Hypoallergenic Infant 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 14 to 16 cover three specialised groups: infant milk substitutes for lactose-intolerant infants (regulation 14), hypoallergenic infant milk substitutes for infants allergic to milk protein (regulation 15) and foods for infants with inborn errors of metabolism, or IEM (regulation 16). All are for use on medical advice, and each has fixed label statements.
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. Producers of these specialised foods can see our central FSSAI licence page.
A lactose-intolerance formula must not exceed 0.05 per cent by weight of lactose, with vegetable-oil fat not less than 18 per cent by weight. A hypoallergenic formula uses extensively hydrolysed whey protein or casein, or amino acids alone, and is labelled "HYPOALLERGENIC FORMULA". IEM foods may be made only for conditions the Food Authority specifies, and carry "FOOD FOR SPECIAL MEDICAL PURPOSE".
Regulation 14: infant milk substitutes for lactose intolerance
Regulation 14 deals with the formula for infants who cannot tolerate lactose, called here the lactose-intolerance formula. Regulation 14(1) adds requirements to the nutrient requirements for infant formula (except milk fat) and follow-up formula:
- (a) A soy-protein based formula for lactose intolerance shall have soy protein, and glucose, dextrose, dextrin/maltodextrin, maltose and/or sucrose as carbohydrates.
- (b) A cow or buffalo milk-based formula for lactose intolerance shall have carbohydrate as glucose, dextrose, dextrin/maltodextrin, maltose and sucrose. It may also contain caseinates, milk protein concentrates, isolates and hydrolysates.
- (c) Lactose content shall not exceed 0.05 per cent by weight.
- (d) The fat content derived from vegetable oils shall not be less than 18 per cent by weight.
Regulation 14(2) requires the container or label to indicate conspicuously, in capital and bold letters, the Regulations' prescribed statement that the product has no lactose.
Regulation 14(3) requires an advisory warning "RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY" in capital and bold letters, and two statements: the product shall be used only in case of diarrhoea in infants due to lactose intolerance, and it shall be withdrawn if there is no improvement in symptoms of intolerance.
Regulation 15: hypoallergenic infant milk substitutes
- 15(1) In addition to the nutrient requirements for infant formula and follow-up formula, except milk fat and milk protein, the protein used shall be extensively hydrolysed whey protein or casein, or shall consist of amino acids alone, in their single unbound form.
- 15(2) A product that contains neither milk nor any milk derivative shall be labelled "CONTAINS NO MILK OR MILK PRODUCTS" in a conspicuous manner.
- 15(3) The container of an infant milk substitute meant for infants with allergy to cow, buffalo or other milch animal milk protein (as specified under the Food Products Standards and Food Additives Regulations, 2011) shall indicate conspicuously "HYPOALLERGENIC FORMULA" and the statement "RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" in capital and bold letters on the label.
Regulation 16: foods for infants with inborn errors of metabolism
The standard applies to food intended for the specific dietary management of a disease or condition of infants with specific inborn error(s) of metabolism. The food is intended to be given under medical supervision.
Regulation 16(1): description
- (a) A food formulated or processed to be consumed orally or given enterally through a tube, for the specific dietary management of a disease or condition with distinctive nutritional requirements, based on well-established scientific principles, studies and medical evaluation.
- (b) It is specially processed and formulated with nutrients desirable for the infant with a specific IEM and shall exclude the ingredients or nutrients that are harmful to that infant. Its essential characteristic is a specific modification of the content or nature of proteins, fats or carbohydrates.
- (c) It is for an infant who, because of therapeutic or chronic needs, has restricted, limited or impaired capacity to ingest, digest, absorb or metabolise ordinary foodstuffs, infant formula or certain nutrients.
- (d) Such foods meet unique nutritional needs through specific modifications of the food components.
- (e) The Food Authority shall specify the IEM conditions as approved by it after 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."
Regulation 16(2): composition
Composition shall be based on sound medical and nutritional principles with scientifically demonstrated safety and adequacy (16(2)(a)). Ingredients shall be suitable and safe and comply with the Food Products Standards and Food Additives Regulations, 2011; the product may contain milk, carbohydrates, vegetable oils, hydrolysed proteins, amino acids or other ingredients required for the infants (16(2)(b)). Ingredients scientifically and medically proven to be necessary may be used, but prior approval of the authority has to be taken (16(2)(c)). Vitamins, minerals and amino acids may be added at levels greater than the RDA based on scientific or medical needs and under strict medical supervision (16(2)(d)).
Regulation 16(3): labelling
| Clause | Label requirement |
|---|---|
| (a) | "FOOD FOR SPECIAL MEDICAL PURPOSE" in capital and bold letters near the name or brand name |
| (b) | A statement "For the nutrition management of ..." naming the IEM disease, disorder or condition |
| (c) | The advisory warning "RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY" in capital and bold letters, in an area separated from other information |
| (d) | Osmolality or osmolarity and/or acid-base balance information, when appropriate |
| (e) | A description of any modification of proteins, fats or carbohydrates, with amino acid, fatty acid or carbohydrate profile when necessary |
| (f) | A prominent statement whether the product is intended as the sole source of nutrition |
| (g) | The nature of animal or plant proteins or protein hydrolysates |
| (h) | Feeding instructions, including method of administration and serving size if applicable |
| (i) | Precautions, known side effects, contraindications and product-drug interaction, as applicable |
| (j) | The rationale for use and the properties that make the product useful |
| (k) | A prominent statement if formulated for a specific age group |
| (l) | The nutrients reduced, omitted, increased or modified, with the rationale |
| (m) | A warning that the product is not for parenteral use |
An invented example
Aarogya Infant Foods wants to sell a soy-based powder for infants with lactose intolerance. Its lactose may not exceed 0.05 per cent by weight and its vegetable-oil fat must be not less than 18 per cent by weight; the label carries the capital-and-bold no-lactose statement, the medical advice warning and the diarrhoea and withdrawal statements. It also plans a formula for a rare metabolic disorder: unless the Food Authority has specified that condition, regulation 16(1)(e) bars manufacture, sale, marketing or import of the product.
Need help with specialised infant formulas?
These products depend on what the Food Authority has specified, the evidence on file, and exact capital-and-bold label statements. Our central FSSAI licence team can help you check which pathway applies, prepare the licence and review the label before launch.
Key takeaways
- Lactose-intolerance formula: lactose not above 0.05 per cent by weight; vegetable-oil fat not below 18 per cent by weight.
- Hypoallergenic formula: extensively hydrolysed whey protein or casein, or amino acids alone; label "HYPOALLERGENIC FORMULA".
- IEM foods only for conditions specified by the Food Authority.
- All three carry "RECOMMENDED TO BE TAKEN/USED UNDER MEDICAL ADVICE ONLY" in capital and bold letters.
- IEM labels carry thirteen listed particulars in regulation 16(3).
Read next
- Regulations 12 and 13: FSMP and preterm formula
- Schedules I(a)–I(d): permitted nutrient sources
- Regulations 4–6: infant food labelling, additives and hygiene
- 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.