Calcium Disodium EDTA (E385) — What You Need to Know

Current dataset status: FDA — Approved — limited to specific food categories with maximum levels of 25-800 ppm depending on food type; EFSA/EU — ADI of 1.9 mg/kg bw/day as EDTA (established 2010, re-evaluated 2019). Reported concerns: A chelating agent (sequestrant) that binds metal ions (iron, copper) that would otherwise catalyze oxidation and discoloration. EFSA set ADI at 1.9 mg/kg bw/day in 2010. Not permitted for food use in Australia and New Zealand. Concerns include: potential to chelate and remove essential minerals from the body, possible effects on mineral bioavailability, and limited biodegradation in the environment (environmental persistence). The 2019 EFSA re-evaluation noted that exposure estimates for high consumers were close to the ADI. Regulatory status and individual risk are not the same; check the primary sources and permitted conditions of use.