Regulation 7 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.
Regulation 7 is the standard for infant formula, in liquid or powdered form, intended for use where necessary as a substitute for human milk in meeting the normal nutritional requirements of infants during the first six months. It fixes the base, the energy range, a 34-row composition table, optional ingredients and permitted additives.
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. Manufacturers will need the right licence for this category; see our central FSSAI licence service.
Infant formula is based on the milk of cow, buffalo or other milch animals and the ingredients listed in the Regulations. Ready for consumption it must provide not less than 60 kcal and not more than 70 kcal per 100 ml (regulation 7(1)(f)). Hydrogenated vegetable oils and fats shall not be used. The composition table in 7(1)(g) gives a requirement per 100 g and per 100 kcal, and only the additives in 7(2) may be used.
Regulation 7(1): composition
- (a) Infant formula is a product based on milk of cow, buffalo or other milch animals as defined under the Food Products Standards and Food Additives Regulations, 2011 or a mixture, and other nutrients and ingredients provided under these Regulations.
- (b) It may be modified by partial removal or substitution of different milk solids and addition of carbohydrates, and salts such as phosphates and citrates. Only precooked and/or gelatinised starches that are naturally without gluten may be added, up to 30 per cent of total carbohydrates and up to 2 gm/100ml.
- (c) It may contain vegetable oils rich in polyunsaturated fatty acids to partially substitute milk fat, and medium chain triglycerides. "Hydrogenated vegetable oils and fats shall not be used in infant formula."
- (d) It may contain fructo-oligosaccharides and/or galacto-oligosaccharides, whose content shall not exceed 0.8 gm/100ml; in combination the ratio shall be 90:10 of galacto-oligosaccharides and fructo-oligosaccharides.
- (e) It may contain L(+) lactic acid producing bacteria with prior approval of the Food Authority.
- (f) Ready for consumption, in accordance with the manufacturer's instructions, it shall contain not less than 60 kcal and not more than 70kcal of energy per 100 ml.
- (g) It shall conform to the requirements in the table below.
The composition table in 7(1)(g)
The table has four columns: serial number, parameter, requirement per 100 g and requirement per 100 kcal. It runs from serial number 1 (moisture) to 34 (selenium). Some rows carry a maximum or minimum ("Max", "Min") in the parameter name, some a range, and three carry footnotes. A few rows printed exactly:
| Serial | Parameter | Per 100 g | Per 100 kcal |
|---|---|---|---|
| 1 | Moisture, per cent by weight, Max | 4.50 | - |
| 2 | Total Protein, per cent by weight | 10.00 - 16.00 | 2.10 - 3.40 |
| 5 | Carbohydrates, per cent by weight | 45.00 -70.00 | 9.60 - 14.90 |
| 12 | Vitamin C, mg | 25.00 - 75.00 | 5.30 - 16.00 |
| 25 | Calcium, mg | 250.00 - 700.00 | 53.20 - 148.90 |
| 29 | Iron, mg | 3.00 - 7.00 | 0.60 - 1.50 |
| 32 | Zinc, mg | 2.50 - 5.90 | 0.50- 1.25 |
Other rows cover total fat including milk fat (serial 3), linoleic and alpha-linolenic acid (serial 4), ash (serials 6 and 7), the vitamins (serials 8 to 20), choline (21), sodium, potassium and chloride (22 to 24), the calcium to phosphorus ratio (27), and magnesium, iodine, copper, manganese and selenium (28, 30, 31, 33, 34). Serial number 19 (vitamin B12) is an amended row, shown in the compendium as inserted by a notification. Row 4 sets a ratio of linoleic acid to alpha-linolenic acid, minimum 6:1.
The three notes to the table say: where only milk protein is used, a different nitrogen factor may be used (note 1); lauric and myristic acids combined shall not exceed 20 per cent of total fatty acids, trans fatty acids shall not exceed 3 per cent of total fatty acids, erucic acid shall not exceed 1 per cent of total fatty acids and total phospholipids shall not exceed 300 mg/100 kcal (note 2); and 1 microgram DFE = 0.6 microgram folic acid (note 3). Anyone designing a recipe should read every row and the units in the compendium itself.
Regulation 7(1)(h): optional ingredients
When prepared in accordance with the instructions for use, infant formula may contain other nutrients ordinarily found in human milk in the amounts prescribed in a second table of 18 serial numbers, with requirements per 100 ml of the ready product. Examples as printed: carotenes, mg, Min 0.025 (serial 1); L-carnitine, mg, Min 0.72 (serial 5); inositol, mg, Min 2.70 (serial 10); taurine, mg, Max 8.40 (serial 16). The table also lists amino acids, nucleotides, lactoferrin, cholesterol and others.
Regulation 7(2): food additives
Regulation 7(2)(a) lists additives that may be used in infant formula ready for consumption, with a recommended maximum level per 100 ml. They are grouped as thickeners, emulsifiers, acidity regulators, antioxidants and packaging gases. Three entries as printed:
| Additive | INS | Recommended maximum level per 100 ml |
|---|---|---|
| Carob bean gum (Locust bean gum) | 410 | 0.1gm in all types of infant formula |
| Lecithin | 322 | 0.5 gm in all types of infant formula (with a note that where more than one of INS 322 and 471 is added, each maximum is lowered in proportion) |
| Mixed tocopherol concentrate | 307b | 1 mg in all types of infant formula singly or in combination |
Several entries are "GMP" (good manufacturing practice) with no number, among them L(+) lactic acid (270), citric acid (330) and the packaging gases carbon dioxide (290) and nitrogen (941). Regulation 7(2)(b) allows the additives in Schedule I(d) for special nutrient formulations. The general additive rules are in regulation 5 (see regulations 4 to 6).
Regulation 7(3): "Infant Milk Food"
A sub-regulation inserted by amendment says that where an infant formula in powder format is manufactured without use of any vegetable oil, linoleate, vitamin E, starch, specified food additive and optional ingredients, the product may be named "Infant Milk Food".
An invented example
Kaveri Dairy Nutrition prepares a powdered formula from cow milk. It wants to add a hydrogenated fat to improve texture; regulation 7(1)(c) bars that. It modifies the milk solids and adds lactose as a carbohydrate, and checks the reconstituted energy against the range of not less than 60 kcal and not more than 70kcal per 100 ml. It uses lecithin at a level within the 0.5 gm per 100 ml maximum for the ready product. Its iron declaration is tested against serial number 29 of the table. A stripped-down powder without oil, added starch or additives may carry the name in regulation 7(3).
Need help with an infant formula range?
Infant formula needs the correct licence, a composition file that matches the table, additives checked against 7(2) and a label that follows regulation 4. Our central FSSAI licence team can help prepare the licence and the product file together.
Key takeaways
- Infant formula is milk-based, in liquid or powder form, for the first six months (regulation 7).
- Energy ready for consumption: not less than 60 kcal and not more than 70kcal per 100 ml.
- No hydrogenated vegetable oils or fats; starches added must be naturally without gluten, within the printed limits.
- The 34-row table has per 100 g and per 100 kcal requirements.
- Only the additives in 7(2) and Schedule I(d) may be used.
Read next
- Regulations 4–6: labelling, additives and hygiene
- Regulations 8 and 9: cereal based complementary food
- Schedules I(a)–I(d): permitted nutrient sources
- 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.