Our Verdict: RATING UNKNOWN

Amyl Butyrate

CAS540-18-1

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

Amyl Butyrate — food additive

Amyl butyrate is an organic ester compound used as a flavoring agent in food products to provide fruity, banana-like sensory notes. It is not approved as a food additive by the FDA but may be used in certain flavoring preparations under specific regulatory frameworks.

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 Amyl Butyrate?

Amyl butyrate (CAS Number 540-18-1) is an organic ester compound composed of amyl alcohol and butyric acid. It is a colorless to pale yellow liquid with a characteristic fruity aroma reminiscent of bananas and pears. The compound occurs naturally in small quantities in various fruits and fermented foods, though it is primarily synthesized for commercial flavoring applications.

Common Uses

Amyl butyrate is used in the food industry as a flavoring agent and flavor enhancer, primarily in:

- Confectionery and candy products

- Beverage formulations

- Baked goods and desserts

- Dairy products

- Flavoring compounds and mixtures

The compound is valued for its ability to impart fruity, ester-type flavors that enhance the sensory profile of processed foods. It is typically used in very small concentrations, as is standard practice with flavor compounds.

Safety Assessment

Amyl butyrate has not generated adverse event reports in the FDA database, and no food recalls have been associated with this ingredient. The absence of reported adverse events suggests it has not been identified as causing harm at typical use levels.

As an ester, amyl butyrate is structurally similar to naturally occurring compounds found in fruits and fermented beverages. Like many flavor compounds, it is used at minimal concentrations in finished food products, which limits potential exposure.

The compound undergoes metabolism similar to other short-chain esters, being hydrolyzed in the gastrointestinal tract into its component parts (amyl alcohol and butyric acid), which are further metabolized through standard biochemical pathways.

Regulatory Status

Amyl butyrate is not on the FDA's Generally Recognized as Safe (GRAS) list, meaning it has not received formal GRAS determination. However, this classification does not indicate safety concerns; rather, it reflects that formal GRAS notification has not been submitted or completed for this particular compound.

In the European Union, amyl butyrate may be used as a flavoring substance under Regulation (EC) No 1334/2008, which governs flavorings in food. This suggests acceptance in some regulatory jurisdictions for use in flavoring preparations.

The regulatory approach to amyl butyrate reflects the framework for flavor compounds, which are typically regulated differently from food additives due to their use in minimal quantities and the extensive history of similar esters in food applications.

Key Studies

Limited published research specifically addresses amyl butyrate safety, consistent with the general approach to flavor compounds. Safety evaluation typically relies on:

- Chemical structure analysis and comparison to approved esters

- Historical use data in food applications

- Metabolic studies of related compounds

- Acute toxicity data from animal studies

The lack of reported adverse events in food use and the absence of regulatory warnings suggest that amyl butyrate has not raised safety concerns at typical exposure levels. However, comprehensive modern safety studies specific to this compound are not readily available in public databases.

When evaluating flavor compounds, regulatory agencies consider that these substances are used at extremely low concentrations and that the human body has established metabolic pathways for processing similar esters found naturally in foods.

Frequently Asked Questions

What is Amyl Butyrate?

Amyl butyrate is an organic ester compound used as a flavoring agent in food products to provide fruity, banana-like sensory notes. It is not approved as a food additive by the FDA but may be used in certain flavoring preparations under specific regulatory frameworks.

Is Amyl Butyrate safe?

Amyl Butyrate 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 Amyl Butyrate banned in any country?

Amyl Butyrate 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.