De-notification under Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011

Introduction to the De-Notification under Food Safety and Standards

The Food Safety and Standards Authority of India (FSSAI) has issued a notification on 17 October 2024 regarding the de-notification of certain provisions as well as products under the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011.

This amendment is officially titled the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2024 and has been introduced in order to update and streamline food safety regulations in India.

Key changes you should know

1. Certain prohibitions under the 2011 Regulations have been made inoperative for specific products.
2. The restriction under Regulation 2.1.1(5) will not apply to Multi-Source Edible Oil.
3. Multi-Source Edible Oil can be sold, but pack size must not exceed 15 litres.
4. Some regulations, clauses, and Form A have been omitted as part of this amendment.
5. Several food products have been removed from BIS Scheme I and brought fully under FSSAI regulation.
6. The affected products include items related to milk, infant food, packaged drinking water, as well as special medical foods:

• IS 15757 ( Follow–up formula –complementary foods),
• IS 11536 (Processed cereal based complementary foods),
• IS 1165 (Milk-powder),
• IS 1166 (Condensed milk, partly skimmed and skimmed condensed milk),
• IS 12176(Sweetened ultra high temperature treated condensed milk ),
• IS 13334 (Part 1) (Skimmed milk-powder, standard grade),
• IS 13334 (Part 2)( Skimmed milk-powder, extra grade),
• IS 13428 ( Packaged Natural Mineral Water),
• IS 14433 ( Infant milk substitutes) ,
• IS 17945: 2022 ( Food for Special Medical Purpose intended for Infants ),
• IS 14543 ( Packaged Drinking Water (Other than Packaged Natural Mineral Water),
• IS 1656 ( Milk- cereal Based Complementary foods)

What is the date of implementation?

This amendment regulation comes into force from the date of its publication in the Official Gazette, i.e., 17 October 2024. Businesses must follow the revised provisions from this date onwards.

Benefits of this Order for the Industry / Businesses

• Reduces overlapping regulation between BIS and FSSAI.
• Brings better clarity on compliance requirements for food businesses.
• Allows regulated sale of Multi-Source Edible Oil with clear limits.
• Simplifies licensing as well as approval processes for notified food products.
• Supports smoother regulatory control under a single authority.
• Helps businesses avoid confusion and non-compliance risks.

Now, what to do?

Food businesses, manufacturers, as well as importers should follow the given steps:

• Review whether their products fall under the de-notified or revised categories.
• Ensure compliance with FSSAI standards instead of BIS where applicable.
• Check packaging limits, especially for Multi-Source Edible Oil.
• Update licences, labels, as well as internal compliance systems as required.
• Stay aligned with the latest FSSAI regulations.

Brand Liaison provides complete regulatory support for food businesses, including scope assessment, transition from BIS to FSSAI compliance, licence and documentation assistance, regulatory interpretation, and ongoing compliance guidance, ensuring smooth alignment with the latest food safety regulations in India.