FSSAI Proposed Draft Regulations For Foods For Infant Nutrition

FSSAI proposed a draft related to standards of foods for infant nutrition through a notification dated 27^th December 2017. This draft describes in detail the regulations to be followed by different categories of infant foods.

Although each category of Infant Food has different specifications, some generalised requirements are applied to almost all of them. These requirements should be followed by manufacturers of food for infant nutrition to get approval from the FSSAI. The generalized requirements for ease of understanding have been listed in the new regulations as following:

(1) 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 & Labelling) Regulations, 2011, so as to protect the contents from deterioration. It shall be packed in an inert atmosphere.

(2) The category ‘infant formula for special medical purposes’ provided under these regulations shall be exempted from provisions specified under Regulation 2.4 of the Food Safety and Standards (Packaging and Labelling) Regulations, 2011. Further, a warning shall be declared on the label if any ingredients with known allergenicity are present.

(3) The categories ‘infant formula for special medical purpose’ and ‘food for infants based on traditional food ingredients’ provided under these regulations shall conform to the microbiological standards for milk and milk products of category infant formula as provided under Appendix B of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

(4) A variation of ± 5.0% of the declared values of the added ingredients due to analytical variations shall be allowed.

(5) 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.

(6) Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) from Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkenia sp. at the level of maximum 0.5% 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% of total fatty acids, if a claim related to the addition of DHA is made.

Provided further that infant milk substitutes for premature infants shall contain not less than 0.2% DHA of total fatty acids and ratio of ARA:DHA as 1:1 minimum.

(7) No person shall manufacture, sell, store, or exhibit for sale infant milk food, infant formula and milk cereal-based complementary food, processed cereal-based complementary food, and follow-up formula, except under the Bureau of Indian Standards (BIS) certification mark.

Provided that the category ‘infant formula for special medical purpose’ provided under these regulations shall be exempted from the above provision.

(8) Food for infant nutrition except in the category of special medical purpose shall also comply with the requirements of the ‘Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 as amended in 2003 (IMS Act)’

As per the current regulations of FSSAI, the standards for Infant foods have been specified in the FSSRs (Food Products Standards & Food Additives) as category 2.1.9 Foods for Infant Nutrition. The proposed standards have the detailed requirements that specifies 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 Purpose (FSMP)
• Premature Infant Milk Substitute
• Lactose-free – Lactose and sucrose free – and sucrose free – Infant milk substitutes
• Hypoallergenic infant milk substitutes
• Foods for Infants with Inborn Errors of Metabolism (IEM)
• Food for Infant based on Traditional food ingredients

Wherever required, specific packaging and labelling guidelines have also been mentioned for the above categories. This detailed information in the new draft may simplify process for the manufacturers to follow the regulations, but as the guidelines are quite vast and also keep on updating, so it is difficult for the manufacturers to comply with them. FSSAI is a very strict authority and even a small deviation from their rules and regulations may cause rejection of the food product, wasting all the efforts of the manufacturer. Expert guidance is the best way to ensure smooth approval process. The experts know every guideline, regulation and procedure for approval of all the food categories. They will guide you at each and every step to avoid any rejections or delayed approvals. So it is advisable to take services of the experts and get approval of your food product as early as possible.

Reference

• FSSAI WTO-SPS Notifications draft notification related to the standards of Foods for Infant Nutrition. (Uploaded on: 27.12.2017)- https://www.fssai.gov.in/dam/jcr:0c893922-b961-4439-b1d0-d8da47f7f36c/Draft_WTO_TBT_Notification_Food_Infant_Nutrition_27_12_2017.pdf