If your product, or an ingredient in it, has no standard laid down by FSSAI, it needs prior approval under the FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 before you manufacture, import or sell it. This covers novel foods, new ingredients, and foods made with new processing technology. Assuming no approval is needed, or filing a weak dossier, is how launches slip by many months.
We confirm whether your product genuinely needs this route, compile the Form I dossier, file it on FoSCoS, and manage the scientific-panel queries that decide most applications, through to the Form II grant.
Who is this service for?
- Brands launching a novel or first-of-its-kind formulation in India
- Manufacturers and importers using an ingredient with no Indian standard
- Companies whose product uses a new processing technology
- Businesses whose earlier non-specified application was returned with queries or rejected
What is included?
- Applicability assessment: whether the product needs non-specified approval or fits an existing category
- Form I dossier compilation: composition, history of use, safety data, process, specifications and intended use
- Filing and submission management on the FoSCoS portal
- Scientific-panel and additional-data query handling
- Follow-through to the Form II decision and compliant-launch guidance
How does the process work?
- 1Product and formulation review with an applicability opinion
- 2Dossier compilation against the 2017 regulations
- 3Form I filing and submission tracking
- 4Query and scientific-panel management until decision
Which documents will you need?
- Full quantitative formulation with ingredient sources
- Ingredient specifications and certificates of analysis
- Safety and history-of-use evidence for the food or ingredient
- Intended use, target category and proposed conditions of use
How long does it take?
9 to 12 months
Applicability assessment is typically completed within a week or two. The approval itself is a scientific-panel process and runs in months, commonly in the range of 9–12 months, which is why the dossier has to be right the first time. We set a realistic expectation per application at scoping.
How long is it valid?
A Form II approval is granted for the specific food or ingredient, the composition and the conditions of use set out in your Form I. A change to the composition or to the conditions of use can take the product outside what was approved, and the approval does not replace the licence and labelling the product still needs.
Common mistakes we correct
- Selling first and seeking approval only after a marketplace or FSO challenge
- Assuming an ingredient permitted abroad is automatically permitted in India
- A safety dossier built on marketing material rather than primary evidence
- Choosing the non-specified route when the product actually fits a specified category, or the reverse
Frequently Asked Questions
What is the difference between Form I and Form II?
Form I is the application you file: the safety dossier and supporting documents submitted to the Food Authority for a non-specified food or ingredient. Form II is the approval the Food Authority grants after its scrutiny and scientific-panel review. In short, you file Form I and you receive Form II.
When does a product need non-specified food approval?
When it, or an ingredient in it, is not standardised under any FSSAI regulation: a novel food, a new or unscheduled ingredient, or a food made with a new manufacturing technology. Products that fit a specified category need correct licensing and labelling but not this separate approval. Our assessment tells you definitively.
Can I sell the product while the application is pending?
No. Approval under the 2017 regulations is a prior requirement, so manufacture, import or sale must wait until the Form II grant is issued. Sequencing your launch around that timeline is part of the engagement.
Regulations that apply
- FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017
- FSS (Health Supplements, Nutraceuticals…) Regulations: category and ingredient rules
- FoSCoS portal (foscos.fssai.gov.in): application filing