92002E2562

WRITTEN QUESTION P-2562/02

by Professor Sir Neil MacCormick (Verts/ALE) to the Commission

(10 September 2002)

Subject: REACH system

Is the Commission aware of the concern held by many people concerning aspects of the REACH system proposed for the testing and registering of chemicals? In particular, will the Commission reconsider those elements of the REACH system which will radically increase the amount of animal testing in ways which are deeply repugnant to many European citizens? Will the Commission also indicate its opinion on the relevance of the REACH system to chemicals which are bonded elements of the final products and which therefore exhibit none of the chemical properties in their pure state?

Answer given by Mrs Wallström on behalf of the Commission

(3 October 2002)

The REACH system was proposed by the Commission in the White Paper on the Strategy for a future Chemicals Policy(1) in order to strengthen the protection of human health and the environment from the potential risks of chemicals. For a very high proportion of the chemical substances on the Community market, available knowledge about dangerous properties and uses is not sufficient to ensure the required high level of protection.

To increase the knowledge, and therefore improve the management and control of chemicals, the White Paper does not simply propose a testing programme but rather the collection of information about chemicals. Appropriate information may come from any source in the Community and world-wide. Testing on laboratory animals should only be the last resort.

Indeed one of the political objectives of the Strategy is the promotion of non-animal testing.

The following elements of REACH will be proposed with a view to keep animal testing to a minimum:

- for substances produced/imported in quantities between 1-10 tonnes per year, testing should generally be limited to in vitro methods. 20 000 out of the estimated 30 000 existing substances on the Community market fall into this category;

- existing information on the toxicity and ecotoxicity of substances, including epidemiological studies, will be taken into account;

- the general testing requirements will be modified to incorporate exposure-driven testing where appropriate;

- tailor-made testing programmes for substances will be developed under the control of authorities for testing of higher production volume chemicals;

- efforts will be made to develop further alternative testing methods using fewer or no animals;

- substances will be grouped to minimise testing, where appropriate;

- data-sharing on animal test data among companies submitting registrations will be made mandatory, with very limited exceptions to respect confidentiality.

The Commission held meetings with eight Working Groups from October 2001 to February 2002 to seek technical expert advice on specific aspects of the White Paper. This included testing aspects and their relation to animal welfare. Experts, including from animal welfare organisations, were invited to provide their suggestions.

The Commission is aware that chemical substances, when bonded within polymers, may change their properties significantly. However, also those properties should also be known to ensure a safe use. The Commission will therefore develop an appropriate and proportionate scheme that provides the necessary information.

In conclusion, the Commission is seeking to balance animal welfare considerations against the potentially serious threats to human health and the environment presented by chemicals when their properties and uses are not sufficiently known.

(1) COM(2001) 88final, available on the Internet http://europa.eu.int/comm/environment/chemicals/0188_en.pdf.