Our Verdict: SAFE

Sodium Stearate

CAS822-16-2

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

Sodium Stearate โ€” food additive

Sodium stearate is a salt derived from stearic acid, commonly used as an emulsifier and anti-caking agent in food products. It helps improve texture, prevent clumping, and stabilize mixtures in various processed foods and supplements.

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 Sodium Stearate?

Sodium stearate (CAS Number 822-16-2) is the sodium salt of stearic acid, a saturated fatty acid. It appears as a white to off-white powder with a fatty, soap-like odor. The compound is produced through the saponification of stearic acid with sodium hydroxide or sodium carbonate. Chemically, it functions as an anionic surfactant, meaning it has both hydrophobic (water-repelling) and hydrophilic (water-attracting) properties that allow it to bridge different types of substances.

Common Uses

Sodium stearate serves multiple functions in food manufacturing:

**Emulsifier and Stabilizer**: Its primary role is emulsifying fats and oils with water-based ingredients, creating stable, uniform mixtures. This is particularly valuable in processed foods, chocolate products, and confectionery where texture consistency is critical.

**Anti-caking Agent**: In powdered products such as table salt, spice blends, and baking mixes, sodium stearate prevents clumping and maintains free-flowing properties during storage.

**Formulation Aid**: The ingredient assists in achieving desired product consistency and mouthfeel in various applications.

**Additional Functions**: Sodium stearate is also listed as a masticatory substance (affecting chewing properties), propellant, and thickener, though these uses are less common in conventional food products.

The ingredient is particularly useful in supplement manufacturing, where it's added to tablets and capsules to prevent aggregation and improve processability.

Safety Assessment

Sodium stearate has an extensive history of use in food and pharmaceutical applications. The FDA has received zero adverse event reports associated with this additive and no product recalls have been linked to its use. The compound is readily metabolized in the body, as stearic acid is a naturally occurring fatty acid found in many foods including cocoa, shea butter, and animal fats.

Stearic acid metabolism follows normal lipid digestion pathways, being converted to oleic acid and other compounds through beta-oxidation. Sodium stearate dissolves or hydrolyzes in the digestive system, breaking down into stearic acid and sodium ionsโ€”both of which are normal dietary components.

Dermatological and respiratory safety studies on sodium stearate have not raised significant concerns at levels used in food. The International Agency for Research on Cancer (IARC) does not classify stearic acid or its derivatives as carcinogenic.

Regulatory Status

While sodium stearate is not on the FDA's Generally Recognized as Safe (GRAS) list, this designation does not indicate a safety concern. Rather, it reflects the regulatory pathway and historical approval basis for the ingredient. Sodium stearate is permitted for use in foods under FDA regulations as a food additive, with specific limitations on maximum usage levels depending on the food category.

In the European Union, sodium stearate is approved as food additive E570 under Regulation (EC) No 1333/2008. The European Food Safety Authority (EFSA) has not identified safety concerns at current permitted use levels.

The ingredient is also accepted in many other countries including Canada, Japan, and Australia, where regulatory agencies have reviewed its safety profile.

Key Studies

Limited dedicated safety studies exist for sodium stearate specifically, as the compound has been used in food and cosmetics for decades without documented safety issues. Most safety data derives from general stearic acid toxicology, which demonstrates low systemic toxicity and rapid metabolism.

General lipid metabolism studies confirm that stearic acid from sodium stearate enters normal metabolic pathways identical to dietary sources. Animal studies on stearic acid have not identified reproductive, developmental, or systemic toxicity concerns at food-relevant doses.

The lack of adverse event reports and recalls in FDA databases, combined with extensive historical use and regulatory approval in multiple jurisdictions, provides substantial evidence for the practical safety of this ingredient at permitted usage levels.

Frequently Asked Questions

What is Sodium Stearate?

Sodium stearate is a salt derived from stearic acid, commonly used as an emulsifier and anti-caking agent in food products. It helps improve texture, prevent clumping, and stabilize mixtures in various processed foods and supplements.

Is Sodium Stearate safe?

Sodium 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 Sodium Stearate banned in any country?

Sodium 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.