Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 29 aliphatic secondary alcohols, ketones and related esters evaluated by JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to the inclusion of nine additional substances cleared for genotoxicity concern in FGE.205 Revision 1. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by JECFA for all 29 substances considered in this FGE. For all substances, the Panel concludes that there is 'no safety concern at the estimated levels of intake as flavouring substances based on the MSDI approach'. For all 29 substances, the specifications for the materials of commerce have also been considered and found adequate. Ten out of the 14 substances for which use levels became available exceed the modified theoretical added maximum daily intake (mTAMDI) and more reliable exposure data are required to finalise their evaluation. On the basis of such data, additional toxicological data might become necessary. For 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.