FSSAI Proposes Restrictions on Registration for High-Risk Food Categories Including Infant Foods and Packaged Water

India proposes to restrict new registrations and renewals for certain high-risk food products, including infant nutrition, milk powders, and packaged drinking/mineral water. A 6-month transition period is proposed to help use up existing packaging and labeling stock.

On May 2, 2025, the Food Safety and Standards Authority of India proposes to restrict new registrations and renewals for certain high-risk food products, including infant nutrition, milk powders, and packaged drinking/mineral water. Only State or Central Licenses will be allowed going forward. The deadline to submit comments on the proposal is 30 days from the date of issuance via the official Google Form.

Background

Through a notification dated October 17, 2024, FSSAI removed the requirement for mandatory BIS certification for several food products, including certain types of dairy products, packaged drinking water and mineral water. However, packaged drinking /mineral water were later classified as high-risk categories through an order dated November 29, 2024, triggering stricter inspection and audit requirements. These included annual inspections and third-party audits for centrally licensed manufacturers.

Currently, these products can be manufactured under either FSSAI Registration or a State/Central License. Registration comes with significantly lighter compliance obligations compared to licensing. It does not require regular product analysis or submission of test results, annual returns, qualified technical personnel, or third-party audits, and demands only minimal hygiene standards. As a result, many registered food businesses may not have the technical, financial, or infrastructural capability to safely produce complex and sensitive products like infant nutrition and packaged drinking water.

Proposed Restrictions

Ban on New Registrations & Renewals: Food businesses producing the following will no longer be eligible for new registrations and renewal of existing registration. Only State or Central Licenses shall be permitted.

Food Product Category as per FoSCoS

Sub-category/ Product Name as per FoSCoS

01 - Dairy products and analogues, excluding products of food category 2.0

1.3 - Condensed milk and analogues (plain)

Sweetened Condensed Milk (1.3.1)

1.5 - Milk powder and cream powder and powder analogues (plain)

Milk Powders and Cream Powder (1.5.1)

13 - Foodstuffs intended for particular nutritional uses

13.1 Infant formulae, follow-up formulae, and formulae for special medical purposes for infants

Infant formula (13.1.1)
Infant Milk Food (13.1.1)
Follow-up Formula (13.1.2)
Food for special medical purpose intended for infants (13.1.3)
Preterm infant milk substitute (13.1.3)
Lactose free infant milk substitutes (13.1.3)
Hypoallergenic infant milk substitutes (13.1.3)
Foods for Infants with Inborn Errors of Metabolism (IEM) (13.1.3)

13.2 Complementary foods for infants and young children

Milk cereal based complementary Food (13.2)
Processed cereal based complementary Food (13.2)
Food for Infants based on traditional food ingredients (13.2)
Formulated supplements for children (13.2)

14 - Beverages, excluding dairy products

14.1 Non- alcoholic("soft") beverages ·

Packaged Drinking Water (14.1.1)

14.1 Non-alcoholic ("soft") beverages

Mineral Water (14.1.1)

14.1- Non-alcoholic ("soft") beverages

Non-carbonated Water Based Beverages [Non-Alcoholic] (14.1.4.2)

Note: Although BIS certification is not mandatory for this product, proposed to add this product considering that the product comprises of package drinking /mineral water as major ingredient.

Transition Plan for Existing Registered FBOs

A special conversion drive will be launched to help current registered manufacturers shift to the license category. A 6-month transition period is proposed to help use up existing packaging and labeling stock. After the transition, the FoSCoS system will automatically remove these product categories from Registration Certificates, debar future production under registration, and enforce license-only operations.