Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world.

Traditional animal models are increasingly being replaced by new approach methodologies (NAMs) which focus on predicting toxicity of chemicals based on mechanistic data rather than apical endpoint data usually obtained from animal models. Beyond in vitro genetic tests, however, only a handful of NAMs have been successfully implemented in regulatory decision-making processes, mostly in the cosmetics and chemicals sector. Regulatory guidance on food safety testing in many jurisdictions still relies on data obtained from animal studies. This is due to the lack of validated models to predict systemic toxicity, which is essential to develop health-based guidance values for food additives. Other factors limiting the adoption of NAMs into food safety assessment include sector legislation lagging behind scientific progress, and lack of training and expertise to use the new models. While regulatory and industry bodies are working to combat these challenges, more needs to be done before these models can be used as standalone tools for regulatory decision-making. This review summarizes the current state and challenges of regulatory acceptance of NAMs for decision-making, and the efforts by governing bodies and industry to transition from animal testing for food safety assessments.
Competing Interests: Declaration of competing interest Intertek Health Sciences Inc. Received financial support from Tate & Lyle to assist in the preparation of the manuscript. Tate & Lyle was involved in the conceptualization of the content of this manuscript and also reviewed the content of the complete manuscript; however, Intertek Health Sciences Inc. mintained responsibility for the final content.
(Copyright © 2023 Elsevier Inc. All rights reserved.)