Our Verdict: SAFE

Cinchona, Extract (cinchona Spp.)

CAS68990-12-5

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

Cinchona, Extract (cinchona Spp.) — food additive

Cinchona extract is a flavoring agent derived from the bark of cinchona tree species, used to impart bitter taste notes in beverages and food products. It contains alkaloids including quinine and has been used historically in traditional medicine and as a flavoring component in some beverages.

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 Cinchona, Extract?

Cinchona extract (CAS Number: 68990-12-7) is a flavoring agent derived from the bark of cinchona tree species (Cinchona spp.), native to South America. The extract contains naturally occurring alkaloid compounds, with quinine being the most notable constituent. Cinchona extract is used in the food industry primarily as a flavoring agent to provide bitter taste characteristics to various food and beverage products. The extract can be processed in various forms to concentrate or modify its flavor profile for specific applications.

Common Uses

Cinchona extract functions as a flavoring agent and flavor adjuvant in the food industry. It is commonly used in:

- Bitter aperitif beverages

- Tonic waters and soft drinks

- Herbal and botanical beverage products

- Bitters used in food preparation and cocktails

- Some confectionery and dessert applications

The bitter compounds in cinchona extract appeal to specific consumer preferences for complex, herbal flavor profiles. The alkaloid content, particularly quinine, contributes the characteristic bitter taste sought in traditional beverages like tonic water. Typical use levels are relatively low, as the extract is potent in flavor delivery.

Safety Assessment

Cinchona extract has not been granted Generally Recognized As Safe (GRAS) status by the FDA. However, this designation status does not inherently indicate safety concerns; rather, it reflects that the additive has not undergone the specific FDA GRAS review process or notification procedure. Historically, cinchona has been used in food and beverages for centuries, particularly in traditional preparations.

According to FDA records, there have been zero reported adverse events and zero recalls associated with cinchona extract used as a food additive, indicating no documented safety incidents in the food supply. The alkaloid content of cinchona, particularly quinine, has been studied in various contexts, and quinine is also approved as a flavoring agent in certain food applications in the United States and Europe.

The European Food Safety Authority (EFSA) has evaluated quinine, the primary alkaloid in cinchona extract, as a flavoring substance. Natural extracts of cinchona are listed in the EU's inventory of flavoring substances that can be used in food products, with specific limitations on acceptable use levels.

Regulatory Status

In the United States, cinchona extract is not GRAS-designated, meaning it may be used only under specific regulatory provisions or food additive regulations. Some cinchona-derived products, particularly those containing standardized quinine levels, may fall under different regulatory categories depending on their intended use and concentration.

International regulatory status varies by jurisdiction. In the European Union, cinchona extracts and quinine are permitted as flavoring agents with defined use limitations. In other countries, regulatory frameworks differ, with some permitting unrestricted use while others impose restrictions based on alkaloid content or intended application.

The absence of GRAS status does not prevent the use of cinchona extract in food; rather, manufacturers must ensure compliance with applicable food additive regulations in their jurisdiction and maintain accurate documentation of safety and composition data.

Key Studies

Historical use data and traditional beverage formulations represent the primary evidence base for cinchona extract's safety profile in food applications. The alkaloid composition of cinchona extracts has been characterized in phytochemical literature. Quinine, the major active alkaloid, has been extensively studied in pharmaceutical and nutritional contexts, providing supporting evidence for safety profiles at typical food-use concentrations.

The absence of documented adverse events or recalls in FDA records over decades of food use suggests an acceptable safety profile at current usage levels in food products. However, comprehensive clinical or toxicological studies specifically designed to evaluate cinchona extract as a food additive flavoring agent appear limited in published scientific literature.

Frequently Asked Questions

What is Cinchona, Extract (cinchona Spp.)?

Cinchona extract is a flavoring agent derived from the bark of cinchona tree species, used to impart bitter taste notes in beverages and food products. It contains alkaloids including quinine and has been used historically in traditional medicine and as a flavoring component in some beverages.

Is Cinchona, Extract (cinchona Spp.) safe?

Cinchona, Extract (cinchona Spp.) 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 Cinchona, Extract (cinchona Spp.) banned in any country?

Cinchona, Extract (cinchona Spp.) 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.