Our Verdict: SAFE

Edta, Disodium Iron

E-numberE385CAS14729-89-6

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 Iron — food additive

Disodium iron EDTA is a chelate compound that binds iron to improve stability and prevent oxidation in food products. It functions as a sequestrant and stabilizer, commonly used in fortified foods and beverages to enhance shelf life while delivering bioavailable iron.

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
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Iron EDTA?

Disodium iron EDTA (ethylenediaminetetraacetic acid iron disodium salt, CAS 14729-89-6) is a chelate complex formed by binding iron to the chelating agent EDTA. This compound serves dual purposes in food manufacturing: it stabilizes products against oxidative degradation while simultaneously functioning as a source of bioavailable iron for nutritional fortification. The chelation process encapsulates the iron atom within an organic molecule, preventing unwanted chemical reactions that would otherwise cause discoloration, off-flavors, or nutrient degradation.

Common Uses

Disodium iron EDTA is primarily used in fortified grain products, cereals, and prepared foods where iron supplementation is desired. It appears in some beverages, protein drinks, and nutritional supplements targeting iron-deficient populations. The compound is particularly valuable in products prone to oxidative degradation, where free iron would accelerate rancidity or color loss. By chelating the iron, manufacturers achieve nutritional fortification while simultaneously extending shelf life and maintaining product quality.

The bioavailability of iron from disodium iron EDTA is notably high compared to other iron sources, making it attractive for public health fortification programs in developing nations. Some countries use it specifically in wheat flour and rice fortification initiatives.

Safety Assessment

Disodium iron EDTA has not been granted Generally Recognized as Safe (GRAS) status by the FDA, indicating it requires specific regulatory authorization rather than general approval. However, this classification does not indicate safety concerns; rather, it reflects its status as a specific-use additive subject to individual authorization for particular food applications.

The compound has not generated any reported adverse events according to FDA data, and no recalls have been associated with its use. This absence of safety signals suggests a favorable safety profile at permitted usage levels. The toxicity profile of chelated iron compounds generally shows low systemic toxicity because the iron remains bound and is not freely available for absorption or interaction with body systems at the levels used in food.

Oral bioavailability studies of disodium iron EDTA demonstrate that the chelate remains substantially intact during typical food preparation and storage, releasing iron gradually during digestion. This controlled release mechanism may contribute to improved tolerability compared to soluble iron salts, which can cause gastrointestinal irritation.

Regulatory Status

Regulatory approval varies by jurisdiction. In the European Union, iron chelate compounds including EDTA complexes are permitted under Regulation (EC) 1333/2008 in specified food categories with defined maximum levels. The FDA permits use of ferrous EDTA and related iron chelates in certain fortified foods and dietary supplements, though disodium iron EDTA specifically must be authorized through formal food additive petitions for intended uses.

The compound is recognized by Codex Alimentarius, which sets international standards for food safety and quality. Its inclusion in international food standards reflects scientific consensus on its acceptability at permitted levels.

Key Studies

Research on iron chelates has demonstrated superior stability compared to ferrous sulfate or other common iron fortification compounds. Studies published in food chemistry journals document the chelate's resistance to oxidative degradation and its consistent bioavailability across various food matrices. Absorption studies in human subjects show iron from disodium iron EDTA is bioavailable and absorbed at rates comparable to or exceeding other fortification sources, supporting its use in public health nutrition programs.

No published studies report adverse health outcomes from consumption of foods fortified with disodium iron EDTA at permitted levels. The extensive global use in fortification programs without documented safety concerns provides additional evidence supporting its safety profile at approved usage levels.

Frequently Asked Questions

What is Edta, Disodium Iron?

Disodium iron EDTA is a chelate compound that binds iron to improve stability and prevent oxidation in food products. It functions as a sequestrant and stabilizer, commonly used in fortified foods and beverages to enhance shelf life while delivering bioavailable iron.

Is Edta, Disodium Iron safe?

Edta, Disodium Iron 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 Iron banned in any country?

Edta, Disodium Iron 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.