Food Product Approval
Obtain FSSAI approval for novel foods, proprietary products, and health supplements.
Food Product Approval is a pre-market authorisation from FSSAI required before manufacturing or importing certain categories of food products that are not covered by existing food standards under the Food Safety and Standards Act, 2006. Product approval is mandatory for: novel foods (no history of human consumption in India), proprietary foods ( formulations not covered by existing standards), health supplements and nutraceuticals, foods for special dietary use, fortified foods with claims beyond FSS standards, and imported food products without applicable Indian standards. Applications are filed on the Food Safety Compliance System (FoSCoS) portal with detailed product formulation, manufacturing process, safety assessment data, lab test reports, and label mock-ups. FSSAI's Product Approval Division reviews applications against safety criteria, and approved products receive a unique approval number referenced on the FSSAI licence. Complianceer handles product categorisation, dossier preparation, test report coordination through NABL labs, FoSCoS filing, and query response for food innovators, supplement brands, and importers introducing new products to the Indian market.
At a glance
- Timeline: 60–180 working days (FSSAI product approval review is thorough and timeline varies by product complexity)
- Government fee: ₹25,000–₹1,00,000 per product (varies by product category and complexity)
- Professional fee: Starting from ₹14,999
Who needs this
- Brands launching novel food products without existing FSS standards
- Health supplement and nutraceutical manufacturers
- Proprietary food manufacturers with unique formulations (energy bars, functional foods)
- Importers bringing food products without applicable Indian standards
- Fortified food manufacturers making claims beyond standard fortification levels
- Startups developing innovative food products for retail or e-commerce launch
Benefits
- Legal clearance to manufacture or import products not covered by existing standards
- Required for retail listing and e-commerce sale of novel/proprietary foods
- Demonstrates safety assessment to institutional buyers and export partners
- Protects against product seizure and enforcement action for unapproved formulations
- Foundation for trademark, label compliance, and marketing claims validation
Eligibility
- Applicant must hold valid FSSAI State or Central licence covering the manufacturing/import activity
- Product must fall under categories requiring approval: novel, proprietary, health supplement, or non-standard imported food
- Product must not contain ingredients prohibited under FSS Act or FSS (Prohibition and Restriction on Sales) Regulations
- Safety data must demonstrate product is safe for intended consumption at proposed levels
Documents
- Valid FSSAI State or Central licence (product approval requires existing FSSAI licence)
- Product approval application on FoSCoS with detailed formulation
- Manufacturing process flow chart and critical control points
- Ingredient specifications with source and purity details
- Finished product test reports from NABL-accredited laboratory (microbiological, chemical, heavy metals)
- Safety assessment report (for novel foods: toxicology and allergenicity data)
- Label mock-up complying with FSS (Packaging and Labelling) Regulations, 2011
- Stability study data (shelf life validation)
- Certificate of analysis from foreign manufacturer (for imported products)
FAQs
Which food products need FSSAI product approval?
Novel foods, proprietary foods not covered by existing standards, health supplements, nutraceuticals, foods for special dietary use, and imported foods without applicable Indian standards all require product approval before market launch.
Can I sell my product while approval is pending?
No. Manufacturing or selling products requiring approval before receiving FSSAI clearance is a violation. Plan product launch timeline accounting for 60–180 day approval process.
How is product approval different from FSSAI licence?
FSSAI licence authorises you to operate a food business. Product approval authorises a specific product formulation. You need both: a valid licence AND product approval for each novel/proprietary product you manufacture or import.