WRITTEN QUESTION E-2903/00

by Chris Davies (ELDR) to the Commission

(14 September 2000)

Subject: EU chemicals policy

What is the Commission's estimate of the number of chemicals in use across the EU which should be subjected to safety-testing procedures, and:

- how many animals would have to be killed in order to carry out such tests;

- what type of animals would these include;

- what measures would the Commission recommend to reduce the number of tests on live animals?

Joint answer to Written Questions E-2903/00, E-3071/00 and E-3303/00 given by Mrs Wallström on behalf of the Commission

(24 November 2000)

Laboratory animals such as rats, mice, birds, fish or daphniae, and also microorganisms, are used to test the intrinsic dangerous properties of chemicals that potentially damage human health and the environment. Knowledge about the dangerous properties is the first step to ensure the safe use of chemicals. The European citizen expects that chemicals are safe.

A large majority of the chemicals currently on the Community market are so-called existing substances, meaning that they were first marketed before 1981, rather than that they are drawn from stockpiles. They are produced and marketed without the same level of testing that is required by 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) for so-called new substances, i.e. those that were first marketed after 1981.

A study from the European Chemicals Bureau showed that it is only for a small number of the existing substances produced in high volumes that we have the amount of toxicological and ecotoxicological data required for new substances. For other existing chemicals no data exists.

In order to ensure a higher level of protection from existing substances, possibly equivalent to new substances, it is therefore necessary to increase considerably the knowledge about existing substances. In such an exercise it is essential to achieve a balance between the protection of human health and the environment, and the protection of laboratory animals.

The Commission will make every effort to ensure that the number of animals to be used is as low as possible. In part, this will be done through use of existing alternative testing methods and continuing development of new alternative methods. Indeed, one of the major tasks of the Commission's Joint Research Centre is to validate alternative methods that reduce, refine or replace animal experiments. This is supported by Community legislation requiring that, where equivalent methods exist, that using the minimum number of animals shall be chosen.

Other approaches under consideration include collecting further data that may become available, extrapolating from existing data on similar substances, encouraging data sharing between companies, using results from non-Community test programmes and reducing test requirements for substances used only in industry under strict control of exposure.

The white paper on a future Community chemicals policy, which should be adopted by the Commission before the end of this year, will provide more detail on ways in which our knowledge about the properties of chemicals can be improved in order to ensure their safe use. It is not possible to give an estimate of the number of animals required in order to meet the safety testing requirements for chemicals until the details of the new strategy have been decided.

(1) OJ B 196, 16.8.1967.