Our Verdict: SAFE

Isoborneol

CAS124-76-5

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

Isoborneol — food additive

Isoborneol is a naturally-derived organic compound used as a flavoring agent in food and beverages. It provides a camphor-like, minty aroma and is valued for its sensory properties 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 Isoborneol?

Isoborneol (CAS Number 124-76-5) is a bicyclic monoterpene alcohol with the molecular formula C₁₀H₁₈O. It is a structural isomer of borneol and occurs naturally in essential oils of various plants, including camphor laurel and other aromatic species. The compound has a distinctive camphor-like, minty odor and is colorless to pale yellow in appearance. Isoborneol can be isolated from natural sources or synthesized through chemical processes.

Common Uses

Isoborneol functions primarily as a flavoring agent and flavoring adjuvant in food and beverage products. It is used in small quantities to impart or enhance minty, camphor-like notes in various applications including beverages, confectionery, baked goods, and other flavor formulations. The compound's sensory profile makes it valuable in creating complex flavor profiles in both alcoholic and non-alcoholic beverages. Like many essential oil components, isoborneol is used in trace amounts to achieve desired taste and aroma characteristics.

Safety Assessment

Isoborneol has a favorable safety profile based on available data. The FDA has received zero adverse event reports associated with isoborneol consumption, and there are no recorded recalls related to this ingredient. While isoborneol is not on the FDA's Generally Recognized As Safe (GRAS) list, this classification does not indicate safety concerns but rather reflects that formal GRAS determination has not been pursued or completed for this specific substance.

The compound's natural occurrence in plant essential oils and its long history of use in food flavoring suggest established safety at typical usage levels. As a flavoring agent, isoborneol is used in minimal concentrations—typically in the parts per million range—which further supports its safe application in food products.

Regulatory Status

Isoborneol's regulatory status varies by jurisdiction. In the United States, while not officially GRAS-listed, it has been used as a food flavoring without documented safety concerns. The ingredient is permitted for use as a flavoring substance in food applications in various countries under their respective food additive regulations. The lack of FDA GRAS status does not prevent its use in food, as flavoring agents can be marketed under the food additive provisions when appropriate safety documentation is provided.

Manufacturers using isoborneol in food products are responsible for ensuring the ingredient meets applicable food safety standards and regulations in their target markets. The European Union includes related borneol compounds in flavor regulations, indicating regulatory acceptance of this class of compounds at appropriate usage levels.

Key Studies

While extensive peer-reviewed safety studies specifically focused on isoborneol as a food additive are limited in public literature, the compound's safety profile is supported by its natural occurrence and historical use in food flavoring. Toxicological data on borneol and related monoterpene compounds indicate favorable safety profiles at typical food use levels. The absence of adverse events reported to the FDA over years of use provides practical evidence of safety in commercial food applications.

The minimal quantities used in food flavoring—typically less than 10 mg/kg in finished products—represent exposures well below levels that would raise toxicological concern based on available safety data for structurally similar compounds. Continued monitoring through FDA adverse event reporting systems maintains ongoing safety surveillance.

Frequently Asked Questions

What is Isoborneol?

Isoborneol is a naturally-derived organic compound used as a flavoring agent in food and beverages. It provides a camphor-like, minty aroma and is valued for its sensory properties in various food applications.

Is Isoborneol safe?

Isoborneol 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 Isoborneol banned in any country?

Isoborneol 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.