Our Verdict: SAFE

Ferrous Lactate

E-numberE585CAS5905-52-2

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

Ferrous Lactate — food additive

Ferrous lactate is an iron compound used in food as both a colorant and nutrient supplement to fortify products with iron. It appears as a grayish-green powder and is employed primarily in fortified foods and beverages to address iron deficiency.

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 Ferrous Lactate?

Ferrous lactate (CAS Number: 5905-52-2) is an iron salt formed from the combination of ferrous iron (Fe²⁺) and lactic acid. It exists as a grayish-green powder and belongs to the class of iron compounds used in food fortification. As a ferrous salt, it is more readily absorbed by the human body compared to ferric (Fe³⁺) forms, making it a preferred choice for nutritional supplementation.

Common Uses

Ferrous lactate serves dual functions in food manufacturing. Primarily, it is used as a nutrient supplement to fortify foods with bioavailable iron, addressing nutritional deficiencies in populations at risk. This function is particularly important in countries with widespread iron deficiency anemia.

Secondarily, ferrous lactate functions as a color adjunct in food products. Its grayish-green hue can be utilized in certain fortified food applications where color development is desired as part of the fortification process.

Common applications include fortified grain products, breakfast cereals, flour, nutritional supplements, and beverages designed for iron supplementation. The compound is valued in fortification programs because ferrous iron demonstrates superior bioavailability compared to alternative iron sources.

Safety Assessment

Ferrous lactate has been extensively studied as an iron fortification agent. The compound itself demonstrates a favorable safety profile when used at appropriate levels in food fortification. Iron toxicity is primarily a concern with excessive intake, typically from supplements rather than food sources, as iron absorption is naturally regulated by the body's physiological needs.

The FDA has recorded zero adverse events associated with ferrous lactate and zero recalls involving this additive, indicating a strong safety record in commercial food applications. The absence of reported adverse events reflects both the safety of the compound at permitted levels and the effectiveness of current regulatory oversight.

As an iron salt, ferrous lactate is metabolized similarly to dietary iron from natural sources. The lactic acid component is a naturally occurring compound produced during fermentation and is present in many traditional foods. Both components are handled by normal metabolic pathways.

Special populations such as individuals with hemochromatosis or other iron metabolism disorders should be cautious with iron-fortified foods, though this consideration applies to all iron fortification rather than ferrous lactate specifically.

Regulatory Status

Ferrous lactate does not hold GRAS (Generally Recognized As Safe) status from the FDA. However, this designation does not indicate a safety concern; rather, it reflects that the compound is regulated through specific approvals rather than the GRAS pathway. The additive is approved for use in food fortification in many countries, including the United States, where it is permitted under FDA regulations for nutrient supplementation.

Regulatory agencies including the FDA and EFSA recognize ferrous lactate as an acceptable iron source for food fortification when used within established limits. Maximum permitted levels vary by food category and jurisdiction, typically based on nutritional requirements and safety margins.

Key Studies

Research on ferrous lactate has demonstrated bioavailability comparable to other ferrous salts used in fortification. Studies examining iron absorption from ferrous lactate-fortified foods show effective iron uptake, particularly in populations with demonstrated iron deficiency.

The compound's stability in various food matrices has been documented, ensuring consistent iron retention throughout product shelf life. This stability is important for maintaining fortification effectiveness.

Long-term safety monitoring and epidemiological data from countries with established ferrous lactate fortification programs have not identified safety concerns at permitted use levels.

Frequently Asked Questions

What is Ferrous Lactate?

Ferrous lactate is an iron compound used in food as both a colorant and nutrient supplement to fortify products with iron. It appears as a grayish-green powder and is employed primarily in fortified foods and beverages to address iron deficiency.

Is Ferrous Lactate safe?

Ferrous Lactate 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 Ferrous Lactate banned in any country?

Ferrous Lactate 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.