One of the areas of application of laboratory animal research is the legal requirement to test the safety of chemicals. Chemicals must be tested for potential risks under the EU REACH regulation*. In 2022, in response to concerns about low dose levels, the European Chemicals Agency (ECHA) recommended that such studies should be conducted using the highest possible doses. However, since implementing the recommended higher doses, the parties involved reported increased suffering of the animals used in these studies.
In response to these alarming reports, we independently prepared a signal report titled ‘Severe discomfort in regulatory toxicity testing’. In this report, we state that the increased suffering conflicts with the 3R policy (Replacement, Reduction and Refinement) of the Dutch government and the European Commission. Insufficient attention has been paid to innovative methods based on the 3Rs that could improve the scientific quality and validity of the studies.
In this signal report we also provide recommendations to minimise violations of animal welfare in regulatory safety research. These recommendations are directed at the Minster of LVVN. We ask her to make her response part of a government-wide policy and to inform and involve all relevant departments.
*REACH is an EU regulation governing the production of and trade in chemical substances. It describes rules with which businesses and governmental bodies must comply. REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals. This Regulation applies to all member states of the European Union (source: rijksoverheid.nl).
Netherlands Committee for the protection of animals used for scientific purposes. For the laboratory animals of today and the innovations of tomorrow.
At the NCad we are concerned about increased suffering of animals used for safety testing of chemicals. As an independent advisory body dedicated to the protection of laboratory animals we see a worrying trend: in Europe animal welfare and the quality of chemical safety tests is ensured by OECD test guidelines. These state that the test dose should be as small as possible to induce an effect while suffering of animals is minimized. However, in 2022 the European Chemical Agency published clarifying advice in an effort to improve the test method quality stating that the test dose should be as high as possible without causing severe suffering. Thus, instead of minimal suffering severe suffering of animals is frequently the endpoint. The grave consequence is that suffering is increased. But the quality of testing is not improved and possibly even compromised. Therefore, the NCad issued a Policy Advice to the ministry of agriculture urging immediate action to prevent this unnecessary suffering of animals. To learn more about our assessment download the Policy Advice from our website.