Flavouring Group Evaluation 51, Revision 2 (FGE.51Rev2): Consideration of alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting) structurally related to alicyclic ketones secondary alcohols and related esters in FGE.09Rev6 (2015)

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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, Karl-Heinz Engel, Paul Fowler, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin, for the preparatory work on this scientific opinion, the hearing experts Vibe Beltoft and Karin Nørby and EFSA staff Annamaria Rossi, Maria Carfi and Maria Anastassiadou for the support provided to this scientific opinion.  

EFSA Journal
EFSA Journal 2016;14(1):4338 [57 pp.].
doi
10.2903/j.efsa.2016.4338
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, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00315
EFSA-Q-2015-00316
EFSA-Q-2015-00317
EFSA-Q-2015-00319
Adopted
3 December 2015
Published
12 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of 24 alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting in 2002 and 63rd meeting in 2004). This revision is made due to inclusion of four additional substances cleared for genotoxicity concern compared to the previous version [FL-no: 07.033, 07.094, 07.112 and 07.140]. The Panel concluded for 23 substances that these do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach [FL-no: 02.209, 07.034, 07.035, 07.045, 07.094, 07.095, 07.098, 07.112, 07.126, 07.129, 07.140, 07.148, 07.149, 07.172, 07.179, 07.180, 07.257, 09.027, 09.140, 09.160, 09.230, 09.464 and 09.930]. However, for all substances use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered and are adequate for 21 substances. For [FL-no: 07.094 and 07.112], information on the solubility in water and ethanol is missing. The chemical identity could not be unambiguously confirmed for substance [FL-no: 07.033]. Therefore the Panel could not consider the JECFA evaluation of this substance and information as to its chemical identity should be submitted.

Keywords
alicyclic ketones, JECFA 59th meeting, alicyclic secondary alcohols, FGE.09, FGE.212.
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Number of Pages
57