ABSTRACT
Calcium disodium ethylenediaminetetraacetate (Calcium Disodium EDTA, C10H12CaN2Na2O8.2H2O) is a derivative of EthylenediamineTetraacetic Acid and is an approved food additive (E385). It is used as preservative, sequestrant, flavouring agent, and colour retention agent in foods. As a drug it is used for the reduction of blood and mobile depot lead in the treatment of acute and chronic lead poisoning. Calcium Disodium EDTA is very poorly absorbed from the gastrointestinal tract following ingestion. The compound is metabolically inert and no accumulation in the body has been found. Acute, short-term, sub chronic and chronic toxicity studies carried out with Calcium Disodium EDTA in laboratory animals found that the compound is nephrotoxic at high doses. In similar high doses, application of Calcium Disodium EDTAcan result in complexation of zinc ions, thus interfering with the zinc homeostasis and causing developmental toxicity. No evidence exists suggesting the compound exerts genotoxic or carcinogenic effects. Overall, Calcium Disodium EDTAseems to be safe for use as a food additive, as the noted toxic doses are higher than can be achieved via the addition of Calcium Disodium EDTA to food. However, human data is limited and the gross of available (human and animal) data, as well as the ADI, stems from several decades ago. Caution should also be taken when Calcium Disodium EDTA is administered as treatment for lead poisoning, as the exposure increases greatly. Until 2020, EFSA will carry out new risk assessments, and subsequently the Commission will revise the list of food additives and the conditions of use specified therein. The deadline for food additives other than colours and sweeteners is 31 December 2018, which seems appropriate regarding the non-acute need for reevaluation of Calcium Disodium EDTA as food additive.