Introduction
The Food Safety and Standards Authority of India (FSSAI) is responsible for regulating food safety in India. While most food products fall under predefined categories, some novel foods, functional foods, nutraceuticals, and genetically modified foods do not fit into standard classifications. These products are categorized under Non-Specified Food and require special approval from FSSAI before being introduced into the market.
What is the Non-Specified Food Category?
The Non-Specified Food Category includes food products that do not fall under standard FSSAI regulations. These products may be new to the market, contain innovative ingredients, or be processed using novel techniques.
According to FSSAI regulations, any food that does not fall under the existing categories in the Food Safety and Standards Act, 2006, needs to go through the Non-Specified Food Approval Process.
Why is Non-Specified Food Approval Required?
FSSAI ensures that even non-specified food products meet the necessary safety and quality standards before being sold to consumers. This approval process prevents harmful or untested food products from entering the market.
Types of Products Under Non-Specified Food Category
The Non-Specified Food Category includes the following products:
1. Novel Foods
- Foods that do not have a history of human consumption.
- Examples: Lab-grown meat, edible insects, new plant-based proteins.
2. Functional Foods
- Foods that provide additional health benefits beyond basic nutrition.
- Examples: Omega-3 fortified milk, probiotics, prebiotic drinks.
3. Nutraceuticals
- Products derived from food sources with medical or health benefits.
- Examples: Herbal supplements, fortified cereals, dietary supplements.
4. Genetically Modified (GM) Foods
- Foods containing genetically modified organisms (GMOs).
- Examples: GM corn, soy, rice with enhanced vitamins.
5. New Ingredients or Processing Methods
- Foods that use new ingredients or processing technologies.
- Examples: Cold-pressed juices with added bioactive compounds, plant-based meat substitutes.
Step-by-Step Process for Applying via ePAAS Portal
Step 1: Prepare a Dossier with Scientific Information
Before applying, prepare a comprehensive dossier that includes:
✔️ Scientific evidence, safety studies, and risk assessment data
✔️ Clinical trials (if applicable)
✔️ Nutritional composition and labeling details
Step 2: Fill Out Form-I
- Form-I is the official application form for the approval of non-specified food and ingredients.
- This form collects detailed product information, composition, and intended use.
Step 3: Upload Required Documents
Ensure you have the following documents ready for submission:
✔️ Scientific and safety studies
✔️ Toxicology reports
✔️ Stability studies & shelf-life data
✔️ Manufacturing process details
✔️ GMP (Good Manufacturing Practices) Certificate
Step 4: Pay the Online Fees
- The application fee for Non-Specified Food Approval must be paid online through the ePAAS portal.
- Fees may vary based on product type and testing requirements.
Step 5: Submit the Application via ePAAS Portal
- Visit the ePAAS portal on the FSSAI website.
- Log in with your credentials and submit the completed Form-I along with the required documents.
Step 6: Track Application Status Online
- After submission, you can track the progress of your application via the ePAAS portal.
- If additional information is required, FSSAI will notify you within 45 days.
Regulatory Review Process by FSSAI
Once the application is submitted, the Food Authority follows a structured review process:
1️⃣ Expert Committee Review – The Food Authority appoints a specialized expert committee to evaluate the application.
2️⃣ Deficiency Notification – If any missing information or clarifications are needed, the applicant is informed within 45 days.
3️⃣ Approval or Rejection – Based on the evaluation, the Food Authority may either approve or reject the application.
Appeal Process for Rejected Applications
If the application is rejected, the applicant has the right to appeal:
✔️ Step 1: Appeal to the CEO of FSSAI within 30 days of rejection.
✔️ Step 2: If the CEO rejects the appeal, the applicant can appeal to the Chairperson of FSSAI.
✔️ Step 3: The Chairperson’s decision is final and binding.
Using the Food Product Approval System (FPAS)
The Food Product Approval System (FPAS) is an online tool that helps businesses determine whether their food products require FSSAI Non-Specified Food Approval.
✅ How FPAS Helps:
- Self-assessment tool to check if FSSAI approval is needed
- Guidelines on regulatory classification of food products
- Simplifies compliance by directing applicants to the correct approval process
You can access FPAS on the FSSAI website for quick verification before applying via the ePAAS portal.
Final Thoughts
For businesses introducing novel, functional, or non-standard food products, obtaining FSSAI Non-Specified Food Approval is mandatory. The ePAAS portal streamlines the process, ensuring transparency and regulatory compliance.
By following the application steps, tracking the status online, and using FPAS for pre-verification, businesses can efficiently navigate the FSSAI approval process and bring their products to market legally.
🔹 Need help with FSSAI Non-Specified Food Approval? Consult an FSSAI expert to ensure a smooth application process! 🚀
