Scientific Opinion on Flavouring Group Evaluation 11, Revision 3 (FGE.11Rev3): Aliphatic dialcohols, diketones, and hydroxyketones from chemical groups 8 and 10


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(11):3888 [60 pp.].
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn.

The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby for the preparatory work on this scientific opinion and EFSA staff: Maria Carfí, Annamaria Rossi and Kim Rygaard Nielsen for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
23 October 2014
Published in the EFSA Journal
13 November 2014
European Food Safety Authority (EFSA), Parma, Italy

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 11 flavouring substances in the Flavouring Group Evaluation 11, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The present Revision of FGE.11, FGE.11Rev3, is prepared due to the evaluation of genotoxicity data, which have been requested in the previous version of FGE.11, for 3-methylnona-2,4-dione [FL-no: 07.184]. Additionally, new information on the stereoisomerism of [FL-no: 07.184 and 07.260] has become available. Based on the new data received the Panel concluded that all 11 flavouring substances [FL-no: 02.133, 07.071, 07.097, 07.152, 07.165, 07.167, 07.168, 07.184, 07.238, 07.248 and 07.260] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all candidate substances.

flavourings, safety, alpha-diketones, ketals, hydroxyketones, diols, FGE.11
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