Our Verdict: SAFE

Amyl Hexanoate

CAS540-07-8

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

Amyl Hexanoate — food additive

Amyl hexanoate is a naturally occurring ester compound used as a flavoring agent in food products. It imparts fruity, banana-like sensory characteristics and is employed in confectionery, beverages, and other processed foods to enhance taste profiles.

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
ApprovedHealth 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 Hexanoate?

Amyl hexanoate, also known as pentyl hexanoate or amyl caproate, is an ester with the chemical formula C11H22O2 and CAS number 540-07-8. It is a volatile organic compound that occurs naturally in various fruits and fermented foods. The compound consists of a pentyl (5-carbon) alcohol group combined with hexanoic acid (a 6-carbon fatty acid). In its pure form, amyl hexanoate is a colorless liquid with a characteristic fruity aroma.

Common Uses

Amyl hexanoate functions primarily as a flavoring agent and flavoring adjuvant in the food industry. Its fruity, banana-like aroma makes it valuable in:

- Confectionery products including candies and chewing gums

- Beverage flavorings, particularly fruit-flavored drinks

- Baked goods and desserts

- Dairy products and ice cream

- Processed fruit preparations

The compound is typically used in very small concentrations, measured in parts per million (ppm), to achieve the desired sensory effect without contributing significantly to the caloric or nutritional content of foods.

Safety Assessment

Amyl hexanoate has generated no adverse event reports in the FDA database and has not been associated with any food recalls. The compound's safety profile is supported by its presence in naturally occurring foods and fermented products, where it exists as part of the natural flavor matrix.

As an ester, amyl hexanoate belongs to a class of compounds generally recognized as having low systemic toxicity when ingested in the small quantities used in food applications. The volatile nature of the compound means that substantial portions are lost during typical food preparation and storage processes.

Animal studies on related aliphatic esters have not demonstrated significant toxicological concerns at food-relevant exposure levels. The compound does not appear on lists of known allergens and has not been documented to cause allergic reactions in the general population at typical usage levels.

Regulatory Status

Amyl hexanoate does not currently hold FDA GRAS (Generally Recognized As Safe) status, which reflects the absence of a formal petition or sufficient publicly available safety data meeting FDA's stringent documentation requirements for GRAS affirmation. However, the lack of GRAS status does not indicate a safety concern; rather, it reflects the regulatory pathway not having been formally pursued.

The compound may be used in food in many jurisdictions under various regulatory frameworks. In the European Union, ester-based flavorings including amyl hexanoate are evaluated and approved under Regulation (EC) No 1334/2008 on flavorings. Usage levels are typically established based on traditional use and safety assessments.

Importers and manufacturers using amyl hexanoate must ensure compliance with their specific regulatory jurisdiction's requirements regarding flavoring ingredients and proper labeling practices.

Key Studies

Limited published peer-reviewed research specifically focuses on amyl hexanoate in isolation. Most relevant toxicological data derives from:

1. General ester safety assessments conducted by regulatory bodies

2. EFSA (European Food Safety Authority) evaluations of flavoring compounds

3. Studies on structurally similar aliphatic esters and their metabolic pathways

4. Natural occurrence data documenting amyl hexanoate in fruits and fermented beverages

The compound is readily metabolized through standard fatty acid and alcohol oxidation pathways when ingested. No evidence suggests bioaccumulation or persistence in body tissues. Regulatory agencies have not identified genotoxic or carcinogenic potential based on available evidence.

Additional research or formal safety documentation would strengthen the evidence base for regulatory approval in jurisdictions where such documentation is required.

Frequently Asked Questions

What is Amyl Hexanoate?

Amyl hexanoate is a naturally occurring ester compound used as a flavoring agent in food products. It imparts fruity, banana-like sensory characteristics and is employed in confectionery, beverages, and other processed foods to enhance taste profiles.

Is Amyl Hexanoate safe?

Amyl Hexanoate 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 Amyl Hexanoate banned in any country?

Amyl Hexanoate 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.