Flavor ingredient regulatory record
2-Methylbutyric acid
2-Methylbutyric acid is an acid in the fruity family, FEMA GRAS under FEMA number 2695 (CAS 116-53-0). Its odor is fruity, sour, tangy, apple.
- FEMA
- 2695
- CAS
- 116-53-0
- JECFA
- 255
- EU FL
- 08.046
- Formula
- C5H10O2
- EC
- 204-145-2
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 116-53-0.
Structure
Identity
Also known as: Butanoic acid, 2-methyl-, Butyric acid, 2-methyl-, Butyric acid, α-methyl-, 2-Methylbutanoic acid, Active valeric acid, Ethylmethylacetic acid, α-Methylbutyric acid, Methylethylacetic acid, α-Methyl-n-butyric acid, 2-Methyl-n-butyric acid, DL-2-Methylbutyric acid, (±)-2-Methylbutyric acid.
Can 2-Methylbutyric acid be labeled natural?
The process decides for 2-Methylbutyric acid. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic 2-Methylbutyric acid 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
2-Methylbutyric acid is FEMA GRAS under FEMA number 2695. 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 08.046, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 255, evaluated at the 49th meeting in 1997. 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. 2-Methylbutyric acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 116-53-0, where EPA names it Butanoic acid, 2-methyl-.
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: Fruity, sour, tangy, apple.
Where it is used
2-Methylbutyric acid is used in beverage, confection, fruit flavors and savory dishes, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 2-Methylbutyric acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2-Ethylbutyric acid | 2429 | 95% | In nature |
| trans-2-Methyl-2-butenoic acid | 3599 | 94% | In nature |
| Butyric acid | 2221 | 89% | In nature |
| 3-Hydroxy-2-pentanone | 3550 | 88% | In nature |
| (+/-)-2-Methyl-1-butanol | 3998 | 86% | In nature |
More acids in this index
3-Octenoic acid · trans-2-Methyl-2-butenoic acid · 2-Ethylbutyric acid · 5-Methylhexanoic acid · 3-Hexenoic acid · 4-Hydroxy-3-methoxycinnamic acid
2-Methylbutyric acid FAQ
Does 2-Methylbutyric acid have FEMA GRAS status?
2-Methylbutyric acid holds FEMA GRAS status under FEMA number 2695. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite 2-Methylbutyric acid by FEMA or CAS number?
Cite 2-Methylbutyric acid as FEMA 2695 or CAS 116-53-0; both point to the same entry. Its flavor category is fruity.
What does 2-Methylbutyric acid smell and taste like, and where is it used?
The odor of 2-Methylbutyric acid is fruity, sour, tangy, apple. Typical uses are beverage, confection, fruit flavors and savory dishes.
What did JECFA conclude about 2-Methylbutyric acid?
JECFA evaluated 2-Methylbutyric acid at the 49th meeting in 1997 under JECFA number 255. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Can 2-Methylbutyric acid be used in the EU and UK?
Yes. FL 08.046 is the Union List entry for 2-Methylbutyric acid, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Can 2-Methylbutyric acid be labeled a natural flavor?
Nature makes 2-Methylbutyric acid, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial 2-Methylbutyric acid, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 2-Methylbutyric acid 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 2-METHYLBUTYRIC ACID under CAS 116-53-0 and carries its FEMA number, its JECFA flavor 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.