Our Verdict: SAFE

Glyceryl Monostearate

E-numberE471CAS31566-31-1FDA GRAS

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

Glyceryl Monostearate โ€” food additive

Glyceryl monostearate (GMS) is an emulsifier derived from glycerin and stearic acid, commonly used in food manufacturing to stabilize mixtures of oil and water. It functions as a texturizer and firming agent in numerous processed foods including baked goods, margarine, and dairy products.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
ApprovedMFDS
Brazil
ApprovedANVISA
China
Not EvaluatedNHC / GB 2760
India
ApprovedFSSAI
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 Glyceryl Monostearate?

Glyceryl monostearate (GMS), identified by CAS number 31566-31-1, is a mono- and diglyceride emulsifier produced through the esterification of glycerin with stearic acid. It exists as a waxy, off-white solid at room temperature and is virtually insoluble in water but soluble in oils and fats. GMS is classified as a food-grade emulsifier and is one of the most widely used emulsifying agents in the global food industry.

Common Uses

GMS serves multiple functional roles in food manufacturing. Its primary function is as an emulsifier, helping to stabilize mixtures of immiscible ingredients such as oil and water. This property makes it invaluable in baked goods, where it improves crumb structure, moisture retention, and shelf-life. In margarine and butter-like spreads, GMS enhances stability and spreadability. The additive is also used in confectionery products, icings, and fillings to improve texture and consistency.

Beyond emulsification, GMS functions as a texturizer and firming agent, contributing to the desired mouthfeel and structural integrity of food products. In some applications, it acts as a lubricant or release agent, facilitating food processing and preventing sticking. Minor applications include its use as a masticatory substance and flavor enhancer in certain formulations.

Safety Assessment

Glyceryl monostearate has an extensive history of safe use in food applications. The FDA has designated GMS as Generally Recognized As Safe (GRAS), affirming its safety for use in human food when used according to good manufacturing practices. This classification is based on a long history of safe consumption and scientific evidence supporting its safety profile.

The regulatory databases show zero adverse events reported to the FDA associated with GMS consumption, and zero food recalls attributed to this additive. These data points represent decades of widespread global use without identified safety concerns. Toxicological studies have consistently demonstrated that GMS does not present acute toxicity risks at typical food consumption levels.

GMS is readily absorbed and metabolized in the digestive system, breaking down into glycerin and stearic acidโ€”both naturally occurring compounds in the diet. The metabolic fate is well-characterized, with no evidence of bioaccumulation or systemic toxicity. Studies evaluating potential allergenicity have not identified GMS as a common allergen, though individuals with specific sensitivities may need to verify product ingredients.

Regulatory Status

GMS is approved for use in numerous countries and regulatory jurisdictions. In the European Union, it is listed as food additive E471 and is permitted in a wide range of food categories. The FDA approval as GRAS means it may be used without prior specific authorization in food products. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has reviewed GMS and established acceptable intake levels.

Due to its natural origin (derived from glycerin and plant-based stearic acid sources) and long history of safe use, GMS is acceptable in many "natural" and "clean label" food formulations, though labeling requirements vary by jurisdiction.

Key Studies

Long-term safety studies conducted on GMS have not identified adverse health effects at exposure levels far exceeding typical dietary intake. Research examining the metabolic fate of GMS confirms rapid hydrolysis and metabolism to known dietary components. Safety reviews by international regulatory bodies, including the European Food Safety Authority (EFSA) and JECFA, have consistently supported the safety of GMS at current permitted levels of use.

The extensive global use of GMS since its introduction in food manufacturing provides substantial real-world evidence of safety. Continued monitoring through regulatory surveillance systems maintains oversight of this widely-used additive.

Frequently Asked Questions

What is Glyceryl Monostearate?

Glyceryl monostearate (GMS) is an emulsifier derived from glycerin and stearic acid, commonly used in food manufacturing to stabilize mixtures of oil and water. It functions as a texturizer and firming agent in numerous processed foods including baked goods, margarine, and dairy products.

Is Glyceryl Monostearate safe?

Glyceryl Monostearate 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 Glyceryl Monostearate banned in any country?

Glyceryl Monostearate 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.