Our Verdict: RATING UNKNOWN

Hexyl Butyrate

CAS2639-63-6

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

Hexyl Butyrate — food additive

Hexyl butyrate is an ester compound used as a flavoring agent in food products to impart fruity, apple-like sensory characteristics. It is not currently approved as a food additive by the FDA but may be used in some food applications under different 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 Hexyl Butyrate?

Hexyl butyrate (CAS Number: 2639-63-6) is an organic ester compound composed of hexanol and butyric acid. It is a colorless to pale yellow liquid with a characteristic fruity odor, commonly described as apple-like or similar to tropical fruits. As a naturally occurring compound found in some fruits and fermented products, hexyl butyrate belongs to the class of volatile organic compounds used in flavor chemistry.

Common Uses

Hexyl butyrate functions as a flavoring agent and flavor adjuvant in the food industry. It is primarily used in:

- Processed fruit beverages and drinks

- Confectionery products

- Dairy products including yogurts and flavored milks

- Baked goods and desserts

- Flavored snack foods

- Non-alcoholic beverages

The compound is valued for its ability to enhance or replicate natural fruit flavors at very low concentrations, typically in the range of parts per million (ppm). It contributes to the overall flavor profile without significantly altering other sensory characteristics of the final product.

Safety Assessment

Hexyl butyrate has not been formally evaluated by the FDA's GRAS (Generally Recognized As Safe) process. However, the absence of FDA GRAS status does not necessarily indicate a safety concern. The compound has generated zero adverse events reports to the FDA and zero product recalls associated with its use.

As an ester, hexyl butyrate is structurally similar to numerous food components and other approved flavorings. Esters are generally recognized as having low acute toxicity. The butyric acid component is a short-chain fatty acid naturally produced during human digestion and found in various foods. Hexanol, the alcohol component, is also present in small quantities in various food and beverage products.

The lack of reported adverse events in regulatory databases suggests that any exposure through food consumption has not resulted in documented health concerns. However, comprehensive toxicological studies specific to this compound's use as a food additive have not been widely published in peer-reviewed literature accessible to the general public.

Regulatory Status

Hexyl butyrate's regulatory status varies by jurisdiction:

**United States:** The FDA has not granted GRAS status to hexyl butyrate. This means it cannot be used as a flavoring in conventional foods without prior FDA approval through the food additive petition process. However, it may be used in certain food applications under specific regulatory exemptions or in countries where it has received approval.

**European Union:** The European Food Safety Authority (EFSA) may have evaluated this compound under different regulatory frameworks for flavoring substances. Regulatory status in EU member states may differ from the United States.

**International:** The compound may be approved or permitted in other countries with their own food safety evaluation systems. Regulatory acceptance varies significantly by region.

Manufacturers seeking to use hexyl butyrate in FDA-regulated food products would need to either establish a history of safe use prior to 1958 (which is unlikely given its synthetic nature) or submit a food additive petition to the FDA for evaluation and approval.

Key Studies

Published toxicological research specifically addressing hexyl butyrate as a food additive is limited in publicly available scientific literature. Most safety information derives from:

- General toxicological data for ester compounds

- Structure-activity relationship assessments comparing similar flavor esters

- Regulatory evaluations by international food safety bodies

- Historical use data in regions where the compound is permitted

The absence of extensive published studies may reflect the compound's limited current use in FDA-regulated markets rather than a specific safety concern. Additional research and regulatory assessment would be necessary to establish formal safety parameters for food use in the United States.

Frequently Asked Questions

What is Hexyl Butyrate?

Hexyl butyrate is an ester compound used as a flavoring agent in food products to impart fruity, apple-like sensory characteristics. It is not currently approved as a food additive by the FDA but may be used in some food applications under different regulatory frameworks.

Is Hexyl Butyrate safe?

Hexyl 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 Hexyl Butyrate banned in any country?

Hexyl 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.