Our Verdict: RATING UNKNOWN

Ethyl Nitrite

CAS109-95-5

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 Nitrite — food additive

Ethyl nitrite (CAS 109-95-5) is a volatile organic compound used as a flavoring agent in food products. It imparts a characteristic sharp, pungent flavor and is utilized in very small quantities in food 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
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 Nitrite?

Ethyl nitrite is an organic compound with the chemical formula C2H5NO2. It is a colorless to pale yellow liquid with a sharp, distinctive odor. As a nitrite compound, ethyl nitrite belongs to a class of chemicals that have been studied extensively for food safety purposes. The compound is volatile and exists in equilibrium with nitrogen oxide gases, which contributes to its sensory characteristics.

Common Uses

Ethyl nitrite is classified as a flavoring agent or flavoring adjuvant in food applications. Its primary function is to contribute distinctive flavor notes to food products. Due to its volatility and potent flavor profile, it is used in extremely small quantities—typically measured in parts per million. The compound may be employed in specialty food products, seasonings, or flavoring formulations where its unique organoleptic properties are desired. However, its use in commercial food products is limited compared to more traditional flavoring agents.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with ethyl nitrite and zero product recalls related to this additive. This lack of adverse event reporting suggests that products containing this ingredient have not generated safety concerns significant enough to warrant FDA investigation or consumer complaints.

The safety profile of ethyl nitrite should be understood in the context of its intended use levels. As with many flavoring compounds, the dose and exposure level are critical factors in safety assessment. The extremely low concentrations at which ethyl nitrite is used in food applications—typically parts per million or even lower—are substantially different from amounts that might pose toxicological concerns.

Like other nitrite compounds used in food, ethyl nitrite has been subject to scientific scrutiny regarding potential formation of nitrosamines or other reaction products. However, under normal food storage and processing conditions, and at the low levels used for flavoring purposes, such concerns are minimized.

Regulatory Status

Ethyl nitrite is not currently listed as a GRAS (Generally Recognized As Safe) substance by the FDA. This designation does not indicate that the substance is unsafe; rather, it means that it has not undergone the formal GRAS affirmation process or does not meet the criteria for GRAS classification. The absence of GRAS status may reflect limited commercial use, limited safety data in the published scientific literature, or the specialized nature of its applications.

For products containing ethyl nitrite, manufacturers would typically need to comply with FDA regulations for food additives, which may require appropriate labeling and documentation of safety. The regulatory landscape for flavoring agents can vary by intended use and market, and compliance requirements should be verified with current FDA regulations and guidance documents.

Key Studies

Scientific literature on ethyl nitrite specifically is limited, which is consistent with its narrow application in food products. Most research on nitrite compounds in food has focused on sodium nitrite and potassium nitrite, which are more widely used as curing agents and preservatives. General toxicological studies on volatile organic compounds and nitrite chemistry provide the scientific foundation for understanding ethyl nitrite's behavior in food systems.

The absence of published adverse event data and recall information in FDA records indicates that products containing this additive have not raised significant safety flags in regulatory oversight. Continued monitoring and adherence to established food safety protocols remain standard practice for all food additives, including those with limited GRAS designation.

Frequently Asked Questions

What is Ethyl Nitrite?

Ethyl nitrite (CAS 109-95-5) is a volatile organic compound used as a flavoring agent in food products. It imparts a characteristic sharp, pungent flavor and is utilized in very small quantities in food applications.

Is Ethyl Nitrite safe?

Ethyl Nitrite 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 Nitrite banned in any country?

Ethyl Nitrite 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.