The FSSAI has issued an order dated 06th November 2020 related to the Exclusion of Food Category “13” (Foodstuffs intended for particular nutritional uses) from the scope of Proprietary Foods.
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 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.
Further, the sub-regulation 2.4.1 (1) under Food Safety and Standards (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.
Since the Food Category 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, in view of the above, it is inferred that the products covered under all the sub- categories under the Food Category 13, i.e. Foodstuffs intended for particular nutritional uses shall either have to comply with the standards set out in the respective regulations or have to seek product approval under Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations 2017. Hence, all such products cannot be licensed as Proprietary Foods in any case.
The existing database under FLRS was reviewed and it has come to notice that a few licenses under category 13 have been issued as Proprietary Foods. 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.
Henceforth category 13 shall not be indicated under Proprietary Foods in FoSCoS. Since the change in FoSCoS is likely to take a few days’ time the Central Licensing Authorities are requested to inform and advise all such food business operators who apply for Food Category 13 under the Proprietary Category suitably. In case any such product is noticed, which merits Food Category 13 under Proprietary as per law, the same may be informed to the Regulatory Compliance Division of the FSSAI.
Further the FSSAI has directed all Central Licensing Authorities to identify such licenses granted under Proprietary Foods with Food Category 13 and advice such FBOs to get them suitably modified under FoSCoS (without any modification fee up to 30 June 2021)
The FSSAI has also directed further to ensure compliance of the above guidelines for all such prospective licenses with effect from date of issue of this order. In case of any difficulty in the implementation of this order, it must be brought to the notice of the Executive Director. Regulatory Compliance Division.
Foods under food Category 13 as mentioned in (Food Products Standards and Food Additives Regulations), 2011 are as under
13.0 Foodstuffs intended for particular nutritional uses
13.1 Infant formulae, follow-up formulae, and formulae for special medical purposes for infants
13.1.1 Infant formulae
13.1.2 Follow-up formulae
13.2 Complementary foods for infants and young children
13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1)
13.4 Dietetic formulae for slimming purposes and weight reduction
13.5 Dietetic foods (e.g., supplementary foods for dietary use) excluding products of food categories 13.1 -13.4 and 13.6
13.6 Food supplements
