Flavor ingredient regulatory record
Epoxy oxophorone
Epoxy oxophorone is a ketone in the fruity family, FEMA GRAS under FEMA number 4109 (CAS 38284-11-6). Its odor is sweet, fruity, floral, tropical, green.
- FEMA
- 4109
- CAS
- 38284-11-6
- JECFA
- 1573
- Formula
- C9H12O3
GRAS status: FEMA GRAS, publication 22. Recorded by FDA in the Substances Added to Food inventory under CAS 38284-11-6.
Structure
Identity
Also known as: 7-Oxabicyclo[4.1.0]heptane-2,5-dione, 1,3,3-trimethyl-, 1,3,3-Trimethyl-7-oxabicyclo[4.1.0]heptane-2,5-dione, 2,3-Epoxy-3,5,5-trimethyl-1,4-cyclohexanedione, 3,5,5-Trimethyl-2,3-epoxycyclohexane-1,4-dione, 2,3-Oxido-2,6,6-trimethyl-1,4-cyclohexanedione, 1,3,3-Trimethyl-7-oxabicyclo[4.1.0]heptan-2,5-dione, 1,3,3-Trimethyl-7-oxabicyclo[4.1.0]heptan-2,5-dion, epoxyoxophorone, 1,3,3-trimethyl-7-oxabicyclo[4.1.0]heptane-2,5-dione, 3,5,5-trimethyl-2,3-epoxycyclohexane-1,4-dione, 2,3-epoxy-3,5,5-trimethyl-1,4-cyclohexanedione, 2,3-oxido-2,6,6-trimethyl-1,4-cyclohexanedione.
Can Epoxy oxophorone be labeled natural?
Nature makes epoxy oxophorone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial epoxy oxophorone, 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
Epoxy oxophorone is FEMA GRAS under FEMA number 4109. 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 Epoxy oxophorone. 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 1573, evaluated at the 65th meeting in 2005. 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, floral, tropical, green.
Where it is used
Epoxy oxophorone is used in beverage, confection, fruit flavors, bakery and desserts, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Epoxy oxophorone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2,6,6-Trimethylcyclohex-2-en-1,4-dione | 3421 | 78% | In nature |
| Piperitenone oxide | 4199 | 76% | In nature |
| beta-Ionone epoxide | 4144 | 73% | In nature |
| 3,3,5-Trimethyl cyclohexanol | 3962 | 71% | In nature |
| trans-Carvone-5,6-oxide | 4084 | 60% | In nature |
More ketones in this index
beta-Ionone epoxide · 1-Ethyl-2-acetylpyrrole · 2-Nonanone · 2-Hydroxyacetophenone · 5-Methyl-5-hexen-2-one · Vanillylidene acetone
Epoxy oxophorone FAQ
Is epoxy oxophorone on the FEMA GRAS list?
It is. FEMA number 4109 covers epoxy oxophorone. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for epoxy oxophorone?
The FEMA number for epoxy oxophorone is 4109 and its CAS registry number is 38284-11-6. Its flavor category is fruity.
What is epoxy oxophorone used for?
Epoxy oxophorone is described as sweet, fruity, floral, tropical, green. It shows up in beverage, confection, fruit flavors, bakery and desserts.
What did JECFA conclude about epoxy oxophorone?
JECFA evaluated epoxy oxophorone at the 65th meeting in 2005 under JECFA number 1573. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is epoxy oxophorone approved in the EU?
No EU FL number is on file for epoxy oxophorone. It has a JECFA evaluation (JECFA 1573), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Is epoxy oxophorone natural or artificial?
The process decides for epoxy oxophorone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic epoxy oxophorone 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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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
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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 EPOXYOXOPHORONE under CAS 38284-11-6 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.