FSSAI Product Approval for Non-Specified and Proprietary Foods: 2026 Checklist
PhD, FRSC · Head of Regulatory Affairs & Nutrition Science, Food Research Lab
✓ Technically reviewed by the FRL Formulation & Regulatory Panel · Last reviewed: 24 October 2026 · Next review: April 2027
24 October 2026
Last checked
24 October 2026
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9 min
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- Non-specified foods and ingredients (novel foods, new additives and processing aids, microbial foods) need FSSAI’s prior approval before manufacture or import.
- Standardised and proprietary foods need only a licence; nutraceuticals and other Category 13 products can never be licensed as proprietary.
- File Form I and the fee on ePAAS; the licence that follows is applied for on FoSCoS.
- The 2025–26 Citizen’s Charter lists 4–6 months and ₹50,000 plus GST; the regulations add 45-day and 30-day clocks but no overall deadline.
- Most delays come from the wrong route or a thin safety dossier, so settle both at the prototype stage.
What Is FSSAI Product Approval?
Standardised, proprietary and non-specified foods
Every food sold in India falls into one of three regulatory positions, and the position decides whether you need prior approval.
- Standardised food: meets a standard prescribed by FSSAI. It needs a licence, not product approval.
- Proprietary food: an article of food that is not standardised, under regulation 2.12.1 of the Food Products Standards and Food Additives Regulations, 2011. The definition excludes novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals, health supplements and other articles the government notifies.[2] It is licensed, not approved.
- Non-specified food: any food or food ingredient, other than proprietary food, for which no standard exists.[1] It needs FSSAI’s prior approval before manufacture or import.
Since FSSAI’s order of 6 November 2020, products in Food Category 13 (foodstuffs for particular nutritional uses) cannot be licensed as proprietary foods; they must meet the standards of their own regulation or obtain product approval.[3]
When product approval is required
Regulation 3(1) of the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 bars the manufacture or import of any non-specified food or food ingredient without prior approval.[1] FSSAI’s 2017 notification lists the main groups: novel foods and ingredients, new additives, new processing aids including enzymes, and foods made from or isolated from microorganisms, bacteria, yeast, fungi or algae.[4]
The regulations replaced an advisory-based product approval system. That system stopped after the Supreme Court, on 19 August 2015, dismissed FSSAI’s appeal against a Bombay High Court ruling that the advisories lacked legal backing; FSSAI then needed regulations to approve products.[4] The current text includes the First Amendment Regulations, 2022, which rewrote the approval procedure in regulation 4.[1] For a short background note, see our earlier note on non-specified food approval.
Non-Specified Food (NSF) Approval Explained
What counts as a non-specified food
The test is regulatory status, not recipe novelty. A bar built only from permitted ingredients and additives within their category limits stays proprietary; the same bar with an ingredient that has no standard and no approval becomes non-specified. FSSAI decides each application after a safety assessment and may refer it to an expert committee or panel.[1]
Novel foods, nutraceuticals and new ingredients
Form I describes a novel food as one that may not have a history of human consumption, or that contains an ingredient or source without such history, or that is made by a new technology that may significantly change its composition, structure, size, nutritional value, metabolism or level of undesirable substances.[1] For more on the definition, see how FSSAI defines novel food.
Nutraceuticals and health supplements are not automatically non-specified. FSSAI’s 2020 order says Category 13 products must comply with the standards of their own regulation or obtain product approval, and FoSCoS now blocks them from being licensed as proprietary food.[3] In practice, a supplement built from ingredients listed in the nutraceutical regulations is licensed under those regulations; one using an unlisted ingredient needs NSF approval first. Our guide to FSSAI rules for dietary supplements covers that route. Foods for special medical purposes have their own approval, with a Citizen’s Charter timeframe of 9–12 months.[5]
Formulation decisions that change the route
Many approval files start as formulation choices. Three checks made at the prototype stage can avoid a filing, or make one inevitable:
- Ingredient status: if one ingredient has no standard and no approval, the whole product needs NSF approval. Swapping it for a listed equivalent can keep the product proprietary or within its own standard, at the cost of re-checking taste, stability and cost.
- Additives: proprietary foods may use only the additives permitted for their food category, at the levels in Appendix A of the 2011 regulations, and the label must state the category.[2] An additive outside that list moves the product towards approval.
The 2026 Compliance Checklist
Documents and the ingredient safety dossier
This checklist follows Form I as amended in 2022.[1] Check each item against the current Gazette text before filing.
Table 1. FSSAI product approval: required documents and safety dossier
| Item | What to prepare |
|---|---|
| Product and sourcing | Applicant, licence and premises details; product category; ingredients and their sources[1] |
| Analysis and process | Certificate of analysis from a laboratory accredited by NABL or an ILAC-member body (physical, chemical and microbiological parameters); manufacturing flow sheet[1] |
| Safety dossier | Published studies from indexed journals, plus studies run to OECD guidelines or Schedule Y of the Drugs and Cosmetics Rules, 1945; evidence of no adverse effect on pregnant or lactating women, children, the elderly or other vulnerable groups[1] |
| Toxicity design | Acute study showing safety at 2 g/kg or at least ten times the intended human exposure; long-term studies at three dose levels (intended exposure, average and high) with a vehicle control[1] |
| Claims and label | Scientific support for any health-benefit claim under the Advertising and Claims Regulations, 2018; proposed prototype label[1] |
| Declarations | Undertaking to provide post-market surveillance data; confidentiality declaration[1] |
The safety dossier is where most of the work sits: if the indexed-journal evidence does not cover the intended dose and population, plan the toxicity studies before filing rather than after a deficiency notice.
Filing on ePAAS, then licensing on FoSCoS
- Confirm the route. Check the food category, any applicable standard and the proprietary-food exclusions before spending on a dossier.[2][3]
- Build the dossier. Compile the safety, analysis and process documents in Table 1.[1]
- File Form I and pay the fee on ePAAS. FSSAI made its ePAAS portal mandatory for these applications from 1 October 2022.[6]
- Answer deficiencies. FSSAI must point out deficiencies within 45 days of receiving the application. Where it asks for further documents or clarification, you have 30 days to reply, which FSSAI may extend for reasons recorded in writing.[1]
- Receive the Form II decision. FSSAI grants or rejects the application after its safety assessment. A rejection can be appealed to the Chief Executive Officer within 30 days, and the CEO decides within 30 days; a further review lies with the Chairperson on the same timescale.[1]
- Apply for the licence on FoSCoS. Approval is followed by a licence under the Licensing and Registration of Food Businesses Regulations, 2011,[1] which FSSAI administers through its FoSCoS portal.[3]
Common Reasons Approvals Are Delayed or Rejected
In FRL’s experience, most delays trace back to the route or the dossier rather than to review capacity. Table 2 maps the common causes to what the rules require.
Table 2. Common FSSAI approval delays: causes and corrective actions
| Cause | What the rules show | Fix |
|---|---|---|
| Wrong route | Category 13 products cannot be licensed as proprietary; earlier licences had to be modified[3] | Confirm the category and standard before building the file |
| Thin safety data | Form I asks for indexed-journal studies and defined toxicity designs[1] | Close dossier gaps, or commission studies, before filing |
| Novelty not evidenced | Novel food status turns on history of human consumption[1] | Document use history or run the studies |
| Unaccredited analysis | The certificate of analysis must come from an NABL- or ILAC-accredited laboratory[1] | Test at an accredited laboratory |
| Unsupported claim | Health-benefit claims need scientific support under the 2018 claims regulations[1] | Remove the claim or substantiate it |
| Slow replies | A 30-day reply window applies to FSSAI’s requests[1] | Prepare answers to likely questions in advance |
Timelines, Fees and What to Expect
FSSAI’s Citizen’s Charter 2025–26 lists approval of non-specified foods and food ingredients at 4–6 months and ₹50,000 plus GST, filed through ePAAS.[5] The regulations themselves set no overall decision deadline. They fix 45 days for FSSAI’s deficiency notice, 30 days for your reply to a request for information, and 30-day windows for appeal and for the appellate decision.[1] The fee can be revised by FSSAI and is not refunded under any circumstances.[1]
The charter figure is a service standard, not a guarantee: deficiency rounds and expert-committee referrals extend it. Check the current fee and timeframe on FSSAI’s portal before you budget, because the charter is revised each year.
Post-Approval Compliance and Labelling
Approval is not permission to sell. You must then obtain a licence.[1] Proprietary foods skip approval and go straight to licensing and labelling.
- Post-market data: you must supply post-market surveillance data on safety and efficacy within one year of launch whenever FSSAI asks.[1]
- Suspension and recall: FSSAI may suspend or revoke an approval for reasons recorded in writing. If you find the product may pose a health risk, you must stop manufacture, import and sale, recall it under the Food Recall Procedure Regulations, 2017 and inform FSSAI.[1]
- Labelling: the Labelling and Display Regulations, 2020 require the date of manufacture or packing and the expiry or use-by date, with storage conditions where validity depends on them.[7]
The regulations call the outcome an approval in Form II, not a ‘No Objection Certificate (NOC)’.
Regulatory note: verify before you file. Clause numbers, fees and timeframes in this article come from FSSAI’s 2022 compendium of the regulations and the 2025–26 Citizen’s Charter. FSSAI amends regulations and revises its charter, so check the current Gazette and portal before filing.
Conclusion
The route decides the workload. A product that meets a standard, or qualifies as proprietary, needs a licence and a compliant label. A product with an unapproved ingredient, additive or processing aid needs a Form I dossier, an ePAAS filing and a 4–6 month charter timeframe before it can be licensed. Settle the route at the prototype stage, while swapping an ingredient is still cheaper than filing for it.
For Brands & Formulators
If you are launching a novel ingredient, a nutraceutical or a new additive in India, FRL can confirm the route and close the dossier gaps before you file.
- Route check: category, standard, proprietary-food exclusions and Category 13 status for your exact formulation.
- Dossier gap review: indexed-journal evidence, toxicity design, accredited analysis and claim support against Form I.
- Reformulation options: where an ingredient or additive triggers approval, test listed alternatives through food product development or nutraceutical product development.
Start with FRL’s regulatory and scientific research service, or contact the team to scope a route review. For an international comparison, see the EU novel food authorisation pathway.
- ✓Map every ingredient and additive against its standard, the nutraceutical schedules and the Appendix A category limits.
- ✓Decide the route at prototype stage: standardised, proprietary, own-regulation (nutraceutical, FSDU, FSMP) or non-specified.
- ✓If approval is needed, audit the safety evidence against Form I and the Annexure A toxicity design before filing.
- ✓Book accredited analysis (NABL or ILAC) and prepare a prototype label and claim support.
- ✓Get a route review from FRL’s regulatory and scientific research team.
Which foods need FSSAI product approval?
What is the difference between proprietary and non-specified food?
What documents are needed for FSSAI product approval?
Form I with the fee, a certificate of analysis from an NABL- or ILAC-accredited laboratory, a manufacturing flow sheet, a safety dossier, claim support and a prototype label, plus post-market and confidentiality declarations.[1] Gaps in the safety data are the usual trigger for deficiency notices.
How long does FSSAI product approval take?
Where do I apply for FSSAI product approval?
On FSSAI’s ePAAS portal, which has been mandatory for these applications since 1 October 2022.[6] The licence that follows approval is applied for on FoSCoS.
- Food Safety and Standards Authority of India. (2022). Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017: Compendium incorporating the First Amendment Regulations, 2022 (Version I, 14 October 2022). https://fssai.gov.in/upload/uploadfiles/files/Compendium_FSS_NFS_FA_17_10_2022.pdf (cited for the regulation 3 prohibition, the regulation 4 procedure and day counts, fees, appeals, post-market duties, licensing, and the Form I dossier and toxicity requirements)
- Food Safety and Standards Authority of India. (n.d.). Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, regulation 2.12: Proprietary food. https://www.fssai.gov.in/upload/uploadfiles/files/13_%20Chapter%202_12%20(Proprietary%20Food).pdf (cited for the proprietary food definition and exclusions, Appendix A additive limits, and treatment of added ingredients in standardised foods)
- Food Safety and Standards Authority of India. (2020, November 6). Order: Exclusion of Food Category 13 (foodstuffs intended for particular nutritional uses) from the scope of proprietary foods. https://www.fssai.gov.in/upload/advisories/2020/11/5fa5386d5d07cOrder_Category_13_Proprietary_Foods_06_11_2020.pdf (cited for Category 13 products not being licensable as proprietary food and the FoSCoS block)
- Food Safety and Standards Authority of India. (2017, September 11). Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017: Notification and press note. https://cdd.fssai.gov.in/viewFile.php?id=33 (cited for the 2017 scope (novel foods, new additives, processing aids, microbial foods) and the link to the 2015 Supreme Court order)
- Food Safety and Standards Authority of India. (2025). Citizen’s Charter 2025–2026. https://fssai.gov.in/upload/6a4373a9408c6citizen_charter_2025-26.pdf (cited for the 4–6 month timeframe, ₹50,000 + GST fee and ePAAS portal for NSF approval, and the 9–12 month FSMP timeframe)
- Food Safety and Standards Authority of India. (2022, August 31). Notice: Online submission of applications under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 through the ePAAS portal. https://fssai.gov.in/upload/advisories/2022/08/630f48113a0e3Notice_ePAAS_31_08_2022.pdf (cited for mandatory ePAAS filing from 1 October 2022)
- Food Safety and Standards Authority of India. (2025). Food Safety and Standards (Labelling and Display) Regulations, 2020: Compendium (Version VIII, 9 September 2025). https://fssai.gov.in/upload/uploadfiles/files/Comp_Labelling%20Display_Version%20VIII_09_09_2025.pdf (cited for date-marking and storage-condition labelling requirements)
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