FSSAI Nutraceutical licence — 2026 amendments digest

Pb limit tightened from 1.0 to 0.5 ppm in finished nutra products. This affects herbal and mineral-supplemented products most.

Mandatory testing added for two emerging contaminants: phthalate residue and microplastic load. Per-batch cost adds ₹2,400 – ₹3,800 at notified labs.

Label format updated for serving-size disclosure — brands must show per-serving and per-100g of active in standardised format.

Upstream provenance documentation now mandatory — brands must document supplier chain back to original processor.

Re-test in-market SKUs within the 90-day grace window. Pull samples from current production and test against the new Pb limit.

Update label templates before October printing slots. Pre-print only once amendment text is final (expected by July).

Re-qualify raw-material suppliers against the new Pb limit. Some currently-acceptable herbal raw materials will fail at 0.5 ppm.

Add the two new tests to standard COA template. Most Tier-1 notified labs already offer the assays — confirm coverage with your lab.

Update provenance documentation system. Most partners have informal supplier records; the amendment requires formal documentation suitable for audit.

October 1, 2026: amendments effective. 90-day grace for in-market inventory.

January 1, 2027: all in-market SKUs must comply or be withdrawn. Notice-period for non-compliant SKUs starts.

April 1, 2027: licences may be suspended for non-compliant manufacturers.