Following a request from the European Commission, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion 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.
In Flavouring Group Evaluation 75 (FGE.75), the European Food Safety Authority (EFSA) considered 11 substances in the JECFA flavouring group of tetrahydrofuran and furanone derivatives. The Panel concluded that the 11 substances evaluated by the JECFA were structurally related to the six tetrahydrofuran derivatives evaluated by EFSA in Flavouring Group Evaluation (FGE.33). This revision of FGE.75 (FGE.75Rev1) is made because EFSA received additional toxicity data for the candidate substance anhydrolinalool oxide [FL-no: 13.097].
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 substances [FL-no: 13.010, 13.084, 13.085, 13.089 and 13.099] are α,β-unsaturated furanone and will be considered together with other α,β-unsaturated aldehydes and ketones in a separate FGE (EFSA CEF Panel, 2015). This consideration will, therefore, only deal with 11 JECFA-evaluated substances.
The JECFA reached a conclusion for all 11 substances at step A3 of their procedure. 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) of 52 mg/kg body weight (bw) was derived from a 90-day study in rats and compared with an exposure estimate of 0.9 µg/capita per day for anhydrolinalool oxide a margin of safety of 3.5 × 106 can be calculated. Accordingly, the Panel agrees with the JECFA conclusion ‘No safety concern at estimated level of intake as flavouring substances’ based on the maximised survey-derived daily intake (MSDI) approach.
For all 11 substances, the JECFA evaluation is based on MSDI values derived from production figures from the European Union (EU).
In order to determine whether the conclusion for the 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 all 11 JECFA-evaluated substances.
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 and 13.166], the Panel agrees with the JECFA conclusion ‘No safety concern at estimated levels of intake as flavouring substances’ based on the MSDI approach
For all substances, evaluated through the Procedure, use levels are needed to calculate the modified theoretical added maximum daily intake (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.