Scientific opinion of Flavouring Group Evaluation 205 Revision 1 (FGE.205Rev1): consideration of genotoxicity data on representatives for 13 α,β-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup 1.2.2 of FGE.19
The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested to consider in the Flavouring Group Evaluation 205 (FGE.205), the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [FL-no: 07.081] and pent-1-en-3-one [FL-no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent-1-en-3-one being the most potent (previously available data). In these assays, the representative substances were highly cytotoxic with a steep toxicity curve and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells, the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells. Therefore, the Panel recommended to test the most potent of the representative substances, pent-1-en-3-one, in an in vivo Comet assay on the first site of contact (e.g. the stomach or duodenum) and on the liver. The Industry has now submitted new data, a combined micronucleus and Comet assay for pent-1-en-3-one, with scoring in the liver and duodenum, and an Ames test and a Comet assay with scoring in the liver for oct-1-en-3-one. Based on these new data, the Panel concluded that the concern for a genotoxic potential could be ruled out for the two representative substances and accordingly for the remaining 11 substances in FGE.205Rev1. The 13 substances in FGE.205Rev1 can therefore be evaluated via the Procedure.