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Papain

Papain (also known as 1101(ii)) is a nutraceutical permitted for use in nutraceuticals and health supplements under India's FSSAI framework, with a permitted limit of GMP. Regulyze tracks its regulatory status, limits and label requirements across regulatory frameworks.

NutraceuticalsBotanicalsAdditives

Regulatory status

FrameworkStatusLimitSourceLast reviewed
India — FSSAI Permitted 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 Papain

Papain is tracked in the Regulyze Ingredient Intelligence database as a nutraceutical. 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 Papain permitted in nutraceuticals under FSSAI (India)?

Papain 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 Papain?

The permitted level recorded for Papain is GMP. Limits can vary by product type and market — confirm against the current regulation.

What product category does Papain belong to?

Papain is classified under: Nutraceuticals, Botanicals, Additives.

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.