Calcium Disodium EDTA
Calcium disodium EDTA is FDA-permitted as a direct food additive with use-level restrictions under 21 CFR 172.120. JECFA established an ADI of 2.5 mg/kg bw/day.
What it is
Calcium disodium ethylenediaminetetraacetate (calcium disodium EDTA), a chelating agent that binds metal ions.
Sequestrant; binds trace metals to prevent oxidation, color/flavor changes, and rancidity.
Why it's flagged
- Possible mineral chelation (Ca, Fe, Zn) at high intake
- Restricted-use additive, not general-purpose
- EFSA called for re-evaluation data
What regulators actually say
"Calcium disodium EDTA (calcium disodium ethylenediamine-tetraacetate) may be safely used in food in accordance with the following prescribed conditions..."
"Call for data for the re-evaluation of Calcium disodium EDTA (E 385) as food additive."
Regulatory status
United States — FDA
Permitted direct food additive under 21 CFR 172.120 with use-level limits
European Union — EFSA
Authorized as E385; ADI 2.5 mg/kg bw/day (JECFA); EFSA call for re-evaluation data
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