# Biotin > Source URL: https://additivefacts.com/additives/biotin > Markdown URL: https://additivefacts.com/additives/biotin.md **Safety rating:** SAFE **CAS number:** 58-85-5 **Category:** nutrient **FDA GRAS:** yes **Adverse events (FDA AERS):** 0 **FDA recalls:** 0 **Last updated:** 2026-04-04 ## Summary Biotin (vitamin B7) is an essential water-soluble B vitamin naturally found in foods and used as a nutrient supplement in fortified products. In food applications, it functions as both a nutritional fortification agent and a sequestrant to improve product stability and nutrient retention. ## 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 Biotin? Biotin, also known as vitamin B7 or coenzyme R, is a water-soluble B vitamin with the CAS number 58-85-5. It is an essential micronutrient required for normal human metabolism and is naturally present in many foods including eggs, almonds, salmon, and sweet potatoes. Biotin functions as a coenzyme in various metabolic pathways, particularly in carbohydrate, lipid, and amino acid metabolism. In food manufacturing, biotin is added as a synthetic or naturally-derived supplement to fortify products and enhance their nutritional profile. ## Common Uses Biotin is primarily used in food and beverage applications as a nutrient supplement to fortify products such as breakfast cereals, nutritional bars, dietary supplements, and functional beverages. Its inclusion helps manufacturers meet or exceed daily value requirements for biotin, supporting consumer health claims. Additionally, biotin functions as a sequestrant in certain applications, where it can bind to trace metals and improve product shelf stability. The compound is tasteless and odorless, making it suitable for incorporation into a wide variety of food formats without affecting sensory characteristics. ## Safety Assessment Biotin has been extensively studied and demonstrates an excellent safety profile. The FDA has designated biotin as Generally Recognized as Safe (GRAS), meaning it is permitted for use in food with no established safety concerns at intended use levels. According to FDA adverse event reporting systems, there have been zero recorded adverse events associated with biotin as a food additive. Similarly, no FDA recalls have been associated with biotin itself as an additive ingredient. The European Food Safety Authority (EFSA) has also established that biotin does not present safety concerns when used as a food additive. Biotin is water-soluble, meaning excess amounts are excreted through urine rather than accumulating in body tissues. This characteristic significantly reduces the potential for toxicity from excessive intake through food sources. Toxicological studies have not identified a tolerable upper intake level for biotin, indicating that even high intake levels do not produce adverse health effects. The compound does not bioaccumulate and poses no known carcinogenic, mutagenic, or teratogenic risks at food additive concentrations. ## Regulatory Status Biotin is approved for use as a nutrient supplement in food products throughout North America and Europe. In the United States, the FDA permits biotin in food under 21 CFR 182.3045 (GRAS affirmed) and 21 CFR 184.1675 (indirect food additives). It is also approved in Canada, the European Union (E161j in some applications), and most other regulatory jurisdictions. The compound is not subject to maximum use level restrictions in most food categories, reflecting confidence in its safety margin. Manufacturers must comply with current Good Manufacturing Practice (cGMP) standards when producing biotin for food fortification. ## Key Studies Numerous clinical and toxicological studies support biotin's safety profile. Research published in peer-reviewed journals confirms biotin's essential role in human nutrition and demonstrates its safety at supplemental levels. A 2012 review in the journal Nutrients concluded that biotin supplementation is well-tolerated with no documented cases of toxicity in humans, even at high intake levels. Bioavailability studies show that dietary and supplemental biotin are effectively absorbed and utilized by the human body. Additionally, biotin's role as a coenzyme in multiple metabolic pathways has been well-characterized through biochemical research, establishing its nutritional necessity and functional safety in food applications. ## Brands using Biotin - Abbott (22 products) - KSF Acquisition Corporation (13 products) - Enfamil (11 products) - Abbott Nutrition (9 products) - Talking Rain Beverage Company (7 products) - Abbott Laboratories Inc (5 products) - Wal-Mart Stores, Inc. (5 products) - Rexall Sundown, Inc. (4 products) - Bobbie (2 products) - Bristol-Myers Squibb/Mead Johnson Nutritionals (2 products) - Bubs (2 products) - Designer Protein LLC (2 products) - Garden of Life, Inc. (2 products) - Harvest Hill Beverage Company (2 products) - Kabrita (2 products) - Kendamil (2 products) - Kirkland Signature (2 products) - Nestle USA Inc. (2 products) - Nutricia (2 products) - Rosa Foods, Inc. (2 products) - Sprout (2 products) - The Quaker Oats Co./gatorade-Van Camp (2 products) - A-Game Beverages Inc (1 product) - Alani Nutrition LLC (1 product) - BYHEART (1 product) - CLIF (1 product) - Clif (1 product) - Clif Bar and Company (1 product) - Conagra Brands Inc (1 product) - DrBrowns (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. "Biotin — Safety, regulation, and evidence." https://additivefacts.com/additives/biotin. Accessed 2026-05-20.