Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

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Acknowledgements

: The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Trine Husøy, John Christian Larsen, Wim Mennes, Gerard Mulder and Harriet Wallin for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby and EFSA staff: Annamaria Rossi and Kim Rygaard Nielsen for the support provided to this scientific opinion.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(11):3451 [96 pp.].
doi
10.2903/j.efsa.2013.3451
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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00181
EFSA-Q-2013-00224
EFSA-Q-2013-00225
EFSA-Q-2013-00226
EFSA-Q-2013-00227
EFSA-Q-2013-00228
Adopted
24 October 2013
Published
15 November 2013
Last Updated
15 January 2014. This version replaces the previous one/s.
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 59 flavouring substances in the Flavouring Group Evaluation 21, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of new toxicity data on one supporting substance 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine [FL-no: 15.113], which is considered to be structurally related to the candidate substances 2-butyl-4-methyl(4H)pyrrolidino[1,2d]-1,3,5-dithiazine [FL-no: 15.042], dihydro-2,4,6-triethyl-1,3,5(4H)-dithiazine [FL-no: 15.054], 2,4-dimethyl(4H)pyrrolidino[1,2e]-1,3,5-dithiazine [FL-no: 15.055], 4,6-dimethyl-2-(1-methylethyl)dihydro-1,3,5-dithiazine [FL-no: 15.057], 2-isobutyldihydro-4,6-dimethyl-1,3,5-dithiazine [FL-no: 15.079] and ethyl thialdine [FL-no: 15.135]. Furthermore, new in vitro genotoxicity studies have become available on the supporting substance 2-acetyl-2-thiazoline [FL-no: 15.010], which is considered to be structurally related to and a supportive substance for 2-methyl-2-thiazoline [FL-no: 15.086]. Eighteen of the original 59 candidate substances [FL-no: 15.037, 15.042, 15.043, 15.064, 15.070, 15.072, 15.077, 15.088, 15.090, 15.091, 15.092, 15.094, 15.099, 15.106, 15.107, 15.114, 15.129 and 15.133], for which additional data were requested, are no longer supported by Industry for use as flavouring substances in Europe and will therefore not be considered any further. Therefore, FGE.21Rev4 will only deal with 41 candidate substances. Two of the substances, 3-thiazolines, 2,4-dimethyl-3-thiazoline [FL-no: 15.060] and 2-isobutyl-3-thiazoline [FL-no: 15.119], were considered to have genotoxic potential. The remaining 39 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 32 flavouring substances [FL-no: 15.038, 15.039, 15.044, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.079, 15.080, 15.082, 15.084, 15.085, 15.086, 15.087, 15.089, 15.098, 15.108, 15.115, 15.116, 15.118 and 15.135] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining seven candidate substances [FL-no: 15.040, 15.045, 15.074, 15.076, 15.093, 15.096 and 15.097] 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. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 41 candidate substances.

Keywords
flavourings, safety, thiophene derivatives, thiazole derivatives, thiazoline derivatives, dithiazine derivatives, FGE.21
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Number of Pages
96