FSSAI Product Approval Process – Step-by-Step Guide

1.FSSAI Product Approval for Food Business

In India’s rapidly growing food and beverage industry, launching a new product isn’t just about taste or packaging — it’s about compliance. Whether you’re an entrepreneur developing a plant-based protein bar, a startup formulating herbal nutraceuticals, or an importer bringing in exotic superfoods, one thing remains non-negotiable: FSSAI product approval.

The Food Safety and Standards Authority of India (FSSAI) is the apex body responsible for ensuring that every food item sold in India meets strict safety, quality, and labeling standards. While many food businesses are familiar with obtaining an FSSAI license, far fewer understand the need for product-specific approval. This distinction is critical — and often misunderstood.

An FSSAI license allows you to operate as a food business operator (FBO), but it does not automatically authorize you to sell every type of food product. For certain categories — especially proprietary foods, nutraceuticals, dietary supplements, novel ingredients, and imported foods — you must go through a separate FSSAI product approval process before your product hits the market.

Difference between FSSAI license vs product approval.

Why? Because these products often contain ingredients or formulations not covered under existing FSSAI standards. Without proper scientific evaluation, they could pose health risks or mislead consumers with false claims.

With the rise of health-conscious consumers, functional foods, and global food trends, demand for innovative food products is soaring. According to industry reports, India’s nutraceutical market alone is projected to reach $18 billion by 2026. But innovation without regulation can be dangerous. That’s why FSSAI enforces a rigorous product approval in FSSAI framework to balance safety, transparency, and growth.

This comprehensive guide walks you through the entire FSSAI product approval step-by-step process — from eligibility and documentation to submission, review, and final clearance. Whether you’re launching a new energy drink, importing collagen peptides, or creating a sugar-free dessert line, this article will help you navigate the FoSCoS product approval system confidently and compliantly.

By the end of this guide, you’ll know:

When your product needs FSSAI approval
How to apply via the FoSCoS portal
What documents are required
How much it costs and how long it takes
Common mistakes to avoid
And how to stay legally compliant

Let’s dive into the world of food product approval India, so you can bring your vision to life — safely and successfully.

2. What is FSSAI Product Approval?

FSSAI product approval refers to the formal process by which the Food Safety and Standards Authority of India evaluates and authorizes specific food products that fall outside the scope of existing food safety standards. Unlike standardized foods (like milk, wheat flour, or edible oil), which already have defined specifications under the FSS Rules, certain innovative or specialized products require individual scrutiny before they can be legally manufactured, imported, or sold in India.

What Does “Product Approval” Mean?

Product approval means that FSSAI has reviewed your product’s formulation, ingredients, labeling, and intended use, and confirmed that it is safe for human consumption and compliant with Indian food laws.

This approval is mandatory for any food product that:

Contains ingredients not listed in current FSSAI standards
Makes health or nutritional claims
Is imported from another country
Falls under special categories like nutraceuticals or proprietary foods

Once approved, the product receives a unique FSSAI product registration number, which must appear on its label.

Who Needs FSSAI Product Approval?

You need product approval in FSSAI if you are:

Launching a proprietary food (e.g., energy drinks, fortified snacks)
Manufacturing or importing nutraceuticals or dietary supplements
Introducing a novel food (a food not traditionally consumed in India)
Selling imported food items not covered under general standards
Using food additives beyond prescribed limits

It’s important to note: Having an FSSAI license does not exempt you from product approval. The license permits business operations; product approval ensures the safety and legality of each unique product.

Legal Framework: The FSS Act, 2006

The foundation of FSSAI’s authority lies in the Food Safety and Standards Act, 2006. Under this law:

Section 9 empowers FSSAI to regulate the manufacture, sale, and distribution of food.
Regulation 2.1.12 of the FSS (Licensing and Registration of Food Businesses) Regulations, 2011 mandates product approval for certain categories.
The FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016 provide detailed guidelines for product-specific approvals.

These regulations ensure that even as food innovation accelerates, consumer safety remains the top priority.

Categories of Food Requiring FSSAI Product Approval

Not all food products need individual approval. Only those falling into non-standardized or special-risk categories require it. Here’s a breakdown:

Category	Examples	Approval Required?
Standardized Foods	Milk, salt, edible oils, honey	❌ No
Proprietary Foods	Energy drinks, fortified cereals, flavored waters	✅ Yes
Nutraceuticals & Dietary Supplements	Vitamin tablets, protein powders, herbal capsules	✅ Yes
Novel Foods	Lab-grown meat, insect-based protein, algae oils	✅ Yes
Foods for Special Dietary Use	Gluten-free products, low-sodium foods	✅ Yes
Imported Foods	Foreign-branded snacks, beverages, health foods	✅ Yes (if not standardized)

Understanding where your product fits is the first step toward compliance.

Why FSSAI Reviews Products Scientifically

FSSAI doesn’t approve products based on popularity or marketing appeal. Each application undergoes scientific evaluation by expert panels to assess:

Toxicity and allergenic potential of ingredients
Nutritional adequacy
Stability and shelf life
Labeling accuracy
Potential for misleading health claims

This rigorous process protects consumers and builds trust in India’s food ecosystem.

In short, FSSAI product approval is not a bureaucratic hurdle — it’s a safety checkpoint that ensures your innovation contributes positively to public health.

3. When Do You Need FSSAI Product Approval?

Knowing when to seek FSSAI product approval is crucial. Many startups mistakenly assume that once they have an FSSAI license, they can launch any product. This misconception can lead to legal trouble, product recalls, and financial losses.

Let’s break down the key scenarios where product approval in FSSAI becomes mandatory.

1. Launching a Proprietary Food Product

A proprietary food is any food product that does not conform to the compositional standards laid down by FSSAI. These are typically formulated for specific benefits — such as energy boosting, weight management, or immune support — and may include added nutrients, herbs, or functional ingredients.

Examples:

Energy drinks with caffeine, taurine, and B-vitamins
Fortified breakfast cereals with added iron and folic acid
Protein bars with whey isolate and sweeteners
Flavored plant-based milks with added calcium and DHA

Even if your product seems similar to others on the market, if it contains ingredients or combinations not listed in FSSAI standards, you need approval.

💡 Pro Tip: Just because a similar product exists doesn’t mean yours is automatically approved. Each formulation is evaluated individually.

2. Manufacturing or Selling Nutraceuticals & Dietary Supplements

Nutraceuticals — foods or parts of foods that provide medical or health benefits — are among the fastest-growing segments in India. However, they are also highly regulated due to their potential impact on health.

Under the FSS (Health Supplements, Nutraceuticals, etc.) Regulations, 2016, all nutraceutical products must undergo FSSAI product approval step-by-step before sale.

Covered Categories:

Vitamins and minerals
Herbal extracts (e.g., ashwagandha, turmeric)
Amino acids and protein isolates
Omega-3 fatty acids
Probiotics and prebiotics
Weight management supplements
Sports nutrition products

These products often make structure-function claims (e.g., “supports immunity” or “aids digestion”), which require scientific backing and regulatory scrutiny.

🚫 Warning: You cannot legally sell a supplement labeled as “immunity booster” or “fat burner” without FSSAI approval — even if it’s made from natural ingredients.

3. Importing Food Products into India

Imported food products — whether snacks, beverages, or health supplements — must comply with Indian food laws. While some standardized imported items (like packaged butter or canned tuna) may be allowed under general import rules, non-standardized or novel imported foods require prior FSSAI approval.

Examples Needing Approval:

Korean probiotic drinks (e.g., Yakult-style beverages)
U.S.-branded protein powders with proprietary blends
European herbal teas with unapproved botanicals
Australian bone broth powders
Japanese functional candies with added collagen

FSSAI evaluates imported products for:

Ingredient safety
Compliance with Indian food additive limits
Accurate labeling in English or Hindi
Presence of banned substances (e.g., certain colors, preservatives)

Without approval, customs authorities can seize shipments, leading to inventory loss and penalties.

4. Using Food Additives Beyond Permitted Levels

FSSAI sets strict limits on food additives like preservatives, colors, sweeteners, and flavor enhancers. If your product uses any additive above the Maximum Permissible Level (MPL), or uses an additive not listed in FSSAI standards, you must seek product approval.

For example:

Using sucralose at 500 mg/kg when the limit is 300 mg/kg
Adding steviol glycosides (from stevia) in a product category not permitted
Using a new synthetic flavor compound not yet recognized

Even minor deviations require justification and scientific validation.

5. Introducing a Novel Food

A novel food is any food or ingredient that has not been traditionally consumed in India and lacks a history of safe use. FSSAI treats these with extra caution.

Examples of Novel Foods:

Lab-grown meat or cultured proteins
Insect-based protein powders
Algae-derived oils (e.g., DHA from microalgae)
CRISPR-edited crops
Fermented plant proteins (e.g., mycoprotein like Quorn)

The novel food approval process India involves extensive data submission, including toxicological studies, allergenicity reports, and metabolic fate analysis.

FSSAI may convene a Scientific Panel to evaluate long-term health impacts before granting approval.

6. Making Health or Nutritional Claims

If your product label says:

“Rich in antioxidants”
“Supports heart health”
“Low glycemic index”
“Clinically proven to improve focus”

…you likely need FSSAI product approval.

Health claims are tightly regulated to prevent misleading consumers. Only approved claims backed by scientific evidence are allowed.

FSSAI maintains a list of permissible claims under Regulation 2.4.4 of the FSS (Packaging and Labeling) Regulations. Any claim outside this list requires prior approval.

✅ Checklist: Do You Need FSSAI Product Approval?

Answer “Yes” to any of the following? Then you need approval.

Question	Yes/No
Is your product a proprietary food (not covered under FSSAI standards)?	☐
Does it contain vitamins, herbs, or supplements?	☐
Are you importing the product into India?	☐
Does it use food additives above permitted levels?	☐
Is it a novel food or contains a new ingredient?	☐
Are you making health or nutritional claims on the label?	☐

👉 If you checked even one box: Start the FSSAI product approval process now.

4. FSSAI Product Approval Process – Step-by-Step Guide

Now that you know when you need approval, let’s walk through how to get it.

The FSSAI product approval process is conducted entirely online via the FoSCoS (Food Safety Compliance System) portal — the unified digital platform for all FSSAI services.

Here’s your complete FSSAI product approval step-by-step roadmap:

Step 1: Determine Your Product Category (Standardized vs Non-Standardized)

Before applying, confirm whether your product is standardized or non-standardized.

Standardized foods have defined composition, quality, and labeling rules in FSSAI regulations (e.g., milk, ghee, honey).
Non-standardized foods do not have such standards and require individual approval.

💡 How to Check:

Visit the FSSAI website
Go to “Regulations” > “Food Standards”
Search for your product category (e.g., “energy drink”, “protein bar”)
If no standard exists → You need product approval

📌 Example: There is no FSSAI standard for “collagen gummies” → Approval required.

Step 2: Register on the FoSCoS Portal

All applications must be submitted via FoSCoS (https://foscos.fssai.gov.in).

How to Register:

Go to https://foscos.fssai.gov.in
Click “Register” → Select “Food Business Operator (FBO)”
Enter:

FSSAI License Number (if already licensed)
Business name, address, email, mobile

Verify your mobile number and email
Set a password and log in

🔐 Note: You must have a valid FSSAI license or registration to apply for product approval.

If you don’t have one, apply for a Basic, State, or Central License first.

Step 3: Submit Online Application (Form I)

Once logged in:

Go to “Services” → “Product Approval”
Click “Apply” → Select “New Application”
Fill Form I – Application for Product Approval

Key Fields in Form I:

Product Name
Category (e.g., Proprietary Food, Nutraceutical, Novel Food)
Sub-category (e.g., Dietary Supplement, Functional Food)
Intended Use (e.g., adult nutrition, sports performance)
Target Population (e.g., adults, athletes, diabetics)
Dosage & Consumption Pattern
Full Product Composition (ingredient-wise % and source)

📌 Critical Tip: Be precise. Even small errors in composition (e.g., 0.5% vs 0.6%) can trigger delays.

Step 4: Upload Required Documents

You’ll need to upload scanned copies of the following documents in PDF format:

Document	Purpose
Product Formulation Sheet	Lists all ingredients with percentages and sources
Ingredient Safety Data Sheets (SDS)	Prove safety of each component
Certificate of Free Sale (for imported products)	Issued by the country of origin
Manufacturing License Copy	Proof of FSSAI license
NABL-Accredited Lab Test Reports	Confirm purity, contamination, and compliance
Label Artwork (Front & Back)	Show proposed packaging with nutrition facts and claims
Undertaking on Product Safety	Signed declaration of compliance
Patent or Trademark Certificate (if applicable)	Optional but strengthens application

📁 File Size & Format: Max 2 MB per file, PDF only.

Step 5: Pay the Applicable Fees

The government fee for FSSAI product approval is:

Product Type	Fee (INR)
Proprietary Food	₹5,000
Nutraceutical / Health Supplement	₹10,000
Novel Food	₹25,000
Imported Food	₹10,000

Payment is made online via:

Net Banking
Credit/Debit Card
UPI

After payment, you’ll receive a Transaction ID and Application Reference Number.

Step 6: Product Review & Scientific Panel Evaluation

Once submitted, your application enters the review phase:

Initial Screening (7–10 days): FSSAI checks for completeness.
Technical Evaluation (30–60 days): Experts analyze:

Ingredient safety
Nutritional profile
Label claims
Manufacturing process

Scientific Panel Review (if needed): For complex cases (e.g., novel foods), a panel of scientists may be convened.

You may be asked to provide:

Additional test reports
Clinical study data
Justification for high-dose ingredients

Step 7: Respond to Clarifications (If Required)

If FSSAI has questions, you’ll receive a Request for Information (RFI) via email and FoSCoS dashboard.

Common clarifications:

“Please provide toxicological data for Ingredient X.”
“Justify the high level of vitamin B12 used.”
“Revise health claim to match FSSAI guidelines.”

🎯 Response Deadline: Usually 15–30 days. Failure to respond leads to application rejection.

💡 Pro Tip: Assign a compliance officer to monitor your FoSCoS account daily during review.

Step 8: Final Approval or Rejection

After evaluation:

Approved: You’ll receive a Product Approval Certificate with a unique number (e.g., IN-12345678).
Rejected: You’ll get a reason (e.g., unsafe ingredient, insufficient data).

Approved products can now be manufactured, imported, or sold — provided the label includes the approval number.

🔁 Validity: Product approval is valid for permanent unless revoked. However, any change in formulation requires re-approval.

📊 FSSAI Product Approval Flowchart

[Start]
   ↓
Check Product Category (Standardized vs Non-Standardized)
   ↓
Register on FoSCoS Portal
   ↓
Log In → Apply for Product Approval (Form I)
   ↓
Upload Documents
   ↓
Pay Fees (₹5,000 – ₹25,000)
   ↓
FSSAI Initial Screening
   ↓
Technical & Scientific Review
   ↓
Receive Clarification Request? → Yes → Submit Response
   ↓ No
Final Decision: Approved / Rejected
   ↓
Receive Certificate (if approved)
   ↓
Label Product with FSSAI Approval Number
   ↓
Launch Product

✅ FSSAI Product Approval Checklist

Before submitting, verify:

Task	Done?
Confirmed product needs approval	☐
Registered on FoSCoS portal	☐
Filled Form I accurately	☐
Uploaded all required documents	☐
Paid government fees	☐
Reviewed label claims for compliance	☐
Assigned team to respond to RFIs	☐

Use this checklist to avoid delays and rejections.

5. Documents Required for FSSAI Product Approval

Submitting the correct documents is half the battle in the FSSAI product approval process. Missing or incorrect paperwork is the #1 reason for application rejection.

Here’s a detailed list of mandatory documents and tips to prepare them correctly.

1. Product Formulation & Composition Details

Provide a complete ingredient list with:

Name of each ingredient
Percentage by weight
Source (e.g., bovine collagen, sunflower lecithin)
Grade/purity (e.g., 98% pure curcumin)

📌 Format: Use a table in PDF or Excel.

❌ Avoid vague terms like “natural flavors” or “proprietary blend” — FSSAI requires full disclosure.

2. Ingredient List with Safety Data

For each ingredient, especially active compounds (vitamins, herbs, additives), attach:

Safety Data Sheet (SDS)
Toxicological reports (if novel or high-dose)
GRAS (Generally Recognized As Safe) certification (if available)
COC (Certificate of Composition) from supplier

For herbal ingredients, include:

Botanical name (e.g., Withania somnifera)
Part used (root, leaf)
Extraction method

3. Copy of FSSAI License or Registration

You must have a valid FSSAI license (Central or State) or registration (for small businesses).

Upload:

Front and back of the license
Ensure it’s active and not expired

4. Lab Test Reports from NABL-Accredited Labs

FSSAI only accepts test results from NABL-accredited laboratories.

Tests typically include:

Purity and potency (e.g., vitamin content)
Contaminants (heavy metals, pesticides, aflatoxins)
Microbial load (E. coli, Salmonella)
Adulteration (melamine, synthetic dyes)

📌 Report must include:

Lab name and NABL logo
Sample ID
Test methods used (e.g., HPLC, GC-MS)
Date of testing

5. Label Sample & Artwork (Front & Back)

Submit high-resolution images or PDFs of your proposed label, including:

Product name
FSSAI license number
Product approval number (to be added post-approval)
Net quantity
Best before date
Mfg. & expiry date
Nutrition facts table
Ingredient list
Usage instructions
Health claims (must be FSSAI-approved)

🚫 Avoid: Exaggerated claims like “cures diabetes” or “100% effective.”

6. Undertaking on Product Safety

A signed declaration stating:

The product is safe for consumption
All ingredients comply with FSSAI standards
No misleading claims are made

Format provided on FoSCoS. Must be signed by the proprietor or authorized signatory.

7. Certificate of Free Sale (For Imported Products)

Issued by the food authority in the country of origin, confirming:

The product is legally sold in that country
It meets local food safety laws

Must be notarized and apostilled (if required).

8. Additional Documents (If Applicable)

Situation	Required Document
Patent/trademark	Copy of registration
Clinical studies	Summary report (in English)
Novel ingredient	Toxicity, allergenicity, metabolism data
Export intent	No additional docs needed

📝 Pro Tips for Document Preparation

Use clear, legible fonts (Arial, Calibri, size 10+)
Keep files under 2 MB
Name files clearly: Label_Artwork.pdf, Lab_Report_Collagen.pdf
Double-check ingredient percentages — they must match lab reports

6. Cost of FSSAI Product Approval

While the government fee is fixed, the total cost of FSSAI product approval varies depending on your product type and testing needs.

Here’s a breakdown:

1. Government Application Fees

Product Type	Fee (INR)
Proprietary Food	₹5,000
Nutraceutical / Health Supplement	₹10,000
Novel Food	₹25,000
Imported Food	₹10,000

Fees are non-refundable, even if your application is rejected.

2. Testing & Lab Certification Costs

Lab tests are often the biggest expense.

Test Type	Approx. Cost (INR)
Basic Nutritional Analysis	₹3,000 – ₹5,000
Heavy Metal Testing	₹4,000 – ₹8,000
Pesticide Residue	₹5,000 – ₹10,000
Microbial Testing	₹2,000 – ₹4,000
HPLC for Active Compounds	₹6,000 – ₹12,000
Full Panel (All Tests)	₹15,000 – ₹30,000

💡 Tip: Choose a NABL-accredited lab early. Some offer package deals.

3. Consultant or Agent Fees

Many startups hire FSSAI consultants to handle the process.

Service	Cost (INR)
Application filing only	₹8,000 – ₹15,000
Full support (docs + follow-up)	₹20,000 – ₹50,000
For novel foods	₹50,000+

While not mandatory, consultants reduce errors and speed up approval.

Total Estimated Cost by Product Type

Product	Govt. Fee	Testing	Consultant	Total
Proprietary Food	₹5,000	₹15,000	₹10,000	₹30,000
Nutraceutical	₹10,000	₹25,000	₹20,000	₹55,000
Novel Food	₹25,000	₹40,000	₹50,000	₹1,15,000
Imported Supplement	₹10,000	₹20,000	₹15,000	₹45,000

These are approximate costs — actual expenses depend on complexity.

7. Timelines for FSSAI Product Approval

How long does FSSAI product approval step-by-step take?

There’s no fixed timeline, but here’s what to expect:

Stage	Duration
Application Submission	1–2 days
Initial Screening	7–10 days
Technical Review	30–60 days
Clarifications & Response	15–30 days
Final Decision	7–14 days

🟢 Best-case scenario: 60 days
🔴 Worst-case (with delays): 6+ months

Factors That Delay Approval

Incomplete documents
Vague ingredient descriptions
Unapproved health claims
Slow response to RFIs
Need for scientific panel review

Tips for Faster Approval

Hire a consultant familiar with FoSCoS
Run lab tests early
Pre-clear label claims with FSSAI guidelines
Monitor your FoSCoS dashboard daily
Respond to RFIs within 7 days

8. FSSAI Regulations & Standards for Product Approval

Understanding the rules is key to approval.

Proprietary Food Guidelines

Must not mislead consumers
Cannot claim to cure diseases
Must list all ingredients

Nutraceutical Standards

Daily intake must not exceed RDA
No drug-like claims
Label must say “Food Supplement”

Novel Food Approval Process India

Requires full safety dossier
May need animal/human studies
Longest review time

Imported Food Product Approval FSSAI

Must comply with Indian standards
COFS required
Labeling in English/Hindi

9. Penalties for Selling Without Product Approval

Selling unapproved products is illegal.

Legal Consequences

Fine up to ₹10 lakh (Section 59)
Product seizure
FSSAI license cancellation
Imprisonment up to 6 months

Real Case:

A Delhi company selling unapproved collagen gummies was fined ₹5 lakh and barred from operations for 2 years.

10. Benefits of Getting FSSAI Product Approval

Builds consumer trust
Enables e-commerce listing (Amazon, Flipkart)
Opens export opportunities
Enhances brand credibility

11. Common Mistakes to Avoid

Omitting minor ingredients
Using banned additives
Copying labels from other brands
Ignoring RFI emails

12. FAQs

Q: What is the difference between FSSAI license and product approval?

A: License allows operation; product approval authorizes specific items.

Q: How long does the process take?

A: 2–6 months, depending on complexity.

Q: Do imported supplements need approval?

A: Yes, unless standardized.

Q: Can proprietary food be sold without approval?

A: No — it’s illegal and risky.

13. Conclusion & Call-to-Action

The FSSAI product approval process ensures your food product is safe, legal, and trustworthy. While it requires effort, the rewards — consumer confidence, market access, and compliance — are worth it.

Don’t risk penalties or recalls. Start your FoSCoS product approval today.

📞 Need help? Our FSSAI consultants guide startups through every step — from document prep to label design. [Contact us] for a free consultation.

Stay compliant. Stay successful.

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