Infant formula in India: FSSAI proposes regulations for products with special medical purposes
The draft details more comprehensive regulatory measures as an update to the existing 2011 regulations, covering standards for infant formula for special medical purposes, particularly food for infants with inborn errors of metabolism (IEM).
While most nutritional products for infants with IEM are imported into India, the FSSAI's proposed regulatory changes would make it possible for such products to be manufactured locally.
The proposed standards contain detailed requirements that specify the scope, composition, and food additives for each of the following categories:
- Infant milk food
- Infant formula
- Milk cereal-based complementary food
- Processed cereal-based complementary food
- Follow-up formula
- Infant formula for special medical purposes
- Premature infant milk substitute
- Lactose-free and / or sucrose-free infant milk substitutes
- Hypoallergenic infant milk substitutes
- Foods for infants with IEM
- Food for infants based on traditional food ingredients
Standards and exemptions
In the draft, the FSSAI stated that while foods for infant nutrition must be packed in "hermetically sealed, clean, and sound containers or in flexible packs made from paper, polymer, and / or metallic film", infant formula for special medical purposes "shall be exempted" from provisions specified under the same regulations.
The regulatory body went on to state that the categories 'infant formula for special medical purposes' and 'food for infants based on traditional food ingredients' "shall conform to the microbiological standards for milk and milk products in the category of infant formula".
It also laid out standards for ingredient sources, saying that foods for infant nutrition may contain algal and fungal oil as sources of DHA and ARA — with Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkenia sp. among the approved sources — at a maximum level of 0.5% DHA of total fatty acids, and a minimum 1:1 ratio of ARA to DHA.
The FSSAI added that this was "provided that DHA content shall not be less than 0.2% of total fatty acids, if a claim related to the addition of DHA is made", and that infant milk substitutes for premature infants contain not less than 0.2% DHA of total fatty acids and a minimum 1:1 ratio of ARA to DHA.
It further said: "No person shall manufacture, sell, store, or exhibit for sale infant milk food, infant formula, milk cereal-based complementary food, processed cereal-based complementary food, and follow-up formula, except under the Bureau of Indian Standards (BIS) certification mark."
Once again, the infant formula for special medical purposes category as specified by the draft regulations is exempt from this provision.
In light of concerns that companies have been exploiting regulatory loopholes to market baby food — an activity banned under the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act or IMS Act — the FSSAI also included a standard specifically targeting such activity.
It stated: "Food for infant nutrition, except in the category of special medical purposes, shall also comply with the requirements of the IMS Act 1992."
Industry stakeholders can submit their comments regarding the draft regulations to the FSSAI until June 14, 2019.