Our Verdict: RATING UNKNOWN

Aluminum Stearate

CAS637-12-7

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

Aluminum Stearate — food additive

Aluminum stearate is an aluminum salt of stearic acid used as an anticaking agent, free-flow agent, and emulsifier in food processing. It helps prevent clumping in powdered products and improves 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
Not EvaluatedUK FSA
Canada
ApprovedHealth 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 Aluminum Stearate?

Aluminum stearate (CAS Number 637-12-7) is an inorganic compound formed from aluminum and stearic acid, a naturally occurring fatty acid. It appears as a white or off-white powder and functions primarily as an anticaking agent and emulsifier in food manufacturing. The compound helps maintain the free-flowing properties of powdered ingredients and can assist in stabilizing emulsions where oil and water need to remain mixed.

Common Uses

Aluminum stearate is used in various food applications where flow properties and stability are important. Common uses include:

- Anticaking agent in powdered spice blends and seasonings

- Free-flow agent in dry mixes and powdered ingredients

- Emulsifier or emulsifier salt in certain food formulations

- Formulation aid in processed foods requiring texture modification

The compound's primary benefit is preventing the agglomeration (clumping) that can occur in powdered products during storage, particularly in humid conditions. This maintains product consistency and usability throughout shelf life.

Safety Assessment

Aluminum stearate has not been approved by the FDA as a Generally Recognized as Safe (GRAS) substance, indicating it has not undergone the formal GRAS affirmation process. However, the FDA has recorded zero adverse events and zero recalls associated with this additive, suggesting no documented safety incidents in the food supply.

The safety profile of aluminum stearate is influenced by its aluminum content. While aluminum is ubiquitous in the environment and present in many foods naturally, the amount of aluminum exposure from food additives is generally considered minimal compared to other dietary and environmental sources. The stearate component is derived from stearic acid, a fatty acid recognized as safe and present naturally in many foods.

Since aluminum stearate is used in small quantities as a processing aid and typically represents a minor fraction of total dietary aluminum intake, the risk from this specific additive appears limited. The lack of reported adverse events or recalls further supports the absence of documented acute safety concerns in commercial food use.

Regulatory Status

Aluminum stearate's regulatory status varies internationally. In the United States, it is not listed as a GRAS substance by the FDA, meaning it may be used under specific conditions or may require approval for particular applications. The compound may be classified as a food additive subject to FDA regulations, with permissible uses and limits dependent on its intended application.

In the European Union, aluminum compounds used in food are subject to strict regulations through EFSA (European Food Safety Authority) assessments. Some aluminum-based additives have been evaluated and approved for specific uses with maximum level restrictions, reflecting the regulatory approach of limiting total aluminum exposure from food sources.

Manufacturers using aluminum stearate must comply with applicable national food additive regulations and labeling requirements. Its non-GRAS status in the United States means applications require regulatory approval before use in foods intended for U.S. distribution.

Key Studies

Limited published scientific literature specifically addresses aluminum stearate in food applications. Most relevant research examines aluminum compounds in food generally or stearic acid as a food component. Broader studies on dietary aluminum exposure, such as those conducted by EFSA and various national food safety authorities, provide context for assessing aluminum from food additives.

Research on aluminum bioavailability suggests that aluminum from food additives is poorly absorbed in the gastrointestinal tract, with most ingested aluminum being excreted. Studies on stearic acid demonstrate it is readily metabolized as a normal dietary fatty acid.

The absence of reported adverse events and recalls associated with this additive suggests either its use is limited, its safety profile is acceptable, or both. Additional research specific to aluminum stearate's effects at typical food-use levels would provide further clarity, though the existing safety record appears reassuring.

Frequently Asked Questions

What is Aluminum Stearate?

Aluminum stearate is an aluminum salt of stearic acid used as an anticaking agent, free-flow agent, and emulsifier in food processing. It helps prevent clumping in powdered products and improves texture and stability in various food formulations.

Is Aluminum Stearate safe?

Aluminum Stearate 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 Aluminum Stearate banned in any country?

Aluminum 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.