Scientific Opinion on Flavouring Group Evaluation 67 Revision 2 (FGE.67Rev2): Consideration of 28 furan‐substituted compounds evaluated by JECFA at the 55th, 65th and 69th meetings (JECFA, 2001, 2006a, 2009b)

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of 28 furan-substituted compounds evaluated by the JECFA. This revision of FGE.67 is due to new data on toxicity for 3-(-methyl-2-furyl) butanal .058] providing an appropriate NOAEL for the evaluation of candidate substance ]. The Panel concluded that 11 substances [FLnos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for these eleven candidate substances, except .058], more reliable intake data are required for a re-evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered, which for all candidate substances are adequate. For 17 substances 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] a concern for genotoxicity was raised and therefore these were not evaluated using the Procedure. The Panel noted further that for 7 of these 17 substances 13.052, 13.054, 13.059, 13.061, 13.069 The 28 candidate substances considered in this FGE 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.052, 13.054, 13.058, 13.059, 13.061, 13.066, 13.069, 13.070, 13.074, 13.083, 13.101, 13.103, 13.105, 13.106, 13.116, 13.123, 13.138, 13.148, 13.163 and 13.190] have been allocated to various subgroups, based on their chemical structures. These substances are structurally related to the group of 27 furfuryl and furan derivatives evaluated by EFSA in FGE.13Rev2. Part of the substances is also structurally related to a group of 33 sulphur-substituted furan derivatives used as flavouring agents, evaluated by EFSA in FGE.65Rev1 and another part is structurally related to 14 furfuryl derivatives evaluated in FGE.66Rev1.The Panel agrees with the JECFA for 17 of the substances 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] that these substances cannot be evaluated through the Procedure, based on concerns with respect to genotoxicity.On the basis of the new data on toxicity for 3-(5-methyl-2-furyl) butanal .058] an appropriate NOAEL of 5.9mg/kg bw per day was derived, supporting the evaluation of this candidate...

Identification of flavouring substances of genotoxic concern present in e-cigarette refills

“…For two compounds, trans-hexenal and 2-furylmethylketon, an evaluation was done by EFSA, but no conclusion on the in vivo genotoxic potential of the compounds could be made and therefore further data was requested [40,41]. 2-Furylmethylketon is used as a food flavouring and fragrance and can also be found in tobacco.…”

“…The EFSA concluded that the genotoxic potential of furylmethylketon could not be excluded. Based on the available experimental information the substance may give rise to DNA damage, possibly resulting in chromosomal aberrations rather than gene mutations [40]. Trans-hexenal was found in e-liquids with a green fruit flavor.…”