Flavor ingredient regulatory record
Thiamine hydrochloride
Thiamine hydrochloride is an amine in the nutty family, FEMA GRAS under FEMA number 3322 (CAS 67-03-8). Its odor is nutty, earthy, slightly sweet, toasted.
- FEMA
- 3322
- CAS
- 67-03-8
- JECFA
- 1030
- EU FL
- 16.027
- Formula
- C12H18Cl2N4OS
- EC
- 200-641-8
GRAS status: FEMA GRAS, publication 5. Recorded by FDA in the Substances Added to Food inventory under CAS 67-03-8.
Structure
Identity
Also known as: Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-, chloride, hydrochloride (1:1:1), Thiamine, monohydrochloride, Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-, chloride, monohydrochloride, 3-(4-Amino-2-methylpyrimidyl-5-methyl)-4-methyl-5,β-hydroxyethylthiazolium chloride hydrochloride, Aneurine hydrochloride, Apate drops, Beatine, Bedome, Begiolan, Benerva, Bequin, Berin.
Can Thiamine hydrochloride be labeled natural?
Since thiamine hydrochloride is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when thiamine hydrochloride is synthesized. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic thiamine hydrochloride 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
Thiamine hydrochloride is FEMA GRAS under FEMA number 3322. It is cited in the Code of Federal Regulations at 21 CFR 184.1875.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.027, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1030, evaluated at the 59th meeting in 2002. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Thiamine hydrochloride appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 67-03-8, where EPA names it Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-, chloride, hydrochloride (1:1:1).
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. What active and inactive mean.
EPA publishes no regulatory flags on this listing. What the flags mean.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Nutty, earthy, slightly sweet, toasted.
Where it is used
Thiamine hydrochloride is used in nutritional supplements, beverage, baked goods and confection, typically as a nutty note.
More amines in this index
sec-Butylamine · Phenethylamine · Isopropylamine · Pyrrolidine · Tripropylamine · Ammonia
Thiamine hydrochloride FAQ
Does thiamine hydrochloride have FEMA GRAS status?
Thiamine hydrochloride holds FEMA GRAS status under FEMA number 3322. It is also codified at 21 CFR 184.1875.
How do I cite thiamine hydrochloride by FEMA or CAS number?
Cite thiamine hydrochloride as FEMA 3322 or CAS 67-03-8; both point to the same entry. FEMA files it in the nutty flavor category.
Can thiamine hydrochloride be labeled a natural flavor?
Thiamine hydrochloride occurs in nature, so the label depends on the route: thiamine hydrochloride won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized thiamine hydrochloride is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
Can thiamine hydrochloride be used in the EU and UK?
Thiamine hydrochloride is on the EU Union List of flavouring substances as FL 16.027 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated thiamine hydrochloride?
Yes. JECFA number 1030, evaluated at the 59th meeting in 2002. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
What does thiamine hydrochloride smell and taste like, and where is it used?
The odor of thiamine hydrochloride is nutty, earthy, slightly sweet, toasted. Typical uses are nutritional supplements, beverage, baked goods and confection.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
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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 THIAMINE HYDROCHLORIDE under CAS 67-03-8 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, nutrient supplement.
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.