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

First published in the EFSA Journal
16 May 2013
15 May 2013
Last Updated
4 June 2013. This version replaces the previous one/s.
Scientific Opinion


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.

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
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef [at]
EFSA Journal 2013;11(5):3227
Question Number
On request from
European Commission