Scientific Opinion on Flavouring Group Evaluation 75, Revision 1 (FGE.75Rev1): Consideration of tetrahydrofuran derivatives evaluated by JECFA (63rd meeting) structurally related to tetrahydrofuran derivatives evaluated by EFSA in FGE.33 (2008)

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4335 [25 pp.].
doi
10.2903/j.efsa.2016.4335
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 Groups 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 and 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-2013-00194
Adopted
2 December 2015
Published
13 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) of the EFSA 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 10 tetrahydrofuran derivatives and one furanone derivative evaluated by the JECFA at the 63rd meeting in 2004. This revision is made due to additional toxicity data have become available for anhydrolinalool oxide (5) [FL-no: 13.097]. 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 JECFA concluded all the 11 tetrahydrofuran derivatives at step A3. The Panel agrees with the application of the Procedure as performed by the JECFA for 10 of the 11 substances. For the remaining substance [FL-no: 13.097] the Panel did not find that it could be metabolised to innocuous products and should accordingly be evaluated via the B-side of the Procedure scheme. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight was derived from a 90-day study in rats and compared with an exposure estimate of 0.9 µg/ capita / per day for anhydrolinalool oxide a margin of safety of 3.5 × 106 was calculated. Accordingly, the Panel agrees with the JECFA conclusion ‘No safety concern at estimated level of intake as flavouring substances’ based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered and for all 11 substances, the information is adequate.

Summary

Following a request from the European Commission, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion to provide 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 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.

In Flavouring Group Evaluation 75 (FGE.75), the European Food Safety Authority (EFSA) considered 11 substances in the JECFA flavouring group of tetrahydrofuran and furanone derivatives. The Panel concluded that the 11 substances evaluated by the JECFA were structurally related to the six tetrahydrofuran derivatives evaluated by EFSA in Flavouring Group Evaluation (FGE.33). This revision of FGE.75 (FGE.75Rev1) is made because EFSA received additional toxicity data for the candidate substance anhydrolinalool oxide [FL-no: 13.097].  

Seven other substances were also evaluated by the JECFA in this group, but two are not in the Register [2-hexyl-4-acetoxytetrahydrofuran (JECFA-no: 1440) and (+/-)-2-(5-methyl-5-vinyltetrahydrofuran-2-yl)propionaldehyde (JECFA-no: 1457)] and five substances [FL-no: 13.010, 13.084, 13.085, 13.089 and 13.099] are α,β-unsaturated furanone and will be considered together with other α,β-unsaturated aldehydes and ketones in a separate FGE (EFSA CEF Panel, 2015). This consideration will, therefore, only deal with 11 JECFA-evaluated substances.

The JECFA reached a conclusion for all 11 substances at step A3 of their procedure. The Panel agrees with the application of the Procedure as performed by the JECFA for 10 of the 11 substances. For the remaining substance [FL-no: 13.097], the Panel did not find that it could be metabolised to innocuous products and should accordingly be evaluated via the B-side of the Procedure scheme. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight (bw) was derived from a 90-day study in rats and compared with an exposure estimate of 0.9 µg/capita per day for anhydrolinalool oxide a margin of safety of 3.5 × 106 can be calculated. Accordingly, the Panel agrees with the JECFA conclusion ‘No safety concern at estimated level of intake as flavouring substances’ based on the maximised survey-derived daily intake (MSDI) approach.

For all 11 substances, the JECFA evaluation is based on MSDI values derived from production figures from the European Union (EU).

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 are available for all 11 JECFA-evaluated substances.

Thus, for all 11 substances [FL-no: 13.007, 13.020, 13.042, 13.048, 13.049, 13.060, 13.090, 13.095, 13.097, 13.140 and 13.166], the Panel agrees with the JECFA conclusion ‘No safety concern at estimated levels of intake as flavouring substances’ based on the MSDI approach

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
tetrahydrofuran derivatives, furanone derivatives, food safety, JECFA, 63rd meeting, FGE.33
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Number of Pages
25