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. 2023 Feb 13;21(2):e07777.
doi: 10.2903/j.efsa.2023.7777. eCollection 2023 Feb.

Flavouring Group Evaluation 21 Revision 6 (FGE.21Rev6): thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

EFSA Panel on Food Additives and Flavourings (FAF); Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela Degen, Karl-Heinz Engel, Paul J Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Sabina Passamonti, Peter Moldeus, Romina Shah, Ine Waalkens-Berendsen, Matthew Wright, Romualdo Benigni, Claudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Karin Nørby, Camilla Svendsen, Maria Carfì, Wim Mennes

Flavouring Group Evaluation 21 Revision 6 (FGE.21Rev6): thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

EFSA Panel on Food Additives and Flavourings (FAF) et al. EFSA J. .

Abstract

The Panel on Food additives and Flavourings (FAF) was requested to evaluate the flavouring substances 2,4-dimethyl-3-thiazoline [FL-no: 15.060] and 2-isobutyl-3-thiazoline [FL-no: 15.119] in Flavouring Group Evaluation 21 revision 6 (FGE.21Rev6). FGE.21Rev6 deals with 41 flavouring substances of which 39 have been already evaluated to be of no safety concern when based on the MSDI approach. For [FL-no: 15.060 and 15.119], a concern for genotoxicity was raised in FGE.21. Genotoxicity data have been submitted for the supporting substance 4,5-dimethyl-2-isobutyl-3-thiazoline [FL-no: 15.032] evaluated in FGE.76Rev2. The concerns for gene mutations and clastogenicity are ruled out for [FL-no: 15.032] and for the structurally related substances [FL-no: 15.060 and 15.119], but not for aneugenicity. Therefore, the aneugenic potential of [FL-no: 15.060 and 15.119] should be investigated in studies with the individual substances. For [FL-no: 15.054, 15.055, 15.057, 15.079 and 15.135], (more reliable) information on uses and use levels is needed to (re)calculate the mTAMDIs in order to finalise their evaluation. Provided that information is submitted for [FL-no: 15.060 and 15.119] with respect to potential aneugenicity, that would allow evaluation of these substances through the Procedure, also for these two substances, more reliable data on uses and use levels would be required. Upon submission of such data, additional data on toxicity may become necessary for all seven substances. For [FL-no: 15.054, 15.057, 15.079 and 15.135], information on the actual percentages of stereoisomers in the material of commerce based on analytical data should be provided.

Keywords: FGE.76; FGE.93; flavouring; thiazoles; thiazolines and dithiazines FGE.21; thiophenes.

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Figures

Figure 1
Figure 1
Summary of the history of evaluation of the substances in FGE.21
Figure A.1
Figure A.1
Procedure for the safety evaluation of chemically defined flavouring substances
See this image and copyright information in PMC

References

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