Our Verdict: RATING UNKNOWN

Bornyl Butyrate

CAS13109-70-1

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

Bornyl Butyrate — food additive

Bornyl butyrate is a synthetic flavoring compound derived from borneol and butyric acid. It is used in the food industry to provide fruity and herbal 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 Bornyl Butyrate?

Bornyl butyrate (CAS Number 13109-70-1) is a synthetic ester compound formed from the combination of borneol, a bicyclic monoterpene alcohol, and butyric acid. It belongs to the class of organic compounds known as flavor esters. The compound is characterized by its fruity and slightly herbal sensory profile, making it useful in flavor formulation for food and beverage applications.

Common Uses

Bornyl butyrate is utilized as a flavoring agent in the food industry. Its primary applications include use in beverages, confectionery, baked goods, and dairy products where fruity or herbal notes are desired. The compound is employed in small quantities—typically in parts per million (ppm)—to enhance or create specific flavor profiles. Like other synthetic flavor esters, bornyl butyrate allows food manufacturers to achieve consistent flavor characteristics across batches and products.

Safety Assessment

Bornyl butyrate has not been designated as Generally Recognized As Safe (GRAS) by the FDA, which means it does not have formal GRAS status in the United States. However, the FDA's adverse events database contains zero reported adverse events associated with this additive, and there are no recorded recalls linked to bornyl butyrate. This absence of reported safety incidents suggests the compound has not raised acute safety concerns in the food supply.

The safety profile of flavor esters like bornyl butyrate is generally considered favorable due to their use in minimal quantities and the body's natural capacity to metabolize ester compounds. Borneol, one of the component parts, is naturally occurring in various plant sources and has a history of use in traditional and modern applications.

Regulatory Status

In the United States, bornyl butyrate is not officially approved as a food additive under FDA GRAS provisions. This means manufacturers cannot claim GRAS status for its use and would need to work through the FDA's food additive petition process if they wish to market products containing this ingredient with a specific approved use. However, the lack of GRAS status does not necessarily indicate safety concerns; rather, it reflects that the formal review process for this particular compound has not been completed or pursued through FDA channels.

Regulatory frameworks vary internationally. The European Food Safety Authority (EFSA) maintains its own evaluations of flavoring compounds. Manufacturers in different regions should verify the regulatory status of bornyl butyrate in their respective jurisdictions before use.

Key Studies

Limited published scientific literature is available specifically addressing bornyl butyrate's safety profile. Most safety data for flavor esters comes from broader toxicological assessments of ester compounds and their metabolic pathways. The general toxicological understanding of esters suggests they are hydrolyzed by intestinal and hepatic esterases into their component parts—in this case, borneol and butyric acid—which are then further metabolized through normal biochemical pathways.

Borneol itself has been studied more extensively due to its presence in essential oils and traditional medicines. Butyric acid is a short-chain fatty acid naturally produced in the human colon during dietary fiber fermentation. The combination of these well-understood components in ester form suggests a relatively low toxicity profile, though specific toxicological studies on bornyl butyrate itself would strengthen this assessment.

Manufacturers interested in obtaining GRAS status or formal approval for bornyl butyrate would need to sponsor or commission safety studies meeting FDA requirements, including toxicological data, metabolism studies, and dietary exposure assessments.

Frequently Asked Questions

What is Bornyl Butyrate?

Bornyl butyrate is a synthetic flavoring compound derived from borneol and butyric acid. It is used in the food industry to provide fruity and herbal flavor notes to various food and beverage products.

Is Bornyl Butyrate safe?

Bornyl Butyrate 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 Bornyl Butyrate banned in any country?

Bornyl Butyrate 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.