Other

Miscellaneous prepared enzymes not elsewhere specified

FSSAI CLEARANCE

HSN 3507 90 69 (Other prepared enzymes) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, where the enzyme is intended for food use. Consignments must comply with General Note 4(D) of Schedule I of the ITC (HS) 2022 governing designated food-import entry points, with Central Board of Indirect Taxes and Customs (CBIC) customs overlays applying at the bill-of-entry stage.

What this is

HSN code

3507 90 69

Chapter

35 · Albuminoidal substances; modified starches; glues; enzymes

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

Import Licence from FSSAI
Certificate of Analysis from CBIC
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 valid FSSAI Import Licence (document code 911001) before filing the bill of entry. Ensure the foreign manufacturing facility and product comply with FSSAI import-registration requirements, and upload the FSSAI Import Licence in e-Sanchit prior to customs out-of-charge.
FSSAI · Food Safety and Standards Act, 2006 · General Note 4(D) of Schedule I, ITC (HS) 2022
2
Upload all mandatory documents in e-Sanchit before the bill of entry is given out-of-charge: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Specimen Copy of Label (0110FS), Registration Certificate (Drugs) (101DC1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111DC).
CBIC Instruction 10/2022-Customs dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023
3
Ensure labelling complies with the FSS (Labelling and Display) Regulations, 2020. Rectifiable labelling deficiencies — including per-serve percentage contribution to recommended dietary allowance and date of expiry alongside best-before date — may be corrected at the customs bound warehouse by affixing a single non-detachable sticker, without altering the original label, before authorised-officer inspection.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022 · FSSAI clarification order dated 18-11-2022

A word of counsel

The most common error on this tariff line is treating it as a purely industrial chemical outside the FSSAI regime. Where the enzyme is destined for food processing or food-contact use, the full high-risk food-import document set — including FSSAI Import Licence (911001), Specimen Copy of Label (0110FS), and the drug-side documents (0010DC, 0030DC, 101DC1, 9111DC) — must all be present in e-Sanchit simultaneously; a missing single document code is treated as an incomplete PGA clearance and will attract detention at the port pending rectification.

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Frequently asked

Does HSN 3507 90 69 require BIS certification?

No, prepared enzymes under this tariff line are not within the BIS Quality Control Order regime. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with CBIC customs-clearance overlays and DGFT ITC (HS) policy conditions at the bill-of-entry stage.

Which document codes must be uploaded in e-Sanchit for this HSN?

The mandatory document codes are 0010DC (Certificate of Analysis — Drug), 0030DC (Batch Release Certificate), 0110DC (Label of Consignment), 0110FS (Specimen Copy of Label), 101DC1 (Registration Certificate — Drugs), 911001 (FSSAI Import Licence), and 9111DC (Import Licence for Drugs), per CBIC Instruction 09/2023-Cus dated 07-03-2023.

Can labelling deficiencies be rectified at the port for enzyme consignments?

Yes, but only for the specific rectifiable items enumerated under CBIC Instruction 10/2022-Customs and the FSSAI clarification order dated 18-11-2022 — such as per-serve RDA contribution and expiry-date placement — and only by affixing a non-detachable sticker at the customs bound warehouse before the authorised officer's inspection; a missing PGA licence or registration document is not rectifiable under this dispensation.

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