ABSTRACT
During the last years, a lot of key changes took place in the European Union (EU) cosmetic legislation. In particular, of importance was the implementation of the so-called 6th Amendment, Council Directive 93/35/EEC, which drastically modied the policy behind Council Directive 76/768/ EEC. The modication introduced can be summarized as follows: (i) notication of any cosmetic product marketed in the EU; (ii) production of an inventory of ingredients by the Commission with the help of the industry; (iii) changes in ingredient labeling, including the introduction of International Nomenclature of Cosmetic Ingredients (INCI) and labeling of the qualitative composition on the packaging; (iv) labeling of the product function where relevant; (v) for every cosmetic product on the EU market, the obligation of compiling a technical information le (TIF) or product information requirement (PIR), containing the safety assessment of the product and proof of the claims made for the product; and (vi) ban of animal testing of ingredients whenever validated methods are available. This ban was postponed twice (97/18/EC and 2000/41/EC), and the nal expiry date was xed on June 30, 2002. In the meantime, the 7th amendment became available (2003/15/EC), which established a prohibition to test nished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the European Community nished cosmetic products and ingredients included in cosmetic products that were tested on animals (marketing ban). The testing ban on nished cosmetic products has already applied since September 11, 2004, whereas the testing ban on ingredients or combination of ingredients was applied step by step as soon as alternative methods became validated and adopted, but with a maximum cutoff date of 6 years after entry into force of the Directive, that is, March 11, 2009, irrespective of the availability of alternative nonanimal tests. The marketing ban was simultaneously applied, making that from March 11, 2009, all animal testing of cosmetic ingredients was prohibited and
products in which tested ingredients (after that date) were present could not be sold anymore on the EU market. An exception was made for repeated dose toxicity tests, reproductive toxicity, and toxicokinetics. For these, testing was allowed but only when done outside the EU.
