The order reads, “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”.
FSSAI reasoned that the Food Safety and Standards (Food Products Standards and Food Additives Regulations), 2011, under its Sub-regulation 2.12 defines ‘Proprietary Food’ as an article of food that has not been standardised 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.
Further, the Sub-regulation 2.4.1 (1) under FSS (Packaging and Labelling) Regulations, 2011, also states that an article of infant milk substitutes /infant foods, whose standards are not prescribed under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, shall be manufactured for sale, exhibited for sale or stored for sale, only after obtaining the approval of such articles of food and its label from the Authority.
Meanwhile, the order also says that under FoSCoS, the Category 13 will remain blocked for proprietary food product applications.
An official with the FSSAI informed that the existing database under FLRS was reviewed and it was found that a few licences under Category 13 have been issued as Proprietary Foods. The order says, “In order to prevent inadvertent errors and considering the sensitivity of the Food Category 13 and aligned law already in place, it has been decided to presently block Food Category 13 from the scope of Proprietary Foods under FoSCOS,”.
The Central Licensing Authorities were also directed by the FSSAI to identify such licences granted earlier under Proprietary Foods with FC 13 and advise such FBOs to get them suitably modified under FoSCOS without any modification fee up to June 30, 2021