Scientific Opinion on Flavouring Group Evaluation 18, Revision 2 (FGE.18Rev2): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8.
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 32 flavouring substances in the Flavouring Group Evaluation 18, Revision 2, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were 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 Panel concluded that 28 substances [FL-no: 02.041, 02.052, 02.054, 02.120, 02.123, 02.129, 02.140, 02.144, 02.147, 02.149, 02.150, 02.168, 02.171, 02.181, 02.184, 02.197, 02.203, 02.206, 02.219, 02.226, 02.230, 02.253, 09.171, 09.356, 09.614, 09.617, 09.671 and 09.808] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining four substances [FL-no: 02.146, 02.185, 02.191 and 09.669] no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for six substances information is lacking.