What is the Food Safety and Standards Authority of India (FSSAI)’s Non-Specified Food Regulations?

India’s food landscape is involving innovation—think plant-based meats, algae-based proteins, or exotic imported nutraceuticals. But what happens when a food product doesn’t quite fit into the usual Regulatory boxes?

That’s where FSSAI’s Non-Specified Food and Food Ingredients Regulations (2017) come in—a game-changer for food businesses (FBOs) aiming to innovate responsibly.

What Are Non-Specified Foods (NSFs)?

“Non-specified food” means any food other than Proprietary Food FSSAI or food ingredients, including additives, processing aids, and enzymes, for which standards have not been specified in any regulation made under the Act. In simple terms, these are novel or innovative items that do not currently fit into the established categories under India’s food safety framework. For products falling under NSF, the FBO must get it approved from the FSSAI mandatorily before manufacturing, importing, or selling in India.

• NSF is applicable for the following categories of food or ingredients: Novel food, novel food ingredients, or those processed using new technology.
• New food additives;
• New processing aids, including enzymes;
• Articles of food and food Ingredients consisting of or derived from microorganisms, algae, fungi, bacteria, or yeasts; and
• Imported foods not previously consumed in India.

Why Were These Regulations Introduced?

Before 2017, product approvals were based on advisories, which lacked legal clarity and transparency. Following a Supreme Court directive, the advisory system was discontinued, prompting FSSAI to create a formal Regulatory pathway. The 2017 regulations ensure that novel foods are scientifically evaluated and deemed safe before reaching consumers.

Key Steps in the Approval Process

1. Prepare a Detailed Application (Form I)

Food Business Operators (FBOs) must gather comprehensive information, including:

• General information regarding the applicant and the manufacturer
• Product composition and nutritional profile
• Brief manufacturing process and safety data
• Regulatory status in other countries
• History of human consumption
• Target consumers and intended use of product-specific documents

All documents must be submitted through an online FSSAI ePAAS portal, along with a ₹50,000 application fee.

2. Scrutiny and Risk Assessment

FSSAI’s scientific panels assess the safety, quality, and efficacy of the product. They may request additional information during the evaluation process.

3. Approval or Rejection

If the product is deemed safe, FSSAI issues an approval via Form-II. If rejected, FBOs have the right to appeal within 30 days.

4. Post-Approval Compliance

Upon receiving approval:

• FBOs must obtain or update their FSSAI license
• Maintain records on product safety and traceability
• Comply with any additional conditions set by FSSAI

If a health risk is identified after the product is on the market, it must be withdrawn and reported under the Food Recall Regulations, 2017.

Why This Matters for Food Businesses

For food innovators, the regulations provide a transparent and scientific process to bring novel products to market. However, they also introduce several challenges:

• Time-intensive Reviews
• High Documentation Requirements
• Potential Need for Reformulation

Understanding the regulations is essential for launching products like plant-based alternatives, fortified foods, imported nutraceuticals, or bioactive ingredients in India.

Conclusion

FSSAI’s Non-Specified Food Regulations are crucial for balancing consumer safety with food innovation. By ensuring that all new and unconventional food products undergo rigorous evaluation, the system builds trust while opening doors for next-generation nutrition solutions.

If you’re a food manufacturer planning to introduce a novel product in India, it’s essential to consult with Freyr Regulatory experts to navigate the approval process smoothly and stay compliant with Indian food laws.