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. By contrast, "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 infant formula and food ingredients or additives for commercial use to India, are under the purview of the Central Licensing Authority appointed by the FSSAI. For more detailed licensing requirements, please refer to Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation 2011.

3.2 Importer-Exporter Code (IEC) Registration

An Importer-Exporter Code (IEC), issued by DGFT, is a key business identification number which is mandatory for import to India. No person shall make any import except under an IEC Number. A Permanent Account Number (PAN) is a mandatory document required for IEC registration.

3.3 Mandatory Registration of Foreign Food Manufacturers

Foreign food manufacturing facilities of certain food categories, including infant food, are required to register with FSSAI before being exported to India. These facilities must submit, either directly or through an authorized representative, their registration application along with the necessary documents and fees as specified by the Food Authority. The facilities are registered in the FSSAI ReFoM website.

3.4 Integrated Veterinary Health Certificate (VHS)

For milk-based infant formula or infant milk food, the requirement for an Integrated Veterinary Health Certificate for milk and milk products should be confirmed and, where applicable, the integrated VHS needs to be certified by the exporting country's authority for consignments being exported to India..

3.5 Designated Ports-of-Entry

Certain high-risk food products shall be imported through designated ports-of-entry. Infant milk food is treated as a high-risk food item for import control purposes and is subject to higher regulatory scrutiny at import clearance.

3.6 Inspection and sampling

The inspection begins once the Authorized Officer schedules an appointment, provided all necessary information is submitted. During the inspection, if the consignment meets all requirements, including labeling and packaging, samples will be drawn. High-risk products are subject to risk-based scrutiny and sampling under RMS; sampling rates may be higher depending on risk category and compliance history.

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.

Our Services

• Food Ingredient Review

• Label Review

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• Regulatory Consultation

• Monitoring, Training and Customized report

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