Scientific Opinion on re-evaluation of one flavouring substance 3-acetyl-2,5-dimethylthiophene [FL-no 15.024] from FGE.19 subgroup 5.2

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(5):3227 [10 pp.].
doi
10.2903/j.efsa.2013.3227
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, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Pocas, Fidel Toldra and Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Genotoxicity Working Groups on Flavourings: Mona-Lise Binderup, Claudia Bolognesi, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Rainer Gürtler, Daniel Marzin, 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 Carfi, 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-2013-00323
Adopted
15 May 2013
Published in the EFSA Journal
16 May 2013
Last Updated
4 June 2013. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The 26th Plenary meeting of the AFC Panel on 27-29 November 2007 discussed the flavouring group evaluation 19 (FGE.19) which included alpha, beta-unsaturated aldehydes or ketones considered to be a structural alert for genotoxicity. The flavour industry was requested to submit data on genotoxicity of 3-acetyl-2,5-dimethylthiophene [FL-no 15.024] (subgroup 5.2 in the FGE.19; the other substances of this subgroup were evaluated in FGE.224). An in vitro bacterial mutation assay was positive in Salmonella typhimurium strains TA98, TA100 and TA102 in the presence of rat liver metabolic activation system (S9-mix), and an in vivo study on mutant frequency in Muta™Mice was positive in liver after exposure to 3-acetyl-2,5-dimethylthiophene. Based on this outcome the CEF Panel considered 3-acetyl-2,5-dimethylthiophene as mutagenic in vitro and in vivo and concluded that its use as flavouring substance raises a safety concern.

Keywords
FL-NO 15.024, 3-ACETYL-2,5-DIMETHYLTHIOPHENE, FGE.19, SUBGROUP 5.2
Print on demand
Number of Pages
10