Scientific Opinion on Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Flavourings, safety, thiophene, thiophene derivatives, dihydrothiophene, benzothiazole derivatives thiazole derivatives, thiazoline derivatives, thiazolidine derivatives, dihydrothiazine derivatives, dithiazine derivatives, FGE.21.
First published in the EFSA Journal
2 February 2012
Adopted
24 November 2011
Last Updated
7 March 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 evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, including an additional three substances in this Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. Since the publication of the last revision of this FGE, the EFSA has been requested to evaluate three additional substances [FL-no: 15.057, 15.079 and 15.135], which have been included in the present revision of FGE.21. Seven of the substances [FL-no: 15.060, 15.086, 15.090, 15.099, 15.114, 15.119 and 15.133] were considered to have genotoxic potential. The remaining 52 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 26 substances [FL-no: 15.038, 15.039, 15.044, 15.050, 15.051, 15.052, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.080, 15.082, 15.084, 15.085, 15.087, 15.089, 15.098, 15.108, 15.115, 15.116 and 15.118] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining 26 candidate substances [FL-no: 15.037, 15.040, 15.042, 15.043, 15.045, 15.054, 15.055, 15.057, 15.064, 15.070, 15.072, 15.074, 15.076, 15.077, 15.079, 15.088, 15.091, 15.092, 15.093, 15.094, 15.096, 15.097, 15.106, 15.107, 15.129 and 15.135] evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For one substance [FL-no: 15.129], evaluated using the Procedure, an identity test is lacking and for four substances [FL-no: 15.042, 15.057, 15.079 and 15.135] the stereoisomeric composition has not been specified sufficiently.

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, 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.2012.2457
EFSA Journal 2012;10(2):2457
On request from
European Commission