Division II.6.2.4

Pharmacokinetic data in laboratory animals shall also be used to determine whether the metabolites that consumers will ingest in animal-derived food commodities are also produced in the laboratory animals used for safety testing. This is necessary in order to determine the relevance of the toxicological effects and NO(A)ELs or BMDLs obtained in the toxicology studies. If the laboratory animals produce the same metabolites to those produced by the food-producing animal, the laboratory animals shall be considered to have been auto-exposed to the metabolites that humans would consume. This is ordinarily taken as evidence that the safety of metabolites has been adequately assessed in the toxicology studies. If the metabolites produced by the target animal species are not produced in the laboratory animal studies, there may be a need to conduct safety studies using the major metabolite(s) produced in the target animal.