Genotoxicity assessment of novel foods: insights from EFSA evaluations.

Abstract

The continuous development of innovative food products has reinforced the importance of rigorous safety evaluations within the European Union (EU) novel food framework. Among toxicological endpoints, genotoxicity is a critical determinant, as substances with genotoxic potential relevant to humans raise safety concerns and are not accepted for intentional inclusion in the food chain. This review provides a historical overview of how genotoxicity has been addressed in scientific opinions adopted by the European Food Safety Authority (EFSA) in the context of novel food applications. The analysis demonstrates considerable variability in both the type and form of test items assessed and the genotoxicity strategies employed. While mostly standard in vitro test batteries were sufficient to rule out the genotoxicity concerns, specific scenarios required in vivo tests in order to rule out the risk. Over time, the implementation of updated EFSA guidance has contributed to greater consistency in study design and interpretation. In one case where genotoxicity concerns could not be adequately resolved, a favourable safety conclusion was not supported under any proposed use. By mapping regulatory precedents and decision-making patterns, this review offers practical insight into EFSA's evolving approach to genotoxicity assessment and provides guidance for applicants designing future testing strategies.