What is FSSAI Product Approval?
FSSAI Product Approval is a process required for food products that do not fall under any specified standards in the Food Safety and Standards Regulations (FSSR). These are often referred to as "Non-Specified Food and Food Ingredients".
This includes novel foods, products with new additives, or foods processed using new technologies. The approval ensures that these products are safe for human consumption before they hit the market.
Who Needs FSSAI Product Approval?
You need to apply for product approval if your product falls into one of these categories:
- Non-Specified Foods: Foods or ingredients not listed in FSSAI regulations.
- Novel Foods: Foods with no history of human consumption in India.
- New Additives: Products using additives not approved for that specific category.
- New Technologies: Foods processed using novel technologies (e.g., nanotechnology).
- Imported Foods: Proprietary foods imported from other countries that don't match Indian standards.
- Functional Foods/Nutraceuticals: If they contain ingredients not specified in the relevant schedules.
Documents Required
The documentation for product approval is technical and extensive:
- Product Details: Name, description, and intended use.
- Ingredient List: Complete list with percentages and scientific names.
- Manufacturing Process: Flowchart and detailed description.
- Certificate of Analysis (COA): From an NABL accredited lab.
- Safety Data: Scientific evidence, toxicity studies, or history of safe use.
- Label: Prototype label complying with FSSAI labeling regulations.
- Method of Analysis: Test methods for the ingredients.
- Import Documents: If the product or ingredients are imported.
Approval Process
- Application Submission: Submit the application online via the FoSCoS portal (Form for Non-Specified Food).
- Initial Scrutiny: FSSAI officials check the application for completeness.
- Scientific Panel Review: The application is forwarded to a specific Scientific Panel for technical assessment.
- Clarifications: The panel may ask for additional data or clarifications.
- Approval/Rejection: Based on the safety assessment, the product is either approved or rejected.
- Issuance: If approved, an approval letter is issued, which must be used to apply for the FSSAI License.
Fees and Timeline
Government Fee: The application fee for product approval is typically ₹50,000 (non-refundable). There may be additional costs for lab testing if required.
Timeline: The process is lengthy and can take anywhere from 3 to 6 months or more, depending on the complexity and the response time to queries.
Validity and Renewal
Product approval is generally valid indefinitely unless the regulations change or safety concerns arise. However, the FSSAI License obtained based on this approval must be renewed every 1 to 5 years.
If you change the composition or manufacturing process of the approved product, you must apply for fresh approval.
