Calcium Disodium Ethylenediaminetetraacetate

About

What it is and where it shows up.

Calcium disodium EDTA is a chelating agent (sequestrant) used as a food additive to prevent discolouration and rancidity by binding trace metal ions that would otherwise catalyse oxidative spoilage. It is used in canned vegetables, seafood, mayonnaise, carbonated soft drinks, and other processed foods to preserve colour, flavour, and shelf life.

Safety summary

The regulatory and scientific consensus.

The ADI is 2.5 mg/kg bw/day (as CaNa2EDTA), established by JECFA and the EU Scientific Committee for Food in 1977; JECFA later expressed this equivalently as 1.9 mg EDTA/kg bw/day in 2007. EFSA formally called for additional toxicological data ahead of a full re-evaluation, citing unresolved concerns from prenatal developmental animal studies and a limited long-term toxicity database. EDTA chelates zinc and other essential minerals, with disproportionately greater zinc depletion observed in smaller, lighter children.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Restricted	Permitted under Regulation (EC) No 1333/2008 with food-category-specific maximum levels (e.g., 75 mg/kg in canned legumes, 250 mg/kg in emulsified sauces). Currently under formal re-evaluation by EFSA's FAF Panel; the EFSA ANS Panel (2018) identified shortcomings in the toxicity database and called for additional prenatal developmental data before the re-evaluation can be completed.source
FDA (Food and Drug Administration) (United States)	Approved	Regulated as a food additive under 21 CFR 172.120. Food-specific use levels range from 25 ppm in fermented malt beverages to 800 ppm in dry pinto beans; approved functions include color retention, flavor promotion, anti-gushing agent in malt beverages, and struvite inhibition in canned seafood. FDA has not established a general ADI; compliance is enforced through per-food maximum levels.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Animal studies at high dietary EDTA levels showed severe malformation of offspring, and EFSA's ANS Panel noted unresolved concerns from prenatal developmental studies that prompted a call for additional toxicological data.

Infants — Calcium disodium EDTA chelates zinc, and studies show that smaller, lighter infants lose a disproportionately larger fraction of zinc compared to larger children, raising risk of essential mineral depletion during critical growth periods.

Children — Dietary exposure relative to the ADI is proportionally higher in children than adults, and EFSA exposure modelling across seven population groups found toddlers and children among the highest-exposed groups.

Kidney Disease — EDTA is primarily renally excreted, and high-dose clinical use of EDTA has been associated with acute tubular necrosis and proteinuria, suggesting elevated risk in individuals with compromised renal function.

Research citations

The sources behind this verdict.

1FDA. FDA Food Additive Status List – Calcium Disodium EDTA (21 CFR 172.120), 2026. fda.gov
2EFSA. Call for data for the re-evaluation of Calcium disodium EDTA (E 385) as food additive, 2024. efsa.europa.eu
3EFSA. Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013, 2018. efsa.onlinelibrary.wiley.com
4PubMed. Reasons for raising the maximum acceptable daily intake of EDTA and the benefits for iron fortification of foods for children 6–24 months of age, 2015. pmc.ncbi.nlm.nih.gov
5EFSA. Scientific Opinion on the use of ferric sodium EDTA as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses, 2010. efsa.europa.eu

Independently researched6 citations