The Complete Document Checklist for FSSAI Non-Specified Food (NSF) Approval

Understanding Form I and Form II

Parameter	Form I — Application form	Form II — Approval/ Rejection
Nature	Application form prescribed under the NSF Regulations	Format used by FSSAI for communicating approval or rejection
Purpose	Submission of an application for prior approval of a Non-Specified Food or Food Ingredient	Communication of the Food Authority’s decision after scientific evaluation
Applicable For	Novel foods, novel food ingredients, additives, processing aids, enzymes, probiotics, prebiotics, new botanicals and other categories specified under Form I, as applicable	All applications submitted under Form I
Submitted By	Manufacturer or importer seeking prior approval	Issued by the Food Authority
Stage of Use	At the time of application	After completion of regulatory review
Fee	₹50,000+ GST(non-refundable)

The Master Document Checklist — All 8 Sections

#	Document	Applicable To	Critical Notes
SECTION A — APPLICANT & GENERAL INFORMATION
A1	Completed Form I — filed via e-PAAS portal	All applicants	Prescribed application format under Regulation 4(1). Ensure all applicable sections are completed accurately.
A2	Payment confirmation — ₹50,000 + GST	All applicants	Non-refundable.
A3	Applicant details	All applicants	Name of applicant, authorised person, contact number, email ID, organisation name and registered office address as prescribed in Form I
A4	Manufacturing/processing premises details	All applicants	Name, address and contact details of the manufacturing or processing premises.
A5	Licence number (if applicable)	Applicants holding FSSAI licence	Mention the licence number, if available.
A6	Nature of business	All applicants	State whether the applicant is a manufacturer, importer or other Food Business Operator, as applicable.
A7	Relationship agreement between applicant and other entities	All applicants	Where the proposed product involves a manufacturer, marketer, importer or repacker other than the applicant, submit the agreement establishing the relationship between the entities.
SECTION B — PRODUCT / INGREDIENT IDENTITY DOCUMENTS
B1	Product name and proposed food category	All applicants	The product name, justification (where applicable) and proposed food category should be clearly identified in Form I.
B2	Source of ingredient(s)	All applicants	Declare whether ingredients are of botanical, animal, microbial or chemical origin. Scientific names should be provided where applicable.
B3	Complete product formulation with all ingredients, concentrations, and functions	All applicants	Every ingredient must be listed with % w/w. No ‘proprietary blend’ masking.
B4	Manufacturing / production process description with flow diagram	All applicants	Include extraction, concentration, purification steps. Novel technology products must justify each step.
B5	Intended use, functional purpose, target population, format (capsule / powder / liquid) and proposed conditions of use	All applicants	Clearly describe intended use, target consumers, proposed use level and any relevant directions for use.
B6	End-use declaration (for ingredients/premixes supplied to other FBOs)	All applicants	Must be evidence-based. Overstated dosages trigger rejections.
B7	Microbial identity and source information	Applications involving microorganisms	Include genus, species, strain, source, culture collection details and safety declaration as applicable under Form I.
B8	Proposed India-compliant label / draft label	All applicants	Must comply with FSS (Labelling & Display) Regulations 2020. No unapproved claims.
SECTION C — CERTIFICATE OF ANALYSIS & ANALYTICAL DATA
C1	Certificate of Analysis (CoA) from NABL/ ILAC accredited laboratory-accredited or internationally recognised laboratory	All applicants	Must cover all parameters below. Preferably from an ISO/IEC 17025 accredited lab.
C2	Nutritional composition — macronutrients, micronutrients, active ingredient content per serving / per 100g	All applicants	Method reference (AOAC/ISO/Codex) must be stated for each parameter.
C3	Contaminants and Safety Testing	All applicants	Heavy metals, pesticide residues, microbiological parameters, mycotoxins and other relevant contaminants, as applicable.
C4	Stability data — shelf life under proposed storage conditions	All applicants	Real time or accelerated stability studies required”
SECTION D — SAFETY, TOXICOLOGY & CLINICAL DATA
D1	Safety information / Risk assessment	All applicants	Submit safety information based on published literature (indexed journals) and/or safety studies conducted on the product or ingredient. Safety summaries should be prepared in the format prescribed in Annexure A.
D2	Toxicological studies	All applicants	Where toxicity studies are available or generated by the applicant, provide supporting reports. Depending on the product, these may include acute, sub-chronic or other toxicological investigations.
D3	Human safety information	Where applicable	For novel foods, include available human studies addressing dietary exposure, nutritional impact and consumer safety.
D4	Genotoxicity and specialised toxicology	All applicants	Where relevant, provide available studies such as Ames test, chromosomal aberration studies, reproductive toxicity or prenatal developmental toxicity as prescribed in Form I.
D5	Allergenicity assessment	Where applicable	Provide published or unpublished reports on allergenicity or adverse effects associated with consumption, including information from WHO or other recognised food safety agencies where available.
SECTION E — HISTORY OF CONSUMPTION & INTERNATIONAL REGULATORY STATUS
E1	History of safe use documentation — which countries, how long, estimated population exposed	All applicants	Strongest dossier element. If product has 20+ years safe use in US/EU/Japan, document this comprehensively.
E2	GRAS (Generally Recognized as Safe) determination — FDA GRAS Notice	US-origin or US-approved ingredients	GRAS Notice number + FDA non-objection letter preferred.
E3	International regulatory approvals	Where available	Include approvals, notifications or safety evaluations issued by recognised regulatory authorities to support the application.
E4	Scientific opinions from recognised organisations	Where available	Include evaluations published by internationally recognised scientific or regulatory organisations where relevant to the product.
SECTION F — SCIENTIFIC LITERATURE & EVIDENCE SUMMARY
F1	Comprehensive literature review — published peer-reviewed studies on safety and efficacy	Where available	Include in-vitro, in-vivo and human studies relevant to the application. Health benefit studies should be summarised in Annexure B, where applicable.
F2	Full-text copies of key cited studies (not just abstracts)	All applicants	Panel may request studies not submitted. Proactively include all cited literature.
F3	Executive summary of safety dossier — structured scientific narrative, 5–10 pages	All applicants	This is what the Panel reads first. Quality of summary significantly influences review speed.
F4	Risk characterisation document — hazard identification, exposure assessment, risk characterisation narrative	All applicants	Structured per Codex risk analysis framework. Demonstrates regulatory sophistication.
SECTION G — LABELLING & CLAIMS DOCUMENTS
G1	Draft India-compliant label — all panels, including ingredient list, nutritional information, allergen declaration	All applicants	Must comply with FSS (Labelling & Display) Regulations 2020 and FSS (Advertisement & Claims) Regulations 2018.
SECTION H — POST-MARKET COMMITMENTS (SUBMITTED AT FILING)
H1	Declaration to conduct post-market surveillance	Where indicated in Form II	Form I requires the applicant to provide a declaration to conduct and submit post-market surveillance data in specific cases where indicated in Form II.
H2	Declaration regarding confidentiality	All applicants	Declaration that the information submitted in Form I shall be treated as confidential.

How CliniExperts Can Help

CliniExperts provides end-to-end regulatory support for NSF applications, including feasibility assessment, dossier gap analysis, preparation and review of Form I, compilation of scientific and safety documentation, label and claim review, e-PAAS submission support, and preparation of responses to regulatory queries. Our objective is to help Food Business Operators develop scientifically robust and regulatory-compliant dossiers that facilitate efficient review by the Food Authority.