EFSA publishes latest safety conclusion on two flavours

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids to evaluate two flavouring substances - a sulphur substituted pyrimidin-derivative and its hydrochloride salt.

In its conclusion the panel said 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”​. The MSDI is the Maximised Survey-derived Daily Intake.

However questions have been raised about what the food industry considers to be the normal regular intake by consumers.

The flavours are used in flavoured food products and were found in nine out of the 18 food categories listed by the panel.

The nine categories include dairy products, edible ices, confectionery, cereals and cereal products, bakery, meat and meat products, foodstuffs intended for particular nutritional uses, non-alcoholic and alcoholic beverages and composite foods such as meat pies.

The report said that, according to the flavour industry, the normal use levels for the candidate substances were in the range of 4 - 10 mg/kg food and the maximum use levels were in the range of 8.5 - 25 mg/kg.

However when the panel examined the information provided by the European Flavouring Industry on the use levels in various foods “it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small.”​

The panel then performed its own estimate of the daily intakes per person using a modified Theoretical Added Maximum Daily Intake (mTAMDI) approach based on the normal use levels reported by Industry.

The report said: “In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the panel decided not to carry out a formal safety assessment using the procedure. ​

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“In these cases the panel requires more precise data on use and use levels.”​

The flavours​

The official name for the substances is 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].

Both fall within the Flavouring Group Evaluation 301 and chemical group 30 under commission regulation.

Neither of the substances has been reported to occur naturally in any food items.

In tests of the substances some changes were noted, such as changes in liver weight and plasma cholesterol concentrations but the panel considered that they “were not of toxicological concern”​ and the top dose fell within the No Observed Adverse Effect Level (NOAEL).

None of the substances were considered to have genotoxic potential.