Flavor ingredient regulatory record
Caffeine
Caffeine is an alkaloid in the bitter family, FEMA GRAS under FEMA number 2224 (CAS 58-08-2). Its odor is earthy, bitter, herbal, nutty.
- FEMA
- 2224
- CAS
- 58-08-2
- EU FL
- 16.016
- Formula
- C8H10N4O2
- EC
- 200-362-1
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 58-08-2.
Structure
Identity
Also known as: 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-, 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione, Guaranine, Methyltheobromine, No-Doz, Thein, Theine, 1,3,7-Trimethyl-2,6-dioxopurine, 1,3,7-Trimethylxanthine, Caffein, Cafipel, Alert-Pep.
Can Caffeine be labeled natural?
Caffeine occurs in nature, so the label depends on the route: caffeine won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized caffeine is artificial. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
- 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
Caffeine is FEMA GRAS under FEMA number 2224. It is cited in the Code of Federal Regulations at 21 CFR 182.1180.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.016, 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. Restrictions for use as a flavouring substance: In category 1 - not more than 70 mg/kg In category 3 - not more than 70 mg/kg In category 5 - not more than 100 mg/kg In category 14.1 - not more than 150 mg/kg
JECFA (WHO / FAO)
Caffeine 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.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Caffeine appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 58-08-2, where EPA names it 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-.
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. 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: Earthy, bitter, herbal, nutty. Detectable at about 130 ppm.
Taste: Bitter, slightly acidic, astringent. Taste threshold about 130 ppm.
Where it is used
Caffeine is used in beverage, energy drinks, dietary supplements and confectionery, typically as a bitter note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Caffeine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Theobromine | 3591 | 81% | In nature |
| 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione | 4725 | 53% | Not determined |
| 1-Phenyl-(3 or 5)-propylpyrazole | 3727 | 52% | In nature |
| 1-Ethyl-2-acetylpyrrole | 3147 | 52% | In nature |
| 1-Methyl-2-acetylpyrrole | 3184 | 49% | In nature |
More alkaloids in this index
Quinine bisulfate · Quinine sulfate · Quinine hydrochloride · Theobromine · 2-(3-Phenylpropyl)pyridine · Isoquinoline
Caffeine FAQ
Does caffeine have FEMA GRAS status?
Caffeine holds FEMA GRAS status under FEMA number 2224. It is also codified at 21 CFR 182.1180.
How do I cite caffeine by FEMA or CAS number?
Cite caffeine as FEMA 2224 or CAS 58-08-2; both point to the same entry. FEMA files it in the bitter flavor category.
Can caffeine be labeled a natural flavor?
Since caffeine is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when caffeine is synthesized. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
Can caffeine be used in the EU and UK?
Caffeine is on the EU Union List of flavouring substances as FL 16.016 (Annex I Part A) under Regulation 1334/2008. Its entry carries use restrictions, listed on this page.
What does caffeine smell and taste like, and where is it used?
The odor of caffeine is earthy, bitter, herbal, nutty. On the palate it is bitter, slightly acidic, astringent. Its odor threshold is about 130 ppm. Typical uses are beverage, energy drinks, dietary supplements and confectionery.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
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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 CAFFEINE under CAS 58-08-2 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.