Flavor ingredient regulatory record
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione is a pyrazole in the fruity family, FEMA GRAS under FEMA number 4725 (CAS 1119831-25-2). Its odor is sweet, fruity, floral, herbal, complex.
- FEMA
- 4725
- CAS
- 1119831-25-2
- JECFA
- 2161
- EU FL
- 16.127
- Formula
- C19H19N5O4
GRAS status: FEMA GRAS, publication 25. Recorded by FDA in the Substances Added to Food inventory under CAS 1119831-25-2.
Structure
Identity
Also known as: 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1h-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione, 2,4-imidazolidinedione, 3-(1-((3,5-dimethyl-4-isoxazolyl)-methyl)-1h-pyrazol-4-yl)-1-((3-hydroxyphenyl)methyl)-, s6821, 3-{1-[(3,5-dimethyl-1,2-oxazol-4-yl)methyl]-1h-pyrazol-4-yl}-1-[(3-hydroxyphenyl)methyl]imidazolidine-2,4-dione, 3-[1-[(3,5-dimethyl-1,2-oxazol-4-yl)methyl]-1h-pyrazol-4-yl]-1-[(3-hydroxyphenyl)methyl]imidazolidine-2,4-dione, glxc-22413, ebc-253173, 3-[1-[(3,5-dimethyl-1,2-oxazol-4-yl)methyl]pyrazol-4-yl]-1-[(3-hydroxyphenyl)methyl]imidazolidine-2,4-dione, hy-139899, en300-37109066, us9247759, 10-10.
Can 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione 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
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione is FEMA GRAS under FEMA number 4725. 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 16.127, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list. The entry carries use restrictions.
Use restrictions. Restrictions of use as a flavouring substance: In category 1.4, - not more than 4 mg/kg In category 1.8,- not more than 8 mg/kg In category 3 - not more than 4 mg/kg In category 5.1. - not more than 15 mg/kg In category 5.2. - not more than 16 mg/kg In category 5.3. - not more than 30 mg/kg In category 5.4 - not more than 15 mg/kg In category 6.3. - not more than 25 mg/kg In category 12.1. - not more than 75 mg/kg In category 12.2. - not more than 100 mg/kg In category 12.3. - not more than 25 mg/kg In category 12.4. - not more than 25 mg/kg In category 12.5. - not more than 4 mg/kg In category 13.2. - not more than 4 mg/kg In category 13.3, - not more than 4 mg/kg In category 14.1.4 - not more than 4 mg/l (for dairy based drinks only) In category 14.1.5. - not more than 8 mg/kg In category 15.1. - not more than 20 mg/kg In category 16. - not more than 4 mg/l (for dairy based deserts only)
Purity. at least 99 %, assay (HPLC/UV)
JECFA (WHO / FAO)
JECFA number 2161, evaluated at the meeting in 2012. 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, herbal, complex.
Taste: Sweet, slightly bitter, rich.
Where it is used
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione is used in beverage, confection, flavoring agent and snacks, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-5,5-dimethylimidazolidine-2,4-dione | 4726 | 94% | Not determined |
| (E)-3-Benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide | 4788 | 67% | Not determined |
| Piperine | 2909 | 66% | In nature |
| 2-(4-Methylphenoxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)acetamide | 4809 | 59% | Not determined |
| (+/-) N,N-Dimethyl menthyl succinamide | 4230 | 59% | Not determined |
More pyrazoles in this index
1-Phenyl-(3 or 5)-propylpyrazole · 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-5,5-dimethylimidazolidine-2,4-dione
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione FAQ
Is 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione FEMA GRAS?
Yes. The FEMA Expert Panel lists 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione as GRAS under FEMA number 4725. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione?
3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione is FEMA 4725, CAS 1119831-25-2. Its flavor category is fruity.
How is 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione described, and where does it show up?
Flavorists describe 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione as sweet, fruity, floral, herbal, complex. On the palate it is sweet, slightly bitter, rich. It is used in beverage, confection, flavoring agent and snacks.
What did JECFA conclude about 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione?
JECFA evaluated 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione at the meeting in 2012 under JECFA number 2161. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione on the EU Union List?
Yes. FL 16.127 is the Union List entry for 3-(1-((3,5-Dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)-imidazolidine-2,4-dione, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list. Its entry carries use restrictions, listed on this page.
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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 3-(1-((3,5-DIMETHYLISOXAZOL-4-YL)METHYL)-1H-PYRAZOL-4-YL)-1-(3- HYDROXYBENZYL)IMIDAZOLIDINE-2,4-DIONE under CAS 1119831-25-2 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.