The Food Safety and Standards Authority of India (FSSAI) on October 12, 2022, issued the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022 to further amend the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.
The following amendments have been stated:
• For regulation 4, relating to the „Procedure for grant of prior approval‟ the following has been substituted, namely: -
“4. Procedure for grant of prior approval. - (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 shall scrutinize the application and information provided by the applicant and on preliminary scrutiny, deficiencies, if any, shall inform the applicant within a period of forty-five days from the date of receipt of the application.
(3) The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required.
(4) The Food Business Operator shall submit the information sought for within a period of thirty days from the issuance of the letter. Provided that the Food Authority may, for reasons to be recorded in writing, extend the timeline beyond thirty days.
(5) The Food Authority may appoint an expert committee or panel to examine the application submitted by the Food Business Operator.
(6) The Food Authority may either grant approval or reject the application, as per FORM-II, on the basis of the safety assessment of the article of food.
(7) After the approval of the product by the Food Authority, the Food Business Operator shall conduct and provide a 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) The Food Business Operator may file an appeal before the Chief Executive Officer of the Food Authority against any decision of rejection of application within a period of thirty days of the receipt of rejection letter and the Chief Executive Officer shall dispose off such appeal within a period of thirty days of its receipt and any delay beyond this shall be allowed with reasons to be recorded in writing. Provided that the Chief Executive Officer may allow the appeal after the period of thirty days if there are sufficient cause for the delay.
(9) A Food Business Operator, who is aggrieved by the decision of the Chief Executive Officer of the Food Authority may file a review petition to be placed for consideration of the Chairperson of the Food Authority, within a period of thirty days from the date of issue of appellate order and such review shall be disposed off within a period of thirty days of its receipt and any delay beyond this shall be allowed with reasons to be recorded in writing. Provided that the Chairperson may allow the appeal after the period of thirty days if there are sufficient cause for the delay.
(10) The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.
(11) The Food Authority may review from time to time, the amount of fee for filing an application and the fees paid by the applicant for processing of application shall not be refunded under any circumstances.
(12) The Food Business Operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (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 received regarding safety of any product approved by the Food Authority under these regulations.
(14) If a Food Business Operator has reason to believe that the food for which the approval has been granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall Procedure) Regulations, 2017.
FORM – I specifies the Application for approval of non-specified food and food ingredient.
FORM-II specifies Approval/Rejection
Annexure A specifies a Format for providing a summary of data for safety.
Annexure B specifies a Format for providing a summary of data for health benefit claims.
[Notification No. Std/EC/T(NSF-01)]
