Our Verdict: RATING UNKNOWN

Cyclohexane

CAS110-82-7

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

Cyclohexane — food additive

Cyclohexane is a cyclic hydrocarbon solvent used in food processing to extract oils and other compounds from natural materials. It is not approved as a food additive by the FDA and is not present in finished food products intended for consumption.

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 Cyclohexane?

Cyclohexane is a cyclic hydrocarbon with the chemical formula C₆H₁₂. It is a clear, colorless liquid with a mild odor commonly found in petroleum products. In industrial applications, cyclohexane serves as an effective solvent for extracting lipids, oils, and other non-polar compounds from plant and animal materials. Its low polarity makes it particularly efficient at dissolving fats and oils while remaining immiscible with water.

Common Uses

In food processing, cyclohexane has been used historically as an extraction solvent in oil refining operations, particularly for vegetable oil processing. The solvent is used to separate oils from seeds and plant materials during industrial extraction procedures. After the extraction process is complete, cyclohexane is typically removed through evaporation and other purification methods before the extracted oil enters the food supply. This means cyclohexane itself does not remain as a residue in finished food products.

Safety Assessment

While cyclohexane has not been designated as Generally Recognized as Safe (GRAS) by the FDA for direct food use, this classification primarily reflects the limited necessity for it as a food additive rather than documented safety concerns specific to food applications. The FDA has recorded zero adverse events and zero recalls associated with cyclohexane in food products, indicating no identified harm from its use in food processing operations.

From a toxicological perspective, cyclohexane is recognized as having relatively low oral toxicity when ingested in small quantities. However, as an industrial solvent, it does present occupational health concerns for workers exposed to vapors in high concentrations. The primary health concerns associated with cyclohexane relate to inhalation exposure in industrial settings rather than dietary consumption.

The European Union's Scientific Committee on Food and the European Food Safety Authority have examined cyclohexane in food processing contexts. Its use in solvent extraction is acknowledged as an established industrial practice, though its residual presence in foods is carefully controlled and monitored.

Regulatory Status

Cyclohexane is not approved as a direct food additive by the FDA and does not appear on the FDA's Generally Recognized as Safe (GRAS) list for use in foods. However, this does not mean it is prohibited in food processing. Rather, it is an established solvent used in manufacturing processes where residual levels are minimized or eliminated before the food reaches consumers.

Under FDA regulations, processing aids and solvents used in food manufacturing may be permitted even without GRAS status, provided they are removed during processing or their residual levels are demonstrated to be safe. The FDA's Generally Recognized as Safe designation applies specifically to substances intended to be added to food, not necessarily to processing solvents that do not remain in the finished product.

In the European Union, cyclohexane is listed as an approved solvent for use in certain food processing operations under Regulation (EC) No 1107/2008, with restrictions on residual levels in finished foods. The permitted residue limits reflect the assumption of no dietary risk from trace amounts remaining after proper processing.

Key Studies

Toxicological research on cyclohexane has primarily focused on occupational exposure scenarios rather than dietary ingestion. Studies examining the compound's effects on animal models at high doses have shown effects primarily in the nervous system at extreme exposure levels not relevant to food processing residues.

Industrial hygiene research has established occupational exposure limits for cyclohexane vapors, with organizations like OSHA and ACGIH setting workplace threshold limit values. These standards inform best practices for industrial handling but do not directly assess food safety.

Life cycle assessments and environmental studies have examined cyclohexane's fate in solvent extraction operations, documenting recovery and recycling practices that minimize both environmental release and product residues.

Frequently Asked Questions

What is Cyclohexane?

Cyclohexane is a cyclic hydrocarbon solvent used in food processing to extract oils and other compounds from natural materials. It is not approved as a food additive by the FDA and is not present in finished food products intended for consumption.

Is Cyclohexane safe?

Cyclohexane 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 Cyclohexane banned in any country?

Cyclohexane 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.