Scientific Opinion on Flavouring Group Evaluation 216, Revision 1 (FGE.216Rev1). Consideration of genotoxic potential for α,β-unsaturated 2-Phenyl -2-Alkenals from Subgroup 3.3 of FGE.19

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(7):3305 [20 pp.].
doi
10.2903/j.efsa.2013.3305
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 Poças, Fidel Toldra and Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Genotoxicity Working Group on Flavourings: Mona-Lise Binderup, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Rainer Gürtler, Daniel Marzin, Pasquale Mosesso, for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund, Karin Nørby and EFSA staff: Maria Carfi, Annamaria Rossi 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-2013-00170
EFSA-Q-2013-00171
EFSA-Q-2013-00172
EFSA-Q-2013-00173
EFSA-Q-2013-00174
Adopted
4 July 2013
Published
25 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 five flavouring substances from subgroup 3.3 of FGE.19. In the Flavouring Group Evaluation 216 (FGE.216) additional genotoxicity data were requested. Additional genotoxicity studies have now been provided for the representative substance 2-phenylcrotonaldehyde [FL-no: 05.062]. Based on these new data the Panel concluded that the concern for genotoxicity could not be ruled out and requests a proof of sufficient systemic exposure of animals treated with 2-phenylcrotonaldehyde. Moreover, since the substance was genotoxic only without metabolic activation, it appears necessary to prove the absence of genotoxic effect locally in the gastro intestinal system using the Comet assay.

Summary

Following a request from the European Commission the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) 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 5 flavouring substances in Flavouring Group Evaluation 216 (FGE.216) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.

The FGE.216 concerned five α,β-unsaturated 2-phenyl substituted aldehydes, 2-phenylcrotonaldehyde [FL-no: 05.062], 5-methyl-2-phenylhex-2-enal [FL-no: 05.099], 4-methyl-2-phenylpent-2-enal [FL-no: 05.100], 2-phenylpent-2-enal [FL-no: 05.175] and 2-phenyl-4-methyl-2-hexenal [FL-no: 05.222], corresponding to subgroup 3.3 of FGE.19. The conclusion of the Panel in FGE.216 was that the available data on genotoxicity were too limited to evaluate the five substances through the Procedure and additional genotoxicity studies were requested.

The Flavouring Industry has now submitted new data in reply to the above requested data for FGE.19 subgroup 3.3 (FGE.216) for the representative flavouring substance, 2-phenylcrotonaldehyde [FL-no: 05.062], covering the remaining four substances [FL-no: 05.099, 05.100, 05.175 and 05.222].

Based on these new data, the Panel concluded that the concern for genotoxicity could not be ruled out and requests a proof of sufficient systemic exposure of animals treated with 2-phenylcrotonaldehyde. Moreover, since the substance was genotoxic only without metabolic activation, it appears necessary to prove the absence of genotoxic effect locally in the gastrointestinal system using the Comet assay.

Keywords
FGE.216, alpha,beta-Unsaturated ketones, 3(2H)-furanones, flavouring substances, safety evaluation, Subgroup 3.3, FGE.19
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Number of Pages
20