Our Verdict: SAFE

2-octanone

CAS111-13-7

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

2-octanone — food additive

2-Octanone is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity and herbaceous notes and is derived from sources including natural fermentation and synthetic production.

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
ApprovedHealth 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 2-Octanone?

2-Octanone (also known as methyl hexyl ketone) is an eight-carbon ketone with the chemical formula C8H16O. It is a volatile organic compound that occurs naturally in various plants, fruits, and fermented foods. The compound has a fruity, slightly fatty odor reminiscent of mushrooms, herbs, and tropical fruits. 2-Octanone can be produced through both natural extraction and synthetic chemical synthesis.

Common Uses

2-Octanone is used as a flavoring agent and flavoring adjuvant in the food industry to create or enhance fruity, herbaceous, and savory flavor profiles. It is particularly valued in applications requiring subtle fruity notes. The compound may be used in beverages, baked goods, dairy products, confectionery, and savory food formulations. Due to its potent flavor characteristics, it is typically used in very small concentrations to achieve the desired sensory effect without overpowering other flavor components.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 2-octanone consumption, and zero product recalls have been issued involving this compound. This safety profile reflects both its natural occurrence in foods and controlled use at flavoring levels. The compound has been studied for toxicological properties, though formal comprehensive safety dossiers are limited in public literature.

When considering safety, it is important to note that 2-octanone is volatile and is primarily present in foods in minimal quantities as a flavoring component. Exposure through food consumption is substantially lower than what would be used in toxicological studies. The absence of reported adverse events in FDA's database indicates no documented harm from food-level exposure in the United States.

Regulatory Status

2-Octanone does not have GRAS (Generally Recognized as Safe) status from the FDA, meaning it has not undergone the formal GRAS notification process or does not meet the criteria for GRAS determination. However, this does not mean the compound is unsafe or prohibited. Rather, it indicates that it has not been formally affirmed through the GRAS process or submitted for GRAS notification. The lack of GRAS status may reflect limited commercial use volume, reliance on existing safety data, or other regulatory considerations.

In the European Union, 2-octanone is listed as a flavoring substance and is subject to EFSA (European Food Safety Authority) regulations. Its use in the EU is permitted as a flavoring agent under the regulations governing food flavoring substances.

Key Studies

Published toxicological data on 2-octanone is limited in the open literature. Available studies have examined the compound's basic toxicological properties, including acute and subchronic effects. The volatile nature of the compound and its rapid metabolism limit accumulation in biological tissues. Animal studies have not identified significant toxicological concerns at exposure levels relevant to food use.

The natural occurrence of 2-octanone in fermented foods, mushrooms, and other plant sources suggests a long history of incidental human exposure at low levels. This natural presence provides additional context for understanding its safety profile in food applications.

Research on flavor compounds generally indicates that ketones of this type are metabolized efficiently and do not bioaccumulate. The olfactory potency of 2-octanone means that effective flavoring doses are extremely small, further minimizing potential exposure concerns.

Frequently Asked Questions

What is 2-octanone?

2-Octanone is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity and herbaceous notes and is derived from sources including natural fermentation and synthetic production.

Is 2-octanone safe?

2-octanone is currently rated "safe" 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 2-octanone banned in any country?

2-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.