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Scientific Opinion on Flavouring Group Evaluation 51, Revision 1 (FGE.51Rev1): Consideration of alicyclic ketones and secondary alcohols and related esters evaluated by the JECFA (59th meeting) structurally related to alicyclic ketones secondary alcohols and related esters in FGE.09Rev3 (2011)

EFSA Journal 2012;10(4):2636 [52 pp.]. doi:10.2903/j.efsa.2012.2636
  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Panel Members Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Fidel Toldra, Detlef Wölfle Acknowledgment The Panel wishes to thank the members of the Working Group on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Leon Brimer, Wilfried Bursch, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerrit Speijers, Harriet Wallin and EFSA’s staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion. Contact cef@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2011-01040 , EFSA-Q-2011-01041 , EFSA-Q-2011-01042 , EFSA-Q-2011-01043 , EFSA-Q-2011-01044 , EFSA-Q-2011-01045 , EFSA-Q-2011-01046 Adopted: 22 March 2012 Published: 18 April 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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 20 alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting) in 2002. This revision is made due to inclusion of seven additional substances cleared for genotoxicity concern compared to the previous version. 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 20 substances 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 20 substances, the information is adequate.

© European Food Safety Authority, 2012

Summary

The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to give 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.

This revision of FGE.51 is made due to the consideration of the seven the alpha,beta-unsaturated substances [FL-no: 07.034, 07.035, 07.098, 07.126, 07.129, 07.172 and 09.930] compared to the previous version of FGE.51. Furthermore, EU production volume on one substance [FL-no: 09.230] and data on stereoisomerism for four substances [FL-no: 02.209, 07.045, 07.095 and 07.257] have been provided since the publication of FGE.51.

The JECFA has evaluated a group of 25 flavouring substances consisting of alicyclic ketones, secondary alcohols and related esters at its 59th meeting. Two of the JECFA-evaluated substances are not in the Register (4-methyl cyclohexanone (JECFA no: 1104) and (E)-2-(2-octenyl) cyclopentanone (JECFA no: 1116)) and ten of the substances are alpha,beta-unsaturated ketones or precursors for such, which is recognized as a structural alert for genotoxicity. Seven of these 10 alpha,beta-unsaturated substances [FL-no: 07.034, 07.035, 07.098, 07.126, 07.129, 07.172 and 09.930] have been evaluated with respect to their genotoxic potential in FGE.211 (EFSA, 2011e) or in FGE.212Rev1 (EFSA, 2011f), and the Panel concluded that the data available ruled out the concern for genotoxicity and accordingly these seven substances can be evaluated through the Procedure.

The present consideration therefore concerns 20 alicyclic ketones, secondary alcohols and related esters evaluated by the JECFA at its 59th meeting and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 17 secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols evaluated in the Flavouring Group Evaluation 09, Revision 3 (FGE.09Rev3).

The Panel agrees with the application of the Procedure as performed by the JECFA for the 20 substances considered in this FGE.

For all substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs 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 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 20 substances evaluated in this FGE.51Rev1.

For all 20 evaluated alicyclic ketones, secondary alcohols and related esters [FL-no: 02.209 07.034, 07.035, 07.045, 07.095, 07.098, 07.126, 07.129, 07.148, 07.149, 07.172, 07.179, 07.180, 07.257, 09.027, 09.140, 09.160, 09.230, 09.464 and 09.930], the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substance” based on the MSDI approach.

Keywords

Alicyclic ketones, JECFA 59th meeting, alicyclic secondary alcohols, FGE.09