Signal report: Severe suffering in regulatory toxicity testing

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).