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22.12.2009 22.12.2009 32009R1223_en |
EN ES 32009R1223_en |
Official Journal of the European Union Diario Oficial de la Unión Europea 32009R1223_en |
L 342/59 L 342/59 32009R1223_en |
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL REGLAMENTO (CE) N o 1223/2009 DEL PARLAMENTO EUROPEO Y DEL CONSEJO 32009R1223_en |
of 30 November 2009 de 30 de noviembre de 2009 32009R1223_en |
on cosmetic products sobre los productos cosméticos 32009R1223_en |
(recast) (versión refundida) 32009R1223_en |
(Text with EEA relevance) (Texto pertinente a efectos del EEE) 32009R1223_en |
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, EL PARLAMENTO EUROPEO Y EL CONSEJO DE LA UNIÓN EUROPEA, 32009R1223_en |
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Visto el Tratado constitutivo de la Comunidad Europea, y en particular su artículo 95, 32009R1223_en |
Having regard to the proposal from the Commission, Vista la propuesta de la Comisión, 32009R1223_en |
Having regard to the opinion of the European Economic and Social Committee ( 1), Visto el dictamen del Comité Económico y Social Europeo ( 1), 32009R1223_en |
Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2), De conformidad con el procedimiento establecido en el artículo 251 del Tratado ( 2), 32009R1223_en |
Whereas: Considerando lo siguiente: 32009R1223_en |
(1) (1) 32009R1223_en |
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ( 3) has been significantly amended on several occasions. La Directiva 76/768/CEE del Consejo, de 27 de julio de 1976, relativa a la aproximación de las legislaciones de los Estados miembros ... |
Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity. Con motivo de nuevas modificaciones, conviene en este caso particular, en aras de una mayor claridad, proceder a la refundición de dicha Directiva. 32009R1223_en |
(2) (2) 32009R1223_en |
A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Un reglamento es el instrumento jurídico apropiado, ya que impone normas claras y detalladas que no dejan lugar para transposiciones divergentes por parte de los E... |
Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community. Además, un reglamento garantiza que los requisitos legales se apliquen al mismo tiempo en toda la Comunidad. 32009R1223_en |
(3) (3) 32009R1223_en |
This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. El presente Reglamento tiene por objeto simplificar los procedimientos y racionalizar la terminología, reduciendo así cargas administrativas y ambigüedades. 32009R1223_en |
Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health. Además, refuerza determinados elementos del marco regulador de los cosméticos, como el control del mercado, con el fin de garantizar un elev... |
(4) (4) 32009R1223_en |
This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health. El presente Reglamento armoniza íntegramente las normas comunitarias a fin de lograr un mercado interior para los productos cosmét... |
(5) (5) 32009R1223_en |
The environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establis... |
(6) (6) 32009R1223_en |
This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. El presente Reglamento se refiere sólo a los productos cosméticos y no a los medicamentos, los productos sanitarios o los biocidas. 32009R1223_en |
The delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use. La delimitación se deriva, fundamentalmente, de la definición detallada de los productos cosméticos, la cual contiene indicaciones tanto de los luga... |
(7) (7) 32009R1223_en |
The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product. Para determinar si un producto es un producto cosmético ha de efectuarse un análisis caso por caso, teniendo en cuenta todas las características del... |
Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, g... |
(8) (8) 32009R1223_en |
The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation. La Comisión debe definir las categorías de productos cosméticos que son pertinentes para la aplicación del presente Reglamento. 32009R1223_en |
(9) (9) 32009R1223_en |
Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. Los productos cosméticos deben ser seguros en condiciones de utilización normales o razonablemente previsibles. 32009R1223_en |
In particular, a risk-benefit reasoning should not justify a risk to human health. En especial, un razonamiento basado en el balance entre riesgos y beneficios no debe servir como justificación de un riesgo para la salud humana. 32009R1223_en |
(10) (10) 32009R1223_en |
The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the ... |
(11) (11) 32009R1223_en |
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. Con objeto de establecer claras responsabilidades, procede disponer que cada producto esté relacionado con una persona responsable establecida en la Comunidad. 32009R1223_en |
(12) (12) 32009R1223_en |
Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. La garantía de la trazabilidad de un producto cosmético en toda la cadena de suministro contribuye a simplificar y hacer más eficaz la vigilancia del mercado. 32009R1223_en |
An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators. Un sistema eficiente de trazabilidad facilita la tarea de las autoridades de vigilancia del mercado de localizar a los operadores económicos. 32009R1223_en |
(13) (13) 32009R1223_en |
It is necessary to determine under which conditions a distributor is to be considered as the responsible person. Es necesario determinar las condiciones en las que un distribuidor ha de considerarse como la persona responsable. 32009R1223_en |
(14) (14) 32009R1223_en |
All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. Todas las personas físicas o jurídicas en el comercio al por mayor, así como los minoristas que vendan directamente al consumidor, están amparados por referencia al dist... |
The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators. Las obligaciones del distribuidor, por lo tanto, deben adaptarse al papel y a la parte de la actividad respectivos de cada uno de estos operadores. 32009R1223_en |
(15) (15) 32009R1223_en |
The European cosmetics sector is one of the industrial activities affected by counterfeiting, which may increase risks to human health. El sector europeo de los cosméticos es una de las actividades industriales víctimas de falsificación, lo que puede incrementar los riesgos para la salud humana. 32009R1223_en |
Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain ... |
In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation. Los controles del mercado constituyen una herramienta poderosa para identificar los productos que no cumplan los requisitos del presente Reglamento. 32009R1223_en |
(16) (16) 32009R1223_en |
To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice. Para garantizar su seguridad, los productos cosméticos que se introduzcan en el mercado deben ser elaborados conforme a buenas prácticas de fabricación. 32009R1223_en |
(17) (17) 32009R1223_en |
For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. Para una efectiva vigilancia del mercado, un expediente de información sobre el producto d... |
(18) (18) 32009R1223_en |
In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation. Para ser comparables y de alta calidad, los resultados de los estudios no clínicos de seguridad ... |
(19) (19) 32009R1223_en |
It should be made clear which information is to be made available to the competent authorities. Procede precisar qué datos deben ponerse a disposición de las autoridades competentes. 32009R1223_en |
That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. Estos datos deben incluir todos los elementos necesarios relacionados con la identidad, la calidad, la seguridad para la salud humana y los efectos reivi... |
In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted. En particular, esta información sobre el producto debe incluir un informe sobre la seguridad del producto cosmético que acredite que se ha realizado una evaluación de la segur... |
(20) (20) 32009R1223_en |
To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner. Para que las restricciones relativas a las sustancias se apliquen y controlen uniformemente, conviene que el muestreo y el análisis se efectúen de modo... |
(21) (21) 32009R1223_en |
The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation. El término «mezcla» según se define en el presente Reglamento debe tener el mismo significado que el término «preparado» que se utilizaba anteriormente en la legislación comu... |
(22) (22) 32009R1223_en |
For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market. En aras de una vigilancia eficaz del mercado, conviene prever que se notifique a las autoridades competentes cierta información sobre el producto cosmético i... |
(23) (23) 32009R1223_en |
In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end. Con objeto de hacer posible u... |
(24) (24) 32009R1223_en |
In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface. Para reducir al mínimo las cargas administrativas, la información notificada a las ... |
(25) (25) 32009R1223_en |
In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application. Con el fin de garantizar una transición sin tropiezos a la nueva interfaz electrónica, los operadores económi... |
(26) (26) 32009R1223_en |
The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III. Procede respaldar el principio general de que el fabricante es responsable de la seguridad de su producto mediante las restricciones apl... |
Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses. Además, las sustancias que vayan a utilizarse como colorantes, conservantes y filtros ultravioletas deben figurar en los anexos I... |
(27) (27) 32009R1223_en |
To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction. Para evitar ambigüedades, conviene aclarar que la l... |
(28) (28) 32009R1223_en |
To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory struct... |
To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure. Para ello, conviene que la Comisión tenga la posibilidad de incluir colorantes del pelo en el ámbito de aplicación de ese anexo mediante el procedimiento de comitología. 32009R1223_e... |
(29) (29) 32009R1223_en |
The use of nanomaterials in cosmetic products may increase with the further development of technology. El desarrollo ulterior de la tecnología puede hacer que se incremente la utilización de nanomateriales en los productos cosméticos. 32009R1223_en |
In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. A fin de velar por un alto nivel de protección de los consumidores, la libre circulación de mercancías y la segu... |
The Community should endeavour to reach an agreement on a definition in appropriate international fora. La Comunidad debe esforzarse por alcanzar un acuerdo sobre tal definición en los foros internacionales pertinentes. 32009R1223_en |
Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly. Si se alcanza tal acuerdo, debe adaptarse convenientemente la definición de nanomateriales incluida en el presente Reglamento. 32009R1223_en |
(30) (30) 32009R1223_en |
At present, there is inadequate information on the risks associated with nanomaterials. En la actualidad, la información sobre los riesgos asociados a los nanomateriales es inadecuada. 32009R1223_en |
In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials. Con el fin de evaluar mejor su seguridad, el CCSC debe proporcionar orientación, en cooperación con los órganos pertinentes... |
(31) (31) 32009R1223_en |
The Commission should regularly review the provisions on nanomaterials in the light of scientific progress. La Comisión debe reexaminar regularmente las disposiciones relativas a los nanomateriales a la luz del progreso científico. 32009R1223_en |
(32) (32) 32009R1223_en |
Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ( 9)... |
However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the... |
With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substa... |
Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No 1272/2008. Si se cumplen tales condiciones, la Comisión debe modificar los anexos pertinentes del presente Reglamento en... |
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