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

摘要

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 [ ‐no: 05.090] and 2 methylcrotonaldehyde [ ‐no: 05.095], from subgroup 1.1.2 of .19. In .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 [ ‐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 [ ‐no: 05.090] and 2‐methylcrotonaldehyde [ ‐no: 05.095]. 2‐Methylpent‐2‐enal [ ‐no: 05.090] tested in a combined micronucleus/comet assay did not induce damage, overruling the weak gene mutation effect observed in bacteria and confirming the negative results observed in the micronucleus assay. 2‐Methylcrotonaldehyde [ ‐no: 05.095] did not induce gene mutations in liver and glandular stomach of transgenic rats. In addition, 2‐methylcrotonaldehyde [ ‐no: 05.095] tested in an comet assay in liver and duodenum, it did not induce damage. Overall, the Panel concluded that the genotoxic evidence observed , was not confirmed for the representative substances 2‐methylcrotonaldehyde [ ‐no: 05.095] and 2‐methylpent‐2‐enal [ ‐no: 05.090], therefore all the 10 substances in this subgroup [ ‐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.