Which Imported Products Require FSSAI Import Clearance?

Every article of food imported into India requires FSSAI import clearance under the Food Safety and Standards (Import) Regulations, 2017, with no category exempted. The obligation is absolute and arises at the point of import, before goods can be released from Customs. Assuming that certain product types are exempt or that low-risk categories receive automatic clearance takes on a risk that the law does not support.

What is the scope of fssai's import clearance requirement?

Section 3(1)(j) of the Food Safety and Standards Act, 2006 defines ‘food’ in a broad manner as any article used as food or drink for human consumption, any article that ordinarily enters into or is used in the composition or preparation of human food or drink and any flavouring matter or condiment. It covers not only packaged consumer foods and beverages but also raw agricultural commodities, bulk ingredients, food additives, flavourings, nutraceuticals and dietary supplements.

Regulation 3 of the Food Safety and Standards (Import) Regulations, 2017 states that no article of food shall be imported into India except through a Food Safety Officer authorised by the Food Authority with no minimum quantity threshold below which the requirement falls away.

The product categories that encounter FSSAI import clearance requirements include processed and packaged foods, fresh fruits and vegetables, meat and poultry products, fish and seafood, dairy products, edible oils and fats, alcoholic beverages, non-alcoholic beverages including fruit juices and energy drinks, confectionery, bakery products, cereals and cereal products, spices and condiments, health supplements and nutraceuticals and infant food. The operative test is whether the product falls within the FSS Act's definition of food.

FSSAI regulates nutraceuticals and dietary supplements under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022. Previous classification as pharmaceutical inputs or chemical intermediates to avoid FSSAI scrutiny now face enhanced enforcement as FSSAI has specifically directed Customs to flag such mis-declarations.

Implications for businesses

For foreign food manufacturers and exporters, there is no food product that can be shipped to India without confirming pre-shipment that it meets Indian food standards.

Exporters assuming compliance with Codex Alimentarius standards or EU food law will pass FSSAI clearance automatically risk non-compliance as FSSAI has its own standards, its own permitted additives lists and its own MRL schedules which may differ materially from international benchmarks.

For products containing ingredients not yet standardised under Indian food law, the exporter must factor in the time and cost of obtaining an FSSAI No Objection Certificate before the first shipment.

For Indian importers and distributors, due diligence on product compliance must happen before a purchase order is placed. The product must be assessed against the relevant FSSAI standards for that category, covering permissible additives, MRLs, contaminant limits and labelling requirements. A post-shipment discovery of an unapproved additive or exceeding an MRL has no practical remedy. Categories including flavour compounds imported as ingredients, food-grade packaging materials and enzyme preparations need individual assessment.

How FSSAI import product scope compliance works

Before any shipment is planned, the importer must determine the relevant Indian Standard applicable to the product under FSSAI's standards schedule. If the product falls within a standardised category, it must meet those standards in full. If the product category is not yet standardised under Indian law, the importer may still import it provided the product complies with an internationally recognised standard such as Codex and provided FSSAI does not require a prior NOC for that category.

For products containing novel food ingredients, defined under the 2022 Regulations as food or food ingredient that does not have a significant history of consumption or is produced by a method not previously used, the importer must obtain a prior NOC from FSSAI before the first shipment. This application is made through the FSSAI online portal (https://foscos.fssai.gov.in/apply-for-lic-and-reg) and requires submission of safety data, scientific evidence of safety, the manufacturing process and proposed standards.

The Bill of Entry filed on ICEGATE triggers the FSSAI Participating Government Agency (PGA) module. The system assigns the consignment to a clearance channel based on risk assessment. For products with a history of compliance, the Green Channel is most common. For products with a history of violations in the category or for first-time imports of a particular product, the Yellow or Red Channel may be assigned with samples sent to an FSSAI-notified laboratory and results taking between 5 and 21 working days.

Legality and risks

Section 25 of the FSS Act gives FSSAI authority to regulate all food imports and Regulation 3 of the Import Regulations, 2017 makes clearance mandatory for every article of food. The penalty for importing food without FSSAI clearance set out in Section 63 of the FSS Act includes imprisonment up to six months, a fine extending to Rs 5 lakh or both. Section 66 makes company directors and officers personally liable for offences committed by the company.

At the port, a consignment of food imported without FSSAI clearance is subject to seizure. The Authorised Officer at the port has power under Section 47 of the FSS Act to take samples, detain consignments and issue rejection orders. A rejection order requires the importer to re-export or destroy the goods with no provision for conditional release. The rejection costs, re-export freight, demurrage and penalties add to the risk.

Attempting to clear food products under a non-food customs heading to avoid FSSAI scrutiny is treated as a mis-declaration under Customs law and carries penalties under the Customs Act, 1962 in addition to FSS Act violations.

Word of counsel

Importers should treat product scope ambiguity with the same rigour applied to clear-cut food categories and the prudent course is to treat the product as a food article and seek clearance before shipment.

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