Our Verdict: SAFE

Glyceryl Palmitostearate

CAS8067-32-1

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 Palmitostearate โ€” food additive

Glyceryl palmitostearate is a synthetic lipid compound created by combining glycerol with palmitic and stearic acids. It functions as a formulation aid in food products, helping to improve texture, stability, and processing characteristics.

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
Not EvaluatedHealth 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 Glyceryl Palmitostearate?

Glyceryl palmitostearate (CAS Number: 8067-32-1) is a manufactured emulsifier and formulation aid derived from glycerol and mixed fatty acidsโ€”specifically palmitic acid (C16) and stearic acid (C18). It belongs to the class of glycerides, which are esters formed from glycerol and fatty acids. This compound is a white to off-white solid at room temperature and is lipophilic (fat-soluble), making it useful in oil-based food systems.

Common Uses

Glyceryl palmitostearate is used in food manufacturing as a formulation aid, which means it assists in the processing and structural development of foods rather than serving as a primary ingredient. It is occasionally found in baked goods, confectionery products, and other processed foods where it helps stabilize emulsions, improve texture consistency, and enhance the distribution of fats throughout the product. Its primary function is to maintain homogeneity in multi-phase food systems and support consistent product quality during manufacturing and storage.

Safety Assessment

Glycerol esters of fatty acids have a long history of use in food production, and glyceryl palmitostearate belongs to this generally recognized group of compounds. The FDA has recorded zero adverse events and zero recalls associated with this additive, suggesting a favorable safety profile in actual use. As a lipid-based compound similar to naturally occurring fats, it presents a lower toxicological concern compared to many synthetic additives.

Digestion and metabolism of glyceryl palmitostearate would follow pathways similar to dietary fats and oils, as the human digestive system readily breaks down glycerides into glycerol and fatty acids for absorption and metabolism. Palmitic acid and stearic acid are saturated fatty acids commonly present in food sources like meat, dairy, and vegetable oils, making their chemical components familiar to human physiology.

No significant toxicological studies have reported adverse effects from glyceryl palmitostearate at levels used in food applications. The absence of FDA adverse event reports and recalls provides empirical evidence of safety in commercial use.

Regulatory Status

Glyceryl palmitostearate is not listed on the FDA's Generally Recognized as Safe (GRAS) list, meaning it has not undergone the formal GRAS notification process. However, this designation does not indicate the additive is unsafe; rather, it reflects that the manufacturer or petitioner has not submitted a GRAS determination to the FDA. Some food additives operate under prior sanctions, indirect food additives regulations, or other compliance pathways that do not require explicit GRAS status.

The compound may be approved for use in specific food categories under FDA regulations for food additives (21 CFR Part 172 or similar sections) without holding a dedicated GRAS status. Regulatory approval varies internationally; it may be permitted in certain food categories in the European Union, Japan, and other jurisdictions under their respective food additive regulations.

Key Studies

Limited published research specifically addresses glyceryl palmitostearate as an isolated compound. Most safety data derives from the broader category of glyceryl esters of fatty acids, which have been extensively studied. General research on saturated fatty acid esters supports the safety profile of these compounds when used as minor food components.

The lack of adverse event reports and recalls represents the strongest practical safety indicator available for this additive. Industrial safety and quality assurance data from manufacturers using this compound would provide additional evidence, though such proprietary information is typically not published in peer-reviewed literature.

Further research, including modern toxicological assessments and potential biological availability studies, could provide additional safety data for regulatory purposes.

Frequently Asked Questions

What is Glyceryl Palmitostearate?

Glyceryl palmitostearate is a synthetic lipid compound created by combining glycerol with palmitic and stearic acids. It functions as a formulation aid in food products, helping to improve texture, stability, and processing characteristics.

Is Glyceryl Palmitostearate safe?

Glyceryl Palmitostearate 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 Palmitostearate banned in any country?

Glyceryl Palmitostearate 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.