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 29 aliphatic and aromatic ethers evaluated by JECFA (61st meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 14 aliphatic, alicyclic and aromatic ethers including anisole derivatives evaluated in the Flavouring Group Evaluation 23 (FGE. 23).
The Panel concluded that all the 29 substances in the JECFA flavouring group of aliphatic and aromatic ethers are structurally related to the group of 14 aliphatic, alicyclic and aromatic ethers including anisole derivatives from chemical groups 15, 16 and 26 evaluated by EFSA in FGE. 23. The Panel agrees with the application of the Procedure as performed by the JECFA for the 29 substances considered in this FGE.
For seven substances [FL-no: 03.010, 04.033, 04.040, 04.062, 04.063, 04.074 and 13.165] 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 29 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 to finalise the evaluation. In order to determine whether the conclusion for the 29 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 20 of the 29 JECFA evaluated substances. For seven substances [FL-no: 03.005, 13.037, 13.072, 13.088, 13.094, 13.098 and 13.165] information on the isomeric composition is lacking and for another two substances [FL-no: 03.007 and 03.010] further information on the composition is requested.
Thus, for 14 substances [FL-no: 03.005, 03.007, 03.010, 04.033, 04.040, 04.062, 04.063, 04.074, 13.037, 13.072, 13.088, 13.094, 13.098 and 13.165] the Panel has reservations (only USA production volumes are available and/or data are missing on specifications and/or isomerism/composition). For the remaining 15 of the 29 JECFA evaluated aliphatic and aromatic ethers [FL-no: 03.001, 03.003, 03.004, 03.006, 03.019, 04.014, 04.015, 04.016, 04.032, 04.034, 04.035, 04.038, 04.039, 04.043 and 04.054] the Panel agrees with the JECFA conclusion " No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.