WRITTEN QUESTION E-2428/98

by Ben Fayot (PSE) to the Commission

(30 July 1998)

Subject: Alternatives to animal experiments

Under the terms of Directive 93/35/EEC(1), the ban on animal experiments for the purpose of testing cosmetic products should have come into effect on 1 January 1998. However, to date neither the Member States nor the Commission have made any serious efforts to develop and test alternatives to animal experimentation. As a result the ban in question has been postponed to 1 June 2000, although there is absolutely no question that there are ways of testing products without resorting to experiments on animals.

Can the Commission tell me what criteria it sets ECVAM for the testing of animal experiments prior to authorisation, and what changes it plans to make to Directive 93/35/EEC on cosmetics?

Answer given by Mrs Cresson on behalf of the Commission

(30 October 1998)

Directive 93/35/EEC stated that the testing in animal of ingredients for use in cosmetic products in compliance with the provisions of Directive 76/768/EEC would not be permitted after 1 January 1998, if alternative methods of testing, which offered an equivalent level of protection for the consumer, had been developed, taking into account Organization for economic cooperation and development (OECD) testing guidelines. Despite a great deal of effort and cooperation, no such tests had been produced by 1 January 1997, the date by which consideration of a postponement of the ban on animal testing had to be completed, so the ban was postponed until June 2000.

The Commission has been funding research for the replacement of animal experimentation by alternative methods since 1986. In particular successive biotechnology and biomedicine and health programmes have been made major contributions to the development of alternative tests in pharmaco-toxicology. Considerable efforts have been invested by the Commission and all other organisations, including the cosmetic industry, in the development and validation of alternatives, and the scale of cooperation among them is impressive. However, the scientific validation of alternative methods for particular purposes is a complex and lengthy process, and those responsible for their acceptance for application bear a heavy responsibility for the safety of workers and consumers.

Nevertheless, progress has been made in increasing the speed and efficiency of the validation process, and also in relation to particular tests. Three in vitro tests for skin corrosivity and phototoxic potential have been scientifically validated and these validations have been endorsed within the Commission. The application of these methods to the cosmetics sector is currently under review by the scientific committee on cosmetics and non-food products (SCCNFP) as part of the acceptance of these tests within a regulatory framework.

Meanwhile, further progress is being made in the development and validation of in vitro tests and testing strategies for eye irritation, skin irritation and sensitisation, and percutaneous absorption, all of which are important aspects of cosmetic ingredient safety. It must be recognised that test methods are usually designed to provide information on particular kinds of toxic hazard, rather than for use with particular products.

Directive 86/609/EEC clearly establishes that no animal test should be conducted or introduced unless it can be shown to be scientifically necessary in comparison with other alternative procedures. The Commission set up the European centre for the validation of alternative methods (ECVAM) to apply the criterion that all new or substantially modified tests must be shown to be reliable and relevant for their stated purpose, before they can be accepted for use in compliance with Community directives.

The main criterion for replacing an animal test, as stated in Directive 93/35/EEC, is that the replacement alternative method must offer protection at least as great as that afforded by the current test procedure. Much effort is being focused on alternative methods which will have a sounder scientific basis and which will employ human cells and tissues, as a means of overcoming the problem of extrapolating data to the human situation.

(1) OJ L 151, 23.6.1993, p. 32.