Our Verdict: RATING UNKNOWN

Copaiba (south American Spp. Of Copaifera L.)

CAS8001-61-4

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

Copaiba is a resinous oleogum derived from South American Copaifera tree species, used as a flavoring agent in food products. It imparts woody, balsamic notes and is utilized in small quantities in beverages, confectionery, and other 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
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?

Copaiba (CAS Number 8001-61-4) is a natural resinous oleogum obtained from the trunk of Copaifera species trees native to South America, particularly found in the Amazon region. The oleogum is collected by tapping the trees and has been used for centuries in traditional medicine and as a fragrance component. In food applications, copaiba is employed as a flavoring agent, contributing woody, balsamic, and slightly spicy aromatic characteristics to finished products.

Common Uses

Copaiba is used primarily in the flavor industry as a minor ingredient in various food and beverage applications. It appears in alcoholic beverages, non-alcoholic drinks, baked goods, confectionery, and processed foods where woody or balsamic flavor notes are desired. The substance is typically used in very small concentrations, measured in parts per million, due to its potent aromatic profile. Like other natural flavor components, copaiba functions both as a flavoring agent and as a flavor adjuvant that enhances or modifies existing flavor profiles in food formulations.

Safety Assessment

Copaiba has not been formally designated as GRAS (Generally Recognized As Safe) by the FDA, indicating it has not undergone the specific GRAS notification process. However, the absence of GRAS status does not necessarily indicate safety concerns. The FDA has recorded zero reported adverse events associated with copaiba in the Adverse Event Reporting System (FAERS), and there have been no FDA-initiated recalls involving this ingredient.

The European Food Safety Authority (EFSA) has not issued specific safety evaluations for copaiba as a food flavoring. Limited toxicological data exists in the published scientific literature regarding copaiba's use specifically as a food additive, though the compound has been studied in other contexts. The volatile oil fraction of copaiba has been characterized chemically, with major constituents including sesquiterpenes and diterpenes.

Historically, copaiba has been used in cosmetic and pharmaceutical applications without significant documented safety incidents at typical usage levels. However, the lack of comprehensive modern safety studies specific to food use means that complete toxicological data is limited.

Regulatory Status

Copaiba's regulatory status varies internationally. In the United States, it is not listed as GRAS for food use, though it may be permitted under the Food Additive Amendment or as a natural flavor under certain conditions depending on specific formulations and intended uses. The FDA does not maintain an explicit prohibition against copaiba in foods, but manufacturers seeking to use it should verify compliance with current regulations.

In the European Union, copaiba may be listed in flavor compound registries, though specific regulatory status should be confirmed with current EU food additive regulations. Many countries recognize copaiba's traditional use but may not have comprehensive regulatory frameworks specific to its food application.

Key Studies

Limited peer-reviewed research exists specifically examining copaiba as a food additive. Most scientific literature focuses on copaiba's traditional medicinal uses, chemical composition, and applications in cosmetics and pharmaceuticals rather than food safety. The chemical profile of copaiba oleogum has been characterized through gas chromatography and mass spectrometry analyses, identifying volatile and semi-volatile components.

Any manufacturer considering use of copaiba should conduct or reference appropriate safety studies and ensure compliance with applicable food regulations in their target markets. Consultation with regulatory specialists and toxicologists is recommended given the limited GRAS status and sparse safety data specific to food use.

Frequently Asked Questions

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

Copaiba is a resinous oleogum derived from South American Copaifera tree species, used as a flavoring agent in food products. It imparts woody, balsamic notes and is utilized in small quantities in beverages, confectionery, and other processed foods.

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

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

Copaiba (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.