Division II.6.3.6.14

If the structure of a minor metabolite is known or can be hypothesised and if the metabolite is or is expected to interact directly with DNA, then the potential risk for consumers shall be addressed. Evidence shall be provided to confirm that its level is low enough to be considered virtually safe — i.e. the level shall be low enough to ensure that the increased cancer risk that would result from consumer exposure to the substance would be less than 1 in 10⁶. This shall be achieved either using chemical specific data or, in the absence of such data, using the threshold of toxicological concern (‘TTC’) concept which provides an approach for quantifying the risk associated with a given exposure to a substance. Guidance published by the EFSA and the WHO on the TTC approach shall be followed^f1.