Our Verdict: RATING UNKNOWN

2-hydroxy-2-cyclohexen-1-one

CAS10316-66-2

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

2-hydroxy-2-cyclohexen-1-one — food additive

2-hydroxy-2-cyclohexen-1-one is a synthetic organic compound used as a flavoring agent in food products. It imparts a characteristic woody, earthy flavor profile and is employed in small quantities in various food applications.

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-hydroxy-2-cyclohexen-1-one?

2-hydroxy-2-cyclohexen-1-one (CAS Number 10316-66-2) is a synthetic flavoring compound belonging to the class of organic chemicals known as cyclohexenones. It is a colorless to pale yellow liquid with a distinctive woody and earthy odor. The compound is chemically derived through synthetic routes and does not occur naturally in significant quantities in food sources.

Common Uses

This additive functions as a flavoring agent or flavor adjuvant in the food industry. It is used in very small concentrations to enhance or modify the sensory profile of various food and beverage products. Typical applications may include baked goods, beverages, condiments, and other processed foods where woody or earthy flavor notes are desired. Like most synthetic flavoring agents, it is used at levels far below those that would produce any physiological effect, with typical usage rates measured in parts per million (ppm).

Safety Assessment

The safety profile of 2-hydroxy-2-cyclohexen-1-one is characterized by limited but relevant data. The FDA has recorded zero adverse events associated with this additive and zero product recalls linked to its use, suggesting no documented safety incidents in the U.S. food supply. The compound has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA, which indicates it has not undergone the specific GRAS affirmation process, though this does not necessarily indicate safety concerns.

Toxicological considerations for this class of compounds typically focus on acute and subchronic toxicity assessments. The lipophilic nature of the compound suggests potential for absorption through the gastrointestinal tract, though the very low concentrations used in food applications would result in minimal systemic exposure. Standard safety evaluations for flavoring agents include assessment of potential mutagenic, reproductive, or developmental effects.

As with most synthetic flavoring agents used in food, the margin of safety between typical food-use levels and levels at which adverse effects might be observed in animal studies is substantial, often several orders of magnitude.

Regulatory Status

In the United States, 2-hydroxy-2-cyclohexen-1-one is not listed on the FDA's GRAS (Generally Recognized as Safe) list. However, it may be used in food under specific regulatory provisions if appropriate safety data supports its use, or through the food additive petition process. The lack of GRAS status should not be interpreted as an indication of unsafety, but rather as a reflection of the specific regulatory pathway or extent of safety review completed.

Regulatory status varies internationally. Some regions may have different classifications or approval requirements for this compound. Manufacturers using this additive must comply with the specific regulations of each jurisdiction in which their products are marketed.

Key Studies

Published scientific literature on 2-hydroxy-2-cyclohexen-1-one is limited compared to more widely-used flavoring agents. Available data derives primarily from manufacturers' safety submissions and proprietary toxicological studies. The absence of published peer-reviewed research specifically on this compound limits independent verification of safety claims, though this is not uncommon for specialized industrial chemicals.

Safety assessments for this additive would typically include standard battery testing protocols: acute oral toxicity, skin and eye irritation, and potentially subchronic toxicity studies in relevant animal models. The lack of reported adverse events in actual food use, combined with the minimal exposure levels from food consumption, provides practical reassurance of safety under normal conditions of use.

Frequently Asked Questions

What is 2-hydroxy-2-cyclohexen-1-one?

2-hydroxy-2-cyclohexen-1-one is a synthetic organic compound used as a flavoring agent in food products. It imparts a characteristic woody, earthy flavor profile and is employed in small quantities in various food applications.

Is 2-hydroxy-2-cyclohexen-1-one safe?

2-hydroxy-2-cyclohexen-1-one 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 2-hydroxy-2-cyclohexen-1-one banned in any country?

2-hydroxy-2-cyclohexen-1-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.