About
Thiamine (vitamin B1) is a water-soluble B-vitamin that acts as a coenzyme in carbohydrate, branched-chain amino acid, and energy-yielding metabolism, and is essential for healthy nervous and cardiovascular system function. It is added to fortified foods, breakfast cereals, infant formulas, and dietary supplements to maintain adequate population intake and prevent deficiency diseases such as beriberi and Wernicke-Korsakoff syndrome.
Safety summary
Thiamine has an excellent safety profile; neither the EU Scientific Committee on Food/EFSA nor the U.S. Institute of Medicine has established a tolerable upper intake level (UL) for oral thiamine because no adverse effects from high dietary or supplemental intake have been documented, and excess is rapidly excreted in urine. Populations at greatest risk of deficiency—rather than toxicity—include individuals with alcohol use disorder, chronic malabsorption, persistent vomiting, or long-term restricted diets. No major regulatory body has flagged dietary or supplemental thiamine as a safety concern for any population group at normal intake levels.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved as a nutrient source for food supplements under Directive 2002/46/EC and for food fortification under Regulation (EC) No 1925/2006. EFSA NDA Panel (2016) confirmed Population Reference Intake (PRI) of 0.1 mg/MJ for all population groups older than 7 months. No tolerable upper intake level (UL) established due to absence of documented adverse effects from high oral intake.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as Vitamin B1 (thiamine chloride hydrochloride and thiamine mononitrate) under FSSAI Health Supplements, Nutraceuticals, Food for Special Dietary Use, and Food for Special Medical Purpose Regulations (2021). Maximum daily dose in health supplements capped at the ICMR RDA; permissible manufacturing overage of 25% allowed under Schedule I, Table C.source |
| FDA (Food and Drug Administration) (United States) | Approved | Thiamine hydrochloride affirmed GRAS under 21 CFR §184.1875; thiamine mononitrate affirmed GRAS under 21 CFR §184.1878. No usage limits other than current Good Manufacturing Practices (cGMPs). FDA also approves parenteral thiamine for treatment of Wernicke encephalopathy, infantile beriberi, and cardiovascular disease resulting from thiamine deficiency.source |
Who should approach with care
Research citations
- 1FDA. Code of Federal Regulations Title 21, Part 184.1875 – Thiamine Hydrochloride (and §184.1878 Thiamine Mononitrate). accessdata.fda.gov
- 2other. Vitamin B1 (Thiamine) – StatPearls, NCBI Bookshelf (NIH), 2024. ncbi.nlm.nih.gov
- 3FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations – Compendium Version-I (29.09.2021), 2021. fssai.gov.in
- 4EFSA. Dietary reference values for thiamin – EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2016. efsa.europa.eu
- 5EFSA. Benfotiamine, thiamine monophosphate chloride and thiamine pyrophosphate chloride as sources of vitamin B1 added for nutritional purposes to food supplements – Scientific Opinion of the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), 2008. efsa.europa.eu