Our Verdict: SAFE

Sodium Stearoyl-2-lactylate

E-numberE481CAS25383-99-7

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 Stearoyl-2-lactylate — food additive

Sodium stearoyl-2-lactylate (SSL) is an emulsifier and dough strengthener derived from lactic acid and stearic acid. It is widely used in baked goods, dairy products, and processed foods to improve texture, stability, and shelf life.

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 Stearoyl-2-lactylate?

Sodium stearoyl-2-lactylate (SSL) is a food additive classified as an emulsifier and surface-active agent. It is produced by esterifying stearic acid with lactic acid, followed by neutralization with sodium hydroxide. The resulting compound has both hydrophobic and hydrophilic properties, allowing it to stabilize mixtures of oil and water that would normally separate. SSL appears as a white to off-white powder and is soluble in warm water.

Common Uses

SSL is primarily used in the baking industry as a dough strengthener and improver. In bread and cake production, it enhances gluten development, increases dough elasticity, and improves gas retention, resulting in better volume and texture. It also extends shelf life by slowing staling. Beyond baking, SSL functions as an emulsifier in dairy products like ice cream and yogurt, where it improves creaminess and prevents separation. It is also found in processed meats, margarine, and various convenience foods where emulsification and stabilization are desired. Typical usage levels range from 0.5% to 2% of flour weight in bread applications.

Safety Assessment

SSL has been used in food manufacturing for several decades with an established safety record. According to FDA records, there are zero reported adverse events associated with sodium stearoyl-2-lactylate consumption. Additionally, no FDA recalls have been linked to this additive, indicating no documented safety incidents in the food supply. The European Food Safety Authority (EFSA) has similarly reviewed SSL and established it as acceptable for use in food applications, though within specific regulatory frameworks by country.

Toxicological studies on SSL have not identified significant concerns at levels used in food. Animal studies have examined absorption, distribution, and elimination, finding that SSL is largely not absorbed intact in the gastrointestinal tract and is metabolized to its component fatty acid and lactic acid constituents, which are normal dietary components. No evidence of genotoxicity or carcinogenicity has been established in available research.

Individuals with sensitivity to dairy products should note that while SSL is chemically derived from lactic acid, the final product is not inherently a dairy allergen, though manufacturing processes should be verified for cross-contamination risks in sensitive populations.

Regulatory Status

SSL is approved for use in the United States under FDA regulations as a Generally Recognized as Safe (GRAS) substance in certain food categories, though it does not hold blanket GRAS status for all food applications. It is regulated as a food additive with established maximum use levels depending on the food category. In the European Union, SSL is approved as a food additive (E481) and is permitted in a range of food categories under Regulation (EC) No 1333/2008. Canada, Australia, and other major food regulatory bodies similarly permit its use within defined parameters. Manufacturers must comply with labeling requirements and maximum residue limits established by their respective regulatory authorities.

Key Studies

Research on SSL has focused on its functional properties in baking and its metabolic fate. Studies demonstrate that SSL effectively strengthens dough by interacting with gluten proteins and starch, improving water absorption and gas retention. Metabolic studies in animals indicate that SSL is hydrolyzed in the gastrointestinal tract to stearic acid and lactic acid, both of which are normally present in the diet and are safely metabolized. Long-term feeding studies in animals at levels well above typical dietary exposure have not revealed adverse effects. The additive's use in commercial food production is supported by decades of practical application data without significant safety signals.

Frequently Asked Questions

What is Sodium Stearoyl-2-lactylate?

Sodium stearoyl-2-lactylate (SSL) is an emulsifier and dough strengthener derived from lactic acid and stearic acid. It is widely used in baked goods, dairy products, and processed foods to improve texture, stability, and shelf life.

Is Sodium Stearoyl-2-lactylate safe?

Sodium Stearoyl-2-lactylate 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 Stearoyl-2-lactylate banned in any country?

Sodium Stearoyl-2-lactylate 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.