Résumé
The Scientific Panel on 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 seven flavouring substances consisting of four maltol related substances and three 6-keto-1,4-dioxane derivatives, in the JECFA group "Maltol and related substances". Two of the JECFA evaluated substances are not in the Register (2-hexyl-5 or 6-keto-1,4-dioxane (JECFA-no: 1486) and 2-methyl-3-(1-oxypropoxy)-4H-pyran-4-one (JECFA-no: 1483)) and three substances [FL-no: 07.014, 07.047 and 09.525] are alpha, beta-unsaturated ketones.
The genotoxicity of the three substances being alpha, beta-unsaturated ketones [FL-no: 07.014, 07.047 and 09.525] has been considered in FGE. 213 (EFSA, 2009x). The Panel concluded that for two substances [FL-no: 07.014 and 09.525] a final conclusion as to their genotoxic properties could not be reached and additional data were requested. Accordingly, these two substances will not be considered in this FGE.
For ethyl maltol [FL-no: 07.047], also considered in FGE. 213, the Panel concluded that the data available did rule out the concern for genotoxicity and thus concluded that the substance can be evaluated through the Procedure. The present FGE.83Rev1 therefore in total deals with three substances [FL-no: 09.047, 13.027 and 13.028].
The Panel concluded that no corresponding FGE is available. The Panel agrees with the way the application of the Procedure has been performed by the JECFA for the three substances considered in this FGE. However, the JECFA evaluation of two of the three substances is only based on Maximised Survey-derived Daily Intake (MSDI) values derived from USA production figures. EU production figures are needed in order to finalise the evaluation of these two substances [FL-no: 13.027 and 13.028].
For all three 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 and to finalise the evaluation.
In order to determine whether the conclusion for the three JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. For the two JECFA evaluated substances [FL-no: 13.027 and 13.028] information on the stereoisomeric composition has not been provided.
Thus, for two substances [FL-no: 13.027 and 13.028] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure, and missing information on stereoisomerism). For the remaining substance [FL-no: 07.047] the Panel agrees with the JECFA conclusion "No safety concern at estimated level of intake as flavouring substance" based on the MSDI approach.