India Food Safety Regulations for Food Businesses

The principal national legislation is the Food Safety and Standards Act, 2006 (FSS Act). It established FSSAI and sets out responsibilities for food business operators, enforcement powers and offences.

Key regulations made under the Act include:

• Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 — licensing, registration, hygiene and sanitary requirements under Schedule 4
• Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 — product standards and permitted additives
• Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011
• Food Safety and Standards (Packaging) Regulations, 2018
• Food Safety and Standards (Labelling and Display) Regulations, 2020
• Food Safety and Standards (Advertising and Claims) Regulations, 2018
• Food Safety and Standards (Import) Regulations, 2017
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
• Food Safety and Standards (Organic Foods) Regulations, 2017
• Food Safety and Standards (Food Recall Procedure) Regulations, 2017
• Food Safety and Standards (Food Safety Auditing) Regulations, 2018

Not every regulation applies to every food or activity. Requirements depend on the product, business size, process, premises, origin, destination and whether the product is imported or exported.

Food Safety and Standards Authority of India (FSSAI) / भारतीय खाद्य सुरक्षा एवं मानक प्राधिकरण is established under the Ministry of Health and Family Welfare. It sets standards and regulations, administers central licensing functions, approves non-specified foods and food ingredients, and oversees food-import clearance.

Enforcement and licensing responsibilities are shared with state and union territory authorities through Commissioners of Food Safety, Designated Officers, licensing authorities and Food Safety Officers. Their functions include inspection, sampling, improvement notices and enforcement action.

Other bodies may have product- or trade-specific roles:

• Central Board of Indirect Taxes and Customs (CBIC) — customs processes for imported and exported consignments
• Export Inspection Council and Export Inspection Agencies (EIC/EIAs) — export inspection and certification for notified products and destination requirements
• Agricultural and Processed Food Products Export Development Authority (APEDA) — export development, registration and sector-specific schemes for scheduled products
• Marine Products Export Development Authority (MPEDA) — registration and export-development functions for marine products
• Bureau of Indian Standards (BIS) — standards and conformity assessment, including mandatory certification where a specific legal requirement applies

The authority responsible in a particular case depends on the location, activity, product and destination market.

Food business operators are responsible for ensuring that food under their control complies with the FSS Act and applicable regulations. Core duties include:

• Safety and compliance: food must not be manufactured, stored, sold, distributed or imported in contravention of applicable safety and standards requirements.
• Licensing or registration: each operator must hold the registration or licence required for its premises and activities unless exempt.
• Hygiene and food safety management: operators must comply with the applicable Schedule 4 hygienic and sanitary practices and licence conditions.
• Records and traceability: operators must maintain the records required for their activity and sufficient information to support distribution tracing and recall.
• Recall: where food must be recalled, operators must follow the Food Recall Procedure Regulations and communicate with the appropriate authority.
• Cooperation: operators must permit lawful inspection and sampling and provide required records.
• Imported food: importers remain responsible for compliance with Indian requirements.

Schedule 4 of the Licensing and Registration Regulations sets sector-specific hygienic and sanitary practices covering matters such as premises, equipment, water, cleaning, pest control, personal hygiene, storage, transport and waste.

Licensed businesses must maintain a documented food safety management system appropriate to their activities. HACCP-based procedures apply where required by the relevant Schedule 4 provisions, licence conditions or sector requirements. FSSAI publishes sector guidance that can assist implementation but does not replace the regulations.

Under the Food Safety Auditing Regulations, FSSAI may direct specified categories of licensed businesses to undergo audits by recognised food-safety auditing agencies. The applicable audit requirement should be checked for the business category rather than assumed to apply universally.

Food businesses generally require one of the following for each relevant premises or activity:

• FSSAI registration for qualifying petty food businesses
• state FSSAI licence
• central FSSAI licence for activities and thresholds assigned to the central licensing authority, including food importers

Applications are made through FoSCoS (Food Safety Compliance System). The correct category depends on the kind of business, turnover, production capacity, premises, number of units and criteria in the Licensing and Registration Regulations and current eligibility guidance.

The required registration or licence must be obtained before commencing the relevant food business. Exporters should check whether their operation falls within a central-licence category rather than assuming that every export activity is treated identically.

The Food Safety and Standards (Labelling and Display) Regulations, 2020 govern prepacked food sold in India. Depending on the food and applicable exemptions, declarations include:

• name of the food and list of ingredients
• specified allergen declarations
• nutritional information
• net quantity and date marking
• storage conditions and instructions where required
• manufacturer, packer or importer details, as applicable
• FSSAI logo and licence number
• country of origin for imported food
• vegetarian or non-vegetarian symbol where required

Mandatory particulars must be in English or Hindi in Devanagari script. Additional languages may be used, provided the information does not contradict the mandatory declarations. Organic, fortified, health-supplement and other specialised foods can have additional requirements.

Imported food is controlled under the Food Safety and Standards (Import) Regulations, 2017. Food importers require the applicable central FSSAI licence.

Import information is submitted through the customs single-window process and handled in FSSAI’s Food Import Clearance System (FICS). Depending on the consignment, clearance can involve document scrutiny, visual inspection, sampling and testing. Customs release is subject to the applicable FSSAI clearance decision, including a no-objection certificate where required.

Non-specified foods and food ingredients require prior approval unless they fall within an applicable exclusion. Novel foods, health supplements and other specialised categories must meet their relevant approval and compositional requirements.

Imported food must comply with Indian product and labelling requirements, subject only to corrections or rectification expressly permitted during import clearance. Supplier certificates do not remove the importer’s responsibility.

Export requirements depend on the food, destination and importing-country rules. The exporter must hold the FSSAI registration or licence applicable to its Indian food business, but an FSSAI licence is not itself an export health certificate.

Official certificates are issued only by the authority designated for the product and destination. This may involve an Export Inspection Agency, animal-quarantine or plant-quarantine authority, or another competent government body. APEDA and MPEDA also administer registration, traceability and sector programmes, but their precise role depends on the commodity and requested document.

Consultants, private certification bodies and directories cannot issue government certificates or guarantee destination acceptance. Exporters should identify the exact certificate and issuing authority before dispatch.

• Contaminants, toxins and residues: limits under the 2011 regulations and amendments
• Food additives and product standards: the Food Products Standards and Food Additives Regulations
• Packaging: the Packaging Regulations, 2018
• Health supplements and novel foods: applicable standards and approvals under the 2016 regulations and non-specified-food framework
• Organic foods: compliance with the Organic Foods Regulations and a recognised certification system, subject to applicable provisions
• Fortified foods: applicable FSSAI standards and labelling requirements
• Non-specified foods: prior approval unless an exclusion applies

Requirements vary with the product, ingredients, claims, process, origin, destination and business type.

• Identify the FSSAI regulations and product standards applicable to the activity.
• Obtain the correct registration or licence before commencing operations.
• Implement the relevant Schedule 4 hygiene requirements and a documented, proportionate food safety management system.
• Review labels, claims and language requirements before market placement.
• For imports, complete customs and FSSAI clearance through the applicable systems before release.
• For exports, confirm destination requirements and the competent authority for each official certificate.
• Treat customer and private certification schemes separately from statutory compliance.
• Do not rely on consultants or directory listings for official licences, approvals or certificates.