Flavor ingredient regulatory record
Isoamyl acetoacetate
Isoamyl acetoacetate is an ester in the fruity family, FEMA GRAS under FEMA number 3551 (CAS 2308-18-1). Its odor is sweet, fruity, banana, pear, apple.
- FEMA
- 3551
- CAS
- 2308-18-1
- JECFA
- 598
- EU FL
- 09.401
- Formula
- C9H16O3
GRAS status: FEMA GRAS, publication 11. Recorded by FDA in the Substances Added to Food inventory under CAS 2308-18-1.
Structure
Identity
Also known as: Butanoic acid, 3-oxo-, 3-methylbutyl ester, Acetoacetic acid, isopentyl ester, Isopentyl alcohol, acetoacetate, 3-Methylbutyl 3-oxobutanoate, Isopentyl acetoacetate, Isoamyl acetylacetate, Isoamyl 3-oxo-butanoate, 3-Methyl-1-butyl 3-oxobutanoate, acetoacetic acid isoamyl ester, 3-methylbutyl 3-oxobutanoate, isopentyl 3-oxobutanoate, isopentyl acetoacetate.
Can Isoamyl acetoacetate be labeled natural?
The process decides for isoamyl acetoacetate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic isoamyl acetoacetate is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic isoamyl acetoacetate 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
Isoamyl acetoacetate is FEMA GRAS under FEMA number 3551. 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 09.401, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 598, evaluated at the 53rd meeting in 1999. 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, banana, pear, apple.
Where it is used
Isoamyl acetoacetate is used in beverage, confection, fruit flavors, bakery and ice cream, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Isoamyl acetoacetate by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Isoamyl isovalerate | 2085 | 86% | In nature |
| Butyl isovalerate | 2218 | 84% | In nature |
| Ethyl 3-oxohexanoate | 3683 | 71% | In nature |
| Isoamyl acetate | 2055 | 67% | In nature |
More esters in this index
Cinnamyl isobutyrate · cis-3-Hexenyl acetate · Menthyl valerate · Isoamyl salicylate · Menthyl isovalerate · Butyl butyryllactate
Isoamyl acetoacetate FAQ
Is isoamyl acetoacetate on the FEMA GRAS list?
It is. FEMA number 3551 covers isoamyl acetoacetate. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for isoamyl acetoacetate?
The FEMA number for isoamyl acetoacetate is 3551 and its CAS registry number is 2308-18-1. Its flavor category is fruity.
What is isoamyl acetoacetate used for?
Isoamyl acetoacetate is described as sweet, fruity, banana, pear, apple. It shows up in beverage, confection, fruit flavors, bakery and ice cream.
What did JECFA conclude about isoamyl acetoacetate?
JECFA evaluated isoamyl acetoacetate at the 53rd meeting in 1999 under JECFA number 598. The panel concluded: no safety concern at current levels of intake when used as a flavouring agent.
Is isoamyl acetoacetate approved in the EU?
Yes. FL 09.401 is the Union List entry for isoamyl acetoacetate, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Is isoamyl acetoacetate natural or artificial?
Nature makes isoamyl acetoacetate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial isoamyl acetoacetate, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Isoamyl acetoacetate 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 ISOAMYL ACETOACETATE under CAS 2308-18-1 and carries its FEMA number, its JECFA flavor number and its 21 CFR citations. 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.