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

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.