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

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011;9(5):1988 [131 pp.].
doi
10.2903/j.efsa.2011.1988
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
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Wilfried Bursch, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerard Pascal, Iona Pratt, Gerrit Speijers, Harriet Wallin and EFSA’s staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-0038
EFSA-Q-2011-0039
EFSA-Q-2011-0040
Adopted
4. Februar 2011
Published in the EFSA Journal
11. Mai 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
Flavourings, safety, aliphatic, alicyclic, monosulphides, disulphides, trisulphides, polysulphides, FGE.08
Print on demand
Number of Pages
131