Flavor ingredient regulatory record
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine is a natural complex flavoring material in the savory family, FEMA GRAS under FEMA number 3781 (CAS 101517-86-6). Its odor is earthy, sulfurous, savory, umami.
- FEMA
- 3781
- CAS
- 101517-86-6
- JECFA
- 1046
GRAS status: FEMA GRAS, publication 16. Recorded by FDA in the Substances Added to Food inventory under CAS 977161-98-0.
Structure
Material
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine is a natural complex material rather than a single molecule, so it has no one structure. FEMA lists it as 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine (mixture).
Identity
Also known as: 4H-1,3,5-Dithiazine, dihydro-2,4-dimethyl-6-(2-methylpropyl)-, Dihydro-2,4-dimethyl-6-(2-methylpropyl)-4H-1,3,5-dithiazine, 2,4-Dimethyl-6-(2-methylpropyl)-1,3,5-dithiazinane, 4-isobutyl-2,6-dimethyl-1,3,5-dithiazinane, 4h-1,3,5-dithiazine, dihydro-2,4-dimethyl-6-(2-methylpropyl)-, dihydro-6-isobutyl-2,4-dimethyl-4h-1,3,5-dithiazine, (+-)-4-isobutyl-2,6-dimethyl-1,3,5-dithiazinane, 4-isobutyl-2,6-dimethyl-1,3,5-dithiazinane, (+-)-, 4-isobutyl-2,6-dimethyl-1,3,5-dithiazinane, (+/-)-, dihydro-2,4-dimethyl-6-(2-methylpropyl)-4h-1,3,5-dithiazine, 2,4-dimethyl-6-(2-methylpropyl)-1,3,5-dithiazinane.
Can 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine be labeled natural?
Nature makes 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine, 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-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine is FEMA GRAS under FEMA number 3781. 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 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine. 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 1046, evaluated at the 59th meeting in 2002. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Earthy, sulfurous, savory, umami.
Where it is used
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine is used in savory snacks, seasonings, sauces and meat products, typically as a savory note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2-Ethyl-4,6-dimethyl-dihydro-1,3,5-dithiazine | 4667 | 73% | Not determined |
| (+/-) 4-Methyl-2-propyl-1,3-oxathiane | 4677 | 72% | Not determined |
| 2-Isopropyl-4,6-dimethyl and 4-Isopropyl-2,6-dimethyldihydro-1,3,5-dithiazine | 3782 | 69% | In nature |
| 4,5-Dimethyl-2-isobutyl-3-thiazoline | 3621 | 68% | In nature |
More thiols in this index
2-Acetyl-5-methylthiophene · l-Cysteine · 2-Isopropyl-4,6-dimethyl and 4-Isopropyl-2,6-dimethyldihydro-1,3,5-dithiazine · 2-Ethyl-4,6-dimethyl-dihydro-1,3,5-dithiazine · 2-Naphthalenethiol · Ethyl 2-Mercapto-2-methylpropionate
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine FAQ
Does 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine have FEMA GRAS status?
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine holds FEMA GRAS status under FEMA number 3781. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine by FEMA or CAS number?
Cite 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine as FEMA 3781 or CAS 101517-86-6; both point to the same entry. Its flavor category is savory.
What does 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine smell and taste like, and where is it used?
The odor of 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine is earthy, sulfurous, savory, umami. Typical uses are savory snacks, seasonings, sauces and meat products.
What did JECFA conclude about 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine?
JECFA evaluated 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine at the 59th meeting in 2002 under JECFA number 1046. The panel concluded: no safety concern at current levels of intake.
Is 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine approved in the EU?
No EU FL number is on file for 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine. It has a JECFA evaluation (JECFA 1046), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Can 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine be labeled a natural flavor?
The process decides for 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic 2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine 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)-ISOBUTYL-4(2),6-DIMETHYLDIHYDRO-4H-1,3,5-DITHIAZINE under CAS 977161-98-0 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.