FSSAI has notified regulations for approval of ‘non-specified’ food products through the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022 – as reported in fnbnews.

Read: October 2022 Issue of Food InfoTech Magazine.

In this regard, the regulation fixes the timeline for an appeal by the food businesses against the decision of rejection of their applications.

The regulations say that 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 30 days of the receipt of rejection letter and the Chief Executive Officer shall dispose off such appeal within a period of 30 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 30 days if there is sufficient cause for the delay.

Further, the Food Business Operator, who is aggrieved by the decision of the Chief Executive Officer of the Food Authority may file a review petition before the Chairperson of the Food Authority, within a period of 30 days from the date of issue of appellate order and such review shall be disposed off within a period of 30 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 30 days if there is sufficient cause for the delay.

These regulations specify the procedure for grant of prior approval and prescribe the ‘Form-1’ for the approval. And the Food Authority has asked food businesses to provide post-market surveillance data on the ‘non specified’ food products after getting approval.

“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,” reads the regulations notified by the FSSAI.

The Form-1 requires the food businesses to detail out the type of food (whether it was novel food product, novel food ingredient or processed using novel technology), additive not listed by the FSSAI, new processing aid/enzyme, or new botanical, new fruit, probiotic & prebiotic, or any other.

To get approval, food businesses are required to submit all the necessary documents describing the safety of the ‘product’ within 30 days, if clarification was sought by the authority.

Also, the FBOs need to submit the functional benefits of the product like health benefits, if claimed with support documents including scientific studies comprising human intervention studies or human clinical studies.

According to the FSSAI, novel food is a food that may not have a history of human consumption; or may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.

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