Flavor ingredient regulatory record
Capsaicin
Capsaicin is a phenol in the herbal family, FEMA GRAS under FEMA number 3404 (CAS 404-86-4). Its odor is highly volatile with a pungent odor.
- FEMA
- 3404
- CAS
- 404-86-4
- Formula
- C18H27NO3
- EC
- 206-969-8
GRAS status: FEMA GRAS, publication 7. Recorded by FDA in the Substances Added to Food inventory under CAS 404-86-4.
Structure
Identity
Also known as: 6-Nonenamide, N-[(4-hydroxy-3-methoxyphenyl)methyl]-8-methyl-, (6E)-, 6-Nonenamide, 8-methyl-N-vanillyl-, (E)-, 6-Nonenamide, N-[(4-hydroxy-3-methoxyphenyl)methyl]-8-methyl-, (E)-, (6E)-N-[(4-Hydroxy-3-methoxyphenyl)methyl]-8-methyl-6-nonenamide, Capsaicine, (E)-N-(4-Hydroxy-3-methoxybenzyl)-8-methylnon-6-enamide, Ratden PE 40, Zostrix, Capsin P 50, Mioton, trans-8-Methyl-N-vanillyl-6-nonenamide, Axsain.
Can Capsaicin be labeled natural?
Capsaicin occurs in nature, so the label depends on the route: capsaicin won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized capsaicin is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic capsaicin 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
Capsaicin is FEMA GRAS under FEMA number 3404. 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 Capsaicin. 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)
Capsaicin 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. Capsaicin appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 404-86-4, where EPA names it 6-Nonenamide, N-[(4-hydroxy-3-methoxyphenyl)methyl]-8-methyl-, (6E)-.
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: Highly volatile with a pungent odor.
Taste: Burning taste detectable in 1 part in 100,000.
Where it is used
Typical applications for Capsaicin are not on file yet.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Capsaicin by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Nonanoyl 4-hydroxy-3-methoxybenzylamide | 2787 | 89% | In nature |
| (1R,2S,5R)-N-(4-Methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide | 4681 | 79% | Not determined |
| N1-(2-Methoxy-4-methylbenzyl)-N2-(2-(5-methylpyridin-2-yl)ethyl)oxalamide | 4234 | 78% | Not determined |
| N1-(2,4-Dimethoxybenzyl)-N2-(2-(pyridin-2-yl)ethyl)oxalamide | 4233 | 77% | Not determined |
| N-(2-(Pyridin-2-yl)ethyl)-3-p-menthanecarboxamide | 4549 | 77% | Not determined |
Capsaicin FAQ
Is capsaicin on the FEMA GRAS list?
It is. FEMA number 3404 covers capsaicin. It is also codified at 21 CFR 172.515.
What is the FEMA number for capsaicin?
The FEMA number for capsaicin is 3404 and its CAS registry number is 404-86-4. FEMA files it in the herbal flavor category.
Is capsaicin natural or artificial?
Since capsaicin is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when capsaicin is synthesized. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic capsaicin identical-to-natural.
What is capsaicin used for?
Capsaicin is described as highly volatile with a pungent odor. On the palate it is burning taste detectable in 1 part in 100,000.
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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 N-(4-HYDROXY-3-METHOXYBENZYL)-8-METHYL-6-NONENAMIDE under CAS 404-86-4 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.