Our Verdict: SAFE

Ethyl Palmitate

CAS628-97-7

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

Ethyl Palmitate — food additive

Ethyl palmitate is a fatty acid ester used as a flavoring agent and adjuvant in food products. It occurs naturally in some foods and is employed in small quantities to enhance or modify flavor profiles in various processed foods.

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 Ethyl Palmitate?

Ethyl palmitate (CAS Number 628-97-7) is an ester formed from palmitic acid and ethanol. It is a colorless to pale yellow liquid with a mild, waxy odor. As a fatty acid ester, ethyl palmitate is chemically classified among compounds that naturally occur in foods, particularly in fats and oils. The compound has been identified in trace amounts in various foods including dairy products, meats, and plant-based oils.

Common Uses

Ethyl palmitate functions as a flavoring agent and flavoring adjuvant in the food industry. It is used in small quantities to contribute to or enhance the sensory profile of food products. The compound's waxy characteristics make it useful in formulations where fatty or creamy flavor notes are desired. It may appear in processed foods, flavorings, and food additives at very low concentrations, typically measured in parts per million (ppm).

Safety Assessment

Ethyl palmitate has generated no reported adverse events in the FDA database and has not been associated with any food recalls. The compound's safety profile is supported by its occurrence in the natural food supply and its chemical similarity to compounds already recognized as safe in foods. As a fatty acid ester, it undergoes normal metabolic pathways similar to dietary lipids when ingested.

The low molecular weight and fatty acid nature of ethyl palmitate suggest it would be readily metabolized by standard lipid digestion processes in the human body. No specific toxicological studies have raised concerns about this compound at typical food use levels.

Regulatory Status

Ethyl palmitate is not listed on the FDA's Generally Recognized as Safe (GRAS) list, meaning it has not undergone formal GRAS notification procedures. However, this does not indicate the substance is unsafe; rather, it reflects the regulatory pathway chosen by manufacturers. Some fatty acid esters are approved as food additives in various jurisdictions under different regulatory frameworks.

The European Food Safety Authority (EFSA) evaluates similar fatty acid esters as flavoring substances. Ethyl palmitate may be used in food flavoring applications in jurisdictions that permit it, though regulatory status varies by country and specific food application.

Key Studies

Limited published research specifically addresses ethyl palmitate in isolation. The compound's safety assessment relies primarily on its structural similarity to naturally occurring fatty acid esters and the absence of any documented adverse health effects. Fatty acid esters of this type are generally recognized as undergoing standard lipid metabolism.

The lack of FDA adverse event reports or recalls associated with ethyl palmitate over decades of potential food use suggests an acceptable safety margin at typical food application levels. As with all food additives, the principle of safe use depends on appropriate concentration levels and intended food applications.

Future research, if conducted, would likely focus on specific toxicological endpoints or use levels in particular food categories. Current evidence does not suggest concerning safety issues at typical food flavoring concentrations.

Frequently Asked Questions

What is Ethyl Palmitate?

Ethyl palmitate is a fatty acid ester used as a flavoring agent and adjuvant in food products. It occurs naturally in some foods and is employed in small quantities to enhance or modify flavor profiles in various processed foods.

Is Ethyl Palmitate safe?

Ethyl Palmitate 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 Ethyl Palmitate banned in any country?

Ethyl Palmitate 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.