Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6-methylcoumarin [FL-no: 13.012] and 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023] the concern for genotoxicity was ruled out. 6-Methylcoumarin was evaluated using the Procedure in FGE.80Rev1. For 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023] and the structurally related substance 3-hydroxy-4,5-dimethylfuran-2(5H)-one [FL-no: 10.030], no further EFSA considerations were needed because these substances were evaluated by JECFA before 2000. Also based on experimental data, in FGE217Rev1, the concern for genotoxicity could not be ruled out for furan-2(5H)-one [FL-no: 10.066] and 3,4-dimethyl-5-pentylidenefuran-2(5H)-one [FL-no: 10.042], which later substance represents the following flavourings: [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170]. In the current revision of this FGE (FGE217Rev2), based on the results of additional genotoxicity studies, the FAF Panel concluded that [FL-no: 10.066] is genotoxic in vivo. Therefore, furan-2(5H)-one [FL-no: 10.066] cannot be evaluated according to the Procedure. For [FL-no: 10.042] in order to rule out a concern for clastogenicity at site of first contact, the FAF Panel requests results from an in vivo comet assay in duodenum. In addition, [FL-no: 10.042] has also been identified as an aneugenic substance in vitro. Until the concern for clastogenicity at site of first contact for [FL-no: 10.042] and the concern for aneugenicity can be ruled out, this substance and [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170] cannot be evaluated through the Procedure.