Scientific Opinion on Flavouring Group Evaluation 8, Revision 3 (FGE.08Rev3): Aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups from chemical groups 20 and 30


Flavourings, safety, aliphatic, alicyclic, monosulphides, disulphides, trisulphides, polysulphides, FGE.08
First published in the EFSA Journal
11. Mai 2011
4. Februar 2011
Opinion of the Scientific Committee/Scientific Panel

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 70 flavouring substances in the Flavouring Group Evaluation 08, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. For the substances 2-methylpropane-2-thiol [FL-no: 12.174], methyl methanethiosulphonate [FL-no: 12.159], 2-methylbutane-2-thiol [FL-no: 12.172] and 2,4,4-trimethyl-1,3-oxathiane [FL-no: 16.057] there is an indication of a genotoxic potential in vitro. Therefore, in the absence of further genotoxicity data, the Panel concluded that the Procedure could not be applied to these four substances. For four substances, 3-mercaptooctanal [FL-no: 12.268], 3-mercaptodecanal [FL-no: 12.269], methanedithiol diacetate [FL-no: 12.271] and 3,5-dimethyl-1,2-dithiolane-4-one [FL-no: 12.295] no data on use as flavouring substances in Europe are available. Therefore, no intakes in Europe can be estimated and accordingly the Panel concluded that the Procedure could not be applied to these four substances either. The remaining 62 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 concluded that 48 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining fourteen substances [FL-no: 12.120, 12.093, 12.094, 12.097, 12.100, 12.112, 12.116, 12.164, 12.167, 12.199, 15.007, 15.102 and 15.125 and 15.134] 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 and for eightteen substances information on specifications is lacking.

Panel members at the time of adoption
Arturo Anadon, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary Waring, Detlef Wölfle
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef-unit [at]
EFSA Journal 2011;9(5):1988 [131 pp.].
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European Commission
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