Scientific Opinion on Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3): 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 29 flavouring substances in the Flavouring Group Evaluation 18, as laid down in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have a 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. This revision deals with new toxicity data on the supporting substance myrcene [FL-no: 01.008], providing an appropriate NOAEL for the evaluation of candidate substance [FL-no: 02.146]. The Panel concluded that all 29 substances [FL-nos: 02.041, 02.052, 02.054, 02.120, 02.123, 02.129, 02.140, 02.146, 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. However, based on mTAMDI calculations, for all candidate substances except [FL-no: 02.146] more reliable intake data are required for a re-evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For four substances [FL-nos: 02.129, 02.147, 02.168, 02.197] additional information on purity criteria and/or stereoisomeric composition is required.