Flavor ingredient regulatory record
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is a natural complex flavoring material in the fruity family, FEMA GRAS under FEMA number 3989 (CAS 163038-04-8). Its odor is sweet, fruity, creamy, caramel, nutty.
- FEMA
- 3989
- CAS
- 163038-04-8
- JECFA
- 2034
- EU FL
- 07.260
GRAS status: FEMA GRAS, publication 20. Recorded by FDA in the Substances Added to Food inventory under CAS 246511-74-0.
Structure
Material
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is a natural complex material rather than a single molecule, so it has no one structure. FEMA lists it as Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone.
Identity
Also known as: 2-Hexanone, 3-hydroxy-5-methyl-, 3-Hydroxy-5-methyl-2-hexanone, 3-Hydroxy-5-methylhexan-2-one, 3-hydroxy-5-methyl-2-hexanone, 3-hydroxy-5-methylhexan-2-one, 3-hydroxy-5-methyl-hexan-2-one, 2-hexanone, 3-hydroxy-5-methyl, 2-hexanone, 3-hydroxy-5-methyl-, (+-)-3-hydroxy-5-methylhexan-2-one, 3-hydroxy-5-methylhexan-2-one, (+-)-, 3-hydroxy-5-methylhexan-2-one, (+/-)-, 2-hexanone, 3-hydroxy-5-methyl- (9ci).
Can Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone be labeled natural?
Nature makes Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone, same molecule. 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
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is FEMA GRAS under FEMA number 3989. 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 07.260, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 2034, evaluated at the 73rd meeting in 2010. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, creamy, caramel, nutty.
Where it is used
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is used in beverage, confection, dairy and baked goods, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 1-Hydroxy-4-methyl-2-pentanone | 4463 | 89% | Not determined |
| 4-Methyl-2-oxopentanoic acid | 3871 | 80% | In nature |
| Isobutyl acetate | 2175 | 75% | In nature |
| 3-Methyl-2-oxopentanoic acid | 3870 | 69% | In nature |
| 4-Methylpentanoic acid | 3463 | 69% | In nature |
More ketones in this index
4-Methyl-3-penten-2-one · d,l-Isomenthone · Dehydrodihydroionone · Epoxy oxophorone · beta-Ionone epoxide · Dihydro-beta-ionone
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone FAQ
Is Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone on the FEMA GRAS list?
It is. FEMA number 3989 covers Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone?
The FEMA number for Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is 3989 and its CAS registry number is 163038-04-8. Its flavor category is fruity.
What is Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone used for?
Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone is described as sweet, fruity, creamy, caramel, nutty. It shows up in beverage, confection, dairy and baked goods.
What did JECFA conclude about Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone?
JECFA evaluated Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone at the 73rd meeting in 2010 under JECFA number 2034. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone approved in the EU?
Yes. FL 07.260 is the Union List entry for Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Is Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone natural or artificial?
The process decides for Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone 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.
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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-HYDROXY-5-METHYL-3-HEXANONE under CAS 246511-74-0 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.