Our Verdict: RATING UNKNOWN

Ethyl 4-phenylbutyrate

CAS10031-93-3

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

Ethyl 4-phenylbutyrate — food additive

Ethyl 4-phenylbutyrate is an organic compound used as a flavoring agent and flavor enhancer in food products. It contributes fruity and floral aromatic notes to various food and beverage formulations.

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 Ethyl 4-phenylbutyrate?

Ethyl 4-phenylbutyrate (CAS Number: 10031-93-3) is a synthetic organic compound belonging to the ester class of chemicals. It is composed of an ethyl group attached to a 4-phenylbutyric acid backbone, creating a colorless to pale yellow liquid with characteristic fruity and floral aromatic properties. The compound is manufactured through chemical synthesis rather than extracted from natural sources, though similar aromatic compounds occur in various fruits.

Common Uses

Ethyl 4-phenylbutyrate is used primarily in the food and beverage industry as a flavoring agent and flavor enhancer. Its fruity and floral sensory characteristics make it suitable for:

- Beverages (soft drinks, flavored waters, alcoholic drinks)

- Confectionery and candy products

- Dairy products (yogurts, ice cream, flavored milk)

- Baked goods and desserts

- Savory food applications where subtle fruity notes are desired

The compound functions to enhance or modify the overall flavor profile of food products, typically used in very small quantities to achieve the desired sensory effect. Its use follows standard flavoring agent practices in the food industry.

Safety Assessment

Ethyl 4-phenylbutyrate has not been designated as Generally Recognized as Safe (GRAS) by the FDA, meaning it has not completed the formal GRAS notification process. However, this designation does not indicate the substance is unsafe; rather, it reflects that the compound may have limited commercial history or that formal GRAS documentation has not been submitted and accepted by regulatory authorities.

According to FDA records available through adverse event reporting systems, there are zero reported adverse events associated with this additive. Similarly, no food recalls attributable to ethyl 4-phenylbutyrate have been documented in FDA databases. This absence of reported incidents suggests the additive has not raised significant safety concerns in practical food applications.

The compound's safety profile is comparable to other synthetic flavoring esters used in food manufacturing. Like all food additives, it is subject to quantity restrictions and is intended for use in flavor applications where only small amounts are required to achieve the intended effect.

Regulatory Status

In the United States, ethyl 4-phenylbutyrate is not on the FDA's GRAS list, which means its use may require pre-market approval or compliance with specific regulations depending on the intended application and food category. Manufacturers using this additive must ensure compliance with FDA food additive regulations and labeling requirements.

The European Food Safety Authority (EFSA) maintains separate evaluations of flavoring substances under EC Regulation No 1334/2008. Regulatory status may vary between regions, and manufacturers should verify compliance requirements for their specific markets before use.

Any food product containing ethyl 4-phenylbutyrate must be properly labeled according to applicable regulations in the jurisdiction where it is sold. In the United States, it would typically appear on ingredient lists under its chemical name or an acceptable alternative designation.

Key Studies

Limited published scientific literature specifically focuses on ethyl 4-phenylbutyrate's safety in food applications, which is typical for specialized synthetic flavoring compounds. The compound's chemical structure is well-characterized, and its properties are consistent with other aliphatic esters used in the flavor industry.

General toxicology data on structurally similar phenylbutyrate compounds suggests these substances are rapidly metabolized and do not accumulate in tissues. Standard safety evaluation principles applied to flavoring agents involve assessment of the compound's metabolic fate, potential for bioaccumulation, and any genotoxic or reproductive effects.

The absence of adverse event reports and recalls provides empirical evidence of safe use at levels currently employed in food manufacturing. However, comprehensive toxicological studies specific to this compound may be limited in public literature.

Frequently Asked Questions

What is Ethyl 4-phenylbutyrate?

Ethyl 4-phenylbutyrate is an organic compound used as a flavoring agent and flavor enhancer in food products. It contributes fruity and floral aromatic notes to various food and beverage formulations.

Is Ethyl 4-phenylbutyrate safe?

Ethyl 4-phenylbutyrate 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 Ethyl 4-phenylbutyrate banned in any country?

Ethyl 4-phenylbutyrate 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.