Scientific Opinion on Flavouring Group Evaluation 215 (FGE.215): Seven α,β-Unsaturated Cinnamyl Ketones from subgroup 3.2 of FGE.19

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(4):3623 [23 pp.].
doi
10.2903/j.efsa.2014.3623
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, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldrá and Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Genotoxicity Working Group on Flavourings: Mona-Lise Binderup, Claudia Bolognesi, Angelo Carere, Riccardo Crebelli, Rainer Gürtler, Natália Kovalkovičová, Daniel Marzin and Pasquale Mosesso for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby, and EFSA staff: Maria Carfi, Kim Rygaard Nielsen and Annamaria Rossi, 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-2013-00668
EFSA-Q-2013-00669
EFSA-Q-2013-00670
EFSA-Q-2013-00671
EFSA-Q-2013-00672
EFSA-Q-2013-00673
EFSA-Q-2014-00125
Adopted
26 March 2014
Published
10 April 2014
Last Updated
1 August 2014. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (279.93 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 flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215 (FGE.215). The Flavour Industry has provided in vitro genotoxicity studies for the representative substances in FGE.215, namely 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. Based on these genotoxicity data, the Panel concluded that the genotoxicity concern could not be ruled out and in vivo genotoxicity data are requested.

Summary

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 seven a,b-unsaturated substances in the Flavouring Group Evaluation 215 (FGE.215) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.

The present FGE.215, corresponding to subgroup 3.2 of FGE.19, concerns six cinnamyl ketones with the a,b-unsaturation in the side-chain [FL-no: 07.024, 07.027, 07.030, 07.046, 07.049 and 07.206] and one precursor [FL-no: 02.066] for such ketones.

he seven substances under consideration in FGE.215 are listed in Table 3.

The α,β-unsaturated ketone structure is a structural alert for genotoxicity and the data previously available did not rule out the concern for genotoxicity for these seven flavouring substances.

The Flavour Industry has now submitted in vitro data for two representative substances (4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]) which are going to cover the evaluation of the other five substances in this subgroup 3.2 of FGE.19.

The Panel has evaluated these data and concluded that the genotoxicity concern could not be ruled out. To further assess the genotoxic potential of both representative substances (4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]) of subgroup 3.2 of FGE.19, a combined in vivo micronucleus and Comet assays in liver and duodenum are requested.

Keywords
α,β-unsaturated aldehydes, straight chain, FGE.215, α,β-unsaturated cinnamyl ketones, subgroup 3.2, FGE.19
Print on demand
Number of Pages
23