FSSAI Product Approval for Novel and Non-Specified Foods
Prepare the scientific dossier, labelling and safety data for FSSAI product approval of novel foods and new ingredients.
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FSSAI product approval is the regulatory clearance for food products and ingredients that are not covered by the standards notified under the Food Safety and Standards Act, commonly called non-specified foods, and for novel foods. It applies to manufacturers and importers who want to launch a new formulation, ingredient or food type and need the Food Authority to review its safety. The application is made on FoSCoS with a dossier covering composition, manufacturing process, safety evidence, labelling and intended use, and it is evaluated by the Scientific Panel. Our team helps organise the dossier, identify gaps and respond to queries raised during evaluation.
Who provides this service: our team of Company Secretaries and compliance specialists.
Who Needs FSSAI Product Approval?
- Manufacturers launching a new food formulation that is not covered by an existing standard.
- Importers of novel foods or ingredients that are not specified under the food regulations.
- Nutraceutical and functional food brands introducing new ingredients or blends.
- Startups developing alternative proteins, new beverages or ingredient innovations.
- Brands expanding a product range into categories where the regulatory status is unclear.
Key Benefits
- Early assessment of whether your product genuinely needs product approval or already fits an existing standard or category.
- Dossier structure built around what the evaluators look for: composition, process, safety evidence, intended use and labelling.
- Gap analysis on scientific data, test reports and ingredient sourcing before the application goes in.
- Review of label claims and ingredient declarations so the label does not become a separate problem later.
- Support in drafting responses when the Scientific Panel or the authority asks for clarification.
- Clear separation of the product approval from your licence, so both are in place before commercial launch.
How It Works
Classify the product
We study the formulation and intended use against the notified standards, to confirm whether the product is standardised, non-specified or novel, and which regulation and category the application should follow.
Collect composition and process data
We gather the ingredient list with sources and functions, the manufacturing flow, quality specifications and shelf-life information, and mark any data that must come from a laboratory or the ingredient supplier.
Assemble safety and scientific evidence
The dossier needs evidence on safety, such as test reports, literature references or history of use. We help organise this material logically so the evaluators can follow the reasoning without guesswork.
Review labelling and claims
We examine the draft label, ingredient declaration, nutritional information and any claims against the labelling and advertising rules, and suggest corrections that avoid objections during evaluation.
File on FoSCoS and track the evaluation
The application and dossier are submitted on the portal with the prescribed fee. We track the file, monitor for queries from the authority and keep your team informed of each step.
Reply to queries and obtain the approval
If the Scientific Panel seeks more data, we prepare structured replies with supporting documents. On approval, we check the conditions attached and align your licence and label with them.
Documents Required
- Application details of the manufacturer or importer along with a valid FSSAI licence where applicable
- Complete composition of the product with the quantity, source and function of each ingredient
- Manufacturing process description with a flow chart and quality control points
- Product specifications and certificates of analysis from a recognised laboratory
- Safety data, toxicological information or scientific literature supporting the use of the ingredient
- Evidence of use in other countries or history of safe consumption, where available
- Draft label showing ingredient list, nutrition information, claims and storage instructions
- Shelf-life study or stability data for the product
- Authorisation letter for the person filing the application on behalf of the company
Timeline and Fees
Indicative timeline: Evaluation can take several months or longer, depending on the Scientific Panel schedule, the quality of the dossier and the number of queries raised by the authority.
Professional fee: Our professional fee depends on the novelty of the product, the volume and quality of existing scientific data, the number of ingredients and the support needed for queries. Government fees are set by FSSAI and any laboratory or testing cost is separate and paid to the laboratory.
What Can Go Wrong if This Is Missed or Done Incorrectly
- Selling a product that needed approval but was launched without it can lead to action under the Food Safety and Standards Act.
- Weak or inconsistent safety evidence is a common reason for repeated queries and long delays.
- Claims on the label that go beyond what the evidence supports can cause objections or enforcement.
- A stocked batch may have to be held or withdrawn if approval conditions are not met.
Frequently Asked Questions
Which food products need FSSAI product approval?
Product approval is meant for food and ingredients that are not covered by the standards under the Food Safety and Standards Act, along with novel foods. Products that fit an existing standard generally do not need it. The position on which categories need approval has been revised by the authority from time to time, so always check the current FSSAI notices.
Is product approval the same as an FSSAI licence?
No. A licence or registration permits you to run a food business from a premises, while product approval concerns the safety and legality of a particular product or ingredient. A non-specified or novel product may need both in place before you manufacture, import or sell it. Having a licence does not by itself clear a new product.
Who evaluates the product approval application?
The application is examined by the Food Authority, with scientific evaluation carried out by its Scientific Panel, which reviews the safety and composition data. The panel can ask for more information or studies. The outcome depends on the quality of the dossier and the evidence, so careful preparation before filing makes a real difference.
What are the common reasons product approval gets delayed?
Delays commonly come from incomplete safety data, unclear ingredient functions, missing specifications, gaps between the process description and the label, and slow replies to queries. Dossiers that read as an assembled set of unrelated papers draw more questions than those that explain the product and its safety logically from the start.
Can I sell the product while the approval is pending?
Generally no. A product that requires approval should not be manufactured for sale, imported or marketed until the approval is granted. Selling in the meantime exposes the business to action under the food safety law. Plan the launch date around the evaluation period, which is uncertain and depends on the product and the queries raised.
Do imported novel foods need approval too?
Yes. Importers of foods or ingredients that are non-specified or novel need the corresponding approval before clearance, in addition to the import licence and the checks at the port. Overseas manufacturers can supply safety data and specifications to support the application, and we help the importer structure those papers for filing.
Official Sources
Rules, forms and fees change. Check the current position on the official portal:
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Last reviewed: . Laws, fees and procedures change; check the official portal before you act.
Disclaimer: The information on this page is for general informational purposes only and does not constitute professional legal, tax or compliance advice. Requirements vary by situation. Please consult a qualified CA or CS for advice specific to your needs. Government fees and timelines are subject to change; verify with the relevant authority before proceeding.