About
What it is and where it shows up.
Disodium EDTA is a synthetic chelating (sequestrant) agent that tightly binds divalent and trivalent metal ions in food, thereby inhibiting metal-catalysed oxidation, discolouration, and rancidity. It is used in canned and frozen vegetables, salad dressings, mayonnaise, cooked sausages, and non-nutritive sweeteners as a preservative and colour-retention aid.
Safety summary
The regulatory and scientific consensus.
JECFA established an unconditional ADI of 0–1.25 mg/kg body weight per day, with a conditional range of 1.25–2.5 mg/kg bw/day; oral absorption is poor (less than 5–10%). Animal studies at extremely high dietary doses show mineral sequestration causing imbalances, and teratogenic effects were observed at 3% in gestational rat diets (approximately 1,500 mg/kg bw/day), far above food-use levels. EFSA's 2018 ANS Panel flagged shortcomings in the toxicity database and recommended additional prenatal developmental data before completing its formal re-evaluation.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Banned | E386 (disodium EDTA) does not appear on the EU positive list of authorised food additives in Annex II of Regulation (EC) No 1333/2008; it is therefore not permitted for use in food in the EU. Note: the structurally related E385 (calcium disodium EDTA) is separately authorised in the EU and is currently under EFSA re-evaluation (call for data issued June 2024).source |
| Health Canada (Canada) | Restricted | EDTA and its salts (including Na2EDTA) subject to environmental and health screening assessment by Health Canada / Environment and Climate Change Canada. Substance is permitted in food at regulated levels; health effects characterisation drew on EU RAR 2004 and EFSA 2010 risk assessment reports.source |
| JECFA (JECFA (FAO/WHO)) | Approved | JECFA INS 386. Unconditional ADI: 0–1.25 mg/kg bw/day; conditional ADI: 1.25–2.5 mg/kg bw/day (first evaluated at JECFA 9th meeting, 1965; specifications finalised at 17th meeting, 1973). The conditional range is applicable only where benefit of use has been demonstrated and intake is unlikely to exceed the unconditional limit chronically.source |
| FDA (Food and Drug Administration) (United States) | Approved | Approved as a direct food additive (sequestrant/preservative) under 21 CFR 172.135 at specified maximum levels: 100 ppm in frozen white potatoes, 110 ppm in canned potatoes, 165 ppm in canned cooked legumes, 315 ppm in dried banana component of ready-to-eat cereals, 75 ppm alone or with calcium disodium EDTA in non-standardised dressings/sauces/French dressings/mayonnaise/salad dressing, 36 ppm as cure accelerator in cooked sausage, and 0.1% by weight of dry sweeteners as sequestrant in non-nutritive sweeteners. |
Who should approach with care
Whose guidance would steer them away.
Pregnancy — Animal studies at very high EDTA doses demonstrated teratogenic and developmental effects attributed to mineral (particularly zinc) chelation and depletion; while food-use levels are far below harmful doses, precautionary minimisation is advisable during pregnancy.
Infants — Infants have proportionally higher food intake relative to body weight, which could push EDTA exposure closer to the conditional ADI threshold; the EFSA ANS Panel 2018 specifically flagged infant/young-child foods as a priority concern for EDTA intake assessment.
Children — Dietary exposure estimates across multiple child population groups (toddlers, other children) approached or exceeded the unconditional ADI when maximum permitted levels are consumed, per EFSA dietary exposure modelling referenced in the 2024 call-for-data document.
Kidney Disease — EDTA is eliminated almost exclusively via renal excretion; impaired kidney function may reduce clearance of absorbed EDTA complexes and increase systemic exposure to chelated minerals.
Research citations
The sources behind this verdict.
- 1FDA. Code of Federal Regulations Title 21 §172.135 – Disodium EDTA. accessdata.fda.gov
- 2FDA. Food Additive Status List – Disodium EDTA entry. fda.gov
- 3other. Health Canada Screening Assessment – EDTA and its Salts Group. canada.ca
- 4EFSA. Scientific opinion on the evaluation of authorised ferric sodium EDTA as a novel food ingredient – EFSA ANS Panel 2018, 2018. efsa.europa.eu
- 5PubMed. 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, 2014. pmc.ncbi.nlm.nih.gov
- 6WHO. JECFA Food Additives Database – Disodium ethylenediaminetetraacetate (INS 386), 1973. apps.who.int
Independently researched6 citations