Statement on the applicability of the Margin of Exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic in substances added to food/feed

Abstract Following a request from EFSA, the Scientific Committee was asked to deliver a statement on the applicability of the margin of exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic in substances added to food or feed. The Scientific Committee acknowledges that analytical methodology is continually improving, and an increasing number of impurities, including some substances which are both genotoxic and carcinogenic, can be detected at low levels in, for example, food/feed additives or food contact materials. As a result it can be foreseen that these impurities may end up in food, including products from animal origin. The Scientific Committee is of the opinion that the MOE approach can be applied to impurities which are both genotoxic and carcinogenic, irrespective of their origin. The Scientific Committee reiterates its view expressed in 2005 that in general a margin of exposure of 10,000 or higher, if it is based on the BMDL10 from an animal study, and taking into account overall uncertainties in the interpretation, would be of low concern from a public health point of view; the magnitude of an MOE however only indicates a level of concern and does not quantify risk. When using the MOE approach for assessing impurities, the derivation of the MOE, its magnitude, and the uncertainties regarding its derivation should be described. A conclusion on whether the MOE is of high concern, low concern, or unlikely to be of safety concern should also be provided. The Scientific Committee reiterates its recommendation that follow‐up discussion should be organised with EFSA partners on the weighing of the potential health significance of the magnitude of particular MOEs and how to band MOEs with respect to conclusions that use expressions such as high concern, low concern, or unlikely to be of safety concern.