Our Verdict: RATING UNKNOWN

5-oxooctanoic Acid

CAS3637-14-7

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-oxooctanoic Acid — food additive

5-oxooctanoic acid (CAS 3637-14-7) is an organic compound used as a flavoring agent in food products. This fatty acid derivative contributes to flavor profiles in various food applications where it is permitted.

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-oxooctanoic Acid?

5-oxooctanoic acid is an eight-carbon organic compound with a ketone functional group and a carboxylic acid moiety. Its chemical structure (CAS Number: 3637-14-7) classifies it as a branched fatty acid derivative. This compound exists as a white to off-white solid or liquid and is used in food manufacturing primarily for its organoleptic properties.

Common Uses

5-oxooctanoic acid functions as a flavoring agent or flavor adjuvant in the food industry. Flavor adjuvants are compounds that enhance, modify, or round out the sensory characteristics of food products without necessarily providing a distinct flavor themselves. This additive is used in various processed foods where regulatory frameworks permit its application. The specific foods in which it appears depend on regional approval status and manufacturer formulation practices.

Safety Assessment

The available safety data for 5-oxooctanoic acid shows no reported adverse events to the FDA and no associated product recalls. This absence of documented safety incidents in the U.S. market provides a baseline indicator that the compound has not generated consumer health complaints or regulatory enforcement actions.

However, it is important to note that the absence of reported adverse events does not constitute formal safety approval. The compound has not been granted GRAS (Generally Recognized As Safe) status by the FDA, which means it has not undergone the formal safety evaluation process that GRAS designation requires. GRAS status involves either FDA affirmation through formal petition review or qualified expert consensus based on published scientific literature.

As a fatty acid derivative, 5-oxooctanoic acid would be expected to have low systemic toxicity profiles similar to related compounds in this chemical class, though specific toxicological studies for this particular substance may be limited in the public domain. The European Food Safety Authority (EFSA) maintains separate evaluation standards and approval lists for flavoring substances used in the EU market.

Regulatory Status

In the United States, 5-oxooctanoic acid is not approved as a GRAS substance and does not appear on the FDA's official GRAS list. This means food manufacturers cannot market products containing this ingredient with GRAS claims in the U.S. market under current regulations.

The additive may be permitted in other jurisdictions with different regulatory frameworks. Manufacturers using this ingredient are responsible for ensuring compliance with applicable regulations in their target markets. International regulatory status varies by country and regional regulatory body.

Any U.S. manufacturer wishing to use 5-oxooctanoic acid in food would need to submit a Food Additive Petition to the FDA, providing safety data and manufacturing specifications for evaluation.

Key Studies

Published scientific literature specifically addressing the safety and toxicology of 5-oxooctanoic acid appears limited in publicly available databases. Most available data on this compound derives from chemical suppliers' technical documentation and regulatory submissions rather than independent peer-reviewed safety studies.

Research on structurally related fatty acid derivatives suggests that compounds in this chemical class generally have favorable safety profiles when used at low concentrations in food applications. However, substance-specific toxicological data for 5-oxooctanoic acid would be necessary to establish its safety profile definitively.

Frequently Asked Questions

What is 5-oxooctanoic Acid?

5-oxooctanoic acid (CAS 3637-14-7) is an organic compound used as a flavoring agent in food products. This fatty acid derivative contributes to flavor profiles in various food applications where it is permitted.

Is 5-oxooctanoic Acid safe?

5-oxooctanoic Acid 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-oxooctanoic Acid banned in any country?

5-oxooctanoic Acid 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.