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

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Article
EFSA Journal 2012;10(5):2748 [18 pp.].
doi
10.2903/j.efsa.2012.2748
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Panel Members
Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Pocas, Fidel Toldra, Detlef Wölfle
Acknowledgement

The Panel wishes to thank the members of the CEF Working Group on Genotoxicity: Mona-Lise Binderup, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Rainer Guertler, Daniel Marzin, Pasquale Mosesso for the preparatory work on this scientific opinion the hearing experts: Vibe Beltoft, Pia Lund, Karin Nørby and EFSA staff: Andrea Terron and Kim Rygaard Nielsen for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2012-00248
EFSA-Q-2012-00249
EFSA-Q-2012-00250
EFSA-Q-2012-00251
EFSA-Q-2012-00391
EFSA-Q-2012-00392
Adopted
24 May 2012
Published
30 May 2012
Last Updated
7 June 2012. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (225.79 KB)225.79 KB
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 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.

Summary

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.

Keywords
FGE.222, α,β-unsaturated aldehydes and ketones
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Number of Pages
18