Our Verdict: RATING UNKNOWN

Ethyl Formate

CAS109-94-4

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

Ethyl Formate — food additive

Ethyl formate is a naturally occurring organic compound used as a flavoring agent in food products. It provides fruity, rum-like flavor notes and is also utilized in food preservation 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 Ethyl Formate?

Ethyl formate (CAS Number 109-94-4) is a simple formate ester composed of formic acid and ethanol. It is a colorless liquid with a characteristic fruity, pleasant odor reminiscent of rum and other spirits. The compound occurs naturally in various fruits and fermented beverages, contributing to their distinctive flavor profiles. In food manufacturing, ethyl formate is synthesized chemically for use as a flavoring additive.

Common Uses

Ethyl formate is primarily employed as a flavoring agent in the food and beverage industry. It is used to impart fruity and rum-like flavor notes to products including beverages, confectionery, baked goods, and desserts. Beyond flavoring applications, ethyl formate has been investigated for use as a fumigant in food processing, particularly for pest control in grains and dried fruits. Its volatile nature makes it suitable for applications where rapid dissipation is desired after treatment.

Safety Assessment

Ethyl formate has a documented history of use in food flavoring with no reported adverse events in the FDA database and no associated recalls. The compound has been evaluated for safety in food applications based on its chemical properties and observed effects in various studies. Toxicological data indicates that ethyl formate is metabolized readily in the body, breaking down into formic acid and ethanol, both of which occur naturally in foods and are processed through normal metabolic pathways. Acute toxicity studies show relatively low toxicity in animal models at reasonable exposure levels.

The European Food Safety Authority (EFSA) and other regulatory bodies have reviewed ethyl formate as a flavoring substance. Its use aligns with safety thresholds established for volatile organic compounds used in food applications. The compound's rapid volatilization and metabolism support its generally recognized safety profile when used in appropriate concentrations.

Regulatory Status

Ethyl formate does not currently hold FDA GRAS (Generally Recognized As Safe) status in the United States. However, this designation does not indicate a safety concern; rather, it reflects that a formal GRAS petition has not been submitted or approved through FDA channels. The absence of GRAS status means its use in food requires appropriate regulatory authorization. In the European Union, ethyl formate is authorized as a flavoring compound under regulations governing food additives and flavorings. Various countries maintain approval for its use as a flavoring agent in food products at specified maximum levels.

Manufacturers using ethyl formate must comply with local regulatory requirements, including maximum use levels and labeling requirements. Current regulations typically restrict ethyl formate to flavoring applications at levels that provide the desired sensory effect while remaining well below levels of toxicological concern.

Key Studies

Toxicological evaluations of ethyl formate have demonstrated low acute toxicity in standard animal models. Studies examining the metabolic fate of ethyl formate show rapid breakdown into endogenous compounds, supporting its safety profile when used at appropriate levels. Research on volatile flavor compounds, including esters like ethyl formate, indicates that such substances are processed efficiently through standard metabolic pathways. Published literature on formate esters supports their use in food applications at regulated concentrations, with no indication of cumulative toxicity or long-term health concerns at typical dietary exposure levels.

Frequently Asked Questions

What is Ethyl Formate?

Ethyl formate is a naturally occurring organic compound used as a flavoring agent in food products. It provides fruity, rum-like flavor notes and is also utilized in food preservation applications.

Is Ethyl Formate safe?

Ethyl Formate 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 Ethyl Formate banned in any country?

Ethyl Formate 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.