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.

α,β-Unsaturated aldehydes, 2-alkylated substances, flavouring substances, safety evaluation
First published in the EFSA Journal
31 May 2012
Adopted
24 May 2012
Last Updated
7 June 2012. This version replaces the previous one/s.
Type
Scientific Opinion

Abstract

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.

Panel members at the time of adoption

Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Daniel Marzin, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Pocas, Fidel Toldra, Detlef Wölfle
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
cef [at] efsa.europa.eu
doi
10.2903/j.efsa.2012.2749
EFSA Journal 2012;10(5):2749
On request from
European Commission