Scientific Opinion on Flavouring Group Evaluation 12, Revision 5 (FGE.12Rev5): Primary saturated or unsaturated alicyclic alcohol, aldehyde, acid, and esters from chemical groups 1, 7 and 8)

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 15 flavouring substances in the Flavouring Group Evaluation 12, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of three additional candidate substances, beta-isomethylionone [FL-no: 07.041], 4-(2,5,6,6-tetramethyl-1-cyclohexenyl)but-3-en-2-one [FL-no: 07.200] and tr-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)but-2-en-1-one [FL-no: 07.224], compared to FGE.12Rev4. These three substances have been cleared for a genotoxic concern in FGE.213Rev1 and can accordingly be evaluated using the Procedure in the present revision of FGE.12. The 15 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 Panel concluded that all 15 flavouring substances [FL-no: 02.134, 02.186, 02.216, 02.217, 05.157, 05.182, 05.183, 05.198, 07.041, 07.200, 07.224, 08.135, 09.342, 09.670 and 09.829] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI (Maximised Survey-derived Daily Intake) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 15 candidate substances.