Our Verdict: RATING UNKNOWN

3-hydroxy-4-phenylbutan-2-one

CAS5355-63-5

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

3-hydroxy-4-phenylbutan-2-one — food additive

3-hydroxy-4-phenylbutan-2-one is an organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS (Generally Recognized as Safe) substance by the FDA, though no adverse events or recalls have been associated with it.

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 3-hydroxy-4-phenylbutan-2-one?

3-hydroxy-4-phenylbutan-2-one (CAS Number: 5355-63-5) is a synthetic organic compound belonging to the class of aromatic ketones. It contains a phenyl group (a benzene ring) attached to a four-carbon backbone with a hydroxyl group and a ketone functional group. This chemical structure gives it properties that make it suitable for use as a flavoring agent or flavor adjuvant in food applications.

Common Uses

As a flavoring agent, 3-hydroxy-4-phenylbutan-2-one is used to impart or enhance specific taste and aroma profiles in food and beverage products. Flavoring agents like this compound are typically used in very small quantities—often measured in parts per million—to achieve desired sensory characteristics. The compound would likely be used in products such as beverages, confectionery, baked goods, or other processed foods where complex flavor profiles are desired.

The specific organoleptic properties (taste and smell characteristics) of this compound make it valuable in flavor formulation, though detailed information about its exact sensory profile is limited in publicly available sources.

Safety Assessment

According to FDA records, there have been zero adverse events reported and zero recalls associated with 3-hydroxy-4-phenylbutan-2-one. This lack of reported adverse outcomes is noteworthy, though it should be understood in context: the absence of reported adverse events does not automatically indicate that comprehensive safety testing has been completed.

The compound has not been granted GRAS (Generally Recognized as Safe) status by the FDA. GRAS status requires either a substantial history of safe use in food or completion of toxicological testing demonstrating safety. The lack of GRAS status suggests that either the compound has not undergone the formal GRAS petition process, the evidence of safety was considered insufficient to support such a designation, or the compound simply has not been formally evaluated through this regulatory pathway.

For synthetic flavoring agents, manufacturers are typically required to ensure safety through appropriate testing before market introduction. The specific safety data for this compound—such as acute toxicity studies, subchronic toxicity data, or genotoxicity assessments—would need to be reviewed from manufacturer submissions or scientific literature to make a comprehensive safety determination.

Regulatory Status

In the United States, 3-hydroxy-4-phenylbutan-2-one is not listed as a GRAS substance, meaning it cannot be assumed to be safe based on common knowledge or extensive history of safe use. If used in food products, its safety would need to be substantiated through other means, such as notification to the FDA's Flavoring Inventory or completion of adequate safety testing.

In the European Union, flavoring substances are subject to evaluation by the European Food Safety Authority (EFSA) and must be listed in the EU Register of Flavoring Substances. The regulatory status of this compound in the EU may differ from its status in the United States.

Manufacturers utilizing this compound in food products would need to ensure compliance with applicable regulations in their target markets and maintain appropriate safety documentation.

Key Studies

Publicly available scientific literature on 3-hydroxy-4-phenylbutan-2-one appears limited. Most information about this compound exists in proprietary industry databases, manufacturer technical documents, or regulatory submissions not readily accessible to the general public. Additional toxicological and safety data may exist in confidential manufacturer files or regulatory agency records.

Because this compound is a specialty flavoring ingredient, comprehensive safety studies may have been conducted by manufacturers but not published in peer-reviewed journals. Consumers seeking detailed safety information about products containing this ingredient can contact manufacturers directly for additional documentation.

Frequently Asked Questions

What is 3-hydroxy-4-phenylbutan-2-one?

3-hydroxy-4-phenylbutan-2-one is an organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS (Generally Recognized as Safe) substance by the FDA, though no adverse events or recalls have been associated with it.

Is 3-hydroxy-4-phenylbutan-2-one safe?

3-hydroxy-4-phenylbutan-2-one 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 3-hydroxy-4-phenylbutan-2-one banned in any country?

3-hydroxy-4-phenylbutan-2-one 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.