Scientific Opinion on Flavouring Group Evaluation 9, Revision 6 (FGE.09Rev6): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 and 30, and an ester of a phenol derivative from chemical group 25

flavourings, alcohols, ketones, esters, secondary alicyclic, saturated, unsaturated, food safety, FGE.09
First published in the EFSA Journal
30 September 2015
9 September 2015
Scientific Opinion
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 22 flavouring substances in the Flavouring Group Evaluation 9, Revision 6, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances was considered to have genotoxic potential. 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.09 includes the assessment of one additional flavouring substance, trans-3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one [FL-no: 07.219]. The Panel concluded that the 22 substances [FL-nos: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.219, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for 11 flavouring substances [FL-nos: 07.059, 07.109, 07.202, 07.203, 09.154, 09.520, 09.618, 09.619, 09.843, 09.935 and 09.949] more reliable exposure data are required for a re-evaluation. For two substances [FL-nos: 07.219 and 09.929] no use levels are available and these should be submitted. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered. Specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all candidate substances.
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, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldrá, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at]
EFSA Journal 2015;13(9):4243
Question Number
On request from
European Commission