Baby Safety / Compounds / Disodium EDTA (ethylenediaminetetraacetic acid; E385)

Is Disodium EDTA (ethylenediaminetetraacetic acid; E385) safe for babies and kids?

Moderate risk for kids

Infants face elevated exposure to Disodium EDTA (ethylenediaminetetraacetic acid; E385) through formula, baby food, and breast milk contamination. Immature hepatic metabolism and higher intake-to-body-weight ratio amplify dose.

What is disodium edta (ethylenediaminetetraacetic acid; e385)?

The IUPAC name is disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate.

Also known as: disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate, EDTA disodium salt, Disodium EDTA, Edta disodium.

IUPAC name
disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate
CAS number
139-33-3
Molecular formula
C10H14N2Na2O8
Molecular weight
336.21 g/mol
SMILES
C(CN(CC(=O)O)CC(=O)[O-])N(CC(=O)O)CC(=O)[O-].[Na+].[Na+]
PubChem CID
8759

Risk for babies

Moderate risk

Infants face elevated exposure to Disodium EDTA (ethylenediaminetetraacetic acid; E385) through formula, baby food, and breast milk contamination. Immature hepatic metabolism and higher intake-to-body-weight ratio amplify dose.

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Context-dependent

Pregnancy alters metabolism and increases susceptibility to Disodium EDTA (ethylenediaminetetraacetic acid; E385). Dietary additives consumed during pregnancy cross the placenta; safety margins for adults may not protect the developing fetus.

No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.

What to do: Minimize exposure during pregnancy and lactation. Consult healthcare provider regarding specific risks. Consider alternative products with lower hazard profiles.

Regulatory consensus

3 regulatory and scientific bodies have classified Disodium EDTA (ethylenediaminetetraacetic acid; E385). The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC2004Not evaluated by IARC for carcinogenicity — Disodium EDTA (CAS 139-33-3; disodium ethylenediaminetetraacetate; Na2EDTA; E385; a chelating agent) is FDA approved for specific food uses (21 CFR 172.120 — mayonnaise and salad dressings at ≤75 ppm as EDTA; 21 CFR 172.135 — canned legumes; 21 CFR 172.140 — canned carbonated beverages; 21 CFR 172.145 — canned shellfish and certain canned foods — each with specific maximum levels); EU E385 for specific food categories; JECFA ADI 2.5 mg/kg/day (as EDTA); EFSA opinion 2004 (EFSA Journal 2004;2:39) confirmed ADI 2.5 mg/kg/day — the same as JECFA; no IARC, EPA, or EFSA carcinogenicity classification; the primary food safety concern with dietary EDTA is its ability to chelate essential divalent minerals (Ca2+, Mg2+, Zn2+, Fe2+) in the GI tract, potentially reducing their absorption — this concern is relevant primarily at the ADI level and above; at typical food use levels (≤75 ppm in specific products), dietary EDTA intake is estimated well below the ADI for most consumers; EDTA is widely used medically as a chelating agent for heavy metal poisoning (lead, mercury, cadmium) — this therapeutic use ('chelation therapy') involves much higher doses than food additive exposure
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 6 positive / 3 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 6 positive / 3 negative reports)

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter disodium edta (ethylenediaminetetraacetic acid; e385)

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles
  • Food — processed food, beverages, candy, baked goods

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Disodium EDTA (ethylenediaminetetraacetic acid; E385):

  • Physical/mechanical pest control (IPM)
    Trade-offs: More labor-intensive. May not be sufficient for severe infestations.
    Relative cost: 1.2-2×

Frequently asked questions

Is disodium edta (ethylenediaminetetraacetic acid; e385) safe for kids?

Infants face elevated exposure to Disodium EDTA (ethylenediaminetetraacetic acid; E385) through formula, baby food, and breast milk contamination. Immature hepatic metabolism and higher intake-to-body-weight ratio amplify dose.

What products contain disodium edta (ethylenediaminetetraacetic acid; e385)?

Disodium EDTA (ethylenediaminetetraacetic acid; E385) appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); processed food (Food).

What should I do if my child is exposed to disodium edta (ethylenediaminetetraacetic acid; e385)?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Why do regulators disagree about disodium edta (ethylenediaminetetraacetic acid; e385)?

Disodium EDTA (ethylenediaminetetraacetic acid; E385) has been classified by 3 agencies including IARC, EPA CTX / Genetox, EPA CTX / Genetox, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

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Sources (1)
  1. Disodium EDTA CAS 139-33-3 Na2-EDTA C10H14N2Na2O8 E385 Chelating Agent; FDA 21 CFR 172.120 Mayonnaise ≤75 ppm 172.135 Canned Legumes 172.145 Shellfish; JECFA ADI 2.5 mg/kg/day; EFSA 2004 EFSA Journal 2:39 ADI 2.5 mg/kg/day; Log K: Ca2+ 10.7 Mg2+ 8.7 Fe3+ 25.7 Zn2+ 16.1 Metal Stability Constants; CaNa2EDTA Calcium Form E385 Pre-Loaded Calcium Reduces GI Chelation; Mineral Chelation Ca Mg Zn Fe Absorption Reduction Marginal Status Concern; IV CaEDTA Lead Poisoning Treatment Standard of Care Blood Lead >45 µg/dL; Chelation Therapy Alternative Medicine Not FDA Approved; Environmental Persistence Resistant Biological WWTP European Rivers Groundwater µg/L; Metal Mobilization Sediment Fe Cd Pb Hg; EDDS GLDA IDS Biodegradable Alternatives; Lipid Oxidation Pro-Oxidant Metal Sequestration Fe Cu; Mayonnaise Salad Dressing Canned Food Shelf Life (2004) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →