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
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.
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.  

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
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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.

Summary

Following a request from the European commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.

The present revision of FGE.51, FGE.51Rev2, is due to new genotoxicity data evaluated in FGE.212Rev3 (EFSA CEF Panel, 2015a), which deals only with the genotoxic potential of a, b‑unsaturated flavouring substances. Based on these data, the Panel concluded that the data available could rule out the concern for genotoxicity for [FL-no: 07.033, 07.094, 07.112 and 07.140] and accordingly these substances can be evaluated through the Procedure in this revision. Three of these substances were evaluated by the JECFA at its 59th meeting in 2002 [FL-no: 07.033, 07.094 and 07.112] and the fourth was evaluated by the JECFA at its 63rd meeting. Since in the previous version of this FGE (FGE.51Rev1) 20 substances were discussed, the present revision will address 24 flavouring substances.

The Panel concluded that the 24 substances in the JECFA flavouring groups of alicyclic ketones, secondary alcohols and related esters and monocyclic and bicyclic secondary alcohols, ketones and related esters are structurally related to the group of secondary alicyclic saturated and unsaturated alcohols, ketones and esters with secondary alicyclic alcohol moieties evaluated by EFSA in Flavouring Group Evaluation 09, Revision 6 (FGE.09Rev6) (EFSA CEF Panel, 2015b).

The chemical identity of [FL-no: 07.033] could not be unambiguously confirmed. Therefore the Panel could not consider the JECFA evaluation of this substance. The current revision of FGE.51 will consider only the safety of 23 JECFA-evaluated substances.

For all 23 substances considered in this FGE, the Panel concluded that either they did not raise a concern with respect to genotoxicity, or that concerns with respect to genotoxicity due to the presence of a structural alert for this could be ruled out, based on experimental data.

The Panel agrees with the application of the Procedure as performed by the JECFA for the 23 substances considered in this FGE.

For 23 JECFA evaluated alicyclic ketones, secondary alcohols and related esters [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] the Panel agrees with the JECFA conclusion ‘no safety concern at estimated levels of intake as flavouring substance’ based on the MSDI approach.

In order to determine whether the conclusion for the JECFA-evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specifications including complete purity criteria and identity tests are available for 21 JECFA-evaluated substances. For [FL-no: 07.094 and 07.112] information on the solubility in water and ethanol is missing and therefore the conclusions on the named substance cannot be applied to the materials of commerce that correspond to these two FL-numbers. For substance [FL-no: 07.033] unambiguous information with respect to the chemical identity should be provided.

For all substances evaluated through the Procedure use levels are needed to calculate the modified theoretical added maximum daily intake (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

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