New Approach Methodologies (NAMs) are gaining momentum globally as tools to reduce animal testing and improve the efficiency and human relevance of chemical safety assessment. However, despite strong EU commitment, their full regulatory adoption remains challenging.

A recent paper developed within the European Partnership for the Assessment of Risks from Chemicals (PARC) examines this disconnect. It highlights how academic research focuses on developing NAMs, while regulatory authorities must operate within existing legal frameworks that often still require in vivo animal data.

The analysis focuses on hazard assessment for genotoxicity and carcinogenicity, which stand as frontrunners in the implementation of alternatives to animal testing. It identifies regulatory needs, gaps, and challenges that still affect the broader regulatory uptake of non-animal methods. While EU initiatives such as the Chemical Strategy for Sustainability support NAMs development, legislation like CLP and REACH continues to rely heavily on animal data for classification purposes. This creates a structural tension between reducing animal testing and maintaining current hazard classification criteria.

At the same time, some sectors – such as cosmetics and certain EFSA-regulated areas – show greater flexibility in integrating NAMs.

The study provides a structured overview of available non-animal tests and current evaluation practices, contributing to ongoing discussions on how to advance human health protection while supporting the gradual replacement of animal testing.

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