Flavor ingredient regulatory record
4-Hydroxy-3-methyloctanoic acid gamma-lactone
4-Hydroxy-3-methyloctanoic acid gamma-lactone is a lactone in the fruity family, FEMA GRAS under FEMA number 3803 (CAS 39212-23-2). Its odor is sweet, creamy, coconut, fruity.
- FEMA
- 3803
- CAS
- 39212-23-2
- JECFA
- 437
- EU FL
- 10.053
- Formula
- C9H16O2
- EC
- 254-357-4
GRAS status: FEMA GRAS, publication 17. Recorded by FDA in the Substances Added to Food inventory under CAS 39212-23-2.
Structure
Identity
Also known as: 2(3H)-Furanone, 5-butyldihydro-4-methyl-, 5-Butyldihydro-4-methyl-2(3H)-furanone, β-Methyl-γ-octalactone, Oaklactone, Whiskey lactone, 3-Methyl-4-octanolide, 3-Methyloctano-4-lactone, 5-Butyl-4-methyldihydrofuran-2(3H)-one, oaklactone, 3-methyl-4-octanolide, beta-methyl-gamma-octalactone, 4-hydroxy-3-methyloctanoic acid lactone.
Can 4-Hydroxy-3-methyloctanoic acid gamma-lactone be labeled natural?
The process decides for 4-Hydroxy-3-methyloctanoic acid gamma-lactone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic 4-Hydroxy-3-methyloctanoic acid gamma-lactone is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 4-Hydroxy-3-methyloctanoic acid gamma-lactone 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
4-Hydroxy-3-methyloctanoic acid gamma-lactone is FEMA GRAS under FEMA number 3803. 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 10.053, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 437, 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. 4-Hydroxy-3-methyloctanoic acid gamma-lactone appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 39212-23-2, where EPA names it 2(3H)-Furanone, 5-butyldihydro-4-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: Sweet, creamy, coconut, fruity.
Taste: Sweet, rich, tropical.
Where it is used
4-Hydroxy-3-methyloctanoic acid gamma-lactone is used in beverage, confection, dairy, ice cream and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 4-Hydroxy-3-methyloctanoic acid gamma-lactone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Hydroxynonanoic acid delta-lactone | 3356 | 86% | In nature |
| gamma-Nonalactone | 2781 | 85% | In nature |
| delta-Octalactone | 3214 | 85% | Not determined |
| (+/-) 3-Methyl-gamma-decalactone | 3999 | 85% | In nature |
| gamma-Decalactone | 2360 | 75% | In nature |
More lactones in this index
delta-Dodecalactone · (+/-) 3-Methyl-gamma-decalactone · (+/-)-(2,6,6,-Trimethyl-2-hydroxycyclohexylidene)acetic acid gamma-lactone · 2-(2-Hydroxyphenyl)-cyclopropanecarbocyclic acid delta-lactone · gamma-Nonalactone · 5-Hydroxy-8-undecenoic acid delta-lactone
4-Hydroxy-3-methyloctanoic acid gamma-lactone FAQ
Is 4-Hydroxy-3-methyloctanoic acid gamma-lactone on the FEMA GRAS list?
It is. FEMA number 3803 covers 4-Hydroxy-3-methyloctanoic acid gamma-lactone. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for 4-Hydroxy-3-methyloctanoic acid gamma-lactone?
The FEMA number for 4-Hydroxy-3-methyloctanoic acid gamma-lactone is 3803 and its CAS registry number is 39212-23-2. Its flavor category is fruity.
What is 4-Hydroxy-3-methyloctanoic acid gamma-lactone used for?
4-Hydroxy-3-methyloctanoic acid gamma-lactone is described as sweet, creamy, coconut, fruity. On the palate it is sweet, rich, tropical. It shows up in beverage, confection, dairy, ice cream and flavoring.
What did JECFA conclude about 4-Hydroxy-3-methyloctanoic acid gamma-lactone?
JECFA evaluated 4-Hydroxy-3-methyloctanoic acid gamma-lactone at the 49th meeting in 1997 under JECFA number 437. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is 4-Hydroxy-3-methyloctanoic acid gamma-lactone approved in the EU?
Yes. FL 10.053 is the Union List entry for 4-Hydroxy-3-methyloctanoic acid gamma-lactone, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Is 4-Hydroxy-3-methyloctanoic acid gamma-lactone natural or artificial?
Nature makes 4-Hydroxy-3-methyloctanoic acid gamma-lactone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial 4-Hydroxy-3-methyloctanoic acid gamma-lactone, 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 4-HYDROXY-3-METHYLOCTANOIC ACID LACTONE under CAS 39212-23-2 and carries its FEMA number, its JECFA flavor 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.