Scientific Opinion on Flavouring Group Evaluation 304, Revision 1 (FGE.304Rev1): Four carboxamides from Chemical Groups 30

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Acknowledgements

The Panel wishes to thank the members of the Working Group on Flavourings: Ulla Beckman Sundh, Leon Brimer, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, 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: Annamaria Rossi and Kim Rygaard Nielsen for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2014;12(7):3769 [35 pp.].
doi
10.2903/j.efsa.2014.3769
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, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00860
Adopted
3 July 2014
Published
22 July 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 four flavouring substances in the Flavouring Group Evaluation 304, Revision 1 (FGE.304Rev1) using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to a re-evaluation of one flavouring substance N-(2-(pyridine-2-yl)ethyl)-3-p-menthanecarboxamide [FL-no: 16.118], as a 90-day dietary rat study has become available. One of the original five flavouring substances [FL-no: 16.124], for which additional data were requested, is no longer supported by the Industry for use as flavouring substance in Europe and will therefore not be considered any further in FGE.304Rev1. Therefore, FGE.304Rev1 will deal with four flavouring substances. None of the four substances were considered to have genotoxic potential. The substances were 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 four substances [FL-no: 16.117, 16.118, 16.123 and 16.125] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all four candidate substances.

Keywords
FGE.304, carboxamides, flavourings, food safety
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Number of Pages
35