Scientific Opinion on Flavouring Group Evaluation 62, Revision 1 (FGE. 62Rev1): Consideration of of linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids, and related esters evaluated by JECFA (61st and 68th meeting) structurally related to branched- and straight-chain unsaturated carboxylic acids and esters of these with aliphatic saturated alcohols evaluated by EFSA in FGE.05Rev2 (2010) and to straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters evaluated by EFSA in FGE.06Rev1 (2008)

The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to give scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. The JECFA has evaluated a group of 28 flavouring substances, 27 new and one previously evaluated consisting of linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids and related esters at the 68th meeting. The JECFA has previously evaluated a group of 20 flavouring substances consisting of linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids, and related esters at the 61st meeting. Of the in total 48 substances in the group of linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids and related esters evaluated by JECFA at the 61st and 68th meeting, 18 substances are not in the Register, six substances have been evaluated in FGE.06 and FGE.06Rev1, one substance has been evaluated in FGE.05Rev1 and one substance is an alpha, beta-unsaturated substance for which the Panel concluded (in FGE.201) that it could not be evaluated through the Procedure and that additional data are needed before it can be re-evaluated. This consideration therefore only deals with 22 substances. The Panel concluded that the 22 substances in the JECFA flavouring group of linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids, and related esters are structurally related to the group of branched- and straight-chain unsaturated carboxylic acids and esters of these with aliphatic saturated alcohols evaluated by EFSA in the Flavouring Group Evaluation 05, Revision 2 (FGE.05Rev2) and related to straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters evaluated by EFSA in the Flavouring Group Evaluation 06, Revision 1 (FGE.06Rev1). The Panel agrees with the way the application of the Procedure has been performed by the JECFA for the 22 substances considered in this FGE. For two substances [FL-no: 02.189 and 02.243] the JECFA evaluation is only based on MSDI values derived from production figures from the USA. EU production figures are needed in order to finalise the evaluation of these substances. For five substances [FL-no: 05.208, 09.559, 09.566, 09.568 and 09.655] use levels have been provided by the Industry. Except for one substance [FL-no: 05.208], the mTAMDI figures calculated were above the threshold of concern for structural class I. For these four substances more reliable exposure data are needed. On the basis on such additional data these flavouring substances should be reconsidered using the Procedure. 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 and to finalise the evaluation. In order to determine whether the conclusion for the 22 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications are available for 16 of the 22 JECFA evaluated substances. For four substances [FL-no: 05.192, 08.075, 09.540 and 09.846] information on the isomeric composition is lacking and for three substances additional information on the composition is requested [FL-no: 02.243, 05.192, and 09.932]. Thus, for 7 substances [FL-no: 02.189, 02.243, 05.192, 08.075, 09.540, 09.846 and 09.932] the Panel has reservations (no European production volumes available, preventing them to be evaluated using the Procedure and/or missing data on isomerism/composition of isomers). For the remaining 15 substances [FL-no: 02.249, 05.139, 05.208, 05.224, 09.559, 09.563, 09.564, 09.566, 09.568, 09.571, 09.655, 09.917, 09.918, 09.921 and 09.922] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.