Nutritional Use of Proprietary Food is Blocked by the FSSAI.


The Food Safety and Standards Authority of India (FSSAI) has issued an order exempting Food Category ‘13', which refers to foods intended for specific nutritional purposes, from the definition of proprietary foods. According to the order, FBOs must apply for product approval for Category 13.

'Proprietary Food' is specified in sub-regulation 2.12 of the Food Safety and Standards (Food Products Standards and Food Additives Regulations) of 2011 as - an article of food that has not been standardized under these regulations, but does not include novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals, health supplements and such other food articles which the Central Government may notify in this behalf.

The order released by FSSAI says, “Since the FC 13 broadly covers Infant food products and products covered under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, therefore, it is inferred that the products covered under all the sub-categories under the Food Category 13, i.e., Foodstuffs intended for particular nutritional shall either have to comply with the standards set out in the respective regulations or have to seek product approval under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. Hence, all such products cannot be licensed as Proprietary Foods in any case”.

Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Use, Functional Food, and Novel Food) Regulations, 2016 broadly cover infant food products. Foodstuffs intended for specific nutritional purposes, as defined by all subcategories of Food Category 13, must either meet the requirements set forth in the regulations or apply for product approval under the FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. In any case, such items cannot be certified as Proprietary Food.

The current FLRS database was examined, and it was discovered that a few category 13 licenses had been granted as Proprietary Foods. To avoid inadvertent mistakes, and in light of the importance of food category 13 and the existing legislation, it has been agreed to exclude “food category 13” from the scope of Proprietary Foods under FoSCOS for the time being.

The FSSAI also directed the Central Licensing Authorities to recognize any licenses issued previously under Proprietary Food with FC 13 and advise such FBOs to get them suitably updated under FoSCOS without any modification fee until June 30, 2021. With immediate effect from November 6, 2020, all Food Business License holders who come under Food Category 13 must comply with the new FoSCOS guidelines.

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