Critical appraisal of the european commission roadmap towards phasing out animal testing: navigating sociotechnical barriers to the regulatory acceptance of NAMs.

Authors

Aleksandra Čavoški, Laura Holden, Robert G Lee

Published in

NAM journal. Volume 2. Pages 100145. Epub Oct 10, 2026.

Abstract

The gradual rate of phasing out animal use in regulatory testing has been attracting greater attention from policy makers, the scientific community, and industry. In this paper we analyse the extent to which the strategic 'Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments' of the European Commission is able to address sociotechnical barriers that have thus far hindered the greater regulatory acceptance of NAMs, including: the lack of consensus when applying scientific developments to value-laden risk assessments that have inherent uncertainties; the lack of stakeholder participation; regulatory culture; and routes to assurance. The roadmap is predominantly focused on the technical aspects of the transition, leaving the social nature of barriers to be addressed in greater detail in the implementation phase. A review of legal frameworks underpinning the roadmap identifies that more extensive statutory interpretation, particularly regarding the use of Weight-of-Evidence, would aid regulatory acceptance of NAMs. The paper critiques the short-, mid-, and long-term actions of the roadmap, and notes the absence of consideration of the EU judicial system, which plays an important role in providing interpretation to EU chemical law and its enforcement, in particular the obligation to use animal testing as a last resort. Although setting a clear final intention, this paper notes that with the longer-term goal to replace the use of non-protected life stages and invertebrates, and without hard milestone dates by which to indicate progress, the roadmap as a strategy is only able to provide limited clarity that NAM innovators and investors seek.

PMID:
42927064
Bibliographic data and abstract were imported from PubMed on 25 Oct 2026.

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