The Animal-Free Safety Assessment Collaboration (AFSA) is an initiative that aims to accelerate the application of modern chemical safety assessment without the use of animals. AFSA authors have investigated why, despite the requirements of the EU Animal Experiments Directive and the REACH Regulation, countless animal experiments are still being carried out.
According to the Directive on the protection of animals used for scientific purposes (63/2010/EU), the use of animals for scientific or educational purposes should only be considered if there is no animal-free alternative. According to Article 13 of the REACH Regulation, information on toxicity to humans in particular must be obtained, if possible, by means other than tests on vertebrate animals, i.e. by using alternative methods. These are, for example, in vitro methods, models of qualitative or quantitative structure-activity relationships or data based on the principle of structurally related substances (grouping or analogy).

The authors report that despite the many developments in recent years, it is difficult for registrants to argue that animal testing is not necessary. While the importance of validated methods to demonstrate safety is recognized, all too often it is automatically assumed that the information requirements can only be met by animal testing. There is evidence that non-animal data is systematically questioned and rejected by ECHA and/or Member States if the non-animal study does not provide information identical to animal testing. Comments in support of non-animal approaches during the comment period would only be considered to a limited extent, to name just a few examples.

The AFSA authors provide recommendations for improving compliance and implementation.

Original publication:
Macmillan DS, Bergqvist A, Burgess-Allen E, Callan I, Dawick J, Carrick B, Ellis G, Ferro R, Goyak K, Smulders C, Stackhouse RA, Troyano E, Westmoreland C, Ramón BS, Rocha V, Zhang X. (2023). The last resort requirement under REACH: From principle to practice. Regul Toxicol Pharmacol. 2023 Dec 23;147:105557. doi: 10.1016/j.yrtph.2023.105557.