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

Published:
Adopted:
EFSA Journal logo
Wiley Online Library

Meta data

DOI
https://doi.org/10.2903/j.efsa.2013.3390
Keywords
alpha,beta-unsaturated ketones, 3(2H)-furanones, flavouring substances, safety evaluation
On request from
European Commission
Question Number
EFSA-Q-2013-00201
EFSA-Q-2013-00202
EFSA-Q-2013-00203
EFSA-Q-2013-00204
Panels
Food Contact Materials, Enzymes and Processing Aids
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Pocas, Fidel Toldra, Detlef Wölfle.

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 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.

© European Food Safety Authority, 2013