Scientific Opinion on Flavouring Group Evaluation 21, Revision 5 (FGE.21Rev5): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Flavourings,

doi:10.2903/j.efsa.2015.4066

Cited by 3 publications

(7 citation statements)

References 32 publications

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“…In addition, the following references were used: EFSA scientific opinion on FGE.76Rev1 (EFSA CEF Panel, 2013b ) EFSA scientific opinion on FGE.76Rev2 (EFSA FAF Panel, 2023 ) EFSA scientific opinion on FGE.21Rev5 (EFSA CEF Panel, 2015 ) …”

Section: Data and Methodologiesmentioning

confidence: 99%

“…In FGE.21Rev6, only genotoxicity data relevant for subgroup B‐II are reported. Data relevant for other subgroups can be retrieved in FGE.21Rev5 (EFSA CEF Panel, 2015 ).…”

Section: Appendix D – Genotoxicity Data Considered In Fge21rev3mentioning

confidence: 99%

“…For two substances , additional genotoxicity data were required. The CEF Panel concluded that 39 flavouring substances evaluated using the Procedure 15.039,15.040,15.044,15.045,15.050,15.051,15.052,15.054,15.055,15.057,15.058,15.061,15.062,15.063,15.067,15.068,15.069,15.071,15.074,15.076,15.078,15.079,15.080,15.082,15.084,15.085,15.086,15.087,15.089,15.093,15.096,15.097,15.098,15.108,15.115,15.116,15.118 and 15.135] would present no safety concerns at their estimated levels of intake based on the MSDI approach (EFSA CEF Panel, 2015).…”

Section: Fge21rev5mentioning

confidence: 99%

“…Only subgroup B‐II, which includes the two substances that will be evaluated in FGE.21Rev6, is described. No descriptions are given for subgroups A‐Ib, A‐Ic, AII and BIV, which can be found in FGE.21Rev5 (EFSA CEF Panel, 2015 ).…”

Section: Introductionmentioning

confidence: 99%

“…1: Summary of specifications for flavouring substances in FGE.21Rev6 (for chemical structures, see Appendix F) that are included in the Union List. Substances which are not included in the EU Union list are referenced in FGE.21Rev5(EFSA CEF Panel, 2015) …”

mentioning

confidence: 99%

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

Younes¹,

Aquilina²,

Castle³

et al. 2023

EFS2

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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.

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Section: Data and Methodologiesmentioning

confidence: 99%

“…In FGE.21Rev6, only genotoxicity data relevant for subgroup B‐II are reported. Data relevant for other subgroups can be retrieved in FGE.21Rev5 (EFSA CEF Panel, 2015 ).…”

Section: Appendix D – Genotoxicity Data Considered In Fge21rev3mentioning

confidence: 99%

Section: Fge21rev5mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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

Younes¹,

Aquilina²,

Castle³

et al. 2023

EFS2

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Safety evaluation of substituted thiophenes used as flavoring ingredients

Cohen

Fukushima²,

Gooderham

et al. 2017

Food and Chemical Toxicology

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This publication is the second in a series by the Expert Panel of the Flavor and Extract Manufacturers Association summarizing the conclusions of its third systematic re-evaluation of the safety of flavorings previously considered to be generally recognized as safe (GRAS) under conditions of intended use. Re-evaluation of GRAS status for flavorings is based on updated considerations of exposure, structural analogy, metabolism, pharmacokinetics and toxicology and includes a comprehensive review of the scientific information on the flavorings and structurally related substances. Of the 12 substituted thiophenes reviewed here, 11 were reaffirmed as GRAS based on their rapid absorption, metabolism and excretion in humans and animals; the low estimated dietary exposure from flavor use; the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels; and the lack of significant genotoxic and mutagenic potential. For one of the substituted thiophenes, 3-acetyl-2,5-dimethylthiophene, it was concluded that more detailed exposure information, comparative metabolism studies and comprehensive toxicity data, including an in-depth evaluation of the mechanism of action for any adverse effects observed, are required for continuation of its FEMA GRAS™ status. In the absence of these data, the compound was removed from the FEMA GRAS list.

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Flavouring Group Evaluation 76 Revision 2 (FGE.76Rev2): Consideration of sulfur‐containing heterocyclic compounds, evaluated by JECFA, structurally related to thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21Rev5

Younes¹,

Aquilina²,

Castle³

et al. 2023

EFS2

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The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 28 flavouring substances in the Flavouring Group Evaluation 76 (FGE.76Rev2). Twenty‐one of these substances have been considered in FGE.76Rev1. Seven substances could not be evaluated, because of concerns with respect to genotoxicity. New genotoxicity data have been provided for 4‐methyl‐5‐vinylthiazole [FL‐no: 15.018] and 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032], which are representative substances of [FL‐no: 15.005] and [FL‐no: 15.029, 15.030, 15.130 and 15.131], respectively. The Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 15.018 and 15.005]. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032, 15.029, 15.030, 15.130 and 15.131]. In vitro, [FL‐no: 15.032] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus study was not adequate to rule out the concern for potential aneugenicity in vivo. The Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for [FL‐no: 15.032]. Based on this comparison, the Panel concluded that the use of [FL‐no: 15.032] at the maximum reported use levels does not raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances [FL‐no: 15.029, 15.030, 15.130 and 15.131], an aneugenic potential may also be anticipated. Individual genotoxicity data are needed to establish whether they have aneugenic potential. The Panel agrees with JECFA conclusions for 24 flavouring substances ‘No safety concern at estimated levels of intake as flavouring substances’ when based on the MSDI approach. For six substances, more reliable information on uses and use levels are needed to refine the mTAMDI estimates. For 15 substances, use levels are needed to calculate the mTAMDIs. For [FL‐no: 15.109 and 15.113], information on the actual stereochemical composition is inadequate and the conclusion reached for the named substances cannot be applied to the materials of commerce.

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Scientific Opinion on Flavouring Group Evaluation 21, Revision 5 (FGE.21Rev5): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Cited by 3 publications

References 32 publications

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

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

Safety evaluation of substituted thiophenes used as flavoring ingredients

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