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Scientific Opinion on Flavouring Group Evaluation 222 (FGE.222): Consideration of genotoxicity data on representatives for alpha,beta-unsaturated furyl derivatives with the α,β-unsaturation in the side chain from subgroup 4.6 of FGE.19 by EFSA
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 six flavouring substances from subgroup 4.6 of FGE.19 in the Flavouring Group Evaluation 222. The Flavour Industry have provided additional genotoxicity studies for two representative substances, 3-(2-furyl)acrylaldehyde [FL-no: 13.034] and 4-(2-furyl)but-3-en-2-one [FL-no: 13.044], in FGE.222. Based on these new data the Panel could not rule out a clastogenic and aneugenic potential for the two substances and a in vivo Comet assay was requested for both substances, the one including a micronucleus assay.
© European Food Safety Authority, 2012
The European Food Safety Authority (EFSA) asked the Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission 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 requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.
The present Flavouring Group Evaluation 222 (FGE.222), corresponding to subgroup 4.6 of FGE.19, concerns five α,β-unsaturated aldehydes and one ketone which are furyl derivatives with the α,β-unsaturation in the side chain. The six substances under consideration in the present evaluation contain an α,β-unsaturated aldehyde or ketone structure which are structural alerts for genotoxicity and the data on genotoxicity previously available did not rule out the concern for genotoxicity.
The Panel has identified two substances, 3-(2-Furyl)acrylaldehyde (furylacrolein) [FL-no: 13.034] and 4-(2-Furyl)but-3-en-2-one (furfurylidene acetone) [FL-no: 13.044], in FGE.19 subgroup 4.6 which will represent the other four substances in this subgroup. For these two substances genotoxicity data according to the test strategy worked out by the Panel have been requested.
The Industry has submitted data concerning genotoxicity studies for the two representative substances, 3-(2-furyl)acrylaldehyde [FL-no: 13.034] and 4-(2-furyl)but-3-en-2-one [FL-no: 13.044], for this subgroup.
Based on the data submitted the Panel considered that in order to clarify the clastogenic and aneugenic potential of 4-(2-furyl)but-3-en-2-one [FL-no: 13.044], an in vivo Comet assay should be performed and for 3-(2-furyl)acrylaldehyde [FL-no: 13.034], an in vivo combined Comet and micronucleus assay should be performed.
FGE.222, α,β-unsaturated aldehydes and ketones