Flavouring Group Evaluation 51, (FGE.51) - Consideration of alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting) and structurally related to alicyclic ketones, secondary alcohols and related esters evaluated by EFS

Abstract

The present consideration concerns 13 alicyclic ketones, secondary alcohols and related esters evaluated by the JECFA (59 th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of ten alicyclic ketones, secondary alcohols and related esters evaluated in the Flavouring Group Evaluation 09 (FGE.09).The Panel concluded that all the 13 substances in the JECFA group of alicyclic ketones, secondary alcohols and related esters are structurally related to the group of ten secondary A further twelve substances were evaluated by the JECFA in this group. Two of these substances are not in the Register (4-methyl cyclohexanone (JECFA no: 1104) and (E)-2-(2-octenyl) cyclopentanone (JECFA no: 1116)) and ten are alpha,beta-unsaturated ketones or precursors for such 07.034, 07.035, 07.094, 07.098, 07.112, 07.126, 07.129, 07.172 and 09.930] and will be considered together with other alpha,beta-unsaturated aldehydes and ketones.The Panel agrees with the application of the Procedure as performed by the JECFA for the 13 substances considered in this FGE.For one substance ] the JECFA evaluation is only based on the Maximised Survey-derived Daily Intake (MSDI) derived from production figure from the USA. EU production figure is needed in order to finalise the evaluation of this substance.For all 13 substances evaluated through the Procedure use levels are needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.In order to determine whether the conclusion for the 13 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:Adequate specifications including complete purity criteria and identity tests are available for nine of the 13 JECFA evaluated substances. For four substances information of the isomeric composition is lacking 07.045, 07.095 and 07.257], and for one substance [FLno: 07.095] further information on the composition is also requested.Thus, for five substances 07.045, 07.095, 07.257 and 09.230] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure and/or data are missing on stereoisomerism/composition). For the remaining eight of the 13 JECFA evaluated alicyclic ketones, secondary alcohols and related esters 07.149, 07.179, 07.180, 09.027, 09.140, 09.160 and 09.464] the Panel agrees with the JECFA conclusion "no safety concern at estimated levels of intake as flavouring substance" based on the MSDI approach.