Our Verdict: RATING UNKNOWN

Ferrous L-lactate

CAS85993-25-5

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Ferrous L-lactate — food additive

Ferrous L-lactate is an iron compound combined with lactic acid, used as a flavoring agent and adjuvant in food products. It provides a mild acidic taste while delivering bioavailable iron, making it useful in fortified 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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth 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 Ferrous L-lactate?

Ferrous L-lactate (CAS Number: 85993-25-5) is a chelate compound formed by combining ferrous iron (Fe2+) with L-lactic acid. This organic iron salt creates a complex that is more stable and potentially more bioavailable than inorganic iron forms. The compound appears as a greenish powder or crystalline solid and is soluble in water, making it suitable for liquid food applications.

Common Uses

Ferrous L-lactate is primarily used in the food industry as a flavoring agent and flavoring adjuvant. Its applications include:

- Iron-fortified beverages, particularly fruit juices and sports drinks

- Nutritional supplements and fortified food products

- Functional foods designed to address iron deficiency

- Products targeting pregnant women, athletes, and individuals at risk of iron deficiency

The lactic acid component contributes a mild acidic note that can enhance overall flavor profiles while the iron component serves a nutritional function in fortified products.

Safety Assessment

Ferrous L-lactate has not been granted GRAS (Generally Recognized as Safe) status by the FDA. However, the compound presents a notably clean safety profile based on available data:

- Zero adverse events have been reported to the FDA

- Zero product recalls associated with this additive

- The compound is composed of well-understood, naturally-occurring components (iron and lactic acid)

- Iron in the ferrous form is an essential micronutrient required for human health

- Lactic acid is widely recognized as safe and naturally occurs in fermented foods

The absence of documented adverse events and recalls suggests that, where used, ferrous L-lactate has demonstrated safety. However, the lack of GRAS designation may indicate limited commercial use, regulatory review, or that the compound has not undergone formal FDA petition review.

General iron safety considerations apply: excess iron intake can be problematic for certain populations, particularly young children and individuals with iron metabolism disorders. Typical food fortification levels are designed to provide supplemental iron without reaching toxic levels.

Regulatory Status

In the United States, ferrous L-lactate is not designated as GRAS, meaning it cannot be used in food without specific FDA authorization or approval. This status does not indicate safety concerns but rather reflects the regulatory requirement that food additives undergo formal approval processes.

The compound may be permitted in specific food categories under FDA regulations as a food additive with established tolerances, though it has not achieved the broader approval status of GRAS substances. Use would typically require:

- Specific FDA authorization for particular food applications

- Compliance with maximum use levels if established

- Proper labeling as a food additive

Regulatory acceptance varies internationally. Some countries classify iron salts more liberally in fortification contexts, while others maintain stricter approval requirements.

Key Studies

Scientific literature on ferrous L-lactate specifically is limited, reflecting its niche application in food fortification. Related research supports the safety and efficacy of:

- Organic iron salts in food fortification applications

- Ferrous compounds' superior bioavailability compared to ferric forms

- Lactic acid's safety in food products as flavoring and preservative

- The general safety profile of iron fortification at established levels

Most supportive evidence comes from broader iron fortification research and the well-established safety of lactic acid in food systems. Additional formal toxicological studies specific to ferrous L-lactate would strengthen the available safety data.

Frequently Asked Questions

What is Ferrous L-lactate?

Ferrous L-lactate is an iron compound combined with lactic acid, used as a flavoring agent and adjuvant in food products. It provides a mild acidic taste while delivering bioavailable iron, making it useful in fortified foods and beverages.

Is Ferrous L-lactate safe?

Ferrous L-lactate is currently rated "unknown" 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 L-lactate banned in any country?

Ferrous L-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.