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FSSAI Labeling Requirements for Infant Formula in India

Ensuring the safety and quality of infant formula is paramount for the health and development of infants. In India, the Food Safety and Standards Authority of India (FSSAI) has established rigorous labeling requirements for infant formulas to ensure that parents and caregivers have all the necessary information to make informed choices. This blog explores the detailed labeling requirements that must be adhered to by manufacturers and sellers of infant formulas:

FSSAI Labeling Requirements for Infant Formula in India

General FSSAI Labeling Requirements for Infant Formula in India

All infant nutrition products must comply with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, along with specific regulations. Key labeling requirements include:

  • A statement, "IMPORTANT NOTICE : MOTHER’S MILK IS BEST FOR YOUR BABY," must be included in capital letters with text no smaller than five millimeters on the front of the package. The color of the text must contrast with the background. In cases where infant food is designed for special medical purposes and breastfeeding is medically contraindicated due to specific diseases, disorders, or medical conditions, the labeling requirement stating "MOTHER’S MILK IS BEST FOR YOUR BABY" is not required.

  • Use and Preparation Instructions: A statement that the product should be used only on the advice of a health worker.

  • A warning that the product is not the sole source of nourishment.

  • Detailed instructions for preparation, including hygiene precautions, such as:

"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."

  • Nutritional Information: The approximate composition of nutrients per 100 grams or 100 milliliters, including energy value.

  • Specific storage instructions, such as "Store in a cool and dry place in an airtight container."

  • Feeding Chart and Directions: Instructions for using a measuring scoop and the quantity per scoop.

  • Directions for discarding leftover feed.

  • Product Identification and Safety: Batch number, manufacturing date, expiry date, or recommended last consumption date.

  • Warnings about allergenic ingredients and inherent contamination risks, such as:

"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."

  • Restrictions on Imagery and Claims: No images of infants or women are allowed.

  • Prohibited terms include "Humanised," "Maternalised," "Full Protein Food," "Energy Food," "Complete Food," or "Health Food."

  • Milk Content Declaration: Products without milk or milk derivatives must be labeled "Contains no milk or milk products or milk derivatives."

Specific FSSAI Labeling Requirements for Infant Formula in India

The specific labeling requirements for different types of infant formulas as mandated by FSSAI.

Lactose-Free Infant Milk Substitutes

Lactose-free infant milk substitutes are designed for infants with lactose intolerance. The FSSAI has specific labeling requirements for these products to ensure they are used appropriately:

  • Lactose-free Label: The container must prominently display "LACTOSE-FREE" in capital and bold letters.

  • Medical Advisory Warning: A statement, "RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY," must be included in capital and bold letters.

  • Lactose-free infant milk substitute shall only be used in case of diarrhoea in infants due to lactose intolerance.

  • The lactose-free infant milk substitute shall be withdrawn if there is no improvement in symptoms of intolerance.

Hypoallergenic Infant Milk Substitutes

For infants with milk allergies, hypoallergenic formulas are essential. The labeling requirements for these products are as follows:

  • No Milk Declaration: Products containing no milk or milk derivatives must be labeled "CONTAINS NO MILK OR MILK PRODUCTS" conspicuously.

  • Hypoallergenic formula Label: The container must indicate "HYPOALLERGENIC FORMULA" along with the statement "RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" in capital and bold letters.

Foods for Infants with Inborn Errors of Metabolism (IEM)

Infants with specific metabolic disorders require special formulas. The labeling for these products must include:

  • Special Medical Purpose Declaration: The words "FOOD FOR SPECIAL MEDICAL PURPOSE" must be printed in capital and bold letters next to the product name or brand.

  • Medical Advisory Warning: An advisory stating "RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY" must be prominently displayed in capital and bold letters, separate from other information on the label.

Infant Milk Substitute for Preterm Babies

Preterm infants have unique nutritional needs. The labeling requirements for formulas designed for them include:

  • Preterm Baby Statement: The label must include a statement, "FOR THE PRETERM BABY (BORN BEFORE 37 WEEKS)," in capital and bold letters along with the product name.

  • Medical Advisory Warning: The statement "RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" must be included in capital and bold letters.

Adhering to FSSAI labeling requirements is crucial for ensuring the safety, quality, and appropriate use of infant formulas. These guidelines help parents and caregivers make informed choices while ensuring that the products meet the highest standards of safety and nutrition. By following these regulations, manufacturers can contribute to the healthy growth and development of infants in India.

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