In 2003, the 7th amendment to the Cosmetics Directive established a testing ban prohibiting the use of animals in the testing of cosmetic ingredients, with deadlines of 11 March 2009 for acute toxicity, local effects, skin absorption and genotoxicity, and 11 March 2013 for the more complex toxicological end-points (including toxicokinetics, skin sensitization, repeated dose toxicity, reproductive toxicity and carcinogenicity). A report from the European Commission notes that there are currently only four legally accepted alternative (in vitro) test methods for three toxicological end-points (skin corrosion, acute phototoxicity and dermal absorption) listed in Annex V of Directive 67/548/EEC (on the classification, packaging and labelling of dangerous substances) and one method for genotoxicity under Annex VIII of Regulation 1907/2006 (REACH). [Apparently a method for skin irritation is also likely to receive regulatory approval soon.] To meet the 2009 deadline, the Commission will focus its efforts on eye irritation and acute toxicity, the two areas where progress has been disappointing. The 2013 deadline for the more complex toxicological end-points “remains scientifically difficult, despite the additional efforts launched at various levels”.

[Report from the Commission to the Council and the European Parliament. Report on the development, validation and legal acceptance of alternative methods to animal tests in the field of cosmetics (2007). Brussels, 2 July.2008. COM(2008) 416 final. Available at http://ec.europa.eu/enterprise/cosmetics/doc/com_2008_416/com_2008_416_en.pdf on the internet.] {178222}

A publication from the European Centre for the Validation of Alternative Methods (ECVAM) provides further insights into the progress that was made in 2006-2007 in the development and validation of alternative methods to animal testing for cosmetic ingredients.

[ECVAM technical report (2006-2007). Available via http://ecvam.jrc.it/index.htm then click on “publications” and ECVAM & EU Policies.] {178223}

The above item was taken from the September 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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