Overcoming Difficult, Impossible, and Meaningless Animal Testing under REACH: Opportunities for Robust Chemical Risk Assessment with Non-Animal Approaches.

Authors

Martijn van Velthoven, Giorgia Pallocca, Vicente Aranda, Anders Bergqvist, Maria Blanco-Rubio, Kevin Bonnot, Jay Dawick, Mojca Fuart-Gatnik, Marlly Guarin, Steve Gutsell, Jean Knight, Aleksandra Mostrag-Szlichtyng, Kyle Roush, Marten Schults, Eva Serrano-Candelas, Sagar Thakali, Paul Thomas, Xiaoling Zhang, Jay Ingram

Published in

Regulatory toxicology and pharmacology : RTP. Pages 106216. Aug 09, 2026. Epub Aug 09, 2026.

Abstract

The European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC No. 1907/2006) (REACH) includes the principle of testing only when scientifically necessary, integrating mechanisms for data sharing, read-across, and adaptations to minimise vertebrate animal testing. REACH already provides a framework to promote non-animal testing (Annex XI). Nevertheless, the challenge lies in translating its flexibility into consistent practice. New in vivo (vertebrates) studies are still requested to meet information requirements in cases where these tests may add limited or no regulatory or scientific value. In this paper, an initiative of the Animal-Free Safety Assessment (AFSA) Collaboration to define specific scientific and procedural criteria to identify when animal testing is difficult, impossible, or meaningless (DIM), and how non-animal methods can effectively address such cases. Objective DIM criteria were defined and applied to screen REACH registration dossiers for potential DIM testing cases. More specifically, the AFSA DIM initiative identifies concrete scenarios where animal testing adds no value and demonstrates how existing non-animal approaches can address information needs in those situations. Based on these cases, the following recommendations were: i) further refine the DIM criteria and considerations to be suitable for other REACH endpoints, prioritising human health; ii) evaluate adaptations for avoiding DIM testing for human health endpoints; iii) address more specifically the use of exposure-driven assessment under Next-Generation Risk Assessment (NGRA) considerations (major use of exposure-driven assessment).

PMID:
42571837
Bibliographic data and abstract were imported from PubMed on 10 Aug 2026.

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