Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2-alkylated, aliphatic, acyclic alpha,beta-unsaturated aldehydes and precursors, with or without additional double-bonds, from chemical subgroup 1.1.2 of FGE.19.

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2-methylpent-2-enal [FL-no: 05.090] and 2 methylcrotonaldehyde [FL-no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic potential of this subgroup and considered the testing of 2-methylcrotonaldehyde [FL-no: 05.095] in a comet assay in liver and duodenum, the first site of contact, as a preferred option to further investigate the genotoxicity . New genotoxicity studies have been submitted for both 2-methylpent-2-enal [FL-no: 05.090] and 2-methylcrotonaldehyde [FL-no: 05.095]. 2-Methylpent-2-enal [FL-no: 05.090] tested in a combined micronucleus/comet assay did not induce DNA damage, overruling the weak gene mutation effect observed in bacteria and confirming the negative results observed in the micronucleus assay. 2-Methylcrotonaldehyde [FL-no: 05.095] did not induce gene mutations in liver and glandular stomach of transgenic rats. In addition, 2-methylcrotonaldehyde [FL-no: 05.095] tested in an comet assay in liver and duodenum, it did not induce DNA damage. Overall, the Panel concluded that the genotoxic evidence observed , was not confirmed for the representative substances 2-methylcrotonaldehyde [FL-no: 05.095] and 2-methylpent-2-enal [FL-no: 05.090], therefore all the 10 substances in this subgroup [FL-no: 02.174, 05.033, 05.090, 05.095, 05.105, 05.107, 05.126, 07.261, 12.065 and 12.079] can be evaluated through the Procedure for the evaluation of flavouring substances.