EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 301 (FGE.301): A sulphur substituted pyrimidin-derivative and its hydrochloride salt : Flavouring Group Evaluation 301

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.