Our Verdict: RATING UNKNOWN

Copaiba, Oil (south American Spp. Of Copaifera L.)

CAS8013-97-6

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

Copaiba, Oil (south American Spp. Of Copaifera L.) — food additive

Copaiba oil is a natural oleoresin extracted from South American Copaifera tree species, used as a flavoring agent in food products. It has not received FDA GRAS (Generally Recognized As Safe) status and has limited regulatory approval for food use in most jurisdictions.

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
ApprovedANVISA
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 Copaiba Oil?

Copaiba oil (CAS Number 8013-97-6) is a viscous oleoresin derived from the trunk of Copaifera species trees native to South America, particularly found in the Amazon region. The oleoresin is collected by tapping the tree bark and contains a complex mixture of volatile and semi-volatile compounds, primarily consisting of sesquiterpenes and diterpenes. In the food industry, it is classified as a natural flavoring agent or flavoring adjuvant.

Common Uses

Copaiba oil is used primarily as a flavoring agent in food and beverage formulations, particularly in products where tropical or woody flavor notes are desired. It may appear in small quantities in beverages, confectionery, and other processed foods. The oil's distinctive sensory profile—characterized by warm, woody, and slightly balsamic notes—makes it valued in flavor chemistry applications. However, its use in food products remains limited compared to more established natural flavoring ingredients.

Safety Assessment

The safety profile of copaiba oil for food use remains incompletely characterized. The FDA has not designated this substance as GRAS (Generally Recognized As Safe) for food applications, which means it does not have the regulatory clearance granted to many other natural flavor ingredients. This does not necessarily indicate the substance is unsafe, but rather that sufficient safety data for food use has not been formally established or submitted to the FDA.

Historically, copaiba oil has been used in traditional medicine in South American cultures, though such traditional use does not automatically establish food safety in modern regulatory contexts. The FDA's database shows zero reported adverse events and zero recalls associated with this additive, suggesting either minimal use in food products or absence of documented safety incidents in the U.S. food supply.

Limited toxicological data exists specifically for copaiba oil as a food additive. Safety assessments would typically evaluate acute toxicity, potential allergenicity, and any concerning chemical constituents. The European Food Safety Authority (EFSA) has not conducted a formal risk assessment of copaiba oil for food use.

Regulatory Status

Copaiba oil's regulatory status varies internationally. In the United States, it is not listed as a GRAS ingredient for food use, which restricts its legal use as a food additive. Some countries may permit its use under specific regulatory frameworks for natural flavoring substances, though documentation is limited. The lack of FDA GRAS status means any food manufacturer wishing to use this ingredient would need to establish its safety through appropriate studies or apply for approval through formal channels.

The ingredient may be permitted in some jurisdictions under general provisions for traditional or natural flavoring substances, but this varies by country and regulatory authority. Manufacturers considering use should verify current regulations in their target markets.

Key Studies

Published scientific literature on copaiba oil's safety specifically for food use is limited. Most available research focuses on traditional medicinal applications, topical use, or basic chemical composition rather than dietary safety at food-relevant concentrations. The absence of published toxicological studies specifically designed for food additive risk assessment represents a significant data gap.

The chemical composition of copaiba oil has been characterized in various studies, identifying sesquiterpenes such as copaene and β-caryophyllene as major components. However, safety data from feeding studies, allergenicity assessments, or long-term exposure studies in food contexts appear absent from the published literature.

To achieve GRAS status or broader regulatory approval for food use, safety data would need to be generated through standard toxicological protocols, including acute and subchronic toxicity studies, with particular attention to any potential allergenic or sensitizing properties.

Frequently Asked Questions

What is Copaiba, Oil (south American Spp. Of Copaifera L.)?

Copaiba oil is a natural oleoresin extracted from South American Copaifera tree species, used as a flavoring agent in food products. It has not received FDA GRAS (Generally Recognized As Safe) status and has limited regulatory approval for food use in most jurisdictions.

Is Copaiba, Oil (south American Spp. Of Copaifera L.) safe?

Copaiba, Oil (south American Spp. Of Copaifera L.) 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 Copaiba, Oil (south American Spp. Of Copaifera L.) banned in any country?

Copaiba, Oil (south American Spp. Of Copaifera L.) 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.