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Report on the Capacity of Legal and Regulatory Frameworks to Accommodate NAMs

By February 10, 2025No Comments
This report undertakes a critique of key risk assessment models, such as the framing of chemical testing as either protective or predictive and the focus of different jurisdictions on either hazard or exposure. The review serves to illustrate the inextricable links between these debates and suggests that value can be added from NAMs, which is not fully recognised by EU law as currently drafted, applied, or interpreted. A review of judicial interpretation of legislation through an analysis of toxicological court cases relating to the utility of chemical safety testing methods reveals significant complexities for all actors involved in the decision-making process. This review questions the extent to which the last resort principle is applied in oversight of regulatory decision making, and it exposes the wider political accountability of the decision-makers involved. Finally, this report provides an analysis of key legislative instruments in the chemical domain to uncover the extent that NAMs are recognised in EU regulatory structures. While the testing requirements lean very heavily on traditional animal testing, there does appear to be greater scope for the use of NAMs under REACH and CLP, which defies general opinion. To improve the regulatory acceptance of NAMs, we recommend clearer policy direction to address a key issue of interpretation of what determines adversity. This may be achieved to an extent by utilising soft law guidance rather than hard law legislative change, coupled with applying lessons learnt from the Cosmetics Regulation and pharmaceutical sectors’ pursuit of alternative methods to animal testing. 

 

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