Our Verdict: SAFE

Propylene Glycol Stearate

E-numberE477CAS1323-39-3

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

Propylene Glycol Stearate โ€” food additive

Propylene glycol stearate is a synthetic emulsifier derived from propylene glycol and stearic acid. It functions to blend oil and water-based ingredients in food products while also providing stabilizing and flavoring properties.

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 Propylene Glycol Stearate?

Propylene glycol stearate (PGS) is a non-ionic surfactant created through the esterification of propylene glycol with stearic acid. It appears as a waxy or oily substance and belongs to the class of polyglycerol esters and propylene glycol esters used extensively in food manufacturing. The compound is identified by CAS Number 1323-39-3 and serves multiple functional roles in food formulation.

Common Uses

Propylene glycol stearate is primarily employed as an emulsifier in food products, helping to create stable mixtures of ingredients that would otherwise separate, such as oil and water. Common applications include:

- Baked goods and bread products

- Confectionery and chocolate coatings

- Dairy products and ice cream

- Processed meat products

- Whipped toppings and dessert preparations

- Margarine and spreads

- Sauces and dressings

Beyond emulsification, PGS functions as a stabilizer to maintain product texture and consistency throughout shelf life, and as a flavoring adjuvant to enhance or modify taste profiles in food formulations.

Safety Assessment

Propylene glycol stearate has demonstrated a favorable safety profile in available data. The FDA has recorded zero adverse events associated with this additive and zero recalls involving its use. This absence of reported incidents suggests a long history of safe use in food applications where it has been employed.

The compound is generally recognized as safe by regulatory bodies in multiple jurisdictions. Toxicological studies have not identified significant concerns regarding its use at typical food application levels. As a propylene glycol derivative, it inherits the well-established safety profile of propylene glycol, which is widely accepted in food, pharmaceutical, and cosmetic industries.

The ester bond connecting propylene glycol to stearic acid is readily hydrolyzed in the digestive system, breaking down into propylene glycol and stearic acidโ€”both of which have established safety histories. This metabolic fate supports the safety assessment of the compound.

Regulatory Status

Notably, propylene glycol stearate does not carry FDA GRAS (Generally Recognized as Safe) status, despite its extensive use and favorable safety record. This distinction is important: lack of GRAS status does not indicate a safety concern but rather reflects regulatory classification and approval pathways.

The additive is approved and utilized in food products across multiple countries and regions, including the European Union and other jurisdictions with rigorous food safety standards. Its authorization in these markets reflects positive safety assessments by regulatory authorities.

Manufacturers using propylene glycol stearate must comply with all applicable regulations regarding allowable use levels and food categories. These regulations are established based on safety data and intended to ensure consumer protection.

Key Studies

While specific peer-reviewed studies on propylene glycol stearate are limited in public databases, the safety profile is supported by:

- Historical use data spanning decades without documented adverse effects

- The established safety of its component parts (propylene glycol and stearic acid)

- Toxicological assessments conducted during regulatory approval processes

- The compound's ready biodegradability and metabolic breakdown into recognized safe compounds

The absence of FDA adverse event reports and recalls provides real-world evidence of safe use in commercial food applications. Regulatory agencies continue to monitor food additive safety through post-market surveillance systems.

Frequently Asked Questions

What is Propylene Glycol Stearate?

Propylene glycol stearate is a synthetic emulsifier derived from propylene glycol and stearic acid. It functions to blend oil and water-based ingredients in food products while also providing stabilizing and flavoring properties.

Is Propylene Glycol Stearate safe?

Propylene Glycol 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 Propylene Glycol Stearate banned in any country?

Propylene Glycol 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.