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 13 aliphatic secondary alcohols, ketones and related esters evaluated by the JECFA (59th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 35 saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated in the Flavouring Group Evaluation 07 (FGE. 07).
The Panel concluded that the 13 substances in the JECFA flavouring group of aliphatic secondary alcohols, ketones and related esters are structurally related to the group of saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated in FGE. 07.
Further 26 substances were evaluated by the JECFA in this group, two of these substances [(E) & (Z)-4,8-dimethyl- 3,7-nonadien-2-one and (E,R)-3,7-dimethyl-1,5,7-octatrien-3-ol] are not in the Register, and 24 substances [02.023, 02.099, 02.102, 02.104, 02.136, 02.193, 07.044, 07.048, 07.081, 07.082, 07.099, 07.101, 07.102, 07.104, 07.105, 07.106, 07.107, 07.121, 07.138, 07.139, 07.177, 07.188, 07.244, 07.247] are alpha, beta-unstaurated ketones or may be metabolised to alpha, beta-unsaturated ketones and will be evaluated 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 three substances [FL-no: 07.069, 07.100, and 09.658] 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 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 in order 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 are available for seven of the 13 JECFA evaluated substances. For the remaining six substances [FL-no: 07.069, 07.114, 09.657, 09.658, 09.923 and 09.925] information on the isomeric composition is lacking.
Thus, for seven substances [FL-no: 07.069, 07.100, 07.114, 09.657, 09.658, 09.923 and 09.925] the Panel has reservations (only USA production volumes available and/or missing data on isomerism/composition). For the remaining six of the 13 JECFA evaluated aliphatic secondary alcohols, ketones and related esters [FL-no: 07.015, 07.123, 07.151, 07.240, 07.249 and 09.924] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.