Infant Formula explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulations 4 to 6 of the Foods for Infant Nutrition Regulations, 2020 set the label for every infant food (an "IMPORTANT NOTICE" block with required statements), ban pictures and certain words, allow only listed additives and no preservatives, colours or flavours, and tie hygiene to the Licensing Regulations and a Codex code.
The text is read as amended up to 30 August 2022 (FSSAI Compendium Version II dated 04.01.2024). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. Brands can have a pack reviewed through our FSSAI label compliance service.
Every container must show the words "IMPORTANT NOTICE" in capital letters with the statements in regulation 4(1), including a mother's-milk statement in capitals of not less than five millimetres on the front of the pack. No picture of an infant or a woman may appear. Only additives listed in the Regulations may be used, and no preservatives, added colours or flavours.
Regulation 4: labelling
The opening words of regulation 4 say the labelling shall be in accordance with the Labelling and Display Regulations, 2020 (a substitution made in the compendium for the earlier Packaging and Labelling Regulations, 2011) and the specific requirements in these Regulations.
Regulation 4(1): the "IMPORTANT NOTICE"
Without prejudice to other labelling provisions, every container or its label shall indicate, in a clear, conspicuous and easily readable manner, the words "IMPORTANT NOTICE" in capital letters, with the following particulars underneath:
| Clause | Particular |
|---|---|
| (a) | A statement in capital letters, in letters not less than five millimetres, on the front of every pack, that mother's milk is the preferred feed for the baby (the exact wording is printed in the Regulations); the colour of the text must differ from the background. For infant food, a statement that infant food shall be introduced only after the age of six months and up to the age of two years. A proviso: for food for special medical purpose intended for infants where breastfeeding is contraindicated on medical grounds, the mother's-milk statement is not required |
| (b) | 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 use |
| (c) | A warning that infant milk substitute or infant food is not the sole source of nourishment of an infant |
| (d) | A statement on appropriate and hygienic preparation, including cleaning of utensils, bottles and teats, and warning against hazards of inappropriate preparation (see below) |
| (e) | The approximate composition of nutrients per 100 gm or 100 ml, including energy value in kilo calories or kilo joules |
| (f) | The storage condition, 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) |
| (g) | The feeding chart and directions for use, and instruction for discarding leftover feed |
| (h) | Instruction for use of the measuring scoop (level or heaped) and the quantity per scoop (scoop to be given with pack) |
| (i) | Batch number, month and year of manufacture, use by date or Recommended Last Consumption date or expiry date |
| (j) | The protein efficiency ratio (PER), which shall be minimum 2.5, if a product other than infant milk substitute is claimed to have higher quality protein |
| (k) | The specific name of the food additives and appropriate class titles, if permitted |
The preparation statement in clause (d) is printed as: "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."
Regulation 4(2) to 4(6)
- 4(2) No container or label shall have a picture of an infant or women or both. It shall not have pictures, graphic materials or phrases designed to increase the saleability of the infant milk substitute or infant food. The terms "Humanised" or "Maternalised" or similar words shall not be used. The package shall not exhibit "Full Protein Food", "Energy Food", "Completer Food" or "Health Food" or any similar expression.
- 4(3) A product that contains neither milk nor any milk derivative shall be labelled "Contains no milk or milk products or milk derivatives" in a conspicuous manner.
- 4(4) Where the words "unsuitable for babies" are required, there shall be a surrounding line enclosing the declaration, and the distance between any part of those words and the line shall not be less than 1.5 mm.
- 4(5) A warning relating to allergens, if any ingredient with known allergenicity is present.
- 4(6) A warning against inherent contamination: "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".
The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 is named in regulation 3(8); it is not explained here.
Regulation 5: food additives
Regulation 5(1) says food for infant nutrition shall contain no preservatives, added colours or flavours. Regulation 5(2) says only the food additives listed under these Regulations shall be used. Articles of food may contain carry over food additives, subject to compliance with clause 3.1.1(10) of the Food Products Standards and Food Additives Regulations, 2011. Each product regulation lists its own additives; the next articles show the structure.
Regulation 6: hygiene
The products shall be prepared and handled in accordance with Schedule IV of the Licensing and Registration of Food Businesses Regulations, 2011 and the Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (CAC/RCP 66-2008) specified by the Codex Alimentarius Commission. The Schedule 4 hygiene rules are in the live Licensing Regulations articles; the Codex text is only named in the Regulations.
Notified change from 1 July 2027
The Labelling and Display First Amendment Regulations, 2026 (notified 24 March 2026, in force 1 July 2027) insert a second proviso in regulation 5(3)(b)(iv) of the Labelling and Display Regulations: "Provided further that per serve percentage (%) contribution to Recommended dietary allowances (RDA) and number of servings per pack may not be given for Infant Nutrition products as defined under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020." Until that date, the existing text of the Labelling and Display Regulations applies to infant foods. See our article on regulation 5(3) nutritional information and the definitions and general requirements of the Labelling and Display Regulations.
An invented example
Tiny Steps Foods prepares a label for a follow-up formula. The front carries the "IMPORTANT NOTICE" block with the mother's-milk statement in capitals not less than five millimetres, the six-months statement, the health-worker statement and the preparation warning. The designer proposes a smiling baby photo and the phrase "Complete Health Food". Regulation 4(2) bars both, so the artwork is changed to a plain graphic and the phrase is dropped. The product has no milk, so the label also carries the statement in regulation 4(3).
Need help with an infant food label?
Infant labels combine a fixed notice block, restricted words and pictures, and the general Labelling and Display rules. Our FSSAI label compliance team can check artwork against regulation 4 and the product standard before printing.
Key takeaways
- The "IMPORTANT NOTICE" block with the regulation 4(1) statements goes on every container or label.
- Pictures of infants or women, and words such as "Humanised", are barred (regulation 4(2)).
- No preservatives, added colours or flavours; only listed additives (regulation 5).
- Hygiene follows Schedule IV of the Licensing Regulations and a Codex code (regulation 6).
- A 2026 amendment to the Labelling and Display Regulations, in force 1 July 2027, adds a proviso for infant nutrition products.
Read next
- Regulation 3: general requirements
- Regulation 7: infant formula standard
- Regulation 5(3): nutritional information on labels
- Infant food and baby food standards: an overview
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.