Cosmetic products: animal experiments (7th amend. to "Cosmetics Directive" 76/768/EEC)

2000/0077(COD)

The Commission has presented its eighth report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics. It reflects the state of play in terms of the number and type of experiments on animals relating to cosmetic products in 2007 and 2008, the current status of alternative replacement methods, and the acceptance and recognition of alternative methods at international level.

The main points are as follows:

Animal testing data: according to the information supplied by the 27 Member States, cosmetic ingredients have only been tested on animals in the territories of France and Spain. These Member States provided detailed information, including the testing period, the toxicological endpoint, species of animals used for experiments and number of animals used for testing. In total, 1818 animals in 2007 and 1510 animals in 2008 were used in tests carried out in relation to the safety of cosmetic ingredients. The total number of animals used for testing the safety of cosmetics showed a slight increase compared to the last report's figures for 2006 (2005: 2 276, 2006: 1 329). Nevertheless, the reported number of animals used for the testing of cosmetics or toiletries remains small compared to the total number of animals used for experimental and other scientific purposes.

Evaluation of submitted data: the majority of Member States replied that no animal testing in relation to cosmetic products was performed in 2007 and 2008 in their territory. The main explanations they gave to substantiate their replies were the following: i) national legislation prohibits the carrying out of animal experiments in order to test and develop cosmetic products and their ingredients and ii) national legislation stipulates that animal testing must be authorised in order to be lawfully performed.

Some Member States elaborated on their replies by mentioning the difficulties they had in collecting the information. In fact, the majority of animal tests are conducted for multiple uses by manufacturers of chemical substances (industry assumes that approximately 80-90% of cosmetic ingredients are tested for multiple uses).

In view of the efforts requested of the Member States by the Commission to deliver the appropriate information, some Member States described the measures taken to improve data.

This present report is the last report covering the period before the coming into force of the full testing ban for ingredients and combinations of ingredients for cosmetics and the marketing ban for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics on 11 March 2009.

In view of the forthcoming marketing ban, Member States have essentially informed the Commission that they will use the market surveillance instruments in place in order to enforce the marketing ban. A number of Member States also planned to particularly draw the attention of market surveillance authorities to the ban through guidance notes and similar tools.

In conclusion, the Commission acknowledges that Member States have made efforts to improve the availability of data and that the overall availability has improved. However, the Commission continues to be concerned about the accuracy of the figures being reported, and this concern is shared by certain Member States.

The main issue relates to multiple use substances. Some Member States, when mentioning that no animal testing has been performed for cosmetic ingredients, reported that no toxicological tests were carried out for multiple or uncertain purposes where it could be considered that the substance might be used as an ingredient in cosmetic products. Legislation stipulating that animal testing must be authorised in order to be lawfully performed appears a useful tool to determine the purpose of testing.