Flavouring Group Evaluation 42: Iron containing organic substances from chemical group 30

Abstract

The Scientific Panel on Materials in Contact with Food, 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 Scientific Panel was asked to evaluate two flavouring substances in the Flavouring Group Evaluation 42 (FGE.42), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These two flavouring substances belong to chemical group 30, Annex I of the Commission Regulation (EC) No 1565/2000. The two candidate substances (ferric ammonium citrate .089] and ferrous lactate .096]) are organic non-haem iron complexes. The Panel considered it inappropriate to evaluate these two substances using the Procedure for the evaluation of flavouring substances, because in their Opinion, the Procedure is not sufficiently underpinned for the evaluation of metal containing compounds. Instead, the Panel decided to evaluate the safety of these flavouring substances on the basis of data on iron toxicity in general and on toxicity data for several iron salts and complexes, including the candidate substances. Candidate substance .096] possesses a chiral centre and may occur as optical isomers. This substance has been presented without specifying the stereoisomeric composition. The substances have not been reported to occur naturally. However, the substances are complexes or salts which are composed of naturally occurring substances (iron with ammonium and citrate or iron and lactate). these levels are additional to a background exposure that would suffice to cover the daily iron requirement. However, for people suffering from hereditary haemochromatosis (inadequate down-regulation of iron absorption) a safety concern is concluded. In order to improve the safety assessment for ferrous lactate [FLno: 16.096] based on the mTAMDI exposure estimates, more detailed information on use levels and the foods in which these substances are used are required. For ferric ammonium citrate .089], the conservative exposure estimate for the Scottish subpopulation corresponds to a consumption of the particular drink of about 1 L per adult per day. That may be a large amount, but in comparison with other non-alcoholic drinks it is not an extreme amount. In order to determine whether the conclusion for the candidate substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Incomplete specifications have been provided for the two flavouring substances. For .089] no assay minimum and identification test have been provided. For ] no identification test is available and no information on stereochemical composition has been submitted. Thus, the final evaluation of the materials of commerce cannot be performed for both candidate substances, pending further information. KEY WORDS