Other names for the additive (synonyms)
General Information
Additive E385 is calcium disodium salt of ethylenediaminetetraacetic acid, or simply calcium disodium EDTA (from EthyleneDiamineTetraacetic Acid). In the food industry, it is mainly used as an antioxidant and preservative.
Calcium disodium EDTA is a synthetic compound that does not naturally occur in its ready-made form and is entirely produced industrially.
Ethylenediaminetetraacetic acid was first synthesized by the German chemist Ferdinand Munz in 1935. Initially, it was obtained from ethylenediamine and chloroacetic acid, later from ethylenediamine, formaldehyde, and sodium cyanide. Today, global EDTA production exceeds 80,000 tons per year, a significant portion of which is used in the chemical and food industries.
Chemically, additive E385 is a chelating compound, meaning a molecule capable of binding metal ions and keeping them in a stable form. This ability is due to its special structure: the central metal atom is “clamped” by the molecule in a claw-like manner, hence the term “chelate” (from Latin chelate — claw). Thanks to this property, EDTA prevents oxidative processes associated with iron, calcium, and other metal ions.
The chemical formula of calcium disodium EDTA is C10H12CaN2O8·2Na. Visually, additive E385 appears as a white crystalline powder without odor, highly soluble in water. The compound is heat-stable, does not decompose under normal storage conditions, and hardly breaks down in natural conditions, which makes additive E385 environmentally persistent. Due to its extremely slow degradation, EDTA and its salts accumulate in water bodies and can negatively impact ecosystems.
In the food industry, calcium disodium EDTA is produced synthetically. Its main purpose is to prevent oxidation and preserve the color and taste of food products. Additive E385 is commonly used in mayonnaise and sauces, canned foods, and soft drinks, where it prevents the formation of carcinogenic benzene in the presence of ascorbic acid (additive E300) and sodium benzoate (additive E211).
Effects on the Body
Benefit of Additive E385
Calcium disodium EDTA is practically not absorbed by the human body and does not perform any physiological functions. Its minor benefit may lie in its ability to bind heavy metals and help remove them from the body, which is used medically to treat lead, cadmium, or mercury poisoning. However, in dietary doses, this property is very weak and has no significant effect.
Risks of Additive E385
Absorption of calcium disodium EDTA in the gastrointestinal tract is extremely low: only 2–5% of the administered dose is absorbed in humans and animals, the rest is excreted in feces. Additive E385 is practically not metabolized — the compound is mostly excreted unchanged, without accumulation in the body.
The additive is classified as low-toxicity. The lethal dose for rats is approximately 2 g/kg of body weight.
Under normal consumption, additive E385 is considered relatively safe: the acceptable daily intake (ADI), established by the JECFA committee and confirmed by the FDA, is approximately 0–2.5 mg per kilogram of body weight.
Nevertheless, studies indicate that at high doses, EDTA and its salts can bind and excrete essential elements like calcium, iron, and zinc, potentially causing deficiencies.
Calcium disodium EDTA may replace or be used alongside additive E386 (disodium EDTA). Additive E385 is considered the safer form because it already contains calcium and does not remove it from the body. In contrast, the disodium form carries a risk of hypocalcemia and is unsafe for systemic use. In medical practice, the calcium disodium salt of EDTA is preferred.
Animal studies have shown nephrotoxicity and mineral metabolism disturbances at high doses of EDTA salts.
Notably, a 2021 study demonstrated that EDTA can enhance intestinal inflammation and increase the risk of colorectal cancer in experimental models of inflammatory bowel disease in mice. These findings prompted a safety review by EFSA, and in 2024, an open call for new data to assess risks was announced.
Uses
The main function of additive E385 in the food industry is to prevent discoloration and taste changes caused by metal ion oxidation. It is used as an antioxidant, preservative, and stabilizer.
Calcium disodium EDTA is used in mayonnaise, sauces, margarines, canned vegetables, legumes, and seafood. Additionally, additive E385 is added to carbonated drinks to prevent formation of unwanted by-products.
Outside the food sector, EDTA has wide applications:
- in medicine (treatment of heavy metal toxicity, dentistry, blood analysis),
- in cosmetics (as a preservative and formula stabilizer),
- in the pulp and paper industry for paper bleaching,
- in industrial detergents.
Legal Status
In the European Union, additive E385 is approved for use in the food industry according to Regulation (EC) No 1333/2008. In the USA, the FDA has also approved the use of calcium disodium EDTA in certain products, including mayonnaise and sauces.
In Ukraine, the use of this additive is also permitted in accordance with European legislation. In Canada and Japan, additive E385 is included in the list of approved preservatives. In Russia and most CIS countries, the use of E385 is allowed with established content limits.
An updated safety assessment by EFSA is expected soon, and its results may affect the additive's status in different countries.