Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19

The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances.