Our Verdict: RATING UNKNOWN

Phenyl Butyrate

CAS4346-18-3

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

Phenyl Butyrate — food additive

Phenyl butyrate is an organic compound used as a flavoring agent in food products. It imparts a fruity, floral aroma and is classified as a flavor adjuvant in food manufacturing.

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 Phenyl Butyrate?

Phenyl butyrate (CAS Number 4346-18-3) is an organic ester compound composed of phenol and butyric acid. It exists as a colorless to pale yellow liquid with a characteristic fruity and floral odor. The compound belongs to the class of chemical flavoring agents used to enhance or modify the taste and aroma profiles of food and beverage products. As a volatile organic compound, phenyl butyrate readily releases aromatic compounds that contribute to product flavor perception.

Common Uses

Phenyl butyrate is employed in the food industry primarily as a flavoring agent and flavor adjuvant. Its fruity-floral sensory characteristics make it suitable for use in a variety of applications, including:

- Beverages (both alcoholic and non-alcoholic)

- Confectionery and candy products

- Baked goods

- Dairy products

- Flavored yogurts and desserts

- Processed snacks

Typical usage levels are relatively low, measured in parts per million (ppm), as the compound is potent in delivering flavor impact. Food manufacturers select phenyl butyrate when specific fruity or floral flavor notes are desired to meet consumer preferences or product formulation requirements.

Safety Assessment

Phenyl butyrate has not been designated as Generally Recognized As Safe (GRAS) by the FDA, meaning it does not have blanket approval for use in all food applications. However, this designation does not indicate a safety concern; rather, it reflects that the compound may not have undergone the comprehensive safety review process required for GRAS status, or its use may be limited to specific applications.

The FDA adverse event database contains zero reported adverse events associated with phenyl butyrate consumption, and there are no documented recalls linked to this additive. This absence of reported safety incidents suggests the additive has not caused identifiable public health concerns in food applications.

The toxicological profile of phenyl butyrate remains relatively understudied compared to more widely used food additives. Most phenolic compounds and their esters display low systemic toxicity when consumed in typical food flavoring amounts. The compound's volatility means significant portions are likely lost during food processing and preparation, further reducing potential exposure levels.

Regulatory Status

In the United States, phenyl butyrate's regulatory status depends on its intended use and application. Since it lacks FDA GRAS status, its use may be restricted or require specific authorization for particular food categories. Food manufacturers wishing to use phenyl butyrate in new applications or foods may need to submit supporting safety documentation to the FDA.

International regulatory bodies maintain varying approval statuses for phenyl butyrate. The European Food Safety Authority (EFSA) maintains databases of approved flavoring substances, and phenyl butyrate's inclusion depends on the specific food application and regional regulations.

Manufacturers using phenyl butyrate must comply with all applicable food additive regulations in their operating jurisdictions, including proper labeling and dosage limitations. The compound is subject to food additive compliance programs that ensure quality and purity standards.

Key Studies

Limited published research specifically evaluates phenyl butyrate's safety in food applications. Most available scientific literature focuses on phenolic compounds and ester derivatives as chemical classes rather than this specific compound. Research on related flavor compounds suggests that phenolic esters are generally metabolized efficiently by the body and do not accumulate in tissues.

The absence of peer-reviewed toxicology studies specific to phenyl butyrate reflects both its limited use scope and the general regulatory approach to minor flavor compounds. Manufacturers relying on phenyl butyrate typically support its safety through acute toxicity testing, metabolic studies, and reference to structural analogs with established safety profiles.

Further independent research would help establish more comprehensive safety data for this flavoring agent, particularly regarding long-term exposure at typical food consumption levels.

Frequently Asked Questions

What is Phenyl Butyrate?

Phenyl butyrate is an organic compound used as a flavoring agent in food products. It imparts a fruity, floral aroma and is classified as a flavor adjuvant in food manufacturing.

Is Phenyl Butyrate safe?

Phenyl 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 Phenyl Butyrate banned in any country?

Phenyl 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.