Our Verdict: RATING UNKNOWN

Ethyl 5-oxodecanoate

CAS93919-00-7

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

Ethyl 5-oxodecanoate — food additive

Ethyl 5-oxodecanoate is a synthetic flavoring compound belonging to the ester family, used to impart fruity and creamy notes to food products. It is not currently approved as a food additive in major regulatory jurisdictions and has not undergone formal GRAS (Generally Recognized as Safe) determination by the FDA.

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 Ethyl 5-oxodecanoate?

Ethyl 5-oxodecanoate (CAS Number 93919-00-7) is a synthetic organic compound classified as an ester-type flavoring agent. It is characterized by a 10-carbon chain with a ketone functional group at the fifth carbon position and an ethyl ester moiety. This chemical structure contributes to its sensory properties, which are typically described as fruity with subtle creamy or dairy undertones.

As a synthetic flavoring compound, ethyl 5-oxodecanoate is manufactured through chemical synthesis rather than derived from natural sources, though similar flavor compounds may exist in nature in trace amounts.

Common Uses

Ethyl 5-oxodecanoate is primarily used in the flavor industry as a flavoring agent or adjuvant for food and beverage products. Its fruity-creamy character makes it suitable for applications in:

- Confectionery and candy products

- Baked goods and pastries

- Dairy-based products

- Beverages including soft drinks and flavored waters

- Dairy alternatives and plant-based products

The compound is typically used at very low concentrations (parts per million level) due to its potency as a flavoring agent. Like most synthetic flavors, it serves primarily as a sensory enhancer rather than a functional ingredient with nutritional benefit.

Safety Assessment

Ethyl 5-oxodecanoate has not been extensively studied in published scientific literature available through major databases. The FDA has received zero adverse event reports associated with this compound and there have been no recalls related to its use. However, the lack of adverse events does not constitute formal safety approval.

The compound has not received GRAS (Generally Recognized as Safe) status from the FDA, which means it has not undergone the formal petition and expert panel review process required for this designation. This status differs from being unsafe; rather, it indicates that formal regulatory approval has not been sought or granted in the United States.

The European Food Safety Authority (EFSA) maintains strict frameworks for flavor chemical approval. The regulatory status of ethyl 5-oxodecanoate in the European Union would need to be verified against the EU's FL flavorings list.

Regulatory Status

In the United States, ethyl 5-oxodecanoate is not listed on the FDA's GRAS list for flavoring substances. This means that any food manufacturer wishing to use this compound would require either:

1. A GRAS determination through self-affirmation followed by FDA notification, or

2. Prior FDA approval through a food additive petition

The compound's regulatory status in other jurisdictions including Canada, Japan, Australia, and the European Union would require individual verification against their respective flavor chemical approval lists.

Flavor chemicals in international commerce are typically only used after achieving approval in the intended market. The limited regulatory approval of ethyl 5-oxodecanoate suggests it may have niche applications or may be primarily used in jurisdictions with different approval frameworks.

Key Studies

Published toxicological or safety assessment studies specifically on ethyl 5-oxodecanoate are not readily available in the scientific literature. Most safety data for synthetic flavor chemicals comes from:

- In vitro and animal toxicity studies

- Structural analogue comparisons

- Industry submissions to regulatory agencies

- Flavor and Extract Manufacturers Association (FEMA) assessments

For synthetic esters used as flavorings, safety assessments typically evaluate acute toxicity, genotoxicity, and metabolism. The ketone functionality and alkyl chain length are structural features that inform safety predictions based on similar approved compounds.

Any future regulatory approval of ethyl 5-oxodecanoate would likely require submission of toxicological data packages to support safety determinations. Stakeholders seeking information about this compound should contact relevant regulatory agencies or flavor manufacturers directly.

Frequently Asked Questions

What is Ethyl 5-oxodecanoate?

Ethyl 5-oxodecanoate is a synthetic flavoring compound belonging to the ester family, used to impart fruity and creamy notes to food products. It is not currently approved as a food additive in major regulatory jurisdictions and has not undergone formal GRAS (Generally Recognized as Safe) determination by the FDA.

Is Ethyl 5-oxodecanoate safe?

Ethyl 5-oxodecanoate 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 Ethyl 5-oxodecanoate banned in any country?

Ethyl 5-oxodecanoate 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.