Our Verdict: SAFE

Edta, Disodium

E-numberE385CAS139-33-3FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Edta, Disodium — food additive

Disodium EDTA is a chelating agent classified as a flavoring adjuvant that binds metal ions in food products. It is used to preserve flavor quality and prevent metal-catalyzed spoilage in various processed foods and beverages.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Disodium EDTA?

Disodium EDTA (ethylenediaminetetraacetic acid, disodium salt) is a synthetic chelating compound with the CAS number 139-33-3. It functions as a flavoring agent and adjuvant in food applications, meaning it supports flavor stability rather than directly adding flavor. The compound works by binding divalent metal ions such as iron, copper, and zinc that can otherwise catalyze oxidative reactions and cause flavor degradation, discoloration, or rancidity in food products.

Common Uses

Disodium EDTA is utilized in a variety of processed food and beverage applications where metal-catalyzed degradation poses a concern. Common uses include:

- Canned vegetables and legumes

- Salad dressings and mayonnaise

- Soft drinks and beverages

- Canned fish and seafood products

- Processed meat products

- Sandwich spreads

- Beer and other alcoholic beverages

The additive is typically used at very low concentrations, generally recognized as safe levels that maintain product stability without accumulating to concerning amounts in the human diet.

Safety Assessment

Disodium EDTA has been extensively evaluated for safety by regulatory authorities. The FDA has affirmed the Generally Recognized as Safe (GRAS) status of this additive for its intended uses in food. According to FDA records, there have been zero reported adverse events associated with disodium EDTA consumption from food sources, and zero product recalls have been issued due to safety concerns related to this ingredient.

Toxicological studies have examined disodium EDTA's absorption, distribution, and excretion in the human body. Research indicates that the compound is poorly absorbed in the gastrointestinal tract and is largely excreted unchanged. Animal studies at various dose levels have not demonstrated significant organ toxicity, reproductive effects, or carcinogenic potential at the levels relevant to food use.

The low bioavailability of disodium EDTA when consumed through food is a key safety factor. Because it remains largely in the digestive tract and is not substantially absorbed, systemic exposure is minimal compared to pharmaceutical applications where EDTA chelation therapy is administered parenterally under medical supervision.

Regulatory Status

Disodium EDTA is approved for use in food by the FDA under 21 CFR 182.3669 (GRAS affirmation) and 21 CFR 182.6669 (prior sanctioned use). It is listed as a permitted flavoring adjuvant in the Electronic Code of Federal Regulations.

The European Food Safety Authority (EFSA) has also reviewed EDTA compounds and established acceptable intake levels. Disodium EDTA is approved for use in certain food categories under EU Regulation 1333/2008 with specific maximum use levels depending on the food application.

International regulatory bodies, including Codex Alimentarius, recognize disodium EDTA as an acceptable food additive when used in accordance with good manufacturing practices.

Key Studies

Multiple safety assessments have evaluated disodium EDTA:

- Acute toxicity studies show low oral toxicity with LD50 values significantly above food-use levels

- Subchronic and chronic feeding studies in animals demonstrated no adverse effects at doses relevant to human dietary exposure

- Absorption and excretion studies confirm that dietary disodium EDTA is poorly absorbed and rapidly excreted

- Safety margins between actual food use levels and those showing no observable adverse effects in animal studies are substantial

The comprehensive safety database, combined with the GRAS affirmation and zero adverse event reports, supports the conclusion that disodium EDTA is safe for its intended use as a flavoring adjuvant in food products when used in accordance with regulatory specifications.

Frequently Asked Questions

What is Edta, Disodium?

Disodium EDTA is a chelating agent classified as a flavoring adjuvant that binds metal ions in food products. It is used to preserve flavor quality and prevent metal-catalyzed spoilage in various processed foods and beverages.

Is Edta, Disodium safe?

Edta, Disodium is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Edta, Disodium banned in any country?

Edta, Disodium is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.