Scientific Opinion on Flavouring Group Evaluation 213, Revision 2 (FGE.213Rev2): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.7 of FGE.19

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in Flavouring Group Evaluation (FGE) 213. In the first version of FGE.213 the Panel concluded, based on available genotoxicity data, that a concern regarding genotoxicity could be ruled out for 11 substances [FL-nos: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-nos: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525]. In FGE.213Rev2, new data on maltol were considered and the Panel concluded that for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525] in food the concern for genotoxicity could be ruled out. Moreover, the Panel reconsidered the available data on p-mentha-1,4(8)-dien-3-one [FL-no: 07.127], based on new data on the structurally related substance pulegone, and concluded that additional genotoxicity data are needed to rule out the concern for genotoxicity of p-mentha-1,4(8)-dien-3-one [FL-no: 07.127].