Scientific Opinion on Flavouring Group Evaluation 213, Revision 1 (FGE.213Rev1): Consideration of genotoxic potential for α,β-Unsaturated Alicyclic ketones and precursors from chemical subgroup 2.7 of FGE.19

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(5):3661 [46 pp.].
doi
10.2903/j.efsa.2014.3661
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 Toldra 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: Annamaria Rossi, Maria Carfi 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-2013-00102
EFSA-Q-2013-00103
EFSA-Q-2013-00104
EFSA-Q-2013-00105
EFSA-Q-2013-00106
EFSA-Q-2013-00107
EFSA-Q-2013-00108
EFSA-Q-2013-00109
EFSA-Q-2013-00110
EFSA-Q-2013-00111
EFSA-Q-2013-00112
EFSA-Q-2013-00113
EFSA-Q-2013-00560
EFSA-Q-2013-00561
EFSA-Q-2013-00554
Adopted
10 April 2014
Published
7 May 2014
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 26 flavouring substances from subgroup 2.7 of FGE.19 in the Flavouring Group Evaluation 213. In the first version of FGE.213 the Panel concluded based on available genotoxicity data that a concern regarding genotoxicity could be ruled out for [FL-no: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525].

Summary

The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) is asked to advise 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 Scientific Panel is asked to evaluate flavouring substances using the procedure as referred to in the Commission Regulation EC No 1565/2000.

The present revision of FGE.213, FGE.213Rev1 is due to additional genotoxicity data submitted by the Industry in response to genotoxicity data requests presented in FGE.213. New genotoxicity studies have been submitted for the five substances beta-ionone [FL-no: 07.008], maltol [FL-no: 07.014], beta-damascone [FL-no: 07.083], nootkatone [FL-no: 07.089] and 2,6,6-trimethylcyclohex-2-en-1,4-dione [FL-no: 07.109].

The Flavouring Group Evaluation 213 concerns 26 substances, corresponding to subgroup 2.7 of FGE.19. Twenty-three of the substances are α,β-unsaturated alicyclic ketones [FL-no: 07.008, 07.010, 07.014, 07.041, 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.083, 07.089, 07.108, 07.109, 07.117, 07.118, 07.119, 07.120, 07.127, 07.136, 07.168, 07.200 and 07.224] and three are precursors for such ketones [FL-no: 02.106, 09.305 and 09.525].

In the first version of FGE.213 the Panel concluded that the genotoxicity concern for ethyl maltol [FL-no: 07.047], 3-ethylcyclopentan-1,2-dione [FL-no: 07.057] and the nine structurally related substances [FL-no: 07.117, 07.118, 07.119, 07.120, 07.056, 07.168, 07.075, 07.076 and 07.080] could be ruled out and the 11 substances could accordingly be evaluated through the Procedure.

For maltol [FL-no: 07.014], a micronucleus assay after oral application was required in addition to an in vivo Comet assay in order to clarify the genotoxic potential. The outcome would also be applicable to maltyl isobutyrate [FL-no: 09.525].

The remaining 13 substances (including two precursors of a ketone) [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] could not be evaluated through the Procedure. Accordingly, additional data on genotoxicity were required for representatives of these 13 substances.
The flavouring Industry has informed that it does not longer support the representative flavouring substance, piperitenone oxide [FL-no: 16.044], for which the Panel requested additional data. Since the previous version of the FGE, one additional substance has been included in subgroup 2.7, tr-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)but-2-en-1-one [FL-no: 07.224], which is structurally related to the other substances for which the genotoxic potential could not be ruled out.

In FGE.213Rev1 the Panel has evaluated the new data submitted by the Industry in response to the data request presented in FGE.213. Based on these new data the Panel concluded that the genotoxicity concern could be ruled out for the representative substances beta-ionone [FL-no: 07.008], beta-damascone [FL-no: 07.083], nootkatone [FL-no: 07.089], 2,6,6-trimethylcyclohex-2-en-1,4-dione [FL-no: 07.109] and the nine substances that they represent, being [FL-no: 02.106, 07.010, 07.041, 07.108, 07.127, 07.136, 07.200, 07.224 and 09.305].

The Panel considered also the new data submitted for maltol [FL-no: 07.014] and concluded that for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525] the concern for genotoxicity could not be ruled out.

Keywords
FGE.213, α,β-Unsaturated alicyclic ketones, flavouring substances, safety evaluation, Subgroup 2.7, FGE.19
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Number of Pages
46