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, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87.


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011;9(12):1924 [60 pp.].
Panel members at the time of adoption
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

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.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
25 November 2010
Published in the EFSA Journal
9 December 2011
European Food Safety Authority (EFSA), Parma, Italy

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.

Footnote 8, European anticipated production volume, MSDI
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