Biotin
Biotin (also known as D-biotin, Vitamin B7) is a vitamin permitted for use in nutraceuticals and health supplements under India's FSSAI framework. Regulyze tracks its regulatory status, limits and label requirements across regulatory frameworks.
Regulatory status
| Framework | Status | Limit | Source | Last reviewed |
|---|---|---|---|---|
| India — FSSAI | Permitted | As specified / GMP | FSS (Health Supplements, Nutraceuticals…) Regulations 2022 | 2026-06-20 |
Coverage for the USA (FDA), EU (EFSA), UK, GCC and ASEAN is being added — this page updates automatically as frameworks are assessed.
Recommended Dietary Allowance (ICMR-NIN 2020)
| Group | RDA |
|---|---|
| Adult man | 40 mcg |
| Adult woman | 40 mcg |
| Pregnant | 40 mcg |
| Lactating | 45 mcg |
| Child (1–3 yr) | 20 mcg |
Source: ICMR RDA 2020 Annexure IB. RDA is a reference dietary intake — distinct from the maximum permitted supplement limit.
About Biotin
Biotin is tracked in the Regulyze Ingredient Intelligence database as a vitamin. The regulatory details on this page are generated from Regulyze's structured regulatory dataset and are reviewed against the cited source.
Frequently asked questions
Is Biotin permitted in nutraceuticals under FSSAI (India)?
Biotin is currently permitted for use in health supplements and nutraceuticals under India's FSSAI framework, per FSS (Health Supplements, Nutraceuticals…) Regulations 2022. Always verify against the current official regulation for your product and market.
What is the permitted dosage of Biotin?
No single numeric limit is listed in the source for Biotin; permitted use is at GMP or as specified. Confirm against the current regulation.
What product category does Biotin belong to?
Biotin is classified under: Vitamins.
What is the recommended daily allowance (RDA) of Biotin in India?
Per ICMR-NIN (2020), the RDA of Biotin for adult man is 40 mcg. RDA is a dietary reference intake and is distinct from the maximum permitted supplement limit.
Source: FSS (Health Supplements, Nutraceuticals…) Regulations 2022 · Last reviewed: 2026-06-20 · Data version: db-2026-06-20. Indicative only — verify against the current official regulation before use.
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