Our Verdict: SAFE

2-hepten-4-one

CAS4643-25-8

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-hepten-4-one — food additive

2-hepten-4-one is a naturally occurring organic compound used as a flavoring agent in food products. It contributes fruity and herbaceous notes to various food and beverage formulations.

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 2-hepten-4-one?

2-hepten-4-one (CAS Number: 4643-25-8) is an unsaturated ketone compound that occurs naturally in various plants and fruits. It is a volatile organic compound characterized by a seven-carbon chain with a double bond between the second and third carbons and a ketone functional group at the fourth position. The compound is used in the food industry exclusively as a flavoring agent or flavoring adjuvant to impart specific taste and aroma characteristics to food and beverage products.

Common Uses

2-hepten-4-one is utilized in the formulation of artificial and natural flavoring systems. It is typically employed in very small quantities in products such as beverages, confectionery, baked goods, and processed foods where fruity, green, or herbaceous flavor notes are desired. The compound contributes to the overall flavor profile by enhancing certain aromatic characteristics. As with most flavoring compounds, it is used at levels well below those that would trigger safety concerns, reflecting standard industry practices for flavor ingredients.

Safety Assessment

The safety profile of 2-hepten-4-one has not generated any adverse event reports in the FDA database, and there are no documented recalls associated with this ingredient. The compound has not been formally evaluated through the FDA's Generally Recognized As Safe (GRAS) notification process, meaning it operates under food additive regulations rather than the GRAS framework. However, the absence of reported adverse events and safety incidents suggests a benign safety history in commercial use.

As a flavoring compound used at minimal concentrations in food, 2-hepten-4-one follows the principle that safety is determined by exposure level. Flavoring agents are typically used at concentrations measured in parts per million (ppm), which significantly limits potential exposure. The European Food Safety Authority (EFSA) evaluates similar flavor compounds through their flavor assessment process, applying comparable safety standards based on data from animal studies, chemical structure analysis, and typical use levels.

Regulatory Status

2-hepten-4-one is permitted for use as a flavoring agent in food products in the United States under the Code of Federal Regulations (CFR Title 21). It is not classified as a food additive requiring pre-market approval through the standard food additive petition process, instead being used as a flavoring substance. This regulatory classification reflects its designation as a flavoring ingredient rather than a functional additive. The compound's regulatory status remains consistent across major regulatory jurisdictions where flavor compounds are subject to established safety frameworks.

Key Studies

Limited published peer-reviewed literature is available specifically examining 2-hepten-4-one in isolation. The safety assessment for this compound relies on structural alerts analysis, comparison to toxicologically characterized analogs, and industrial experience data rather than extensive clinical studies. Such approaches are standard for flavor ingredients used at minimal dietary exposure levels. Regulatory bodies typically apply predictive models based on chemical structure and metabolic pathways when comprehensive testing data are unavailable for specific flavor compounds. The absence of adverse event reports following decades of commercial use provides additional reassurance regarding its safety profile in food applications.

Frequently Asked Questions

What is 2-hepten-4-one?

2-hepten-4-one is a naturally occurring organic compound used as a flavoring agent in food products. It contributes fruity and herbaceous notes to various food and beverage formulations.

Is 2-hepten-4-one safe?

2-hepten-4-one 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-hepten-4-one banned in any country?

2-hepten-4-one 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.