Flavor ingredient regulatory record
1-Hydroxy-4-methyl-2-pentanone
1-Hydroxy-4-methyl-2-pentanone is a ketone in the fruity family, FEMA GRAS under FEMA number 4463 (CAS 68113-55-3). Its odor is sweet, fruity, creamy, banana, caramel.
- FEMA
- 4463
- CAS
- 68113-55-3
- JECFA
- 1952
- Formula
- C6H12O2
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 68113-55-3.
Structure
Identity
Also known as: 2-Pentanone, 1-hydroxy-4-methyl-, 2-pentanone, 1-hydroxy-4-methyl-, 1-hydroxy-4-methylpentan-2-one, oxymethylisobutylketon, en300-370711.
Can 1-Hydroxy-4-methyl-2-pentanone be labeled natural?
Nature occurrence: Not yet found in nature (provisional).
Nature occurrence has not been settled for this substance, so the natural or artificial class is not stated here. The FEMA GRAS status does not depend on it.
Regulatory status, with citations
United States
1-Hydroxy-4-methyl-2-pentanone is FEMA GRAS under FEMA number 4463. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for 1-Hydroxy-4-methyl-2-pentanone. That is not a finding either way. The Union List covers defined flavouring substances, so natural complex materials are handled as flavouring preparations under Parts B to F and never receive a number, and substances used as additives sit under Regulation 1333/2008 instead. Confirm the position before EU or UK use.
JECFA (WHO / FAO)
JECFA number 1952.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, creamy, banana, caramel.
Where it is used
1-Hydroxy-4-methyl-2-pentanone 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 1-Hydroxy-4-methyl-2-pentanone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone | 3989 | 89% | In nature |
| 4-Methyl-2-oxopentanoic acid | 3871 | 88% | In nature |
| 3-Methyl-2-oxopentanoic acid | 3870 | 77% | In nature |
| 3-Methylpentanoic acid | 3437 | 77% | In nature |
| 2-Methylvaleric acid | 2754 | 70% | In nature |
More ketones in this index
3-Methyl-2,4-nonanedione · Hydroxyacetone · 1-(p-Methoxyphenyl)-1-penten-3-one · 1-(2-Hydroxyphenyl)-3-(pyridin-4-yl)propan-1-one · Mixture of 3-Hydroxy-5-methyl-2-hexanone and 2-Hydroxy-5-methyl-3-hexanone · Methyl 2-pyrrolyl ketone
1-Hydroxy-4-methyl-2-pentanone FAQ
Is 1-Hydroxy-4-methyl-2-pentanone on the FEMA GRAS list?
It is. FEMA number 4463 covers 1-Hydroxy-4-methyl-2-pentanone. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for 1-Hydroxy-4-methyl-2-pentanone?
The FEMA number for 1-Hydroxy-4-methyl-2-pentanone is 4463 and its CAS registry number is 68113-55-3. Its flavor category is fruity.
What is 1-Hydroxy-4-methyl-2-pentanone used for?
1-Hydroxy-4-methyl-2-pentanone is described as sweet, fruity, creamy, banana, caramel. It shows up in beverage, confection, dairy and baked goods.
What did JECFA conclude about 1-Hydroxy-4-methyl-2-pentanone?
JECFA evaluated 1-Hydroxy-4-methyl-2-pentanone under JECFA number 1952.
Is 1-Hydroxy-4-methyl-2-pentanone approved in the EU?
No EU FL number is on file for 1-Hydroxy-4-methyl-2-pentanone. It has a JECFA evaluation (JECFA 1952), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
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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 1-HYDROXY-4-METHYL-2-PENTANONE under CAS 68113-55-3 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.