Flavor ingredient regulatory record
3-Hydroxy-4-phenylbutan-2-one
3-Hydroxy-4-phenylbutan-2-one is a ketone in the fruity family, FEMA GRAS under FEMA number 4052 (CAS 5355-63-5). Its odor is sweet, fruity, creamy, floral, buttery.
- FEMA
- 4052
- CAS
- 5355-63-5
- JECFA
- 2041
- EU FL
- 07.242
- Formula
- C10H12O2
GRAS status: FEMA GRAS, publication 21. Recorded by FDA in the Substances Added to Food inventory under CAS 5355-63-5.
Structure
Identity
Also known as: 2-Butanone, 3-hydroxy-4-phenyl-, 3-Hydroxy-4-phenyl-2-butanone, 4-Phenyl-3-hydroxybutan-2-one, 3-hydroxy-4-phenyl-2-butanone, 2-butanone, 3-hydroxy-4-phenyl-, 4-phenyl-3-hydroxybutan-2-one, 3-hydroxy-4-phenylbutan-2-one [fhfi], 2-butanone, 3-hydroxy-4-phenyl, ebc-627300.
Can 3-Hydroxy-4-phenylbutan-2-one be labeled natural?
3-Hydroxy-4-phenylbutan-2-one occurs in nature, so the label depends on the route: 3-Hydroxy-4-phenylbutan-2-one won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized 3-Hydroxy-4-phenylbutan-2-one is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 3-Hydroxy-4-phenylbutan-2-one 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
3-Hydroxy-4-phenylbutan-2-one is FEMA GRAS under FEMA number 4052. 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 07.242, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
Purity. At least 93%; secondary component 3-5% 4-hydroxy-4-phenylbutan-2-one
JECFA (WHO / FAO)
JECFA number 2041, evaluated at the 73rd meeting in 2010. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, creamy, floral, buttery.
Where it is used
3-Hydroxy-4-phenylbutan-2-one is used in beverage, confection, dairy, bakery and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 3-Hydroxy-4-phenylbutan-2-one by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 4-Phenyl-2-butanol | 2879 | 82% | In nature |
| Phenoxyacetic acid | 2872 | 66% | In nature |
| 3-Phenylpropionic acid | 2889 | 64% | In nature |
| DL-Phenylalanine | 3726 | 63% | In nature |
| L-Phenylalanine | 3585 | 63% | In nature |
More ketones in this index
trans-alpha-Damascone · 1-Octen-3-one · Acetophenone · Isophorone · 4-(p-Tolyl)-2-butanone · 3-Nonanone
3-Hydroxy-4-phenylbutan-2-one FAQ
Is 3-Hydroxy-4-phenylbutan-2-one on the FEMA GRAS list?
It is. FEMA number 4052 covers 3-Hydroxy-4-phenylbutan-2-one. It is also codified at 21 CFR 172.515.
What is the FEMA number for 3-Hydroxy-4-phenylbutan-2-one?
The FEMA number for 3-Hydroxy-4-phenylbutan-2-one is 4052 and its CAS registry number is 5355-63-5. FEMA files it in the fruity flavor category.
Is 3-Hydroxy-4-phenylbutan-2-one natural or artificial?
Since 3-Hydroxy-4-phenylbutan-2-one is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when 3-Hydroxy-4-phenylbutan-2-one is synthesized. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 3-Hydroxy-4-phenylbutan-2-one identical-to-natural.
Is 3-Hydroxy-4-phenylbutan-2-one approved in the EU?
3-Hydroxy-4-phenylbutan-2-one is on the EU Union List of flavouring substances as FL 07.242 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated 3-Hydroxy-4-phenylbutan-2-one?
Yes. JECFA number 2041, evaluated at the 73rd meeting in 2010. Conclusion: no safety concern at current levels of intake.
What is 3-Hydroxy-4-phenylbutan-2-one used for?
3-Hydroxy-4-phenylbutan-2-one is described as sweet, fruity, creamy, floral, buttery. It shows up in beverage, confection, dairy, bakery and flavoring.
Ingredient lookup
Check an ingredient
Start typing to search the ingredient corpus.
Or browse every ingredient page, A to Z.
Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check 3-Hydroxy-4-phenylbutan-2-one in a formula
Screened against FEMA GRAS, 21 CFR and EU rules as you build. Free to start.
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 3-HYDROXY-4-PHENYLBUTAN-2-ONE under CAS 5355-63-5 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.