Résumé
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise 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 Scientific Panel is 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 present consideration concerns 19 linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids, and related esters evaluated by the JECFA (61st meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluations of esters of branched- and straight-chain aliphatic saturated primary alcohols and of one secondary alcohol, and branched- and straight-chain unsaturated carboxylic acids evaluated in the Flavouring Group Evaluation 05 (FGE. 05) and straight- and branched- chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters evaluated in the Flavouring Group Evaluation 06 ( FGE. 06).
The Panel concluded that the 19 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 esters of branched- and straight-chain aliphatic saturated primary alcohols and of one secondary alcohol, and branched- and straight-chain unsaturated carboxylic acids evaluated by EFSA in FGE. 05 and related to straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters evaluated by EFSA in FGE. 06.
One additional substance ((E)-3-(Z)-6-nonadien-1-ol acetate) considered by the JECFA is not in the Register and was therefore not evaluated in this FGE.
The Panel agrees with the application of the Procedure as performed by the JECFA for the 19 substances considered in this FGE.
For two substances [FL-no: 02.189 and 02.243] 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 19 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 19 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:
Adequate specifications are available for 12 of the 19 JECFA evaluated substances. For six substances [FL-no: 05.192, 08.075, 09.566, 09.568, 09.571 and 09.846] information of the isomeric composition is lacking and for three substances additional information on the composition is requested [FL-no: 05.192, 09.568 and 09.922].
Thus, for nine substances [FL-no: 02.189, 02.243, 05.192, 08.075, 09.566, 09.568, 09.571, 09.846 and 09.922] the Panel has reservations (only USA production volumes available and/or missing data on specifications and/or isomerism/composition). For the remaining ten substances [FL-no: 02.249, 05.139, 09.559, 09.563, 09.564, 09.655, 09.917, 09.918, 09.921 and 09.932] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.