FSSAI Product Approval

Overview

FSSAI Product Approval is the formal process by which the Food Safety and Standards Authority of India (FSSAI) evaluates and grants prior approval for food products and food ingredients that are not covered by any existing FSSAI standard. It applies to non-specified foods, novel foods, novel food ingredients, and new additives or processing aids that need a safety assessment before they can be manufactured, imported, or sold in India.

This approval is required for Food Business Operators (FBOs) dealing in products such as health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purposes, functional foods, products containing probiotics, prebiotics or botanicals, and any ingredient or product being introduced in India for the first time for which standards have not been laid down.

The objective is to ensure that any food which falls outside the prescribed standards is independently assessed for safety and efficacy before it reaches consumers. Approval is granted by the Food Authority after a scientific risk assessment, and an FBO cannot manufacture or import such a product without this prior approval.

What is FSSAI Product Approval?

FSSAI Product Approval is the prior approval granted by the Food Safety and Standards Authority of India for food products and food ingredients that do not fall under any standard prescribed in the FSSAI regulations. It is primarily governed by the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.

The following categories typically require product approval:

• Non-specified foods and food ingredients (no standard laid down in any FSSAI regulation)
• Novel foods and novel food ingredients (no history of human consumption in India)
• Health supplements, nutraceuticals and functional foods (where required)
• Foods for special dietary uses and foods for special medical purposes
• Products with probiotics, prebiotics, botanicals or other new ingredients
• New food additives, processing aids or enzymes
• Products or ingredients introduced in India for the first time

Approval is granted only after the Food Authority, supported by its Scientific Panels and an expert committee, completes a risk assessment confirming the product is safe for consumption. Without this prior approval, the product cannot be lawfully manufactured, imported, or marketed in India.

Required Documentation

Only PAN Card and Aadhaar Card are mandatory; the rest are optional.

• PAN Card
• Aadhaar Card
• Passport-size Photograph
• Address Proof (Utility / Electricity Bill)
• Bank Statement
• FSSAI Product Approval Application Form
• Ingredients List (with sources and quantities)
• Manufacturing Process / Flow Chart
• Test Reports / Certificate of Analysis (NABL-accredited lab)
• Nutritional Information
• Product Label and Artwork (FSSAI-compliant)
• Shelf Life Data
• Quality Control Measures / Safety and Efficacy Data
• Scientific Evidence supporting safety and benefits
• Food Additive Details (if applicable)
• Import Documents (if applicable)
• Declaration and Undertaking

Apply Process

Getting your FSSAI Product Approval through TaxoSure is simple and completely online. Just follow these steps:

1. Visit our website. Go to taxosure.com and open this FSSAI Product Approval service page.
2. Login or Register. Create your free TaxoSure account, or log in if you already have one.
3. Upload your documents. Upload the required documents on this page — your KYC documents (PAN & Aadhaar) are auto-filled from your account, and you simply upload the remaining documents as per the checklist.
4. Submit your application. Submit your FSSAI Product Approval application in one click.
5. Talk to our consultant. Our consultant connects with you on WhatsApp / Call to confirm the details, share the pricing and begin the work.
6. Get your approval. Our experts complete the entire process — dossier preparation, laboratory test reports and scientific scrutiny — and deliver your FSSAI Product Approval (Form-II) to you.

Timelines depend on the completeness of the dossier and the nature of the product; deficiencies or additional information requests must be addressed within the periods specified by FSSAI.

Benefits

• Legal compliance: Allows lawful manufacture, import and sale of foods and ingredients that fall outside existing FSSAI standards.
• Consumer trust: An independent safety assessment builds public confidence that the product is safe for consumption.
• Market access: Approval is a prerequisite for selling non-specified, novel and similar products in the Indian market.
• Credibility for claims: Scientific validation supports nutritional, health and label claims, reducing the risk of regulatory challenge.
• Reputation protection: A standardised, documented assessment process minimises reputational and legal risk for the business.
• Stakeholder confidence: Helps gain the trust of distributors, retailers, investors and international buyers.

Key Points

• Product approval is governed mainly by the FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.
• It is required only for products and ingredients not covered by any existing FSSAI standard (non-specified, novel, and similar categories).
• Standardised products already covered under FSSAI regulations do not need separate product approval.
• No person may manufacture or import a non-specified food or ingredient without prior approval from the Food Authority.
• Test reports must come from an NABL-accredited (or equivalent) laboratory.
• Approval is granted after scientific risk assessment by the Scientific Panels and an expert committee.
• Product approval is separate from, and in addition to, the requirement of holding a valid FSSAI licence/registration.
• Government fees and timelines apply as per current FSSAI norms.

Summary

FSSAI Product Approval is the prior approval required for food products and ingredients that have no standard prescribed under FSSAI regulations, including non-specified foods, novel foods, health supplements, nutraceuticals and new additives. Food Business Operators must file an online application with supporting documents and NABL-accredited test reports, after which the Food Authority conducts a scientific risk assessment before granting approval.

Obtaining this approval ensures legal compliance, validates product safety and label claims, and builds consumer and stakeholder confidence. As the process involves detailed documentation, laboratory testing and scientific scrutiny, many businesses seek professional assistance to prepare an accurate dossier and navigate the procedure smoothly.

FAQs