Other

Other prepared enzymes, residual category (industrial, food-grade)

FSSAI CLEARANCE

HSN 3507 90 99 (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 preparation is intended for food use. Central Board of Indirect Taxes and Customs (CBIC) customs overlays and Directorate General of Foreign Trade (DGFT) General Note 4(D) designated-port conditions apply as additional clearance requirements at the bill-of-entry stage.

What this is

HSN code

3507 90 99

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 CDSCO
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
Upload all mandatory documents in e-Sanchit before filing the bill of entry. The CCR mandates: 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). Confirm each document code is uploaded and the e-Sanchit IRN is quoted on the bill of entry before out-of-charge.
CBIC Instruction 09/2023-Cus dated 07-03-2023; CBIC Instruction 10/2022-Cus dated 28-06-2022
2
Route food-grade enzyme consignments only through the designated food-import entry points notified under General Note 4(D) of Schedule I of the ITC (HS) 2022. Non-designated port arrival of food-categorised goods triggers detention pending re-routing or re-export.
General Note 4(D) of Schedule I of the ITC (HS) 2022; CBIC Instruction 05/2023-Cus dated 08-02-2023
3
Ensure labelling complies with the FSS (Labelling and Display) Regulations, 2020 before arrival. Rectifiable labelling deficiencies — including per-serve percentage contributions to recommended dietary allowance and expiry-date presentation — may be corrected at Customs bonded warehouses by affixing a single non-detachable sticker adjacent to the principal display panel, without altering the original label, prior to the Authorised Officer's inspection.
FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022; CBIC Instruction 10/2022-Cus dated 28-06-2022; FSSAI clarification order dated 18-11-2022 under F.No. Import/TFM/Apex/2022-FSSAI

A word of counsel

The predominant error on this residual tariff line is misreading the dual-document-code set as a choice between the food-regime path (FSSAI Import Licence, 911001) and the drug-regime path (Import Licence for Drugs, 9111DC; Registration Certificate (Drugs), 101DC1). The CCR mandates both sets simultaneously, reflecting that enzyme preparations under 3507 90 99 can attract concurrent FSSAI and drug-regulatory scrutiny at the same bill of entry. Presenting only the FSSAI licence while omitting the drug-side codes will result in customs detention pending a complete e-Sanchit upload.

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Frequently asked

Does HSN 3507 90 99 require BIS certification?

No, prepared enzymes in this residual category 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 CBIC customs overlays requiring mandatory e-Sanchit upload of both food-regime and drug-regime document codes.

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

Seven codes are mandated: 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), per CBIC Instruction 09/2023-Cus.

Can labelling defects be rectified at port rather than prior to shipment?

Yes, but only for the categories of rectifiable information specified under the FSS (Labelling and Display) Regulations, 2020 and the FSSAI clarification order dated 18-11-2022 — correction must occur at a Customs bonded warehouse before the Authorised Officer's visual inspection, by a single non-detachable sticker that does not alter the original label.

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