Résumé
The Scientific Panel on Food Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide scientific advice to 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 Panel was 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 JECFA has evaluated a group of 43 flavouring substances consisting of phenethyl alcohol, aldehyde, acid and related acetals and esters. Two of the JECFA evaluated substances [FL-no: 09.704 and 09.712] may be metabolised to alpha, beta-unsaturated aldehydes. As the alpha, betaunsaturated aldehyde and ketone structures are considered by the Panel to be structural alerts for genotoxicity (EFSA, 2008b), these two substances have been given special considerations.
The remaining 41 flavouring substances have originally been considered by the European Food Safety Authority (EFSA) in the Flavouring Group Evaluation (FGE) 53 (EFSA, 2008z).
The genotoxicity of one of the alpha, beta-unsaturated substances, geranyl phenylacetate [FL-no: 09.704] has been considered in FGE. 202 (EFSA, 2009ac). The structural alert for genotoxicity is present in the metabolite citral. The Panel concluded that the data available on citral did rule out the concern for genotoxicity and thus concluded that geranyl phenylacetate can be evaluated through the Procedure in this FGE.
For the second substance, santalyl phenylacetate [FL-no: 09.712], considered in subgroup 2.1 of FGE. 19 (EFSA, 2008b), concern with respect to genotoxicity could not be ruled out and additional data were requested. Accordingly, this substance will not be considered in the present FGE.
The present FGE. 53Rev1 therefore only deals with 42 flavouring substances.
The Panel concluded that all the 42 substances in the JECFA flavouring group of phenethyl alcohol, aldehyde, acid and related acetals and esters are structurally related to the group of 13 phenethyl alcohol, aldehyde, esters and related phenylacetic acid esters evaluated by EFSA in the Flavouring Group Evaluation 14, Revision 1 (FGE. 14Rev1) and one phenoxyethyl ester evaluated in the Flavouring Group Evaluation 23, Revision1 (FGE. 23Rev1).
The Panel agrees with the way the application of the Procedure has been performed by the JECFA for the 42 phenylethyl derivatives. However, 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. Accordingly, the safety in use in Europa could not be assessed using the Procedure, so EU production figures are needed in order to finalise the evaluation of these four substances.
For all 42 substances 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 42 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications are available for 39 of the 42 materials of commerce. For two substances [FL-no: 06.007 and 06.027] 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 of mixture is requested. Thus, for six substances [FL-no: 06.007, 06.027, 09.702, 09.783, 09.805 and 16.041] the Panel has reservations (no European production volumes available, preventing them to be evaluated using the Procedure, and/or stereoisomerism/composition of mixture).
For the remaining 36 substances [FL-no: 02.019, 05.030, 05.042, 05.044, 06.006, 06.016, 06.024, 06.036, 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, 09.538, 09.703, 09.704, 09.707, 09.758, 09.772, 09.784, 09.785, 09.786, 09.787, 09.788, 09.789, 09.791, 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.