Flavouring Group Evaluation 300 Revision 1

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Article
flavouring, food safety, cyclo-aliphatic amide, FGE.300
First published in the EFSA Journal
14 November 2014
Adopted
23 October 2014
Type
Scientific Opinion
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate a flavouring substance,cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide [FL-no: 16.115] in the Flavouring Group Evaluation 300, Revision 1 (FGE.300Rev1) using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to a re-evaluation of the flavouring substance, cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide [FL-no: 16.115], as a 90-day dietary study in rats has become available. The substance was not considered to have genotoxic potential. The substance was 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 the substance [FL-no: 16.115] does not give rise to safety concern at its levels of dietary intake estimated on the basis of the Maximised Survey-derived Daily Intake MSDI approach. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.

Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3887
EFSA Journal 2014;12(11):3887 [34 pp.].
Question Number
On request from
European Commission
Print on demand
Number of Pages
34