Our Verdict: RATING UNKNOWN

Sucrose Monopalmitate

CAS26446-38-8

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Sucrose Monopalmitate — food additive

Sucrose monopalmitate is a synthetic emulsifier derived from sucrose and palmitic acid. It functions as a flavoring agent and adjuvant in food products, helping to improve texture and stability in various applications.

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 Sucrose Monopalmitate?

Succrose monopalmitate (CAS Number: 26446-38-8) is a synthetic compound created through the chemical combination of sucrose (table sugar) and palmitic acid (a saturated fatty acid). It belongs to the class of sugar esters, which are compounds formed when sugars react with fatty acids. The resulting molecule functions as both an emulsifier and flavoring agent, allowing it to blend ingredients that would normally separate, such as oil and water-based components.

Common Uses

Succrose monopalmitate is utilized in the food industry primarily as a flavoring agent adjuvant, meaning it supports and enhances flavor characteristics in food formulations. Sugar esters like this compound are employed in various food applications including baked goods, dairy products, confectionery, and processed foods where emulsification and texture improvement are desired. The additive helps maintain product consistency and extends shelf life by preventing ingredient separation.

Safety Assessment

According to FDA records, there have been zero adverse events reported associated with sucrose monopalmitate. Additionally, no food recalls linked to this additive have been documented in FDA databases. The compound has not been designated as Generally Recognized as Safe (GRAS) by the FDA, which means it has not undergone the formal GRAS affirmation process, though this classification does not necessarily indicate a safety concern.

As a sugar ester, sucrose monopalmitate is structurally similar to naturally occurring esters found in foods. When metabolized, the compound would theoretically break down into its component parts: sucrose and palmitic acid, both of which are common food ingredients with established safety profiles. The absence of reported adverse events and recalls suggests the additive has not posed observable safety issues in commercial food applications to date.

Regulatory Status

The regulatory status of sucrose monopalmitate varies internationally. While not GRAS-affirmed in the United States, it may be permitted in certain food applications under FDA regulations governing food additives. Its use would be subject to FDA oversight as a food additive, meaning manufacturers must comply with established safety and labeling requirements.

In the European Union, sugar esters including sucrose monopalmitate are evaluated by the European Food Safety Authority (EFSA). The regulatory framework in Europe may differ from United States regulations, with some formulations approved for specific uses while others may have restrictions.

Manufacturers using this additive must ensure compliance with labeling requirements and food safety regulations in their respective jurisdictions. The lack of GRAS status does not prevent its use but requires adherence to established food additive regulations.

Key Studies

Limited peer-reviewed research specifically addressing sucrose monopalmitate exists in publicly available scientific literature. The safety profile of sugar esters as a class has been studied more broadly, with research generally supporting their safety when used at typical food additive levels. The absence of reported adverse events and recalls in FDA databases suggests that any human consumption of this additive through food products has not resulted in documented safety concerns.

Further research on the specific toxicology, metabolism, and long-term effects of sucrose monopalmitate would provide additional data for safety assessment, though current evidence suggests no significant safety hazards.

Frequently Asked Questions

What is Sucrose Monopalmitate?

Sucrose monopalmitate is a synthetic emulsifier derived from sucrose and palmitic acid. It functions as a flavoring agent and adjuvant in food products, helping to improve texture and stability in various applications.

Is Sucrose Monopalmitate safe?

Sucrose Monopalmitate is currently rated "unknown" 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 Sucrose Monopalmitate banned in any country?

Sucrose Monopalmitate 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.