FSSAI Product Approval via ePAAS Portal — Complete 2026 Guide + Filing Service
Last updated: 26 July 2026
FSSAI Product Approval (PA) is a product-level regulatory clearance — separate from and additional to your FSSAI License — required before you can legally manufacture, import, or market nutraceuticals, health supplements, novel foods, non-specified foods, foods with health claims, functional foods, foods for special dietary uses, foods for special medical purposes, infant nutrition products, and specialty categories in India.
FSSAI Product Approval
CA Pre-reviewed dossier filing for Nutraceuticals, Novel Foods & Non-Specified Products.
Since 1 June 2026, FSSAI has made the ePAAS Portal (Product & Claim Approval Application System) mandatory for all such applications. The uniform application fee is ₹50,000 + 18% GST per product, timeline is typically 60-120 working days, and once granted, the Product Approval is valid for lifetime unless the underlying regulation is amended.
Attempting to market products in these categories without PA is a serious regulatory breach — leading to product recalls, market withdrawal orders, penalties under Section 63 of the FSS Act, 2006, and platform delisting on Amazon, Flipkart, Blinkit, Zepto, and other e-commerce platforms that now verify PA status.
This page covers the complete ePAAS-mandated process, dossier requirements, timeline realities, both regulatory frameworks that trigger PA requirements, and how to navigate scientific panel evaluations efficiently.
1. What is FSSAI Product Approval?
Product Approval is a regulatory mechanism established under Section 22 of the Food Safety and Standards Act, 2006, and operationalized through two primary regulations:
1. FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017
Governs approval of foods and ingredients not covered under any existing FSSAI standard, including novel foods, foods produced through novel technology, and non-native ingredients.
2. FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purpose, Functional Food, Novel Food and Food Fortification) Regulations, 2022
Governs approval of nutraceuticals, health supplements, FSDU, FSMP, functional foods, and food fortification.
Under these frameworks, FSSAI Scientific Panels evaluate the safety, efficacy, formulation, label claims, and intended use of each product formulation. Upon approval, FSSAI issues a Product Approval Number that must appear on the product label.
2. The ePAAS Portal — Mandatory from 1 June 2026
FSSAI has made the ePAAS (electronic Product & Claim Approval Application System) portal mandatory for all Product Approval and risk assessment applications from 1 June 2026. This replaces the earlier partially offline process.
What ePAAS handles:
- Non-specified food and food ingredient approvals
- Nutraceutical and health supplement product approvals
- Functional food approvals
- Novel food approvals
- High RDA product approvals
- Botanical ingredient approvals
- Purified chemical entity approvals
- Product-specific health claim approvals
- Infant nutrition product approvals
- Caffeinated beverage approvals
- Herbal beverage ingredient approvals
- Advertisement and claims approvals
Key advantages of ePAAS:
- Fully digital submission
- Complete dossier upload online
- Query and response tracking
- Payment integration
- Application status transparency
- FSSAI-side workflow automation
Related portals:
• FoSCoS — for FBO license/registration applications and payments
• FICS (Food Import Clearance System) — for import consignment clearance
• ReFoM Portal — for Registration of Foreign Manufacturers (mandatory for importers)
Understanding which portal handles which activity is essential — using the wrong portal wastes time and requires re-submission.
3. Two Regulatory Frameworks — Which Applies to Your Product
Non-Specified Food & Food Ingredients Regulations, 2017
- Do not fall under any existing FSSAI standard
- Cannot be classified as proprietary food
- Use novel ingredients or processes requiring safety assessment
- Are made from microorganisms, bacteria, yeast, fungi, or algae
- Are non-native to India
- Involve pre-mix of ingredients or additives requiring approval
- New plant extracts not previously used in Indian food
- Insect-based protein products
- Foods produced through synthetic biology
- Novel probiotic or prebiotic ingredients
- Cell-cultured food products
Health Supplements, Nutraceuticals & Food Fortification Regulations, 2022
- Nutraceuticals and health supplements
- Foods for Special Dietary Uses (FSDU)
- Foods for Special Medical Purposes (FSMP)
- Functional foods
- Novel foods (with health-focused positioning)
- Fortified foods (food fortification is included in this regulation)
- Ingredients must be listed in Schedules I to VIII of the Nutraceutical Regulations
- Vitamins/minerals must follow ICMR RDA limits
- No pharmaceutical ingredients permitted
- Herbal/botanical ingredients must have traditional or scientific evidence
- Only specific forms and quantities of vitamins/minerals allowed (e.g., Vitamin C as ascorbic acid)
- Ayurveda Aahara — a separate category governed by its own regulation for foods prepared according to authoritative Ayurveda books listed in Schedule A.
4. Products Requiring Approval via ePAAS
The following categories require PA before manufacture, import, or marketing:
Health & Wellness Products:
- Nutraceuticals
- Health supplements
- Functional foods
- Fortified foods (specific categories)
- Products with health claims
- Products with disease risk reduction claims
Specialty Nutrition:
- Foods for Special Dietary Uses (FSDU)
- Foods for Special Medical Purposes (FSMP)
- Infant food and formula
- Foods for children with special nutritional needs
- Foods for pregnant and lactating women
- Foods for athletes and sportspeople
Novel & Non-Specified Products:
- Novel foods (not previously in Indian food chain)
- Non-specified foods (no existing FSSAI standard)
- Products with new processing technology
- Pre-mix of ingredients or additives
- Foods with new botanicals or processed botanicals
Specific Categories:
- High RDA products (vitamin/mineral levels above one RDA)
- Botanical ingredients (new)
- Purified chemical entities
- Caffeinated beverages
- Herbal beverage ingredients
- Ayurveda Aahara
- Foods containing microorganisms, bacteria, yeast, fungi, or algae
Not requiring PA (but still need FSSAI License):
- Standard packaged foods conforming to notified FSSAI product category standards
- Fresh produce, meat, dairy, grains in standard forms
- Restaurant/food service preparations
- Standard beverages (packaged water, standard juices, tea, coffee)
- Products with only nutrient content claims (no health/disease claims)
If uncertain whether your product requires PA, err on the side of consultation. Marketing without required PA is a serious breach with severe consequences.
Filing ePAAS Dossier for Non-Specified Foods?
₹50,000 FSSAI application fee is non-refundable. Have your safety evidence, label claims, and lab test reports pre-audited by our scientific & CA advisory team.
5. Product Approval vs FSSAI License — Both Required
FBOs frequently confuse these two — they are distinct approvals with different scopes and both are typically required.
| Parameter | Product Approval (PA) | FSSAI License |
|---|---|---|
| What it authorizes | Specific product formulation | Business operation |
| Applied by | Product owner (manufacturer/importer/brand owner) | Food Business Operator (FBO) |
| Portal | ePAAS | FoSCoS |
| Fee | ₹50,000 + GST per product (uniform) | ₹7,500/year (Central) or ₹2,000-5,000/year (State) |
| Validity | 1 to 5 Years (unless regulation changes) | 1 to 5 Years under 2026 rules (annual fee) |
| Scope | Product-specific | Business-wide |
| Number per business | One per distinct formulation | One per legal entity |
| Governing law | Section 22 of FSS Act + product-category regulations | Section 31 of FSS Act |
Typical workflow:
- PA application filed on ePAAS for each product formulation
- FSSAI License application on FoSCoS (State or Central based on scale)
- Products cannot be marketed until both PA and appropriate License are in place
- For nutraceutical manufacturers with multiple formulations, PA strategy significantly affects go-to-market timeline. Filing PA for product A while Central License is being set up, and adding product B via license modification post-PA, is a common efficient sequence.
6. Application Fees — What You Actually Pay
FSSAI fees for PA are standardized, not variable by product category:
Product Approval Application Fee
₹50,000 + 18% GST = ₹59,000 total per application
This applies uniformly to: Non-specified food approval, Nutraceutical product approval, Health supplement approval, Functional food approval, Novel food approval, All other PA-requiring categories.
Fee submitted as demand draft in favor of "Senior Accounts Officer, FSSAI" or via ePAAS payment integration.
Fee refund policy: Non-refundable once submitted. FSSAI has issued specific fee refund policy notification (dated 1 November 2022) — refunds available only in specific documented circumstances.
Related Fees
- FSSAI Central License (for FBO operations): ₹7,500 + 18% GST/year
- FSSAI State License (if applicable): ₹2,000-5,000/year
- Advertisement & Claims Approval: ₹50,000 per application (allows up to 3 claims per application)
Third-Party Costs (Scientific Evidence)
These are the largest cost bucket:
| Item | Typical Cost |
|---|---|
| Toxicological studies (per ingredient) | ₹50,000 – ₹5,00,000 |
| Stability studies (3-6 month protocol) | ₹1,00,000 – ₹5,00,000 |
| Clinical evidence compilation | ₹50,000 – ₹5,00,000 |
| Microbiological safety testing | ₹25,000 – ₹1,00,000 |
| Contaminants and residues testing | ₹25,000 – ₹1,00,000 |
| NABL/ILAC certified lab test reports | ₹15,000 – ₹1,00,000 |
| Label claim substantiation research | ₹25,000 – ₹1,00,000 |
Our Service Fees
Customized based on product complexity, category, and dossier depth required. Discussed during regulatory strategy consultation.
7. The Complete Application Process
Step 1: Regulatory Strategy Consultation (Week 0)
- Product categorization confirmation (Non-Specified Food vs Nutraceutical vs other)
- Regulatory pathway identification
- Timeline projection
- Evidence gap analysis
Step 2: Evidence Gap Analysis (Weeks 1-2)
- Detailed audit of available scientific evidence against dossier requirements
- Identify gaps requiring fresh testing or literature research
- International regulatory precedent review
Step 3: Testing Coordination (Weeks 2-16)
- NABL/ILAC lab bookings for required tests
- Stability study initiation (parallel with other work)
- International literature gathering
- Clinical evidence compilation
- Ingredient sourcing verification
Step 4: Form I Dossier Preparation (Weeks 8-16)
- Section-by-section dossier compilation per Form I requirements
- Label finalization with precise claim language
- Internal review by regulatory experts
- Applicant company review and approval
Step 5: ePAAS Submission (Week 16-18)
- Complete dossier upload on ePAAS portal
- Application fee ₹50,000 + 18% GST payment
- Application Reference Number generated
Step 6: FSSAI Initial Review (Weeks 18-22)
- Completeness check
- Category classification confirmation
- Any early clarifications addressed
Step 7: Scientific Panel Evaluation (Weeks 22-38)
- Relevant Scientific Panel reviews dossier
- Safety assessment
- Efficacy evaluation
- Composition compliance verification
Step 8: Query Response Rounds (Weeks 25-42)
- Queries received via ePAAS
- Applicant response within 15-30 days per query
- Deficiencies to be corrected within 45 days
- Additional information provided within 30 days
- Multiple rounds typical (2-4)
Step 9: Final Decision — Form II Issuance (Weeks 40-52)
- Scientific Panel recommendation to Central Licensing Authority
- Form II approval or rejection letter issued
- Product Approval Number allocated (if approved)
Step 10: Post-Approval Integration
- PA Number reference added to FSSAI License (via modification if License already exists)
- PA Number included on product label design
- Product ready for market launch
- Post-approval compliance obligations activated
8. Form I Dossier — What Goes In
The Form I dossier is the core of your PA application. Typical dossier size: 100-500 pages depending on product complexity.
Section 1: General Information
- Company details
- Authorized person contact
- Existing FSSAI license details
- Kind of Business (KoB)
Section 2: Product-Related Information
- Proposed product name and brand
- Category classification (nutraceutical, FSDU, novel food, non-specified food)
- Product formulation with quantities
- Functional use explanation
- Intended use and target population
- Recommended dosage or serving size
- End use declaration
Section 3: Source & Species Details
- Source of each food ingredient
- Species details (for botanical/animal-derived ingredients)
- Country of origin per ingredient
Section 4: Manufacturing Process
- Complete process description
- Manufacturing process flowchart
- Critical Control Points identification
- Manufacturing environment (GMP compliance evidence)
Section 5: Safety Information
- Toxicological studies (per ingredient and combination)
- Allergenicity assessment
- Pre-clinical trials data
- Clinical trials data (where available)
- Contaminants and residues data
- Microbiological safety
- Stability studies (3-6 months minimum)
- Shelf life justification
Section 6: Efficacy & Health Claims
- Scientific literature supporting claimed benefits
- Claim statement with justification
- Interaction/possible adverse effects
- Contraindications
- Advisories on product use
- International regulatory precedents
Section 7: Labeling & Packaging
- Complete draft label
- Health claim language exactly as intended
- Warning statements
- Storage instructions
- Packaging material specifications
Section 8: Regulatory Status
- Worldwide regulatory status (approvals in other countries)
- Any prior FSSAI communication on the product
- Related product PAs held by applicant
Section 9: Laboratory Reports
- NABL or ILAC recognized laboratory test certificates (mandatory)
- Method of analysis validated for ingredients
- Quantity of nutrients for each claim
- Test methodology documentation
Section 10: Agreements & Manufacturing
- Agreement between applicant and manufacturer
- Third-party manufacturing arrangements
- Contract manufacturing documentation
Section 11: Post-Market Surveillance Plan
- Consumer complaint handling
- Adverse event reporting mechanism
- Batch recall procedure
- Ongoing quality monitoring
Dossier preparation is where 80% of PA delays originate. A well-prepared dossier reduces query rounds from typical 3-4 to 1-2, cutting overall timeline significantly.
9. Timeline — Realistic Expectations (60-120 Working Days)
FSSAI's operational timeline for Product Approval, per industry data and published application status:
| Phase | Duration |
|---|---|
| Pre-application preparation | 2-4 months (evidence gathering, dossier compilation) |
| FSSAI initial review | 3-6 weeks |
| Scientific Panel review | 8-14 weeks |
| Query resolution rounds | 4-12 weeks (varies by product complexity) |
| Final decision (Form II) | 2-4 weeks |
| Total from ePAAS submission | 60-120 working days |
| Total including pre-preparation | 6-9 months typical, up to 12+ months for complex cases |
Faster timelines (60-80 working days):
- Simple nutraceuticals with standard ingredients from approved lists
- Foods with clear precedent in existing approvals
- Dossiers with complete, high-quality safety data
Slower timelines (120+ working days):
- Novel foods with limited precedent
- Foods for Special Medical Purposes (higher clinical evidence bar)
- Products with ingredients not in permitted lists (requiring novel food evaluation)
- Multi-ingredient combinations without prior safety assessment
- Dossiers with evidence gaps requiring fresh testing
Delay-causing factors:
- Incomplete safety data
- Missing stability studies
- Health claims exceeding scientific evidence
- Ingredient combinations without precedent
- Labeling non-compliance
- Slow response to scientific queries
- Repeated deficiency notifications
Any consultant promising Product Approval in 30-45 days is misrepresenting the process — even the fastest approvals take 60+ working days.
10. Query Response, Deficiency Correction & Appeals
FSSAI has specified timelines for applicant response at each stage. Missing these can lead to application closure.
• Query response: 15-30 days from receipt of query on ePAAS
• Deficiency correction: 45 days to correct any deficiencies flagged by FSSAI
• Additional information submission: 30 days when FSSAI requests supporting documents, data, or clarification
• Appeal against rejection: 30 days from receipt of rejection letter (Form II)
• Appeal authority: Chairperson, Food Authority
• Beyond 30 days: Appeals not considered — application closed permanently
Best practice:
- Track ePAAS notifications daily
- Respond within 50% of allowed time to build FSSAI goodwill
- Never miss a deadline — extensions rarely granted
- Legal counsel involvement for rejection appeals
Our regulatory team monitors ePAAS notifications and drafts responses within FSSAI-specified timelines.
11. Scientific Panel Evaluation
FSSAI Scientific Panels conduct risk assessment for product categories. Understanding their approach helps in dossier preparation.
Relevant Scientific Panels:
- Panel on Nutrition and Fortification — for nutraceuticals, health supplements, fortified foods
- Panel on Functional Foods, Nutraceuticals, Dietetic Products and Other Similar Products — comprehensive SNF category coverage
- Panel on Novel Foods — for novel food evaluations
- Panel on Contaminants — for contaminant safety assessment
- Panel on Additives and Flavourings — for products with additive-focused questions
- Panel on Biological Hazards — for products with microbiological/probiotic components
- Panel on Genetically Modified Foods — for GM-derived ingredients
Evaluation criteria:
- Weight of evidence — quality and quantity of scientific evidence
- Precautionary principle — higher bar where uncertainty exists
- Comparative safety — how does product compare to alternatives already approved?
- Population-level considerations — impact on specific populations (children, pregnant women, elderly)
- International consensus — alignment with EFSA, FDA, Codex positions
- Traditional use evidence — history of use in Indian food chain (relevant for herbal ingredients)
FSSAI publishes application status publicly:
FSSAI maintains a running status list of applications: Approved/Rejected/Closed/Withdrawn/Under Process. As of March 2026, the list runs to 61 pages of applications tracked — showing significant transparency and volume. Latest status as of 3 June 2026 uploaded 9 June 2026.
This public tracking allows applicants to gauge processing patterns and rejection reasons in their category.
12. Advertisement & Claims Approval (Separate Process)
For nutraceuticals and health supplements making specific health, nutrition, or risk reduction claims, a separate Advertisement & Claims Approval is required.
Key details:
- Fee: ₹50,000 per application
- Claims per application: Up to 3 claims
- Validity: Lifetime (unless regulation changes)
- Fee refundability: Non-refundable once submitted
- Application address: CEO, FSSAI, FDA Bhawan, Kotla Road, New Delhi - 110002 OR Advisor (Science & Standards)
- Current mode: Offline (may shift to ePAAS)
Required documentation:
- Validated method of analysis of ingredient/substance
- Name of ingredient/nutrient/substance for the claim
- Claim statement with detailed justification
- Interaction, possible adverse effects, contraindications
- Advisories on product use
- Scientific evidence for each claim
Governing regulation: FSS (Advertising and Claims) Regulations, 2018
Advertisement/Claims Approval is often needed in addition to Product Approval — PA covers the product's regulatory status, while Advertisement/Claims Approval covers specific claims made in marketing.
13. Foreign Manufacturers — ReFoM Portal
Foreign food manufacturers exporting to India must register on the ReFoM Portal (Registration of Foreign Manufacturers) in addition to any PA required for their products.
What ReFoM covers:
- Registration of foreign manufacturing facilities
- Facility inspection compliance
- Foreign supplier verification for importers
- Compliance monitoring
Interaction with PA process:
- For imported non-specified foods and nutraceuticals, ReFoM registration is prerequisite
- PA and ReFoM run in parallel
- Both must be in place before import operations
Timeline for ReFoM registration: Varies by facility complexity and inspection requirements.
Importers require coordinated approach across ReFoM + PA + Central License + IEC — our regulatory support handles this multi-agency coordination.
14. Post-Approval Obligations
Product Approval is not "file and forget." Post-approval obligations continue throughout the product's market life:
1. Composition consistency: Manufactured product must match approved formulation. Any composition change requires PA modification.
2. Label consistency: Marketed labels must match approved labels. PA Number must appear on product label. Claim modifications require PA modification.
3. Batch testing: Ongoing batch testing per approved specifications. Records maintained for regulatory inspection.
4. Adverse event reporting: Consumer adverse events reported to FSSAI within specified timelines.
5. Post-market surveillance: Ongoing monitoring of product safety in market. Any safety concerns escalated proactively.
6. Advertisement compliance: All product advertising (print, digital, social media) must conform to approved claims.
7. Ingredient sourcing consistency: Approved ingredient sources should not change without notification. Major sourcing changes may require PA modification.
8. Manufacturing facility maintenance: Manufacturing facility must maintain GMP conditions consistent with PA approval.
9. Complaints handling and CAPA: Consumer complaints logged, root-caused, preventive actions documented.
10. Regulatory monitoring: Track any FSSAI amendments affecting approved product category. Comply with new regulations even for previously approved products.
Our End-to-End PA support includes ongoing post-approval compliance advisory for 12 months post-approval.
15. Common Rejection Reasons
Based on FSSAI's published application status data and consulting experience:
- Health claims exceeding scientific evidence — most common rejection reason
- Insufficient stability data — shelf life claimed without adequate stability studies
- Ingredient combinations without precedent — novel combinations lacking safety evaluation
- Toxicology gaps — missing acute, sub-chronic, or chronic toxicity data
- Composition non-compliance — ingredients not in approved Schedules I-VIII of Nutraceutical Regulations
- Vitamin/mineral quantities exceeding RDA limits without justification
- Manufacturing GMP inadequacies
- Labeling non-compliance — mandatory declarations missing
- Contaminants above limits — heavy metals, pesticide residues, microbiological contamination
- Allergenicity assessment absent — for products with allergen potential
- International safety concerns — ingredients banned or restricted in major markets not addressed
- Advertising and marketing plans exceeding claim scope
- Post-market surveillance plan inadequate
- Lab reports not from NABL/ILAC accredited labs
- Missed response deadlines — 15-30 day query, 45 day deficiency, 30 day info windows
Rejections are recoverable — you can address concerns and re-submit, or appeal within 30 days. But each rejection round adds 3-6 months to timeline.
16. What Happens Without Product Approval
Marketing a product requiring PA without obtaining approval carries severe consequences:
• Product recall order from FSSAI — company-funded market withdrawal
• Penalty up to ₹10 lakh under Section 22 read with Section 63 of the FSS Act, 2006
• FSSAI License suspension — impacting all products, not just the unapproved one
• Trade channel damage — retailers, distributors, and e-commerce platforms permanently blacklist violators
• Consumer safety cases — any adverse event linked to unapproved product creates civil liability
• Media and reputational damage — FSSAI publishes enforcement actions; public search results carry brand damage indefinitely
• Import consignment seizure — for imported products without PA, customs authorities can seize entire consignments
The 14 D2C brand notices issued by FSSAI on 14 June 2026 for misleading claims illustrate active enforcement in this space.
For nutraceutical and health supplement companies, market entry without PA is not a risk to take. PA investment of ₹5-10 lakh (including third-party testing) protects a product line that may generate ₹5-50 crore over its market life.
17. Why Choose Us for Product Approval Support
• ePAAS Portal expertise — from-launch familiarity with the mandatory June 2026 platform
• Regulatory strategy first — we design PA strategy fitting your product portfolio and market plans
• Scientific writing expertise — Form I dossiers written by regulatory professionals, not template-filled
• NABL/ILAC lab network — coordinated testing across toxicology, microbiology, stability, contaminants
• Health claim substantiation — literature research, clinical evidence compilation, defensible claim language
• Scientific Panel familiarity — understanding of each panel's evaluation frameworks
• Multi-product portfolio strategy — efficient sequential PA approach
• International regulatory alignment — dossiers structured to align with EFSA/FDA precedent
• Query response within FSSAI timelines — 15-30 day, 45 day, 30 day windows tracked strictly
• Post-approval compliance advisory — 12 months included in End-to-End package
• Honest timeline commitment — 60-120 working days realistic estimate, no false promises
• Appeal support — for rejected applications, 30-day appeal preparation
18. Frequently Asked Questions
19. Book Regulatory Consultation
Product Approval via ePAAS is technically complex, financially significant, and time-critical. Getting the strategy right upfront determines whether your product reaches market in 6 months or 12+ months.
• For single product launch: 45-minute regulatory strategy consultation covering product classification, evidence gap analysis, timeline projection, and filing roadmap.
• For multi-product portfolio (nutraceutical brand planning): Strategic session covering sequential PA approach, ingredient sourcing consistency, and portfolio-level regulatory strategy.
• For rejected applications requiring appeal: Urgent consultation — appeals must be filed within 30 days of rejection letter.
• For foreign manufacturers/importers: Coordinated ReFoM + PA + Central License + IEC strategy session.
FSSAI Product Approval
CA Pre-reviewed dossier filing for Nutraceuticals, Novel Foods & Non-Specified Products.
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