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Label Compliance Guide for Infant Food Brands in India


India is host to some of the most widely recognized global brands as well as popular indigenous manufacturers in baby foods segment. While a dominant player like Nestle has multiple brands in its portfolio which include names like Lactogen, Cerelac, Nestum, Nan Pro1 and Pro2, there is growing commitment from other companies to introduce more products in this category. The competition has intensified with the entry of new players such as Mead Johnson. In fact, several market studies peg baby food to be among the fastest growing segments in Indian FMCG industry with a CAGR of more than 12%.

Quite rightly, the regulation in India for this segment is comprehensive and stringent. The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act 1992 (IMS Act) amended in 2003 has clear guidelines to the manufacturers.

Provision 6 of the IMS Act has explicit instructions for “Information on containers and labels of infant milk substitutes or infant foods.”

The words “IMPORTANT NOTICE” in capital letters is a must on every label on infant milk substitute or infant food containers. This is followed by:

  • “MOTHER’S MILK IS BEST FOR YOUR BABY” in capital letters.
  • A statement that infant milk substitutes or infant food should 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 to convey the following message – infant milk substitute or infant food is not the sole source of nourishment of an infant
  • Instructions for:
    • Appropriate preparation
    • Warning against the health hazards of its inappropriate preparation
  • Ingredients used
  • Composition or analysis
  • Storage conditions
  • Batch number
  • Date of manufacture
  • Date before which it is to be consumed taking into account climatic and storage conditions of the country

The act also clearly mentions the elements of a label that are forbidden to be present on infant milk substitute or infant food as given in the following list:

  • Should not have pictures of an infant or a woman or both
  • Should not have pictures or other graphic material or phrases designed to increase the saleability of infant milk substitute or infant      food
  • Should not have the following words:
    • Humanised
    • Maternalised or
    • Any other similar words or phrases

Breastfeeding Promotion Network of India (BPNI), a not-for-profit advocacy group dedicated to promoting mother and child health, has highlighted examples of violations of IMS Act in the following link: https://www.bpni.org/IMS-ACT/Examples-of-violation-of-IMS-Act.pdf.

The infant milk substitute and infant food manufacturers should also comply with provisions related to packaging as stipulated in the following regulations:

A. The Legal Metrology (Packaged Commodities) Rules, 2011 – pre-packaged commodities are required to comply with certain mandatory      labeling requirements w.r.t net quantity, MRP and Customer care information. PCR is harmonized with Food Safety & Standard      Regulations (FSSR) 2017.

B. “The Prevention of Food Adulteration Act, 1954 and the Prevention of Food Adulteration Rules, 1955 and its first ammendment, 2003      (PFA)”

For instance, the FSSR has the following conditions for compliance (in addition to provisions of IMS Act):

  • Warning/caution – “Careful and hygienic preparation of infant foods/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”
  • Approximate composition of nutrients per 100 gms. of the product including its energy value in Kilo Calories/Joules
  • 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)
  • 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);
  • 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 labels of infant milk substitute meant for premature baby shall contain the following additional information:
    • PREMATURE BABY (BORN BEFORE 37 WEEKS) LOW BIRTH WEIGHT (LESS THAN 2.5 KG] in capital letters along with the product name in central      panel
    • “The low birth weight infant milk substitute shall be withdrawn under medical advice as soon as the mother’s milk is sufficiently      available”
    • In capital, “TO BE TAKEN UNDER MEDICAL ADVICE”
  • The product which contains neither milk nor any milk derivatives shall be labelled “contains no milk or milk product” in conspicuous      manner
  • Infant milk substitute for lactose or lactose and sucrose intolerant infants or label affixed thereto shall indicate conspicuously      “LACTOSE-FREE or SUCROSE-FREE or LACTOSE and SUCROSE-FREE” in capital letters and statement “TO BE TAKEN UNDER MEDICAL      ADVICE” and shall also bear the following statements, namely:—“Lactose free Infant Milk Substitute should only be used in      case of diarrhea due to lactose intolerance. The lactose free/sucrose free Infant Milk Substitute should be withdrawn if      there is no improvement in symptoms of intolerance”
  • Infant milk substitute meant for infants with allergy to cow’s /buffalo’s milk protein or soy protein or label affixed thereto shall      indicate conspicuously “HYPOALLERGENIC FORMULA” in capital letters and statement “TO BE TAKEN UNDER MEDICAL ADVICE”

The prohibitions in FSSR for infant food in additon to those stipulated in IMS Act are as follows:

  • The Package and/or any other label of infant milk substitute or infant food shall not exhibit the words, “Full Protein Food”, “energy      Food”, “Complete food” or “Health Food” or any other similar expression.

It is pertinent to note here that FSSAI has granted exemptions for infant Foods for Special Medical Purposes (FSMP) in which case the label should carry “This is neither an infant milk substitute nor an infant food.”

The infant food category is also closely monitored by child nutrition and welfare organisations and any infractions on labelling requirements instantly garner unfavourable online and press coverage. Hence the manufacturers have to be constantly vigilant to ensure that they avoid litigations as well as protect brand integrity.

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