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 41 phenylethyl alcohol, aldehyde, acid and related acetals and esters and related substances evaluated by the JECFA (59th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 10 phenethyl alcohol, aldehyde, esters and related phenylacetic acid esters evaluated in the Flavouring Group Evaluation 14 (FGE. 14) and one phenoxyethyl ester evaluated in Flavouring Group Evaluation 23 (FGE. 23).
The Panel concluded that the 41 substances in the JECFA flavouring group of 41 phenylethyl alcohol, aldehyde, acid and related acetals and esters and related substances are structurally related to the group of ten phenethyl derivatives evaluated by EFSA in FGE. 14 and one phenoxyethyl ester evaluated in FGE. 23.
Further two substances [FL-no: 09.704 and 09.712] were evaluated by the JECFA in this group, which may be metabolised to alpha, beta-unsaturated aldehydes and will be considered together with other alpha, beta-unsaturated compounds.
The Panel agrees with the application of the Procedure as performed by the JECFA for the 41 phenylethyl derivatives. For four substances [ FL-no: 06.027, 09.702, 09.783 and 16.041] 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 41 substances evaluated through the Procedure use levels are needed to calculate the modified Theorical 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 41 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:
Adequate specifications are available for 31 of the materials of commerce. For nine substances [FL-no: 06.007, 06.016, 06.027, 06.036, 09.538, 09.772, 09.785, 09.791 and 16.041] information on the stereoisomeric composition is lacking and for three substances [FL-no: 06.007, 06.027 and 09.805] further information on the composition is requested.
Thus for 12 substances [FL-no: 06.007, 06.016, 06.027, 06.036, 09.538, 09.702, 09.772, 09.783, 09.785, 09.791, 09.805 and 16.041] the Panel has reservations (only USA production volumes available and/or missing data on specifications and/or isomerism/composition). For the remaining 29 substances [FL-no: 02.019, 05.030, 05.042, 05.044, 06.006, 06.024, 08.038, 08.049, 09.031, 09.083, 09.137, 09.168, 09.261, 09.262, 09.407, 09.427, 09.466, 09.487, 09.496, 09.703, 09.707, 09.758, 09.784, 09.786, 09.787, 09.788, 09.789, 09.797 and 09.804] the Panel agrees with the JECFA conclusion "no safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.