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)
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 [FL-no: 13.058] providing an appropriate NOAEL for the evaluation of candidate substance [FL-no: 13.058]. The Panel concluded that 11 substances [FL-nos: 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 [FL-no: 13.058], 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 [FL-nos: 13.045, 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 [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.069 and 13.083], use levels have not yet been submitted.