Our Verdict: RATING UNKNOWN

Isobornyl Isobutyrate

CAS85586-67-0

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

Isobornyl Isobutyrate — food additive

Isobornyl isobutyrate (CAS 85586-67-8) is a synthetic flavoring compound used to impart fruity, herbal, and woody notes to food and beverages. It is a chemical ester composed of isoborneol and isobutyric acid, functioning as a flavoring agent in processed foods.

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 Isobornyl Isobutyrate?

Isobornyl isobutyrate is a synthetic organic compound classified as a flavoring agent or adjuvant. It is an ester formed from the combination of isoborneol (derived from borneol, a natural compound found in camphor and other plants) and isobutyric acid. This colorless to pale yellow liquid is primarily used in the food industry to enhance or create specific taste profiles in consumer products.

Common Uses

Isobornyl isobutyrate is employed in the flavor industry to provide fruity, woody, herbaceous, and slightly spicy taste notes. It is commonly incorporated into:

- Beverages, including soft drinks and flavored water

- Confectionery products

- Baked goods and desserts

- Dairy products such as yogurt and flavored milk

- Ice cream and frozen desserts

- Savory snacks

The compound typically appears in finished food products at very low concentrations, as flavoring agents are used in trace amounts to achieve desired sensory characteristics. Its specific aromatic profile makes it useful for creating complex flavor blends in multi-ingredient formulations.

Safety Assessment

Isobornyl isobutyrate has not been formally approved by the FDA as a GRAS (Generally Recognized as Safe) substance, though it is utilized in food production. According to available FDA records, there have been zero reported adverse events and zero recalls associated with this additive, indicating no documented safety incidents in the United States food supply.

The absence of adverse event reports and recalls suggests the compound has not raised significant safety concerns in practical food applications. However, the lack of formal GRAS status indicates that comprehensive safety data packages may not have been submitted to or evaluated by the FDA through their standardized review process.

As with all synthetic flavoring compounds, isobornyl isobutyrate is used in minimal quantities—typically parts per million—which substantially limits potential exposure. The low levels of use in food products is a critical factor in the overall safety profile of such additives.

Regulatory Status

In the United States, isobornyl isobutyrate is not listed on the FDA's GRAS inventory, meaning it has not received formal FDA approval through the GRAS notification process. However, this does not necessarily indicate safety concerns; rather, it may reflect that formal petitions or notification dossiers have not been submitted, or that the compound is used under the FDA's provisions for flavoring agents through other regulatory pathways.

The compound may be regulated as a flavoring ingredient under 21 CFR 182.60 (Food Additives Permitted in Food for Human Consumption - Flavoring Agents and Related Substances), which allows certain flavoring compounds to be used if they meet specific criteria and historical use patterns.

Regulatory status varies internationally. Different countries maintain separate approval lists for food additives, and isobornyl isobutyrate's acceptance may differ in the European Union, Canada, Australia, and other jurisdictions.

Key Studies

Limited published scientific literature specifically addresses isobornyl isobutyrate toxicity or safety testing. Most safety data for this compound comes from proprietary industry testing rather than peer-reviewed public literature. The lack of published adverse event data or safety concerns suggests that any testing conducted by manufacturers has not identified significant hazards.

Flavor and Extract Manufacturers Association (FEMA) maintains a database of flavor ingredients with safety assessments, though specific detailed studies on isobornyl isobutyrate are not widely available in open scientific literature. The general class of simple esters used in flavoring has extensive historical use data supporting their safety at typical food use levels.

Further research or transparency regarding toxicology and safety testing protocols specific to this compound could provide additional confidence in its continued use.

Frequently Asked Questions

What is Isobornyl Isobutyrate?

Isobornyl isobutyrate (CAS 85586-67-8) is a synthetic flavoring compound used to impart fruity, herbal, and woody notes to food and beverages. It is a chemical ester composed of isoborneol and isobutyric acid, functioning as a flavoring agent in processed foods.

Is Isobornyl Isobutyrate safe?

Isobornyl Isobutyrate 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 Isobornyl Isobutyrate banned in any country?

Isobornyl Isobutyrate 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.