What is FSSAI and What Does It Regulate?

The Food Safety and Standards Authority of India (FSSAI) is the statutory body that controls every aspect of food safety in India including all food imports. Every food product entering India requires FSSAI import clearance before it can be released from Customs. Without one, goods cannot legally enter commerce and the importer faces penalties, rejection and potential destruction of the consignment.

What is FSSAI?

The Food Safety and Standards Authority of India (FSSAI) was established under the Food Safety and Standards Act, 2006. The FSS Act consolidated a fragmented collection of food laws that had governed India's food sector since 1947 including the Prevention of Food Adulteration Act, 1954 and the Fruit Products Order, 1955. FSSAI operates under the Ministry of Health and Family Welfare, Government of India, headquartered in New Delhi and regional offices across the country.

FSSAI's mandate covers production, processing, distribution, sale, and import of food products. For imported food products, FSSAI derives its authority from Regulation 3 of the Food Safety and Standards (Import) Regulations, 2017 making import clearance a mandatory pre-condition for release of any food consignment from Customs. The authority sets food safety standards, including permissible limits for contaminants, additives and pesticide residues known as Maximum Residue Limits or MRLs.

FSSAI's regulatory scope, as defined under Section 3(1)(j) of the FSS Act, covers food products of plant origin, animal origin, packaged foods, beverages, dietary supplements, nutraceuticals, novel foods and is broad enough to capture certain health supplements that a trader might not ordinarily regard as food.

The FSS Act expressly requires importers to hold a Central Licence issued by FSSAI's central licensing authority as a state FSSAI licence used for domestic operations is not sufficient.

Implications for businesses

For foreign food manufacturers and exporters, FSSAI does not allow a product that does not conform to FSSAI standards in composition, labelling, or permissible additives to legally enter India regardless of what certifications it carries in its home country. Foreign manufacturers must ensure their products are formulated to Indian standards before shipment, reviewing ingredient lists against FSSAI's permitted additives schedule, checking MRLs for agricultural produce and confirming that any novel food ingredient has received prior NOC clearance.

For Indian importers and distributors, compliance necessitates a valid FSSAI Central Licence and all applicable standards met before the consignment arrives at an Indian port. The importer's name, address and FSSAI Central Licence number must appear on the product label. If goods are found non-compliant after import, the importer faces enforcement action under the FSS Act.

For Customs House Agents and freight forwarders, FSSAI clearance is a mandatory step along with a Customs clearance. A consignment held for FSSAI inspection under the Yellow or Red Channel will incur demurrage and container detention charges that accumulate daily.

How FSSAI regulation works

The importer begins with obtaining a valid FSSAI Central Licence through the Food Licensing and Registration System portal (https://foscos.fssai.gov.in/apply-for-lic-and-reg). The Central Licence is product-category specific, listing the categories of food products the importer is authorised to import.

Once goods are shipped and a Bill of Entry is filed on ICEGATE, FSSAI operates as a Partner Government Agency within that platform. The system automatically routes the Bill of Entry to FSSAI for clearance assessment and FSSAI assigns the consignment to one of three risk-based channels. The Green Channel involves document verification only. The Yellow Channel adds laboratory testing with goods remaining under Customs bond for between 5 and 21 working days. The Red Channel involves physical inspection, document verification and laboratory testing and is reserved for higher-risk or repeat non-compliant consignments.

Legality and risks

The FSS Act creates the legal framework for FSSAI enforcement at the import stage. Section 25 authorises FSSAI to regulate and monitor the quality of food imports. Regulation 3 of the Import Regulations, 2017 makes it unlawful to import food without FSSAI clearance. Section 59 deals with substandard food and provides for penalties up to Rs 5 lakh. Section 63 deals with the import of food without a licence with penalties extending to imprisonment of up to six months and a fine of up to Rs 5 lakh. Section 66 makes directors and officers of companies personally liable where the company commits an offence under the Act.

A consignment at the port that FSSAI determines is non-compliant is issued a rejection order. The importer then either re-exports the consignment at their own cost or applies to FSSAI for permission to destroy it. There is no provision for conditional release of non-compliant food into the Indian market.

A consignment can receive an Out of Customs Order from Customs and still remain under FSSAI hold, pending laboratory results. During this period the goods are not free, demurrage accrues and the importer has no right to remove the consignment from the port.

Word of counsel

Importers should review their FSSAI Central Licence scope before adding any new product to their import portfolio. The licence lists permitted categories explicitly and an importer who brings in a product outside those categories becomes non-compliant on that consignment and is operating an unlicensed food business in respect of that product, triggering a more serious set of penalties than a labelling error or a failed lab test. The licensing authority can amend the licence but that amendment must be in place before the first shipment.

Further, Do not assume that Customs clearance and FSSAI clearance are the same thing.

CHAs should have an understanding of which channel a consignment is likely to be directed to and advise the importer accordingly before shipment.

Have a question about a specific product or regulation? Speak to an expert at accessindiaplatform.com