Our Verdict: SAFE

Calcium Gluconate

E-numberE578CAS299-28-5

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 Gluconate — food additive

Calcium gluconate is a calcium salt derived from gluconic acid, functioning as a firming agent, flavor enhancer, and nutrient supplement in food products. It is used to improve texture, maintain firmness in processed foods, and provide bioavailable calcium fortification.

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 Calcium Gluconate?

Calcium gluconate (CAS Number: 299-28-5) is an organic calcium salt formed from the combination of calcium and gluconic acid. It appears as a white to off-white crystalline powder and is highly soluble in water. This compound is naturally derived and commonly used in food manufacturing to provide multiple functional benefits including calcium supplementation, texture modification, and flavor enhancement.

Common Uses

Calcium gluconate serves multiple functions in food formulation. As a firming agent, it is frequently added to canned vegetables, fruits, and processed produce to maintain structural integrity and crispness during processing and storage. The additive is commonly used in baking applications where it functions as a formulation aid, improving dough handling properties and bread structure.

In beverages and fortified foods, calcium gluconate acts as a nutrient supplement, providing bioavailable calcium for products marketed toward bone health and nutritional enhancement. It also functions as a sequestrant, binding metal ions that might otherwise cause discoloration or off-flavors, and as a stabilizer in various emulsions and suspensions. Its role as a texturizer helps create desirable mouthfeel in dairy alternatives and plant-based products.

Safety Assessment

Calcium gluconate has demonstrated a strong safety profile in food applications. The FDA has recorded zero adverse events associated with its use in food products, and there are no recalls linked to this additive. While calcium gluconate does not currently hold GRAS (Generally Recognized as Safe) status with the FDA, this does not indicate a safety concern but rather reflects that formal GRAS petition procedures have not been completed for this particular substance in all intended uses.

As an organic calcium salt, calcium gluconate is bioavailable and metabolized similarly to other dietary calcium sources. The gluconic acid component is a weak organic acid naturally present in foods and is readily metabolized. Studies on calcium gluconate in nutritional supplement formulations have not identified safety concerns at typical food use levels.

The European Food Safety Authority has evaluated calcium gluconate in various applications, and it appears on the EU's list of approved food additives for specific uses without identified safety restrictions at established levels of use.

Regulatory Status

Calcium gluconate is permitted for use in foods in many countries with specific regulatory frameworks. In the United States, while not holding GRAS affirmation, it is permitted in certain applications under FDA regulations. The additive is listed in the FDA's electronic Code of Federal Regulations for use as a nutrient supplement and formulation aid in various food categories.

In the European Union, calcium gluconate is approved as a food additive (E578) and is permitted in specific food categories including certain dairy products, processed fruits and vegetables, and fortified foods, subject to defined maximum levels.

Canada, Australia, and other regulatory jurisdictions recognize calcium gluconate for food use with appropriate quality specifications.

Key Studies

Limited peer-reviewed research specifically addresses calcium gluconate in food formulations, as the compound has a well-established historical use without identified safety concerns. Published research on calcium supplements demonstrates that gluconate forms of calcium show good bioavailability in nutritional applications. Studies on firming agents in processed vegetables indicate that calcium salts, including calcium gluconate, effectively maintain texture without adverse sensory or safety outcomes.

The safety of gluconic acid and its salts is well-documented in nutritional literature, with no genotoxic, mutagenic, or carcinogenic effects identified at levels relevant to food use. Toxicological data on calcium gluconate specifically support its safe use at typical food fortification levels.

Frequently Asked Questions

What is Calcium Gluconate?

Calcium gluconate is a calcium salt derived from gluconic acid, functioning as a firming agent, flavor enhancer, and nutrient supplement in food products. It is used to improve texture, maintain firmness in processed foods, and provide bioavailable calcium fortification.

Is Calcium Gluconate safe?

Calcium Gluconate 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 Gluconate banned in any country?

Calcium Gluconate 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.