Recent suggestions from DEFRA’s Hazardous Substances Advisory Committee (HSAC) outline a path that could position the UK as a frontrunner in ethical, safer, and more cost-effective chemical testing by adopting a risk-based regulatory approach, also known as next-generation risk assessment.
The Department for Environment, Food & Rural Affairs (DEFRA) has released a report on the recommendations for incorporating New Approach Methodologies (NAMs) in UK chemical regulations. This report features insights from experts affiliated with the University of Birmingham, King’s College London, and HSAC members.
NAMs are innovative testing methods that leverage cutting-edge technologies. They aim to improve the assessment and regulation of hazardous substances by increasing the speed, reliability, and relevance of toxicological studies, while also promoting the reduction of animal testing.
The findings indicate that the UK possesses highly advanced technological and scientific capacities, placing it in a prime position to lead globally in implementing NAMs for chemical safety evaluations.
Iseult Lynch, Professor of Environmental Nanosciences at the University of Birmingham (UoB) and Chair of the HSAC, stated: “The existing method of regulating chemicals, which depends heavily on animal testing, is inadequate for managing the expansive range of chemicals available today. It has not kept pace with scientific advancements that offer new insights into the toxicological effects of various substances and their combinations on human and environmental health. The time is right for the UK to move toward a regulation framework based on NAMs.”
Key Advices for UK Chemical Regulation include:
- Implementation of a technology-neutral definition of NAMs based on an understanding of chemical action mechanisms.
- Development of criteria for NAMs within an evolving regulatory framework, starting with guidelines for chemical grouping and prioritization.
- Utilization of a Progressive Regulatory Framework where NAMs are applied to a broad range of regulatory purposes as the assurance of hazard assessment findings improves.
- Creation of specialized UK centres of excellence and a national reference laboratory dedicated to the development and validation of NAMs, ensuring technological growth in both governmental and private sectors.
- Encouragement for chemical registrants under UK REACH* to present NAMs data that reflects the action mechanisms of their substances, supporting a “group first” strategy in chemical safety evaluations.
John Colbourne, Professor of Environmental Genomics at the University of Birmingham and Director of the Centre for Environmental Research and Justice (CERJ), expressed optimism that the barriers to this transition may be removed after years of significant investment in public and private scientific research. “The UK is well-positioned to benefit from nearly a billion pounds invested in national and European research initiatives by reassessing what kind of evidence is required to enhance protection against toxic chemicals. This can be integrated into current legal reforms in a post-Brexit UK.”
The report not only highlights the potential for the UK to lead in NAMs if these recommendations are adopted, but also suggests that effectively implementing NAMs could dramatically decrease, refine, and potentially eliminate the need for mammalian testing in chemical safety assessments while enhancing the thoroughness and efficiency of hazard evaluations.
Dr. Luigi Margiotta-Casaluci, a Senior Lecturer in Mechanistic and Integrative Toxicology at King’s College London and HSAC member, noted: “NAMs and AI-driven predictive models are significantly advancing our capacity to understand and forecast the effects of chemicals on humans and wildlife. These novel approaches are increasingly shaping safety decisions across various sectors and minimizing the necessity for animal testing when alternative methods are available. However, achieving a significant impact will necessitate coordinated strategies to hasten their adoption in regulatory environments both in the UK and on a global scale.”
The report concludes that establishing a progressive regulatory framework is a crucial initial measure to incorporate NAMs, ultimately leading to reduced testing expenditures while enhancing the safety and sustainability of the chemical industry.
