Our Verdict: RATING UNKNOWN

Ethyl 3-oxohexanoate

CAS3249-68-1

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

Ethyl 3-oxohexanoate — food additive

Ethyl 3-oxohexanoate is a synthetic flavoring compound used to create fruity and creamy taste profiles in food products. It is not currently approved as a Generally Recognized As Safe (GRAS) ingredient by the FDA but has no recorded adverse events or recalls.

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 3-oxohexanoate?

Ethyl 3-oxohexanoate (CAS Number: 3249-68-1) is a synthetic organic compound belonging to the class of ester-based flavoring agents. It is characterized by a six-carbon backbone with a ketone functional group at the third position and an ethyl ester group. This chemical structure contributes to its sensory properties, which are described as fruity with subtle creamy undertones, making it useful in flavor formulation.

Common Uses

Ethyl 3-oxohexanoate is used as a flavoring agent in various processed food and beverage applications. Its primary function is to enhance or create fruity flavor profiles, particularly in dairy products, beverages, confectionery, and baked goods. The compound may be used in very small quantities—typically parts per million (ppm)—as flavor compounds are potent and require minimal amounts to achieve desired sensory effects.

Due to its synthetic nature, it is employed primarily in industrial food manufacturing where precise flavor control and consistency are required. It is not typically used in home cooking or in products labeled as "naturally flavored."

Safety Assessment

Ethyl 3-oxohexanoate has no recorded adverse events in the FDA database and has been involved in zero product recalls. These metrics indicate that the compound has not been associated with documented food safety incidents or consumer health complaints. However, the absence of adverse events does not automatically establish safety status; it reflects historical use patterns and reporting.

The compound has not been evaluated under the FDA's Generally Recognized As Safe (GRAS) program, which means it has not undergone formal GRAS notification review. This classification does not indicate that the additive is unsafe, but rather that the manufacturer has not sought or obtained GRAS status. Some flavoring compounds are used under FDA regulations without GRAS designation, provided they comply with FDA Color Additives Status List or other applicable regulatory frameworks.

Toxicological data on ethyl 3-oxohexanoate is limited in publicly available literature. For synthetic flavoring compounds, safety assessments typically consider acute toxicity, potential for bioaccumulation, metabolic pathways, and structural similarity to known safe compounds. Many synthetic esters used in flavoring are rapidly metabolized and excreted, reducing systemic exposure concerns.

Regulatory Status

In the United States, ethyl 3-oxohexanoate is not listed on the FDA's GRAS inventory. However, it may be used in foods under the Color Additives Status List (CASL) or as a food additive subject to specific regulations, depending on how it has been classified and approved by the FDA in specific applications.

The European Food Safety Authority (EFSA) maintains separate evaluation systems for flavorings. Synthetic flavoring compounds in the European Union are subject to different approval processes than in the United States. Availability and approval status may vary by country and regulatory jurisdiction.

Manufacturers using this compound in food products are required to declare it on ingredient labels according to local regulations, typically listed under "natural and artificial flavors" or with its specific chemical name, depending on jurisdiction.

Key Studies

Published scientific literature on ethyl 3-oxohexanoate is limited. Most flavoring compounds are evaluated through confidential industry studies submitted to regulatory agencies rather than through published peer-reviewed research. Structural analogues of this compound—other ethyl ester-based flavorings—have been studied for metabolic pathways and safety profiles.

The compound's chemical structure suggests it would be metabolized similarly to other food-grade esters, typically through ester hydrolysis and subsequent metabolism of the resulting alcohols and carboxylic acids. This metabolic predictability based on structure is one approach used in safety assessment when direct toxicological studies are limited.

Frequently Asked Questions

What is Ethyl 3-oxohexanoate?

Ethyl 3-oxohexanoate is a synthetic flavoring compound used to create fruity and creamy taste profiles in food products. It is not currently approved as a Generally Recognized As Safe (GRAS) ingredient by the FDA but has no recorded adverse events or recalls.

Is Ethyl 3-oxohexanoate safe?

Ethyl 3-oxohexanoate 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 3-oxohexanoate banned in any country?

Ethyl 3-oxohexanoate 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.