Scientific Opinion on Flavouring Group Evaluation 201 Revision 1 (FGE.201Rev1): 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

摘要

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in this revision 1 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. First the Panel concluded that genotoxicity data on [FL‐no: 05.095] can be representative for the substances [FL‐no: 02.174, 05.033, 05.090, 05.105, 05.107 and 05.126], but not for [FL‐no: 05.130, 05.178, 09.177 and 09.931], for which it was concluded in the previous version of this FGE that the available data were insufficient to evaluate their genotoxicity. Secondly, the Panel considers that the mutagenicity hazard could not be cleared by the endpoints evaluated in the in vivo micronucleus assay submitted. The Panel therefore concluded that further data are required in order to clarify the genotoxic potential of this subgroup. The Panel considers the Comet assay with [FL‐no: 05.095] as test material and performed on liver, blood and first site of contact, as a preferred option to further investigate the genotoxicity in vivo. The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in this revision 1 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. First the Panel concluded that genotoxicity data on [FL‐no: 05.095] can be representative for the substances [FL‐no: 02.174, 05.033, 05.090, 05.105, 05.107 and 05.126], but not for [FL‐no: 05.130, 05.178, 09.177 and 09.931], for which it was concluded in the previous version of this FGE that the available data were insufficient to evaluate their genotoxicity. Secondly, the Panel considers that the mutagenicity hazard could not be cleared by the endpoints evaluated in the in vivo micronucleus assay submitted. The Panel therefore concluded that further data are required in order to clarify the genotoxic potential of this subgroup. The Panel considers the Comet assay with [FL‐no: 05.095] as test material and performed on liver, blood and first site of contact, as a preferred option to further investigate the genotoxicity in vivo.