Signal Report: Severe suffering in regulatory toxicity testing
The NCad has offered unsolicited advice to Minister Wiersma of LVVN about severe animal suffering in legally required safety research for chemical substances. The reason for this advice were signals from the field about an increase in animal suffering. This is due to the implementation of advice from the European Chemicals Agency (ECHA) which states that the highest dose in these studies must be chosen 'with the aim of selecting the highest possible dose without causing serious discomfort or the death of the animal.' In practice, this formulation means that legally required safety studies, unlike before, must be carried out on the borderline between moderate and serious discomfort.
Harm-benefit analysis
For this signal report, the NCad has carried out a harm-benefit analysis to assess whether the damage in the form of suffering, pain and fear of the animals outweighs the importance of the research and the expected result. In this regard, much weight is placed on the suffering of the individual animal.
The NCad believes that, in accordance with the European test guidelines, serious discomfort should not be permitted in animal experiments for legally required safety research. We note that in countries of the European Union, including the Netherlands, the desire to minimize risks from chemical substances and the perception of safety that accompanies this have been leading in the advice to use higher test doses. However, it is questionable whether the higher doses will actually lead to better safety research. Therefore, the NCad considers the increased harm to animal welfare to be ethically unjustified, given the intrinsic value of the animal.
In addition, insufficient attention has been paid to applying the 3Rs (replacement, reduction and refinement) and innovative methods to improve the quality of research. This is at odds with the 3R policy of the national government and the European Commission.
Recommendations
In its signal report, the NCad provides recommendations to limit the increased damage to animal welfare as much as possible. We expect that following these recommendations will also lead to an improvement in the quality and validity of legally required safety research on chemical substances.
You can read our recommendations and their substantiation in the signal advice Severe suffering in regulatory toxicity. The NCad will continue to monitor the developments and report about them on our website.