New Approach Methodologies (NAMs) for safety testing of complex food matrices: A review of status, considerations, and regulatory adoption

Abstract

Background: The conventional toxicological approach which primarily relies on animal testing has undergone several transformations in recent years due to limitations in translational relevance, ethical and reproducibility concerns, high costs, and time-consuming procedures. New Approach Methodologies (NAMs) have emerged as alternative techniques that incorporate in silico, in chemico, and in vitro approaches to provide mechanism-based insights with improved ethics and human-relevant safety data. Scope and approach: The current landscape of NAMs employed for food risk assessments in research and regulatory settings is examined with a focus on their strengths, limitations, validation, standardisation, and regulatory status. Furthermore, the challenges associated with the safety evaluation of complex food matrices are highlighted with key considerations for the utilisation of NAMs in their risk assessments. Key findings and conclusions: The regulatory acceptance of NAMs is progressive with the majority demonstrating more relevance for general chemical risk assessments in the pharmaceutical and cosmetics industries. There is a need to advance the regulatory approval of NAMs which address limitations of the current battery of in vitro tests and have demonstrated applicable relevance to the safety assessment of complex food matrices. The review provides insights into the current status of food-relevant NAMs and identifies key areas requiring regulatory adoption to increase their wider applicability.