Our Verdict: RATING UNKNOWN

3-hydroxy-2-octanone

CAS37160-77-3

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-octanone — food additive

3-hydroxy-2-octanone is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS substance by the FDA, though no adverse events or recalls have been associated with its use.

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-octanone?

3-hydroxy-2-octanone (CAS Number 37160-77-3) is an organic compound belonging to the class of ketone alcohols. It is characterized by a hydroxyl group (-OH) and a ketone functional group (-C=O) on an eight-carbon backbone. This compound occurs naturally in various plant sources and has been identified in food matrices, though its presence is typically in trace amounts. The chemical structure contributes to its sensory properties, which are relevant to its application in the food industry.

Common Uses

3-hydroxy-2-octanone is utilized as a flavoring agent or flavoring adjuvant in the food industry. Flavoring agents in this chemical class are intended to contribute to the taste and aroma profile of food products. As a ketone alcohol, this compound may impart fruity, floral, or other sensory characteristics depending on concentration and application. It would typically be used in small quantities in products such as beverages, confections, baked goods, or other processed foods where flavor enhancement is desired. The specific food categories in which this substance is employed may vary by region and manufacturer.

Safety Assessment

According to FDA records, there have been zero adverse events reported in association with 3-hydroxy-2-octanone, and no product recalls have been linked to this additive. This absence of reported safety incidents provides a baseline indicator of safety in current use patterns. However, the lack of GRAS (Generally Recognized as Safe) status indicates that the FDA has not formally evaluated and approved this substance as safe for general use in food. GRAS status requires comprehensive safety data and scientific consensus, which may not have been formally established for this particular compound.

Limited published toxicological data is available in scientific literature for 3-hydroxy-2-octanone. Safety assessment of flavoring agents typically considers acute toxicity, chronic toxicity, genotoxicity, and reproductive effects. The compound's molecular structure and similarity to other approved ketone alcohols suggest it may have a reasonable safety profile, but definitive conclusions require adequate study data.

Regulatory Status

In the United States, 3-hydroxy-2-octanone does not hold GRAS status with the FDA. This means it cannot be used in food products without specific FDA approval or pre-market notification under the flavor regulations. Some flavoring substances may be marketed under a Flavor and Extract Manufacturers' Association (FEMA) GRAS determination, which operates under FDA oversight but represents an alternative approval pathway. The regulatory status of this additive may differ in other countries; the European Food Safety Authority (EFSA) and other international regulatory bodies maintain separate approval processes and substance lists.

Manufacturers seeking to use 3-hydroxy-2-octanone in food products would need to ensure compliance with applicable regulations in their target markets. Regulatory requirements may include providing safety data, usage levels, and technical specifications to relevant authorities.

Key Studies

Scientific literature on 3-hydroxy-2-octanone remains limited compared to more widely used food additives. Most safety evaluations of related ketone alcohols come from broader assessments of naturally occurring flavor compounds or structural analogs. The absence of reported adverse events suggests acceptable safety margins in practical use scenarios, but formal peer-reviewed toxicological studies specific to this compound would strengthen the scientific basis for its safety assessment. Further research on absorption, metabolism, and potential long-term effects could provide additional clarity regarding its safety profile.

Frequently Asked Questions

What is 3-hydroxy-2-octanone?

3-hydroxy-2-octanone is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS substance by the FDA, though no adverse events or recalls have been associated with its use.

Is 3-hydroxy-2-octanone safe?

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

3-hydroxy-2-octanone 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.