ABSTRACT
The Council of the European Communities in regard to the Treaty establishing the European Economic Community (today European Union, E.U.), and in particular Article 100 thereof has decided to harmonize the legislations in the E.U. (1,2). The Directive gives a clear definition of the 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 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 odors, and/or 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 E.U., provided that they are proven safe for human use. The Directive has been adapted, completed, and modified several times between 1976 and 2003. The important 6th Amendment has made mandatory that by January 01, 1997, the cosmetic products shall be marketed only if the labeling bear specific information in a legible and visible lettering (Article 6) as follows: the name and address of the 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, and the list of ingredients in descending order of weight. The Article 7a requires that for control purposes the following information shall be readily accessible to the competent authorities of the Member State: the qualitative and quantitative composition of the product (perfumes may still be coded, but the composition shall be available for the Health Authorities at the Perfume Manufacturer’s) [(GLP) Good Laboratory Procedures: O.J. EU n L 15, 17/01/87, p.29], the physico-chemical 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 (GMP, good manufacturing procedures), the person responsible for the manufacturing or first importation into the Union (who 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 in cosmetics according to Article 1 of Directive 89/48/EEC), undesirable effects if existing, proof of effect by the nature of effect. The competent authority of the Member State shall be notified of the place of manufacture of the cosmetic products or its initial import into the Union. Before the product is placed in the market, the Poison Information Centers shall be informed about the formula, and the European cosmetic and perfumery association (COLIPA) has negotiated that only major deviations from basic formulas shall be indicated, (the basic formulas have been given by COLIPA).
