Scientific Opinion on Flavouring Group Evaluation 94, Revision 2 (FGE.94Rev2): Consideration of aliphatic amines and amides evaluated in an addendum to the group of aliphatic and aromatic amines and amides evaluated by the JECFA (68th meeting)

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(4):3622 [33 pp.].
doi
10.2903/j.efsa.2014.3622
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldrá and Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Angelo Carere, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, 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: 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-2013-00688
Adopted
25 March 2014
Published
10 April 2014
Last Updated
1 August 2014. This version replaces the previous one/s.
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 12 aliphatic amines and amides evaluated by the JECFA at the 68th meeting in 2007. This revision is required owing to additional toxicity data on 3-(3,4-dimethoxyphenyl)-N-[2-(3,4-dimethoxyphenyl)-ethyl]-acrylamide [FL-no: 16.090]. 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 JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach for all substances considered in this FGE. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered and for all 12 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 a scientific opinion 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 Flavouring Group Evaluation 94, Revision 1 (FGE.94Rev1), the EFSA considered 12 aliphatic amines and amides evaluated by the JECFA at the 68th meeting. This revision 2 is made due to additional toxicity data received on 3-(3,4-dimethoxyphenyl)-N-[2-(3,4-dimethoxyphenyl)-ethyl]-acrylamide [FL-no: 16.090] that were requested in the previous opinion.

The Panel concluded that no supporting Flavouring Group Evaluation was available for the substances in the present FGE.

Genotoxicity data from in vitro and in vivo studies were available for seven [FL-no: 16.090, 16.095, 16.098, 16.099, 16.102, 16.103 and 16.111] of the flavouring substances and the results did not indicate any concern for genotoxicity of the substances in this flavouring group.

In the previous version of FGE.94 (FGE.94Rev1), the Panel concluded that it could agree with the way the application of the Procedure has been performed by the JECFA for 11 substances. For one substance [FL-no: 16.090] no adequate NOAEL was available. A new 90-day study has now become available for [FL-no: 16.090] and a NOAEL to provide an adequate margin of safety can be derived.

For 10 of the 12 substances, use levels have been provided by the Industry. Based on the use levels, the mTAMDI figures calculated for nine substances [FL-no: 16.090, 16.095, 16.098, 16.099, 16.102, 16.103, 16.104, 16.111 and 17.035] are above the threshold of concern for their structural classes. For these nine substances more reliable data are needed. On the basis of such data the flavouring substances should be reconsidered using the Procedure. For the remaining two substances [FL-no: 16.100 and 16.101], use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment.

In order to determine whether the conclusion for the 12 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications are available for all 12 substances. 

For all 12 substances [FL-no: 16.090, 16.095, 16.098, 16.099, 16.100, 16.101, 16.102, 16.103, 16.104, 16.105, 16.111 and 17.035] the Panel agrees with the JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.

Keywords
JECFA 68th meeting, food safety, flavourings, aliphatic amines, aliphatic amides, FGE.94
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Number of Pages
33