Scientific Opinion on Flavouring Group Evaluation 72 (FGE. 72): Consideration of aliphatic, branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters evaluated by the JECFA (61st meeting) structurally related to branched-and straight-chain unsaturated carboxylic acids. Esters of these and straight-chain aliphatic saturated alcohols evaluated by EFSA in FGE. 05Rev2 (2010)

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 evaluated a group of 22 aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters at the 61st meeting. The Panel concluded that the 22 substances 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). Although genotoxicity data are only available for a limited number of substances, the data available do not preclude the evaluation of the substances using the Procedure. The Panel agrees with the way the application of the Procedure has been performed by the JECFA for 20 of the 22 substances considered in this FGE. However, for two substances [FL-no: 05.148 and 08.079] 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 all 22 substances 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 including complete purity criteria and identity are available for ten of the 22 JECFA evaluated substances. For seven substances [FL-no: 02.029, 05.020, 05.148, 08.036, 08.055, 08.079 and 09.273] information on stereoisomerism has not been specified and for six substances [FL-no: 02.011, 02.012, 02.027, 05.021, 08.036 and 08.044] further information on the composition is requested. Thus, for 12 substances [FL-no: 02.011, 02.012, 02.027, 02.029, 05.020, 05.021, 05.148, 08.036, 08.044, 08.055, 08.079 and 09.273] the Panel has reservations (no European production volumes available, preventing them to be evaluated using the Procedure. and/or missing data on composition and/or isomerism). For the remaining 10 of the 22 JECFA evaluated aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters [FL-no: 02.058, 02.076, 02.109, 05.124, 05.169, 08.047, 08.064, 08.070, 09.408 and 16.001] the Panel agrees with JECFA conclusion " No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.