Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double‐bonds and with or without additional non‐conjugated double‐bonds

a,b-unsaturated aldehydes, straight chain, FGE.203, a,b-unsaturated conjugated double-bonds, FGE.19, subgroup 1.1.4
First published in the EFSA Journal
20 juillet 2018
Adopted
5 juin 2018
Type
Scientific Opinion

Abstract

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 flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca‐2(trans),4(trans)‐dienal [FL‐no: 05.140] and hexa‐2(trans),4(trans)‐dienal [FL‐no: 05.057]. In addition, new studies on hepta‐2,4‐dienal [FL‐no: 05.084], 2,4‐octadienal [FL‐no: 05.186] and tr‐2,tr‐4‐nonadienal [FL‐no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta‐2,4‐dienal [FL‐no: 05.084], 2,4‐octadienal [FL‐no: 05.186] and tr‐2,tr‐4‐nonadienal [FL‐no: 05.194] did not induce gene mutations in bacteria. Hexa‐2(trans),4(trans)‐dienal [FL‐no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa‐2(trans),4(trans)‐dienal [FL‐no: 05.057] was also tested in an in vivogene mutation assay giving negative results. Both hexa‐2(trans),4(trans)‐dienal [FL‐no: 05.057] and deca‐2(trans),4(trans)‐dienal [FL‐no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa‐2(trans),4(trans)‐dienal [FL‐no: 05.057] and deca‐2(trans),4(trans)‐dienal [FL‐no: 05.140] and therefore also for the other substances in this group [FL‐no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.

Panel members at the time of adoption

Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean‐Pierre Cravedi, Karl‐Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Jannavi Srinivasan, Vittorio Silano, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5322
EFSA Journal 2018;16(7):5322
On request from
European Commission