Our Verdict: SAFE

Calcium Stearate

CAS1592-23-0FDA 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 Stearate — food additive

Calcium stearate is a salt derived from stearic acid and calcium, functioning primarily as an anticaking agent and emulsifier in food products. It prevents clumping in powdered ingredients and helps maintain uniform texture and stability in various food formulations.

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 Stearate?

Calcium stearate (CAS Number: 1592-23-0) is an inorganic salt compound formed from the reaction of stearic acid (a saturated fatty acid) with calcium. It appears as a white or off-white powder with a fine, smooth texture. The compound is lipophilic, meaning it has an affinity for fats and oils, which makes it particularly useful in food manufacturing where moisture control and texture consistency are important.

Common Uses

Calcium stearate serves multiple functions in food manufacturing. As an anticaking agent, it is commonly added to powdered products such as spice blends, baking mixes, powdered sugar, and dry seasonings to prevent clumping during storage and handling. Its hydrophobic properties allow it to create a barrier against moisture absorption.

In baked goods, calcium stearate functions as an emulsifier, helping to combine ingredients that would normally separate, such as fats and water-based components. This improves the texture and shelf life of products like cakes, breads, and pastries. The compound also serves as a lubricant and release agent, facilitating easier removal of products from manufacturing equipment and molds.

Additionally, calcium stearate is used as a formulation aid and stabilizer in various food applications, helping to maintain product consistency and prevent separation of ingredients during storage.

Safety Assessment

Calcium stearate has an extensive safety history in food applications. The compound is recognized as Generally Recognized As Safe (GRAS) by the FDA, meaning it has a long history of safe use and is approved for direct addition to food. The additive is also permitted in food products across the European Union and other major regulatory jurisdictions.

According to FDA records, there have been zero reported adverse events associated with calcium stearate consumption, and zero recalls linked to this additive. This demonstrates a strong safety profile after decades of food industry use.

Stearic acid, the primary component of calcium stearate, is naturally present in many foods including cocoa, beef fat, and vegetable oils. Calcium, the other component, is an essential mineral required for human health. When calcium stearate is ingested, it is broken down in the digestive system into its component parts, which are then processed through normal metabolic pathways.

Regulatory Status

Calcium stearate is approved for use in food in multiple regulatory frameworks:

- **United States (FDA)**: GRAS status for use as an anticaking agent, emulsifier, formulation aid, lubricant, and stabilizer

- **European Union (EFSA)**: Approved as food additive E470b under EU Regulation 1333/2008

- **Other Jurisdictions**: Accepted in Canada, Australia, Japan, and numerous other countries

The compound is typically limited to specific food categories and maximum use levels as defined by each regulatory authority, though these levels are generally not restrictive for typical food manufacturing applications.

Key Studies

While calcium stearate does not have extensive recent clinical research due to its well-established safety history, historical toxicological studies have consistently shown it to be safe for human consumption. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has reviewed stearate compounds and determined them to be acceptable food ingredients.

The lipophilic nature of calcium stearate means it has limited bioavailability in the digestive system and passes through largely unchanged. Any absorbed components are processed through standard metabolic pathways. No genotoxic, mutagenic, or carcinogenic effects have been identified in available toxicological data.

The long history of safe use in food manufacturing, combined with zero adverse event reports and the naturally occurring nature of its component parts, supports its continued classification as a safe food additive.

Frequently Asked Questions

What is Calcium Stearate?

Calcium stearate is a salt derived from stearic acid and calcium, functioning primarily as an anticaking agent and emulsifier in food products. It prevents clumping in powdered ingredients and helps maintain uniform texture and stability in various food formulations.

Is Calcium Stearate safe?

Calcium Stearate 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 Stearate banned in any country?

Calcium Stearate 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.