Our Verdict: RATING UNKNOWN

5-hydroxy-4-octanone

CAS496-77-5

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

5-hydroxy-4-octanone — food additive

5-hydroxy-4-octanone (CAS 496-77-5) is an organic compound used as a flavoring agent in food products. It functions to impart or enhance flavor characteristics in various food and beverage applications.

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 5-hydroxy-4-octanone?

5-hydroxy-4-octanone is an organic chemical compound classified as a flavoring agent or flavoring adjuvant. It is an eight-carbon chain molecule with a ketone functional group and a hydroxyl group, giving it both hydrophobic and hydrophilic properties. This structural composition enables it to dissolve and disperse effectively in food systems while contributing specific sensory characteristics.

The compound is produced through synthetic chemical processes and is used in very small quantities in food formulations. Like many flavoring compounds, it exists naturally in trace amounts in some foods, though commercial applications typically utilize synthetically produced versions.

Common Uses

5-hydroxy-4-octanone is employed as a flavoring agent in processed foods and beverages where it contributes to overall flavor profiles. It may be used in dairy products, confectionery, beverages, and other food categories where subtle flavor enhancement is desired. The compound typically appears in ingredient lists under the broad category of "natural and artificial flavors" or "flavoring agents" rather than as a specifically named ingredient.

Its use follows standard industry practice for complex flavor compounds, where multiple ingredients work synergistically to achieve desired taste profiles. The specific concentration used in food products is generally very low, consistent with typical flavoring agent applications.

Safety Assessment

According to FDA records, there have been zero adverse events reported in association with 5-hydroxy-4-octanone and zero product recalls involving this ingredient. This lack of documented safety incidents suggests a favorable safety profile in current use.

The compound has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA, which means it has not undergone the formal GRAS notification process. However, the absence of GRAS status does not necessarily indicate a safety concern; rather, it reflects regulatory pathway choices made by manufacturers. Some food additives are used under FDA approval through other regulatory mechanisms or have not been formally petitioned for GRAS status despite safe usage.

Toxicological data on 5-hydroxy-4-octanone remains limited in published scientific literature. The compound's structural similarity to other approved flavoring compounds and the absence of reported adverse events in decades of use suggest it does not pose obvious toxicological concerns at current use levels.

Regulatory Status

In the United States, 5-hydroxy-4-octanone is permitted for use as a flavoring agent in food, though it operates under indirect food additive or flavoring agent regulations rather than as a directly approved food additive with explicit GRAS status. It may be used in food products subject to FDA oversight and labeling requirements.

International regulatory status varies by jurisdiction. The European Food Safety Authority (EFSA) maintains separate approval processes for food flavorings, and availability in EU markets may differ from United States regulations.

Manufacturers using this ingredient in food products are responsible for ensuring compliance with all applicable regulations in their target markets and for maintaining appropriate documentation of ingredient safety.

Key Studies

Published scientific literature specifically evaluating 5-hydroxy-4-octanone remains sparse. Most information about this compound derives from chemical databases, regulatory filings, and industry documentation rather than published peer-reviewed research.

The compound's safety assessment largely relies on structural analogy to related approved flavoring compounds, the absence of reported adverse events in actual use, and standard toxicological principles applied to flavoring compounds used at very low concentrations.

Further research into the toxicological profile and metabolism of 5-hydroxy-4-octanone could provide additional safety data, though current evidence does not indicate urgent safety concerns requiring such investigation.

Frequently Asked Questions

What is 5-hydroxy-4-octanone?

5-hydroxy-4-octanone (CAS 496-77-5) is an organic compound used as a flavoring agent in food products. It functions to impart or enhance flavor characteristics in various food and beverage applications.

Is 5-hydroxy-4-octanone safe?

5-hydroxy-4-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 5-hydroxy-4-octanone banned in any country?

5-hydroxy-4-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.