Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51,

Tabs

Article
EFSA Journal 2011;9(12):1924 [60 pp.].
doi
10.2903/j.efsa.2011.1924
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Panel Members
Arturo Anadon, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary Waring, Detlef Wölfle
Acknowledgement

The Panel wishes to thank the members of the Working Groups on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, 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, Gerard Pascal, Iona Pratt, Gerrit Speijers, Harriet Wallin and EFSA’s staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2010-01246
Adopted
25 November 2010
Published
9 December 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (357.69 KB)357.69 KB
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 FGE.96 concerns 88 JECFA-evaluated substances from different FGEs. Common for all the 88 substances was that for none of them European production volumes were available at the time for the first consideration of the FGEs in question. As a consequence, no MSDI could be calculated for EU and accordingly the substances could not be considered by EFSA using the evaluation Procedure. Industry has now provided production volumes for these substances. Based on these newly provided production figures, MSDI values for EU have been calculated and based on these MSDI values the substances have been re-considered by the stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. In the FGEs in question, genotoxicity of the substances considered in FGE.96 has already been addressed. For none of the substances a concern for genotoxicity was identified. The Panel concluded that 87 of the substances do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, for the substance 2-acetyl-1-ethylpyrrole [FL-no: 14.045], the Panel could not identify an appropriate NOAEL and accordingly additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for eight stereoisomeric substances [FL-no: 06.040, 08.073, 09.371, 09.780, 10.050, 13.060, 13.161 and 16.039], the stereoisomeric composition has to be specified further.

Summary

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) 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.

The present FGE.96 concerns 88 JECFA-evaluated substances from different groups. These groups have been previously considered by EFSA in FGE.51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87. Common for all the 88 substances was that for none of them European production volumes were available at the time for the first consideration in the above-mentioned FGEs. As a consequence, no MSDI could be calculated for EU and accordingly the substances could not be considered by EFSA using the Procedure.

By February/April 2010 Industry provided production volumes for these substances. Based on these newly provided (anticipated) production figures, MSDI values for EU have been calculated (see Table 1.1 and Table 2), and based on these MSDI values the substances have been re-considered by EFSA in the current FGE.96. For the flavouring substances for which the production volumes are anticipated figures, the present evaluation will have to be reconsidered when actual production volumes become available.

In the FGEs mentioned above, genotoxicity of the substances considered in FGE.96 has already been addressed. For none of the substances a concern for genotoxicity was identified.

The Panel has considered 87 of the JECFA evaluated substances to be of no safety concern when used at the estimated intake based on the MSDI approach. For the remaining substance, 2-acetyl-1-ethylpyrrole [FL-no: 14.045] the Panel could not identify an appropriate NOAEL and accordingly additional data are required.

In order to determine whether the conclusion for the 88 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 79 of the JECFA-evaluated substances. For [FL-no: 15.008], the solubility in water is missing. Otherwise the specifications for this substance are appropriate. For eight stereoisomeric substances [FL-no: 06.040, 08.073, 09.371, 09.780, 10.050, 16.039, 13.060 and 13.161], the stereoisomeric composition has to be specified further.

Thus, for 79 of the 88 substances, the Panel concluded that they would be of no safety concern when used at their estimated levels of intake as flavouring substances based on the MSDI approach. For eight of the remaining nine substances, additional data on stereochemical composition are required to finalise their evaluation as material of commerce. For [FL-no: 14.045] additional toxicity data are required to finalise the evaluation.

The Panel noted that amino acids [FL-no: 16.056, 17.001, 17.003, 17.015 and 17.026] may react with other food constituents upon heating. The reaction mixtures formed are commonly referred to as “process flavours” which have not been evaluated by the Panel. The present evaluation is therefore on the basis that the present flavouring substances are in an unchanged form when they are consumed, thus in food that is not intended to be heated.

Keywords
Footnote 8, European anticipated production volume, MSDI
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Number of Pages
60