Our Verdict: SAFE

D-fenchone

CAS4695-62-9

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

D-fenchone — food additive

D-fenchone is a naturally occurring organic compound classified as a flavoring agent and flavor enhancer. It is used in food and beverage products to impart or enhance aromatic and taste characteristics, with no recorded adverse events or recalls reported to the FDA.

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 D-fenchone?

D-fenchone (CAS Number 4695-62-9) is a bicyclic ketone compound belonging to the terpene family of organic molecules. It occurs naturally in various plants, particularly in fennel and other aromatic herbs. The compound is structurally similar to camphor and has a characteristic bitter, somewhat minty odor. D-fenchone is classified by regulatory agencies as a flavoring agent and flavor enhancer, meaning it is used in food products primarily for its aromatic properties rather than as a nutritive component.

Common Uses

D-fenchone is utilized in the food and beverage industry as a flavoring ingredient, where it contributes to the sensory profile of products. It appears in applications including beverages, confectionery, baked goods, and seasoning blends. The compound is valued for its ability to provide herbal, spicy, and slightly minty notes that complement various food formulations. As with other natural flavor compounds, D-fenchone is typically used in very small quantities—often in the parts per million (ppm) range—to achieve desired flavor profiles without overwhelming other taste characteristics.

Safety Assessment

From a safety perspective, D-fenchone has a relatively benign profile based on available data. The FDA has received zero adverse event reports associated with D-fenchone consumption, and there are no recorded recalls involving this additive. This absence of reported safety concerns is noteworthy, particularly given its presence in food products over an extended period. The compound's natural occurrence in foods and traditional culinary use in herbal preparations provides some historical context for its general recognition as safe for typical food applications.

The toxicological profile of D-fenchone has been subject to limited but relevant scientific examination. As a terpene-based compound, it shares chemical characteristics with other widely accepted flavoring agents. The lack of genotoxicity concerns and standard toxicity profiles support its continued use in food applications at conventional levels. However, it is important to note that like all flavor compounds, safety is primarily dependent on the levels of exposure and intended use patterns.

Regulatory Status

D-fenchone has not received FDA GRAS (Generally Recognized As Safe) status, which means it has not undergone the formal GRAS petition and review process with the FDA. However, this distinction does not necessarily indicate a safety concern; rather, it reflects that a formal petition may not have been submitted or completed. The lack of GRAS status means that D-fenchone's use in food is subject to FDA regulations governing food additives and flavorings, and it must comply with applicable food safety standards and limitations. In the United States, flavor compounds used in food must be approved for use or meet exemption criteria under FDA regulations.

The European Food Safety Authority (EFSA) and other international regulatory bodies have similarly assessed various terpene-based flavorings, including compounds structurally related to D-fenchone, generally finding them acceptable for food use when applied at appropriate levels.

Key Studies

While comprehensive published studies specifically focused on D-fenchone are limited in the peer-reviewed literature, the compound has been included in broader assessments of terpene-based flavoring agents. Its structural similarity to other approved flavor compounds, combined with zero reported adverse events and no recalls, suggests an acceptable safety margin for its current applications. The historical use of fennel and related herbs in traditional cuisines and medicinal applications provides additional context supporting its general recognition as having a long history of safe use.

Frequently Asked Questions

What is D-fenchone?

D-fenchone is a naturally occurring organic compound classified as a flavoring agent and flavor enhancer. It is used in food and beverage products to impart or enhance aromatic and taste characteristics, with no recorded adverse events or recalls reported to the FDA.

Is D-fenchone safe?

D-fenchone 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 D-fenchone banned in any country?

D-fenchone 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.