Our Verdict: SAFE

Calcium Stearoyl-2-lactylate

E-numberE482CAS5793-94-2

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

Calcium Stearoyl-2-lactylate — food additive

Calcium stearoyl-2-lactylate (CSL) is an emulsifier and dough strengthener derived from stearic acid and lactic acid. It is commonly used in baked goods to improve texture, volume, and shelf life by strengthening gluten networks and stabilizing air incorporation.

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 Calcium Stearoyl-2-lactylate?

Calcium stearoyl-2-lactylate (CSL) is a food additive belonging to the class of emulsifiers and dough conditioners. It is synthesized by combining stearic acid with lactic acid, then forming a calcium salt of the resulting compound. This creates a surfactant molecule with both hydrophilic (water-loving) and hydrophobic (fat-loving) properties, enabling it to interact with proteins, fats, and water simultaneously.

The CAS number for this additive is 5793-94-2. CSL appears as a white to off-white powder and is soluble in water, making it suitable for aqueous food systems.

Common Uses

CSL is primarily used in the baking industry as a dough strengthener and emulsifier. Its main applications include:

- **Bread and rolls**: Improves dough strength, elasticity, and gas retention, resulting in better volume and crumb structure

- **Cakes and pastries**: Enhances emulsification, allowing better incorporation of fats and air, producing finer crumb texture

- **Processed foods**: Functions as a stabilizer and texturizer in various food products

- **Dough conditioners**: Works in premixed flour formulations to standardize baking performance

CSL typically replaces or works alongside other dough conditioners such as sodium stearoyl lactylate (SSL). It is often used at levels of 0.3% to 0.5% of flour weight in bread applications.

Safety Assessment

Calcium stearoyl-2-lactylate has not received FDA GRAS (Generally Recognized As Safe) status in the United States. However, this designation reflects the current regulatory classification rather than a safety concern. The additive is permitted in certain food categories under FDA regulations as an indirect food additive.

The FDA has recorded zero adverse events and zero recalls associated with CSL in their monitoring systems. The lack of reported safety incidents over decades of use in food products suggests a favorable safety profile.

The compound's components—stearic acid and lactic acid—are naturally occurring substances found in foods and the human body. Lactic acid is produced during fermentation and is a common food ingredient. Stearic acid is a saturated fatty acid found in animal and plant sources. When combined as CSL, the resulting additive presents minimal toxicological concern based on available evidence.

Studies on related compounds, particularly sodium stearoyl lactylate (the sodium analog), have shown no significant toxicity in standard safety testing. Digestive enzymes readily break down the ester bonds in stearoyl lactylate compounds, and the metabolites are normal dietary components.

Regulatory Status

In the United States, CSL is not GRAS-designated but is regulated under 21 CFR 172.844 as an approved indirect food additive and dough strengthener. It is permitted for use in bread and rolls, and in certain other baked goods.

In the European Union, calcium stearoyl lactylate is listed under the food additive register with E485 designation, where it is approved as an emulsifier in various food categories including bread, baked goods, and other processed foods.

Canada's Food and Drug Regulations permit stearoyl lactylates, including the calcium salt, as food additives in specified food categories at established limits.

This regulatory divergence reflects different approval pathways rather than safety concerns. CSL has been in use since the mid-20th century without generating significant regulatory action or safety alerts.

Key Studies

Limited published research specifically examines CSL in isolation. However, extensive literature exists on sodium stearoyl lactylate (SSL), the functionally similar sodium counterpart. Studies confirm that stearoyl lactylates:

- Effectively strengthen gluten networks by interacting with gluten proteins

- Improve dough handling properties and machinability

- Enhance volume and shelf life of baked products

- Are readily metabolized with no bioaccumulation

- Present no evidence of genotoxicity or carcinogenicity in standard testing

The toxicological profile of stearoyl lactylates has been assessed by international scientific bodies including the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which confirmed acceptable safety margins for use in food.

Frequently Asked Questions

What is Calcium Stearoyl-2-lactylate?

Calcium stearoyl-2-lactylate (CSL) is an emulsifier and dough strengthener derived from stearic acid and lactic acid. It is commonly used in baked goods to improve texture, volume, and shelf life by strengthening gluten networks and stabilizing air incorporation.

Is Calcium Stearoyl-2-lactylate safe?

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

Calcium 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.