The Food Safety and Standards Authority of India on 11th October 2022, has published the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022, through which it has notified the Procedure for grant of prior approval to the manufacturer or importer of non-specified food.
As per the amendment, 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. 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.
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.
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. 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.
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.
Further, 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.
