Scientific Opinion on Flavouring Group Evaluation 76, Revision 1 (FGE.76Rev1): Consideration of sulphur-containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21Rev3

flavouring safety, sulphur-containing heterocyclic compounds, thiazoles, thiophene, thiazoline and thienyl derivatives, 59th JECFA meeting, FGE.21
First published in the EFSA Journal
15 November 2013
Adopted
24 October 2013
Last Updated
15 January 2014. 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 evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present opinion concerns a group of 26 sulphur-containing heterocyclic compounds evaluated by the JECFA at the 59th meeting in 2008. This revision is made due to the inclusion of one additional substance, 5-methyl-2-thiophenecarbaldehyde [FL-no: 15.004], cleared for genotoxicity concern in FGE.224. Additionally, new toxicity data have become available for 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine [FL-no: 15.113]. Since publication of FGE.76, one substance, thiazole [FL-no: 15.028], is no longer supported by Industry for use as a flavouring substance in Europe and will therefore not be considered any further. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for 21, [FL-no: 15.001, 15.002, 15.004, 15.008, 15.011, 15.013, 15.014, 15.015, 15.016, 15.017, 15.019, 15.020, 15.021, 15.022, 15.026, 15.027, 15.033, 15.035, 15.109, 15.113 and 16.027], of the 26 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For five substances [FL-no: 15.005, 15.018, 15.029, 15.030 and 15.032], the Panel could not conclude on their safety when used as flavouring substances, as these substances could not be evaluated because of concern with respect to genotoxicity. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 26 substances, the information is adequate.

Substances

Panel members at the time of adoption

Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Poças, Fidel Toldra and Detlef Wölfle.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
cef [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3455
EFSA Journal 2013;11(11):3455
On request from
European Commission