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 seven aliphatic acetals evaluated by the JECFA (57(th) meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 41 acetals of branched-and straight-chain aliphatic saturated primary alcohols and branched-and straight-chain saturated aldehydes, and an orthoester of formic acid evaluated in the Flavouring Group Evaluation 03 (FGE. 03).
The Panel concluded that the seven substances in the JECFA flavouring group of aliphatic acyclic acetals are structurally related to the group of acetals of branched-and straight-chain aliphatic saturated primary alcohols and branched-and straight-chain saturated aldehydes, and an orthoester of formic acid evaluated by EFSA in FGE. 03.
Further three substances were evaluated by the JECFA in this group [FL-no: 06.004, 06.005 and 06.025], which may be metabolised to alpha, beta-unsaturated aldehydes 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 seven substances considered in this FGE.
For one substance [FL-no: 06.081] the JECFA evaluation is only based on the Maximised Surveyderived Daily Intake (MSDI) value derived from a production figure from the USA. An EU production figure is needed in order to finalise the evaluation of this substance.
For all seven substances evaluated through the Procedure use levels are needed to calculate the 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 seven 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 five of the seven JECFA evaluated substances. For two substances [FL-no: 06.037 and 06.081] information on the stereoisomeric composition is lacking.
Thus, for two substances [FL-no: 06.037 and 06.081] the Panel has reservations (only USA production volumes available and/or missing data on isomerism/composition). For the remaining five of the seven JECFA evaluated aliphatic acyclic acetals [FL-no: 06.001, 06.008, 06.009, 06.015 and 06.028] the Panel agrees with the JECFA conclusion " No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.