FSSAI has notified a draft regulation for infant nutrition called the Food Safety Standards (Food for Infant Nutrition) Regulations 2019, having comprehensive regulations to supersede the provisions related to the food for infant nutrition in Sub-regulations 2.1.9 of the Food Safety and Standards (Food Products and Food Additive) Regulations, 2011.  

This draft contains standards for infant formula for special medical purpose, specifically food for infants with inborn errors in metabolism (IEM).

FSSAI, in a statement, said IEM is a life-threatening special medical condition affecting thousands of infants in the country, and without these specialised diets, children suffering from IEM would not only face cognitive and physical difficulties, but in fact would not even survive.

The proposed regulations also contains standards for premature infant milk substitutes, lactose-free, lactose- and sucrose-free infant milk substitutes, sucrose-free infant milk substitutes, hypoallergenic infant milk substitutes under the infant formula for special medical purposes and food for infants based on traditional food ingredients.

The apex regulator has also clarified that food for special purposes is a separate category of food for infant nutrition, and the requirement of the Infant Milk Substitute, Feeding Bottles, And Infant Foods (Regulations Of Production, Supply And Distribution) Act, 1992, as amended in 2003 (IMS Act) would henceforth apply to these products, also except the requirement of labelling mother’s milk is best for your baby, wher breastfeeding is contraindicated on medical grounds for the diseases, disorders or medical conditions.

According to FSSAI, the draft regulation also specifies the compositional/identity standards of the infant nutrition products and also specifies the source of the permitted ingredients.

The stakeholders can also submit their comments to FSSAI on the draft till June 14, 2019.

As reported earlier, FSSAI was working on IEM products which are currently imported in India. With these standards the road to manufacture these products in India shall be cleared. Further, experts also raised concerns about big food giants misusing the regulations to sell their baby food, which is banned in India under the IMS Act.

The IMS Act provides for the regulation of production, supply and distribution of infant milk substitutes, feeding bottles and infant foods with a view to the protection and promotion of breastfeeding and ensuring the proper use of infant foods and for matters connected therewith or incidental thereto.