Scientific Opinion on Flavouring Group Evaluation 224 (FGE.224): Consideration of genotoxic potential for two α,β-unsaturated thiophenes from subgroup 5.2 of FGE.19 by EFSA

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Article
EFSA Journal 2013;11(2):3093 [18 pp.].
doi
10.2903/j.efsa.2013.3093
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Panel Members
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, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Poças, Fidel Toldra and Detlef Wölfle.
Acknowledgement

The Panel wishes to thank the members of the Genotoxicity Working Group on Flavourings: Mona-Lise Binderup, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Rainer Gürtler, Daniel Marzin and Pasquale Mosesso for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby and EFSA staff: Maria Carfì 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-2012-00678
Adopted
31 January 2013
Published
20 February 2013
Last Updated
10 April 2013. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (217.65 KB)217.65 KB
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of two flavouring substances from subgroup 5.2 of FGE.19 in the Flavouring Group Evaluation 224 (FGE.224). The Flavour Industry has provided additional genotoxicity studies for one of the two substances in FGE.224, namely 5-methyl-2-thiophenecarbaldehyde [FL-no: 15.004]. The data requested by EFSA for the other substance, 3-acetyl-2,5-dimethylthiophene [FL-no: 15.024] of FGE.224 will be provided subsequently according to the Flavour Industry. Based on the new data the Panel concluded that 5-methyl-2-thiophenecarbaldehyde does not give rise to concern with respect to genotoxicity and can accordingly be evaluated using the Procedure. For the other substance in subgroup 5.2, 3-acetyl-2,5-dimethylthiophene, the requested genotoxicity data are still pending and no conclusion could be drawn in the present FGE.

Summary

Following a request from the European Commission the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion 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 Flavouring Group Evaluation 224 (FGE.224), corresponding to subgroup 5.2 of FGE.19, concerns two α,β-unsaturated thiophenes. The two substances in the present evaluation are one α,β-unsaturated aldehyde and one α,β-unsaturated ketone, structures which are considered to be structural alerts for genotoxicity and the data on genotoxicity previously available for these two substances did not rule out the concern for genotoxicity.

The Panel did not find that genotoxicity data for either of the substances in subgroup 5.2 could be used for reading across to the other substance in the subgroup; therefore genotoxicity data have been requested for both substances, according to the test strategy worked out by the Panel.

The Flavour Industry has provided additional genotoxicity data for one 5-methyl-2-thiophenecarbaldehyde [FL-no: 15.004] of the two substances in FGE.224. The requested data for the other substance, 3-acetyl-2,5-dimethylthiophene [FL-no: 15.024], will be provided subsequently, according to the Flavour Industry.

Based on the data submitted the Panel concluded that 5-methyl-2-thiophenecarbaldehyde [FL-no: 15.004] does not give rise to concern with respect to genotoxicity and can accordingly be evaluated using the Procedure. For the other substance in subgroup 5.2, 3-acetyl-2,5-dimethylthiophene [FL-no: 15.024]., the requested genotoxicity data are still pending and no conclusion could be drawn in the present FGE.
 

Keywords
FGE.224, alpha,beta-unsaturated thiophenes, α,β-unsaturated thiophenes, Subgroup 5.2, FGE.19
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Number of Pages
18