Scientific Opinion on Flavouring Group Evaluation 220 Revision 3 (FGE.220Rev3): Consideration of genotoxic potential for α,β‐unsaturated 3(2H)‐Furanones from subgroup 4.4 of FGE.19

Abstract

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 FGE.19 subgroup 4.4, 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 that for the substances in subgroup 4.4b there is no concern for genotoxicity. In FGE.220, Revision 2, the Panel evaluated genotoxicity studies on 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 submitted 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, therefore the Panel requested a repetition of the submitted micronucleus study in the presence of S9-mix, or a combined in vivo micronucleus and Comet assay, including analysis of the liver. The Flavour Industry has tested again 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in an in vitro micronucleus assay as was requested by the Panel. This new study is evaluated in FGE.220, Revision 3, where the Panel concluded that [FL-no: 13.175] does not give rise to concern with respect to genotoxicity and can be evaluated using the Procedure. This is also applicable to other two substances in subgroup 4.4a: 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl4-ethoxyfuran-3(2H)-one [FL-no:13.117]. Based on the available data the substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.