Our Verdict: SAFE

Calcium Fumarate

CAS7718-51-6FDA 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

Calcium Fumarate — food additive

Calcium fumarate is a nutrient supplement derived from fumaric acid and calcium that serves as a source of dietary calcium. It is used in food products to fortify or supplement calcium content and support nutritional requirements.

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 Calcium Fumarate?

Calcium fumarate is an inorganic salt compound combining calcium with fumaric acid (a naturally occurring organic acid found in fruits). It appears as a white to off-white crystalline powder and serves primarily as a calcium nutrient supplement in food fortification applications. The compound has the molecular formula C4H4CaO4 and CAS number 7718-51-6. Fumaric acid itself is a key intermediate in cellular metabolism (the citric acid cycle), making calcium fumarate a form of calcium that leverages an endogenous metabolic pathway.

Common Uses

Calcium fumarate is used in the food industry as a nutrient fortification agent, particularly in products where calcium supplementation is desired or required by regulatory standards. Common applications include:

- Fortified grain and cereal products

- Nutritional supplements and fortified beverages

- Functional food products marketed for bone health

- Dairy alternative products

- Processed foods requiring calcium fortification

The use of calcium fumarate instead of other calcium salts may be selected when manufacturers seek to combine calcium fortification with the metabolic benefits associated with fumaric acid, though the physiological significance of the fumarate component in fortification remains limited.

Safety Assessment

Calcium fumarate has been designated as Generally Recognized as Safe (GRAS) by the FDA, indicating that it has a long history of safe use in food or has been demonstrated to be safe through scientific procedures. The FDA database records zero adverse events and zero recalls associated with calcium fumarate, suggesting a strong safety profile in food applications.

Calcium salts in general have extensive safety data. The bioavailability of calcium from fumarate salts is comparable to other common calcium supplement forms. Fumaric acid and fumarates are naturally present in foods and are metabolized through normal cellular pathways. Individual tolerance may vary based on total calcium intake, as excessive calcium supplementation can cause gastrointestinal distress in some individuals, but this is not specific to the fumarate form.

No evidence currently suggests that calcium fumarate presents toxicological concerns at levels used in food fortification. Safety assessments by regulatory agencies in multiple jurisdictions have not identified specific contraindications.

Regulatory Status

In the United States, calcium fumarate is GRAS for use as a nutrient supplement, allowing its addition to foods without pre-market approval provided manufacturers comply with GRAS notification procedures and use requirements. It is approved for use in various food categories under 21 CFR regulations.

Internationally, calcium fumarate is permitted in food fortification in the European Union and other developed markets. National regulatory agencies in Canada, Australia, and Japan also recognize its use in food fortification applications. Approval status and specific use levels may vary by jurisdiction and product category.

Key Studies

Limited peer-reviewed literature specifically addresses calcium fumarate as a distinct compound, though abundant research exists on calcium bioavailability from various salt forms and on fumaric acid metabolism. Calcium bioavailability studies demonstrate that calcium from fumarate sources is absorbed comparably to calcium citrate and other soluble calcium salts. Fumaric acid has been extensively studied as both a food additive and metabolic compound, with established safety margins for dietary exposure.

The combination form has not been extensively studied in isolation, but safety conclusions rest on the established safety profile of both calcium salts generally and fumarates specifically in the food supply. Regulatory acceptance reflects decades of use data without documented adverse effects.

Frequently Asked Questions

What is Calcium Fumarate?

Calcium fumarate is a nutrient supplement derived from fumaric acid and calcium that serves as a source of dietary calcium. It is used in food products to fortify or supplement calcium content and support nutritional requirements.

Is Calcium Fumarate safe?

Calcium Fumarate 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 Calcium Fumarate banned in any country?

Calcium Fumarate 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.