Our Verdict: RATING UNKNOWN

Cyclopentanone

CAS120-92-3

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

Cyclopentanone — food additive

Cyclopentanone is a cyclic ketone compound used as a flavoring agent in food products. It is not approved as Generally Recognized As Safe (GRAS) by the FDA, though no adverse events or recalls have been reported.

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 Cyclopentanone?

Cyclopentanone (CAS Number 120-92-3) is an organic compound belonging to the cyclic ketone family. Its chemical structure consists of a five-membered carbon ring with one ketone functional group. In its pure form, cyclopentanone is a colorless to pale yellow liquid with a characteristic sharp, solvent-like odor. The compound has a molecular weight of 84.12 g/mol and is soluble in organic solvents and water.

Common Uses

Cyclopentanone is employed in the food industry as a flavoring agent and flavoring adjuvant. Its role is to contribute to or enhance the overall flavor profile of food products. As a volatile organic compound, it is often used in very small concentrations in beverages, baked goods, dairy products, and confectionery items. The compound's sensory characteristics make it suitable for creating complex flavor notes in processed foods.

Beyond food applications, cyclopentanone serves as a solvent and intermediate chemical in pharmaceutical and industrial synthesis. However, its primary food-related function remains as a flavoring component.

Safety Assessment

Cyclopentanone has not been designated as Generally Recognized As Safe (GRAS) by the FDA. This designation does not necessarily indicate that the substance is unsafe; rather, it means the compound has not undergone the formal GRAS notification process or lacks sufficient published safety data to support such recognition by the FDA.

According to FDA records, there have been zero adverse events reported in connection with cyclopentanone, and no recalls of food products containing this additive have been issued. This absence of reported incidents suggests that if cyclopentanone is used in food products, any exposure at current usage levels has not resulted in documented consumer health complaints or safety issues serious enough to warrant regulatory action.

Inhalation exposure to cyclopentanone in occupational settings has been studied, as workers in chemical manufacturing may encounter this compound. Industrial safety data indicates that cyclopentanone is classified as a skin and eye irritant at high concentrations. However, the amounts used in food flavoring are substantially lower than occupational exposure levels, and food products containing cyclopentanone would involve ingestion rather than inhalation exposure.

The European Food Safety Authority (EFSA) maintains a flavoring database that evaluates substances used in food. Regulatory approaches to cyclopentanone may vary between jurisdictions, and its approval status differs across different countries and regulatory regions.

Regulatory Status

Cyclopentanone does not have GRAS status in the United States. This means that while it may be used in food products under specific regulatory pathways, it does not have the presumption of safety that GRAS substances enjoy. Companies using cyclopentanone in foods would need to ensure compliance with applicable regulations, which may include FDA approval through the Food Additive Petition process or reliance on pre-1958 use documentation.

The regulatory landscape for flavoring agents is complex, with different rules applying to natural versus synthetic flavorings. Cyclopentanone, as a synthetic compound, would be subject to requirements for food additives unless it qualifies under specific exemptions.

Key Studies

Published scientific literature specifically addressing cyclopentanone's safety in food applications is limited. Most available toxicological data comes from occupational health studies and chemical safety databases rather than food-specific research. The absence of extensive food safety literature may reflect both limited historical use in foods and the general safety record with no reported adverse events.

Toxicological assessments typically evaluate acute toxicity, chronic toxicity, genotoxicity, and reproductive effects. For cyclopentanone, available data from chemical manufacturers and safety data sheets provide baseline information, though formal food additive safety studies may not have been conducted. Any company seeking to expand the use of cyclopentanone in foods would likely need to generate additional safety data to support regulatory approval or GRAS determination.

Frequently Asked Questions

What is Cyclopentanone?

Cyclopentanone is a cyclic ketone compound used as a flavoring agent in food products. It is not approved as Generally Recognized As Safe (GRAS) by the FDA, though no adverse events or recalls have been reported.

Is Cyclopentanone safe?

Cyclopentanone 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 Cyclopentanone banned in any country?

Cyclopentanone 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.