DEFRA's New Recommendations for the Implementation of NAMs in UK Chemical Regulations

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently published a report setting out a new set of recommendations for the integration of New Approach Methodologies (NAMs) into UK chemical regulations. These methodologies support a transition away from traditional animal testing by relying on advanced scientific approaches, including in vitro and in silico methods. The new recommendations mark an important step in improving the reliability of chemical safety testing, while aligning with the UK’s post-Brexit regulatory landscape.

Key Recommendations for NAM Integration

The report sets out DEFRA's strategy for the progressive adoption of NAMs, detailing a framework to enhance chemical safety through:

• Technology Agnostic NAMs: DEFRA proposes a broad definition of NAMs, focusing utility of the data in assessing the mode of action of chemicals.

• Progressive Regulatory Framework: Phased implementation would allow NAMs to progressively replace animal testing as scientific certainty increases.

• Investment in UK Centres of Excellence: The establishment of dedicated NAMs research centres is recommended to ensure regulatory alignment and technological advancement within the UK.

Benefits of Early Adoption of NAMs

By adopting NAMs, the UK will gain ethical and economic benefits and position itself as a global leader in chemical safety. Early adoption is also in line with the “3Rs” principle (Reduce, Refine and Replace animal testing), further strengthening public trust in the UK’s regulatory framework. The report highlights that NAMs enable high confidence safety evaluations and support group-based testing and prioritization, reducing the need for traditional methods.

Challenges and Future Outlook

While the integration of NAMs holds great promise, DEFRA notes the need for robust acceptance criteria to ensure scientific reliability. As NAMs continue to develop, the UK is encouraged to take a lead in establishing reporting standards, drawing on international research and collaboration. With the progressive framework, NAMs are expected to play a greater role in chemical safety assessments, promising a safer and more sustainable future for the industry.

DEFRA’s latest recommendations underline the UK’s commitment to scientific innovation in chemical regulation and highlight a strategic shift towards a safer and more ethical approach to chemical safety assessment.