Flavor ingredient regulatory record
4,5-Octanedione
4,5-Octanedione is a ketone in the fruity family, FEMA GRAS under FEMA number 4533 (CAS 5455-24-3). Its odor is sweet, fruity, creamy, buttery, nutty.
- FEMA
- 4533
- CAS
- 5455-24-3
- JECFA
- 2037
- EU FL
- 07.071
- Formula
- C8H14O2
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 5455-24-3.
Structure
Identity
Also known as: Bibutyryl, 4,5-Octadione, n-Octane-4,5-dione, NSC 23256, bibutyryl, n-octane-4,5-dione, 4,5-octadione, dipropyl diketone, di-n-butyryl, octane-4,5-dione, 4,5-octane dione, db-082509.
Can 4,5-Octanedione 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
4,5-Octanedione is FEMA GRAS under FEMA number 4533. 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 07.071, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 2037.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, creamy, buttery, nutty.
Where it is used
4,5-Octanedione 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 4,5-Octanedione by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 3,4-Hexanedione | 3168 | 72% | In nature |
| 4-Heptanone | 2546 | 58% | In nature |
More ketones in this index
9-Decen-2-one · Isophorone · Pseudoionone · 2-Hydroxyacetophenone · 3-Nonanone · Damascenone
4,5-Octanedione FAQ
Is 4,5-Octanedione FEMA GRAS?
Yes. The FEMA Expert Panel lists 4,5-Octanedione as GRAS under FEMA number 4533. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for 4,5-Octanedione?
4,5-Octanedione is FEMA 4533, CAS 5455-24-3. Its flavor category is fruity.
How is 4,5-Octanedione described, and where does it show up?
Flavorists describe 4,5-Octanedione as sweet, fruity, creamy, buttery, nutty. It is used in beverage, confection, dairy and baked goods.
What did JECFA conclude about 4,5-Octanedione?
JECFA evaluated 4,5-Octanedione under JECFA number 2037.
Is 4,5-Octanedione on the EU Union List?
Yes. FL 07.071 is the Union List entry for 4,5-Octanedione, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
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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 4,5-OCTANEDIONE under CAS 5455-24-3 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.