D-Biotin | whatsinit

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Thyroid Disease — High-dose biotin supplementation (≥10 mg/day), which far exceeds typical food-fortification levels, is recognised by the FDA to interfere with immunoassay-based thyroid hormone tests, potentially producing false results and leading to misdiagnosis; patients on such supplements should disclose use to their healthcare provider before laboratory testing.

Heart Disease — High-dose biotin supplementation can interfere with troponin and other cardiac-biomarker immunoassays used to diagnose myocardial infarction, creating a patient-safety risk; this interference is not relevant at food or standard fortification intake levels.

Research citations

The sources behind this verdict.

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

Independently researched5 citations