Our Verdict: RATING UNKNOWN

3-hydroxy-2-pentanone

CAS3142-66-3

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

3-hydroxy-2-pentanone — food additive

3-hydroxy-2-pentanone is an organic compound used as a flavoring agent in food products. It is not approved as a GRAS (Generally Recognized As Safe) substance by the FDA but has generated no adverse event reports or recalls.

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-2-pentanone?

3-hydroxy-2-pentanone (CAS Number: 3142-66-3) is an organic chemical compound classified as a ketone alcohol. It consists of a five-carbon chain with a hydroxyl group (-OH) and a ketone group (C=O) in its structure. The compound exists as a clear liquid with characteristic flavoring properties that make it useful in food manufacturing.

Common Uses

3-hydroxy-2-pentanone is utilized as a flavoring agent or flavoring adjuvant in the food industry. As a flavoring adjuvant, it may enhance, modify, or support other flavoring compounds in food formulations. It is used in very small quantities to achieve desired sensory profiles in various food products. The specific applications typically involve beverages, baked goods, confectionery, and other processed foods where complex flavor development is desired. Like most artificial flavoring compounds, it would be used in trace amounts, measured in parts per million (ppm).

Safety Assessment

The safety profile of 3-hydroxy-2-pentanone is characterized by the absence of reported adverse events to the FDA and zero product recalls associated with this substance. These facts indicate that the compound has not generated consumer safety concerns in the marketplace.

However, the compound is not listed as GRAS (Generally Recognized As Safe) by the FDA. This designation means it has not undergone or completed the formal GRAS determination process, which typically involves expert panel review and scientific literature assessment. The lack of GRAS status does not necessarily indicate a safety concern; rather, it may reflect limited submission for formal review or insufficient data supporting a GRAS petition.

For food additives not designated as GRAS, manufacturers must obtain FDA approval through the food additive petition process before marketing the ingredient for its intended use. The absence of adverse events and recalls suggests acceptable safety margins at levels used in food products, though comprehensive toxicological data may be limited in the public domain.

Regulatory Status

3-hydroxy-2-pentanone operates under a regulatory status that requires clarification regarding its approval in different markets. In the United States, while not GRAS-listed, it may be permitted under certain regulatory frameworks or may require specific food additive approval. Manufacturers using this ingredient must ensure compliance with FDA regulations and potentially obtain food additive clearance.

Regulatory status may vary internationally. The European Food Safety Authority (EFSA) maintains separate assessments and lists for approved food flavoring substances. Businesses operating across multiple jurisdictions must verify current regulations in each market, as flavoring ingredient regulations differ between regions.

Key Studies

Limited published peer-reviewed data specifically addresses 3-hydroxy-2-pentanone toxicity or safety. Most food flavoring compounds undergo safety evaluation through proprietary industry-sponsored studies submitted to regulatory agencies as part of approval processes. These submissions may not be publicly available or published in academic literature.

General understanding of this compound's safety derives from structural similarity to other hydroxyl ketones used in food, which have undergone safety assessment. The five-carbon chain length and functional group composition place it within a chemical class with established safety profiles for food applications.

The zero adverse event reports in the FDA database and absence of recalls over the period of its use suggest that exposures from food consumption have not resulted in recognized safety issues. Ongoing regulatory monitoring by the FDA through adverse event reporting systems provides continued surveillance.

Frequently Asked Questions

What is 3-hydroxy-2-pentanone?

3-hydroxy-2-pentanone is an organic compound used as a flavoring agent in food products. It is not approved as a GRAS (Generally Recognized As Safe) substance by the FDA but has generated no adverse event reports or recalls.

Is 3-hydroxy-2-pentanone safe?

3-hydroxy-2-pentanone 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-2-pentanone banned in any country?

3-hydroxy-2-pentanone 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.