Cosmetic products: animal experiments (7th amend. to "Cosmetics Directive" 76/768/EEC)
This is the Commission’s fifth report on the development, validation and legal acceptance of alternative methods to animal testing in cosmetics. It is, however, the first Report to assess the approximation of national laws relating to cosmetic products, as required by the seventh amendment to the Cosmetic Directive, (Council Directive 2003/15/EC). To recall, this amendment allowed, for the first time, the establishment of a clear and detailed framework for a ban on animal testing and on the marketing of cosmetic products and ingredients which have been tested on animals.
In preparing this study, the Commission refers to a 2005 Commission paper relating to the “Number of Animals used for Experimentation and their Scientific Purposes in the EU’s Member States”. The findings of that, earlier Report, indicate that in 2002 10.7 million animals were used for testing purposes. Only a fraction of that figure was used by the cosmetic industry. Based on information received from the Member States, the number of animals used in tests for cosmetic products decreased significantly between 1998-2003 down from 4200 to 1600. On the other hand, in all other areas of animal testing (research and human medicine, medicine and dentistry, fundamental biology etc.) the use of animal testing has increased. Moreover, according to information received by the Commission from the Member States, the only countries to have tested animals for the cosmetic purposes are France, Italy and Denmark.
As the Commission points out, however, the cosmetic industry is a “downstream” user of many ingredients. A large proportion of the ingredients used in cosmetic products are industrial in nature. In order to assess the safety of ingredients in cosmetic products, the cosmetic industry relies on data produced by their suppliers who, in turn have tested their ingredients, under chemicals legislation. It is, therefore, difficult for the Commission to assess the figures accurately, which makes it difficult to make a comprehensive assessment of the use of animals in cosmetic tests. The Commission promises to open a dialogue with the cosmetic industry on this matter in order to establish a more complete picture of animal tests carried out on ingredients used or intended to be used in cosmetic products.
As far as progress in the development, validation and legal acceptance of alternative methods is concerned the Commission notes significant progress, particularly when compared to 1999 findings. In 2005 the Commission established a timetable for the phasing-out of animal tests in accordance with the revised Article 4 of Directive 76/768/EEC. Together with the Ad Hoc Group of 75 scientific experts the most valuable and/or advanced alternative methods currently known vis-à-vis toxicological tests have been identified. It is expected that these will become law before the cut-off-dates in 2009/2013. Indeed, some human health effects can already be assessed using alternative methods and relate mostly to conditions such as skin corrosion, skin absorption and acute phototoxicity.
Lastly, the manufacture, distribution and sale of cosmetics are a global industry. The EU’s cosmetics and perfumes industry market volume, based on retail prices at the point of sales, amounted in 2000, to some EUR 50 billion compared to the US EUR 30 billion and Japan’s EUR 14.3billlion. An estimated EUR 7 160 billion was exported to third countries in 2001. The acceptance of alternative methods at an international level is therefore of clear importance to the EU cosmetics industry. One of the major breakthroughs reported by the Commission is the OECD adoption of alternative methods aimed at replacing animal tests given that alternative methods have the broad support of both the scientific community and the regulatory authorities.