Pepsin (excluding medicament)

Pepsin enzyme for food and industrial use

FSSAI CLEARANCE

HSN 3507 90 30 (Pepsin excluding medicament) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence under the Food Safety and Standards Act, 2006, as a food-grade enzyme falling within the high-risk food import regime. Central Board of Indirect Taxes and Customs (CBIC) requires mandatory e-Sanchit document uploads — including a Certificate of Analysis, Batch Release Certificate, and Specimen Copy of Label — before out-of-charge is granted. Compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 governing designated food-import entry points applies as a concurrent policy overlay administered by the Directorate General of Foreign Trade (DGFT).

What this is

HSN code

3507 90 30

Chapter

35 · Albuminoidal substances; modified starches; glues; enzymes

Primary regulator

FSSAI · Food Safety and Standards Act, 2006 (food-grade enzyme import regime)

Customs documentation

Import Licence from FSSAI
Certificate of Analysis from accredited laboratory
Specimen copy of label from FSSAI

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Obtain a current FSSAI Import Licence (document code 911001) before filing the bill of entry. Upload the licence in e-Sanchit together with the Certificate of Analysis — Drug (document code 0010DC), Batch Release Certificate (document code 0030DC), Label of Consignment (document code 0110DC), and Specimen Copy of Label (document code 0110FS). Out-of-charge will not be granted until all five documents are verified in e-Sanchit.
CBIC Instruction 10/2022-Customs dated 28-06-2022; CBIC Instruction 09/2023-Cus dated 07-03-2023
2
Route the consignment only through a designated food-import entry point in compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Consignments arriving at non-designated ports are liable to detention and re-export without customs clearance.
General Note 4(D) of Schedule I of ITC (HS) 2022; CBIC Instruction 05/2023-Cus dated 08-02-2023
3
Ensure labelling compliance with FSS (Labelling and Display) Regulations, 2020 before shipment. Rectifiable labelling deficiencies — including per-serve percentage contribution to recommended dietary allowance and date-of-expiry information — may be corrected at a Customs bonded warehouse by a single non-detachable sticker affixed next to the principal display panel, but only before visual inspection by the Authorised Officer.
FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022; CBIC Instruction 10/2022-Customs dated 28-06-2022; FSSAI clarification order dated 18-11-2022

A word of counsel

The most common error on this tariff line is conflating the food-grade (FSSAI) and drug-registration (CDSCO) documentary streams: the CCR mandates both an FSSAI Import Licence (911001) and a Registration Certificate for Drugs (101DC1) with an Import Licence for Drugs (9111DC), reflecting that pepsin sits at the food-drug interface. Importers who upload only the FSSAI set and omit the drug-track documents face consignment detention while the discrepancy is resolved — a process that routinely attracts demurrage and ground rent at designated ports.

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Frequently asked

Does HSN 3507 90 30 require BIS certification?

No. No BIS Quality Control Order covers food-grade pepsin or prepared enzymes under Chapter 35. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with CBIC document-verification requirements at the bill-of-entry stage.

Which document codes must be uploaded in e-Sanchit for pepsin imports?

The mandatory set is: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Specimen Copy of Label (0110FS), Registration Certificate for Drugs (101DC1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111DC) — all must be present before out-of-charge is granted.

Can labelling deficiencies be corrected at the port of import?

Yes, but only for the specific rectifiable items listed under FSS (Labelling and Display) Regulations, 2020 — such as per-serve dietary allowance data and expiry-date information — and only by affixing a single non-detachable sticker before the Authorised Officer's visual inspection, per CBIC Instruction 10/2022-Customs and the FSSAI clarification order dated 18-11-2022.

Last verified against gazette notifications: 2026-05-16. Source: FSSAI / DGFT / CBIC / Indian Customs CUSDATA.