Home › Ingredients › EDTA (E385)
Is EDTA (E385) safe?
- Permitted within limits in the EU, UK, US and India — nobody has restricted or withdrawn it
- WHO/JECFA: acceptable daily intake of 0–2.5 mg per kg of body weight, set in 1973 and unchanged
- EFSA: opened a call for data in June 2024 for a full re-evaluation of E385 — still in progress
- LabelCop: flags E385 as high risk — an additive on a 50-year-old limit, now back under review
What is EDTA?
- A synthetic sequestrant — a molecule that grabs and holds metal ions
- The food-grade form is usually calcium disodium EDTA; disodium EDTA is also used in some products
- Its job: bind trace iron and copper that leach in from equipment, cans or the food itself
- Those trace metals speed up oxidation — so binding them stops fats going rancid and stops colour and flavour fading
- Label names: calcium disodium EDTA, disodium EDTA, calcium disodium edetate, E385, INS 385
- Watch for the bare word "sequestrant" with no name or number — that is a labelling gap, not proof of EDTA
Which foods contain it?
- Mayonnaise, salad dressings, French dressing, sandwich spreads and sauces
- Canned and bottled pulses, beans, chickpeas, mushrooms and white potatoes
- Pickled cucumber and pickled cabbage
- Canned shellfish — crab, clams, shrimp (also used to retard struvite crystals)
- Fat spreads, margarine and oleomargarine
- Some canned carbonated soft drinks, fermented malt beverages and distilled spirits
- In India: most likely to appear in jarred mayonnaise, salad dressings, sauces and canned pulses — look for INS 385, or for an unnamed "sequestrant" in the additive list
What the regulators actually say
| Regulator | Status | Reasoning |
|---|---|---|
| EFSA / European Union | Permitted within limits, re-evaluation under way | E385 is authorised in Annex II of Regulation (EC) No 1333/2008 for a limited list of foods at product-specific maximum levels. EFSA published a call for data in June 2024 (deadline 31 December 2024) for a full re-evaluation of E385 under Regulation (EU) No 257/2010, covering manufacturing, impurities, genotoxicity and use levels. No opinion has been published yet — authorisation is unchanged in the meantime. |
| FDA (United States) | Permitted within limits | Regulated as a direct food additive at 21 CFR 172.120, with food-by-food caps: 75 ppm in mayonnaise, salad dressing and sauces; 100 ppm in sandwich spread and potato salad; 220 ppm in pickled cucumber and cabbage; 365 ppm in canned legumes; 25–33 ppm in canned soft drinks, malt beverages and spirits. The eCFR records no change to this section since 2017. |
| FSSAI (India) | Permitted in specified foods | INS 385 is listed as a permitted sequestrant/preservative in specified food categories within prescribed limits under FSSAI's food additive regulations. FSSAI's 2020 labelling rules also require the class name plus the common name or INS number — so "sequestrant" alone does not meet the rule. |
| WHO / JECFA | Safe daily limit set in 1973, not revisited | The joint FAO/WHO expert committee set an acceptable daily intake of 0–2.5 mg per kg of body weight for calcium disodium EDTA at its 17th meeting in 1973, with the condition that no excess disodium EDTA should remain in foods. Specifications were revised in 1986; the ADI itself has not been re-examined since. |
| UK (FSA) | Authorised | The Food Standards Agency register lists E385 as authorised in England, Scotland and Wales, under assimilated Regulation (EC) No 1333/2008 — the same conditions of use as the EU list. |
Why we flag it anyway
- The safe limit is old. 0–2.5 mg/kg was set in 1973, before modern gut-microbiome and inflammation research existed
- EFSA agrees the file needs reopening. Its 2024 call for data explicitly asks for genotoxicity data and current use levels — a signal, not a verdict
- It binds minerals by design. EDTA is added precisely because it grabs metal ions, and it can bind zinc and iron in the gut. Human absorption studies have produced mixed results and no regulator treats this as a reason to change its status
- Animal work has raised questions. A 2021 study in Scientific Reports reported that EDTA compounds worsened colitis and colon tumour development in two mouse models of inflammatory bowel disease, at doses assumed to be safe. The authors' point was that additive testing is normally done in healthy animals only
- Read that carefully. The study tested iron-EDTA and sodium EDTA in mice already made to have gut disease — not calcium disodium EDTA in healthy people. It is a study link, not a regulatory finding, and no named regulator has acted on it
- We show you the disagreement between an old approval and new evidence instead of quietly picking a side
- EDTA (E385) is a high-risk flag in LabelCop
- Why: a synthetic metal-binder on a safe limit set in 1973, with animal evidence of gut inflammation and an EFSA re-evaluation still open
- It is permitted everywhere — we flag it on a precautionary basis, not because anyone banned it
- An unnamed "sequestrant" is flagged separately as a labelling gap: it may or may not be EDTA, and the label does not say
- The product's score takes a penalty — and you see the flag, the reason and the sources. No black box
Frequently asked questions
Is EDTA banned in food?
No. E385 / INS 385 is permitted within limits in the EU, UK, United States and India, and no named regulator has banned or restricted it. EFSA opened a call for data in June 2024 for a full re-evaluation, which is still under way.
Why is EDTA added to food at all?
It binds trace iron and copper that leach in from equipment, cans or the food itself. Those metals accelerate oxidation, so removing them keeps fats from going rancid and keeps colour and flavour stable. In canned shellfish it also retards struvite crystals.
Isn't EDTA a medical chelation drug?
Related compounds are used in hospital chelation therapy for heavy-metal poisoning, but at doses vastly higher than anything in food and given by infusion. The food additive question is about small oral amounts eaten repeatedly, which is a different exposure and a different evidence base.
Does EDTA in food affect iron or zinc levels?
It can bind minerals such as zinc and iron in the gut — that is what sequestrants do. Human absorption studies have produced mixed results, and no regulator currently treats mineral binding at permitted use levels as a reason to change EDTA's status. EFSA's ongoing re-evaluation is expected to look at the question.
How do I avoid it?
Read the ingredients list for calcium disodium EDTA, disodium EDTA, calcium disodium edetate, E385 or INS 385 — most likely in jarred mayonnaise, dressings and canned pulses. Or scan the label with LabelCop and it's flagged automatically, with the regulator reasoning shown.
LabelCop reads any food label you photograph and flags additives like E385 instantly — no barcode needed.
Join the early-access listSources
EFSA (2024): Call for data for the re-evaluation of calcium disodium EDTA (E 385) · Regulation (EC) No 1333/2008 on food additives (Annex II) · FDA: 21 CFR 172.120 — Calcium disodium EDTA · WHO/JECFA: calcium disodium ethylenediaminetetraacetate, ADI 0–2.5 mg/kg bw · UK FSA: E 385 authorisation register · FSSAI: Food Safety and Standards (Food Products Standards and Food Additives) Regulations · Evstatiev et al., Scientific Reports (2021): the food additive EDTA aggravates colitis and colon carcinogenesis in mouse models
Related ingredients: Sodium benzoate (E211) · Class II preservatives (India) · Phosphates (E338, E339, E341)
This article explains regulatory status and published scientific assessments in plain English. It is not medical advice.