Our Verdict: SAFE

Isobornyl Formate

CAS1200-67-5

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

Isobornyl Formate — food additive

Isobornyl formate is a synthetic flavoring compound derived from isoborneol and formic acid. It is used in food manufacturing to impart fruity and woody flavor notes to various food and beverage products.

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 Formate?

Isobornyl formate (CAS Number: 1200-67-5) is a synthetic ester classified as a flavoring agent. It is produced through the esterification of isoborneol, a naturally derived alcohol found in some essential oils and resins, with formic acid. The resulting compound is a colorless to pale yellow liquid with a characteristic fruity and woody aroma profile. As a synthetic flavoring substance, isobornyl formate is manufactured through controlled chemical processes rather than extracted directly from natural sources.

Common Uses

Isobornyl formate is used as a flavoring agent and flavor adjuvant in the food and beverage industry. Its primary applications include:

- Beverages (soft drinks, flavored water, alcoholic drinks)

- Confectionery and candy products

- Baked goods and desserts

- Dairy products

- Savory food applications

The compound is valued for its ability to contribute fruity, woody, and slightly spicy notes to flavor formulations. It is typically used in very small concentrations, as is standard for synthetic flavor compounds, where even minimal amounts can significantly impact the overall flavor profile of a product.

Safety Assessment

Isobornyl formate has not been formally evaluated by the FDA's Generally Recognized as Safe (GRAS) program, meaning it does not hold official GRAS status in the United States. However, this status does not indicate safety concerns; rather, it reflects that the substance has not undergone the formal GRAS notification process.

The available safety data on isobornyl formate is limited but indicates no significant adverse health effects. The FDA's adverse event database contains zero reported adverse events associated with isobornyl formate, and there have been no product recalls related to this ingredient. This absence of reported incidents suggests a favorable safety profile in food use.

Isobornyl formate shares chemical similarity with borneol and isoborneol, which have been used in food flavoring for many years. The toxicological data available for structurally related compounds supports the use of isobornyl formate at typical flavoring levels. Ester compounds in this class have generally been found to have low systemic toxicity when consumed at food-relevant doses.

Regulatory Status

In the European Union, isobornyl formate may be approved under the European Commission Regulation on flavorings. Different jurisdictions maintain varying approval lists for synthetic flavoring substances, and compliance requirements depend on local regulatory frameworks.

In the United States, while isobornyl formate lacks formal GRAS status, it may be used in foods if the manufacturer can demonstrate safety through alternative regulatory pathways, such as the Food Contact Substance (FCS) notification program or under FDA's threshold of regulation approach for low-level flavoring substances.

Manufacturers using this ingredient are required to ensure it meets food-grade purity standards and is used at safe, functional levels in food formulations.

Key Studies

Direct human safety studies specific to isobornyl formate are limited in the published literature. However, safety assessment has been based on:

- Chemical structure analysis and comparison to approved flavoring compounds

- In vitro and animal toxicology studies on related ester compounds

- Concentration-of-use data in food applications

- Historical use data in food flavoring applications

The absence of adverse event reports and recalls over decades of use in food flavoring provides real-world evidence supporting its safety profile at typical application levels. As with all synthetic flavoring agents, isobornyl formate is used in minimal concentrations where flavor impact is maximized and safety margin is substantial.

Frequently Asked Questions

What is Isobornyl Formate?

Isobornyl formate is a synthetic flavoring compound derived from isoborneol and formic acid. It is used in food manufacturing to impart fruity and woody flavor notes to various food and beverage products.

Is Isobornyl Formate safe?

Isobornyl Formate 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 Isobornyl Formate banned in any country?

Isobornyl Formate 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.