toilette
(c)
0,042 % in other products
98
Benzoic acid, 2-hydroxy- (10)
Salicylic acid
69-72-7
200-712-3
(a)
Rinse-off hair products
(b)
Other products
(a)
3,0 %
(b)
2,0 %
Not to be used in preparations for children under 3 years of age, except for shampoos
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
Not to be used for children under 3 years of age (11)
99
Inorganic sulfites and bisulfites (12)
(a)
Oxidative hair dye products
(a)
0,67 % (as free SO2)
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
(b)
Hair straightening products
(b)
6,7 % (as free SO2)
(c)
Self-tanning products for the face
(c)
0,45 % (as free SO2)
(d)
Other self-tanning products
(d)
0,40 % (as free SO2)
100
1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea (13)
Triclocarban
101-20-2
202-924-1
Rinse-off products
1,5 %
Purity criteria:
3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm
3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
101
Pyrithione zinc (14)
Zinc pyrithione
13463-41-7
236-671-3
Leave-on hair products
0,1 %
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
102
1,2-Dimethoxy-4-(2-propenyl)-benzene
Methyl eugenol
93-15-2
202-223-0
Fine fragrance
0,01 %
Eau de toilette
0,004 %
Fragrance cream
0,002 %
Other leave-on products and oral products
0,0002 %
Rinse-off products
0,001 %
215
4-Amino-3-nitrophenol and its salts
4-Amino-3-nitrophenol
610-81-1
210-236-8
(a)
Oxidising colouring agents for hair dyeing
(a)
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
3,0 %
216
2,7-Naphthalenediol and its salts
Naphthalene-2,7-diol
582-17-2
209-478-7
Oxidising colouring agents for hair dyeing
1,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %
Not to be used after 31.12.2009
217
m-Aminophenol and its salts
3-Aminophenol
591-27-5
209-711-2
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
Can cause allergic reaction
218
2,6-Dihydroxy-3,4-dimethylpyridine and its salts
2,6-Dihydroxy-3,4-dimethylpyridine
84540-47-6
283-141-2
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
219
1-Hydroxy-3-nitro-4-(3-hydroxypropylamino)benzene and its salts
4-Hydroxypropylamino-3-nitrophenol
92952-81-3
406-305-9
(a)
Oxidising colouring agents for hair dyeing
(a)
5,2 %
In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
2,6 %
220
1-[(2'-Methoxyethyl)amino]-2-nitro-4-[di-(2'-hydroxyethyl)amino]benzene and its salts
HC Blue No 11
23920-15-2
459-980-7
(a)
Oxidising colouring agents for hair dyeing
(a)
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
2,0 %
221
1-Methyl-3-nitro-4-(.beta.-hydroxyethyl)aminobenzene and its salts
Hydroxyethyl-2-nitro-p-toluidine
100418-33-5
408-090-7
(a)
Oxidising colouring agents for hair dyeing
(a)
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
1,0 %
222
1-Hydroxy-2-.beta.-hydroxyethylamino-4,6-dinitrobenzene and its salts
2-Hydroxyethylpicramic acid
99610-72-7
412-520-9
(a)
Oxidising colouring agents for hair dyeing
(a)
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
2,0 %
223
4-Methylaminophenol and its salts
p-Methylaminophenol
150-75-4
205-768-2
Oxidising colouring agent for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
Can cause allergic reaction
224
1-(3-Hydroxypropylamino)-2-nitro-4-bis(2-hydroxyethylamino)benzene and its salts
HC Violet No 2
104226-19-9
410-910-3
Non-oxidising colouring agent for hair dyeing
2,0 %
Not to be used after 31.12.2009
225
1-(.beta.-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its salts
HC Blue No 12
104516-93-0
407-020-2
(a)
Oxidising colouring agents for hair dyeing
(a)
1,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 %
Not to be used after 31.12.2009
(a) (b)
Can cause allergic reaction
(b)
Non-oxidising colouring agents for hair dyeing
(b)
1,5 %
226
4,4'-[1,3-Propanediylbis(oxy)]bis-, benzene-1,3-diamine and its salts
1,3-Bis-(2,4-diaminophenoxy)propane
81892-72-0
279-845-4
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
Can cause allergic reaction
227
3-Amino-2,4-dichlorophenol and its salts
3-Amino-2,4-dichlorophenol
61693-43-4
262-909-0
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
Can cause allergic reaction
228
3-Methyl-1-phenyl-5-pyrazolone and its salts
Phenyl methyl pyrazolone
89-25-8
201-891-0
Oxidising colouring agents for hair dyeing
0,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %
Not to be used after 31.12.2009
229
5-[(2-Hydroxyethyl)amino]-o-cresol and its salts
2-Methyl-5-hydroxyethylaminophenol
55302-96-0
259-583-7
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
Can cause allergic reaction
230
3,4-Dihydro-2H-1,4-benzoxazin-6-ol and its salts
Hydroxybenzomorpholine
26021-57-8
247-415-5
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
Can cause allergic reaction
231
1,5-bis(.beta.-Hydroxyethyl)amino-2-nitro-4-chlorobenzene and its salts
HC Yellow No 10
109023-83-8
416-940-3
Non-oxidising colouring agents for hair dyeing
0,2 %
Not to be used after 31.12.2009
232
3,5-Diamino-2,6-dimethoxypyridine and its salts
2,6-Dimethoxy-3,5-pyridinediamine HCl
85679-78-3/56216-28-5
- / 260-062-1
Oxidising colouring agents for hair dyeing
0,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %
Not to be used after 31.12.2009
Can cause allergic reaction
233
1-(2-Aminoethyl)amino-4-(2-hydroxyethyl)oxy-2-nitrobenzene and its salts
HC Orange No 2
85765-48-6
416-410-1
Non-oxidising colouring agents for hair dyeing
1,0 %
Not to be used after 31.12.2009
234
Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)amino]-and its salts
HC Violet No 1
82576-75-8
417-600-7
(a)
Oxidising colouring agents for hair dyeing
(a)
0,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
0,5 %
235
2-[3-(Methylamino)-4-nitrophenoxy]ethanol and its salts
3-Methylamino-4-nitro-phenoxyethanol
59820-63-2
261-940-7
Non-oxidising colouring agents for hair dyeing
1,0 %
Not to be used after 31.12.2009
236
2-[(2-Methoxy-4-nitrophenyl)amino]ethanol and its salts
2-Hydroxy-ethylamino-5-nitro-anisole
66095-81-6
266-138-0
Non-oxidising colouring agents for hair dyeing
1,0 %
Not to be used after 31.12.2009
237
2,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and other salts
HC Red No 13
94158-13-1
303-083-4
(a)
Oxidising colouring agents for hair dyeing
(a)
2,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
2,5 %
238
Naphthalene-1,5-diol and its salts
1,5-Naphthalenediol
83-56-7
201-487-4
Oxidising colouring agents for hair dyeing
1,0 %
Not to be used after 31.12.2009
239
Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its salts
Hydroxypropyl bis(N-hydroxyethyl-p-phenyldiamine) HCl
128729-30-6
416-320-2
Oxidising colouring agents for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
Can cause allergic reaction
240
o-Aminophenol and its salts
o-Aminophenol
95-55-6
202-431-1
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
241
5-Amino-o-cresol and its salts
4-Amino-2-hydroxytoluene
2835-95-2
220-618-6
Oxidising colouring agents for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
242
2,4-Diaminophenoxyethanol and its salts
2,4-Diaminophenoxyethanol HCl
66422-95-5
266-357-1
Oxidising colouring agents for hair dyeing
4,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 %
Not to be used after 31.12.2009
243
1,3-Benzenediol, 2-methyl-, and its salts -
2-Methylresorcinol
608-25-3
210-155-8
Oxidising colouring agents for hair dyeing
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
244
4-Amino-m-cresol and its salts
4-Amino-m-cresol
2835-99-6
220-621-2
Oxidising colouring agents for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
245
2-[(3-amino-4-methoxyphenyl)amino]ethanol and its salts
2-Amino-4-hydroxyethylaminoanisole
83763-47-7
280-733-2
Oxidising colouring agents for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
246
Hydroxyethyl-3,4-methylenedioxyaniline 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride and other salts
Hydroxyethyl-3,4-methylenedioxyaniline HCI
81329-90-0
303-085-5
Oxidising colouring agents for hair dyeing
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
247
2,2'-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol. and its salts
HC Blue No 2
33229-34-4
251-410-3
Non-oxidising colouring agents for hair dyeing
2,8 %
Not to be used after 31.12.2009
248
4-[(2-Hydroxyethyl)amino]-3-nitrophenol and its salts
3-Nitro-p-hydroxyethylaminophenol
65235-31-6
265-648-0
(a)
Oxidising colouring agents for hair dyeing
(a)
6,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
6,0 %
249
1-(.beta.-Ureidoethyl)amino-4-nitrobenzene and its salts
4-Nitrophenyl aminoethylurea
27080-42-8
410-700-1
(a)
Oxidising colouring agents for hair dyeing
(a)
0,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
0,5 %
250
1-amino-2-nitro-4-(2',3'-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2',3'-dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its salts
HC Red No 10 and HC Red No 11
95576-89-9 and 95576-92-4
—
(a)
Oxidising colouring agents for hair dyeing
(a)
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
1,0 %
251
Phenol, 2-chloro-6-(ethylamino)-4-nitro- and its salts
2-Chloro-6-ethylamino-4-nitrophenol
131657-78-8
411-440-1
(a)
Oxidising colouring agents for hair dyeing
(a)
3,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
3,0 %
252
2-Amino-6-chloro-4-nitrophenol and its salts
2-Amino-6-chloro-4-nitrophenol
6358-09-4
228-762-1
(a)
Oxidising colouring agents for hair dyeing
(a)
2,0 %
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
2,0 %
253
[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (CI 44045) and other salts
Basic Blue 26 (CI 44045)
2580-56-5
219-943-6
(a)
Oxidising colouring agents for hair dyeing
(a)
0,5 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
0,5 %
254
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CI 17200) and other salts
Acid Red 33 (CI 17200)
3567-66-6
222-656-9
Non-oxidising colouring agents for hair dyeing
2,0 %
Not to be used after 31.12.2009
255
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CI 14700) and other salts
Ponceau SX (CI 14700)
4548-53-2
224-909-9
Non-oxidising colouring agents for hair dyeing
2,0 %
Not to be used after 31.12.2009
256
(4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride (CI 42510) and other salts
Basic Violet 14 (CI 42510)
632-99-5
211-189-6
(a)
Oxidising colouring agents for hair dyeing
(a)
0,3 %
In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 %
Not to be used after 31.12.2009
(b)
Non-oxidising colouring agents for hair dyeing
(b)
0,3 %
(1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
(2) For use as a preservative, see Annex V, No. 5.
(3) Only if the concentration exceeds 0,05 %.
(4) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2.
(5) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.
(6) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.
(7) For use as a preservative, see Annex V, No. 34.
(8) For use as a preservative, see Annex V, No 43.
(9) For use as a preservative, see Annex V, No. 54.
(10) For use as a preservative, see Annex V, No 3.
(11) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
(12) For use as a preservative, see Annex V, No 9.
(13) For use as a preservative, see AnnexV, No 23.
(14) For use as a preservative, see Annex V, No 8.
ANNEX IV
LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS
Preamble
Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included.
Reference number
Substance identification
Conditions
Wording of conditions of use and warnings
Chemical Name
Colour index Number/Name of Common Ingredients Glossary
CAS number
EC number
Colour
Product type, Body parts
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
j
1
Sodium tris(1,2-naphthoquinone 1-oximato-O,O')ferrate(1-)
10006
Green
Rinse-off products
2
Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)
10020
Green
Not to be used in products applied on mucous membranes
3
Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
10316
Yellow
Not to be used in eye products
4
2-[(4-Methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
11680
Yellow
Not to be used in products applied on mucous membranes
5
2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
11710
Yellow
Not to be used in products applied on mucous membranes
6
2-[(4-Methoxy-2-nitrophenyl)azo]-3-oxo-N-(o-tolyl)butyramide
11725
Orange
Rinse-off products
7
4-(Phenylazo)resorcinol
11920
Orange
8
4-[(4-Ethoxyphenyl)azo]naphthol
12010
Red
Not to be used in products applied on mucous membranes
9
1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol and its insoluble barium, strontium and zirconium lakes, salts and pigments
12085
Red
3 %
10
1-[(4-Methyl-2-nitrophenyl)azo]-2-naphthol
12120
Red
Rinse-off products
11
3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide
12370
Red
Rinse-off products
12
N-(4-Chloro-2-methylphenyl)-4-[(4-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
12420
Red
Rinse-off products
13
4-[(2,5-Dichlorophenyl)azo]-N-(2,5-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
12480
Brown
Rinse-off products
14
N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
12490
Red
15
2,4-Dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one
12700
Yellow
Rinse-off products
16
Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate
13015
Yellow
17
Sodium 4-(2,4-dihydroxyphenylazo)benzenesulphonate
14270
Orange
18
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
14700
Red
19
Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
14720
222-657-4
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 122)
20
Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate
14815
Red
21
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
15510
Orange
Not to be used in eye products
22
Calcium disodium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]-4-sulphonatobenzoate]
15525
Red
23
Barium bis[4-[(2-hydroxy-1-naphthyl)azo]-2-methylbenzenesul-phonate]
15580
Red
24
Sodium 4-[(2-Hydroxy-1-naphthyl)azo]naphthalenesulphonate
15620
Red
Rinse-off products
25
Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
15630
Red
3 %
26
Calcium bis[3-hydroxy-4-(phenylazo)-2-naphthoate]
15800
Red
Not to be used in products applied on mucous membranes
27
Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments
15850
226-109-5
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 180)
28
Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments
15865
Red
29
Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate
15880
Red
30
Disodium 6-hydroxy-5-[(3-sulphonatophenyl)azo]naphthalene-2-sulphonate
15980
Orange
31
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
15985
220-491-7
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 110)
32
Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
16035
247-368-0
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 129)
33
Trisodium 3-hydroxy-4-[(4'-sulphonatonaphthyl)azo]naphthalene-2,7-disulphonate
16185
213-022-2
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 123)
34
Disodium 7-hydroxy-8-(phenylazo)naphthalene-1,3-disulphonate
16230
Orange
Not to be used in products applied on mucous membranes
35
Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
16255
220-036-2
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 124)
36
Tetrasodium 7-hydroxy-8-[(4-sulphonato-1-naphthyl)azo]naphthalene-1,3,6-trisulphonate
16290
Red
37
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments
17200
Red
38
Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
18050
223-098-9
Red
Not to be used in products applied on mucous membranes
Purity criteria as set out in Commission Directive 95/45/EC (E 128)
39
2,7-Naphthalenedisulfonic acid, 3-((4-cyclohexyl-2-methylphenyl)azo)-4-hydroxy-5-(((4-methylphenyl)sulfonyl)amino)-, disodium salt
18130
Red
Rinse-off products
40
Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
18690
Yellow
Rinse-off products
41
Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-)
18736
Red
Rinse-off products
42
Sodium 4-(3-hydroxy-5-methyl-4-(phenylazo)pyrazol-2-yl)benzenesulphonate
18820
Yellow
Rinse-off products
43
Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-((sulphophenyl)azo)pyrazol-1-yl)benzenesulphonate
18965
Yellow
44
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-((4-sulphophenyl)azo)pyrazole-3-carboxylate and its insoluble barium, strontium and zirconium lakes, salts and pigments
19140
217-699-5
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 102)
45
N,N'-(3,3'-Dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide]
20040
Yellow
Rinse-off products
Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
46
Sodium 4-amino-5-hydroxy-3-((4-nitrophenyl)azo)-6-(phenylazo)naphthalene-2,7-disulphonate
20470
Black
Rinse-off products
47
2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
21100
Yellow
Rinse-off products
Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
48
2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]
21108
Yellow
Rinse-off products
Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
49
2,2'-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol]
21230
Yellow
Not to be used in products applied on mucous membranes
50
Disodium 4,6-dihydroxy-3-[[4-[1-[4-[[1-hydroxy-7-[(phenylsulphonyl)oxy]-3-sulphonato-2-naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2-sulphonate
24790
Red
Rinse-off products
51
1-(4-(Phenylazo)phenylazo)-2-naphthol
26100
Red
Not to be used in products applied on mucous membranes
Purity criteria:
aniline ≤ 0,2 %
2-naphtol ≤ 0,2 %
4-aminoazobenzene ≤ 0,1 %
1-(phenylazo)-2-naphtol ≤ 3 %
1-[2-(phenylazo)phenylazo]-2-napthalenol ≤ 2 %
52
Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
27755
Black
53
Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
28440
219-746-5
Black
Purity criteria as set out in Commission Directive 95/45/EC (E 151)
54
Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo] benzenesulfonic acid, sodium salts
40215
Orange
Rinse-off products
55
beta Carotene
40800
230-636-6
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E160a)
56
8'-apo-.beta.-Caroten-8'-al
40820
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 160e)
57
Ethyl 8'-apo-.beta.-caroten-8'-oate
40825
214-173-7
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 160f)
58
Canthaxanthin
40850
208-187-2
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 161g)
59
Ammonium, (4-(alpha-(p-(diethylamino)phenyl)-2,4-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethyl-, hydroxide, monosodium salt
42045
Blue
Not to be used in products applied on mucous membranes
60
Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) and its insoluble barium, strontium and zirconium lakes, salts and pigments
42051
222-573-8
Blue
Purity criteria as set out in Commission Directive 95/45/EC (E 131)
61
Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt
42053
Green
62
Hydrogen (benzyl)[4-[[4-[benzylethylamino]phenyl](2,4-disulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)ammonium, sodium salt
42080
Blue
Rinse-off products
63
Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt
42090
223-339-8
Blue
Purity criteria as set out in Commission Directive 95/45/EC (E 133)
64
Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
42100
Green
Rinse-off products
65
Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
42170
Green
Rinse-off products
66
(4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
42510
Violet
Not to be used in products applied on mucous membranes
67
4-[(4-Amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride
42520
Violet
Rinse-off products
5ppm
68
Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
42735
Blue
Not to be used in products applied on mucous membranes
69
[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
44045
Blue
Not to be used in products applied on mucous membranes
70
Hydrogen [4-[4-(dimethylamino)-.alpha.-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
44090
221-409-2
Green
Purity criteria as set out in Commission Directive 95/45/EC (E 142)
71
Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt
45100
Red
Rinse-off products
72
Hydrogen 9-(2-carboxylatophenyl)-3-(2-methylanilino)-6-(2-methyl-4-sulphoanilino)xanthylium, monosodium salt
45190
Violet
Rinse-off products
73
Hydrogen 9-(2,4-disulphonatophenyl)-3,6-bis(ethylamino)-2,7-dimethylxanthylium, monosodium salt
45220
Red
Rinse-off products
74
Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
45350
Yellow
6 %
75
4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one and its insoluble barium, strontium and zirconium lakes, salts and pigments
45370
Orange
Not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
76
Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments
45380
Red
Not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
77
3',6'-Dihydroxy-4',5'-dinitrospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one
45396
Orange
1 %, when used in lip products
Only in free acid form, when used in lip products
78
Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
45405
Red
Not to be used in eye products
Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
79
3,4,5,6-Tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid and its insoluble barium, strontium and zirconium lakes, salts and pigments
45410
Red
Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
80
Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments
45430
240-474-8
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 127)
81
1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline
47000
Yellow
Not to be used in products applied on mucous membranes
82
1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
47005
305-897-5
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 104)
83
Hydrogen 9-[(3-methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt
50325
Violet
Rinse-off products
84
Sulfonated nigrosine color
50420
Black
Not to be used in products applied on mucous membranes
85
8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine
51319
Violet
Rinse-off products
86
1,2-Dihydroxyanthraquinone
58000
Red
87
Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
59040
Green
Not to be used in products applied on mucous membranes
88
1-Anilino-4-hydroxyanthraquinone
60724
Violet
Rinse-off products
89
1-Hydroxy-4-(p-toluidino)anthraquinone
60725
Violet
90
Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
60730
Violet
Not to be used in products applied on mucous membranes
91
1,4-bis(p-Tolylamino)anthraquinone
61565
Green
92
Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)
61570
Green
93
Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)
61585
Blue
Rinse-off products
94
Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
62045
Blue
Rinse-off products
95
6,15-Dihydroanthrazine-5,9,14,18-tetrone
69800
Blue
96
7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone
69825
Blue
97
Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione
71105
Orange
Not to be used in products applied on mucous membranes
98
2-(1,3-Dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one
73000
Blue
99
Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
73015
212-728-8
Blue
Purity criteria as set out in Commission Directive 95/45/EC (E 132)
100
6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one
73360
Red
101
5-Chloro-2-(5-chloro-7-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-7-methylbenzo[b]thiophene-3(2H)-one
73385
Violet
102
5,12-Dihydroquino[2,3-b]acridine-7,14-dione
73900
Violet
Rinse-off products
103
5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione
73915
Red
Rinse-off products
104
29H,31H-Phthalocyanine
74100
Blue
Rinse-off products
105
29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32 copper
74160
Blue
106
Disodium [29H,31H-phthalocyaninedisulphonato (4-)-N29,N30,N31,N32] cuprate (2-)
74180
Blue
Rinse-off products
107
Polychloro copper phthalocyanine
74260
Green
Not to be used in eye products
108
8,8'-diapo-.psi.,.psi.-Carotenedioic acid
75100
Yellow
109
Annatto
75120
215-735-4/289-561-2/230-248-7
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 160b)
110
Lycopene
75125
—
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 160d)
111
CI Food Orange 5
75130
214-171-6
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 160a)
112
(3R)-beta-4-Caroten-3-ol
75135
Yellow
113
2-Amino-1,7-dihydro-6H-purin-6-one
75170
White
114
Curcumins
75300
207-280-5
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 100)
115
Carmines
75470
215-680-6/215-023-3/215-724-4
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 120)
116
Trisodium (2S-trans)-[18-carboxy-20-(carboxymethyl)-13-ethyl-2,3-dihydro-3,7,12,17-tetramethyl-8-vinyl-21H,23H-porphine-2-propionato(5-)-N21,N22,N23,N24]cuprate(3-) (Chlorophylls)
75810
215-800-7/207-536-6/208-272-4/287-483-3/239-830-5/246-020-5
Green
Purity criteria as set out in Commission Directive 95/45/EC (E 140, E 141)
117
Aluminium
77000
231-072-3
White
Purity criteria as set out in Commission Directive 95/45/EC (E 173)
118
Aluminium hydroxide sulphate
77002
White
119
Natural hydrated aluminium silicate, Al2O3.2SiO2.2H2O, containing calcium, magnesium or iron carbonates, ferric hydroxide, quartz-sand, mica, etc. as impurities
77004
White
120
Lazurite
77007
Blue
121
Aluminum silicate coloured with ferric oxide
77015
Red
122
Barium sulfate
77120
White
123
Bismuth chloride oxide
77163
White
124
Calcium carbonate
77220
207-439-9/215-279-6
White
Purity criteria as set out in Commission Directive 95/45/EC (E 170)
125
Calcium sulfate
77231
White
126
Carbon black
77266
215-609-9
Black
Purity criteria as set out in Commission Directive 95/45/EC (E 153)
127
Charcoal, bone. A fine black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon
77267
Black
128
Coke black
77268:1
Black
129
Chromium (III) oxide
77288
Green
free from chromate ion
130
Chromium (III) hydroxide
77289
Green
free from chromate ion
131
Cobalt Aluminum Oxide
77346
Green
132
Copper
77400
Brown
133
Gold
77480
231-165-9
Brown
Purity criteria as set out in Commission Directive 95/45/EC (E 175)
134
Iron oxide
77489
Orange
135
Iron Oxide Red
77491
215-168-2
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 172)
136
Iron Oxide Yellow
77492
51274-00-1
257-098-5
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 172)
137
Iron Oxide Black
77499
235-442-5
Black
Purity criteria as set out in Commission Directive 95/45/EC (E 172)
138
Ferric Ammonium Ferrocyanide
77510
Blue
free from cyanide ions
139
Magnesium carbonate
77713
White
140
Ammonium manganese(3+) diphosphate
77742
Violet
141
Trimanganese bis (orthophosphate)
77745
Red
142
Silver
77820
231-131-3
White
Purity criteria as set out in Commission Directive 95/45/EC (E 174)
143
Titanium dioxide (1)
77891
236-675-5
White
Purity criteria as set out in Commission Directive 95/45/EC (E 171)
144
Zinc oxide
77947
White
145
Riboflavin
Lactoflavin
201-507-1/204-988-6
Yellow
Purity criteria as set out in Commission Directive 95/45/EC (E 101)
146
Caramel
Caramel
232-435-9
Brown
Purity criteria as set out in Commission Directive 95/45/EC (E 150a-d)
147
Paprika extract, Capsanthin, capsorubin
Capsanthin, capsorubin
207-364-1/207-425-2
Orange
Purity criteria as set out in Commission Directive 95/45/EC (E 160c)
148
Beetroot red
Beetroot Red
7659-95-2
231-628-5
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 162)
149
Anthocyanins
(Cyanidin,
Peonidin
Malvidin
Delphinidin
Petunidin
Pelargonidin)
Anthocyanins
528-58-5
134-01-0
528-53-0
643-84-5
134-04-3
208-438-6
205-125-6
211-403-8
208-437-0
—
205-127-7
Red
Purity criteria as set out in Commission Directive 95/45/EC (E 163)
150
Aluminium, zinc, magnesium and calcium stearates
Aluminum stearate
Zinc stearate
Magnesium stearate
Calcium stearate
7047-84-9
557-05-1
557-04-0
216-472-8
230-325-5
209-151-9
209-150-3
216-472-8
White
151
Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide
Bromothymol blue
76-59-5
200-971-2
Blue
Rinse-off products
152
Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide
Bromocresol green
76-60-8
200-972-8
Green
Rinse-off products
153
Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonate
Acid red 195
12220-24-5
—
Red
Not to be used in products applied on mucous membranes
(1) For use as a UV-Filter, see Annex VI, No. 27.
ANNEX V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Preamble
1. For the purposes of this list:
—
‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
—
‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.
2. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0,05 %.
Reference number
Substance identification
Conditions
Wording of conditions of use and warnings
Chemical name/INN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, Body parts
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
1
Benzoic acid and its sodium salt
Benzoic acid
Sodium Benzoate
65-85-0
532-32-1
200-618-2
208-534-8
Rinse-off products, except oral products
2,5 % (acid)
Oral products
1,7 % (acid)
Leave-on products
0,5 % (acid)
1a
Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid
Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate
1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2
217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-2
0,5 % (acid)
2
Propionic acid and its salts
Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate
79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6
201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4
2 % (acid)
3
Salicylic acid (1) and its salts
Salicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate
69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5
200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3
0,5 % (acid)
Not to be used in products for children under 3 years of age, except for shampoos
Not to be used for children under 3 years of age (2)
4
Hexa-2,4-dienoic acid and its salts
Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate
110-44-1, 7492-55-9, 7757-81-5, 24634-61-5
203-768-7, 231-321-6, 231-819-3, 246-376-1
0,6 % (acid)
5
Formal-dehyde, paraformaldehyde (3)
Formaldehyde
Paraformaldehyde
50-00-0, 30525-89-4
200-001-8
Oral products
0,1 % (free formaldehyde)
Not to be used in aerosol dispensers (sprays)
Other products
0,2 % (free formaldehyde)
6
Moved or deleted
7
Biphenyl-2-ol, and its salts
o-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate
90-43-7, 132-27-4, 13707-65-8, 84145-04-0
201-993-5, 205-055-6, 237-243-9, 282-227-7
0,2 % (as phenol)
8
Pyrithione zinc (4)
Zinc pyrithione
13463-41-7
236-671-3
Hair products
1,0 %
Only in rinse-off products
Not to be used in oral products
Other products
0,5 %
9
Inorganic sulphites and hydrogen- sulphites (5)
Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite
7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8
231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3
0,2 % (as free SO2)
10
Moved or deleted
11
Chlorobutanol
Chlorobutanol
57-15-8
200-317-6
0,5 %
Not to be used in aerosol dispensers (sprays)
Contains Chlorobutanol
12
4-Hydroxybenzoic acid and its salts and esters
4-Hydroxybenzoic acid, methylparaben, butylparaben, potassium ethylparaben, potassium paraben, propylparaben, isobutylparaben, sodium methylparaben, sodium ethylparaben, sodium propylparaben, sodium butylparaben, sodium isobutylparaben, ethylparaben, sodium paraben, isopropylparaben, potassium methylparaben, potassium butylparaben, potassium propylparaben, sodium propylparaben, calcium paraben, phenylparaben
99-96-7, 99-76-3, 94-26-8, 36457-19–9,16782-08-4, 94-13-3, 4247-02-3, 5026-62-0, 35285-68-8, 35285-69-9, 36457-20-2, 84930-15-4, 120-47-8, 114-63-6, 4191-73-5, 2611-07-2, 38566-94-8, 84930-17-4, 35285-69-9, 69959-44-0, 17696-62-7
202-804-9, 202-785-7, 202-318-7, 253-048-1, 240-830-2, 202-307-7, 224-208-8, 225-714-1, 252-487-6, 252-488-1, 253-049-7, 284-595-4, 204-399-4, 204-051-1, 224-069-3, 247-464-2, 254-009-1, 284-597-5, 252-488-1, 274-235-4, 241-698-9
0,4 % (as acid) for single ester,
0,8 % (as acid) for mixtures of esters
13
3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts
Dehydroacetic acid, sodium dehydroacetate
520-45-6, 4418-26-2, 16807-48-0
208-293-9, 224-580-1
0,6 % (as acid)
Not to be used in aerosol dispensers (sprays)
14
Formic acid and its sodium salt
Formic acid, sodium formate
64-18-6, 141-53-7
200-579-1, 205-488-0
0,5 % (as acid)
15
3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)
Dibromohexamidine Isethionate
93856-83-8
299-116-4
0,1 %
16
Thiomersal
Thimerosal
54-64-8
200-210-4
Eye products
0,007 % (of Hg)
If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 %
Contains Thiomersal
17
Phenylmercuric salts (including borate)
Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate
62-38-4, 94-43-9
200-532-5, 202-331-8
Eye products
0,007 % (of Hg)
If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 %
Contains Phenylmercuric compounds
18
Undec-10-enoic acid and its salts
Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate
112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2
203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7
0,2 % (as acid)
19
5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-
Hexetidine
141-94-6
205-513-5
0,1 %
20
5-Bromo-5-nitro-1,3-dioxane
5-Bromo-5-nitro-1,3-dioxane
30007-47-7
250-001-7
Rinse-off products
0,1 %
Avoid formation of nitrosamines
21
Bronopol
2-Bromo-2-nitropropane-1,3-diol
52-51-7
200-143-0
0,1 %
Avoid formation of nitrosamines
22
2,4-Dichlorobenzyl alcohol
Dichlorobenzyl Alcohol
1777-82-8
217-210-5
0,15 %
23
1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea (6)
Triclocarban
101-20-2
202-924-1
0,2 %
Purity criteria:
3,3',4,4'-Tetrachloroazobenzene <1 ppm
3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24
Chlorocresol
p-Chloro-m-Cresol
59-50-7
200-431-6
Not to be used in products applied on mucuous membranes
0,2 %
25
5-Chloro-2- (2,4- dichlorophenoxy) phenol
Triclosan
3380-34-5
222-182-2
0,3 %
26
Chloro-xylenol
Chloroxylenol
88-04-0
201-793-8
0,5 %
27
N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
Imidazolidinyl urea
39236-46-9
254-372-6
0,6 %
28
Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloride
Polyaminopropyl biguanide
70170-61-5, 28757-47-3, 133029-32-0
0,3 %
29
2-Phenoxyethanol
Phenoxyethanol
122-99-6
204-589-7
1,0 %
30
Methenamine
Methenamine
100-97-0
202-905-8
0,15 %
31
Methenamine 3-chloroallylochloride
Quaternium-15
4080-31-3
223-805-0
0,2 %
32
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one
Climbazole
38083-17-9
253-775-4
0,5 %
33
1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione
DMDM Hydantoin
6440-58-0
229-222-8
0,6 %
34
Benzyl alcohol (7)
Benzyl alcohol
100-51-6
202-859-9
1,0 %
35
1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt
1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine
50650-76-5, 68890-66-4
272-574-2
Rinse-off products
1,0 %
Other products
0,5 %
36
Moved or deleted
37
2,2'-methylenebis(6-bromo-4-chlorophenol)
Bromochlorophene
15435-29-7
239-446-8
0,1 %
38
4-Isopropyl-m-cresol
o-Cymen-5-ol
3228-02-2
221-761-7
0,1 %
39
Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate
Methylchloroisothiazolinone and Methylisothiazolinone
26172-55-4, 2682-20-4, 55965-84-9
247-500-7, 220-239-6
0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one
40
2-Benzyl-4-chlorophenol
Chlorophene
120-32-1
204-385-8
0,2 %
41
2-Chloroacetamide
Chloroacetamide
79-07-2
201-174-2
0,3 %
Contains chloroacetamide
42
N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride
55-56-1, 56-95-1, 18472-51-0, 3697-42-5
200-238-7, 200-302-4, 242-354-0, 223-026-6
0,3 % (as chlorhexidine)
43
1-Phenoxypropan-2-ol (8)
Phenoxyisopropanol
770-35-4
212-222-7
Only for rinse-off products
1,0 %
44
Alkyl (C 12-22) trimethyl ammonium bromide and chloride
Behentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride
17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8
241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-1
0,1 %
45
4,4-Dimethyl-1,3-oxazolidine
Dimethyl Oxazolidine
51200-87-4
257-048-2
0,1 %
pH > 6
46
N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea
Diazolidinyl Urea
78491-02-8
278-928-2
0,5 %
47
Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)
Hexamidine, Hexamidine diisethionate, Hexamidine paraben
3811-75-4, 659-40-5, 93841-83-9
211-533-5, 299-055-3
0,1 %
48
Glutaraldehyde (Pentane-1,5-dial)
Glutaral
111-30-8
203-856-5
0,1 %
Not to be used in aerosols (sprays)
Contains glutaral (9)
49
5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane
7-Ethylbicyclooxazolidine
7747-35-5
231-810-4
0,3 %
Not to be used in oral products and in products applied on mucous membranes
50
3-(p-Chlorophenoxy)-propane-1,2 diol
Chlorphenesin
104-29-0
203-192-6
0,3 %
51
Sodium hydroxymethylamino acetate
Sodium Hydroxymethylglycinate
70161-44-3
274-357-8
0,5 %
52
Silver chloride deposited on titanium dioxide
Silver chloride
7783-90-6
232-033-3
0,004 % (as AgCl)
20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products
53
Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride
Benzethonium Chloride
121-54-0
204-479-9
(a)
Rinse-off products
(b)
Leave-on products other than oral products
0,1 %
54
Benzalkonium chloride, bromide and saccharinate (10)
Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate
8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9
264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1
0,1 % (as benzalkonium chloride)
Avoid contact with eyes
55
Methanol, (phenylmethoxy-)
Benzylhemiformal
14548-60-8
238-588-8
Rinse-off products
0,15 %
56
3-Iodo-2-propynylbutylcarbamate
Iodopropynyl butylcarbamate
55406-53-6
259-627-5
(a)
Rinse-off products
(b)
Leave-on products
(c)
Deo-dorants/anti-perspirants
(a)
0,02 %
(b)
0,01 %,
(c)
0,0075 %
Not to be used in oral and lip products
(a)
Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo
(b)
Not to be used in body lotion and body cream (13)
(b) and (c)
Not to be used in products for children under 3 years of age
(a)
Not to be used for children under 3 years of age (11)
(b) and (c)
Not to be used for children under 3 years of age (12)
57
2-Methyl-2H-isothiazol-3-one
Methylisothiazolinone
2682-20-4
220-239-6
0,01 %
(1) For use other than as a preservative, see Annex III, No. 98.
(2) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
(3) For use other than as a preservative, see Annex III, No. 13.
(4) For use other than as a preservative, see Annex III. No. 101.
(5) For use other than as a preservative, see Annex III, No. 99.
(6) For use other than as a preservative, see Annex III, No. 100.
(7) For use other than as a preservative, see Annex III, No. 45, 68.
(8) For use other than as a preservative, see Annex III, No. 54.
(9) Only if the concentration exceeds 0,05 %.
(10) For use other than as a preservative, see Annex III, No. 65.
(11) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.
(12) Solely for products which might be used for children under 3 years of age.
(13) Concerns any products aimed to be applied on a large part of the body.
ANNEX VI
LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS
Reference number
Substance identification
Conditions
Wording of conditions of use and warnings
Chemical name/INN/XAN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, body parts
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
1
4-Aminobenzoic acid
PABA
150-13-0
205-753-0
5 %
2
N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate
Camphor Benzalkonium Methosulfate
52793-97-2
258-190-8
6 %
3
Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate
Homosalate
118-56-9
204-260-8
10 %
4
2-Hydroxy-4-methoxybenzophenone/Oxybenzone
Benzophenone-3
131-57-7
205-031-5
10 %
Contains Benzophenone-3 (1)
5
Moved or deleted
6
2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole
Phenylbenzimidazole Sulfonic Acid
27503-81-7
248-502-0
8 %(as acid)
7
3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule
Terephthalylidene Dicamphor Sulfonic Acid
92761-26-7, 90457-82-2
410-960-6
10 %(as acid)
8
1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone
Butyl Methoxydibenzoylmethane
70356-09-1
274-581-6
5 %
9
alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts
Benzylidene Camphor Sulfonic Acid
56039-58-8
6 % (as acid)
10
2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrilene
Octocrylene
6197-30-4
228-250-8
10 % (as acid)
11
Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide
Polyacrylamidomethyl Benzylidene Camphor
113783-61-2
6 %
12
2-Ethylhexyl 4-methoxycinnamate/Octinoxate
Ethylhexyl Methoxycinnamate
5466-77-3
226-775-7
10 %
13
Ethoxylated ethyl-4-aminobenzoate
PEG-25 PABA
116242-27-4
10 %
14
Isopentyl-4-methoxycinnamate/Amiloxate
Isoamyl p-Methoxycinnamate
71617-10-2
275-702-5
10 %
15
2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine
Ethylhexyl Triazone
88122-99-0
402-070-1
5 %
16
Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)
Drometrizole Trisiloxane
155633-54-8
15 %
17
Benzoic acid, 4,4-((6-((4-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5-triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl) ester/Iscotrizinol (USAN)
Diethylhexyl Butamido Triazone
154702-15-5
10 %
18
3-(4-Methylbenzylidene)-d1 camphor/Enzacamene
4-Methylbenzylidene Camphor
38102-62-4/36861-47-9
- / 253-242-6
4 %
19
3-Benzylidene camphor
3-Benzylidene Camphor
15087-24-8
239-139-9
2 %
20
2-Ethylhexyl salicylate/Octisalate
Ethylhexyl Salicylate
118-60-5
204-263-4
5 %
21
2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN)
Ethylhexyl Dimethyl PABA
21245-02-3
244-289-3
8 %
22
2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/Sulisobenzone
Benzophenone-4, Benzophenone-5
4065-45-6/6628-37-1
223-772-2 / -
5 % (as acid)
23
2,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol) / Bisoctrizole
Methylene Bis-Benzotriazolyl Tetramethylbutylphenol
103597-45-1
403-800-1
10 %
24
Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN)
Disodium Phenyl Dibenzimidazole Tetrasulfonate
180898-37-7
429-750-0
10 % (as acid)
25
2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
187393-00-6
10 %
26
Dimethicodiethylbenzalmalonate
Polysilicone-15
207574-74-1
426-000-4
10 %
27
Titanium dioxide (2)
Titanium Dioxide
13463-67-7/1317-70-0/1317-80-2
236-675-5/205-280-1/215-282-2
25 %
28
Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester
Diethylamino Hydroxybenzoyl Hexyl Benzoate
302776-68-7
443-860-6
10 % in sunscreen products
(1) Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.
(2) For use other than as a colorant, see Annex IV, No. 143.
ANNEX VII
SYMBOLS USED ON PACKAGING/CONTAINER
1. Reference to enclosed or attached information
2. Period-after-opening
3. Date of minimum durability
ANNEX VIII
LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of this Regulation and which are not listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex VIII whether the alternative method fully or partially replaces animal testing.
Reference number
Validated alternative methods
Nature of replacement full or partial
A
B
C
ANNEX IX
PART A
Repealed Directive with its successive amendments
(referred to in Article 33)
Council Directive 76/768/EEC of 27 July 1976
(OJ L 262, 27.9.1976, p. 169)
Council Directive 79/661/EEC of 24 July 1979
(OJ L 192, 31.7.1979, p. 35)
Commission Directive 82/147/EEC of 11 February 1982
(OJ L 63, 6.3.1982, p. 26)
Council Directive 82/368/EEC of 17 May 1982
(OJ L 167, 15.6.1982, p. 1)
Commission Directive 83/191/EEC of 30 March 1983
(OJ L 109, 26.4.1983, p. 25)
Commission Directive 83/341/EEC of 29 June 1983
(OJ L 188, 13.7.1983, p. 15)
Commission Directive 83/496/EEC of 22 September 1983
(OJ L 275, 8.10.1983, p. 20)
Council Directive 83/574/EEC of 26 October 1983
(OJ L 332, 28.11.1983, p. 38)
Commission Directive 84/415/EEC of 18 July 1984
(OJ L 228, 25.8.1984, p. 31)
Commission Directive 85/391/EEC of 16 July 1985
(OJ L 224, 22.8.1985, p. 40)
Commission Directive 86/179/EEC of 28 February 1986
(OJ L 138, 24.5.1986, p. 40)
Commission Directive 86/199/EEC of 26 March 1986
(OJ L 149, 3.6.1986, p. 38)
Commission Directive 87/137/EEC of 2 February 1987
(OJ L 56, 26.2.1987, p. 20)
Commission Directive 88/233/EEC of 2 March 1988
(OJ L 105, 26.4.1988, p. 11)
Council Directive 88/667/EEC of 21 December 1988
(OJ L 382, 31.12.1988, p. 46)
Commission Directive 89/174/EEC of 21 February 1989
(OJ L 64, 8.3.1989, p. 10)
Council Directive 89/679/EEC of 21 December 1989
(OJ L 398, 30.12.1989, p. 25)
Commission Directive 90/121/EEC of 20 February 1990
(OJ L 71, 17.3.1990, p. 40)
Commission Directive 91/184/EEC of 12 March 1991
(OJ L 91, 12.4.1991, p. 59)
Commission Directive 92/8/EEC of 18 February 1992
(OJ L 70, 17.3.1992, p. 23)
Commission Directive 92/86/EEC of 21 October 1992
(OJ L 325, 11.11.1992, p. 18)
Council Directive 93/35/EEC of 14 June 1993
(OJ L 151, 23.6.1993, p. 32)
Commission Directive 93/47/EEC of 22 June 1993
(OJ L 203, 13.8.1993, p. 24)
Commission Directive 94/32/EC of 29 June 1994
(OJ L 181, 15.7.1994, p. 31)
Commission Directive 95/17/EC of 19 June 1995
(OJ L 140, 23.6.1995, p. 26)
Commission Directive 95/34/EC of 10 July 1995
(OJ L 167, 18.7.1995, p. 19)
Commission Directive 96/41/EC of 25 June 1996
(OJ L 198, 8.8.1996, p. 36)
Commission Directive 97/1/EC of 10 January 1997
(OJ L 16, 18.1.1997, p. 85)
Commission Directive 97/18/EC of 17 April 1997
(OJ L 114, 1.5.1997, p. 43)
Commission Directive 97/45/EC of 14 July 1997
(OJ L 196, 24.7.1997, p. 77)
Commission Directive 98/16/EC of 5 March 1998
(OJ L 77, 14.3.1998, p. 44)
Commission Directive 98/62/EC of 3 September 1998
(OJ L 253, 15.9.1998, p. 20)
Commission Directive 2000/6/EC of 29 February 2000
(OJ L 56, 1.3.2000, p. 42)
Commission Directive 2000/11/EC of 10 March 2000
(OJ L 65, 14.3.2000, p. 22)
Commission Directive 2000/41/EC of 19 June 2000
(OJ L 145, 20.6.2000, p. 25)
Commission Directive 2002/34/EC of 15 April 2002
(OJ L 102, 18.4.2002, p. 19)
Commission Directive 2003/1/EC of 6 January 2003
(OJ L 5, 10.1.2003, p. 14)
Commission Directive 2003/16/EC of 19 February 2003
(OJ L 46, 20.2.2003, p. 24)
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003
(OJ L 66, 11.3.2003, p. 26)
Commission Directive 2003/80/EC of 5 September 2003
(OJ L 224, 6.9.2003, p. 27)
Commission Directive 2003/83/EC of 24 September 2003
(OJ L 238, 25.9.2003, p. 23)
Commission Directive 2004/87/EC of 7 September 2004
(OJ L 287, 8.9.2004, p. 4)
Commission Directive 2004/88/EC of 7 September 2004
(OJ L 287, 8.9.2004, p. 5)
Commission Directive 2004/94/EC of 15 September 2004
(OJ L 294, 17.9.2004, p. 28)
Commission Directive 2004/93/EC of 21 September 2004
(OJ L 300, 25.9.2004, p. 13)
Commission Directive 2005/9/EC of 28 January 2005
(OJ L 27, 29.1.2005, p. 46)
Commission Directive 2005/42/EC of 20 June 2005
(OJ L 158, 21.6.2005, p. 17)
Commission Directive 2005/52/EC of 9 September 2005
(OJ L 234, 10.9.2005, p. 9)
Commission Directive 2005/80/EC of 21 November 2005
(OJ L 303, 22.11.2005, p. 32)
Commission Directive 2006/65/EC of 19 July 2006
(OJ L 198, 20.7.2006, p. 11)
Commission Directive 2006/78/EC of 29 September 2006
(OJ L 271, 30.9.2006, p. 56)
Commission Directive 2007/1/EC of 29 January 2007
(OJ L 25, 1.2.2007, p. 9)
Commission Directive 2007/17/EC of 22 March 2007
(OJ L 82, 23.3.2007, p. 27)
Commission Directive 2007/22/EC of 17 April 2007
(OJ L 101, 18.4.2007, p. 11)
Commission Directive 2007/53/EC of 29 August 2007
(OJ L 226, 30.8.2007, p. 19)
Commission Directive 2007/54/EC of 29 August 2007
(OJ L 226, 30.8.2007, p. 21)
Commission Directive 2007/67/EC of 22 November 2007
(OJ L 305, 23.11.2007, p. 22)
Commission Directive 2008/14/EC of 15 February 2008
OJ L 42, 16.2.2008, p. 43
Commission Directive 2008/42/EC of 3 April 2008
OJ L 93, 4.4.2008, p. 13
Commission Directive 2008/88/EC of 23 September 2008
OJ L 256, 24.9.2008, p. 12
Commission Directive 2008/123/EC of 18 December 2008
OJ L 340, 19.12.2008, p. 71
Commission Directive 2009/6/EC of 4 February 2009
OJ L 36, 5.2.2009, p. 15
Commission Directive 2009/36/EC of 16 April 2009
OJ L 98, 17.4.2009, p. 31
PART B
List of time-limits for transposition into national law and application
(referred to in Article 33)
Directive
Time-limit for transposition
Council Directive 76/768/EEC of 27 July 1976
30.1.1978
Council Directive 79/661/EEC of 24 July 1979
30.7.1979
Commission Directive 82/147/EEC of 11 February 1982
31.12.1982
Council Directive 82/368/EEC of 17 May 1982
31.12.1983
Commission Directive 83/191/EEC of 30 March 1983
31.12.1984
Commission Directive 83/341/EEC of 29 June 1983
31.12.1984
Commission Directive 83/496/EEC of 22 September 1983
31.12.1984
Council Directive 83/574/EEC of 26 October 1983
31.12.1984
Commission Directive 84/415/EEC of 18 July 1984
31.12.1985
Commission Directive 85/391/EEC of 16 July 1985
31.12.1986
Commission Directive 86/179/EEC of 28 February 1986
31.12.1986
Commission Directive 86/199/EEC of 26 March 1986
31.12.1986
Commission Directive 87/137/EEC of 2 February 1987
31.12.1987
Commission Directive 88/233/EEC of 2 March 1988
30.9.1988
Council Directive 88/667/EEC of 21 December 1988
31.12.1993
Commission Directive 89/174/EEC of 21 February 1989
31.12.1989
Council Directive 89/679/EEC of 21 December 1989
3.1.1990
Commission Directive 90/121/EEC of 20 February 1990
31.12.1990
Commission Directive 91/184/EEC of 12 March 1991
31.12.1991
Commission Directive 92/8/EEC of 18 February 1992
31.12.1992
Commission Directive 92/86/EEC of 21 October 1992
30.6.1993
Council Directive 93/35/EEC of 14 June 1993
14.6.1995
Commission Directive 93/47/EEC of 22 June 1993
30.6.1994
Commission Directive 94/32/EC of 29 June 1994
30.6.1995
Commission Directive 95/17/EC of 19 June 1995
30.11.1995
Commission Directive 95/34/EC of 10 July 1995
30.6.1996
Commission Directive 96/41/EC of 25 June 1996
30.6.1997
Commission Directive 97/1/EC of 10 January 1997
30.6.1997
Commission Directive 97/18/EC of 17 April 1997
31.12.1997
Commission Directive 97/45/EC of 14 July 1997
30.6.1998
Commission Directive 98/16/EC of 5 March 1998
1.4.1998
Commission Directive 98/62/EC of 3 September 1998
30.6.1999
Commission Directive 2000/6/EC of 29 February 2000
1.7.2000
Commission Directive 2000/11/EC of 10 March 2000
1.6.2000
Commission Directive 2000/41/EC of 19 June 2000
29.6.2000
Commission Directive 2002/34/EC of 15 April 2002
15.4.2003
Commission Directive 2003/1/EC of 6 January 2003
15.4.2003
Commission Directive 2003/16/EC of 19 February 2003
28.2.2003
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003
10.9.2004
Commission Directive 2003/80/EC of 5 September 2003
11.9.2004
Commission Directive 2003/83/EC of 24 September 2003
23.9.2004
Commission Directive 2004/87/EC of 7 September 2004
1.10.2004
Commission Directive 2004/88/EC of 7 September 2004
1.10.2004
Commission Directive 2004/94/EC of 15 September 2004
21.9.2004
Commission Directive 2004/93/EC of 21 September 2004
30.9.2004
Commission Directive 2005/9/EC of 28 January 2005
16.2.2006
Commission Directive 2005/42/EC of 20 June 2005
31.12.2005
Commission Directive 2005/52/EC of 9 September 2005
1.1.2006
Commission Directive 2005/80/EC of 21 November 2005
22.5.2006
Commission Directive 2006/65/EC of 19 July 2006
1.9.2006
Commission Directive 2006/78/EC of 29 September 2006
30.3.2007
Commission Directive 2007/1/EC of 29 January 2007
21.8.2007
Commission Directive 2007/17/EC of 22 March 2007
23.9.2007
Commission Directive 2007/22/EC of 17 April 2007
18.1.2008
Commission Directive 2007/53/EC of 29 August 2007
19.4.2008
Commission Directive 2007/54/EC of 29 August 2007
18.3.2008
Commission Directive 2007/67/EC of 22 November 2007
31.12.2007
Commission Directive 2008/14/EC of 15 February 2008
16.8.2008
Commission Directive 2008/42/EC of 3 April 2008
4.10.2008
Commission Directive 2008/88/EC of 23 September 2008
14.2.2009
Commission Directive 2008/123/EC of 18 December 2008
8.7.2009
Commission Directive 2009/6/EC of 4 February 2009
5.8.2009
Commission Directive 2009/36/EC of 16 April 2009
15.11.2009
ANNEX X
CORRELATION TABLE
Directive 76/768/EEC
This Regulation
Article 1
Article 2(1)(a)
Article 2
Article 3
Article 3
—
Article 4(1)
Article 14(1)
Article 4(2)
Article 17
Article 4a
Article 18
Article 4b
Article 15(1)
Article 5
—
Article 5a
Article 33
Article 6(1),(2)
Article 19(1),(2),(3),(4)
Article 6(3)
Article 20
Article 7(1)
Article 9
Article 7(2)
Article 19(5), (6)
Article 7(3)
Article 13
Article 7a (1) (h)
Article 21
Article 7a(1),(2),(3)
Article 10, 11, Annex I
Article 7a(4)
Article 13
Article 7a(5)
Article 29, 34
Article 8(1)
Article 12
Article 8(2)
Article 31
Article 8a
—
Article 9
Article 35
Article 10
Article 32
Article 11
—
Article 12
Article 27
Article 13
Article 28
Article 14
—
Article 15
—
Annex I
Preamble, No. 7
Annex II
Annex II
Annex III
Annex III
Annex IV
Annex IV
Annex V
—
Annex VI
Annex V
Annex VII
Annex VI
Annex VIII
Annex VII
Annex VIIIa
Annex VII
Annex IX
Annex VIII
—
Annex IX
—
Annex X
|
Safer cosmetics for EU citizens
Safer cosmetics for EU citizens
SUMMARY OF:
Regulation (EC) No 1223/2009 on cosmetic products
WHAT IS THE AIM OF THE REGULATION?
Makes cosmetics products sold in the EU safer by tightening safety requirements.
Simplifies procedures for companies and regulatory authorities in the sector.
Updates the rules to take account of the latest technological developments, including the possible use of nanomaterials.
Maintains the existing ban on animal testing.
KEY POINTS
Extra requirements for manufacturers in compiling the safety report they need to place a product on the market.
New concept of ‘responsible person’ for each product: businesses can only sell cosmetic products in the EU when a natural or legal person is designated as a ‘responsible person’;the responsible person must ensure the product meets all the relevant safety requirements under Regulation (EC) No 1223/2009.
Red tape for manufacturers is reduced as they have to register their products only once, with the EU’s Cosmetic Products Notification Portal.
New requirement to report serious undesirable effects: responsible persons and distributors are required to report such effects to their national authorities;national authorities must then share this information — together with any they receive from other sources (users, health professionals) — with their counterparts in other EU Member States.
Packaging must include a range of information, including the name and the address of the responsible person, the contents, precautions for use and the list of ingredients.
New rules for the use of nanomaterials.
Lists of substances which are prohibited, restricted or authorised for use in cosmetics.
Distributors must check that labelling, including the use-by date, and language requirements are all in order.
The main points of the regulation are summarised in this infographic. The regulation repealed and replaced Directive 76/768/EEC.
The various annexes to the regulation have been amended many times. These changes have been incorporated into the consolidated version of the regulation.
In addition, since in some cases it is difficult to distinguish between medical devices and cosmetic products, Article 119 of Regulation (EU) 2017/745 (see summary) amends Regulation (EC) No 1223/2009 by making it possible to take an EU-wide decision on regulatory status of a product. Since 26 May 2021, the European Commission may, at the request of a Member State or on its own initiative, decide whether or not a specific product or group of products falls within the definition ‘cosmetic product’.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 11 July 2013.
BACKGROUND
For more information, see:
Cosmetics (European Commission).
MAIN DOCUMENT
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, pp. 59-209)
Successive amendments to Regulation (EC) No 1223/2009 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Report from the Commission to the European Parliament and the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2018) (COM(2019) 479 final, 15.10.2019)
Report from the Commission to the European Parliament and the Council — Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties (COM(2018) 739 final, 7.11.2018)
Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics (COM(2016) 580 final, 19.9.2016)
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics (COM(2013) 135 final, 11.3.2013)
last update 18.05.2021
|
32009R1007
|
31.10.2009
EN
Official Journal of the European Union
L 286/36
REGULATION (EC) No 1007/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 September 2009
on trade in seal products
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
Seals are sentient beings that can experience pain, distress, fear and other forms of suffering. In its declaration on banning seal products in the European Union (3), the European Parliament requested the Commission immediately to draft a regulation to ban the import, export and sale of all harp and hooded seal products. In its resolution of 12 October 2006 on a Community Action Plan on the Protection and Welfare of Animals 2006-2010 (4), the European Parliament called on the Commission to propose a total import ban on seal products. In its Recommendation 1776 (2006) of 17 November 2006 on seal hunting, the Parliamentary Assembly of the Council of Europe recommended inviting the Member States of the Council of Europe practising seal hunting to ban all cruel hunting methods which do not guarantee the instantaneous death, without suffering, of the animals, to prohibit the stunning of animals with instruments such as hakapiks, bludgeons and guns, and to promote initiatives aimed at prohibiting trade in seal products.
(2)
The import into Member States for commercial purposes of skins of harp seal pups and hooded seal pups and products derived therefrom is prohibited under Council Directive 83/129/EEC of 28 March 1983 concerning the importation into Member States of skins of certain seal pups and products derived therefrom (5).
(3)
Seals are hunted within and outside the Community and used for obtaining products and articles, such as meat, oil, blubber, organs, fur skins and articles made therefrom, which include products as diverse as Omega-3 capsules and garments incorporating processed seal skins and fur. Those products are sold commercially on different markets, including the Community market. Given the nature of those products, it is difficult or impossible for consumers to distinguish them from similar products not derived from seals.
(4)
The hunting of seals has led to expressions of serious concerns by members of the public and governments sensitive to animal welfare considerations due to the pain, distress, fear and other forms of suffering which the killing and skinning of seals, as they are most frequently performed, cause to those animals.
(5)
In response to concerns of citizens and consumers about the animal welfare aspects of the killing and skinning of seals and the possible presence on the market of products obtained from animals killed and skinned in a way that causes pain, distress, fear and other forms of suffering, several Member States have adopted or intend to adopt legislation regulating trade in seal products by prohibiting the import and production of such products, while no restrictions are placed on trade in these products in other Member States.
(6)
There are therefore differences between national provisions governing the trade, import, production and marketing of seal products. Those differences adversely affect the operation of the internal market in products which contain or may contain seal products, and constitute barriers to trade in such products.
(7)
The existence of such diverse provisions may further discourage consumers from buying products not made from seals, but which may not be easily distinguishable from similar goods made from seals, or products which may include elements or ingredients obtained from seals without this being clearly recognisable, such as furs, Omega-3 capsules and oils and leather goods.
(8)
The measures provided for in this Regulation should therefore harmonise the rules across the Community as regards commercial activities concerning seal products, and thereby prevent the disturbance of the internal market in the products concerned, including products equivalent to, or substitutable, for seal products.
(9)
In accordance with the Protocol on protection and welfare of animals annexed to the Treaty, the Community is to pay full regard to the welfare requirements of animals when formulating and implementing, inter alia, its internal market policy. The harmonised rules provided for in this Regulation should accordingly take fully into account considerations of the welfare of animals.
(10)
To eliminate the present fragmentation of the internal market, it is necessary to provide for harmonised rules while taking into account animal welfare considerations. In order to counter barriers to the free movement of products concerned in an effective and proportionate fashion, the placing on the market of seal products should, as a general rule, not be allowed in order to restore consumer confidence while, at the same time, ensuring that animal welfare concerns are fully met. Since the concerns of citizens and consumers extend to the killing and skinning of seals as such, it is also necessary to take action to reduce the demand leading to the marketing of seal products and, hence, the economic demand driving the commercial hunting of seals. In order to ensure effective enforcement, the harmonised rules should be enforced at the time or point of import for imported products.
(11)
Although it might be possible to kill and skin seals in such a way as to avoid unnecessary pain, distress, fear or other forms of suffering, given the conditions in which seal hunting occurs, consistent verification and control of hunters’ compliance with animal welfare requirements is not feasible in practice or, at least, is very difficult to achieve in an effective way, as concluded by the European Food Safety Authority on 6 December 2007.
(12)
It is also clear that other forms of harmonised rules, such as labelling requirements, would not achieve the same result. Additionally, requiring manufacturers, distributors or retailers to label products that derive wholly or partially from seals would impose a significant burden on those economic operators, and would also be disproportionately costly in cases where seal products represent only a minor part of the product concerned. Conversely, the measures contained in this Regulation will be easier to comply with, whilst also reassuring consumers.
(13)
In order to ensure that the harmonised rules provided for in this Regulation are fully effective, those rules should apply not only to seal products originating from the Community, but also to those introduced into the Community from third countries.
(14)
The fundamental economic and social interests of Inuit communities engaged in the hunting of seals as a means to ensure their subsistence should not be adversely affected. The hunt is an integral part of the culture and identity of the members of the Inuit society, and as such is recognised by the United Nations Declaration on the Rights of Indigenous Peoples. Therefore, the placing on the market of seal products which result from hunts traditionally conducted by Inuit and other indigenous communities and which contribute to their subsistence should be allowed.
(15)
This Regulation establishes harmonised rules concerning the placing on the market of seal products. It is therefore without prejudice to other Community or national rules regulating the hunting of seals.
(16)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6).
(17)
In particular, the Commission should be empowered to define the conditions for the placing on the market of seal products which result from hunts traditionally conducted by Inuit and other indigenous communities and contribute to their subsistence; to define the conditions for the import of seal products which is of an occasional nature and consists exclusively of goods for the personal use of travellers or their families; and to define the conditions for the placing on the market of seal products resulting from hunts regulated by national law with the sole purpose of the sustainable management of marine resources. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(18)
With the aim of facilitating enforcement operations carried out by the relevant national authorities, the Commission should issue technical guidance notes providing non-binding indications about the codes of the Combined Nomenclature which may cover seal products subject to this Regulation.
(19)
Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(20)
Member States should report on a regular basis on the actions taken to implement this Regulation. On the basis of those reports, the Commission should report to the European Parliament and to the Council on the implementation of this Regulation.
(21)
Since the objective of this Regulation, namely the elimination of obstacles to the functioning of the internal market by harmonising national bans concerning the trade in seal products at Community level, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation establishes harmonised rules concerning the placing on the market of seal products.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
1.
‘seal’ means specimens of all species of pinnipeds (Phocidae, Otariidae and Odobenidae);
2.
‘seal product’ means all products, either processed or unprocessed, deriving or obtained from seals, including meat, oil, blubber, organs, raw fur skins and fur skins, tanned or dressed, including fur skins assembled in plates, crosses and similar forms, and articles made from fur skins;
3.
‘placing on the market’ means introducing onto the Community market, thereby making available to third parties, in exchange for payment;
4.
‘Inuit’ means indigenous members of the Inuit homeland, namely those arctic and subarctic areas where, presently or traditionally, Inuit have aboriginal rights and interests, recognised by Inuit as being members of their people and includes Inupiat, Yupik (Alaska), Inuit, Inuvialuit (Canada), Kalaallit (Greenland) and Yupik (Russia);
5.
‘import’ means any entry of goods into the customs territory of the Community.
Article 3
Conditions for placing on the market
1. The placing on the market of seal products shall be allowed only where the seal products result from hunts traditionally conducted by Inuit and other indigenous communities and contribute to their subsistence. These conditions shall apply at the time or point of import for imported products.
2. By way of derogation from paragraph 1:
(a)
the import of seal products shall also be allowed where it is of an occasional nature and consists exclusively of goods for the personal use of travellers or their families. The nature and quantity of such goods shall not be such as to indicate that they are being imported for commercial reasons;
(b)
the placing on the market of seal products shall also be allowed where the seal products result from by-products of hunting that is regulated by national law and conducted for the sole purpose of the sustainable management of marine resources. Such placing on the market shall be allowed only on a non-profit basis. The nature and quantity of the seal products shall not be such as to indicate that they are being placed on the market for commercial reasons.
The application of this paragraph shall not undermine the achievement of the objective of this Regulation.
3. The Commission shall, in accordance with the management procedure referred to in Article 5(2), issue technical guidance notes setting out an indicative list of the codes of the Combined Nomenclature which may cover seal products subject to this Article.
4. Without prejudice to paragraph 3, measures for the implementation of this Article, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 5(3).
Article 4
Free movement
Member States shall not impede the placing on the market of seal products which comply with this Regulation.
Article 5
Committee procedure
1. The Commission shall be assisted by the committee established under Article 18(1) of Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (7). That committee may call upon other existing regulatory committees as necessary, such as the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (8).
2. Where reference is made to this paragraph, Article 4 and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 6
Penalties and enforcement
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those provisions by 20 August 2010, and shall notify it without delay of any subsequent amendment thereto.
Article 7
Reporting
1. By 20 November 2011 and thereafter every 4 years, Member States shall submit to the Commission a report outlining the actions taken to implement this Regulation.
2. On the basis of the reports referred to in paragraph 1, the Commission shall report to the European Parliament and to the Council on the implementation of this Regulation within 12 months of the end of each reporting period concerned.
Article 8
Entry into force and application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 3 shall apply from 20 August 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 16 September 2009.
For the European Parliament
The President
J. BUZEK
For the Council
The President
C. MALMSTRÖM
(1) Opinion delivered on 26 February 2009 (not yet published in the Official Journal).
(2) Opinion of the European Parliament of 5 May 2009 (not yet published in the Official Journal) and Council Decision of 27 July 2009.
(3) OJ C 306 E, 15.12.2006, p. 194.
(4) OJ C 308 E, 16.12.2006, p. 170.
(5) OJ L 91, 9.4.1983, p. 30.
(6) OJ L 184, 17.7.1999, p. 23.
(7) OJ L 61, 3.3.1997, p. 1.
(8) OJ L 31, 1.2.2002, p. 1.
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Trade in seal products
Trade in seal products
SUMMARY OF:
Regulation (EC) No 1007/2009 on trade in seal products
SUMMARY
WHAT DOES THIS REGULATION DO?
It sets out harmonised rules for placing seal products on the EU market.
KEY POINTS
Seal products may only be placed on the market in the EU if they come from hunts carried out by Inuit* or other indigenous communities. The hunt must:
be traditionally conducted by the community
contribute to the community’s subsistence in order to provide food and income and not be primarily conducted for commercial reasons
pay due care to animal welfare, while taking account of the community’s way of life and the subsistence purpose of the hunt.
When being placed on the market, a seal product must have a certificate confirming all the above conditions have been complied with.
Bodies authorised by the European Commission issue the certificates.
Travellers and their families may import seal products which are for their personal use. If such products are to be imported at a later date, the travellers should have the relevant documentation.
If the Commission has evidence that products come from a seal hunt conducted primarily for commercial reasons, it may ban, or limit, their being placed on the EU market.
The Commission informs the public, the competent authorities and the customs authorities about the conditions under which seal products may be placed on the market in the EU.
By 31 December 2018, and then every 4 years, EU countries report to the Commission on the measures they have taken to implement the legislation.
The Commission, within a year of receiving the national reports, provides an overall report to the European Parliament and the Council. The first report will be submitted by 31 December 2019.
FROM WHEN DOES THE REGULATION APPLY?
It applies since 20 November 2009.
BACKGROUND
Seals are hunted inside and outside the EU for a variety of purposes. They are used to obtain meat, oil, blubber, organs and fur skins, and for articles as diverse as Omega-3 capsules and clothing.
Trade in seal products
KEY TERM
* Inuit: indigenous members of the Inuit homeland, namely those arctic and subarctic areas where, presently or traditionally, Inuit have aboriginal rights and interests, recognised by Inuit as being members of their people. The term includes Inupiat, Yupik (Alaska), Inuit, Inuvialuit (Canada), Kalaallit (Greenland) and Yupik (Russia).
ACT
Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products (OJ L 286, 31.10.2009, pp. 36–39)
Successive amendments to Regulation (EC) No 1007/2009 have been incorporated into the basic text. This consolidated version is for reference purposes only.
RELATED ACTS
Commission Implementing Regulation (EU) 2015/1850 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products (OJ L 271, 16.10.2015, pp. 1–11)
last update 31.03.2016
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32009R0595
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18.7.2009
EN
Official Journal of the European Union
L 188/1
REGULATION (EC) No 595/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 18 June 2009
on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured. To that end a comprehensive Community type-approval system for motor vehicles is in place. The technical requirements for the type-approval of motor vehicles with regard to emissions should therefore be harmonised to avoid requirements that differ from one Member State to another and to ensure a high level of environmental protection.
(2)
This Regulation is a new separate regulation in the context of the Community type-approval procedure under Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (3). Therefore, Annexes IV, VI and XI to that Directive should be amended accordingly.
(3)
Following the request of the European Parliament, a new regulatory approach has been introduced in Community vehicle legislation. This Regulation should therefore lay down only fundamental provisions on vehicle emissions, whereas the technical specifications should be laid down by implementing measures adopted under the comitology procedures.
(4)
The Sixth Community Environment Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 (4) establishes the need to reduce pollution to levels which minimise harmful effects on human health, paying particular attention to sensitive populations and to the environment as a whole. Community legislation has established appropriate standards for ambient air quality for the protection of human health and sensitive individuals in particular, as well as for national emission ceilings. Following its communication of 4 May 2001, which established the ‘Clean Air For Europe (CAFE) programme’, the Commission adopted another communication on 21 September 2005 entitled ‘Thematic strategy for air pollution’. One of the conclusions of that thematic strategy is that further reductions in emissions from the transport sector (air, maritime and land transport), from households and from the energy, agricultural and industrial sectors are needed to achieve EU air quality objectives. In this context, the task of reducing vehicle emissions should be approached as part of an overall strategy. The Euro VI standards are one of the measures designed to reduce the actual in-use emissions of air pollutants such as particulate pollutants (PM) as well as ozone precursors such as nitrogen oxides (NOx) and hydrocarbons.
(5)
Achieving EU air quality objectives requires a continuous effort to reduce vehicle emissions. For that reason, industry should be provided with clear information on future emission limit values and should be allowed an appropriate period of time in which to attain them and pursue the requisite technical developments.
(6)
In particular, a reduction in NOx emissions from heavy duty vehicles is necessary to improve air quality and comply with limit values for pollution and national emission ceilings. Setting limit values for NOx emissions at an early stage should provide long-term, European Union-wide planning certainty for vehicle manufacturers.
(7)
In setting emission standards it is important to take into account the implications for competitiveness of markets and manufacturers, the direct and indirect costs imposed on business and the benefits that accrue in terms of stimulating innovation, improving air quality, reducing health costs and increasing life expectancy.
(8)
Unrestricted access to vehicle repair information, via a standardised format which can be used to retrieve the technical information, and effective competition on the market for vehicle repair and maintenance information services are necessary to improve the functioning of the internal market, particularly as regards the free movement of goods, freedom of establishment and freedom to provide services. A great proportion of such information is related to on-board diagnostic (OBD) systems and their interaction with other vehicle systems. It is necessary to lay down technical specifications to be followed by the manufacturers concerning the provision of information on their websites, along with targeted measures to ensure reasonable access for small and medium-sized enterprises (SMEs).
(9)
Not later than 7 August 2013, the Commission should review the operation of the system of unrestricted access to vehicle repair and maintenance information with a view to determining whether it would be appropriate to consolidate all provisions governing access to vehicle repair and maintenance information within the revised framework legislation on type-approval. If the provisions governing access to such information are consolidated in this way, the corresponding provisions of this Regulation should be repealed, as long as existing rights of access to repair and maintenance information are preserved.
(10)
The Commission should encourage the development of an international standard format for unrestricted and standardised access to vehicle repair and maintenance information, for example through the work of the European Committee for Standardisation (CEN).
(11)
It is essential to establish a common European standard for the format of vehicle OBD and vehicle repair and maintenance information. Until such time as that standard is adopted, vehicle OBD and vehicle repair and maintenance information for heavy duty vehicles should be presented in a readily accessible manner and in a format guaranteeing non-discriminatory access. The information should be made available on the websites of manufacturers, or, if this is not feasible due to the nature of the information, in another appropriate format.
(12)
The Commission should keep under review emissions which are, as yet, unregulated and which arise as a consequence of the wider use of new fuel formulations, engine technologies and emission control systems. The Commission should also, where necessary, submit a proposal to the European Parliament and to the Council with a view to regulating such emissions.
(13)
It is appropriate to encourage the introduction of alternative fuel vehicles, which can have low NOx and particulate emissions. Thus, limit values for hydrocarbons, non-methane hydrocarbons and methane should be introduced.
(14)
In order to ensure that emissions of ultrafine particulate pollutants (PM 0,1 μm and below) are controlled, the Commission should be empowered to adopt a number-based approach to emissions of particulate pollutants in addition to the mass-based approach which is currently used. The number-based approach to emissions of particles should draw on the results of the Particulate measurement programme (PMP) of the United Nations Economic Commission for Europe (UN/ECE) and be consistent with the existing ambitious objectives for the environment.
(15)
In order to achieve these environmental objectives, it is appropriate to indicate that the particle number limits are likely to reflect the highest levels of performance currently obtained with particle filters by using the best available technology.
(16)
The Commission should adopt worldwide harmonised driving cycles in the test procedure that provides the basis for EC type-approval emissions regulations. The application of portable emissions measurement systems for verifying the actual in-use emissions and the introduction of procedures to control off-cycle emissions should also be considered.
(17)
Retrofitting heavy duty vehicles with diesel particle filters could result in higher nitrogen dioxide (NO2) emissions. As part of the thematic strategy on air pollution, the Commission should therefore draft a legislative proposal to harmonise national legislation on retrofitting and ensure that it incorporates environmental conditions.
(18)
OBD systems are important to control emissions during the use of a vehicle. Due to the importance of controlling real-world emissions, the Commission should keep under review the requirements for such systems and the tolerance thresholds for monitoring faults.
(19)
In order to monitor the contribution of this sector, as a whole, to the global emissions of greenhouse gases, the Commission should introduce the measuring of fuel consumption and carbon dioxide (CO2) emissions of heavy duty vehicles.
(20)
In order to promote the market for clean and energy efficient vehicles, the Commission should study the feasibility and the development of a definition and a methodology of energy consumption and CO2 emissions for whole vehicles and not only for engines, without prejudice to the use of virtual and actual testing. Such a definition and the methodology should also cover alternative driveline concepts (e.g. hybrid vehicles) and the effects of improvements on vehicles such as aerodynamics, weight, loading capacity and rolling resistance. If a suitable method of presentation and comparison can be identified, the derived fuel consumption and CO2 emissions should be made publicly available for separate vehicle types.
(21)
In order to better control actual in-use emissions including off-cycle emissions and to facilitate the in-service conformity process, a testing methodology and performance requirements based on the use of portable emission measurement systems should be adopted within an appropriate timeframe.
(22)
With a view to meeting EU air quality objectives, the Commission should introduce harmonised provisions to ensure that off-cycle emissions from heavy duty engines and vehicles are appropriately controlled over a broad range of engine and ambient operating conditions.
(23)
The correct functioning of the after-treatment system, and more specifically in the case of NOx, is the basic requirement for fulfilling the established standards for pollutant emissions. In this context, measures to guarantee the proper operation of systems relying on the use of a reagent should be introduced.
(24)
Member States are able, by means of financial incentives, to accelerate the placing on the market of vehicles which satisfy the requirements adopted at Community level. This Regulation should not affect the right of Member States to include emissions in the method for calculating taxes levied on vehicles.
(25)
When Member States draw up measures to ensure retrofitting of existing heavy duty vehicles, such measures should be based on the Euro VI standards.
(26)
Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(27)
The requirements of engine power of motor vehicles contained in Council Directive 80/1269/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the engine power of motor vehicles (5) should be introduced in this Regulation and in Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (6). Therefore, Regulation (EC) No 715/2007 should be amended accordingly and Directive 80/1269/EEC should be repealed.
(28)
In order to simplify Community legislation, it is appropriate to replace the existing heavy duty vehicles emissions legislation, namely Directive 2005/55/EC (7) and Commission Directive 2005/78/EC (8), by a regulation. The use of a regulation should ensure that the detailed technical provisions are directly applicable to manufacturers, approval authorities and technical services and that they can be updated in a fast and efficient way. Therefore Directives 2005/55/EC and 2005/78/EC should be repealed and Regulation (EC) No 715/2007 should be amended accordingly.
(29)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9).
(30)
In particular, the Commission should be empowered to introduce particle number based limit values in Annex I, to specify, if appropriate, the value of the admissible level of the NO2 component in the NOx limit value, to establish specific procedures, tests and requirements for type-approval, as well as a particle number measurement procedure, and to adopt measures concerning off-cycle emissions, the use of portable emissions measurement systems, access to vehicle repair and maintenance information and test cycles used to measure emissions. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(31)
Since the objective of this Regulation, namely the realisation of the internal market through the introduction of common technical requirements concerning emissions from motor vehicles and guaranteed access to vehicle repair and maintenance information for independent operators on the same basis as for authorised dealers and repairers, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation establishes common technical requirements for the type-approval of motor vehicles, engines and replacement parts with regard to their emissions.
This Regulation also lays down rules for in-service conformity of vehicles and engines, durability of pollution control devices, OBD systems, measurement of fuel consumption and CO2 emissions and accessibility of vehicle OBD and vehicle repair and maintenance information.
Article 2
Scope
This Regulation shall apply to motor vehicles of categories M1, M2, N1 and N2 as defined in Annex II of Directive 2007/46/EC with a reference mass exceeding 2 610 kg and to all motor vehicles of categories M3 and N3, as defined in that Annex.
This Regulation shall apply without prejudice to Article 2(2) of Regulation (EC) No 715/2007.
At the request of the manufacturer, the type-approval of a completed vehicle granted under this Regulation and its implementing measures shall be extended to its incomplete vehicle with a reference mass not exceeding 2 610 kg. Type-approvals shall be extended if the manufacturer can demonstrate that all bodywork combinations expected to be built onto the incomplete vehicle increase the reference mass of the vehicle to above 2 610 kg.
At the request of the manufacturer, the type-approval of a vehicle granted under this Regulation and its implementing measures shall be extended to its variants and versions with a reference mass exceeding 2 380 kg provided that it also meets the requirements relating to the measurement of greenhouse gas emissions and fuel consumption established in Regulation (EC) No 715/2007 and its implementing measures.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
1.
‘engine’ means the motive propulsion source of a vehicle for which type-approval as a separate technical unit, as defined in point 25 of Article 3 of Directive 2007/46/EC, may be granted;
2.
‘gaseous pollutants’ means the exhaust gas emissions of carbon monoxide, NOx, expressed in NO2 equivalent, and hydrocarbons;
3.
‘particulate pollutants’ means components of the exhaust gas which are removed from the diluted exhaust gas at a maximum temperature of 325 K (52 °C) by means of the filters described in the test procedure for verifying average tailpipe emissions;
4.
‘tailpipe emissions’ means the emission of gaseous and particulate pollutants;
5.
‘crankcase’ means the spaces in, or external to, an engine which are connected to the oil sump by internal or external ducts through which gases and vapours can be emitted;
6.
‘pollution control device’ means those components of a vehicle that control and/or limit tailpipe emissions;
7.
‘on-board diagnostic (OBD) system’ means a system on board a vehicle or connected to an engine which has the capability of detecting malfunctions, and, if applicable, of indicating their occurrence by means of an alert system, of identifying the likely area of malfunction by means of information stored in computer memory, and of communicating that information off-board;
8.
‘defeat strategy’ means an emission control strategy that reduces the effectiveness of the emission controls under ambient or engine operating conditions encountered either during normal vehicle operation or outside the type-approval test procedures;
9.
‘original pollution control device’ means a pollution control device or an assembly of such devices covered by the type-approval granted for the vehicle concerned;
10.
‘replacement pollution control device’ means a pollution control device or an assembly of such devices intended to replace an original pollution control device and which can be approved as a separate technical unit, as defined in point 25 of Article 3 of Directive 2007/46/EC;
11.
‘vehicle repair and maintenance information’ means all information required for diagnosis, servicing, inspection, periodic monitoring, repair, re-programming or re-initialising or the remote diagnostic support of the vehicle and which the manufacturers provide for their authorised dealers and repairers, including all subsequent amendments and supplements to such information. This information includes all information required for fitting parts or equipment onto vehicles;
12.
‘manufacturer’ means the person or body who is responsible to the approval authority for all aspects of the type-approval or authorisation process and for ensuring conformity of production. It is not essential that the person or body be directly involved in all stages of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process;
13.
‘independent operator’ means undertakings other than authorised dealers and repairers which are directly or indirectly involved in the repair and maintenance of motor vehicles, in particular repairers, manufacturers or distributors of repair equipment, tools or spare parts, publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative fuel vehicles;
14.
‘alternative fuel vehicle’ means a vehicle designed to be capable of running on at least one type of fuel that is either gaseous at atmospheric temperature and pressure, or substantially non-mineral oil derived;
15.
‘reference mass’ means the mass of the vehicle in running order less the uniform mass of the driver of 75 kg and increased by a uniform mass of 100 kg;
16.
‘tampering’ means inactivation, adjustment or modification of the vehicle emissions control or propulsion system, including any software or other logical control elements of those systems, that has the effect, whether intended or not, of worsening the emissions performance of the vehicle.
The Commission may adapt the definition in point 7 of the first subparagraph to reflect technical progress in OBD systems. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
Article 4
Obligations of the manufacturers
1. Manufacturers shall demonstrate that all new vehicles sold, registered or put into service within the Community, all new engines sold or put into service within the Community and all new replacement pollution control devices requiring type-approval pursuant to Articles 8 and 9, which are sold or put into service within the Community, are type-approved in accordance with this Regulation and its implementing measures.
2. Manufacturers shall ensure that type-approval procedures for verifying conformity of production, durability of pollution control devices and in-service conformity are followed.
The technical measures taken by the manufacturer shall be such as to ensure that the tailpipe emissions are effectively limited, pursuant to this Regulation and its implementing measures, throughout the normal life of the vehicles under normal conditions of use.
For that purpose, the mileage and period of time by reference to which the tests for durability of pollution control devices undertaken for type-approval and testing of conformity of in-service vehicles or engines are to be carried out shall be the following:
(a)
160 000 km or five years, whichever is the sooner, in the case of engines fitted to vehicles of category M1, N1 and M2;
(b)
300 000 km or six years, whichever is the sooner, in the case of engines fitted to vehicles of category N2, N3 with a maximum technically permissible mass not exceeding 16 tonnes and M3 Class I, Class II and Class A, and Class B with a maximum technically permissible mass not exceeding 7,5 tonnes;
(c)
700 000 km or seven years, whichever is the sooner, in the case of engines fitted to vehicles of category N3 with a maximum technically permissible mass exceeding 16 tonnes and M3, Class III and Class B with a maximum technically permissible mass exceeding 7,5 tonnes.
3. The Commission shall establish specific procedures and requirements for the implementation of paragraphs 1 and 2 of this Article. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
Article 5
Requirements and tests
1. Manufacturers shall ensure compliance with the emission limits set out in Annex I.
2. Manufacturers shall equip vehicles and engines so that the components likely to affect emissions are designed, constructed and assembled so as to enable the vehicle or engine, in normal use, to comply with this Regulation and its implementing measures.
3. The use of defeat strategies that reduce the effectiveness of emission control equipment shall be prohibited.
4. The Commission shall adopt measures for the implementation of this Article including measures in relation to the following:
(a)
tailpipe emissions, including test cycles, the use of portable emissions measurement systems for verifying the actual in-use emissions, verifying and limiting off-cycle emissions, the setting of limits for particle numbers while retaining the existing ambitious environmental requirements, and emissions at idling speed;
(b)
crankcase emissions;
(c)
OBD systems and in-service performance of pollution control devices;
(d)
durability of pollution control devices, replacement pollution control devices, conformity of in-service engines and vehicles, conformity of production and roadworthiness;
(e)
CO2 emissions and fuel consumption;
(f)
granting extension of type-approvals;
(g)
test equipment;
(h)
reference fuels such as petrol, diesel, gaseous fuels and biofuels, such as bioethanol, biodiesel and biogas;
(i)
measurement of engine power;
(j)
correct functioning and regeneration of pollution control devices;
(k)
specific provisions to ensure the correct operation of NOx control measures; such provisions shall ensure that vehicles cannot be operated if the NOx control measures are inoperative due, for example, to lack of any required reagent, incorrect exhaust gas recirculation (EGR) flow or deactivation of EGR.
Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
Article 6
Access to information
1. Manufacturers shall provide unrestricted and standardised access to vehicle OBD information, diagnostic and other equipment, tools including any relevant software and vehicle repair and maintenance information to independent operators.
Manufacturers shall provide a standardised, secure and remote facility to enable independent repairers to complete operations which involve access to the vehicle security system.
In the case of multi-stage type-approval, the manufacturer responsible for the respective type-approval shall also be responsible for communicating repair information relating to the particular stage to both the final manufacturer and independent operators. The final manufacturer shall be responsible for communicating information about the whole vehicle to independent operators.
Articles 6 and 7 of Regulation (EC) No 715/2007 shall apply mutatis mutandis.
Until the adoption of the relevant standard, for example through the work of CEN, the vehicle OBD and vehicle repair and maintenance information shall be presented in an easily accessible, non-discriminatory manner.
That information shall be made available on the websites of manufacturers, or, if this is not feasible due to the nature of the information, in another appropriate format.
2. The Commission shall establish and update, for the implementation of paragraph 1, the appropriate technical specifications relating to the way in which vehicle OBD and vehicle repair and maintenance information shall be provided. The Commission shall take into account current information technology, foreseeable vehicle technology developments, existing ISO standards and the possibility of a worldwide ISO standard.
The Commission may adopt other measures necessary for the implementation of paragraph 1.
Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
Article 7
Obligations concerning systems using a consumable reagent
1. Manufacturers, repairers and operators of the vehicles shall not tamper with systems which use a consumable reagent.
2. Operators of the vehicles shall ensure that vehicles are not being driven without a consumable reagent.
Article 8
Timetable for application of type-approval of vehicles and engines
1. With effect from 31 December 2012, national authorities shall refuse, on grounds relating to emissions, to grant EC type-approval or national type-approval in respect of new types of vehicles or engines which do not comply with this Regulation and its implementing measures.
Type-approval technical certificates corresponding to the emission stages prior to Euro VI may be granted to vehicles and engines intended for export to third countries, provided such certificates clearly state that the vehicles and engines in question cannot be placed on the Community market.
2. With effect from 31 December 2013, national authorities shall, in the case of new vehicles which do not comply with this Regulation and its implementing measures, consider certificates of conformity to be no longer valid for the purposes of Article 26 of Directive 2007/46/EC and shall, on grounds relating to emissions, prohibit the registration, sale and entry into service of such vehicles.
With effect from the same date and except in the case of replacement engines for in-service vehicles, national authorities shall prohibit the sale or use of new engines which do not comply with this Regulation and its implementing measures.
3. Without prejudice to paragraphs 1 and 2 of this Article, and subject to entry into force of the implementing measures referred to in Article 4(3), Article 5(4) and in the first subparagraph of Article 6(2), if a manufacturer so requests, national authorities may not, on grounds relating to emissions of vehicles, refuse to grant EC type-approval or national type-approval for a new type of vehicle or engine, or prohibit the registration, sale or entry into service of a new vehicle and the sale or use of new engines, where the vehicle or engines concerned comply with this Regulation and its implementing measures.
Article 9
Obligations of Member States concerning type-approval of replacement parts
The sale or installation on a vehicle of new replacement pollution control devices intended to be fitted on vehicles approved under this Regulation and its implementing measures shall be prohibited if they are not of a type in respect of which a type-approval has been granted in compliance with this Regulation and its implementing measures.
Article 10
Financial incentives
1. Subject to the entry into force of the implementing measures to this Regulation, Member States may provide for financial incentives that apply to motor vehicles in series production, which comply with this Regulation and its implementing measures.
Those incentives shall apply to all new vehicles put on the market of the Member State concerned, which comply with this Regulation and its implementing measures. However, they shall cease to apply on 31 December 2013 at the latest.
2. Subject to the entry into force of the implementing measures to this Regulation, Member States may grant financial incentives for retrofitting in order to meet the emission limit values set out in Annex I of in-use vehicles and for scrapping vehicles which do not comply with this Regulation and its implementing measures.
3. For each type of motor vehicle, the financial incentives referred to in paragraphs 1 and 2 shall not exceed the additional cost of the technical devices used to ensure compliance with the emission limits specified in Annex I, including the cost of installation on the vehicle.
4. The Commission shall be informed of plans to institute or change the financial incentives referred to in paragraphs 1 and 2.
Article 11
Penalties
1. Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and its implementing measures and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 7 February 2011 and shall notify it without delay of any subsequent amendment affecting them.
2. The types of infringements by manufacturers which are subject to a penalty shall include:
(a)
making false declarations during the approval procedures or procedures leading to a recall;
(b)
falsifying test results for type-approval or in-service conformity;
(c)
withholding data or technical specifications which could lead to recall or withdrawal of type-approval;
(d)
use of defeat strategies;
(e)
refusal to provide access to information.
The types of infringements by manufacturers, repairers and operators of the vehicles which are subject to a penalty shall include tampering with systems which control NOx emissions. This shall include, for example, tampering with systems which use a consumable reagent.
The types of infringements committed by operators of the vehicles which are subject to a penalty shall include driving a vehicle without a consumable reagent.
Article 12
Redefinition of specifications
1. After the completion of the relevant parts of the PMP of the UN/ECE, conducted under the auspices of the World Forum for Harmonisation of Vehicle Regulations, the Commission shall, without lowering the level of environmental protection within the Community:
(a)
introduce as an additional control upon emissions of particulate matter particle number based limit values set at a level appropriate to the technologies actually being used at that time to meet the particulate mass limit;
(b)
adopt a measurement procedure for particle number.
The Commission shall also, without lowering the level of environmental protection within the Community, specify a limit value for emissions of NO2 in addition to that for total emissions of NOx, if appropriate. The limit for emissions of NO2 shall be set at a level reflecting the performance of then existing technologies.
Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
2. The Commission shall establish correlation factors between the European transient cycle (ETC) and the European steady state cycle (ESC) as described in Directive 2005/55/EC, and the worldwide harmonised transient driving cycle (WHTC) and the worldwide harmonised steady state driving cycle (WHSC) and shall adapt the limit values to that effect. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
3. The Commission shall keep under review the procedures, tests and requirements referred to in Article 5(4) as well as the test cycles used to measure emissions.
If the review finds that those procedures, tests, requirements and test cycles are no longer adequate or no longer reflect actual world emissions, they shall be adapted so as to adequately reflect the emissions generated by real driving on the road. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2).
4. The Commission shall keep under review the pollutants listed in point 2 of Article 3. If the Commission concludes that it is appropriate to regulate the emissions of additional pollutants, it shall submit to the European Parliament and to the Council a proposal for amending this Regulation.
Article 13
Committee procedure
1. The Commission shall be assisted by the Technical Committee — Motor Vehicles (TCMV) established by Article 40(1) of Directive 2007/46/EC.
2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 14
Implementation
The Commission shall adopt the implementing measures referred to in Article 4(3), Article 5(4), Article 6(2) and Article 12(1)(a) and (b) by 1 April 2010.
Article 15
Amendments to Regulation (EC) No 715/2007
Regulation (EC) No 715/2007 is hereby amended as follows:
1.
Article 5(3) shall be amended as follows:
(i)
after point (h), the word ‘and’ shall be deleted;
(ii)
the following point shall be added:
‘(j)
measurement of engine power.’;
2.
Article 14(6) shall be deleted.
Article 16
Amendments to Directive 2007/46/EC
Annexes IV, VI and XI to Directive 2007/46/EC are amended in accordance with Annex II to this Regulation.
Article 17
Repeal
1. Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC are repealed with effect from 31 December 2013.
2. References made to the repealed Directives shall be construed as references to this Regulation.
Article 18
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 7 August 2009. However, Articles 8(3) and 10 shall apply from 7 August 2009 and points 1(a)(i), 1(b)(i), 2(a), 3(a)(i), 3(b)(i), 3(c)(i), 3(d)(i) and 3(e)(i) of Annex II shall apply from 31 December 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 June 2009.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
Š. FÜLE
(1) OJ C 211, 19.8.2008, p. 12.
(2) Opinion of the European Parliament of 16 December 2008 (not yet published in Official Journal) and Council Decision of 8 June 2009.
(3) OJ L 263, 9.10.2007, p. 1.
(4) OJ L 242, 10.9.2002, p. 1.
(5) OJ L 375, 31.12.1980, p. 46.
(6) OJ L 171, 29.6.2007, p. 1.
(7) Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive-ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (OJ L 275, 20.10.2005, p. 1).
(8) Commission Directive 2005/78/EC of 14 November 2005 implementing Directive 2005/55/EC and amending Annexes I, II, III, IV and VI thereto (OJ L 313, 29.11.2005, p. 1).
(9) OJ L 184, 17.7.1999, p. 23.
ANNEX I
Euro VI emission limits
Limit values
CO
(mg/kWh)
THC
(mg/kWh)
NMHC
(mg/kWh)
CH4
(mg/kWh)
NOX
(1)
(mg/kWh)
NH3
(ppm)
PM mass
(mg/kWh)
PM (2) number
(#/kWh)
ESC (CI)
1 500
130
400
10
10
ETC (CI)
4 000
160
400
10
10
ETC (PI)
4 000
160
500
400
10
10
WHSC (3)
WHTC (3)
Note:
PI
=
positive ignition.
CI
=
compression ignition.
(1) The admissible level of NO2 component in the NOx limit value may be defined at a later stage.
(2) A number standard is to be defined at a later stage and no later than 1 April 2010.
(3) The limit values relating to WHSC and WHTC, replacing the limit values relating to ESC and ETC, will be introduced, at a later stage, once correlation factors with respect to the current cycles (ESC and ETC) have been established, no later than 1 April 2010.
ANNEX II
Amendments to Directive 2007/46/EC
Directive 2007/46/EC is hereby amended as follows:
1.
Part I of Annex IV shall be amended as follows:
(a)
the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Subject
Regulatory act reference
Official Journal reference
Applicability
M1
M2
M3
N1
N2
N3
O1
O2
O3
O4
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
OJ L 188, 18.7.2009, p. 1
X12
X12
X
X12
X12
X’
(iii)
the following note shall be added:
‘(12)
For vehicles with a reference mass exceeding 2 610 kg which are not type-approved (at the manufacturer’s request and provided their reference mass does not exceed 2 840 kg) under Regulation (EC) No 715/2007.’;
(b)
in the Appendix, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Subject
Regulatory act reference
Official Journal reference
M1
‘41a
Emissions (Euro VI) heavy duty vehicles, with the exception of the whole set of requirements relating to on-board diagnostics (OBDs) and access to information/access to information
Regulation (EC) No 595/2009
OJ L 188, 18.7.2009, p. 1
A’
2.
in the Appendix to Annex VI, the table shall be amended as follows:
(a)
points 40 and 41 shall be deleted;
(b)
the following point shall be inserted:
Subject
Regulatory act reference
As amended by
Applicable to versions
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009’
3.
Annex XI shall be amended as follows:
(a)
in Appendix 1, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Item
Subject
Regulatory act reference
M1 ≤ 2 500 (1) kg
M1 > 2 500 (1) kg
M2
M3
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
G + H
G + H
G + H
G + H’
(b)
in Appendix 2, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Item
Subject
Regulatory act reference
M1
M2
M3
N1
N2
N3
O1
O2
O3
O4
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
X
X
X
X
X
X’
(c)
in Appendix 3, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Item
Subject
Regulatory act reference
M1
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
X’
(d)
in Appendix 4, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Item
Subject
Regulatory act reference
M2
M3
N1
N2
N3
O1
O2
O3
O4
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
H
H
H
H
H’
(e)
in Appendix 5, the table shall be amended as follows:
(i)
points 40 and 41 shall be deleted;
(ii)
the following point shall be inserted:
Item
Subject
Regulatory act reference
Mobile crane of category N3
‘41a
Emissions (Euro VI) heavy duty vehicles/access to information
Regulation (EC) No 595/2009
V’
|
Emissions from heavy-duty vehicles (Euro VI): certification rules
Emissions from heavy-duty vehicles (Euro VI): certification rules
SUMMARY OF:
Regulation (EC) No 595/2009 on type-approval of motor vehicles and engines (with respect to emissions from heavy-duty vehicles and access to vehicle repair and maintenance information)
WHAT IS THE AIM OF THE REGULATION?
It defines the rules for type approval* of motor vehicles, engines and replacement parts for heavy-duty vehicles (lorries, buses and coaches) with respect to their emission performance. It also sets out rules on: in-service conformity of vehicles and engines;durability of pollution-control devices;on-board diagnostic (OBD) systems;accessibility of vehicle OBD and vehicle repair and maintenance information;measurement of fuel consumption and CO2 emissions.
It repeals Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC with effect from 31 December 2013.
Regulation (EU) 2018/858 (see summary), which has applied from 1 September 2020, amends Regulation (EC) No 595/2009 by removing the references regarding access to vehicle OBD and vehicle repair and maintenance information.
KEY POINTS
Scope
This regulation applies to motor vehicles of categories M1, M2, N1 and N2 with a reference mass exceeding 2 610 kg, and to all motor vehicles of categories M3 and N3, as defined in Regulation (EU) 2018/858.
Manufacturer obligations
Manufacturers must:
be able to demonstrate that all new vehicles, engines or spare parts sold, registered or put into service in the EU have been type-approved in accordance with this regulation;
take technical measures to guarantee effective limitation of exhaust emissions throughout the normal life of the vehicles under normal conditions of use.
Requirements and tests
Manufacturers must equip their vehicles or engines with components that they comply with the emission limits laid down in Annex I of this regulation under conditions specified by the European Commission in this regulation and in the implementing acts.
Access to information
Manufacturers must: guarantee independent operators (i.e. businesses which are independent from authorised dealers and repairers of a given vehicle brand) access to information on OBD systems and on diagnostic equipment, tools or software;provide a standardised, secure and remote facility to enable independent repairers to complete operations which involve access to the vehicle security system.
The information should be made available on manufacturers' websites, or, if this is not feasible, in another appropriate format.
From 1 September 2020, all rules relating to vehicle repair and maintenance information will be found in Chapter XIV of Regulation (EU) 2018/858.
Timetable
National authorities must not lgrant EU or national type approval for vehicles that do not comply with this regulation from 31 December 2012, and must prohibit the registration of new vehicles that do not comply with this regulation from 31 December 2013.
Financial incentives
Countries could grant financial incentives for the purchase of motor vehicles produced in series which comply with this regulation until 31 December 2013. Retrofitting measures may also be considered either to adapt in-use motor vehicles or for scrapping.
The amount of the financial incentives must be equal to the additional cost of the technical measures introduced to ensure compliance of the vehicle with emission limits.
Implementing legislation
Implementing acts set out measures to implement Regulation (EC) No 595/2009:
Commission Regulation (EU) No 582/2011 sets out the specific technical requirements for the approval of heavy-duty vehicles with regard to emissions and access to vehicle repair and maintenance information. It has been amended several times and covers aspects such as: arrangements to ensure that vehicle OBD and vehicle repair and maintenance information is accessible in a non-discriminatory manner and that training material is available to independent operators and authorised dealers and repairers;rules regarding multi-stage type-approval, customer adaptations, small volume manufacturers, carry-over systems and fees for access to vehicle repair and maintenance information;extending the scope of the Forum on Access to Vehicle Information’s activities to vehicles covered by Regulation (EC) No 595/2009;a requirement to ensure all engine systems and vehicles are equipped with an OBD system;conformity of production;in-service conformity;remedial measures in the event of non-compliance;requirements to limit off-cycle emissions;pollution-control devices;detailed requirements for type approval;rules for EC type approval of: an engine system or engine family* as a separate technical unit with regard to emissions and access to repair and maintenance information,a vehicle with regard to emissions and access to vehicle repair and maintenance information,a type of replacement pollution-control device as a separate technical unit.
Commission Regulation (EU) 2017/2400 (see summary) complements the legal rules established by Regulation (EU) No 582/2011. It lays down the rules for: certifying lorry components with an impact on CO2 emissions and the fuel consumption of vehicles;issuing licences to perform simulations to determine CO2 emissions and fuel consumption of new vehicles to be sold, registered or put into service in the EU;using simulation tools and declaring the CO2 emissions and fuel consumption values that they determine.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 7 August 2009. However, some of the amendments to Directive 2007/46/EC included in Annex II of Regulation (EC) No 595/2009 have only applied since 31 December 2013.
BACKGROUND
For more information, see:
Reducing CO2 emissions from Heavy-Duty Vehicles (European Commission).
KEY TERMS
Type-approval: the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies certain legal requirements.
Engine family: manufacturer’s grouping of engine types which, through their design, havesimilar exhaust emission characteristics, and respect the applicable emissionlimit values.
MAIN DOCUMENTS
Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy-duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, pp. 1-13)
Successive amendments to Regulation (EC) No 595/2009 have been incorporated into the original text. This consolidated version is of documentary value only.
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, pp. 1-218)
RELATED DOCUMENTS
Commission Regulation (EU) 2017/2400 of 12 December 2017 implementing Regulation (EC) No 595/2009 of the European Parliament and of the Council as regards the determination of the CO2 emissions and fuel consumption of heavy-duty vehicles and amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EU) No 582/2011 (OJ L 349, 29.12.2017, pp. 1-247)
See consolidated version.
Commission Regulation (EU) No 136/2014 of 11 February 2014 amending Directive 2007/46/EC of the European Parliament and of the Council, Commission Regulation (EC) No 692/2008 as regards emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and Commission Regulation (EU) No 582/2011 as regards emissions from heavy duty vehicles (Euro VI) (OJ L 43, 13.2.2014, pp. 12-46)
Commission Regulation (EU) No 582/2011 of 25 May 2011 implementing and amending Regulation (EC) No 595/2009 of the European Parliament and of the Council with respect to emissions from heavy duty vehicles (Euro VI) and amending Annexes I and III to Directive 2007/46/EC of the European Parliament and of the Council (OJ L 167, 25.6.2011, pp. 1-168)
See consolidated version.
Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 199, 28.7.2008, pp. 1-136)
See consolidated version.
last update 28.05.2021
|
32008R1008
|
31.10.2008
EN
Official Journal of the European Union
L 293/3
REGULATION (EC) No 1008/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 24 September 2008
on common rules for the operation of air services in the Community (Recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
(1)
A number of substantial changes are to be made to Council Regulations (EEC) No 2407/92 of 23 July 1992 on licensing of air carriers (4), (EEC) No 2408/92 of 23 July 1992 on access of Community air carriers to intra-Community air routes (5), and (EEC) No 2409/92 of 23 July 1992 on fares and rates for air services (6). In the interests of clarity, these Regulations should be recast and consolidated into one single Regulation.
(2)
In order to ensure a more efficient and consistent application of Community legislation for the internal aviation market a series of adjustments to the current legal framework is required.
(3)
Recognising the potential link between the financial health of an air carrier and safety, more stringent monitoring of the financial situation of air carriers should be established.
(4)
Given the growing importance of air carriers with operational bases in several Member States and the need to ensure the efficient supervision of these air carriers, the same Member State should be responsible for the oversight of the air operator certificate and of the operating licence.
(5)
To ensure consistent monitoring of the compliance with the requirements of the operating licences of all Community air carriers, licensing authorities should carry out regular assessments of the air carriers' financial situation. Therefore, the latter should provide sufficient information on their financial situation, especially in the first two years of their existence as these are particularly critical for the survival of an air carrier on the market. In order to avoid a distortion of competition arising from the different application of the rules at national level, it is necessary to reinforce the financial oversight of all Community air carriers by Member States.
(6)
To reduce risks to passengers, Community air carriers failing to fulfil the requirements for maintaining a valid operating licence should not be allowed to continue operations. In such cases, the competent licensing authority should revoke or suspend the operating licence.
(7)
According to Regulation (EC) No 785/2004 of the European Parliament and of the Council of 21 April 2004 on insurance requirements for air carriers and aircraft operators (7) an air carrier should be insured to cover liability in case of accidents with respect to passengers, cargo and third parties. Obligations should also be placed upon air carriers for insurance to cover liability in case of accidents with respect to mail.
(8)
In order to avoid excessive recourse to lease agreements of aircraft registered in third countries, especially wet lease, these possibilities should only be allowed in exceptional circumstances, such as a lack of adequate aircraft on the Community market, and they should be strictly limited in time and fulfil safety standards equivalent to the safety rules of Community and national legislation.
(9)
With respect to employees of a Community air carrier operating air services from an operational base outside the territory of the Member State where that Community air carrier has its principal place of business, Member States should ensure the proper application of Community and national social legislation.
(10)
In order to complete the internal aviation market, still existing restrictions applied between Member States, such as restrictions on the code sharing on routes to third countries or on the price setting on routes to third countries with an intermediate stop in another Member State (sixth freedom flights) should be lifted.
(11)
To take into account the special characteristics and constraints of the outermost regions, in particular their remoteness, insularity and small size, and the need to properly link them with the central regions of the Community, special arrangements may be justified regarding the rules on the period of validity of the contracts for public service obligations covering routes to such regions.
(12)
The conditions under which public service obligations may be imposed should be defined clearly in an unambiguous way, while the associated tender procedures should allow a sufficient number of competitors to take part in the tenders. The Commission should be able to obtain as much information as necessary to be able to assess the economic justifications for public service obligations in individual cases.
(13)
The rules in force with regard to traffic distribution between airports serving the same city or conurbation should be clarified and simplified.
(14)
It is appropriate to ensure that Member States have the possibility to react to sudden problems resulting from unforeseeable and unavoidable circumstances, which make it technically or practically very difficult to carry out air services.
(15)
Customers should have access to all air fares and air rates irrespective of their place of residence within the Community or their nationality and irrespective of the place of establishment of the travel agents within the Community.
(16)
Customers should be able to compare effectively the prices for air services of different airlines. Therefore the final price to be paid by the customer for air services originating in the Community should at all times be indicated, inclusive of all taxes, charges and fees. Community air carriers are also encouraged to indicate the final price for their air services from third countries to the Community.
(17)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).
(18)
Since the objective of this Regulation, namely more homogeneous application of Community legislation with regard to the internal aviation market cannot be sufficiently achieved by the Member States because of the international character of air transport, and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(19)
The Ministerial Statement on Gibraltar Airport, agreed in Cordoba on 18 September 2006, during the first ministerial meeting of the Forum of Dialogue on Gibraltar, will replace the Joint Declaration on the airport made in London on 2 December 1987, and full compliance with it will be deemed to constitute compliance with the 1987 declaration.
(20)
It is therefore necessary to repeal Regulations (EEC) No 2407/92, (EEC) No 2408/92 and (EEC) No 2409/92,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
1. This Regulation regulates the licensing of Community air carriers, the right of Community air carriers to operate intra-Community air services and the pricing of intra-Community air services.
2. The application of Chapter III of this Regulation to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated.
Article 2
Definitions
For the purposes of this Regulation:
1.
‘operating licence’ means an authorisation granted by the competent licensing authority to an undertaking, permitting it to provide air services as stated in the operating licence;
2.
‘competent licensing authority’ means an authority of a Member State entitled to grant, refuse, revoke or suspend an operating licence in accordance with Chapter II;
3.
‘undertaking’ means any natural or legal person, whether profit-making or not, or any official body whether having its own legal personality or not;
4.
‘air service’ means a flight or a series of flights carrying passengers, cargo and/or mail for remuneration and/or hire;
5.
‘flight’ means a departure from a specified airport towards a specified destination airport;
6.
‘local flight’ means a flight not involving carriage of passengers, mail and/or cargo between different airports or other authorised landing points;
7.
‘airport’ means any area in a Member State especially adapted for air services;
8.
‘air operator certificate (AOC)’ means a certificate delivered to an undertaking confirming that the operator has the professional ability and organisation to ensure the safety of operations specified in the certificate, as provided in the relevant provisions of Community or national law, as applicable;
9.
‘effective control’ means a relationship constituted by rights, contracts or any other means which, either separately or jointly and having regard to the considerations of fact or law involved, confer the possibility of directly or indirectly exercising a decisive influence on an undertaking, in particular by:
(a)
the right to use all or part of the assets of an undertaking;
(b)
rights or contracts which confer a decisive influence on the composition, voting or decisions of the bodies of an undertaking or otherwise confer a decisive influence on the running of the business of the undertaking;
10.
‘air carrier’ means an undertaking with a valid operating licence or equivalent;
11.
‘Community air carrier’ means an air carrier with a valid operating licence granted by a competent licensing authority in accordance with Chapter II;
12.
‘business plan’ means a detailed description of the air carrier's intended commercial activities for the period in question, in particular in relation to the expected market development and the investments to be carried out, including the financial and economic implications of these activities;
13.
‘intra-Community air service’ means an air service operated within the Community;
14.
‘traffic right’ means the right to operate an air service between two Community airports;
15.
‘seat-only sales’ means the sale of seats, without any other service bundled, such as accommodation, directly to the public by the air carrier or its authorised agent or a charterer;
16.
‘scheduled air service’ means a series of flights possessing all the following characteristics:
(a)
on each flight seats and/or capacity to transport cargo and/or mail are available for individual purchase by the public (either directly from the air carrier or from its authorised agents);
(b)
it is operated so as to serve traffic between the same two or more airports, either:
—
according to a published timetable, or
—
with flights so regular or frequent that they constitute a recognisably systematic series;
17.
‘capacity’ means the number of seats or the payload offered to the general public on a scheduled air service over a given period;
18.
‘air fares’ means the prices expressed in euro or in local currency to be paid to air carriers or their agents or other ticket sellers for the carriage of passengers on air services and any conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services;
19.
‘air rates’ means the prices expressed in euro or in local currency to be paid for the carriage of cargo and the conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services;
20.
‘Member State(s) concerned’ means the Member State(s) between or within which an air service is operated;
21.
‘Member State(s) involved’ means the Member State(s) concerned and the Member State(s) where the air carrier(s) operating the air service is (are) licensed;
22.
‘conurbation’ means an urban area comprising a number of cities or towns which, through population growth and expansion, have physically merged to form one continuous built up area;
23.
‘management account’ means a detailed statement of income and costs of an air carrier for the period in question including a breakdown between air-transport-related and other activities as well as between pecuniary and non-pecuniary elements;
24.
‘dry lease agreement’ means an agreement between undertakings pursuant to which the aircraft is operated under the AOC of the lessee;
25.
‘wet lease agreement’ means an agreement between air carriers pursuant to which the aircraft is operated under the AOC of the lessor;
26.
‘principal place of business’ means the head office or registered office of a Community air carrier in the Member State within which the principal financial functions and operational control, including continued airworthiness management, of the Community air carrier are exercised.
CHAPTER II
OPERATING LICENCE
Article 3
Operating licence
1. No undertaking established in the Community shall be permitted to carry by air passengers, mail and/or cargo for remuneration and/or hire unless it has been granted the appropriate operating licence.
An undertaking meeting the requirements of this Chapter shall be entitled to receive an operating licence.
2. The competent licensing authority shall not grant operating licences or maintain them in force where any of the requirements of this Chapter are not complied with.
3. Without prejudice to any other applicable provisions of Community, national, or international law, the following categories of air services shall not be subject to the requirement to hold a valid operating licence:
(a)
air services performed by non-power-driven aircraft and/or ultralight power-driven aircraft; and
(b)
local flights.
Article 4
Conditions for granting an operating licence
An undertaking shall be granted an operating licence by the competent licensing authority of a Member State provided that:
(a)
its principal place of business is located in that Member State;
(b)
it holds a valid AOC issued by a national authority of the same Member State whose competent licensing authority is responsible for granting, refusing, revoking or suspending the operating licence of the Community air carrier;
(c)
it has one or more aircraft at its disposal through ownership or a dry lease agreement;
(d)
its main occupation is to operate air services in isolation or combined with any other commercial operation of aircraft or the repair and maintenance of aircraft;
(e)
its company structure allows the competent licensing authority to implement the provisions of this Chapter;
(f)
Member States and/or nationals of Member States own more than 50 % of the undertaking and effectively control it, whether directly or indirectly through one or more intermediate undertakings, except as provided for in an agreement with a third country to which the Community is a party;
(g)
it meets the financial conditions specified in Article 5;
(h)
it complies with the insurance requirements specified in Article 11 and in Regulation (EC) No 785/2004; and
(i)
it complies with the provisions on good repute as specified in Article 7.
Article 5
Financial conditions for granting an operating licence
1. The competent licensing authority shall closely assess whether an undertaking applying for the first time for an operating licence can demonstrate that:
(a)
it can meet at any time its actual and potential obligations established under realistic assumptions, for a period of 24 months from the start of operations; and
(b)
it can meet its fixed and operational costs incurred by operations according to its business plan and established under realistic assumptions, for a period of three months from the start of operations, without taking into account any income from its operations.
2. For the purposes of the assessment referred to in paragraph 1, each applicant shall submit a business plan for, at least, the first three years of operation. The business plan shall also detail the applicant's financial links with any other commercial activities in which the applicant is engaged either directly or through related undertakings. The applicant shall also provide all relevant information, in particular the data referred to in point 1 of Annex I.
3. Paragraphs 1 and 2 shall not apply to an undertaking applying for an operating licence intended to cover operations with aircraft of less than 10 tonnes maximum take-off mass (MTOM) and/or less than 20 seats. Such undertakings shall demonstrate that their net capital is at least EUR 100 000 or provide, when required by the competent licensing authority, all relevant information for the purposes of the assessment referred to in paragraph 1, in particular the data referred to in point 1 of Annex I.
The competent licensing authority may nevertheless apply paragraphs 1 and 2 to an undertaking applying for an operating licence under the provisions of the previous subparagraph that intends to operate scheduled air services or whose turnover exceeds EUR 3 million per year.
Article 6
Air operator certificate
1. The granting and validity of an operating licence shall at any time be dependent upon the possession of a valid AOC specifying the activities covered by the operating licence.
2. Any modification in the AOC of a Community air carrier shall be reflected, where appropriate, in its operating licence.
Article 7
Proof of good repute
1. Where, for the purpose of issuing an operating licence, proof is required that the persons who will continuously and effectively manage the operations of the undertaking are of good repute or that they have not been declared bankrupt, the competent licensing authority shall accept as sufficient evidence in respect of nationals of Member States the production of documents issued by the competent authorities in the Member State of origin or the Member State where the person has his/her permanent residence showing that those requirements are met.
2. Where the Member State of origin or the Member State where the person has his/her permanent residence does not issue the documents referred to in paragraph 1, such documents shall be replaced by a declaration on oath or — in Member States where there is no provision for declaration on oath — by a solemn declaration made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary or qualified professional body of the Member State of origin or the Member State where the person has his/her permanent residence. Such authority, notary or qualified professional body shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration.
3. The competent licensing authority may require that the documents and certificates referred to in paragraphs 1 and 2 be presented no more than three months after their date of issue.
Article 8
Validity of an operating licence
1. An operating licence shall be valid as long as the Community air carrier complies with the requirements of this Chapter.
A Community air carrier shall at all times be able on request to demonstrate to the competent licensing authority that it meets all the requirements of this Chapter.
2. The competent licensing authority shall closely monitor compliance with the requirements of this Chapter. It shall in any case review compliance with these requirements in the following cases:
(a)
two years after a new operating licence has been granted;
(b)
when a potential problem has been suspected; or
(c)
at the request of the Commission.
In case the competent licensing authority suspects that financial problems of a Community air carrier might affect the safety of its operations, it shall immediately inform the authority competent for the AOC.
3. The operating licence shall be resubmitted for approval when a Community air carrier:
(a)
has not started operations within six months of the granting of an operating licence;
(b)
has ceased its operations for more than six months; or
(c)
which has been licensed on the basis of the first subparagraph of Article 5(3) intends to engage in operations with aircraft above the size threshold specified in Article 5(3) or no longer complies with the financial conditions set out therein.
4. A Community air carrier shall provide to the competent licensing authority its audited accounts no later than six months following the last day of the respective financial year, unless otherwise provided for in national law. During the first two years of operation of a Community air carrier, the data as referred to in point 3 of Annex I shall be made available to the competent licensing authority upon request.
The competent licensing authority may at any time assess the financial performance of a Community air carrier to which it has granted an operating licence by requesting the relevant information. As part of such an assessment, the Community air carrier in question shall update the data referred to in point 3 of Annex I and provide it to the competent licensing authority upon request.
5. A Community air carrier shall notify the competent licensing authority:
(a)
in advance of any plans for the operation of a new air service to a continent or a world region not previously served, or any other substantial change in the scale of its activities, including, but not limited to, changes in the type or number of aircraft used;
(b)
in advance of any intended mergers or acquisitions; and
(c)
within 14 days of any change in the ownership of any single shareholding which represents 10 % or more of the total shareholding of the Community air carrier or of its parent or ultimate holding company.
6. If the competent licensing authority deems the changes notified under paragraph 5 to have a significant bearing on the finances of the Community air carrier, it shall require the submission of a revised business plan incorporating the changes in question and covering, at least, a period of 12 months from its date of implementation as well as the data referred to in point 2 of Annex I, in addition to the information to be provided under paragraph 4.
The competent licensing authority shall take a decision on the revised business plan as to whether the Community air carrier can meet its existing and potential obligations during that period of 12 months. Such a decision shall be taken not later than three months after all the necessary information has been submitted to it.
7. In relation to Community air carriers licensed by it the competent licensing authority shall decide whether the operating licence shall be resubmitted for approval in case of change in one or more elements affecting the legal situation of a Community air carrier and, in particular, in the case of a merger or takeover.
8. Paragraphs 4, 5 and 6 shall not apply to Community air carriers exclusively engaged in operations with aircraft of less than 10 tonnes MTOM and/or less than 20 seats. Such Community air carriers shall at all times be able to demonstrate that their net capital is at least EUR 100 000 or to provide when required by the competent licensing authority the information relevant for the purposes of the assessment referred to in Article 9(2).
The competent licensing authority may nevertheless apply paragraphs 4, 5 and 6 to Community air carriers licensed by it that operate scheduled air services or whose turnover exceeds EUR 3 million per year.
Article 9
Suspension and revocation of an operating licence
1. The competent licensing authority may at any time assess the financial performance of a Community air carrier which it has licensed. Based upon its assessment, the authority shall suspend or revoke the operating licence if it is no longer satisfied that this Community air carrier can meet its actual and potential obligations for a 12-month period. Nevertheless, the competent licensing authority may grant a temporary licence, not exceeding 12 months pending financial reorganisation of a Community air carrier provided that safety is not at risk, that this temporary licence reflects, when appropriate, any changes to the AOC, and that there is a realistic prospect of a satisfactory financial reconstruction within that time period.
2. Whenever there are clear indications that financial problems exist or when insolvency or similar proceedings are opened against a Community air carrier licensed by it the competent licensing authority shall without delay make an in-depth assessment of the financial situation and on the basis of its findings review the status of the operating licence in compliance with this Article within a time period of three months.
The competent licensing authority shall inform the Commission of its decisions, relating to the status of the operating licence.
3. When the audited accounts referred to in Article 8(4) have not been communicated within the deadline indicated in that Article, the competent licensing authority shall, without undue delay, request the Community air carrier to communicate these audited accounts.
If the audited accounts are not communicated within one month, the operating licence may be revoked or suspended.
4. The competent licensing authority shall suspend or revoke the operating licence if the Community air carrier knowingly or recklessly furnishes the competent licensing authority with false information on an important point.
5. In case a Community air carrier's AOC is suspended or withdrawn, the competent licensing authority shall immediately suspend or revoke that air carrier's operating licence.
6. The competent licensing authority may suspend or revoke the operating licence of a Community air carrier if such a carrier no longer satisfies the requirements relating to good repute set out in Article 7.
Article 10
Decisions on operating licences
1. The competent licensing authority shall take a decision on an application as soon as possible, and not later than three months after all the necessary information has been submitted, taking into account all available evidence. The decision shall be communicated to the applicant. A refusal shall indicate the reasons therefor.
2. Procedures for granting, suspending and revoking operating licences shall be made public by the competent licensing authorities, which shall inform the Commission thereof.
3. A list of decisions of the competent licensing authorities to grant, suspend or revoke operating licences shall be published annually in the Official Journal of the European Union.
Article 11
Insurance requirements
Notwithstanding Regulation (EC) No 785/2004, an air carrier shall be insured to cover liability in case of accidents with respect to mail.
Article 12
Registration
1. Without prejudice to Article 13(3), aircraft used by a Community air carrier shall be registered, at the option of the Member State whose competent authority issues the operating licence, in its national register or within the Community.
2. In accordance with paragraph 1, the competent authority shall, subject to applicable laws and regulations, accept on its national register, without any discriminatory fee and without delay, aircraft owned by nationals of other Member States and transfers from aircraft registers of other Member States. No fee shall be applied to transfers of aircraft in addition to the normal registration fee.
Article 13
Leasing
1. Without prejudice to Article 4(c), a Community air carrier may have one or more aircraft at its disposal through dry or wet lease agreement. Community air carriers may freely operate wet-leased aircraft registered within the Community except where this would lead to endangering safety. The Commission shall ensure that the implementation of such a provision is reasonable and proportionate and based on safety considerations.
2. A dry lease agreement to which a Community air carrier is a party or a wet lease agreement under which the Community air carrier is the lessee of the wet-leased aircraft shall be subject to prior approval in accordance with applicable Community or national law on aviation safety.
3. A Community air carrier wet leasing aircraft registered in a third country from another undertaking shall obtain prior approval for the operation from the competent licensing authority. The competent authority may grant an approval if:
(a)
the Community air carrier demonstrates to the satisfaction of the competent authority that all safety standards equivalent to those imposed by Community or national law are met; and
(b)
one of the following conditions is fulfilled:
(i)
the Community air carrier justifies such leasing on the basis of exceptional needs, in which case an approval may be granted for a period of up to seven months that may be renewed once for a further period of up to seven months;
(ii)
the Community air carrier demonstrates that the leasing is necessary to satisfy seasonal capacity needs, which cannot reasonably be satisfied through leasing aircraft registered within the Community, in which case the approval may be renewed; or
(iii)
the Community air carrier demonstrates that the leasing is necessary to overcome operational difficulties and it is not possible or reasonable to lease aircraft registered within the Community, in which case the approval shall be of limited duration strictly necessary for overcoming the difficulties.
4. The competent authority may attach conditions to the approval. Such conditions shall form part of the wet lease agreement.
The competent authority may refuse to grant an approval if there is no reciprocity as regards wet leasing between the Member State concerned or the Community and the third country where the wet-leased aircraft is registered.
The competent authority shall inform the Member States concerned about an approval it has granted for wet leasing aircraft registered in a third country.
Article 14
Right to be heard
The competent licensing authority shall ensure that, when adopting a decision to suspend or revoke the operating licence of a Community air carrier, the Community air carrier concerned is given the opportunity of being heard, taking into account the need, in some cases, for an urgency procedure.
CHAPTER III
ACCESS TO ROUTES
Article 15
Provision of intra-Community air services
1. Community air carriers shall be entitled to operate intra-Community air services.
2. Member States shall not subject the operation of intra-Community air services by a Community air carrier to any permit or authorisation. Member States shall not require Community air carriers to provide any documents or information which they have already supplied to the competent licensing authority, provided that the relevant information may be obtained from the competent licensing authority in due time.
3. If the Commission, on the basis of information obtained under Article 26(2), finds that the operating licence granted to a Community air carrier is not in compliance with the requirements of this Regulation it shall forward its findings to the competent licensing authority which shall send its comments to the Commission within 15 working days.
If the Commission, after examining the comments of the competent licensing authority, maintains that the operating licence is not compliant, or no comments have been received from the competent licensing authority it shall, in accordance with the procedure referred to in Article 25(2), take a decision to request the competent licensing authority to take the appropriate corrective measures or to suspend or revoke the operating licence.
The decision shall set a date by which the corrective measures or actions by the competent licensing authority shall be implemented. If the corrective measures or actions have not been implemented by that date the Community air carrier shall not be entitled to exercise its rights under paragraph 1.
The Community air carrier may resume exercising its rights under paragraph 1 upon notification to the Commission by the competent licensing authority that the corrective measures have been implemented and that the competent licensing authority has verified the implementation.
4. When operating intra-Community air services, a Community air carrier shall be permitted to combine air services and to enter into code share arrangements, without prejudice to the Community competition rules applicable to undertakings.
Any restrictions on the freedom of Community air carriers to operate intra-Community air services arising from bilateral agreements between Member States are hereby superseded.
5. Notwithstanding the provisions of bilateral agreements between Member States, and subject to the Community competition rules applicable to undertakings, Community air carriers shall be permitted by the Member State(s) concerned to combine air services and to enter into code share arrangements with any air carrier on air services to, from or via any airport in their territory from or to any point(s) in third countries.
A Member State may, in the framework of the bilateral air service agreement with the third country concerned, impose restrictions on code share arrangements between Community air carriers and air carriers of a third country, in particular if the third country concerned does not allow similar commercial opportunities to Community air carriers operating from the Member State concerned. In doing so, Member States shall ensure that restrictions imposed under such agreements do not restrict competition and are non-discriminatory between Community air carriers and that they are not more restrictive than necessary.
Article 16
General principles for public service obligations
1. A Member State, following consultations with the other Member States concerned and after having informed the Commission, the airports concerned and air carriers operating on the route, may impose a public service obligation in respect of scheduled air services between an airport in the Community and an airport serving a peripheral or development region in its territory or on a thin route to any airport on its territory any such route being considered vital for the economic and social development of the region which the airport serves. That obligation shall be imposed only to the extent necessary to ensure on that route the minimum provision of scheduled air services satisfying fixed standards of continuity, regularity, pricing or minimum capacity, which air carriers would not assume if they were solely considering their commercial interest.
The fixed standards imposed on the route subject to that public service obligation shall be set in a transparent and non-discriminatory way.
2. In instances where other modes of transport cannot ensure an uninterrupted service with at least two daily frequencies, the Member States concerned may include in the public service obligation the requirement that any Community air carrier intending to operate the route gives a guarantee that it will operate the route for a certain period, to be specified, in accordance with the other terms of the public service obligation.
3. The necessity and the adequacy of an envisaged public service obligation shall be assessed by the Member State(s) having regard to:
(a)
the proportionality between the envisaged obligation and the economic development needs of the region concerned;
(b)
the possibility of having recourse to other modes of transport and the ability of such modes to meet the transport needs under consideration, in particular when existing rail services serve the envisaged route with a travel time of less than three hours and with sufficient frequencies, connections and suitable timings;
(c)
the air fares and conditions which can be quoted to users;
(d)
the combined effect of all air carriers operating or intending to operate on the route.
4. When a Member State wishes to impose a public service obligation, it shall communicate the text of the envisaged imposition of the public service obligation to the Commission, to the other Member States concerned, to the airports concerned and to the air carriers operating the route in question.
The Commission shall publish an information notice in the Official Journal of the European Union:
(a)
identifying the two airports connected by the route concerned and possible intermediate stop-over point(s);
(b)
mentioning the date of entry into force of the public service obligation; and
(c)
indicating the complete address where the text and any relevant information and/or documentation related to the public service obligation shall be made available without delay and free of charge by the Member State concerned.
5. Notwithstanding the provisions of paragraph 4, with respect to routes where the number of passengers expected to use the air service is less than 10 000 per annum, the information notice on a public service obligation shall be published either in the Official Journal of the European Union or in the national official journal of the Member State concerned.
6. The date of entry into force of a public service obligation shall not be earlier than the date of publication of the information notice referred to in the second subparagraph of paragraph 4.
7. When a public service obligation has been imposed in accordance with paragraphs 1 and 2 the Community air carrier shall be able to offer seat-only sales provided that the air service in question meets all the requirements of the public service obligation. Consequently that air service shall be considered as a scheduled air service.
8. When a public service obligation has been imposed in accordance with paragraphs 1 and 2, any other Community air carrier shall at any time be allowed to commence scheduled air services meeting all the requirements of the public service obligation, including the period of operation that may be required in accordance with paragraph 2.
9. Notwithstanding paragraph 8, if no Community air carrier has commenced or can demonstrate that it is about to commence sustainable scheduled air services on a route in accordance with the public service obligation which has been imposed on that route, the Member State concerned may limit access to the scheduled air services on that route to only one Community air carrier for a period of up to four years, after which the situation shall be reviewed.
This period may be up to five years if the public service obligation is imposed on a route to an airport serving an outermost region, referred to in Article 299(2) of the Treaty.
10. The right to operate the services referred to in paragraph 9 shall be offered by public tender in accordance with Article 17, either singly or, in cases where justified for reasons of operational efficiency, for a group of such routes to any Community air carrier entitled to operate such air services. For reasons of administrative efficiency, a Member State may issue a single invitation to tender covering different routes.
11. A public service obligation shall be deemed to have expired if no scheduled air service has been operated during a period of 12 months on the route subject to such obligation.
12. In case of sudden interruption of service by the Community air carrier selected in accordance with Article 17, the Member State concerned may, in case of emergency, select by mutual agreement a different Community air carrier to operate the public service obligation for a period up to seven months, not renewable, under the following conditions:
(a)
any compensation paid by the Member State shall be made in compliance with Article 17(8);
(b)
the selection shall be made among Community air carriers in compliance with the principles of transparency and non-discrimination;
(c)
a new call for tender shall be launched.
The Commission and the Member State(s) concerned shall be informed without delay of the emergency procedure and of its reasons. At the request of a Member State, or on its own initiative, the Commission may, in accordance with the procedure referred to in Article 25(2) suspend the procedure if it considers after its assessment that it does not meet the requirements of this paragraph or is otherwise contrary to Community law.
Article 17
Public tender procedure for public service obligation
1. The public tender required in Article 16(10) shall be conducted according to the procedure set out in paragraphs 2 to 10 of this Article.
2. The Member State concerned shall communicate the entire text of the invitation to tender to the Commission except where, in accordance with Article 16(5), it has made the public service obligation known through the publication of a notice in its national official journal. In such case the tender shall also be published in the national official journal.
3. The invitation to tender and the subsequent contract shall cover, inter alia, the following points:
(a)
the standards required by the public service obligation;
(b)
rules concerning amendment and termination of the contract, in particular to take account of unforeseeable changes;
(c)
the period of validity of the contract;
(d)
penalties in the event of failure to comply with the contract;
(e)
objective and transparent parameters on the basis of which compensation, if any, for the discharging of the public service obligations shall be calculated.
4. The Commission shall make the invitation to tender known through an information notice published in the Official Journal of the European Union. The deadline for submission of tenders shall not be earlier than two months after the day of publication of such an information notice. In case the tender concerns a route to which the access had already been limited to one carrier in accordance with Article 16(9), the invitation to tender will be published at least six months before the start of the new concession in order to assess the continued necessity of the restricted access.
5. The information notice shall provide the following information:
(a)
Member State(s) concerned;
(b)
air route concerned;
(c)
period of validity of the contract;
(d)
complete address where the text of the invitation to tender and any relevant information and/or documentation related to the public tender and the public service obligation shall be made available by the Member State concerned;
(e)
deadline for submission of tenders.
6. The Member State(s) concerned shall communicate without delay and free of charge any relevant information and documents requested by a party interested in the public tender.
7. The selection among the submissions shall be made as soon as possible taking into consideration the adequacy of the service, including the prices and conditions which can be quoted to users, and the cost of the compensation required from the Member State(s) concerned, if any.
8. The Member State concerned may compensate an air carrier, which has been selected under paragraph 7, for adhering to the standards required by a public service obligation imposed under Article 16. Such compensation may not exceed the amount required to cover the net costs incurred in discharging each public service obligation, taking account of revenue relating thereto kept by the air carrier and a reasonable profit.
9. The Commission shall be informed in writing and without delay of the results of the public tender and of the selection by the Member State including the following information:
(a)
numbers, names and corporate information of tenderers;
(b)
operational elements contained in the offers;
(c)
compensation requested in the offers;
(d)
name of the selected tenderer.
10. At a request of a Member State or on its own initiative, the Commission may request Member States to communicate, within one month, all relevant documents relating to the selection of an air carrier for the operation of a public service obligation. In case the requested documents are not communicated within the deadline, the Commission may decide to suspend the invitation to tender in accordance with the procedure referred to in Article 25(2).
Article 18
Examination of public service obligations
1. Member States shall take all necessary measures to ensure that any decision taken under Articles 16 and 17 can be reviewed effectively and, in particular, as soon as possible on the grounds that such decisions have infringed Community law or national rules implementing Community law.
In particular, at a request of a Member State or on its own initiative, the Commission may request Member States to communicate, within two months:
(a)
a document justifying the need for the public service obligation and its compliance with the criteria mentioned in Article 16;
(b)
an analysis of the economy of the region;
(c)
an analysis of the proportionality between the envisaged obligations and the economic development objectives;
(d)
an analysis of the existing air services, if any, and of the other modes of transport available which could be considered a substitute for the envisaged imposition.
2. At the request of a Member State which considers that the development of a route is being unduly restricted by the terms of Articles 16 and 17, or on its own initiative, the Commission shall carry out an investigation and, within six months of receipt of the request and in accordance with the procedure referred to in Article 25(2), shall take a decision on the basis of all relevant factors on whether Articles 16 and 17 shall continue to apply in respect of the route concerned.
Article 19
Traffic distribution between airports and exercise of traffic rights
1. The exercise of traffic rights shall be subject to published Community, national, regional and local operational rules relating to safety, security, the protection of the environment and the allocation of slots.
2. A Member State, after consultation with interested parties including the air carriers and airports concerned, may regulate, without discrimination among destinations inside the Community or on grounds of nationality or identity of air carriers, the distribution of air traffic between airports satisfying the following conditions:
(a)
the airports serve the same city or conurbation;
(b)
the airports are served by adequate transport infrastructure providing, to the extent possible, a direct connection making it possible to arrive at the airport within 90 minutes including, where necessary, on a cross-border basis;
(c)
the airports are linked to one another and to the city or conurbation they serve by frequent, reliable and efficient public transport services; and
(d)
the airports offer necessary services to air carriers, and do not unduly prejudice their commercial opportunities.
Any decision to regulate the distribution of air traffic between the airports concerned shall respect the principles of proportionality and transparency, and shall be based on objective criteria.
3. A Member State concerned shall inform the Commission of its intention to regulate the distribution of air traffic or to change an existing traffic distribution rule.
The Commission shall examine the application of paragraphs 1 and 2 of this Article and, within six months of receipt of the information from the Member State, and in accordance with the procedure referred to in Article 25(2), shall decide whether the Member State may apply the measures.
The Commission shall publish its decision in the Official Journal of the European Union and the measures shall not be applied before the publication of the Commission's approval.
4. With respect to traffic distribution rules existing at the time of the entry into force of this Regulation, the Commission shall at the request of a Member State and may on its own initiative examine the application of paragraphs 1 and 2 and, in accordance with the procedure referred to in Article 25(2), shall decide whether the Member State may continue to apply the measure.
5. The Commission shall publish its decisions made under this Article in the Official Journal of the European Union.
Article 20
Environmental measures
1. When serious environmental problems exist, the Member State responsible may limit or refuse the exercise of traffic rights, in particular when other modes of transport provide appropriate levels of service. The measure shall be non-discriminatory, shall not distort competition between air carriers, shall not be more restrictive than necessary to relieve the problems, and shall have a limited period of validity, not exceeding three years, after which it shall be reviewed.
2. When a Member State considers that action under paragraph 1 is necessary it shall, at least three months before the entry into force of the action, inform the other Member States and the Commission, providing adequate justification for the action. The action may be implemented unless within one month of receipt of the information a Member State concerned contests the action or the Commission, in accordance with paragraph 3, takes it up for further examination.
3. At the request of another Member State or on its own initiative, the Commission may, in accordance with the procedure referred to in Article 25(2), suspend the measures if they do not meet the requirements of paragraph 1 or are otherwise contrary to Community law.
Article 21
Emergency measures
1. A Member State may refuse, limit or impose conditions on the exercise of traffic rights to deal with sudden problems of short duration resulting from unforeseeable and unavoidable circumstances. Such action shall respect the principles of proportionality and transparency and shall be based on objective and non-discriminatory criteria.
The Commission and the other Member States shall be informed without delay of such action with its adequate justification. If the problems necessitating such action continue to exist for more than 14 days, the Member State shall inform the Commission and the other Member States accordingly and may, with the agreement of the Commission, prolong the action for further periods of up to 14 days.
2. At the request of the Member State(s) involved or on its own initiative, the Commission may suspend this action if it does not meet the requirements of paragraph 1 or is otherwise contrary to Community law.
CHAPTER IV
PROVISIONS ON PRICING
Article 22
Pricing freedom
1. Without prejudice to Article 16(1), Community air carriers and, on the basis of reciprocity, air carriers of third countries shall freely set air fares and air rates for intra-Community air services.
2. Notwithstanding the provisions of bilateral agreements between Member States, Member States may not discriminate on grounds of nationality or identity of air carriers in allowing Community air carriers to set fares and rates for air services between their territory and a third country. Any remaining restrictions on pricing, including with respect to routes to third countries, arising from bilateral agreements between Member States are hereby superseded.
Article 23
Information and non-discrimination
1. Air fares and air rates available to the general public shall include the applicable conditions when offered or published in any form, including on the Internet, for air services from an airport located in the territory of a Member State to which the Treaty applies. The final price to be paid shall at all times be indicated and shall include the applicable air fare or air rate as well as all applicable taxes, and charges, surcharges and fees which are unavoidable and foreseeable at the time of publication. In addition to the indication of the final price, at least the following shall be specified:
(a)
air fare or air rate;
(b)
taxes;
(c)
airport charges; and
(d)
other charges, surcharges or fees, such as those related to security or fuel;
where the items listed under (b), (c) and (d) have been added to the air fare or air rate. Optional price supplements shall be communicated in a clear, transparent and unambiguous way at the start of any booking process and their acceptance by the customer shall be on an ‘opt-in’ basis.
2. Without prejudice to Article 16(1), access to air fares and air rates for air services from an airport located in the territory of a Member State to which the Treaty applies, available to the general public shall be granted without any discrimination based on the nationality or the place of residence of the customer or on the place of establishment of the air carrier's agent or other ticket seller within the Community.
Article 24
Penalties
Member States shall ensure compliance with the rules set out in this Chapter and shall lay down penalties for infringements thereof. Those penalties shall be effective, proportionate and dissuasive.
CHAPTER V
FINAL PROVISIONS
Article 25
Committee
1. The Commission shall be assisted by a committee.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 26
Cooperation and right to obtain information
1. Member States and the Commission shall cooperate in applying and in monitoring the application of this Regulation.
2. In order to carry out its duties under this Regulation the Commission may obtain all necessary information from Member States, which shall also facilitate the provision of information by air carriers licensed by their competent licensing authorities.
3. Member States shall, according to their national legislation, take the necessary measures to ensure appropriate confidentiality of the information received by them pursuant to this Regulation.
Article 27
Repeal
Regulations (EEC) No 2407/92, (EEC) No 2408/92 and (EEC) No 2409/92 shall be repealed.
References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.
Article 28
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 24 September 2008.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
J.-P. JOUYET
(1) OJ C 175, 27.7.2007, p. 85.
(2) OJ C 305, 15.12.2007, p. 11.
(3) Opinion of European Parliament of 11 July 2007 (OJ C 175 E, 10.7.2008, p. 371), Council Common Position of 18 April 2008 (OJ C 129 E, 27.5.2008, p. 1) and Position of the European Parliament of 9 July 2008 (not yet published in the Official Journal).
(4) OJ L 240, 24.8.1992, p. 1.
(5) OJ L 240, 24.8.1992, p. 8.
(6) OJ L 240, 24.8.1992, p. 15.
(7) OJ L 138, 30.4.2004, p. 1.
(8) OJ L 184, 17.7.1999, p. 23.
ANNEX I
INFORMATION TO BE PROVIDED PURSUANT TO ARTICLES 5 AND 8
1.
Information to be provided by a first-time applicant from a financial fitness point of view
1.1.
The most recent internal management accounts and, if available, audited accounts for the previous financial year.
1.2.
A projected balance sheet, including profit-and-loss account, for the following three years.
1.3.
The basis for projected expenditure and income figures on such items as fuel, fares and rates, salaries, maintenance, depreciation, exchange rate fluctuations, airport charges, air navigation charges, ground handling costs, insurance, etc. Traffic/revenue forecasts.
1.4.
Details of the start-up costs incurred in the period from submission of an application to the commencement of operations and an explanation of how it is proposed to finance these costs.
1.5.
Details of existing and projected sources of finance.
1.6.
Details of shareholders, including nationality and type of shares to be held, and the Articles of Association. If part of a group of undertakings, information on the relationship between them.
1.7.
Projected cash-flow statements and liquidity plans for the first three years of operation.
1.8.
Details of the financing of aircraft purchase/leasing including, in the case of leasing, the terms and conditions of contract.
2.
Information to be provided for assessment of the continuing financial fitness of existing licence holders planning a change in their structures or in their activities with a significant bearing on their finances
2.1.
If necessary, the most recent internal management balance sheet and audited accounts for the previous financial year.
2.2.
Precise details of all proposed changes e.g. change of type of service, proposed takeover or merger, modifications in share capital, changes in shareholders, etc.
2.3.
A projected balance sheet, with a profit-and-loss account, for the current financial year, including all proposed changes in structure or activities with a significant bearing on finances.
2.4.
Past and projected expenditure and income figures on such items as fuel, fares and rates, salaries, maintenance, depreciation, exchange rate fluctuations, airport charges, air navigation charges, ground handling costs, insurance, etc. Traffic/revenue forecasts.
2.5.
Cash-flow statements and liquidity plans for the following year, including all proposed changes in structure or activities with a significant bearing on finances.
2.6.
Details of the financing of aircraft purchase/leasing including, in the case of leasing, the terms and conditions of contract.
3.
Information to be provided for assessment of the continuing financial fitness of existing licence holders
3.1.
Audited accounts no later than six months following the last day of the relevant financial year, unless otherwise provided for in national law and, if necessary, the most recent internal management balance sheet.
3.2.
A projected balance sheet, including profit-and-loss account, for the forthcoming year.
3.3.
Past and projected expenditure and income figures on such items as fuel, fares and rates, salaries, maintenance, depreciation, exchange rate fluctuations, airport charges, air navigation charges, ground handling costs, insurance, etc. Traffic/revenue forecasts.
3.4.
Cash-flow statements and liquidity plans for the following year.
ANNEX II
CORRELATION TABLE
(Referred to in Article 27)
Regulation (EEC) No 2407/92
This Regulation
Article 1(1)
Article 1
Article 1(2)
Article 3(3)
Article 2
Article 2
Article 3(1)
Article 3(2)
Article 3(2)
the second subparagraph of Article 3(1)
Article 3(3)
the first subparagraph of Article 3(1)
Article 4(1)
Article 4
Article 4(2)
Article 4(f)
Article 4(3)
—
Article 4(4)
Article 4(f)
Article 4(5)
the second subparagraph of Article 8(1)
Article 5(1)
Article 5(1)
Article 5(2)
Article 5(2)
Article 5(3)
Article 8(5)
Article 5(4)
Article 8(6)
Article 5(5)
Article 9(1)
Article 5(6)
Article 8(4)
Article 5(7)
Article 5(3) and Article 8(8)
Article 6
Article 7
Article 7
Article 11
Article 8(1)
Article 4(c)
Article 8(2)
Article 12(1)
Article 8(3)
Article 13(2) and (3)
Article 8(4)
Article 12(2)
Article 9
Article 6
Article 10(1)
Article 13(2) and (3)
Article 10(2)
Article 13(2) and (3)
Article 11(1)
Article 8(1)
Article 11(2)
Article 8(3)
Article 11(3)
Article 8(7)
Article 12
Articles 9(2) to (6)
Article 13(1)
Article 10(2)
Article 13(2)
Article 10(1)
Article 13(3)
—
Article 13(4)
Article 10(3)
Article 14
—
Article 15
—
Article 16
—
Article 17
—
Article 18(1)
Article 26(1)
Article 18(2)
Article 26(3)
Article 19
—
ANNEX
ANNEX I
Regulation (EEC) No 2408/92
This Regulation
Article 1(1)
Article 1
Article 1(2)
Article 1(2)
Article 1(3)
—
Article 1(4)
—
Article 2
Article 2
Article 3(1)
Article 15(1) and (2)
Article 3(2)
—
Article 3(3)
—
Article 3(4)
—
Article 4(1)(a)
Article 16(1)
Article 4(1)(b)
Article 16(3)
Article 4(1)(c)
Article 16(2)
Article 4(1)(d)
Article 16(9)
—
Article 17(1)
—
Article 17(2)
—
Article 17(4)
—
Article 17(5)
—
Article 17(6)
Article 4(1)(e)
Article 17(3)
Article 4(1)(f)
Article 17(7)
Article 4(1)(g)
—
Article 4(1)(h)
Article 17(8)
—
Article 17(9)
—
Article 17(10)
Article 4(1)(i)
Article 18(1)
Article 4(1)(j)
Article 16(7)
Article 4(1)(k)
—
Article 4(2)
—
Article 4(3)
Article 18(2)
Article 4(4)
—
Article 5
—
Article 6(1) and (2)
—
Article 7
Article 15(4) and (5)
Article 8(1)
Article 19(2)
Article 8(2)
Article 19(1)
Article 8(3)
Article 19(3)
Article 8(4)
—
Article 8(5)
—
Article 9(1)
Article 20(1)
Article 9(2)
Article 20(1)
Article 9(3)
Article 20(2)
Article 9(4)
Article 20(3)
Article 9(5)
Article 22(1)
Article 9(6)
Article 22(2)
Article 9(7)
—
Article 9(8)
—
Article 10
—
Article 11
Article 25
Article 12(1)
Article 26(2)
Article 12(2)
—
Article 13
—
Article 14(1)
Article 26(1)
Article 14(2)
Article 26(3)
Article 15
—
Article 16
—
ANNEX I
—
ANNEX II
—
ANNEX III
—
—
ANNEX II
Regulation (EEC) No 2409/92
This Regulation
Article 1(1)
Article 1
Article 1(2)
Article 21(1)
Article 1(3)
—
Article 2
Article 2
Article 3
—
Article 4
Article 23
Article 5(1)
Article 22
Article 5(2)
—
Article 5(3)
—
Article 5(4)
—
Article 6
—
Article 7
—
Article 8
—
Article 9
—
Article 10(1)
Article 26(1)
Article 10(2)
Article 26(3)
Article 11
—
Article 12
—
—
Article 27
—
Article 28
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Operation of air services: EU rules
Operation of air services: EU rules
SUMMARY OF:
Regulation (EC) No 1008/2008 on common rules for the operation of air services in the EU
WHAT IS THE AIM OF THE REGULATION?
It lays down common rules for the operation of air transport services in the European Union (EU), including the licensing of EU air carriers and price transparency.
KEY POINTS
Operating licences and aircraft leasing
Criteria for the award and validity of airlines’ operating licences in the EU are harmonised.
Conditions for the award and validity of an operating licence in the EU include: the possession of a valid air operator certificate (AOC) which specifies the activities covered by the operating licence,ownership and control by EU countries and nationals of EU countries, andmeeting a number of financial conditions.
Failure to comply with the conditions of the operating licence can ultimately result in the suspension or withdrawal of the licence.
Leasing of aircraft registered in the EU is permitted. However, leasing of non-EU aircraft is only possible under special circumstances, for example to satisfy seasonal capacity needs. In this case, the EU air carrier in question must be able to demonstrate to the relevant competent authority that the aircraft meets all EU safety standards.
Price transparency
Airlines are free to set the price of their intra-EU air services.
The final price — together with the terms and conditions of carriage — of the air service must be published inclusive of all taxes, airport charges, charges and surcharges that are unavoidable and foreseeable at the time of booking. In addition, air carriers must provide a breakdown of all these unavoidable and foreseeable price elements that make up the final price.
Optional price supplements must be communicated in a clear, transparent and unambiguous way at the start of any booking and their acceptance must be on an ‘opt-in’ basis.
Price discrimination based on nationality or place of residence of the customer, as well as on the place of establishment of the air carrier’s agent or other ticket seller, is forbidden.
EU countries must ensure compliance with the pricing rules; penalties for infringements have to be effective, proportionate and dissuasive.
Public service obligations
An EU country may impose a public service obligation for a scheduled air route between an EU airport and an airport serving a peripheral or development region in its territory, or on a thin route to an airport in its territory, if ensuring minimum services on that route is considered vital for the economic and social development of the region which the airport serves.
An EU country needs to assess the necessity and the adequacy of an envisaged public service obligation.
In the event that no air carrier is interested in operating the route on which the obligations have been imposed, the country concerned may restrict the access to the route to a single air carrier for a period of up to 4 years and compensate its operational losses resulting from the public service obligation. The selection of the operator must be made by public tender at EU level.
Distribution of air traffic between airports
EU countries may regulate the distribution of air traffic between airports provided in particular that:
they serve the same city or conurbation,
they are served by adequate transport infrastructure and are linked to one another and to the city or conurbation they serve by frequent, reliable and efficient public transport services,
the decision to regulate the distribution of air traffic respects the principles of proportionality and transparency, and is based on objective criteria.
COVID-19 — special measuresRegulation (EU) 2020/696 and Commission Delegated Regulations (EU) 2020/2114 and 2020/2115 temporarily amend Regulation (EC) No 1008/2008 to help airlines and airports to cope with the sharp fall in air traffic caused by the COVID-19 pandemic.
These regulations:
temporarily amend the rules on the licensing of air carriers in the event of financial difficulties due to the COVID-19 pandemic. They temporarily suspend the obligation for EU countries to suspend or revoke the operating licence of any carrier that is facing financial difficulties or to replace it with a temporary licence, provided that safety is not at risk. This will avoid creating unnecessary administrative burdens for authorities and air carriers;
introduce a temporary derogation from the procedures that apply when EU countries want to refuse or impose conditions on the exercise of traffic rights in order to deal with emergency situations of short duration. EU countries may temporarily maintain an emergency measure in place for a period longer than 14 days but such a measure may only remain in force as long as there are clear public health risks related to the pandemic. Any emergency measures must respect the principles of proportionality and transparency and be based on objective and non-discriminatory criteria;
introduce new temporary rules on the provision of ground handling services to help airports to continue their activities in the context of the COVID-19 outbreak: by allowing airports to prolong the existing contracts of ground handling suppliers until 31 December 2022, andin the event of the bankruptcy of a ground handling company, by allowing the airport to directly choose a new provider of ground handling services for a maximum period of 6 months or until 31 December 2021.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 November 2008.
BACKGROUND
For more information, see:
Air — Internal market (European Commission)
Communication from the Commission European Commission Guidelines: Facilitating Air Cargo Operations during COVID-19 outbreak (European Commission).
MAIN DOCUMENT
Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (Recast) (OJ L 293, 31.10.2008, pp. 3-20)
Successive amendments to Regulation (EC) No 1008/2008 have been incorporated in the original text. This consolidated version is of documentary value only.
last update 14.01.2021
|
32014R0910
|
28.8.2014
EN
Official Journal of the European Union
L 257/73
REGULATION (EU) No 910/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 July 2014
on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
Building trust in the online environment is key to economic and social development. Lack of trust, in particular because of a perceived lack of legal certainty, makes consumers, businesses and public authorities hesitate to carry out transactions electronically and to adopt new services.
(2)
This Regulation seeks to enhance trust in electronic transactions in the internal market by providing a common foundation for secure electronic interaction between citizens, businesses and public authorities, thereby increasing the effectiveness of public and private online services, electronic business and electronic commerce in the Union.
(3)
Directive 1999/93/EC of the European Parliament and of the Council (3), dealt with electronic signatures without delivering a comprehensive cross-border and cross-sector framework for secure, trustworthy and easy-to-use electronic transactions. This Regulation enhances and expands the acquis of that Directive.
(4)
The Commission communication of 26 August 2010 entitled ‘A Digital Agenda for Europe’ identified the fragmentation of the digital market, the lack of interoperability and the rise in cybercrime as major obstacles to the virtuous cycle of the digital economy. In its EU Citizenship Report 2010, entitled ‘Dismantling the obstacles to EU citizens’ rights’, the Commission further highlighted the need to solve the main problems that prevent Union citizens from enjoying the benefits of a digital single market and cross-border digital services.
(5)
In its conclusions of 4 February 2011 and of 23 October 2011, the European Council invited the Commission to create a digital single market by 2015, to make rapid progress in key areas of the digital economy and to promote a fully integrated digital single market by facilitating the cross-border use of online services, with particular attention to facilitating secure electronic identification and authentication.
(6)
In its conclusions of 27 May 2011, the Council invited the Commission to contribute to the digital single market by creating appropriate conditions for the mutual recognition of key enablers across borders, such as electronic identification, electronic documents, electronic signatures and electronic delivery services, and for interoperable e-government services across the European Union.
(7)
The European Parliament, in its resolution of 21 September 2010 on completing the internal market for e-commerce (4), stressed the importance of the security of electronic services, especially of electronic signatures, and of the need to create a public key infrastructure at pan-European level, and called on the Commission to set up a European validation authorities gateway to ensure the cross-border interoperability of electronic signatures and to increase the security of transactions carried out using the internet.
(8)
Directive 2006/123/EC of the European Parliament and of the Council (5) requires Member States to establish ‘points of single contact’ (PSCs) to ensure that all procedures and formalities relating to access to a service activity and to the exercise thereof can be easily completed, at a distance and by electronic means, through the appropriate PSC with the appropriate authorities. Many online services accessible through PSCs require electronic identification, authentication and signature.
(9)
In most cases, citizens cannot use their electronic identification to authenticate themselves in another Member State because the national electronic identification schemes in their country are not recognised in other Member States. That electronic barrier excludes service providers from enjoying the full benefits of the internal market. Mutually recognised electronic identification means will facilitate cross-border provision of numerous services in the internal market and enable businesses to operate on a cross-border basis without facing many obstacles in interactions with public authorities.
(10)
Directive 2011/24/EU of the European Parliament and of the Council (6) set up a network of national authorities responsible for e-health. To enhance the safety and the continuity of cross-border healthcare, the network is required to produce guidelines on cross-border access to electronic health data and services, including by supporting ‘common identification and authentication measures to facilitate transferability of data in cross-border healthcare’. Mutual recognition of electronic identification and authentication is key to making cross-border healthcare for European citizens a reality. When people travel for treatment, their medical data need to be accessible in the country of treatment. That requires a solid, safe and trusted electronic identification framework.
(11)
This Regulation should be applied in full compliance with the principles relating to the protection of personal data provided for in Directive 95/46/EC of the European Parliament and of the Council (7). In this respect, having regard to the principle of mutual recognition established by this Regulation, authentication for an online service should concern processing of only those identification data that are adequate, relevant and not excessive to grant access to that service online. Furthermore, requirements under Directive 95/46/EC concerning confidentiality and security of processing should be respected by trust service providers and supervisory bodies.
(12)
One of the objectives of this Regulation is to remove existing barriers to the cross-border use of electronic identification means used in the Member States to authenticate, for at least public services. This Regulation does not aim to intervene with regard to electronic identity management systems and related infrastructures established in Member States. The aim of this Regulation is to ensure that for access to cross-border online services offered by Member States, secure electronic identification and authentication is possible.
(13)
Member States should remain free to use or to introduce means for the purposes of electronic identification for accessing online services. They should also be able to decide whether to involve the private sector in the provision of those means. Member States should not be obliged to notify their electronic identification schemes to the Commission. The choice to notify the Commission of all, some or none of the electronic identification schemes used at national level to access at least public online services or specific services is up to Member States.
(14)
Some conditions need to be set out in this Regulation with regard to which electronic identification means have to be recognised and how the electronic identification schemes should be notified. Those conditions should help Member States to build the necessary trust in each other’s electronic identification schemes and to mutually recognise electronic identification means falling under their notified schemes. The principle of mutual recognition should apply if the notifying Member State’s electronic identification scheme meets the conditions of notification and the notification was published in the Official Journal of the European Union. However, the principle of mutual recognition should only relate to authentication for an online service. The access to those online services and their final delivery to the applicant should be closely linked to the right to receive such services under the conditions set out in national legislation.
(15)
The obligation to recognise electronic identification means should relate only to those means the identity assurance level of which corresponds to the level equal to or higher than the level required for the online service in question. In addition, that obligation should only apply when the public sector body in question uses the assurance level ‘substantial’ or ‘high’ in relation to accessing that service online. Member States should remain free, in accordance with Union law, to recognise electronic identification means having lower identity assurance levels.
(16)
Assurance levels should characterise the degree of confidence in electronic identification means in establishing the identity of a person, thus providing assurance that the person claiming a particular identity is in fact the person to which that identity was assigned. The assurance level depends on the degree of confidence that electronic identification means provides in claimed or asserted identity of a person taking into account processes (for example, identity proofing and verification, and authentication), management activities (for example, the entity issuing electronic identification means and the procedure to issue such means) and technical controls implemented. Various technical definitions and descriptions of assurance levels exist as the result of Union-funded Large-Scale Pilots, standardisation and international activities. In particular, the Large-Scale Pilot STORK and ISO 29115 refer, inter alia, to levels 2, 3 and 4, which should be taken into utmost account in establishing minimum technical requirements, standards and procedures for the assurances levels low, substantial and high within the meaning of this Regulation, while ensuring consistent application of this Regulation in particular with regard to assurance level high related to identity proofing for issuing qualified certificates. The requirements established should be technology-neutral. It should be possible to achieve the necessary security requirements through different technologies.
(17)
Member States should encourage the private sector to voluntarily use electronic identification means under a notified scheme for identification purposes when needed for online services or electronic transactions. The possibility to use such electronic identification means would enable the private sector to rely on electronic identification and authentication already largely used in many Member States at least for public services and to make it easier for businesses and citizens to access their online services across borders. In order to facilitate the use of such electronic identification means across borders by the private sector, the authentication possibility provided by any Member State should be available to private sector relying parties established outside of the territory of that Member State under the same conditions as applied to private sector relying parties established within that Member State. Consequently, with regard to private sector relying parties, the notifying Member State may define terms of access to the authentication means. Such terms of access may inform whether the authentication means related to the notified scheme is presently available to private sector relying parties.
(18)
This Regulation should provide for the liability of the notifying Member State, the party issuing the electronic identification means and the party operating the authentication procedure for failure to comply with the relevant obligations under this Regulation. However, this Regulation should be applied in accordance with national rules on liability. Therefore, it does not affect those national rules on, for example, definition of damages or relevant applicable procedural rules, including the burden of proof.
(19)
The security of electronic identification schemes is key to trustworthy cross-border mutual recognition of electronic identification means. In this context, Member States should cooperate with regard to the security and interoperability of the electronic identification schemes at Union level. Whenever electronic identification schemes require specific hardware or software to be used by relying parties at the national level, cross-border interoperability calls for those Member States not to impose such requirements and related costs on relying parties established outside of their territory. In that case appropriate solutions should be discussed and developed within the scope of the interoperability framework. Nevertheless technical requirements stemming from the inherent specifications of national electronic identification means and likely to affect the holders of such electronic means (e.g. smartcards), are unavoidable.
(20)
Cooperation by Member States should facilitate the technical interoperability of the notified electronic identification schemes with a view to fostering a high level of trust and security appropriate to the degree of risk. The exchange of information and the sharing of best practices between Member States with a view to their mutual recognition should help such cooperation.
(21)
This Regulation should also establish a general legal framework for the use of trust services. However, it should not create a general obligation to use them or to install an access point for all existing trust services. In particular, it should not cover the provision of services used exclusively within closed systems between a defined set of participants, which have no effect on third parties. For example, systems set up in businesses or public administrations to manage internal procedures making use of trust services should not be subject to the requirements of this Regulation. Only trust services provided to the public having effects on third parties should meet the requirements laid down in the Regulation. Neither should this Regulation cover aspects related to the conclusion and validity of contracts or other legal obligations where there are requirements as regards form laid down by national or Union law. In addition, it should not affect national form requirements pertaining to public registers, in particular commercial and land registers.
(22)
In order to contribute to their general cross-border use, it should be possible to use trust services as evidence in legal proceedings in all Member States. It is for the national law to define the legal effect of trust services, except if otherwise provided in this Regulation.
(23)
To the extent that this Regulation creates an obligation to recognise a trust service, such a trust service may only be rejected if the addressee of the obligation is unable to read or verify it due to technical reasons lying outside the immediate control of the addressee. However, that obligation should not in itself require a public body to obtain the hardware and software necessary for the technical readability of all existing trust services.
(24)
Member States may maintain or introduce national provisions, in conformity with Union law, relating to trust services as far as those services are not fully harmonised by this Regulation. However, trust services that comply with this Regulation should circulate freely in the internal market.
(25)
Member States should remain free to define other types of trust services in addition to those making part of the closed list of trust services provided for in this Regulation, for the purpose of recognition at national level as qualified trust services.
(26)
Because of the pace of technological change, this Regulation should adopt an approach which is open to innovation.
(27)
This Regulation should be technology-neutral. The legal effects it grants should be achievable by any technical means provided that the requirements of this Regulation are met.
(28)
To enhance in particular the trust of small and medium-sized enterprises (SMEs) and consumers in the internal market and to promote the use of trust services and products, the notions of qualified trust services and qualified trust service provider should be introduced with a view to indicating requirements and obligations that ensure high-level security of whatever qualified trust services and products are used or provided.
(29)
In line with the obligations under the United Nations Convention on the Rights of Persons with Disabilities, approved by Council Decision 2010/48/EC (8), in particular Article 9 of the Convention, persons with disabilities should be able to use trust services and end-user products used in the provision of those services on an equal basis with other consumers. Therefore, where feasible, trust services provided and end-user products used in the provision of those services should be made accessible for persons with disabilities. The feasibility assessment should include, inter alia, technical and economic considerations.
(30)
Member States should designate a supervisory body or supervisory bodies to carry out the supervisory activities under this Regulation. Member States should also be able to decide, upon a mutual agreement with another Member State, to designate a supervisory body in the territory of that other Member State.
(31)
Supervisory bodies should cooperate with data protection authorities, for example, by informing them about the results of audits of qualified trust service providers, where personal data protection rules appear to have been breached. The provision of information should in particular cover security incidents and personal data breaches.
(32)
It should be incumbent on all trust service providers to apply good security practice appropriate to the risks related to their activities so as to boost users’ trust in the single market.
(33)
Provisions on the use of pseudonyms in certificates should not prevent Member States from requiring identification of persons pursuant to Union or national law.
(34)
All Member States should follow common essential supervision requirements to ensure a comparable security level of qualified trust services. To ease the consistent application of those requirements across the Union, Member States should adopt comparable procedures and should exchange information on their supervision activities and best practices in the field.
(35)
All trust service providers should be subject to the requirements of this Regulation, in particular those on security and liability to ensure due diligence, transparency and accountability of their operations and services. However, taking into account the type of services provided by trust service providers, it is appropriate to distinguish as far as those requirements are concerned between qualified and non-qualified trust service providers.
(36)
Establishing a supervisory regime for all trust service providers should ensure a level playing field for the security and accountability of their operations and services, thus contributing to the protection of users and to the functioning of the internal market. Non-qualified trust service providers should be subject to a light touch and reactive ex post supervisory activities justified by the nature of their services and operations. The supervisory body should therefore have no general obligation to supervise non-qualified service providers. The supervisory body should only take action when it is informed (for example, by the non-qualified trust service provider itself, by another supervisory body, by a notification from a user or a business partner or on the basis of its own investigation) that a non-qualified trust service provider does not comply with the requirements of this Regulation.
(37)
This Regulation should provide for the liability of all trust service providers. In particular, it establishes the liability regime under which all trust service providers should be liable for damage caused to any natural or legal person due to failure to comply with the obligations under this Regulation. In order to facilitate the assessment of financial risk that trust service providers might have to bear or that they should cover by insurance policies, this Regulation allows trust service providers to set limitations, under certain conditions, on the use of the services they provide and not to be liable for damages arising from the use of services exceeding such limitations. Customers should be duly informed about the limitations in advance. Those limitations should be recognisable by a third party, for example by including information about the limitations in the terms and conditions of the service provided or through other recognisable means. For the purposes of giving effect to those principles, this Regulation should be applied in accordance with national rules on liability. Therefore, this Regulation does not affect those national rules on, for example, definition of damages, intention, negligence, or relevant applicable procedural rules.
(38)
Notification of security breaches and security risk assessments is essential with a view to providing adequate information to concerned parties in the event of a breach of security or loss of integrity.
(39)
To enable the Commission and the Member States to assess the effectiveness of the breach notification mechanism introduced by this Regulation, supervisory bodies should be requested to provide summary information to the Commission and to European Union Agency for Network and Information Security (ENISA).
(40)
To enable the Commission and the Member States to assess the effectiveness of the enhanced supervision mechanism introduced by this Regulation, supervisory bodies should be requested to report on their activities. This would be instrumental in facilitating the exchange of good practice between supervisory bodies and would ensure the verification of the consistent and efficient implementation of the essential supervision requirements in all Member States.
(41)
To ensure sustainability and durability of qualified trust services and to boost users’ confidence in the continuity of qualified trust services, supervisory bodies should verify the existence and the correct application of provisions on termination plans in cases where qualified trust service providers cease their activities.
(42)
To facilitate the supervision of qualified trust service providers, for example, when a provider is providing its services in the territory of another Member State and is not subject to supervision there, or when the computers of a provider are located in the territory of a Member State other than the one where it is established, a mutual assistance system between supervisory bodies in the Member States should be established.
(43)
In order to ensure the compliance of qualified trust service providers and the services they provide with the requirements set out in this Regulation, a conformity assessment should be carried out by a conformity assessment body and the resulting conformity assessment reports should be submitted by the qualified trust service providers to the supervisory body. Whenever the supervisory body requires a qualified trust service provider to submit an ad hoc conformity assessment report, the supervisory body should respect, in particular, the principles of good administration, including the obligation to give reasons for its decisions, as well as the principle of proportionality. Therefore, the supervisory body should duly justify its decision to require an ad hoc conformity assessment.
(44)
This Regulation aims to ensure a coherent framework with a view to providing a high level of security and legal certainty of trust services. In this regard, when addressing the conformity assessment of products and services, the Commission should, where appropriate, seek synergies with existing relevant European and international schemes such as the Regulation (EC) No 765/2008 of the European Parliament and of the Council (9) which sets out the requirements for accreditation of conformity assessment bodies and market surveillance of products.
(45)
In order to allow an efficient initiation process, which should lead to the inclusion of qualified trust service providers and the qualified trust services they provide into trusted lists, preliminary interactions between prospective qualified trust service providers and the competent supervisory body should be encouraged with a view to facilitating the due diligence leading to the provisioning of qualified trust services.
(46)
Trusted lists are essential elements in the building of trust among market operators as they indicate the qualified status of the service provider at the time of supervision.
(47)
Confidence in and convenience of online services are essential for users to fully benefit and consciously rely on electronic services. To this end, an EU trust mark should be created to identify the qualified trust services provided by qualified trust service providers. Such an EU trust mark for qualified trust services would clearly differentiate qualified trust services from other trust services thus contributing to transparency in the market. The use of an EU trust mark by qualified trust service providers should be voluntary and should not lead to any requirement other than those provided for in this Regulation.
(48)
While a high level of security is needed to ensure mutual recognition of electronic signatures, in specific cases, such as in the context of Commission Decision 2009/767/EC (10), electronic signatures with a lower security assurance should also be accepted.
(49)
This Regulation should establish the principle that an electronic signature should not be denied legal effect on the grounds that it is in an electronic form or that it does not meet the requirements of the qualified electronic signature. However, it is for national law to define the legal effect of electronic signatures, except for the requirements provided for in this Regulation according to which a qualified electronic signature should have the equivalent legal effect of a handwritten signature.
(50)
As competent authorities in the Member States currently use different formats of advanced electronic signatures to sign their documents electronically, it is necessary to ensure that at least a number of advanced electronic signature formats can be technically supported by Member States when they receive documents signed electronically. Similarly, when competent authorities in the Member States use advanced electronic seals, it would be necessary to ensure that they support at least a number of advanced electronic seal formats.
(51)
It should be possible for the signatory to entrust qualified electronic signature creation devices to the care of a third party, provided that appropriate mechanisms and procedures are implemented to ensure that the signatory has sole control over the use of his electronic signature creation data, and the qualified electronic signature requirements are met by the use of the device.
(52)
The creation of remote electronic signatures, where the electronic signature creation environment is managed by a trust service provider on behalf of the signatory, is set to increase in the light of its multiple economic benefits. However, in order to ensure that such electronic signatures receive the same legal recognition as electronic signatures created in an entirely user-managed environment, remote electronic signature service providers should apply specific management and administrative security procedures and use trustworthy systems and products, including secure electronic communication channels, in order to guarantee that the electronic signature creation environment is reliable and is used under the sole control of the signatory. Where a qualified electronic signature has been created using a remote electronic signature creation device, the requirements applicable to qualified trust service providers set out in this Regulation should apply.
(53)
The suspension of qualified certificates is an established operational practice of trust service providers in a number of Member States, which is different from revocation and entails the temporary loss of validity of a certificate. Legal certainty calls for the suspension status of a certificate to always be clearly indicated. To that end, trust service providers should have the responsibility to clearly indicate the status of the certificate and, if suspended, the precise period of time during which the certificate has been suspended. This Regulation should not impose the use of suspension on trust service providers or Member States, but should provide for transparency rules when and where such a practice is available.
(54)
Cross-border interoperability and recognition of qualified certificates is a precondition for cross-border recognition of qualified electronic signatures. Therefore, qualified certificates should not be subject to any mandatory requirements exceeding the requirements laid down in this Regulation. However, at national level, the inclusion of specific attributes, such as unique identifiers, in qualified certificates should be allowed, provided that such specific attributes do not hamper cross-border interoperability and recognition of qualified certificates and electronic signatures.
(55)
IT security certification based on international standards such as ISO 15408 and related evaluation methods and mutual recognition arrangements is an important tool for verifying the security of qualified electronic signature creation devices and should be promoted. However, innovative solutions and services such as mobile signing and cloud signing rely on technical and organisational solutions for qualified electronic signature creation devices for which security standards may not yet be available or for which the first IT security certification is ongoing. The level of security of such qualified electronic signature creation devices could be evaluated by using alternative processes only where such security standards are not available or where the first IT security certification is ongoing. Those processes should be comparable to the standards for IT security certification insofar as their security levels are equivalent. Those processes could be facilitated by a peer review.
(56)
This Regulation should lay down requirements for qualified electronic signature creation devices to ensure the functionality of advanced electronic signatures. This Regulation should not cover the entire system environment in which such devices operate. Therefore, the scope of the certification of qualified signature creation devices should be limited to the hardware and system software used to manage and protect the signature creation data created, stored or processed in the signature creation device. As detailed in relevant standards, the scope of the certification obligation should exclude signature creation applications.
(57)
To ensure legal certainty as regards the validity of the signature, it is essential to specify the components of a qualified electronic signature, which should be assessed by the relying party carrying out the validation. Moreover, specifying the requirements for qualified trust service providers that can provide a qualified validation service to relying parties unwilling or unable to carry out the validation of qualified electronic signatures themselves, should stimulate the private and public sector to invest in such services. Both elements should make qualified electronic signature validation easy and convenient for all parties at Union level.
(58)
When a transaction requires a qualified electronic seal from a legal person, a qualified electronic signature from the authorised representative of the legal person should be equally acceptable.
(59)
Electronic seals should serve as evidence that an electronic document was issued by a legal person, ensuring certainty of the document’s origin and integrity.
(60)
Trust service providers issuing qualified certificates for electronic seals should implement the necessary measures in order to be able to establish the identity of the natural person representing the legal person to whom the qualified certificate for the electronic seal is provided, when such identification is necessary at national level in the context of judicial or administrative proceedings.
(61)
This Regulation should ensure the long-term preservation of information, in order to ensure the legal validity of electronic signatures and electronic seals over extended periods of time and guarantee that they can be validated irrespective of future technological changes.
(62)
In order to ensure the security of qualified electronic time stamps, this Regulation should require the use of an advanced electronic seal or an advanced electronic signature or of other equivalent methods. It is foreseeable that innovation may lead to new technologies that may ensure an equivalent level of security for time stamps. Whenever a method other than an advanced electronic seal or an advanced electronic signature is used, it should be up to the qualified trust service provider to demonstrate, in the conformity assessment report, that such a method ensures an equivalent level of security and complies with the obligations set out in this Regulation.
(63)
Electronic documents are important for further development of cross-border electronic transactions in the internal market. This Regulation should establish the principle that an electronic document should not be denied legal effect on the grounds that it is in an electronic form in order to ensure that an electronic transaction will not be rejected only on the grounds that a document is in electronic form.
(64)
When addressing formats of advanced electronic signatures and seals, the Commission should build on existing practices, standards and legislation, in particular Commission Decision 2011/130/EU (11).
(65)
In addition to authenticating the document issued by the legal person, electronic seals can be used to authenticate any digital asset of the legal person, such as software code or servers.
(66)
It is essential to provide for a legal framework to facilitate cross-border recognition between existing national legal systems related to electronic registered delivery services. That framework could also open new market opportunities for Union trust service providers to offer new pan-European electronic registered delivery services.
(67)
Website authentication services provide a means by which a visitor to a website can be assured that there is a genuine and legitimate entity standing behind the website. Those services contribute to the building of trust and confidence in conducting business online, as users will have confidence in a website that has been authenticated. The provision and the use of website authentication services are entirely voluntary. However, in order for website authentication to become a means to boosting trust, providing a better experience for the user and furthering growth in the internal market, this Regulation should lay down minimal security and liability obligations for the providers and their services. To that end, the results of existing industry-led initiatives, for example the Certification Authorities/Browsers Forum — CA/B Forum, have been taken into account. In addition, this Regulation should not impede the use of other means or methods to authenticate a website not falling under this Regulation nor should it prevent third country providers of website authentication services from providing their services to customers in the Union. However, a third country provider should only have its website authentication services recognised as qualified in accordance with this Regulation, if an international agreement between the Union and the country of establishment of the provider has been concluded.
(68)
The concept of ‘legal persons’, according to the provisions of the Treaty on the Functioning of the European Union (TFEU) on establishment, leaves operators free to choose the legal form which they deem suitable for carrying out their activity. Accordingly, ‘legal persons’, within the meaning of the TFEU, means all entities constituted under, or governed by, the law of a Member State, irrespective of their legal form.
(69)
The Union institutions, bodies, offices and agencies are encouraged to recognise electronic identification and trust services covered by this Regulation for the purpose of administrative cooperation capitalising, in particular, on existing good practices and the results of ongoing projects in the areas covered by this Regulation.
(70)
In order to complement certain detailed technical aspects of this Regulation in a flexible and rapid manner, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of criteria to be met by the bodies responsible for the certification of qualified electronic signature creation devices. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(71)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission, in particular for specifying reference numbers of standards the use of which would raise a presumption of compliance with certain requirements laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12).
(72)
When adopting delegated or implementing acts, the Commission should take due account of the standards and technical specifications drawn up by European and international standardisation organisations and bodies, in particular the European Committee for Standardisation (CEN), the European Telecommunications Standards Institute (ETSI), the International Organisation for Standardisation (ISO) and the International Telecommunication Union (ITU), with a view to ensuring a high level of security and interoperability of electronic identification and trust services.
(73)
For reasons of legal certainty and clarity, Directive 1999/93/EC should be repealed.
(74)
To ensure legal certainty for market operators already using qualified certificates issued to natural persons in compliance with Directive 1999/93/EC, it is necessary to provide for a sufficient period of time for transitional purposes. Similarly, transitional measures should be established for secure signature creation devices, the conformity of which has been determined in accordance with Directive 1999/93/EC, as well as for certification service providers issuing qualified certificates before 1 July 2016. Finally, it is also necessary to provide the Commission with the means to adopt the implementing acts and delegated acts before that date.
(75)
The application dates set out in this Regulation do not affect existing obligations that Member States already have under Union law, in particular under Directive 2006/123/EC.
(76)
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(77)
The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (13) and delivered an opinion on 27 September 2012 (14),
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
With a view to ensuring the proper functioning of the internal market while aiming at an adequate level of security of electronic identification means and trust services this Regulation:
(a)
lays down the conditions under which Member States recognise electronic identification means of natural and legal persons falling under a notified electronic identification scheme of another Member State;
(b)
lays down rules for trust services, in particular for electronic transactions; and
(c)
establishes a legal framework for electronic signatures, electronic seals, electronic time stamps, electronic documents, electronic registered delivery services and certificate services for website authentication.
Article 2
Scope
1. This Regulation applies to electronic identification schemes that have been notified by a Member State, and to trust service providers that are established in the Union.
2. This Regulation does not apply to the provision of trust services that are used exclusively within closed systems resulting from national law or from agreements between a defined set of participants.
3. This Regulation does not affect national or Union law related to the conclusion and validity of contracts or other legal or procedural obligations relating to form.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘electronic identification’ means the process of using person identification data in electronic form uniquely representing either a natural or legal person, or a natural person representing a legal person;
(2)
‘electronic identification means’ means a material and/or immaterial unit containing person identification data and which is used for authentication for an online service;
(3)
‘person identification data’ means a set of data enabling the identity of a natural or legal person, or a natural person representing a legal person to be established;
(4)
‘electronic identification scheme’ means a system for electronic identification under which electronic identification means are issued to natural or legal persons, or natural persons representing legal persons;
(5)
‘authentication’ means an electronic process that enables the electronic identification of a natural or legal person, or the origin and integrity of data in electronic form to be confirmed;
(6)
‘relying party’ means a natural or legal person that relies upon an electronic identification or a trust service;
(7)
‘public sector body’ means a state, regional or local authority, a body governed by public law or an association formed by one or several such authorities or one or several such bodies governed by public law, or a private entity mandated by at least one of those authorities, bodies or associations to provide public services, when acting under such a mandate;
(8)
‘body governed by public law’ means a body defined in point (4) of Article 2(1) of Directive 2014/24/EU of the European Parliament and of the Council (15);
(9)
‘signatory’ means a natural person who creates an electronic signature;
(10)
‘electronic signature’ means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
(11)
‘advanced electronic signature’ means an electronic signature which meets the requirements set out in Article 26;
(12)
‘qualified electronic signature’ means an advanced electronic signature that is created by a qualified electronic signature creation device, and which is based on a qualified certificate for electronic signatures;
(13)
‘electronic signature creation data’ means unique data which is used by the signatory to create an electronic signature;
(14)
‘certificate for electronic signature’ means an electronic attestation which links electronic signature validation data to a natural person and confirms at least the name or the pseudonym of that person;
(15)
‘qualified certificate for electronic signature’ means a certificate for electronic signatures, that is issued by a qualified trust service provider and meets the requirements laid down in Annex I;
(16)
‘trust service’ means an electronic service normally provided for remuneration which consists of:
(a)
the creation, verification, and validation of electronic signatures, electronic seals or electronic time stamps, electronic registered delivery services and certificates related to those services, or
(b)
the creation, verification and validation of certificates for website authentication; or
(c)
the preservation of electronic signatures, seals or certificates related to those services;
(17)
‘qualified trust service’ means a trust service that meets the applicable requirements laid down in this Regulation;
(18)
‘conformity assessment body’ means a body defined in point 13 of Article 2 of Regulation (EC) No 765/2008, which is accredited in accordance with that Regulation as competent to carry out conformity assessment of a qualified trust service provider and the qualified trust services it provides;
(19)
‘trust service provider’ means a natural or a legal person who provides one or more trust services either as a qualified or as a non-qualified trust service provider;
(20)
‘qualified trust service provider’ means a trust service provider who provides one or more qualified trust services and is granted the qualified status by the supervisory body;
(21)
‘product’ means hardware or software, or relevant components of hardware or software, which are intended to be used for the provision of trust services;
(22)
‘electronic signature creation device’ means configured software or hardware used to create an electronic signature;
(23)
‘qualified electronic signature creation device’ means an electronic signature creation device that meets the requirements laid down in Annex II;
(24)
‘creator of a seal’ means a legal person who creates an electronic seal;
(25)
‘electronic seal’ means data in electronic form, which is attached to or logically associated with other data in electronic form to ensure the latter’s origin and integrity;
(26)
‘advanced electronic seal’ means an electronic seal, which meets the requirements set out in Article 36;
(27)
‘qualified electronic seal’ means an advanced electronic seal, which is created by a qualified electronic seal creation device, and that is based on a qualified certificate for electronic seal;
(28)
‘electronic seal creation data’ means unique data, which is used by the creator of the electronic seal to create an electronic seal;
(29)
‘certificate for electronic seal’ means an electronic attestation that links electronic seal validation data to a legal person and confirms the name of that person;
(30)
‘qualified certificate for electronic seal’ means a certificate for an electronic seal, that is issued by a qualified trust service provider and meets the requirements laid down in Annex III;
(31)
‘electronic seal creation device’ means configured software or hardware used to create an electronic seal;
(32)
‘qualified electronic seal creation device’ means an electronic seal creation device that meets mutatis mutandis the requirements laid down in Annex II;
(33)
‘electronic time stamp’ means data in electronic form which binds other data in electronic form to a particular time establishing evidence that the latter data existed at that time;
(34)
‘qualified electronic time stamp’ means an electronic time stamp which meets the requirements laid down in Article 42;
(35)
‘electronic document’ means any content stored in electronic form, in particular text or sound, visual or audiovisual recording;
(36)
‘electronic registered delivery service’ means a service that makes it possible to transmit data between third parties by electronic means and provides evidence relating to the handling of the transmitted data, including proof of sending and receiving the data, and that protects transmitted data against the risk of loss, theft, damage or any unauthorised alterations;
(37)
‘qualified electronic registered delivery service’ means an electronic registered delivery service which meets the requirements laid down in Article 44;
(38)
‘certificate for website authentication’ means an attestation that makes it possible to authenticate a website and links the website to the natural or legal person to whom the certificate is issued;
(39)
‘qualified certificate for website authentication’ means a certificate for website authentication, which is issued by a qualified trust service provider and meets the requirements laid down in Annex IV;
(40)
‘validation data’ means data that is used to validate an electronic signature or an electronic seal;
(41)
‘validation’ means the process of verifying and confirming that an electronic signature or a seal is valid.
Article 4
Internal market principle
1. There shall be no restriction on the provision of trust services in the territory of a Member State by a trust service provider established in another Member State for reasons that fall within the fields covered by this Regulation.
2. Products and trust services that comply with this Regulation shall be permitted to circulate freely in the internal market.
Article 5
Data processing and protection
1. Processing of personal data shall be carried out in accordance with Directive 95/46/EC.
2. Without prejudice to the legal effect given to pseudonyms under national law, the use of pseudonyms in electronic transactions shall not be prohibited.
CHAPTER II
ELECTRONIC IDENTIFICATION
Article 6
Mutual recognition
1. When an electronic identification using an electronic identification means and authentication is required under national law or by administrative practice to access a service provided by a public sector body online in one Member State, the electronic identification means issued in another Member State shall be recognised in the first Member State for the purposes of cross-border authentication for that service online, provided that the following conditions are met:
(a)
the electronic identification means is issued under an electronic identification scheme that is included in the list published by the Commission pursuant to Article 9;
(b)
the assurance level of the electronic identification means corresponds to an assurance level equal to or higher than the assurance level required by the relevant public sector body to access that service online in the first Member State, provided that the assurance level of that electronic identification means corresponds to the assurance level substantial or high;
(c)
the relevant public sector body uses the assurance level substantial or high in relation to accessing that service online.
Such recognition shall take place no later than 12 months after the Commission publishes the list referred to in point (a) of the first subparagraph.
2. An electronic identification means which is issued under an electronic identification scheme included in the list published by the Commission pursuant to Article 9 and which corresponds to the assurance level low may be recognised by public sector bodies for the purposes of cross-border authentication for the service provided online by those bodies.
Article 7
Eligibility for notification of electronic identification schemes
An electronic identification scheme shall be eligible for notification pursuant to Article 9(1) provided that all of the following conditions are met:
(a)
the electronic identification means under the electronic identification scheme are issued:
(i)
by the notifying Member State;
(ii)
under a mandate from the notifying Member State; or
(iii)
independently of the notifying Member State and are recognised by that Member State;
(b)
the electronic identification means under the electronic identification scheme can be used to access at least one service which is provided by a public sector body and which requires electronic identification in the notifying Member State;
(c)
the electronic identification scheme and the electronic identification means issued thereunder meet the requirements of at least one of the assurance levels set out in the implementing act referred to in Article 8(3);
(d)
the notifying Member State ensures that the person identification data uniquely representing the person in question is attributed, in accordance with the technical specifications, standards and procedures for the relevant assurance level set out in the implementing act referred to in Article 8(3), to the natural or legal person referred to in point 1 of Article 3 at the time the electronic identification means under that scheme is issued;
(e)
the party issuing the electronic identification means under that scheme ensures that the electronic identification means is attributed to the person referred to in point (d) of this Article in accordance with the technical specifications, standards and procedures for the relevant assurance level set out in the implementing act referred to in Article 8(3);
(f)
the notifying Member State ensures the availability of authentication online, so that any relying party established in the territory of another Member State is able to confirm the person identification data received in electronic form.
For relying parties other than public sector bodies the notifying Member State may define terms of access to that authentication. The cross-border authentication shall be provided free of charge when it is carried out in relation to a service online provided by a public sector body.
Member States shall not impose any specific disproportionate technical requirements on relying parties intending to carry out such authentication, where such requirements prevent or significantly impede the interoperability of the notified electronic identification schemes;
(g)
at least six months prior to the notification pursuant to Article 9(1), the notifying Member State provides the other Member States for the purposes of the obligation under Article 12(5) a description of that scheme in accordance with the procedural arrangements established by the implementing acts referred to in Article 12(7);
(h)
the electronic identification scheme meets the requirements set out in the implementing act referred to in Article 12(8).
Article 8
Assurance levels of electronic identification schemes
1. An electronic identification scheme notified pursuant to Article 9(1) shall specify assurance levels low, substantial and/or high for electronic identification means issued under that scheme.
2. The assurance levels low, substantial and high shall meet respectively the following criteria:
(a)
assurance level low shall refer to an electronic identification means in the context of an electronic identification scheme, which provides a limited degree of confidence in the claimed or asserted identity of a person, and is characterised with reference to technical specifications, standards and procedures related thereto, including technical controls, the purpose of which is to decrease the risk of misuse or alteration of the identity;
(b)
assurance level substantial shall refer to an electronic identification means in the context of an electronic identification scheme, which provides a substantial degree of confidence in the claimed or asserted identity of a person, and is characterised with reference to technical specifications, standards and procedures related thereto, including technical controls, the purpose of which is to decrease substantially the risk of misuse or alteration of the identity;
(c)
assurance level high shall refer to an electronic identification means in the context of an electronic identification scheme, which provides a higher degree of confidence in the claimed or asserted identity of a person than electronic identification means with the assurance level substantial, and is characterised with reference to technical specifications, standards and procedures related thereto, including technical controls, the purpose of which is to prevent misuse or alteration of the identity.
3. By 18 September 2015, taking into account relevant international standards and subject to paragraph 2, the Commission shall, by means of implementing acts, set out minimum technical specifications, standards and procedures with reference to which assurance levels low, substantial and high are specified for electronic identification means for the purposes of paragraph 1.
Those minimum technical specifications, standards and procedures shall be set out by reference to the reliability and quality of the following elements:
(a)
the procedure to prove and verify the identity of natural or legal persons applying for the issuance of electronic identification means;
(b)
the procedure for the issuance of the requested electronic identification means;
(c)
the authentication mechanism, through which the natural or legal person uses the electronic identification means to confirm its identity to a relying party;
(d)
the entity issuing the electronic identification means;
(e)
any other body involved in the application for the issuance of the electronic identification means; and
(f)
the technical and security specifications of the issued electronic identification means.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 9
Notification
1. The notifying Member State shall notify to the Commission the following information and, without undue delay, any subsequent changes thereto:
(a)
a description of the electronic identification scheme, including its assurance levels and the issuer or issuers of electronic identification means under the scheme;
(b)
the applicable supervisory regime and information on the liability regime with respect to the following:
(i)
the party issuing the electronic identification means; and
(ii)
the party operating the authentication procedure;
(c)
the authority or authorities responsible for the electronic identification scheme;
(d)
information on the entity or entities which manage the registration of the unique person identification data;
(e)
a description of how the requirements set out in the implementing acts referred to in Article 12(8) are met;
(f)
a description of the authentication referred to in point (f) of Article 7;
(g)
arrangements for suspension or revocation of either the notified electronic identification scheme or authentication or the compromised parts concerned.
2. One year from the date of application of the implementing acts referred to in Articles 8(3) and 12(8), the Commission shall publish in the Official Journal of the European Union a list of the electronic identification schemes which were notified pursuant to paragraph 1 of this Article and the basic information thereon.
3. If the Commission receives a notification after the expiry of the period referred to in paragraph 2, it shall publish in the Official Journal of the European Union the amendments to the list referred to in paragraph 2 within two months from the date of receipt of that notification.
4. A Member State may submit to the Commission a request to remove an electronic identification scheme notified by that Member State from the list referred to in paragraph 2. The Commission shall publish in the Official Journal of the European Union the corresponding amendments to the list within one month from the date of receipt of the Member State’s request.
5. The Commission may, by means of implementing acts, define the circumstances, formats and procedures of notifications under paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 10
Security breach
1. Where either the electronic identification scheme notified pursuant to Article 9(1) or the authentication referred to in point (f) of Article 7 is breached or partly compromised in a manner that affects the reliability of the cross-border authentication of that scheme, the notifying Member State shall, without delay, suspend or revoke that cross-border authentication or the compromised parts concerned, and shall inform other Member States and the Commission.
2. When the breach or compromise referred to in paragraph 1 is remedied, the notifying Member State shall re-establish the cross-border authentication and shall inform other Member States and the Commission without undue delay.
3. If the breach or compromise referred to in paragraph 1 is not remedied within three months of the suspension or revocation, the notifying Member State shall notify other Member States and the Commission of the withdrawal of the electronic identification scheme.
The Commission shall publish in the Official Journal of the European Union the corresponding amendments to the list referred to in Article 9(2) without undue delay.
Article 11
Liability
1. The notifying Member State shall be liable for damage caused intentionally or negligently to any natural or legal person due to a failure to comply with its obligations under points (d) and (f) of Article 7 in a cross-border transaction.
2. The party issuing the electronic identification means shall be liable for damage caused intentionally or negligently to any natural or legal person due to a failure to comply with the obligation referred to in point (e) of Article 7 in a cross-border transaction.
3. The party operating the authentication procedure shall be liable for damage caused intentionally or negligently to any natural or legal person due to a failure to ensure the correct operation of the authentication referred to in point (f) of Article 7 in a cross-border transaction.
4. Paragraphs 1, 2 and 3 shall be applied in accordance with national rules on liability.
5. Paragraphs 1, 2 and 3 are without prejudice to the liability under national law of parties to a transaction in which electronic identification means falling under the electronic identification scheme notified pursuant to Article 9(1) are used.
Article 12
Cooperation and interoperability
1. The national electronic identification schemes notified pursuant to Article 9(1) shall be interoperable.
2. For the purposes of paragraph 1, an interoperability framework shall be established.
3. The interoperability framework shall meet the following criteria:
(a)
it aims to be technology neutral and does not discriminate between any specific national technical solutions for electronic identification within a Member State;
(b)
it follows European and international standards, where possible;
(c)
it facilitates the implementation of the principle of privacy by design; and
(d)
it ensures that personal data is processed in accordance with Directive 95/46/EC.
4. The interoperability framework shall consist of:
(a)
a reference to minimum technical requirements related to the assurance levels under Article 8;
(b)
a mapping of national assurance levels of notified electronic identification schemes to the assurance levels under Article 8;
(c)
a reference to minimum technical requirements for interoperability;
(d)
a reference to a minimum set of person identification data uniquely representing a natural or legal person, which is available from electronic identification schemes;
(e)
rules of procedure;
(f)
arrangements for dispute resolution; and
(g)
common operational security standards.
5. Member States shall cooperate with regard to the following:
(a)
the interoperability of the electronic identification schemes notified pursuant to Article 9(1) and the electronic identification schemes which Member States intend to notify; and
(b)
the security of the electronic identification schemes.
6. The cooperation between Member States shall consist of:
(a)
the exchange of information, experience and good practice as regards electronic identification schemes and in particular technical requirements related to interoperability and assurance levels;
(b)
the exchange of information, experience and good practice as regards working with assurance levels of electronic identification schemes under Article 8;
(c)
peer review of electronic identification schemes falling under this Regulation; and
(d)
examination of relevant developments in the electronic identification sector.
7. By 18 March 2015, the Commission shall, by means of implementing acts, establish the necessary procedural arrangements to facilitate the cooperation between the Member States referred to in paragraphs 5 and 6 with a view to fostering a high level of trust and security appropriate to the degree of risk.
8. By 18 September 2015, for the purpose of setting uniform conditions for the implementation of the requirement under paragraph 1, the Commission shall, subject to the criteria set out in paragraph 3 and taking into account the results of the cooperation between Member States, adopt implementing acts on the interoperability framework as set out in paragraph 4.
9. The implementing acts referred to in paragraphs 7 and 8 of this Article shall be adopted in accordance with the examination procedure referred to in Article 48(2).
CHAPTER III
TRUST SERVICES
SECTION 1
General provisions
Article 13
Liability and burden of proof
1. Without prejudice to paragraph 2, trust service providers shall be liable for damage caused intentionally or negligently to any natural or legal person due to a failure to comply with the obligations under this Regulation.
The burden of proving intention or negligence of a non-qualified trust service provider shall lie with the natural or legal person claiming the damage referred to in the first subparagraph.
The intention or negligence of a qualified trust service provider shall be presumed unless that qualified trust service provider proves that the damage referred to in the first subparagraph occurred without the intention or negligence of that qualified trust service provider.
2. Where trust service providers duly inform their customers in advance of the limitations on the use of the services they provide and where those limitations are recognisable to third parties, trust service providers shall not be liable for damages arising from the use of services exceeding the indicated limitations.
3. Paragraphs 1 and 2 shall be applied in accordance with national rules on liability.
Article 14
International aspects
1. Trust services provided by trust service providers established in a third country shall be recognised as legally equivalent to qualified trust services provided by qualified trust service providers established in the Union where the trust services originating from the third country are recognised under an agreement concluded between the Union and the third country in question or an international organisation in accordance with Article 218 TFEU.
2. Agreements referred to in paragraph 1 shall ensure, in particular, that:
(a)
the requirements applicable to qualified trust service providers established in the Union and the qualified trust services they provide are met by the trust service providers in the third country or international organisations with which the agreement is concluded, and by the trust services they provide;
(b)
the qualified trust services provided by qualified trust service providers established in the Union are recognised as legally equivalent to trust services provided by trust service providers in the third country or international organisation with which the agreement is concluded.
Article 15
Accessibility for persons with disabilities
Where feasible, trust services provided and end-user products used in the provision of those services shall be made accessible for persons with disabilities.
Article 16
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation. The penalties provided for shall be effective, proportionate and dissuasive.
SECTION 2
Supervision
Article 17
Supervisory body
1. Member States shall designate a supervisory body established in their territory or, upon mutual agreement with another Member State, a supervisory body established in that other Member State. That body shall be responsible for supervisory tasks in the designating Member State.
Supervisory bodies shall be given the necessary powers and adequate resources for the exercise of their tasks.
2. Member States shall notify to the Commission the names and the addresses of their respective designated supervisory bodies.
3. The role of the supervisory body shall be the following:
(a)
to supervise qualified trust service providers established in the territory of the designating Member State to ensure, through ex ante and ex post supervisory activities, that those qualified trust service providers and the qualified trust services that they provide meet the requirements laid down in this Regulation;
(b)
to take action if necessary, in relation to non-qualified trust service providers established in the territory of the designating Member State, through ex post supervisory activities, when informed that those non-qualified trust service providers or the trust services they provide allegedly do not meet the requirements laid down in this Regulation.
4. For the purposes of paragraph 3 and subject to the limitations provided therein, the tasks of the supervisory body shall include in particular:
(a)
to cooperate with other supervisory bodies and provide them with assistance in accordance with Article 18;
(b)
to analyse the conformity assessment reports referred to in Articles 20(1) and 21(1);
(c)
to inform other supervisory bodies and the public about breaches of security or loss of integrity in accordance with Article 19(2);
(d)
to report to the Commission about its main activities in accordance with paragraph 6 of this Article;
(e)
to carry out audits or request a conformity assessment body to perform a conformity assessment of the qualified trust service providers in accordance with Article 20(2);
(f)
to cooperate with the data protection authorities, in particular, by informing them without undue delay, about the results of audits of qualified trust service providers, where personal data protection rules appear to have been breached;
(g)
to grant qualified status to trust service providers and to the services they provide and to withdraw this status in accordance with Articles 20 and 21;
(h)
to inform the body responsible for the national trusted list referred to in Article 22(3) about its decisions to grant or to withdraw qualified status, unless that body is also the supervisory body;
(i)
to verify the existence and correct application of provisions on termination plans in cases where the qualified trust service provider ceases its activities, including how information is kept accessible in accordance with point (h) of Article 24(2);
(j)
to require that trust service providers remedy any failure to fulfil the requirements laid down in this Regulation.
5. Member States may require the supervisory body to establish, maintain and update a trust infrastructure in accordance with the conditions under national law.
6. By 31 March each year, each supervisory body shall submit to the Commission a report on its previous calendar year’s main activities together with a summary of breach notifications received from trust service providers in accordance with Article 19(2).
7. The Commission shall make the annual report referred to in paragraph 6 available to Member States.
8. The Commission may, by means of implementing acts, define the formats and procedures for the report referred to in paragraph 6. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 18
Mutual assistance
1. Supervisory bodies shall cooperate with a view to exchanging good practice.
A supervisory body shall, upon receipt of a justified request from another supervisory body, provide that body with assistance so that the activities of supervisory bodies can be carried out in a consistent manner. Mutual assistance may cover, in particular, information requests and supervisory measures, such as requests to carry out inspections related to the conformity assessment reports as referred to in Articles 20 and 21.
2. A supervisory body to which a request for assistance is addressed may refuse that request on any of the following grounds:
(a)
the supervisory body is not competent to provide the requested assistance;
(b)
the requested assistance is not proportionate to supervisory activities of the supervisory body carried out in accordance with Article 17;
(c)
providing the requested assistance would be incompatible with this Regulation.
3. Where appropriate, Member States may authorise their respective supervisory bodies to carry out joint investigations in which staff from other Member States’ supervisory bodies is involved. The arrangements and procedures for such joint actions shall be agreed upon and established by the Member States concerned in accordance with their national law.
Article 19
Security requirements applicable to trust service providers
1. Qualified and non-qualified trust service providers shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust services they provide. Having regard to the latest technological developments, those measures shall ensure that the level of security is commensurate to the degree of risk. In particular, measures shall be taken to prevent and minimise the impact of security incidents and inform stakeholders of the adverse effects of any such incidents.
2. Qualified and non-qualified trust service providers shall, without undue delay but in any event within 24 hours after having become aware of it, notify the supervisory body and, where applicable, other relevant bodies, such as the competent national body for information security or the data protection authority, of any breach of security or loss of integrity that has a significant impact on the trust service provided or on the personal data maintained therein.
Where the breach of security or loss of integrity is likely to adversely affect a natural or legal person to whom the trusted service has been provided, the trust service provider shall also notify the natural or legal person of the breach of security or loss of integrity without undue delay.
Where appropriate, in particular if a breach of security or loss of integrity concerns two or more Member States, the notified supervisory body shall inform the supervisory bodies in other Member States concerned and ENISA.
The notified supervisory body shall inform the public or require the trust service provider to do so, where it determines that disclosure of the breach of security or loss of integrity is in the public interest.
3. The supervisory body shall provide ENISA once a year with a summary of notifications of breach of security and loss of integrity received from trust service providers.
4. The Commission may, by means of implementing acts,:
(a)
further specify the measures referred to in paragraph 1; and
(b)
define the formats and procedures, including deadlines, applicable for the purpose of paragraph 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
SECTION 3
Qualified trust services
Article 20
Supervision of qualified trust service providers
1. Qualified trust service providers shall be audited at their own expense at least every 24 months by a conformity assessment body. The purpose of the audit shall be to confirm that the qualified trust service providers and the qualified trust services provided by them fulfil the requirements laid down in this Regulation. The qualified trust service providers shall submit the resulting conformity assessment report to the supervisory body within the period of three working days after receiving it.
2. Without prejudice to paragraph 1, the supervisory body may at any time audit or request a conformity assessment body to perform a conformity assessment of the qualified trust service providers, at the expense of those trust service providers, to confirm that they and the qualified trust services provided by them fulfil the requirements laid down in this Regulation. Where personal data protection rules appear to have been breached, the supervisory body shall inform the data protection authorities of the results of its audits.
3. Where the supervisory body requires the qualified trust service provider to remedy any failure to fulfil requirements under this Regulation and where that provider does not act accordingly, and if applicable within a time limit set by the supervisory body, the supervisory body, taking into account, in particular, the extent, duration and consequences of that failure, may withdraw the qualified status of that provider or of the affected service it provides and inform the body referred to in Article 22(3) for the purposes of updating the trusted lists referred to in Article 22(1). The supervisory body shall inform the qualified trust service provider of the withdrawal of its qualified status or of the qualified status of the service concerned.
4. The Commission may, by means of implementing acts, establish reference number of the following standards:
(a)
accreditation of the conformity assessment bodies and for the conformity assessment report referred to in paragraph 1;
(b)
auditing rules under which conformity assessment bodies will carry out their conformity assessment of the qualified trust service providers as referred to in paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 21
Initiation of a qualified trust service
1. Where trust service providers, without qualified status, intend to start providing qualified trust services, they shall submit to the supervisory body a notification of their intention together with a conformity assessment report issued by a conformity assessment body.
2. The supervisory body shall verify whether the trust service provider and the trust services provided by it comply with the requirements laid down in this Regulation, and in particular, with the requirements for qualified trust service providers and for the qualified trust services they provide.
If the supervisory body concludes that the trust service provider and the trust services provided by it comply with the requirements referred to in the first subparagraph, the supervisory body shall grant qualified status to the trust service provider and the trust services it provides and inform the body referred to in Article 22(3) for the purposes of updating the trusted lists referred to in Article 22(1), not later than three months after notification in accordance with paragraph 1 of this Article.
If the verification is not concluded within three months of notification, the supervisory body shall inform the trust service provider specifying the reasons for the delay and the period within which the verification is to be concluded.
3. Qualified trust service providers may begin to provide the qualified trust service after the qualified status has been indicated in the trusted lists referred to in Article 22(1).
4. The Commission may, by means of implementing acts, define the formats and procedures for the purpose of paragraphs 1 and 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 22
Trusted lists
1. Each Member State shall establish, maintain and publish trusted lists, including information related to the qualified trust service providers for which it is responsible, together with information related to the qualified trust services provided by them.
2. Member States shall establish, maintain and publish, in a secured manner, the electronically signed or sealed trusted lists referred to in paragraph 1 in a form suitable for automated processing.
3. Member States shall notify to the Commission, without undue delay, information on the body responsible for establishing, maintaining and publishing national trusted lists, and details of where such lists are published, the certificates used to sign or seal the trusted lists and any changes thereto.
4. The Commission shall make available to the public, through a secure channel, the information referred to in paragraph 3 in electronically signed or sealed form suitable for automated processing.
5. By 18 September 2015 the Commission shall, by means of implementing acts, specify the information referred to in paragraph 1 and define the technical specifications and formats for trusted lists applicable for the purposes of paragraphs 1 to 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 23
EU trust mark for qualified trust services
1. After the qualified status referred to in the second subparagraph of Article 21(2) has been indicated in the trusted list referred to in Article 22(1), qualified trust service providers may use the EU trust mark to indicate in a simple, recognisable and clear manner the qualified trust services they provide.
2. When using the EU trust mark for the qualified trust services referred to in paragraph 1, qualified trust service providers shall ensure that a link to the relevant trusted list is made available on their website.
3. By 1 July 2015 the Commission shall, by means of implementing acts, provide for specifications with regard to the form, and in particular the presentation, composition, size and design of the EU trust mark for qualified trust services. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 24
Requirements for qualified trust service providers
1. When issuing a qualified certificate for a trust service, a qualified trust service provider shall verify, by appropriate means and in accordance with national law, the identity and, if applicable, any specific attributes of the natural or legal person to whom the qualified certificate is issued.
The information referred to in the first subparagraph shall be verified by the qualified trust service provider either directly or by relying on a third party in accordance with national law:
(a)
by the physical presence of the natural person or of an authorised representative of the legal person; or
(b)
remotely, using electronic identification means, for which prior to the issuance of the qualified certificate, a physical presence of the natural person or of an authorised representative of the legal person was ensured and which meets the requirements set out in Article 8 with regard to the assurance levels ‘substantial’ or ‘high’; or
(c)
by means of a certificate of a qualified electronic signature or of a qualified electronic seal issued in compliance with point (a) or (b); or
(d)
by using other identification methods recognised at national level which provide equivalent assurance in terms of reliability to physical presence. The equivalent assurance shall be confirmed by a conformity assessment body.
2. A qualified trust service provider providing qualified trust services shall:
(a)
inform the supervisory body of any change in the provision of its qualified trust services and an intention to cease those activities;
(b)
employ staff and, if applicable, subcontractors who possess the necessary expertise, reliability, experience, and qualifications and who have received appropriate training regarding security and personal data protection rules and shall apply administrative and management procedures which correspond to European or international standards;
(c)
with regard to the risk of liability for damages in accordance with Article 13, maintain sufficient financial resources and/or obtain appropriate liability insurance, in accordance with national law;
(d)
before entering into a contractual relationship, inform, in a clear and comprehensive manner, any person seeking to use a qualified trust service of the precise terms and conditions regarding the use of that service, including any limitations on its use;
(e)
use trustworthy systems and products that are protected against modification and ensure the technical security and reliability of the processes supported by them;
(f)
use trustworthy systems to store data provided to it, in a verifiable form so that:
(i)
they are publicly available for retrieval only where the consent of the person to whom the data relates has been obtained,
(ii)
only authorised persons can make entries and changes to the stored data,
(iii)
the data can be checked for authenticity;
(g)
take appropriate measures against forgery and theft of data;
(h)
record and keep accessible for an appropriate period of time, including after the activities of the qualified trust service provider have ceased, all relevant information concerning data issued and received by the qualified trust service provider, in particular, for the purpose of providing evidence in legal proceedings and for the purpose of ensuring continuity of the service. Such recording may be done electronically;
(i)
have an up-to-date termination plan to ensure continuity of service in accordance with provisions verified by the supervisory body under point (i) of Article 17(4);
(j)
ensure lawful processing of personal data in accordance with Directive 95/46/EC;
(k)
in case of qualified trust service providers issuing qualified certificates, establish and keep updated a certificate database.
3. If a qualified trust service provider issuing qualified certificates decides to revoke a certificate, it shall register such revocation in its certificate database and publish the revocation status of the certificate in a timely manner, and in any event within 24 hours after the receipt of the request. The revocation shall become effective immediately upon its publication.
4. With regard to paragraph 3, qualified trust service providers issuing qualified certificates shall provide to any relying party information on the validity or revocation status of qualified certificates issued by them. This information shall be made available at least on a per certificate basis at any time and beyond the validity period of the certificate in an automated manner that is reliable, free of charge and efficient.
5. The Commission may, by means of implementing acts, establish reference numbers of standards for trustworthy systems and products, which comply with the requirements under points (e) and (f) of paragraph 2 of this Article. Compliance with the requirements laid down in this Article shall be presumed where trustworthy systems and products meet those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
SECTION 4
Electronic signatures
Article 25
Legal effects of electronic signatures
1. An electronic signature shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements for qualified electronic signatures.
2. A qualified electronic signature shall have the equivalent legal effect of a handwritten signature.
3. A qualified electronic signature based on a qualified certificate issued in one Member State shall be recognised as a qualified electronic signature in all other Member States.
Article 26
Requirements for advanced electronic signatures
An advanced electronic signature shall meet the following requirements:
(a)
it is uniquely linked to the signatory;
(b)
it is capable of identifying the signatory;
(c)
it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under his sole control; and
(d)
it is linked to the data signed therewith in such a way that any subsequent change in the data is detectable.
Article 27
Electronic signatures in public services
1. If a Member State requires an advanced electronic signature to use an online service offered by, or on behalf of, a public sector body, that Member State shall recognise advanced electronic signatures, advanced electronic signatures based on a qualified certificate for electronic signatures, and qualified electronic signatures in at least the formats or using methods defined in the implementing acts referred to in paragraph 5.
2. If a Member State requires an advanced electronic signature based on a qualified certificate to use an online service offered by, or on behalf of, a public sector body, that Member State shall recognise advanced electronic signatures based on a qualified certificate and qualified electronic signatures in at least the formats or using methods defined in the implementing acts referred to in paragraph 5.
3. Member States shall not request for cross-border use in an online service offered by a public sector body an electronic signature at a higher security level than the qualified electronic signature.
4. The Commission may, by means of implementing acts, establish reference numbers of standards for advanced electronic signatures. Compliance with the requirements for advanced electronic signatures referred to in paragraphs 1 and 2 of this Article and in Article 26 shall be presumed when an advanced electronic signature meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
5. By 18 September 2015, and taking into account existing practices, standards and Union legal acts, the Commission shall, by means of implementing acts, define reference formats of advanced electronic signatures or reference methods where alternative formats are used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 28
Qualified certificates for electronic signatures
1. Qualified certificates for electronic signatures shall meet the requirements laid down in Annex I.
2. Qualified certificates for electronic signatures shall not be subject to any mandatory requirement exceeding the requirements laid down in Annex I.
3. Qualified certificates for electronic signatures may include non-mandatory additional specific attributes. Those attributes shall not affect the interoperability and recognition of qualified electronic signatures.
4. If a qualified certificate for electronic signatures has been revoked after initial activation, it shall lose its validity from the moment of its revocation, and its status shall not in any circumstances be reverted.
5. Subject to the following conditions, Member States may lay down national rules on temporary suspension of a qualified certificate for electronic signature:
(a)
if a qualified certificate for electronic signature has been temporarily suspended that certificate shall lose its validity for the period of suspension;
(b)
the period of suspension shall be clearly indicated in the certificate database and the suspension status shall be visible, during the period of suspension, from the service providing information on the status of the certificate.
6. The Commission may, by means of implementing acts, establish reference numbers of standards for qualified certificates for electronic signature. Compliance with the requirements laid down in Annex I shall be presumed where a qualified certificate for electronic signature meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 29
Requirements for qualified electronic signature creation devices
1. Qualified electronic signature creation devices shall meet the requirements laid down in Annex II.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for qualified electronic signature creation devices. Compliance with the requirements laid down in Annex II shall be presumed where a qualified electronic signature creation device meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 30
Certification of qualified electronic signature creation devices
1. Conformity of qualified electronic signature creation devices with the requirements laid down in Annex II shall be certified by appropriate public or private bodies designated by Member States.
2. Member States shall notify to the Commission the names and addresses of the public or private body referred to in paragraph 1. The Commission shall make that information available to Member States.
3. The certification referred to in paragraph 1 shall be based on one of the following:
(a)
a security evaluation process carried out in accordance with one of the standards for the security assessment of information technology products included in the list established in accordance with the second subparagraph; or
(b)
a process other than the process referred to in point (a), provided that it uses comparable security levels and provided that the public or private body referred to in paragraph 1 notifies that process to the Commission. That process may be used only in the absence of standards referred to in point (a) or when a security evaluation process referred to in point (a) is ongoing.
The Commission shall, by means of implementing acts, establish a list of standards for the security assessment of information technology products referred to in point (a). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 47 concerning the establishment of specific criteria to be met by the designated bodies referred to in paragraph 1 of this Article.
Article 31
Publication of a list of certified qualified electronic signature creation devices
1. Member States shall notify to the Commission without undue delay and no later than one month after the certification is concluded, information on qualified electronic signature creation devices that have been certified by the bodies referred to in Article 30(1). They shall also notify to the Commission, without undue delay and no later than one month after the certification is cancelled, information on electronic signature creation devices that are no longer certified.
2. On the basis of the information received, the Commission shall establish, publish and maintain a list of certified qualified electronic signature creation devices.
3. The Commission may, by means of implementing acts, define formats and procedures applicable for the purpose of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 32
Requirements for the validation of qualified electronic signatures
1. The process for the validation of a qualified electronic signature shall confirm the validity of a qualified electronic signature provided that:
(a)
the certificate that supports the signature was, at the time of signing, a qualified certificate for electronic signature complying with Annex I;
(b)
the qualified certificate was issued by a qualified trust service provider and was valid at the time of signing;
(c)
the signature validation data corresponds to the data provided to the relying party;
(d)
the unique set of data representing the signatory in the certificate is correctly provided to the relying party;
(e)
the use of any pseudonym is clearly indicated to the relying party if a pseudonym was used at the time of signing;
(f)
the electronic signature was created by a qualified electronic signature creation device;
(g)
the integrity of the signed data has not been compromised;
(h)
the requirements provided for in Article 26 were met at the time of signing.
2. The system used for validating the qualified electronic signature shall provide to the relying party the correct result of the validation process and shall allow the relying party to detect any security relevant issues.
3. The Commission may, by means of implementing acts, establish reference numbers of standards for the validation of qualified electronic signatures. Compliance with the requirements laid down in paragraph 1 shall be presumed where the validation of qualified electronic signatures meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 33
Qualified validation service for qualified electronic signatures
1. A qualified validation service for qualified electronic signatures may only be provided by a qualified trust service provider who:
(a)
provides validation in compliance with Article 32(1); and
(b)
allows relying parties to receive the result of the validation process in an automated manner, which is reliable, efficient and bears the advanced electronic signature or advanced electronic seal of the provider of the qualified validation service.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for qualified validation service referred to in paragraph 1. Compliance with the requirements laid down in paragraph 1 shall be presumed where the validation service for a qualified electronic signature meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 34
Qualified preservation service for qualified electronic signatures
1. A qualified preservation service for qualified electronic signatures may only be provided by a qualified trust service provider that uses procedures and technologies capable of extending the trustworthiness of the qualified electronic signature beyond the technological validity period.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for the qualified preservation service for qualified electronic signatures. Compliance with the requirements laid down in paragraph 1 shall be presumed where the arrangements for the qualified preservation service for qualified electronic signatures meet those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
SECTION 5
Electronic seals
Article 35
Legal effects of electronic seals
1. An electronic seal shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements for qualified electronic seals.
2. A qualified electronic seal shall enjoy the presumption of integrity of the data and of correctness of the origin of that data to which the qualified electronic seal is linked.
3. A qualified electronic seal based on a qualified certificate issued in one Member State shall be recognised as a qualified electronic seal in all other Member States.
Article 36
Requirements for advanced electronic seals
An advanced electronic seal shall meet the following requirements:
(a)
it is uniquely linked to the creator of the seal;
(b)
it is capable of identifying the creator of the seal;
(c)
it is created using electronic seal creation data that the creator of the seal can, with a high level of confidence under its control, use for electronic seal creation; and
(d)
it is linked to the data to which it relates in such a way that any subsequent change in the data is detectable.
Article 37
Electronic seals in public services
1. If a Member State requires an advanced electronic seal in order to use an online service offered by, or on behalf of, a public sector body, that Member State shall recognise advanced electronic seals, advanced electronic seals based on a qualified certificate for electronic seals and qualified electronic seals at least in the formats or using methods defined in the implementing acts referred to in paragraph 5.
2. If a Member State requires an advanced electronic seal based on a qualified certificate in order to use an online service offered by, or on behalf of, a public sector body, that Member State shall recognise advanced electronic seals based on a qualified certificate and qualified electronic seal at least in the formats or using methods defined in the implementing acts referred to in paragraph 5.
3. Member States shall not request for the cross-border use in an online service offered by a public sector body an electronic seal at a higher security level than the qualified electronic seal.
4. The Commission may, by means of implementing acts, establish reference numbers of standards for advanced electronic seals. Compliance with the requirements for advanced electronic seals referred to in paragraphs 1 and 2 of this Article and Article 36 shall be presumed when an advanced electronic seal meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
5. By 18 September 2015, and taking into account existing practices, standards and legal acts of the Union, the Commission shall, by means of implementing acts, define reference formats of advanced electronic seals or reference methods where alternative formats are used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 38
Qualified certificates for electronic seals
1. Qualified certificates for electronic seals shall meet the requirements laid down in Annex III.
2. Qualified certificates for electronic seals shall not be subject to any mandatory requirements exceeding the requirements laid down in Annex III.
3. Qualified certificates for electronic seals may include non-mandatory additional specific attributes. Those attributes shall not affect the interoperability and recognition of qualified electronic seals.
4. If a qualified certificate for an electronic seal has been revoked after initial activation, it shall lose its validity from the moment of its revocation, and its status shall not in any circumstances be reverted.
5. Subject to the following conditions, Member States may lay down national rules on temporary suspension of qualified certificates for electronic seals:
(a)
if a qualified certificate for electronic seal has been temporarily suspended, that certificate shall lose its validity for the period of suspension;
(b)
the period of suspension shall be clearly indicated in the certificate database and the suspension status shall be visible, during the period of suspension, from the service providing information on the status of the certificate.
6. The Commission may, by means of implementing acts, establish reference numbers of standards for qualified certificates for electronic seals. Compliance with the requirements laid down in Annex III shall be presumed where a qualified certificate for electronic seal meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
Article 39
Qualified electronic seal creation devices
1. Article 29 shall apply mutatis mutandis to requirements for qualified electronic seal creation devices.
2. Article 30 shall apply mutatis mutandis to the certification of qualified electronic seal creation devices.
3. Article 31 shall apply mutatis mutandis to the publication of a list of certified qualified electronic seal creation devices.
Article 40
Validation and preservation of qualified electronic seals
Articles 32, 33 and 34 shall apply mutatis mutandis to the validation and preservation of qualified electronic seals.
SECTION 6
Electronic time stamps
Article 41
Legal effect of electronic time stamps
1. An electronic time stamp shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements of the qualified electronic time stamp.
2. A qualified electronic time stamp shall enjoy the presumption of the accuracy of the date and the time it indicates and the integrity of the data to which the date and time are bound.
3. A qualified electronic time stamp issued in one Member State shall be recognised as a qualified electronic time stamp in all Member States.
Article 42
Requirements for qualified electronic time stamps
1. A qualified electronic time stamp shall meet the following requirements:
(a)
it binds the date and time to data in such a manner as to reasonably preclude the possibility of the data being changed undetectably;
(b)
it is based on an accurate time source linked to Coordinated Universal Time; and
(c)
it is signed using an advanced electronic signature or sealed with an advanced electronic seal of the qualified trust service provider, or by some equivalent method.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for the binding of date and time to data and for accurate time sources. Compliance with the requirements laid down in paragraph 1 shall be presumed where the binding of date and time to data and the accurate time source meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
SECTION 7
Electronic registered delivery services
Article 43
Legal effect of an electronic registered delivery service
1. Data sent and received using an electronic registered delivery service shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements of the qualified electronic registered delivery service.
2. Data sent and received using a qualified electronic registered delivery service shall enjoy the presumption of the integrity of the data, the sending of that data by the identified sender, its receipt by the identified addressee and the accuracy of the date and time of sending and receipt indicated by the qualified electronic registered delivery service.
Article 44
Requirements for qualified electronic registered delivery services
1. Qualified electronic registered delivery services shall meet the following requirements:
(a)
they are provided by one or more qualified trust service provider(s);
(b)
they ensure with a high level of confidence the identification of the sender;
(c)
they ensure the identification of the addressee before the delivery of the data;
(d)
the sending and receiving of data is secured by an advanced electronic signature or an advanced electronic seal of a qualified trust service provider in such a manner as to preclude the possibility of the data being changed undetectably;
(e)
any change of the data needed for the purpose of sending or receiving the data is clearly indicated to the sender and addressee of the data;
(f)
the date and time of sending, receiving and any change of data are indicated by a qualified electronic time stamp.
In the event of the data being transferred between two or more qualified trust service providers, the requirements in points (a) to (f) shall apply to all the qualified trust service providers.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for processes for sending and receiving data. Compliance with the requirements laid down in paragraph 1 shall be presumed where the process for sending and receiving data meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
SECTION 8
Website authentication
Article 45
Requirements for qualified certificates for website authentication
1. Qualified certificates for website authentication shall meet the requirements laid down in Annex IV.
2. The Commission may, by means of implementing acts, establish reference numbers of standards for qualified certificates for website authentication. Compliance with the requirements laid down in Annex IV shall be presumed where a qualified certificate for website authentication meets those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2).
CHAPTER IV
ELECTRONIC DOCUMENTS
Article 46
Legal effects of electronic documents
An electronic document shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in electronic form.
CHAPTER V
DELEGATIONS OF POWER AND IMPLEMENTING PROVISIONS
Article 47
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 30(4) shall be conferred on the Commission for an indeterminate period of time from 17 September 2014.
3. The delegation of power referred to in Article 30(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 30(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 48
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER VI
FINAL PROVISIONS
Article 49
Review
The Commission shall review the application of this Regulation and shall report to the European Parliament and to the Council no later than 1 July 2020. The Commission shall evaluate in particular whether it is appropriate to modify the scope of this Regulation or its specific provisions, including Article 6, point (f) of Article 7 and Articles 34, 43, 44 and 45, taking into account the experience gained in the application of this Regulation, as well as technological, market and legal developments.
The report referred to in the first paragraph shall be accompanied, where appropriate, by legislative proposals.
In addition, the Commission shall submit a report to the European Parliament and the Council every four years after the report referred to in the first paragraph on the progress towards achieving the objectives of this Regulation.
Article 50
Repeal
1. Directive 1999/93/EC is repealed with effect from 1 July 2016.
2. References to the repealed Directive shall be construed as references to this Regulation.
Article 51
Transitional measures
1. Secure signature creation devices of which the conformity has been determined in accordance with Article 3(4) of Directive 1999/93/EC shall be considered as qualified electronic signature creation devices under this Regulation.
2. Qualified certificates issued to natural persons under Directive 1999/93/EC shall be considered as qualified certificates for electronic signatures under this Regulation until they expire.
3. A certification-service-provider issuing qualified certificates under Directive 1999/93/EC shall submit a conformity assessment report to the supervisory body as soon as possible but not later than 1 July 2017. Until the submission of such a conformity assessment report and the completion of its assessment by the supervisory body, that certification-service-provider shall be considered as qualified trust service provider under this Regulation.
4. If a certification-service-provider issuing qualified certificates under Directive 1999/93/EC does not submit a conformity assessment report to the supervisory body within the time limit referred to in paragraph 3, that certification-service-provider shall not be considered as qualified trust service provider under this Regulation from 2 July 2017.
Article 52
Entry into force
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. This Regulation shall apply from 1 July 2016, except for the following:
(a)
Articles 8(3), 9(5), 12(2) to (9), 17(8), 19(4), 20(4), 21(4), 22(5), 23(3), 24(5), 27(4) and (5), 28(6), 29(2), 30(3) and (4), 31(3), 32(3), 33(2), 34(2), 37(4) and (5), 38(6), 42(2), 44(2), 45(2), and Articles 47 and 48 shall apply from 17 September 2014;
(b)
Article 7, Article 8(1) and (2), Articles 9, 10, 11 and Article 12(1) shall apply from the date of application of the implementing acts referred to in Articles 8(3) and 12(8);
(c)
Article 6 shall apply from three years as from the date of application of the implementing acts referred to in Articles 8(3) and 12(8).
3. Where the notified electronic identification scheme is included in the list published by the Commission pursuant to Article 9 before the date referred to in point (c) of paragraph 2 of this Article, the recognition of the electronic identification means under that scheme pursuant to Article 6 shall take place no later than 12 months after the publication of that scheme but not before the date referred to in point (c) of paragraph 2 of this Article.
4. Notwithstanding point (c) of paragraph 2 of this Article, a Member State may decide that electronic identification means under electronic identification scheme notified pursuant to Article 9(1) by another Member State are recognised in the first Member State as from the date of application of the implementing acts referred to in Articles 8(3) and 12(8). Member States concerned shall inform the Commission. The Commission shall make this information public.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 July 2014.
For the Parliament
The President
M. SCHULZ
For the Council
The President
S. GOZI
(1) OJ C 351, 15.11.2012, p. 73.
(2) Position of the European Parliament of 3 April 2014 (not yet published in the Official Journal) and decision of the Council of 23 July 2014.
(3) Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (OJ L 13, 19.1.2000, p. 12).
(4) OJ C 50 E, 21.2.2012, p. 1.
(5) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36).
(6) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(7) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(8) Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p. 35).
(9) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(10) Commission Decision 2009/767/EC of 16 October 2009 setting out measures facilitating the use of procedures by electronic means through the ‘points of single contact’ under Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (OJ L 274, 20.10.2009, p. 36).
(11) Commission Decision 2011/130/EU of 25 February 2011 establishing minimum requirements for the cross-border processing of documents signed electronically by competent authorities under Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (OJ L 53, 26.2.2011, p. 66).
(12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(13) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(14) OJ C 28, 30.1.2013, p. 6.
(15) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).
ANNEX I
REQUIREMENTS FOR QUALIFIED CERTIFICATES FOR ELECTRONIC SIGNATURES
Qualified certificates for electronic signatures shall contain:
(a)
an indication, at least in a form suitable for automated processing, that the certificate has been issued as a qualified certificate for electronic signature;
(b)
a set of data unambiguously representing the qualified trust service provider issuing the qualified certificates including at least, the Member State in which that provider is established and:
—
for a legal person: the name and, where applicable, registration number as stated in the official records,
—
for a natural person: the person’s name;
(c)
at least the name of the signatory, or a pseudonym; if a pseudonym is used, it shall be clearly indicated;
(d)
electronic signature validation data that corresponds to the electronic signature creation data;
(e)
details of the beginning and end of the certificate’s period of validity;
(f)
the certificate identity code, which must be unique for the qualified trust service provider;
(g)
the advanced electronic signature or advanced electronic seal of the issuing qualified trust service provider;
(h)
the location where the certificate supporting the advanced electronic signature or advanced electronic seal referred to in point (g) is available free of charge;
(i)
the location of the services that can be used to enquire about the validity status of the qualified certificate;
(j)
where the electronic signature creation data related to the electronic signature validation data is located in a qualified electronic signature creation device, an appropriate indication of this, at least in a form suitable for automated processing.
ANNEX II
REQUIREMENTS FOR QUALIFIED ELECTRONIC SIGNATURE CREATION DEVICES
1.
Qualified electronic signature creation devices shall ensure, by appropriate technical and procedural means, that at least:
(a)
the confidentiality of the electronic signature creation data used for electronic signature creation is reasonably assured;
(b)
the electronic signature creation data used for electronic signature creation can practically occur only once;
(c)
the electronic signature creation data used for electronic signature creation cannot, with reasonable assurance, be derived and the electronic signature is reliably protected against forgery using currently available technology;
(d)
the electronic signature creation data used for electronic signature creation can be reliably protected by the legitimate signatory against use by others.
2.
Qualified electronic signature creation devices shall not alter the data to be signed or prevent such data from being presented to the signatory prior to signing.
3.
Generating or managing electronic signature creation data on behalf of the signatory may only be done by a qualified trust service provider.
4.
Without prejudice to point (d) of point 1, qualified trust service providers managing electronic signature creation data on behalf of the signatory may duplicate the electronic signature creation data only for back-up purposes provided the following requirements are met:
(a)
the security of the duplicated datasets must be at the same level as for the original datasets;
(b)
the number of duplicated datasets shall not exceed the minimum needed to ensure continuity of the service.
ANNEX III
REQUIREMENTS FOR QUALIFIED CERTIFICATES FOR ELECTRONIC SEALS
Qualified certificates for electronic seals shall contain:
(a)
an indication, at least in a form suitable for automated processing, that the certificate has been issued as a qualified certificate for electronic seal;
(b)
a set of data unambiguously representing the qualified trust service provider issuing the qualified certificates including at least the Member State in which that provider is established and:
—
for a legal person: the name and, where applicable, registration number as stated in the official records,
—
for a natural person: the person’s name;
(c)
at least the name of the creator of the seal and, where applicable, registration number as stated in the official records;
(d)
electronic seal validation data, which corresponds to the electronic seal creation data;
(e)
details of the beginning and end of the certificate’s period of validity;
(f)
the certificate identity code, which must be unique for the qualified trust service provider;
(g)
the advanced electronic signature or advanced electronic seal of the issuing qualified trust service provider;
(h)
the location where the certificate supporting the advanced electronic signature or advanced electronic seal referred to in point (g) is available free of charge;
(i)
the location of the services that can be used to enquire as to the validity status of the qualified certificate;
(j)
where the electronic seal creation data related to the electronic seal validation data is located in a qualified electronic seal creation device, an appropriate indication of this, at least in a form suitable for automated processing.
ANNEX IV
REQUIREMENTS FOR QUALIFIED CERTIFICATES FOR WEBSITE AUTHENTICATION
Qualified certificates for website authentication shall contain:
(a)
an indication, at least in a form suitable for automated processing, that the certificate has been issued as a qualified certificate for website authentication;
(b)
a set of data unambiguously representing the qualified trust service provider issuing the qualified certificates including at least the Member State in which that provider is established and:
—
for a legal person: the name and, where applicable, registration number as stated in the official records,
—
for a natural person: the person’s name;
(c)
for natural persons: at least the name of the person to whom the certificate has been issued, or a pseudonym. If a pseudonym is used, it shall be clearly indicated;
for legal persons: at least the name of the legal person to whom the certificate is issued and, where applicable, registration number as stated in the official records;
(d)
elements of the address, including at least city and State, of the natural or legal person to whom the certificate is issued and, where applicable, as stated in the official records;
(e)
the domain name(s) operated by the natural or legal person to whom the certificate is issued;
(f)
details of the beginning and end of the certificate’s period of validity;
(g)
the certificate identity code, which must be unique for the qualified trust service provider;
(h)
the advanced electronic signature or advanced electronic seal of the issuing qualified trust service provider;
(i)
the location where the certificate supporting the advanced electronic signature or advanced electronic seal referred to in point (h) is available free of charge;
(j)
the location of the certificate validity status services that can be used to enquire as to the validity status of the qualified certificate.
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More secure transactions on the Internet
More secure transactions on the Internet
SUMMARY OF
Regulation (EU) No 910/2014: on electronic identification and trust services for electronic transactions in the internal market
SUMMARY
WHAT DOES THIS REGULATION DO?
The Electronic Identification and Trust Services (eIDAS) Regulation creates a new system for secure electronic interactions across the EU between businesses, citizens and public authorities.
It aims to improve trust in EU-wide electronic transactions and to increase the effectiveness of public and private online services and e-commerce. It applies to:
electronic identification (eID)* schemes notified to the European Commission by EU countries;
trust service providers based in the EU.
It removes existing barriers to the use of eID in the EU. For instance, it would now be straightforward for a Portuguese firm to tender for a public service contract in Sweden, while EU funding grants can be managed wholly online.
KEY POINTS
Electronic identification
eID issued in one EU country must be recognised in all others. This applies only if the eID meets the regulation’s requirements and has been notified to the Commission and published in a list. Mutual recognition of eIDs will be mandatory from 28 September 2018 and will facilitate secure electronic transactions across the EU.
An eID scheme must specify one of three levels of assurance (low, substantial and high) for the form of electronic identification issued under that scheme. Mutual recognition is mandatory only when the relevant public sector body uses the ‘substantial’ or ‘high’ levels for accessing that service online.
Notification
When notifying the Commission of eID schemes, EU countries must provide information on aspects such as:
the level of assurance and the issuer of eID under that scheme;
the applicable supervisory and liability systems;
the body managing the registration of unique personal ID data.
In the event of a security breach of the eID scheme or authentication, the notifying EU country must:
quickly suspend/revoke the EU-wide authentication or the compromised parts of the scheme; and
inform other EU countries and the Commission.
Liability
In any transaction between EU countries where there is a failure to comply with the regulation’s obligations, the following parties can be held liable for any damage caused intentionally or negligently to any person or body:
a notifying EU country;
the party issuing the eID;
the party managing the authentication procedure.
Cooperation and operability among EU countries
National eID schemes notified must be interoperable. The interoperability framework must be technology-neutral, not favouring any specific national technical solutions for eID.
Trust services
The regulation defines trust services as paid-for services that include:
the creation, verification and validation of electronic signatures, electronic seals or electronic time stamps, electronic registered delivery services and certificates related to those services; or
the creation, verification and validation of certificates for website authentication; or
the preservation of electronic signatures, seals or certificates related to those services.
Trust service providers based in the EU are considered ‘qualified’ if they meet the regulation's applicable requirements. They are legally entitled to provide qualified trust services (e.g. qualified electronic signatures, seals or certificates) in all EU countries. Trust services offered by service providers from non-EU countries can be considered legally equivalent to qualified ones, but only after an agreement between the EU and the non-EU country or an international organisation.
Supervision
EU countries must select one or more bodies for the supervisory activities under this regulation. These bodies must cooperate with data protection authorities where appropriate.
All trust service providers are subject to supervision and to risk management and security breach notification obligations.
Non-qualified trust service providers are subject to ‘light-touch’ supervision, i.e. the supervisory body only reacts if the provider is suspected of misconduct.
Qualified trust service providers based in the EU are subject to strict supervision. This includes prior authorisation by supervisory bodies and auditing at least once every 2 years by an organisation that assesses whether they meet regulation requirements.
A new, voluntary EU trust mark will identify the qualified trust services provided by the relevant providers.
A series of acts adopted by the European Commission in the course of 2015 set out:
procedural arrangements for cooperation between EU countries on electronic identification
specifications relating to the form of the EU trust mark for qualified trust services;
technical and operational requirements of the interoperability framework;
minimum technical specifications and procedures for assurance levels for eID means;
technical specifications and formats relating to trusted lists;
specifications relating to formats of advanced electronic signatures and advanced seals to be recognised by public sector bodies; and
circumstances, formats and procedures of notification of eID schemes.
FROM WHEN DOES THIS REGULATION APPLY?
It applies from 17 September 2014.
KEY TERM
*electronic identification (eID): tangible or intangible forms of identification containing personal ID data as used for authenticating an online service.
ACT
Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, pp. 73-114)
The successive amendments to Regulation (EU) No 910/2014 have been incorporated in to the original document. This consolidated version is of documentary value only.
last update 17.03.2016
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32014R0536
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27.5.2014
EN
Official Journal of the European Union
L 158/1
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 April 2014
on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)
In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests.
(2)
In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation.
(3)
The existing definition of a clinical trial as contained in Directive 2001/20/EC of the European Parliament and of the Council (3) should be clarified. For that purpose, the concept of clinical trial should be more precisely defined by introducing the broader concept of ‘clinical study’ of which the clinical trial is a category. That category should be defined on the basis of specific criteria. This approach takes due account of international guidelines, and is in line with the Union law governing medicinal products, which builds on the dichotomy of ‘clinical trial’ and ‘non-interventional study’.
(4)
Directive 2001/20/EC aims to simplify and harmonise the administrative provisions governing clinical trials in the Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a given clinical trial in several Member States. Scientific development, however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information. In order to include a sufficient number of patients for such clinical trials it may be necessary to involve many, or all, Member States. The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many Member States as possible. Therefore, in order to simplify the procedures for the submission of an application dossier for the authorisation of a clinical trial, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier to all the Member States concerned through a single submission portal. Given that clinical trials carried out in a single Member State are equally important to European clinical research, the application dossier for such clinical trials should also be submitted through that single portal.
(5)
As regards Directive 2001/20/EC, experience also indicates that the legal form of a Regulation would present advantages for sponsors and investigators, for example in the context of clinical trials taking place in more than one Member State, since they will be able to rely on its provisions directly, but also in the context of safety reporting and labelling of investigational medicinal products. Divergences of approach among different Member States will be therefore kept to a minimum.
(6)
The Member States concerned should cooperate in assessing a request for authorisation of a clinical trial. This cooperation should not include aspects of an intrinsically national nature, such as informed consent.
(7)
In order to avoid administrative delays for starting a clinical trial, the procedure to be used should be flexible and efficient, without compromising patient safety or public health.
(8)
The timelines for assessing an application dossier for clinical trials should be sufficient to assess the file while, at the same time, ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials. Against this background, Directive 2001/20/EC introduced the concept of tacit authorisation. This concept should be maintained in order to ensure that timelines are adhered to. In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly. No minimal timelines for approval should therefore be established.
(9)
Clinical trials for the development of orphan medicinal products as defined in Regulation (EC) No 141/2000 of the European Parliament and of the Council (4) and of medicinal products addressed to subjects affected by severe, debilitating and often life-threatening diseases affecting no more than one person in 50 000 in the Union (ultra-rare diseases) should be fostered.
(10)
Member States should efficiently assess all clinical trials applications within the given timelines. A rapid yet in-depth assessment is of particular importance for clinical trials concerning medical conditions which are severely debilitating and/or life threatening and for which therapeutic options are limited or non-existent, as in the case of rare and ultra-rare diseases.
(11)
The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention. Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice. This is particularly the case where the investigational medicinal product is covered by a marketing authorisation, that is the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure" or, if that product is not used in accordance with the terms of the marketing authorisation, that use is evidence- based and supported by published scientific evidence on the safety and efficacy of that product, and the intervention poses only very limited additional risk to the subject compared to normal clinical practice. Those low-intervention clinical trials are often of crucial importance for assessing standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health. Those clinical trials should be subject to less stringent rules, as regards monitoring, requirements for the contents of the master file and traceability of investigational medicinal products. In order to ensure subject safety they should however be subject to the same application procedure as any other clinical trial. The published scientific evidence supporting the safety and efficacy of an investigational medicinal product not used in accordance with the terms of the marketing authorisation could include high quality data published in scientific journal articles, as well as national, regional or institutional treatment protocols, health technology assessment reports or other appropriate evidence.
(12)
The Recommendation of the Organisation for Economic Cooperation and Development (OECD) Council on the Governance of Clinical Trials of 10 December 2012 introduced different risk categories for clinical trials. Those categories are compatible with the categories of clinical trials defined in this Regulation as the OECD Categories A and B(1) correspond to the definition of a low-intervention clinical trial as set out in this Regulation, and the OECD Categories B(2) and C correspond to the definition of a clinical trial as set out in this Regulation.
(13)
The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (relevance) and the risk and inconvenience for the subject. In respect of the relevance, various aspects should be taken into account, including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment of medicinal products and the authorisation of their placing on the market and whether surrogate end-points, when they are used, are justified.
(14)
Unless otherwise justified in the protocol, the subjects participating in a clinical trial should represent the population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trial.
(15)
In order to improve treatments available for vulnerable groups such as frail or older people, people suffering from multiple chronic conditions, and people affected by mental health disorders, medicinal products which are likely to be of significant clinical value should be fully and appropriately studied for their effects in these specific groups, including as regards requirements related to their specific characteristics and the protection of the health and well-being of subjects belonging to these groups.
(16)
The authorisation procedure should provide for the possibility to extend the timelines for the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier. Moreover, it should be ensured that, within the extension period, there is always sufficient time for assessing the additional information submitted.
(17)
The authorisation to conduct a clinical trial should address all aspects of subject protection and data reliability and robustness. That authorisation should therefore be contained in a single administrative decision by the Member State concerned.
(18)
It should be left to the Member State concerned to determine the appropriate body or bodies to be involved in the assessment of the application to conduct a clinical trial and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical trial as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. When determining the appropriate body or bodies, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available. In accordance with international guidelines, the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. The persons assessing the application should be independent of the sponsor, the clinical trial site, and the investigators involved, as well as free from any other undue influence.
(19)
The assessment of applications for the authorisation of clinical trials should be conducted on the basis of appropriate expertise. Specific expertise should be considered when assessing clinical trials involving subjects in emergency situations, minors, incapacitated subjects, pregnant and breastfeeding women and, where appropriate, other identified specific population groups, such as elderly people or people suffering from rare and ultra rare diseases.
(20)
In practice, sponsors do not always have all the information needed for submitting a complete application for authorisation of a clinical trial in all of the Member States where a clinical trial is eventually going to be conducted. It should be possible for sponsors to submit an application solely on the basis of documents assessed jointly by those Member States where the clinical trial might be conducted.
(21)
The sponsor should be allowed to withdraw the application for authorisation of a clinical trial. To ensure the reliable functioning of the assessment procedure, however, an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial. It should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application.
(22)
In practice, in order to reach recruitment targets or for other reasons, sponsors may have an interest in extending the clinical trial to an additional Member States after the initial authorisation of the clinical trial. An authorisation mechanism should be provided to allow for such extension, while avoiding the re-assessment of the application by all the Member States concerned which were involved in the initial authorisation of the clinical trial.
(23)
Clinical trials are usually subject to many modifications after they have been authorised. Those modifications may relate to the conduct, the design, the methodology, the investigational or auxiliary medicinal product, or the investigator or clinical trial site involved. Where those modifications have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial, they should be subject to an authorisation procedure similar to the initial authorisation procedure.
(24)
The content of the application dossier for authorisation of a clinical trial should be harmonised in order to ensure that all Member States have the same information available and to simplify the application process for clinical trials.
(25)
In order to increase transparency in the area of clinical trials, data from a clinical trial should only be submitted in support of a clinical trial application if that clinical trial has been recorded in a publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP). Data providers to the WHO ICTRP create and manage clinical trial records in a manner that is consistent with the WHO registry criteria. Specific provision should be made for data from clinical trials started before the date of application of this Regulation.
(26)
It should be left to Member States to establish the language requirements for the application dossier. To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should consider accepting a commonly understood language in the medical field as the language for the documentation not destined for the subject.
(27)
Human dignity and the right to the integrity of the person are recognised in the Charter of Fundamental Rights of the European Union (the ‘Charter’). In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned. Directive 2001/20/EC contains an extensive set of rules for the protection of subjects. These rules should be upheld. Regarding the rules concerning the determination of the legally designated representatives of incapacitated persons and minors, those rules diverge in Member States. It should therefore be left to Member States to determine the legally designated representatives of incapacitated persons and minors. Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection measures.
(28)
An appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner should be responsible for all medical care provided to the subject, including the medical care provided by other medical staff.
(29)
It is appropriate that universities and other research institutions, under certain circumstances that are in accordance with the applicable law on data protection, be able to collect data from clinical trials to be used for future scientific research, for example for medical, natural or social sciences research purposes. In order to collect data for such purposes it is necessary that the subject gives consent to use his or her data outside the protocol of the clinical trial and has the right to withdraw that consent at any time. It is also necessary that research projects based on such data be made subject to reviews that are appropriate for research on human data, for example on ethical aspects, before being conducted.
(30)
In accordance with international guidelines, the informed consent of a subject should be in writing. When the subject is unable to write, it may be recorded through appropriate alternative means, for instance through audio or video recorders. Prior to obtaining informed consent, the potential subject should receive information in a prior interview in a language which is easily understood by him or her. The subject should have the opportunity to ask questions at any moment. Adequate time should be provided for the subject to consider his or her decision. In view of the fact that in certain Member States the only person qualified under national law to perform an interview with a potential subject is a medical doctor while in other Member States this is done by other professionals, it is appropriate to provide that the prior interview with a potential subject should be performed by a member of the investigating team qualified for this task under the national law of the Member State where the recruitment takes place.
(31)
In order to certify that informed consent is given freely, the investigator should take into account all relevant circumstances which might influence the decision of a potential subject to participate in a clinical trial, in particular whether the potential subject belongs to an economically or socially disadvantaged group or is in a situation of institutional or hierarchical dependency that could inappropriately influence her or his decision to participate.
(32)
This Regulation should be without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, should himself or herself assent in order to participate in a clinical trial.
(33)
It is appropriate to allow that informed consent be obtained by simplified means for certain clinical trials where the methodology of the trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products. In those clinical trials the investigational medicinal products are used in accordance with the marketing authorisations, and the individual subject receives a standard treatment regardless of whether he or she accepts or refuses to participate in the clinical trial, or withdraws from it, so that the only consequence of non-participation is that data relating to him or her are not used for the clinical trial. Such clinical trials, which serve to compare established treatments, should always be conducted within a single Member State.
(34)
Specific provisions should be defined for the protection of pregnant and breastfeeding women participating in clinical trials and in particular when the clinical trial does not have the potential to produce results of direct benefit to her or to her embryo, foetus or child after birth.
(35)
Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures. Member States should be allowed to maintain such additional measures.
(36)
This Regulation should provide for clear rules concerning informed consent in emergency situations. Such situations relate to cases where for example a patient has suffered a sudden life-threatening medical condition due to multiple traumas, strokes or heart attacks, necessitating immediate medical intervention. For such cases, intervention within an ongoing clinical trial, which has already been approved, may be pertinent. However, in certain emergency situations, it is not possible to obtain informed consent prior to the intervention. This Regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions. In addition, the said clinical trial should relate directly to the medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative. Any previously expressed objection by the patient should be respected, and informed consent from the subject or from his or her legally designated representative should be sought as soon as possible.
(37)
In order to allow patients to assess possibilities to participate in a clinical trial, and to allow for effective supervision of a clinical trial by the Member State concerned, the start of the clinical trial, the end of the recruitment of subjects for the clinical trial and the end of the clinical trial should be notified. In accordance with international standards, the results of the clinical trial should be reported within one year from the end of the clinical trial.
(38)
The date of the first act of recruitment of a potential subject is the date on which the first act of the recruitment strategy described in the protocol was performed, e. g. the date of a contact with a potential subject or the date of the publication of an advertisement for a particular clinical trial.
(39)
The sponsor should submit a summary of the results of the clinical trial together with a summary that is understandable to a layperson, and the clinical study report, where applicable, within the defined timelines. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, for example when the clinical trial is still ongoing in third countries and data from that part of the trial are not available, which makes a statistical analysis not relevant, the sponsor should justify this in the protocol and specify when the results are going to be submitted.
(40)
In order for the sponsor to assess all potentially relevant safety information, the investigator should, as a rule, report to him all serious adverse events.
(41)
The sponsor should assess the information received from the investigator, and report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the European Medicines Agency (‘the Agency’).
(42)
The Agency should forward that information to the Member States for them to assess it.
(43)
The members of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have agreed on a detailed set of guidelines on good clinical practice which is an internationally accepted standard for designing, conducting, recording and reporting clinical trials, consistent with principles that have their origin in the World Medical Association's Declaration of Helsinki. When designing, conducting, recording and reporting clinical trials, detailed questions may arise as to the appropriate quality standard. In such a case, the ICH guidelines on good clinical practice should be taken appropriately into account for the application of the rules set out in this Regulation, provided that there is no other specific guidance issued by the Commission and that those guidelines are compatible with this Regulation.
(44)
The conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results. Monitoring may also contribute to subject safety, taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects. When establishing the extent of monitoring, the characteristics of the clinical trial should be taken into account.
(45)
The individuals involved in conducting a clinical trial, in particular investigators and other healthcare professionals, should be sufficiently qualified to perform their tasks, and the facilities where a clinical trial is to be conducted should be suitable for that clinical trial.
(46)
In order to ensure subject safety and the reliability and robustness of data from clinical trials, it is appropriate to provide that there should be arrangements for traceability, storage, return and destruction of investigational medicinal products, depending on the nature of the clinical trial. For the same reasons, there should also be such arrangements for unauthorised auxiliary medicinal products.
(47)
During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of that clinical trial. This should be reported to the Member States concerned in order for action to be taken by those Member States, where necessary.
(48)
Apart from the reporting of suspected unexpected serious adverse reactions, there may be other events which are relevant in terms of benefit-risk balance and which should be reported in a timely manner to the Member States concerned. It is important for subject safety that, in addition to serious adverse events and reactions, all unexpected events that might materially influence the benefit-risk assessment of the medicinal product or that would lead to changes in the administration of a medicinal product or in overall conduct of a clinical trial are notified to the Member States concerned. Examples of such unexpected events include an increase in the rate of occurrence of expected serious adverse reactions which may be clinically important, a significant hazard to the patient population, such as lack of efficacy of a medicinal product, or a major safety finding from a newly completed animal study (such as carcinogenicity).
(49)
Where unexpected events require an urgent modification of a clinical trial, it should be possible for the sponsor and the investigator to take urgent safety measures without awaiting prior authorisation. If such measures constitute a temporary halt of the clinical trial, the sponsor should apply for a substantial modification before restarting the clinical trial.
(50)
In order to ensure compliance of the conduct of a clinical trial with the protocol, and in order for investigators to be informed about the investigational medicinal products they administer, the sponsor should supply the investigators with an investigator's brochure.
(51)
The information generated in a clinical trial should be recorded, handled and stored adequately for the purpose of ensuring subject rights and safety, the robustness and reliability of the data generated in the clinical trial, accurate reporting and interpretation, effective monitoring by the sponsor and effective inspection by Member States.
(52)
In order to be able to demonstrate compliance with the protocol and with this Regulation, a clinical trial master file, containing relevant documentation to allow effective supervision (monitoring by the sponsor and inspection by Member States), should be kept by the sponsor and by the investigator. The clinical trial master file should be archived appropriately to allow for supervision after the clinical trial has ended.
(53)
Where there are problems with respect to the availability of authorised auxiliary medicinal products, unauthorised auxiliary medicinal products may be used in a clinical trial in justified cases. The price of the authorised auxiliary medicinal product should not be considered as having an effect on the availability of such medicinal products.
(54)
Medicinal products intended for research and development trials fall outside the scope of Directive 2001/83/EC of the European Parliament and of the Council (5). Such medicinal products include medicinal products used in the context of a clinical trial. They should be covered by specific rules taking account of their peculiarities. In establishing these rules, a distinction should be made between investigational medicinal products (the tested product and its reference products, including placebos) and auxiliary medicinal products (medicinal products used in the context of a clinical trial but not as investigational medicinal products), such as medicinal products used for background treatment, challenge agents, rescue medication, or used to assess end-points in a clinical trial. Auxiliary medicinal products should not include concomitant medications, that is medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
(55)
In order to ensure subject safety and the reliability and robustness of data generated in a clinical trial, and in order to allow for the distribution of investigational and auxiliary medicinal products to clinical trial sites throughout the Union, rules on the manufacturing and import of both investigational and auxiliary medicinal products should be established. As is already the case for Directive 2001/20/EC, those rules should reflect the existing rules of good manufacturing practices for products covered by Directive 2001/83/EC. In some specific cases, it should be possible to allow deviations from those rules in order to facilitate the conduct of a clinical trial. Therefore, the applicable rules should allow for some flexibility, provided that subject safety, as well as reliability and robustness of the data generated in the clinical trial are not compromised.
(56)
The requirement to hold an authorisation for manufacture or import of investigational medicinal products should not apply to the preparation of investigational radiopharmaceuticals from radionuclide generators, kits or radionuclide precursors in accordance with the manufacturer's instructions for use in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State.
(57)
Investigational and auxiliary medicinal products should be appropriately labelled in order to ensure subject safety and the reliability and robustness of data generated in clinical trials, and in order to allow for the distribution of those products to clinical trial sites throughout the Union. The rules for labelling should be adapted to the risks to subject safety and the reliability and robustness of data generated in clinical trials. Where the investigational or auxiliary medicinal product have already been placed on the market as an authorised medicinal product in accordance with Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council (6), as a general rule no additional labelling should be required for clinical trials that do not involve the blinding of the label. Moreover, there are specific products, such as radiopharmaceuticals used as diagnostic investigational medicinal product, where the general rules on labelling are inappropriate in view of the very controlled setting of the use of radiopharmaceuticals in clinical trials.
(58)
In order to ensure clear responsibilities, the concept of a ‘sponsor’ of a clinical trial, in line with international guidelines, was introduced by Directive 2001/20/EC. This concept should be upheld.
(59)
In practice, there may be loose, informal networks of researchers or research institutions which jointly conduct a clinical trial. Those networks should be able to be co-sponsors of a clinical trial. In order not to weaken the concept of responsibility in a clinical trial, where a clinical trial has several sponsors, they should all be subject to the obligations of a sponsor under this Regulation. However, the co-sponsors should be able to split up the responsibilities of the sponsor by contractual agreement.
(60)
In order to ensure that enforcement action may be taken by Member States and that legal proceedings may be brought in appropriate cases, it is appropriate to provide that sponsors that are not established in the Union should be represented by a legal representative in the Union. However in view of the divergent approaches of the Member States as regards civil and criminal liability, it is appropriate to leave to each Member State concerned, as regards its territory, the choice as to whether or not to require such a legal representative, provided that at least a contact person is established in the Union.
(61)
Where, in the course of a clinical trial, damage caused to the subject leads to the civil or criminal liability of the investigator or the sponsor, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
(62)
In clinical trials compensation should be ensured for damages successfully claimed in accordance with the applicable laws. Therefore Member States should ensure that systems for compensation for damages suffered by a subject are in place which are appropriate to the nature and the extent of the risk.
(63)
The Member State concerned should be given the power to revoke the authorisation of a clinical trial, suspend a clinical trial or require the sponsor to modify a clinical trial.
(64)
In order to ensure compliance with this Regulation, Member States should be able to conduct inspections and should have adequate inspection capacities.
(65)
The Commission should be able to control whether Member States correctly supervise compliance with this Regulation. Moreover, the Commission should be able to control whether regulatory systems of third countries ensure compliance with the specific provisions of this Regulation and Directive 2001/83/EC concerning clinical trials conducted in third countries.
(66)
In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the Agency should, in collaboration with Member States and the Commission, set up and maintain an EU database, accessed through an EU portal.
(67)
In order to ensure a sufficient level of transparency in the clinical trials, the EU database should contain all relevant information as regards the clinical trial submitted through the EU portal. The EU database should be publicly accessible and data should be presented in an easily searchable format, with related data and documents linked together by the EU trial number and with hyperlinks, for example linking together the summary, the layperson's summary, the protocol and the clinical study report of one clinical trial, as well as linking to data from other clinical trials which used the same investigational medicinal product. All clinical trials should be registered in the EU database prior to being started. As a rule, the start and end dates of the recruitment of subjects should also be published in the EU database. No personal data of data subjects participating in a clinical trial should be recorded in the EU database. The information in the EU database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter. Publicly available information contained in the EU database should contribute to protecting public health and fostering the innovation capacity of European medical research, while recognising the legitimate economic interests of sponsors.
(68)
For the purposes of this Regulation, in general the data included in a clinical study report should not be considered commercially confidential once a marketing authorisation has been granted, the procedure for granting themarketing authorisation has been completed, the application for marketing authorisation has been withdrawn. In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt and early termination, in general, should not be considered confidential.
(69)
Within a Member State, there may be several bodies involved in the authorisation of clinical trials. In order to allow for effective and efficient cooperation between Member States, each Member State should designate one contact point.
(70)
The authorisation procedure set out in this Regulation is largely controlled by Member States. Nevertheless, the Commission and the Agency should support the good functioning of that procedure, in accordance with this Regulation.
(71)
In order to carry out the activities provided for in this Regulation, Member States should be allowed to levy fees. However, Member States should not require multiple payments to different bodies involved in the assessment, in a given Member State, of an application for authorisation of a clinical trial.
(72)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the establishment and modification of rules on cooperation between the Member States when assessing the information provided by the sponsor on the Eudravigilance database and the specification of detailed arrangements for inspection procedures. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (7).
(73)
In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of: the amendment of Annexes I, II, IV and V to this Regulation in order to adapt them to technical progress or to take account of international regulatory developments in which the Union or the Member States are involved, in the field of clinical trials; the amendment of Annex III in order to improve the information on the safety of medicinal products, to adapt technical requirements to technical progress or to take account of international regulatory developments in the field of safety requirements in clinical trials endorsed by bodies in which the Union or the Member States participate; the specification of the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products; the amendment of Annex VI in order to ensure subject safety and the reliability and robustness of data generated in a clinical trial or to take account of technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(74)
Directive 2001/83/EC provides that that Directive does not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as abortifacients. Directive 2001/83/EC provides that national legislation prohibiting or restricting the use of any specific type of human or animal cells is not, in principle, affected by either that Directive or any of the Regulations referred to therein. Likewise, this Regulation should not affect national law prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products used as abortifacients. In addition, this Regulation should not affect national law prohibiting or restricting the sale, supply or use of medicinal products containing narcotic substances within the meaning of the relevant international conventions in force such as the Single Convention on Narcotic Drugs of 1961 of the United Nations. Member States should communicate those national provisions to the Commission.
(75)
Directive 2001/20/EC provides that no gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity. It is appropriate to maintain that provision.
(76)
Directive 95/46/EC of the European Parliament and of the Council (8) applies to the processing of personal data carried out in the Member States within the framework of this Regulation, under the supervision of the Member States competent authorities, in particular the public independent authorities designated by the Member States and Regulation (EC) No 45/2001 of the European Parliament and of the Council (9) applies to the processing of personal data carried out by the Commission and the Agency within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. Those instruments strengthen personal data protection rights, encompassing the right to access, rectification and withdrawal, as well as specify the situations when restriction on those rights may be imposed. With a view to respecting those rights, while safeguarding the robustness and reliability of data from clinical trials used for scientific purposes and the safety of subjects participating in clinical trials, it is appropriate to provide that, without prejudice to Directive 95/46/EC, the withdrawal of informed consent should not affect the results of activities already carried out, such as the storage and use of data obtained on the basis of informed consent before withdrawal.
(77)
Subjects should not have to pay for investigational medicinal products, auxiliary medicinal products, medical devices used for their administration and procedures specifically required by the protocol, unless the law of the Member State concerned provides otherwise.
(78)
The authorisation procedure set out in this Regulation should apply as soon as possible, in order for sponsors to reap the benefits of a streamlined authorisation procedure. However, in view of the importance of the extensive IT functionalities required for the authorisation procedure, it is appropriate to provide that this Regulation should only become applicable once it has been verified that the EU portal and the EU database are fully functional.
(79)
Directive 2001/20/EC should be repealed to ensure that only one set of rules applies to the conduct of clinical trials in the Union. In order to facilitate the transition to the rules set out in this Regulation, sponsors should be allowed to start and conduct a clinical trial in accordance with Directive 2001/20/EC during a transitional period.
(80)
This Regulation is in line with the major international guidance documents on clinical trials, such as the 2008 version of the World Medical Association's Declaration of Helsinki and good clinical practice, which has its origins in the Declaration of Helsinki.
(81)
As regards Directive 2001/20/EC, experience also shows that a large proportion of clinical trials are conducted by non-commercial sponsors. Non-commercial sponsors frequently rely on funding which comes partly or entirely from public funds or charities. In order to maximise the valuable contribution of such non-commercial sponsors and to further stimulate their research but without compromising the quality of clinical trials, measures should be taken by Member States to encourage clinical trials conducted by those sponsors.
(82)
This Regulation is based on the double legal basis of Articles 114 and 168(4)(c) TFEU. It aims at achieving an internal market as regards clinical trials and medicinal products for human use, taking as a base a high level of protection of health. At the same time, this Regulation sets high standards of quality and safety for medicinal products in order to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously. These two objectives are inseparably linked and one is not secondary to another. Regarding Article 114 TFEU, this Regulation harmonises the rules for the conduct of clinical trials in the Union, therefore ensuring the functioning of the internal market in view of the conduct of a clinical trial in several Member States, the acceptability throughout the Union of data generated in a clinical trial and submitted in the application for the authorisation of another clinical trial or of the placing on the market of a medicinal product, and the free movement of medicinal products used in the context of a clinical trial. Regarding Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medicinal products by ensuring that data generated in clinical trials are reliable and robust, thus ensuring that treatments and medicines which are intended to be an improvement of a treatment of patients build on reliable and robust data. Moreover, this Regulation sets high standards of quality and safety of medicinal products used in the context of a clinical trial, thus ensuring the safety of subjects in a clinical trial.
(83)
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science. This Regulation should be applied by the Member States in accordance with those rights and principles.
(84)
The European Data Protection Supervisor has given an opinion (10) pursuant to Article 28(2) of Regulation (EC) No 45/2001.
(85)
Since the objective of this Regulation, namely to ensure that, throughout the Union, clinical trial data are reliable and robust while ensuring respect for the rights, safety, dignity and well-being of subjects, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
This Regulation applies to all clinical trials conducted in the Union.
It does not apply to non-interventional studies.
Article 2
Definitions
1. For the purposes of this Regulation, the definitions of ‘medicinal product’, ‘radiopharmaceutical’, ‘adverse reaction’, ‘serious adverse reaction’, ‘immediate packaging’ and ‘outer packaging’ set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply.
2. For the purposes of this Regulation, the following definitions also apply:
(1)
‘Clinical study’ means any investigation in relation to humans intended:
(a)
to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
(b)
to identify any adverse reactions to one or more medicinal products; or
(c)
to study the absorption, distribution, metabolism and excretion of one or more medicinal products;
with the objective of ascertaining the safety and/or efficacy of those medicinal products;
(2)
‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
(a)
the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b)
the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c)
diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
(3)
‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions:
(a)
the investigational medicinal products, excluding placebos, are authorised;
(b)
according to the protocol of the clinical trial,
(i)
the investigational medicinal products are used in accordance with the terms of the marketing authorisation; or
(ii)
the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and
(c)
the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned;
(4)
‘Non-interventional study’ means a clinical study other than a clinical trial;
(5)
‘Investigational medicinal product’ means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial;
(6)
‘Normal clinical practice’ means the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder;
(7)
‘Advanced therapy investigational medicinal product’ means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council (11);
(8)
‘Auxiliary medicinal product’ means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product;
(9)
‘Authorised investigational medicinal product’ means a medicinal product authorised in accordance with Regulation (EC) No 726/2004 or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an investigational medicinal product;
(10)
‘Authorised auxiliary medicinal product’ means a medicinal product authorised in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an auxiliary medicinal product;
(11)
‘Ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
(12)
‘Member State concerned’ means the Member State where an application for authorisation of a clinical trial or of a substantial modification has been submitted under Chapters II or III of this Regulation respectively;
(13)
‘Substantial modification’ means any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;
(14)
‘Sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial;
(15)
‘Investigator’ means an individual responsible for the conduct of a clinical trial at a clinical trial site;
(16)
‘Principal investigator’ means an investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site;
(17)
‘Subject’ means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control;
(18)
‘Minor’ means a subject who is, according to the law of the Member State concerned, under the age of legal competence to give informed consent;
(19)
‘Incapacitated subject’ means a subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the Member State concerned;
(20)
‘Legally designated representative’ means a natural or legal person, authority or body which, according to the law of the Member State concerned, is empowered to give informed consent on behalf of a subject who is an incapacitated subject or a minor;
(21)
‘Informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject's decision to participate or, in case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical trial;
(22)
‘Protocol’ means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. The term ‘protocol’ encompasses successive versions of the protocol and protocol modifications;
(23)
‘Investigator's brochure’ means a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in humans;
(24)
‘Manufacturing’ means total and partial manufacture, as well as the various processes of dividing up, packaging and labelling (including blinding);
(25)
‘Start of a clinical trial’ means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol;
(26)
‘End of a clinical trial’ means the last visit of the last subject, or at a later point in time as defined in the protocol;
(27)
‘Early termination of a clinical trial’ means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with;
(28)
‘Temporary halt of a clinical trial’ means an interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it;
(29)
‘Suspension of a clinical trial’ means interruption of the conduct of a clinical trial by a Member State;
(30)
‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust;
(31)
‘Inspection’ means the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the clinical trial site, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;
(32)
‘Adverse event’ means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment;
(33)
‘Serious adverse event’ means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death;
(34)
‘Unexpected serious adverse reaction’ means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information;
(35)
‘Clinical study report’ means a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation.
3. For the purposes of this Regulation, a subject who falls under the definition of both ‘minor’ and ‘incapacitated subject’ shall be deemed to be an incapacitated subject.
Article 3
General principle
A clinical trial may be conducted only if:
(a)
the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests; and
(b)
it is designed to generate reliable and robust data.
CHAPTER II
AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL
Article 4
Prior authorisation
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation.
The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned. The review by the ethics committee may encompass aspects addressed in Part I of the assessment report for the authorisation of a clinical trial as referred to in Article 6 and in Part II of that assessment report as referred to in Article 7 as appropriate for each Member State concerned.
Member States shall ensure that the timelines and procedures for the review by the ethics committees are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial.
Article 5
Submission of an application
1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 80 (the ‘EU portal’).
The sponsor shall propose one of the Member States concerned as reporting Member State.
If a Member State concerned other than the proposed reporting Member State is willing to be the reporting Member State or where the proposed reporting Member State does not wish to be the reporting Member State, this shall be notified through the EU portal to all Member States concerned not later than three days after the application dossier is submitted.
If only one Member State concerned is willing to be the reporting Member State or if the clinical trial involves only one Member State, that Member State shall be the reporting Member State.
If there is no Member State concerned willing to be the reporting Member State or if there is more than one Member State concerned willing to be the reporting Member State, the reporting Member State shall be selected by agreement among the Member States concerned taking into account the recommendations referred to in point (c) of Article 85(2).
If there is no agreement among the Member States concerned, the proposed reporting Member State shall be the reporting Member State.
The reporting Member State shall notify the sponsor and the other Member States concerned that it is the reporting Member State, through the EU portal, within six days from the submission of the application dossier.
2. The sponsor shall, when applying for a low-intervention clinical trial, where the investigational medicinal product is not used in accordance with the terms of the marketing authorisation but the use of that product is evidence-based and supported by published scientific evidence on the safety and efficacy of that product, propose one of the Member States concerned where the use is evidence-based, as reporting Member State.
3. Within 10 days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor, through the EU portal, of the following:
(a)
whether the clinical trial applied for falls within the scope of this Regulation;
(b)
whether the application dossier is complete in accordance with Annex I;
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application within seven days from the submission of the application dossier.
4. Where the reporting Member State has not notified the sponsor within the period referred to in the first subparagraph of paragraph 3, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
5. Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application dossier is not complete, or that the clinical trial applied for does not fall within the scope of this Regulation, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of the first subparagraph of paragraph 3.
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
6. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 3 or 5 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 3 and 5.
Article 6
Assessment report — Aspects covered by Part I
1. The reporting Member State shall assess the application with regard to the following aspects:
(a)
Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor;
(b)
Compliance with Chapter V with respect to the following:
(i)
The anticipated therapeutic and public health benefits taking account of all of the following:
—
the characteristics of and knowledge about the investigational medicinal products;
—
the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council (12);
—
the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints;
(ii)
The risks and inconveniences for the subject, taking account of all of the following:
—
the characteristics of and knowledge about the investigational medicinal products and the auxiliary medicinal products;
—
the characteristics of the intervention compared to normal clinical practice;
—
the safety measures, including provisions for risk minimisation measures, monitoring, safety reporting, and the safety plan;
—
the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated;
(c)
Compliance with the requirements concerning the manufacturing and import of investigational medicinal products and auxiliary medicinal products set out in Chapter IX;
(d)
Compliance with the labelling requirements set out in Chapter X;
(e)
The completeness and adequateness of the investigator's brochure.
2. The reporting Member State shall draw up an assessment report. The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report.
3. The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report:
(a)
the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation;
(b)
the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation, but subject to compliance with specific conditions which shall be specifically listed in that conclusion; or
(c)
the conduct of the clinical trial is not acceptable in view of the requirements set out in this Regulation.
4. The reporting Member State shall submit, through the EU portal, the final Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within 45 days from the validation date.
5. For clinical trials involving more than one Member State, the assessment process shall include three phases:
(a)
an initial assessment phase performed by the reporting Member State within 26 days from the validation date;
(b)
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned;
(c)
a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase.
During the initial assessment phase, the reporting Member State shall develop a draft Part I of the assessment report and circulate it to all other Member States concerned.
During the coordinated review phase, all Member States concerned shall jointly review the application based on the draft Part I of the assessment report and shall share any considerations relevant to the application.
During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising Part I of the assessment report and shall record how all such considerations have been dealt with. The reporting Member State shall submit the final Part I of the assessment report to the sponsor and all other Member States concerned within the period referred to in paragraph 4.
6. For the purposes of this Chapter, the date on which the final Part I of the assessment report is submitted by the reporting Member State to the sponsor and to the other Member States concerned shall be the reporting date.
7. The reporting Member State may also extend the period referred to in paragraph 4 by a further 50 days for clinical trials involving an advanced therapy investigational medicinal products or a medicinal product as defined in point 1 of the Annex to Regulation (EC) No 726/2004, for the purpose of consulting with experts. In such case, the periods referred to in paragraphs 5 and 8 of this Article shall apply mutatis mutandis.
8. Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 5.
For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraph, the reporting Member State may extend the period referred to in paragraph 4 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the reporting Member State which shall not exceed 12 days from the receipt of the request.
Upon receipt of the additional information, the Member States concerned shall jointly review any additional information provided by the sponsor together with the original application and shall share any considerations relevant to the application. The coordinated review shall be performed within a maximum of 12 days of the receipt of the additional information and the further consolidation shall be performed within a maximum of seven days of the end of coordinated review. When finalising Part I of the assessment report, the reporting Member State shall take due account of the considerations of the Member States concerned and shall record how all such considerations have been dealt with.
Where the sponsor does not provide additional information within the period set by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
The request for additional information and the additional information shall be submitted through the EU portal.
Article 7
Assessment report — Aspects covered by Part II
1. Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects:
(a)
compliance with the requirements for informed consent as set out in Chapter V;
(b)
compliance of the arrangements for rewarding or compensating subjects with the requirements set out in Chapter V and investigators;
(c)
compliance of the arrangements for recruitment of subjects with the requirements set out in Chapter V;
(d)
compliance with Directive 95/46/EC;
(e)
compliance with Article 49;
(f)
compliance with Article 50;
(g)
compliance with Article 76;
(h)
compliance with the applicable rules for the collection, storage and future use of biological samples of the subject.
The assessment of the aspects referred to in the first subparagraph shall constitute Part II of the assessment report.
2. Each Member State concerned shall complete its assessment within 45 days from the validation date and submit, through the EU portal, Part II of the assessment report, including its conclusion, to the sponsor.
Each Member State concerned may request, with justified reasons, additional information from the sponsor regarding the aspects referred to in paragraph 1 only within the period referred to in the first subparagraph.
3. For the purpose of obtaining and reviewing the additional information referred to in the second subparagraph of paragraph 2 from the sponsor in accordance with the second and third subparagraph, the Member State concerned may extend the period referred to in the first subparagraph of paragraph 2 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from the receipt of the request.
Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.
Where the sponsor does not provide additional information within the period set by the Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in that Member State concerned.
The request for additional information and the additional information shall be submitted through the EU portal.
Article 8
Decision on the clinical trial
1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the clinical trial is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Notification shall be done by way of one single decision within five days from the reporting date or from the last day of the assessment referred to in Article 7, whichever is later.
An authorisation of a clinical trial subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
2. Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member State concerned.
Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the reporting Member State as regards Part I of the assessment report only on the following grounds:
(a)
when it considers that participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal clinical practice in the Member State concerned;
(b)
infringement of its national law as referred to in Article 90;
(c)
considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 8 of Article 6.
Where a Member State concerned disagrees with the conclusion on the basis of the second subparagraph, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States, and to the sponsor.
3. Where, regarding the aspects covered by Part I of the assessment report, the clinical trial is acceptable or acceptable subject to compliance with specific conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report.
4. A Member State concerned shall refuse to authorise a clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in the second subparagraph of paragraph 2, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which in accordance with the law of the Member State concerned is valid for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal.
5. Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the clinical trial is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
6. Where the Member State concerned has not notified the sponsor of its decision within the relevant periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the clinical trial.
7. The Member States concerned shall not request additional information regarding the aspects addressed in Part I of the assessment report from the sponsor after the reporting date.
8. For the purposes of this Chapter, the notification date shall be the date on which the decision referred to in paragraph 1 is notified to the sponsor. Where the sponsor has not been notified in accordance with paragraph 1, the notification date shall be deemed to be the last day of the period provided for in paragraph 1.
9. If no subject has been included in the clinical trial in a Member State concerned within two years from the notification date of the authorisation, the authorisation shall expire in that Member State concerned unless an extension, on request of the sponsor, has been approved following the procedure set out in Chapter III.
Article 9
Persons assessing the application
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, of the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence.
In order to guarantee independence and transparency, the Member States shall ensure that persons admitting and assessing the application as regards the aspects addressed in Parts I and II of the assessment report have no financial or personal interests which could affect their impartiality. These persons shall make an annual declaration of their financial interests.
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience.
3. At least one layperson shall participate in the assessment.
Article 10
Specific considerations for vulnerable populations
1. Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of paediatric expertise or after taking advice on clinical, ethical and psychosocial problems in the field of paediatrics.
2. Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical and psychosocial questions in the field of the relevant disease and the patient population concerned.
3. Where the subjects are pregnant or breastfeeding women, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant condition and the population represented by the subject concerned.
4. If according to the protocol a clinical trial provides for the participation of specific groups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of the application for authorisation of that clinical trial on the basis of expertise in the population represented by the subjects concerned.
5. In any application for authorisation of a clinical trial referred to in Article 35, specific consideration shall be given to the circumstances of the conduct of the clinical trial.
Article 11
Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the conclusion shall be limited to the aspects covered by Part I of the assessment report.
After the notification of the conclusion on the aspects covered by Part I of the assessment report, the sponsor may within two years apply for an authorisation limited to aspects covered by Part II of the assessment report. In that application the sponsor shall declare that he is not aware of any new substantial scientific information that would change the validity of any item submitted in the application on the aspects covered by Part I of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision on the clinical trial in accordance with Article 8. In those Member States where the sponsor does not apply for an authorisation limited to aspects covered by Part II of the assessment report within two years, the application on the aspects covered by Part I of the assessment report shall be deemed to have lapsed.
Article 12
Withdrawal
The sponsor may withdraw the application at any time until the reporting date. In such a case, the application may only be withdrawn with respect to all Member States concerned. The reasons for the withdrawal shall be communicated through the EU portal.
Article 13
Resubmission
This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned. That application shall be deemed to be a new application for authorisation of another clinical trial.
Article 14
Subsequent addition of a Member State concerned
1. Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additional Member State concerned’), the sponsor shall submit an application dossier to that Member State through the EU portal.
The application dossier may be submitted only after the notification date of the initial authorisation decision.
2. The reporting Member State for the application dossier referred to in paragraph 1 shall be the reporting Member State for the initial authorisation procedure.
3. The additional Member State concerned shall notify the sponsor through the EU portal, within 52 days from the date of submission of the application dossier referred to in paragraph 1, by way of one single decision as to whether the clinical trial is authorised, whether it is authorised subject to conditions, or whether the authorisation is refused.
An authorisation of a clinical trial subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
4. Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the additional Member State concerned.
Notwithstanding the first subparagraph, an additional Member State concerned may disagree with the conclusion of the reporting Member State as regards Part I of the assessment report only on the following grounds:
(a)
when it considers that participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal clinical practice in the Member State concerned;
(b)
infringement of its national law as referred to in Article 90;
(c)
considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 6.
Where an additional Member State concerned disagrees with the conclusion on the basis of the second subparagraph, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States, and to the sponsor.
5. Between the date of submission of the application dossier referred to in paragraph 1 and five days before the expiry of the period referred to in paragraph 3, the additional Member State concerned may communicate to the reporting Member State and the other Member States concerned any considerations relevant to the application through the EU portal.
6. Between the date of submission of the application dossier referred to in paragraph 1 and the expiry of the period referred to in paragraph 3, only the reporting Member State may request additional information from the sponsor concerning the aspects addressed in Part I of the assessment report, taking into account the considerations referred to in paragraph 5.
For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraphs, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the reporting Member State which shall not exceed 12 days from receipt of the request.
Upon receipt of the additional information, the additional Member State concerned together with all other Member States concerned shall jointly review any additional information provided by the sponsor together with the original application and shall share any considerations relevant to the application. The coordinated review shall be performed within a maximum of 12 days from the receipt of the additional information and the further consolidation shall be performed within a maximum of seven days from the end of the coordinated review. The reporting Member State shall take due account of the considerations of the Member States concerned and shall record how all such considerations have been dealt with.
Where the sponsor does not provide additional information within the period set by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in the additional Member State concerned.
The request for additional information and the additional information shall be submitted through the EU portal.
7. The additional Member State concerned shall assess, for its territory, the aspects addressed in Part II of the assessment report within the period referred to in paragraph 3 and submit, through the EU portal, Part II of the assessment report, including its conclusion, to the sponsor. Within that period it may request, with justified reasons, additional information from the sponsor regarding aspects addressed in Part II of the assessment report as far as its territory is concerned.
8. For the purpose of obtaining and reviewing the additional information referred to in paragraph 7 from the sponsor in accordance with the second and third subparagraphs, the additional Member State concerned may extend the period referred to in paragraph 7 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the additional Member State concerned which shall not exceed 12 days from receipt of the request.
Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.
Where the sponsor does not provide additional information within the period set by the additional Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in the additional Member State concerned.
The request for additional information and the additional information shall be submitted through the EU portal.
9. Where, regarding the aspects covered by Part I of the assessment report, the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, the additional Member State concerned shall include in its decision its conclusion on Part II of the assessment report.
10. The additional Member State concerned shall refuse to authorise the clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 4, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which, in accordance with the law of the additional Member State concerned, is valid for that entire additional Member State. That additional Member State concerned shall provide for an appeal procedure in respect of such refusal.
11. Where the additional Member State concerned has not notified the sponsor of its decision within the period referred to in paragraph 3, or in case that period has been extended in accordance with paragraph 6 or 8 where that additional Member State concerned has not notified the sponsor of its decision within the extended period, the conclusion on Part I of the assessment report shall be deemed to be the decision of that additional Member State concerned on the application for authorisation of the clinical trial.
12. A sponsor shall not submit an application dossier in accordance with this Article where a procedure set out in Chapter III is pending as regards that clinical trial.
CHAPTER III
AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
Article 15
General principles
A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clinical trial site, may only be implemented if it has been approved in accordance with the procedure set out in this Chapter.
Article 16
Submission of application
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.
Article 17
Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
1. The reporting Member State for the authorisation of a substantial modification shall be the reporting Member State for the initial authorisation procedure.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application of a substantial modification within five days from the submission of the application dossier.
2. Within six days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor through the EU portal as to whether:
(a)
the substantial modification concerns an aspect covered by Part I of the assessment report; and
(b)
the application dossier is complete in accordance with Annex II.
3. Where the reporting Member State has not notified the sponsor within the period referred to in paragraph 2, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
4. Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application does not concern an aspect covered by Part I of the assessment report or that the application dossier is not complete, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of paragraph 2.
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
5. For the purposes of Articles 18, 19 and 22, the date on which the sponsor is notified in accordance with paragraph 2 or 4 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 2 and 4.
Article 18
Assessment of a substantial modification of an aspect covered by Part I of the assessment report
1. The reporting Member State shall assess the application with regard to an aspect covered by Part I of the assessment report, including whether the clinical trial will remain a low-intervention clinical trial after its substantial modification, and draw up an assessment report.
2. The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report:
(a)
the substantial modification is acceptable in view of the requirements set out in this Regulation;
(b)
the substantial modification is acceptable in view of the requirements set out in this Regulation, but subject to compliance with specific conditions which shall be specifically listed in that conclusion; or
(c)
the substantial modification is not acceptable in view of the requirements set out in this Regulation.
3. The reporting Member State shall submit, through the EU portal, the final assessment report including its conclusion, to the sponsor and to the other Member States concerned within 38 days from the validation date.
For the purposes of this Article and Articles 19 and 23, the reporting date shall be the date on which the final assessment report is submitted to the sponsor and to the other Member States concerned.
4. For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases:
(a)
an initial assessment phase performed by the reporting Member State within 19 days from the validation date;
(b)
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned; and
(c)
a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase.
During the initial assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all Member States concerned.
During the coordinated review phase, all Member States concerned shall jointly review the application based on the draft assessment report and shall share any considerations relevant to the application.
During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising the assessment report and shall record how all such considerations have been dealt with. The reporting Member State shall submit the final assessment report to the sponsor and all other Member States concerned by the reporting date.
5. The reporting Member State may extend the period referred to in paragraph 3 by a further 50 days for clinical trials involving an advanced therapy investigational medicinal product or a medicinal product as set out in point 1 of the Annex to Regulation (EC) No 726/2004, for the purpose of consulting with experts. In such case, the periods referred to in paragraphs 4 and 6 of this Article shall apply mutatis mutandis.
6. Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 4.
For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraph, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the reporting Member State which shall not exceed 12 days from receipt of the request.
Upon receipt of the additional information, the Member States concerned shall jointly review any additional information provided by the sponsor together with the original application and shall share any considerations relevant to the application. The coordinated review shall be performed within a maximum of 12 days from receipt of the additional information and the further consolidation shall be performed within a maximum of seven days from the end of the coordinated review. When finalising the assessment report, the reporting Member State shall take due account of the considerations of the other Member States concerned and shall record how all such considerations have been dealt with.
Where the sponsor does not provide additional information within the period determined by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
The request for additional information and the additional information shall be submitted through the EU portal.
Article 19
Decision on the substantial modification of an aspect covered by Part I of the assessment report
1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Notification shall be done by way of a single decision within five days from the reporting date.
An authorisation of a substantial modification subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
2. Where the conclusion of the reporting Member State is that the substantial modification is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member State concerned.
Notwithstanding the first subparagraph, a Member State concerned may disagree with that conclusion of the reporting Member State only on the following grounds:
(a)
when it considers that participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal clinical practice in the Member State concerned;
(b)
infringement of its national law as referred to in Article 90;
(c)
considerations as regards subject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.
Where the Member State concerned disagrees with the conclusion on the basis of the second subparagraph, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States and to the sponsor.
A Member State concerned shall refuse to authorise a substantial modification if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in the second subparagraph, or where an ethics committee has issued a negative opinion which, in accordance with the law of that Member State concerned, is valid for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal.
3. Where the conclusion of the reporting Member State, as regards the substantial modification of aspects covered by Part I of the assessment report, is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
4. Where the Member State concerned has not notified the sponsor of its decision within the period referred to in paragraph 1, the conclusion of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the substantial modification.
Article 20
Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
1. Within six days from the submission of the application dossier, the Member State concerned shall notify the sponsor through the EU portal of the following:
(a)
whether the substantial modification concerns an aspect covered by Part II of the assessment report; and
(b)
whether the application dossier is complete in accordance with Annex II.
2. Where the Member State concerned has not notified the sponsor within the period referred to in paragraph 1, the substantial modification applied for shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.
3. Where the Member State concerned finds that the substantial modification does not concern an aspect covered by Part II of the assessment report or that the application dossier is not complete, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of paragraph 1.
Where the Member State concerned has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.
Where the sponsor has not provided comments nor completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in the Member State concerned.
4. For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 1 and 3.
5. The Member State concerned shall assess the application and shall submit to the sponsor, through the EU portal, Part II of the assessment report, including its conclusion, and the decision as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Notification shall be done by way of a single decision within 38 days from the validation date.
An authorisation of a substantial modification subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
6. During the period referred to in the second subparagraph of paragraph 5, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding the substantial modification as far as its territory is concerned.
For the purpose of obtaining and reviewing this additional information from the sponsor, the Member State concerned may extend the period referred to in the second subparagraph of paragraph 5 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from receipt of the request.
Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.
Where the sponsor does not provide additional information within the period set by the Member State concerned in accordance with the third subparagraph, the application shall be deemed to have lapsed in that Member State.
The request for additional information and the additional information shall be submitted through the EU portal.
7. A Member State concerned shall refuse to authorise a substantial modification if it finds, on duly justified grounds, that the aspects covered by Part II of the assessment report are not complied with or where an ethics committee has issued a negative opinion which, in accordance with the law of that Member State concerned, is valid for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal.
8. Where the Member State concerned has not notified the sponsor of its decision within the periods set out in paragraphs 5 and 6, the substantial modification shall be deemed to be authorised in that Member State.
Article 21
Substantial modification of aspects covered by Parts I and II of the assessment report
1. Where a substantial modification relates to aspects covered by Parts I and II of the assessment report, the application for authorisation of that substantial modification shall be validated in accordance with Article 17.
2. The aspects covered by Part I of the assessment report shall be assessed in accordance with Article 18 and the aspects covered by Part II of the assessment report shall be assessed in accordance with Article 22.
Article 22
Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
1. Each Member State concerned shall assess, for its own territory, the aspects of the substantial modification which are covered by Part II of the assessment report and submit, through the EU portal, that report, including its conclusion, to the sponsor within 38 days from the validation date.
2. During the period referred to in paragraph 1, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding this substantial modification as far as its territory is concerned.
3. For the purpose of obtaining and reviewing the additional information referred to in paragraph 2 from the sponsor in accordance with the third and fourth subparagraph, the Member State concerned may extend the period referred to paragraph 1 by a maximum of 31 days.
The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from the receipt of the request.
Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.
Where the sponsor does not provide the requested additional information within the period set by the Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in that Member State.
The request for additional information and the additional information shall be submitted through the EU portal.
Article 23
Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Notification shall be done by way of a single decision within five days from the reporting date or from the last day of the assessment period referred to in Article 22, whichever is later.
An authorisation of a substantial modification subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
2. Where the conclusion of the reporting Member State is that the substantial modification of aspects covered by Part I of the assessment report is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member State concerned.
Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the reporting Member State only on the following grounds:
(a)
when it considers that participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal clinical practice in the Member State concerned;
(b)
infringement of its national law as referred to in Article 90;
(c)
considerations as regards suject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.
Where the Member State concerned disagrees with the conclusion regarding the substantial modification of aspects covered by Part I of the assessment report on the basis of the second subparagraph, it shall communicate its disagreement, together with a detailed justification through the EU portal to the Commission, to all Member States, and to the sponsor.
3. Where, regarding the substantial modification of aspects covered by Part I of the assessment report, the substantial modification is acceptable or acceptable subject to compliance with specific conditions, the Member State concerned shall include in its decision its conclusion on the substantial modification of aspects covered by Part II of the assessment report.
4. A Member State concerned shall refuse to authorise a substantial modification if it disagrees with the conclusion of the reporting Member State as regards the substantial modification of aspects covered by Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 2, or if it finds, on duly justified grounds, that the aspects covered by Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which in accordance with the law of the Member State concerned, is valid for that entire Member State. That Member State concerned shall provide for an appeal procedure in respect of such refusal.
5. Where the conclusion of the reporting Member State as regards the substantial modification of aspects covered by Part I of the assessment report is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of the Member State concerned.
6. Where the Member State concerned has not notified the sponsor of its decision within the periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the substantial modification.
Article 24
Persons assessing the application for a substantial modification
Article 9 applies to assessments made under this Chapter.
CHAPTER IV
APPLICATION DOSSIER
Article 25
Data submitted in the application dossier
1. The application dossier for the authorisation of a clinical trial shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter II and relating to:
(a)
the conduct of the clinical trial, including the scientific context and arrangements taken,
(b)
the sponsor, investigators, potential subjects, subjects, and clinical trial sites;
(c)
the investigational medicinal products and, where necessary, the auxiliary medicinal products, in particular their properties, labelling, manufacturing and control;
(d)
measures to protect subjects;
(e)
justification as to why the clinical trial is a low-intervention clinical trial, in cases where this is claimed by the sponsor.
The list of required documentation and information is set out in Annex I.
2. The application dossier for the authorisation of a substantial modification shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter III:
(a)
a reference to the clinical trial or clinical trials which are substantially modified using the EU trial number referred to in the third subparagraph of Article 81(1) (the ‘EU trial number’);
(b)
a clear description of the substantial modification, in particular, the nature of and the reasons for substantial modification;
(c)
a presentation of data and additional information in support of the substantial modification, where necessary;
(d)
a clear description of the consequences of the substantial modification as regards the rights and safety of the subject and the reliability and robustness of the data generated in the clinical trial.
The list of required documentation and information is set out in Annex II.
3. Non-clinical information submitted in an application dossier shall be based on data derived from studies complying with Union law on the principles of good laboratory practice, as applicable at the time of performance of those studies.
4. Where reference is made in the application dossier to data generated in a clinical trial, that clinical trial shall have been conducted in accordance with this Regulation or, if conducted prior to the date referred to in the second paragraph of Article 99, in accordance with Directive 2001/20/EC.
5. Where the clinical trial referred to in paragraph 4 has been conducted outside the Union, it shall have been conducted in accordance with principles equivalent to those of this Regulation as regards the rights and safety of the subject and the reliability and robustness of the data generated in the clinical trial.
6. Data from a clinical trial started as from the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial has been registered prior to its start in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP.
Data from a clinical trial started before the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial is registered in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP or if the results of that clinical trial have been published in an independent peer-reviewed scientific publication.
7. Data submitted in an application dossier which do not comply with paragraphs 3 to 6 shall not be considered in the assessment of an application for authorisation of a clinical trial or of a substantial modification.
Article 26
Language requirements
The language of the application dossier, or parts thereof, shall be determined by the Member State concerned.
Member States, in applying the first paragraph, shall consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field.
Article 27
Update by way of delegated acts
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in respect of amending Annexes I and II in order to adapt them to technical progress or to take account of international regulatory developments in which the Union or the Member States are involved, in the field of clinical trials.
CHAPTER V
PROTECTION OF SUBJECTS AND INFORMED CONSENT
Article 28
General rules
1. A clinical trial may be conducted only where all of the following conditions are met:
(a)
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
(b)
the subjects, or where a subject is not able to give informed consent, his or her legally designated representative, have been informed in accordance with Article 29(2) to (6);
(c)
the subjects, or where a subject is not able to give informed consent, his or her legally designated representative, have given informed consent in accordance with Article 29(1), (7) and (8);
(d)
the rights of the subjects to physical and mental integrity, to privacy and to the protection of the data concerning them in accordance with Directive 95/46/EC are safeguarded;
(e)
the clinical trial has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects and both the risk threshold and the degree of distress are specifically defined in the protocol and constantly monitored;
(f)
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner;
(g)
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has been provided with the contact details of an entity where further information can be received in case of need;
(h)
no undue influence, including that of a financial nature, is exerted on subjects to participate in the clinical trial.
2. Without prejudice to Directive 95/46/EC, the sponsor may ask the subject or, where the subject is not able to give informed consent, his or her legally designated representative at the time when the subject or the legally designated representative gives his or her informed consent to participate in the clinical trial to consent to the use of his or her data outside the protocol of the clinical trial exclusively for scientific purposes. That consent may be withdrawn at any time by the subject or his or her legally designated representative.
The scientific research making use of the data outside the protocol of the clinical trial shall be conducted in accordance with the applicable law on data protection.
3. Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical trial at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.
Article 29
Informed consent
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document (or the record) by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the clinical trial.
2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
(a)
enable the subject or his or her legally designated representative to understand:
(i)
the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial;
(ii)
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting detriment and without having to provide any justification;
(iii)
the conditions under which the clinical trial is to be conducted, including the expected duration of the subject's participation in the clinical trial; and
(iv)
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical trial is discontinued;
(b)
be kept comprehensive, concise, clear, relevant, and understandable to a layperson;
(c)
be provided in a prior interview with a member of the investigating team who is appropriately qualified according to the law of the Member State concerned;
(d)
include information about the applicable damage compensation system referred to in Article 76(1); and
(e)
include the EU trial number and information about the availability of the clinical trial results in accordance with paragraph 6.
3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperson will be made available in the EU database, referred to in Article 81 (the ‘EU database’), pursuant to Article 37(4), irrespective of the outcome of the clinical trial, and, to the extent possible, when the summaries become available.
7. This Regulation is without prejudice to national law requiring that both the signature of the incapacitated person and the signature of his or her legally designated representative may be required on the informed consent form.
8. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical trial.
Article 30
Informed consent in cluster trials
1. Where a clinical trial is to be conducted exclusively in one Member State, that Member State may, without prejudice to Article 35, and by way of derogation from points (b), (c), and (g) of Article 28(1), Article 29(1), point (c) of Article 29(2), Article 29(3), (4) and (5), points (a), (b) and (c) of Article 31(1) and points (a), (b) and (c) of Article 32(1), allow the investigator to obtain informed consent by the simplified means set out in paragraph 2 of this Article, provided that all of the conditions set out in paragraph 3 of this Article are fulfilled.
2. For clinical trials that fulfil the conditions set out in paragraph 3, informed consent shall be deemed to have been obtained if:
(a)
the information required under points (a), (b), (d) and (e) of Article 29(2) is given, in accordance with what is laid down in the protocol, prior to the inclusion of the subject in the clinical trial, and this information makes clear, in particular, that the subject can refuse to participate in, or withdraw at any time from, the clinical trial without any resulting detriment; and
(b)
the potential subject, after being informed, does not object to participating in the clinical trial.
3. Informed consent may be obtained by the simplified means set out in paragraph 2, if all the following conditions are fulfilled:
(a)
the simplified means for obtaining informed consent do not contradict national law in the Member State concerned;
(b)
the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial;
(c)
the clinical trial is a low-intervention clinical trial and the investigational medicinal products are used in accordance with the terms of the marketing authorisation;
(d)
there are no interventions other than the standard treatment of the subjects concerned;
(e)
the protocol justifies the reasons for obtaining informed consent with simplified means and describes the scope of information provided to the subjects, as well as the ways of providing information.
4. The investigator shall document all refusals and withdrawals and shall ensure that no data for the clinical trial are collected from subjects that refuse to participate in or have withdrawn from the clinical trial.
Article 31
Clinical trials on incapacitated subjects
1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical trial may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
(a)
the informed consent of their legally designated representative has been obtained;
(b)
the incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their capacity to understand it;
(c)
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
(d)
no incentives or financial inducements are given to the subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
(e)
the clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical trials on persons able to give informed consent, or by other research methods;
(f)
the clinical trial relates directly to a medical condition from which the subject suffers;
(g)
there are scientific grounds for expecting that participation in the clinical trial will produce:
(i)
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
(ii)
some benefit for the population represented by the incapacitated subject concerned when the clinical trial relates directly to the life-threatening or debilitating medical condition from which the subject suffers and such trial will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition.
2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on incapacitated subjects, where there are no scientific grounds to expect that participation in the clinical trial will produce a direct benefit to the subject outweighing the risks and burdens involved.
3. The subject shall as far as possible take part in the informed consent procedure.
Article 32
Clinical trials on minors
1. A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
(a)
the informed consent of their legally designated representative has been obtained;
(b)
the minors have received the information referred to in Article 29(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
(c)
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
(d)
no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
(e)
the clinical trial is intended to investigate treatments for a medical condition that only occurs in minors or the clinical trial is essential with respect to minors to validate data obtained in clinical trials on persons able to give informed consent or by other research methods;
(f)
the clinical trial either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;
(g)
there are scientific grounds for expecting that participation in the clinical trial will produce:
(i)
a direct benefit for the minor concerned outweighing the risks and burdens involved; or
(ii)
some benefit for the population represented by the minor concerned and such a clinical trial will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition.
2. The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity.
3. If during a clinical trial the minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial.
Article 33
Clinical trials on pregnant or breastfeeding women
A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 28, the following conditions are met:
(a)
the clinical trial has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; or
(b)
if such clinical trial has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:
(i)
a clinical trial of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;
(ii)
the clinical trial contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and
(iii)
the clinical trial poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;
(c)
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; and
(d)
no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial.
Article 34
Additional national measures
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, or persons in residential care institutions.
Article 35
Clinical trials in emergency situations
1. By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) and from points (a) and (b) of Article 32(1), informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial, provided that this decision is taken at the time of the first intervention on the subject, in accordance with the protocol for that clinical trial" and that all of the following conditions are fulfilled:
(a)
due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical trial;
(b)
there are scientific grounds to expect that participation of the subject in the clinical trial will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;
(c)
it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;
(d)
the investigator certifies that he or she is not aware of any objections to participate in the clinical trial previously expressed by the subject;
(e)
the clinical trial relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical trial is of such a nature that it may be conducted exclusively in emergency situations;
(f)
the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
2. Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation of the subject in the clinical trial, and information on the clinical trial shall be given, in accordance with the following requirements:
(a)
regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 29(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
(b)
regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever is sooner and the information referred to in Article 29(2) shall be given as soon as possible to the the subject or his or her legally designated representative, whichever is sooner.
For the purposes of point (b), where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical trial shall be obtained from the subject as soon as he or she is capable of giving informed consent.
3. If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the clinical trial.
CHAPTER VI
START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL
Article 36
Notification of the start of a clinical trial and of the end of the recruitment of subjects
1. The sponsor shall notify each Member State concerned of the start of a clinical trial in relation to that Member State through the EU portal.
That notification shall be made within 15 days from the start of the clinical trial in relation to that Member State.
2. The sponsor shall notify each Member State concerned of the first visit of the first subject in relation to that Member State through the EU portal.
That notification shall be made within 15 days from the first visit of the first subject in relation to that Member State.
3. The sponsor shall notify each Member State concerned of the end of the recruitment of subjects for a clinical trial in that Member State through the EU portal.
That notification shall be made within 15 days from the end of the recruitment of subjects. In case of re-start of recruitment, paragraph 1 shall apply.
Article 37
End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
1. The sponsor shall notify each Member State concerned of the end of a clinical trial in relation to that Member State through the EU portal.
That notification shall be made within 15 days from the end of the clinical trial in relation to that Member State.
2. The sponsor shall notify each Member State concerned of the end of a clinical trial in all Member States concerned through the EU portal.
That notification shall be made within 15 days from the end of the clinical trial in the last Member State concerned.
3. The sponsor shall notify each Member State concerned of the end of a clinical trial in all Member States concerned and in all third countries in which the clinical trial has been conducted through the EU portal.
That notification shall be made within 15 days from the end of the clinical trial in the last of the Member States concerned and third countries in which the clinical trial has been conducted.
4. Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial in all Member States concerned, the sponsor shall submit to the EU database a summary of the results of the clinical trial. The content of that summary is set out in Annex IV.
It shall be accompanied by a summary written in a manner that is understandable to laypersons. The content of that summary is set out in Annex V.
However, where, for scientific reasons detailed in the protocol, it is not possible to submit a summary of the results within one year, the summary of results shall be submitted as soon as it is available. In this case, the protocol shall specify when the results are going to be submitted, together with a justification.
In addition to the summary of the results, where the clinical trial was intended to be used for obtaining a marketing authorisation for the investigational medicinal product, the applicant for marketing authorisation shall submit to the EU database the clinical study report within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application.
For cases where the sponsor decides to share raw data on a voluntary basis, the Commission shall produce guidelines for the formatting and sharing of those data.
5. The sponsor shall notify each Member State concerned of a temporary halt of a clinical trial in all Member States concerned for reasons not affecting the benefit-risk balance through the EU portal.
That notification shall be made within 15 days from the temporary halt of the clinical trial in all Member States concerned and shall include the reasons for such action.
6. When a temporarily halted clinical trial referred to in paragraph 5 is resumed the sponsor shall notify each Member State concerned through the EU portal.
That notification shall be made within 15 days from the restart of the temporarily halted clinical trial in all Member States concerned.
7. If a temporarily halted clinical trial is not resumed within two years, the expiry date of this period or the date of the decision of the sponsor not to resume the clinical trial, whichever is earlier, shall be deemed to be the date of the end of the clinical trial. In the case of early termination of the clinical trial, the date of the early termination shall be deemed to be the date of the end of the clinical trial.
In the case of early termination of the clinical trial for reasons not affecting the benefit-risk balance, the sponsor shall notify each Member State concerned through the EU portal of the reasons for such action and, when appropriate, follow-up measures for the subjects.
8. Without prejudice to paragraph 4, where the clinical trial protocol provides for an intermediate data analysis date prior to the end of the clinical trial, and the respective results of the clinical trial are available, a summary of those results shall be submitted to the EU database within one year of the intermediate data analysis date.
Article 38
Temporary halt or early termination by the sponsor for reasons of subject safety
1. For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a change of the benefit-risk balance shall be notified to the Member States concerned through the EU portal.
That notification shall be made without undue delay but not later than in 15 days of the date of the temporary halt or early termination. It shall include the reasons for such action and specify follow-up measures.
2. The restart of the clinical trial following a temporary halt as referred to in paragraph 1 shall be deemed to be a substantial modification subject to the authorisation procedure laid down in Chapter III.
Article 39
Update of the contents of the summary of results and summary for laypersons
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to amend Annexes IV and V, in order to adapt them to technical progress or to take account of international regulatory developments, in which the Union or the Member States are involved, in the field of clinical trials.
CHAPTER VII
SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
Article 40
Electronic database for safety reporting
1. The European Medicines Agency established by Regulation (EC) No 726/2004 (the ‘Agency’) shall set up and maintain an electronic database for the reporting provided for in Articles 42 and 43. That database shall be a module of the database referred to in Article 24 of Regulation (EC) No 726/2004 (the ‘Eudravigilance database’).
2. The Agency shall, in collaboration with Member States, develop a standard web-based structured form for the reporting by sponsors to the database referred to in paragraph 1 of suspected unexpected serious adverse reactions.
Article 41
Reporting of adverse events and serious adverse events by the investigator to the sponsor
1. The investigator shall record and document adverse events or laboratory abnormalities identified in the protocol as critical to the safety evaluation and report them to the sponsor in accordance with the reporting requirements and within the periods specified in the protocol.
2. The investigator shall record and document all adverse events, unless the protocol provides differently. The investigator shall report to the sponsor all serious adverse events occurring to subjects treated by him or her in the clinical trial, unless the protocol provides differently.
The investigator shall report serious adverse events to the sponsor without undue delay but not later than within 24 hours of obtaining knowledge of the events, unless, for certain serious adverse events, the protocol provides that no immediate reporting is required. Where relevant, the investigator shall send a follow-up report to the sponsor to allow the sponsor to assess whether the serious adverse event has an impact on the benefit-risk balance of the clinical trial.
3. The sponsor shall keep detailed records of all adverse events reported to it by the investigator.
4. If the investigator becomes aware of a serious adverse event with a suspected causal relationship to the investigational medicinal product that occurs after the end of the clinical trial in a subject treated by him or her, the investigator shall, without undue delay, report the serious adverse event to the sponsor.
Article 42
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
1. The sponsor of a clinical trial performed in at least one Member State shall report electronically and without delay to the database referred to in Article 40(1) all relevant information about the following suspected unexpected serious adverse reactions.:
(a)
all suspected unexpected serious adverse reactions to investigational medicinal products occurring in that clinical trial, irrespective of whether the suspected unexpected serious adverse reaction has occurred at a clinical trial site in the Union or in a third country;
(b)
all suspected unexpected serious adverse reactions related to the same active substance, regardless of pharmaceutical form and strength or indication investigated, in investigational medicinal products used in the clinical trial, occurring in a clinical trial performed exclusively in a third country, if that clinical trial is sponsored:
(i)
by that sponsor, or
(ii)
by another sponsor who is either part of the same parent company as the sponsor of the clinical trial, or who develops a medicinal product jointly, on the basis of a formal agreement, with the sponsor of the clinical trial. For this purpose, provision of the investigational medicinal product or information to a future potential marketing authorisation holder on safety matters shall not be considered a joint development; and
(c)
all suspected unexpected serious adverse reactions to investigational medicinal products occurring in any of the subjects of the clinical trial, which are identified by or come to the attention of the sponsor after the end of the clinical trial.
2. The period for the reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency shall take account of the seriousness of the reaction and shall be as follows:
(a)
in the case of fatal or life-threatening suspected unexpected serious adverse reactions, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction;
(b)
in the case of non-fatal or non-life-threatening suspected unexpected serious adverse reactions, not later than 15 days after the sponsor became aware of the reaction;
(c)
in the case of a suspected unexpected serious adverse reaction which was initially considered to be non-fatal or non-life threatening but which turns out to be fatal or life-threatening, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction being fatal or life-threatening.
Where necessary to ensure timely reporting, the sponsor may, in accordance with section 2.4 of Annex III, submit an initial incomplete report followed up by a complete report.
3. Where a sponsor, due to a lack of resources, does not have the possibility to report to the database referred to in Article 40(1) and the sponsor has the agreement of the Member State concerned, it may report to the Member State where the suspected unexpected serious adverse reaction occurred. That Member State shall report the suspected unexpected serious adverse reaction in accordance with paragraph 1 of this Article.
Article 43
Annual reporting by the sponsor to the Agency
1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually through the database referred to in Article 40(1) to the Agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor.
2. In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may, if provided for in the protocol, submit a single safety report on all investigational medicinal products used in that clinical trial.
3. The annual report referred to in paragraph 1 shall only contain aggregate and anonymised data.
4. The obligation referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product.
Article 44
Assessment by Member States
1. The Agency shall, by electronic means, forward to the Member States concerned the information reported in accordance with Article 42 and 43.
2. Member States shall cooperate in assessing the information reported in accordance with Articles 42and 43. The Commission may, by means of implementing acts, set up and modify the rules on such cooperation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).
3. The responsible ethics committee shall be involved in the assessment of the information referred to in paragraphs 1 and 2, if it has been provided for in the law of the Member State concerned.
Article 45
Technical aspects
Technical aspects for safety reporting in accordance with Articles 41 to 44 are contained in Annex III. Where necessary in order to improve the level of protection of subjects, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to amend Annex III for any of the following purposes:
(a)
improving the information on the safety of medicinal products;
(b)
adapting technical requirements to technical progress;
(c)
taking account of international regulatory developments in the field of safety requirements in clinical trials, endorsed by bodies in which the Union or the Member States participate.
Article 46
Reporting with regard to auxiliary medicinal products
Safety reporting with regard to auxiliary medicinal products shall be made in accordance with Chapter 3 of Title IX of Directive 2001/83/EC.
CHAPTER VIII
CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
Article 47
Compliance with the protocol and good clinical practice
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with the principles of good clinical practice.
Without prejudice to any other provision of Union law or Commission guidelines, the sponsor and the investigator, when drawing up the protocol and when applying this Regulation and the protocol, shall also take appropriate account of the quality standards and the ICH guidelines on good clinical practice.
The Commission shall make publicly available the detailed ICH guidelines on good clinical practice referred to in the second paragraph.
Article 48
Monitoring
In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical trial is in compliance with the requirements of this Regulation, the sponsor shall adequately monitor the conduct of a clinical trial. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical trial, including the following characteristics:
(a)
whether the clinical trial is a low-intervention clinical trial;
(b)
the objective and methodology of the clinical trial; and
(c)
the degree of deviation of the intervention from normal clinical practice.
Article 49
Suitability of individuals involved in conducting the clinical trial
The investigator shall be a medical doctor as defined in national law, or a person following a profession which is recognised in the Member State concerned as qualifying for an investigator because of the necessary scientific knowledge and experience in patient care.
Other individuals involved in conducting a clinical trial shall be suitably qualified by education, training and experience to perform their tasks.
Article 50
Suitability of clinical trial sites
The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical trial in compliance with the requirements of this Regulation.
Article 51
Traceability, storage, return and destruction of investigational medicinal products
1. Investigational medicinal products shall be traceable. They shall be stored, returned and/or destroyed as appropriate and proportionate to ensure the safety of the subject and the reliability and robustness of the data generated in the clinical trial, in particular, taking into account whether the investigational medicinal product is an authorised investigational medicinal product, and whether the clinical trial is a low-intervention clinical trial.
The first subparagraph shall also apply to unauthorised auxiliary medicinal products.
2. The relevant information regarding the traceability, storage, return and destruction of medicinal products referred to in paragraph 1 shall be contained in the application dossier.
Article 52
Reporting of serious breaches
1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach through the EU portal without undue delay but not later than seven days of becoming aware of that breach.
2. For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.
Article 53
Other reporting obligations relevant for subject safety
1. The sponsor shall notify the Member States concerned through the EU portal of all unexpected events which affect the benefit-risk balance of the clinical trial, but are not suspected unexpected serious adverse reactions as referred to in Article 42. That notification shall be made without undue delay but no later than 15 days from the date the sponsor became aware of this event.
2. The sponsor shall submit to the Member States concerned, through the EU portal, all inspection reports of third country authorities concerning the clinical trial. When requested by a Member State concerned, the sponsor shall submit a translation of the report or of its summary in an official language of the Union indicated in the request.
Article 54
Urgent safety measures
1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects.
2. The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken.
That notification shall be made without undue delay but no later than seven days from the date the measures have been taken.
3. This Article is without prejudice to Chapters III and VII.
Article 55
Investigator's brochure
1. The sponsor shall provide the investigator with the investigator's brochure.
2. The investigator's brochure shall be updated where new and relevant safety information becomes available, and shall be reviewed by the sponsor at least once per year.
Article 56
Recording, processing, handling and storage of information
1. All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
2. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves the transmission over a network.
Article 57
Clinical trial master file
The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a low-intervention clinical trial. It shall be readily available, and directly accessible upon request, to the Member States.
The clinical trial master file kept by the investigator and that kept by the sponsor may have a different content if this is justified by the different nature of the responsibilities of the investigator and the sponsor.
Article 58
Archiving of the clinical trial master file
Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national law.
The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.
Any transfer of ownership of the content of the clinical trial master file shall be documented. The new owner shall assume the responsibilities set out in this Article.
The sponsor shall appoint individuals within its organisation to be responsible for archives. Access to archives shall be restricted to those individuals.
The media used to archive the content of the clinical trial master file shall be such that the content remains complete and legible throughout the period referred to in the first paragraph.
Any alteration to the content of the clinical trial master file shall be traceable.
Article 59
Auxiliary medicinal products
1. Only authorised auxiliary medicinal products may be used in a clinical trial.
2. Paragraph 1 shall not apply where no authorised auxiliary medicinal product is available in the Union or where the sponsor cannot reasonably be expected to use an authorised auxiliary medicinal product. A justification to this effect shall be included in the protocol.
3. Member States shall ensure that unauthorised auxiliary medicinal products may enter their territories for the purpose of their use in a clinical trial in accordance with paragraph 2.
CHAPTER IX
MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
Article 60
Scope of this Chapter
This Chapter shall apply to the manufacture and import of investigational medicinal products and auxiliary medicinal products.
Article 61
Authorisation of manufacturing and import
1. The manufacturing and import of investigational medicinal products in the Union shall be subject to the holding of an authorisation.
2. In order to obtain the authorisation referred to in paragraph 1, the applicant shall meet the following requirements:
(a)
it shall have at its disposal, for manufacture or import, suitable and sufficient premises, technical equipment and control facilities complying with the requirements set out in this Regulation;
(b)
it shall have permanently and continuously at its disposal the services of at least one qualified person who fulfils the conditions of qualification set out in Article 49(2) and (3) of Directive 2001/83/EC (‘qualified person’).
3. The applicant shall specify, in the application for authorisation, the types and pharmaceutical forms of the investigational medicinal product manufactured or imported, the manufacturing or import operations, the manufacturing process where relevant, the site where the investigational medicinal products are to be manufactured or the site in the Union to which they are to be imported, and detailed information concerning the qualified person.
4. Articles 42 to 45, and point (e) of Article 46 of Directive 2001/83/EC shall apply mutatis mutandis to the authorisation referred to in paragraph 1.
5. Paragraph 1 shall not apply to any of the following processes:
(a)
re-labelling or re-packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such processes, and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State;
(b)
preparation of radiopharmaceuticals used as diagnostic investigational medicinal products where this process is carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State;
(c)
the preparation of medicinal products referred to in points (1) and (2) of Article 3 of Directive 2001/83/EC for use as investigational medicinal products, where this process is carried out in hospitals, health centres or clinics legally authorised in the Member State concerned to carry out such process and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State.
6. Member States shall make the processes set out in paragraph 5 subject to appropriate and proportionate requirements to ensure subject safety and reliability and robustness of the data generated in the clinical trial. They shall subject the processes to regular inspections.
Article 62
Responsibilities of the qualified person
1. The qualified person shall ensure that each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 and shall certify that those requirements are fulfilled.
2. The certification referred to in paragraph 1 shall be made available by the sponsor at the request of the Member State concerned.
Article 63
Manufacturing and import
1. Investigational medicinal products shall be manufactured by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject and the reliability and robustness of clinical data generated in the clinical trial (‘good manufacturing practice’). The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products, taking account of subject safety or data reliability and robustness, technical progress and global regulatory developments in which the Union or the Member States are involved.
In addition, the Commission shall also adopt and publish detailed guidelines in line with those principles of good manufacturing practice and revise them when necessary in order to take account of technical and scientific progress.
2. Paragraph 1 shall not apply to the processes referred to in Article 61(5).
3. Investigational medicinal products imported into the Union shall be manufactured by applying quality standards at least equivalent to those laid down pursuant to paragraph 1.
4. The Member States shall ensure compliance with the requirements of this Article by means of inspections.
Article 64
Modification of authorised investigational medicinal products
Articles 61, 62 and 63 shall apply to authorised investigational medicinal products only as regards any modification of such products not covered by a marketing authorisation.
Article 65
Manufacturing of auxiliary medicinal products
Where the auxiliary medicinal product is not authorised, or where an authorised auxiliary medicinal product is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to the good manufacturing practice referred to in Article 63(1) orto at least an equivalent standard, in order to ensure appropriate quality.
CHAPTER X
LABELLING
Article 66
Unauthorised investigational and unauthorised auxiliary medicinal products
1. The following information shall appear on the outer packaging and on the immediate packaging of unauthorised investigational medicinal products and unauthorised auxiliary medicinal products:
(a)
information to identify contact persons or persons involved in the clinical trial;
(b)
information to identify the clinical trial;
(c)
information to identify the medicinal product;
(d)
information related to the use of the medicinal product.
2. The information which is to appear on the outer packaging and immediate packaging shall ensure subject safety and reliability and robustness of the data generated in the clinical trial, while taking account of the design of the clinical trial, whether the products are investigational or auxiliary medicinal product, and whether they are products with particular characteristics.
The information which is to appear on the outer packaging and immediate packaging shall be clearly legible.
A list of information which is to appear on the outer packaging and immediate packaging is set out in Annex VI.
Article 67
Authorised investigational and authorised auxiliary medicinal products
1. Authorised investigational medicinal products and authorised auxiliary medicinal products shall be labelled:
(a)
in accordance with Article 66(1); or
(b)
in accordance with Title V of Directive 2001/83/EC.
2. Notwithstanding point (b) of paragraph 1, where the specific circumstances, provided for in the protocol, of a clinical trial so require in order to ensure the safety of the subject or the reliability and robustness of data generated in a clinical trial, additional particulars relating to the identification of the clinical trial and of the contact person shall appear on the outer packaging and the immediate packaging of authorised investigational medicinal products. A list of these additional particulars appearing on the outer packaging and immediate packaging is set out in section C of Annex VI.
Article 68
Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
Articles 66 and 67 shall not apply to radiopharmaceuticals used as diagnostic investigational medicinal products or as diagnostic auxiliary medicinal products.
The products referred to in the first paragraph shall be labelled appropriately in order to ensure the safety of the subject and the reliability and robustness of data generated in the clinical trial.
Article 69
Language
The language of the information on the label shall be determined by the Member State concerned. The medicinal product may be labelled in several languages.
Article 70
Delegated act
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in respect of amending Annex VI in order to ensure subject safety and the reliability and robustness of data generated in a clinical trial or to take account of technical progress.
CHAPTER XI
SPONSOR AND INVESTIGATOR
Article 71
Sponsor
A clinical trial may have one or several sponsors.
Any sponsor may delegate, in a written contract, any or all of its tasks to an individual, a company, an institution or an organisation. Such delegation shall be without prejudice to the responsibility of the sponsor, in particular regarding the safety of subjects and the reliability and robustness of the data generated in the clinical trial.
The investigator and the sponsor may be the same person.
Article 72
Co-sponsorship
1. Without prejudice to Article 74, where a clinical trial has more than one sponsor, all sponsors shall have the responsibilities of a sponsor set out in this Regulation, unless the sponsors decide otherwise in a written contract setting out their respective responsibilities. Where the contract does not specify to which sponsor a given responsibility is attributed, that responsibility shall lie with all sponsors.
2. By way of derogation from paragraph 1, the sponsors shall be jointly responsible for establishing:
(a)
a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III;
(b)
a sponsor responsible for being a contact point for receiving all questions from subjects, investigators or any Member State concerned regarding the clinical trial and providing answers to them;
(c)
a sponsor responsible for implementing the measures taken in accordance with Article 77.
Article 73
Principal investigator
A principal investigator shall ensure compliance of a clinical trial at a clinical trial site with the requirements of this Regulation.
The principal investigator shall assign tasks among the members of the team of investigators in a way which is not compromising the safety of subjects and the reliability and robustness of the data generated in the clinical trial at that clinical trial site.
Article 74
Legal representative of the sponsor in the Union
1. Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication to that legal representative shall be deemed to be a communication to the sponsor.
2. Member States may choose not to apply paragraph 1 as regards clinical trials to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
3. As regards clinical trials to be conducted in more than one Member State, all those Member States may choose not to apply paragraph 1 provided that they ensure that the sponsor establishes at least a contact person in the Union in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
Article 75
Liability
This Chapter shall not affect the civil and criminal liability of the sponsor, investigator, or persons to whom the sponsor has delegated tasks.
CHAPTER XII
DAMAGE COMPENSATION
Article 76
Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical trial conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.
2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State concerned where the clinical trial is conducted.
3. Member States shall not require any additional use of the system referred to in paragraph 1 from the sponsor for low-intervention clinical trials, if any possible damage that could be suffered by a subject resulting from the use of the investigational medicinal product in accordance with the protocol of that specific clinical trial on the territory of that Member State is covered by the applicable compensation system already in place.
CHAPTER XIII
SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS
Article 77
Corrective measures to be taken by Member States
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a)
revoke the authorisation of a clinical trial;
(b)
suspend a clinical trial;
(c)
require the sponsor to modify any aspect of the clinical trial.
2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor and/or the investigator for their opinion. That opinion shall be delivered within seven days.
3. The Member State concerned shall immediately after taking a measure referred to in paragraph 1 inform all Member States concerned through the EU portal.
4. Each Member State concerned may consult the other Member States concerned before taking any of the measures referred to in paragraph 1.
Article 78
Member State inspections
1. Member States shall appoint inspectors to perform inspections in order to supervise compliance with this Regulation. They shall ensure that those inspectors are adequately qualified and trained.
2. Inspections shall be conducted under the responsibility of the Member State where the inspection takes place.
3. Where a Member State concerned intends to carry out an inspection on its territory or in a third country with regard to one or several clinical trials which are conducted in more than one Member State concerned, it shall notify its intention to the other Member States concerned, the Commission and the Agency, through the EU portal, and shall inform them of its findings after the inspection.
4. Inspections fees, if any, may be waived for non-commercial sponsors.
5. In order to efficiently use the resources available and to avoid duplications, the Agency shall coordinate the cooperation between Member States concerned on inspections conducted in Member States, in third countries, and inspections conducted in the framework of an application for a marketing authorisation under Regulation (EC) No 726/2004.
6. Following an inspection, the Member State under whose responsibility the inspection has been conducted shall draw up an inspection report. That Member State shall make the inspection report available to the inspected entity and the sponsor of the relevant clinical trial and shall submit the inspection report through the EU portal.
7. The Commission shall specify, by means of implementing acts, the detailed arrangements for the inspection procedures including the qualification and training requirements for inspectors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).
Article 79
Union controls
1. The Commission may conduct controls in order to verify:
(a)
whether Member States correctly supervise compliance with this Regulation;
(b)
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that point 8 of the Introduction and general principles contained in Annex I to Directive 2001/83/EC is complied with;
(c)
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that Article 25(5) of this Regulation is complied with.
2. The Union controls referred to in point (a) of paragraph 1 shall be organised in cooperation with the Member States concerned.
The Commission shall prepare in cooperation with the Member States a programme for the Union controls referred to in points (b) and (c) of paragraph 1.
The Commission shall report on the findings of each Union control carried out. Those reports shall, if appropriate, contain recommendations. The Commission shall submit those reports through the EU portal.
CHAPTER XIV
IT INFRASTRUCTURE
Article 80
EU portal
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a portal at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this Regulation. The EU portal shall be technically advanced and user-friendly so as to avoid unnecessary work.
Data and information submitted through the EU portal shall be stored in the EU database.
Article 81
EU database
1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a EU database at Union level. The Agency shall be considered to be the controller of the EU database and shall be responsible for avoiding unnecessary duplication between the EU database and the EudraCT and Eudravigilance databases.
The EU database shall contain the data and information submitted in accordance with this Regulation.
The EU database shall identify each clinical trial by a unique EU trial number. The sponsor shall refer to this EU trial number in any subsequent submission relating or referring to that clinical trial.
2. The EU database shall be established to enable cooperation between the competent authorities of the Member States concerned to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials. It shall also facilitate the communication between sponsors and Member States concerned and enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification. It shall also enable citizens of the Union to have access to clinical information about medicinal products. To this end all data held in the EU database shall be in an easily searchable format, all related data shall be grouped together by way of the EU trial number, and hyperlinks shall be provided to link together related data and documents held on the EU database and other databases managed by the Agency.
3. The EU database shall support the recording and submission to the Medicinal Product Dictionary, contained in the Eudravigilance database, of all the data on medicinal products without a marketing authorisation in the Union and substances not authorised as part of a medicinal product in the Union, that are necessary for the maintenance of that dictionary. To this effect and also with the purpose of enabling the sponsor to cross-refer to prior applications, an EU medicinal product number shall be issued for every medicinal product without a marketing authorisation and an EU active substances code shall be issued for each new active substance not previously authorised as part of a medicinal product in the Union. This shall be done before or during the application for authorisation of the first clinical trial with that product or active substance submitted in accordance with this Regulation. Those numbers shall be mentioned in all subsequent applications for clinical trials and for substantial modifications.
The data submitted, in accordance with the first subparagraph, describing medicinal products and substances shall comply with Union and international standards for the identification of medicinal products and active substances. When an investigational medicinal product which already has a marketing authorisation in the Union and/or an active substance which is part of a medicinal product with a marketing authorisation in the Union, is to be used in a clinical trial, the relevant product and active substance numbers shall be referred to in the application for that clinical trial.
4. The EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified on any of the following grounds:
(a)
protecting personal data in accordance with Regulation (EC) No 45/2001;
(b)
protecting commercially confidential information, in particular through taking into account the status of the marketing authorisation for the medicinal product, unless there is an overriding public interest in disclosure;
(c)
protecting confidential communication between Member States in relation to the preparation of the assessment report;
(d)
ensuring effective supervision of the conduct of a clinical trial by Member States.
5. Without prejudice to paragraph 4, unless there is an overriding public interest in disclosure, data contained in the application dossier shall not be publicly accessible before the decision on the clinical trial has been made.
6. The EU database shall contain personal data only insofar as this is necessary for the purposes of paragraph 2.
7. No personal data of subjects shall be publicly accessible.
8. The user interface of the EU database shall be available in all official languages of the Union.
9. The sponsor shall permanently update in the EU database information on any changes to the clinical trials which are not substantial modifications but are relevant for the supervision of the clinical trial by the Member States concerned.
10. The Agency, the Commission and Member States shall ensure that the data subject may effectively exercise his or her rights to information, to access, to rectify and to object in accordance with Regulation (EC) No 45/2001 and national data protection legislation implementing Directive 95/46/EC, respectively. They shall ensure that the data subject may effectively exercise the right of access to data relating to him or her, and the right to have inaccurate or incomplete data corrected or erased. Within their respective responsibilities, the Agency, the Commission and Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable law. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days of a request being made by a data subject.
Article 82
Functionality of the EU portal and the EU database
1. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the EU portal and the EU database, together with the time frame for their implementation.
2. The Management Board of the Agency shall, on the basis of an independent audit report, inform the Commission when it has verified that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications drawn up pursuant to paragraph 1.
3. The Commission shall, when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
CHAPTER XV
COOPERATION BETWEEN MEMBER STATES
Article 83
National contact points
1. Each Member State shall designate one national contact point in order to facilitate the functioning of the procedures set out in Chapters II and III.
2. Each Member State shall communicate the contact point referred to in paragraph 1 to the Commission. The Commission shall publish a list of the national contact points.
Article 84
Support by the Agency and the Commission
The Agency shall support the functioning of the cooperation of the Member States in the framework of the authorisation procedures set out in Chapters II and III of this Regulation by maintaining and updating the EU portal and the EU database in accordance with the experience acquired during the implementation of this Regulation.
The Commission shall support the functioning of the cooperation of the Member States referred to in Article 44(2).
Article 85
Clinical Trials Coordination and Advisory Group
1. A Clinical Trials Coordination and Advisory Group (CTAG), composed of the national contact points referred to in Article 83 is hereby established.
2. The CTAG shall have the following tasks:
(a)
to support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Regulation;
(b)
to assist the Commission in providing the support referred to in the second paragraph of Article 84;
(c)
to prepare recommendations on criteria regarding the selection of a reporting Member State.
3. The CTAG shall be chaired by a representative of the Commission.
4. The CTAG shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State. Any item of the agenda of the meeting shall be placed at the request of the Commission or a Member State.
5. The secretariat shall be provided by the Commission.
6. The CTAG shall draw up its rules of procedure. The rules of procedure shall be made public.
CHAPTER XVI
FEES
Article 86
General principle
This Regulation shall be without prejudice to the possibility for Member States to levy a fee for the activities set out in this Regulation, provided that the level of the fee is set in a transparent manner and on the basis of cost recovery principles. Member States may establish reduced fees for non-commercial clinical trials.
Article 87
One payment per activity per Member State
A Member State shall not require, for an assessment as referred to in Chapters II and III, multiple payments to different bodies involved in this assessment.
CHAPTER XVII
IMPLEMENTING ACTS AND DELEGATED ACTS
Article 88
Committee procedure
1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Directive 2001/83/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 89
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 27, 39, 45, 63(1) and 70 shall be conferred on the Commission for a period of five years from the date referred to in the second paragraph of Article 99. The Commission shall draw up a report in respect of the delegated powers not later than six months before the end of the five year period. The delegation of powers shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Articles 27, 39, 45, 63(1) and 70 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 27, 39, 45, 63(1) and 70 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months from notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
CHAPTER XVIII
MISCELLANEOUS PROVISIONS
Article 90
Specific requirements for special groups of medicinal products
This Regulation shall not affect the application of national law prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from those cells, or of medicinal products used as abortifacients or of medicinal products containing narcotic substances within the meaning of the relevant international conventions in force such as the Single Convention on Narcotic Drugs of 1961 of the United Nations. The Member States shall communicate that national law to the Commission.
No gene therapy clinical trials may be carried out which result in modifications to the subject's germ line genetic identity.
Article 91
Relation with other Union legislation
This Regulation shall be without prejudice to Council Directive 97/43/Euratom (13), Council Directive 96/29/Euratom (14), Directive 2001/18/EC of the European Parliament and of the Council (15), Directive 2004/23/EC of the European Parliament and of the Council (16), Directive 2002/98/EC of the European Parliament and of the Council (17), Directive 2010/53/EC of the European Parliament and of the Council (18), and Directive 2009/41/EC of the European Parliament and of the Council. (19)
Article 92
Investigational medicinal products, other products and procedures, free of charge for the subject
Without prejudice to the Member States' competence for the definition of their health policy and for the organisation and delivery of health services and medical care, the costs for investigational medicinal products, auxiliary medicinal products, medical devices used for their administration and procedures specifically required by the protocol shall not be borne by the subject, unless the law of the Member State concerned provides otherwise.
Article 93
Data protection
1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.
Article 94
Penalties
1. Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
2. The rules referred to in paragraph 1 shall address, inter alia, the following:
(a)
non-compliance with the provisions laid down in this Regulation on submission of information intended to be made publicly available to the EU database;
(b)
non-compliance with the provisions laid down in this Regulation on subject safety.
Article 95
Civil and criminal liability
This Regulation is without prejudice to national and Union law on the civil and criminal liability of a sponsor or an investigator.
CHAPTER XIX
FINAL PROVISIONS
Article 96
Repeal
1. Directive 2001/20/EC is repealed as from the date referred to in the second paragraph of Article 99.
2. References to Directive 2001/20/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex VII.
Article 97
Review
Five years after the date referred to in the second paragraph of Article 99, and every five years thereafter, the Commission shall present a report to the European Parliament and to the Council on the application of this Regulation. That report shall include an assessment of the impact that the Regulation has had on scientific and technological progress, comprehensive information on the different types of clinical trials authorised pursuant to this Regulation, and the measures required in order to maintain the competitiveness of European clinical research. The Commission shall, if appropriate, present a legislative proposal based on that report in order to update the provisions set out in this Regulation.
Article 98
Transitional provision
1. By way of derogation from Article 96(1) of this Regulation, where the request for authorisation of a clinical trial has been submitted before the date referred to in the second paragraph of Article 99 of this Regulation pursuant to Directive 2001/20/EC, that clinical trial shall continue to be governed by that Directive until three years from that date.
2. By way of derogation from Article 96(1) of this Regulation, where the request for authorisation of a clinical trial is submitted between six months after the date of publication of the notice referred to in Article 82(3) of this Regulation and 18 months after the date of publication of that notice, or, if the publication of that notice occurs earlier than 28 November 2015, where that request is submitted between 28 May 2016 and 28 May 2017, that clinical trial may be started in accordance with Articles 6, 7 and 9 of Directive 2001/20/EC. That clinical trial shall continue to be governed by that Directive until 42 months after the date of publication of the notice referred to in Article 82(3) of this Regulation, or, if that publication occurs earlier than 28 November 2015, until 28 May 2019.
Article 99
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply as from six months after the publication of the notice referred to in Article 82(3), but in any event no earlier than 28 May 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 16 April 2014.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
D. KOURKOULAS
(1) OJ C 44, 15.2.2013, p. 99.
(2) Position of the European Parliament of 3 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014.
(3) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(4) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
(5) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(6) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1.)
(7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(8) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(9) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(10) OJ C 253, 3.9.2013, p. 10.
(11) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(12) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.11.2006, p. 1).
(13) Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom (OJ L 180, 9.7.1997, p. 22).
(14) Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).
(15) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(16) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(17) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
(18) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
(19) Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75).
ANNEX I
APPLICATION DOSSIER FOR THE INITIAL APPLICATION
A. INTRODUCTION AND GENERAL PRINCIPLES
1.
The sponsor shall, where appropriate, refer to any previous applications. If these applications have been submitted by another sponsor, the written agreement from that sponsor shall be submitted.
2.
Where a clinical trial has more than one sponsor, detailed information of the responsibilities of each of the sponsors shall be submitted in the application dossier.
3.
The application shall be signed by the sponsor or a representative of the sponsor. This signature confirms that the sponsor is satisfied that:
(a)
the information provided is complete;
(b)
the attached documents contain an accurate account of the information available;
(c)
the clinical trial is to be conducted in accordance with the protocol; and
(d)
the clinical trial is to be conducted in accordance with this Regulation.
4.
The application dossier for an application limited to Part I of the assessment report referred to in Article 11 shall be limited to sections B to J and Q of this Annex.
5.
Without prejudice to Article 26, the application dossier for an application limited to Part II of the assessment report referred to in Article 11 and the application dossier for an application referred to in Article 14 shall be limited to sections K to R of this Annex.
B. COVER LETTER
6.
The cover letter shall specify the EU trial number and the universal trial number and shall draw attention to any features which are particular to the clinical trial.
7.
However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:
(a)
specific features of the clinical trial population, such as subjects not able to give informed consent, minors and pregnant or breastfeeding women;
(b)
whether the clinical trial involves the first administration of a new active substance to humans;
(c)
whether scientific advice relating to the clinical trial or the investigational medicinal product has been given by the Agency, a Member State or a third country;
(d)
whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website);
(e)
whether investigational medicinal products or auxiliary medicinal products are a narcotic, psychotropic or radiopharmaceutical;
(f)
whether the investigational medicinal products consist of or contain a genetically-modified organism or organisms;
(g)
whether the sponsor has obtained an orphan designation for the investigational medicinal product for an orphan condition;
(h)
a comprehensive list, including the regulatory status, of all investigational medicinal products and a list of all auxiliary medicinal products; and
(i)
a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.
8.
The cover letter shall indicate where the information listed in paragraph 7 is contained in the application dossier.
9.
The cover letter shall indicate if the clinical trial is considered by the sponsor to be a low-intervention clinical trial and shall contain a detailed justification thereof.
10.
The cover letter shall indicate if the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial, and as a consequence whether informed consent will be obtained by simplified means.
11.
The cover letter shall indicate the location in the application dossier of the information necessary for assessing whether an adverse reaction is a suspected unexpected serious adverse reaction, that is the reference safety information.
12.
In the case of a resubmission, the cover letter shall specify the EU trial number for the previous clinical trial application, highlight the changes as compared to the previous submission and, if applicable, specify how any unresolved issues in the first submission have been addressed.
C. EU APPLICATION FORM
13.
The EU application form, duly completed.
D. PROTOCOL
14.
The protocol shall describe the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.
15.
The protocol shall be identified by:
(a)
the title of the clinical trial;
(b)
the EU trial number;
(c)
the sponsor's protocol code number specific for all versions of it (if relevant);
(d)
the date and number of the version, to be updated when it is amended;
(e)
a short title or name assigned to the protocol; and
(f)
the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.
16.
The protocol shall, when possible, be written in an easily accessible and searchable format, rather than scanned images.
17.
The protocol shall at least include:
(a)
a statement that the clinical trial is to be conducted in compliance with the protocol, with this Regulation and with the principles of good clinical practice;
(b)
a comprehensive list of all investigational medicinal products and of all auxiliary medicinal products;
(c)
a summary of findings from non-clinical studies that potentially have clinical significance and from other clinical trials that are relevant to the clinical trial;
(d)
a summary of the known and potential risks and benefits including an evaluation of the anticipated benefits and risks to allow assessment in accordance with Article 6; for subjects in a clinical trial in an emergency situation, the scientific grounds for expecting that the participation of the subjects has the potential to produce a direct clinically relevant benefit shall be documented;
(e)
where patients were involved in the design of the clinical trial, a description of their involvement;
(f)
a description of, and justification for, the dosage, the dosage regime, the route and mode of administration, and the treatment period for all investigational medicinal products and auxiliary medicinal products;
(g)
a statement of whether the investigational medicinal products and auxiliary medicinal products used in the clinical trial are authorised; if authorised, whether they are to be used in the clinical trial in accordance with the terms of their marketing authorisations, and, if not authorised, a justification for the use of non-authorised auxiliary medicinal products in the clinical trial;
(h)
a description of the groups and subgroups of the subjects participating in the clinical trial, including, where relevant, groups of subjects with specific needs, for example. age, gender, participation of healthy volunteers, subjects with rare and ultra rare diseases;
(i)
references to literature and data that are relevant to the clinical trial, and that provide background for the clinical trial;
(j)
a discussion of the relevance of the clinical trial in order to allow assessment in accordance with Article 6;
(k)
a description of the type of clinical trial to be conducted and a discussion of the trial design (including a schematic diagram of trial design, procedures and stages, if relevant);
(l)
a specification of the primary end-points and the secondary end-points, if any, to be measured during the clinical trial;
(m)
a description of the measures taken to minimise bias, including, if applicable, randomisation and blinding;
(n)
a description of the expected duration of subject participation and a description of the sequence and duration of all clinical trial periods, including follow-up, if relevant;
(o)
a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof;
(p)
a description of the criteria for discontinuing parts of the clinical trial or the entire clinical trial;
(q)
arrangements for the maintenance of clinical trial treatment randomisation codes and procedures for breaking codes, if relevant;
(r)
a description of procedures for the identification of data to be recorded directly on the Case Report Forms considered as source data;
(s)
a description of the arrangements to comply with the applicable rules for the collection, storage and future use of biological samples from clinical trial subjects, where applicable, unless contained in a separate document;
(t)
a description of the arrangements for tracing, storing, destroying and returning the investigational medicinal product and unauthorised auxiliary medicinal product in accordance with Article 51;
(u)
a description of the statistical methods to be employed, including, if relevant:
—
timing of any planned interim analysis and the number of subjects planned to be enrolled;
—
reasons for choice of sample size;
—
calculations of the power of the clinical trial and clinical relevance;
—
the level of significance to be used;
—
criteria for the termination of the clinical trial;
—
procedures for accounting for missing, unused, and spurious data and for reporting any deviation from the original statistical plan; and
—
the selection of subjects to be included in the analyses;
(v)
a description of the subject inclusion and exclusion criteria, including criteria for withdrawing individual subjects from treatment or from the clinical trial;
(w)
a description of procedures relating to the withdrawal of subjects from treatment or from the clinical trial including procedures for the collection of data regarding withdrawn subjects, procedures for replacement of subjects and the follow-up of subjects that have withdrawn from treatment or from the clinical trial;
(x)
a justification for including subjects who are incapable of giving informed consent or other special populations, such as minors;
(y)
a justification for the gender and age allocation of subjects and, if a specific gender or age group is excluded from or underrepresented in the clinical trials, an explanation of the reasons and justification for these exclusion criteria;
(z)
a detailed description of the recruitment and informed consent procedure, especially when subjects are incapable of giving informed consent;
(aa)
a description of the treatments, including medicinal products, which are permitted or not permitted, before or during the clinical trial;
(ab)
a description of the accountability procedures for the supply and administration of medicinal products to subjects including the maintenance of blinding, if applicable;
(ac)
a description of procedures for monitoring subject compliance, if applicable;
(ad)
a description of arrangements for monitoring the conduct of the clinical trial;
(ae)
a description of the arrangements for taking care of the subjects after their participation in the clinical trial has ended, where such additional care is necessary because of the subjects' participation in the clinical trial and where it differs from that normally expected for the medical condition in question;
(af)
a specification of the efficacy and safety parameters as well as the methods and timing for assessing, recording, and analysing these parameters;
(ag)
a description of ethical considerations relating to the clinical trial if those have not been described elsewhere;
(ah)
a statement from the sponsor (either in the protocol or in a separate document) confirming that the investigators and institutions involved in the clinical trial are to permit clinical trial-related monitoring, audits and regulatory inspections, including provision of direct access to source data and documents;
(ai)
a description of the publication policy;
(aj)
duly substantiated reasons for the submission of the summary of the results of the clinical trials after more than one year;
(ak)
a description of the arrangements to comply with the applicable rules on the protection of personal data; in particular organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
(al)
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects;
(am)
a description of measures that will be implemented in case of data security breach in order to mitigate the possible adverse effects.
18.
If a clinical trial is conducted with an active substance available in the Union under different trade names in a number of authorised medicinal products, the protocol may define the treatment in terms of the active substance or Anatomical Therapeutic Chemical (ATC) code (level 3-5) only and not specify the trade name of each product.
19.
With regard to the notification of adverse events, the protocol shall identify the categories of:
(a)
adverse events or laboratory anomalies that are critical to safety evaluations and must be reported by the investigator to the sponsor, and
(b)
serious adverse events which do not require immediate reporting by the investigator to the sponsor.
20.
The protocol shall describe the procedures for:
(a)
eliciting and recording adverse events by the investigator, and the reporting of relevant adverse events by the investigator to the sponsor;
(b)
reporting by the investigator to the sponsor of those serious adverse events which have been identified in the protocol as not requiring immediate reporting;
(c)
reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database; and
(d)
follow-up of subjects after adverse reactions including the type and duration of follow-up.
21.
In case the sponsor intends to submit a single safety report on all investigational medicinal products used in the clinical trial in accordance with Article 43(2), the protocol shall indicate the reasons thereof.
22.
Issues regarding labelling and the unblinding of investigational medicinal products shall be addressed in the protocol, where necessary.
23.
The protocol shall be accompanied by the Charter of the Data Safety Monitoring Committee, if applicable.
24.
The protocol shall be accompanied by a synopsis of the protocol.
E. INVESTIGATOR'S BROCHURE (IB)
25.
An IB, which has been prepared in accordance with the state of scientific knowledge and international guidance, shall be submitted.
26.
The purpose of the IB is to provide the investigators and others involved in the clinical trial with information to facilitate their understanding of the rationale for, and their compliance with, key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures.
27.
The information in the IB shall be presented in a concise, simple, objective, balanced and non-promotional form that enables a clinician or investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial. It shall be prepared from all available information and evidence that supports the rationale for the proposed clinical trial and the safe use of the investigational medicinal product in the clinical trial and be presented in the form of summaries.
28.
If the investigational medicinal product is authorised, and is used in accordance with the terms of the marketing authorisation, the approved summary of product characteristics (SmPC) shall be the IB. If the conditions of use in the clinical trial differ from those authorised, the SmPC shall be supplemented with a summary of relevant non-clinical and clinical data that support the use of the investigational medicinal product in the clinical trial. Where the investigational medicinal product is identified in the protocol only by its active substance, the sponsor shall select one SmPC as equivalent to the IB for all medicinal products that contain that active substance and are used at any clinical trial site.
29.
For a multinational clinical trial where the medicinal product to be used in each Member State concerned is authorised at national level, and the SmPC varies among Member States concerned, the sponsor shall choose one SmPC for the whole clinical trial. This SmPC shall be the one best suited to ensure patient safety.
30.
If the IB is not an SmPC, it shall contain a clearly identifiable section called the ‘Reference Safety Information’ (RSI). In accordance with paragraphs 10 and 11 of Annex III, the RSI shall contain product information on the investigational medicinal product and on how to determine what adverse reactions are to be considered as expected adverse reactions, and on the frequency and nature of those adverse reactions.
F. DOCUMENTATION RELATING TO COMPLIANCE WITH GOOD MANUFACTURING PRACTICE (GMP) FOR THE INVESTIGATIONAL MEDICINAL PRODUCT
31.
As regards documentation relating to GMP compliance, the following shall apply.
32.
No documentation needs to be submitted where the investigational medicinal product is authorised and is not modified, whether or not it is manufactured in the Union.
33.
If the investigational medicinal product is not authorised, and does not have a marketing authorisation from a third country that is party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and is not manufactured in the Union, the following documentation shall be submitted:
(a)
a copy of the authorisation referred to in Article 61; and
(b)
certification by the qualified person in the Union that the manufacturing complies with GMP at least equivalent to the GMP in the Union, unless there are specific arrangements provided for in mutual recognition agreements between the Union and third countries.
34.
In all other cases, a copy of the authorisation referred to in Article 61 shall be submitted.
35.
For processes related to investigational medicinal products set out in Article 61(5), which are not subject to an authorisation in accordance with Article 61, documentation to demonstrate compliance with the requirements referred to in Article 61(6) shall be submitted.
G. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)
36.
The IMPD shall give information on the quality of any investigational medicinal product, the manufacture and control of the investigational medicinal product, and data from non-clinical studies and from its clinical use.
1.1. Data relating to the investigational medicinal product
Introduction
37.
Regarding data, the IMPD may be replaced by other documentation which may be submitted alone or with a simplified IMPD. The details of this ‘simplified IMPD’ are set out in section 1.2 ‘Simplified IMPD by referring to other documentation’.
38.
Each section of the IMPD shall be prefaced with a detailed table of contents and a glossary of terms.
39.
The information in the IMPD shall be concise. The IMPD must not be unnecessarily voluminous. It is preferable to present data in tabular form accompanied by a brief narrative highlighting the main salient points.
Quality data
40.
Quality data shall be submitted in a logical structure such as that of Module 3 of the ICH Common Technical Document format.
Non-clinical pharmacology and toxicology data
41.
The IMPD shall also contain summaries of non-clinical pharmacology and toxicology data for any investigational medicinal product used in the clinical trial in accordance with international guidance. It shall contain a reference list of studies conducted and appropriate literature references. Wherever appropriate, it is preferable to present data in tabular form accompanied by a brief narrative highlighting the main salient points. The summaries of the studies conducted shall allow an assessment of the adequacy of the study and whether the study has been conducted according to an acceptable protocol.
42.
Non-clinical pharmacology and toxicology data shall be submitted in a logical structure, such as that of Module 4 of the ICH Common Technical Document format.
43.
The IMPD shall provide a critical analysis of the data, including justification for omissions of data, and an assessment of the safety of the product in the context of the proposed clinical trial rather than a mere factual summary of the studies conducted.
44.
The IMPD shall contain a statement of the good laboratory practice status or equivalent standards, as referred to in Article 25(3).
45.
The test material used in toxicity studies shall be representative of that of the clinical trial use in terms of qualitative and quantitative impurity profiles. The preparation of the test material shall be subject to the controls necessary to ensure this and thus support the validity of the study.
Data from previous clinical trials and human experience
46.
Data from previous clinical trials and human experience shall be submitted in a logical structure, such as that of Module 5 of the ICH Common Technical Document format.
47.
This section shall provide summaries of all available data from previous clinical trials and human experience with the investigational medicinal products.
It shall also contain a statement of the compliance with good clinical practice of those previous clinical trials, as well as a reference to the public entry referred to in Article 25(6).
Overall risk and benefit assessment
48.
This section shall provide a brief integrated summary that critically analyses the non-clinical and clinical data in relation to the potential risks and benefits of the investigational medicinal product in the proposed clinical trial unless this information is already provided in the protocol. In the latter case, it shall cross-refer to the relevant section in the protocol. The text shall identify any studies that were terminated prematurely and discuss the reasons. Any evaluation of foreseeable risks and anticipated benefits for studies on minors or incapacitated adults shall take account of the specific provisions set out in this Regulation.
49.
Where appropriate, safety margins shall be discussed in terms of relative systemic exposure to the investigational medicinal product, preferably based on ‘area under the curve’ (AUC) data, or peak concentration (Cmax) data, whichever is considered more relevant, rather than in terms of applied dose. The clinical relevance of any findings in the non-clinical and clinical studies along with any recommendations for further monitoring of effects and safety in the clinical trials shall also be discussed.
1.2. Simplified IMPD by referring to other documentation
50.
The applicant may refer to other documentation submitted alone or with a simplified IMPD.
Possibility of referring to the IB
51.
The applicant may either provide a stand-alone IMPD or cross-refer to the IB for the reference safety information and the summaries of pre-clinical and clinical parts of the IMPD. In the latter case, the summaries of pre-clinical information and clinical information shall include data, preferably in tables, providing sufficient detail to allow assessors to reach a decision on the potential toxicity of the investigational medicinal product and the safety of its use in the proposed clinical trial. If there is some special aspect of the pre-clinical data or clinical data that requires a detailed expert explanation or discussion beyond what would usually be included in the IB, the pre-clinical and clinical information shall be submitted as part of the IMPD.
Possibility of referring to the SmPC
52.
The applicant may submit the version of the SmPC valid at the time of application, as the IMPD if the investigational medicinal product is authorised. The exact requirements are detailed in Table 1. Where new data are provided, it should be clearly identified.
Table 1: Content of the simplified IMPD
Types of previous assessment
Quality data
Non-clinical data
Clinical data
The investigational medicinal product is authorised or has a marketing authorisation in an ICH country and is used in the clinical trial:
—
within the conditions of the SmPC
SmPC
—
outside the conditions of the SmPC
SmPC
If appropriate
If appropriate
—
after modification (for example blinding)
P+A
SmPC
SmPC
Another pharmaceutical form or strength of the investigational medicinal product is authorised or has a marketing authorisation in an ICH country and the investigational medicinal product is supplied by the marketing authorisation holder
SmPC+P+A
Yes
Yes
The investigational medicinal product is not authorised and has no marketing authorisation in an ICH country but the active substance is contained in an authorised medicinal product, and
—
is supplied by the same manufacturer
SmPC+P+A
Yes
Yes
—
is supplied by another manufacturer
SmPC+S+P+A
Yes
Yes
The investigational medicinal product was subject to a previous clinical trial application and authorised in the Member State concerned and has not been modified, and
—
no new data are available since last amendment to the clinical trial application,
Reference to previous submission
—
new data are available since last amendment to the clinical trial application,
New data
New data
New data
—
is used under different conditions
If appropriate
If appropriate
If appropriate
(S: Data relating to the active substance; P: Data relating to the investigational medicinal product; A: Additional information on Facilities and Equipment, Adventitious Agents Safety Evaluation, Novel Excipients, and Solvents for Reconstitution and Diluents)
53.
If the investigational medicinal product is defined in the protocol in terms of active substance or ATC code (see above, paragraph 18), the applicant may replace the IMPD by one representative SmPC for each active substance/active substance pertaining to that ATC group. Alternatively, the applicant may provide a collated document containing information equivalent to that in the representative SmPCs for each active substance that could be used as an investigational medicinal product in the clinical trial.
1.3. IMPD in cases of placebo
54.
If the investigational medicinal product is a placebo, the information requirements shall be limited to quality data. No additional documentation is required if the placebo has the same composition as the tested investigational medicinal product (with the exception of the active substance), is manufactured by the same manufacturer, and is not sterile.
H. AUXILIARY MEDICINAL PRODUCT DOSSIER
55.
Without prejudice to Article 65, the documentation requirements set out in sections F and G shall also apply to auxiliary medicinal products. However, where the auxiliary medicinal product is authorised in the Member State concerned, no additional information is required.
I. SCIENTIFIC ADVICE AND PAEDIATRIC INVESTIGATION PLAN (PIP)
56.
If available, a copy of the summary of scientific advice of the Agency, or of any Member State or third country, with regard to the clinical trial shall be submitted.
57.
If the clinical trial is part of an agreed PIP, a copy of the Agency's decision on the agreement on the PIP, and the opinion of the Paediatric Committee, unless these documents are fully accessible via the internet shall be submitted. In the latter case, a link to this documentation in the cover letter is sufficient (see section B).
J. CONTENT OF THE LABELLING OF THE INVESTIGATIONAL MEDICINAL PRODUCTS
58.
A description of the content of the labelling of the investigational medicinal product in accordance with Annex VI shall be provided.
K. RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
59.
Unless described in the protocol, a separate document shall describe in detail the procedures for inclusion of subjects and shall provide a clear indication of what the first act of recruitment is.
60.
Where the recruitment of subjects is done through advertisement, copies of the advertising material shall be submitted, including any printed materials, and audio or visual recordings. The procedures proposed for handling responses to the advertisement shall be outlined. This includes copies of communications used to invite subjects to participate in the clinical trial and arrangements for information or advice to the respondents found not to be suitable for inclusion in the clinical trial.
L. SUBJECT INFORMATION, INFORMED CONSENT FORM AND INFORMED CONSENT PROCEDURE (INFORMATION PER MEMBER STATE CONCERNED)
61.
All information given to the subjects (or, where applicable, to their legally designated representatives) before their decision to participate or abstain from participation shall be submitted together with the form for written informed consent, or other alternative means according to Article 29(1) for recording informed consent.
62.
A description of procedures relating to informed consent for all subjects, and in particular:
(a)
in clinical trials with minors or incapacitated subjects, the procedures to obtain informed consent from the legally designated representatives, and the involvement of the minor or incapacitated subject shall be described;
(b)
if a procedure with consent witnessed by an impartial witness is to be used, relevant information on the reason for using an impartial witness, on the selection of the impartial witness and on the procedure for obtaining informed consent shall be provided;
(c)
in the case of clinical trials in emergency situations as referred to in Article 35, the procedure for obtaining the informed consent of the subject or the legally designated representative to continue the clinical trial shall be described;
(d)
in the case of clinical trials in emergency situations as referred to in Article 35, the description of the procedures followed to identify the urgency of the situation and to document it;
(e)
in the case of clinical trials where their methodology requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products, as referred to in Article 30, and where, as a consequence, simplified means for obtaining informed consent will be used, the simplified means shall be described.
63.
In the cases set out in paragraph 62, the information given to the subject and to his or her legally designated representative shall be submitted.
M. SUITABILITY OF THE INVESTIGATOR (INFORMATION PER MEMBER STATE CONCERNED)
64.
A list of the planned clinical trial sites, the name and position of the principal investigators and the planned number of subjects at the sites shall be submitted.
65.
Description of the qualification of the investigators in a current curriculum vitae and other relevant documents shall be submitted. Any previous training in the principles of good clinical practice or experience obtained from work with clinical trials and patient care shall be described.
66.
Any conditions, such as economic interests and institutional affiliations, that might influence the impartiality of the investigators shall be presented.
N. SUITABILITY OF THE FACILITIES (INFORMATION PER MEMBER STATE CONCERNED)
67.
A duly justified written statement on the suitability of the clinical trial sites adapted to the nature and use of the investigational medicinal product and including a description of the suitability of facilities, equipment, human resources and description of expertise, issued by the head of the clinic/institution at the clinical trial site or by some other responsible person, according to the system in the Member State concerned, shall be submitted.
O. PROOF OF INSURANCE COVER OR INDEMNIFICATION (INFORMATION PER MEMBER STATE CONCERNED)
68.
Proof of insurance, a guarantee, or a similar arrangement shall be submitted, if applicable.
P. FINANCIAL AND OTHER ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
69.
A brief description of the financing of the clinical trial.
70.
Information on financial transactions and compensation paid to subjects and investigator/site for participating in the clinical trial shall be submitted.
71.
Description of any other agreement between the sponsor and the site shall be submitted.
Q. PROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)
72.
Proof of payment shall be submitted, if applicable.
R. PROOF THAT DATA WILL BE PROCESSED IN COMPLIANCE WITH UNION LAW ON DATA PROTECTION
73.
A statement by the sponsor or his or her representative that data will be collected and processed in accordance with Directive 95/46/EEC shall be provided.
ANNEX II
APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION
A. INTRODUCTION AND GENERAL PRINCIPLES
1.
Where a substantial modification concerns more than one clinical trial of the same sponsor and the same investigational medicinal product, the sponsor may make a single request for authorisation of the substantial modification. The cover letter shall contain a list of all clinical trials to which the application for substantial modification relates, with the EU trial numbers and respective modification code numbers of each of those clinical trials.
2.
The application shall be signed by the sponsor or a representative of the sponsor. This signature shall confirm that the sponsor is satisfied that:
(a)
the information provided is complete;
(b)
the attached documents contain an accurate account of the information available; and
(c)
the clinical trial will be conducted in accordance with the amended documentation.
B. COVER LETTER
3.
A cover letter with the following information:
(a)
in its subject line, the EU trial number with the title of the clinical trial and the substantial modification code number which allows unique identification of the substantial modification, and which shall be used consistently throughout the application dossier;
(b)
identification of the applicant;
(c)
identification of the substantial modification (the sponsor's substantial modification code number and date), whereby the modification may refer to several changes in the protocol or scientific supporting documents;
(d)
a highlighted indication of any special issues relating to the modification and an indication as to where the relevant information or text is located in the original application dossier;
(e)
identification of any information not contained in the modification application form that might impact on the risk to subjects; and
(f)
where applicable, a list of all clinical trials which are substantially modified, with EU trial numbers and respective modification code numbers.
C. MODIFICATION APPLICATION FORM
4.
The modification application form, duly completed.
D. DESCRIPTION OF THE MODIFICATION
5.
The modification shall be presented and described as follows:
(a)
an extract from the documents to be amended showing previous and new wording in track changes, as well as an extract showing only the new wording, and a explanation of the changes; and
(b)
notwithstanding point (a), if the changes are so widespread or far-reaching that they justify an entirely new version of the document, a new version of the entire document (in such cases, an additional table lists the amendments to the documents, whereby identical changes can be grouped).
6.
The new version of the document shall be identified by the date and an updated version number.
E. SUPPORTING INFORMATION
7.
Where applicable, additional supporting information shall at least include:
(a)
summaries of data;
(b)
an updated overall risk/benefit assessment;
(c)
possible consequences for subjects already included in the clinical trial;
(d)
possible consequences for the evaluation of the results;
(e)
documents which relate to any changes to the information provided to subjects or their legally designated representatives, the informed consent procedure, informed consent forms, information sheets, or to letters of invitation; and
(f)
a justification for the changes sought in the application for a substantial modification.
F. UPDATE OF EU APPLICATION FORM
8.
If a substantial modification involves changes to entries on the EU application form referred to in Annex I, a revised version of that form shall be submitted. The fields affected by the substantial modification shall be highlighted in the revised form.
G. PROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)
9.
Proof of payment shall be submitted, if applicable.
ANNEX III
SAFETY REPORTING
1. REPORTING OF SERIOUS ADVERSE EVENTS BY THE INVESTIGATOR TO THE SPONSOR
1.
The investigator does not need to actively monitor subjects for adverse events once the clinical trial has ended with regard to the subjects treated by him, unless otherwise provided for in the protocol.
2. REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS) BY THE SPONSOR TO THE AGENCY IN ACCORDANCE WITH ARTICLE 42
2.1. Adverse Events and Causality
2.
Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the product, shall be subject to the same obligation to report as adverse reactions.
3.
In determining whether an adverse event is an adverse reaction, consideration shall be given to whether there is a reasonable possibility of establishing a causal relationship between the event and the investigational medicinal product based on an analysis of available evidence.
4.
In the absence of information on causality provided by the reporting investigator, the sponsor shall consult the reporting investigator and encourage him to express an opinion on this issue. The causality assessment given by the investigator shall not be downgraded by the sponsor. If the sponsor disagrees with the investigator's causality assessment, the opinion of both the investigator and the sponsor shall be provided with the report.
2.2. Expectedness, unexpectedness and the RSI
5.
In determining whether an adverse event is unexpected, consideration shall be given to whether the event adds significant information on the specificity, increase of occurrence, or severity of a known, already documented serious adverse reaction.
6.
The expectedness of an adverse reaction shall be set out by the sponsor in the RSI. Expectedness shall be determined on the basis of events previously observed with the active substance and not on the basis of the anticipated pharmacological properties of a medicinal product or events related to the subject's disease.
7.
The RSI shall be contained in the SmPC or the IB. The covering letter shall refer to the location of the RSI in the application dossier. If the investigational medicinal product is authorised in several Member States concerned with different SmPCs, the sponsor shall select the most appropriate SmPC, with reference to subject safety, as the RSI.
8.
The RSI may change during the conduct of a clinical trial. For the purpose of reporting SUSARs the version of the RSI at the moment of occurrence of the SUSAR shall apply. Thus, a change of the RSI impacts on the number of adverse reactions to be reported as SUSARs. Regarding the applicable RSI for the purpose of the annual safety report, see section 3 of this Annex.
9.
If information on expectedness has been provided by the reporting investigator, this shall be taken into consideration by the sponsor.
2.3. Information for the reporting of SUSARs
10.
The information shall at least include:
(a)
a valid EU trial number;
(b)
a sponsor study number;
(c)
an identifiable coded subject;
(d)
an identifiable reporter;
(e)
a SUSAR;
(f)
a suspect investigational medicinal product (including active substance name-code);
(g)
a causality assessment.
11.
In addition, in order to properly process the report electronically, the following administrative information shall be provided:
(a)
the sender's (case) safety report unique identifier;
(b)
the receive date of the initial information from the primary source;
(c)
the receipt date of the most recent information;
(d)
the worldwide unique case identification number;
(e)
the sender identifier.
2.4. Follow-up reports of SUSARs
12.
If the initial report of a SUSAR referred to in point (a) of Article 42(2) (fatal or life-threatening) is incomplete, for example if the sponsor has not provided all the information within seven days, the sponsor shall submit a completed report based on the initial information within an additional eight days.
13.
The clock for initial reporting (day 0 = Di 0) starts as soon as the information containing the minimum reporting criteria has been received by the sponsor.
14.
If significant new information on an already reported case is received by the sponsor, the clock starts again at day zero, that is the date of receipt of the new information. This information shall be reported as a follow-up report within 15 days.
15.
If the initial report of a SUSAR referred to in Article 42(2)(c) (initially considered to be non-fatal or non-life-threatening but which turns out to be fatal or life-threatening) is incomplete, a follow-up report shall be made as soon as possible, but within a maximum of seven days of first knowledge of the reaction being fatal or life-threatening. The sponsor shall submit a completed report within an additional eight days.
16.
In cases where a SUSAR turns out to be fatal or life-threatening, whereas initially it was considered as non-fatal or not life-threatening, if the initial report has not yet been submitted, a combined report shall be created.
2.5. Unblinding treatment allocation
17.
The investigator shall only unblind the treatment allocation of a subject in the course of a clinical trial if unblinding is relevant to the safety of the subject.
18.
When reporting a SUSAR to the Agency, the sponsor shall only unblind the treatment allocation of the affected subject to whom the SUSAR relates.
19.
If an event is potentially a SUSAR the blind shall be broken for that subject only by the sponsor. The blind shall be maintained for other persons responsible for the ongoing conduct of the clinical trial (such as the management, monitors, investigators) and those persons responsible for data analysis and interpretation of results at the conclusion of the clinical trial, such as biometrics personnel.
20.
Unblinded information shall be accessible only to persons who need to be involved in the safety reporting to the Agency, to Data Safety Monitoring Boards (’DSMB’), or to persons performing ongoing safety evaluations during the clinical trial.
21.
However, for clinial trials carried out in high morbidity or high mortality disease, where efficacy end-points could also be SUSARs or when mortality or another ’serious’ outcome, that may potentially be reported as a SUSAR, is the efficacy end-point in a clinical trial, the integrity of the clinical trial may be compromised if the blind is systematically broken. Under these and similar circumstances, the sponsor shall highlight in the protocol which serious events are to be treated as disease-related and are not subject to systematic unblinding and expedited reporting.
22.
If following unblinding, an event turns out to be a SUSAR the reporting rules for SUSARs set out in Article 42 and in Section 2 of this Annex shall apply.
3. ANNUAL SAFETY REPORTING BY THE SPONSOR
23.
The report shall contain, in an appendix, the RSI in effect at the start of the reporting period.
24.
The RSI in effect at the start of the reporting period shall serve as RSI during the reporting period.
25.
If there are significant changes to the RSI during the reporting period they shall be listed in the annual safety report. Moreover, in this case the revised RSI shall be submitted as an appendix to the report, in addition to the RSI in effect at the start of the reporting period. Despite the change to the RSI, the RSI in effect at the start of the reporting period serves as RSI during the reporting period.
ANNEX IV
CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL
The summary of the results of the clinical trial shall contain information on the following elements:
A. CLINICAL TRIAL INFORMATION:
1.
Clinical trial identification (including title of the trial and protocol number);
2.
Identifiers (including EU trial number, other identifiers);
3.
Sponsor details (including scientific and public contact points);.
4.
Paediatric regulatory details (including information whether the clinical trial is a part of a Paediatric Investigation Plan);
5.
Result analysis stage (including information about intermediate data analysis date, interim or final analysis stage, date of global end of the clinical trial). For clinical trials replicating studies on already authorised investigational medicinal products and used in accordance with the terms of the marketing authorisation, the summary of the results should also indicate identified concerns in the overall results of the clinical trial relating to relevant aspects of the efficacy of the related medicinal product;
6.
General information about the clinical trial (including information about main objectives of the trial, trial design, scientific background and explanation of rationale for the trial; date of the start of the trial, measures of protection of subjects taken, background therapy; and statistical methods used);
7.
Population of subjects (including information with actual number of subjects included in the clinical trial in the Member State concerned, in the Union and in third countries; age group breakdown, gender breakdown).
B. SUBJECT DISPOSITION:
1.
Recruitment (including information on the number of subjects screened, recruited and withdrawn; inclusion and exclusion criteria; randomisation and blinding details; investigational medicinal products used);
2.
Pre-assignment Period;
3.
Post Assignment Periods.
C. BASELINE CHARACTERISTICS:
1.
Baseline Characteristics (Required) Age;
2.
Baseline Characteristics (Required) Gender;
3.
Baseline Characteristics (Optional) Study Specific Characteristic.
D. END POINTS:
1.
End point definitions (1)
2.
End Point #1
Statistical Analyses
3.
End Point #2
Statistical Analyses
E. ADVERSE EVENTS:
1.
Adverse events information;
2.
Adverse event reporting group;
3.
Serious adverse event;
4.
Non-serious adverse event.
F. ADDITIONAL INFORMATION:
1.
Global Substantial Modifications;
2.
Global Interruptions and re-starts;
3.
Limitations, addressing sources of potential bias and imprecisions and Caveats;
4.
A declaration by the submitting party on the accuracy of the submitted information.
(1) Information shall be provided for as many end points as defined in the protocol.
ANNEX V
CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS
The summary of the results of the clinical trial for laypersons shall contain information on the following elements:
1.
Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);
2.
Name and contact details of the sponsor;
3.
General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);
4.
Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria);
5.
Investigational medicinal products used;
6.
Description of adverse reactions and their frequency;
7.
Overall results of the clinical trial;
8.
Comments on the outcome of the clinical trial;
9.
Indication if follow up clinical trials are foreseen;
10.
Indication where additional information could be found.
ANNEX VI
LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
A. UNAUTHORISED INVESTIGATIONAL MEDICINAL PRODUCTS
A.1. General rules
1.
The following particulars shall appear on the immediate and the outer packaging:
(a)
name, address and telephone number of the main contact for information on the product, clinical trial and emergency unblinding; this may be the sponsor, contract research organisation or investigator (for the purpose of this Annex this is referred to as the ’main contact’);
(b)
the name of the substance and its strength or potency, and in the case of blind clinical trials the name of the substance is to appear with the name of the comparator or placebo on the packaging of both the unauthorised investigational medicinal product and the comparator or placebo;
(c)
pharmaceutical form, route of administration, quantity of dosage units;
(d)
the batch or code number identifying the contents and packaging operation;
(e)
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
(f)
the subject identification number and/or the treatment number and, where relevant, the visit number;
(g)
the name of the investigator (if not included in (a) or (e));
(h)
directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);
(i)
’For clinical trial use only’ or similar wording;
(j)
the storage conditions;
(k)
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity; and
(l)
’Keep out of reach of children’, except when the product is for use in trials where the product is not taken home by subjects.
2.
Symbols or pictograms may be included to clarify certain information mentioned above. Additional information, warnings or handling instructions may be displayed.
3.
The address and telephone number of the main contact shall not be required to appear on the label if subjects have been given a leaflet or card which provides these details and have been instructed to keep this in their possession at all times.
A.2. Limited labelling of immediate packaging
A.2.1. Immediate and outer packaging provided together
4.
When the product is provided to the subject or the person administering the medicinal product in an immediate packaging and outer packaging intended to remain together, and the outer packaging carries the particulars listed in section A.1., the following particulars shall appear on the immediate packaging (or any sealed dosing device that contains the immediate package):
(a)
name of the main contact;
(b)
pharmaceutical form, route of administration (may be excluded for oral solid dose forms), quantity of dosage units and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
(c)
batch and/or code number identifying the contents and packaging operation;
(d)
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
(e)
the subject identification number and/or the treatment number and, where relevant, the visit number; and
(f)
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity.
A.2.2. Small immediate packaging
5.
If the immediate packaging takes the form of blister packs or small units such as ampoules on which the particulars required in section A.1. cannot be displayed, the outer packaging provided shall bear a label with those particulars. The immediate packaging shall contain the following:
(a)
name of the main contact;
(b)
route of administration (may be excluded for oral solid dose forms) and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
(c)
batch or code number identifying the contents and packaging operation;
(d)
a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
(e)
the subject identification number/treatment number and, where relevant, the visit number; and
(f)
period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity.
B. UNAUTHORISED AUXILIARY MEDICINAL PRODUCTS
6.
The following particulars shall appear on the immediate and the outer packaging:
(a)
name of the main contact;
(b)
name of the medicinal product, followed by its strength and pharmaceutical form;
(c)
statement of the active substances expressed qualitatively and quantitatively per dosage unit;
(d)
batch or code number identifying the contents and packaging operation;
(e)
clinical trial reference code allowing identification of the clinical trial site, investigator and subject;
(f)
directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);
(g)
’For clinical trial use only’ or similar wording;
(h)
the storage conditions; and
(i)
period of use (expiry date or retest date as applicable).
C. ADDITIONAL LABELLING FOR AUTHORISED INVESTIGATIONAL MEDICINAL PRODUCTS
7.
In accordance with Article 67(2), the following particulars shall appear on the immediate and the outer packaging:
(a)
name of the main contact;
(b)
clinical trial reference code allowing identification of the clinical trial site, investigator, sponsor and subject;
(c)
’For clinical trial use only’ or similar wording.
D. REPLACING OF INFORMATION
8.
The particulars listed in sections A, B and C, other than those particulars listed in paragraph 9, may be omitted from the label of a product and made available by other means, for example by use of a centralised electronic randomisation system, use of a centralised information system, provided that the safety of the subject and the reliability and robustness of data are not compromised. This shall be justified in the protocol.
9.
The particulars referred to in the following points shall not be omitted from the label of a product:
(a)
paragraph 1, points (b), (c), (d), (f), (j) and (k);
(b)
paragraph 4, points (b), (c), (e), and (f);
(c)
paragraph 5, points (b), (c), (e), and (f);
(d)
paragraph 6, points (b), (d), (e), (h), and (i).
ANNEX VII
CORRELATION TABLE
Directive 2001/20/EC
This Regulation
Article 1(1)
Article 1 and Article 2(1) and (2) points (1), (2) and (4)
Article 1(2)
Article 2(2) point (30)
Article 1(3), first subparagraph
—
Article 1(3), second subparagraph
Article 47, third subparagraph
Article 1(4)
Article 47, second subparagraph
Article 2
Article 2
Article 3(1)
—
Article 3(2)
Articles 4, 28, 29 and 76
Article 3(3)
Article 28(1)(f)
Article 3(4)
Article 28(1)(g)
Article 4
Articles 10(1), 28, 29 and 32
Article 5
Articles 10(2), 28, 29 and 31
Article 6
Articles 4 to 14
Article 7
Articles 4 to 14
Article 8
—
Article 9
Articles 4 to 14
Article 10(a)
Articles 15 to 24
Article 10(b)
Article 54
Article 10(c)
Articles 37 and 38
Article 11
Article 81
Article 12
Article 77
Article 13(1)
Article 61(1) to (4)
Article 13(2)
Article 61(2)
Article 13(3), first subparagraph
Articles 62(1) and 63(1) and (3)
Article 13(3), second subparagraph
Article 63(1)
Article 13(3), third subparagraph
—
Article 13(4)
Article 62
Article 13(5)
—
Article 14
Articles 66 to 70
Article 15(1)
Article 78(1), (2) and (5)
Article 15(2)
Article 78(6)
Article 15(3)
—
Article 15(4)
—
Article 15(5)
Articles 57, 58 and 78(7)
Article 16
Article 41
Article 17(1)(a) to (c)
Article 42
Article 17(1)(d)
—
Article 17(2)
Article 43
Article 17(3)(a)
—
Article 17(3)(b)
Article 44(1)
Article 18
—
Article 19, first paragraph, first sentence
Article 75
Article 19, first paragraph, second sentence
Article 74
Article 19, second paragraph
Article 92
Article 19, third paragraph
—
Article 20
—
Article 21
Article 88
Article 22
—
Article 23
—
Article 24
—
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High safety standards and streamlined procedures for EU clinical trials
High safety standards and streamlined procedures for EU clinical trials
SUMMARY OF:
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
WHAT IS THE AIM OF THE REGULATION?
The regulation aims to ensure the safety of those participating in clinical trials. It also aims to simplify and speed up procedures authorising these trials which are vital for developing new medicines and improving treatments using existing medicines.
It repeals Directive 2001/20, which is still in force (see section ‘From when does the regulation apply?’ below).
KEY POINTS
General principle
A clinical trial may be held only if:
the rights, safety, dignity and well-being of participants are protected and prevail over all other interests; and
it is designed to generate reliable and robust data.
Rules
1.Less bureaucracy (‘red tape’): sponsors of clinical trials will only need to submit a single application for approval irrespective of where in the EU the trial is to be held. There will be less red tape for less-risky trials.
2.Shorter authorisation times: the timeline to authorise clinical trials is set at 60 days. If no decision is taken within this period, the trial may go ahead (‘tacit approval’). Decisions on applications for substantial modifications of clinical trials must be taken within 49 days. Where no decision is issued, the authorisation is considered to be given.
3.Vulnerable groups: applications for the authorisation of clinical trials must be assessed on the basis of appropriate expertise. Specific expertise must be used to assess clinical trials involving participants in emergency situations, minors, those who are incapacitated, pregnant and breast-feeding women and, where appropriate, certain other groups, such as older people or those suffering from rare and extremely rare diseases.
4.Ethical review: all trials are subject to scientific and ethical review. The ethical review must be performed by an ethics committee in accordance with the law of the EU country concerned. However, the procedures and the timelines for the ethical review must be compatible with the authorisation procedure stipulated by this regulation.
5.Informed consent: prior to the trial, participants must be given clear information about their rights (including the right to withdraw); conditions, duration, nature, objectives, implications, risks and inconveniences of the trial; possible treatment alternatives; and the possible-damage compensation system.
6.Publicly accessible EU database on clinical trials: the European Medicines Agency will set up a database containing information on all clinical trials held in the EU, whether successful or not.
FROM WHEN DOES THE REGULATION APPLY?
Regulation (EU) No 536/2014 shall apply as from six months after the publication of the notice referred to in Article 82(3) stating that an independent audit report verified that the EU portal and the EU database have achieved full functionality. The existing legislation in the field (Directive 2001/20/EC) will be repealed following a three year transition period from that date.
BACKGROUND
For more information, see:
Clinical trials (European Commission)
MAIN DOCUMENT
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1-76)
Successive amendments to Regulation (EU) No 536/2014 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34-44)
See consolidated version.
last update 07.05.2020
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