Suitability of the Ames test to characterise genotoxicity of food contact material migrates

ABSTRACTNon-intentionally added substances (NIAS) are chemical impurities which can migrate from packaging materials (FCM) into food. Safety assessment of NIAS is required by European law, but currently there is no comprehensive testing strategy available. In this context, one key element is to get insight on the potential presence of genotoxic NIAS in FCM migrates. This raises questions about the limit at which genotoxins can be detected in complex mixtures such as FCM migrates, and if such limits of detection (LOD) would be compatible with safety. In this context, the present review assesses the suitability of the Ames assay to address genotoxicity of FCM migrates. Lowest effective concentrations of packaging-related and other chemicals in test media were retrieved from scientific literature and used as surrogates of LODs to be benchmarked against a value of 0.01 mg kg−1 (10 ppb) in migrates. This is a pragmatic threshold used in FCM safety evaluation to prioritise substances requiring proper identifica...