FSSAI Product Approval for Non-Specified Foods
FSSAI product approval is the prior permission you need before making, importing or selling a food or ingredient that has no standard under Indian food regulations. It covers novel foods, new additives, new processing aids and enzymes. We assess whether your product needs it, compile the Form I application and follow it through to a decision.
What it is
Most foods sold in India fit an existing standard. Paneer has one. So do biscuits, fruit juice and edible oil. Others are not standardised but are made only from ingredients and additives that are already permitted; these are proprietary foods. A third group fits neither box. That third group is “non-specified food”, and it needs FSSAI’s approval before it reaches the market.
The power comes from Section 22 of the Food Safety and Standards Act, 2006, which bars making, selling or importing novel foods, functional foods, health supplements and similar products except as the Act and its regulations allow. The process sits in the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, notified on 11 September 2017 and amended on 11 October 2022. Approval is applied for in Form I and granted or refused in Form II.
Who it applies to
You make a novel food
Foods or ingredients with no history of human consumption in India, or made with a new technology, such as a new plant protein or a food produced by fermentation.
You use a new additive or enzyme
An additive, processing aid or enzyme that is not listed in the Food Safety and Standards regulations.
Your ingredient comes from microbes or algae
Food articles and ingredients made from or isolated from micro-organisms, bacteria, yeast, fungi or algae, where no standard exists.
Why it matters
Your licence cannot cover it otherwise
A food business licence covers products the law already recognises. An unapproved non-specified product cannot simply be added to your licence or label.
Imports need it
Imported food must meet FSSAI’s standards. For a novel ingredient with no standard, the Form II approval is the document that shows it is permitted.
It keeps the product on shelves
Selling first and applying later exposes you to penalties under the FSS Act and to product withdrawal.
Documents required
About the applicant
- Valid FSSAI licence of the manufacturer or importer
- Company or firm registration papers
- Authorisation for the signatory
About the product
- Full composition with the quantity of each ingredient
- Specifications of the novel ingredient or additive
- Manufacturing process flow chart
- Proposed label and intended use
- Test reports from an NABL or ILAC-accredited laboratory
Safety evidence
- History of consumption, in India or abroad
- Regulatory status in other countries
- Toxicology and safety studies, where needed
- Published scientific literature
Standardised, proprietary or non-specified?
| Standardised food | Proprietary food | Non-specified food | |
|---|---|---|---|
| What it is | Has a set standard in FSSAI regulations | No product standard, but every ingredient and additive is permitted | A food or ingredient with no standard at all |
| Example type | Ghee, bread, packaged water | A new snack blend from approved ingredients | A novel protein or a new enzyme |
| Prior approval | Not needed | Not needed | Needed (Form I) |
| Route to market | FSSAI licence | FSSAI licence, with labelling rules | Approval first, then licence |
Here is the catch: many products that look new turn out to be proprietary foods. Take a Faridabad snack maker launching a millet bar with jaggery and seeds. Every ingredient is already permitted, so it needs a licence, not an approval. Swap in a new sweetener that is not on the permitted list, and the answer changes.
How it works
Check whether approval is needed
We match every ingredient and additive against FSSAI’s standards and permitted lists. Sometimes the answer is no.
Assemble the safety dossier
Your technical team and accredited labs supply the safety and composition data. We organise it into the Form I structure and spot gaps before FSSAI does.
File Form I and pay the fee
We submit the application to FSSAI with the ₹50,000 non-refundable fee.
Answer queries within 30 days
FSSAI completes a preliminary scrutiny within 45 days and flags gaps. You have 30 days to reply, and we draft the responses.
Receive the decision in Form II
The Food Authority approves, usually with conditions, or rejects with reasons. Then the product is added to your licence.
Timelines
Preliminary scrutiny
FSSAI scrutinises the application and points out deficiencies within 45 days of receipt.
Your reply
You must furnish additional information within 30 days of the request. The authority can extend this for reasons recorded in writing.
After approval
Post-market surveillance data on safety and efficacy is due within one year of placing the product on the market.
What happens if you sell without approval
Up to ₹3 lakh for misbranding
Section 52 of the FSS Act: up to ₹3 lakh where the product or its label is found misbranded.
Up to ₹2 lakh for other breaches
Section 58: up to ₹2 lakh where the Act or regulations are breached and no separate penalty is provided.
Prison risk without a licence
Running a food business without a valid licence attracts up to six months’ imprisonment and a fine up to ₹5 lakh under Section 63.
Frequently asked questions
What is a non-specified food under FSSAI rules?
It is any food, other than a proprietary food, or any food ingredient, additive, processing aid or enzyme for which no standard has been specified. The Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 govern it. Novel foods, new additives and ingredients drawn from micro-organisms or algae are typical examples. We review your formula and tell you which category it falls in before any fee is paid.
What is the government fee for FSSAI product approval?
The fee is ₹50,000 for each application, paid when Form I is filed. It is non-refundable, even if the application is rejected or withdrawn. That is why classification comes first. The regulations let the Food Authority review the fee from time to time. We confirm the current amount at filing and quote our own fee separately before we start.
Does a proprietary food need product approval?
No. A proprietary food is excluded from the definition of non-specified food. It has no product standard of its own, but every ingredient and additive in it must already be permitted. It goes straight to licensing and must follow the labelling rules. Many products that look new qualify as proprietary foods, which saves both time and the ₹50,000 fee. We check this for you.
How long does FSSAI product approval take?
The regulations fix the early steps: FSSAI scrutinises the application within 45 days, and you get 30 days to answer queries. The final decision follows scientific review and has no fixed day count, so an ingredient with thin data can take many months. A complete dossier with test reports and safety data shortens the wait. We file only when the dossier is complete.
What if FSSAI rejects my application?
You can appeal to the Chief Executive Officer of FSSAI within 30 days of the rejection letter, and the appeal is to be disposed of within 30 days. If that fails, a review lies with the Chairperson within 30 days of the appellate order. The rejection letter in Form II gives reasons, so you know what to fix. We draft the appeal around those reasons.
Can an importer apply for product approval?
Yes. Importers of novel foods and ingredients apply in the same way as manufacturers. Every food importer also needs a central FSSAI licence, so the licence and the approval should be planned together. Safety data from the overseas manufacturer and the product’s status abroad form a large part of the dossier. In practice, a Delhi NCR importer of a novel plant-protein isolate spends most of the effort getting the supplier’s data into shape. We coordinate with your supplier to collect it.
Do I need an FSSAI licence before applying?
Usually yes. The application is made by a food business operator, and an existing licence is part of the standard document set. After approval, the product is added to your licence under the Licensing and Registration Regulations. Since 1 April 2026, licences issued are valid without a renewal date, provided the annual fee is paid. We can set up or modify the licence alongside the approval.
Is there anything to do after approval?
Yes. The regulations require post-market surveillance data on safety and efficacy within one year of placing the product on the market. You must also follow every condition written into the Form II approval, including any limits on use or labelling. We set reminders and prepare the submission, so the year-one filing goes in on time.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
The government fee for an approval application in Form I is ₹50,000, non-refundable. Laboratory testing and any safety studies are billed separately by the laboratories that carry them out.
Our role and yours
We handle classification, the Form I application, the document file, query replies, appeals and liaison with FSSAI. Testing and safety studies come from accredited laboratories and your food technologists; we do not run a lab. Once approved, we update your central FSSAI licence or state FSSAI licence and can help you protect the brand through trademark registration.
Ready to begin?
Send us your formula. We will tell you if it needs FSSAI approval before you spend ₹50,000 finding out.