diff --git "a/train.jsonl" "b/train.jsonl" new file mode 100644--- /dev/null +++ "b/train.jsonl" @@ -0,0 +1,503 @@ +{"id": "article-1-chunk-0", "text": "Article 1 - Subject matter\n\n1. The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of\nhuman-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety,\nfundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against\nthe harmful effects of AI systems in the Union and supporting innovation.\n2. This Regulation lays down:\n(a) harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;\n(b) prohibitions of certain AI practices;\n(c) specific requirements for high-risk AI systems and obligations for operators of such systems;\n(d) harmonised transparency rules for certain AI systems;\n(e) harmonised rules for the placing on the market of general-purpose AI models;\n(f) rules on market monitoring, market surveillance, governance and enforcement;\n(g) measures to support innovation, with a particular focus on SMEs, including start-ups.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-1", "title": "Article 1 - Subject matter", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 44, "page_end": 45, "chunk_index": 0} +{"id": "article-2-chunk-0", "text": "Article 2 - Scope\n\n1. This Regulation applies to:\n(a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models\nin the Union, irrespective of whether those providers are established or located within the Union or in a third country;\n(b) deployers of AI systems that have their place of establishment or are located within the Union;\n(c) providers and deployers of AI systems that have their place of establishment or are located in a third country, where the\noutput produced by the AI system is used in the Union;\n(d) importers and distributors of AI systems;\n(e) product manufacturers placing on the market or putting into service an AI system together with their product and\nunder their own name or trademark;\n(f) authorised representatives of providers, which are not established in the Union;\n(g) affected persons that are located in the Union.\n2. For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the\nUnion harmonisation legislation listed in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 apply.\nArticle 57 applies only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in\nthat Union harmonisation legislation.\n3. This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the\ncompetences of the Member States concerning national security, regardless of the type", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-2", "title": "Article 2 - Scope", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 45, "page_end": 46, "chunk_index": 0} +{"id": "article-2-chunk-1", "text": ". This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the\ncompetences of the Member States concerning national security, regardless of the type of entity entrusted by the Member\nStates with carrying out tasks in relation to those competences.\nThis Regulation does not apply to AI systems where and in so far they are placed on the market, put into service, or used\nwith or without modification exclusively for military, defence or national security purposes, regardless of the type of entity\ncarrying out those activities.\nThis Regulation does not apply to AI systems which are not placed on the market or put into service in the Union, where\nthe output is used in the Union exclusively for military, defence or national security purposes, regardless of the type of\nentity carrying out those activities.\n4. This Regulation applies neither to public authorities in a third country nor to international organisations falling\nwithin the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the\nframework of international cooperation or agreements for law enforcement and judicial cooperation with the Union or\nwith one or more Member States, provided that such a third country or international organisation provides adequate\nsafeguards with respect to the protection of fundamental rights and freedoms of individuals.\n5. This Regulation shall not affect the application of the provisions on", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-2", "title": "Article 2 - Scope", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 45, "page_end": 46, "chunk_index": 1} +{"id": "article-2-chunk-2", "text": "al organisation provides adequate\nsafeguards with respect to the protection of fundamental rights and freedoms of individuals.\n5. This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services\nas set out in Chapter II of Regulation (EU) 2022/2065.\n6. This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into\nservice for the sole purpose of scientific research and development.\n7. Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal\ndata processed in connection with the rights and obligations laid down in this Regulation. This Regulation shall not affect\nRegulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680, without prejudice to Article\n10(5) and Article 59 of this Regulation.\n8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models\nprior to their being placed on the market or put into service. Such activities shall be conducted in accordance with\napplicable Union law. Testing in real world conditions shall not be covered by that exclusion.\n9. This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection\nand product safety.\n10. This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of\na purely pers", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-2", "title": "Article 2 - Scope", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 45, "page_end": 46, "chunk_index": 2} +{"id": "article-2-chunk-3", "text": "ion legal acts related to consumer protection\nand product safety.\n10. This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of\na purely personal non-professional activity.\n11. This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or\nadministrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of\nAI systems by employers, or from encouraging or allowing the application of collective agreements which are more\nfavourable to workers.\n12. This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on\nthe market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-2", "title": "Article 2 - Scope", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 45, "page_end": 46, "chunk_index": 3} +{"id": "article-3-chunk-0", "text": "Article 3 - Definitions\n\nFor the purposes of this Regulation, the following definitions apply:\n(1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may\nexhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives,\nhow to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or\nvirtual environments;\n(2) ‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;\n(3) ‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or\na general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the\nmarket or puts the AI system into service under its own name or trademark, whether for payment or free of charge;\n(4) ‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its\nauthority except where the AI system is used in the course of a personal non-professional activity;\n(5) ‘authorised representative’ means a natural or legal person located or established in the Union who has received and\naccepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform\nand carry out on its behalf the obligations and procedures established by this Regulation;\n(6) ‘importer’ means a natural or legal person located or", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 0} +{"id": "article-3-chunk-1", "text": "general-purpose AI model to, respectively, perform\nand carry out on its behalf the obligations and procedures established by this Regulation;\n(6) ‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system\nthat bears the name or trademark of a natural or legal person established in a third country;\n(7) ‘distributor’ means a natural or legal person in the supply chain, other than the provider or the importer, that makes\nan AI system available on the Union market;\n(8) ‘operator’ means a provider, product manufacturer, deployer, authorised representative, importer or distributor;\n(9) ‘placing on the market’ means the first making available of an AI system or a general-purpose AI model on the Union\nmarket;\n(10) ‘making available on the market’ means the supply of an AI system or a general-purpose AI model for distribution or\nuse on the Union market in the course of a commercial activity, whether in return for payment or free of charge;\n(11) ‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union\nfor its intended purpose;\n(12) ‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context\nand conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional\nor sales materials and statements, as well as in the technical documentation;\n(13) ‘reasonably fores", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 1} +{"id": "article-3-chunk-2", "text": ", as specified in the information supplied by the provider in the instructions for use, promotional\nor sales materials and statements, as well as in the technical documentation;\n(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended\npurpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems,\nincluding other AI systems;\n(14) ‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product\nor AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property;\n(15) ‘instructions for use’ means the information provided by the provider to inform the deployer of, in particular, an AI\nsystem’s intended purpose and proper use;\n(16) ‘recall of an AI system’ means any measure aiming to achieve the return to the provider or taking out of service or\ndisabling the use of an AI system made available to deployers;\n(17) ‘withdrawal of an AI system’ means any measure aiming to prevent an AI system in the supply chain being made\navailable on the market;\n(18) ‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;\n(19) ‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures\nfor the assessment, designation and notification of conformity assessment bodies and for their monitoring;\n(20) ‘co", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 2} +{"id": "article-3-chunk-3", "text": "ional authority responsible for setting up and carrying out the necessary procedures\nfor the assessment, designation and notification of conformity assessment bodies and for their monitoring;\n(20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in Chapter III, Section 2\nrelating to a high-risk AI system have been fulfilled;\n(21) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including\ntesting, certification and inspection;\n(22) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant\nUnion harmonisation legislation;\n(23) ‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which\nis not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the\ncompliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in\na modification to the intended purpose for which the AI system has been assessed;\n(24) ‘CE marking’ means a marking by which a provider indicates that an AI system is in conformity with the requirements\nset out in Chapter III, Section 2 and other applicable Union harmonisation legislation providing for its affixing;\n(25) ‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review\nexperience gained from the us", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 3} +{"id": "article-3-chunk-4", "text": "rmonisation legislation providing for its affixing;\n(25) ‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review\nexperience gained from the use of AI systems they place on the market or put into service for the purpose of\nidentifying any need to immediately apply any necessary corrective or preventive actions;\n(26) ‘market surveillance authority’ means the national authority carrying out the activities and taking the measures\npursuant to Regulation (EU) 2019/1020;\n(27) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU)\nNo 1025/2012;\n(28) ‘common specification’ means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU)\nNo 1025/2012, providing means to comply with certain requirements established under this Regulation;\n(29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;\n(30) ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable\nparameters and its learning process in order, inter alia, to prevent underfitting or overfitting;\n(31) ‘validation data set’ means a separate data set or part of the training data set, either as a fixed or variable split;\n(32) ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the\nexpected performance of that system before its placing", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 4} +{"id": "article-3-chunk-5", "text": "s a fixed or variable split;\n(32) ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the\nexpected performance of that system before its placing on the market or putting into service;\n(33) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an\noutput;\n(34) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological\nor behavioural characteristics of a natural person, such as facial images or dactyloscopic data;\n(35) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, or psychological\nhuman features for the purpose of establishing the identity of a natural person by comparing biometric data of that\nindividual to biometric data of individuals stored in a database;\n(36) ‘biometric verification’ means the automated, one-to-one verification, including authentication, of the identity of\nnatural persons by comparing their biometric data to previously provided biometric data;\n(37) ‘special categories of personal data’ means the categories of personal data referred to in Article 9(1) of Regulation (EU)\n2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;\n(38) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation or\nprosecution of criminal offences, the disclos", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 5} +{"id": "article-3-chunk-6", "text": "1) of Regulation (EU) 2018/1725;\n(38) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation or\nprosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings;\n(39) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of\nnatural persons on the basis of their biometric data;\n(40) ‘biometric categorisation system’ means an AI system for the purpose of assigning natural persons to specific\ncategories on the basis of their biometric data, unless it is ancillary to another commercial service and strictly\nnecessary for objective technical reasons;\n(41) ‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without\ntheir active involvement, typically at a distance through the comparison of a person’s biometric data with the\nbiometric data contained in a reference database;\n(42) ‘real-time remote biometric identification system’ means a remote biometric identification system, whereby the\ncapturing of biometric data, the comparison and the identification all occur without a significant delay, comprising\nnot only instant identification, but also limited short delays in order to avoid circumvention;\n(43) ‘post-remote biometric identification system’ means a remote biometric identification system other than a real-time\nremote biometric identification system;\n(44) ‘pub", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 6} +{"id": "article-3-chunk-7", "text": "order to avoid circumvention;\n(43) ‘post-remote biometric identification system’ means a remote biometric identification system other than a real-time\nremote biometric identification system;\n(44) ‘publicly accessible space’ means any publicly or privately owned physical place accessible to an undetermined number\nof natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential\ncapacity restrictions;\n(45) ‘law enforcement authority’ means:\n(a) any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or\nthe execution of criminal penalties, including the safeguarding against and the prevention of threats to public\nsecurity; or\n(b) any other body or entity entrusted by Member State law to exercise public authority and public powers for the\npurposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of\ncriminal penalties, including the safeguarding against and the prevention of threats to public security;\n(46) ‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention,\ninvestigation, detection or prosecution of criminal offences or the execution of criminal penalties, including\nsafeguarding against and preventing threats to public security;\n(47) ‘AI Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI\nsystems and genera", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 7} +{"id": "article-3-chunk-8", "text": "eguarding against and preventing threats to public security;\n(47) ‘AI Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI\nsystems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January\n2024; references in this Regulation to the AI Office shall be construed as references to the Commission;\n(48) ‘national competent authority’ means a notifying authority or a market surveillance authority; as regards AI systems\nput into service or used by Union institutions, agencies, offices and bodies, references to national competent\nauthorities or market surveillance authorities in this Regulation shall be construed as references to the European Data\nProtection Supervisor;\n(49) ‘serious incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the\nfollowing:\n(a) the death of a person, or serious harm to a person’s health;\n(b) a serious and irreversible disruption of the management or operation of critical infrastructure;\n(c) the infringement of obligations under Union law intended to protect fundamental rights;\n(d) serious harm to property or the environment;\n(50) ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;\n(51) ‘non-personal data’ means data other than personal data as defined in Article 4, point (1), of Regulation (EU)\n2016/679;\n(52) ‘profiling’ means profiling as defined in Article", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 8} +{"id": "article-3-chunk-9", "text": "ion (EU) 2016/679;\n(51) ‘non-personal data’ means data other than personal data as defined in Article 4, point (1), of Regulation (EU)\n2016/679;\n(52) ‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;\n(53) ‘real-world testing plan’ means a document that describes the objectives, methodology, geographical, population and\ntemporal scope, monitoring, organisation and conduct of testing in real-world conditions;\n(54) ‘sandbox plan’ means a document agreed between the participating provider and the competent authority describing\nthe objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox;\n(55) ‘AI regulatory sandbox’ means a controlled framework set up by a competent authority which offers providers or\nprospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world\nconditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;\n(56) ‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking\ninto account their respective rights and obligations in the context of this Regulation, to make an informed deployment\nof AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;\n(57) ‘testing in real-world conditions’ means the temporary testing of an AI system for its intended", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 9} +{"id": "article-3-chunk-10", "text": "well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;\n(57) ‘testing in real-world conditions’ means the temporary testing of an AI system for its intended purpose in real-world\nconditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data\nand to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does\nnot qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation,\nprovided that all the conditions laid down in Article 57 or 60 are fulfilled;\n(58) ‘subject’, for the purpose of real-world testing, means a natural person who participates in testing in real-world\nconditions;\n(59) ‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her\nwillingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of\nthe testing that are relevant to the subject’s decision to participate;\n(60) ‘deep fake’ means AI-generated or manipulated image, audio or video content that resembles existing persons, objects,\nplaces, entities or events and would falsely appear to a person to be authentic or truthful;\n(61) ‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals,\nwhich:\n(a) has harmed or is likely to harm the collective interests of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 10} +{"id": "article-3-chunk-11", "text": "truthful;\n(61) ‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals,\nwhich:\n(a) has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other\nthan the Member State in which:\n(i) the act or omission originated or took place;\n(ii) the provider concerned, or, where applicable, its authorised representative is located or established; or\n(iii) the deployer is established, when the infringement is committed by the deployer;\n(b) has caused, causes or is likely to cause harm to the collective interests of individuals and has common features,\nincluding the same unlawful practice or the same interest being infringed, and is occurring concurrently,\ncommitted by the same operator, in at least three Member States;\n(62) ‘critical infrastructure’ means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557;\n(63) ‘general-purpose AI model’ means an AI model, including where such an AI model is trained with a large amount of\ndata using self-supervision at scale, that displays significant generality and is capable of competently performing\na wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into\na variety of downstream systems or applications, except AI models that are used for research, development or\nprototyping activities before they are placed on the market;\n(64) ‘high-impact capabil", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 11} +{"id": "article-3-chunk-12", "text": "into\na variety of downstream systems or applications, except AI models that are used for research, development or\nprototyping activities before they are placed on the market;\n(64) ‘high-impact capabilities’ means capabilities that match or exceed the capabilities recorded in the most advanced\ngeneral-purpose AI models;\n(65) ‘systemic risk’ means a risk that is specific to the high-impact capabilities of general-purpose AI models, having\na significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects\non public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale\nacross the value chain;\n(66) ‘general-purpose AI system’ means an AI system which is based on a general-purpose AI model and which has the\ncapability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;\n(67) ‘floating-point operation’ means any mathematical operation or assignment involving floating-point numbers, which\nare a subset of the real numbers typically represented on computers by an integer of fixed precision scaled by an\ninteger exponent of a fixed base;\n(68) ‘downstream provider’ means a provider of an AI system, including a general-purpose AI system, which integrates an\nAI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by\nanother entity based on contractual relations.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 12} +{"id": "article-3-chunk-13", "text": "which integrates an\nAI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by\nanother entity based on contractual relations.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Definitions", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 46, "page_end": 50, "chunk_index": 13} +{"id": "article-4-chunk-0", "text": "Article 4 - AI literacy\n\nProviders and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of\ntheir staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their\ntechnical knowledge, experience, education and training and the context the AI systems are to be used in, and considering\nthe persons or groups of persons on whom the AI systems are to be used.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - AI literacy", "chapter_number": "I", "chapter_title": "GENERAL PROVISIONS", "page_start": 51, "page_end": 51, "chunk_index": 0} +{"id": "article-5-chunk-0", "text": "Article 5 - Prohibited AI practices\n\n1. The following AI practices shall be prohibited:\n(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond\na person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of\nmaterially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an\ninformed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that\ncauses or is reasonably likely to cause that person, another person or group of persons significant harm;\n(b) the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of\na natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with\nthe objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in\na manner that causes or is reasonably likely to cause that person or another person significant harm;\n(c) the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural\npersons or groups of persons over a certain period of time based on their social behaviour or known, inferred or\npredicted personal or personality characteristics, with the social score leading to either or both of the following:\n(i) detrimental or unfavoura", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 0} +{"id": "article-5-chunk-1", "text": "based on their social behaviour or known, inferred or\npredicted personal or personality characteristics, with the social score leading to either or both of the following:\n(i) detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are\nunrelated to the contexts in which the data was originally generated or collected;\n(ii) detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or\ndisproportionate to their social behaviour or its gravity;\n(d) the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk\nassessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence,\nbased solely on the profiling of a natural person or on assessing their personality traits and characteristics; this\nprohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in\na criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;\n(e) the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or\nexpand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;\n(f) the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 1} +{"id": "article-5-chunk-2", "text": "through the untargeted scraping of facial images from the internet or CCTV footage;\n(f) the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions\nof a natural person in the areas of workplace and education institutions, except where the use of the AI system is\nintended to be put in place or into the market for medical or safety reasons;\n(g) the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation\nsystems that categorise individually natural persons based on their biometric data to deduce or infer their race, political\nopinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does\nnot cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or\ncategorizing of biometric data in the area of law enforcement;\n(h) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law\nenforcement, unless and in so far as such use is strictly necessary for one of the following objectives:\n(i) the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human\nbeings, as well as the search for missing persons;\n(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or\na genuine and present or ge", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 2} +{"id": "article-5-chunk-3", "text": "n\nbeings, as well as the search for missing persons;\n(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or\na genuine and present or genuine and foreseeable threat of a terrorist attack;\n(iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of\nconducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in\nAnnex II and punishable in the Member State concerned by a custodial sentence or a detention order for\na maximum period of at least four years.\nPoint (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of\nbiometric data for purposes other than law enforcement.\n2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law\nenforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the\npurposes set out in that point only to confirm the identity of the specifically targeted individual, and it shall take into\naccount the following elements:\n(a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm\nthat would be caused if the system were not used;\n(b) the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular th", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 3} +{"id": "article-5-chunk-4", "text": "probability and scale of the harm\nthat would be caused if the system were not used;\n(b) the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the\nseriousness, probability and scale of those consequences.\nIn addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of\nlaw enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), of this Article shall\ncomply with necessary and proportionate safeguards and conditions in relation to the use in accordance with the national\nlaw authorising the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the\n‘real-time’ remote biometric identification system in publicly accessible spaces shall be authorised only if the law\nenforcement authority has completed a fundamental rights impact assessment as provided for in Article 27 and has\nregistered the system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such\nsystems may be commenced without the registration in the EU database, provided that such registration is completed\nwithout undue delay.\n3. For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law\nenforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior\nauthorisati", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 4} +{"id": "article-5-chunk-5", "text": "h, point (h) and paragraph 2, each use for the purposes of law\nenforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior\nauthorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the\nMember State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of\nnational law referred to in paragraph 5. However, in a duly justified situation of urgency, the use of such system may be\ncommenced without an authorisation provided that such authorisation is requested without undue delay, at the latest\nwithin 24 hours. If such authorisation is rejected, the use shall be stopped with immediate effect and all the data, as well as\nthe results and outputs of that use shall be immediately discarded and deleted.\nThe competent judicial authority or an independent administrative authority whose decision is binding shall grant the\nauthorisation only where it is satisfied, on the basis of objective evidence or clear indications presented to it, that the use of\nthe ‘real-time’ remote biometric identification system concerned is necessary for, and proportionate to, achieving one of the\nobjectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains\nlimited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In de", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 5} +{"id": "article-5-chunk-6", "text": "ubparagraph, point (h), as identified in the request and, in particular, remains\nlimited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In deciding\non the request, that authority shall take into account the elements referred to in paragraph 2. No decision that produces an\nadverse legal effect on a person may be taken based solely on the output of the ‘real-time’ remote biometric identification\nsystem.\n4. Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification system in publicly\naccessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the\nnational data protection authority in accordance with the national rules referred to in paragraph 5. The notification shall, as\na minimum, contain the information specified under paragraph 6 and shall not include sensitive operational data.\n5. A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote\nbiometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and\nunder the conditions listed in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member States concerned\nshall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as\nsupervision and reporting relating to, the authorisations referred to in par", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 6} +{"id": "article-5-chunk-7", "text": "ned\nshall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as\nsupervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect\nof which of the objectives listed in paragraph 1, first subparagraph, point (h), including which of the criminal offences\nreferred to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of\nlaw enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption\nthereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric\nidentification systems.\n6. National market surveillance authorities and the national data protection authorities of Member States that have been\nnotified of the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement\npurposes pursuant to paragraph 4 shall submit to the Commission annual reports on such use. For that purpose, the\nCommission shall provide Member States and national market surveillance and data protection authorities with a template,\nincluding information on the number of the decisions taken by competent judicial authorities or an independent\nadministrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and\ntheir result.\n7. The Commis", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 7} +{"id": "article-5-chunk-8", "text": "n by competent judicial authorities or an independent\nadministrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and\ntheir result.\n7. The Commission shall publish annual reports on the use of real-time remote biometric identification systems in\npublicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the\nannual reports referred to in paragraph 6. Those annual reports shall not include sensitive operational data of the related\nlaw enforcement activities.\n8. This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Prohibited AI practices", "chapter_number": "II", "chapter_title": "PROHIBITED AI PRACTICES", "page_start": 51, "page_end": 53, "chunk_index": 8} +{"id": "article-6-chunk-0", "text": "Article 6 - Classification rules for high-risk AI systems\n\n1. Irrespective of whether an AI system is placed on the market or put into service independently of the products\nreferred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions\nare fulfilled:\n(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by\nthe Union harmonisation legislation listed in Annex I;\n(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is\nrequired to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into\nservice of that product pursuant to the Union harmonisation legislation listed in Annex I.\n2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be\nconsidered to be high-risk.\n3. By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it\ndoes not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not\nmaterially influencing the outcome of decision making.\nThe first subparagraph shall apply where any of the following conditions is fulfilled:\n(a) the AI system is intended to perform a narrow procedural task;\n(b) the AI system is intended to improve the result of a previously completed human activity;\n(c) the AI system is intended to detect decis", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Classification rules for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 53, "page_end": 54, "chunk_index": 0} +{"id": "article-6-chunk-1", "text": "e AI system is intended to perform a narrow procedural task;\n(b) the AI system is intended to improve the result of a previously completed human activity;\n(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is\nnot meant to replace or influence the previously completed human assessment, without proper human review; or\n(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases\nlisted in Annex III.\nNotwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk\nwhere the AI system performs profiling of natural persons.\n4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment\nbefore that system is placed on the market or put into service. Such provider shall be subject to the registration obligation\nset out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of\nthe assessment.\n5. The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than\n2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together\nwith a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.\n6. The Commission is empowered to adopt delegated acts", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Classification rules for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 53, "page_end": 54, "chunk_index": 1} +{"id": "article-6-chunk-2", "text": "n line with Article 96 together\nwith a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.\n6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3,\nsecond subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where\nthere is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose\na significant risk of harm to the health, safety or fundamental rights of natural persons.\n7. The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second\nsubparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable\nevidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by\nthis Regulation.\n8. Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with\nparagraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights\nprovided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and\ntake account of market and technological developments.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Classification rules for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 53, "page_end": 54, "chunk_index": 2} +{"id": "article-6-chunk-3", "text": "pursuant to Article 7(1), and\ntake account of market and technological developments.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Classification rules for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 53, "page_end": 54, "chunk_index": 3} +{"id": "article-7-chunk-0", "text": "Article 7 - Amendments to Annex III\n\n1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding\nor modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:\n(a) the AI systems are intended to be used in any of the areas listed in Annex III;\n(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is\nequivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred\nto in Annex III.\n2. When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following\ncriteria:\n(a) the intended purpose of the AI system;\n(b) the extent to which an AI system has been used or is likely to be used;\n(c) the nature and amount of the data processed and used by the AI system, in particular whether special categories of\npersonal data are processed;\n(d) the extent to which the AI system acts autonomously and the possibility for a human to override a decision or\nrecommendations that may lead to potential harm;\n(e) the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on\nfundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact,\nas demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by\nother reports, as appro", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-7", "title": "Article 7 - Amendments to Annex III", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 54, "page_end": 55, "chunk_index": 0} +{"id": "article-7-chunk-1", "text": "relation to the likelihood of such harm or adverse impact,\nas demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by\nother reports, as appropriate;\n(f) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect\nmultiple persons or to disproportionately affect a particular group of persons;\n(g) the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome\nproduced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out\nfrom that outcome;\n(h) the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse\nimpact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority,\nknowledge, economic or social circumstances, or age;\n(i) the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account\nthe technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or\nfundamental rights, shall not be considered to be easily corrigible or reversible;\n(j) the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large,\nincluding possible improvements in product safety;\n(k) the extent to which exis", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-7", "title": "Article 7 - Amendments to Annex III", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 54, "page_end": 55, "chunk_index": 1} +{"id": "article-7-chunk-2", "text": "the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large,\nincluding possible improvements in product safety;\n(k) the extent to which existing Union law provides for:\n(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for\ndamages;\n(ii) effective measures to prevent or substantially minimise those risks.\n3. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III\nby removing high-risk AI systems where both of the following conditions are fulfilled:\n(a) the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking\ninto account the criteria listed in paragraph 2;\n(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-7", "title": "Article 7 - Amendments to Annex III", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 54, "page_end": 55, "chunk_index": 2} +{"id": "article-8-chunk-0", "text": "Article 8 - Compliance with the requirements\n\n1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended\npurpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management\nsystem referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.\n2. Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the\nUnion harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their\nproduct is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring\nthe compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order\nto ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as\nappropriate, the necessary testing and reporting processes, information and documentation they provide with regard to\ntheir product into documentation and procedures that already exist and are required under the Union harmonisation\nlegislation listed in Section A of Annex I.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-8", "title": "Article 8 - Compliance with the requirements", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 55, "page_end": 56, "chunk_index": 0} +{"id": "article-9-chunk-0", "text": "Article 9 - Risk management system\n\n1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI\nsystems.\n2. The risk management system shall be understood as a continuous iterative process planned and run throughout the\nentire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following\nsteps:\n(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose\nto health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;\n(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its\nintended purpose, and under conditions of reasonably foreseeable misuse;\n(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring\nsystem referred to in Article 72;\n(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to\npoint (a).\n3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through\nthe development or design of the high-risk AI system, or the provision of adequate technical information.\n4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and\npossible interaction resulting from the combined ap", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Risk management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 56, "page_end": 57, "chunk_index": 0} +{"id": "article-9-chunk-1", "text": "equate technical information.\n4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and\npossible interaction resulting from the combined application of the requirements set out in this Section, with a view to\nminimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those\nrequirements.\n5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk\nassociated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.\nIn identifying the most appropriate risk management measures, the following shall be ensured:\n(a) elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible\nthrough adequate design and development of the high-risk AI system;\n(b) where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be\neliminated;\n(c) provision of information required pursuant to Article 13 and, where appropriate, training to deployers.\nWith a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given\nto the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context\nin which the system is intended to be used.\n6. High-risk AI systems shall be tested for the pu", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Risk management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 56, "page_end": 57, "chunk_index": 1} +{"id": "article-9-chunk-2", "text": "knowledge, experience, education, the training to be expected by the deployer, and the presumable context\nin which the system is intended to be used.\n6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management\nmeasures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in\ncompliance with the requirements set out in this Section.\n7. Testing procedures may include testing in real-world conditions in accordance with Article 60.\n8. The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development\nprocess, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against\nprior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.\n9. When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give\nconsideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on\npersons under the age of 18 and, as appropriate, other vulnerable groups.\n10. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes\nunder other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with,\nthe risk management procedures establi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Risk management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 56, "page_end": 57, "chunk_index": 2} +{"id": "article-9-chunk-3", "text": "ding internal risk management processes\nunder other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with,\nthe risk management procedures established pursuant to that law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Risk management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 56, "page_end": 57, "chunk_index": 3} +{"id": "article-10-chunk-0", "text": "Article 10 - Data and data governance\n\n1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed\non the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5\nwhenever such data sets are used.\n2. Training, validation and testing data sets shall be subject to data governance and management practices appropriate\nfor the intended purpose of the high-risk AI system. Those practices shall concern in particular:\n(a) the relevant design choices;\n(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data\ncollection;\n(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and\naggregation;\n(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and\nrepresent;\n(e) an assessment of the availability, quantity and suitability of the data sets that are needed;\n(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact\non fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence\ninputs for future operations;\n(g) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);\n(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Re", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-10", "title": "Article 10 - Data and data governance", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 57, "page_end": 58, "chunk_index": 0} +{"id": "article-10-chunk-1", "text": "ppropriate measures to detect, prevent and mitigate possible biases identified according to point (f);\n(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those\ngaps and shortcomings can be addressed.\n3. Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible,\nfree of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including,\nwhere applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be\nused. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination\nthereof.\n4. Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that\nare particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI\nsystem is intended to be used.\n5. To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the\nhigh-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may\nexceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and\nfreedoms of natural persons. In addition to the provisions set out in Regu", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-10", "title": "Article 10 - Data and data governance", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 57, "page_end": 58, "chunk_index": 1} +{"id": "article-10-chunk-2", "text": "y\nexceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and\nfreedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and\nDirective (EU) 2016/680, all the following conditions must be met in order for such processing to occur:\n(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or\nanonymised data;\n(b) the special categories of personal data are subject to technical limitations on the re-use of the personal data, and\nstate-of-the-art security and privacy-preserving measures, including pseudonymisation;\n(c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured,\nprotected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and\nensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;\n(d) the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;\n(e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the\nend of its retention period, whichever comes first;\n(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU)\n2016/680 include the reas", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-10", "title": "Article 10 - Data and data governance", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 57, "page_end": 58, "chunk_index": 2} +{"id": "article-10-chunk-3", "text": "d the\nend of its retention period, whichever comes first;\n(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU)\n2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect\nand correct biases, and why that objective could not be achieved by processing other data.\n6. For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2\nto 5 apply only to the testing data sets.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-10", "title": "Article 10 - Data and data governance", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 57, "page_end": 58, "chunk_index": 3} +{"id": "article-11-chunk-0", "text": "Article 11 - Technical documentation\n\n1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or\nput into service and shall be kept up-to date.\nThe technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with\nthe requirements set out in this Section and to provide national competent authorities and notified bodies with the\nnecessary information in a clear and comprehensive form to assess the compliance of the AI system with those\nrequirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the\nelements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall\nestablish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME,\nincluding a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form\nreferred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.\n2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section\nA of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up\ncontaining all the information set out in paragraph 1, as well as the information required under those legal acts.\n3. The Commission is empowered to adopt", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-11", "title": "Article 11 - Technical documentation", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 58, "page_end": 58, "chunk_index": 0} +{"id": "article-11-chunk-1", "text": "of technical documentation shall be drawn up\ncontaining all the information set out in paragraph 1, as well as the information required under those legal acts.\n3. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV,\nwhere necessary, to ensure that, in light of technical progress, the technical documentation provides all the information\nnecessary to assess the compliance of the system with the requirements set out in this Section.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-11", "title": "Article 11 - Technical documentation", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 58, "page_end": 58, "chunk_index": 1} +{"id": "article-12-chunk-0", "text": "Article 12 - Record-keeping\n\n1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the\nsystem.\n2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended\npurpose of the system, logging capabilities shall enable the recording of events relevant for:\n(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or\nin a substantial modification;\n(b) facilitating the post-market monitoring referred to in Article 72; and\n(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).\n3. For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:\n(a) recording of the period of each use of the system (start date and time and end date and time of each use);\n(b) the reference database against which input data has been checked by the system;\n(c) the input data for which the search has led to a match;\n(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-12", "title": "Article 12 - Record-keeping", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 59, "page_end": 59, "chunk_index": 0} +{"id": "article-13-chunk-0", "text": "Article 13 - Transparency and provision of information to deployers\n\n1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently\ntransparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of\ntransparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and\ndeployer set out in Section 3.\n2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that\ninclude concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.\n3. The instructions for use shall contain at least the following information:\n(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;\n(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:\n(i) its intended purpose;\n(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the\nhigh-risk AI system has been tested and validated and which can be expected, and any known and foreseeable\ncircumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;\n(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its\nintended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks t", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Transparency and provision of information to deployers", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 59, "page_end": 60, "chunk_index": 0} +{"id": "article-13-chunk-1", "text": "known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its\nintended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and\nsafety or fundamental rights referred to in Article 9(2);\n(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information\nthat is relevant to explain its output;\n(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is\nintended to be used;\n(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training,\nvalidation and testing data sets used, taking into account the intended purpose of the high-risk AI system;\n(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it\nappropriately;\n(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the\nmoment of the initial conformity assessment, if any;\n(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the\ninterpretation of the outputs of the high-risk AI systems by the deployers;\n(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary\nmaintenance and care measures, including their frequency, to ensure the proper functio", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Transparency and provision of information to deployers", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 59, "page_end": 60, "chunk_index": 1} +{"id": "article-13-chunk-2", "text": "e computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary\nmaintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including\nas regards software updates;\n(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to\nproperly collect, store and interpret the logs in accordance with Article 12.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Transparency and provision of information to deployers", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 59, "page_end": 60, "chunk_index": 2} +{"id": "article-14-chunk-0", "text": "Article 14 - Human oversight\n\n1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine\ninterface tools, that they can be effectively overseen by natural persons during the period in which they are in use.\n2. Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge\nwhen a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable\nmisuse, in particular where such risks persist despite the application of other requirements set out in this Section.\n3. The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk\nAI system, and shall be ensured through either one or both of the following types of measures:\n(a) measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed\non the market or put into service;\n(b) measures identified by the provider before placing the high-risk AI system on the market or putting it into service and\nthat are appropriate to be implemented by the deployer.\n4. For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in\nsuch a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:\n(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor it", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Human oversight", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 60, "page_end": 61, "chunk_index": 0} +{"id": "article-14-chunk-1", "text": "human oversight is assigned are enabled, as appropriate and proportionate:\n(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its\noperation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;\n(b) to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk\nAI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for\ndecisions to be taken by natural persons;\n(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and\nmethods available;\n(d) to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse\nthe output of the high-risk AI system;\n(e) to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar\nprocedure that allows the system to come to a halt in a safe state.\n5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article\nshall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification\nresulting from the system unless that identification has been separately verified and confirmed by at least two natural\npersons with the necessary compete", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Human oversight", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 60, "page_end": 61, "chunk_index": 1} +{"id": "article-14-chunk-2", "text": "e deployer on the basis of the identification\nresulting from the system unless that identification has been separately verified and confirmed by at least two natural\npersons with the necessary competence, training and authority.\nThe requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for\nthe purposes of law enforcement, migration, border control or asylum, where Union or national law considers the\napplication of this requirement to be disproportionate.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Human oversight", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 60, "page_end": 61, "chunk_index": 2} +{"id": "article-15-chunk-0", "text": "Article 15 - Accuracy, robustness and cybersecurity\n\n1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy,\nrobustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.\n2. To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in\nparagraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders\nand organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of\nbenchmarks and measurement methodologies.\n3. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying\ninstructions of use.\n4. High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within\nthe system or the environment in which the system operates, in particular due to their interaction with natural persons or\nother systems. Technical and organisational measures shall be taken in this regard.\nThe robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include\nbackup or fail-safe plans.\nHigh-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such\na way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations\n(feedback lo", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-15", "title": "Article 15 - Accuracy, robustness and cybersecurity", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 61, "page_end": 61, "chunk_index": 0} +{"id": "article-15-chunk-1", "text": "on the market or put into service shall be developed in such\na way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations\n(feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.\n5. High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or\nperformance by exploiting system vulnerabilities.\nThe technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant\ncircumstances and the risks.\nThe technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect,\nrespond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained\ncomponents used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial\nexamples or model evasion), confidentiality attacks or model flaws.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-15", "title": "Article 15 - Accuracy, robustness and cybersecurity", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 61, "page_end": 61, "chunk_index": 1} +{"id": "article-16-chunk-0", "text": "Article 16 - Obligations of providers of high-risk AI systems\n\nProviders of high-risk AI systems shall:\n(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;\n(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation,\nas applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;\n(c) have a quality management system in place which complies with Article 17;\n(d) keep the documentation referred to in Article 18;\n(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in\nArticle 19;\n(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43,\nprior to its being placed on the market or put into service;\n(g) draw up an EU declaration of conformity in accordance with Article 47;\n(h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying\ndocumentation, to indicate conformity with this Regulation, in accordance with Article 48;\n(i) comply with the registration obligations referred to in Article 49(1);\n(j) take the necessary corrective actions and provide information as required in Article 20;\n(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with\nthe requirements set out in Section 2;\n(l) ensure that the high-risk AI system complies with", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-16", "title": "Article 16 - Obligations of providers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 62, "page_end": 62, "chunk_index": 0} +{"id": "article-16-chunk-1", "text": "soned request of a national competent authority, demonstrate the conformity of the high-risk AI system with\nthe requirements set out in Section 2;\n(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU)\n2016/2102 and (EU) 2019/882.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-16", "title": "Article 16 - Obligations of providers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 62, "page_end": 62, "chunk_index": 1} +{"id": "article-17-chunk-0", "text": "Article 17 - Quality management system\n\n1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this\nRegulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures\nand instructions, and shall include at least the following aspects:\n(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for\nthe management of modifications to the high-risk AI system;\n(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the\nhigh-risk AI system;\n(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of\nthe high-risk AI system;\n(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk\nAI system, and the frequency with which they have to be carried out;\n(e) technical specifications, including standards, to be applied and, where the relevant harmonised standards are not\napplied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that\nthe high-risk AI system complies with those requirements;\n(f) systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling,\ndata storage, data filtration, data mining, data aggregation, data retention and any other operation re", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-17", "title": "Article 17 - Quality management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 62, "page_end": 63, "chunk_index": 0} +{"id": "article-17-chunk-1", "text": "for data management, including data acquisition, data collection, data analysis, data labelling,\ndata storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data\nthat is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI\nsystems;\n(g) the risk management system referred to in Article 9;\n(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;\n(i) procedures related to the reporting of a serious incident in accordance with Article 73;\n(j) the handling of communication with national competent authorities, other relevant authorities, including those\nproviding or supporting the access to data, notified bodies, other operators, customers or other interested parties;\n(k) systems and procedures for record-keeping of all relevant documentation and information;\n(l) resource management, including security-of-supply related measures;\n(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all the\naspects listed in this paragraph.\n2. The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s\norganisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the\ncompliance of their high-risk AI systems with this Regulation.\n3. Providers of high-risk AI s", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-17", "title": "Article 17 - Quality management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 62, "page_end": 63, "chunk_index": 1} +{"id": "article-17-chunk-2", "text": "iders shall, in any event, respect the degree of rigour and the level of protection required to ensure the\ncompliance of their high-risk AI systems with this Regulation.\n3. Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an\nequivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality\nmanagement systems pursuant to that law.\n4. For providers that are financial institutions subject to requirements regarding their internal governance, arrangements\nor processes under Union financial services law, the obligation to put in place a quality management system, with the\nexception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on\ninternal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any\nharmonised standards referred to in Article 40 shall be taken into account.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-17", "title": "Article 17 - Quality management system", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 62, "page_end": 63, "chunk_index": 2} +{"id": "article-18-chunk-0", "text": "Article 18 - Documentation keeping\n\n1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put\ninto service, keep at the disposal of the national competent authorities:\n(a) the technical documentation referred to in Article 11;\n(b) the documentation concerning the quality management system referred to in Article 17;\n(c) the documentation concerning the changes approved by notified bodies, where applicable;\n(d) the decisions and other documents issued by the notified bodies, where applicable;\n(e) the EU declaration of conformity referred to in Article 47.\n2. Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at\nthe disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider\nor its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that\nperiod.\n3. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or\nprocesses under Union financial services law shall maintain the technical documentation as part of the documentation kept\nunder the relevant Union financial services law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-18", "title": "Article 18 - Documentation keeping", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 63, "page_end": 64, "chunk_index": 0} +{"id": "article-19-chunk-0", "text": "Article 19 - Automatically generated logs\n\n1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their\nhigh-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law,\nthe logs shall be kept for a period appropriate to the intended purpose of the high-risk AI system, of at least six months,\nunless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal\ndata.\n2. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or\nprocesses under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems\nas part of the documentation kept under the relevant financial services law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-19", "title": "Article 19 - Automatically generated logs", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 64, "page_end": 64, "chunk_index": 0} +{"id": "article-20-chunk-0", "text": "Article 20 - Corrective actions and duty of information\n\n1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have\nplaced on the market or put into service is not in conformity with this Regulation shall immediately take the necessary\ncorrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall\ninform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised\nrepresentative and importers accordingly.\n2. Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of\nthat risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and\ninform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the\nnotified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature\nof the non-compliance and of any relevant corrective action taken.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-20", "title": "Article 20 - Corrective actions and duty of information", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 64, "page_end": 64, "chunk_index": 0} +{"id": "article-21-chunk-0", "text": "Article 21 - Cooperation with competent authorities\n\n1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all\nthe information and documentation necessary to demonstrate the conformity of the high-risk AI system with the\nrequirements set out in Section 2, in a language which can be easily understood by the authority in one of the official\nlanguages of the institutions of the Union as indicated by the Member State concerned.\n2. Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as\napplicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent\nsuch logs are under their control.\n3. Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the\nconfidentiality obligations set out in Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-21", "title": "Article 21 - Cooperation with competent authorities", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 64, "page_end": 64, "chunk_index": 0} +{"id": "article-22-chunk-0", "text": "Article 22 - Authorised representatives of providers of high-risk AI systems\n\n1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries\nshall, by written mandate, appoint an authorised representative which is established in the Union.\n2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the\nprovider.\n3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall\nprovide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the\ninstitutions of the Union, as indicated by the competent authority. For the purposes of this Regulation, the mandate shall\nempower the authorised representative to carry out the following tasks:\n(a) verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in\nArticle 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the\nprovider;\n(b) keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for\na period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details\nof the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in\nArticle 47, the technical documentation and, if applicable, the certificate issued by the notified bo", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-22", "title": "Article 22 - Authorised representatives of providers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 65, "page_end": 65, "chunk_index": 0} +{"id": "article-22-chunk-1", "text": "appointed the authorised representative, a copy of the EU declaration of conformity referred to in\nArticle 47, the technical documentation and, if applicable, the certificate issued by the notified body;\n(c) provide a competent authority, upon a reasoned request, with all the information and documentation, including that\nreferred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the\nrequirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by\nthe high-risk AI system, to the extent such logs are under the control of the provider;\n(d) cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk\nAI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;\n(e) where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried\nout by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.\nThe mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the\ncompetent authorities, on all issues related to ensuring compliance with this Regulation.\n4. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be\nacting contrary to its obligations pursuant", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-22", "title": "Article 22 - Authorised representatives of providers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 65, "page_end": 65, "chunk_index": 1} +{"id": "article-22-chunk-2", "text": "compliance with this Regulation.\n4. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be\nacting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market\nsurveillance authority, as well as, where applicable, the relevant notified body, about the termination of the mandate and the\nreasons therefor.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-22", "title": "Article 22 - Authorised representatives of providers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 65, "page_end": 65, "chunk_index": 2} +{"id": "article-23-chunk-0", "text": "Article 23 - Obligations of importers\n\n1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this\nRegulation by verifying that:\n(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the\nhigh-risk AI system;\n(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;\n(c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in\nArticle 47 and instructions for use;\n(d) the provider has appointed an authorised representative in accordance with Article 22(1).\n2. Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this\nRegulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has\nbeen brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the\nimporter shall inform the provider of the system, the authorised representative and the market surveillance authorities to\nthat effect.\n3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can\nbe contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.\n4. Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions,\nwhere", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-23", "title": "Article 23 - Obligations of importers", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 65, "page_end": 66, "chunk_index": 0} +{"id": "article-23-chunk-1", "text": "on its packaging or its accompanying documentation, where applicable.\n4. Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions,\nwhere applicable, do not jeopardise its compliance with the requirements set out in Section 2.\n5. Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into\nservice, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU\ndeclaration of conformity referred to in Article 47.\n6. Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary\ninformation and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI\nsystem with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose,\nthey shall also ensure that the technical documentation can be made available to those authorities.\n7. Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to\na high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-23", "title": "Article 23 - Obligations of importers", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 65, "page_end": 66, "chunk_index": 1} +{"id": "article-24-chunk-0", "text": "Article 24 - Obligations of distributors\n\n1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE\nmarking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for\nuse, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as\nlaid down in Article 16, points (b) and (c) and Article 23(3).\n2. Where a distributor considers or has reason to consider, on the basis of the information in its possession, that\na high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI\nsystem available on the market until the system has been brought into conformity with those requirements. Furthermore,\nwhere the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider\nor the importer of the system, as applicable, to that effect.\n3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport\nconditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.\n4. A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI\nsystem which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall\ntake the corrective actions necessary", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-24", "title": "Article 24 - Obligations of distributors", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 66, "page_end": 66, "chunk_index": 0} +{"id": "article-24-chunk-1", "text": "tion in its possession, a high-risk AI\nsystem which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall\ntake the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall\nit, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions.\nWhere the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform\nthe provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details,\nin particular, of the non-compliance and of any corrective actions taken.\n5. Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that\nauthority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to\ndemonstrate the conformity of that system with the requirements set out in Section 2.\n6. Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to\na high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by\nit.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-24", "title": "Article 24 - Obligations of distributors", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 66, "page_end": 66, "chunk_index": 1} +{"id": "article-24-chunk-2", "text": "sk posed by\nit.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-24", "title": "Article 24 - Obligations of distributors", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 66, "page_end": 66, "chunk_index": 2} +{"id": "article-25-chunk-0", "text": "Article 25 - Responsibilities along the AI value chain\n\n1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system\nfor the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the\nfollowing circumstances:\n(a) they put their name or trademark on a high-risk AI system already placed on the market or put into service, without\nprejudice to contractual arrangements stipulating that the obligations are otherwise allocated;\n(b) they make a substantial modification to a high-risk AI system that has already been placed on the market or has already\nbeen put into service in such a way that it remains a high-risk AI system pursuant to Article 6;\n(c) they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified\nas high-risk and has already been placed on the market or put into service in such a way that the AI system concerned\nbecomes a high-risk AI system in accordance with Article 6.\n2. Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the\nmarket or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of\nthis Regulation. That initial provider shall closely cooperate with new providers and shall make available the necessary\ninformation and provide the reasonably expected technical access and other assistance that are required for the fulfilment of\nthe", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-25", "title": "Article 25 - Responsibilities along the AI value chain", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 67, "chunk_index": 0} +{"id": "article-25-chunk-1", "text": "ly cooperate with new providers and shall make available the necessary\ninformation and provide the reasonably expected technical access and other assistance that are required for the fulfilment of\nthe obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of\nhigh-risk AI systems. This paragraph shall not apply in cases where the initial provider has clearly specified that its AI\nsystem is not to be changed into a high-risk AI system and therefore does not fall under the obligation to hand over the\ndocumentation.\n3. In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation\nlegislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk\nAI system, and shall be subject to the obligations under Article 16 under either of the following circumstances:\n(a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product\nmanufacturer;\n(b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product\nhas been placed on the market.\n4. The provider of a high-risk AI system and the third party that supplies an AI system, tools, services, components, or\nprocesses that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information,\ncapabilities, technical access and other", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-25", "title": "Article 25 - Responsibilities along the AI value chain", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 67, "chunk_index": 1} +{"id": "article-25-chunk-2", "text": "tools, services, components, or\nprocesses that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information,\ncapabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable\nthe provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall\nnot apply to third parties making accessible to the public tools, services, processes, or components, other than\ngeneral-purpose AI models, under a free and open-source licence.\nThe AI Office may develop and recommend voluntary model terms for contracts between providers of high-risk AI systems\nand third parties that supply tools, services, components or processes that are used for or integrated into high-risk AI\nsystems. When developing those voluntary model terms, the AI Office shall take into account possible contractual\nrequirements applicable in specific sectors or business cases. The voluntary model terms shall be published and be available\nfree of charge in an easily usable electronic format.\n5. Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual property rights, confidential\nbusiness information and trade secrets in accordance with Union and national law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-25", "title": "Article 25 - Responsibilities along the AI value chain", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 67, "chunk_index": 2} +{"id": "article-25-chunk-3", "text": "Union and national law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-25", "title": "Article 25 - Responsibilities along the AI value chain", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 67, "chunk_index": 3} +{"id": "article-26-chunk-0", "text": "Article 26 - Obligations of deployers of high-risk AI systems\n\n1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use\nsuch systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.\n2. Deployers shall assign human oversight to natural persons who have the necessary competence, training and\nauthority, as well as the necessary support.\n3. The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or\nnational law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the\nhuman oversight measures indicated by the provider.\n4. Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that\ndeployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the\nhigh-risk AI system.\n5. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where\nrelevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the\nhigh-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of\nArticle 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance\nauthority, and shall suspend the use of that system. Where deployers have identif", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 0} +{"id": "article-26-chunk-1", "text": "rticle 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance\nauthority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also\nimmediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities\nof that incident. If the deployer is not able to reach the provider, Article 73 shall apply mutatis mutandis. This obligation\nshall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities.\nFor deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or\nprocesses under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to\nbe fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the\nrelevant financial service law.\n6. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent\nsuch logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six\nmonths, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of\npersonal data.\nDeployers that are financial institutions subject to requirements regarding their internal governance, arrangements", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 1} +{"id": "article-26-chunk-2", "text": "ion or national law, in particular in Union law on the protection of\npersonal data.\nDeployers that are financial institutions subject to requirements regarding their internal governance, arrangements or\nprocesses under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the\nrelevant Union financial service law.\n7. Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform\nworkers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This\ninformation shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and\nnational law and practice on information of workers and their representatives.\n8. Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall\ncomply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system\nthat they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system\nand shall inform the provider or the distributor.\n9. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this\nRegulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation\n(EU) 2016/679 or Article 27 of Directive (EU)", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 2} +{"id": "article-26-chunk-3", "text": "ovided under Article 13 of this\nRegulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation\n(EU) 2016/679 or Article 27 of Directive (EU) 2016/680.\n10. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of\na person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for\npost-remote biometric identification shall request an authorisation, ex ante, or without undue delay and no later than 48\nhours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the\nuse of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable\nfacts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific\ncriminal offence.\nIf the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric\nidentification system linked to that requested authorisation shall be stopped with immediate effect and the personal data\nlinked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.\nIn no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in\nan untargeted way, without any link to a criminal offence, a crimi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 3} +{"id": "article-26-chunk-4", "text": "e deleted.\nIn no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in\nan untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and\nforeseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that\nproduces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of\nsuch post-remote biometric identification systems.\nThis paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680\nfor the processing of biometric data.\nRegardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file\nand shall be made available to the relevant market surveillance authority and the national data protection authority upon\nrequest, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be\nwithout prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities.\nDeployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their\nuse of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law\nenforcement. The reports may be aggregated to cover more than one deployment.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 4} +{"id": "article-26-chunk-5", "text": "use of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law\nenforcement. The reports may be aggregated to cover more than one deployment.\nMember States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric\nidentification systems.\n11. Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that\nmake decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject\nto the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive\n(EU) 2016/680 shall apply.\n12. Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to\nthe high-risk AI system in order to implement this Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Obligations of deployers of high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 67, "page_end": 69, "chunk_index": 5} +{"id": "article-27-chunk-0", "text": "Article 27 - Fundamental rights impact assessment for high-risk AI systems\n\n1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems\nintended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private\nentities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall\nperform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose,\ndeployers shall perform an assessment consisting of:\n(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;\n(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to\nbe used;\n(c) the categories of natural persons and groups likely to be affected by its use in the specific context;\n(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified\npursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to\nArticle 13;\n(e) a description of the implementation of human oversight measures, according to the instructions for use;\n(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal\ngovernance and complaint mechanisms.\n2. The obligation laid down in paragraph 1 applies to the first use of the", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-27", "title": "Article 27 - Fundamental rights impact assessment for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 69, "page_end": 70, "chunk_index": 0} +{"id": "article-27-chunk-1", "text": "the case of the materialisation of those risks, including the arrangements for internal\ngovernance and complaint mechanisms.\n2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in\nsimilar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried\nout by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in\nparagraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.\n3. Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the\nmarket surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as\npart of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.\n4. If any of the obligations laid down in this Article is already met through the data protection impact assessment\nconducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental\nrights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact\nassessment.\n5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers\nin complying with their obligations under", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-27", "title": "Article 27 - Fundamental rights impact assessment for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 69, "page_end": 70, "chunk_index": 1} +{"id": "article-27-chunk-2", "text": "data protection impact\nassessment.\n5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers\nin complying with their obligations under this Article in a simplified manner.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-27", "title": "Article 27 - Fundamental rights impact assessment for high-risk AI systems", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 69, "page_end": 70, "chunk_index": 2} +{"id": "article-28-chunk-0", "text": "Article 28 - Notifying authorities\n\n1. Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying\nout the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their\nmonitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.\n2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by\na national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.\n3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with\nconformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.\n4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity\nassessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.\n5. Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any\nconsultancy services on a commercial or competitive basis.\n6. Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with\nArticle 78.\n7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper\nperformance of their task", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Notifying authorities", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 70, "page_end": 70, "chunk_index": 0} +{"id": "article-28-chunk-1", "text": "he information that they obtain, in accordance with\nArticle 78.\n7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper\nperformance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in\nfields such as information technologies, AI and law, including the supervision of fundamental rights.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Notifying authorities", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 70, "page_end": 70, "chunk_index": 1} +{"id": "article-29-chunk-0", "text": "Article 29 - Application of a conformity assessment body for notification\n\n1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member\nState in which they are established.\n2. The application for notification shall be accompanied by a description of the conformity assessment activities, the\nconformity assessment module or modules and the types of AI systems for which the conformity assessment body claims\nto be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting\nthat the conformity assessment body fulfils the requirements laid down in Article 31.\nAny valid document related to existing designations of the applicant notified body under any other Union harmonisation\nlegislation shall be added.\n3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the\nnotifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of\nits compliance with the requirements laid down in Article 31.\n4. For notified bodies which are designated under any other Union harmonisation legislation, all documents and\ncertificates linked to those designations may be used to support their designation procedure under this Regulation, as\nappropriate. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever\nrelevant changes occur, in order to enable the authority responsible for notified bodies to mon", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-29", "title": "Article 29 - Application of a conformity assessment body for notification", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 70, "page_end": 71, "chunk_index": 0} +{"id": "article-29-chunk-1", "text": "notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever\nrelevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous\ncompliance with all the requirements laid down in Article 31.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-29", "title": "Article 29 - Application of a conformity assessment body for notification", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 70, "page_end": 71, "chunk_index": 1} +{"id": "article-30-chunk-0", "text": "Article 30 - Notification procedure\n\n1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down\nin Article 31.\n2. Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool\ndeveloped and managed by the Commission, of each conformity assessment body referred to in paragraph 1.\n3. The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment\nactivities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of\ncompetence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying\nauthority shall provide the Commission and the other Member States with documentary evidence which attests to the\ncompetence of the conformity assessment body and to the arrangements in place to ensure that that body will be\nmonitored regularly and will continue to satisfy the requirements laid down in Article 31.\n4. The conformity assessment body concerned may perform the activities of a notified body only where no objections\nare raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where\nit includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying\nauthority where it includes documentary evidence referred to in Article 29(3).\n5. Where object", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-30", "title": "Article 30 - Notification procedure", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 71, "chunk_index": 0} +{"id": "article-30-chunk-1", "text": "itation certificate referred to in Article 29(2), or within two months of a notification by the notifying\nauthority where it includes documentary evidence referred to in Article 29(3).\n5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member\nStates and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is\njustified. The Commission shall address its decision to the Member State concerned and to the relevant conformity\nassessment body.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-30", "title": "Article 30 - Notification procedure", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 71, "chunk_index": 1} +{"id": "article-31-chunk-0", "text": "Article 31 - Requirements relating to notified bodies\n\n1. A notified body shall be established under the national law of a Member State and shall have legal personality.\n2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are\nnecessary to fulfil their tasks, as well as suitable cybersecurity requirements.\n3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall\nensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies\nconduct.\n4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform\nconformity assessment activities. Notified bodies shall also be independent of any other operator having an economic\ninterest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of\nassessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such\nhigh-risk AI systems for personal purposes.\n5. Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its\nconformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems,\nnor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with\ntheir independence of judgement or integ", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-31", "title": "Article 31 - Requirements relating to notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 72, "chunk_index": 0} +{"id": "article-31-chunk-1", "text": "r use of high-risk AI systems,\nnor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with\ntheir independence of judgement or integrity in relation to conformity assessment activities for which they are notified.\nThis shall, in particular, apply to consultancy services.\n6. Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of\ntheir activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to\npromote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.\n7. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries,\nsubcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the\nconfidentiality of the information which comes into their possession during the performance of conformity assessment\nactivities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional\nsecrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the\nnotifying authorities of the Member State in which their activities are carried out.\n8. Notified bodies shall have procedures for the performance of activities which take due account of the size of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-31", "title": "Article 31 - Requirements relating to notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 72, "chunk_index": 1} +{"id": "article-31-chunk-2", "text": "he\nnotifying authorities of the Member State in which their activities are carried out.\n8. Notified bodies shall have procedures for the performance of activities which take due account of the size of\na provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.\n9. Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability\nis assumed by the Member State in which they are established in accordance with national law or that Member State is itself\ndirectly responsible for the conformity assessment.\n10. Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of\nprofessional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified\nbodies themselves or on their behalf and under their responsibility.\n11. Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by\nexternal parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical,\nlegal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and\ndata computing, and relating to the requirements set out in Section 2.\n12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part\ndirect", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-31", "title": "Article 31 - Requirements relating to notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 72, "chunk_index": 2} +{"id": "article-31-chunk-3", "text": "d\ndata computing, and relating to the requirements set out in Section 2.\n12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part\ndirectly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in\nrespect of relevant standards.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-31", "title": "Article 31 - Requirements relating to notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 71, "page_end": 72, "chunk_index": 3} +{"id": "article-32-chunk-0", "text": "Article 32 - Presumption of conformity with requirements relating to notified bodies\n\nWhere a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised\nstandards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall\nbe presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover\nthose requirements.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-32", "title": "Article 32 - Presumption of conformity with requirements relating to notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 72, "page_end": 72, "chunk_index": 0} +{"id": "article-33-chunk-0", "text": "Article 33 - Subsidiaries of notified bodies and subcontracting\n\n1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to\na subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and\nshall inform the notifying authority accordingly.\n2. Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.\n3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified\nbodies shall make a list of their subsidiaries publicly available.\n4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and\nthe work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of\nfive years from the termination date of the subcontracting.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-33", "title": "Article 33 - Subsidiaries of notified bodies and subcontracting", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 73, "chunk_index": 0} +{"id": "article-34-chunk-0", "text": "Article 34 - Operational obligations of notified bodies\n\n1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment\nprocedures set out in Article 43.\n2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account\nof the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI\nsystem concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small\nenterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree\nof rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this\nRegulation.\n3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’\ndocumentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment,\ndesignation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-34", "title": "Article 34 - Operational obligations of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 73, "chunk_index": 0} +{"id": "article-35-chunk-0", "text": "Article 35 - Identification numbers and lists of notified bodies\n\n1. The Commission shall assign a single identification number to each notified body, even where a body is notified under\nmore than one Union act.\n2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their\nidentification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept\nup to date.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-35", "title": "Article 35 - Identification numbers and lists of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 73, "chunk_index": 0} +{"id": "article-36-chunk-0", "text": "Article 36 - Changes to notifications\n\n1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the\nnotification of a notified body via the electronic notification tool referred to in Article 30(2).\n2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.\nFor changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall\napply.\n3. Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and\nthe providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its\nactivities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified\nbody’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the\nhigh-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk\nAI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the\nnotified body has ceased its activity, the notifying authority shall withdraw the designation.\n4. Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements\nlaid down in Article 31, or that it is failing to fulfil its obligations, the notifyi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Changes to notifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 75, "chunk_index": 0} +{"id": "article-36-chunk-1", "text": "here a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements\nlaid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the\nmatter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised\nand give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body\nno longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend\nor withdraw the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil\nthose obligations. It shall immediately inform the Commission and the other Member States accordingly.\n5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform\nthe providers concerned within 10 days.\n6. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take\nappropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying\nauthorities in other Member States and to market surveillance authorities at their request.\n7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:\n(a) assess the impact on the certificat", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Changes to notifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 75, "chunk_index": 1} +{"id": "article-36-chunk-2", "text": "market surveillance authorities at their request.\n7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:\n(a) assess the impact on the certificates issued by the notified body;\n(b) submit a report on its findings to the Commission and the other Member States within three months of having notified\nthe changes to the designation;\n(c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any\ncertificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the\nmarket;\n(d) inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;\n(e) provide the national competent authorities of the Member State in which the provider has its registered place of\nbusiness with all relevant information about the certificates of which it has required the suspension or withdrawal; that\nauthority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental\nrights.\n8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the\ncertificates shall remain valid in one of the following circumstances:\n(a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health,\nsafety or fundamental rights in relation to certificates affected", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Changes to notifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 75, "chunk_index": 2} +{"id": "article-36-chunk-3", "text": "tances:\n(a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health,\nsafety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying\nauthority has outlined a timeline for actions to remedy the suspension or restriction; or\n(b) the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued\nduring the course of the suspension or restriction, and states whether the notified body has the capability of continuing\nto monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the\nevent that the notifying authority determines that the notified body does not have the capability to support existing\ncertificates issued, the provider of the system covered by the certificate shall confirm in writing to the national\ncompetent authorities of the Member State in which it has its registered place of business, within three months of the\nsuspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified\nbody to monitor and remain responsible for the certificates during the period of suspension or restriction.\n9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall\nremain valid for a period of nine months under the following circumstances:\n(a) the na", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Changes to notifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 75, "chunk_index": 3} +{"id": "article-36-chunk-4", "text": "h the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall\nremain valid for a period of nine months under the following circumstances:\n(a) the national competent authority of the Member State in which the provider of the high-risk AI system covered by the\ncertificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights\nassociated with the high-risk AI systems concerned; and\n(b) another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and\ncompletes its assessment within 12 months of the withdrawal of the designation.\nIn the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which\nthe provider of the system covered by the certificate has its place of business may extend the provisional validity of the\ncertificates for additional periods of three months, which shall not exceed 12 months in total.\nThe national competent authority or the notified body assuming the functions of the notified body affected by the change\nof designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Changes to notifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 73, "page_end": 75, "chunk_index": 4} +{"id": "article-37-chunk-0", "text": "Article 37 - Challenge to the competence of notified bodies\n\n1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of\na notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its\napplicable responsibilities.\n2. The notifying authority shall provide the Commission, on request, with all relevant information relating to the\nnotification or the maintenance of the competence of the notified body concerned.\n3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this\nArticle is treated confidentially in accordance with Article 78.\n4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its\nnotification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures,\nincluding the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary\ncorrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation.\nThat implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-37", "title": "Article 37 - Challenge to the competence of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 75, "page_end": 75, "chunk_index": 0} +{"id": "article-38-chunk-0", "text": "Article 38 - Coordination of notified bodies\n\n1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation\nbetween notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and\nproperly operated in the form of a sectoral group of notified bodies.\n2. Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in\nparagraph 1, directly or through designated representatives.\n3. The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-38", "title": "Article 38 - Coordination of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 75, "page_end": 75, "chunk_index": 0} +{"id": "article-39-chunk-0", "text": "Article 39 - Conformity assessment bodies of third countries\n\nConformity assessment bodies established under the law of a third country with which the Union has concluded an\nagreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet\nthe requirements laid down in Article 31 or they ensure an equivalent level of compliance.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-39", "title": "Article 39 - Conformity assessment bodies of third countries", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 76, "chunk_index": 0} +{"id": "article-40-chunk-0", "text": "Article 40 - Harmonised standards and standardisation deliverables\n\n1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts\nthereof the references of which have been published in the Official Journal of the European Union in accordance with\nRegulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this\nChapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that\nthose standards cover those requirements or obligations.\n2. In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay,\nstandardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation\nrequests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall\nalso ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as\nreducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the\nenergy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission\nshall consult the Board and relevant stakeholders, including the advisory forum.\nWhen issuing a standardisation request to European standardisation organisations, the Commission shall specify that\nstandards have to be clear, consistent, including with th", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Harmonised standards and standardisation deliverables", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 76, "chunk_index": 0} +{"id": "article-40-chunk-1", "text": "luding the advisory forum.\nWhen issuing a standardisation request to European standardisation organisations, the Commission shall specify that\nstandards have to be clear, consistent, including with the standards developed in the various sectors for products covered by\nthe existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or\ngeneral-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or\nobligations laid down in this Regulation.\nThe Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil\nthe objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of\nRegulation (EU) No 1025/2012.\n3. The participants in the standardisation process shall seek to promote investment and innovation in AI, including\nthrough increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to\nstrengthening global cooperation on standardisation and taking into account existing international standards in the field of\nAI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance\nensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with\nArticles 5, 6, and 7 of Regulation (EU) No 1025/2012.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Harmonised standards and standardisation deliverables", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 76, "chunk_index": 1} +{"id": "article-40-chunk-2", "text": "balanced representation of interests and the effective participation of all relevant stakeholders in accordance with\nArticles 5, 6, and 7 of Regulation (EU) No 1025/2012.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Harmonised standards and standardisation deliverables", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 76, "chunk_index": 2} +{"id": "article-41-chunk-0", "text": "Article 41 - Common specifications\n\n1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in\nSection 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following\nconditions have been fulfilled:\n(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European\nstandardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter,\nor, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:\n(i) the request has not been accepted by any of the European standardisation organisations; or\n(ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with\nArticle 10(1) of Regulation (EU) No 1025/2012; or\n(iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or\n(iv) the harmonised standards do not comply with the request; and\n(b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as\napplicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the\nEuropean Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published\nwithin a reasonable period.\nWhen drafting the common specifications, the Commission shall consult the advisory forum referred to in Art", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-41", "title": "Article 41 - Common specifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 77, "chunk_index": 0} +{"id": "article-41-chunk-1", "text": "No 1025/2012, and no such reference is expected to be published\nwithin a reasonable period.\nWhen drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.\nThe implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the\nexamination procedure referred to in Article 98(2).\n2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of\nRegulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.\n3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred\nto in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in\nSection 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to\nthe extent those common specifications cover those requirements or those obligations.\n4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the\nCommission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the\nharmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is\npublished in the Official Journal of the European Union, the Commission shall repeal the", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-41", "title": "Article 41 - Common specifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 77, "chunk_index": 1} +{"id": "article-41-chunk-2", "text": "harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is\npublished in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in\nparagraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the\nsame obligations set out in Sections 2 and 3 of Chapter V.\n5. Where providers of high-risk AI systems or general-purpose AI models do not comply with the common\nspecifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the\nrequirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and\n3 of Chapter V to a level at least equivalent thereto.\n6. Where a Member State considers that a common specification does not entirely meet the requirements set out in\nSection 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the\nCommission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend\nthe implementing act establishing the common specification concerned.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-41", "title": "Article 41 - Common specifications", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 76, "page_end": 77, "chunk_index": 2} +{"id": "article-42-chunk-0", "text": "Article 42 - Presumption of conformity with certain requirements\n\n1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural,\ncontextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant\nrequirements laid down in Article 10(4).\n2. High-risk AI systems that have been certified or for which a statement of conformity has been issued under\na cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the\nOfficial Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15\nof this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those\nrequirements.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-42", "title": "Article 42 - Presumption of conformity with certain requirements", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 77, "page_end": 77, "chunk_index": 0} +{"id": "article-43-chunk-0", "text": "Article 43 - Conformity assessment\n\n1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI\nsystem with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40,\nor, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following\nconformity assessment procedures based on:\n(a) the internal control referred to in Annex VI; or\n(b) the assessment of the quality management system and the assessment of the technical documentation, with the\ninvolvement of a notified body, referred to in Annex VII.\nIn demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall\nfollow the conformity assessment procedure set out in Annex VII where:\n(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not\navailable;\n(b) the provider has not applied, or has applied only part of, the harmonised standard;\n(c) the common specifications referred to in point (a) exist, but the provider has not applied them;\n(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the\npart of the standard that was restricted.\nFor the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the\nnotified bodies. However, where the high-risk AI system is intended to be p", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Conformity assessment", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 78, "page_end": 79, "chunk_index": 0} +{"id": "article-43-chunk-1", "text": "ricted.\nFor the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the\nnotified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration\nor asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in\nArticle 74(8) or (9), as applicable, shall act as a notified body.\n2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment\nprocedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified\nbody.\n3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider\nshall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in\nSection 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5.\nand the fifth paragraph of point 4.6 of Annex VII shall also apply.\nFor the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to\ncontrol the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance\nof those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Conformity assessment", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 78, "page_end": 79, "chunk_index": 1} +{"id": "article-43-chunk-2", "text": "with the requirements set out in Section 2, provided that the compliance\nof those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of\nthe notification procedure under those legal acts.\nWhere a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity\nassessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements,\nthat manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common\nspecifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.\n4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new\nconformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is\nintended to be further distributed or continues to be used by the current deployer.\nFor high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk\nAI system and its performance that have been pre-determined by the provider at the moment of the initial conformity\nassessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV,\nshall not constitute a substantial modification.\n5. The Commission is empowered to adopt delegated a", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Conformity assessment", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 78, "page_end": 79, "chunk_index": 2} +{"id": "article-43-chunk-3", "text": "of the information contained in the technical documentation referred to in point 2(f) of Annex IV,\nshall not constitute a substantial modification.\n5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI\nand VII by updating them in light of technical progress.\n6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1\nand 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity\nassessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into\naccount the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in\npreventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well\nas the availability of adequate capacities and resources among notified bodies.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Conformity assessment", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 78, "page_end": 79, "chunk_index": 3} +{"id": "article-44-chunk-0", "text": "Article 44 - Certificates\n\n1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be\neasily understood by the relevant authorities in the Member State in which the notified body is established.\n2. Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by\nAnnex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may\nbe extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI\nsystems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment\nprocedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.\n3. Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking\naccount of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless\ncompliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within\nan appropriate deadline set by the notified body. The notified body shall give reasons for its decision.\nAn appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-44", "title": "Article 44 - Certificates", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 79, "page_end": 79, "chunk_index": 0} +{"id": "article-45-chunk-0", "text": "Article 45 - Information obligations of notified bodies\n\n1. Notified bodies shall inform the notifying authority of the following:\n(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality\nmanagement system approvals issued in accordance with the requirements of Annex VII;\n(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality\nmanagement system approval issued in accordance with the requirements of Annex VII;\n(c) any circumstances affecting the scope of or conditions for notification;\n(d) any request for information which they have received from market surveillance authorities regarding conformity\nassessment activities;\n(e) on request, conformity assessment activities performed within the scope of their notification and any other activity\nperformed, including cross-border activities and subcontracting.\n2. Each notified body shall inform the other notified bodies of:\n(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality\nsystem approvals which it has issued;\n(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn,\nsuspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.\n3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities\ncovering the same types of AI systems", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Information obligations of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 79, "page_end": 80, "chunk_index": 0} +{"id": "article-45-chunk-1", "text": "nd/or supplements thereto which it has issued.\n3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities\ncovering the same types of AI systems with relevant information on issues relating to negative and, on request, positive\nconformity assessment results.\n4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Information obligations of notified bodies", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 79, "page_end": 80, "chunk_index": 1} +{"id": "article-46-chunk-0", "text": "Article 46 - Derogation from conformity assessment procedure\n\n1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may\nauthorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the\nMember State concerned, for exceptional reasons of public security or the protection of life and health of persons,\nenvironmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for\na limited period while the necessary conformity assessment procedures are being carried out, taking into account the\nexceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.\n2. In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial\nand imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection\nauthorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1,\nprovided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in\nparagraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and\noutputs of such use shall be immediately discarded.\n3. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-46", "title": "Article 46 - Derogation from conformity assessment procedure", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 80, "page_end": 80, "chunk_index": 0} +{"id": "article-46-chunk-1", "text": "ect and all the results and\noutputs of such use shall be immediately discarded.\n3. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that\nthe high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the\nCommission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall\nnot cover sensitive operational data in relation to the activities of law-enforcement authorities.\n4. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised\nby either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of\na Member State in accordance with paragraph 1, that authorisation shall be deemed justified.\n5. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by\na Member State against an authorisation issued by a market surveillance authority of another Member State, or where the\nCommission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the\ncompliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into\nconsultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to\npresent their views. Having re", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-46", "title": "Article 46 - Derogation from conformity assessment procedure", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 80, "page_end": 80, "chunk_index": 1} +{"id": "article-46-chunk-2", "text": "ded, the Commission shall, without delay, enter into\nconsultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to\npresent their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The\nCommission shall address its decision to the Member State concerned and to the relevant operators.\n6. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance\nauthority of the Member State concerned.\n7. For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of\nAnnex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall\napply.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-46", "title": "Article 46 - Derogation from conformity assessment procedure", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 80, "page_end": 80, "chunk_index": 2} +{"id": "article-47-chunk-0", "text": "Article 47 - EU declaration of conformity\n\n1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity\nfor each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the\nhigh-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the\nhigh-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the\nrelevant national competent authorities upon request.\n2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in\nSection 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into\na language that can be easily understood by the national competent authorities of the Member States in which the high-risk\nAI system is placed on the market or made available.\n3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU\ndeclaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to\nthe high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation\nlegislation to which the declaration relates.\n4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the\nrequirements set out in Se", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - EU declaration of conformity", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 80, "page_end": 81, "chunk_index": 0} +{"id": "article-47-chunk-1", "text": "rmonisation\nlegislation to which the declaration relates.\n4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the\nrequirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.\n5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by\nupdating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become\nnecessary in light of technical progress.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - EU declaration of conformity", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 80, "page_end": 81, "chunk_index": 1} +{"id": "article-48-chunk-0", "text": "Article 48 - CE marking\n\n1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.\n2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the\ninterface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.\n3. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or\nnot warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the\naccompanying documentation, as appropriate.\n4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for\nthe conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed\nby the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification\nnumber shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the\nrequirements for CE marking.\n5. Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the\nCE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-48", "title": "Article 48 - CE marking", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 81, "page_end": 81, "chunk_index": 0} +{"id": "article-49-chunk-0", "text": "Article 49 - Registration\n\n1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of\nhigh-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative\nshall register themselves and their system in the EU database referred to in Article 71.\n2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not\nhigh-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register\nthemselves and that system in the EU database referred to in Article 71.\n3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI\nsystems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or\npersons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to\nin Article 71.\n4. For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration,\nasylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in\na secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as\napplicable, referred to in:\n(a) Section A, points 1 to 10, of Annex VIII, with the exception of poi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Registration", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 81, "page_end": 82, "chunk_index": 0} +{"id": "article-49-chunk-1", "text": "on of the EU database referred to in Article 71 and shall include only the following information, as\napplicable, referred to in:\n(a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;\n(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;\n(c) Section C, points 1 to 3, of Annex VIII;\n(d) points 1, 2, 3 and 5, of Annex IX.\nOnly the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted\nsections of the EU database listed in the first subparagraph of this paragraph.\n5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Registration", "chapter_number": "III", "chapter_title": "HIGH-RISK AI SYSTEMS", "page_start": 81, "page_end": 82, "chunk_index": 1} +{"id": "article-50-chunk-0", "text": "Article 50 - Transparency obligations for providers and deployers of certain AI systems\n\n1. Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in\nsuch a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is\nobvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking\ninto account the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to\ndetect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of\nthird parties, unless those systems are available for the public to report a criminal offence.\n2. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text\ncontent, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as\nartificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and\nreliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content,\nthe costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical\nstandards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or\ndo not substantially alter the input data provided by the depl", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-50", "title": "Article 50 - Transparency obligations for providers and deployers of certain AI systems", "chapter_number": "IV", "chapter_title": "TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS", "page_start": 82, "page_end": 83, "chunk_index": 0} +{"id": "article-50-chunk-1", "text": "t technical\nstandards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or\ndo not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to\ndetect, prevent, investigate or prosecute criminal offences.\n3. Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons\nexposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU)\n2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems\nused for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate\ncriminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with\nUnion law.\n4. Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall\ndisclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is\nauthorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently\nartistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph\nare limited to disclosure of the existence of such generated or manipulat", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-50", "title": "Article 50 - Transparency obligations for providers and deployers of certain AI systems", "chapter_number": "IV", "chapter_title": "TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS", "page_start": 82, "page_end": 83, "chunk_index": 1} +{"id": "article-50-chunk-2", "text": "rtistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph\nare limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not\nhamper the display or enjoyment of the work.\nDeployers of an AI system that generates or manipulates text which is published with the purpose of informing the public\non matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall\nnot apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the\nAI-generated content has undergone a process of human review or editorial control and where a natural or legal person\nholds editorial responsibility for the publication of the content.\n5. The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and\ndistinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the\napplicable accessibility requirements.\n6. Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without\nprejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.\n7. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective\nimplementation of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-50", "title": "Article 50 - Transparency obligations for providers and deployers of certain AI systems", "chapter_number": "IV", "chapter_title": "TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS", "page_start": 82, "page_end": 83, "chunk_index": 2} +{"id": "article-50-chunk-3", "text": "n in Union or national law for deployers of AI systems.\n7. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective\nimplementation of the obligations regarding the detection and labelling of artificially generated or manipulated content.\nThe Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid\ndown in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an implementing act specifying\ncommon rules for the implementation of those obligations in accordance with the examination procedure laid down in\nArticle 98(2).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-50", "title": "Article 50 - Transparency obligations for providers and deployers of certain AI systems", "chapter_number": "IV", "chapter_title": "TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS", "page_start": 82, "page_end": 83, "chunk_index": 3} +{"id": "article-51-chunk-0", "text": "Article 51 - Classification of general-purpose AI models as general-purpose AI models with systemic risk\n\n1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the\nfollowing conditions:\n(a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including\nindicators and benchmarks;\n(b) based on a decision of the Commission, ex officio or following a qualified alert from the scientific panel, it has\ncapabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.\n2. A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a),\nwhen the cumulative amount of computation used for its training measured in floating point operations is greater than\n1025.\n3. The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in\nparagraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological\ndevelopments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to\nreflect the state of the art.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-51", "title": "Article 51 - Classification of general-purpose AI models as general-purpose AI models with systemic risk", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 83, "page_end": 83, "chunk_index": 0} +{"id": "article-52-chunk-0", "text": "Article 52 - Procedure\n\n1. Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider\nshall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes\nknown that it will be met. That notification shall include the information necessary to demonstrate that the relevant\nrequirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of\nwhich it has not been notified, it may decide to designate it as a model with systemic risk.\n2. The provider of a general-purpose AI model that meets the condition referred to in Article 51(1), point (a), may\npresent, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets that\nrequirement, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore\nshould not be classified as a general-purpose AI model with systemic risk.\n3. Where the Commission concludes that the arguments submitted pursuant to paragraph 2 are not sufficiently\nsubstantiated and the relevant provider was not able to demonstrate that the general-purpose AI model does not present,\ndue to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be\nconsidered to be a general-purpose AI model with systemic risk.\n4. The Commission may designate a general-purpose AI model as presen", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-52", "title": "Article 52 - Procedure", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 83, "page_end": 84, "chunk_index": 0} +{"id": "article-52-chunk-1", "text": "l reject those arguments, and the general-purpose AI model shall be\nconsidered to be a general-purpose AI model with systemic risk.\n4. The Commission may designate a general-purpose AI model as presenting systemic risks, ex officio or following\na qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of criteria set out in Annex XIII.\nThe Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIII by\nspecifying and updating the criteria set out in that Annex.\n5. Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic\nrisk pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the\ngeneral-purpose AI model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII.\nSuch a request shall contain objective, detailed and new reasons that have arisen since the designation decision. Providers\nmay request reassessment at the earliest six months after the designation decision. Where the Commission, following its\nreassessment, decides to maintain the designation as a general-purpose AI model with systemic risk, providers may request\nreassessment at the earliest six months after that decision.\n6. The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep\nthat list up to date, without prejudice t", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-52", "title": "Article 52 - Procedure", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 83, "page_end": 84, "chunk_index": 1} +{"id": "article-52-chunk-2", "text": "arliest six months after that decision.\n6. The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep\nthat list up to date, without prejudice to the need to observe and protect intellectual property rights and confidential\nbusiness information or trade secrets in accordance with Union and national law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-52", "title": "Article 52 - Procedure", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 83, "page_end": 84, "chunk_index": 2} +{"id": "article-53-chunk-0", "text": "Article 53 - Obligations for providers of general-purpose AI models\n\n1. Providers of general-purpose AI models shall:\n(a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and\nthe results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of\nproviding it, upon request, to the AI Office and the national competent authorities;\n(b) draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to\nintegrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect\nintellectual property rights and confidential business information or trade secrets in accordance with Union and\nnational law, the information and documentation shall:\n(i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the\ngeneral-purpose AI model and to comply with their obligations pursuant to this Regulation; and\n(ii) contain, at a minimum, the elements set out in Annex XII;\n(c) put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply\nwith, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of\nDirective (EU) 2019/790;\n(d) draw up and make publicly available a sufficiently detailed summary about the content used for training of the\ngeneral-purpose AI model, according to a template provided by the AI Office", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-53", "title": "Article 53 - Obligations for providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 84, "page_end": 85, "chunk_index": 0} +{"id": "article-53-chunk-1", "text": "2019/790;\n(d) draw up and make publicly available a sufficiently detailed summary about the content used for training of the\ngeneral-purpose AI model, according to a template provided by the AI Office.\n2. The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI models that are released\nunder a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and\nwhose parameters, including the weights, the information on the model architecture, and the information on model usage,\nare made publicly available. This exception shall not apply to general-purpose AI models with systemic risks.\n3. Providers of general-purpose AI models shall cooperate as necessary with the Commission and the national\ncompetent authorities in the exercise of their competences and powers pursuant to this Regulation.\n4. Providers of general-purpose AI models may rely on codes of practice within the meaning of Article 56 to\ndemonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is\npublished. Compliance with European harmonised standards grants providers the presumption of conformity to the extent\nthat those standards cover those obligations. Providers of general-purpose AI models who do not adhere to an approved\ncode of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of\ncompliance for assessment by the Commiss", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-53", "title": "Article 53 - Obligations for providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 84, "page_end": 85, "chunk_index": 1} +{"id": "article-53-chunk-2", "text": "I models who do not adhere to an approved\ncode of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of\ncompliance for assessment by the Commission.\n5. For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e) thereof, the Commission is\nempowered to adopt delegated acts in accordance with Article 97 to detail measurement and calculation methodologies\nwith a view to allowing for comparable and verifiable documentation.\n6. The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII\nin light of evolving technological developments.\n7. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in\naccordance with the confidentiality obligations set out in Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-53", "title": "Article 53 - Obligations for providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 84, "page_end": 85, "chunk_index": 2} +{"id": "article-54-chunk-0", "text": "Article 54 - Authorised representatives of providers of general-purpose AI models\n\n1. Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by\nwritten mandate, appoint an authorised representative which is established in the Union.\n2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the\nprovider.\n3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall\nprovide a copy of the mandate to the AI Office upon request, in one of the official languages of the institutions of the\nUnion. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the\nfollowing tasks:\n(a) verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in\nArticle 53 and, where applicable, Article 55 have been fulfilled by the provider;\n(b) keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national\ncompetent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and\nthe contact details of the provider that appointed the authorised representative;\n(c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to\nin point (b), necessary to demonstrate compliance with the obligations in this Chapter;\n(d) cooperate with the AI Office and competent authorities", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-54", "title": "Article 54 - Authorised representatives of providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 85, "page_end": 86, "chunk_index": 0} +{"id": "article-54-chunk-1", "text": "rmation and documentation, including that referred to\nin point (b), necessary to demonstrate compliance with the obligations in this Chapter;\n(d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to\nthe general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into\nservice in the Union.\n4. The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider,\nby the AI Office or the competent authorities, on all issues related to ensuring compliance with this Regulation.\n5. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be\nacting contrary to its obligations pursuant to this Regulation. In such a case, it shall also immediately inform the AI Office\nabout the termination of the mandate and the reasons therefor.\n6. The obligation set out in this Article shall not apply to providers of general-purpose AI models that are released under\na free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose\nparameters, including the weights, the information on the model architecture, and the information on model usage, are\nmade publicly available, unless the general-purpose AI models present systemic risks.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-54", "title": "Article 54 - Authorised representatives of providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 85, "page_end": 86, "chunk_index": 1} +{"id": "article-54-chunk-2", "text": "el usage, are\nmade publicly available, unless the general-purpose AI models present systemic risks.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-54", "title": "Article 54 - Authorised representatives of providers of general-purpose AI models", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 85, "page_end": 86, "chunk_index": 2} +{"id": "article-55-chunk-0", "text": "Article 55 - Obligations of providers of general-purpose AI models with systemic risk\n\n1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk\nshall:\n(a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including\nconducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;\n(b) assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development,\nthe placing on the market, or the use of general-purpose AI models with systemic risk;\n(c) keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent\nauthorities, relevant information about serious incidents and possible corrective measures to address them;\n(d) ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the\nphysical infrastructure of the model.\n2. Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of\nArticle 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised\nstandard is published. Compliance with European harmonised standards grants providers the presumption of conformity to\nthe extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do\nnot adhere to an approved code of practice or do not comply", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-55", "title": "Article 55 - Obligations of providers of general-purpose AI models with systemic risk", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 86, "chunk_index": 0} +{"id": "article-55-chunk-1", "text": "of conformity to\nthe extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do\nnot adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate\nalternative adequate means of compliance for assessment by the Commission.\n3. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in\naccordance with the confidentiality obligations set out in Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-55", "title": "Article 55 - Obligations of providers of general-purpose AI models with systemic risk", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 86, "chunk_index": 1} +{"id": "article-56-chunk-0", "text": "Article 56 - Codes of practice\n\n1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute\nto the proper application of this Regulation, taking into account international approaches.\n2. The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in\nArticles 53 and 55, including the following issues:\n(a) the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of\nmarket and technological developments;\n(b) the adequate level of detail for the summary about the content used for training;\n(c) the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;\n(d) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level,\nincluding the documentation thereof, which shall be proportionate to the risks, take into consideration their severity\nand probability and take into account the specific challenges of tackling those risks in light of the possible ways in\nwhich such risks may emerge and materialise along the AI value chain.\n3. The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent\nauthorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other\nrelevant stakeholders, such as downstream providers and independent e", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Codes of practice", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 87, "chunk_index": 0} +{"id": "article-56-chunk-1", "text": "tent\nauthorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other\nrelevant stakeholders, such as downstream providers and independent experts, may support the process.\n4. The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and\ncontain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of\nthose objectives, and that they take due account of the needs and interests of all interested parties, including affected\npersons, at Union level.\n5. The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the\nimplementation of the commitments and the measures taken and their outcomes, including as measured against the key\nperformance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in\nsize and capacity between various participants.\n6. The AI Office and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of\npractice by the participants and their contribution to the proper application of this Regulation. The AI Office and the Board\nshall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly\nmonitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy o", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Codes of practice", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 87, "chunk_index": 1} +{"id": "article-56-chunk-2", "text": "f practice cover the obligations provided for in Articles 53 and 55, and shall regularly\nmonitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes\nof practice.\nThe Commission may, by way of an implementing act, approve a code of practice and give it a general validity within the\nUnion. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).\n7. The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers\nof general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in\nArticle 53, unless they declare explicitly their interest to join the full code.\n8. The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in\nparticular in light of emerging standards. The AI Office shall assist in the assessment of available standards.\n9. Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including\ninviting providers pursuant to paragraph 7.\nIf, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its\nassessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules\nfor the implementation of the obligations provided for in Articles", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Codes of practice", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 87, "chunk_index": 2} +{"id": "article-56-chunk-3", "text": "following its\nassessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules\nfor the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of\nthis Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article\n98(2).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Codes of practice", "chapter_number": "V", "chapter_title": "GENERAL-PURPOSE AI MODELS", "page_start": 86, "page_end": 87, "chunk_index": 3} +{"id": "article-57-chunk-0", "text": "Article 57 - AI regulatory sandboxes\n\n1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national\nlevel, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent\nauthorities of other Member States. The Commission may provide technical support, advice and tools for the establishment\nand operation of AI regulatory sandboxes.\nThe obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that\nparticipation provides an equivalent level of national coverage for the participating Member States.\n2. Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of\nother Member States may also be established.\n3. The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies,\noffices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this\nChapter.\n4. Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient\nresources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities\nshall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem.\nThis Article shall not affect other regulatory sandboxes established under Union or national law", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 0} +{"id": "article-57-chunk-1", "text": "other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem.\nThis Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure\nan appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent\nauthorities.\n5. AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters\ninnovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time\nbefore their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the\nproviders or prospective providers and the competent authority. Such sandboxes may include testing in real world\nconditions supervised therein.\n6. Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory\nsandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures,\nand their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union\nand national law supervised within the sandbox.\n7. Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox\nwith guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Reg", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 1} +{"id": "article-57-chunk-2", "text": "l provide providers and prospective providers participating in the AI regulatory sandbox\nwith guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.\nUpon request of the provider or prospective provider of the AI system, the competent authority shall provide a written\nproof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report\ndetailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such\ndocumentation to demonstrate their compliance with this Regulation through the conformity assessment process or\nrelevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national\ncompetent authority shall be taken positively into account by market surveillance authorities and notified bodies, with\na view to accelerating conformity assessment procedures to a reasonable extent.\n8. Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider,\nthe Commission and the Board shall be authorised to access the exit reports and shall take them into account, as\nappropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national\ncompetent authority explicitly agree, the exit report may be made publicly available through the single information\nplatform referr", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 2} +{"id": "article-57-chunk-3", "text": "ation. If both the provider or prospective provider and the national\ncompetent authority explicitly agree, the exit report may be made publicly available through the single information\nplatform referred to in this Article.\n9. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:\n(a) improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable\nUnion and national law;\n(b) supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory\nsandbox;\n(c) fostering innovation and competitiveness and facilitating the development of an AI ecosystem;\n(d) contributing to evidence-based regulatory learning;\n(e) facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including\nstart-ups.\n10. National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of\npersonal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing\nor supporting access to data, the national data protection authorities and those other national or competent authorities are\nassociated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of\ntheir respective tasks and powers.\n11. The AI regulatory sandboxes shall not affect the supervisory or corrective powers o", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 3} +{"id": "article-57-chunk-4", "text": "ory sandbox and involved in the supervision of those aspects to the extent of\ntheir respective tasks and powers.\n11. The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities\nsupervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental\nrights identified during the development and testing of such AI systems shall result in an adequate mitigation. National\ncompetent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation\nin the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent\nauthorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers\nwhen implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting\ninnovation in AI in the Union.\n12. Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable\nUnion and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in\nthe sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for\ntheir participation and follow in good faith the guidance given by the national competent authority, no administrative fines\nshall be i", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 4} +{"id": "article-57-chunk-5", "text": "iders observe the specific plan and the terms and conditions for\ntheir participation and follow in good faith the guidance given by the national competent authority, no administrative fines\nshall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for\nother Union and national law were actively involved in the supervision of the AI system in the sandbox and provided\nguidance for compliance, no administrative fines shall be imposed regarding that law.\n13. The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate\ncross-border cooperation between national competent authorities.\n14. National competent authorities shall coordinate their activities and cooperate within the framework of the Board.\n15. National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may\nask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and\nkeep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.\n16. National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after\nthe establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those\nreports shall provide information on the progress and results of the implementati", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 5} +{"id": "article-57-chunk-6", "text": "establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those\nreports shall provide information on the progress and results of the implementation of those sandboxes, including best\npractices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible\nrevision of this Regulation, including its delegated and implementing acts, and on the application of other Union law\nsupervised by the competent authorities within the sandbox. The national competent authorities shall make those annual\nreports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual\nreports into account when exercising its tasks under this Regulation.\n17. The Commission shall develop a single and dedicated interface containing all relevant information related to AI\nregulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent\nauthorities, and to seek non-binding guidance on the conformity of innovative products, services, business models\nembedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with\nnational competent authorities, where relevant.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 6} +{"id": "article-57-chunk-7", "text": "relevant.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 88, "page_end": 89, "chunk_index": 7} +{"id": "article-58-chunk-0", "text": "Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes\n\n1. In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the\ndetailed arrangements for the establishment, development, implementation, operation and supervision of the AI regulatory\nsandboxes. The implementing acts shall include common principles on the following issues:\n(a) eligibility and selection criteria for participation in the AI regulatory sandbox;\n(b) procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox,\nincluding the sandbox plan and the exit report;\n(c) the terms and conditions applicable to the participants.\nThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).\n2. The implementing acts referred to in paragraph 1 shall ensure:\n(a) that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils\neligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform\napplicants of their decision within three months of the application;\n(b) that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and\nprospective providers may also submit applications in partnerships with deployers and other relevant third parties;\n(c) that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent\npossible, flexi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 90, "page_end": 91, "chunk_index": 0} +{"id": "article-58-chunk-1", "text": "s in partnerships with deployers and other relevant third parties;\n(c) that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent\npossible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;\n(d) that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to\nexceptional costs that national competent authorities may recover in a fair and proportionate manner;\n(e) that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory\nsandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application\nof the codes of conduct referred to in Article 95;\n(f) that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified\nbodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimenta-\ntion facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence,\nindividual researchers, in order to allow and facilitate cooperation with the public and private sectors;\n(g) that procedures, processes and administrative requirements for application, selection, participation and exiting the AI\nregulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the particip", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 90, "page_end": 91, "chunk_index": 1} +{"id": "article-58-chunk-2", "text": "dministrative requirements for application, selection, participation and exiting the AI\nregulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of\nSMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order\nto avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the\nEuropean Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the\nUnion;\n(h) that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of\nthe project and that may be extended by the national competent authority;\n(i) that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing\nand explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and\ncybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.\n3. Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where\nrelevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding\nservices such as help with standardisation documents and certification, testing and experimentation facilities, European\nDigital Innovation Hubs and centres of exce", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 90, "page_end": 91, "chunk_index": 2} +{"id": "article-58-chunk-3", "text": "s Regulation, to other value-adding\nservices such as help with standardisation documents and certification, testing and experimentation facilities, European\nDigital Innovation Hubs and centres of excellence.\n4. Where national competent authorities consider authorising testing in real world conditions supervised within the\nframework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and\nconditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting\nfundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities\nwith a view to ensuring consistent practices across the Union.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 90, "page_end": 91, "chunk_index": 3} +{"id": "article-59-chunk-0", "text": "Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory\n\nsandbox\n1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the\npurpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:\n(a) AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or\nlegal person and in one or more of the following areas:\n(i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and\nimprovement of health care systems;\n(ii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection\nagainst pollution, green transition measures, climate change mitigation and adaptation measures;\n(iii) energy sustainability;\n(iv) safety and resilience of transport systems and mobility, critical infrastructure and networks;\n(v) efficiency and quality of public administration and public services;\n(b) the data processed are necessary for complying with one or more of the requirements referred to in Chapter III,\nSection 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other\nnon-personal data;\n(c) there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as\nreferred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise\nduring the san", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-59", "title": "Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 91, "page_end": 92, "chunk_index": 0} +{"id": "article-59-chunk-1", "text": "ify if any high risks to the rights and freedoms of the data subjects, as\nreferred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise\nduring the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where\nnecessary, stop the processing;\n(d) any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected\ndata processing environment under the control of the prospective provider and only authorised persons have access to\nthose data;\n(e) providers can further share the originally collected data only in accordance with Union data protection law; any\npersonal data created in the sandbox cannot be shared outside the sandbox;\n(f) any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data\nsubjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;\n(g) any personal data processed in the context of the sandbox are protected by means of appropriate technical and\norganisational measures and deleted once the participation in the sandbox has terminated or the personal data has\nreached the end of its retention period;\n(h) the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in\nthe sandbox, unless provided otherwise by Union or national law;\n(i) a complete and det", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-59", "title": "Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 91, "page_end": 92, "chunk_index": 1} +{"id": "article-59-chunk-2", "text": "the processing of personal data in the context of the sandbox are kept for the duration of the participation in\nthe sandbox, unless provided otherwise by Union or national law;\n(i) a complete and detailed description of the process and rationale behind the training, testing and validation of the AI\nsystem is kept together with the testing results as part of the technical documentation referred to in Annex IV;\n(j) a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the\nwebsite of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities\nof law enforcement, border control, immigration or asylum authorities.\n2. For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of\ncriminal penalties, including safeguarding against and preventing threats to public security, under the control and\nresponsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on\na specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.\n3. Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other\npurposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the\nprocessing of personal data which is necessary for the purpose o", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-59", "title": "Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 91, "page_end": 92, "chunk_index": 2} +{"id": "article-59-chunk-3", "text": "data for other\npurposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the\nprocessing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or\nany other legal basis, in compliance with Union law on the protection of personal data.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-59", "title": "Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 91, "page_end": 92, "chunk_index": 3} +{"id": "article-60-chunk-0", "text": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes\n\n1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by\nproviders or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the\nreal-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.\nThe Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those\nimplementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).\nThis paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI\nsystems related to products covered by Union harmonisation legislation listed in Annex I.\n2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world\nconditions at any time before the placing on the market or the putting into service of the AI system on their own or in\npartnership with one or more deployers or prospective deployers.\n3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical\nreview that is required by Union or national law.\n4. Providers or prospective providers may conduct the testing in real world conditions only where all of the following\nconditions are met:\n(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 0} +{"id": "article-60-chunk-1", "text": "rs may conduct the testing in real world conditions only where all of the following\nconditions are met:\n(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance\nauthority in the Member State where the testing in real world conditions is to be conducted;\n(b) the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has\napproved the testing in real world conditions and the real-world testing plan; where the market surveillance authority\nhas not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be\nunderstood to have been approved; where national law does not provide for a tacit approval, the testing in real world\nconditions shall remain subject to an authorisation;\n(c) the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems\nreferred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control\nmanagement, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world\nconditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the\ninformation specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1,\n6 and 7 of Annex III in the areas of law enforcement, migra", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 1} +{"id": "article-60-chunk-2", "text": "number and with the\ninformation specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1,\n6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered\nthe testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point\n(d), with a Union-wide unique single identification number and with the information specified therein; the provider or\nprospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world\nconditions in accordance with Article 49(5);\n(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or has\nappointed a legal representative who is established in the Union;\n(e) data collected and processed for the purpose of the testing in real world conditions shall be transferred to third\ncountries only provided that appropriate and applicable safeguards under Union law are implemented;\n(f) the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not\nlonger than six months, which may be extended for an additional period of six months, subject to prior notification by\nthe provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need\nfor such an extension;\n(g) the subjects of the testing in real w", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 2} +{"id": "article-60-chunk-3", "text": "or notification by\nthe provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need\nfor such an extension;\n(g) the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or\ndisability, are appropriately protected;\n(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more\ndeployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their\ndecision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the\nprovider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their\nroles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions\nunder this Regulation and under other applicable Union and national law;\n(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the\ncase of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the\ntesting itself and the outcome of the testing in the real world conditions shall not have any negative effect on the\nsubjects, and their personal data shall be deleted after the test is performed;\n(j) the testing in real world conditions is effectively overseen", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 3} +{"id": "article-60-chunk-4", "text": "ld conditions shall not have any negative effect on the\nsubjects, and their personal data shall be deleted after the test is performed;\n(j) the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by\ndeployers or prospective deployers through persons who are suitably qualified in the relevant field and have the\nnecessary capacity, training and authority to perform their tasks;\n(k) the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.\n5. Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may,\nwithout any resulting detriment and without having to provide any justification, withdraw from the testing at any time by\nrevoking their informed consent and may request the immediate and permanent deletion of their personal data. The\nwithdrawal of the informed consent shall not affect the activities already carried out.\n6. In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of\nrequiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site\ninspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI\nsystems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world\nconditions.\n7. Any serious incide", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 4} +{"id": "article-60-chunk-5", "text": "world conditions and the related high-risk AI\nsystems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world\nconditions.\n7. Any serious incident identified in the course of the testing in real world conditions shall be reported to the national\nmarket surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate\nmitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or\notherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI\nsystem upon such termination of the testing in real world conditions.\n8. Providers or prospective providers shall notify the national market surveillance authority in the Member State where\nthe testing in real world conditions is to be conducted of the suspension or termination of the testing in real world\nconditions and of the final outcomes.\n9. The provider or prospective provider shall be liable under applicable Union and national liability law for any damage\ncaused in the course of their testing in real world conditions.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 92, "page_end": 93, "chunk_index": 5} +{"id": "article-61-chunk-0", "text": "Article 61 - Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes\n\n1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained\nfrom the subjects of testing prior to their participation in such testing and after their having been duly informed with\nconcise, clear, relevant, and understandable information regarding:\n(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to\ntheir participation;\n(b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of\nthe subject or subjects’ participation;\n(c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the\nright to withdraw from, testing in real world conditions at any time without any resulting detriment and without having\nto provide any justification;\n(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of\nthe AI system;\n(e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article\n60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be\nobtained.\n2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal\nrepresentative.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-61", "title": "Article 61 - Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 94, "page_end": 94, "chunk_index": 0} +{"id": "article-62-chunk-0", "text": "Article 62 - Measures for providers and deployers, in particular SMEs, including start-ups\n\n1. Member States shall undertake the following actions:\n(a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI\nregulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access\nshall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI\nregulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;\n(b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of\nSMEs including start-ups, deployers and, as appropriate, local public authorities;\n(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including\nstart-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to\nqueries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;\n(d) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.\n2. The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the\nfees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other\nrelevant indicators.\n3. The AI Office shall und", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-62", "title": "Article 62 - Measures for providers and deployers, in particular SMEs, including start-ups", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 94, "page_end": 95, "chunk_index": 0} +{"id": "article-62-chunk-1", "text": "into account when setting the\nfees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other\nrelevant indicators.\n3. The AI Office shall undertake the following actions:\n(a) provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;\n(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for\nall operators across the Union;\n(c) organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;\n(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-62", "title": "Article 62 - Measures for providers and deployers, in particular SMEs, including start-ups", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 94, "page_end": 95, "chunk_index": 1} +{"id": "article-63-chunk-0", "text": "Article 63 - Derogations for specific operators\n\n1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the\nquality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not\nhave partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the\nCommission shall develop guidelines on the elements of the quality management system which may be complied with in\na simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for\ncompliance with the requirements in respect of high-risk AI systems.\n2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other\nrequirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15,\n72 and 73.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-63", "title": "Article 63 - Derogations for specific operators", "chapter_number": "VI", "chapter_title": "MEASURES IN SUPPORT OF INNOVATION", "page_start": 95, "page_end": 95, "chunk_index": 0} +{"id": "article-64-chunk-0", "text": "Article 64 - AI Office\n\n1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.\n2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-64", "title": "Article 64 - AI Office", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 95, "page_end": 95, "chunk_index": 0} +{"id": "article-65-chunk-0", "text": "Article 65 - Establishment and structure of the European Artificial Intelligence Board\n\n1. A European Artificial Intelligence Board (the ‘Board’) is hereby established.\n2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall\nparticipate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national\nand Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the\nissues discussed are of relevance for them.\n3. Each representative shall be designated by their Member State for a period of three years, renewable once.\n4. Member States shall ensure that their representatives on the Board:\n(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the\nBoard’s tasks referred to in Article 66;\n(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’\nneeds, as a single contact point for stakeholders;\n(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State\nas regards the implementation of this Regulation, including through the collection of relevant data and information for\nthe purpose of fulfilling their tasks on the Board.\n5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds\nmajority. The rules of procedure shall, in particular, lay down procedures for the", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Establishment and structure of the European Artificial Intelligence Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 95, "page_end": 96, "chunk_index": 0} +{"id": "article-65-chunk-1", "text": "d.\n5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds\nmajority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the\nmandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the\nBoard’s activities and those of its sub-groups.\n6. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market\nsurveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.\nThe standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this\nRegulation within the meaning of Article 30 of Regulation (EU) 2019/1020.\nThe Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific\nissues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups\nor to specific meetings of those subgroups as observers.\n7. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.\n8. The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the\nsecretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the\ntasks of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Establishment and structure of the European Artificial Intelligence Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 95, "page_end": 96, "chunk_index": 1} +{"id": "article-65-chunk-2", "text": "representatives of the Member States. The AI Office shall provide the\nsecretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the\ntasks of the Board pursuant to this Regulation and its rules of procedure.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Establishment and structure of the European Artificial Intelligence Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 95, "page_end": 96, "chunk_index": 2} +{"id": "article-66-chunk-0", "text": "Article 66 - Tasks of the Board\n\nThe Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective\napplication of this Regulation. To that end, the Board may in particular:\n(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation\nand, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint\nactivities of market surveillance authorities referred to in Article 74(11);\n(b) collect and share technical and regulatory expertise and best practices among Member States;\n(c) provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on\ngeneral-purpose AI models;\n(d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the\nderogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory\nsandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;\n(e) at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant\nmatters related to the implementation of this Regulation and to its consistent and effective application, including:\n(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well\nas of the Commission’s guidelines;\n(ii) the evaluation and review of this R", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 96, "page_end": 97, "chunk_index": 0} +{"id": "article-66-chunk-1", "text": "uding:\n(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well\nas of the Commission’s guidelines;\n(ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident\nreports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation\nof the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union\nharmonisation legislation listed in Annex I;\n(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;\n(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41;\n(v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of\ndigital skills;\n(vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of\naccountability;\n(vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for\npossible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the\nlatest developments in technology;\n(f) support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks,\nsafeguards and rights and obligations in relation to the use of AI systems;\n(g) facilitate the developm", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 96, "page_end": 97, "chunk_index": 1} +{"id": "article-66-chunk-2", "text": "Commission in promoting AI literacy, public awareness and understanding of the benefits, risks,\nsafeguards and rights and obligations in relation to the use of AI systems;\n(g) facilitate the development of common criteria and a shared understanding among market operators and competent\nauthorities of the relevant concepts provided for in this Regulation, including by contributing to the development of\nbenchmarks;\n(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert\ngroups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services,\nfinancial services, consumer protection, data and fundamental rights protection;\n(i) contribute to effective cooperation with the competent authorities of third countries and with international\norganisations;\n(j) assist national competent authorities and the Commission in developing the organisational and technical expertise\nrequired for the implementation of this Regulation, including by contributing to the assessment of training needs for\nstaff of Member States involved in implementing this Regulation;\n(k) assist the AI Office in supporting national competent authorities in the establishment and development of AI\nregulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;\n(l) contribute to, and provide relevant advice on, the development of guidance documents;\n(m) advise the Co", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 96, "page_end": 97, "chunk_index": 2} +{"id": "article-66-chunk-3", "text": "sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;\n(l) contribute to, and provide relevant advice on, the development of guidance documents;\n(m) advise the Commission in relation to international matters on AI;\n(n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;\n(o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national\nexperiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the\ngeneral-purpose AI models.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 96, "page_end": 97, "chunk_index": 3} +{"id": "article-67-chunk-0", "text": "Article 67 - Advisory forum\n\n1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and\nto contribute to their tasks under this Regulation.\n2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry,\nstart-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to\ncommercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other\nundertakings.\n3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in\nparagraph 2, from amongst stakeholders with recognised expertise in the field of AI.\n4. The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more\nthan four years.\n5. The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European\nCommittee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute\n(ETSI) shall be permanent members of the advisory forum.\n6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in\naccordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.\n7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other\nstakeholders", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-67", "title": "Article 67 - Advisory forum", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 97, "page_end": 98, "chunk_index": 0} +{"id": "article-67-chunk-1", "text": "2. The term of office of the co-chairs shall be two years, renewable once.\n7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other\nstakeholders to its meetings.\n8. The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or\nthe Commission.\n9. The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining\nspecific questions related to the objectives of this Regulation.\n10. The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-67", "title": "Article 67 - Advisory forum", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 97, "page_end": 98, "chunk_index": 1} +{"id": "article-68-chunk-0", "text": "Article 68 - Scientific panel of independent experts\n\n1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel\nof independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That\nimplementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).\n2. The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or\ntechnical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting\nall of the following conditions:\n(a) having particular expertise and competence and scientific or technical expertise in the field of AI;\n(b) independence from any provider of AI systems or general-purpose AI models;\n(c) an ability to carry out activities diligently, accurately and objectively.\nThe Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with\nthe required needs and shall ensure fair gender and geographical representation.\n3. The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:\n(a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems,\nin particular by:\n(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with\nArticle 90;\n(ii) contributing to the devel", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-68", "title": "Article 68 - Scientific panel of independent experts", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 98, "page_end": 99, "chunk_index": 0} +{"id": "article-68-chunk-1", "text": "I models and systems,\nin particular by:\n(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with\nArticle 90;\n(ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI\nmodels and systems, including through benchmarks;\n(iii) providing advice on the classification of general-purpose AI models with systemic risk;\n(iv) providing advice on the classification of various general-purpose AI models and systems;\n(v) contributing to the development of tools and templates;\n(b) supporting the work of market surveillance authorities, at their request;\n(c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers\nof market surveillance authorities;\n(d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to\nArticle 81.\n4. The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the\nconfidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take\ninstructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of\ninterests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage\nand prevent potential conflicts of interest.\n5. The implementing a", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-68", "title": "Article 68 - Scientific panel of independent experts", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 98, "page_end": 99, "chunk_index": 1} +{"id": "article-68-chunk-2", "text": "aration of\ninterests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage\nand prevent potential conflicts of interest.\n5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed\narrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the\nperformance of the tasks of the scientific panel.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-68", "title": "Article 68 - Scientific panel of independent experts", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 98, "page_end": 99, "chunk_index": 2} +{"id": "article-69-chunk-0", "text": "Article 69 - Access to the pool of experts by the Member States\n\n1. Member States may call upon experts of the scientific panel to support their enforcement activities under this\nRegulation.\n2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and\nthe level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in\nArticle 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and\nthe necessity of ensuring effective access to experts for all Member States.\n3. The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the\ncombination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to\nthis Article is efficiently organised and provides the best possible added value.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-69", "title": "Article 69 - Access to the pool of experts by the Member States", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 99, "page_end": 99, "chunk_index": 0} +{"id": "article-70-chunk-0", "text": "Article 70 - Designation of national competent authorities and single points of contact\n\n1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and\nat least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall\nexercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and\ntasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain\nfrom any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be\nperformed by one or more designated authorities, in accordance with the organisational needs of the Member State.\n2. Member States shall communicate to the Commission the identity of the notifying authorities and the market\nsurveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall\nmake publicly available information on how competent authorities and single points of contact can be contacted, through\nelectronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as\nthe single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact.\nThe Commission shall make a list of the single points of contact publicly available.\n3. Member States shall ensure that their national competent authorities are pro", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Designation of national competent authorities and single points of contact", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 99, "page_end": 100, "chunk_index": 0} +{"id": "article-70-chunk-1", "text": "ity of the single point of contact.\nThe Commission shall make a list of the single points of contact publicly available.\n3. Member States shall ensure that their national competent authorities are provided with adequate technical, financial\nand human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national\ncompetent authorities shall have a sufficient number of personnel permanently available whose competences and expertise\nshall include an in-depth understanding of AI technologies, data and data computing, personal data protection,\ncybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements.\nMember States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on\nan annual basis.\n4. National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.\n5. When performing their tasks, the national competent authorities shall act in accordance with the confidentiality\nobligations set out in Article 78.\n6. By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status\nof the financial and human resources of the national competent authorities, with an assessment of their adequacy. The\nCommission shall transmit that information to the Board for discussion and possible recommendations.\n7. The Commission shall facilitate the e", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Designation of national competent authorities and single points of contact", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 99, "page_end": 100, "chunk_index": 1} +{"id": "article-70-chunk-2", "text": "ent authorities, with an assessment of their adequacy. The\nCommission shall transmit that information to the Board for discussion and possible recommendations.\n7. The Commission shall facilitate the exchange of experience between national competent authorities.\n8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in\nparticular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as\nappropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system\nin areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as\nappropriate.\n9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data\nProtection Supervisor shall act as the competent authority for their supervision.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Designation of national competent authorities and single points of contact", "chapter_number": "VII", "chapter_title": "GOVERNANCE", "page_start": 99, "page_end": 100, "chunk_index": 2} +{"id": "article-71-chunk-0", "text": "Article 71 - EU database for high-risk AI systems listed in Annex III\n\n1. The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing\ninformation referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2)\nwhich are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to\nArticle 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional\nspecifications of such database, the Commission shall consult the relevant experts, and when updating the functional\nspecifications of such database, the Commission shall consult the Board.\n2. The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where\napplicable, by the authorised representative.\n3. The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on\nbehalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).\n4. With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in\nthe EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner.\nThe information should be easily navigable and machine-readable. The information registered in accordance with Article 60\nshall be accessible only to market surveillance authorities and the Commission, unless the", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-71", "title": "Article 71 - EU database for high-risk AI systems listed in Annex III", "chapter_number": "VIII", "chapter_title": "EU DATABASE FOR HIGH-RISK AI SYSTEMS", "page_start": 100, "page_end": 101, "chunk_index": 0} +{"id": "article-71-chunk-1", "text": "ion should be easily navigable and machine-readable. The information registered in accordance with Article 60\nshall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider\nhas given consent for also making the information accessible the public.\n5. The EU database shall contain personal data only in so far as necessary for collecting and processing information in\naccordance with this Regulation. That information shall include the names and contact details of natural persons who are\nresponsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.\n6. The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers\nand deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility\nrequirements.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-71", "title": "Article 71 - EU database for high-risk AI systems listed in Annex III", "chapter_number": "VIII", "chapter_title": "EU DATABASE FOR HIGH-RISK AI SYSTEMS", "page_start": 100, "page_end": 101, "chunk_index": 1} +{"id": "article-72-chunk-0", "text": "Article 72 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems\n\n1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the\nnature of the AI technologies and the risks of the high-risk AI system.\n2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data\nwhich may be provided by deployers or which may be collected through other sources on the performance of high-risk AI\nsystems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with\nthe requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the\ninteraction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are\nlaw-enforcement authorities.\n3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring\nplan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act\nlaying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be\nincluded in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination\nprocedure referred to in Article 98(2).\n4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where\na post-market monitoring system and plan are already establishe", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-72", "title": "Article 72 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 101, "chunk_index": 0} +{"id": "article-72-chunk-1", "text": "ed to in Article 98(2).\n4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where\na post-market monitoring system and plan are already established under that legislation, in order to ensure consistency,\navoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the\nnecessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans\nalready existing under that legislation, provided that it achieves an equivalent level of protection.\nThe first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed\non the market or put into service by financial institutions that are subject to requirements under Union financial services\nlaw regarding their internal governance, arrangements or processes.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-72", "title": "Article 72 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 101, "chunk_index": 1} +{"id": "article-73-chunk-0", "text": "Article 73 - Reporting of serious incidents\n\n1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market\nsurveillance authorities of the Member States where that incident occurred.\n2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link\nbetween the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than\n15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.\nThe period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.\n3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as\ndefined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and\nnot later than two days after the provider or, where applicable, the deployer becomes aware of that incident.\n4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the\nprovider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and\nthe serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer\nbecomes aware of the serious incident.\n5. Where necessary to ensure timely reporting, the provider or, where applicable,", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-73", "title": "Article 73 - Reporting of serious incidents", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 102, "chunk_index": 0} +{"id": "article-73-chunk-1", "text": "10 days after the date on which the provider or, where applicable, the deployer\nbecomes aware of the serious incident.\n5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial\nreport that is incomplete, followed by a complete report.\n6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the\nnecessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment\nof the incident, and corrective action.\nThe provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during\nthe investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the\nAI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing\nthe competent authorities of such action.\n7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market\nsurveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission\nshall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That\nguidance shall be issued by 2 August 2025, and shall be assessed regularly.\n8. The market surveillance authority shall take appropriate", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-73", "title": "Article 73 - Reporting of serious incidents", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 102, "chunk_index": 1} +{"id": "article-73-chunk-2", "text": "ith the obligations set out in paragraph 1 of this Article. That\nguidance shall be issued by 2 August 2025, and shall be assessed regularly.\n8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU)\n2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall\nfollow the notification procedures as provided in that Regulation.\n9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are\nsubject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the\nnotification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).\n10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations\n(EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3,\npoint (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the\nMember States where the incident occurred.\n11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not\nthey have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-73", "title": "Article 73 - Reporting of serious incidents", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 102, "chunk_index": 2} +{"id": "article-73-chunk-3", "text": "incident, whether or not\nthey have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-73", "title": "Article 73 - Reporting of serious incidents", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 101, "page_end": 102, "chunk_index": 3} +{"id": "article-74-chunk-0", "text": "Article 74 - Market surveillance and control of AI systems in the Union market\n\n1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective\nenforcement of this Regulation:\n(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators\nidentified in Article 2(1) of this Regulation;\n(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling\nwithin the scope of this Regulation.\n2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance\nauthorities shall report annually to the Commission and relevant national competition authorities any information\nidentified in the course of market surveillance activities that may be of potential interest for the application of Union law on\ncompetition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred\nduring that year and about the measures taken.\n3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of\nAnnex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market\nsurveillance activities designated under those legal acts.\nBy derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another\nrelevant authority to act as a market surveillance authority, provided they ensure co", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 0} +{"id": "article-74-chunk-1", "text": ".\nBy derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another\nrelevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral\nmarket surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.\n4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products\ncovered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for\nprocedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral\nprocedures shall apply instead.\n5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020,\nfor the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the\npowers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.\n6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union\nfinancial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national\nauthority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the\nmarket, putting into service", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 1} +{"id": "article-74-chunk-2", "text": "Regulation shall be the relevant national\nauthority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the\nmarket, putting into service, or the use of the AI system is in direct connection with the provision of those financial\nservices.\n7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured,\nanother relevant authority may be identified by the Member State as market surveillance authority for the purposes of this\nRegulation.\nNational market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU,\nwhich are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report,\nwithout delay, to the European Central Bank any information identified in the course of their market surveillance activities\nthat may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that\nRegulation.\n8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law\nenforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7\nand 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of\nthis Regulation either the competent data protection supervisory authorities under Regula", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 2} +{"id": "article-74-chunk-3", "text": "x III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of\nthis Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive\n(EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of\nDirective (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or\notherwise interfere with their activities when acting in their judicial capacity.\n9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data\nProtection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the\nEuropean Union acting in its judicial capacity.\n10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation\nand other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed\nin Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.\n11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint\ninvestigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the\nCommission, that have the aim of promoting compliance, identif", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 3} +{"id": "article-74-chunk-4", "text": "uding joint\ninvestigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the\nCommission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing\nguidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present\na serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office\nshall provide coordination support for joint investigations.\n12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to\nwhat is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the\ndocumentation as well as the training, validation and testing data sets used for the development of high-risk AI systems,\nincluding, where appropriate and subject to security safeguards, through application programming interfaces (API) or other\nrelevant technical means and tools enabling remote access.\n13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned\nrequest and only when both of the following conditions are fulfilled:\n(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in\nChapter III, Section 2; and\n(b) testing or auditing procedures and verifications", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 4} +{"id": "article-74-chunk-5", "text": ") access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in\nChapter III, Section 2; and\n(b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have\nbeen exhausted or proved insufficient.\n14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with\nthe confidentiality obligations set out in Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Market surveillance and control of AI systems in the Union market", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 102, "page_end": 104, "chunk_index": 5} +{"id": "article-75-chunk-0", "text": "Article 75 - Mutual assistance, market surveillance and control of general-purpose AI systems\n\n1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the\nsame provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations\nunder this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market\nsurveillance authority provided for in this Section and Regulation (EU) 2019/1020.\n2. Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that\ncan be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be\nnon-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out\ncompliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.\n3. Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its\ninability to access certain information related to the general-purpose AI model despite having made all appropriate efforts\nto obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be\nenforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days,\nany information that the AI Office considers to be relevant in order to establish whether a h", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-75", "title": "Article 75 - Mutual assistance, market surveillance and control of general-purpose AI systems", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 104, "page_end": 104, "chunk_index": 0} +{"id": "article-75-chunk-1", "text": "ase, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days,\nany information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is\nnon-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in\naccordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020\nshall apply mutatis mutandis.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-75", "title": "Article 75 - Mutual assistance, market surveillance and control of general-purpose AI systems", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 104, "page_end": 104, "chunk_index": 1} +{"id": "article-76-chunk-0", "text": "Article 76 - Supervision of testing in real world conditions by market surveillance authorities\n\n1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in\naccordance with this Regulation.\n2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory\nsandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their\nsupervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world\nconditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article\n60(4), points (f) and (g).\n3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party\nof a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it\nmay take either of the following decisions on its territory, as appropriate:\n(a) to suspend or terminate the testing in real world conditions;\n(b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the\ntesting in real world conditions.\n4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an\nobjection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor\nand how the provider or prospective provider can c", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-76", "title": "Article 76 - Supervision of testing in real world conditions by market surveillance authorities", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 104, "page_end": 105, "chunk_index": 0} +{"id": "article-76-chunk-1", "text": "Article, or has issued an\nobjection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor\nand how the provider or prospective provider can challenge the decision or objection.\n5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall\ncommunicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system\nhas been tested in accordance with the testing plan.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-76", "title": "Article 76 - Supervision of testing in real world conditions by market surveillance authorities", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 104, "page_end": 105, "chunk_index": 1} +{"id": "article-77-chunk-0", "text": "Article 77 - Powers of authorities protecting fundamental rights\n\n1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law\nprotecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems\nreferred to in Annex III shall have the power to request and access any documentation created or maintained under this\nRegulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their\nmandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance\nauthority of the Member State concerned of any such request.\n2. By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and\nmake a list of them publicly available. Member States shall notify the list to the Commission and to the other Member\nStates, and shall keep the list up to date.\n3. Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of\nobligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in\nparagraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI\nsystem through technical means. The market surveillance authority shall organise the testing with the close involvement of\nthe requesting public authority or body within a reasonable time following the request.\n4", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-77", "title": "Article 77 - Powers of authorities protecting fundamental rights", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 105, "page_end": 105, "chunk_index": 0} +{"id": "article-77-chunk-1", "text": "gh technical means. The market surveillance authority shall organise the testing with the close involvement of\nthe requesting public authority or body within a reasonable time following the request.\n4. Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of\nthis Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-77", "title": "Article 77 - Powers of authorities protecting fundamental rights", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 105, "page_end": 105, "chunk_index": 1} +{"id": "article-78-chunk-0", "text": "Article 78 - Confidentiality\n\n1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved\nin the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of\ninformation and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:\n(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person,\nincluding source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European\nParliament and of the Council (57);\n(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;\n(c) public and national security interests;\n(d) the conduct of criminal or administrative proceedings;\n(e) information classified pursuant to Union or national law.\n2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is\nstrictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with\nthis Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures\nto protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon\nas it is no longer needed for the purpose for which it was obtained, in accordance with", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-78", "title": "Article 78 - Confidentiality", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 105, "page_end": 106, "chunk_index": 0} +{"id": "article-78-chunk-1", "text": "security and confidentiality of the information and data obtained, and shall delete the data collected as soon\nas it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.\n3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national\ncompetent authorities or between national competent authorities and the Commission shall not be disclosed without prior\nconsultation of the originating national competent authority and the deployer when high-risk AI systems referred to in\npoint 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such\ndisclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive\noperational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.\nWhen the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1,\n6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those\nauthorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as\napplicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market\nsurveillance authority holding the appropriate level of security cleara", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-78", "title": "Article 78 - Confidentiality", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 105, "page_end": 106, "chunk_index": 1} +{"id": "article-78-chunk-2", "text": "d (9), as\napplicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market\nsurveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or\nany copy thereof.\n4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant\nauthorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of\nwarnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned\nto provide information under criminal law of the Member States.\n5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of\ninternational and trade agreements, confidential information with regulatory authorities of third countries with which they\nhave concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-78", "title": "Article 78 - Confidentiality", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 105, "page_end": 106, "chunk_index": 2} +{"id": "article-79-chunk-0", "text": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk\n\n1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of\nRegulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.\n2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present\na risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of\nits compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to\nAI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance\nauthority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article\n77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other\nnational public authorities or bodies referred to in Article 77(1).\n(57) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how\nand business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).\nWhere, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance\nauthority in cooperation with the national public authority referred", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 106, "page_end": 107, "chunk_index": 0} +{"id": "article-79-chunk-1", "text": "16, p. 1).\nWhere, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance\nauthority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not\ncomply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant\noperator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from\nthe market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the\nshorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.\nThe market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU)\n2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.\n3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it\nshall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the\nactions which it has required the operator to take.\n4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that\nit has made available on the Union market.\n5. Where the operator of an AI system does not take adequate corrective action within the period refer", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 106, "page_end": 107, "chunk_index": 1} +{"id": "article-79-chunk-2", "text": "taken in respect of all the AI systems concerned that\nit has made available on the Union market.\n5. Where the operator of an AI system does not take adequate corrective action within the period referred to in\nparagraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI\nsystem’s being made available on its national market or put into service, to withdraw the product or the standalone AI\nsystem from that market or to recall it. That authority shall without undue delay notify the Commission and the other\nMember States of those measures.\n6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary\nfor the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the\nnon-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments\nput forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the\nnon-compliance is due to one or more of the following:\n(a) non-compliance with the prohibition of the AI practices referred to in Article 5;\n(b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;\n(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring\na presumption of conformity;\n(d) non-compliance with Article", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 106, "page_end": 107, "chunk_index": 2} +{"id": "article-79-chunk-3", "text": "Chapter III, Section 2;\n(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring\na presumption of conformity;\n(d) non-compliance with Article 50.\n7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the\nprocedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of\nany additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of\ndisagreement with the notified national measure, of their objections.\n8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has\nbeen raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional\nmeasure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This\nshall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation\n(EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of\nnon-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.\n9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the\nproduct or the AI system concerned, such as wit", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 106, "page_end": 107, "chunk_index": 3} +{"id": "article-79-chunk-4", "text": "o in Article 5 of this Regulation.\n9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the\nproduct or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue\ndelay.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Procedure at national level for dealing with AI systems presenting a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 106, "page_end": 107, "chunk_index": 4} +{"id": "article-80-chunk-0", "text": "Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III\n\n1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as\nnon-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of\nthe AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article\n6(3) and the Commission guidelines.\n2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is\nhigh-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into\ncompliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action\nwithin a period the market surveillance authority may prescribe.\n3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its\nnational territory, it shall inform the Commission and the other Member States without undue delay of the results of the\nevaluation and of the actions which it has required the provider to take.\n4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the\nrequirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring\nthe AI system into compliance with those requirements and obligations within the period referred to in paragrap", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-80", "title": "Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 107, "page_end": 108, "chunk_index": 0} +{"id": "article-80-chunk-1", "text": "aid down in this Regulation. Where the provider of an AI system concerned does not bring\nthe AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this\nArticle, the provider shall be subject to fines in accordance with Article 99.\n5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that\nit has made available on the Union market.\n6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to\nin paragraph 2 of this Article, Article 79(5) to (9) shall apply.\n7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority\nestablishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of\nrequirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.\n8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation\n(EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular\ninformation stored in the EU database referred to in Article 71 of this Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-80", "title": "Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 107, "page_end": 108, "chunk_index": 1} +{"id": "article-80-chunk-2", "text": "is Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-80", "title": "Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 107, "page_end": 108, "chunk_index": 2} +{"id": "article-81-chunk-0", "text": "Article 81 - Union safeguard procedure\n\n1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of\nnon-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market\nsurveillance authority of a Member State to a measure taken by another market surveillance authority, or where the\nCommission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into\nconsultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall\nevaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or\nwithin 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from\nthe notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to\nthe market surveillance authority of the Member State concerned. The Commission shall also inform all other market\nsurveillance authorities of its decision.\n2. Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States\nshall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the\nwithdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where\nthe Commission c", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-81", "title": "Article 81 - Union safeguard procedure", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 108, "page_end": 108, "chunk_index": 0} +{"id": "article-81-chunk-1", "text": "ures in respect of the AI system concerned, such as requiring the\nwithdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where\nthe Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure\nand shall inform the Commission accordingly.\n3. Where the national measure is considered justified and the non-compliance of the AI system is attributed to\nshortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation,\nthe Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-81", "title": "Article 81 - Union safeguard procedure", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 108, "page_end": 108, "chunk_index": 1} +{"id": "article-82-chunk-0", "text": "Article 82 - Compliant AI systems which present a risk\n\n1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority\nreferred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system\ncomplies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to\nother aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure\nthat the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue\ndelay, within a period it may prescribe.\n2. The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems\nconcerned that it has made available on the Union market within the timeline prescribed by the market surveillance\nauthority of the Member State referred to in paragraph 1.\n3. The Member States shall immediately inform the Commission and the other Member States of a finding under\nparagraph 1. That information shall include all available details, in particular the data necessary for the identification of the\nAI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and\nduration of the national measures taken.\n4. The Commission shall without undue delay enter into consultation with the Member States concerned and the\nrelevant operators, and shall evaluate th", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-82", "title": "Article 82 - Compliant AI systems which present a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 108, "page_end": 109, "chunk_index": 0} +{"id": "article-82-chunk-1", "text": "ture and\nduration of the national measures taken.\n4. The Commission shall without undue delay enter into consultation with the Member States concerned and the\nrelevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the\nCommission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.\n5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant\noperators. It shall also inform the other Member States.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-82", "title": "Article 82 - Compliant AI systems which present a risk", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 108, "page_end": 109, "chunk_index": 1} +{"id": "article-83-chunk-0", "text": "Article 83 - Formal non-compliance\n\n1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the\nrelevant provider to put an end to the non-compliance concerned, within a period it may prescribe:\n(a) the CE marking has been affixed in violation of Article 48;\n(b) the CE marking has not been affixed;\n(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;\n(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;\n(e) the registration in the EU database referred to in Article 71 has not been carried out;\n(f) where applicable, no authorised representative has been appointed;\n(g) technical documentation is not available.\n2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State\nconcerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made\navailable on the market or to ensure that it is recalled or withdrawn from the market without delay.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - Formal non-compliance", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 109, "page_end": 109, "chunk_index": 0} +{"id": "article-84-chunk-0", "text": "Article 84 - Union AI testing support structures\n\n1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under\nArticle 21(6) of Regulation (EU) 2019/1020 in the area of AI.\n2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide\nindependent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-84", "title": "Article 84 - Union AI testing support structures", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 109, "page_end": 109, "chunk_index": 0} +{"id": "article-85-chunk-0", "text": "Article 85 - Right to lodge a complaint with a market surveillance authority\n\nWithout prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that\nthere has been an infringement of the provisions of this Regulation may submit complaints to the relevant market\nsurveillance authority.\nIn accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting\nmarket surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market\nsurveillance authorities.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-85", "title": "Article 85 - Right to lodge a complaint with a market surveillance authority", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 110, "page_end": 110, "chunk_index": 0} +{"id": "article-86-chunk-0", "text": "Article 86 - Right to explanation of individual decision-making\n\n1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI\nsystem listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or\nsimilarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or\nfundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI\nsystem in the decision-making procedure and the main elements of the decision taken.\n2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation\nunder that paragraph follow from Union or national law in compliance with Union law.\n3. This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under\nUnion law.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-86", "title": "Article 86 - Right to explanation of individual decision-making", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 110, "page_end": 110, "chunk_index": 0} +{"id": "article-87-chunk-0", "text": "Article 87 - Reporting of infringements and protection of reporting persons\n\nDirective (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons\nreporting such infringements.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-87", "title": "Article 87 - Reporting of infringements and protection of reporting persons", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 110, "page_end": 110, "chunk_index": 0} +{"id": "article-88-chunk-0", "text": "Article 88 - Enforcement of the obligations of providers of general-purpose AI models\n\n1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural\nguarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without\nprejudice to the powers of organisation of the Commission and the division of competences between Member States and\nthe Union based on the Treaties.\n2. Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the\npowers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under\nthis Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-88", "title": "Article 88 - Enforcement of the obligations of providers of general-purpose AI models", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 110, "page_end": 110, "chunk_index": 0} +{"id": "article-89-chunk-0", "text": "Article 89 - Monitoring actions\n\n1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary\nactions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI\nmodels, including their adherence to approved codes of practice.\n2. Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation.\nA complaint shall be duly reasoned and indicate at least:\n(a) the point of contact of the provider of the general-purpose AI model concerned;\n(b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream\nprovider considers that the provider of the general-purpose AI model concerned infringed this Regulation;\n(c) any other information that the downstream provider that sent the request considers relevant, including, where\nappropriate, information gathered on its own initiative.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-89", "title": "Article 89 - Monitoring actions", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 111, "page_end": 111, "chunk_index": 0} +{"id": "article-90-chunk-0", "text": "Article 90 - Alerts of systemic risks by the scientific panel\n\n1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:\n(a) a general-purpose AI model poses concrete identifiable risk at Union level; or\n(b) a general-purpose AI model meets the conditions referred to in Article 51.\n2. Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise\nthe powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any\nmeasure according to Articles 91 to 94.\n3. A qualified alert shall be duly reasoned and indicate at least:\n(a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned;\n(b) a description of the relevant facts and the reasons for the alert by the scientific panel;\n(c) any other information that the scientific panel considers to be relevant, including, where appropriate, information\ngathered on its own initiative.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-90", "title": "Article 90 - Alerts of systemic risks by the scientific panel", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 111, "page_end": 111, "chunk_index": 0} +{"id": "article-91-chunk-0", "text": "Article 91 - Power to request documentation and information\n\n1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation\ndrawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the\npurpose of assessing compliance of the provider with this Regulation.\n2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the\ngeneral-purpose AI model.\n3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to\na provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment\nof the tasks of the scientific panel under Article 68(2).\n4. The request for information shall state the legal basis and the purpose of the request, specify what information is\nrequired, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for\nsupplying incorrect, incomplete or misleading information.\n5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested.\nIn the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to\nrepresent them by law or by their statutes, shall supply the information requested on behalf of the provider of the\ngeneral-purpose AI model concerned. Lawyers duly authorised to act may supply inform", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-91", "title": "Article 91 - Power to request documentation and information", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 111, "page_end": 112, "chunk_index": 0} +{"id": "article-91-chunk-1", "text": "represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the\ngeneral-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The\nclients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-91", "title": "Article 91 - Power to request documentation and information", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 111, "page_end": 112, "chunk_index": 1} +{"id": "article-92-chunk-0", "text": "Article 92 - Power to conduct evaluations\n\n1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:\n(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant\nto Article 91 is insufficient; or\n(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following\na qualified alert from the scientific panel in accordance with Article 90(1), point (a).\n2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the\nscientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria\noutlined in Article 68(2).\n3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned\nthrough APIs or further appropriate technical means and tools, including source code.\n4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within\nwhich the access is to be provided, and the fines provided for in Article 101 for failure to provide access.\n5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested.\nIn the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to\nrepresent them by law or by their statutes, shall provide the access requested on", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-92", "title": "Article 92 - Power to conduct evaluations", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 112, "page_end": 112, "chunk_index": 0} +{"id": "article-92-chunk-1", "text": "case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to\nrepresent them by law or by their statutes, shall provide the access requested on behalf of the provider of the\ngeneral-purpose AI model concerned.\n6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the\nevaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection\nthereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article\n98(2).\n7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue\nwith the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal\nsafeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate\nsuch risks.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-92", "title": "Article 92 - Power to conduct evaluations", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 112, "page_end": 112, "chunk_index": 1} +{"id": "article-93-chunk-0", "text": "Article 93 - Power to request measures\n\n1. Where necessary and appropriate, the Commission may request providers to:\n(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;\n(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious\nand substantiated concern of a systemic risk at Union level;\n(c) restrict the making available on the market, withdraw or recall the model.\n2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the\ngeneral-purpose AI model.\n3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with\nsystemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the\nCommission may, by decision, make those commitments binding and declare that there are no further grounds for action.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-93", "title": "Article 93 - Power to request measures", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 112, "page_end": 113, "chunk_index": 0} +{"id": "article-94-chunk-0", "text": "Article 94 - Procedural rights of economic operators of the general-purpose AI model\n\nArticle 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model,\nwithout prejudice to more specific procedural rights provided for in this Regulation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-94", "title": "Article 94 - Procedural rights of economic operators of the general-purpose AI model", "chapter_number": "IX", "chapter_title": "POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE", "page_start": 113, "page_end": 113, "chunk_index": 0} +{"id": "article-95-chunk-0", "text": "Article 95 - Codes of conduct for voluntary application of specific requirements\n\n1. The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including\nrelated governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems,\nof some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and\nindustry best practices allowing for the application of such requirements.\n2. The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary\napplication, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key\nperformance indicators to measure the achievement of those objectives, including elements such as, but not limited to:\n(a) applicable elements provided for in Union ethical guidelines for trustworthy AI;\n(b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient\nprogramming and techniques for the efficient design, training and use of AI;\n(c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;\n(d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse\ndevelopment teams and the promotion of stakeholders’ participation in that process;\n(e) assessing and preventing the negative impact of AI systems on vulnerable persons or group", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-95", "title": "Article 95 - Codes of conduct for voluntary application of specific requirements", "chapter_number": "X", "chapter_title": "CODES OF CONDUCT AND GUIDELINES", "page_start": 113, "page_end": 113, "chunk_index": 0} +{"id": "article-95-chunk-1", "text": "inclusive and diverse\ndevelopment teams and the promotion of stakeholders’ participation in that process;\n(e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons,\nincluding as regards accessibility for persons with a disability, as well as on gender equality.\n3. Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations\nrepresenting them or by both, including with the involvement of any interested stakeholders and their representative\norganisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems\ntaking into account the similarity of the intended purpose of the relevant systems.\n4. The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including\nstart-ups, when encouraging and facilitating the drawing up of codes of conduct.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-95", "title": "Article 95 - Codes of conduct for voluntary application of specific requirements", "chapter_number": "X", "chapter_title": "CODES OF CONDUCT AND GUIDELINES", "page_start": 113, "page_end": 113, "chunk_index": 1} +{"id": "article-96-chunk-0", "text": "Article 96 - Guidelines from the Commission on the implementation of this Regulation\n\n1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:\n(a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;\n(b) the prohibited practices referred to in Article 5;\n(c) the practical implementation of the provisions related to substantial modification;\n(d) the practical implementation of transparency obligations laid down in Article 50;\n(e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I,\nas well as with other relevant Union law, including as regards consistency in their enforcement;\n(f) the application of the definition of an AI system as set out in Article 3, point (1).\nWhen issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of\nlocal public authorities and of the sectors most likely to be affected by this Regulation.\nThe guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged\nstate of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in\nArticles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union\nharmonisation law.\n2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines\npreviously adopted when d", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-96", "title": "Article 96 - Guidelines from the Commission on the implementation of this Regulation", "chapter_number": "X", "chapter_title": "CODES OF CONDUCT AND GUIDELINES", "page_start": 114, "page_end": 114, "chunk_index": 0} +{"id": "article-96-chunk-1", "text": "hat are set out pursuant to Union\nharmonisation law.\n2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines\npreviously adopted when deemed necessary.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-96", "title": "Article 96 - Guidelines from the Commission on the implementation of this Regulation", "chapter_number": "X", "chapter_title": "CODES OF CONDUCT AND GUIDELINES", "page_start": 114, "page_end": 114, "chunk_index": 1} +{"id": "article-97-chunk-0", "text": "Article 97 - Exercise of the delegation\n\n1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.\n2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5)\nand (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for\na period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power\nnot later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for\nperiods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three\nmonths before the end of each period.\n3. The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6),\nArticle 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament\nor by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall\ntake effect the day following that of its publication in the Official Journal of the European Union or at a later date specified\ntherein. It shall not affect the validity of any delegated acts already in force.\n4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance\nwith the principles laid down", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-97", "title": "Article 97 - Exercise of the delegation", "chapter_number": "XI", "chapter_title": "DELEGATION OF POWER AND COMMITTEE PROCEDURE", "page_start": 114, "page_end": 115, "chunk_index": 0} +{"id": "article-97-chunk-1", "text": "he validity of any delegated acts already in force.\n4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance\nwith the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.\n5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to\nthe Council.\n6. Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6),\nArticle 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been\nexpressed by either the European Parliament or the Council within a period of three months of notification of that act to\nthe European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council\nhave both informed the Commission that they will not object. That period shall be extended by three months at the\ninitiative of the European Parliament or of the Council.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-97", "title": "Article 97 - Exercise of the delegation", "chapter_number": "XI", "chapter_title": "DELEGATION OF POWER AND COMMITTEE PROCEDURE", "page_start": 114, "page_end": 115, "chunk_index": 1} +{"id": "article-98-chunk-0", "text": "Article 98 - Committee procedure\n\n1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of\nRegulation (EU) No 182/2011.\n2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-98", "title": "Article 98 - Committee procedure", "chapter_number": "XI", "chapter_title": "DELEGATION OF POWER AND COMMITTEE PROCEDURE", "page_start": 115, "page_end": 115, "chunk_index": 0} +{"id": "article-99-chunk-0", "text": "Article 99 - Penalties\n\n1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on\npenalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to\ninfringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and\neffectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The\npenalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs,\nincluding start-ups, and their economic viability.\n2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission\nof the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of\nany subsequent amendment to them.\n3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative\nfines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the\npreceding financial year, whichever is higher.\n4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid\ndown in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up\nto 3 % of its total worldwid", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Penalties", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 115, "page_end": 116, "chunk_index": 0} +{"id": "article-99-chunk-1", "text": "rs or notified bodies, other than those laid\ndown in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up\nto 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:\n(a) obligations of providers pursuant to Article 16;\n(b) obligations of authorised representatives pursuant to Article 22;\n(c) obligations of importers pursuant to Article 23;\n(d) obligations of distributors pursuant to Article 24;\n(e) obligations of deployers pursuant to Article 26;\n(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;\n(g) transparency obligations for providers and deployers pursuant to Article 50.\n5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in\nreply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to\n1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.\n6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount\nreferred to in paragraphs 3, 4 and 5, whichever thereof is lower.\n7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine\nin each individual case, all relevant circumstances of the specific situation shall be ta", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Penalties", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 115, "page_end": 116, "chunk_index": 1} +{"id": "article-99-chunk-2", "text": "n deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine\nin each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate,\nregard shall be given to the following:\n(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI\nsystem, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;\n(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for\nthe same infringement;\n(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of\nother Union or national law, when such infringements result from the same activity or omission constituting a relevant\ninfringement of this Regulation;\n(d) the size, the annual turnover and market share of the operator committing the infringement;\n(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained,\nor losses avoided, directly or indirectly, from the infringement;\n(f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the\npossible adverse effects of the infringement;\n(g) the degree of responsibility of the operator taking into account the technical and organisational mea", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Penalties", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 115, "page_end": 116, "chunk_index": 2} +{"id": "article-99-chunk-3", "text": "rder to remedy the infringement and mitigate the\npossible adverse effects of the infringement;\n(g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented\nby it;\n(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and\nif so to what extent, the operator notified the infringement;\n(i) the intentional or negligent character of the infringement;\n(j) any action taken by the operator to mitigate the harm suffered by the affected persons.\n8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities\nand bodies established in that Member State.\n9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such\na manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States.\nThe application of such rules in those Member States shall have an equivalent effect.\n10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with\nUnion and national law, including effective judicial remedies and due process.\n11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued\nduring that year, in accordance with this Article, and about any related litigation or judicial proceedings.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Penalties", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 115, "page_end": 116, "chunk_index": 3} +{"id": "article-99-chunk-4", "text": "the Commission about the administrative fines they have issued\nduring that year, in accordance with this Article, and about any related litigation or judicial proceedings.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Penalties", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 115, "page_end": 116, "chunk_index": 4} +{"id": "article-100-chunk-0", "text": "Article 100 - Administrative fines on Union institutions, bodies, offices and agencies\n\n1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and\nagencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when\ndeciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation\nshall be taken into account and due regard shall be given to the following:\n(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI\nsystem concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by\nthem;\n(b) the degree of responsibility of the Union institution, body, office or agency, taking into account technical and\norganisational measures implemented by them;\n(c) any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;\n(d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and\nmitigate the possible adverse effects of the infringement, including compliance with any of the measures previously\nordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned\nwith regard to the same subject matter;\n(e) any similar previous infringements by the Union institution, body, office or agency;\n(f) the manner in which the infringement became known", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-100", "title": "Article 100 - Administrative fines on Union institutions, bodies, offices and agencies", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 116, "page_end": 117, "chunk_index": 0} +{"id": "article-100-chunk-1", "text": "agency concerned\nwith regard to the same subject matter;\n(e) any similar previous infringements by the Union institution, body, office or agency;\n(f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular\nwhether, and if so to what extent, the Union institution, body, office or agency notified the infringement;\n(g) the annual budget of the Union institution, body, office or agency.\n2. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative\nfines of up to EUR 1 500 000.\n3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those\nlaid down in Article 5, shall be subject to administrative fines of up to EUR 750 000.\n4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union\ninstitution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection\nSupervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data\nProtection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned\nhave been able to comment. Complainants, if any, shall be associated closely with the proceedings.\n5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to\nhave access to the European", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-100", "title": "Article 100 - Administrative fines on Union institutions, bodies, offices and agencies", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 116, "page_end": 117, "chunk_index": 1} +{"id": "article-100-chunk-2", "text": ", shall be associated closely with the proceedings.\n5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to\nhave access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or\nundertakings in the protection of their personal data or business secrets.\n6. Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines\nshall not affect the effective operation of the Union institution, body, office or agency fined.\n7. The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines\nit has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-100", "title": "Article 100 - Administrative fines on Union institutions, bodies, offices and agencies", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 116, "page_end": 117, "chunk_index": 2} +{"id": "article-101-chunk-0", "text": "Article 101 - Fines for providers of general-purpose AI models\n\n1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total\nworldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds\nthat the provider intentionally or negligently:\n(a) infringed the relevant provisions of this Regulation;\n(b) failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect,\nincomplete or misleading information;\n(c) failed to comply with a measure requested under Article 93;\n(d) failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with\nsystemic risk with a view to conducting an evaluation pursuant to Article 92.\nIn fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the\ninfringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into\naccount commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with\nArticle 56.\n2. Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to\nthe provider of the general-purpose AI model and give it an opportunity to be heard.\n3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.\n4. Information on fines imposed under this Article shall also be co", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-101", "title": "Article 101 - Fines for providers of general-purpose AI models", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 117, "page_end": 118, "chunk_index": 0} +{"id": "article-101-chunk-1", "text": "ve it an opportunity to be heard.\n3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.\n4. Information on fines imposed under this Article shall also be communicated to the Board as appropriate.\n5. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission\nfixing a fine under this Article. It may cancel, reduce or increase the fine imposed.\n6. The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for\nproceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts\nshall be adopted in accordance with the examination procedure referred to in Article 98(2).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-101", "title": "Article 101 - Fines for providers of general-purpose AI models", "chapter_number": "XII", "chapter_title": "PENALTIES", "page_start": 117, "page_end": 118, "chunk_index": 1} +{"id": "article-102-chunk-0", "text": "Article 102 - Amendment to Regulation (EC) No 300/2008\n\nIn Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:\n‘When adopting detailed measures related to technical specifications and procedures for approval and use of security\nequipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European\nParliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into\naccount.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-102", "title": "Article 102 - Amendment to Regulation (EC) No 300/2008", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 118, "page_end": 118, "chunk_index": 0} +{"id": "article-103-chunk-0", "text": "Article 103 - Amendment to Regulation (EU) No 167/2013\n\nIn Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:\n‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety\ncomponents within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the\nrequirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-103", "title": "Article 103 - Amendment to Regulation (EU) No 167/2013", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 118, "page_end": 118, "chunk_index": 0} +{"id": "article-104-chunk-0", "text": "Article 104 - Amendment to Regulation (EU) No 168/2013\n\nIn Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:\n‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety\ncomponents within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the\nrequirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-104", "title": "Article 104 - Amendment to Regulation (EU) No 168/2013", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 119, "page_end": 119, "chunk_index": 0} +{"id": "article-105-chunk-0", "text": "Article 105 - Amendment to Directive 2014/90/EU\n\nIn Article 8 of Directive 2014/90/EU, the following paragraph is added:\n‘5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of\nthe European Parliament and of the Council (*), when carrying out its activities pursuant to paragraph 1 and when adopting\ntechnical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into\naccount the requirements set out in Chapter III, Section 2, of that Regulation.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-105", "title": "Article 105 - Amendment to Directive 2014/90/EU", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 119, "page_end": 119, "chunk_index": 0} +{"id": "article-106-chunk-0", "text": "Article 106 - Amendment to Directive (EU) 2016/797\n\nIn Article 5 of Directive (EU) 2016/797, the following paragraph is added:\n‘12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11\nconcerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689\nof the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall\nbe taken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-106", "title": "Article 106 - Amendment to Directive (EU) 2016/797", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 119, "page_end": 119, "chunk_index": 0} +{"id": "article-107-chunk-0", "text": "Article 107 - Amendment to Regulation (EU) 2018/858\n\nIn Article 5 of Regulation (EU) 2018/858 the following paragraph is added:\n‘4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety\ncomponents within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the\nrequirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-107", "title": "Article 107 - Amendment to Regulation (EU) 2018/858", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 120, "page_end": 120, "chunk_index": 0} +{"id": "article-108-chunk-0", "text": "Article 108 - Amendments to Regulation (EU) 2018/1139\n\nRegulation (EU) 2018/1139 is amended as follows:\n(1) in Article 17, the following paragraph is added:\n‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning\nArtificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the\nEuropean Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be\ntaken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down\nharmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)\nNo 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797\nand (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.\neu/eli/reg/2024/1689/oj).’;\n(2) in Article 19, the following paragraph is added:\n‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which\nare safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,\nSection 2, of that Regulation shall be taken into account.’;\n(3) in Article 43, the following paragraph is added:\n‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are\nsafety components within the meaning of Regulation (EU) 2024/1689, the requiremen", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-108", "title": "Article 108 - Amendments to Regulation (EU) 2018/1139", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 120, "page_end": 121, "chunk_index": 0} +{"id": "article-108-chunk-1", "text": "dded:\n‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are\nsafety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,\nSection 2, of that Regulation shall be taken into account.’;\n(4) in Article 47, the following paragraph is added:\n‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which\nare safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,\nSection 2, of that Regulation shall be taken into account.’;\n(5) in Article 57, the following subparagraph is added:\n‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within\nthe meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall\nbe taken into account.’;\n(6) in Article 58, the following paragraph is added:\n‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which\nare safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,\nSection 2, of that Regulation shall be taken into account.’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-108", "title": "Article 108 - Amendments to Regulation (EU) 2018/1139", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 120, "page_end": 121, "chunk_index": 1} +{"id": "article-109-chunk-0", "text": "Article 109 - Amendment to Regulation (EU) 2019/2144\n\nIn Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:\n‘3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are\nsafety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*),\nthe requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.\n(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-109", "title": "Article 109 - Amendment to Regulation (EU) 2019/2144", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 121, "page_end": 121, "chunk_index": 0} +{"id": "article-110-chunk-0", "text": "Article 110 - Amendment to Directive (EU) 2020/1828\n\nIn Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council (58), the following point is added:\n‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised\nrules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,\n(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)\n2024/1689/oj).’.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-110", "title": "Article 110 - Amendment to Directive (EU) 2020/1828", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 121, "page_end": 121, "chunk_index": 0} +{"id": "article-111-chunk-0", "text": "Article 111 - AI systems already placed on the market or put into service and general-purpose AI models already placed on the\n\nmarked\n1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are\ncomponents of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market\nor put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.\nThe requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system\nestablished by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts\nare replaced or amended.\n2. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply\nto operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed\non the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant\nchanges in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public\nauthorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August\n2030.\n3. Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the\nnecessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.\n(58) Directive", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-111", "title": "Article 111 - AI systems already placed on the market or put into service and general-purpose AI models already placed on the", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 121, "page_end": 121, "chunk_index": 0} +{"id": "article-111-chunk-1", "text": "AI models that have been placed on the market before 2 August 2025 shall take the\nnecessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.\n(58) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the\nprotection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-111", "title": "Article 111 - AI systems already placed on the market or put into service and general-purpose AI models already placed on the", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 121, "page_end": 121, "chunk_index": 1} +{"id": "article-112-chunk-0", "text": "Article 112 - Evaluation and review\n\n1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI\npractices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period\nof the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the\nEuropean Parliament and the Council.\n2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European\nParliament and to the Council on the following:\n(a) the need for amendments extending existing area headings or adding new area headings in Annex III;\n(b) amendments to the list of AI systems requiring additional transparency measures in Article 50;\n(c) amendments enhancing the effectiveness of the supervision and governance system.\n3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review\nof this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the\nstructure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of\nthe findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The\nreports shall be made public.\n4. The reports referred to in paragraph 2 shall pay specific attention to the following:\n(a) the status of the financial, technical and", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-112", "title": "Article 112 - Evaluation and review", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 122, "page_end": 123, "chunk_index": 0} +{"id": "article-112-chunk-1", "text": "amendment of this Regulation. The\nreports shall be made public.\n4. The reports referred to in paragraph 2 shall pay specific attention to the following:\n(a) the status of the financial, technical and human resources of the national competent authorities in order to effectively\nperform the tasks assigned to them under this Regulation;\n(b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for\ninfringements of this Regulation;\n(c) adopted harmonised standards and common specifications developed to support this Regulation;\n(d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of\nthem are SMEs.\n5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been\ngiven sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper\nimplementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to\nincrease its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the\nCouncil.\n6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress\non the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and\nasses the need for further measures or actions, includ", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-112", "title": "Article 112 - Evaluation and review", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 122, "page_end": 123, "chunk_index": 1} +{"id": "article-112-chunk-2", "text": "e review of the progress\non the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and\nasses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the\nEuropean Parliament and to the Council, and it shall be made public.\n7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of\nvoluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems\nother than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems,\nincluding as regards environmental sustainability.\n8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide\nthe Commission with information upon its request and without undue delay.\n9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account\nthe positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.\n10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into\naccount developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light\nof the state of progress in the information society.\n11. To guide", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-112", "title": "Article 112 - Evaluation and review", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 122, "page_end": 123, "chunk_index": 2} +{"id": "article-112-chunk-3", "text": "taking into\naccount developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light\nof the state of progress in the information society.\n11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to\ndevelop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the\nrelevant Articles and the inclusion of new systems in:\n(a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in\nthat Annex;\n(b) the list of prohibited practices set out in Article 5; and\n(c) the list of AI systems requiring additional transparency measures pursuant to Article 50.\n12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which\nconcerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory\nspecificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and\nauthorities established therein.\n13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall\nreport on it to the European Parliament, the Council and the European Economic and Social Committee, taking into\naccount the first years of application of this Regulation. On the basis of the findings, that report shall, wh", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-112", "title": "Article 112 - Evaluation and review", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 122, "page_end": 123, "chunk_index": 3} +{"id": "article-112-chunk-4", "text": "opean Parliament, the Council and the European Economic and Social Committee, taking into\naccount the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be\naccompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for\na Union agency to resolve any identified shortcomings.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-112", "title": "Article 112 - Evaluation and review", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 122, "page_end": 123, "chunk_index": 4} +{"id": "article-113-chunk-0", "text": "Article 113 - Entry into force and application\n\nThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the\nEuropean Union.\nIt shall apply from 2 August 2026.\nHowever:\n(a) Chapters I and II shall apply from 2 February 2025;\n(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the\nexception of Article 101;\n(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.\nThis Regulation shall be binding in its entirety and directly applicable in all Member States.\nDone at Brussels, 13 June 2024.\nFor the European Parliament\nThe President\nR. METSOLA\nFor the Council\nThe President\nM. MICHEL", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "article", "ref_id": "article-113", "title": "Article 113 - Entry into force and application", "chapter_number": "XIII", "chapter_title": "FINAL PROVISIONS", "page_start": 123, "page_end": 123, "chunk_index": 0} +{"id": "annex-I-chunk-0", "text": "Annex I - List of Union harmonisation legislation\n\nSection A. List of Union harmonisation legislation based on the New Legislative Framework\n1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending\nDirective 95/16/EC (OJ L 157, 9.6.2006, p. 24);\n2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ\nL 170, 30.6.2009, p. 1);\n3. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft\nand personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);\n4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of\nthe laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);\n5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of\nthe laws of the Member States relating to equipment and protective systems intended for use in potentially explosive\natmospheres (OJ L 96, 29.3.2014, p. 309);\n6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the\nlaws of the Member States relating to the making available on the market of radio equipment and repealing Directive\n1999/5/EC (OJ L 153, 22.5.2014, p. 62);\n7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the\nlaws of the Member States relati", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-I", "title": "Annex I - List of Union harmonisation legislation", "chapter_number": null, "chapter_title": null, "page_start": 124, "page_end": 125, "chunk_index": 0} +{"id": "annex-I-chunk-1", "text": "ling Directive\n1999/5/EC (OJ L 153, 22.5.2014, p. 62);\n7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the\nlaws of the Member States relating to the making available on the market of pressure equipment (OJ L 189,\n27.6.2014, p. 164);\n8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway\ninstallations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);\n9. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective\nequipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);\n10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning\ngaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);\n11. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,\namending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing\nCouncil Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);\n12. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic\nmedical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017,\np. 176).\nSection B. List of other Union harmonisation legislation\n13. Regulation (EC) No 300/2008 of the European Parliament and of", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-I", "title": "Annex I - List of Union harmonisation legislation", "chapter_number": null, "chapter_title": null, "page_start": 124, "page_end": 125, "chunk_index": 1} +{"id": "annex-I-chunk-2", "text": "e 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017,\np. 176).\nSection B. List of other Union harmonisation legislation\n13. Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules\nin the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);\n14. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval\nand market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);\n15. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval\nand market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);\n16. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and\nrepealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);\n17. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of\nthe rail system within the European Union (OJ L 138, 26.5.2016, p. 44);\n18. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and\nmarket surveillance of motor vehicles and their trailers, and of systems, components and separate technical units\nintended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive\n2007/46/EC (OJ L 151, 14.6", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-I", "title": "Annex I - List of Union harmonisation legislation", "chapter_number": null, "chapter_title": null, "page_start": 124, "page_end": 125, "chunk_index": 2} +{"id": "annex-I-chunk-3", "text": "ilers, and of systems, components and separate technical units\nintended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive\n2007/46/EC (OJ L 151, 14.6.2018, p. 1);\n19. Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval\nrequirements for motor vehicles and their trailers, and systems, components and separate technical units intended\nfor such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users,\namending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC)\nNo 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and\nCommission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010,\n(EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU)\nNo 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012\nand (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);\n20. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the\nfield of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC)\nNo 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and\n2014/53/EU of the European Parliament and of the Council, and re", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-I", "title": "Annex I - List of Union harmonisation legislation", "chapter_number": null, "chapter_title": null, "page_start": 124, "page_end": 125, "chunk_index": 3} +{"id": "annex-I-chunk-4", "text": "Agency, and amending Regulations (EC)\nNo 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and\n2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC)\nNo 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212,\n22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1),\npoints (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to\ncontrol them remotely, are concerned.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-I", "title": "Annex I - List of Union harmonisation legislation", "chapter_number": null, "chapter_title": null, "page_start": 124, "page_end": 125, "chunk_index": 4} +{"id": "annex-II-chunk-0", "text": "Annex II - List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)\n\nCriminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):\n— terrorism,\n— trafficking in human beings,\n— sexual exploitation of children, and child pornography,\n— illicit trafficking in narcotic drugs or psychotropic substances,\n— illicit trafficking in weapons, munitions or explosives,\n— murder, grievous bodily injury,\n— illicit trade in human organs or tissue,\n— illicit trafficking in nuclear or radioactive materials,\n— kidnapping, illegal restraint or hostage-taking,\n— crimes within the jurisdiction of the International Criminal Court,\n— unlawful seizure of aircraft or ships,\n— rape,\n— environmental crime,\n— organised or armed robbery,\n— sabotage,\n— participation in a criminal organisation involved in one or more of the offences listed above.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-II", "title": "Annex II - List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)", "chapter_number": null, "chapter_title": null, "page_start": 126, "page_end": 126, "chunk_index": 0} +{"id": "annex-III-chunk-0", "text": "Annex III - High-risk AI systems referred to in Article 6(2)\n\nHigh-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:\n1. Biometrics, in so far as their use is permitted under relevant Union or national law:\n(a) remote biometric identification systems.\nThis shall not include AI systems intended to be used for biometric verification the sole purpose of which is to\nconfirm that a specific natural person is the person he or she claims to be;\n(b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or\ncharacteristics based on the inference of those attributes or characteristics;\n(c) AI systems intended to be used for emotion recognition.\n2. Critical infrastructure: AI systems intended to be used as safety components in the management and operation of\ncritical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.\n3. Education and vocational training:\n(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and\nvocational training institutions at all levels;\n(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer\nthe learning process of natural persons in educational and vocational training institutions at all levels;\n(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual\nwill receive or will be able to access, in the context of or", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 0} +{"id": "annex-III-chunk-1", "text": "utions at all levels;\n(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual\nwill receive or will be able to access, in the context of or within educational and vocational training institutions\nat all levels;\n(d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the\ncontext of or within educational and vocational training institutions at all levels.\n4. Employment, workers’ management and access to self-employment:\n(a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted\njob advertisements, to analyse and filter job applications, and to evaluate candidates;\n(b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or\ntermination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal\ntraits or characteristics or to monitor and evaluate the performance and behaviour of persons in such\nrelationships.\n5. Access to and enjoyment of essential private services and essential public services and benefits:\n(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility\nof natural persons for essential public assistance benefits and services, including healthcare services, as well as to\ngrant, reduce, revoke, or reclaim such benefits and services;\n(", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 1} +{"id": "annex-III-chunk-2", "text": "e the eligibility\nof natural persons for essential public assistance benefits and services, including healthcare services, as well as to\ngrant, reduce, revoke, or reclaim such benefits and services;\n(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score,\nwith the exception of AI systems used for the purpose of detecting financial fraud;\n(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life\nand health insurance;\n(d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to\nestablish priority in the dispatching of, emergency first response services, including by police, firefighters and\nmedical aid, as well as of emergency healthcare patient triage systems.\n6. Law enforcement, in so far as their use is permitted under relevant Union or national law:\n(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,\noffices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural\nperson becoming the victim of criminal offences;\n(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,\noffices or agencies in support of law enforcement authorities as polygraphs or similar tools;\n(c) AI systems intended to be used by or on behalf of law enforcement", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 2} +{"id": "annex-III-chunk-3", "text": "s or by Union institutions, bodies,\noffices or agencies in support of law enforcement authorities as polygraphs or similar tools;\n(c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,\noffices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course\nof the investigation or prosecution of criminal offences;\n(d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions,\nbodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person\noffending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4)\nof Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of\nnatural persons or groups;\n(e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,\noffices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in\nArticle 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal\noffences.\n7. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or\nnational law:\n(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,\no", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 3} +{"id": "annex-III-chunk-4", "text": "gement, in so far as their use is permitted under relevant Union or\nnational law:\n(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,\noffices or agencies as polygraphs or similar tools;\n(b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,\noffices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed\nby a natural person who intends to enter or who has entered into the territory of a Member State;\n(c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,\noffices or agencies to assist competent public authorities for the examination of applications for asylum, visa or\nresidence permits and for associated complaints with regard to the eligibility of the natural persons applying for\na status, including related assessments of the reliability of evidence;\n(d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies,\noffices or agencies, in the context of migration, asylum or border control management, for the purpose of\ndetecting, recognising or identifying natural persons, with the exception of the verification of travel documents.\n8. Administration of justice and democratic processes:\n(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial au", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 4} +{"id": "annex-III-chunk-5", "text": "on of the verification of travel documents.\n8. Administration of justice and democratic processes:\n(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in\nresearching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in\na similar way in alternative dispute resolution;\n(b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting\nbehaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI\nsystems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise\nor structure political campaigns from an administrative or logistical point of view.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-III", "title": "Annex III - High-risk AI systems referred to in Article 6(2)", "chapter_number": null, "chapter_title": null, "page_start": 127, "page_end": 129, "chunk_index": 5} +{"id": "annex-IV-chunk-0", "text": "Annex IV - Technical documentation referred to in Article 11(1)\n\nThe technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to\nthe relevant AI system:\n1. A general description of the AI system including:\n(a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous\nversions;\n(b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI\nsystems, that are not part of the AI system itself, where applicable;\n(c) the versions of relevant software or firmware, and any requirements related to version updates;\n(d) the description of all the forms in which the AI system is placed on the market or put into service, such as\nsoftware packages embedded into hardware, downloads, or APIs;\n(e) the description of the hardware on which the AI system is intended to run;\n(f) where the AI system is a component of products, photographs or illustrations showing external features, the\nmarking and internal layout of those products;\n(g) a basic description of the user-interface provided to the deployer;\n(h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where\napplicable;\n2. A detailed description of the elements of the AI system and of the process for its development, including:\n(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to\npre-trained systems or tools provided by thi", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IV", "title": "Annex IV - Technical documentation referred to in Article 11(1)", "chapter_number": null, "chapter_title": null, "page_start": 130, "page_end": 131, "chunk_index": 0} +{"id": "annex-IV-chunk-1", "text": "he process for its development, including:\n(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to\npre-trained systems or tools provided by third parties and how those were used, integrated or modified by the\nprovider;\n(b) the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key\ndesign choices including the rationale and assumptions made, including with regard to persons or groups of\npersons in respect of who, the system is intended to be used; the main classification choices; what the system is\ndesigned to optimise for, and the relevance of the different parameters; the description of the expected output\nand output quality of the system; the decisions about any possible trade-off made regarding the technical\nsolutions adopted to comply with the requirements set out in Chapter III, Section 2;\n(c) the description of the system architecture explaining how software components build on or feed into each other\nand integrate into the overall processing; the computational resources used to develop, train, test and validate the\nAI system;\n(d) where relevant, the data requirements in terms of datasheets describing the training methodologies and\ntechniques and the training data sets used, including a general description of these data sets, information about\ntheir provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures\n(e.g. f", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IV", "title": "Annex IV - Technical documentation referred to in Article 11(1)", "chapter_number": null, "chapter_title": null, "page_start": 130, "page_end": 131, "chunk_index": 1} +{"id": "annex-IV-chunk-2", "text": "sets used, including a general description of these data sets, information about\ntheir provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures\n(e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);\n(e) assessment of the human oversight measures needed in accordance with Article 14, including an assessment of\nthe technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in\naccordance with Article 13(3), point (d);\n(f) where applicable, a detailed description of pre-determined changes to the AI system and its performance,\ntogether with all the relevant information related to the technical solutions adopted to ensure continuous\ncompliance of the AI system with the relevant requirements set out in Chapter III, Section 2;\n(g) the validation and testing procedures used, including information about the validation and testing data used and\ntheir main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant\nrequirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test\nreports dated and signed by the responsible persons, including with regard to pre-determined changes as referred\nto under point (f);\n(h) cybersecurity measures put in place;\n3. Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to:\nits capa", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IV", "title": "Annex IV - Technical documentation referred to in Article 11(1)", "chapter_number": null, "chapter_title": null, "page_start": 130, "page_end": 131, "chunk_index": 2} +{"id": "annex-IV-chunk-3", "text": "as referred\nto under point (f);\n(h) cybersecurity measures put in place;\n3. Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to:\nits capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of\npersons on which the system is intended to be used and the overall expected level of accuracy in relation to its\nintended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights\nand discrimination in view of the intended purpose of the AI system; the human oversight measures needed in\naccordance with Article 14, including the technical measures put in place to facilitate the interpretation of the\noutputs of AI systems by the deployers; specifications on input data, as appropriate;\n4. A description of the appropriateness of the performance metrics for the specific AI system;\n5. A detailed description of the risk management system in accordance with Article 9;\n6. A description of relevant changes made by the provider to the system through its lifecycle;\n7. A list of the harmonised standards applied in full or in part the references of which have been published in the\nOfficial Journal of the European Union; where no such harmonised standards have been applied, a detailed description\nof the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant\nstandards and technical s", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IV", "title": "Annex IV - Technical documentation referred to in Article 11(1)", "chapter_number": null, "chapter_title": null, "page_start": 130, "page_end": 131, "chunk_index": 3} +{"id": "annex-IV-chunk-4", "text": "ed standards have been applied, a detailed description\nof the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant\nstandards and technical specifications applied;\n8. A copy of the EU declaration of conformity referred to in Article 47;\n9. A detailed description of the system in place to evaluate the AI system performance in the post-market phase in\naccordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IV", "title": "Annex IV - Technical documentation referred to in Article 11(1)", "chapter_number": null, "chapter_title": null, "page_start": 130, "page_end": 131, "chunk_index": 4} +{"id": "annex-V-chunk-0", "text": "Annex V - EU declaration of conformity\n\nThe EU declaration of conformity referred to in Article 47, shall contain all of the following information:\n1. AI system name and type and any additional unambiguous reference allowing the identification and traceability of\nthe AI system;\n2. The name and address of the provider or, where applicable, of their authorised representative;\n3. A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of\nthe provider;\n4. A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant\nUnion law that provides for the issuing of the EU declaration of conformity referred to in Article 47;\n5. Where an AI system involves the processing of personal data, a statement that that AI system complies with\nRegulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;\n6. References to any relevant harmonised standards used or any other common specification in relation to which\nconformity is declared;\n7. Where applicable, the name and identification number of the notified body, a description of the conformity\nassessment procedure performed, and identification of the certificate issued;\n8. The place and date of issue of the declaration, the name and function of the person who signed it, as well as an\nindication for, or on behalf of whom, that person signed, a signature.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-V", "title": "Annex V - EU declaration of conformity", "chapter_number": null, "chapter_title": null, "page_start": 132, "page_end": 132, "chunk_index": 0} +{"id": "annex-VI-chunk-0", "text": "Annex VI - Conformity assessment procedure based on internal control\n\n1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on\npoints 2, 3 and 4.\n2. The provider verifies that the established quality management system is in compliance with the requirements of\nArticle 17.\n3. The provider examines the information contained in the technical documentation in order to assess the compliance\nof the AI system with the relevant essential requirements set out in Chapter III, Section 2.\n4. The provider also verifies that the design and development process of the AI system and its post-market monitoring\nas referred to in Article 72 is consistent with the technical documentation.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VI", "title": "Annex VI - Conformity assessment procedure based on internal control", "chapter_number": null, "chapter_title": null, "page_start": 133, "page_end": 133, "chunk_index": 0} +{"id": "annex-VII-chunk-0", "text": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the\n\ntechnical documentation\n1. Introduction\nConformity based on an assessment of the quality management system and an assessment of the technical\ndocumentation is the conformity assessment procedure based on points 2 to 5.\n2. Overview\nThe approved quality management system for the design, development and testing of AI systems pursuant to\nArticle 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5.\nThe technical documentation of the AI system shall be examined in accordance with point 4.\n3. Quality management system\n3.1. The application of the provider shall include:\n(a) the name and address of the provider and, if the application is lodged by an authorised representative, also their\nname and address;\n(b) the list of AI systems covered under the same quality management system;\n(c) the technical documentation for each AI system covered under the same quality management system;\n(d) the documentation concerning the quality management system which shall cover all the aspects listed under\nArticle 17;\n(e) a description of the procedures in place to ensure that the quality management system remains adequate and\neffective;\n(f) a written declaration that the same application has not been lodged with any other notified body.\n3.2. The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the\nrequirements referred to in Article 17.\nThe decision shall be notified to the provider or i", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 0} +{"id": "annex-VII-chunk-1", "text": "ity management system shall be assessed by the notified body, which shall determine whether it satisfies the\nrequirements referred to in Article 17.\nThe decision shall be notified to the provider or its authorised representative.\nThe notification shall contain the conclusions of the assessment of the quality management system and the reasoned\nassessment decision.\n3.3. The quality management system as approved shall continue to be implemented and maintained by the provider so\nthat it remains adequate and efficient.\n3.4. Any intended change to the approved quality management system or the list of AI systems covered by the latter shall\nbe brought to the attention of the notified body by the provider.\nThe proposed changes shall be examined by the notified body, which shall decide whether the modified quality\nmanagement system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is\nnecessary.\nThe notified body shall notify the provider of its decision. The notification shall contain the conclusions of the\nexamination of the changes and the reasoned assessment decision.\n4. Control of the technical documentation.\n4.1. In addition to the application referred to in point 3, an application with a notified body of their choice shall be\nlodged by the provider for the assessment of the technical documentation relating to the AI system which the\nprovider intends to place on the market or put into service and which is covered by the quality management sys", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 1} +{"id": "annex-VII-chunk-2", "text": "der for the assessment of the technical documentation relating to the AI system which the\nprovider intends to place on the market or put into service and which is covered by the quality management system\nreferred to under point 3.\n4.2. The application shall include:\n(a) the name and address of the provider;\n(b) a written declaration that the same application has not been lodged with any other notified body;\n(c) the technical documentation referred to in Annex IV.\n4.3. The technical documentation shall be examined by the notified body. Where relevant, and limited to what is\nnecessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data\nsets used, including, where appropriate and subject to security safeguards, through API or other relevant technical\nmeans and tools enabling remote access.\n4.4. In examining the technical documentation, the notified body may require that the provider supply further evidence\nor carry out further tests so as to enable a proper assessment of the conformity of the AI system with the\nrequirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by\nthe provider, the notified body shall itself directly carry out adequate tests, as appropriate.\n4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III,\nSection 2, after all other reasonable means to verify conformity have been exhau", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 2} +{"id": "annex-VII-chunk-3", "text": "4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III,\nSection 2, after all other reasonable means to verify conformity have been exhausted and have proven to be\ninsufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained\nmodels of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the\nprotection of intellectual property and trade secrets.\n4.6. The decision of the notified body shall be notified to the provider or its authorised representative. The notification\nshall contain the conclusions of the assessment of the technical documentation and the reasoned assessment\ndecision.\nWhere the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall\nissue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of\nthe provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the\nidentification of the AI system.\nThe certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be\nevaluated, and to allow for control of the AI system while in use, where applicable.\nWhere the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body\nshall refuse to issue a Union te", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 3} +{"id": "annex-VII-chunk-4", "text": "ol of the AI system while in use, where applicable.\nWhere the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body\nshall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant\naccordingly, giving detailed reasons for its refusal.\nWhere the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system\nwill be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment\ndecision of the notified body refusing to issue the Union technical documentation assessment certificate shall\ncontain specific considerations on the quality data used to train the AI system, in particular on the reasons for\nnon-compliance.\n4.7. Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended\npurpose shall be assessed by the notified body which issued the Union technical documentation assessment\ncertificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned\nchanges, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed\nby the notified body, which shall decide whether those changes require a new conformity assessment in accordance\nwith Article 43(4) or whether they could be addressed by means of a supplement to the Union technical\ndocumentation assessment cert", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 4} +{"id": "annex-VII-chunk-5", "text": "ther those changes require a new conformity assessment in accordance\nwith Article 43(4) or whether they could be addressed by means of a supplement to the Union technical\ndocumentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the\nprovider of its decision and, where the changes are approved, issue to the provider a supplement to the Union\ntechnical documentation assessment certificate.\n5. Surveillance of the approved quality management system.\n5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the\nprovider duly complies with the terms and conditions of the approved quality management system.\n5.2. For assessment purposes, the provider shall allow the notified body to access the premises where the design,\ndevelopment, testing of the AI systems is taking place. The provider shall further share with the notified body all\nnecessary information.\n5.3. The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality\nmanagement system and shall provide the provider with an audit report. In the context of those audits, the notified\nbody may carry out additional tests of the AI systems for which a Union technical documentation assessment\ncertificate was issued.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 5} +{"id": "annex-VII-chunk-6", "text": "assessment\ncertificate was issued.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VII", "title": "Annex VII - Conformity based on an assessment of the quality management system and an assessment of the", "chapter_number": null, "chapter_title": null, "page_start": 134, "page_end": 135, "chunk_index": 6} +{"id": "annex-VIII-chunk-0", "text": "Annex VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with\n\nArticle 49\nSection A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)\nThe following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be\nregistered in accordance with Article 49(1):\n1. The name, address and contact details of the provider;\n2. Where submission of information is carried out by another person on behalf of the provider, the name, address and\ncontact details of that person;\n3. The name, address and contact details of the authorised representative, where applicable;\n4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of\nthe AI system;\n5. A description of the intended purpose of the AI system and of the components and functions supported through\nthis AI system;\n6. A basic and concise description of the information used by the system (data, inputs) and its operating logic;\n7. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);\n8. The type, number and expiry date of the certificate issued by the notified body and the name or identification\nnumber of that notified body, where applicable;\n9. A scanned copy of the certificate referred to in point 8, where applicable;\n10. Any Member States in which the AI system has been placed on the market, put into service or made available in the\nUnion;\n11. A copy of the EU declaration of conformity referred to in", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VIII", "title": "Annex VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with", "chapter_number": null, "chapter_title": null, "page_start": 136, "page_end": 137, "chunk_index": 0} +{"id": "annex-VIII-chunk-1", "text": "applicable;\n10. Any Member States in which the AI system has been placed on the market, put into service or made available in the\nUnion;\n11. A copy of the EU declaration of conformity referred to in Article 47;\n12. Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law\nenforcement or migration, asylum and border control management referred to in Annex III, points 1, 6 and 7;\n13. A URL for additional information (optional).\nSection B — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2)\nThe following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in\naccordance with Article 49(2):\n1. The name, address and contact details of the provider;\n2. Where submission of information is carried out by another person on behalf of the provider, the name, address and\ncontact details of that person;\n3. The name, address and contact details of the authorised representative, where applicable;\n4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of\nthe AI system;\n5. A description of the intended purpose of the AI system;\n6. The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;\n7. A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the\nprocedure under Article 6(3);\n8", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VIII", "title": "Annex VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with", "chapter_number": null, "chapter_title": null, "page_start": 136, "page_end": 137, "chunk_index": 1} +{"id": "annex-VIII-chunk-2", "text": "which the AI system is considered to be not-high-risk;\n7. A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the\nprocedure under Article 6(3);\n8. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);\n9. Any Member States in which the AI system has been placed on the market, put into service or made available in the\nUnion.\nSection C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)\nThe following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be\nregistered in accordance with Article 49(3):\n1. The name, address and contact details of the deployer;\n2. The name, address and contact details of the person submitting information on behalf of the deployer;\n3. The URL of the entry of the AI system in the EU database by its provider;\n4. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;\n5. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU)\n2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where\napplicable.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-VIII", "title": "Annex VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with", "chapter_number": null, "chapter_title": null, "page_start": 136, "page_end": 137, "chunk_index": 2} +{"id": "annex-IX-chunk-0", "text": "Annex IX - Information to be submitted upon the registration of high-risk AI systems listed in Annex III in\n\nrelation to testing in real world conditions in accordance with Article 60\nThe following information shall be provided and thereafter kept up to date with regard to testing in real world conditions to\nbe registered in accordance with Article 60:\n1. A Union-wide unique single identification number of the testing in real world conditions;\n2. The name and contact details of the provider or prospective provider and of the deployers involved in the testing in\nreal world conditions;\n3. A brief description of the AI system, its intended purpose, and other information necessary for the identification of\nthe system;\n4. A summary of the main characteristics of the plan for testing in real world conditions;\n5. Information on the suspension or termination of the testing in real world conditions.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-IX", "title": "Annex IX - Information to be submitted upon the registration of high-risk AI systems listed in Annex III in", "chapter_number": null, "chapter_title": null, "page_start": 138, "page_end": 138, "chunk_index": 0} +{"id": "annex-X-chunk-0", "text": "Annex X - Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice\n\n1. Schengen Information System\n(a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of\nthe Schengen Information System for the return of illegally staying third-country nationals (OJ L 312,\n7.12.2018, p. 1).\n(b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the\nestablishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and\namending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC)\nNo 1987/2006 (OJ L 312, 7.12.2018, p. 14).\n(c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the\nestablishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and\njudicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and\nrepealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission\nDecision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).\n2. Visa Information System\n(a) Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending\nRegulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards\nthe establishment of the conditions for accessing other EU information systems for the purposes of the Visa\nInformation System (OJ L 248, 13.7.2021, p. 1).\n(b) Regulation (EU) 2021/", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-X", "title": "Annex X - Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice", "chapter_number": null, "chapter_title": null, "page_start": 139, "page_end": 140, "chunk_index": 0} +{"id": "annex-X-chunk-1", "text": "019/818 as regards\nthe establishment of the conditions for accessing other EU information systems for the purposes of the Visa\nInformation System (OJ L 248, 13.7.2021, p. 1).\n(b) Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending\nRegulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU)\n2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the\nCouncil and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the\nVisa Information System (OJ L 248, 13.7.2021, p. 11).\n3. Eurodac\nRegulation (EU) 2024/1358 of the European Parliament and of the Council of 14 May 2024 on the establishment of\n‘Eurodac’ for the comparison of biometric data in order to effectively apply Regulations (EU) 2024/1315 and (EU)\n2024/1350 of the European Parliament and of the Council and Council Directive 2001/55/EC and to identify\nillegally staying third-country nationals and stateless persons and on requests for the comparison with Eurodac data\nby Member States’ law enforcement authorities and Europol for law enforcement purposes, amending Regulations\n(EU) 2018/1240 and (EU) 2019/818 of the European Parliament and of the Council and repealing Regulation (EU)\nNo 603/2013 of the European Parliament and of the Council (OJ L, 2024/1358, 22.5.2024, ELI: http://data.europa.\neu/eli/reg/2024/1358/oj).\n4. Entry/Exit System\nRegulation (EU) 2017/2226 of the Eur", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-X", "title": "Annex X - Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice", "chapter_number": null, "chapter_title": null, "page_start": 139, "page_end": 140, "chunk_index": 1} +{"id": "annex-X-chunk-2", "text": "(EU)\nNo 603/2013 of the European Parliament and of the Council (OJ L, 2024/1358, 22.5.2024, ELI: http://data.europa.\neu/eli/reg/2024/1358/oj).\n4. Entry/Exit System\nRegulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an\nEntry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing\nthe external borders of the Member States and determining the conditions for access to the EES for law enforcement\npurposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC)\nNo 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).\n5. European Travel Information and Authorisation System\n(a) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing\na European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU)\nNo 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236,\n19.9.2018, p. 1).\n(b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending\nRegulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation\nSystem (ETIAS) (OJ L 236, 19.9.2018, p. 72).\n6. European Criminal Records Information System on third-country nationals and stateless persons\nRegulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing\na centralised", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-X", "title": "Annex X - Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice", "chapter_number": null, "chapter_title": null, "page_start": 139, "page_end": 140, "chunk_index": 2} +{"id": "annex-X-chunk-3", "text": "Criminal Records Information System on third-country nationals and stateless persons\nRegulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing\na centralised system for the identification of Member States holding conviction information on third-country\nnationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and\namending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).\n7. Interoperability\n(a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing\na framework for interoperability between EU information systems in the field of borders and visa and amending\nRegulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU)\n2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and\n2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\n(b) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing\na framework for interoperability between EU information systems in the field of police and judicial cooperation,\nasylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ\nL 135, 22.5.2019, p. 85).", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-X", "title": "Annex X - Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice", "chapter_number": null, "chapter_title": null, "page_start": 139, "page_end": 140, "chunk_index": 3} +{"id": "annex-XI-chunk-0", "text": "Annex XI - Technical documentation referred to in Article 53(1), point (a) — technical documentation for\n\nproviders of general-purpose AI models\nSection 1\nInformation to be provided by all providers of general-purpose AI models\nThe technical documentation referred to in Article 53(1), point (a) shall contain at least the following information as\nappropriate to the size and risk profile of the model:\n1. A general description of the general-purpose AI model including:\n(a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be\nintegrated;\n(b) the acceptable use policies applicable;\n(c) the date of release and methods of distribution;\n(d) the architecture and number of parameters;\n(e) the modality (e.g. text, image) and format of inputs and outputs;\n(f) the licence.\n2. A detailed description of the elements of the model referred to in point 1, and relevant information of the process\nfor the development, including the following elements:\n(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to\nbe integrated in AI systems;\n(b) the design specifications of the model and training process, including training methodologies and techniques,\nthe key design choices including the rationale and assumptions made; what the model is designed to optimise for\nand the relevance of the different parameters, as applicable;\n(c) information on the data used for training, testing and validation, where applicable, including the type and\nprovenance of data and curation methodologies (e.g. cleaning,", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-XI", "title": "Annex XI - Technical documentation referred to in Article 53(1), point (a) — technical documentation for", "chapter_number": null, "chapter_title": null, "page_start": 141, "page_end": 142, "chunk_index": 0} +{"id": "annex-XI-chunk-1", "text": "parameters, as applicable;\n(c) information on the data used for training, testing and validation, where applicable, including the type and\nprovenance of data and curation methodologies (e.g. cleaning, filtering, etc.), the number of data points, their\nscope and main characteristics; how the data was obtained and selected as well as all other measures to detect the\nunsuitability of data sources and methods to detect identifiable biases, where applicable;\n(d) the computational resources used to train the model (e.g. number of floating point operations), training time,\nand other relevant details related to the training;\n(e) known or estimated energy consumption of the model.\nWith regard to point (e), where the energy consumption of the model is unknown, the energy consumption may be\nbased on information about computational resources used.\nSection 2\nAdditional information to be provided by providers of general-purpose AI models with systemic risk\n1. A detailed description of the evaluation strategies, including evaluation results, on the basis of available public\nevaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include\nevaluation criteria, metrics and the methodology on the identification of limitations.\n2. Where applicable, a detailed description of the measures put in place for the purpose of conducting internal and/or\nexternal adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-XI", "title": "Annex XI - Technical documentation referred to in Article 53(1), point (a) — technical documentation for", "chapter_number": null, "chapter_title": null, "page_start": 141, "page_end": 142, "chunk_index": 1} +{"id": "annex-XI-chunk-2", "text": "detailed description of the measures put in place for the purpose of conducting internal and/or\nexternal adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.\n3. Where applicable, a detailed description of the system architecture explaining how software components build or\nfeed into each other and integrate into the overall processing.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-XI", "title": "Annex XI - Technical documentation referred to in Article 53(1), point (a) — technical documentation for", "chapter_number": null, "chapter_title": null, "page_start": 141, "page_end": 142, "chunk_index": 2} +{"id": "annex-XII-chunk-0", "text": "Annex XII - Transparency information referred to in Article 53(1), point (b) — technical documentation for\n\nproviders of general-purpose AI models to downstream providers that integrate the model into their\nAI system\nThe information referred to in Article 53(1), point (b) shall contain at least the following:\n1. A general description of the general-purpose AI model including:\n(a) the tasks that the model is intended to perform and the type and nature of AI systems into which it can be\nintegrated;\n(b) the acceptable use policies applicable;\n(c) the date of release and methods of distribution;\n(d) how the model interacts, or can be used to interact, with hardware or software that is not part of the model\nitself, where applicable;\n(e) the versions of relevant software related to the use of the general-purpose AI model, where applicable;\n(f) the architecture and number of parameters;\n(g) the modality (e.g. text, image) and format of inputs and outputs;\n(h) the licence for the model.\n2. A description of the elements of the model and of the process for its development, including:\n(a) the technical means (e.g. instructions for use, infrastructure, tools) required for the general-purpose AI model to\nbe integrated into AI systems;\n(b) the modality (e.g. text, image, etc.) and format of the inputs and outputs and their maximum size (e.g. context\nwindow length, etc.);\n(c) information on the data used for training, testing and validation, where applicable, including the type and\nprovenance of data and curation methodologies.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-XII", "title": "Annex XII - Transparency information referred to in Article 53(1), point (b) — technical documentation for", "chapter_number": null, "chapter_title": null, "page_start": 143, "page_end": 143, "chunk_index": 0} +{"id": "annex-XIII-chunk-0", "text": "Annex XIII - Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51\n\nFor the purpose of determining that a general-purpose AI model has capabilities or an impact equivalent to those set out in\nArticle 51(1), point (a), the Commission shall take into account the following criteria:\n(a) the number of parameters of the model;\n(b) the quality or size of the data set, for example measured through tokens;\n(c) the amount of computation used for training the model, measured in floating point operations or indicated by\na combination of other variables such as estimated cost of training, estimated time required for the training, or\nestimated energy consumption for the training;\n(d) the input and output modalities of the model, such as text to text (large language models), text to image,\nmulti-modality, and the state of the art thresholds for determining high-impact capabilities for each modality, and\nthe specific type of inputs and outputs (e.g. biological sequences);\n(e) the benchmarks and evaluations of capabilities of the model, including considering the number of tasks without\nadditional training, adaptability to learn new, distinct tasks, its level of autonomy and scalability, the tools it has\naccess to;\n(f) whether it has a high impact on the internal market due to its reach, which shall be presumed when it has been\nmade available to at least 10 000 registered business users established in the Union;\n(g) the number of registered end-users.", "document_id": "eu_ai_act", "celex_id": "32024R1689", "ref_type": "annex", "ref_id": "annex-XIII", "title": "Annex XIII - Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51", "chapter_number": null, "chapter_title": null, "page_start": 144, "page_end": 144, "chunk_index": 0} +{"id": "article-1-chunk-0", "text": "Article 1 - Subject-matter and objectives\n\n1. This Regulation lays down rules relating to the protection of natural persons with regard to the processing of\npersonal data and rules relating to the free movement of personal data.\n2. This Regulation protects fundamental rights and freedoms of natural persons and in particular their right to the\nprotection of personal data.\n3. The free movement of personal data within the Union shall be neither restricted nor prohibited for reasons\nconnected with the protection of natural persons with regard to the processing of personal data.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-1", "title": "Article 1 - Subject-matter and objectives", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 32, "page_end": 32, "chunk_index": 0} +{"id": "article-2-chunk-0", "text": "Article 2 - Material scope\n\n1. This Regulation applies to the processing of personal data wholly or partly by automated means and to the\nprocessing other than by automated means of personal data which form part of a filing system or are intended to form\npart of a filing system.\n2. This Regulation does not apply to the processing of personal data:\n(a) in the course of an activity which falls outside the scope of Union law;\n(b) by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU;\n(c) by a natural person in the course of a purely personal or household activity;\n(d) by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal\noffences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to\npublic security.\n3. For the processing of personal data by the Union institutions, bodies, offices and agencies, Regulation (EC)\nNo 45/2001 applies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal\ndata shall be adapted to the principles and rules of this Regulation in accordance with Article 98.\n4. This Regulation shall be without prejudice to the application of Directive 2000/31/EC, in particular of the liability\nrules of intermediary service providers in Articles 12 to 15 of that Directive.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-2", "title": "Article 2 - Material scope", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 32, "page_end": 32, "chunk_index": 0} +{"id": "article-3-chunk-0", "text": "Article 3 - Territorial scope\n\n1. This Regulation applies to the processing of personal data in the context of the activities of an establishment of a\ncontroller or a processor in the Union, regardless of whether the processing takes place in the Union or not.\n2. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or\nprocessor not established in the Union, where the processing activities are related to:\n(a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data\nsubjects in the Union; or\n(b) the monitoring of their behaviour as far as their behaviour takes place within the Union.\n3. This Regulation applies to the processing of personal data by a controller not established in the Union, but in a\nplace where Member State law applies by virtue of public international law.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-3", "title": "Article 3 - Territorial scope", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 32, "page_end": 33, "chunk_index": 0} +{"id": "article-4-chunk-0", "text": "Article 4 - Definitions\n\nFor the purposes of this Regulation:\n(1) ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an\nidentifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an\nidentifier such as a name, an identification number, location data, an online identifier or to one or more factors\nspecific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;\n(2) ‘processing’ means any operation or set of operations which is performed on personal data or on sets of personal\ndata, whether or not by automated means, such as collection, recording, organisation, structuring, storage,\nadaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making\navailable, alignment or combination, restriction, erasure or destruction;\n(3) ‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in\nthe future;\n(4) ‘profiling’ means any form of automated processing of personal data consisting of the use of personal data to\nevaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning\nthat natural person's performance at work, economic situation, health, personal preferences, interests, reliability,\nbehaviour, location or movements;\n(5) ‘pseudonymisation’ means the processing of personal data", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 0} +{"id": "article-4-chunk-1", "text": "person's performance at work, economic situation, health, personal preferences, interests, reliability,\nbehaviour, location or movements;\n(5) ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer\nbe attributed to a specific data subject without the use of additional information, provided that such additional\ninformation is kept separately and is subject to technical and organisational measures to ensure that the personal\ndata are not attributed to an identified or identifiable natural person;\n(6) ‘filing system’ means any structured set of personal data which are accessible according to specific criteria, whether\ncentralised, decentralised or dispersed on a functional or geographical basis;\n(7) ‘controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with\nothers, determines the purposes and means of the processing of personal data; where the purposes and means of\nsuch processing are determined by Union or Member State law, the controller or the specific criteria for its\nnomination may be provided for by Union or Member State law;\n(8) ‘processor’ means a natural or legal person, public authority, agency or other body which processes personal data\non behalf of the controller;\n(9) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are\ndisclosed, whether a third party or not. However, public authorities whic", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 1} +{"id": "article-4-chunk-2", "text": "ler;\n(9) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are\ndisclosed, whether a third party or not. However, public authorities which may receive personal data in the\nframework of a particular inquiry in accordance with Union or Member State law shall not be regarded as\nrecipients; the processing of those data by those public authorities shall be in compliance with the applicable data\nprotection rules according to the purposes of the processing;\n(10) ‘third party’ means a natural or legal person, public authority, agency or body other than the data subject,\ncontroller, processor and persons who, under the direct authority of the controller or processor, are authorised to\nprocess personal data;\n(11) ‘consent’ of the data subject means any freely given, specific, informed and unambiguous indication of the data\nsubject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the\nprocessing of personal data relating to him or her;\n(12) ‘personal data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration,\nunauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed;\n(13) ‘genetic data’ means personal data relating to the inherited or acquired genetic characteristics of a natural person\nwhich give unique information about the physiology or the health of that natural person and which res", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 2} +{"id": "article-4-chunk-3", "text": "ns personal data relating to the inherited or acquired genetic characteristics of a natural person\nwhich give unique information about the physiology or the health of that natural person and which result, in\nparticular, from an analysis of a biological sample from the natural person in question;\n(14) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physio­\nlogical or behavioural characteristics of a natural person, which allow or confirm the unique identification of that\nnatural person, such as facial images or dactyloscopic data;\n(15) ‘data concerning health’ means personal data related to the physical or mental health of a natural person, including\nthe provision of health care services, which reveal information about his or her health status;\n(16) ‘main establishment’ means:\n(a) as regards a controller with establishments in more than one Member State, the place of its central adminis­\ntration in the Union, unless the decisions on the purposes and means of the processing of personal data are\ntaken in another establishment of the controller in the Union and the latter establishment has the power to\nhave such decisions implemented, in which case the establishment having taken such decisions is to be\nconsidered to be the main establishment;\n(b) as regards a processor with establishments in more than one Member State, the place of its central adminis­\ntration in the Union, or, if the processor has no central administrat", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 3} +{"id": "article-4-chunk-4", "text": "ain establishment;\n(b) as regards a processor with establishments in more than one Member State, the place of its central adminis­\ntration in the Union, or, if the processor has no central administration in the Union, the establishment of the\nprocessor in the Union where the main processing activities in the context of the activities of an establishment\nof the processor take place to the extent that the processor is subject to specific obligations under this\nRegulation;\n(17) ‘representative’ means a natural or legal person established in the Union who, designated by the controller or\nprocessor in writing pursuant to Article 27, represents the controller or processor with regard to their respective\nobligations under this Regulation;\n(18) ‘enterprise’ means a natural or legal person engaged in an economic activity, irrespective of its legal form, including\npartnerships or associations regularly engaged in an economic activity;\n(19) ‘group of undertakings’ means a controlling undertaking and its controlled undertakings;\n(20) ‘binding corporate rules’ means personal data protection policies which are adhered to by a controller or processor\nestablished on the territory of a Member State for transfers or a set of transfers of personal data to a controller or\nprocessor in one or more third countries within a group of undertakings, or group of enterprises engaged in a\njoint economic activity;\n(21) ‘supervisory authority’ means an independent public authority which is established by a", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 4} +{"id": "article-4-chunk-5", "text": "ird countries within a group of undertakings, or group of enterprises engaged in a\njoint economic activity;\n(21) ‘supervisory authority’ means an independent public authority which is established by a Member State pursuant to\nArticle 51;\n(22) ‘supervisory authority concerned’ means a supervisory authority which is concerned by the processing of personal\ndata because:\n(a) the controller or processor is established on the territory of the Member State of that supervisory authority;\n(b) data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be\nsubstantially affected by the processing; or\n(c) a complaint has been lodged with that supervisory authority;\n(23) ‘cross-border processing’ means either:\n(a) processing of personal data which takes place in the context of the activities of establishments in more than\none Member State of a controller or processor in the Union where the controller or processor is established in\nmore than one Member State; or\n(b) processing of personal data which takes place in the context of the activities of a single establishment of a\ncontroller or processor in the Union but which substantially affects or is likely to substantially affect data\nsubjects in more than one Member State.\n(24) ‘relevant and reasoned objection’ means an objection to a draft decision as to whether there is an infringement of\nthis Regulation, or whether envisaged action in relation to the controller or processor compli", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 5} +{"id": "article-4-chunk-6", "text": "and reasoned objection’ means an objection to a draft decision as to whether there is an infringement of\nthis Regulation, or whether envisaged action in relation to the controller or processor complies with this\nRegulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the\nfundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the\nUnion;\n(25) ‘information society service’ means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of\nthe European Parliament and of the Council (1);\n(26) ‘international organisation’ means an organisation and its subordinate bodies governed by public international law,\nor any other body which is set up by, or on the basis of, an agreement between two or more countries.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-4", "title": "Article 4 - Definitions", "chapter_number": "I", "chapter_title": "General provisions", "page_start": 33, "page_end": 35, "chunk_index": 6} +{"id": "article-5-chunk-0", "text": "Article 5 - Principles relating to processing of personal data\n\n1. Personal data shall be:\n(a) processed lawfully, fairly and in a transparent manner in relation to the data subject (‘lawfulness, fairness and\ntransparency’);\n(b) collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible\nwith those purposes; further processing for archiving purposes in the public interest, scientific or historical research\npurposes or statistical purposes shall, in accordance with Article 89(1), not be considered to be incompatible with\nthe initial purposes (‘purpose limitation’);\n(c) adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data\nminimisation’);\n(d) accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that\nare inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay\n(‘accuracy’);\n(1) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the\nprovision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).\n(e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for\nwhich the personal data are processed; personal data may be stored for longer periods insofar as the personal data\nwill be processed solely for archiving purposes", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Principles relating to processing of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 35, "page_end": 36, "chunk_index": 0} +{"id": "article-5-chunk-1", "text": "an is necessary for the purposes for\nwhich the personal data are processed; personal data may be stored for longer periods insofar as the personal data\nwill be processed solely for archiving purposes in the public interest, scientific or historical research purposes or\nstatistical purposes in accordance with Article 89(1) subject to implementation of the appropriate technical and\norganisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject\n(‘storage limitation’);\n(f) processed in a manner that ensures appropriate security of the personal data, including protection against\nunauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical\nor organisational measures (‘integrity and confidentiality’).\n2. The controller shall be responsible for, and be able to demonstrate compliance with, paragraph 1 (‘accountability’).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-5", "title": "Article 5 - Principles relating to processing of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 35, "page_end": 36, "chunk_index": 1} +{"id": "article-6-chunk-0", "text": "Article 6 - Lawfulness of processing\n\n1. Processing shall be lawful only if and to the extent that at least one of the following applies:\n(a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes;\n(b) processing is necessary for the performance of a contract to which the data subject is party or in order to take steps\nat the request of the data subject prior to entering into a contract;\n(c) processing is necessary for compliance with a legal obligation to which the controller is subject;\n(d) processing is necessary in order to protect the vital interests of the data subject or of another natural person;\n(e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official\nauthority vested in the controller;\n(f) processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party,\nexcept where such interests are overridden by the interests or fundamental rights and freedoms of the data subject\nwhich require protection of personal data, in particular where the data subject is a child.\nPoint (f) of the first subparagraph shall not apply to processing carried out by public authorities in the performance of\ntheir tasks.\n2. Member States may maintain or introduce more specific provisions to adapt the application of the rules of this\nRegulation with regard to processing for compliance with points (c) and (e) of paragraph 1 by determining more\nprecisely spe", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Lawfulness of processing", "chapter_number": "II", "chapter_title": "Principles", "page_start": 36, "page_end": 37, "chunk_index": 0} +{"id": "article-6-chunk-1", "text": "duce more specific provisions to adapt the application of the rules of this\nRegulation with regard to processing for compliance with points (c) and (e) of paragraph 1 by determining more\nprecisely specific requirements for the processing and other measures to ensure lawful and fair processing including for\nother specific processing situations as provided for in Chapter IX.\n3. The basis for the processing referred to in point (c) and (e) of paragraph 1 shall be laid down by:\n(a) Union law; or\n(b) Member State law to which the controller is subject.\nThe purpose of the processing shall be determined in that legal basis or, as regards the processing referred to in point (e)\nof paragraph 1, shall be necessary for the performance of a task carried out in the public interest or in the exercise of\nofficial authority vested in the controller. That legal basis may contain specific provisions to adapt the application of\nrules of this Regulation, inter alia: the general conditions governing the lawfulness of processing by the controller; the\ntypes of data which are subject to the processing; the data subjects concerned; the entities to, and the purposes for\nwhich, the personal data may be disclosed; the purpose limitation; storage periods; and processing operations and\nprocessing procedures, including measures to ensure lawful and fair processing such as those for other specific\nprocessing situations as provided for in Chapter IX. The Union or the Member State law shall meet an objecti", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Lawfulness of processing", "chapter_number": "II", "chapter_title": "Principles", "page_start": 36, "page_end": 37, "chunk_index": 1} +{"id": "article-6-chunk-2", "text": "s, including measures to ensure lawful and fair processing such as those for other specific\nprocessing situations as provided for in Chapter IX. The Union or the Member State law shall meet an objective of\npublic interest and be proportionate to the legitimate aim pursued.\n4. Where the processing for a purpose other than that for which the personal data have been collected is not based\non the data subject's consent or on a Union or Member State law which constitutes a necessary and proportionate\nmeasure in a democratic society to safeguard the objectives referred to in Article 23(1), the controller shall, in order to\nascertain whether processing for another purpose is compatible with the purpose for which the personal data are\ninitially collected, take into account, inter alia:\n(a) any link between the purposes for which the personal data have been collected and the purposes of the intended\nfurther processing;\n(b) the context in which the personal data have been collected, in particular regarding the relationship between data\nsubjects and the controller;\n(c) the nature of the personal data, in particular whether special categories of personal data are processed, pursuant to\nArticle 9, or whether personal data related to criminal convictions and offences are processed, pursuant to Article\n10;\n(d) the possible consequences of the intended further processing for data subjects;\n(e) the existence of appropriate safeguards, which may include encryption or pseudonymisation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Lawfulness of processing", "chapter_number": "II", "chapter_title": "Principles", "page_start": 36, "page_end": 37, "chunk_index": 2} +{"id": "article-6-chunk-3", "text": "to Article\n10;\n(d) the possible consequences of the intended further processing for data subjects;\n(e) the existence of appropriate safeguards, which may include encryption or pseudonymisation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-6", "title": "Article 6 - Lawfulness of processing", "chapter_number": "II", "chapter_title": "Principles", "page_start": 36, "page_end": 37, "chunk_index": 3} +{"id": "article-7-chunk-0", "text": "Article 7 - Conditions for consent\n\n1. Where processing is based on consent, the controller shall be able to demonstrate that the data subject has\nconsented to processing of his or her personal data.\n2. If the data subject's consent is given in the context of a written declaration which also concerns other matters, the\nrequest for consent shall be presented in a manner which is clearly distinguishable from the other matters, in an\nintelligible and easily accessible form, using clear and plain language. Any part of such a declaration which constitutes\nan infringement of this Regulation shall not be binding.\n3. The data subject shall have the right to withdraw his or her consent at any time. The withdrawal of consent shall\nnot affect the lawfulness of processing based on consent before its withdrawal. Prior to giving consent, the data subject\nshall be informed thereof. It shall be as easy to withdraw as to give consent.\n4. When assessing whether consent is freely given, utmost account shall be taken of whether, inter alia, the\nperformance of a contract, including the provision of a service, is conditional on consent to the processing of personal\ndata that is not necessary for the performance of that contract.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-7", "title": "Article 7 - Conditions for consent", "chapter_number": "II", "chapter_title": "Principles", "page_start": 37, "page_end": 37, "chunk_index": 0} +{"id": "article-8-chunk-0", "text": "Article 8 - Conditions applicable to child's consent in relation to information society services\n\n1. Where point (a) of Article 6(1) applies, in relation to the offer of information society services directly to a child,\nthe processing of the personal data of a child shall be lawful where the child is at least 16 years old. Where the child is\nbelow the age of 16 years, such processing shall be lawful only if and to the extent that consent is given or authorised\nby the holder of parental responsibility over the child.\nMember States may provide by law for a lower age for those purposes provided that such lower age is not below 13\nyears.\n2. The controller shall make reasonable efforts to verify in such cases that consent is given or authorised by the\nholder of parental responsibility over the child, taking into consideration available technology.\n3. Paragraph 1 shall not affect the general contract law of Member States such as the rules on the validity, formation\nor effect of a contract in relation to a child.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-8", "title": "Article 8 - Conditions applicable to child's consent in relation to information society services", "chapter_number": "II", "chapter_title": "Principles", "page_start": 37, "page_end": 38, "chunk_index": 0} +{"id": "article-9-chunk-0", "text": "Article 9 - Processing of special categories of personal data\n\n1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or\ntrade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a\nnatural person, data concerning health or data concerning a natural person's sex life or sexual orientation shall be\nprohibited.\n2. Paragraph 1 shall not apply if one of the following applies:\n(a) the data subject has given explicit consent to the processing of those personal data for one or more specified\npurposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not\nbe lifted by the data subject;\n(b) processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the\ncontroller or of the data subject in the field of employment and social security and social protection law in so far as\nit is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for\nappropriate safeguards for the fundamental rights and the interests of the data subject;\n(c) processing is necessary to protect the vital interests of the data subject or of another natural person where the data\nsubject is physically or legally incapable of giving consent;\n(d) processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation,\nassociation or any other not-for-profit body with a politica", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Processing of special categories of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 38, "page_end": 39, "chunk_index": 0} +{"id": "article-9-chunk-1", "text": "e of giving consent;\n(d) processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation,\nassociation or any other not-for-profit body with a political, philosophical, religious or trade union aim and on\ncondition that the processing relates solely to the members or to former members of the body or to persons who\nhave regular contact with it in connection with its purposes and that the personal data are not disclosed outside that\nbody without the consent of the data subjects;\n(e) processing relates to personal data which are manifestly made public by the data subject;\n(f) processing is necessary for the establishment, exercise or defence of legal claims or whenever courts are acting in\ntheir judicial capacity;\n(g) processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law which\nshall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for\nsuitable and specific measures to safeguard the fundamental rights and the interests of the data subject;\n(h) processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working\ncapacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management\nof health or social care systems and services on the basis of Union or Member State law or pursuant to contract\nwith a health professional and subject to t", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Processing of special categories of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 38, "page_end": 39, "chunk_index": 1} +{"id": "article-9-chunk-2", "text": "r social care or treatment or the management\nof health or social care systems and services on the basis of Union or Member State law or pursuant to contract\nwith a health professional and subject to the conditions and safeguards referred to in paragraph 3;\n(i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious\ncross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal\nproducts or medical devices, on the basis of Union or Member State law which provides for suitable and specific\nmeasures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;\n(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or\nstatistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be propor­\ntionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific\nmeasures to safeguard the fundamental rights and the interests of the data subject.\n3. Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2\nwhen those data are processed by or under the responsibility of a professional subject to the obligation of professional\nsecrecy under Union or Member State law or rules established by national competent bodies or by another person also", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Processing of special categories of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 38, "page_end": 39, "chunk_index": 2} +{"id": "article-9-chunk-3", "text": "nder the responsibility of a professional subject to the obligation of professional\nsecrecy under Union or Member State law or rules established by national competent bodies or by another person also\nsubject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies.\n4. Member States may maintain or introduce further conditions, including limitations, with regard to the processing\nof genetic data, biometric data or data concerning health.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-9", "title": "Article 9 - Processing of special categories of personal data", "chapter_number": "II", "chapter_title": "Principles", "page_start": 38, "page_end": 39, "chunk_index": 3} +{"id": "article-10-chunk-0", "text": "Article 10 - Processing of personal data relating to criminal convictions and offences\n\nProcessing of personal data relating to criminal convictions and offences or related security measures based on\nArticle 6(1) shall be carried out only under the control of official authority or when the processing is authorised by\nUnion or Member State law providing for appropriate safeguards for the rights and freedoms of data subjects. Any\ncomprehensive register of criminal convictions shall be kept only under the control of official authority.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-10", "title": "Article 10 - Processing of personal data relating to criminal convictions and offences", "chapter_number": "II", "chapter_title": "Principles", "page_start": 39, "page_end": 39, "chunk_index": 0} +{"id": "article-11-chunk-0", "text": "Article 11 - Processing which does not require identification\n\n1. If the purposes for which a controller processes personal data do not or do no longer require the identification of\na data subject by the controller, the controller shall not be obliged to maintain, acquire or process additional\ninformation in order to identify the data subject for the sole purpose of complying with this Regulation.\n2. Where, in cases referred to in paragraph 1 of this Article, the controller is able to demonstrate that it is not in a\nposition to identify the data subject, the controller shall inform the data subject accordingly, if possible. In such cases,\nArticles 15 to 20 shall not apply except where the data subject, for the purpose of exercising his or her rights under\nthose articles, provides additional information enabling his or her identification.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-11", "title": "Article 11 - Processing which does not require identification", "chapter_number": "II", "chapter_title": "Principles", "page_start": 39, "page_end": 39, "chunk_index": 0} +{"id": "article-12-chunk-0", "text": "Article 12 - Transparent information, communication and modalities for the exercise of the rights of the data\n\nsubject\n1. The controller shall take appropriate measures to provide any information referred to in Articles 13 and 14 and\nany communication under Articles 15 to 22 and 34 relating to processing to the data subject in a concise, transparent,\nintelligible and easily accessible form, using clear and plain language, in particular for any information addressed\nspecifically to a child. The information shall be provided in writing, or by other means, including, where appropriate, by\nelectronic means. When requested by the data subject, the information may be provided orally, provided that the\nidentity of the data subject is proven by other means.\n2. The controller shall facilitate the exercise of data subject rights under Articles 15 to 22. In the cases referred to in\nArticle 11(2), the controller shall not refuse to act on the request of the data subject for exercising his or her rights\nunder Articles 15 to 22, unless the controller demonstrates that it is not in a position to identify the data subject.\n3. The controller shall provide information on action taken on a request under Articles 15 to 22 to the data subject\nwithout undue delay and in any event within one month of receipt of the request. That period may be extended by two\nfurther months where necessary, taking into account the complexity and number of the requests. The controller shall\ninform the data subject of any such extension within one month of receipt of the request, together with the reasons for\nthe delay. Where", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-12", "title": "Article 12 - Transparent information, communication and modalities for the exercise of the rights of the data", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 39, "page_end": 40, "chunk_index": 0} +{"id": "article-12-chunk-1", "text": "he complexity and number of the requests. The controller shall\ninform the data subject of any such extension within one month of receipt of the request, together with the reasons for\nthe delay. Where the data subject makes the request by electronic form means, the information shall be provided by\nelectronic means where possible, unless otherwise requested by the data subject.\n4. If the controller does not take action on the request of the data subject, the controller shall inform the data subject\nwithout delay and at the latest within one month of receipt of the request of the reasons for not taking action and on\nthe possibility of lodging a complaint with a supervisory authority and seeking a judicial remedy.\n5. Information provided under Articles 13 and 14 and any communication and any actions taken under Articles 15\nto 22 and 34 shall be provided free of charge. Where requests from a data subject are manifestly unfounded or\nexcessive, in particular because of their repetitive character, the controller may either:\n(a) charge a reasonable fee taking into account the administrative costs of providing the information or communication\nor taking the action requested; or\n(b) refuse to act on the request.\nThe controller shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request.\n6. Without prejudice to Article 11, where the controller has reasonable doubts concerning the identity of the natural\nperson making the request referred to in A", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-12", "title": "Article 12 - Transparent information, communication and modalities for the exercise of the rights of the data", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 39, "page_end": 40, "chunk_index": 1} +{"id": "article-12-chunk-2", "text": "or excessive character of the request.\n6. Without prejudice to Article 11, where the controller has reasonable doubts concerning the identity of the natural\nperson making the request referred to in Articles 15 to 21, the controller may request the provision of additional\ninformation necessary to confirm the identity of the data subject.\n7. The information to be provided to data subjects pursuant to Articles 13 and 14 may be provided in combination\nwith standardised icons in order to give in an easily visible, intelligible and clearly legible manner a meaningful overview\nof the intended processing. Where the icons are presented electronically they shall be machine-readable.\n8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of\ndetermining the information to be presented by the icons and the procedures for providing standardised icons.\nSection 2\nInfor mation and access to personal data", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-12", "title": "Article 12 - Transparent information, communication and modalities for the exercise of the rights of the data", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 39, "page_end": 40, "chunk_index": 2} +{"id": "article-13-chunk-0", "text": "Article 13 - Information to be provided where personal data are collected from the data subject\n\n1. Where personal data relating to a data subject are collected from the data subject, the controller shall, at the time\nwhen personal data are obtained, provide the data subject with all of the following information:\n(a) the identity and the contact details of the controller and, where applicable, of the controller's representative;\n(b) the contact details of the data protection officer, where applicable;\n(c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing;\n(d) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a\nthird party;\n(e) the recipients or categories of recipients of the personal data, if any;\n(f) where applicable, the fact that the controller intends to transfer personal data to a third country or international\norganisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers\nreferred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable\nsafeguards and the means by which to obtain a copy of them or where they have been made available.\n2. In addition to the information referred to in paragraph 1, the controller shall, at the time when personal data are\nobtained, provide the data subject with the following further information necessary to ensure fair and transparent\nprocessing:\n(a) the period for which the personal data will b", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Information to be provided where personal data are collected from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 40, "page_end": 41, "chunk_index": 0} +{"id": "article-13-chunk-1", "text": "when personal data are\nobtained, provide the data subject with the following further information necessary to ensure fair and transparent\nprocessing:\n(a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that\nperiod;\n(b) the existence of the right to request from the controller access to and rectification or erasure of personal data or\nrestriction of processing concerning the data subject or to object to processing as well as the right to data\nportability;\n(c) where the processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to\nwithdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal;\n(d) the right to lodge a complaint with a supervisory authority;\n(e) whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter\ninto a contract, as well as whether the data subject is obliged to provide the personal data and of the possible\nconsequences of failure to provide such data;\n(f) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in\nthose cases, meaningful information about the logic involved, as well as the significance and the envisaged\nconsequences of such processing for the data subject.\n3. Where the controller intends to further process the personal data for a purpose other than that", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Information to be provided where personal data are collected from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 40, "page_end": 41, "chunk_index": 1} +{"id": "article-13-chunk-2", "text": ", as well as the significance and the envisaged\nconsequences of such processing for the data subject.\n3. Where the controller intends to further process the personal data for a purpose other than that for which the\npersonal data were collected, the controller shall provide the data subject prior to that further processing with\ninformation on that other purpose and with any relevant further information as referred to in paragraph 2.\n4. Paragraphs 1, 2 and 3 shall not apply where and insofar as the data subject already has the information.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-13", "title": "Article 13 - Information to be provided where personal data are collected from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 40, "page_end": 41, "chunk_index": 2} +{"id": "article-14-chunk-0", "text": "Article 14 - Information to be provided where personal data have not been obtained from the data subject\n\n1. Where personal data have not been obtained from the data subject, the controller shall provide the data subject\nwith the following information:\n(a) the identity and the contact details of the controller and, where applicable, of the controller's representative;\n(b) the contact details of the data protection officer, where applicable;\n(c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing;\n(d) the categories of personal data concerned;\n(e) the recipients or categories of recipients of the personal data, if any;\n(f) where applicable, that the controller intends to transfer personal data to a recipient in a third country or internat­\nional organisation and the existence or absence of an adequacy decision by the Commission, or in the case of\ntransfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or\nsuitable safeguards and the means to obtain a copy of them or where they have been made available.\n2. In addition to the information referred to in paragraph 1, the controller shall provide the data subject with the\nfollowing information necessary to ensure fair and transparent processing in respect of the data subject:\n(a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that\nperiod;\n(b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by th", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Information to be provided where personal data have not been obtained from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 41, "page_end": 42, "chunk_index": 0} +{"id": "article-14-chunk-1", "text": "nal data will be stored, or if that is not possible, the criteria used to determine that\nperiod;\n(b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a\nthird party;\n(c) the existence of the right to request from the controller access to and rectification or erasure of personal data or\nrestriction of processing concerning the data subject and to object to processing as well as the right to data\nportability;\n(d) where processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to\nwithdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal;\n(e) the right to lodge a complaint with a supervisory authority;\n(f) from which source the personal data originate, and if applicable, whether it came from publicly accessible sources;\n(g) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in\nthose cases, meaningful information about the logic involved, as well as the significance and the envisaged\nconsequences of such processing for the data subject.\n3. The controller shall provide the information referred to in paragraphs 1 and 2:\n(a) within a reasonable period after obtaining the personal data, but at the latest within one month, having regard to\nthe specific circumstances in which the personal data are processed;\n(b) if the personal data are to be us", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Information to be provided where personal data have not been obtained from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 41, "page_end": 42, "chunk_index": 1} +{"id": "article-14-chunk-2", "text": "riod after obtaining the personal data, but at the latest within one month, having regard to\nthe specific circumstances in which the personal data are processed;\n(b) if the personal data are to be used for communication with the data subject, at the latest at the time of the first\ncommunication to that data subject; or\n(c) if a disclosure to another recipient is envisaged, at the latest when the personal data are first disclosed.\n4. Where the controller intends to further process the personal data for a purpose other than that for which the\npersonal data were obtained, the controller shall provide the data subject prior to that further processing with\ninformation on that other purpose and with any relevant further information as referred to in paragraph 2.\n5. Paragraphs 1 to 4 shall not apply where and insofar as:\n(a) the data subject already has the information;\n(b) the provision of such information proves impossible or would involve a disproportionate effort, in particular for\nprocessing for archiving purposes in the public interest, scientific or historical research purposes or statistical\npurposes, subject to the conditions and safeguards referred to in Article 89(1) or in so far as the obligation referred\nto in paragraph 1 of this Article is likely to render impossible or seriously impair the achievement of the objectives\nof that processing. In such cases the controller shall take appropriate measures to protect the data subject's rights\nand freedoms and legitimate i", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Information to be provided where personal data have not been obtained from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 41, "page_end": 42, "chunk_index": 2} +{"id": "article-14-chunk-3", "text": "r seriously impair the achievement of the objectives\nof that processing. In such cases the controller shall take appropriate measures to protect the data subject's rights\nand freedoms and legitimate interests, including making the information publicly available;\n(c) obtaining or disclosure is expressly laid down by Union or Member State law to which the controller is subject and\nwhich provides appropriate measures to protect the data subject's legitimate interests; or\n(d) where the personal data must remain confidential subject to an obligation of professional secrecy regulated by Union\nor Member State law, including a statutory obligation of secrecy.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-14", "title": "Article 14 - Information to be provided where personal data have not been obtained from the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 41, "page_end": 42, "chunk_index": 3} +{"id": "article-15-chunk-0", "text": "Article 15 - Right of access by the data subject\n\n1. The data subject shall have the right to obtain from the controller confirmation as to whether or not personal data\nconcerning him or her are being processed, and, where that is the case, access to the personal data and the following\ninformation:\n(a) the purposes of the processing;\n(b) the categories of personal data concerned;\n(c) the recipients or categories of recipient to whom the personal data have been or will be disclosed, in particular\nrecipients in third countries or international organisations;\n(d) where possible, the envisaged period for which the personal data will be stored, or, if not possible, the criteria used\nto determine that period;\n(e) the existence of the right to request from the controller rectification or erasure of personal data or restriction of\nprocessing of personal data concerning the data subject or to object to such processing;\n(f) the right to lodge a complaint with a supervisory authority;\n(g) where the personal data are not collected from the data subject, any available information as to their source;\n(h) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in\nthose cases, meaningful information about the logic involved, as well as the significance and the envisaged\nconsequences of such processing for the data subject.\n2. Where personal data are transferred to a third country or to an international organisation, the data subject shall\nhave the right to be informed of th", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-15", "title": "Article 15 - Right of access by the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 43, "page_end": 43, "chunk_index": 0} +{"id": "article-15-chunk-1", "text": "ences of such processing for the data subject.\n2. Where personal data are transferred to a third country or to an international organisation, the data subject shall\nhave the right to be informed of the appropriate safeguards pursuant to Article 46 relating to the transfer.\n3. The controller shall provide a copy of the personal data undergoing processing. For any further copies requested\nby the data subject, the controller may charge a reasonable fee based on administrative costs. Where the data subject\nmakes the request by electronic means, and unless otherwise requested by the data subject, the information shall be\nprovided in a commonly used electronic form.\n4. The right to obtain a copy referred to in paragraph 3 shall not adversely affect the rights and freedoms of others.\nSection 3\nRectif ication and erasure", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-15", "title": "Article 15 - Right of access by the data subject", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 43, "page_end": 43, "chunk_index": 1} +{"id": "article-16-chunk-0", "text": "Article 16 - Right to rectification\n\nThe data subject shall have the right to obtain from the controller without undue delay the rectification of inaccurate\npersonal data concerning him or her. Taking into account the purposes of the processing, the data subject shall have the\nright to have incomplete personal data completed, including by means of providing a supplementary statement.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-16", "title": "Article 16 - Right to rectification", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 43, "page_end": 43, "chunk_index": 0} +{"id": "article-17-chunk-0", "text": "Article 17 - Right to erasure (‘right to be forgotten’)\n\n1. The data subject shall have the right to obtain from the controller the erasure of personal data concerning him or\nher without undue delay and the controller shall have the obligation to erase personal data without undue delay where\none of the following grounds applies:\n(a) the personal data are no longer necessary in relation to the purposes for which they were collected or otherwise\nprocessed;\n(b) the data subject withdraws consent on which the processing is based according to point (a) of Article 6(1), or\npoint (a) of Article 9(2), and where there is no other legal ground for the processing;\n(c) the data subject objects to the processing pursuant to Article 21(1) and there are no overriding legitimate grounds\nfor the processing, or the data subject objects to the processing pursuant to Article 21(2);\n(d) the personal data have been unlawfully processed;\n(e) the personal data have to be erased for compliance with a legal obligation in Union or Member State law to which\nthe controller is subject;\n(f) the personal data have been collected in relation to the offer of information society services referred to in\nArticle 8(1).\n2. Where the controller has made the personal data public and is obliged pursuant to paragraph 1 to erase the\npersonal data, the controller, taking account of available technology and the cost of implementation, shall take\nreasonable steps, including technical measures, to inform controllers which are processing the personal data that the\ndata subj", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-17", "title": "Article 17 - Right to erasure (‘right to be forgotten’)", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 43, "page_end": 44, "chunk_index": 0} +{"id": "article-17-chunk-1", "text": "count of available technology and the cost of implementation, shall take\nreasonable steps, including technical measures, to inform controllers which are processing the personal data that the\ndata subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data.\n3. Paragraphs 1 and 2 shall not apply to the extent that processing is necessary:\n(a) for exercising the right of freedom of expression and information;\n(b) for compliance with a legal obligation which requires processing by Union or Member State law to which the\ncontroller is subject or for the performance of a task carried out in the public interest or in the exercise of official\nauthority vested in the controller;\n(c) for reasons of public interest in the area of public health in accordance with points (h) and (i) of Article 9(2) as well\nas Article 9(3);\n(d) for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in\naccordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or\nseriously impair the achievement of the objectives of that processing; or\n(e) for the establishment, exercise or defence of legal claims.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-17", "title": "Article 17 - Right to erasure (‘right to be forgotten’)", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 43, "page_end": 44, "chunk_index": 1} +{"id": "article-18-chunk-0", "text": "Article 18 - Right to restriction of processing\n\n1. The data subject shall have the right to obtain from the controller restriction of processing where one of the\nfollowing applies:\n(a) the accuracy of the personal data is contested by the data subject, for a period enabling the controller to verify the\naccuracy of the personal data;\n(b) the processing is unlawful and the data subject opposes the erasure of the personal data and requests the restriction\nof their use instead;\n(c) the controller no longer needs the personal data for the purposes of the processing, but they are required by the\ndata subject for the establishment, exercise or defence of legal claims;\n(d) the data subject has objected to processing pursuant to Article 21(1) pending the verification whether the legitimate\ngrounds of the controller override those of the data subject.\n2. Where processing has been restricted under paragraph 1, such personal data shall, with the exception of storage,\nonly be processed with the data subject's consent or for the establishment, exercise or defence of legal claims or for the\nprotection of the rights of another natural or legal person or for reasons of important public interest of the Union or of\na Member State.\n3. A data subject who has obtained restriction of processing pursuant to paragraph 1 shall be informed by the\ncontroller before the restriction of processing is lifted.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-18", "title": "Article 18 - Right to restriction of processing", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 44, "page_end": 45, "chunk_index": 0} +{"id": "article-19-chunk-0", "text": "Article 19 - Notification obligation regarding rectification or erasure of personal data or restriction of\n\nprocessing\nThe controller shall communicate any rectification or erasure of personal data or restriction of processing carried out in\naccordance with Article 16, Article 17(1) and Article 18 to each recipient to whom the personal data have been\ndisclosed, unless this proves impossible or involves disproportionate effort. The controller shall inform the data subject\nabout those recipients if the data subject requests it.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-19", "title": "Article 19 - Notification obligation regarding rectification or erasure of personal data or restriction of", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 45, "page_end": 45, "chunk_index": 0} +{"id": "article-20-chunk-0", "text": "Article 20 - Right to data portability\n\n1. The data subject shall have the right to receive the personal data concerning him or her, which he or she has\nprovided to a controller, in a structured, commonly used and machine-readable format and have the right to transmit\nthose data to another controller without hindrance from the controller to which the personal data have been provided,\nwhere:\n(a) the processing is based on consent pursuant to point (a) of Article 6(1) or point (a) of Article 9(2) or on a contract\npursuant to point (b) of Article 6(1); and\n(b) the processing is carried out by automated means.\n2. In exercising his or her right to data portability pursuant to paragraph 1, the data subject shall have the right to\nhave the personal data transmitted directly from one controller to another, where technically feasible.\n3. The exercise of the right referred to in paragraph 1 of this Article shall be without prejudice to Article 17. That\nright shall not apply to processing necessary for the performance of a task carried out in the public interest or in the\nexercise of official authority vested in the controller.\n4. The right referred to in paragraph 1 shall not adversely affect the rights and freedoms of others.\nSection 4\nRight to object and automated individual decision-making", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-20", "title": "Article 20 - Right to data portability", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 45, "page_end": 45, "chunk_index": 0} +{"id": "article-21-chunk-0", "text": "Article 21 - Right to object\n\n1. The data subject shall have the right to object, on grounds relating to his or her particular situation, at any time to\nprocessing of personal data concerning him or her which is based on point (e) or (f) of Article 6(1), including profiling\nbased on those provisions. The controller shall no longer process the personal data unless the controller demonstrates\ncompelling legitimate grounds for the processing which override the interests, rights and freedoms of the data subject or\nfor the establishment, exercise or defence of legal claims.\n2. Where personal data are processed for direct marketing purposes, the data subject shall have the right to object at\nany time to processing of personal data concerning him or her for such marketing, which includes profiling to the\nextent that it is related to such direct marketing.\n3. Where the data subject objects to processing for direct marketing purposes, the personal data shall no longer be\nprocessed for such purposes.\n4. At the latest at the time of the first communication with the data subject, the right referred to in paragraphs 1 and\n2 shall be explicitly brought to the attention of the data subject and shall be presented clearly and separately from any\nother information.\n5. In the context of the use of information society services, and notwithstanding Directive 2002/58/EC, the data\nsubject may exercise his or her right to object by automated means using technical specifications.\n6. Where personal data are processed for scientifi", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-21", "title": "Article 21 - Right to object", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 45, "page_end": 46, "chunk_index": 0} +{"id": "article-21-chunk-1", "text": "and notwithstanding Directive 2002/58/EC, the data\nsubject may exercise his or her right to object by automated means using technical specifications.\n6. Where personal data are processed for scientific or historical research purposes or statistical purposes pursuant to\nArticle 89(1), the data subject, on grounds relating to his or her particular situation, shall have the right to object to\nprocessing of personal data concerning him or her, unless the processing is necessary for the performance of a task\ncarried out for reasons of public interest.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-21", "title": "Article 21 - Right to object", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 45, "page_end": 46, "chunk_index": 1} +{"id": "article-22-chunk-0", "text": "Article 22 - Automated individual decision-making, including profiling\n\n1. The data subject shall have the right not to be subject to a decision based solely on automated processing,\nincluding profiling, which produces legal effects concerning him or her or similarly significantly affects him or her.\n2. Paragraph 1 shall not apply if the decision:\n(a) is necessary for entering into, or performance of, a contract between the data subject and a data controller;\n(b) is authorised by Union or Member State law to which the controller is subject and which also lays down suitable\nmeasures to safeguard the data subject's rights and freedoms and legitimate interests; or\n(c) is based on the data subject's explicit consent.\n3. In the cases referred to in points (a) and (c) of paragraph 2, the data controller shall implement suitable measures\nto safeguard the data subject's rights and freedoms and legitimate interests, at least the right to obtain human\nintervention on the part of the controller, to express his or her point of view and to contest the decision.\n4. Decisions referred to in paragraph 2 shall not be based on special categories of personal data referred to in\nArticle 9(1), unless point (a) or (g) of Article 9(2) applies and suitable measures to safeguard the data subject's rights and\nfreedoms and legitimate interests are in place.\nSection 5\nRestr ictions", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-22", "title": "Article 22 - Automated individual decision-making, including profiling", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 46, "page_end": 46, "chunk_index": 0} +{"id": "article-23-chunk-0", "text": "Article 23 - Restrictions\n\n1. Union or Member State law to which the data controller or processor is subject may restrict by way of a legislative\nmeasure the scope of the obligations and rights provided for in Articles 12 to 22 and Article 34, as well as Article 5 in\nso far as its provisions correspond to the rights and obligations provided for in Articles 12 to 22, when such a\nrestriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in\na democratic society to safeguard:\n(a) national security;\n(b) defence;\n(c) public security;\n(d) the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties,\nincluding the safeguarding against and the prevention of threats to public security;\n(e) other important objectives of general public interest of the Union or of a Member State, in particular an important\neconomic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a\nmatters, public health and social security;\n(f) the protection of judicial independence and judicial proceedings;\n(g) the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions;\n(h) a monitoring, inspection or regulatory function connected, even occasionally, to the exercise of official authority in\nthe cases referred to in points (a) to (e) and (g);\n(i) the protection of the data subject or the rights and freedoms of others;\n(j) the enf", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-23", "title": "Article 23 - Restrictions", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 46, "page_end": 47, "chunk_index": 0} +{"id": "article-23-chunk-1", "text": "en occasionally, to the exercise of official authority in\nthe cases referred to in points (a) to (e) and (g);\n(i) the protection of the data subject or the rights and freedoms of others;\n(j) the enforcement of civil law claims.\n2. In particular, any legislative measure referred to in paragraph 1 shall contain specific provisions at least, where\nrelevant, as to:\n(a) the purposes of the processing or categories of processing;\n(b) the categories of personal data;\n(c) the scope of the restrictions introduced;\n(d) the safeguards to prevent abuse or unlawful access or transfer;\n(e) the specification of the controller or categories of controllers;\n(f) the storage periods and the applicable safeguards taking into account the nature, scope and purposes of the\nprocessing or categories of processing;\n(g) the risks to the rights and freedoms of data subjects; and\n(h) the right of data subjects to be informed about the restriction, unless that may be prejudicial to the purpose of the\nrestriction.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-23", "title": "Article 23 - Restrictions", "chapter_number": "III", "chapter_title": "Rights of the data subject", "page_start": 46, "page_end": 47, "chunk_index": 1} +{"id": "article-24-chunk-0", "text": "Article 24 - Responsibility of the controller\n\n1. Taking into account the nature, scope, context and purposes of processing as well as the risks of varying likelihood\nand severity for the rights and freedoms of natural persons, the controller shall implement appropriate technical and\norganisational measures to ensure and to be able to demonstrate that processing is performed in accordance with this\nRegulation. Those measures shall be reviewed and updated where necessary.\n2. Where proportionate in relation to processing activities, the measures referred to in paragraph 1 shall include the\nimplementation of appropriate data protection policies by the controller.\n3. Adherence to approved codes of conduct as referred to in Article 40 or approved certification mechanisms as\nreferred to in Article 42 may be used as an element by which to demonstrate compliance with the obligations of the\ncontroller.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-24", "title": "Article 24 - Responsibility of the controller", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 47, "page_end": 47, "chunk_index": 0} +{"id": "article-25-chunk-0", "text": "Article 25 - Data protection by design and by default\n\n1. Taking into account the state of the art, the cost of implementation and the nature, scope, context and purposes of\nprocessing as well as the risks of varying likelihood and severity for rights and freedoms of natural persons posed by the\nprocessing, the controller shall, both at the time of the determination of the means for processing and at the time of the\nprocessing itself, implement appropriate technical and organisational measures, such as pseudonymisation, which are\ndesigned to implement data-protection principles, such as data minimisation, in an effective manner and to integrate the\nnecessary safeguards into the processing in order to meet the requirements of this Regulation and protect the rights of\ndata subjects.\n2. The controller shall implement appropriate technical and organisational measures for ensuring that, by default,\nonly personal data which are necessary for each specific purpose of the processing are processed. That obligation applies\nto the amount of personal data collected, the extent of their processing, the period of their storage and their accessibility.\nIn particular, such measures shall ensure that by default personal data are not made accessible without the individual's\nintervention to an indefinite number of natural persons.\n3. An approved certification mechanism pursuant to Article 42 may be used as an element to demonstrate\ncompliance with the requirements set out in paragraphs 1 and 2 of this Article.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-25", "title": "Article 25 - Data protection by design and by default", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 48, "page_end": 48, "chunk_index": 0} +{"id": "article-26-chunk-0", "text": "Article 26 - Joint controllers\n\n1. Where two or more controllers jointly determine the purposes and means of processing, they shall be joint\ncontrollers. They shall in a transparent manner determine their respective responsibilities for compliance with the\nobligations under this Regulation, in particular as regards the exercising of the rights of the data subject and their\nrespective duties to provide the information referred to in Articles 13 and 14, by means of an arrangement between\nthem unless, and in so far as, the respective responsibilities of the controllers are determined by Union or Member State\nlaw to which the controllers are subject. The arrangement may designate a contact point for data subjects.\n2. The arrangement referred to in paragraph 1 shall duly reflect the respective roles and relationships of the joint\ncontrollers vis-à-vis the data subjects. The essence of the arrangement shall be made available to the data subject.\n3. Irrespective of the terms of the arrangement referred to in paragraph 1, the data subject may exercise his or her\nrights under this Regulation in respect of and against each of the controllers.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-26", "title": "Article 26 - Joint controllers", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 48, "page_end": 48, "chunk_index": 0} +{"id": "article-27-chunk-0", "text": "Article 27 - Representatives of controllers or processors not established in the Union\n\n1. Where Article 3(2) applies, the controller or the processor shall designate in writing a representative in the Union.\n2. The obligation laid down in paragraph 1 of this Article shall not apply to:\n(a) processing which is occasional, does not include, on a large scale, processing of special categories of data as referred\nto in Article 9(1) or processing of personal data relating to criminal convictions and offences referred to in Article\n10, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature,\ncontext, scope and purposes of the processing; or\n(b) a public authority or body.\n3. The representative shall be established in one of the Member States where the data subjects, whose personal data\nare processed in relation to the offering of goods or services to them, or whose behaviour is monitored, are.\n4. The representative shall be mandated by the controller or processor to be addressed in addition to or instead of\nthe controller or the processor by, in particular, supervisory authorities and data subjects, on all issues related to\nprocessing, for the purposes of ensuring compliance with this Regulation.\n5. The designation of a representative by the controller or processor shall be without prejudice to legal actions which\ncould be initiated against the controller or the processor themselves.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-27", "title": "Article 27 - Representatives of controllers or processors not established in the Union", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 48, "page_end": 49, "chunk_index": 0} +{"id": "article-28-chunk-0", "text": "Article 28 - Processor\n\n1. Where processing is to be carried out on behalf of a controller, the controller shall use only processors providing\nsufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing\nwill meet the requirements of this Regulation and ensure the protection of the rights of the data subject.\n2. The processor shall not engage another processor without prior specific or general written authorisation of the\ncontroller. In the case of general written authorisation, the processor shall inform the controller of any intended changes\nconcerning the addition or replacement of other processors, thereby giving the controller the opportunity to object to\nsuch changes.\n3. Processing by a processor shall be governed by a contract or other legal act under Union or Member State law,\nthat is binding on the processor with regard to the controller and that sets out the subject-matter and duration of the\nprocessing, the nature and purpose of the processing, the type of personal data and categories of data subjects and the\nobligations and rights of the controller. That contract or other legal act shall stipulate, in particular, that the processor:\n(a) processes the personal data only on documented instructions from the controller, including with regard to transfers\nof personal data to a third country or an international organisation, unless required to do so by Union or\nMember State law to which the processor is subject; in such a case, the proc", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 49, "page_end": 50, "chunk_index": 0} +{"id": "article-28-chunk-1", "text": "ard to transfers\nof personal data to a third country or an international organisation, unless required to do so by Union or\nMember State law to which the processor is subject; in such a case, the processor shall inform the controller of that\nlegal requirement before processing, unless that law prohibits such information on important grounds of public\ninterest;\n(b) ensures that persons authorised to process the personal data have committed themselves to confidentiality or are\nunder an appropriate statutory obligation of confidentiality;\n(c) takes all measures required pursuant to Article 32;\n(d) respects the conditions referred to in paragraphs 2 and 4 for engaging another processor;\n(e) taking into account the nature of the processing, assists the controller by appropriate technical and organisational\nmeasures, insofar as this is possible, for the fulfilment of the controller's obligation to respond to requests for\nexercising the data subject's rights laid down in Chapter III;\n(f) assists the controller in ensuring compliance with the obligations pursuant to Articles 32 to 36 taking into account\nthe nature of processing and the information available to the processor;\n(g) at the choice of the controller, deletes or returns all the personal data to the controller after the end of the provision\nof services relating to processing, and deletes existing copies unless Union or Member State law requires storage of\nthe personal data;\n(h) makes available to the controller all in", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 49, "page_end": 50, "chunk_index": 1} +{"id": "article-28-chunk-2", "text": "d of the provision\nof services relating to processing, and deletes existing copies unless Union or Member State law requires storage of\nthe personal data;\n(h) makes available to the controller all information necessary to demonstrate compliance with the obligations laid\ndown in this Article and allow for and contribute to audits, including inspections, conducted by the controller or\nanother auditor mandated by the controller.\nWith regard to point (h) of the first subparagraph, the processor shall immediately inform the controller if, in its\nopinion, an instruction infringes this Regulation or other Union or Member State data protection provisions.\n4. Where a processor engages another processor for carrying out specific processing activities on behalf of the\ncontroller, the same data protection obligations as set out in the contract or other legal act between the controller and\nthe processor as referred to in paragraph 3 shall be imposed on that other processor by way of a contract or other legal\nact under Union or Member State law, in particular providing sufficient guarantees to implement appropriate technical\nand organisational measures in such a manner that the processing will meet the requirements of this Regulation. Where\nthat other processor fails to fulfil its data protection obligations, the initial processor shall remain fully liable to the\ncontroller for the performance of that other processor's obligations.\n5. Adherence of a processor to an approved code of conduc", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 49, "page_end": 50, "chunk_index": 2} +{"id": "article-28-chunk-3", "text": "tion obligations, the initial processor shall remain fully liable to the\ncontroller for the performance of that other processor's obligations.\n5. Adherence of a processor to an approved code of conduct as referred to in Article 40 or an approved certification\nmechanism as referred to in Article 42 may be used as an element by which to demonstrate sufficient guarantees as\nreferred to in paragraphs 1 and 4 of this Article.\n6. Without prejudice to an individual contract between the controller and the processor, the contract or the other\nlegal act referred to in paragraphs 3 and 4 of this Article may be based, in whole or in part, on standard contractual\nclauses referred to in paragraphs 7 and 8 of this Article, including when they are part of a certification granted to the\ncontroller or processor pursuant to Articles 42 and 43.\n7. The Commission may lay down standard contractual clauses for the matters referred to in paragraph 3 and 4 of\nthis Article and in accordance with the examination procedure referred to in Article 93(2).\n8. A supervisory authority may adopt standard contractual clauses for the matters referred to in paragraph 3 and 4\nof this Article and in accordance with the consistency mechanism referred to in Article 63.\n9. The contract or the other legal act referred to in paragraphs 3 and 4 shall be in writing, including in electronic\nform.\n10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes\nand means", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 49, "page_end": 50, "chunk_index": 3} +{"id": "article-28-chunk-4", "text": "n paragraphs 3 and 4 shall be in writing, including in electronic\nform.\n10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes\nand means of processing, the processor shall be considered to be a controller in respect of that processing.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-28", "title": "Article 28 - Processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 49, "page_end": 50, "chunk_index": 4} +{"id": "article-29-chunk-0", "text": "Article 29 - Processing under the authority of the controller or processor\n\nThe processor and any person acting under the authority of the controller or of the processor, who has access to\npersonal data, shall not process those data except on instructions from the controller, unless required to do so by Union\nor Member State law.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-29", "title": "Article 29 - Processing under the authority of the controller or processor", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 50, "page_end": 50, "chunk_index": 0} +{"id": "article-30-chunk-0", "text": "Article 30 - Records of processing activities\n\n1. Each controller and, where applicable, the controller's representative, shall maintain a record of processing\nactivities under its responsibility. That record shall contain all of the following information:\n(a) the name and contact details of the controller and, where applicable, the joint controller, the controller's representa­\ntive and the data protection officer;\n(b) the purposes of the processing;\n(c) a description of the categories of data subjects and of the categories of personal data;\n(d) the categories of recipients to whom the personal data have been or will be disclosed including recipients in third\ncountries or international organisations;\n(e) where applicable, transfers of personal data to a third country or an international organisation, including the identifi­\ncation of that third country or international organisation and, in the case of transfers referred to in the second\nsubparagraph of Article 49(1), the documentation of suitable safeguards;\n(f) where possible, the envisaged time limits for erasure of the different categories of data;\n(g) where possible, a general description of the technical and organisational security measures referred to in\nArticle 32(1).\n2. Each processor and, where applicable, the processor's representative shall maintain a record of all categories of\nprocessing activities carried out on behalf of a controller, containing:\n(a) the name and contact details of the processor or processors and of each controller on behalf of which", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-30", "title": "Article 30 - Records of processing activities", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 50, "page_end": 51, "chunk_index": 0} +{"id": "article-30-chunk-1", "text": "of all categories of\nprocessing activities carried out on behalf of a controller, containing:\n(a) the name and contact details of the processor or processors and of each controller on behalf of which the processor\nis acting, and, where applicable, of the controller's or the processor's representative, and the data protection officer;\n(b) the categories of processing carried out on behalf of each controller;\n(c) where applicable, transfers of personal data to a third country or an international organisation, including the identifi­\ncation of that third country or international organisation and, in the case of transfers referred to in the second\nsubparagraph of Article 49(1), the documentation of suitable safeguards;\n(d) where possible, a general description of the technical and organisational security measures referred to in\nArticle 32(1).\n3. The records referred to in paragraphs 1 and 2 shall be in writing, including in electronic form.\n4. The controller or the processor and, where applicable, the controller's or the processor's representative, shall make\nthe record available to the supervisory authority on request.\n5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing\nfewer than 250 persons unless the processing it carries out is likely to result in a risk to the rights and freedoms of\ndata subjects, the processing is not occasional, or the processing includes special categories of data as referred to in\nArticle", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-30", "title": "Article 30 - Records of processing activities", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 50, "page_end": 51, "chunk_index": 1} +{"id": "article-30-chunk-2", "text": "carries out is likely to result in a risk to the rights and freedoms of\ndata subjects, the processing is not occasional, or the processing includes special categories of data as referred to in\nArticle 9(1) or personal data relating to criminal convictions and offences referred to in Article 10.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-30", "title": "Article 30 - Records of processing activities", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 50, "page_end": 51, "chunk_index": 2} +{"id": "article-31-chunk-0", "text": "Article 31 - Cooperation with the supervisory authority\n\nThe controller and the processor and, where applicable, their representatives, shall cooperate, on request, with the\nsupervisory authority in the performance of its tasks.\nSection 2\nSecur ity of personal dat a", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-31", "title": "Article 31 - Cooperation with the supervisory authority", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 51, "page_end": 51, "chunk_index": 0} +{"id": "article-32-chunk-0", "text": "Article 32 - Security of processing\n\n1. Taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes\nof processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the\ncontroller and the processor shall implement appropriate technical and organisational measures to ensure a level of\nsecurity appropriate to the risk, including inter alia as appropriate:\n(a) the pseudonymisation and encryption of personal data;\n(b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and\nservices;\n(c) the ability to restore the availability and access to personal data in a timely manner in the event of a physical or\ntechnical incident;\n(d) a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for\nensuring the security of the processing.\n2. In assessing the appropriate level of security account shall be taken in particular of the risks that are presented by\nprocessing, in particular from accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to\npersonal data transmitted, stored or otherwise processed.\n3. Adherence to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as\nreferred to in Article 42 may be used as an element by which to demonstrate compliance with the requirements set out\nin paragraph 1 of this Article.\n4. The", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-32", "title": "Article 32 - Security of processing", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 51, "page_end": 52, "chunk_index": 0} +{"id": "article-32-chunk-1", "text": "40 or an approved certification mechanism as\nreferred to in Article 42 may be used as an element by which to demonstrate compliance with the requirements set out\nin paragraph 1 of this Article.\n4. The controller and processor shall take steps to ensure that any natural person acting under the authority of the\ncontroller or the processor who has access to personal data does not process them except on instructions from the\ncontroller, unless he or she is required to do so by Union or Member State law.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-32", "title": "Article 32 - Security of processing", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 51, "page_end": 52, "chunk_index": 1} +{"id": "article-33-chunk-0", "text": "Article 33 - Notification of a personal data breach to the supervisory authority\n\n1. In the case of a personal data breach, the controller shall without undue delay and, where feasible, not later than\n72 hours after having become aware of it, notify the personal data breach to the supervisory authority competent in\naccordance with Article 55, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of\nnatural persons. Where the notification to the supervisory authority is not made within 72 hours, it shall be\naccompanied by reasons for the delay.\n2. The processor shall notify the controller without undue delay after becoming aware of a personal data breach.\n3. The notification referred to in paragraph 1 shall at least:\n(a) describe the nature of the personal data breach including where possible, the categories and approximate number of\ndata subjects concerned and the categories and approximate number of personal data records concerned;\n(b) communicate the name and contact details of the data protection officer or other contact point where more\ninformation can be obtained;\n(c) describe the likely consequences of the personal data breach;\n(d) describe the measures taken or proposed to be taken by the controller to address the personal data breach,\nincluding, where appropriate, measures to mitigate its possible adverse effects.\n4. Where, and in so far as, it is not possible to provide the information at the same time, the information may be\nprovided in phases without undue further delay.\n5. The controller shall document a", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-33", "title": "Article 33 - Notification of a personal data breach to the supervisory authority", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 52, "page_end": 52, "chunk_index": 0} +{"id": "article-33-chunk-1", "text": "s.\n4. Where, and in so far as, it is not possible to provide the information at the same time, the information may be\nprovided in phases without undue further delay.\n5. The controller shall document any personal data breaches, comprising the facts relating to the personal data\nbreach, its effects and the remedial action taken. That documentation shall enable the supervisory authority to verify\ncompliance with this Article.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-33", "title": "Article 33 - Notification of a personal data breach to the supervisory authority", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 52, "page_end": 52, "chunk_index": 1} +{"id": "article-34-chunk-0", "text": "Article 34 - Communication of a personal data breach to the data subject\n\n1. When the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons, the\ncontroller shall communicate the personal data breach to the data subject without undue delay.\n2. The communication to the data subject referred to in paragraph 1 of this Article shall describe in clear and plain\nlanguage the nature of the personal data breach and contain at least the information and measures referred to in\npoints (b), (c) and (d) of Article 33(3).\n3. The communication to the data subject referred to in paragraph 1 shall not be required if any of the following\nconditions are met:\n(a) the controller has implemented appropriate technical and organisational protection measures, and those measures\nwere applied to the personal data affected by the personal data breach, in particular those that render the personal\ndata unintelligible to any person who is not authorised to access it, such as encryption;\n(b) the controller has taken subsequent measures which ensure that the high risk to the rights and freedoms of data\nsubjects referred to in paragraph 1 is no longer likely to materialise;\n(c) it would involve disproportionate effort. In such a case, there shall instead be a public communication or similar\nmeasure whereby the data subjects are informed in an equally effective manner.\n4. If the controller has not already communicated the personal data breach to the data subject, the supervisory\nauthority, having considered the likelihood of the pers", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-34", "title": "Article 34 - Communication of a personal data breach to the data subject", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 52, "page_end": 53, "chunk_index": 0} +{"id": "article-34-chunk-1", "text": "in an equally effective manner.\n4. If the controller has not already communicated the personal data breach to the data subject, the supervisory\nauthority, having considered the likelihood of the personal data breach resulting in a high risk, may require it to do so\nor may decide that any of the conditions referred to in paragraph 3 are met.\nSection 3\nData protection impact assessment and pr ior consultation", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-34", "title": "Article 34 - Communication of a personal data breach to the data subject", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 52, "page_end": 53, "chunk_index": 1} +{"id": "article-35-chunk-0", "text": "Article 35 - Data protection impact assessment\n\n1. Where a type of processing in particular using new technologies, and taking into account the nature, scope,\ncontext and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons,\nthe controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing\noperations on the protection of personal data. A single assessment may address a set of similar processing operations\nthat present similar high risks.\n2. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data\nprotection impact assessment.\n3. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of:\n(a) a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated\nprocessing, including profiling, and on which decisions are based that produce legal effects concerning the natural\nperson or similarly significantly affect the natural person;\n(b) processing on a large scale of special categories of data referred to in Article 9(1), or of personal data relating to\ncriminal convictions and offences referred to in Article 10; or\n(c) a systematic monitoring of a publicly accessible area on a large scale.\n4. The supervisory authority shall establish and make public a list of the kind of processing operations which are\nsubject to the requirement for a data protection impact assessment p", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-35", "title": "Article 35 - Data protection impact assessment", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 53, "page_end": 54, "chunk_index": 0} +{"id": "article-35-chunk-1", "text": "n a large scale.\n4. The supervisory authority shall establish and make public a list of the kind of processing operations which are\nsubject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory authority\nshall communicate those lists to the Board referred to in Article 68.\n5. The supervisory authority may also establish and make public a list of the kind of processing operations for which\nno data protection impact assessment is required. The supervisory authority shall communicate those lists to the Board.\n6. Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory authority shall\napply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are\nrelated to the offering of goods or services to data subjects or to the monitoring of their behaviour in several\nMember States, or may substantially affect the free movement of personal data within the Union.\n7. The assessment shall contain at least:\n(a) a systematic description of the envisaged processing operations and the purposes of the processing, including, where\napplicable, the legitimate interest pursued by the controller;\n(b) an assessment of the necessity and proportionality of the processing operations in relation to the purposes;\n(c) an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and\n(d) the measures envisaged to address the risks, incl", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-35", "title": "Article 35 - Data protection impact assessment", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 53, "page_end": 54, "chunk_index": 1} +{"id": "article-35-chunk-2", "text": "erations in relation to the purposes;\n(c) an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and\n(d) the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the\nprotection of personal data and to demonstrate compliance with this Regulation taking into account the rights and\nlegitimate interests of data subjects and other persons concerned.\n8. Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors\nshall be taken into due account in assessing the impact of the processing operations performed by such controllers or\nprocessors, in particular for the purposes of a data protection impact assessment.\n9. Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended\nprocessing, without prejudice to the protection of commercial or public interests or the security of processing\noperations.\n10. Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the\nMember State to which the controller is subject, that law regulates the specific processing operation or set of operations\nin question, and a data protection impact assessment has already been carried out as part of a general impact assessment\nin the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be\nnecessary to carr", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-35", "title": "Article 35 - Data protection impact assessment", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 53, "page_end": 54, "chunk_index": 2} +{"id": "article-35-chunk-3", "text": "ready been carried out as part of a general impact assessment\nin the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be\nnecessary to carry out such an assessment prior to processing activities.\n11. Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with\nthe data protection impact assessment at least when there is a change of the risk represented by processing operations.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-35", "title": "Article 35 - Data protection impact assessment", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 53, "page_end": 54, "chunk_index": 3} +{"id": "article-36-chunk-0", "text": "Article 36 - Prior consultation\n\n1. The controller shall consult the supervisory authority prior to processing where a data protection impact\nassessment under Article 35 indicates that the processing would result in a high risk in the absence of measures taken\nby the controller to mitigate the risk.\n2. Where the supervisory authority is of the opinion that the intended processing referred to in paragraph 1 would\ninfringe this Regulation, in particular where the controller has insufficiently identified or mitigated the risk, the\nsupervisory authority shall, within period of up to eight weeks of receipt of the request for consultation, provide written\nadvice to the controller and, where applicable to the processor, and may use any of its powers referred to in Article 58.\nThat period may be extended by six weeks, taking into account the complexity of the intended processing. The\nsupervisory authority shall inform the controller and, where applicable, the processor, of any such extension within one\nmonth of receipt of the request for consultation together with the reasons for the delay. Those periods may be\nsuspended until the supervisory authority has obtained information it has requested for the purposes of the\nconsultation.\n3. When consulting the supervisory authority pursuant to paragraph 1, the controller shall provide the supervisory\nauthority with:\n(a) where applicable, the respective responsibilities of the controller, joint controllers and processors involved in the\nprocessing, in particular for proces", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Prior consultation", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 54, "page_end": 55, "chunk_index": 0} +{"id": "article-36-chunk-1", "text": "provide the supervisory\nauthority with:\n(a) where applicable, the respective responsibilities of the controller, joint controllers and processors involved in the\nprocessing, in particular for processing within a group of undertakings;\n(b) the purposes and means of the intended processing;\n(c) the measures and safeguards provided to protect the rights and freedoms of data subjects pursuant to this\nRegulation;\n(d) where applicable, the contact details of the data protection officer;\n(e) the data protection impact assessment provided for in Article 35; and\n(f) any other information requested by the supervisory authority.\n4. Member States shall consult the supervisory authority during the preparation of a proposal for a legislative\nmeasure to be adopted by a national parliament, or of a regulatory measure based on such a legislative measure, which\nrelates to processing.\n5. Notwithstanding paragraph 1, Member State law may require controllers to consult with, and obtain prior author­\nisation from, the supervisory authority in relation to processing by a controller for the performance of a task carried out\nby the controller in the public interest, including processing in relation to social protection and public health.\nSection 4\nDat a protection off icer", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-36", "title": "Article 36 - Prior consultation", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 54, "page_end": 55, "chunk_index": 1} +{"id": "article-37-chunk-0", "text": "Article 37 - Designation of the data protection officer\n\n1. The controller and the processor shall designate a data protection officer in any case where:\n(a) the processing is carried out by a public authority or body, except for courts acting in their judicial capacity;\n(b) the core activities of the controller or the processor consist of processing operations which, by virtue of their\nnature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale;\nor\n(c) the core activities of the controller or the processor consist of processing on a large scale of special categories of\ndata pursuant to Article 9 and personal data relating to criminal convictions and offences referred to in Article 10.\n2. A group of undertakings may appoint a single data protection officer provided that a data protection officer is\neasily accessible from each establishment.\n3. Where the controller or the processor is a public authority or body, a single data protection officer may be\ndesignated for several such authorities or bodies, taking account of their organisational structure and size.\n4. In cases other than those referred to in paragraph 1, the controller or processor or associations and other bodies\nrepresenting categories of controllers or processors may or, where required by Union or Member State law shall,\ndesignate a data protection officer. The data protection officer may act for such associations and other bodies\nrepresenting controllers or processors.\n5. The data protection officer shall b", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-37", "title": "Article 37 - Designation of the data protection officer", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 55, "page_end": 55, "chunk_index": 0} +{"id": "article-37-chunk-1", "text": "aw shall,\ndesignate a data protection officer. The data protection officer may act for such associations and other bodies\nrepresenting controllers or processors.\n5. The data protection officer shall be designated on the basis of professional qualities and, in particular, expert\nknowledge of data protection law and practices and the ability to fulfil the tasks referred to in Article 39.\n6. The data protection officer may be a staff member of the controller or processor, or fulfil the tasks on the basis of\na service contract.\n7. The controller or the processor shall publish the contact details of the data protection officer and communicate\nthem to the supervisory authority.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-37", "title": "Article 37 - Designation of the data protection officer", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 55, "page_end": 55, "chunk_index": 1} +{"id": "article-38-chunk-0", "text": "Article 38 - Position of the data protection officer\n\n1. The controller and the processor shall ensure that the data protection officer is involved, properly and in a timely\nmanner, in all issues which relate to the protection of personal data.\n2. The controller and processor shall support the data protection officer in performing the tasks referred to in\nArticle 39 by providing resources necessary to carry out those tasks and access to personal data and processing\noperations, and to maintain his or her expert knowledge.\n3. The controller and processor shall ensure that the data protection officer does not receive any instructions\nregarding the exercise of those tasks. He or she shall not be dismissed or penalised by the controller or the processor for\nperforming his tasks. The data protection officer shall directly report to the highest management level of the controller\nor the processor.\n4. Data subjects may contact the data protection officer with regard to all issues related to processing of their\npersonal data and to the exercise of their rights under this Regulation.\n5. The data protection officer shall be bound by secrecy or confidentiality concerning the performance of his or her\ntasks, in accordance with Union or Member State law.\n6. The data protection officer may fulfil other tasks and duties. The controller or processor shall ensure that any such\ntasks and duties do not result in a conflict of interests.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-38", "title": "Article 38 - Position of the data protection officer", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 55, "page_end": 56, "chunk_index": 0} +{"id": "article-39-chunk-0", "text": "Article 39 - Tasks of the data protection officer\n\n1. The data protection officer shall have at least the following tasks:\n(a) to inform and advise the controller or the processor and the employees who carry out processing of their\nobligations pursuant to this Regulation and to other Union or Member State data protection provisions;\n(b) to monitor compliance with this Regulation, with other Union or Member State data protection provisions and with\nthe policies of the controller or processor in relation to the protection of personal data, including the assignment of\nresponsibilities, awareness-raising and training of staff involved in processing operations, and the related audits;\n(c) to provide advice where requested as regards the data protection impact assessment and monitor its performance\npursuant to Article 35;\n(d) to cooperate with the supervisory authority;\n(e) to act as the contact point for the supervisory authority on issues relating to processing, including the prior\nconsultation referred to in Article 36, and to consult, where appropriate, with regard to any other matter.\n2. The data protection officer shall in the performance of his or her tasks have due regard to the risk associated with\nprocessing operations, taking into account the nature, scope, context and purposes of processing.\nSection 5\nCodes of conduct and cer tif ication", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-39", "title": "Article 39 - Tasks of the data protection officer", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 56, "page_end": 56, "chunk_index": 0} +{"id": "article-40-chunk-0", "text": "Article 40 - Codes of conduct\n\n1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of\ncodes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific\nfeatures of the various processing sectors and the specific needs of micro, small and medium-sized enterprises.\n2. Associations and other bodies representing categories of controllers or processors may prepare codes of conduct,\nor amend or extend such codes, for the purpose of specifying the application of this Regulation, such as with regard to:\n(a) fair and transparent processing;\n(b) the legitimate interests pursued by controllers in specific contexts;\n(c) the collection of personal data;\n(d) the pseudonymisation of personal data;\n(e) the information provided to the public and to data subjects;\n(f) the exercise of the rights of data subjects;\n(g) the information provided to, and the protection of, children, and the manner in which the consent of the holders of\nparental responsibility over children is to be obtained;\n(h) the measures and procedures referred to in Articles 24 and 25 and the measures to ensure security of processing\nreferred to in Article 32;\n(i) the notification of personal data breaches to supervisory authorities and the communication of such personal data\nbreaches to data subjects;\n(j) the transfer of personal data to third countries or international organisations; or\n(k) out-of-court proceedings and other dispute reso", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 56, "page_end": 58, "chunk_index": 0} +{"id": "article-40-chunk-1", "text": "unication of such personal data\nbreaches to data subjects;\n(j) the transfer of personal data to third countries or international organisations; or\n(k) out-of-court proceedings and other dispute resolution procedures for resolving disputes between controllers and data\nsubjects with regard to processing, without prejudice to the rights of data subjects pursuant to Articles 77 and 79.\n3. In addition to adherence by controllers or processors subject to this Regulation, codes of conduct approved\npursuant to paragraph 5 of this Article and having general validity pursuant to paragraph 9 of this Article may also be\nadhered to by controllers or processors that are not subject to this Regulation pursuant to Article 3 in order to provide\nappropriate safeguards within the framework of personal data transfers to third countries or international organisations\nunder the terms referred to in point (e) of Article 46(2). Such controllers or processors shall make binding and\nenforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards\nincluding with regard to the rights of data subjects.\n4. A code of conduct referred to in paragraph 2 of this Article shall contain mechanisms which enable the body\nreferred to in Article 41(1) to carry out the mandatory monitoring of compliance with its provisions by the controllers\nor processors which undertake to apply it, without prejudice to the tasks and powers of supervisory authorities\ncompetent pu", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 56, "page_end": 58, "chunk_index": 1} +{"id": "article-40-chunk-2", "text": "e mandatory monitoring of compliance with its provisions by the controllers\nor processors which undertake to apply it, without prejudice to the tasks and powers of supervisory authorities\ncompetent pursuant to Article 55 or 56.\n5. Associations and other bodies referred to in paragraph 2 of this Article which intend to prepare a code of conduct\nor to amend or extend an existing code shall submit the draft code, amendment or extension to the supervisory\nauthority which is competent pursuant to Article 55. The supervisory authority shall provide an opinion on whether the\ndraft code, amendment or extension complies with this Regulation and shall approve that draft code, amendment or\nextension if it finds that it provides sufficient appropriate safeguards.\n6. Where the draft code, or amendment or extension is approved in accordance with paragraph 5, and where the\ncode of conduct concerned does not relate to processing activities in several Member States, the supervisory authority\nshall register and publish the code.\n7. Where a draft code of conduct relates to processing activities in several Member States, the supervisory authority\nwhich is competent pursuant to Article 55 shall, before approving the draft code, amendment or extension, submit it in\nthe procedure referred to in Article 63 to the Board which shall provide an opinion on whether the draft code,\namendment or extension complies with this Regulation or, in the situation referred to in paragraph 3 of this Article,\nprovide", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 56, "page_end": 58, "chunk_index": 2} +{"id": "article-40-chunk-3", "text": "63 to the Board which shall provide an opinion on whether the draft code,\namendment or extension complies with this Regulation or, in the situation referred to in paragraph 3 of this Article,\nprovides appropriate safeguards.\n8. Where the opinion referred to in paragraph 7 confirms that the draft code, amendment or extension complies\nwith this Regulation, or, in the situation referred to in paragraph 3, provides appropriate safeguards, the Board shall\nsubmit its opinion to the Commission.\n9. The Commission may, by way of implementing acts, decide that the approved code of conduct, amendment or\nextension submitted to it pursuant to paragraph 8 of this Article have general validity within the Union. Those\nimplementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2).\n10. The Commission shall ensure appropriate publicity for the approved codes which have been decided as having\ngeneral validity in accordance with paragraph 9.\n11. The Board shall collate all approved codes of conduct, amendments and extensions in a register and shall make\nthem publicly available by way of appropriate means.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-40", "title": "Article 40 - Codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 56, "page_end": 58, "chunk_index": 3} +{"id": "article-41-chunk-0", "text": "Article 41 - Monitoring of approved codes of conduct\n\n1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58, the\nmonitoring of compliance with a code of conduct pursuant to Article 40 may be carried out by a body which has an\nappropriate level of expertise in relation to the subject-matter of the code and is accredited for that purpose by the\ncompetent supervisory authority.\n2. A body as referred to in paragraph 1 may be accredited to monitor compliance with a code of conduct where that\nbody has:\n(a) demonstrated its independence and expertise in relation to the subject-matter of the code to the satisfaction of the\ncompetent supervisory authority;\n(b) established procedures which allow it to assess the eligibility of controllers and processors concerned to apply the\ncode, to monitor their compliance with its provisions and to periodically review its operation;\n(c) established procedures and structures to handle complaints about infringements of the code or the manner in which\nthe code has been, or is being, implemented by a controller or processor, and to make those procedures and\nstructures transparent to data subjects and the public; and\n(d) demonstrated to the satisfaction of the competent supervisory authority that its tasks and duties do not result in a\nconflict of interests.\n3. The competent supervisory authority shall submit the draft criteria for accreditation of a body as referred to in\nparagraph 1 of this Article to the Board pursuant to the consistency mechani", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-41", "title": "Article 41 - Monitoring of approved codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 58, "page_end": 58, "chunk_index": 0} +{"id": "article-41-chunk-1", "text": "rests.\n3. The competent supervisory authority shall submit the draft criteria for accreditation of a body as referred to in\nparagraph 1 of this Article to the Board pursuant to the consistency mechanism referred to in Article 63.\n4. Without prejudice to the tasks and powers of the competent supervisory authority and the provisions of\nChapter VIII, a body as referred to in paragraph 1 of this Article shall, subject to appropriate safeguards, take\nappropriate action in cases of infringement of the code by a controller or processor, including suspension or exclusion\nof the controller or processor concerned from the code. It shall inform the competent supervisory authority of such\nactions and the reasons for taking them.\n5. The competent supervisory authority shall revoke the accreditation of a body as referred to in paragraph 1 if the\nconditions for accreditation are not, or are no longer, met or where actions taken by the body infringe this Regulation.\n6. This Article shall not apply to processing carried out by public authorities and bodies.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-41", "title": "Article 41 - Monitoring of approved codes of conduct", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 58, "page_end": 58, "chunk_index": 1} +{"id": "article-42-chunk-0", "text": "Article 42 - Certification\n\n1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at\nUnion level, the establishment of data protection certification mechanisms and of data protection seals and marks, for\nthe purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors.\nThe specific needs of micro, small and medium-sized enterprises shall be taken into account.\n2. In addition to adherence by controllers or processors subject to this Regulation, data protection certification\nmechanisms, seals or marks approved pursuant to paragraph 5 of this Article may be established for the purpose of\ndemonstrating the existence of appropriate safeguards provided by controllers or processors that are not subject to this\nRegulation pursuant to Article 3 within the framework of personal data transfers to third countries or international\norganisations under the terms referred to in point (f) of Article 46(2). Such controllers or processors shall make binding\nand enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate\nsafeguards, including with regard to the rights of data subjects.\n3. The certification shall be voluntary and available via a process that is transparent.\n4. A certification pursuant to this Article does not reduce the responsibility of the controller or the processor for\ncompliance with this Regulation and is without prejudice to the tasks and powers of", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-42", "title": "Article 42 - Certification", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 58, "page_end": 59, "chunk_index": 0} +{"id": "article-42-chunk-1", "text": "A certification pursuant to this Article does not reduce the responsibility of the controller or the processor for\ncompliance with this Regulation and is without prejudice to the tasks and powers of the supervisory authorities which\nare competent pursuant to Article 55 or 56.\n5. A certification pursuant to this Article shall be issued by the certification bodies referred to in Article 43 or by the\ncompetent supervisory authority, on the basis of criteria approved by that competent supervisory authority pursuant to\nArticle 58(3) or by the Board pursuant to Article 63. Where the criteria are approved by the Board, this may result in a\ncommon certification, the European Data Protection Seal.\n6. The controller or processor which submits its processing to the certification mechanism shall provide the certifi­\ncation body referred to in Article 43, or where applicable, the competent supervisory authority, with all information\nand access to its processing activities which are necessary to conduct the certification procedure.\n7. Certification shall be issued to a controller or processor for a maximum period of three years and may be\nrenewed, under the same conditions, provided that the relevant requirements continue to be met. Certification shall be\nwithdrawn, as applicable, by the certification bodies referred to in Article 43 or by the competent supervisory authority\nwhere the requirements for the certification are not or are no longer met.\n8. The Board shall collate all certifica", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-42", "title": "Article 42 - Certification", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 58, "page_end": 59, "chunk_index": 1} +{"id": "article-42-chunk-2", "text": "ification bodies referred to in Article 43 or by the competent supervisory authority\nwhere the requirements for the certification are not or are no longer met.\n8. The Board shall collate all certification mechanisms and data protection seals and marks in a register and shall\nmake them publicly available by any appropriate means.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-42", "title": "Article 42 - Certification", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 58, "page_end": 59, "chunk_index": 2} +{"id": "article-43-chunk-0", "text": "Article 43 - Certification bodies\n\n1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58,\ncertification bodies which have an appropriate level of expertise in relation to data protection shall, after informing the\nsupervisory authority in order to allow it to exercise its powers pursuant to point (h) of Article 58(2) where necessary,\nissue and renew certification. Member States shall ensure that those certification bodies are accredited by one or both of\nthe following:\n(a) the supervisory authority which is competent pursuant to Article 55 or 56;\n(b) the national accreditation body named in accordance with Regulation (EC) No 765/2008 of the European Parliament\nand of the Council (1) in accordance with EN-ISO/IEC 17065/2012 and with the additional requirements established\nby the supervisory authority which is competent pursuant to Article 55 or 56.\n2. Certification bodies referred to in paragraph 1 shall be accredited in accordance with that paragraph only where\nthey have:\n(a) demonstrated their independence and expertise in relation to the subject-matter of the certification to the\nsatisfaction of the competent supervisory authority;\n(1) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredi­\ntation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,\np. 30).\n(b) undertaken to respect the criteria referred t", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Certification bodies", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 59, "page_end": 60, "chunk_index": 0} +{"id": "article-43-chunk-1", "text": "accredi­\ntation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,\np. 30).\n(b) undertaken to respect the criteria referred to in Article 42(5) and approved by the supervisory authority which is\ncompetent pursuant to Article 55 or 56 or by the Board pursuant to Article 63;\n(c) established procedures for the issuing, periodic review and withdrawal of data protection certification, seals and\nmarks;\n(d) established procedures and structures to handle complaints about infringements of the certification or the manner in\nwhich the certification has been, or is being, implemented by the controller or processor, and to make those\nprocedures and structures transparent to data subjects and the public; and\n(e) demonstrated, to the satisfaction of the competent supervisory authority, that their tasks and duties do not result in\na conflict of interests.\n3. The accreditation of certification bodies as referred to in paragraphs 1 and 2 of this Article shall take place on the\nbasis of criteria approved by the supervisory authority which is competent pursuant to Article 55 or 56 or by the Board\npursuant to Article 63. In the case of accreditation pursuant to point (b) of paragraph 1 of this Article, those\nrequirements shall complement those envisaged in Regulation (EC) No 765/2008 and the technical rules that describe\nthe methods and procedures of the certification bodies.\n4. The certification bodies referred to in", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Certification bodies", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 59, "page_end": 60, "chunk_index": 1} +{"id": "article-43-chunk-2", "text": "hall complement those envisaged in Regulation (EC) No 765/2008 and the technical rules that describe\nthe methods and procedures of the certification bodies.\n4. The certification bodies referred to in paragraph 1 shall be responsible for the proper assessment leading to the\ncertification or the withdrawal of such certification without prejudice to the responsibility of the controller or processor\nfor compliance with this Regulation. The accreditation shall be issued for a maximum period of five years and may be\nrenewed on the same conditions provided that the certification body meets the requirements set out in this Article.\n5. The certification bodies referred to in paragraph 1 shall provide the competent supervisory authorities with the\nreasons for granting or withdrawing the requested certification.\n6. The requirements referred to in paragraph 3 of this Article and the criteria referred to in Article 42(5) shall be\nmade public by the supervisory authority in an easily accessible form. The supervisory authorities shall also transmit\nthose requirements and criteria to the Board. The Board shall collate all certification mechanisms and data protection\nseals in a register and shall make them publicly available by any appropriate means.\n7. Without prejudice to Chapter VIII, the competent supervisory authority or the national accreditation body shall\nrevoke an accreditation of a certification body pursuant to paragraph 1 of this Article where the conditions for the\naccreditation", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Certification bodies", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 59, "page_end": 60, "chunk_index": 2} +{"id": "article-43-chunk-3", "text": "etent supervisory authority or the national accreditation body shall\nrevoke an accreditation of a certification body pursuant to paragraph 1 of this Article where the conditions for the\naccreditation are not, or are no longer, met or where actions taken by a certification body infringe this Regulation.\n8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of\nspecifying the requirements to be taken into account for the data protection certification mechanisms referred to in\nArticle 42(1).\n9. The Commission may adopt implementing acts laying down technical standards for certification mechanisms and\ndata protection seals and marks, and mechanisms to promote and recognise those certification mechanisms, seals and\nmarks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in\nArticle 93(2).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-43", "title": "Article 43 - Certification bodies", "chapter_number": "IV", "chapter_title": "Controller and processor", "page_start": 59, "page_end": 60, "chunk_index": 3} +{"id": "article-44-chunk-0", "text": "Article 44 - General principle for transfers\n\nAny transfer of personal data which are undergoing processing or are intended for processing after transfer to a third\ncountry or to an international organisation shall take place only if, subject to the other provisions of this Regulation, the\nconditions laid down in this Chapter are complied with by the controller and processor, including for onward transfers\nof personal data from the third country or an international organisation to another third country or to another internat­\nional organisation. All provisions in this Chapter shall be applied in order to ensure that the level of protection of\nnatural persons guaranteed by this Regulation is not undermined.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-44", "title": "Article 44 - General principle for transfers", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 60, "page_end": 60, "chunk_index": 0} +{"id": "article-45-chunk-0", "text": "Article 45 - Transfers on the basis of an adequacy decision\n\n1. A transfer of personal data to a third country or an international organisation may take place where the\nCommission has decided that the third country, a territory or one or more specified sectors within that third country, or\nthe international organisation in question ensures an adequate level of protection. Such a transfer shall not require any\nspecific authorisation.\n2. When assessing the adequacy of the level of protection, the Commission shall, in particular, take account of the\nfollowing elements:\n(a) the rule of law, respect for human rights and fundamental freedoms, relevant legislation, both general and sectoral,\nincluding concerning public security, defence, national security and criminal law and the access of public authorities\nto personal data, as well as the implementation of such legislation, data protection rules, professional rules and\nsecurity measures, including rules for the onward transfer of personal data to another third country or international\norganisation which are complied with in that country or international organisation, case-law, as well as effective and\nenforceable data subject rights and effective administrative and judicial redress for the data subjects whose personal\ndata are being transferred;\n(b) the existence and effective functioning of one or more independent supervisory authorities in the third country or to\nwhich an international organisation is subject, with responsibility for ensuring and enforcing compliance with the\ndata prote", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Transfers on the basis of an adequacy decision", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 61, "page_end": 62, "chunk_index": 0} +{"id": "article-45-chunk-1", "text": "one or more independent supervisory authorities in the third country or to\nwhich an international organisation is subject, with responsibility for ensuring and enforcing compliance with the\ndata protection rules, including adequate enforcement powers, for assisting and advising the data subjects in\nexercising their rights and for cooperation with the supervisory authorities of the Member States; and\n(c) the international commitments the third country or international organisation concerned has entered into, or other\nobligations arising from legally binding conventions or instruments as well as from its participation in multilateral\nor regional systems, in particular in relation to the protection of personal data.\n3. The Commission, after assessing the adequacy of the level of protection, may decide, by means of implementing\nact, that a third country, a territory or one or more specified sectors within a third country, or an international\norganisation ensures an adequate level of protection within the meaning of paragraph 2 of this Article. The\nimplementing act shall provide for a mechanism for a periodic review, at least every four years, which shall take into\naccount all relevant developments in the third country or international organisation. The implementing act shall specify\nits territorial and sectoral application and, where applicable, identify the supervisory authority or authorities referred to\nin point (b) of paragraph 2 of this Article. The implementing act shall b", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Transfers on the basis of an adequacy decision", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 61, "page_end": 62, "chunk_index": 1} +{"id": "article-45-chunk-2", "text": "its territorial and sectoral application and, where applicable, identify the supervisory authority or authorities referred to\nin point (b) of paragraph 2 of this Article. The implementing act shall be adopted in accordance with the examination\nprocedure referred to in Article 93(2).\n4. The Commission shall, on an ongoing basis, monitor developments in third countries and international organ­\nisations that could affect the functioning of decisions adopted pursuant to paragraph 3 of this Article and decisions\nadopted on the basis of Article 25(6) of Directive 95/46/EC.\n5. The Commission shall, where available information reveals, in particular following the review referred to in\nparagraph 3 of this Article, that a third country, a territory or one or more specified sectors within a third country, or\nan international organisation no longer ensures an adequate level of protection within the meaning of paragraph 2 of\nthis Article, to the extent necessary, repeal, amend or suspend the decision referred to in paragraph 3 of this Article by\nmeans of implementing acts without retro-active effect. Those implementing acts shall be adopted in accordance with\nthe examination procedure referred to in Article 93(2).\nOn duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts\nin accordance with the procedure referred to in Article 93(3).\n6. The Commission shall enter into consultations with the third country or international organisat", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Transfers on the basis of an adequacy decision", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 61, "page_end": 62, "chunk_index": 2} +{"id": "article-45-chunk-3", "text": "mediately applicable implementing acts\nin accordance with the procedure referred to in Article 93(3).\n6. The Commission shall enter into consultations with the third country or international organisation with a view to\nremedying the situation giving rise to the decision made pursuant to paragraph 5.\n7. A decision pursuant to paragraph 5 of this Article is without prejudice to transfers of personal data to the third\ncountry, a territory or one or more specified sectors within that third country, or the international organisation in\nquestion pursuant to Articles 46 to 49.\n8. The Commission shall publish in the Official Journal of the European Union and on its website a list of the third\ncountries, territories and specified sectors within a third country and international organisations for which it has decided\nthat an adequate level of protection is or is no longer ensured.\n9. Decisions adopted by the Commission on the basis of Article 25(6) of Directive 95/46/EC shall remain in force\nuntil amended, replaced or repealed by a Commission Decision adopted in accordance with paragraph 3 or 5 of this\nArticle.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-45", "title": "Article 45 - Transfers on the basis of an adequacy decision", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 61, "page_end": 62, "chunk_index": 3} +{"id": "article-46-chunk-0", "text": "Article 46 - Transfers subject to appropriate safeguards\n\n1. In the absence of a decision pursuant to Article 45(3), a controller or processor may transfer personal data to a\nthird country or an international organisation only if the controller or processor has provided appropriate safeguards,\nand on condition that enforceable data subject rights and effective legal remedies for data subjects are available.\n2. The appropriate safeguards referred to in paragraph 1 may be provided for, without requiring any specific authoris­\nation from a supervisory authority, by:\n(a) a legally binding and enforceable instrument between public authorities or bodies;\n(b) binding corporate rules in accordance with Article 47;\n(c) standard data protection clauses adopted by the Commission in accordance with the examination procedure referred\nto in Article 93(2);\n(d) standard data protection clauses adopted by a supervisory authority and approved by the Commission pursuant to\nthe examination procedure referred to in Article 93(2);\n(e) an approved code of conduct pursuant to Article 40 together with binding and enforceable commitments of the\ncontroller or processor in the third country to apply the appropriate safeguards, including as regards data subjects'\nrights; or\n(f) an approved certification mechanism pursuant to Article 42 together with binding and enforceable commitments of\nthe controller or processor in the third country to apply the appropriate safeguards, including as regards data\nsubjects' rights.\n3. Subject to the authorisation from the", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-46", "title": "Article 46 - Transfers subject to appropriate safeguards", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 62, "chunk_index": 0} +{"id": "article-46-chunk-1", "text": "nd enforceable commitments of\nthe controller or processor in the third country to apply the appropriate safeguards, including as regards data\nsubjects' rights.\n3. Subject to the authorisation from the competent supervisory authority, the appropriate safeguards referred to in\nparagraph 1 may also be provided for, in particular, by:\n(a) contractual clauses between the controller or processor and the controller, processor or the recipient of the personal\ndata in the third country or international organisation; or\n(b) provisions to be inserted into administrative arrangements between public authorities or bodies which include\nenforceable and effective data subject rights.\n4. The supervisory authority shall apply the consistency mechanism referred to in Article 63 in the cases referred to\nin paragraph 3 of this Article.\n5. Authorisations by a Member State or supervisory authority on the basis of Article 26(2) of Directive 95/46/EC\nshall remain valid until amended, replaced or repealed, if necessary, by that supervisory authority. Decisions adopted by\nthe Commission on the basis of Article 26(4) of Directive 95/46/EC shall remain in force until amended, replaced or\nrepealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of this Article.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-46", "title": "Article 46 - Transfers subject to appropriate safeguards", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 62, "chunk_index": 1} +{"id": "article-47-chunk-0", "text": "Article 47 - Binding corporate rules\n\n1. The competent supervisory authority shall approve binding corporate rules in accordance with the consistency\nmechanism set out in Article 63, provided that they:\n(a) are legally binding and apply to and are enforced by every member concerned of the group of undertakings, or\ngroup of enterprises engaged in a joint economic activity, including their employees;\n(b) expressly confer enforceable rights on data subjects with regard to the processing of their personal data; and\n(c) fulfil the requirements laid down in paragraph 2.\n2. The binding corporate rules referred to in paragraph 1 shall specify at least:\n(a) the structure and contact details of the group of undertakings, or group of enterprises engaged in a joint economic\nactivity and of each of its members;\n(b) the data transfers or set of transfers, including the categories of personal data, the type of processing and its\npurposes, the type of data subjects affected and the identification of the third country or countries in question;\n(c) their legally binding nature, both internally and externally;\n(d) the application of the general data protection principles, in particular purpose limitation, data minimisation, limited\nstorage periods, data quality, data protection by design and by default, legal basis for processing, processing of\nspecial categories of personal data, measures to ensure data security, and the requirements in respect of onward\ntransfers to bodies not bound by the binding corporate rules;\n(e) the", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - Binding corporate rules", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 64, "chunk_index": 0} +{"id": "article-47-chunk-1", "text": "g, processing of\nspecial categories of personal data, measures to ensure data security, and the requirements in respect of onward\ntransfers to bodies not bound by the binding corporate rules;\n(e) the rights of data subjects in regard to processing and the means to exercise those rights, including the right not to\nbe subject to decisions based solely on automated processing, including profiling in accordance with Article 22, the\nright to lodge a complaint with the competent supervisory authority and before the competent courts of the\nMember States in accordance with Article 79, and to obtain redress and, where appropriate, compensation for a\nbreach of the binding corporate rules;\n(f) the acceptance by the controller or processor established on the territory of a Member State of liability for any\nbreaches of the binding corporate rules by any member concerned not established in the Union; the controller or\nthe processor shall be exempt from that liability, in whole or in part, only if it proves that that member is not\nresponsible for the event giving rise to the damage;\n(g) how the information on the binding corporate rules, in particular on the provisions referred to in points (d), (e)\nand (f) of this paragraph is provided to the data subjects in addition to Articles 13 and 14;\n(h) the tasks of any data protection officer designated in accordance with Article 37 or any other person or entity in\ncharge of the monitoring compliance with the binding corporate rules within the", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - Binding corporate rules", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 64, "chunk_index": 1} +{"id": "article-47-chunk-2", "text": "(h) the tasks of any data protection officer designated in accordance with Article 37 or any other person or entity in\ncharge of the monitoring compliance with the binding corporate rules within the group of undertakings, or group\nof enterprises engaged in a joint economic activity, as well as monitoring training and complaint-handling;\n(i) the complaint procedures;\n(j) the mechanisms within the group of undertakings, or group of enterprises engaged in a joint economic activity for\nensuring the verification of compliance with the binding corporate rules. Such mechanisms shall include data\nprotection audits and methods for ensuring corrective actions to protect the rights of the data subject. Results of\nsuch verification should be communicated to the person or entity referred to in point (h) and to the board of the\ncontrolling undertaking of a group of undertakings, or of the group of enterprises engaged in a joint economic\nactivity, and should be available upon request to the competent supervisory authority;\n(k) the mechanisms for reporting and recording changes to the rules and reporting those changes to the supervisory\nauthority;\n(l) the cooperation mechanism with the supervisory authority to ensure compliance by any member of the group of\nundertakings, or group of enterprises engaged in a joint economic activity, in particular by making available to the\nsupervisory authority the results of verifications of the measures referred to in point (j);\n(m) the mechanisms fo", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - Binding corporate rules", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 64, "chunk_index": 2} +{"id": "article-47-chunk-3", "text": "rises engaged in a joint economic activity, in particular by making available to the\nsupervisory authority the results of verifications of the measures referred to in point (j);\n(m) the mechanisms for reporting to the competent supervisory authority any legal requirements to which a member of\nthe group of undertakings, or group of enterprises engaged in a joint economic activity is subject in a third country\nwhich are likely to have a substantial adverse effect on the guarantees provided by the binding corporate rules; and\n(n) the appropriate data protection training to personnel having permanent or regular access to personal data.\n3. The Commission may specify the format and procedures for the exchange of information between controllers,\nprocessors and supervisory authorities for binding corporate rules within the meaning of this Article. Those\nimplementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-47", "title": "Article 47 - Binding corporate rules", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 62, "page_end": 64, "chunk_index": 3} +{"id": "article-48-chunk-0", "text": "Article 48 - Transfers or disclosures not authorised by Union law\n\nAny judgment of a court or tribunal and any decision of an administrative authority of a third country requiring a\ncontroller or processor to transfer or disclose personal data may only be recognised or enforceable in any manner if\nbased on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third\ncountry and the Union or a Member State, without prejudice to other grounds for transfer pursuant to this Chapter.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-48", "title": "Article 48 - Transfers or disclosures not authorised by Union law", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 64, "page_end": 64, "chunk_index": 0} +{"id": "article-49-chunk-0", "text": "Article 49 - Derogations for specific situations\n\n1. In the absence of an adequacy decision pursuant to Article 45(3), or of appropriate safeguards pursuant to\nArticle 46, including binding corporate rules, a transfer or a set of transfers of personal data to a third country or an in­\nternational organisation shall take place only on one of the following conditions:\n(a) the data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of\nsuch transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards;\n(b) the transfer is necessary for the performance of a contract between the data subject and the controller or the\nimplementation of pre-contractual measures taken at the data subject's request;\n(c) the transfer is necessary for the conclusion or performance of a contract concluded in the interest of the data subject\nbetween the controller and another natural or legal person;\n(d) the transfer is necessary for important reasons of public interest;\n(e) the transfer is necessary for the establishment, exercise or defence of legal claims;\n(f) the transfer is necessary in order to protect the vital interests of the data subject or of other persons, where the data\nsubject is physically or legally incapable of giving consent;\n(g) the transfer is made from a register which according to Union or Member State law is intended to provide\ninformation to the public and which is open to consultation either by the public in general or by any per", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Derogations for specific situations", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 64, "page_end": 65, "chunk_index": 0} +{"id": "article-49-chunk-1", "text": "er is made from a register which according to Union or Member State law is intended to provide\ninformation to the public and which is open to consultation either by the public in general or by any person who\ncan demonstrate a legitimate interest, but only to the extent that the conditions laid down by Union or\nMember State law for consultation are fulfilled in the particular case.\nWhere a transfer could not be based on a provision in Article 45 or 46, including the provisions on binding corporate\nrules, and none of the derogations for a specific situation referred to in the first subparagraph of this paragraph is\napplicable, a transfer to a third country or an international organisation may take place only if the transfer is not\nrepetitive, concerns only a limited number of data subjects, is necessary for the purposes of compelling legitimate\ninterests pursued by the controller which are not overridden by the interests or rights and freedoms of the data subject,\nand the controller has assessed all the circumstances surrounding the data transfer and has on the basis of that\nassessment provided suitable safeguards with regard to the protection of personal data. The controller shall inform the\nsupervisory authority of the transfer. The controller shall, in addition to providing the information referred to in\nArticles 13 and 14, inform the data subject of the transfer and on the compelling legitimate interests pursued.\n2. A transfer pursuant to point (g) of the first subparagraph", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Derogations for specific situations", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 64, "page_end": 65, "chunk_index": 1} +{"id": "article-49-chunk-2", "text": "information referred to in\nArticles 13 and 14, inform the data subject of the transfer and on the compelling legitimate interests pursued.\n2. A transfer pursuant to point (g) of the first subparagraph of paragraph 1 shall not involve the entirety of the\npersonal data or entire categories of the personal data contained in the register. Where the register is intended for\nconsultation by persons having a legitimate interest, the transfer shall be made only at the request of those persons or if\nthey are to be the recipients.\n3. Points (a), (b) and (c) of the first subparagraph of paragraph 1 and the second subparagraph thereof shall not apply\nto activities carried out by public authorities in the exercise of their public powers.\n4. The public interest referred to in point (d) of the first subparagraph of paragraph 1 shall be recognised in Union\nlaw or in the law of the Member State to which the controller is subject.\n5. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest,\nexpressly set limits to the transfer of specific categories of personal data to a third country or an international\norganisation. Member States shall notify such provisions to the Commission.\n6. The controller or processor shall document the assessment as well as the suitable safeguards referred to in the\nsecond subparagraph of paragraph 1 of this Article in the records referred to in Article 30.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Derogations for specific situations", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 64, "page_end": 65, "chunk_index": 2} +{"id": "article-49-chunk-3", "text": "ell as the suitable safeguards referred to in the\nsecond subparagraph of paragraph 1 of this Article in the records referred to in Article 30.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-49", "title": "Article 49 - Derogations for specific situations", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 64, "page_end": 65, "chunk_index": 3} +{"id": "article-50-chunk-0", "text": "Article 50 - International cooperation for the protection of personal data\n\nIn relation to third countries and international organisations, the Commission and supervisory authorities shall take\nappropriate steps to:\n(a) develop international cooperation mechanisms to facilitate the effective enforcement of legislation for the protection\nof personal data;\n(b) provide international mutual assistance in the enforcement of legislation for the protection of personal data,\nincluding through notification, complaint referral, investigative assistance and information exchange, subject to\nappropriate safeguards for the protection of personal data and other fundamental rights and freedoms;\n(c) engage relevant stakeholders in discussion and activities aimed at furthering international cooperation in the\nenforcement of legislation for the protection of personal data;\n(d) promote the exchange and documentation of personal data protection legislation and practice, including on jurisdic­\ntional conflicts with third countries.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-50", "title": "Article 50 - International cooperation for the protection of personal data", "chapter_number": "V", "chapter_title": "Transfers of personal data to third countries or international organisations", "page_start": 65, "page_end": 65, "chunk_index": 0} +{"id": "article-51-chunk-0", "text": "Article 51 - Supervisory authority\n\n1. Each Member State shall provide for one or more independent public authorities to be responsible for monitoring\nthe application of this Regulation, in order to protect the fundamental rights and freedoms of natural persons in relation\nto processing and to facilitate the free flow of personal data within the Union (‘supervisory authority’).\n2. Each supervisory authority shall contribute to the consistent application of this Regulation throughout the Union.\nFor that purpose, the supervisory authorities shall cooperate with each other and the Commission in accordance with\nChapter VII.\n3. Where more than one supervisory authority is established in a Member State, that Member State shall designate\nthe supervisory authority which is to represent those authorities in the Board and shall set out the mechanism to ensure\ncompliance by the other authorities with the rules relating to the consistency mechanism referred to in Article 63.\n4. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to this\nChapter, by 25 May 2018 and, without delay, any subsequent amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-51", "title": "Article 51 - Supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 65, "page_end": 65, "chunk_index": 0} +{"id": "article-52-chunk-0", "text": "Article 52 - Independence\n\n1. Each supervisory authority shall act with complete independence in performing its tasks and exercising its powers\nin accordance with this Regulation.\n2. The member or members of each supervisory authority shall, in the performance of their tasks and exercise of\ntheir powers in accordance with this Regulation, remain free from external influence, whether direct or indirect, and\nshall neither seek nor take instructions from anybody.\n3. Member or members of each supervisory authority shall refrain from any action incompatible with their duties\nand shall not, during their term of office, engage in any incompatible occupation, whether gainful or not.\n4. Each Member State shall ensure that each supervisory authority is provided with the human, technical and\nfinancial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its\npowers, including those to be carried out in the context of mutual assistance, cooperation and participation in the\nBoard.\n5. Each Member State shall ensure that each supervisory authority chooses and has its own staff which shall be\nsubject to the exclusive direction of the member or members of the supervisory authority concerned.\n6. Each Member State shall ensure that each supervisory authority is subject to financial control which does not\naffect its independence and that it has separate, public annual budgets, which may be part of the overall state or national\nbudget.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-52", "title": "Article 52 - Independence", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 66, "page_end": 66, "chunk_index": 0} +{"id": "article-53-chunk-0", "text": "Article 53 - General conditions for the members of the supervisory authority\n\n1. Member States shall provide for each member of their supervisory authorities to be appointed by means of a\ntransparent procedure by:\n— their parliament;\n— their government;\n— their head of State; or\n— an independent body entrusted with the appointment under Member State law.\n2. Each member shall have the qualifications, experience and skills, in particular in the area of the protection of\npersonal data, required to perform its duties and exercise its powers.\n3. The duties of a member shall end in the event of the expiry of the term of office, resignation or compulsory\nretirement, in accordance with the law of the Member State concerned.\n4. A member shall be dismissed only in cases of serious misconduct or if the member no longer fulfils the conditions\nrequired for the performance of the duties.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-53", "title": "Article 53 - General conditions for the members of the supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 66, "page_end": 66, "chunk_index": 0} +{"id": "article-54-chunk-0", "text": "Article 54 - Rules on the establishment of the supervisory authority\n\n1. Each Member State shall provide by law for all of the following:\n(a) the establishment of each supervisory authority;\n(b) the qualifications and eligibility conditions required to be appointed as member of each supervisory authority;\n(c) the rules and procedures for the appointment of the member or members of each supervisory authority;\n(d) the duration of the term of the member or members of each supervisory authority of no less than four years, except\nfor the first appointment after 24 May 2016, part of which may take place for a shorter period where that is\nnecessary to protect the independence of the supervisory authority by means of a staggered appointment procedure;\n(e) whether and, if so, for how many terms the member or members of each supervisory authority is eligible for\nreappointment;\n(f) the conditions governing the obligations of the member or members and staff of each supervisory authority,\nprohibitions on actions, occupations and benefits incompatible therewith during and after the term of office and\nrules governing the cessation of employment.\n2. The member or members and the staff of each supervisory authority shall, in accordance with Union or Member\nState law, be subject to a duty of professional secrecy both during and after their term of office, with regard to any\nconfidential information which has come to their knowledge in the course of the performance of their tasks or exercise\nof their powers. During their term of office, that duty of profess", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-54", "title": "Article 54 - Rules on the establishment of the supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 66, "page_end": 67, "chunk_index": 0} +{"id": "article-54-chunk-1", "text": "regard to any\nconfidential information which has come to their knowledge in the course of the performance of their tasks or exercise\nof their powers. During their term of office, that duty of professional secrecy shall in particular apply to reporting by\nnatural persons of infringements of this Regulation.\nSection 2\nCompetence, t asks and po wers", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-54", "title": "Article 54 - Rules on the establishment of the supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 66, "page_end": 67, "chunk_index": 1} +{"id": "article-55-chunk-0", "text": "Article 55 - Competence\n\n1. Each supervisory authority shall be competent for the performance of the tasks assigned to and the exercise of the\npowers conferred on it in accordance with this Regulation on the territory of its own Member State.\n2. Where processing is carried out by public authorities or private bodies acting on the basis of point (c) or (e) of\nArticle 6(1), the supervisory authority of the Member State concerned shall be competent. In such cases Article 56 does\nnot apply.\n3. Supervisory authorities shall not be competent to supervise processing operations of courts acting in their judicial\ncapacity.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-55", "title": "Article 55 - Competence", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 67, "page_end": 67, "chunk_index": 0} +{"id": "article-56-chunk-0", "text": "Article 56 - Competence of the lead supervisory authority\n\n1. Without prejudice to Article 55, the supervisory authority of the main establishment or of the single establishment\nof the controller or processor shall be competent to act as lead supervisory authority for the cross-border processing\ncarried out by that controller or processor in accordance with the procedure provided in Article 60.\n2. By derogation from paragraph 1, each supervisory authority shall be competent to handle a complaint lodged with\nit or a possible infringement of this Regulation, if the subject matter relates only to an establishment in its Member State\nor substantially affects data subjects only in its Member State.\n3. In the cases referred to in paragraph 2 of this Article, the supervisory authority shall inform the lead supervisory\nauthority without delay on that matter. Within a period of three weeks after being informed the lead supervisory\nauthority shall decide whether or not it will handle the case in accordance with the procedure provided in Article 60,\ntaking into account whether or not there is an establishment of the controller or processor in the Member State of\nwhich the supervisory authority informed it.\n4. Where the lead supervisory authority decides to handle the case, the procedure provided in Article 60 shall apply.\nThe supervisory authority which informed the lead supervisory authority may submit to the lead supervisory authority a\ndraft for a decision. The lead supervisory authority shall take utmost account of that draft when preparing", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Competence of the lead supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 67, "page_end": 68, "chunk_index": 0} +{"id": "article-56-chunk-1", "text": "which informed the lead supervisory authority may submit to the lead supervisory authority a\ndraft for a decision. The lead supervisory authority shall take utmost account of that draft when preparing the draft\ndecision referred to in Article 60(3).\n5. Where the lead supervisory authority decides not to handle the case, the supervisory authority which informed the\nlead supervisory authority shall handle it according to Articles 61 and 62.\n6. The lead supervisory authority shall be the sole interlocutor of the controller or processor for the cross-border\nprocessing carried out by that controller or processor.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-56", "title": "Article 56 - Competence of the lead supervisory authority", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 67, "page_end": 68, "chunk_index": 1} +{"id": "article-57-chunk-0", "text": "Article 57 - Tasks\n\n1. Without prejudice to other tasks set out under this Regulation, each supervisory authority shall on its territory:\n(a) monitor and enforce the application of this Regulation;\n(b) promote public awareness and understanding of the risks, rules, safeguards and rights in relation to processing.\nActivities addressed specifically to children shall receive specific attention;\n(c) advise, in accordance with Member State law, the national parliament, the government, and other institutions and\nbodies on legislative and administrative measures relating to the protection of natural persons' rights and freedoms\nwith regard to processing;\n(d) promote the awareness of controllers and processors of their obligations under this Regulation;\n(e) upon request, provide information to any data subject concerning the exercise of their rights under this Regulation\nand, if appropriate, cooperate with the supervisory authorities in other Member States to that end;\n(f) handle complaints lodged by a data subject, or by a body, organisation or association in accordance with Article 80,\nand investigate, to the extent appropriate, the subject matter of the complaint and inform the complainant of the\nprogress and the outcome of the investigation within a reasonable period, in particular if further investigation or\ncoordination with another supervisory authority is necessary;\n(g) cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with\na vie", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - Tasks", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 68, "page_end": 69, "chunk_index": 0} +{"id": "article-57-chunk-1", "text": "stigation or\ncoordination with another supervisory authority is necessary;\n(g) cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with\na view to ensuring the consistency of application and enforcement of this Regulation;\n(h) conduct investigations on the application of this Regulation, including on the basis of information received from\nanother supervisory authority or other public authority;\n(i) monitor relevant developments, insofar as they have an impact on the protection of personal data, in particular the\ndevelopment of information and communication technologies and commercial practices;\n(j) adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2);\n(k) establish and maintain a list in relation to the requirement for data protection impact assessment pursuant to\nArticle 35(4);\n(l) give advice on the processing operations referred to in Article 36(2);\n(m) encourage the drawing up of codes of conduct pursuant to Article 40(1) and provide an opinion and approve such\ncodes of conduct which provide sufficient safeguards, pursuant to Article 40(5);\n(n) encourage the establishment of data protection certification mechanisms and of data protection seals and marks\npursuant to Article 42(1), and approve the criteria of certification pursuant to Article 42(5);\n(o) where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7);\n(p) dra", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - Tasks", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 68, "page_end": 69, "chunk_index": 1} +{"id": "article-57-chunk-2", "text": "ticle 42(1), and approve the criteria of certification pursuant to Article 42(5);\n(o) where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7);\n(p) draft and publish the criteria for accreditation of a body for monitoring codes of conduct pursuant to Article 41\nand of a certification body pursuant to Article 43;\n(q) conduct the accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification\nbody pursuant to Article 43;\n(r) authorise contractual clauses and provisions referred to in Article 46(3);\n(s) approve binding corporate rules pursuant to Article 47;\n(t) contribute to the activities of the Board;\n(u) keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2);\nand\n(v) fulfil any other tasks related to the protection of personal data.\n2. Each supervisory authority shall facilitate the submission of complaints referred to in point (f) of paragraph 1 by\nmeasures such as a complaint submission form which can also be completed electronically, without excluding other\nmeans of communication.\n3. The performance of the tasks of each supervisory authority shall be free of charge for the data subject and, where\napplicable, for the data protection officer.\n4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the\nsupervisory authority may charge a reasonable fee based on administrativ", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - Tasks", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 68, "page_end": 69, "chunk_index": 2} +{"id": "article-57-chunk-3", "text": "tion officer.\n4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the\nsupervisory authority may charge a reasonable fee based on administrative costs, or refuse to act on the request. The\nsupervisory authority shall bear the burden of demonstrating the manifestly unfounded or excessive character of the\nrequest.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-57", "title": "Article 57 - Tasks", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 68, "page_end": 69, "chunk_index": 3} +{"id": "article-58-chunk-0", "text": "Article 58 - Powers\n\n1. Each supervisory authority shall have all of the following investigative powers:\n(a) to order the controller and the processor, and, where applicable, the controller's or the processor's representative to\nprovide any information it requires for the performance of its tasks;\n(b) to carry out investigations in the form of data protection audits;\n(c) to carry out a review on certifications issued pursuant to Article 42(7);\n(d) to notify the controller or the processor of an alleged infringement of this Regulation;\n(e) to obtain, from the controller and the processor, access to all personal data and to all information necessary for the\nperformance of its tasks;\n(f) to obtain access to any premises of the controller and the processor, including to any data processing equipment\nand means, in accordance with Union or Member State procedural law.\n2. Each supervisory authority shall have all of the following corrective powers:\n(a) to issue warnings to a controller or processor that intended processing operations are likely to infringe provisions of\nthis Regulation;\n(b) to issue reprimands to a controller or a processor where processing operations have infringed provisions of this\nRegulation;\n(c) to order the controller or the processor to comply with the data subject's requests to exercise his or her rights\npursuant to this Regulation;\n(d) to order the controller or processor to bring processing operations into compliance with the provisions of this\nRegulation, where appr", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Powers", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 69, "page_end": 70, "chunk_index": 0} +{"id": "article-58-chunk-1", "text": "s to exercise his or her rights\npursuant to this Regulation;\n(d) to order the controller or processor to bring processing operations into compliance with the provisions of this\nRegulation, where appropriate, in a specified manner and within a specified period;\n(e) to order the controller to communicate a personal data breach to the data subject;\n(f) to impose a temporary or definitive limitation including a ban on processing;\n(g) to order the rectification or erasure of personal data or restriction of processing pursuant to Articles 16, 17 and 18\nand the notification of such actions to recipients to whom the personal data have been disclosed pursuant to\nArticle 17(2) and Article 19;\n(h) to withdraw a certification or to order the certification body to withdraw a certification issued pursuant to\nArticles 42 and 43, or to order the certification body not to issue certification if the requirements for the certifi­\ncation are not or are no longer met;\n(i) to impose an administrative fine pursuant to Article 83, in addition to, or instead of measures referred to in this\nparagraph, depending on the circumstances of each individual case;\n(j) to order the suspension of data flows to a recipient in a third country or to an international organisation.\n3. Each supervisory authority shall have all of the following authorisation and advisory powers:\n(a) to advise the controller in accordance with the prior consultation procedure referred to in Article 36;\n(b) to issue, on its own", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Powers", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 69, "page_end": 70, "chunk_index": 1} +{"id": "article-58-chunk-2", "text": "hall have all of the following authorisation and advisory powers:\n(a) to advise the controller in accordance with the prior consultation procedure referred to in Article 36;\n(b) to issue, on its own initiative or on request, opinions to the national parliament, the Member State government or,\nin accordance with Member State law, to other institutions and bodies as well as to the public on any issue related\nto the protection of personal data;\n(c) to authorise processing referred to in Article 36(5), if the law of the Member State requires such prior authorisation;\n(d) to issue an opinion and approve draft codes of conduct pursuant to Article 40(5);\n(e) to accredit certification bodies pursuant to Article 43;\n(f) to issue certifications and approve criteria of certification in accordance with Article 42(5);\n(g) to adopt standard data protection clauses referred to in Article 28(8) and in point (d) of Article 46(2);\n(h) to authorise contractual clauses referred to in point (a) of Article 46(3);\n(i) to authorise administrative arrangements referred to in point (b) of Article 46(3);\n(j) to approve binding corporate rules pursuant to Article 47.\n4. The exercise of the powers conferred on the supervisory authority pursuant to this Article shall be subject to\nappropriate safeguards, including effective judicial remedy and due process, set out in Union and Member State law in\naccordance with the Charter.\n5. Each Member State shall provide by law that its supervisory authorit", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Powers", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 69, "page_end": 70, "chunk_index": 2} +{"id": "article-58-chunk-3", "text": "ards, including effective judicial remedy and due process, set out in Union and Member State law in\naccordance with the Charter.\n5. Each Member State shall provide by law that its supervisory authority shall have the power to bring infringements\nof this Regulation to the attention of the judicial authorities and where appropriate, to commence or engage otherwise\nin legal proceedings, in order to enforce the provisions of this Regulation.\n6. Each Member State may provide by law that its supervisory authority shall have additional powers to those\nreferred to in paragraphs 1, 2 and 3. The exercise of those powers shall not impair the effective operation of\nChapter VII.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-58", "title": "Article 58 - Powers", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 69, "page_end": 70, "chunk_index": 3} +{"id": "article-59-chunk-0", "text": "Article 59 - Activity reports\n\nEach supervisory authority shall draw up an annual report on its activities, which may include a list of types of\ninfringement notified and types of measures taken in accordance with Article 58(2). Those reports shall be transmitted\nto the national parliament, the government and other authorities as designated by Member State law. They shall be made\navailable to the public, to the Commission and to the Board.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-59", "title": "Article 59 - Activity reports", "chapter_number": "VI", "chapter_title": "Independent supervisory authorities", "page_start": 70, "page_end": 70, "chunk_index": 0} +{"id": "article-60-chunk-0", "text": "Article 60 - Cooperation between the lead supervisory authority and the other supervisory authorities\n\nconcerned\n1. The lead supervisory authority shall cooperate with the other supervisory authorities concerned in accordance\nwith this Article in an endeavour to reach consensus. The lead supervisory authority and the supervisory authorities\nconcerned shall exchange all relevant information with each other.\n2. The lead supervisory authority may request at any time other supervisory authorities concerned to provide mutual\nassistance pursuant to Article 61 and may conduct joint operations pursuant to Article 62, in particular for carrying out\ninvestigations or for monitoring the implementation of a measure concerning a controller or processor established in\nanother Member State.\n3. The lead supervisory authority shall, without delay, communicate the relevant information on the matter to the\nother supervisory authorities concerned. It shall without delay submit a draft decision to the other supervisory\nauthorities concerned for their opinion and take due account of their views.\n4. Where any of the other supervisory authorities concerned within a period of four weeks after having been\nconsulted in accordance with paragraph 3 of this Article, expresses a relevant and reasoned objection to the draft\ndecision, the lead supervisory authority shall, if it does not follow the relevant and reasoned objection or is of the\nopinion that the objection is not relevant or reasoned, submit the matter to the consistency mechanism referred to in\nArticle 63.\n5. Where the lead supervisory authority", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Cooperation between the lead supervisory authority and the other supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 71, "page_end": 72, "chunk_index": 0} +{"id": "article-60-chunk-1", "text": "asoned objection or is of the\nopinion that the objection is not relevant or reasoned, submit the matter to the consistency mechanism referred to in\nArticle 63.\n5. Where the lead supervisory authority intends to follow the relevant and reasoned objection made, it shall submit\nto the other supervisory authorities concerned a revised draft decision for their opinion. That revised draft decision shall\nbe subject to the procedure referred to in paragraph 4 within a period of two weeks.\n6. Where none of the other supervisory authorities concerned has objected to the draft decision submitted by the\nlead supervisory authority within the period referred to in paragraphs 4 and 5, the lead supervisory authority and the\nsupervisory authorities concerned shall be deemed to be in agreement with that draft decision and shall be bound by it.\n7. The lead supervisory authority shall adopt and notify the decision to the main establishment or single\nestablishment of the controller or processor, as the case may be and inform the other supervisory authorities concerned\nand the Board of the decision in question, including a summary of the relevant facts and grounds. The supervisory\nauthority with which a complaint has been lodged shall inform the complainant on the decision.\n8. By derogation from paragraph 7, where a complaint is dismissed or rejected, the supervisory authority with which\nthe complaint was lodged shall adopt the decision and notify it to the complainant and shall inform the control", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Cooperation between the lead supervisory authority and the other supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 71, "page_end": 72, "chunk_index": 1} +{"id": "article-60-chunk-2", "text": "raph 7, where a complaint is dismissed or rejected, the supervisory authority with which\nthe complaint was lodged shall adopt the decision and notify it to the complainant and shall inform the controller\nthereof.\n9. Where the lead supervisory authority and the supervisory authorities concerned agree to dismiss or reject parts of\na complaint and to act on other parts of that complaint, a separate decision shall be adopted for each of those parts of\nthe matter. The lead supervisory authority shall adopt the decision for the part concerning actions in relation to the\ncontroller, shall notify it to the main establishment or single establishment of the controller or processor on the territory\nof its Member State and shall inform the complainant thereof, while the supervisory authority of the complainant shall\nadopt the decision for the part concerning dismissal or rejection of that complaint, and shall notify it to that\ncomplainant and shall inform the controller or processor thereof.\n10. After being notified of the decision of the lead supervisory authority pursuant to paragraphs 7 and 9, the\ncontroller or processor shall take the necessary measures to ensure compliance with the decision as regards processing\nactivities in the context of all its establishments in the Union. The controller or processor shall notify the measures\ntaken for complying with the decision to the lead supervisory authority, which shall inform the other supervisory\nauthorities concerned.\n11. Where, in exce", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Cooperation between the lead supervisory authority and the other supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 71, "page_end": 72, "chunk_index": 2} +{"id": "article-60-chunk-3", "text": "oller or processor shall notify the measures\ntaken for complying with the decision to the lead supervisory authority, which shall inform the other supervisory\nauthorities concerned.\n11. Where, in exceptional circumstances, a supervisory authority concerned has reasons to consider that there is an\nurgent need to act in order to protect the interests of data subjects, the urgency procedure referred to in Article 66 shall\napply.\n12. The lead supervisory authority and the other supervisory authorities concerned shall supply the information\nrequired under this Article to each other by electronic means, using a standardised format.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-60", "title": "Article 60 - Cooperation between the lead supervisory authority and the other supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 71, "page_end": 72, "chunk_index": 3} +{"id": "article-61-chunk-0", "text": "Article 61 - Mutual assistance\n\n1. Supervisory authorities shall provide each other with relevant information and mutual assistance in order to\nimplement and apply this Regulation in a consistent manner, and shall put in place measures for effective cooperation\nwith one another. Mutual assistance shall cover, in particular, information requests and supervisory measures, such as\nrequests to carry out prior authorisations and consultations, inspections and investigations.\n2. Each supervisory authority shall take all appropriate measures required to reply to a request of another supervisory\nauthority without undue delay and no later than one month after receiving the request. Such measures may include, in\nparticular, the transmission of relevant information on the conduct of an investigation.\n3. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the\nrequest. Information exchanged shall be used only for the purpose for which it was requested.\n4. The requested supervisory authority shall not refuse to comply with the request unless:\n(a) it is not competent for the subject-matter of the request or for the measures it is requested to execute; or\n(b) compliance with the request would infringe this Regulation or Union or Member State law to which the supervisory\nauthority receiving the request is subject.\n5. The requested supervisory authority shall inform the requesting supervisory authority of the results or, as the case\nmay be, of the progress of the me", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-61", "title": "Article 61 - Mutual assistance", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 72, "chunk_index": 0} +{"id": "article-61-chunk-1", "text": "ry\nauthority receiving the request is subject.\n5. The requested supervisory authority shall inform the requesting supervisory authority of the results or, as the case\nmay be, of the progress of the measures taken in order to respond to the request. The requested supervisory authority\nshall provide reasons for any refusal to comply with a request pursuant to paragraph 4.\n6. Requested supervisory authorities shall, as a rule, supply the information requested by other supervisory\nauthorities by electronic means, using a standardised format.\n7. Requested supervisory authorities shall not charge a fee for any action taken by them pursuant to a request for\nmutual assistance. Supervisory authorities may agree on rules to indemnify each other for specific expenditure arising\nfrom the provision of mutual assistance in exceptional circumstances.\n8. Where a supervisory authority does not provide the information referred to in paragraph 5 of this Article within\none month of receiving the request of another supervisory authority, the requesting supervisory authority may adopt a\nprovisional measure on the territory of its Member State in accordance with Article 55(1). In that case, the urgent need\nto act under Article 66(1) shall be presumed to be met and require an urgent binding decision from the Board pursuant\nto Article 66(2).\n9. The Commission may, by means of implementing acts, specify the format and procedures for mutual assistance\nreferred to in this Article and the arrangements fo", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-61", "title": "Article 61 - Mutual assistance", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 72, "chunk_index": 1} +{"id": "article-61-chunk-2", "text": "m the Board pursuant\nto Article 66(2).\n9. The Commission may, by means of implementing acts, specify the format and procedures for mutual assistance\nreferred to in this Article and the arrangements for the exchange of information by electronic means between\nsupervisory authorities, and between supervisory authorities and the Board, in particular the standardised format\nreferred to in paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination\nprocedure referred to in Article 93(2).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-61", "title": "Article 61 - Mutual assistance", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 72, "chunk_index": 2} +{"id": "article-62-chunk-0", "text": "Article 62 - Joint operations of supervisory authorities\n\n1. The supervisory authorities shall, where appropriate, conduct joint operations including joint investigations and\njoint enforcement measures in which members or staff of the supervisory authorities of other Member States are\ninvolved.\n2. Where the controller or processor has establishments in several Member States or where a significant number of\ndata subjects in more than one Member State are likely to be substantially affected by processing operations, a\nsupervisory authority of each of those Member States shall have the right to participate in joint operations. The\nsupervisory authority which is competent pursuant to Article 56(1) or (4) shall invite the supervisory authority of each\nof those Member States to take part in the joint operations and shall respond without delay to the request of a\nsupervisory authority to participate.\n3. A supervisory authority may, in accordance with Member State law, and with the seconding supervisory\nauthority's authorisation, confer powers, including investigative powers on the seconding supervisory authority's\nmembers or staff involved in joint operations or, in so far as the law of the Member State of the host supervisory\nauthority permits, allow the seconding supervisory authority's members or staff to exercise their investigative powers in\naccordance with the law of the Member State of the seconding supervisory authority. Such investigative powers may be\nexercised only under the guidance and in the presence of members or staff of th", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-62", "title": "Article 62 - Joint operations of supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 73, "chunk_index": 0} +{"id": "article-62-chunk-1", "text": "in\naccordance with the law of the Member State of the seconding supervisory authority. Such investigative powers may be\nexercised only under the guidance and in the presence of members or staff of the host supervisory authority. The\nseconding supervisory authority's members or staff shall be subject to the Member State law of the host supervisory\nauthority.\n4. Where, in accordance with paragraph 1, staff of a seconding supervisory authority operate in another Member\nState, the Member State of the host supervisory authority shall assume responsibility for their actions, including liability,\nfor any damage caused by them during their operations, in accordance with the law of the Member State in whose\nterritory they are operating.\n5. The Member State in whose territory the damage was caused shall make good such damage under the conditions\napplicable to damage caused by its own staff. The Member State of the seconding supervisory authority whose staff has\ncaused damage to any person in the territory of another Member State shall reimburse that other Member State in full\nany sums it has paid to the persons entitled on their behalf.\n6. Without prejudice to the exercise of its rights vis-à-vis third parties and with the exception of paragraph 5, each\nMember State shall refrain, in the case provided for in paragraph 1, from requesting reimbursement from another\nMember State in relation to damage referred to in paragraph 4.\n7. Where a joint operation is intended and a supervisory aut", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-62", "title": "Article 62 - Joint operations of supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 73, "chunk_index": 1} +{"id": "article-62-chunk-2", "text": "case provided for in paragraph 1, from requesting reimbursement from another\nMember State in relation to damage referred to in paragraph 4.\n7. Where a joint operation is intended and a supervisory authority does not, within one month, comply with the\nobligation laid down in the second sentence of paragraph 2 of this Article, the other supervisory authorities may adopt\na provisional measure on the territory of its Member State in accordance with Article 55. In that case, the urgent need\nto act under Article 66(1) shall be presumed to be met and require an opinion or an urgent binding decision from the\nBoard pursuant to Article 66(2).\nSection 2\nConsistency", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-62", "title": "Article 62 - Joint operations of supervisory authorities", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 72, "page_end": 73, "chunk_index": 2} +{"id": "article-63-chunk-0", "text": "Article 63 - Consistency mechanism\n\nIn order to contribute to the consistent application of this Regulation throughout the Union, the supervisory authorities\nshall cooperate with each other and, where relevant, with the Commission, through the consistency mechanism as set\nout in this Section.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-63", "title": "Article 63 - Consistency mechanism", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 73, "page_end": 73, "chunk_index": 0} +{"id": "article-64-chunk-0", "text": "Article 64 - Opinion of the Board\n\n1. The Board shall issue an opinion where a competent supervisory authority intends to adopt any of the measures\nbelow. To that end, the competent supervisory authority shall communicate the draft decision to the Board, when it:\n(a) aims to adopt a list of the processing operations subject to the requirement for a data protection impact assessment\npursuant to Article 35(4);\n(b) concerns a matter pursuant to Article 40(7) whether a draft code of conduct or an amendment or extension to a\ncode of conduct complies with this Regulation;\n(c) aims to approve the criteria for accreditation of a body pursuant to Article 41(3) or a certification body pursuant to\nArticle 43(3);\n(d) aims to determine standard data protection clauses referred to in point (d) of Article 46(2) and in Article 28(8);\n(e) aims to authorise contractual clauses referred to in point (a) of Article 46(3); or\n(f) aims to approve binding corporate rules within the meaning of Article 47.\n2. Any supervisory authority, the Chair of the Board or the Commission may request that any matter of general\napplication or producing effects in more than one Member State be examined by the Board with a view to obtaining an\nopinion, in particular where a competent supervisory authority does not comply with the obligations for mutual\nassistance in accordance with Article 61 or for joint operations in accordance with Article 62.\n3. In the cases referred to in paragraphs 1 and 2, the Board shall issue an opinion on the matter su", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-64", "title": "Article 64 - Opinion of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 73, "page_end": 74, "chunk_index": 0} +{"id": "article-64-chunk-1", "text": "ual\nassistance in accordance with Article 61 or for joint operations in accordance with Article 62.\n3. In the cases referred to in paragraphs 1 and 2, the Board shall issue an opinion on the matter submitted to it\nprovided that it has not already issued an opinion on the same matter. That opinion shall be adopted within eight weeks\nby simple majority of the members of the Board. That period may be extended by a further six weeks, taking into\naccount the complexity of the subject matter. Regarding the draft decision referred to in paragraph 1 circulated to the\nmembers of the Board in accordance with paragraph 5, a member which has not objected within a reasonable period\nindicated by the Chair, shall be deemed to be in agreement with the draft decision.\n4. Supervisory authorities and the Commission shall, without undue delay, communicate by electronic means to the\nBoard, using a standardised format any relevant information, including as the case may be a summary of the facts, the\ndraft decision, the grounds which make the enactment of such measure necessary, and the views of other supervisory\nauthorities concerned.\n5. The Chair of the Board shall, without undue, delay inform by electronic means:\n(a) the members of the Board and the Commission of any relevant information which has been communicated to it\nusing a standardised format. The secretariat of the Board shall, where necessary, provide translations of relevant\ninformation; and\n(b) the supervisory authority referred to,", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-64", "title": "Article 64 - Opinion of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 73, "page_end": 74, "chunk_index": 1} +{"id": "article-64-chunk-2", "text": "been communicated to it\nusing a standardised format. The secretariat of the Board shall, where necessary, provide translations of relevant\ninformation; and\n(b) the supervisory authority referred to, as the case may be, in paragraphs 1 and 2, and the Commission of the opinion\nand make it public.\n6. The competent supervisory authority shall not adopt its draft decision referred to in paragraph 1 within the period\nreferred to in paragraph 3.\n7. The supervisory authority referred to in paragraph 1 shall take utmost account of the opinion of the Board and\nshall, within two weeks after receiving the opinion, communicate to the Chair of the Board by electronic means whether\nit will maintain or amend its draft decision and, if any, the amended draft decision, using a standardised format.\n8. Where the supervisory authority concerned informs the Chair of the Board within the period referred to in\nparagraph 7 of this Article that it does not intend to follow the opinion of the Board, in whole or in part, providing the\nrelevant grounds, Article 65(1) shall apply.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-64", "title": "Article 64 - Opinion of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 73, "page_end": 74, "chunk_index": 2} +{"id": "article-65-chunk-0", "text": "Article 65 - Dispute resolution by the Board\n\n1. In order to ensure the correct and consistent application of this Regulation in individual cases, the Board shall\nadopt a binding decision in the following cases:\n(a) where, in a case referred to in Article 60(4), a supervisory authority concerned has raised a relevant and reasoned\nobjection to a draft decision of the lead authority or the lead authority has rejected such an objection as being not\nrelevant or reasoned. The binding decision shall concern all the matters which are the subject of the relevant and\nreasoned objection, in particular whether there is an infringement of this Regulation;\n(b) where there are conflicting views on which of the supervisory authorities concerned is competent for the main\nestablishment;\n(c) where a competent supervisory authority does not request the opinion of the Board in the cases referred to in\nArticle 64(1), or does not follow the opinion of the Board issued under Article 64. In that case, any supervisory\nauthority concerned or the Commission may communicate the matter to the Board.\n2. The decision referred to in paragraph 1 shall be adopted within one month from the referral of the subject-matter\nby a two-thirds majority of the members of the Board. That period may be extended by a further month on account of\nthe complexity of the subject-matter. The decision referred to in paragraph 1 shall be reasoned and addressed to the lead\nsupervisory authority and all the supervisory authorities concerned and binding on them.\n3. Where the", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Dispute resolution by the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 74, "page_end": 75, "chunk_index": 0} +{"id": "article-65-chunk-1", "text": "ubject-matter. The decision referred to in paragraph 1 shall be reasoned and addressed to the lead\nsupervisory authority and all the supervisory authorities concerned and binding on them.\n3. Where the Board has been unable to adopt a decision within the periods referred to in paragraph 2, it shall adopt\nits decision within two weeks following the expiration of the second month referred to in paragraph 2 by a simple\nmajority of the members of the Board. Where the members of the Board are split, the decision shall by adopted by the\nvote of its Chair.\n4. The supervisory authorities concerned shall not adopt a decision on the subject matter submitted to the Board\nunder paragraph 1 during the periods referred to in paragraphs 2 and 3.\n5. The Chair of the Board shall notify, without undue delay, the decision referred to in paragraph 1 to the supervisory\nauthorities concerned. It shall inform the Commission thereof. The decision shall be published on the website of the\nBoard without delay after the supervisory authority has notified the final decision referred to in paragraph 6.\n6. The lead supervisory authority or, as the case may be, the supervisory authority with which the complaint has\nbeen lodged shall adopt its final decision on the basis of the decision referred to in paragraph 1 of this Article, without\nundue delay and at the latest by one month after the Board has notified its decision. The lead supervisory authority or,\nas the case may be, the supervisory authority with wh", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Dispute resolution by the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 74, "page_end": 75, "chunk_index": 1} +{"id": "article-65-chunk-2", "text": "of this Article, without\nundue delay and at the latest by one month after the Board has notified its decision. The lead supervisory authority or,\nas the case may be, the supervisory authority with which the complaint has been lodged, shall inform the Board of the\ndate when its final decision is notified respectively to the controller or the processor and to the data subject. The final\ndecision of the supervisory authorities concerned shall be adopted under the terms of Article 60(7), (8) and (9). The\nfinal decision shall refer to the decision referred to in paragraph 1 of this Article and shall specify that the decision\nreferred to in that paragraph will be published on the website of the Board in accordance with paragraph 5 of this\nArticle. The final decision shall attach the decision referred to in paragraph 1 of this Article.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-65", "title": "Article 65 - Dispute resolution by the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 74, "page_end": 75, "chunk_index": 2} +{"id": "article-66-chunk-0", "text": "Article 66 - Urgency procedure\n\n1. In exceptional circumstances, where a supervisory authority concerned considers that there is an urgent need to\nact in order to protect the rights and freedoms of data subjects, it may, by way of derogation from the consistency\nmechanism referred to in Articles 63, 64 and 65 or the procedure referred to in Article 60, immediately adopt\nprovisional measures intended to produce legal effects on its own territory with a specified period of validity which shall\nnot exceed three months. The supervisory authority shall, without delay, communicate those measures and the reasons\nfor adopting them to the other supervisory authorities concerned, to the Board and to the Commission.\n2. Where a supervisory authority has taken a measure pursuant to paragraph 1 and considers that final measures\nneed urgently be adopted, it may request an urgent opinion or an urgent binding decision from the Board, giving\nreasons for requesting such opinion or decision.\n3. Any supervisory authority may request an urgent opinion or an urgent binding decision, as the case may be, from\nthe Board where a competent supervisory authority has not taken an appropriate measure in a situation where there is\nan urgent need to act, in order to protect the rights and freedoms of data subjects, giving reasons for requesting such\nopinion or decision, including for the urgent need to act.\n4. By derogation from Article 64(3) and Article 65(2), an urgent opinion or an urgent binding decision referred to in\nparagraphs 2 and", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Urgency procedure", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 75, "page_end": 75, "chunk_index": 0} +{"id": "article-66-chunk-1", "text": "g such\nopinion or decision, including for the urgent need to act.\n4. By derogation from Article 64(3) and Article 65(2), an urgent opinion or an urgent binding decision referred to in\nparagraphs 2 and 3 of this Article shall be adopted within two weeks by simple majority of the members of the Board.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-66", "title": "Article 66 - Urgency procedure", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 75, "page_end": 75, "chunk_index": 1} +{"id": "article-67-chunk-0", "text": "Article 67 - Exchange of information\n\nThe Commission may adopt implementing acts of general scope in order to specify the arrangements for the exchange\nof information by electronic means between supervisory authorities, and between supervisory authorities and the Board,\nin particular the standardised format referred to in Article 64.\nThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).\nSection 3\nEuropean dat a protection board", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-67", "title": "Article 67 - Exchange of information", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 76, "chunk_index": 0} +{"id": "article-68-chunk-0", "text": "Article 68 - European Data Protection Board\n\n1. The European Data Protection Board (the ‘Board’) is hereby established as a body of the Union and shall have legal\npersonality.\n2. The Board shall be represented by its Chair.\n3. The Board shall be composed of the head of one supervisory authority of each Member State and of the European\nData Protection Supervisor, or their respective representatives.\n4. Where in a Member State more than one supervisory authority is responsible for monitoring the application of\nthe provisions pursuant to this Regulation, a joint representative shall be appointed in accordance with that Member\nState's law.\n5. The Commission shall have the right to participate in the activities and meetings of the Board without voting\nright. The Commission shall designate a representative. The Chair of the Board shall communicate to the Commission\nthe activities of the Board.\n6. In the cases referred to in Article 65, the European Data Protection Supervisor shall have voting rights only on\ndecisions which concern principles and rules applicable to the Union institutions, bodies, offices and agencies which\ncorrespond in substance to those of this Regulation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-68", "title": "Article 68 - European Data Protection Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 76, "chunk_index": 0} +{"id": "article-69-chunk-0", "text": "Article 69 - Independence\n\n1. The Board shall act independently when performing its tasks or exercising its powers pursuant to Articles 70\nand 71.\n2. Without prejudice to requests by the Commission referred to in point (b) of Article 70(1) and in Article 70(2), the\nBoard shall, in the performance of its tasks or the exercise of its powers, neither seek nor take instructions from\nanybody.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-69", "title": "Article 69 - Independence", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 76, "chunk_index": 0} +{"id": "article-70-chunk-0", "text": "Article 70 - Tasks of the Board\n\n1. The Board shall ensure the consistent application of this Regulation. To that end, the Board shall, on its own\ninitiative or, where relevant, at the request of the Commission, in particular:\n(a) monitor and ensure the correct application of this Regulation in the cases provided for in Articles 64 and 65\nwithout prejudice to the tasks of national supervisory authorities;\n(b) advise the Commission on any issue related to the protection of personal data in the Union, including on any\nproposed amendment of this Regulation;\n(c) advise the Commission on the format and procedures for the exchange of information between controllers,\nprocessors and supervisory authorities for binding corporate rules;\n(d) issue guidelines, recommendations, and best practices on procedures for erasing links, copies or replications of\npersonal data from publicly available communication services as referred to in Article 17(2);\n(e) examine, on its own initiative, on request of one of its members or on request of the Commission, any question\ncovering the application of this Regulation and issue guidelines, recommendations and best practices in order to\nencourage consistent application of this Regulation;\n(f) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for further\nspecifying the criteria and conditions for decisions based on profiling pursuant to Article 22(2);\n(g) issue guidelines, recommendations and best practices in accordance with point", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 78, "chunk_index": 0} +{"id": "article-70-chunk-1", "text": "graph for further\nspecifying the criteria and conditions for decisions based on profiling pursuant to Article 22(2);\n(g) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing\nthe personal data breaches and determining the undue delay referred to in Article 33(1) and (2) and for the\nparticular circumstances in which a controller or a processor is required to notify the personal data breach;\n(h) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph as to the\ncircumstances in which a personal data breach is likely to result in a high risk to the rights and freedoms of the\nnatural persons referred to in Article 34(1).\n(i) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose\nof further specifying the criteria and requirements for personal data transfers based on binding corporate rules\nadhered to by controllers and binding corporate rules adhered to by processors and on further necessary\nrequirements to ensure the protection of personal data of the data subjects concerned referred to in Article 47;\n(j) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose\nof further specifying the criteria and requirements for the personal data transfers on the basis of Article 49(1);\n(k) draw up guidelines for supervisory authorities concerning the application o", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 78, "chunk_index": 1} +{"id": "article-70-chunk-2", "text": "pose\nof further specifying the criteria and requirements for the personal data transfers on the basis of Article 49(1);\n(k) draw up guidelines for supervisory authorities concerning the application of measures referred to in Article 58(1),\n(2) and (3) and the setting of administrative fines pursuant to Article 83;\n(l) review the practical application of the guidelines, recommendations and best practices referred to in points (e)\nand (f);\n(m) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing\ncommon procedures for reporting by natural persons of infringements of this Regulation pursuant to Article 54(2);\n(n) encourage the drawing-up of codes of conduct and the establishment of data protection certification mechanisms\nand data protection seals and marks pursuant to Articles 40 and 42;\n(o) carry out the accreditation of certification bodies and its periodic review pursuant to Article 43 and maintain a\npublic register of accredited bodies pursuant to Article 43(6) and of the accredited controllers or processors\nestablished in third countries pursuant to Article 42(7);\n(p) specify the requirements referred to in Article 43(3) with a view to the accreditation of certification bodies under\nArticle 42;\n(q) provide the Commission with an opinion on the certification requirements referred to in Article 43(8);\n(r) provide the Commission with an opinion on the icons referred to in Article 12(7);\n(s) provide the Co", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 78, "chunk_index": 2} +{"id": "article-70-chunk-3", "text": "he Commission with an opinion on the certification requirements referred to in Article 43(8);\n(r) provide the Commission with an opinion on the icons referred to in Article 12(7);\n(s) provide the Commission with an opinion for the assessment of the adequacy of the level of protection in a third\ncountry or international organisation, including for the assessment whether a third country, a territory or one or\nmore specified sectors within that third country, or an international organisation no longer ensures an adequate\nlevel of protection. To that end, the Commission shall provide the Board with all necessary documentation,\nincluding correspondence with the government of the third country, with regard to that third country, territory or\nspecified sector, or with the international organisation.\n(t) issue opinions on draft decisions of supervisory authorities pursuant to the consistency mechanism referred to in\nArticle 64(1), on matters submitted pursuant to Article 64(2) and to issue binding decisions pursuant to Article 65,\nincluding in cases referred to in Article 66;\n(u) promote the cooperation and the effective bilateral and multilateral exchange of information and best practices\nbetween the supervisory authorities;\n(v) promote common training programmes and facilitate personnel exchanges between the supervisory authorities and,\nwhere appropriate, with the supervisory authorities of third countries or with international organisations;\n(w) promote the exchange of knowl", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 78, "chunk_index": 3} +{"id": "article-70-chunk-4", "text": "sonnel exchanges between the supervisory authorities and,\nwhere appropriate, with the supervisory authorities of third countries or with international organisations;\n(w) promote the exchange of knowledge and documentation on data protection legislation and practice with data\nprotection supervisory authorities worldwide.\n(x) issue opinions on codes of conduct drawn up at Union level pursuant to Article 40(9); and\n(y) maintain a publicly accessible electronic register of decisions taken by supervisory authorities and courts on issues\nhandled in the consistency mechanism.\n2. Where the Commission requests advice from the Board, it may indicate a time limit, taking into account the\nurgency of the matter.\n3. The Board shall forward its opinions, guidelines, recommendations, and best practices to the Commission and to\nthe committee referred to in Article 93 and make them public.\n4. The Board shall, where appropriate, consult interested parties and give them the opportunity to comment within a\nreasonable period. The Board shall, without prejudice to Article 76, make the results of the consultation procedure\npublicly available.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-70", "title": "Article 70 - Tasks of the Board", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 76, "page_end": 78, "chunk_index": 4} +{"id": "article-71-chunk-0", "text": "Article 71 - Reports\n\n1. The Board shall draw up an annual report regarding the protection of natural persons with regard to processing in\nthe Union and, where relevant, in third countries and international organisations. The report shall be made public and\nbe transmitted to the European Parliament, to the Council and to the Commission.\n2. The annual report shall include a review of the practical application of the guidelines, recommendations and best\npractices referred to in point (l) of Article 70(1) as well as of the binding decisions referred to in Article 65.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-71", "title": "Article 71 - Reports", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 78, "page_end": 78, "chunk_index": 0} +{"id": "article-72-chunk-0", "text": "Article 72 - Procedure\n\n1. The Board shall take decisions by a simple majority of its members, unless otherwise provided for in this\nRegulation.\n2. The Board shall adopt its own rules of procedure by a two-thirds majority of its members and organise its own\noperational arrangements.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-72", "title": "Article 72 - Procedure", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 78, "page_end": 78, "chunk_index": 0} +{"id": "article-73-chunk-0", "text": "Article 73 - Chair\n\n1. The Board shall elect a chair and two deputy chairs from amongst its members by simple majority.\n2. The term of office of the Chair and of the deputy chairs shall be five years and be renewable once.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-73", "title": "Article 73 - Chair", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 78, "page_end": 78, "chunk_index": 0} +{"id": "article-74-chunk-0", "text": "Article 74 - Tasks of the Chair\n\n1. The Chair shall have the following tasks:\n(a) to convene the meetings of the Board and prepare its agenda;\n(b) to notify decisions adopted by the Board pursuant to Article 65 to the lead supervisory authority and the\nsupervisory authorities concerned;\n(c) to ensure the timely performance of the tasks of the Board, in particular in relation to the consistency mechanism\nreferred to in Article 63.\n2. The Board shall lay down the allocation of tasks between the Chair and the deputy chairs in its rules of procedure.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-74", "title": "Article 74 - Tasks of the Chair", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 79, "page_end": 79, "chunk_index": 0} +{"id": "article-75-chunk-0", "text": "Article 75 - Secretariat\n\n1. The Board shall have a secretariat, which shall be provided by the European Data Protection Supervisor.\n2. The secretariat shall perform its tasks exclusively under the instructions of the Chair of the Board.\n3. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by\nthis Regulation shall be subject to separate reporting lines from the staff involved in carrying out tasks conferred on the\nEuropean Data Protection Supervisor.\n4. Where appropriate, the Board and the European Data Protection Supervisor shall establish and publish a\nMemorandum of Understanding implementing this Article, determining the terms of their cooperation, and applicable\nto the staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this\nRegulation.\n5. The secretariat shall provide analytical, administrative and logistical support to the Board.\n6. The secretariat shall be responsible in particular for:\n(a) the day-to-day business of the Board;\n(b) communication between the members of the Board, its Chair and the Commission;\n(c) communication with other institutions and the public;\n(d) the use of electronic means for the internal and external communication;\n(e) the translation of relevant information;\n(f) the preparation and follow-up of the meetings of the Board;\n(g) the preparation, drafting and publication of opinions, decisions on the settlement of disputes between supervisory\nauthor", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-75", "title": "Article 75 - Secretariat", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 79, "page_end": 79, "chunk_index": 0} +{"id": "article-75-chunk-1", "text": "rmation;\n(f) the preparation and follow-up of the meetings of the Board;\n(g) the preparation, drafting and publication of opinions, decisions on the settlement of disputes between supervisory\nauthorities and other texts adopted by the Board.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-75", "title": "Article 75 - Secretariat", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 79, "page_end": 79, "chunk_index": 1} +{"id": "article-76-chunk-0", "text": "Article 76 - Confidentiality\n\n1. The discussions of the Board shall be confidential where the Board deems it necessary, as provided for in its rules\nof procedure.\n2. Access to documents submitted to members of the Board, experts and representatives of third parties shall be\ngoverned by Regulation (EC) No 1049/2001 of the European Parliament and of the Council (1).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-76", "title": "Article 76 - Confidentiality", "chapter_number": "VII", "chapter_title": "Cooperation and consistency", "page_start": 79, "page_end": 80, "chunk_index": 0} +{"id": "article-77-chunk-0", "text": "Article 77 - Right to lodge a complaint with a supervisory authority\n\n1. Without prejudice to any other administrative or judicial remedy, every data subject shall have the right to lodge a\ncomplaint with a supervisory authority, in particular in the Member State of his or her habitual residence, place of work\nor place of the alleged infringement if the data subject considers that the processing of personal data relating to him or\nher infringes this Regulation.\n2. The supervisory authority with which the complaint has been lodged shall inform the complainant on the progress\nand the outcome of the complaint including the possibility of a judicial remedy pursuant to Article 78.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-77", "title": "Article 77 - Right to lodge a complaint with a supervisory authority", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 80, "page_end": 80, "chunk_index": 0} +{"id": "article-78-chunk-0", "text": "Article 78 - Right to an effective judicial remedy against a supervisory authority\n\n1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the\nright to an effective judicial remedy against a legally binding decision of a supervisory authority concerning them.\n2. Without prejudice to any other administrative or non-judicial remedy, each data subject shall have the right to a an\neffective judicial remedy where the supervisory authority which is competent pursuant to Articles 55 and 56 does not\nhandle a complaint or does not inform the data subject within three months on the progress or outcome of the\ncomplaint lodged pursuant to Article 77.\n3. Proceedings against a supervisory authority shall be brought before the courts of the Member State where the\nsupervisory authority is established.\n4. Where proceedings are brought against a decision of a supervisory authority which was preceded by an opinion or\na decision of the Board in the consistency mechanism, the supervisory authority shall forward that opinion or decision\nto the court.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-78", "title": "Article 78 - Right to an effective judicial remedy against a supervisory authority", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 80, "page_end": 80, "chunk_index": 0} +{"id": "article-79-chunk-0", "text": "Article 79 - Right to an effective judicial remedy against a controller or processor\n\n1. Without prejudice to any available administrative or non-judicial remedy, including the right to lodge a complaint\nwith a supervisory authority pursuant to Article 77, each data subject shall have the right to an effective judicial remedy\nwhere he or she considers that his or her rights under this Regulation have been infringed as a result of the processing\nof his or her personal data in non-compliance with this Regulation.\n2. Proceedings against a controller or a processor shall be brought before the courts of the Member State where the\ncontroller or processor has an establishment. Alternatively, such proceedings may be brought before the courts of the\nMember State where the data subject has his or her habitual residence, unless the controller or processor is a public\nauthority of a Member State acting in the exercise of its public powers.\n(1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European\nParliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-79", "title": "Article 79 - Right to an effective judicial remedy against a controller or processor", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 80, "page_end": 80, "chunk_index": 0} +{"id": "article-80-chunk-0", "text": "Article 80 - Representation of data subjects\n\n1. The data subject shall have the right to mandate a not-for-profit body, organisation or association which has been\nproperly constituted in accordance with the law of a Member State, has statutory objectives which are in the public\ninterest, and is active in the field of the protection of data subjects' rights and freedoms with regard to the protection of\ntheir personal data to lodge the complaint on his or her behalf, to exercise the rights referred to in Articles 77, 78 and\n79 on his or her behalf, and to exercise the right to receive compensation referred to in Article 82 on his or her behalf\nwhere provided for by Member State law.\n2. Member States may provide that any body, organisation or association referred to in paragraph 1 of this Article, in­\ndependently of a data subject's mandate, has the right to lodge, in that Member State, a complaint with the supervisory\nauthority which is competent pursuant to Article 77 and to exercise the rights referred to in Articles 78 and 79 if it\nconsiders that the rights of a data subject under this Regulation have been infringed as a result of the processing.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-80", "title": "Article 80 - Representation of data subjects", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 81, "page_end": 81, "chunk_index": 0} +{"id": "article-81-chunk-0", "text": "Article 81 - Suspension of proceedings\n\n1. Where a competent court of a Member State has information on proceedings, concerning the same subject matter\nas regards processing by the same controller or processor, that are pending in a court in another Member State, it shall\ncontact that court in the other Member State to confirm the existence of such proceedings.\n2. Where proceedings concerning the same subject matter as regards processing of the same controller or processor\nare pending in a court in another Member State, any competent court other than the court first seized may suspend its\nproceedings.\n3. Where those proceedings are pending at first instance, any court other than the court first seized may also, on the\napplication of one of the parties, decline jurisdiction if the court first seized has jurisdiction over the actions in question\nand its law permits the consolidation thereof.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-81", "title": "Article 81 - Suspension of proceedings", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 81, "page_end": 81, "chunk_index": 0} +{"id": "article-82-chunk-0", "text": "Article 82 - Right to compensation and liability\n\n1. Any person who has suffered material or non-material damage as a result of an infringement of this Regulation\nshall have the right to receive compensation from the controller or processor for the damage suffered.\n2. Any controller involved in processing shall be liable for the damage caused by processing which infringes this\nRegulation. A processor shall be liable for the damage caused by processing only where it has not complied with\nobligations of this Regulation specifically directed to processors or where it has acted outside or contrary to lawful\ninstructions of the controller.\n3. A controller or processor shall be exempt from liability under paragraph 2 if it proves that it is not in any way\nresponsible for the event giving rise to the damage.\n4. Where more than one controller or processor, or both a controller and a processor, are involved in the same\nprocessing and where they are, under paragraphs 2 and 3, responsible for any damage caused by processing, each\ncontroller or processor shall be held liable for the entire damage in order to ensure effective compensation of the data\nsubject.\n5. Where a controller or processor has, in accordance with paragraph 4, paid full compensation for the damage\nsuffered, that controller or processor shall be entitled to claim back from the other controllers or processors involved in\nthe same processing that part of the compensation corresponding to their part of responsibility for the damage, in\naccordance with the conditions set o", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-82", "title": "Article 82 - Right to compensation and liability", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 81, "page_end": 82, "chunk_index": 0} +{"id": "article-82-chunk-1", "text": "the other controllers or processors involved in\nthe same processing that part of the compensation corresponding to their part of responsibility for the damage, in\naccordance with the conditions set out in paragraph 2.\n6. Court proceedings for exercising the right to receive compensation shall be brought before the courts competent\nunder the law of the Member State referred to in Article 79(2).", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-82", "title": "Article 82 - Right to compensation and liability", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 81, "page_end": 82, "chunk_index": 1} +{"id": "article-83-chunk-0", "text": "Article 83 - General conditions for imposing administrative fines\n\n1. Each supervisory authority shall ensure that the imposition of administrative fines pursuant to this Article in\nrespect of infringements of this Regulation referred to in paragraphs 4, 5 and 6 shall in each individual case be effective,\nproportionate and dissuasive.\n2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or\ninstead of, measures referred to in points (a) to (h) and (j) of Article 58(2). When deciding whether to impose an\nadministrative fine and deciding on the amount of the administrative fine in each individual case due regard shall be\ngiven to the following:\n(a) the nature, gravity and duration of the infringement taking into account the nature scope or purpose of the\nprocessing concerned as well as the number of data subjects affected and the level of damage suffered by them;\n(b) the intentional or negligent character of the infringement;\n(c) any action taken by the controller or processor to mitigate the damage suffered by data subjects;\n(d) the degree of responsibility of the controller or processor taking into account technical and organisational measures\nimplemented by them pursuant to Articles 25 and 32;\n(e) any relevant previous infringements by the controller or processor;\n(f) the degree of cooperation with the supervisory authority, in order to remedy the infringement and mitigate the\npossible adverse effects of the infringement;\n(g) the categories of personal data affected by the i", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - General conditions for imposing administrative fines", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 82, "page_end": 83, "chunk_index": 0} +{"id": "article-83-chunk-1", "text": "of cooperation with the supervisory authority, in order to remedy the infringement and mitigate the\npossible adverse effects of the infringement;\n(g) the categories of personal data affected by the infringement;\n(h) the manner in which the infringement became known to the supervisory authority, in particular whether, and if so\nto what extent, the controller or processor notified the infringement;\n(i) where measures referred to in Article 58(2) have previously been ordered against the controller or processor\nconcerned with regard to the same subject-matter, compliance with those measures;\n(j) adherence to approved codes of conduct pursuant to Article 40 or approved certification mechanisms pursuant to\nArticle 42; and\n(k) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits\ngained, or losses avoided, directly or indirectly, from the infringement.\n3. If a controller or processor intentionally or negligently, for the same or linked processing operations, infringes\nseveral provisions of this Regulation, the total amount of the administrative fine shall not exceed the amount specified\nfor the gravest infringement.\n4. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines\nup to 10 000 000 EUR, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the\npreceding financial year, whichever is higher:\n(a) the obligations of the c", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - General conditions for imposing administrative fines", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 82, "page_end": 83, "chunk_index": 1} +{"id": "article-83-chunk-2", "text": "ative fines\nup to 10 000 000 EUR, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the\npreceding financial year, whichever is higher:\n(a) the obligations of the controller and the processor pursuant to Articles 8, 11, 25 to 39 and 42 and 43;\n(b) the obligations of the certification body pursuant to Articles 42 and 43;\n(c) the obligations of the monitoring body pursuant to Article 41(4).\n5. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines\nup to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the\npreceding financial year, whichever is higher:\n(a) the basic principles for processing, including conditions for consent, pursuant to Articles 5, 6, 7 and 9;\n(b) the data subjects' rights pursuant to Articles 12 to 22;\n(c) the transfers of personal data to a recipient in a third country or an international organisation pursuant to\nArticles 44 to 49;\n(d) any obligations pursuant to Member State law adopted under Chapter IX;\n(e) non-compliance with an order or a temporary or definitive limitation on processing or the suspension of data flows\nby the supervisory authority pursuant to Article 58(2) or failure to provide access in violation of Article 58(1).\n6. Non-compliance with an order by the supervisory authority as referred to in Article 58(2) shall, in accordance\nwith paragraph 2 of this Article, be subject to administrat", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - General conditions for imposing administrative fines", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 82, "page_end": 83, "chunk_index": 2} +{"id": "article-83-chunk-3", "text": "iolation of Article 58(1).\n6. Non-compliance with an order by the supervisory authority as referred to in Article 58(2) shall, in accordance\nwith paragraph 2 of this Article, be subject to administrative fines up to 20 000 000 EUR, or in the case of an\nundertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher.\n7. Without prejudice to the corrective powers of supervisory authorities pursuant to Article 58(2), each\nMember State may lay down the rules on whether and to what extent administrative fines may be imposed on public\nauthorities and bodies established in that Member State.\n8. The exercise by the supervisory authority of its powers under this Article shall be subject to appropriate\nprocedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due\nprocess.\n9. Where the legal system of the Member State does not provide for administrative fines, this Article may be applied\nin such a manner that the fine is initiated by the competent supervisory authority and imposed by competent national\ncourts, while ensuring that those legal remedies are effective and have an equivalent effect to the administrative fines\nimposed by supervisory authorities. In any event, the fines imposed shall be effective, proportionate and dissuasive.\nThose Member States shall notify to the Commission the provisions of their laws which they adopt pursuant to this\nparagraph by 25 May 2018 and, without", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - General conditions for imposing administrative fines", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 82, "page_end": 83, "chunk_index": 3} +{"id": "article-83-chunk-4", "text": "all be effective, proportionate and dissuasive.\nThose Member States shall notify to the Commission the provisions of their laws which they adopt pursuant to this\nparagraph by 25 May 2018 and, without delay, any subsequent amendment law or amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-83", "title": "Article 83 - General conditions for imposing administrative fines", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 82, "page_end": 83, "chunk_index": 4} +{"id": "article-84-chunk-0", "text": "Article 84 - Penalties\n\n1. Member States shall lay down the rules on other penalties applicable to infringements of this Regulation in\nparticular for infringements which are not subject to administrative fines pursuant to Article 83, and shall take all\nmeasures necessary to ensure that they are implemented. Such penalties shall be effective, proportionate and dissuasive.\n2. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to\nparagraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-84", "title": "Article 84 - Penalties", "chapter_number": "VIII", "chapter_title": "Remedies, liability and penalties", "page_start": 83, "page_end": 83, "chunk_index": 0} +{"id": "article-85-chunk-0", "text": "Article 85 - Processing and freedom of expression and information\n\n1. Member States shall by law reconcile the right to the protection of personal data pursuant to this Regulation with\nthe right to freedom of expression and information, including processing for journalistic purposes and the purposes of\nacademic, artistic or literary expression.\n2. For processing carried out for journalistic purposes or the purpose of academic artistic or literary expression,\nMember States shall provide for exemptions or derogations from Chapter II (principles), Chapter III (rights of the data\nsubject), Chapter IV (controller and processor), Chapter V (transfer of personal data to third countries or international\norganisations), Chapter VI (independent supervisory authorities), Chapter VII (cooperation and consistency) and\nChapter IX (specific data processing situations) if they are necessary to reconcile the right to the protection of personal\ndata with the freedom of expression and information.\n3. Each Member State shall notify to the Commission the provisions of its law which it has adopted pursuant to\nparagraph 2 and, without delay, any subsequent amendment law or amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-85", "title": "Article 85 - Processing and freedom of expression and information", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 83, "page_end": 84, "chunk_index": 0} +{"id": "article-86-chunk-0", "text": "Article 86 - Processing and public access to official documents\n\nPersonal data in official documents held by a public authority or a public body or a private body for the performance of\na task carried out in the public interest may be disclosed by the authority or body in accordance with Union or Member\nState law to which the public authority or body is subject in order to reconcile public access to official documents with\nthe right to the protection of personal data pursuant to this Regulation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-86", "title": "Article 86 - Processing and public access to official documents", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 84, "page_end": 84, "chunk_index": 0} +{"id": "article-87-chunk-0", "text": "Article 87 - Processing of the national identification number\n\nMember States may further determine the specific conditions for the processing of a national identification number or\nany other identifier of general application. In that case the national identification number or any other identifier of\ngeneral application shall be used only under appropriate safeguards for the rights and freedoms of the data subject\npursuant to this Regulation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-87", "title": "Article 87 - Processing of the national identification number", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 84, "page_end": 84, "chunk_index": 0} +{"id": "article-88-chunk-0", "text": "Article 88 - Processing in the context of employment\n\n1. Member States may, by law or by collective agreements, provide for more specific rules to ensure the protection of\nthe rights and freedoms in respect of the processing of employees' personal data in the employment context, in\nparticular for the purposes of the recruitment, the performance of the contract of employment, including discharge of\nobligations laid down by law or by collective agreements, management, planning and organisation of work, equality and\ndiversity in the workplace, health and safety at work, protection of employer's or customer's property and for the\npurposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to\nemployment, and for the purpose of the termination of the employment relationship.\n2. Those rules shall include suitable and specific measures to safeguard the data subject's human dignity, legitimate\ninterests and fundamental rights, with particular regard to the transparency of processing, the transfer of personal data\nwithin a group of undertakings, or a group of enterprises engaged in a joint economic activity and monitoring systems\nat the work place.\n3. Each Member State shall notify to the Commission those provisions of its law which it adopts pursuant to\nparagraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-88", "title": "Article 88 - Processing in the context of employment", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 84, "page_end": 84, "chunk_index": 0} +{"id": "article-89-chunk-0", "text": "Article 89 - Safeguards and derogations relating to processing for archiving purposes in the public interest,\n\nscientific or historical research purposes or statistical purposes\n1. Processing for archiving purposes in the public interest, scientific or historical research purposes or statistical\npurposes, shall be subject to appropriate safeguards, in accordance with this Regulation, for the rights and freedoms of\nthe data subject. Those safeguards shall ensure that technical and organisational measures are in place in particular in\norder to ensure respect for the principle of data minimisation. Those measures may include pseudonymisation provided\nthat those purposes can be fulfilled in that manner. Where those purposes can be fulfilled by further processing which\ndoes not permit or no longer permits the identification of data subjects, those purposes shall be fulfilled in that manner.\n2. Where personal data are processed for scientific or historical research purposes or statistical purposes, Union or\nMember State law may provide for derogations from the rights referred to in Articles 15, 16, 18 and 21 subject to the\nconditions and safeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render\nimpossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the\nfulfilment of those purposes.\n3. Where personal data are processed for archiving purposes in the public interest, Union or Member State law may\nprovide for derogations from the rights referred to in Articles 15, 16, 18, 19, 20 and 21 subject to", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-89", "title": "Article 89 - Safeguards and derogations relating to processing for archiving purposes in the public interest,", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 84, "page_end": 85, "chunk_index": 0} +{"id": "article-89-chunk-1", "text": "al data are processed for archiving purposes in the public interest, Union or Member State law may\nprovide for derogations from the rights referred to in Articles 15, 16, 18, 19, 20 and 21 subject to the conditions and\nsafeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render impossible or seriously\nimpair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of those\npurposes.\n4. Where processing referred to in paragraphs 2 and 3 serves at the same time another purpose, the derogations shall\napply only to processing for the purposes referred to in those paragraphs.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-89", "title": "Article 89 - Safeguards and derogations relating to processing for archiving purposes in the public interest,", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 84, "page_end": 85, "chunk_index": 1} +{"id": "article-90-chunk-0", "text": "Article 90 - Obligations of secrecy\n\n1. Member States may adopt specific rules to set out the powers of the supervisory authorities laid down in points (e)\nand (f) of Article 58(1) in relation to controllers or processors that are subject, under Union or Member State law or\nrules established by national competent bodies, to an obligation of professional secrecy or other equivalent obligations\nof secrecy where this is necessary and proportionate to reconcile the right of the protection of personal data with the\nobligation of secrecy. Those rules shall apply only with regard to personal data which the controller or processor has\nreceived as a result of or has obtained in an activity covered by that obligation of secrecy.\n2. Each Member State shall notify to the Commission the rules adopted pursuant to paragraph 1, by 25 May 2018\nand, without delay, any subsequent amendment affecting them.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-90", "title": "Article 90 - Obligations of secrecy", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 85, "page_end": 85, "chunk_index": 0} +{"id": "article-91-chunk-0", "text": "Article 91 - Existing data protection rules of churches and religious associations\n\n1. Where in a Member State, churches and religious associations or communities apply, at the time of entry into\nforce of this Regulation, comprehensive rules relating to the protection of natural persons with regard to processing,\nsuch rules may continue to apply, provided that they are brought into line with this Regulation.\n2. Churches and religious associations which apply comprehensive rules in accordance with paragraph 1 of this\nArticle shall be subject to the supervision of an independent supervisory authority, which may be specific, provided that\nit fulfils the conditions laid down in Chapter VI of this Regulation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-91", "title": "Article 91 - Existing data protection rules of churches and religious associations", "chapter_number": "IX", "chapter_title": "Provisions relating to specific processing situations", "page_start": 85, "page_end": 85, "chunk_index": 0} +{"id": "article-92-chunk-0", "text": "Article 92 - Exercise of the delegation\n\n1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this\nArticle.\n2. The delegation of power referred to in Article 12(8) and Article 43(8) shall be conferred on the Commission for\nan indeterminate period of time from 24 May 2016.\n3. The delegation of power referred to in Article 12(8) and Article 43(8) may be revoked at any time by the\nEuropean Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in\nthat decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at\na later date specified therein. It shall not affect the validity of any delegated acts already in force.\n4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and\nto the Council.\n5. A delegated act adopted pursuant to Article 12(8) and Article 43(8) shall enter into force only if no objection has\nbeen expressed by either the European Parliament or the Council within a period of three months of notification of that\nact to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the\nCouncil have both informed the Commission that they will not object. That period shall be extended by three months at\nthe initiative of the European Parliament or of the Council.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-92", "title": "Article 92 - Exercise of the delegation", "chapter_number": "X", "chapter_title": "Delegated acts and implementing acts", "page_start": 85, "page_end": 86, "chunk_index": 0} +{"id": "article-93-chunk-0", "text": "Article 93 - Committee procedure\n\n1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of\nRegulation (EU) No 182/2011.\n2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.\n3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with\nArticle 5 thereof, shall apply.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-93", "title": "Article 93 - Committee procedure", "chapter_number": "X", "chapter_title": "Delegated acts and implementing acts", "page_start": 86, "page_end": 86, "chunk_index": 0} +{"id": "article-94-chunk-0", "text": "Article 94 - Repeal of Directive 95/46/EC\n\n1. Directive 95/46/EC is repealed with effect from 25 May 2018.\n2. References to the repealed Directive shall be construed as references to this Regulation. References to the Working\nParty on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of\nDirective 95/46/EC shall be construed as references to the European Data Protection Board established by this\nRegulation.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-94", "title": "Article 94 - Repeal of Directive 95/46/EC", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 86, "page_end": 86, "chunk_index": 0} +{"id": "article-95-chunk-0", "text": "Article 95 - Relationship with Directive 2002/58/EC\n\nThis Regulation shall not impose additional obligations on natural or legal persons in relation to processing in\nconnection with the provision of publicly available electronic communications services in public communication\nnetworks in the Union in relation to matters for which they are subject to specific obligations with the same objective\nset out in Directive 2002/58/EC.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-95", "title": "Article 95 - Relationship with Directive 2002/58/EC", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 86, "page_end": 86, "chunk_index": 0} +{"id": "article-96-chunk-0", "text": "Article 96 - Relationship with previously concluded Agreements\n\nInternational agreements involving the transfer of personal data to third countries or international organisations which\nwere concluded by Member States prior to 24 May 2016, and which comply with Union law as applicable prior to that\ndate, shall remain in force until amended, replaced or revoked.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-96", "title": "Article 96 - Relationship with previously concluded Agreements", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 87, "page_end": 87, "chunk_index": 0} +{"id": "article-97-chunk-0", "text": "Article 97 - Commission reports\n\n1. By 25 May 2020 and every four years thereafter, the Commission shall submit a report on the evaluation and\nreview of this Regulation to the European Parliament and to the Council. The reports shall be made public.\n2. In the context of the evaluations and reviews referred to in paragraph 1, the Commission shall examine, in\nparticular, the application and functioning of:\n(a) Chapter V on the transfer of personal data to third countries or international organisations with particular regard to\ndecisions adopted pursuant to Article 45(3) of this Regulation and decisions adopted on the basis of Article 25(6) of\nDirective 95/46/EC;\n(b) Chapter VII on cooperation and consistency.\n3. For the purpose of paragraph 1, the Commission may request information from Member States and supervisory\nauthorities.\n4. In carrying out the evaluations and reviews referred to in paragraphs 1 and 2, the Commission shall take into\naccount the positions and findings of the European Parliament, of the Council, and of other relevant bodies or sources.\n5. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking\ninto account of developments in information technology and in the light of the state of progress in the information\nsociety.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-97", "title": "Article 97 - Commission reports", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 87, "page_end": 87, "chunk_index": 0} +{"id": "article-98-chunk-0", "text": "Article 98 - Review of other Union legal acts on data protection\n\nThe Commission shall, if appropriate, submit legislative proposals with a view to amending other Union legal acts on\nthe protection of personal data, in order to ensure uniform and consistent protection of natural persons with regard to\nprocessing. This shall in particular concern the rules relating to the protection of natural persons with regard to\nprocessing by Union institutions, bodies, offices and agencies and on the free movement of such data.", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-98", "title": "Article 98 - Review of other Union legal acts on data protection", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 87, "page_end": 87, "chunk_index": 0} +{"id": "article-99-chunk-0", "text": "Article 99 - Entry into force and application\n\n1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of\nthe European Union.\n2. It shall apply from 25 May 2018.\nThis Regulation shall be binding in its entirety and directly applicable in all Member States.\nDone at Brussels, 27 April 2016.\nFor the European Parliament\nThe President\nM. SCHULZ\nFor the Council\nThe President\nJ.A. HENNIS-PLASSCHAERT", "document_id": "gdpr", "celex_id": "32016R0679", "ref_type": "article", "ref_id": "article-99", "title": "Article 99 - Entry into force and application", "chapter_number": "XI", "chapter_title": "Final provisions", "page_start": 87, "page_end": 88, "chunk_index": 0}