Our Verdict: SAFE

Quinine Hydrochloride

CAS130-89-2

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

Quinine Hydrochloride — food additive

Quinine hydrochloride is the hydrochloride salt form of quinine, a bitter alkaloid naturally derived from cinchona bark. It is used as a flavoring agent in beverages and other food products to provide a characteristic bitter taste.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Quinine Hydrochloride?

Quinine hydrochloride (CAS Number: 130-89-2) is a salt form of quinine, an alkaloid compound originally extracted from the bark of cinchona trees native to South America. The hydrochloride salt form increases the compound's solubility and stability in aqueous solutions, making it suitable for food and beverage applications. Quinine has a distinctly bitter taste profile and is recognized for its sensory properties in food flavoring applications.

Common Uses

Quinine hydrochloride is primarily used as a flavoring agent in carbonated beverages, most notably in tonic water and quinine-containing soft drinks. The additive is also employed in some bitter aperitifs, bitters, and other flavored beverages where the characteristic bitter taste is desired. In food applications, it may appear in limited quantities in certain confectionery products and flavor formulations. The typical concentration in tonic water ranges from 60-80 parts per million (ppm).

Safety Assessment

Quinine hydrochloride has not received GRAS (Generally Recognized As Safe) status from the FDA, though it remains permitted for use as a flavoring agent in certain food categories. According to FDA records, there have been zero reported adverse events associated with quinine hydrochloride as a food additive, and no product recalls have been issued due to this ingredient.

Historically, quinine was used as an antimalarial medication, and safety concerns relating to food applications stem from studies of therapeutic doses rather than typical flavoring concentrations. At the low levels used in food products, quinine hydrochloride has not demonstrated significant safety concerns in the scientific literature. The European Food Safety Authority (EFSA) has also evaluated quinine and determined it acceptable for use as a flavoring substance.

Some individuals may experience sensitivity to bitter compounds, and quinine-containing beverages have been associated with occasional reports of hypersensitivity reactions in susceptible populations. However, such reactions remain rare at typical consumption levels of quinine-flavored foods.

Regulatory Status

In the United States, quinine hydrochloride is not GRAS-listed but is permitted as a flavoring agent under FDA regulations for specific food categories. The FDA maintains quinine on its list of permitted indirect food additives and flavoring substances. In the European Union, quinine is authorized as a food additive under Regulation (EC) No 1333/2008 and is designated with the E-number E104 when used as a colorant, though it functions as a flavoring in most beverage applications.

Quinine-containing beverages must be labeled as such in most jurisdictions, and some regulatory bodies recommend limiting consumption in certain populations, including pregnant women, though this pertains primarily to therapeutic doses rather than food flavoring levels.

Key Studies

Scientific literature on quinine as a food flavoring agent is limited compared to other food additives, reflecting its long-established use and historical safety profile. Most safety data comes from pharmacological studies examining quinine at therapeutic doses (200-600 mg) rather than food-level concentrations (typically less than 5 mg per serving). Toxicological assessments by the EFSA concluded that quinine poses no safety concern when used at authorized food levels. Research on bitter taste perception indicates that individual sensitivity to quinine varies, with genetic factors influencing taste threshold responses.

Frequently Asked Questions

What is Quinine Hydrochloride?

Quinine hydrochloride is the hydrochloride salt form of quinine, a bitter alkaloid naturally derived from cinchona bark. It is used as a flavoring agent in beverages and other food products to provide a characteristic bitter taste.

Is Quinine Hydrochloride safe?

Quinine Hydrochloride 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 Quinine Hydrochloride banned in any country?

Quinine Hydrochloride 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.