Scientific Opinion on Flavouring Group Evaluation 300, Revision 1 (FGE.300Rev1): One cyclo-aliphatic amide from chemical group 33

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(11):3887 [34 pp.].
doi
10.2903/j.efsa.2014.3887
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.
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby and EFSA staff: Maria Carfí, Annamaria Rossi and Kim Rygaard Nielsen for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2014-00072
Adopted
23 October 2014
Published in the EFSA Journal
14 November 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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.

Keywords
flavouring, food safety, cyclo-aliphatic amide, FGE.300
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Number of Pages
34