Flavor ingredient regulatory record
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine is a thiol in the earthy family, FEMA GRAS under FEMA number 4321 (CAS 116505-60-3). Its odor is earthy, sulfurous, musty, pungent.
- FEMA
- 4321
- CAS
- 116505-60-3
- JECFA
- 1763
- EU FL
- 15.055
- Formula
- C8H15NS2
GRAS status: FEMA GRAS, publication 23. Recorded by FDA in the Substances Added to Food inventory under CAS 116505-60-3.
Structure
![2D structure of Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine](/public/structures/fema-4321.svg)
Identity
Also known as: 4H-Pyrrolo[2,1-d]-1,3,5-dithiazine, tetrahydro-2,4-dimethyl-, (2S,4S,8aR)-, 4H-Pyrrolo[2,1-d]-1,3,5-dithiazine, tetrahydro-2,4-dimethyl-, [2S-(2α,4α,8aβ)]-, (2S,4S,8aR)-Tetrahydro-2,4-dimethyl-4H-pyrrolo[2,1-d]-1,3,5-dithiazine, pyrrolidino-(1,2e)-4h-2,4-dimethyl-1,3,5-dithiazine, 2,4-dimethyl(4h)pyrrolidino(1,2e)-1,3,5-dithiazine, 2,4-dimethyltetrahydropyrrolo(2,1-d)(1,3,5)-dithiazine, pyrrolidino-(1,2e)-4h-2,4-dimethyl-1,3,5-dithiazine [fhfi], 4h-pyrrolo(2,1-d)-1,3,5-dithiazine, tetrahydro-2,4-dimethyl-, (2s-(2.alpha.,4.alpha.,8a.beta.))-, 4h-pyrrolo(2,1-d)-1,3,5-dithiazine, tetrahydro-2,4-dimethyl-, (2s-(2alpha,4alpha,8abeta))-, 2,4-dimethyl(4h)pyrrolidino[1,2e]-1,3,5-dithiazine, 2,4-dimethyltetrahydropyrrolo[2,1-d][1,3,5]-dithiazine, 4h-pyrrolo[2,1-d]-1,3,5-dithiazine, tetrahydro-2,4-dimethyl-, [2s-(2.alpha.,4.alpha.,8a.beta.)]-.
Can Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine be labeled natural?
Nature makes Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial Pyrrolidino-[1,2e]-4H-2,4-dimethyl-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
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine is FEMA GRAS under FEMA number 4321. 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 15.055, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1763, evaluated at the 68th meeting in 2007. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Earthy, sulfurous, musty, pungent.
Where it is used
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine is used in savory dishes, seasoning blends, snack foods and sauces, typically as a earthy note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Pyrrolidino-[1,2e]-4H-2,4-dimethyl-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 | 82% | Not determined |
| 2-Isopropyl-4,6-dimethyl and 4-Isopropyl-2,6-dimethyldihydro-1,3,5-dithiazine | 3782 | 73% | In nature |
| 2-Methyl-4-propyl-1,3-oxathiane | 3578 | 71% | In nature |
| (+/-) 4-Methyl-2-propyl-1,3-oxathiane | 4677 | 58% | Not determined |
| Tripropylamine | 4247 | 55% | Not determined |
More thiols in this index
5,7-Dihydro-2-methylthieno(3,4-d)pyrimidine · 2,4,6-Triisobutyl-5,6-dihydro-4H-1,3,5-dithiazine · Benzothiazole · 2-Pentylthiophene · Thiogeraniol · l-Cysteine
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine FAQ
Does Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine have FEMA GRAS status?
Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine holds FEMA GRAS status under FEMA number 4321. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine by FEMA or CAS number?
Cite Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine as FEMA 4321 or CAS 116505-60-3; both point to the same entry. Its flavor category is earthy.
What does Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine smell and taste like, and where is it used?
The odor of Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine is earthy, sulfurous, musty, pungent. Typical uses are savory dishes, seasoning blends, snack foods and sauces.
What did JECFA conclude about Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine?
JECFA evaluated Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine at the 68th meeting in 2007 under JECFA number 1763. The panel concluded: no safety concern at current levels of intake.
Can Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine be used in the EU and UK?
Yes. FL 15.055 is the Union List entry for Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Can Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine be labeled a natural flavor?
The process decides for Pyrrolidino-[1,2e]-4H-2,4-dimethyl-1,3,5-dithiazine. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic Pyrrolidino-[1,2e]-4H-2,4-dimethyl-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 PYRROLIDINO-[1,2E]-4H-2,4-DIMETHYL-1,3,5-DITHIAZINE under CAS 116505-60-3 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.