RegulyzeBerberine
Berberis vulgaris/aristata/asiatica · Stem/root extract
Berberine (Berberis vulgaris/aristata/asiatica) is a nutraceutical 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.
About Berberine
Berberine is tracked in the Regulyze Ingredient Intelligence database as a nutraceutical (Berberis vulgaris/aristata/asiatica). 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 Berberine permitted in nutraceuticals under FSSAI (India)?
Berberine (Berberis vulgaris/aristata/asiatica) (listed in the regulation as “Berberis vulgaris/aristata/asiatica stem/root extract”) 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 Berberine?
No single numeric limit is listed in the source for Berberine; permitted use is at GMP or as specified. Confirm against the current regulation.
What product category does Berberine belong to?
Berberine is classified under: Nutraceuticals, Botanicals.
What is the botanical (scientific) name of Berberine?
Berberine corresponds to Berberis vulgaris/aristata/asiatica, with the stem/root extract used in nutraceutical preparations.
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.