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, (1)OJ No C 40, 8.4.1974, p. 71. (2)OJ No C 60, 26.7.1973, p. 16.
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. A "cosmetic product" means any substance or preparation intended for placing 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 principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.
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 and cosmetic products containing colouring agents other than those referred to in Annexes III and IV and which are not intended to come into contact with the mucous membranes are excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to these products.
Article 2
Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use.
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
Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing: (a) substances listed in Annex II;
(b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down;
(c) colouring agents other than those listed in the second part of Annex III, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs;
(d) colouring agents listed in the second part of Annex III, beyond the limits and outside the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs.
Article 5
For a period of three years from notification of this Directive, Member States shall accept the marketing of cosmetic products containing: (a) the substances listed in Part 1 of Annex IV within the limits and under the conditions laid down;
(b) the colouring agents listed in Part 2 of Annex IV within the limits and under the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity, or to the external genital organs;
(c) the colouring agents listed in Part 3 of Annex IV, if these products either are not intended to come into contact with the mucous membranes or are only intended to come into brief contact with the skin.
On expiry of the three year period, these substances and colouring agents shall: - either be definitively permitted,
- or definitively prohibited (Annex II),
- or retained for a further period of three years in Annex IV,
- or deleted from all Annexes to this Directive.
Article 6
1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering: (a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who are established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community;
(b) the nominal content at the time of packaging;
(c) the expiry date for products with a stability of less than three years;
(d) particular precautions to be observed in use, and especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III and IV, and which must appear on the container ; where this is impossible for practical reasons, this information must appear on the packaging or on an enclosed leaflet, but in the latter case an abbreviated external indication must appear on the container, referring the consumer to the information specified;
(e) the batch number of manufacture or the reference for identifying the goods ; however, where this is impossible for practical reasons because the cosmetic articles are too small, such information need appear only on the multiple retail pack or sleeve of these articles.
2. Member States shall take all measures necessary to ensure that in the labelling, presentation for sale and advertising of cosmetic products, the wording, use of names, trade marks, images or other signs, figurative or otherwise, suggesting a characteristic which the products in question do not possess, shall be prohibited.
Article 7
1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.
2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c) and (d) be expressed at least in their own national or official language or languages.
3. Furthermore, a Member State may require, for purposes of prompt and appropriate medicial treatment in the event of difficulties, that adequate and sufficient information regarding substances contained in cosmetic products is made available to the competent authority, which shall ensure that this information is used only for the purposes of such treatment.
Article 8
1. In accordance with the procedure laid down in Article 10 the following shall be determined: - the methods of analysis necessary for checking the composition of cosmetic products,
- the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.
2. The amendments necessary for adapting Annex II to technical progress shall be adopted in accordance with the same procedure.
Article 9
1. The Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, hereinafter called "the Committee", is hereby set up. It shall consist of representatives of the Member States with a representative of the Commission as chairman.
2. The Committee shall adopt its own rules of procedure.
Article 10
1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.
3. (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee.
(b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.
(c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 11
Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on the basis of the results of the latest scientific and technical research, submit to the Council appropriate proposals establishing lists of permitted substances.
Article 12
1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.
2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations.
Article 13
Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.
Article 14
1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.
2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.
3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission.
Article 15
This Directive is addressed to the Member States.
Done at Brussels, 27 July 1976.