Scientific Opinion on Flavouring Group Evaluation 99 Revision 1 (FGE.99Rev1): Consideration of furanone derivatives evaluated by the JECFA (63rd, 65th and 69th meetings)

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(11):4286 [31 pp.].
doi
10.2903/j.efsa.2015.4286
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-2015-00321
Adopted
28 October 2015
Approved
25 November 2015
Published
13 November 2015
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) 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 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 six furanone derivatives evaluated by the JECFA at their 63rd, 65th and 69th meetings. This revision of FGE.99 includes the assessment of the 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089] cleared for genotoxicity concern compared to the previous version. The Panel concluded that none of the six substances gives rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach [FL-nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176]. The specifications of the materials of commerce have also been considered and are adequate for all candidate substances in this FGE. However, for all substances use levels are required to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

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 (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.

The present revision of FGE.99, FGE.99Rev1, includes the assessment of one additional candidate substance, the 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089], which was evaluated by the JECFA at its 63rd meeting. This substance, containing an α,β-unsaturated carbonyl, raised concern for genotoxicity. In the recently published FGE.220Rev3, new genotoxicity data on the structurally related 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] have become available. The Panel concluded that the data available rules out the concern for genotoxicity for [FL-no: 13.089] and accordingly this substance can be evaluated through the Procedure in this revision.

This consideration deals with six flavouring substances [FL-nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176], which belong to a group of 18 tetrahydrofuran and furanone derivatives and a group of 40 furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulphides, disulphides and ethers evaluated by the JECFA at the 63rd, 65th and 69th meetings.

The Panel agrees with the application of the Procedure as performed by the JECFA for only one substance [FL-no: 13.010] considered in this FGE. The JECFA stated that the four substances [FL-nos: 13.084, 13.085, 13.089 and 13.099] belong to structural class II, but as data on natural occurrence indicate that these substances cannot be considered to be common components of food, the Panel disagrees with this and allocates these four substances to structural class III. In addition, for substance with [FL-no: 13.176] the JECFA concluded that the Procedure for the Safety Evaluation of Flavouring Agents could not apply because of the unresolved toxicological concerns related to the epoxidation and opening of the furan ring. The Panel disagreed with the conclusions by the JECFA and regarded this substance to be sufficiently structurally related to the other substances in this group.

The Panel concluded that there is no safety concern for the six substances [FL-nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176] in this FGE, based on the MSDI approach.

In order to determine whether the conclusion for the six 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, identity tests and information on stereoisomeric composition are available for all JECFA evaluated substances.

For all six substances evaluated through the Procedure use levels are required to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

Keywords
furanone derivatives, flavourings, food safety, JECFA, 63rd meeting, 65th meeting, 69th meeting, FGE.99, FGE.99Rev1.
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Number of Pages
31