A ‘cosmetic product’ shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
Having regard to the opinion of the Economic and Social Committee(2),
Whereas the provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging; whereas these provisions differ from one Member State to another;
Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market;
Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector; whereas, however, this objective must be attained by means which also take account of economic and technological requirements;
Whereas it is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products;
Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals; whereas this 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; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;
Whereas in the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive;
Whereas cosmetic products must not be harmful under normal or foreseeable conditions of use; whereas in particular it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application;
Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature; whereas it is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure;
Whereas technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field; whereas it is advisable, in order to facilitate implementation of the measures necessary for this purpose, to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector;
Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization;
Whereas it could happen that although conforming to the provisions of this Directive and its Annexes, cosmetic products placed on the market might endanger public health; whereas it is therefore advisable to provide for a procedure intended to remove this danger,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1.
2.
The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I.
3.
Cosmetic products containing one of the substances listed in Annex V shall be excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to those products.
Article 2
A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market.
The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.
Article 3
Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market.
Article 4
1.
Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing:
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substances listed in Annex II;
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substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down;
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colouring agents other than those listed in Annex IV, Part 1, with the exception of cosmetic products containing colouring agents intended solely to colour hair;
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colouring agents listed in Annex IV, Part 1, used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair;
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preservatives other than those listed in Annex VI, Part 1;
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preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid down, unless other concentrations are used for specific purposes apparent from the presentation of the product;
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UV filters other than those listed in Part 1 of Annex VII;
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UV filters listed in Part 1 of Annex VII, beyond the limits and outside the conditions laid down therein.
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ingredients or combinations of ingredients tested on animals after 30 June 2002 in order to meet the requirements of this Directive.
If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1 January 1997, submit draft measures to postpone the date of implementation of this provision, for a sufficient period, and in any case for no less than two years, in accordance with the procedure laid down in Article 10. Before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology.
The Commission shall present an annual report to the European Parliament and the Council on progress in the development, validation and legal acceptance of alternative methods to those involving experiments on animals. That report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. The Commission shall in particular ensure the development, validation and legal acceptance of experimental methods which do not use live animals.
2.
The presence of traces of the substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms with Article 2.