Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was asked to evaluate 10 flavouring substances in Flavouring Group Evaluation 220 (FGE.220) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.
Flavouring Group Evaluation 220 (FGE.220) concerned 10 substances, corresponding to subgroup 4.4 of FGE.19. The 10 substances are α,β-unsaturated 3(2H)-furanones [FL-no: 13.010, 13.084, 13.085,13.089, 13.099, 13.117, 13.119, 13.157, 13.175 and 13.176]. The substances were further subdivided into two subgroups as five [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] of the 10 substances can only exist as α,β-unsaturated ketones (subgroup 4.4a) while in the other five substances [13.010,13.084 and 13.085, 13.099 and 13.176], the α,β-double bond can be involved in keto-enol tautomerism (subgroup 4.4b). For both groups the Panel concluded that the genotoxicity alert could not be ruled out based on data available at that time, and accordingly additional genotoxicity data were requested for both groups.
Revision 1 of FGE.220 (FGE.220Rev1) concerned the evaluation of additional data submitted by Industry in response to the requested genotoxicity data in FGE.220 on the representative substance for subgroup 4.4b, 4-hydroxy-2,5-dimethylfuran-3(2H)-one [FL-no: 13.010]. The Panel concluded that for the substances [13.010, 13.084 and 13.085, 13.099 and 13.176] in subgroup 4.4b there is no concern for genotoxicity, and these substances were accordingly evaluated through the Procedure in FGE.99.
In FGE.220, Revision 2, genotoxicity data related to subgroup 4.4a were evaluated. The Flavour Industry informed that one of the representative substances, 5-methylfuran-3(2H)-one [FL-no: 13.157], is not in common use in the Flavour Industry and is no longer supported. As an alternative substance for testing within this subgroup, the Flavour Industry had proposed the structurally related substance 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119]. Accordingly, additional genotoxicity data were submitted for 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. These data were examined by the Panel which concluded that 2,5-dimethylfuran-3(2H)-one [FLno:13.119] does not give rise to concern with respect to genotoxicity and can accordingly be evaluated using the Procedure. 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 requested a repetition of the 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.
The Industry has tested again 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in an in vitro micronucleus assay in the presence of S9-mix (3+21 hours). These data are evaluated in the present Revision 3 of FGE.220 (FGE.220 Rev3). The available data suggest that 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] did not induce reproducible statistically significant increase in micronucleated binucleate cells across replicate cultures indicating that the test substance can be considered negative for clastogenicity and aneugenicity. The Panel therefore concluded that [FL-no: 13.175] does not give rise to concern with respect to genotoxicity and accordingly can be evaluated using the Procedure. This is also applicable to 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl4-ethoxyfuran-3(2H)-one [FL-no:13.117] which are covered by the representative substance 4-acetyl2,5-dimethylfuran-3(2H)-one [FL-no:13.175].
Based on the available data all 9 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.