European Food Safety Authority (EFSA), Parma, Italy
ABSTRACTThe complexation product of sodium tartrates and iron(III) chloride (Fe mTA) is proposed for use as an anticaking agent, only in salt or its substitutes, with a maximum use level of 106 mg Fe mTA/kg salt. Fe mTA can be expected to dissociate into its constituent iron(III) and tartrate components upon ingestion. Studies in rats demonstrated that up to 90 % of ingested DL-tartrate or tartaric acid were absorbed, studies in humans suggested that only 20 % of an ingested dose of tartaric acid were absorbed. There are no ADME (absorption, distribution, metabolism and excretion) data for meso-tartrate. From a 90-day rat study, the lowest calculated BMDLs (Benchmark Dose Level) for Fe mTA were: 75 mg/kg body weight (bw) per day for males (BMDL 05 for serum bile acids) and 267 mg/kg bw per day for females (BMDL 10 for goblet cells hyperplasia). Several in vitro studies showed that there is no safety concern for genotoxicity. No reprotoxicity and developmental toxicity was reported, however no study was specifically designed for teratogenicity.
SUMMARYFollowing a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion based on a dossier presented by the applicant.According to the applicant, the complexation product of sodium tartrates and iron(III) (Fe mTA) is proposed for use, only in salt or its substitutes, as an alternative to the currently permitted anti-caking agents, with a maximum use level of 106 mg Fe mTA/kg salt.Fe mTA is a mixture of sodium tartrates [DL-and meso-tartrates] with iron(III) chloride. The proportion of each constituent comprising the mixture corresponds to 1.5 moles of tartrates (total), meso-tartrate represents approximately 65 % of the total tartrate content.The Panel noted that although there were no ADME (absorption, distribution, metabolism and excretion) data for Fe mTA, the complexation product can be expected to dissociate into its constituents iron(III) and tartrate, upon ingestion. This was supported by the weak Fe/tartrate interactions identified by electrospray mass spectrometry, where only the individual species were identified. Therefore, in addition to the data available for the Fe mTA as a compound, the Panel considered appropriate to take also into consideration the available biological and toxicological data on its individual constituents for its safety assessment, as reported in the dossier.Studies in rats demonstrated that a large proportion (55 to 90 %) of ingested DL-tartrate or tartaric acid was absorbed. The Panel noted that the retention of tartrates in the kidneys was attributed to precipitation of the poorly soluble calcium DL-tartrate in the renal tubules. The Panel noted that retention of tartrates was observed until the end of the study period (8 days after dosing), but that the actual duration of this retention was not determined. However, the Panel also noted that the metabolic fate of tartrates in humans and rats may dif...