WRITTEN QUESTION E-1456/02

by Chris Davies (ELDR) to the Commission

(23 May 2002)

Subject: Scientific validity of animal toxicity tests

Will the Commission state whether any of the animal-based toxicity tests currently used to assess chemicals have not been fully validated to modern standards such as those applied during the development of new non-animal alternative tests?

Is it the case that for the purpose of regulatory toxicity testing, animal toxicity tests that have failed retrospective validation are still in use and are currently included in Annex V of Directive 67/548/EEC(1) ('the dangerous substances directive')?

(1) JO P 196 du 16.8.1967, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(9 July 2002)

Toxicity tests to assess the properties of chemicals which may be dangerous to human health and the environment are included in Annex V of Council Directive 67/548/EEC(1), the Dangerous Substances Directive. Most of the test methods set out in the Annex are based on those developed and recommended by competent international bodies, in particular the Organisation for Economic Cooperation and Development (OECD). The quality of such methods is therefore recognised internationally. The test methods should be performed in conformity with the principles of Good Laboratory Practice (GLP), in order to ensure as wide as possible the mutual acceptance of data.

It is true that the current animal procedures have not been validated scientifically according to modern standards. However, it could be considered fair and reasonable to evaluate them by a weight-of-evidence approach. That is, since they have been in use for a long while, there is a great deal of experience on which to base an evaluation of their relevance and reliability.

The 1998 OECD document on the Validation of test methods considered for the adoption as OECD test guidelines (ENV/MC/CHEM (98) 6) acknowledged that there seems to be a tendency towards being stricter foralternativeorreplacementtests than forconventionalanimal tests, filling gaps of so far uncovered areas. The general problem that double standards may be operating has thus been recognised.

The Commission is not aware of any formal retrospective validation of testing methods currently included in Annex V of Council Directive 67/548/EEC. The European Centre for the Validation of Alternative Methods (ECVAM) of the Joint Research Centre (JRC) has so far concentrated on prospective validation studies.

The Commission considers that progress in the development and validation of alternative test methods is necessary. ECVAM has recently compiled a report, provided for publication in August 2002, on the current status and future prospects of alternative (non-animal) tests for chemicals testing for human health effects. The report places the emphasis on methods that can replace existing animal tests, either entirely or partially. It makes recommendations for the further development and validation of alternative tests and strategies. According to the ECVAM report there is scope for reducing the numbers of animals required through reconsideration of group sizes and of experimental design of existing methods.

(1) 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.