Our Verdict: SAFE

Sodium Stearyl Fumarate

CAS4070-80-8

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 Stearyl Fumarate — food additive

Sodium stearyl fumarate (CAS 4070-80-8) is a synthetic dough conditioner derived from stearic acid and fumaric acid. It functions as a leavening agent and dough strengthener in baked goods, improving texture and volume while also acting as a lubricant in food processing.

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 Stearyl Fumarate?

Sodium stearyl fumarate is a synthetic food additive created by combining stearic acid (a saturated fatty acid) with fumaric acid (an organic acid naturally found in some foods). The resulting compound is classified as an emulsifier and dough conditioner. It appears as a white to off-white powder and is virtually insoluble in water, making it well-suited for dry ingredient applications.

Common Uses

Sodium stearyl fumarate is primarily used in the baking industry as a dough strengthener and leavening agent. Its main applications include:

- **Bread and cake production**: Enhances dough elasticity and gas retention, resulting in improved volume and crumb structure

- **Flour treatments**: Used in some flour blends to improve baking performance

- **Dough conditioning**: Strengthens gluten networks in wheat-based products

- **Release agent**: Reduces sticking in food processing equipment and molds

The additive is particularly valuable in commercial baking where consistency and shelf-life are important. It allows manufacturers to achieve desired texture and rise without relying solely on traditional fermentation methods.

Safety Assessment

Sodium stearyl fumarate has not been formally affirmed as Generally Recognized as Safe (GRAS) by the FDA, which distinguishes it from some other common dough conditioners like sodium stearoyl lactylate (SSL). However, this lack of GRAS status does not indicate a safety concern; rather, it reflects regulatory categorization. The additive may be approved for use under FDA food additive regulations through the standard approval pathway.

The FDA's adverse event database contains zero reported adverse events associated with sodium stearyl fumarate. Additionally, there have been no FDA recalls involving this additive, indicating no documented safety incidents in the food supply.

As a compound derived from two food-related components (stearic acid and fumaric acid), sodium stearyl fumarate is metabolized through normal digestive processes. The fumarate portion is recognized as an intermediate in normal cellular metabolism, and stearic acid is a common dietary fatty acid.

Regulatory Status

In the United States, sodium stearyl fumarate is listed as a permitted food additive under FDA regulations for use in flour and related products. The specific regulatory framework allows its use in dough conditioning applications, though the exact usage levels and product categories may be defined by regulation.

Regulatory approval varies internationally. Some countries may have different approval statuses or usage restrictions based on their own food safety assessments. Manufacturers exporting baked goods must comply with regulations in each target market.

The lack of GRAS affirmation means the additive is regulated differently than some competing dough conditioners, but this does not reflect on its safety profile.

Key Studies

Limited published peer-reviewed research specifically addresses sodium stearyl fumarate in isolation. Most relevant safety data comes from:

- Toxicological assessments of fumarate compounds, which have been extensively studied due to their presence in foods and use in other applications

- Metabolic studies on stearic acid, one of the most common fatty acids in the food supply

- Food additive safety reviews by regulatory authorities during the approval process

The combination of these two well-known food components suggests a reasonable safety profile, though comprehensive long-term studies specific to the combination are limited in the public literature. Manufacturers using this additive typically rely on regulatory approval and internal safety testing to ensure compliance and safety.

Further research and transparency regarding usage levels and long-term safety would strengthen the evidence base for this additive.

Frequently Asked Questions

What is Sodium Stearyl Fumarate?

Sodium stearyl fumarate (CAS 4070-80-8) is a synthetic dough conditioner derived from stearic acid and fumaric acid. It functions as a leavening agent and dough strengthener in baked goods, improving texture and volume while also acting as a lubricant in food processing.

Is Sodium Stearyl Fumarate safe?

Sodium Stearyl Fumarate 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 Stearyl Fumarate banned in any country?

Sodium Stearyl Fumarate 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.