Good Science Must be the Key Factor in the Development and Use of Alternative Methods for Safety Assessment of Cosmetics

Both the 7th Amendment of the EU Cosmetic Directive 2003/15/EC (OJ L66, 11/03/2003) and the REACH (Registration, Evaluation and Authorisation of Chemicals) proposal for chemicals (Anon., 2003a) assume that alternatives to animal tests for regulatory purposes are or will be available within the near future. In particular, the 7th Amendment imposes a prohibition, not only on testing finished cosmetic products and cosmetic ingredients on animals, but also on marketing such products in the EU. The testing ban on finished products applies from 11 September 2004. So does the testing ban on ingredients, though only when alternative methods become available, i.e. tests that have been officially validated by ECVAM. The maximum cutoff date for the testing ban is 11 March 2009, irrespective of the availability of non-animal alternatives. The marketing ban will be introduced at the latest on the same date, but with the exception of repeated dose toxicity, reproductive toxicity and toxicokinetic testing. For those, the deadline is fixed on 11 March 2013. In the REACH proposal (Anon., 2003a), it is indicated that a scientific objective for the EU is the development and validation of alternative methods and that such methods must be considered as and when they become available. Thus an important difference between both is that in the chemical legislation proposal the 3Rs concept of Russell and Burch (1992) is fully considered, whereas in the cosmetic legislation only replacement was taken up. The concept of using alternative methods to animal testing was first introduced in the EU legislation by Directive 86/609/EEC (OJ L358, 18/12/1986) on the protection of animals used for experimental and other purposes, which was the immediate reason why ECVAM (the European Centre for the Validation of Alternative Methods) was established in 1992. Alternatives were meant to include all of the 3Rs, being methods to replace, reduce or refine animal tests. Only in the cosmetic legislation was this inscribed and subsequently turned into 1R as a direct consequence of political pressure and excessive lobbying of the Parliament. Thus it is important to notice that the actual deadlines of 2009 and Good Science Must be the Key Factor in the Development and Use of Alternative Methods for Safety Assessment of Cosmetics