About
D-Biotin is the biologically active stereoisomer of biotin (Vitamin B7), a water-soluble B-vitamin essential for carboxylation reactions, fatty acid synthesis, and gluconeogenesis. It is added to foods and supplements as a nutritional fortifier and occurs naturally in eggs, meat, nuts, and certain vegetables.
Safety summary
D-Biotin has an excellent safety profile at dietary and supplemental levels; no tolerable upper intake level (UL) or ADI has been established by EFSA or the Institute of Medicine owing to the absence of adverse effects at high intakes from food. EFSA's FEEDAP Panel (2025) confirmed it is non-genotoxic, non-irritant to skin or eyes, and not a dermal sensitiser. However, high-dose biotin supplementation (≥10 mg/day, far exceeding fortification levels) is known to interfere with immunoassay-based clinical laboratory tests, which can produce false results for thyroid hormones, troponin, and other analytes.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Biotin is a permitted vitamin source under Directive 2002/46/EC (food supplements) and Regulation (EC) No 1925/2006 (fortified foods). Authorised as D-(+)-biotin (≥97% purity, code 3a880) as a nutritional feed additive for all animal species; EFSA FEEDAP Panel (2025) found no new safety concerns. Health claims approved under Commission Regulation (EU) No 432/2012 (e.g., contribution to normal macronutrient metabolism, hair maintenance).source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | FSA/FSS concluded sufficient evidence of safety and efficacy based on the 2025 EFSA risk assessment; biotin authorised as a nutritional feed additive under Assimilated Regulation (EC) No 1831/2003.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed in FDA Substances Added to Food inventory (formerly EAFUS) as a nutrient; permitted in conventional foods and dietary supplements under 21 CFR Parts 101 and 104. No formal ADI established; dietary reference intake (DRI) Adequate Intake (AI) for adults is 30 µg/day.source |
Who should approach with care
Research citations
- 1FDA. Substances Added to Food (formerly EAFUS) — Biotin. hfpappexternal.fda.gov
- 2other. FSA/FSS Assessment on the Feed Additive Consisting of Biotin for All Animal Species for the Modification of Its Authorisation (RP2227), 2026. science.food.gov.uk
- 3EFSA. Assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (ADISSEO, DSM Nutritional Products Ltd., NHU Europe GmbH), 2025. efsa.europa.eu
- 4PubMed. Assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (ADISSEO, DSM Nutritional Products Ltd., NHU Europe GmbH) — PMC full text, 2025. pmc.ncbi.nlm.nih.gov
- 5other. Commission Regulation (EU) No 432/2012 — Establishing a list of permitted health claims made on foods, 2012. eur-lex.europa.eu
