92001E2775

WRITTEN QUESTION E-2775/01

by Chris Davies (ELDR) to the Commission

(9 October 2001)

Subject: Funding of Non-Animal Tests

The Commission's White Paper: Strategy for a future Chemicals Policy COM(2001) 88 final. and Parliament's option on the proposed seventh amendment to the Cosmetics Directive both call for the development of new non-animal test methods. Animal Welfare Campaigners claim that animal based toxicity testing is scientifically outdated, that new non-animal tests under development offer scientific benefits, and are frequently quicker and cheaper to perform than animal tests. Their use could prevent the suffering of millions of animals.

Article 23.1 of Directive 86/609/EEC(1) states that: The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures, and shall take such steps as they consider appropriate to encourage research in this field.

What action has been taken by the Commission to ensure such work is encouraged? In particular, what levels of funding have been provided by the Commission and by each Member State for the development of alternative non-animal test methods in all areas of research, and specifically in the development of alternatives to toxicity testing?

(1) OJ L 358, 18.12.1986, p. 1.

Answer given by Mr Busquin on behalf of the Commission

(20 November 2001)

To date, in the current Fifth Framework Programme for research, technological development (RTD) and demonstration activities 1998 to 2002(1), more than 30 projects specifically addressing in vitro alternatives to animal testing are being funded under the Quality of Life and Management of Living Resources Programme, representing a Community contribution of more than 27 million. Of these, 24 million are devoted to the support of alternatives to toxicity testing. Information on the contracts can be obtained through the Cordis Web service at http://www. cordis. lu/life.

As far as the new RTD Framework Programme 2002-2006 is concerned, the Commission has adopted, on 30 May 2001, proposals for the Specific Programmes(2) that can be downloaded at the Web site: http://www. cordis. lu/rtd2002/fp-debate/cec. htm. This text clearly mentions the development of new in vitro tests to replace animal experimentation in the research priority (ii) of the thematic priority 1.1.1 Genomics and biotechnology for health (see page 20 of the text). Furthermore, it includes several general statements regarding the respect of animal welfare, which concern all activities of the new Framework Programme (see footnote 14, page 18 of the text).

Additionally, flexibility for policy-related research is offered under the heading Anticipating the Community's scientific and technological needs which covers policy-orientated research and could include non-animal testing.

Many non-animal methods are in the course of development. However, such methods must be subject to independent validation, before they can be formally accepted into the regulatory process. In order to fulfil its obligations under Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(3), the Commission, in 1991, set up the European Centre for the validation of alternative methods, (ECVAM), as a unit of its Joint Research Centre, located at Ispra, Italy. ECVAM's principal duty is to specifically co-ordinate the validation of advanced, non-animal test methods at the Community level.

In 2000, the first three validated in vitro methods were introduced(4) into Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(5). The Commission attaches great importance to this work and is actively promoting the acceptance of these methods also in the framework of the Organisation for economic cooperation and development (OECD) Test Guidelines Programme, in order to secure their worldwide application. A number of other scientifically-validated methods are to be put forward for regulatory acceptance in the near future.

Furthermore, in consultation with other Commission services and with external experts, ECVAM is preparing a comprehensive review of the current status of non-animal test methods and their future potential, in the light of the challenges and opportunities provided by the White Paper on a future chemicals policy as well as a detailed review on the current status of non-animal test methods for cosmetic ingredients and products.

The total support for ECVAM in the Fifth Framework Programme is 26,5 million.

The Commission has no information on financial support by the Member States for the replacement alternative tests.

(1) OJ L 26, 1.2.1999.

(2) OJ C 240 E, 28.8.2001.

(3) OJ L 358, 18.12.1986.

(4) OJ L 136, 8.6.2000.

(5) OJ B 196, 16.8.1967.