Flavor ingredient regulatory record
Quinine bisulfate
Quinine bisulfate is an alkaloid in the bitter family, FEMA GRAS under FEMA number 2975 (CAS 549-56-4). Its odor is bitter, herbal, woody, earthy.
- FEMA
- 2975
- CAS
- 549-56-4
- Formula
- C20H26N2O6S
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 549-56-4.
Structure
Identity
Also known as: Cinchonan-9-ol, 6′-methoxy-, (8α,9R)-, sulfate (1:1), Quinine, sulfate (1:1) (salt), Cinchonan-9-ol, 6′-methoxy-, (8α,9R)-, sulfate (1:1) (salt), Quinine hydrogen sulfate, quinine hydrogen sulfate, quinine, sulfate (1:1) (salt), anhydrous quinine bisulfate, cinchonan-9-ol, 6'-methoxy-, (8alpha,9r)-, sulfate (1:1) (salt), quinine bisulfate anhydrous, bisulfate, quinine, quinine hydrogen sulphate, (r)-(6-methoxyquinolin-4-yl)((1s,2s,4s,5r)-5-vinylquinuclidin-2-yl)methanol sulfate.
Can Quinine bisulfate be labeled natural?
The process decides for quinine bisulfate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic quinine bisulfate is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic quinine bisulfate 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 bisulfate is FEMA GRAS under FEMA number 2975. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for Quinine bisulfate. That is not a finding either way. The Union List covers defined flavouring substances, so natural complex materials are handled as flavouring preparations under Parts B to F and never receive a number, and substances used as additives sit under Regulation 1333/2008 instead. Confirm the position before EU or UK use.
JECFA (WHO / FAO)
Quinine bisulfate 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.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Quinine bisulfate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 549-56-4, where EPA names it Cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)-, sulfate (1:1).
Inactive in US commerce
EPA designates this substance inactive, so a Notice of Activity Form B is required before anyone manufactures or processes it again. Being FEMA GRAS does not change that. What active and inactive mean.
EPA publishes no regulatory flags on this listing. What the flags mean.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Bitter, herbal, woody, earthy.
Taste: Bitter, astringent, complex.
Where it is used
Quinine bisulfate is used in beverage, cocktails, bitters and medicinal, typically as a bitter note.
More alkaloids in this index
Quinine sulfate · Theobromine · Quinine hydrochloride · Caffeine · Piperine · Isoquinoline
Quinine bisulfate FAQ
Is quinine bisulfate on the FEMA GRAS list?
It is. FEMA number 2975 covers quinine bisulfate. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for quinine bisulfate?
The FEMA number for quinine bisulfate is 2975 and its CAS registry number is 549-56-4. Its flavor category is bitter.
What is quinine bisulfate used for?
Quinine bisulfate is described as bitter, herbal, woody, earthy. On the palate it is bitter, astringent, complex. It shows up in beverage, cocktails, bitters and medicinal.
Is quinine bisulfate natural or artificial?
Nature makes quinine bisulfate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial quinine bisulfate, same molecule. 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 BISULFATE under CAS 549-56-4 and carries its FEMA number. 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.