EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)

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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
Original languageEnglish
Place of PublicationParma, Italy
PublisherEuropean Food Safety Authority
Number of pages96
DOIs
Publication statusPublished - 2013
Seriesthe EFSA Journal
Number3451
Volume11(11)
ISSN1830-5458

Cite this

EFSA Publication. / EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4). Parma, Italy : European Food Safety Authority, 2013. 96 p. (the EFSA Journal; No. 3451, Vol. 11(11)).
@book{6b6bf721d17d427a839681fe86f2c7b9,
title = "EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)",
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",
author = "{EFSA Publication} and Beltoft, {Vibe Meister} and Mona-Lise Binderup and Frandsen, {Henrik Lauritz} and Pia Lund and N{\o}rby, {Karin Kristiane}",
year = "2013",
doi = "10.2903/j.efsa.2013.3451",
language = "English",
series = "the EFSA Journal",
number = "3451",
publisher = "European Food Safety Authority",

}

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4). / EFSA Publication.

Parma, Italy : European Food Safety Authority, 2013. 96 p. (the EFSA Journal; No. 3451, Vol. 11(11)).

Research output: Book/ReportReportCommissionedpeer-review

TY - RPRT

T1 - EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)

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AU - Beltoft, Vibe Meister

AU - Binderup, Mona-Lise

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N2 - 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

AB - 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

U2 - 10.2903/j.efsa.2013.3451

DO - 10.2903/j.efsa.2013.3451

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T3 - the EFSA Journal

BT - EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)

PB - European Food Safety Authority

CY - Parma, Italy

ER -