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 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 11 of 18 flavouring substances consisting of tetrahydrofuran derivatives and a furanone derivative evaluated by the JECFA (63rd meeting). The Panel concluded that the 11 substances evaluated by the JECFA were structurally related to six tetrahydrofuran derivatives evaluated by the European Food Safety Authority (EFSA) in Flavouring Group Evaluation 33 (FGE.33).
Seven other substances were also evaluated by the JECFA in this group, but two are not in the Register [2-hexyl-4-acetoxytetrahydrofuran (JECFA-no: 1440) and (+/-)-2-(5-methyl-5-vinyltetrahydrofuran-2-yl) propionaldehyde (JECFA-no: 1457)] and five are alpha, beta-unsaturated ketones. These five substances will be evaluated together with other alpha, beta-unsaturated ketones and aldehydes.
The JECFA concluded all the 11 tetrahydrofuran derivatives at step A3. The Panel agrees with the application of the Procedure as performed by the JECFA for 10 of the 11 substances. For the remaining substance [FL-no: 13.097] the Panel did not find that it could be metabolised to innocuous products and should accordingly be evaluated via the B-side of the Procedure scheme. A No Observed Adverse Effect Level (NOAEL) could not be identified for the substance or for structurally related substances and accordingly, additional data are required for this substance.
For one substance [FL-no: 13.060] the JECFA evaluation is based on a MSDI derived from an production figure from the USA. An EU production figure is needed in order to finalise the evaluation of this substance.
For all 11 substances evaluated through the Procedure, use levels are needed to calculate the mTAMDIs 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 11 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:
The available specifications for all 11 substances are not fully complete as information on stereoisomerism is lacking for all the substances [FL-no: 13.007, 13.020, 13.042, 13.048, 13.049, 13.060, 13.090, 13.095, 13.097, 13.140 and 13.166] (see Section 1.2). In addition, solubility data are lacking for three substances [FL-no: 13.042, 13.097 and 13.140].
Thus, for all 11 substances [FL-no: 13.007, 13.020, 13.042, 13.048, 13.049, 13.060, 13.090, 13.095, 13.097, 13.140, 13.166] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure, and/or missing information on stereoisomerism and solubility, and/or additional toxicity data required).