ABSTRACT

The Council of the European Communities in regard to the Treaty establishing the European Economic Community (today, the European Union [EU]) and in particular Article 100 thereof has decided to harmonize legislation in the EU [1,2]. The Directive gives a clear definition of cosmetic products: ‘‘Any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and and the mucous membranes of the oral cavity, with a view exclusively or mainly to clean them, perfuming them, changing their appearance and-or correcting body odours andor protecting them or keeping them in good condition.’’ The philosophy of the Directive is that all products should have equal and immediate access to the market throughout the EU provided that they are proven safe for human use. The Directive has been adapted and modified 29 times between 1976 and 1998. The 6th Amendment has made mandatory by January 1, 1997 that cosmetic products may be marketed only if the labeling bears specific information in legible and visible lettering (Article 6) as follows: the name and address or registered office of the manufacturer or the responsible person for marketing in the Union, the nominal content at the time of packaging, the date of minimum durability and the conditions of storage if appropriate, the conditions of use and warnings, the batch number, the function, the list of ingredients in descending order of weight. Article 7a requires that for control purposes the following information be readily accessible to the competent authorities of the Member State: the qualitative and quantitative composition of the product (perfumes may be coded) (good laboratory procedures [GLP], O.J. EU n° L 15, 17-01-87, p. 29), the physicochemical and microbiological specifications of the raw materials and the finished product, the purity and the microbiological control criteria of the cosmetic product, the method of manufacture (good manufacturing procedures, GMP), the person responsible for the manufacturing or first importation into the EU shall possess an appropriate level of qualification, the assessment of the safety (GLP, Council Directive 87-18-EEC of 18 December 1986), the name and address of the responsible person (who must hold a diploma according to Article 1 of Council Directive 89-48EEC), undesirable effects if existing, and proof of effect by the nature of effect. The

competent authority of the Member State shall be notified of the place of manufacture or initial import into the EU of the cosmetic products before the latter are placed on the market, the Poison Information Center shall be informed about the formula, and The European Cosmetic, Toiletry and Perfumery Association (COLIPA) [3] has negotiated that only major deviations from basic formulas shall be indicated (the basic formulas having been given by COLIPA).