REACH out-numbered! The future of REACH and animal numbers

Rovida Costanza, Busquet Francois, Leist Marcel, Hartung Thomas
DOI: 10.14573/altex.2307121
PMID: 37470349
Keyword: animal testing alternatives / methods · animals · risk assessment / methods · toxicity test / methods


The EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation requires animal testing only as a last resort. However, our study (Knight et al., 2023) in this issue reveals that approximately 2.9 million animals have been used for REACH testing for reproductive toxicity, developmental toxicity, and repeated-dose toxicity alone as of December 2022. Currently, additional tests requiring about 1.3 million more animals are in the works. As compliance checks continue, more animal tests are anticipated. According to the European Chemicals Agency (ECHA), 75% of read-across methods have been rejected during compliance checks. Here, we estimate that 0.6 to 3.2 million animals have been used for other endpoints, likely at the lower end of this range. The ongoing discussion about the grouping of 4,500 regis-tered petrochemicals can still have a major impact on these numbers. The 2022 amendment of REACH is estimated to add 3.6 to 7.0 million animals. This information comes as the European Parliament is set to consider changes to REACH that could further increase animal testing. Two proposals currently under discussion would likely necessitate new animal testing: extending the requirement for a chemical safety assessment (CSA) to Annex VII substances could add 1.6 to 2.6 million animals, and the registration of polymers adds a challenge comparable to the petrochemical discussion. These findings high-light the importance of understanding the current state of REACH animal testing for the upcoming debate on REACH revisions as an opportunity to focus on reducing animal use.