EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Flavouring Group Evaluation 46, Revision 1 (FGE.46Rev1): Ammonia and three ammonium salts from chemical group 30

The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to evaluate four flavouring substances in the Flavouring Group Evaluation 46, Revision 1 (FGE.46Rev1), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.

These four flavouring substances belong to chemical group 30, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with ammonia [FL-no: 16.009], and three ammonia salts (diammonium sulphide [FL-no: 16.002], ammonium chloride [FL-no: 16.048] and ammonium hydrogen sulphide [FL-no: 16.059]).

The flavouring substances cannot exist as geometrical or optical isomers. Two of the flavouring substances are classified into structural class I and two are classified into structural class III according to the decision tree approach presented by Cramer et al. (1978). The flavouring substance ammonia in the present group has been reported to occur naturally in a wide range of food items up to very high amounts.

Hydrogen sulphide is also reported to occur naturally in a wide range of food items. In its evaluation, the Panel as a default used the “Maximised Survey-derived Daily Intake” (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. 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.

In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach. In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an 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.

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. In these cases the Panel requires more precise data on use and use levels.

According to the default MSDI approach, the two flavouring substances [FL-no: 16.009 and 16.048] belonging to structural class I have estimated intakes in Europe of 34 and 140 microgram/capita/day, respectively, which are below the threshold of concern for structural class I substances (1800 microgram/person/day).

The two substances belonging to structural class III have estimated intake in Europe of 62 and 5.6 microgram/capita/day, respectively, which is below the threshold of concern for structural class III substances (90 microgram/person/day). Although the genotoxicity data for the flavouring substances in this group are limited, the available data on genotoxicity do not preclude an evaluation of the candidate substances through the Procedure.

For the candidate substance ammonium chloride [FL-no: 16.048] there is a well-performed carcinogenicity study available, which indicates that the substance does not induce tumours. Ammonia is a substance that is readily absorbed in the gut. It is produced endogenously in amounts that far exceed those that are to be ingested as flavourings.

The three ammonium salts are expected to give rise to ammonium ion and chloride or hydrogen sulphide. Ammonia is expected to be transported by the portal circulation to the liver and metabolised to urea by the Krebs urea cycle and subsequently excreted by the kidneys. Hydrogen sulphide is a substance that is produced endogenously.

The major pathway for sulphide metabolism is oxidation to sulphate and excretion by the kidney. The major oxidation product of sulphide is thiosulphate which is then converted to sulphate. The primary location for these reactions is the liver. All four substances are accordingly expected to be metabolised to innocuous substances at the anticipated levels of intake as flavouring substances.

It was noted that where toxicity data were available they were consistent with the conclusions in the present flavouring group evaluation using the Procedure. On the basis of the default MSDI approach the Panel concluded that the flavouring substances would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances.

When the estimated intakes were based on the mTAMDI approach the values for the two substances from structural class I, ammonia and ammonium chloride [FL-no: 16.009 and 16.048], are 110000 microgram/person/day and 220000 microgram/person/day, respectively. These values are above the threshold of concern for structural class I of 1800 microgram/person/day.

For one of the substances from structural class III, ammonium hydrogen sulphide [FL-no: 16.059], the mTAMDI value is 220 microgram/person/day. This value is above the threshold for structural class III of 90 microgram/person/day. For the other substance from structural class III no data are available on use and use levels.

Thus, intake estimates based on the mTAMDI approach exceed the threshold of concern for the three flavouring substances in this flavouring group, and more reliable exposure data are requested for all four substances. On the basis of such additional data, these flavouring substances should be reconsidered using the Procedure.

Subsequently, additional data might become necessary. In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications. Specifications including complete purity criteria for the materials of commerce have been provided for the four flavouring substances.

Identity tests is missing for one of the flavouring substances, ammoniun hydrogen sulphide [FL-no: 16.059]. Thus, the final evaluation of the materials of commerce cannot be performed for this substance, pending further information. The remaining three flavouring substances, ammonia [FL-no: 16.009], ammonium chloride [FL-no: 16.048] and diammoniun sulfide [FL-no: 16.002] would present no safety concern at the levels of intakes estimated on the basis of the MSDI approach.