The Food Safety and Standards Authority of India (FSSAI) has issued an order exempting foods intended for specific nutritional purposes (Category 13) from the definition of proprietary foods. Foods in Category 13 must either meet standards in relevant regulations or seek product approval under the FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. Additionally, a review found some Category 13 licenses had been incorrectly granted as proprietary foods in the past, so FSSAI directed that Category 13 be excluded from proprietary foods going forward and licenses be updated accordingly.

1. Category 13: 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”.

2. 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.