Regulations 10 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 10 is the standard for follow-up formula, powder or liquid, for infants after six months up to twenty-four months. Regulation 11 is a lighter standard for packaged foods made from traditional home ingredients for the same age group, with a fixed front-of-pack term.
The text is read as amended up to 30 August 2022 (FSSAI Compendium Version II dated 04.01.2024, which marks some provisions published in a corrigendum dated 31.03.2021). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. Manufacturers can see our central FSSAI licence page for the licence step.
Follow-up formula must give a minimum of 3 g protein per 100 kcal, fat of not less than 3 gm and not more than 6 gm per 100kcal, and 60 to 85 kcal of energy per 100 ml of the ready-to-use formula. Foods for infants based on traditional ingredients must carry the term "Traditional Food for Infants" prominently on the front of the pack label.
Regulation 10: follow-up formula
The standard applies to the composition of follow-up formula in powder or liquid form for infants after six months up to twenty-four months. The product shall be nutritionally adequate to contribute to normal growth and development when used in accordance with its directions for use. The powdered form requires water for preparation.
Regulation 10(1): composition
- (a) Based on milk of cow, buffalo or other milch animals as specified under the Food Products Standards and Food Additives Regulations, 2011 or a mixture, and other nutrients and ingredients provided under these Regulations.
- (b) Protein content minimum of 3 g per 100 kcal, derived from whole or skimmed milk or with minor modification that does not substantially impair the vitamin or mineral content of milk, and representing a minimum of 90 per cent of total protein. The product may contain vegetable proteins.
- (c) Protein quality shall not be less than 85 per cent of casein. Essential amino acids may be added, only in amounts necessary to improve protein quality, and only L forms.
- (d) Fat not less than 3 gm and not more than 6 gm per 100kcal; linoleic acid in fat not less than 300 mg per 100 kcal; no partially hydrogenated oils and fats; lauric and myristic acids combined not to exceed 20 per cent of total fatty acids; trans fatty acids not to exceed 3 per cent of total fatty acids; erucic acid not to exceed 1 per cent of total fatty acids.
- (e) Nutritionally available carbohydrates suitable for feeding, to adjust the energy density: 100 ml of ready-to-use formula shall provide 60 to 85 kcal. Only precooked and/or gelatinised starches that are naturally without gluten may be added.
- (f) Other vitamins and minerals may be added but shall not exceed the Recommended Dietary Allowances specified by the Indian Council of Medical Research or, where none are specified, the Codex Alimentarius Commission standards.
- (g) It may contain the optional ingredients permitted under infant formula (see regulation 7).
- (h) It shall conform to the table below.
The table in 10(1)(h)
The table has 32 serial numbers, with columns for the requirement per 100 g and per 100 kcal. It starts with moisture, ash and ash insoluble in dilute hydrochloric acid, then the vitamins (serials 4 to 17, with vitamin B12 at serial 15 shown as amended), the minerals (serials 18 to 29), and inositol, taurine and essential amino acids (serials 30 to 32). A few entries as printed:
| Serial | Parameter | Per 100 g | Per 100 kcal |
|---|---|---|---|
| 1 | Moisture, percent by weight, Max | 4.50 | - |
| 2 | Total ash, per cent by weight, Max | 8.50 | - |
| 18 | Sodium, mg | 90.00 - 300.00 | 19.15 - 63.80 |
| 21 | Calcium, mg | 405.00 - 800.00 | 86.20 - 170.20 |
| 24 | Iron, mg | 3.00 - 7.00 | 0.60 - 1.50 |
| 27 | Zinc, mg | 2.50 - 5.90 | 0.50 - 1.25 |
Serials 30 and 32 are stated per 100 ml of the product prepared in accordance with the manufacturer's instructions (inositol Max 40.00; essential amino acids Min 0.90 mg, as printed). A note repeats that 1 microgram DFE = 0.6 microgram folic acid.
Regulation 10(2): additives
Additives may be used in the preparation of follow-up formula ready for consumption, with the recommended maximum level per 100 ml of product ready for consumption: thickening agents, emulsifiers, acidity regulators, antioxidants and packaging gases. As printed: guar gum (INS 412) and locust bean gum (INS 410) at 0.1 g; pectins (INS 440) at 1g; lecithin (INS 322(i)) at 0.5 g; mono- and diglycerides (INS 471) at 0.4 g; the acidity regulators at "GMP within the limits for sodium" in clause (h); mixed tocopherol concentrate and alpha tocopherol at 3 mg singly or in combination; ascorbic acid and its salts at 5 mg expressed as ascorbic acid; and carbon dioxide and nitrogen at "GMP". Regulation 10(2)(b) refers to the additives for special nutrient formulations in "Annexure I (d)"; the Schedules in this compendium are headed Schedule I, so the reference is read as Schedule I(d) (see the Schedule I article).
Regulation 11: food for infants based on traditional food ingredients
The standard applies to food prepared using traditional food ingredients intended for infants after 6 months up to 24 months of age.
- 11(1)(a) Composition based on traditional ingredients such as rice, rice flour, wheat flour, semolina, pulses and other cereals, spices, fruits, dry fruits and vegetables, milk, ghee, egg and egg products.
- 11(1)(b) Ingredients shall be safe and comply with all applicable provisions of the Food Safety and Standards Regulations, 2011.
- 11(1)(c) Either "Ready to Use" or reconstituted with a medium such as milk, water, curd or any other medium appropriate for an infant; clear instructions for use on the label.
- 11(1)(d) Manufactured with technologies in the process and packaging that retain nutritional and other physical and sensory attributes.
- 11(2) If required, the additives specified for milk cereal based complementary food may be used (see regulations 8 and 9).
- 11(3) The products shall bear prominently the term "Traditional Food for Infants" on the front of the pack label.
- 11(4) An explanatory note gives non-exhaustive examples: cooked lentils, cereals, dry fruits or grains mashed to a pasty form, sweetened with sugar, jaggery or honey; cooked vegetables mashed to a pasty form, either sweetened or with a little ghee; ragi malt mix; and semolina or sooji based foods with milk, curd or ghee.
Regulation 11 prints no nutrient table. Unlike regulations 7 to 10, it sets no numerical composition requirement.
An invented example
Gharwali Foods packs a mashed dal-rice mix with ghee for babies of nine months. It is a food for infants based on traditional food ingredients: the front label must carry "Traditional Food for Infants", it may be ready to use or reconstituted with water, milk or curd, and the label must give clear instructions. Separately, its sister brand sells a liquid follow-up formula; each 100 ml when ready to use must provide 60 to 85 kcal, and the label must follow regulation 4, as described in the article on labelling, additives and hygiene.
Need help with follow-up formula or traditional infant foods?
The two products sit under the same Regulations but have very different tests: one has a full nutrient table, the other a fixed front-of-pack term and a safety duty. Our central FSSAI licence team can help match each product to its regulation and prepare the licence file.
Key takeaways
- Follow-up formula: minimum 3 g protein per 100 kcal, fat 3 to 6 gm per 100kcal, 60 to 85 kcal per 100 ml ready to use.
- No partially hydrogenated oils and fats; trans fatty acids not above 3 per cent of total fatty acids.
- A 32-row nutrient table and an additive list with levels per 100 ml apply.
- Traditional infant foods carry "Traditional Food for Infants" on the front of the pack.
- Regulation 11 has no nutrient table.
Read next
- Regulations 8 and 9: cereal based complementary food
- Regulations 12 and 13: FSMP and preterm formula
- Regulation 7: the infant formula standard
- 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.