Our Verdict: RATING UNKNOWN

5-oxodecanoic Acid

CAS624-01-1

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-oxodecanoic Acid — food additive

5-oxodecanoic acid is an organic compound used as a flavoring agent in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has no reported adverse events or recalls 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 5-oxodecanoic Acid?

5-oxodecanoic acid (CAS Number: 624-01-1) is an organic compound belonging to the class of keto acids. It is a ten-carbon chain fatty acid with a ketone functional group at the fifth carbon position. This chemical structure gives it distinctive aromatic and flavor properties that make it suitable for use as a flavoring agent in food applications.

The compound is naturally present in some food sources and can also be synthesized chemically. Its molecular formula is C₁₀H₁₈O₃, and it functions primarily as a flavor component that contributes to the sensory profile of food products.

Common Uses

5-oxodecanoic acid is used in the food industry as a flavoring agent and flavor adjuvant. Flavor adjuvants are substances that enhance, modify, or support the overall flavor profile of food products without necessarily providing a distinct flavor themselves. This compound is utilized in various food categories where complex flavor development is desired.

The additive is typically used in small quantities, as is common with most flavoring compounds. Its specific applications may include beverages, dairy products, baked goods, and other processed foods where flavor enhancement is beneficial. The exact concentration and food applications would depend on the intended sensory effect and regulatory approval in specific jurisdictions.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 5-oxodecanoic acid, and no food recalls have been linked to this substance. This absence of reported incidents suggests that when used as intended, the compound has not raised safety concerns in the marketplace.

However, it is important to note that 5-oxodecanoic acid has not been approved by the FDA as a Generally Recognized as Safe (GRAS) substance. GRAS status requires either a history of safe use in food before 1958 or completion of the FDA's pre-market review process. The lack of GRAS approval does not necessarily indicate the substance is unsafe; rather, it indicates that the specific safety determination has not been formally established through FDA procedures.

As with all food additives, safety depends on appropriate use levels. The compound is generally recognized as having low acute toxicity in typical food applications, though comprehensive toxicological studies would inform more detailed risk assessments.

Regulatory Status

5-oxodecanoic acid operates in a complex regulatory landscape. In the United States, while it lacks FDA GRAS approval, it may be used in certain contexts under different regulatory pathways or in food products subject to specific regulations. The European Union maintains its own approval processes for food additives, and this compound's status may differ between regions.

Manufacturers considering use of this flavoring agent should consult current FDA regulations and may need to pursue formal approval pathways depending on their intended applications. International trade of food products containing this ingredient requires compliance with regulations in all destination markets.

Key Studies

Limited published research specifically addresses 5-oxodecanoic acid in food safety contexts. The compound's chemical properties and metabolism are documented in chemical and biochemical literature, but large-scale epidemiological or clinical safety studies specific to food use are not widely published in peer-reviewed databases.

Chemical suppliers and flavor manufacturers typically maintain technical data sheets and toxicological summaries based on available scientific literature and testing. The absence of adverse event reports and recalls provides practical evidence of safety in current use, though this should be distinguished from comprehensive regulatory approval.

Further research or formal FDA safety petitions could provide additional evidence to support GRAS status determination if manufacturers pursue such approval.

Frequently Asked Questions

What is 5-oxodecanoic Acid?

5-oxodecanoic acid is an organic compound used as a flavoring agent in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has no reported adverse events or recalls associated with its use.

Is 5-oxodecanoic Acid safe?

5-oxodecanoic 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-oxodecanoic Acid banned in any country?

5-oxodecanoic 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.