Scientific Opinion on Flavouring Group Evaluation 73, Revision 4 (FGE.73Rev4): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th and 63rd meeting) structurally related to primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters evaluated by EFSA in FGE.12Rev5
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 revision of FGE.73 concerns the inclusion of four additional flavouring substances (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302]) evaluated by JECFA at the 59th meeting. The substances were evaluated through a stepwise approach integrating information on structure–activity relationships, intake from current uses, toxicological thresholds of concern (TTC), and available data on metabolism and toxicity. In agreement with JECFA, the Panel evaluated 22 and one candidate substances via the A and the B-side of the Procedure, respectively, and concluded for all substances ‘No safety concern at estimated levels of intake as flavouring substances’ based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity data, are available for 22 out of the 23 JECFA substances evaluated in this FGE. For [FL-no: 09.278], the stereoisomeric composition is not specified. For the six substances with [FL-no: 02.060, 02.091, 09.034, 09.278, 09.302 and 09.712] evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For two substances [FL-no: 09.034, and 09.712], the mTAMDI estimates were above the TTC for their structural class and more detailed information is needed to finalise their evaluation. For the remaining 17 substances evaluated through the Procedure, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment in order to finalise the evaluation.