Official Journal of the European Union
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO PEAN UNION, (5)
Having regard to the Treaty establishing the European Commu nity, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (3) has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity. A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are imple mented at the same time throughout the Community. This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health. (8) (4) (6)
The environmental concerns that substances used in cos metic products may raise are considered through the appli cation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 con cerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a Euro pean Chemicals Agency (4), which enables the assessment of environmental safety in a cross-sectoral manner.
This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal prod ucts. 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.
The assessment of whether a product is a cosmetic prod uct has to be made on the basis of a case-by-case assess ment, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower prepa rations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, haircleansing products (lotions, powders, shampoos), hairconditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning with out sun, skin-whitening products and anti-wrinkle products.
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 protec tion of human health. (9)
The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation.
(1) OJ C 27, 3.2.2009, p. 34. (2) Opinion of the European Parliament of 24 March 2009 (not yet pub lished in the Official Journal) and Council Decision of 20 November 2009. (3) ...
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