Flavor ingredient regulatory record
Theobromine
Theobromine is an alkaloid in the bitter family, FEMA GRAS under FEMA number 3591 (CAS 83-67-0). Its odor is bitter, chocolate, earthy, nutty.
- FEMA
- 3591
- CAS
- 83-67-0
- EU FL
- 16.032
- Formula
- C7H8N4O2
- EC
- 201-494-2
GRAS status: FEMA GRAS, publication 11. Recorded by FDA in the Substances Added to Food inventory under CAS 83-67-0.
Structure
Identity
Also known as: 1H-Purine-2,6-dione, 3,7-dihydro-3,7-dimethyl-, 3,7-Dihydro-3,7-dimethyl-1H-purine-2,6-dione, 3,7-Dimethylxanthine, SC 15090, Teobromin, Diurobromine, Santheose, Theosalvose, Theostene, Thesal, 3,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione, NSC 5039.
Can Theobromine be labeled natural?
The process decides for theobromine. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic theobromine is artificial. 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
Theobromine is FEMA GRAS under FEMA number 3591. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.032, 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 14.1 - not more than 100 mg/kg
JECFA (WHO / FAO)
Theobromine 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. Theobromine appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 83-67-0, where EPA names it 1H-Purine-2,6-dione, 3,7-dihydro-3,7-dimethyl-.
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: Bitter, chocolate, earthy, nutty.
Taste: Bitter, slightly sweet, cocoa.
Where it is used
Theobromine is used in beverage, confection, chocolate products and energy foods, typically as a bitter note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Theobromine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Caffeine | 2224 | 76% | In nature |
| 4-Amino-5,6-dimethylthieno[2,3-d]pyrimidin-2(1H)-one | 4669 | 60% | Not determined |
| Skatole | 3019 | 58% | In nature |
| 2-Propionylpyrrole | 3614 | 55% | Not determined |
| Methyl 2-pyrrolyl ketone | 3202 | 53% | In nature |
More alkaloids in this index
Quinine bisulfate · Quinine sulfate · Quinine hydrochloride · Caffeine · 2-(3-Phenylpropyl)pyridine · Isoquinoline
Theobromine FAQ
Is theobromine FEMA GRAS?
Yes. The FEMA Expert Panel lists theobromine as GRAS under FEMA number 3591. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for theobromine?
Theobromine is FEMA 3591, CAS 83-67-0. Its flavor category is bitter.
How is theobromine described, and where does it show up?
Flavorists describe theobromine as bitter, chocolate, earthy, nutty. On the palate it is bitter, slightly sweet, cocoa. It is used in beverage, confection, chocolate products and energy foods.
Is theobromine on the EU Union List?
Yes. FL 16.032 is the Union List entry for theobromine, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list. Its entry carries use restrictions, listed on this page.
Does theobromine count as natural in the US and the EU?
Nature makes theobromine, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial theobromine, same molecule. 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.
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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 THEOBROMINE under CAS 83-67-0 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.