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)


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4335 [25 pp.].
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.
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.
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
2 December 2015
Published in the EFSA Journal
13 January 2016
European Food Safety Authority (EFSA), Parma, Italy
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.
tetrahydrofuran derivatives, furanone derivatives, food safety, JECFA, 63rd meeting, FGE.33
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