Form I explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Form I is the application for approval of a non-specified food or food ingredient. It has a category choice, general information in 24 numbered items, additional information by category, and Annexures that set formats for summarising safety data and health-benefit claim data. Form II is the Authority's decision. This article describes the headings, not each field.
This article reads the text as amended up to 11 October 2022 (FSSAI Compendium Version I dated 14.10.2022). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
Form I, referred to in regulation 4(1), asks the applicant to tick one category: novel food, additive, new processing aid or enzyme, or non-specified food. It then asks for general information, a certificate of analysis from a third-party laboratory accredited by NABL or ILAC, safety information, claim support documentation, a prototype label, and declarations on post-marketing surveillance and confidentiality; Annexures A, I and B set the summary formats. Form II records approval or rejection. Applicants are manufacturers and importers of new foods and ingredients. For help see food product approval support.
Form I: the category choice
Form I is headed "Application for approval of non-specified food and food ingredient" and refers to sub-regulation (1) of regulation 4. Item 1 asks the applicant to tick only one:
| Category | Sub-options as printed |
|---|---|
| Novel food | novel food product; novel food ingredient; processed using novel technology |
| Additive | not listed in the Food Safety and Standards Regulations (FSSR) |
| New processing aid or enzyme | not listed in FSSR |
| Non-specified food | new botanical; new fruit or fruit based product; probiotic and prebiotic; any other, to be specified |
Two notes follow. Data in item 3(d) must be submitted if the application pertains to any of these categories and consists of or is isolated from microorganisms. A second note says that, for these regulations, "novel food" is a food that may not have a history of human consumption, or may have an ingredient or source without such a history, or a food or ingredient obtained by new technology with an innovative engineering process that may give rise to significant change in composition, structure or size and may alter nutritional value, metabolism or level of undesirable substances.
For the novel food route in general, see the topic post on the novel food approval process; for genetically modified food, see GM food regulations and approval.
Item 2: general information, by heading
The 24 numbered items of item 2 cover:
- the applicant, authorised person, contact details, organisation and address, and licence number if any (items 1 to 7), with a note that all communications will be made only through the stated e-mail and phone number;
- the manufacturing premises, nature of business, product name with justification, and proposed product category (items 8 to 12);
- source of the ingredient (animal, chemical, botanical or micro-biological), with genus and species where relevant (items 13 and 14);
- functional benefits, with health benefits claimed and an end-use declaration for pre-mixes or ingredients supplied to other food business operators (item 15), for which the form asks for formulation data and an undertaking;
- a certificate of analysis from a third-party laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or the International Laboratory Accreditation Cooperation, covering physical, chemical and microbiological parameters with validated methods (item 16);
- the manufacturing process in brief, as a flow sheet (item 17);
- regulatory status in other countries, with the level and purpose of consumption and documentary evidence (item 18);
- agreements between the applicant, manufacturer, marketer, importer or re-packer (item 19);
- safety information, summarised in Annexure A (item 20), including evidence about specific population groups such as pregnant women, lactating mothers, children and the elderly;
- claim support documentation, summarised in Annexure B, as provided in the Advertising and Claims Regulations, 2018 (item 21);
- a copy of the proposed prototype label (item 22);
- a declaration to conduct and provide post marketing surveillance data in specific cases indicated in Form II (item 23); and
- a declaration to keep the information shared in Form I confidential (item 24).
Item 3: additional specific information
| Part | Subject | Headings printed |
|---|---|---|
| (1) | novel food, novel food ingredient or food processed with novel technology | target group; detailed composition; details of new technology; safety information (human studies, toxicology, allergenicity); history of consumption (geographical area, quantity, duration) |
| (2) | new additives | chemical name and International Numbering System number; purity; Acceptable Daily Intake; proposed level of use; colour number for colouring agents |
| (3) | new processing aids including enzymes | specification; enzyme activity; purity; residual limit in the final product |
| (4) | articles consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae | a numbered data table on the microbe: nature, name (genus, species, strain), source, culture collection details, material transfer agreement, genetic manipulation, safety status and declaration |
An invented example: Haritha Foods plans a new fruit-based product for which no standard exists. It ticks "non-specified food" and "new fruit or fruit based product", fills item 2 including a certificate of analysis from a laboratory with the stated accreditation, attaches the flow sheet and prototype label, and summarises its safety studies in Annexure A.
The Annexures
Annexure A: summary of data for safety
A format for summarising safety data: in-vitro data (test product, system used, controls, biomarkers, observations, laboratory or reference) and a summary of in-vivo safety (pre-clinical toxicology) investigations, with rows for acute toxicity, long term toxicity and special tests. A note says the operator need not submit in-vitro details if in-vivo data is provided.
Annexure I: guidance notes to the safety summary
Annexure I explains how to fill the in-vitro and in-vivo summaries, with sub-headings on the material tested, concentrations, outcomes, references, the test compound profile and exposure level, acute toxicity and long term toxicity.
Annexure B: summary of data for health benefit claims
Annexure B has four formats for health-benefit claims, under the headings 1A in-vitro data, 1B in-vivo data, 1C meta-analyses and 1D human study data, each with instructions. Part 2 covers claims that are not health-benefit claims, under the headings: claims pertaining to bioavailability, comparative content claims, stability or reduction in degradation during cooking or processing, claims related to adherence or sticking of cooking medium to the food processed, retention of aroma or taste, and others. Part 3 asks for the nature of any intellectual property rights and any regulatory approval in other nations, in a summary table.
Form II: approval or rejection
Form II, referred to in regulation 4(6), is headed "(Approval/Rejection)". It records the application number and date, the organisation, the applicant, the registered office, the authorised person, the food product name and category, the composition (ingredients and food additives with INS number and limits), the application status "Approved/Rejected", conditions for approval and reasons for rejection, over the signature of an authorised signatory. Conditions in Form II are what an operator must follow after approval; the procedure around it is in our article on the approval procedure under regulation 4.
Where this sits
The scope of the Regulations is in our article on regulations 1 to 3. Applications now go through the ePAAS single window under an FSSAI office order of 6 May 2026; the forms and formats remain those of these Regulations unless a relevant regulation says otherwise.
Need help with the dossier?
The dossier is the largest part of an approval application, and gaps are usually found at scrutiny rather than at filing. Our food product approval service helps applicants plan the dossier headings, collect the studies and prepare the summaries.
Key takeaways
- Form I starts with one of four categories: novel food, additive, new processing aid or enzyme, or non-specified food.
- Item 2 has 24 items, including a third-party certificate of analysis, safety information, claim support, a prototype label and two declarations.
- Item 3 adds data for novel foods, additives, processing aids and microorganisms.
- Annexures A, I and B set the formats for safety and claim summaries.
- Form II records approval or rejection with conditions or reasons.
Read next
- Regulations 1–3: non-specified food and prior approval
- Regulation 4: approval procedure
- GM food regulations and approval process
- Novel food approval process under FSSAI
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.