# Thiamine Hydrochloride > Source URL: https://additivefacts.com/additives/thiamine-hydrochloride > Markdown URL: https://additivefacts.com/additives/thiamine-hydrochloride.md **Safety rating:** SAFE **CAS number:** 67-03-8 **Category:** flavoring **FDA GRAS:** no **Adverse events (FDA AERS):** 0 **FDA recalls:** 0 **Last updated:** 2026-04-04 ## Summary Thiamine hydrochloride is a synthetic form of vitamin B1 (thiamine) used in food products as both a nutrient supplement and flavoring agent adjuvant. It is commonly added to fortified grain products, cereals, and nutritional supplements to prevent thiamine deficiency diseases. ## Regulatory status | Country | Status | | --- | --- | | United States | approved | | European Union | not_evaluated | | United Kingdom | approved | | Canada | approved | | Australia | approved | | Japan | approved | | South Korea | approved | | Brazil | approved | | China | approved | | India | approved | ## Detailed analysis ## What is Thiamine Hydrochloride? Thiamine hydrochloride (also known as vitamin B1 hydrochloride) is a water-soluble synthetic compound containing thiamine, an essential B-complex vitamin. The hydrochloride salt form enhances stability and shelf-life compared to free thiamine. It appears as white to off-white crystalline powder and is highly soluble in water, making it suitable for fortification of various food and beverage products. Thiamine itself is an essential micronutrient required for carbohydrate metabolism, nervous system function, and energy production in all cells. The human body cannot synthesize thiamine, making dietary intake necessary for health. ## Common Uses Thiamine hydrochloride is primarily used as a nutrient supplement in grain-based products, including breakfast cereals, flour, bread, pasta, and rice. It is also found in fortified beverages, nutritional supplements, and some processed foods. In these applications, it serves dual roles: restoring nutrient value lost during grain processing and providing essential vitamin B1 intake. In some food formulations, it functions as a flavoring agent adjuvant—a substance that supports or enhances flavor compounds—though this is a secondary application compared to its nutrient supplementation role. ## Safety Assessment Thiamine hydrochloride has an established history of safe use in food fortification. The FDA has recorded zero adverse events and zero recalls associated with this additive, indicating a strong safety profile in food applications. Thiamine is water-soluble and excess amounts are readily excreted through urine, reducing toxicity concerns from overconsumption through food sources. The European Food Safety Authority (EFSA) has also recognized thiamine as a safe nutrient for food fortification purposes. Typical fortification levels in foods are modest—generally 0.5-2 mg per serving—and remain well below any known adverse effect thresholds. Even supplemental intakes of thiamine at levels significantly above Recommended Dietary Allowances (RDAs of 1.1-1.2 mg/day for adults) have not demonstrated safety concerns in published literature. ## Regulatory Status While thiamine hydrochloride is not designated as GRAS (Generally Recognized as Safe) by the FDA for all uses, this does not indicate safety concerns. Rather, it is regulated as a food additive and approved for use in specific food categories including grain products and nutritional supplements. Its use is permitted under FDA food fortification regulations (21 CFR Part 104). The compound is approved for food use in the European Union, Australia, Canada, and other major regulatory jurisdictions. In the United States, it is listed among approved nutrients for grain product enrichment, which is mandatory for refined grain products. ## Key Studies Extensive research confirms thiamine's essential role in human metabolism and the effectiveness of thiamine hydrochloride in addressing deficiency. Fortification programs using thiamine hydrochloride have successfully eliminated thiamine deficiency diseases (beriberi, Wernicke-Korsakoff syndrome) in populations with adequate food access. Bioavailability studies demonstrate that thiamine hydrochloride is efficiently absorbed and utilized by the human body, with absorption rates comparable to natural thiamine sources. Stability studies confirm the compound maintains potency through typical food storage conditions when properly protected from light and moisture. No genotoxicity, reproductive toxicity, or developmental toxicity has been demonstrated in standard safety testing. The additive's long history of use in food fortification without documented safety incidents supports its continued classification as a safe food ingredient. ## Brands using Thiamine Hydrochloride - Abbott (22 products) - Gerber (3 products) - Wal-Mart Stores, Inc. (3 products) - Bubs (2 products) - Earth's Best (2 products) - Nongshim (2 products) - Nutricia (2 products) - Plum Organics (2 products) - Rosa Foods, Inc. (2 products) - Société des Produits Nestlé S.A. (2 products) - Abbott Laboratories Inc (1 product) - Abbott Nutrition (1 product) - BARCODE (1 product) - BYHEART (1 product) - Bobbie (1 product) - Bolner's Fiesta Products, Inc. (1 product) - COMPLIMENTS (1 product) - Colonna Brothers (1 product) - Ensure (1 product) - H E Butt Grocery Company (1 product) - Happybaby (1 product) - Ka'chava (1 product) - Ketchapaw Enterprises (1 product) - Kirkland Signature (1 product) - Nature's Own (1 product) - Nestle USA Inc. (1 product) - Orgain, Inc. (1 product) - Similac (1 product) - The Kroger Co. (1 product) - plum organics (1 product) ## Sources - FDA Substances Added to Food (CFSAN) - OpenFDA Adverse Event Reporting System (AERS) - OpenFDA Food Recalls - EFSA OpenFoodTox - EU Food Additive Portal ## Citation Additive Facts. "Thiamine Hydrochloride — Safety, regulation, and evidence." https://additivefacts.com/additives/thiamine-hydrochloride. Accessed 2026-05-20.