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FSS (Foods for Infant Nutrition) Regulations

General requirements:

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.

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).

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.

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.

Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic acid (ARA) from Crypthecodiniumcohnii, Mortierellaalpina, chizochytrium
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.

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.

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.

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.

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.

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

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

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.

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

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.

Food Additives:

1. Food for infant nutrition shall be free from preservatives, added colours and flavours.
2. Only the food additives listed under these regulations shall be used in the foods covered under these regulations. The articles of food may contain carry over food additives subject to compliance with the provisions specified under 3.1.1 (10) of Food Safety and standards (Food products Standards and Food Additives) Regulations, 2011.

Hygiene:

The product covered under these regulations shall be prepared and handled in accordance with the requirement specified in Schedule-IV of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 and Code of Hygienic Practice for Powdered Formulae for Infants and Young Children specified by Codex Alimentarius Commission.

Lactose free infant milk substitutes:

1. In addition to the nutrient requirements specified for Infant formula (except milk fat) and follow-up formula lactose free infant milk substitute shall also meet the following requirements:
   1. Soy-protein based, lactose free formula shall have soy protein and glucose, dextrose, dextrin/maltodextrin, maltose and/ or sucrose as carbohydrates.
   2. Lactose-free cow/buffalo milk-based formulas shall have carbohydrate as glucose, dextrose, dextrin/maltodextrin, maltose and sucrose. It may also contain caseinates, milk protein concentrates, isolates and hydrolysates.
   3. Lactose content shall not exceed 0.05 per cent by weight.
   4. The fat content derived from vegetable oils shall not be less than 18 per cent by weight.
2. The container of infant milk substitute for lactose intolerant infants or label affixed thereto shall indicate conspicuously “LACTOSE-FREE” in capital and bold letters.
3. An advisory warning “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” shall appear on the label in capital and bold letters. The label shall also bear the following statements, namely: –
   1. “Lactose free infant milk substitute shall only be used in case of diarrhoea in infants due to lactose intolerance”
   2. “The lactose free infant milk substitute shall be withdrawn if there is no improvement in symptoms of intolerance”.

Hypoallergenic infant milk substitutes:

1. In addition to the nutrient requirements specified for infant formula and follow-up formula except for milk fat and milk protein, the hypoallergenic infant milk substitutes shall also meet the following requirement:
   1. Protein used shall be extensively hydrolysed whey protein or casein or contain only free amino acids.
2. The product which contains neither milk nor any milk derivatives shall be labelled “CONTAINS NO MILK OR MILK PRODUCTS” in conspicuous manner.
3. The container of infant milk substitute meant for infants with allergy to cow / buffalo/other milch animal (as specified under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011) milk protein shall indicate conspicuously “HYPOALLERGENIC FORMULA” and statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital and bold letters on the label.

Foods for Infants with Inborn Errors of Metabolism (IEM):

A food for infant with IEM is a food which is formulated or processed to be consumed orally or administered enterally through a tube and is intended for the specific dietary management of a disease or a condition with distinctive nutritional requirements, based on well-established scientific principles, studies and medical evaluation.

It is specially processed and formulated with nutrients desirable for the infant suffering from a specific IEM. The product shall exclude the ingredients/nutrients that are harmful to the diseased infant. The essential characteristic involves a specific modification of the content or nature of proteins, fats or carbohydrates.

It is intended for the dietary management of an infant who, because of therapeutic or chronic needs has restricted, limited or impaired capacity to ingest, digest, absorb or metabolize ordinary foodstuffs or infant formula or certain nutrients or who needs specific nutrients established by medical observations.

Such foods fulfill unique nutritional needs of the infant with IEM through specific modifications or alterations and processing of the food components.

The Food Authority shall specify the IEM conditions as approved by it after undertaking proper scientific evaluation. No food business operator shall manufacture, sell, market, or import products for IEM conditions except those specified by the Food Authority from time to time.

Labelling of the food for infant nutrition: 

It shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, and the specific labelling requirements provided under these regulations.

Without prejudice to any other provisions relating to labelling requirements contained in these regulations, every container of products covered under these regulations or any label affixed thereto
shall indicate in a clear, conspicuous and in an easily readable manner, the words “IMPORTANT NOTICE” in capital letters and indicating thereunder the following particulars, namely: –

• a statement “MOTHER’S MILK IS BEST FOR YOUR BABY” in capital letters. The types of letters used shall not be less than five millimetres and the text of such statement shall be in the front of the pack of every container of food for infant nutrition or any label affixed thereto. The colour of the text printed or used shall be different from that of the background of the label, container as the case maybe. In case of infant food, a statement indicating “Infant food shall be introduced only after the age of six months and up to the age of two years” shall also be given.
  • Provided that in case of food for special medical purpose intended for infants where breastfeeding is contraindicated on medical grounds for the disease(s), disorders(s) or medical condition(s) for which the product is intended, the labelling provision “MOTHERS’ MILK IS BEST FOR YOUR BABY” shall not be required.
  • a statement that infant milk substitute or infant food shall be used only on the advice of a health worker as to the need for its use and the proper method of its use;
  • a warning that Infant milk substitute or infant food is not the sole source of nourishment of an infant; a statement indicating instruction for appropriate and hygienic preparation including cleaning of utensils, bottles and teats and warning against health hazards of inappropriate preparations, as under;
    • Warning/Caution-Careful and hygienic preparation of infant foods or infant milk substitute is most essential for health. Do not use fewer scoops than directed since diluted feeding will not provide adequate nutrients needed by your infant. Do not use more scoops than directed since concentrated feed will not provide the water needed by your infant.
  • the approximate composition of nutrients per 100 gm or 100 ml of the product including its energy value in kilo calories or kilo joules;
  • the storage condition specifically stating “Store in a cool and dry place in an air tight container” or the like (after opening use the contents within the period mentioned or the expiry date whichever is earlier);
  • the feeding chart and directions for use and instruction for discarding leftover feed;
  • instruction for use of measuring scoop (level or heaped) and the quantity per scoop (scoop to be given with pack);
  • indicating the Batch number, Month and Year of its manufacture, Use by date or Recommended Last Consumption date or Expiry Date;
  • the protein efficiency ratio (PER) which shall be minimum 2.5, if the product other than infant milk substitute is claimed to have higher quality protein;
  • the specific name of the food additives and appropriate class titles, if permitted, shall also be declared;
• No containers or label of food for infant nutrition shall have a picture of infant or women or both. It shall not have picture or other graphic materials or phrases designed to increase the saleability or the infant milk substitute or infant food. The terms “Humanised” or “Maternalised” or any other similar words shall not be used. The package and/or any other label of infant milk substitute or infant food shall not exhibit the words, “Full Protein Food”, “Energy Food”, “Completer Food” or “Health Food” or any other similar expression.
• The product which contains neither milk nor any milk derivatives shall be labelled “Contains no milk or milk products or milk derivatives” in conspicuous manner.
• Declaration to be surrounded by line: There shall be a surrounding line enclosing the declaration where the words “unsuitable for babies” are required to be used. The distance between any part of the word “unsuitable for babies” surrounding the line enclosing these words shall not be less than 1.5 mm.
• A warning relating to allergen if any ingredients with known allergenicity are present;
• A warning against inherent contamination as under:
  • “Warning: Boiled and cooled water shall be used to prepare this product and any leftover product must be discarded to reduce the risk of infection”.

Download, Read & Share:

• Clarification regarding Hypoallergenic infant milk substitutes specified under FSS (Foods for Infant Nutrition) Regulations, 2020
• Order related to approved list of Inborn Errors of Metabolism (IEM) conditions as per the provision 16(1)(e) of FSS (Foods for Infant Nutrition) Regulations, 2020
• Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020

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