FSSAI Product Approval

What is Food Product Approval System (FPAS)?

The Food Product Approval System (FPAS) is an important online platform developed by the Food Safety and Standards Authority of India (FSSAI) to streamline and simplify the approval process for food products, especially those that fall outside the scope of existing food safety standards and regulations. Introduced under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, FPAS is specifically designed to help Food Business Operators (FBOs) determine whether their products require prior approval before being introduced to the Indian market. This is particularly crucial for new, non-specified, or innovative products—such as products made with novel ingredients, new additives, or fortifications—that are not covered under existing regulations.

FPAS provides a user-friendly online interface where businesses can easily check their product category, understand regulatory requirements, and submit an online application for approval if necessary. The system helps eliminate manual paperwork, improves tracking, reduces processing time, and enhances transparency for both regulators and applicants.

Key Features of FPAS

1. Online Submission: FBOs can submit their product approval applications online, including all required forms, supporting documents, safety data, and scientific evidence.
2. Simplified Process: The system offers a streamlined workflow, guiding applicants through each step of the approval process and ensuring they meet all necessary requirements.
3. Category Check: FPAS helps businesses check whether their product falls under specified or non-specified categories and whether approval is needed.
4. Faster Processing: Automation and digital tracking help reduce bottlenecks and improve the turnaround time for approvals.
5. Transparency and Monitoring: Applicants can track the status of their submissions online, ensuring transparency and accountability in the approval process.

Importance of FPAS

The Indian food market is constantly evolving, with growing consumer demand for functional foods, dietary supplements, fortified products, and plant-based innovations. Many of these products introduce new ingredients or combinations that were not previously part of FSSAI’s regulatory framework. Without FPAS, these products would either go unregulated, posing potential health risks, or face long delays due to unclear approval pathways.

FPAS ensures that consumer safety remains the top priority while also promoting innovation and growth in the Indian food industry. It bridges the gap between evolving market trends and regulatory oversight, supporting businesses in bringing safe, high-quality products to consumers without unnecessary delays.

Categories of Products That Require FSSAI Product Approval

The FSSAI Product Approval system applies to specific product categories, especially those that are non-standardized or newly introduced. Products requiring approval include:

Health Supplements

These are products designed to supply extra nutrients—like vitamins, minerals, or amino acids—that go beyond what a regular diet offers. They aim to fill nutritional gaps and promote overall wellness but need approval to ensure they’re safe and effective.

Nutraceuticals

These are foods or food products containing bioactive compounds (like antioxidants, omega-3s, or plant extracts) that offer health or medical benefits. Since they are more potent than ordinary foods, FSSAI requires safety evaluation before they can be sold.

Foods for Special Dietary Uses (FSDU)

These products are formulated to meet specific dietary requirements, such as gluten-free foods or lactose-free products, catering to people with allergies, intolerances, or unique nutritional needs. Approval ensures they meet standards for safety and suitability.

Foods for Special Medical Purposes (FSMP)

These are prescribed dietary products meant to manage diseases or medical conditions (e.g., meal replacements for diabetic patients). Because they target vulnerable groups, they undergo strict review for composition, claims, and safety.

Functional Foods

These foods offer health benefits beyond basic nutrition, like cholesterol-lowering spreads or heart-healthy cereals. Since they claim added health effects, they require scientific backing and approval to prevent misleading or unsafe claims.

Specialty Foods with Probiotics, Prebiotics, or Botanicals

These products support gut health or overall wellness through active components like beneficial bacteria (probiotics), fiber compounds (prebiotics), or plant-based bioactives (botanicals). Approval ensures these ingredients are used in safe and effective doses.

Novel Foods or Novel Food Ingredients

This refers to products or ingredients never used in India or created through new technologies (like lab-grown proteins or plant-based meat). Since their safety profile is unfamiliar, they must undergo assessment before entering the market.

Proprietary Products or Ingredients

These are unique, custom-made products or ingredients not clearly covered by existing FSSAI regulations. Since no specific standards exist for them, approval ensures they are safe for consumption.

New Processing Aids and Enzymes

These are newly introduced substances used in food production (such as enzymes for fermentation or clarifying agents in beverages). Approval ensures they don’t leave harmful residues or alter the product’s safety.

New Additives

Additives like colorants, preservatives, or stabilizers enhance a product’s shelf life, taste, or appearance. When new additives are proposed, FSSAI checks their safety before allowing them into the food system.

Ingredients from Bacteria, Microorganisms, Fungi, Yeast, or Algae

If foods or ingredients are derived from biological sources that haven’t been previously assessed (like algae-based protein powders), they need approval to confirm they are free from harmful effects or contaminants.

Also, existing businesses converting to FSSAI licenses or introducing ingredients never assessed before must apply for approval to meet regulatory and safety standards.

Benefits of FSSAI Product Approval

There are several key benefits to obtaining FSSAI Product Approval, both for businesses and consumers:

Builds Consumer Trust

When a product has FSSAI approval, it signals to consumers that the food has passed rigorous safety and quality checks. This builds confidence in the product and the brand, as buyers know the product is compliant with health standards. It also assures customers that the food they consume is free from harmful ingredients or processes. This trust is crucial for brand loyalty and long-term business success.

Expands Consumer Choice

FSSAI approval allows businesses to bring innovative or non-standardized products into the market. As a result, consumers get access to a wider variety of products, such as novel foods, functional items, and specialty health products. This variety keeps the market dynamic and responsive to changing consumer preferences. It also encourages competition, pushing brands to develop better and healthier options.

Reduces Risk of Foodborne Illnesses

The approval process ensures that food products are manufactured under hygienic and controlled conditions. It requires compliance with safety regulations, minimizing contamination, spoilage, or adulteration risks. By approving only safe products, FSSAI helps protect public health and reduces incidents of foodborne diseases. This strengthens the overall food safety ecosystem in India.

Provides Legal Access to the Indian Market

For businesses, FSSAI approval is a legal requirement when introducing non-specified products in India. Without it, companies risk penalties, legal actions, and product recalls. By securing approval, businesses gain lawful entry into one of the world’s largest and fastest-growing food markets. This helps ensure smooth operations without interruptions from compliance authorities.

Opens Doors to International Export Opportunities

Many international markets require that imported food products meet the exporting country’s safety and regulatory standards. Having an FSSAI-approved product improves credibility and increases acceptance in foreign markets. This not only boosts export potential but also positions Indian companies as trusted global suppliers, expanding their business horizons.

Access to Government Grants and Subsidies

FSSAI-approved businesses often qualify for various government incentives, including grants, subsidies, and promotional schemes. These financial supports help reduce operational costs and improve profit margins. They also encourage companies to invest in innovation and better production technologies, making them more competitive both domestically and internationally.

Form IX for FSSAI Product Approval

Form IX is a key document used under the Food Safety and Standards Authority of India (FSSAI) framework for the purpose of food product approval. Specifically, this form acts as the declaration and undertaking by the Food Business Operator (FBO), confirming that all the information provided in the product approval application is true, complete, and compliant with the Food Safety and Standards Act, 2006 and its associated regulations. Whenever a company applies for product approval through the Food Product Approval System (FPAS), especially for non-specified or novel food products, submitting Form IX is a mandatory requirement. This document ensures that the FBO takes full responsibility for the accuracy of the data, the safety of the product, and compliance with food safety norms. Without a properly completed Form IX, the application is considered incomplete and cannot move forward in the approval process.

Purpose of Form IX

Form IX serves as a legal safeguard for the FSSAI. It ensures that businesses are not submitting misleading or false information and that they are committed to following national food safety standards. By signing this form, the company agrees that it will be held accountable if any discrepancies or violations are later discovered. This is crucial because it shifts part of the regulatory burden onto the applicant, ensuring that only serious, compliant businesses apply for approvals.

Key Components of Form IX

The form typically contains:

• Details of the Applicant/FBO (such as name, address, and FSSAI license/registration number)

• Details of the Product being submitted for approval, including product name, category, and ingredients

• Declaration Statement, where the authorized signatory affirms that the product meets all regulatory requirements

• Undertaking, confirming that the FBO will take corrective action if any issue arises post-approval or if the FSSAI requests product withdrawal

Importance of Accurate Declaration

Providing accurate details in Form IX is critical because any false statement can lead to:

• Cancellation or revocation of the product approval

• Penalties or legal action against the company

• Reputational damage that can affect future approvals or licenses

Thus, companies must carefully review all attached documents, scientific data, and product details before signing Form IX.

Eligibility Criteria for FSSAI Product Approval

For any food business operator (FBO) seeking FSSAI product approval, several important eligibility conditions must be met to ensure the application is accepted and processed smoothly. These criteria are set to uphold India’s food safety standards and ensure only compliant, safe products reach consumers.

Business Entity has to be Incorporated

Before applying for FSSAI product approval, the applicant must ensure that the business is a legally incorporated entity. This means it should be registered under the applicable Indian company laws (such as a private limited company, LLP, or partnership). Without proper incorporation, the FSSAI will not accept the application, as unregistered entities lack legal standing.

Obtain a License to Operate a Food Company

The applicant must already hold an FSSAI food license appropriate to the scale of operations—whether it’s a central, state, or registration license. This license verifies that the company is authorized to handle, manufacture, distribute, or sell food products. Applying for product approval without this license will result in rejection, as licensing is the foundation of food safety compliance.

Include Test Reports When Requesting Clearance

The FSSAI requires scientific evidence and product safety data as part of the approval process. Applicants must submit relevant test reports for the product, showing it meets the prescribed safety standards. These reports help the regulator verify that the product is safe for consumption and complies with regulatory norms.

Highly Recommended to Get NABL-Accredited Lab Test Reports

While submitting test reports, it is strongly recommended that businesses get these tests conducted in NABL-accredited laboratories. NABL accreditation assures that the testing processes and results meet international standards of reliability and accuracy, increasing the credibility of the application.

Follow FSSAI Food Product Labeling Standards

The product label must comply with FSSAI’s labeling guidelines, covering details such as ingredient lists, nutritional facts, allergen warnings, and manufacturer details. Non-compliant labels can lead to application rejection or post-approval penalties, as misleading or incomplete information directly affects consumer safety.

Follow the Food Safety Compliance System (FoSCoS) and Apply Online

Applications for product approval must be submitted through the FoSCoS portal, which is FSSAI’s online compliance platform. This system ensures efficient tracking, document submission, and status updates. Manual submissions or incomplete online applications will not be processed.

Comply With All Terms and Conditions Outlined by FSSAI

Finally, applicants must ensure strict adherence to all regulatory terms, including maintaining manufacturing standards, accurate documentation, and timely responses to queries. Any deviation can result in delays, penalties, or cancellation of approval.

Checklist of information required for FSSAI Product Approval

FBOs need to compile a complete set of information when applying for FSSAI Product Approval. The checklist includes:

• Business name, official address, and contact details to establish applicant identity.
• Brand name under which the product will be sold.
• Detailed manufacturing methods to help authorities understand production processes.
• Names of the food product, additive, ingredient, enzyme, and proprietary names, if applicable.
• Any health or functional claims associated with the product.
• Product shelf life, pack sizes, and serving details to determine consumer safety.
• Complete list of ingredients, along with their sources.
• Nutritional details, such as caloric content, vitamins, and minerals.
• Label and packaging information showing compliance with FSSAI labeling norms.
• Certificate of analysis from an accredited lab providing test results.
• Safety data sheets and any relevant scientific literature or research that supports the product’s safety and efficacy.

Documents Required for FSSAI Product Approval

Applicants must submit several important documents when seeking FSSAI Product Approval, including:

• Layout plan of the processing and manufacturing units to ensure hygienic design.
• List of company directors and address proof of directors for regulatory verification.
• Comprehensive list of food categories to be produced under approval.
• Inventory of manufacturing machinery used in production.
• No Objection Certificate (NOC) and manufacturer’s license for raw materials.
• Source documentation verifying the origin of raw materials.
• Water pesticide residue report confirming the use of safe water.
• Certification or food safety management plan to demonstrate safe handling practices.
• Product recall plan to ensure rapid response in case of safety issues.
• Declaration form affirming the accuracy and truthfulness of the submitted information.

Process to Get FSSAI Product Approval in India

The FSSAI Product Approval process follows a structured procedure involving several key steps to ensure food safety and regulatory compliance:

Business Entity Incorporation

Before applying for FSSAI Product Approval, it is recommended that the business entity is formally incorporated as a company or Limited Liability Partnership (LLP). Having a proper legal business structure helps position the product approval as an intangible asset, providing the company with legal authority to manufacture or market the approved product. This formal structure also strengthens the company’s compliance credibility and makes it easier to interact with regulators.

Food Business Operator (FBO) Licence

All businesses involved in manufacturing, selling, distributing, or handling food products must obtain an FBO license from FSSAI. This license is an essential document that must be submitted as part of the product approval application. Without a valid FBO license, businesses are not eligible to apply for approval of their food products or ingredients, as the license ensures they meet minimum food safety requirements.

Test Reports

The FSSAI Product Approval application requires submission of test reports from National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited labs. These test reports validate product safety, ingredient quality, and label claims, ensuring that the food product meets regulatory standards. Especially for products with health claims, it is mandatory to provide supporting evidence through lab test reports. These reports cover microbiological, chemical, and nutritional parameters critical for consumer safety.

Food Product Label

Even though it is not compulsory to print the label at the time of application, businesses must ensure that their food product label design adheres to the FSSAI Food Product Labeling Standards. The label should provide accurate product information, ingredient details, nutritional claims, and safety warnings (if applicable). The inclusion of a compliant label in the application demonstrates the business’s commitment to transparency and consumer safety.

Application for Food Product Approval

FBOs can submit the FSSAI Product Approval application online through the Food Safety Compliance System (FoSCoS) website. The application process involves selecting the relevant state, specifying the product category, uploading the required documents, and paying the applicable fees. The online submission simplifies the approval process by reducing paperwork and ensuring faster communication between FSSAI and businesses.

Scrutiny of Documents

Once the application is submitted, food authorities carefully examine the provided documents and application details. If they find any gaps, missing documents, or unclear information, they may request additional supporting documents or seek clarifications from the FBO. This step is critical because it ensures that only thoroughly vetted and safe food products receive approval.

Issue of FSSAI Product Approval

Based on the safety assessment, FSSAI will either approve or reject the application. If approval is granted, the FBO must submit a certificate of analysis covering all physical, microbiological, chemical, and nutritional parameters of the manufactured or imported product. This certificate provides the final assurance that the product meets safety and quality benchmarks and can be legally sold in India.

Post-Approval Compliance

Obtaining FSSAI Product Approval is not the final step; businesses must maintain strict post-approval compliance to keep their products legally in the market.

• FBOs must ensure they renew their FSSAI license on time to avoid disruptions or legal complications. Regular license renewal helps maintain smooth operations and ensures continued trust from regulators and consumers.
• Companies must stay updated on all FSSAI regulations, including any amendments or new guidelines. This proactive compliance helps businesses avoid penalties and ensures products remain aligned with current safety requirements.
• Product labeling and packaging must consistently meet FSSAI standards, as incorrect or misleading labels can lead to fines or product recalls. Proper labeling also reinforces consumer confidence in the brand.
• Businesses should implement robust Food Safety Management Systems (FSMS) to maintain high standards in production and handling. These systems ensure continuous compliance with FSSAI requirements and facilitate smooth inspections.
• Finally, companies should be prepared for regular monitoring and surveillance by FSSAI authorities. Ongoing quality control and record-keeping are essential for passing inspections and maintaining product approvals.