Flavor ingredient regulatory record
Quinine sulfate
Quinine sulfate is an alkaloid in the bitter family, FEMA GRAS under FEMA number 2977 (CAS 6119-70-6). Its odor is bitter, herbal, woody, earthy.
- FEMA
- 2977
- CAS
- 6119-70-6
- EU FL
- 14.152
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 6119-70-6.
Structure
Under review
The structure for Quinine sulfate is still under identity review, so no drawing is shown until the record is confirmed.
Identity
Also known as: Cinchonan-9-ol, 6′-methoxy-, (8α,9R)-, sulfate, hydrate (2:1:4), Quinine, sulfate (2:1), dihydrate, Cinchonan-9-ol, 6′-methoxy-, (8α,9R)-, sulfate (2:1) (salt), dihydrate, Quinine sulfate dihydrate, quinine sulfate dihydrate, quinine hemisulfate salt monohydrate, quinine hemisulfate hydrate, quinine sulfate hydrate, quinine sulfate (2:1) (salt) dihydrate, (r)-(6-methoxyquinolin-4-yl)((1s,2s,4s,5r)-5-vinylquinuclidin-2-yl)methanol hemisulfate dihydrate, (r)-[(2s,4s,5r)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;sulfuric acid;dihydrate, ncgc00181052-01.
Can Quinine sulfate be labeled natural?
Nature makes quinine sulfate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial quinine sulfate, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
- United States
- Natural or artificial, by process
- European Union and UK
- Natural only from natural material
- Mercosur and Mexico
- Natural or identical-to-natural
How each market defines the classes: natural vs artificial flavor under 21 CFR 101.22.
Regulatory status, with citations
United States
Quinine sulfate is FEMA GRAS under FEMA number 2977. It is cited in the Code of Federal Regulations at 21 CFR 172.575.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 14.152, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list. The entry carries use restrictions.
Use restrictions. In categories 14.1 and 14.2 - not more than 100 mg/kg In spirit drinks as defined in Regulation (EC) No 110/2008 - not more than 250 mg/kg Individually or in combination with FL 14.011 and/or FL 14.155 expressed as quinine base
JECFA (WHO / FAO)
Quinine sulfate has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list. Listed on the EPA TSCA inventory.
Odor and taste
Odor: Bitter, herbal, woody, earthy.
Taste: Bitter, astringent, complex.
Where it is used
Quinine sulfate is used in beverage, cocktails, bitters and medicinal, typically as a bitter note.
More alkaloids in this index
Caffeine · Quinine bisulfate · Quinine hydrochloride · Theobromine · Isoquinoline · Piperine
Quinine sulfate FAQ
Does quinine sulfate have FEMA GRAS status?
Quinine sulfate holds FEMA GRAS status under FEMA number 2977. The Code of Federal Regulations lists it at 21 CFR 172.575.
How do I cite quinine sulfate by FEMA or CAS number?
Cite quinine sulfate as FEMA 2977 or CAS 6119-70-6; both point to the same entry. Its flavor category is bitter.
What does quinine sulfate smell and taste like, and where is it used?
The odor of quinine sulfate is bitter, herbal, woody, earthy. On the palate it is bitter, astringent, complex. Typical uses are beverage, cocktails, bitters and medicinal.
Can quinine sulfate be used in the EU and UK?
Yes. FL 14.152 is the Union List entry for quinine sulfate, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list. Its entry carries use restrictions, listed on this page.
Can quinine sulfate be labeled a natural flavor?
The process decides for quinine sulfate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic quinine sulfate is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
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Sources and attribution. The identity and regulatory facts on this page are taken from the FDA Substances Added to Food inventory, a US government record, which lists this substance as QUININE SULFATE under CAS 6119-70-6 and carries its FEMA number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant.
A FEMA GRAS conclusion is reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States, and the FEMA number names that conclusion. FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record of what the Panel decided and is worth reading alongside this page.
Ambrose Compliance is not affiliated with, endorsed by, or sponsored by FEMA. FEMA and FEMA GRAS are used here as identifiers for a published regulatory determination, not as marks of any relationship between FEMA and Ambrose.
About this page. Facts come from the FDA Substances Added to Food inventory, the Code of Federal Regulations, the EPA TSCA Inventory, the EU Union List, JECFA and the Ambrose database, with FEMA's published determination cited where it applies; parts of the text are written by Ambrose AI, which can make mistakes. Check the cited source before relying on anything here. This is not regulatory or legal advice.