Flavor ingredient regulatory record
Alanine
Alanine is an amino acid in the sweet family, FEMA GRAS under FEMA number 3252 (CAS 107-95-9). Its odor is sweet, nutty, mild, savory.
- FEMA
- 3252
- CAS
- 107-95-9
- JECFA
- 1418
- EU FL
- 17.001
- Formula
- C3H7NO2
- EC
- 203-536-5
GRAS status: FEMA GRAS, publication 5. Recorded by FDA in the Substances Added to Food inventory under CAS 107-95-9.
Structure
Identity
Also known as: β-Alanine, 3-Aminopropanoic acid, β-Aminopropionic acid, Propanoic acid, 3-amino-, 3-Aminopropionic acid, Abufene, ω-Aminopropionic acid, 2-Carboxyethylamine, β-Aminopropanoic acid, NSC 7603, 3-Azaniumylpropanoate, MeSH ID: D015091.
Can Alanine be labeled natural?
Alanine occurs in nature, so the label depends on the route: alanine won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized alanine 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
Alanine is FEMA GRAS under FEMA number 3252. 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 17.001, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1418, evaluated at the 63rd meeting in 2004. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Alanine appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 107-95-9, where EPA names it .beta.-Alanine.
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: Sweet, nutty, mild, savory.
Taste: Sweet, umami, mild.
Where it is used
Alanine is used in beverage, confection, savory dishes and snacks, typically as a sweet note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Alanine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Butyramide | 4252 | 94% | In nature |
| Butyric acid | 2221 | 92% | In nature |
| L-Threonine | 4710 | 91% | In nature |
| Taurine | 3813 | 85% | In nature |
| 3-Mercaptopropionic acid | 4587 | 78% | In nature |
More amino acids in this index
L-Threonine · L-Alanine · L-Phenylalanine · DL-Phenylalanine · L-Alanyl-L-Glutamine · Glycine
Alanine FAQ
Is alanine FEMA GRAS?
Yes. The FEMA Expert Panel lists alanine as GRAS under FEMA number 3252. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for alanine?
Alanine is FEMA 3252, CAS 107-95-9. FEMA files it in the sweet flavor category.
Does alanine count as natural in the US and the EU?
Since alanine is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when alanine is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
Is alanine on the EU Union List?
Alanine is on the EU Union List of flavouring substances as FL 17.001 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated alanine?
Yes. JECFA number 1418, evaluated at the 63rd meeting in 2004. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is alanine described, and where does it show up?
Flavorists describe alanine as sweet, nutty, mild, savory. On the palate it is sweet, umami, mild. It is used in beverage, confection, savory dishes and snacks.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Alanine in a formula
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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 BETA-ALANINE under CAS 107-95-9 and carries its FEMA number, its JECFA flavor number. The inventory is searchable at FDA. FDA records its technical effect as flavor enhancer, flavoring agent or adjuvant, nutrient supplement.
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.