Infant Food 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.
Schedule I of the Foods for Infant Nutrition Regulations, 2020 is split into four parts. Schedules I(a), I(b) and I(c) list the nutrient source compounds (mineral salts, vitamin compounds, amino acids and other nutrients) that may be used in infant foods, with the purity standard each must meet. Schedule I(d) lists additives that may be used as nutrient carriers.
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 licensing step.
Regulation 3(4) says that, wherever applicable, food for infant nutrition shall use the source compounds from Schedules I(a), I(b) and I(c). Each Schedule is headed an "advisory list" and has three columns: the nutrient source, the purity requirements (named pharmacopoeias and standards) and the infant foods in which the source is used, shown by abbreviation. Schedule I(d) lists carriers with a maximum level in mg/kg of ready-to-use food.
How the Schedules connect to the Regulations
Regulation 3(4) requires source compounds for minerals, vitamins and other nutrients to come from Schedules I(a), I(b) and I(c) respectively. Regulations 7(2)(b), 8(2)(b), 9(2)(b) and 12(3) allow the additives in Schedule I(d) for special nutrient formulations; regulation 10(2)(b) refers to the same list by the name "Annexure I (d)". See regulation 3 and the infant formula standard.
Schedule I(a): advisory list of mineral salts
The list is arranged by mineral, numbered 1 to 10: calcium, phosphorus, chloride, iron, magnesium, sodium, potassium, copper, iodine and zinc. Under each mineral, compounds are numbered (1), (2), and so on. The columns are:
| Column | What it holds |
|---|---|
| Sl. No. and nutrient source | The mineral and each compound, for example "Calcium carbonate" under serial 1 |
| Purity requirements by | The standards each compound must meet, for example "JECFA (1973), FCC, USP, BP, IP" |
| Use in foods for infant nutrition | Abbreviations of the products the compound may be used in: IF, MCCF, PCCF, FUF, FSMP |
Sample entries as printed: serial 1, calcium, sub-serial (1) calcium carbonate with the purity entry "JECFA (1973), FCC, USP, BP, IP"; serial 4, iron, sub-serial (7) ferrous sulphate with "FCC, JECFA(1999), USP, BP, DAB, IP"; serial 6, sodium, sub-serial (3) sodium chloride with "FCC, USP, BP, IP"; serial 9, iodine, sub-serial (1) potassium iodide with "FCC, USP, BP, DAB, IP". The use column is a block that applies to several rows: it is printed once beside a group of compounds, and some groups show only some of the abbreviations. For instance, iron compounds (14), (15) and others are shown for MCCF, PCCF and FSMP only. The use column therefore has to be read against the rows it spans in the compendium.
Schedule I(b): advisory list of vitamin compounds
The vitamin list is also numbered by nutrient (for example serial 1 Vitamin A, serial 2 Provitamin A, serial 3 Vitamin D, serial 4 Vitamin E, serial 5 Vitamin C, serial 6 Vitamin B1) and carries the same three columns. Sample entries as printed: serial 1, vitamin A, sub-serial (1) trans retinol, "FCC, USP, PhEur, IP", shown for IF, MCCF, PCCF, FUF and FSMP; serial 3, vitamin D, (1) vitamin D2 (ergocalciferol) and (2) vitamin D3 (cholecalciferol); serial 5, vitamin C, (1) L-ascorbic acid "JECFA(1973), FCC, USP, BP, PhEur, IP". Some vitamin E forms, such as D-alpha-tocopheryl acid succinate, are shown for FSMP alone. A note marks text published in the corrigendum dated 31.03.2021.
Schedule I(c): amino acids and other nutrients
Schedule I(c) is headed "Advisory list of amino acids and other nutrients". Serial 1 is amino acids, from sub-serial (1) L-arginine onward (for example L-arginine hydrochloride, L-cystine, L-cysteine, L-histidine, L-isoleucine and L-leucine), each with a purity standard such as "FCC, USP, PhEur, BP, IP", and the use column with IF, MCCF, PCCF, FUF and FSMP. The remaining serials cover carnitine (serial 2), taurine (serial 3), choline (serial 4), inositols (serial 5) and nucleotides (serial 6), on the same pattern. A closing sentence lets the forms of amino acids and their hydrochloride, sodium and potassium salts be used for food for special medical purpose. Some entries carry a limiting note in the use column, such as N-Acetyl-L-methionine, which is for FSMP only and only for infants above 12 months.
Schedule I(d): additives for special nutrient formulations
Schedule I(d) is an "Advisory list of food additives for special nutrient formulations". It explains that for reasons of stability and safe handling, some vitamins and other nutrients have to be converted into suitable preparations; for this the additives in the respective specific standards may be used, and the following may be used as nutrient carriers. The columns are the additive or carrier, the INS number and the recommended maximum level in ready-to-use foods for infant nutrition (mg/kg). All five rows as printed:
| Additive or carrier | INS | Level (mg/kg) |
|---|---|---|
| Gum Arabic (gum acacia) | 414 | 10 |
| Silicon dioxide | 551 | 10 |
| Mannitol (for vitamin B12 dry rubbing, 0.1% only) | 421 | 10 |
| Starch sodium octenyl succinate | 1450 | 100 |
| Sodium L-ascorbate (in coating of nutrient preparations containing polyunsaturated fatty acids) | 301 | 75 |
The abbreviations key
The Schedules end with a key. Product abbreviations: IF is infant formula, FUF follow up formula, MCCF milk cereal based complementary food, PCCF processed cereal based complementary food and FSMP foods for special medical purposes. Purity references: BP (British Pharmacopoeia), DAB (Deutsches Arzneibuch), FCC (Food Chemicals Codex), IP (Indian Pharmacopoeia), JECFA (FAO/WHO Joint Expert Committee on Food Additives), JP (Pharmacopeia of Japan), MI (Merck Index), MP (Martindale Pharmacopoeia), PhEur (Pharmacopeia Europeia) and USP (United States Pharmacopeia). The Regulations name these references; they do not reproduce the texts.
A closing note records that the principal Regulations were published on 4 December 2020 (F. No. Stds/03/Notification (IFR)/FSSAI-2017) and were amended by the notification F.No. Std/SP-05/T(IFR-01) dated 30th August, 2022.
An invented example
Bluebell Nutrition is preparing a formula and a cereal. For the formula, its technologist picks ferrous sulphate and checks that the compound is listed under iron in Schedule I(a) with an entry for IF. For the cereal, she checks the use column for MCCF. A vitamin B12 premix needs mannitol for dry rubbing; Schedule I(d) allows mannitol (INS 421) at 10 mg/kg of the ready-to-use food, for "0.1% only". A source compound that is not in the Schedules would need a separate check against regulation 3(1) on approval.
Need help with infant food formulations?
Choosing source compounds is a quiet step that decides whether a formulation can be licensed and labelled. Our central FSSAI licence team can help match a recipe to the Schedules, the composition tables and the licence application.
Key takeaways
- Regulation 3(4) points to Schedules I(a), I(b) and I(c) for source compounds, and the lists are called advisory.
- Each entry gives the nutrient source, the purity standards and the infant foods it may be used in.
- Schedule I(d) gives five nutrient carriers with maximum levels in mg/kg.
- A key explains IF, FUF, MCCF, PCCF, FSMP and the pharmacopoeia abbreviations.
- The principal Regulations date from 4 December 2020; the compendium reflects the amendment of 30 August 2022.
Read next
- Regulation 3: general requirements for infant food
- Regulation 7: the infant formula standard
- Regulations 1 and 2: definitions
- 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.