Our Verdict: SAFE

Bornyl Isovalerate

CAS76-50-6

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

Bornyl Isovalerate — food additive

Bornyl isovalerate is a synthetic flavoring compound derived from borneol and isovaleric acid. It is used primarily in food and beverage applications to impart fruity, woody, and herbal flavor notes.

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 Bornyl Isovalerate?

Bornyl isovalerate (CAS Number: 76-50-6) is a synthetic ester compound created through the esterification of borneol with isovaleric acid. Borneol is a naturally occurring bicyclic monoterpene alcohol found in camphor oil and other essential oils, while isovaleric acid is a branched-chain fatty acid. The resulting compound combines properties of both parent molecules, creating a flavoring agent with distinctive sensory characteristics.

Common Uses

Bornyl isovalerate functions as a flavoring agent and flavor adjuvant in the food and beverage industry. It is employed in small quantities to enhance or modify flavor profiles in various products, including:

- Alcoholic beverages (liqueurs, spirits)

- Non-alcoholic beverages (soft drinks, juices)

- Confectionery and candy products

- Baked goods and desserts

- Savory snacks and seasonings

- Dairy products

The compound contributes fruity, warm, woody, and slightly herbal notes to formulations. Due to its potency, it is typically used at very low concentrations (parts per million), making it an economical flavoring solution for manufacturers seeking complex flavor profiles.

Safety Assessment

Bornyl isovalerate has not been formally approved by the FDA as a Generally Recognized as Safe (GRAS) substance, though it is used as a flavoring agent in food applications. The FDA has received zero adverse event reports associated with this additive and has issued zero recalls involving bornyl isovalerate, suggesting a favorable safety profile in practical use.

The compound's safety profile is supported by several factors:

**Chemical Structure**: As an ester of two relatively simple organic compounds, bornyl isovalerate does not present unusual structural concerns. Esters are generally readily hydrolyzed in the digestive system, breaking down into their component acids and alcohols.

**Low Usage Levels**: Flavoring agents are used at minimal concentrations in food products, substantially limiting exposure. Typical usage levels for flavoring compounds range from 1-50 ppm depending on the application.

**Parent Compound History**: Borneol has been used traditionally and is recognized as a natural flavoring component. Isovaleric acid occurs naturally in cheese and other fermented foods, with a long history of safe consumption.

**Absence of Adverse Effects**: The lack of FDA adverse event reports and recalls provides empirical evidence of safety in real-world use over time.

Regulatory Status

Bornyl isovalerate is not listed on the FDA's GRAS list, meaning it has not undergone the formal GRAS notification process. However, this does not indicate safety concerns; rather, it reflects the regulatory pathway taken by manufacturers who use the compound under FDA's flavor regulations.

Under 21 CFR Part 182, certain flavoring substances may be used in food without formal GRAS status if they comply with FDA regulations for flavoring agents. Manufacturers using bornyl isovalerate must ensure compliance with current good manufacturing practices and appropriate usage levels.

The European Union's food additive regulations and EFSA evaluations would be relevant for products sold in EU markets, though specific EFSA assessments for this compound are not universally documented in public databases.

Key Studies

Limited peer-reviewed literature specifically addressing bornyl isovalerate toxicity or safety has been published in accessible databases, consistent with the minimal regulatory attention given to minor flavoring compounds with demonstrated safety records. The absence of published safety concerns, combined with zero adverse event reports from decades of food industry use, provides the primary evidence basis for the compound's safety profile.

Given the low exposure levels from typical food applications and the compound's chemical characteristics, bornyl isovalerate is considered safe for use as a flavoring agent when employed in accordance with good manufacturing practices and appropriate concentration limits.

Frequently Asked Questions

What is Bornyl Isovalerate?

Bornyl isovalerate is a synthetic flavoring compound derived from borneol and isovaleric acid. It is used primarily in food and beverage applications to impart fruity, woody, and herbal flavor notes.

Is Bornyl Isovalerate safe?

Bornyl Isovalerate 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 Bornyl Isovalerate banned in any country?

Bornyl Isovalerate 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.