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 languageEnglish
Pagese04726
Volume15
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Mar 2017

Keywords

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

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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