Scientific Opinion on Flavouring Group Evaluation 21, Revision 5 (FGE.21Rev5): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(4):4066 [105 pp.].
Panel Members
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn.

The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin Nørby and EFSA staff: Annamaria Rossi, Maria Carfi and Maria Anastassiadou for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
19 March 2015
Published in the EFSA Journal
13 April 2015
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 evaluate 41 flavouring substances in Flavouring Group Evaluation 21, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision was carried out because of the inclusion of the assessment of new toxicity data on the candidate substances, 5-ethylthiophene-2-carbaldehyde [FL-no: 15.074] and 2-pentylthiophene [FL-no: 15.096]. These data on 5-ethylthiophene-2-carbaldehyde [FL-no: 15.074] should cover 2-acetylthiophene [FL-no: 15.040] and 2-propionylthiophene [FL-no: 15.097]. These data on 2-pentylthiophene [FL-no: 15.096] should cover 2-butylthiophene [FL-no: 15.045], 2-hexylthiophene [FL-no: 15.076] and 2-octylthiophene [FL-no: 15.093]. For two of the substances [FL-no: 15.060 and 15.119] the Panel concluded that additional genotoxicity data are required. The remaining 39 substances were evaluated through a 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. The Panel concluded that the 39 flavouring substances [FL-no: 15.038, 15.039, 15.040, 15.044, 15.045, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.074, 15.076, 15.078, 15.079, 15.080, 15.082, 15.084, 15.085, 15.086, 15.087, 15.089, 15.093, 15.096, 15.097, 15.098, 15.108, 15.115, 15.116, 15.118 and 15.135] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the Maximised Survey-derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all 41 candidate substances.

flavourings, aliphatic, hydrocarbons, FGE.25
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