Scientific Opinion on Flavouring Group Evaluation 87, Revision 2 (FGE.87Rev2): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and related esters evaluated by EFSA in FGE.47Rev1 (2008)

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(10):3864 [41 pp.].
doi
10.2903/j.efsa.2014.3864
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, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, 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-2014-00348
EFSA-Q-2014-00349
Adopted
25 September 2014
Published
20 October 2014
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 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 (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 19 bicyclic secondary alcohols, ketones and related esters evaluated by the JECFA at the 63rd meeting in 2004. This revision of FGE.87 is made due to inclusion of two additional substances Nookatone [FL-no: 07.089] and 4,4a,5,6-tetrahydro-7-methylnapthalen-2(3H)-one [FL-no: 07.136] cleared for genotoxicity concern in FGE.213 Rev1. 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 Panel agrees with the application of the Procedure as performed by the JECFA for all substances considered in this FGE and for 18 substances the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For one substance [FL-no: 07.136], a production volume for Europe is not available, which precludes the finalisation of the evaluation by EFSA of this substance. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for all 19 substances, the information is adequate.

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  scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the CEF Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the 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.

This consideration deals with 19 bicyclic secondary alcohols, ketones and related esters, which are in the Register and which were evaluated by the JECFA at its 63rd meeting.

The revision is made due to consideration of two additional substances nootkatone and 4,4a,5,6-tetrahydro-7-methylnapthalen-2(3H)-one [FL-no: 07.089 and 07.136] compared to the previous version. These two substances are α,β-unsaturated alicyclic ketones which have been considered with respect to genotoxicity in FGE.213Rev1, and the Panel concluded that the data available ruled out the concern for genotoxicity and thus concluded that the two substances can be evaluated through the Procedure in this FGE.87Rev2.

The Panel concluded that all 19 substances are structurally related to the group of bicyclic secondary alcohols, ketones and related evaluated by EFSA in the Flavouring Group Evaluation 47 (FGE.47Rev1).

The Panel agrees with the application of the Procedure as performed by the JECFA for the 19 bicyclic secondary alcohols, ketones and related esters. It was concluded at step A3 of the Procedure that 18 substances do not pose a safety concern when used as flavouring substances at estimated levels of intake, based on the MSDI approach. For one substance [FL-no: 07.136], the evaluation through the Procedure could not be finalised because of absence of an EU production volume.

For all 19 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 assessments and to finalise the evaluation.

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 are available for all the materials of commerce, however, a production volume for EU for substance [FL-no: 07.136] is not available, which precludes the finalisation of the evaluation by EFSA of this substance.

For the remaining 18 JECFA evaluated bicyclic secondary alcohols, ketones and related esters [FL-no: 02.016, 02.038, 02.059, 02.100, 02.101, 07.089, 07.153, 07.159, 09.017, 09.082, 09.131, 09.153, 09.176, 09.218, 09.269, 09.319, 09.456 and 09.457] the Panel agrees with the JECFA conclusion: “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.

Keywords
flavouring, bicyclic, secondary alcohols, ketones, esters, FGE.47, FGE.87
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Number of Pages
41