Scientific Opinion on the safety of the complexation product of sodium tartrate and iron(III) chloride as a food additive

The complexation product of sodium tartrates and iron(III) chloride (Fe mTA) is proposed for use as an anti-caking 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 (BMDL₀₅ for serum bile acids) and 267 mg/kg bw per day for females (BMDL₁₀ 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. No long-term or carcinogenicity studies were available. The Panel concluded that the toxicity database was insufficient to establish an ADI (Acceptable Daily Intake) and calculated MoS (Margin of Safety) by comparing the highest intake of Fe mTA of 0.092 mg/kg bw per day for children at the 97.5 percentile with the lowest BMDLs. The resulting MoS were 815 and 2 900 for males and females, respectively. Owing to the conservative assumptions included in the exposure assessment, the Panel concluded that there is no safety concern for the single condition of use and use level of Fe mTA proposed. The Panel noted that this evaluation was based on a limited toxicity database, for a single use resulting in a very low exposure, and therefore concluded that any extension of use and/or use level of Fe mTA, would require a new risk assessment.