QUALITY AND SAFETY OF COSMETICS IN THE EEC 71 (2) Harmonization solution The Directive is based on harmonization and the result will be the sub- stitution of Community provisions for the national laws in force. (3) Notes on the proposal These cover the scope of the Directive as exemplified by the 15 Articles and 5 Annexes. The system chosen is based on negative listing: con- consequently all substances not specifically prohibited are accepted, so any cosmetic product is accepted providing it does not contain any of the pro- hibited substances in Annex II and meets the restrictions laid down for any substance in Annex Ill and IV. (4) Acceding countries Technical contacts with the experts of acceding countries have been established. (5) Consultation of the European Parliament and the Economic and Social Committee The opinion of these bodies is necessary to comply with the provisions of Article 100 of the EEC Treaty of Rome. Application of the Directive will require amendments of the laws of all Member States. The Directive Article 1 (Definition of cosmetic) 'Cosmetic product' means any preparation intended to be placed in contact with superficial parts of the body or with teeth and mouth with a view principally for perfuming, cleaning, protecting, keeping in good con- dition, changing appearance or correcting body odours. Annex I lists cosmetic products included in the Directive. Annex V lists substances excluded from the Directive. Article 2 (Products must not cause human damage) Cosmetic products must not be capable of causing damage to human health when they are applied as directed. Article 3 (To be marketed--the product must conform) Member States shall take the necessary steps to ensure that only products conforming to the Directive and its Annexes are put on the market.

72 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Article 4 (Prohibitions Annex If Restrictions Annex III) Member States shall prohibit the marketing of cosmetic products con- taining: (a) the substances listed in Annex If (b) the substances listed in Annex III (part 1) outside the limits and conditions fixed (c) colourants other than those in Annex III (part 2) if the products are intended to be used near the eyes, on the lips or in the mouth. Article 5 (Provisional Restrictions--Annex IV) For a period of 3 years Member States shall accept marketing of cos- metic products containing (a) substances listed in Annex IV part 1 (b) colourants listed in Annex IV part 2 if these products are intended to be used near the eyes, on the lips or in the mouth. Article 6 (Packaging and labelling requirements) (1) The container or outside package must bear the name and address of the manufacturer/packer/importer/distributor having his registered place of business within the Community. (2) The container or outside package shall state the net content at time of packing in legal metric units and expiry date for products which do not have an unlimited shelf life. (3) Special precautions of use shall appear legibly on the container, or if impossible on the outside package and an enclosed leaflet. (4) The use of names, trademarks, images or other signs suggesting a characteristic which the products do not possess is prohibited. A recom- mended amendment to this section includes prohibiting claims for products where there is no, or insufficient, scientific evidence. Article 7 (Freedom of marketing to Member States) Member States must not prohibit or hamper the marketing of products which conform to the Directive but they can demand that the particulars required in Article 6 are expressed in their national language(s). Article 8 (Supervision) Member States shall take the necessary measures to supervise that cosmetic products conform to the Directive.