Scientific Opinion on Flavouring Group Evaluation 73, Revision 3 (FGE.73Rev3): Consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th and 63rd meeting) structurally related to primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters evaluated by EFSA in FGE.12Rev4 (2013)

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(10):3862 [33 pp.].
doi
10.2903/j.efsa.2014.3862
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 Group 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-2014-00347
Adopted
24 September 2014
Published
15 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 18 alicyclic alcohols, aldehydes, acids and related esters and one phenethyl ester evaluated by the JECFA at their 59th and 63rd meetings. This revision is made due to consideration of one additional substance, beta-ionyl acetate [FL-no: 09.305] cleared for genotoxicity concern in FGE.213Rev1. 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 19 substances [FL-no: 02.114, 02.141, 05.098, 05.104, 05.112, 05.119, 05.123, 08.034, 08.060, 08.067, 09.028, 09.034, 09.289, 09.305, 09.488, 09.534, 09.536, 09.615 and 09.712] considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 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.

In the previous version of Flavouring Group Evaluation 73 (FGE.73Rev2), EFSA considered 17 alicyclic primary alcohols, aldehydes, acids and related esters and one phenylethyl alcohol evaluated by the JECFA at their 59th meeting.

This revision is made due to consideration of one additional substance, beta-ionyl acetate [FL-no: 09.305], compared to the previous version of FGE.73 (FGE.73Rev2). This substance has been evaluated in FGE.213Rev1 due to structural concern for genotoxicity, and has been cleared from this concern and thus may be evaluated through the Procedure.

The present consideration therefore concerns 18 alicyclic alcohols, aldehydes, acids and related esters and one phenethyl alcohol evaluated by the JECFA (59th and 63rd meeting) which will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 12 primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated in the Flavouring Group Evaluation 12, Revision 4 (FGE.12Rev4).

The Panel agrees with the application of the Procedure as performed by the JECFA for the 19 substances considered in this FGE.

For all 19 substances evaluated through the Procedure use levels are needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

In order to determine whether the conclusion for the 19 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 all JECFA evaluated substances.

Thus, for all 19 substances [FL-no: 02.114, 02.141, 05.098, 05.104, 05.112, 05.119, 05.123, 08.034, 08.060, 08.067, 09.028, 09.034, 09.289, 09.305, 09.488, 09.534, 09.536,  09.615 and 09.712] the Panel agrees with the JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.

Keywords
alicyclic, alcohols, aldehydes and esters, JECFA, 59th meeting, FGE.12, FGE.73, FGE.213
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Number of Pages
33