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.

Scientific Opinion on Flavouring Group Evaluation 75, Revision 1 (FGE.75Rev1): Consideration of tetrahydrofuran derivatives evaluated by JECFA (63rd meeting) structurally related to tetrahydrofuran derivatives evaluated by EFSA in FGE.33 (2008)

“…Two of the JECFA-evaluated substances are not in the Register [2-hexyl-4-acetoxytetrahydrofuran (JECFA-no: 1440) and (+/-)-2-(5-methyl-5-vinyltetrahydrofuran-2-yl) propionaldehyde (JECFA-no: 1457)] and five substances [FL-no: 13.010, 13.084, 13.085, 13.089 and 13.099] are α,β-unsaturated ketones and will be considered together with other α,β-unsaturated aldehydes and ketones (EFSA, 2015). This consideration will therefore only deal with 11 JECFA-evaluated substances.…”

“…The specifications for the materials of commerce have also been considered and for all 11 substances, the information is adequate. Seven other substances were also evaluated by the JECFA in this group, but two are not in the Register [2-hexyl-4-acetoxytetrahydrofuran (JECFA-no: 1440) and (+/-)-2-(5-methyl-5-vinyltetrahydrofuran-2-yl)propionaldehyde (JECFA-no: 1457)] and five substances [FL-no: 13.010, 13.084, 13.085, 13.089 and 13.099] are α,β-unsaturated furanone and will be considered together with other α,β-unsaturated aldehydes and ketones in a separate FGE (EFSA CEF Panel, 2015). This consideration will, therefore, only deal with 11 JECFA-evaluated substances.…”

“…The Panel concluded that the 11 substances evaluated by the JECFA were structurally related to the six tetrahydrofuran derivatives evaluated by EFSA in Flavouring Group Evaluation (FGE.33). This revision of FGE.75 (FGE.75Rev1) is made because EFSA received additional toxicity data for the candidate substance anhydrolinalool oxide .097].Seven other substances were also evaluated by the JECFA in this group, but two are not in the Register [2-hexyl-4-acetoxytetrahydrofuran (JECFA-no: 1440) and (+/-)-2-(5-methyl-5vinyltetrahydrofuran-2-yl)propionaldehyde (JECFA-no: 1457)] and five substances 13.084, 13.085, 13.089 and 13.099] are α,β-unsaturated furanone and will be considered together with other α,β-unsaturated aldehydes and ketones in a separate FGE (EFSA CEF Panel, 2015). This consideration will, therefore, only deal with 11 JECFA-evaluated substances.The JECFA reached a conclusion for all 11 substances at step A3 of their procedure.…”

Scientific Opinion on Flavouring Group Evaluation 99 Revision 1 (FGE.99Rev1): Consideration of furanone derivatives evaluated by the JECFA (63rd, 65th and 69th meetings)

“…The Panel concluded that the data available ruled out the concern for genotoxicity and thus concluded that these five substances can be evaluated through the Procedure. The substance has been considered with respect to genotoxicity in FGE 220rev3 (EFSA CEF Panel, 2015) and the Panel concluded that the data available did rule out the concern for genotoxicity and accordingly the substance can be evaluated through the Procedure.…”

“…The substance has been considered with respect to genotoxicity in FGE 220rev3 (EFSA CEF Panel, 2015) and the Panel concluded that the data available did rule out the concern for genotoxicity and accordingly the substance can be evaluated through the Procedure.…”