Scientific Opinion on Flavouring Group Evaluation 204 (FGE.204): Consideration of genotoxicity data on representatives for 18 mono-unsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19 by EFSA

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings and Genotoxicity for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Mona-Lise Binderup, Wilfried Bursch, Riccardo Crebelli, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Pia Lund, Daniel Marzin, Wim Mennes, Pasquale Mosesso, Gerard Mulder, Karin Nørby, Gerrit Speijers, Harriet Wallin and EFSA’s staff members Maria Carfi and Kim Rygaard Nielsen for the support provided to this scientific Opinion.

EFSA Journal
EFSA Journal 2012;10(12):2992 [25 pp.].
doi
10.2903/j.efsa.2012.2992
Panel members at the time of adoption
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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00458
EFSA-Q-2012-00459
EFSA-Q-2012-00460
EFSA-Q-2012-00461
EFSA-Q-2012-00462
EFSA-Q-2012-00463
EFSA-Q-2012-00464
EFSA-Q-2012-00465
EFSA-Q-2012-00466
EFSA-Q-2012-00467
EFSA-Q-2012-00468
EFSA-Q-2012-00469
EFSA-Q-2012-00470
EFSA-Q-2012-00471
EFSA-Q-2012-00472
EFSA-Q-2012-00473
EFSA-Q-2012-00474
EFSA-Q-2012-00475
Adopted
21 novembre 2012
Published
12 décembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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 18 flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204. The Flavour Industry provided additional genotoxicity studies for two representative substances, 4-methylpent-3-en-2-one [FL-no: 07.101] and 7-methyl-3-octenone-2 [FL-no: 07.177], which were evaluated in this FGE.204. Based on these new data, the Panel concluded that the flavouring substance [FL-no: 07.101] does not present a safety concern with respect to genotoxicity and accordingly it can be evaluated using the Procedure. On the contrary, the Panel could not conclude on the in vivo genotoxicity of [FL-no: 07.177] and more appropriate in vivo genotoxicity tests, considering also first site of contact, should be performed. In addition, the substance 4-methyl-3-hepten-5-one [FL-no: 07.261] was now identified as a substance for which no representative substances could be identified in the present FGE, resulting in a need for additional data on the genotoxic potential of this flavouring substance. However, the Panel noted that the 2-methyl substituted α,β-unsaturated aldehydes in FGE.201Rev1 can be considered as structurally related to [FL-no: 07.261]. Thus, the final conclusion on [FL-no: 07.261] will be drawn based on the outcome of the evaluation of FGE.201Rev1.

Keywords
FGE.19; subgroup 1.2.1, aliphatic, mono-unsaturated, α,β-unsaturated ketones.
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Number of Pages
25