Scientific Opinion on Flavouring Group Evaluation 220, Revision 2 (FGE.220Rev1): α,β-Unsaturated ketones and precursors from chemical subgroup 4.4 of FGE.19: 3(2H)-Furanones
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from subgroup 4.4 of FGE.19 in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups (subgroup 4.4a containing [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded, based on new submitted data, that for the substances in subgroup 4.4b there is no concern for genotoxicity. The Flavour Industry has now provided additional genotoxicity studies for two representative substances of subgroup 4.4a, 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. Based on the new data the Panel concluded that 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] does not give rise to concern with respect to genotoxicity. For 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] the concern for genotoxicity could not be ruled out and therefore the Panel requests a repetition of the submitted micronucleus study in the presence of S9-mix applying the same conditions and possibly in addition modified conditions, or a combined in vivo micronucleus and Comet assay, including analysis of liver. This is also applicable to 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no:13.117], which are covered by the representative substance 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no:13.175]. The Flavour Industry has informed that 5-methylfuran-3(2H)-one [FL-no: 13.157] is not in common use in the flavour industry and is no longer supported.