Amylases enzymes

Amylases and other industrial enzymes for food use

FSSAI CLEARANCE

HSN 3507 90 62 (Amylases enzymes) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence under the Food Safety and Standards Act, 2006, with consignments restricted to designated food-import entry points under General Note 4(D) of Schedule I of the ITC (HS) 2022. The Directorate General of Foreign Trade (DGFT) Restricted-import policy and Central Board of Indirect Taxes and Customs (CBIC) customs overlays apply as additional clearance requirements, including a rectifiable-labelling regime under FSS (Labelling and Display) Regulations, 2020.

What this is

HSN code

3507 90 62

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 issuing authority
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) and ensure it is uploaded in e-Sanchit before filing the bill of entry. Additionally, upload the Certificate of Analysis – Drug (document code 0010DC), Batch Release Certificate (document code 0030DC), Label of Consignment (document code 0110DC), Specimen Copy of Label (document code 0110FS), Registration Certificate for Drugs (document code 101DC1), and Import Licence for Drugs (document code 9111DC) in e-Sanchit prior to out-of-charge.
CBIC Instruction 09/2023-Cus dated 07-03-2023; CBIC Instruction 10/2022-Customs dated 28-06-2022
2
Route the consignment exclusively through one of the designated food-import entry points as required under General Note 4(D) of Schedule I of the ITC (HS) 2022. Consignments arriving at a non-designated port are liable to detention pending re-routing or re-export.
General Note 4(D) of Schedule I of ITC (HS) 2022; CBIC Instruction 05/2023-Cus
3
Verify label compliance against FSS (Labelling and Display) Regulations, 2020 before port release. Rectifiable labelling deficiencies — including per-serve percentage contribution to recommended dietary allowance and date of expiry alongside best-before date — may be corrected at a customs bonded warehouse by affixing a single non-detachable sticker next to the principal display panel, provided the correction is manufacturer-confirmed and verified 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 treating it as a food-only import and overlooking the drug-regime document set — Certificate of Analysis (0010DC), Batch Release Certificate (0030DC), Registration Certificate for Drugs (101DC1), and Import Licence for Drugs (9111DC) — which must be uploaded in e-Sanchit alongside the FSSAI Import Licence. Customs officers verify the full document set before granting out-of-charge; a missing batch-release or drug-registration upload detains the consignment even when the FSSAI licence itself is current and in order.

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Frequently asked

Does HSN 3507 90 62 require BIS certification?

No, amylases enzymes are not covered by any BIS Quality Control Order. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with a concurrent drug-document overlay and designated food-import entry-point restriction administered by DGFT and CBIC.

Why are drug-category documents such as the Registration Certificate (101DC1) required for an enzyme classified as a food ingredient?

The CCR for this tariff line mandates both food-regime and drug-regime documents at the bill of entry, reflecting a dual-use classification; all seven document codes — 0010DC, 0030DC, 0110DC, 0110FS, 101DC1, 911001, and 9111DC — must be uploaded in e-Sanchit before customs out-of-charge is granted.

Can labelling deficiencies on imported amylases enzyme consignments be corrected after arrival?

Yes, but only for deficiencies specified under the FSSAI rectifiable-labelling regime — corrections must be made at a customs bonded warehouse by affixing a single non-detachable sticker next to the principal display panel, without altering original label information, and must be verified by the Authorised Officer 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.