WRITTEN QUESTION E-0424/00

by Glyn Ford (PSE) to the Commission

(23 February 2000)

Subject: Research and testing using animals

What is the Commission's position with regard to research and testing live animals. What action is the Commission taking to reduce such testing?

Answer given by Mrs Wallström on behalf of the Commission

(11 April 2000)

Council Directive 86/609/EEC of 24 November 1986 on the protection of animals used for experimental and other scientific purposes(1) lays down the provisions to be followed when animals are used for research and testing.

Concerning the Community research programmes, the 5th Framework Programme (Decision 182/1999/EC)(2) states in Article 7 that All research activities conducted pursuant to the 5th Framework Programme shall be carried out in compliance with fundamental ethical principles including animal welfare requirements, in conformity with Community law.

Under the programme Quality of Life and management of living resources, the researchers must apply the principles of replacement by alternative methods, reduction of the number of animals and refinement of experiments. Animal suffering must be avoided or kept to a minimum. These principles must be applied particularly rigorously to animal species that are the closest to human beings. A specific ethical review is performed for all projects raising ethical issues, including those involving non-human primates.

The number of animals used for regulatory testing is approximately 9 % of the total number of animals used in experiments. This can be deduced from the latest Commission report established in accordance with Directive 86/609/EEC. In order to reduce the number of animals for regulatory testing the Commission promotes alternative testing methods requiring either fewer animals or no animals at all (by using in vitro and computer-based methods).

In 1991, the Commission established a European Centre for the Validation of Alternative Methods (ECVAM), which is a unit of the Institute for Health & Consumer Protection of the Commission's Joint Research Centre, located at Ispra, Italy. ECVAM's principal duty is to co-ordinate the validation of advanced, non-animal test methods at Union level, that is, to establish their relevance and reliability for their stated purposes.

In February 2000, the Commission proposed the inclusion of the first three validated in vitro methods into Annex V of Council Directive 67/548/EEC of 27 June 1967 on the classification, packaging and labelling of dangerous substances(3). The Member States voted favourably.

These methods were validated as a part of ECVAM's work programme, in collaboration with laboratories and other institutions in the Member States and the United States, and were endorsed as scientifically validated by the ECVAM scientific advisory committee and accepted by the relevant Commission services. It is anticipated that a further ten methods will be validated during the 5th Framework Programme (1999 2002).

This is the first time ever that validated alternative methods have been included in Annex V. The Commission attaches great importance to this work and is actively promoting the acceptance of these methods into the OECD test guidelines programme, in order to secure their world-wide application.

(1) OJ L 117, 5.5.1987.

(2) OJ L 49, 29.2.1999.

(3) OJ 196, 16.8.1967.