Scientific Opinion on Flavouring Group Evaluation 205 (FGE.205): Consideration of genotoxicity data on representatives for 13 α,β-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup 1.2.2 of FGE.19 by EFSA

α,β-unsaturated ketones, aliphatic ketones, terminal double-bond, flavouring substances, safety evaluation.
First published in the EFSA Journal
19 October 2012
Adopted
27 September 2012
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 the Flavouring Group Evaluation 205, the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [FL-no: 07.081] and pent-1-en-3-one [FL-no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent-1-en-3-one being the most potent (previously available data). In these assays the representative substances were highly cytotoxic with a steep toxicity curve, and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells and the Panel recommend that an in vivo Comet assay on the first site of contact (e.g. the stomach) and on the liver is requested on the most potent of the representative substances, pent-1-en-3-one.

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 Poças, 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.2012.2902
EFSA Journal 2012;10(10):2902
On request from
European Commission