Regulation 4 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.
Regulation 4 is the full procedure for prior approval of a non-specified food. The manufacturer or importer applies in Form I with documents and fee, the Food Authority scrutinises the application, may ask for more material and appoint an expert committee, and either grants approval or rejects the application in Form II. The regulation also covers post-market data, appeal to the CEO, a review before the Chairperson, suspension or revocation, licensing and recall.
This article reads the text as amended up to 11 October 2022 (FSSAI Compendium Version I dated 14.10.2022). Regulation 4 was substituted by the notification of 11 October 2022. FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
The application goes in Form I. The Food Authority informs the applicant of deficiencies within forty-five days from the date of receipt, the applicant answers any request within thirty days (extendable for recorded reasons), and a rejection can be appealed to the CEO within thirty days of the rejection letter, with a review before the Chairperson within thirty days of the appellate order. The Authority may suspend or revoke an approval for reasons recorded in writing. After approval the operator must apply for a licence under the Licensing Regulations. Manufacturers and importers of new products are affected. For help see food product approval support.
One line on the ePAAS office order
An FSSAI office order of 6 May 2026 provides that applications for prior approval of this kind are made through the ePAAS single window. It is administrative and changes no word of regulation 4.
The fourteen sub-regulations
| Sub-reg. | What it says |
|---|---|
| (1) | the manufacturer or importer of non-specified food shall submit an application in Form I along with necessary documents and fee to the Food Authority |
| (2) | the Food Authority scrutinises the application and, on preliminary scrutiny, informs the applicant of deficiencies, if any, within forty-five days from the date of receipt |
| (3) | the Authority may direct the applicant to submit additional supporting documents, data or clarifications |
| (4) | the food business operator shall submit the information sought within thirty days from the issuance of the letter; a proviso lets the Authority, for reasons recorded in writing, extend the timeline beyond thirty days |
| (5) | the Authority may appoint an expert committee or panel to examine the application |
| (6) | the Authority may grant approval or reject the application, as per Form II, on the basis of the safety assessment of the article of food |
| (7) | after approval, the operator shall conduct and provide post market surveillance data on relevant safety and efficacy parameters, within one year of placing the product in the market, whenever asked by the Authority |
| (8) | appeal to the CEO against rejection within thirty days of receipt of the rejection letter; the CEO disposes of the appeal within thirty days of receipt, any delay beyond this to be allowed with reasons recorded in writing; the CEO may allow the appeal after thirty days if there is sufficient cause for the delay |
| (9) | an operator aggrieved by the CEO's decision may file a review petition for consideration of the Chairperson within thirty days from the date of issue of the appellate order; disposed of within thirty days of receipt, with delay allowed for recorded reasons; the Chairperson may allow the appeal after thirty days for sufficient cause |
| (10) | the Authority may, for reasons recorded in writing, suspend or revoke any approval granted to any operator |
| (11) | the Authority may review from time to time the amount of the fee for filing an application, and the fees paid for processing shall not be refunded under any circumstances |
| (12) | after grant of approval, the operator shall apply for a licence under the Licensing and Registration of Food Businesses Regulations, 2011 |
| (13) | the Food Safety Officer and Designated Officer shall immediately inform the Food Authority of any complaint regarding the safety of any approved product |
| (14) | if the operator has reason to believe the approved food poses a risk to health, he shall immediately suspend manufacture, import, sale or distribution and take steps to recall it, under intimation to the Authority, in accordance with the Food Recall Procedure Regulations, 2017 |
No fee amount is printed in the Regulations and none is stated here.
The stages in order
Application and scrutiny: (1) to (4)
The application in Form I goes with documents and the fee. The forty-five days in (2) run from receipt of the application and are for informing the applicant of deficiencies, not for deciding the application. If the Authority asks for more, the thirty days in (4) run from the issuance of the letter, and the Authority can extend them for recorded reasons. Form I and its attachments are described by heading in our article on Form I and the dossier.
Expert review and decision: (5) and (6)
An expert committee or panel may be appointed. The decision is "as per Form II", on the basis of the safety assessment of the article. The regulation sets no overall period for the decision itself.
After approval: (7), (12), (13) and (14)
Post-market surveillance data is due "within one year of placing the product in the market whenever asked by the Authority". The operator then needs a licence under the Licensing Regulations, which have their own posts; see regulation 2.1.2 on the licence for a food business. Sub-regulation (14) links the approval to the recall regime in our article on regulations 5 to 8 of the Food Recall Procedure Regulations.
Appeal, review and revocation: (8) to (10)
A rejected applicant has two further steps: an appeal to the CEO, and then a review before the Chairperson. Each has a thirty-day window and a thirty-day disposal period, with the delay rules in the provisos. Suspension or revocation under (10) needs recorded reasons.
An invented example: Vasudha Foods applies in Form I for approval of a new food ingredient. Within forty-five days from receipt, the Authority writes about deficiencies and asks for data. Vasudha has thirty days from the issuance of that letter to respond. The Authority appoints an expert panel and rejects the application in Form II. Vasudha appeals to the CEO within thirty days of the rejection letter. If the CEO's order goes against it, it may file a review petition for the Chairperson within thirty days from the date of issue of the appellate order.
The periods on one screen
| Step | Period as printed |
|---|---|
| Informing the applicant of deficiencies (4(2)) | within forty-five days from the date of receipt of the application |
| Reply to the Authority's letter (4(4)) | within thirty days from the issuance of the letter, extendable for recorded reasons |
| Post-market data (4(7)) | within one year of placing the product in the market, whenever asked |
| Appeal to the CEO (4(8)) | within thirty days of receipt of the rejection letter; disposal within thirty days of receipt |
| Review petition (4(9)) | within thirty days from the date of issue of the appellate order; disposal within thirty days of receipt |
Where this sits
The previous article explains what counts as non-specified food and when prior approval is required. For the practical process see how to apply for product approval under FSSAI and the product approval process.
Need help with an approval application?
Short fixed periods and a no-refund fee rule make the first application important. Our food product approval service helps manufacturers and importers prepare the dossier, answer the Authority's queries and manage appeals.
Key takeaways
- Apply in Form I with documents and fee; the Authority informs of deficiencies within forty-five days from receipt.
- Reply to queries within thirty days from the letter; the Authority may extend for recorded reasons.
- Decide by Form II after safety assessment, with an optional expert panel.
- Appeal to the CEO and review before the Chairperson, each within thirty days.
- The Authority may suspend or revoke approvals; fees paid are not refunded under any circumstances.
- After approval, apply for a licence under the Licensing Regulations.
Read next
- Regulations 1–3: non-specified food and prior approval
- Form I and Annexures: the application dossier
- How to apply for product approval under FSSAI
- Product 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.