Our Verdict: RATING UNKNOWN

Butylamine

CAS109-73-9

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

Butylamine — food additive

Butylamine (CAS 109-73-9) is a simple organic compound used as a flavoring agent or flavoring adjuvant in food products. It is not approved as generally recognized as safe (GRAS) by the FDA and is used in limited applications within the food industry.

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 Butylamine?

Butylamine is a primary aliphatic amine with the chemical formula C₄H₁₁N and CAS number 109-73-9. It is a colorless to pale yellow liquid with a strong, fishy odor. The compound exists as a simple four-carbon chain with an amino group (-NH₂) attached to the terminal carbon. Butylamine is a basic organic compound that can form salts with various acids and is used in industrial and food chemistry applications.

Common Uses

Butylamine is employed as a flavoring agent or flavoring adjuvant in food manufacturing. As a flavoring adjuvant, it may be used to enhance, modify, or support the sensory characteristics of food products. Its strong, distinctive odor makes it useful in creating certain flavor profiles, though it is not commonly used in mainstream consumer food products. The compound's applications are limited primarily to specialized food manufacturing where specific flavor characteristics are desired.

Safety Assessment

According to FDA records, there are no reported adverse events associated with butylamine in food use. Additionally, the FDA has documented zero recalls related to butylamine in food products. Despite this absence of reported incidents, it is important to note that butylamine has not been designated as GRAS (Generally Recognized As Safe) by the FDA, meaning it has not undergone the standard review process that establishes a substance as safe for its intended food uses.

As a chemical compound, butylamine exhibits the typical toxicological properties of primary amines. In non-food contexts, occupational exposure guidelines exist for butylamine vapor, indicating that industrial safety measures are applied. The absence of adverse event reports does not definitively establish safety; rather, it may reflect limited use, limited exposure, or limited reporting of effects. Any evaluation of safety must account for intended use levels, exposure duration, and individual sensitivity variations.

Regulatory Status

Butylamine's regulatory status differs internationally. In the United States, it is not listed as GRAS, which means it would require specific FDA approval through the food additive petition process for use in food. The lack of GRAS status indicates that the FDA has not completed a formal safety evaluation for food applications. In the European Union, butylamine is not listed on the Community list of food additives, suggesting it is not approved for use in EU member states as a food additive.

Manufacturers wishing to use butylamine in food would need to follow appropriate regulatory pathways, which vary by jurisdiction. The compound's use in food products is therefore restricted or absent in most major markets.

Key Studies

Published scientific literature on butylamine's safety as a food additive is limited. Most toxicological data on butylamine comes from occupational and industrial exposure studies rather than food consumption studies. General toxicological properties of primary amines are well-characterized, but specific safety studies evaluating butylamine as a food additive in realistic consumption scenarios appear limited in the published scientific record.

The lack of established GRAS status and the absence of specific food safety studies suggest that comprehensive safety evaluation for food use has not been completed through formal FDA review processes. Organizations considering the use of butylamine in food products would need to conduct appropriate safety studies and submit regulatory applications in their respective jurisdictions.

Frequently Asked Questions

What is Butylamine?

Butylamine (CAS 109-73-9) is a simple organic compound used as a flavoring agent or flavoring adjuvant in food products. It is not approved as generally recognized as safe (GRAS) by the FDA and is used in limited applications within the food industry.

Is Butylamine safe?

Butylamine 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 Butylamine banned in any country?

Butylamine 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.