EFSA Issues Opinion on Use Levels for Various Flavouring Substances

The JECFA has evaluated 37 flavouring substances in the group aliphatic, linear alpha,beta-unsaturated aldehydes, acids and related alcohols, acetals and esters at their 63rd meeting.

25 Feb 2010 --- The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide 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 37 flavouring substances in the group aliphatic, linear alpha,beta-unsaturated aldehydes, acids and related alcohols, acetals and esters at their 63rd meeting.

Five of the 37 flavouring substances evaluated by the JECFA are not in the Register [(E)-2-octen-1-ol (JECFA-no: 1370), (E)-2-butenoic acid (JECFA-no: 1371), trans-2-hexenyl pentanoate (JECFA-no: 1379), (E)-2-nonenoic acid (JECFA-no: 1380), mixture of (Z)-3-hexenyl propionate and (E)-2-hexenyl propionate (JECFA-no: 1382)]. Twenty-three substances are alpha,beta-unsaturated aldehydes and ketones considered with respect to genotoxicity in subgroup 1.1.1 of FGE.19, for which a final conclusion as to its genotoxic properties could not be reached and additional data were requested. This consideration therefore only deals with nine alpha,beta-unsaturated acids or esters hereof.

The Panel concluded that the nine substances in the JECFA flavouring group of aliphatic, linear alpha,beta-unsaturated carboxylic acids and related esters are structurally related to the group of branched- and straight-chain unsaturated carboxylic acids and esters of these and straight-chain aliphatic saturated alcohols evaluated by EFSA in the Flavouring Group Evaluation 05, Revision 2 (FGE.05Rev2).

The Panel agrees with the way the application of the Procedure has been performed by the JECFA for all nine substances in the group of aliphatic, linear alpha,beta-unsaturated acids and related esters. However, for four substances [FL-no: 08.073, 08.123, 09.157 and 09.239] the JECFA evaluation is only based on Maximised Survey-derived Daily Intake (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 nine 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 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 seven of the nine JECFA evaluated substances. For two substances [FL-no: 08.073 and 09.235] information on stereoisomerism has not been specified.

Thus, for five substances [FL-no: 08.073, 08.123, 09.157, 09.235 and 09.239] the Panel has reservations (no European production volumes available, preventing them being evaluated using the Procedure, and/or missing information on stereoisomerism).

For the remaining four of the nine JECFA evaluated substances [FL-no: 08.054, 09.156, 09.158 and 09.037] the Panel agrees with JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.