RegulyzeNeem
Azadirachta indica · Leaf
Neem (Azadirachta indica) is a botanical permitted for use in nutraceuticals and health supplements under India's FSSAI framework, with a permitted limit of Leaf: 1-3 g; Fruit: 1-2 g; Flower: 2-4 g; Bark: 3-6 g. Regulyze tracks its regulatory status, limits and label requirements across regulatory frameworks.
Regulatory status
| Framework | Status | Limit | Source | Last reviewed |
|---|---|---|---|---|
| India — FSSAI | Permitted | Leaf: 1-3 g; Fruit: 1-2 g; Flower: 2-4 g; Bark: 3-6 g | 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.
Permitted dosage by form
| Preparation / form | Permitted daily quantity |
|---|---|
| Leaf | 1-3 g |
| Fruit | 1-2 g |
| Flower | 2-4 g |
| Bark | 3-6 g |
Per India's FSSAI Schedule listing for Neem. Quantities are per-day permitted ranges for the stated form — confirm against the current official regulation for your product.
About Neem
Neem is tracked in the Regulyze Ingredient Intelligence database as a botanical (Azadirachta indica). It is listed in India's FSSAI schedules under the regulatory name Nimba / Neem. 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 Neem permitted in nutraceuticals under FSSAI (India)?
Neem (Azadirachta indica) (listed in the regulation as “Nimba / Neem”) 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 Neem?
The permitted level recorded for Neem is Leaf: 1-3 g; Fruit: 1-2 g; Flower: 2-4 g; Bark: 3-6 g. Limits can vary by product type and market — confirm against the current regulation.
What product category does Neem belong to?
Neem is classified under: Botanicals.
What is the botanical (scientific) name of Neem?
Neem corresponds to Azadirachta indica, with the leaf 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.