Scientific Opinion on Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Flavourings,

doi:10.2903/j.efsa.2012.2457

Cited by 9 publications

(10 citation statements)

References 28 publications

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“…Application of the Procedure to 59 Thiazoles, Thiophene, Thiazoline and Thienyl Derivatives and Miscellaneous Substances from Chemical Group 30 by EFSA (FGE.21Rev3) (EFSA CEF Panel, 2012 (JECFA, 1995;JECFA, 1996;JECFA, 1997;JECFA, 1999), hereafter named the "JECFA Procedure". The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) compares the JECFA evaluation of structurally related substances with the result of a corresponding EFSA evaluation, focussing on specifications, intake estimations and toxicity data, especially genotoxicity data.…”

Section: Discussionmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 76, Revision 1 (FGE.76Rev1): Consideration of sulphur‐containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21Rev3

Flavourings¹

2013

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present opinion concerns a group of 26 sulphur-containing heterocyclic compounds evaluated by the JECFA at the 59 th meeting in 2008. This revision is made due to the inclusion of one additional substance, 5-methyl-2-thiophenecarbaldehyde .004], cleared for genotoxicity concern in FGE.224. Additionally, new toxicity data have become available for 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine . Since publication of FGE.76, one substance, thiazole .028], is no longer supported by Industry for use as a flavouring substance in Europe and will therefore not be considered any further. The 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 agrees with the application of the .028], is no longer supported by Industry for use as a flavouring substance in Europe and will therefore not be considered any further. The present revision is made due to inclusion of one additional substance, 5-methyl-2-thiophenecarbaldehyde .004], cleared for genotoxicity concern in FGE.224. Additionally, new toxicity data have become available for 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine . Therefore, the present revision of FGE.76, FGE.76Rev1, considers 26 flavouring substances evaluated by the JECFA.The Panel concluded that all 26 Register substances in the JECFA flavouring group of sulphurcontaining heterocyclic compounds are structurally related to the 59 thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in the Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3).In the previous version of FGE.76, the Panel considered that for the substances ] no adequate NOAELs were available. Since then a 90-day study has become available for 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine .113] providing a NOAEL to establish adequate margins of safety for the substance, as well as for the structurally related 2,4,6-trimethyldihydro-1,3,5(4H)-dithiazine ].The Panel agrees with the application of the Procedure as performed by the JECFA for 21 of the 26 substances considered in this FGE. Three of the remaining five substances, 2-(sec-butyl)-4,5-dimethyl-3-thiazoline 4,.030] and 4,5-dimethyl-2-isobutyl-3-thiazoline .032], were considered by the Panel to have genotoxic potential in vitro, and therefore the Panel decided that the Procedure should not be applied to these three flavouring substances until adequate in vivo genotoxicity data become availabl...

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Section: Discussionmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 76, Revision 1 (FGE.76Rev1): Consideration of sulphur‐containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21Rev3

Flavourings¹

2013

EFS2

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“…Derivatives of thiazine and dithiazine, like 5,6-dihydro-2,4,6-trans(2-methylpropyl)4H-1, 3, 5-dithiazine [15.113], are expected to be metabolised primarily via side-chain oxidation and by ring S-and N-oxidation (EFSA CEF Panel, 2012a).…”

Section: Absorption Distribution Metabolism and Excretionmentioning

confidence: 99%

Safety and efficacy of thiazoles, thiophene and thiazoline belonging to chemical group 29 when used as flavourings for all animal species

2016

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 12 compounds belonging to chemical group 29 (thiazoles, thiophene and thiazoline). They are currently authorised as flavours in food. This opinion concerns 10 compounds from this group. The FEEDAP Panel concludes that 2‐isopropyl‐4‐methylthiazole is safe at the proposed maximum use level of 0.5 mg/kg complete feed for cattle, salmonids and non‐food producing animals and at the proposed normal use level of 0.1 mg/kg complete feed for pigs and poultry. All the other compounds, 4,5‐dihydrothiophen‐3(2H)‐one, 2‐isobutylthiazole, 5‐(2‐hydroxyethyl)‐4‐methylthiazole, benzothiazole, 2,4,5‐trimethylthiazole, 2‐acetylthiazole, 2‐ethyl‐4‐methylthiazole, 5,6‐dihydro‐2,4,6‐trans(2‐methylpropyl)4H‐1,3,5‐dithiazine and thiamine hydrochloride are safe at the proposed maximum use level of 0.05 mg/kg feed for all animal species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and fresh water environments. As all the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. In the absence of data on the stability in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

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“…For the remaining substance 3-(methylthio)-methylthiophene .126], supported by FGE.21 subgroup A-Ic, since no genotoxicity data were available on the substance, the Panel referred to the EFSA conclusion on the substances considered in group A-Ic in FGE.21Rev3 (EFSA, 2012b). For this subgroup A-Ic, EFSA had concluded that genotoxicity data were limited, but the data did not preclude evaluating the substances through the Procedure.…”

Section: Efsa Considerationsmentioning

confidence: 99%

“…The substances were allocated into structural subgroups (for description and explanation, see FGE.21Rev3 (EFSA, 2012b) and were evaluated at step B4 in the Procedure, i.e. the substances are not expected to be metabolised to innocuous products and the estimated intakes are below the thresholds for their structural classes II and III.…”

Section: Application Of the Procedures To Sulphur Containing Heterocycmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 93, Revision 1 (FGE.93Rev1): Consideration of sulphur containing heterocyclic compounds evaluated by JECFA (68th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives evaluated by EFSA in FGE.21Rev3

Flavourings¹

2013

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of five sulphur-containing heterocyclic compounds 15.126, 15.128, 15.130 and 15.131] evaluated by the JECFA at its 68 th meeting in 2007. This revision is required owing to additional available genotoxicity data on 2-acetyl-2-thiazoline . Since the publication of FGE.93, the substance ] is no longer supported by Industry for use as a flavouring substance in Europe and will therefore not be considered any further. The 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 two substances 5-ethyl-4-methyl-2-(2-methylpropyl)-thiazoline .130] and 5-ethyl-4-methyl-2-(2-butyl)-thiazoline .131], which are 3-thiazolines, are structural similar to two other 3-thiazolines in FGE.21Rev1 for which the Panel has expressed a genotoxicity concern, and accordingly the Procedure should not be applied to these two substances until adequate genotoxicity data become available. The Panel agrees with the application of the Procedure as performed by the JECFA for the remaining three substances, 2-acetyl-2-thiazoline .010], 3-(methylthio)-methylthiophene ] and 2-propionyl-2-thiazoline , of the five substances considered in this FGE and agrees with the JECFA conclusion, "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach. Besides the safety assessment of these .131], which are 3-thiazolines, are structurally similar to two other 3-thiazolines in FGE.21 for which the Panel has expressed a genotoxicity concern, and accordingly the Procedure should not be applied to these two substances until adequate genotoxicity data become available.Genotoxicity data have become available for 2-acetyl-2-thiazoline .010] and based on these new in vitro studies (gene mutation test in bacteria and micronucleus assay in human peripheral blood lymphocytes), the genotoxicity concern could be ruled out. 2-Acetyl-2-thiazoline ] is supporting the other 2-thiazoline included in this FGE, 2-propionyl-2-thiazoline , thus the two substances can now be evaluated using the Procedure.For 2-acetyl-2-thiazoline .010] and 2-propionyl-2-thiazoline .128] (2-thiazolines), the intakes (MSDI) of 0.51 and 0.19 µg/capita/day are below the threshold for their structural class II. The no observed adverse effect level (NOAEL) of 1.8 mg/kg body weight (bw) per day for 2-acetyl-2-thiazoline from a 90-day and a 52-week rat studies that examined a mixture of four flavouring substances, including .010], provides margins of safety of 2.1 ...

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Scientific Opinion on Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Cited by 9 publications

References 28 publications

Safety and efficacy of thiazoles, thiophene and thiazoline belonging to chemical group 29 when used as flavourings for all animal species

Scientific Opinion on Flavouring Group Evaluation 93, Revision 1 (FGE.93Rev1): Consideration of sulphur containing heterocyclic compounds evaluated by JECFA (68th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives evaluated by EFSA in FGE.21Rev3

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