Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30

Vittorio Silano; Claudia Bolognesi; Laurence Castle; Jean-Pierre Cravedi; Karl-Heinz Engel; Paul Fowler; Roland Franz; Rainer Gürtler; Konrad Grob; Trine Husøy; Sirpa Kärenlampi; Maria Rosaria Milana; André Penninks; Maria de Fátima Tavares Poças; Andrew Smith; Christina Tlustos; Detlef Wölfle; Holger Zorn; Corina-Aurelia Zugravu; Ulla Beckman Sundh; Leon  Brimer; Gerard  Mulder; Maria  Anastassiadou; Wim Mennes; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

doi:10.2903/j.efsa.2017.4726

Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Rainer Gürtler, Konrad Grob, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Andrew Smith, Christina Tlustos, Detlef Wölfle , Holger Zorn, Corina-Aurelia Zugravu, Ulla Beckman SundhLeon Brimer, Gerard Mulder, Maria Anastassiadou, Wim Mennes, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide [FL-no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20–40% and trans 60–80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL-no: 16.119] through the Procedure. The substance was evaluated through the B-side of the Procedure. A ‘No Observed Adverse Effect Level’ (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL-no: 16.119] from a 90-day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the ‘Maximised Survey-Derived Daily Intake’ (MSDI) of 2.4 μg/capita per day. Based on the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.

Original language	English
Pages	e04726
Volume	15
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2017.4726
Publication status	Published - Mar 2017

Keywords

N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide
FGE.302
flavouring
food safety

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30
© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 1.33 MBLicence: CC BY-ND

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Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Engel, K-H., Fowler, P., Franz, R., Gürtler, R., Grob, K., Husøy, T., Kärenlampi, S., Rosaria Milana, M., Penninks, A., de Fátima Tavares Poças, M., Smith, A., Tlustos, C., Wölfle , D., Zorn, H., Zugravu, C-A., ... EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (2017). Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30. EFSA Journal, 15, e04726. https://doi.org/10.2903/j.efsa.2017.4726

Silano, V, Bolognesi, C, Castle, L, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Gürtler, R, Grob, K, Husøy, T, Kärenlampi, S, Rosaria Milana, M, Penninks, A, de Fátima Tavares Poças, M, Smith, A, Tlustos, C, Wölfle , D, Zorn, H, Zugravu, C-A, Sundh, UB, Brimer, L, Mulder, G, Anastassiadou, M, Mennes, W & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2017, 'Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30' EFSA Journal, vol. 15, pp. e04726. https://doi.org/10.2903/j.efsa.2017.4726

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abstract = "The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide [FL-no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20–40% and trans 60–80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL-no: 16.119] through the Procedure. The substance was evaluated through the B-side of the Procedure. A {\textquoteleft}No Observed Adverse Effect Level{\textquoteright} (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL-no: 16.119] from a 90-day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the {\textquoteleft}Maximised Survey-Derived Daily Intake{\textquoteright} (MSDI) of 2.4 μg/capita per day. Based on the {\textquoteleft}modified Theoretical Added Maximum Daily Intake{\textquoteright} (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.",

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doi = "10.2903/j.efsa.2017.4726",

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AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Cravedi, Jean-Pierre

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Franz, Roland

AU - Gürtler, Rainer

AU - Grob, Konrad

AU - Husøy, Trine

AU - Kärenlampi, Sirpa

AU - Rosaria Milana, Maria

AU - Penninks, André

AU - de Fátima Tavares Poças, Maria

AU - Smith, Andrew

AU - Tlustos, Christina

AU - Wölfle , Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Sundh, Ulla Beckman

AU - Brimer, Leon

AU - Mulder, Gerard

AU - Anastassiadou, Maria

AU - Mennes, Wim

AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide [FL-no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20–40% and trans 60–80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL-no: 16.119] through the Procedure. The substance was evaluated through the B-side of the Procedure. A ‘No Observed Adverse Effect Level’ (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL-no: 16.119] from a 90-day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the ‘Maximised Survey-Derived Daily Intake’ (MSDI) of 2.4 μg/capita per day. Based on the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide [FL-no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20–40% and trans 60–80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL-no: 16.119] through the Procedure. The substance was evaluated through the B-side of the Procedure. A ‘No Observed Adverse Effect Level’ (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL-no: 16.119] from a 90-day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the ‘Maximised Survey-Derived Daily Intake’ (MSDI) of 2.4 μg/capita per day. Based on the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.

KW - N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide

KW - FGE.302

KW - flavouring

KW - food safety

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DO - 10.2903/j.efsa.2017.4726

M3 - Article

VL - 15

SP - e04726

JO - EFSA Journal

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SN - 1831-4732

ER -

Scientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide from Chemical Group 30

Abstract

Keywords

UN SDGs

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