Regulations 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 1 and 2 of the Foods for Infant Nutrition Regulations, 2020 give the title, the compliance date and the definitions that sort every infant product into a category. The category decides which standard, label rules and composition table apply.
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. Makers and importers of infant foods can look at our central FSSAI licence page for the licensing side.
Food business operators were to comply with all provisions of the Regulations by 1 July 2021. Regulation 2 defines the product categories by age and purpose: infant formula (the first six months), follow-up formula, milk cereal based and processed cereal based complementary food, food for infants based on traditional food ingredients, and food for special medical purpose intended for infants. "Infant Food" and "Infant Milk substitute" take their meaning from section 3(1)(x) of the Act.
Regulation 1: title and commencement
Regulation 1(1) gives the short title: the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. Regulation 1(2) says the Regulations come into force on the date of their publication in the Official Gazette and that the food business operator shall comply with all the provisions "by 1st July, 2021". The compendium is Version II, consolidated to the notification of 30 August 2022, and carries a corrigendum of 31 March 2021; the later articles in this series note where a text was amended.
Regulation 2: the definitions
Regulation 2(1) lists eleven definitions. Three of them are procedural (Act, Food Authority, Schedules) and the other eight define products.
| Clause | Term | What it says |
|---|---|---|
| (a) | Act | The Food Safety and Standards Act, 2006 (34 of 2006) |
| (b) | Food Authority | The Food Safety and Standards Authority of India established under section 4 of the Act |
| (c) | Food for infants based on traditional food ingredients | Products known to be prepared traditionally at home for feeding infants, but processed and provided in packaged forms, after six months up to twenty-four months of age |
| (d) | Food for special medical purpose intended for infants | A substitute for human milk or formula that is specially manufactured to meet the special nutritional requirements of infants from birth to twenty-four months with specific disorders, diseases or medical conditions |
| (e) | Follow-up formula | A food for infants after six months up to twenty four months of age, intended as the liquid part of the complementary diet when prepared as per the instructions for use |
| (f) | Infant Food | Meaning in clause (x) of sub-section (1) of section 3 of the Act |
| (g) | Infant Milk substitute | Meaning in clause (x) of sub-section (1) of section 3 of the Act |
| (h) | Infant formula | A breast milk substitute product based on milk of cow or buffalo or other milch animals as specified under the Food Products Standards and Food Additives Regulations, 2011 (or a mixture), and other ingredients proven suitable for infant feeding, to meet the nutritional requirements of infants during the first six months |
| (i) | Milk cereal based complementary food | Food for infants after 6 months up to 24 months, based on milk, cereals and/or legumes (pulses), millets, nuts and protein concentrates or isolates and/or defatted edible oilseed extracts, prepared so as to permit dilution with water or milk or another suitable medium |
| (j) | Processed cereal based complementary food | Food for infants after 6 months up to 24 months, based on cereals and legumes (pulses), millets, nuts and protein isolates or concentrates or de-fatted edible oil seed extracts, prepared so as to permit dilution with water or milk or another suitable medium |
| (k) | Schedules | The Schedules to the Regulations |
Regulation 2(2) borrows the meaning from the Act for any word not defined. The Act's definitions are in section 3 of the FSS Act, 2006; this article does not restate them.
How the categories line up by age
The definitions use two ages: the first six months, and after six months up to twenty-four months. Reading them side by side:
- Birth to six months: infant formula (clause (h)); infant milk substitutes in general (clause (g)).
- After six months up to twenty-four months: follow-up formula (clause (e)); milk cereal based and processed cereal based complementary foods (clauses (i) and (j)); food for infants based on traditional food ingredients (clause (c)).
- Birth to twenty-four months with a medical condition: food for special medical purpose intended for infants (clause (d)).
A product's category decides where its standard sits, so a manufacturer should settle the category before drafting the label. The text does not define "infant" itself in regulation 2; it relies on the age wording in the category definitions and the Act.
A map of the rest of the Regulations
The other provisions of the Regulations are:
| Provision | Subject |
|---|---|
| Regulation 3 | General requirements: approval for unspecified products, packaging, tolerance on declared nutrients, source compounds, contaminants, advertising |
| Regulations 4 to 6 | Labelling, food additives, hygiene |
| Regulation 7 | Infant formula standard (Chapter 2, infant milk substitute) |
| Regulations 8 and 9 | Milk cereal based and processed cereal based complementary foods |
| Regulations 10 and 11 | Follow-up formula; food for infants based on traditional food ingredients |
| Regulations 12 and 13 | Food for special medical purpose intended for infants; infant milk substitute for preterm infants |
| Regulations 14 to 16 | Infant milk substitutes for lactose intolerance, hypoallergenic substitutes, and food for infants with inborn errors of metabolism |
| Schedules I(a) to I(d) | Source compounds for minerals, vitamins, amino acids and other nutrients |
Each of these has its own article: regulation 3, regulations 4 to 6, regulation 7, regulations 8 and 9, regulations 10 and 11, regulations 12 and 13, regulations 14 to 16 and Schedule I.
An invented example
Nutri Tots Foods plans three products: a powder to replace breast milk for newborns, a ready-to-mix cereal for a nine-month-old, and a packaged version of a traditional rice and lentil porridge for the same age. Under regulation 2 the first is infant formula (clause (h)), the second is milk cereal based or processed cereal based complementary food depending on whether milk is among its ingredients (clauses (i) and (j)), and the third is a food for infants based on traditional food ingredients (clause (c)). Each will have to meet a different standard and, as the next articles show, a different composition table. If a fourth product is meant for babies with a diagnosed disorder, it would be a food for special medical purpose intended for infants under clause (d).
Where these Regulations sit among the others
Infant foods must also meet the Labelling and Display Regulations, 2020 (regulation 4), the Contaminants Regulations (regulation 3(10)) and the Advertising and Claims Regulations, 2018 (regulation 3(13)). The Regulations name the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 in regulation 3(8); this series does not explain that Act. The overview article on infant food and baby food standards gives a short outline.
Need help with an infant food licence?
Infant foods are among the more demanding categories: the right product category, an approval where no standard exists, and a label that follows two sets of rules. Our central FSSAI licence service covers the licensing for manufacturers that qualify for it, and our team can map each planned product to its definition.
Key takeaways
- Compliance with the Regulations was due by 1 July 2021 (regulation 1(2)).
- Eight product terms are defined by age and purpose in regulation 2(1).
- "Infant Food" and "Infant Milk substitute" mean what section 3(1)(x) of the Act says.
- Infant formula covers the first six months; the complementary and follow-up categories cover six to twenty-four months.
- Food for special medical purpose intended for infants covers birth to twenty-four months with a medical condition.
Read next
- Regulation 3: general requirements for infant food
- Regulations 4–6: labelling, additives and hygiene
- 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.