Scientific Opinion on Flavouring Group Evaluation 301 (FGE.301): A sulphur substituted pyrimidin-derivative and its hydrochloride salt from Chemical Group 30


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011;9(6):1994 [28 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
19 May 2011
Published in the EFSA Journal
6 June 2011
Last Updated
19 October 2011. This version replaces the previous one/s.
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 two flavouring substances, 4-amino-5,6-dimethylthieno[2,3-d]pyrimidin-2(1H)-one [FL-no: 16.116] and 4-amino-5,6-dimethylthieno[2,3-d]pyrimidin-2(1H)-one hydrochloride [FL-no: 16.120] in the Flavouring Group Evaluation 301, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The 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 two substances [FL-no: 16.116 and 16.120] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach.

Flavourings, pyrimidin-derivative, food, safety, FGE.301
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