Open AccessScientific Opinion on Flavouring Group Evaluation 302 (FGE.302): N ‐(2‐methylcyclohexyl)‐2,3,4,5,6‐pentafluoro‐benzamide from Chemical Group 30
Author(s) -
Silano Vittorio,
Bolognesi Claudia,
Castle Laurence,
Cravedi JeanPierre,
Engel KarlHeinz,
Fowler Paul,
Franz Roland,
Grob Konrad,
Gürtler Rainer,
Husøy Trine,
Kärenlampi Sirpa,
Milana Maria Rosaria,
Penninks André,
Tavares Poças Maria de Fátima,
Smith Andrew,
Tlustos Christina,
Wölfle Detlef,
Zorn Holger,
Zugravu CorinaAurelia,
Beckman Sundh Ulla,
Brimer Leon,
Mulder Gerard,
Anastassiadou Maria,
Mennes Wim
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4726
Subject(s) - chemistry , benzamide , acceptable daily intake , genotoxicity , toxicology , food additive , body weight , food science , toxicity , stereochemistry , medicine , pesticide , organic chemistry , biology , agronomy
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 × 10 6 , 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.