WRITTEN QUESTION E-1711/02

by Elspeth Attwooll (ELDR) to the Commission

(13 June 2002)

Subject: Animal testing

How and why do requirements for animal safety testing of drugs and chemicals differ between Member States within the EU? Why is it not possible for alternative non-animal tests that have passed through validation and received regulatory acceptance in one or more Member States to be used in all EU Member States? Surely, in the interests both of animal welfare and the internal market, non-animal alternative tests that are judged to offer a sufficient degree of hazard evaluation in one country should be in use throughout the EU? What action is being carried out by the Commission to ensure that non-animal tests accepted in one or more Member States receive EU-wide regulatory acceptance as soon as possible, and certainly in time for implementation of the new EU chemicals policy?

Joint answerto Written Questions E-1710/02 and E-1711/02given by Mrs Wallström on behalf of the Commission

(31 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 Directive 67/548/EEC, 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(1), hereafter the Dangerous Substances Directive. Such tests are harmonised throughout the Community. If properly applied, they are considered to guarantee reliable results.

For new chemical substances, placed on the market after September 1981, the testing requirements are harmonised across the Community. For existing chemicals, marketed also before that date, the manufacturers, importers and distributors are required to make themselves aware of the relevant and accessible data concerning the properties of such chemicals. They then have to classify and label the chemicals in accordance with the Dangerous Substances Directive. Also this provision applies throughout the Member States.

For medicinal products testing requirements are laid down in Directive 2001/83/EC of the Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use(2). The Directive requires that an application for approval of a medicinal product needs to be accompanied by results of toxicological and pharmacological tests. Part 3 of Annex I to the Directive contains detailed provisions on these toxicological and pharmacological tests.

Most of the test methods set out in Annex V of Directive 67/548/EEC 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.

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 for 'alternative' or 'replacement' tests than for 'conventional' animal 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 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.

In the year 2000 three non-animal testing methods validated by ECVAM have been included in Annex V. These are one method for phototoxicity and two methods for skin corrosion. The methods are since then available for regulatory purposes in all Member States.

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 June 2002, on the current status of alternative tests for human health effects required by Community chemicals legislation. 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.

(1) OJ P 196, 16.8.1967.

(2) OJ L 311, 28.11.2001.