What is Non-Specified Food Product Approval Under FSSAI and Who Needs It?

India’s food regulatory ecosystem is designed to ensure that all food products consumed in the country are safe, properly evaluated, and compliant with the standards set by the Food Safety and Standards Authority of India (FSSAI). While thousands of products fall under predefined categories and standards, the food industry is evolving rapidly with new ingredients, formats, and technologies. As a result, many innovative products do not fit into existing FSSAI regulations. To address this gap, FSSAI introduced the Non-Specified Food Product Approval mechanism.

This regulatory pathway allows manufacturers, importers, and brand owners to legally introduce unique, novel, or unclassified food products into the Indian market after securing the approval from FSSAI. For guidance on Non-Specified Food Product approval, ingredient evaluation, dossier filing, and regulatory compliance, refer here:

What is Non-Specified Food Product Approval Under FSSAI and Who Needs It?

Understanding the Concept of Non-Specified Foods Under FSSAI

Non-specified foods are products or ingredients that do not fall under any existing standards outlined in the:

• Food Safety and Standards (Food Products Standards and Food Additives) Regulations
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022

• Food Safety and Standards (Alcoholic Beverages) Regulation, 2018
• Food Safety and Standards (Fortification of Food) Regulation, 2018

• Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020
• Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011
• Food Safety and Standards (Ayurveda Aahara) Regulations, 2022

If a food or ingredient has no predefined regulatory category, it is treated as non-standardized. FSSAI evaluates such products through a structured process to ensure consumer safety before granting market approval also called Non-Specified Food Product Approval.

When Is Non-Specified Food Product Approval Required?

Several types of products trigger the need for approval under the Non-Specified Food framework, including:

1. Novel Food Ingredients

Ingredients not traditionally consumed in India or not covered under existing FSSAI regulations fall under this category. Examples include:

• New dietary fibers
• Extracts from unconventional sources
• Non-native plants, fruits and vegetables to India

2. New Processing Technologies

Foods using innovative methods such as advanced enzymatic treatment or fermentation techniques may require approval.

3. Imported Foods Without Indian Standards

Many international brands sell products that comply with global or regional standards but lack an equivalent category in India. These products need evaluation and approval before import.

Regulatory Framework Behind the Approval Mechanism

To regulate novel products, FSSAI introduced the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. These regulations mandate that manufacturers and importers seeking approval must submit:

• Safety evaluation data
• Toxicological information
• Scientific literature and proposed label
• Regulatory status in other countries
• Proposed usage levels
• Manufacturing process details
• Specifications and analytical reports
• History of consumption globally, etc.

The purpose is to ensure that the product is safe for consumption and meets scientific, technical, and nutritional benchmarks.

Key Steps in the Non-Specified Food Product Approval Process

Step 1: Determine Applicability

The first step is evaluating whether the product falls outside existing standards. A regulatory assessment is conducted to confirm the need for approval.

Step 2: Compile Safety and Scientific Data

FSSAI requires robust scientific evidence demonstrating product safety. This includes:

• Composition details
• Toxicology data
• Allergen information
• Stability reports
• ADI (Acceptable Daily Intake) data
• International approvals such as GRAS status documentation, WHO/FAO/ CODEX listing, products approvals globally
• Human clinical safety data in prescribed format, etc.

Step 3: Prepare and Submit the Application

Manufacturers/Importers must file a detailed application through the FSSAI portal (EPAAS), including:

• Technical dossier
• Certificates of analysis
• Manufacturing details
• Labeling drafts
• Intended use data, etc.

Step 4: Review by Scientific Panels

FSSAI’s scientific committees evaluate:

• Ingredient safety
• Completed research
• Purity criteria
• Exposure levels
• Potential health effects
• International consumption data
• Toxicology and human clinical data

Step 5: Clarifications and Additional Requirements

FSSAI may request further data, comparative studies, or clarifications based on gaps identified during review.

Step 6: Approval and Compliance

After the product is approved, manufacturers and importers must ensure that labeling, claims, and product usage strictly comply with FSSAI’s conditions.

Step 7: Obtain FSSAI License

The approval secured must be added in the license for market authorization.

Which Businesses Must Obtain This Approval?

The non-specified food approval is essential for:

• Food manufacturers developing innovative products
• Importers introducing new food ingredients or formulations
• Startups in functional foods, nutraceuticals, or plant-based innovation
• Ingredient suppliers launching new raw materials
• Food tech companies using novel processing methods
• Brands expanding global SKUs into India
• R&D-driven companies experimenting with new formulations

Failure to obtain necessary approval can result in product rejection at ports, penalties, recall orders, or restrictions on manufacturing and sales.

Why This Approval Matters for Market Success

Securing Non-Specified Food Product approval provides several advantages:

Compliance Assurance

Ensures your product fully aligns with Indian food safety laws.

Faster Market Entry

Pre-approval reduces the risk of enforcement actions after product launch.

Investor and Distributor Confidence

Compliance strengthens business credibility and facilitates distribution partnerships.

Consumer Safety

Scientific evaluation ensures safe consumption and builds trust.

Competitive Advantage

Approved novel products often enjoy early-mover advantage in emerging categories.

Final Thoughts

India’s food sector is rapidly evolving, with increasing consumer demand for innovative, functional, and global food products. For businesses introducing novel ingredients or formulations, FSSAI’s Non-Specified Food Product approval is an essential regulatory requirement. It ensures that every new product entering the market meets the highest standards of safety, transparency, and scientific validation.

For expert guidance on navigating this approval pathway, dossier preparation, ingredient evaluation, and FSSAI regulatory compliance, refer here:

What is Non-Specified Food Product Approval Under FSSAI and Who Needs It?