Scientific Opinion on Flavouring Group Evaluation 204 (FGE.204): Consideration of genotoxicity data on representatives for 18 mono-unsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19 by EFSA

FGE.19; subgroup 1.2.1, aliphatic, mono-unsaturated, α,β-unsaturated ketones.
First published in the EFSA Journal
12 December 2012
21 November 2012
Scientific Opinion


The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 18 flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204. The Flavour Industry provided additional genotoxicity studies for two representative substances, 4-methylpent-3-en-2-one [FL-no: 07.101] and 7-methyl-3-octenone-2 [FL-no: 07.177], which were evaluated in this FGE.204. Based on these new data, the Panel concluded that the flavouring substance [FL-no: 07.101] does not present a safety concern with respect to genotoxicity and accordingly it can be evaluated using the Procedure. On the contrary, the Panel could not conclude on the in vivo genotoxicity of [FL-no: 07.177] and more appropriate in vivo genotoxicity tests, considering also first site of contact, should be performed. In addition, the substance 4-methyl-3-hepten-5-one [FL-no: 07.261] was now identified as a substance for which no representative substances could be identified in the present FGE, resulting in a need for additional data on the genotoxic potential of this flavouring substance. However, the Panel noted that the 2-methyl substituted α,β-unsaturated aldehydes in FGE.201Rev1 can be considered as structurally related to [FL-no: 07.261]. Thus, the final conclusion on [FL-no: 07.261] will be drawn based on the outcome of the evaluation of FGE.201Rev1.

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, 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
cef [at]
EFSA Journal 2012;10(12):2992
On request from
European Commission