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Such substances should be continuously reviewed by the SCCS. El CCSC debe revisar continuamente esas sustancias. 32009R1223_en |
(33) (33) 32009R1223_en |
A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources. En la evaluación de seguridad de las sustancias, en particular de las clasificadas como CMR 1A o 1B, debe examinarse la exposición global a esas... |
At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates. Resulta asimismo esencial dotar a todos los que intervienen en la realización de evaluaciones de seguridad de un enfoque armonizado sob... |
In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for ... |
(34) (34) 32009R1223_en |
The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised i... |
(35) (35) 32009R1223_en |
The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products. El CCSC debe asesorar, cuando sea oportuno, sobre la seguridad del uso de nanomateriales en productos cosméticos. 32009R1223_en |
These opinions should be based on full information being made available by the responsible person. Dichos dictámenes deben basarse en información exhaustiva facilitada por la persona responsable. 32009R1223_en |
(36) (36) 32009R1223_en |
Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle. Las acciones de la Comisión y de los Estados miembros relativas a la protección de la salud humana deben basarse en el principio de cautela. 32009R1223_en |
(37) (37) 32009R1223_en |
In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe. Para garantizar la seguridad de los productos, las sustancias prohibidas solo deben ser aceptables como tr... |
(38) (38) 32009R1223_en |
The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market. El Protocolo sobre la protección y el bie... |
(39) (39) 32009R1223_en |
Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes ( 10) established common rules for the use of animals for experimental purposes within the... |
In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory. En particular, su artículo 7 requiere que los experimentos con animales se sustituyan por métodos alternativos, en la medida en que éstos existan ... |
(40) (40) 32009R1223_en |
The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Es posible garantizar la seguridad de los productos cosméticos y de sus ingredientes mediante métodos alternativos que no son necesariamen... |
Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers. Conviene, por tanto, promover la utilización de dichos métodos en el conjunto de la industria cosmética y asegurar ... |
(41) (41) 32009R1223_en |
The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Actualmente es posible garantizar la inocuidad de los productos cosméticos acabados sobre la base de los conocimientos relativos a la seguridad de los ingredientes que contienen.... |
Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. Por tanto, conviene adoptar disposiciones en virtud de las cuales se prohíba la realización de experimentos en animales con los productos cosméticos acabados. 32009R1223_en |
The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be fa... |
(42) (42) 32009R1223_en |
It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the develop... |
After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. Previa consulta al CCSC sobre la aplicabilidad al sector de los p... |
In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition. Para lograr el mayor nivel posible de protección de los animales, se debe prever un plazo para la prohibición definitiva de los experimentos con animales. 32009R1223_en |
(43) (43) 32009R1223_en |
The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals. La Comisión ha establecido un... |
In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013. No obstante, para los experimentos en materia de toxicidad por administr... |
On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit. Basándose en informes anuales, la Comisión debe estar autorizada para adaptar el calendario respetando los plazos máximos mencionados. 32009R1223_en |
(44) (44) 32009R1223_en |
Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. Una mejor coordinación de los recursos a escala comunitaria contribuirá a profundizar los conocimientos científicos indispensables para el desarrollo de mé... |
It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research. En ese sentido, es esencial que la Comunidad prosig... |
(45) (45) 32009R1223_en |
The recognition by third countries of alternative methods developed in the Community should be encouraged. Debe fomentarse el reconocimiento, por los terceros países, de métodos alternativos desarrollados en la Comunidad. 32009R1223_en |
In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. A tal fin, la Comisión y los Estados miembros deben tomar las medidas adecuadas para facilitar la aceptación de dichos métodos por parte de la OCDE. 32009R1223... |
The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered ... |
(46) (46) 32009R1223_en |
Transparency is needed regarding the ingredients used in cosmetic products. Es necesaria una transparencia con respecto a los ingredientes empleados en los productos cosméticos. 32009R1223_en |
Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging. Esta transparencia ha de conseguirse mediante la indicación del nombre de los ingredientes empleados en los productos cosméticos en su embalaje. 32009R1223_en |
Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information. Si resulta imposible, desde el punto de vista práctico, indicar estos ingredientes en el embalaje, es conveniente que dichas indicaciones se... |
(47) (47) 32009R1223_en |
A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. La Comisión debe elaborar un glosario de nombres comunes de ingredientes a fin de garantizar un etiquetado uniforme y facilitar la identificación de los ingre... |
This glossary should not be intended to constitute a limitative list of substances used in cosmetic products. Este glosario no debe estar destinado a constituir una lista limitativa de las sustancias empleadas en los productos cosméticos. 32009R1223_en |
(48) (48) 32009R1223_en |
In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. A fin de informar a los consumidores, los productos cosméticos deben incluir indicaciones precisas y fácilmente comprensibles en cuanto al plazo para su utilización. 32009R1223_... |
Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Dado que los consumidores deben ser informados de la fecha hast... |
Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. Cuando la duración mínima sea superior a treinta meses, el consumidor debe ser informado del plazo en el que el producto cosmét... |
However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open. No obstante, este requisito no debe ser de aplicación cuando el concepto de durabilidad después de la... |
(49) (49) 32009R1223_en |
A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. El CCSC ha constatado que varias sustancias pueden causar reacciones alérgicas; será necesario restringir su uso o imponer determ... |
In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. Para que los consumidores estén adecuadamente informados, conviene que la presencia de dichas sustanci... |
This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. Esta información mejorará probablemente el diagnóstico de las alergias de contacto que afectan a los consumidores, permitiéndoles evitar la utilizac... |
For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered. Para las sustancias que pueden provocar alergia a una parte significativa de la población, deben considerarse otras medidas restricti... |
(50) (50) 32009R1223_en |
In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. En la evaluación de la seguridad de un producto cosmético debe ser posible tener presentes los resultados de las evaluaciones de riesgo realizadas en ... |
The use of such data should be duly substantiated and justified. La utilización de tales datos debe estar debidamente documentada y justificada. 32009R1223_en |
(51) (51) 32009R1223_en |
The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. Debe protegerse al consumidor frente a reivindicaciones engañosas relativas a la eficacia y otras características de los productos cosméticos. 32009R1223_en |
In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market ( 11) is applicable. En particular, es de aplicación la Directiva 2005/29/CE del Parlamento Europeo y del Consejo, de 11 de mayo de 2005, rel... |
Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products. Asimismo, la Comisión, en cooperación con los Estados miembros, debe definir criterios comunes en relación con ciertas reivindicaciones para los productos cosméticos. 32009... |
(52) (52) 32009R1223_en |
It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. Se debe poder indicar en un producto cosmético que para su desarrollo no se ha recurrido a la experimentación en animales. 32009R1223_en |
The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. La Comisión, previa consulta a los Estados miembros... |
In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the ‘non-animal testing’ producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between produ... |
(53) (53) 32009R1223_en |
In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices. Además de la información que figure en la etiqueta, debe darse a los consumidores la posibilidad de pedir información s... |
(54) (54) 32009R1223_en |
Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected. Para garantizar el respeto de las disposiciones del presente Reglamento se requiere una vigilancia eficaz del mercado. 32009R1223_en |
To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety. Para ello, los efectos graves no deseados deben notificarse, y las... |
(55) (55) 32009R1223_en |
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States. El presente Reglamento se entiende sin perjuicio de la posibilidad ... |
(56) (56) 32009R1223_en |
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products. El presente Reglamento se entiende sin perjuicio de la posibilidad de que los Estados miembros regulen, en cumplimiento del D... |
(57) (57) 32009R1223_en |
In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary. Para el caso de incumplimiento del presente Reglamento, puede ser necesario disponer de un procedimiento claro y eficiente para la retirada y recuperación de productos. 32009R1223_... |
This procedure should, where possible, build upon existing Community rules for unsafe goods. Tal procedimiento debe basarse, dentro de lo posible, en normas comunitarias existentes sobre mercancías no seguras. 32009R1223_en |
(58) (58) 32009R1223_en |
In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced. Para responder frente a los productos cosméticos que, a pesar de cumplir las prescripciones del presente Reglamento, puedan poner en peligro la ... |
(59) (59) 32009R1223_en |
The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation. La Comisión debe proporcionar indicaciones para una interpretación y una aplicación uniformes del concepto de riesgo grave, co... |
(60) (60) 32009R1223_en |
In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated. Para cumplir los principios de buenas prácticas administrativas, conviene que cualquier decisión de una autoridad competente adoptada en el mar... |
(61) (61) 32009R1223_en |
In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary. Para velar por un control eficiente del mercado es necesario un elevado grado de cooperación entre las autoridades competentes. 32009R1223_en |
This concerns in particular mutual assistance in the verification of product information files located in another Member State. Esto implica, en concreto, la asistencia mutua en la verificación de expedientes de información sobre productos que se encuentren en otro Estado miembro. 32009R1223_en |
(62) (62) 32009R1223_en |
The Commission should be assisted by the SCCS, an independent risk assessment body. La Comisión debe estar asistida por el CCSC, un organismo de evaluación de riesgos independiente. 32009R1223_en |
(63) (63) 32009R1223_en |
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 12). Procede aprobar las medidas necesarias para la ejecución del presente R... |
(64) (64) 32009R1223_en |
In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress. Conviene, en particular, conferir competencias a la Comisión para que adapte al progreso técnico los anexos del presente Reglamento. 32009R1223_en |
Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. Dado que estas medidas son de alcance general y están destinadas a modificar el... |
(65) (65) 32009R1223_en |
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures relating to CMRs, nanomaterials and p... |
(66) (66) 32009R1223_en |
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