Regulation 3 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 3 sets fourteen general requirements that apply to every infant food covered by the Regulations: approval where no standard exists, sealed packaging, a tolerance on declared nutrients, permitted source compounds, DHA and ARA sources, carbohydrates, appearance, and compliance with other laws.
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 who need the licence side sorted can see our central FSSAI licence service.
An infant food whose standard is not specified must have prior approval of the article and its label from the Food Authority. Packs must be sealed and packed under inert atmosphere, and packaging material must not contain Bisphenol A (BPA). A variation of minus 10.0 per cent from the declared nutrient value is allowed, but levels may not exceed the maximum limits in the composition tables. Sucrose and fructose are restricted.
Regulation 3(1): approval for unspecified products
An article of infant milk substitutes, infant food or food for special medical purpose intended for infants, whose standards are not specified in these Regulations, shall be manufactured, exhibited or stored for sale only after obtaining approval of the article and its label from the Food Authority. The text gives no procedure here; approvals for products without a standard follow the separate approval route for non-specified foods, explained in our article on the approval procedure for non-specified food.
Regulation 3(2): packaging
Foods for infant nutrition shall be packed in hermetically sealed, clean and sound containers, or in a flexible pack made from paper, polymer and/or metallic film as per the Packaging Regulations, 2018, so as to protect the contents from deterioration. They shall be packed under inert atmosphere. The packaging material used shall not contain Bisphenol A (BPA).
Regulation 3(3): tolerance on declared nutrients
A variation of minus 10.0 per cent from the declared value of the nutrients or nutritional ingredients on the label is allowed. The nutrient levels shall not exceed the maximum limits specified in the composition tables. The tolerance is stated only on the lower side, and the upper limit is the table maximum, so the label and the composition table must be read together.
Regulation 3(4): source compounds
Wherever applicable, food for infant nutrition shall use the source compounds for minerals, vitamins and other nutrients from Schedule-I(a), Schedule-I(b) and Schedule-I(c) respectively. The Schedules are covered in the Schedule I article.
Regulation 3(5): DHA and ARA
Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic acid (ARA) from the organisms named in the text (Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp. and Ulkenia sp.) or fish oil, "at the level of maximum 0.5 per cent. DHA of total fatty acids and ratio of ARA:DHA as 1:1 minimum". Two provisos follow:
- DHA content shall not be less than 0.2 per cent of total fatty acids if a claim related to the addition of DHA is made.
- Infant milk substitutes for preterm infants shall comply with the requirements specified under the standards.
Regulation 3(6): carbohydrates
Lactose and glucose polymers shall be the preferred carbohydrates. Sucrose and/or fructose shall not be added, unless needed as a carbohydrate source, and provided the sum of these does not exceed 20 per cent of total carbohydrate.
Regulation 3(7): appearance
The food shall have no lumps or coarse particles and shall be uniform in appearance, with no rancid taste or musty odour. A proviso allows milk cereal based and processed cereal based complementary food to be in the form of small granules and flakes.
Regulations 3(8) to 3(14): other laws
| Sub-regulation | Requirement |
|---|---|
| 3(8) | Comply with the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (42 of 1992) as amended in 2003, including advertisement, marketing and promotion, in accordance with sections 3, 4, 5, 7, 8, 9 and 10 of that Act |
| 3(9) | Comply with the Legal Metrology (Packaged Commodities) Rules, 2011, except the standard pack size requirement of the second schedule in the case of food for special medical purpose intended for infants |
| 3(10) | Conform to the Contaminants, Toxins and Residues Regulations, 2011 |
| 3(11) | Conform to the Prohibition and Restriction of Sales Regulation, 2011 |
| 3(12) | Conform to the microbiological requirements in Appendix B of the Food Products Standards and Food Additives Regulations, 2011 |
| 3(13) | Advertisements and claims shall follow the Advertising and Claims Regulations, 2018 |
| 3(14) | Where nutritional composition is specified in a 100 gm or 100 kcal basis in the composition tables, the FBO shall comply with the composition on either per 100 gm or per 100 kcal basis |
Regulation 3(8) only names the 1992 Act; its content is not explained here. For regulation 3(10), the contaminant limits are in the Contaminants Regulations; the limits for melamine in infant formula are discussed in our article on biotoxins and melamine. Under 3(14) the text does not say which basis to choose; it asks for compliance with the composition on either basis, wherever the tables use that basis.
An invented example
Little Sprout Nutrition makes a powdered cereal for infants aged eight months. It packs the powder under inert atmosphere in a sealed laminate pouch with no Bisphenol A in the film. The label declares a nutrient value; the lab results show a value ten per cent under the label figure, which the minus tolerance of regulation 3(3) allows, but a result above the table maximum would not be allowed. Little Sprout adds a DHA claim; its DHA content must then be not less than 0.2 per cent of total fatty acids. Because it also wants to launch a novel cereal blend with no listed standard, it must first get approval of the article and its label under regulation 3(1).
Need help with infant food compliance?
Regulation 3 reaches into packaging, contaminants, microbiology, legal metrology and advertising at once, so a launch checklist helps. Our central FSSAI licence team can help line up the licence with the product approval and label review for an infant food range.
Key takeaways
- Unspecified infant products need approval of the article and label before manufacture for sale (regulation 3(1)).
- Packs are sealed, packed under inert atmosphere and made without Bisphenol A (regulation 3(2)).
- Minus 10.0 per cent tolerance applies to declared nutrients; table maximums still bind (regulation 3(3)).
- Sucrose and fructose together may not exceed 20 per cent of total carbohydrate where added as a carbohydrate source (regulation 3(6)).
- Six other instruments are cross-referred in regulations 3(8) to 3(13).
Read next
- Regulations 1 and 2: definitions
- Regulations 4–6: labelling, additives and hygiene
- 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.