Our Verdict: SAFE

Calcium Citrate

E-numberE333CAS813-94-5FDA 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 Citrate โ€” food additive

Calcium citrate (CAS 813-94-5) is a calcium salt of citric acid used in food as a nutrient supplement, firming agent, and pH control agent. It is Generally Recognized As Safe (GRAS) by the FDA and has no documented adverse events or recalls associated with its use in food products.

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 Citrate?

Calcium citrate is an organic compound formed by the reaction of calcium oxide or calcium carbonate with citric acid. The resulting salt contains approximately 21% elemental calcium by weight and is highly soluble in water, making it an effective bioavailable form of calcium for nutritional fortification. It appears as a white crystalline powder and is designated by CAS Number 813-94-5.

Common Uses

Calcium citrate serves multiple functional roles in food manufacturing. As a nutrient supplement, it fortifies beverages, dairy products, plant-based milk alternatives, breakfast cereals, and nutritional bars to increase dietary calcium content. In baking and processed foods, it acts as a firming agent, helping maintain texture and structural integrity in products like canned vegetables and fruits. The additive also functions as a pH control agent and sequestrant, helping stabilize formulations and prevent metal-catalyzed spoilage by binding trace minerals that could otherwise promote oxidation or discoloration.

Safety Assessment

The FDA has designated calcium citrate as a GRAS (Generally Recognized As Safe) substance, meaning qualified experts have concluded it safe for its intended use in food. This determination is based on extensive scientific literature and historical use patterns. According to FDA records, there have been zero adverse events reported in connection with calcium citrate use in food, and zero product recalls attributed to this ingredient.

The European Food Safety Authority (EFSA) has similarly approved calcium citrate for use as a food additive across EU member states. Safety evaluations have consistently demonstrated that calcium citrate does not present toxicological concerns at the levels used in food applications.

Calcium citrate is also generally recognized as safe by health authorities in Canada, Australia, and Japan. The additive's safety profile is well-established, with no genotoxic, carcinogenic, or reproductive toxicity concerns identified in scientific literature.

Regulatory Status

In the United States, calcium citrate is approved as a direct food additive under 21 CFR ยง 182.1216 for use as a nutrient supplement. It is also listed in the Code of Federal Regulations as acceptable for use in specific food categories without quantity restrictions, reflecting its recognized safety margin.

Within the European Union, calcium citrate is approved as food additive E333, permitted in various food categories at levels specified in Regulation (EC) No 1333/2008. The additive is approved for use in many countries worldwide, including Canada (listed under the Food and Drugs Act), Australia, and New Zealand.

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated calcium citrate and established that no Acceptable Daily Intake (ADI) limit is necessary, indicating the substance presents no safety concern at anticipated levels of dietary exposure.

Key Studies

Numerous bioavailability studies have demonstrated that calcium from calcium citrate is effectively absorbed in the human gastrointestinal tract, supporting its nutritional efficacy as a calcium fortification agent. Research published in peer-reviewed journals has confirmed calcium citrate's stability in various food matrices and its effectiveness in maintaining product quality.

Toxicological studies conducted on calcium citrate have consistently shown no adverse effects at levels far exceeding those used in food applications. The absence of reported adverse events in FDA databases over decades of use further supports the established safety record of this ingredient.

Food chemistry research confirms calcium citrate's effectiveness as a chelating agent and its ability to improve texture retention in processed foods without negative sensory or nutritional impacts.

Frequently Asked Questions

What is Calcium Citrate?

Calcium citrate (CAS 813-94-5) is a calcium salt of citric acid used in food as a nutrient supplement, firming agent, and pH control agent. It is Generally Recognized As Safe (GRAS) by the FDA and has no documented adverse events or recalls associated with its use in food products.

Is Calcium Citrate safe?

Calcium Citrate 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 Citrate banned in any country?

Calcium Citrate 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.