Our Verdict: SAFE

Ethyl Octadecanoate

CAS111-61-5

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 Octadecanoate — food additive

Ethyl octadecanoate is a fatty acid ester derived from stearic acid and ethanol, used as a flavoring agent and sensory adjuvant in food products. It contributes waxy, fatty flavor notes and texture characteristics to various food formulations.

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 Octadecanoate?

Ethyl octadecanoate (CAS Number 111-61-5) is a long-chain fatty acid ester composed of ethanol and octadecanoic acid (stearic acid). It is a colorless to pale yellow waxy or oily compound with a molecular weight of 312.53 g/mol. This ingredient belongs to the class of esters commonly used in the food industry as flavoring agents and sensory modifiers.

Common Uses

Ethyl octadecanoate is employed in the food industry primarily as a flavoring agent and texture adjuvant. Its applications include:

- Contribution to waxy and fatty flavor profiles in processed foods

- Enhancement of mouthfeel and sensory characteristics in confections

- Use in food emulsions and formulations requiring fatty acid components

- Potential applications in flavor compounds and fragrance systems that border food and cosmetic applications

The compound is utilized in relatively small concentrations, as is typical for flavoring agents in food manufacturing.

Safety Assessment

Ethyl octadecanoate has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA, meaning it has not undergone the specific FDA GRAS notification process. However, the absence of GRAS status does not indicate the ingredient is unsafe; rather, it reflects regulatory classification and submission history.

The available data shows no reported adverse events associated with this ingredient in FDA databases and no documented recalls linked to ethyl octadecanoate. The compound is structurally similar to naturally occurring fatty acid esters found in foods, and ethanol and stearic acid are both widely accepted food components.

As a fatty acid ester, ethyl octadecanoate would be expected to undergo normal metabolic pathways similar to other dietary fatty acid esters. The ester would likely be hydrolyzed in the digestive system into its component parts: stearic acid and ethanol, both of which are naturally metabolized by the body.

Regulatory Status

In the United States, ethyl octadecanoate is regulated as a food additive. Its use is permitted under FDA regulations for flavoring purposes in food applications, though specific use levels and applications may be subject to FDA compliance requirements.

The European Union's flavor regulation framework includes assessment procedures for flavoring substances. While specific EU approval status varies by application and concentration, the ingredient is recognized within international flavor and fragrance databases.

The ingredient appears in the International Organization for Standardization (ISO) and various flavor industry standards, indicating recognition within international regulatory frameworks.

Key Studies

Limited published research specifically focuses on ethyl octadecanoate in isolation. However, the safety profile of structurally similar fatty acid esters has been established through numerous studies. The metabolic fate of long-chain fatty acid esters shows they are efficiently hydrolyzed and absorbed through standard lipid metabolism pathways.

General toxicology data for fatty acid esters demonstrates low systemic toxicity when used at food-relevant concentrations. The absence of reported adverse events in regulatory databases supports an acceptable safety profile for intended food applications.

Research on stearic acid and ethanol—the hydrolysis products of this ester—confirms both are normal dietary constituents metabolized without concern at typical exposure levels.

Frequently Asked Questions

What is Ethyl Octadecanoate?

Ethyl octadecanoate is a fatty acid ester derived from stearic acid and ethanol, used as a flavoring agent and sensory adjuvant in food products. It contributes waxy, fatty flavor notes and texture characteristics to various food formulations.

Is Ethyl Octadecanoate safe?

Ethyl Octadecanoate 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 Octadecanoate banned in any country?

Ethyl Octadecanoate 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.