About
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
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
| 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
Research citations
- 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
