Flavor ingredient regulatory record
Levulinic acid
Levulinic acid is an acid in the fruity family, FEMA GRAS under FEMA number 2627 (CAS 123-76-2). Its odor is sweet, fruity, caramel, slightly sour.
- FEMA
- 2627
- CAS
- 123-76-2
- JECFA
- 606
- EU FL
- 08.023
- Formula
- C5H8O3
- EC
- 204-649-2
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 123-76-2.
Structure
Identity
Also known as: Pentanoic acid, 4-oxo-, 4-Oxopentanoic acid, β-Acetylpropionic acid, γ-Ketovaleric acid, Laevulinic acid, Levulic acid, 3-Acetylpropionic acid, 4-Oxovaleric acid, 4-Ketovaleric acid, NSC 3716, 3-Oxobutanecarboxylic acid, 3-Acetylpropanoic acid.
Can Levulinic acid be labeled natural?
The process decides for levulinic acid. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic levulinic acid is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic levulinic acid 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
Levulinic acid is FEMA GRAS under FEMA number 2627. 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 08.023, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 606, evaluated at the 53rd meeting in 1999. 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. Levulinic acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 123-76-2, where EPA names it Pentanoic acid, 4-oxo-.
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, fruity, caramel, slightly sour.
Taste: Sour, sweet, fruity.
Where it is used
Levulinic acid is used in beverage, confection, flavoring agent and food preservative, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Levulinic acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Succinic acid | 4719 | 93% | In nature |
| L-Malic Acid | 2655 | 88% | In nature |
| Fumaric acid | 2488 | 88% | In nature |
| 4-Methylpentanoic acid | 3463 | 80% | In nature |
| L-Aspartic acid | 3656 | 79% | In nature |
More acids in this index
2-Methyl-2-pentenoic acid · cis-4-(2,2,3-Trimethylcyclopentyl)butanoic acid · Heptanoic acid · 4-Hydroxy-3-methoxycinnamic acid · 3-Methoxybenzoic acid · 4-Methylnonanoic acid
Levulinic acid FAQ
Is levulinic acid on the FEMA GRAS list?
It is. FEMA number 2627 covers levulinic acid. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for levulinic acid?
The FEMA number for levulinic acid is 2627 and its CAS registry number is 123-76-2. Its flavor category is fruity.
What is levulinic acid used for?
Levulinic acid is described as sweet, fruity, caramel, slightly sour. On the palate it is sour, sweet, fruity. It shows up in beverage, confection, flavoring agent and food preservative.
What did JECFA conclude about levulinic acid?
JECFA evaluated levulinic acid at the 53rd meeting in 1999 under JECFA number 606. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is levulinic acid approved in the EU?
Yes. FL 08.023 is the Union List entry for levulinic acid, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Is levulinic acid natural or artificial?
Nature makes levulinic acid, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial levulinic acid, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material 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 LEVULINIC ACID under CAS 123-76-2 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 flavor enhancer, 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.