Flavor ingredient regulatory record
2,4-Dimethyl-3-oxazoline
2,4-Dimethyl-3-oxazoline is an oxazoline in the fruity family, FEMA GRAS under FEMA number 4429 (CAS 77311-02-5). Its odor is sweet, fruity, floral, nutty, creamy.
- FEMA
- 4429
- CAS
- 77311-02-5
- JECFA
- 1558
- EU FL
- 13.115
- Formula
- C5H9NO
GRAS status: FEMA GRAS, publication 23. Recorded by FDA in the Substances Added to Food inventory under CAS 77311-02-5.
Structure
Identity
Also known as: Oxazole, 2,5-dihydro-2,4-dimethyl-, 2,5-Dihydro-2,4-dimethyloxazole, 2,4-dimethyl-2,5-dihydro-1,3-oxazole, oxazole, 2,5-dihydro-2,4-dimethyl-, 3-oxazoline, 2,4-dimethyl-, 2,4-dimethyl-3-oxazoline [fhfi], (+-)-2,4-dimethyl-3-oxazoline, 2,4-dimethyl-3-oxazoline, (+-)-, 2,5-dihydro-2,4-dimethyloxazole, 2,4-dimethyl-2,5-dihydrooxazole, 2,5-dihydro-2,4-dimethyl oxazole, 2,4-dimethyl-3-oxazoline, (+/-)-.
Can 2,4-Dimethyl-3-oxazoline be labeled natural?
Nature makes 2,4-Dimethyl-3-oxazoline, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial 2,4-Dimethyl-3-oxazoline, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material 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
2,4-Dimethyl-3-oxazoline is FEMA GRAS under FEMA number 4429. 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 13.115, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1558, 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, nutty, creamy.
Taste: Sweet, mild, creamy.
Where it is used
2,4-Dimethyl-3-oxazoline is used in beverage, confection, desserts and snacks, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 2,4-Dimethyl-3-oxazoline by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2,4,5-Trimethyl-delta-3-oxazoline | 3525 | 93% | In nature |
| 2,4-Dimethyl-1,3-dioxolane | 4099 | 92% | Not determined |
| 2,5-Dimethylfuran | 4106 | 90% | In nature |
| 2-Acetyl-1-pyrroline | 4249 | 86% | In nature |
| 4-Methyl-3-thiazoline | 4644 | 79% | In nature |
More oxazolines in this index
2,4-Dimethyl-3-oxazoline FAQ
Does 2,4-Dimethyl-3-oxazoline have FEMA GRAS status?
2,4-Dimethyl-3-oxazoline holds FEMA GRAS status under FEMA number 4429. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite 2,4-Dimethyl-3-oxazoline by FEMA or CAS number?
Cite 2,4-Dimethyl-3-oxazoline as FEMA 4429 or CAS 77311-02-5; both point to the same entry. Its flavor category is fruity.
What does 2,4-Dimethyl-3-oxazoline smell and taste like, and where is it used?
The odor of 2,4-Dimethyl-3-oxazoline is sweet, fruity, floral, nutty, creamy. On the palate it is sweet, mild, creamy. Typical uses are beverage, confection, desserts and snacks.
What did JECFA conclude about 2,4-Dimethyl-3-oxazoline?
JECFA evaluated 2,4-Dimethyl-3-oxazoline at the 65th meeting in 2005 under JECFA number 1558. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Can 2,4-Dimethyl-3-oxazoline be used in the EU and UK?
Yes. FL 13.115 is the Union List entry for 2,4-Dimethyl-3-oxazoline, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Can 2,4-Dimethyl-3-oxazoline be labeled a natural flavor?
The process decides for 2,4-Dimethyl-3-oxazoline. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic 2,4-Dimethyl-3-oxazoline is artificial. 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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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 2,4-DIMETHYL-3-OXAZOLINE under CAS 77311-02-5 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.