“Food for infants based on traditional food ingredients” are products known to be prepared traditionally at home for feeding infants, but processed and provided in packaged forms, after six months up to twenty-four months of age

“Food for special medical purpose intended for infants” means a substitute for human milk or formula that is specially manufactured to meet the special nutritional requirements of infants from birth to twenty-four months with specific disorders, diseases or medical conditions.

“Follow-up formula” means a food for infants after six months up to twenty-four months of age, which is intended for use as a liquid part of the complementary diet for infants when prepared in accordance with instructions for use

“Infant Food” shall have the meaning assigned to it in clause (x) of sub-section (1) of Section 3 of the Act.

General requirements–

(1) An article of infant milk substitutes or infant foods or food for special medical purpose intended for infants, whose standards are not specified under these regulations shall be manufactured for sale, exhibited for sale or stored for sale only after obtaining approval of such article of food and its label from the Food Authority.

(2) Foods for infant nutrition shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from paper, polymer and/ or metallic film as per the Food Safety and Standards (Packaging) Regulations, 2018, so as to protect the contents from deterioration. It shall be packed under inert atmosphere. The packaging material used for products covered under these regulations shall be free from Bisphenol A (BPA).

(3) A variation of minus 10.0 per cent from the declared value of the nutrients or nutritional ingredients on the label shall be allowed. The nutrient levels shall not exceed maximum limits as specified in the composition tables.

(4) Wherever applicable, food for infant nutrition shall use the source compounds for minerals, vitamins and other nutrients from Schedule-I(a), Schedule-I(b) and Schedule-I(c), respectively provided under these regulations.

(5) Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic acid (ARA) from Crypthecodiniumcohnii, Mortierellaalpina, Schizochytrium sp., and Ulkenia sp. or fish oil at the level of maximum 0.5 per cent. DHA of total fatty acids and ratio of ARA:DHA as 1:1 minimum.

Provided that DHA content shall not be less than 0.2 per cent of total fatty acids, if a claim related to the addition of DHA is made.

Provided further that Infant Milk substitutes for preterm infants shall comply with requirements specified under the standards.

(6) Lactose and glucose polymers shall be the preferred carbohydrates for food for infant nutrition. Sucrose and/or fructose shall not be added, unless needed as a carbohydrate source, and provided the sum of these does not exceed 20 per cent of total carbohydrate.

(7) Food for infant nutrition shall be free from lumps and coarse particles, and shall be uniform in appearance. It shall be free from rancid taste and musty odour.
Provided that milk cereal based complementary food and processed cereal based complementary food may be in the form of small granules and flakes forms.

(8) Food for infant nutrition shall comply with the requirements of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992(42 of 1992) as amended in 2003 including aspect related to advertisement, marketing and promotion of Food products covered under these regulations in accordance with the section 3, 4, 5, 7, 8, 9 and 10 of the said Act.

(9) Food for infant nutrition shall comply with the requirements of the Legal Metrology (Packaged Commodities) Rules, 2011 except for the requirement of standard pack size as per the second schedule of the aforesaid rules in case of food for special medical purpose intended for infants.

(10) Food for infant nutrition shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

(11) Food for infant nutrition shall conform to the Food Safety and Standards (Prohibition and Restriction of Sales) Regulation, 2011.

(12) Food for infant nutrition shall conform to the microbiological requirements specified under Appendix B of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

(13) Advertisements and claims of products covered under these regulations shall be in accordance with the Food Safety and standards (Advertising and Claims) Regulations, 2018

(14) Wherever nutritional composition has been specified in 100 gm or 100 kcal basis under specific product categories in the composition tables, the FBO’s shall comply with the nutrition composition in either per 100 gm or per 100 kcal basis.