India Infant Formula Regulation

1. Definition

Under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, "infant formula" is defined as a breast milk substitute product based on milk of cow or buffalo or other milch animals as specified under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, or a mixture thereof, together with other ingredients which have been proven to be suitable for infant feeding, and is intended to meet the nutritional requirements of infants during the first six months of life. "Follow-up formula" refers to a food intended for infants from six months up to twenty-four months of age, which is designed for use as the liquid part of the complementary diet when prepared in accordance with the instructions for use.

2. Competent Authority

3. Market Access Approval

3.1 FSSAI License

No person shall commence any food business unless the person possesses a valid license. All importers importing food items including food ingredients and additives for commercial use to India are under the purview of Central Licensing Authority appointed by the FSSAI. Prior to applying for a license from FSSAI, the importer must first register with the Directorate General of Foreign Trade (DGFT) to secure a valid Importer-Exporter Code (IEC); if the IEC is suspended, revoked or cancelled by DGFT, the FSSAI import license shall be deemed cancelled. For more detailed licensing requirements, please refer to Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation 2011.

3.2 Mandatory Registration of Foreign Food Manufacturers

Foreign food manufacturing facilities producing specified food categories, including infant food, are required to be registered with FSSAI before exporting such products to India. For this registration, the competent authority of the exporting country must provide the relevant facility information to FSSAI in the prescribed format. Upon review and acceptance of the submitted information, FSSAI updates the facility's registration status on its online ReFoM portal and generates a Unique Registration Number (URN), which can be accessed through the portal.

3.3 Integrated Veterinary Health Certificate (VHC)

For milk-based infant formula, the requirement for an Integrated Veterinary Health Certificate (VHC) for milk and milk products should be confirmed. The integrated VHC, which incorporates the DAHD's sanitary requirements and FSSAI' food safety requirements, are mandatory for the import of milk and milk products into India. The integrated VHC has to be certified by the exporting country along with the consignments to be exported into India.

3.4 Sanitary Import Permits (SIPs)

For milk-based infant formula, the requirement for Sanitary Import Permits (SIPs) for milk and milk products should be confirmed. The import of livestock products, including milk and milk products, is subject to Sanitary Import Permits (SIPs), issued by the DAHD. SIPs must be obtained prior to shipping from the country of origin. The DAHD issues SIPs for livestock products based on the import risk analysis of the livestock products.

3.5 Designated Ports-of-Entry

Certain high-risk food products, including foods for infant nutrition/infant foods, shall be imported through designated ports-of-entry.

3.6 Bill of Entry & Inspection

The Importer/CHA/Customs broker shall file a Bill of Entry (BOE) at Customs Single Window Interface for Facilitating Trade (SWIFT). The BOE is initially assessed by the Customs Risk Management System (RMS), and consignments requiring food safety clearance are referred to the Food Import Clearance System (FICS) under FSSAI for further processing. 

The FSSAI clearance process includes document verification, visual inspection, sampling, and laboratory testing by an FSSAI-notified NABL accredited laboratory. High-risk food items, including infant milk food and infant formula, are subject to higher sampling rates.

If the sample complies with applicable food safety requirements, a No Objection Certificate (NOC) is issued to allow clearance; otherwise, a Non-Conformance Report (NCR) may be issued, rejecting the clearance of food consignment.

4. Product Compliance

4.1 Product Requirements

Infant formula and infant nutrition products in India must comply with the product requirements as shown in the table below:

Where standards are not specified, approval of the article of food from FSSAI is required before manufacture/import for sale, subject to the applicable approval route under FSSAI regulations.

4.2 Label

Infant formula shall follow the general labeling requirements in the Food Safety and Standards (Labelling and Display) Regulations, 2020, and the specific labeling requirements under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. Food businesses should also check the Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011 for the labeling items of consumer care details. Importers should also check the Food Safety and Standards (Import) Regulations, 2017 for labeling requirements for imported food products.

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Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand, etc.

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