Our Verdict: RATING UNKNOWN

Bisabolene

CAS495-62-5

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

Bisabolene — food additive

Bisabolene is a naturally occurring sesquiterpene compound used as a flavoring agent and antimicrobial additive in food products. Derived from plant sources, it contributes aromatic properties while offering potential preservation benefits in food 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 Bisabolene?

Bisabolene (CAS Number: 495-62-5) is a sesquiterpene, a class of organic compounds found naturally in essential oils of various plants, including ginger, hops, and cannabis. It is a colorless to pale yellow liquid with a distinctive woody, spicy aroma. As a naturally occurring compound, bisabolene is classified as a flavoring agent and is used to impart or enhance flavor profiles in food and beverage products. In addition to its sensory properties, bisabolene possesses antimicrobial characteristics that have generated interest in food preservation applications.

Common Uses

Bisabolene is primarily used in the food industry as a flavoring agent, contributing to the aromatic complexity of various food products. Its applications include:

- Beverage flavoring, particularly in craft beers and herbal beverages where its spicy, woody notes complement other botanicals

- Flavoring compounds in processed foods and seasonings

- Potential use as a natural antimicrobial preservative in food formulations

- Fragrance and flavor components in functional foods

The compound's dual functionality—both as a flavor enhancer and antimicrobial agent—makes it attractive to manufacturers seeking natural preservation alternatives. However, its use remains limited compared to more established flavoring agents.

Safety Assessment

Bisabolene has not been approved by the FDA as a Generally Recognized As Safe (GRAS) substance for food use in the United States, which means it does not have formal FDA recognition as safe for its intended use. However, this designation does not necessarily indicate safety concerns; rather, it reflects the absence of a formal GRAS application or determination by the FDA.

According to available FDA data, there have been zero reported adverse events associated with bisabolene and zero product recalls involving this additive. This absence of documented safety incidents is notable, particularly given that the compound occurs naturally in foods and has historical use in botanical products.

The antimicrobial properties of bisabolene have been investigated in scientific literature, with studies suggesting potential efficacy against certain bacterial and fungal pathogens. These properties are consistent with characteristics observed in other plant-derived sesquiterpenes. However, the practical effectiveness and safety profile in actual food applications require further evaluation.

No significant toxicological concerns have been identified in the limited research available, though comprehensive safety data specific to food use in humans remains limited compared to approved flavoring agents.

Regulatory Status

Bisabolene's regulatory status varies globally. In the European Union, while some sesquiterpenes are approved under the EFSA's Flavouring Regulation, bisabolene specifically does not appear on the EU's approved flavoring substances list as of current records, suggesting it has not undergone formal EFSA evaluation for food use.

In the United States, the lack of GRAS status means that any food manufacturer wishing to use bisabolene would technically require FDA approval as a food additive, following the formal food additive petition process. This regulatory hurdle has likely limited its commercial adoption in the U.S. market.

Other jurisdictions have varying approaches, with some permitting limited use of natural flavoring compounds derived from recognized plant sources under less restrictive frameworks.

Key Studies

Scientific investigation of bisabolene remains relatively limited in published peer-reviewed literature focused specifically on food safety. Most research on bisabolene focuses on its extraction from plant sources, chemical structure, or potential pharmaceutical applications rather than food safety or efficacy.

Studies on related sesquiterpenes provide some indirect evidence supporting bisabolene's antimicrobial potential, though direct food application studies are scarce. The compound's natural occurrence in plants like ginger and hops provides some historical context for safety, though this does not substitute for formal toxicological or food safety studies.

Future research examining bisabolene's stability in various food matrices, its effectiveness as a preservative at practical concentrations, and comprehensive safety data would strengthen the evidence base for potential food applications.

Frequently Asked Questions

What is Bisabolene?

Bisabolene is a naturally occurring sesquiterpene compound used as a flavoring agent and antimicrobial additive in food products. Derived from plant sources, it contributes aromatic properties while offering potential preservation benefits in food formulations.

Is Bisabolene safe?

Bisabolene 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 Bisabolene banned in any country?

Bisabolene 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.