The draft regulations further to amend the Food Safety and Standards Foods for Infant Nutrition Regulations

## Policy Analysis Report: Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2021 **1. Executive Summary:** This report analyzes the Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2021, as published in the Gazette of India on September 22, 2021. This amendment modifies the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, primarily focusing on changes to labeling requirements, vitamin B12 specifications, and permissible additives, with the addition of an alternative naming option for certain infant formulas. The core purpose of this amendment, as inferred from the text, is to update and clarify existing regulations related to infant nutrition to align with current scientific understanding and industry practices. Key findings indicate changes to labeling standards, specific nutrient requirements and permissible additives, directly impacting manufacturers of infant nutrition products. **2. Introduction:** This report aims to provide a comprehensive overview of the Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2021, based solely on the information provided in the official Gazette notification. The analysis focuses on the specific changes introduced by this amendment and their potential impact on relevant stakeholders. **3. Policy Overview:** * **Original Policy:** This amendment modifies the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. * **Core Objective(s):** Based on the provided text, the core objectives of this amendment are to: * Update labeling requirements for infant nutrition products. * Modify specifications for Vitamin B12 content in infant formulas. * Introduce the option to name certain formulas as "Infant Milk Food" under specified conditions. * Clarify regulations regarding pH adjusting agents. * Allow the use of specific packaging gases. **4. Background and Rationale:** This is an amendment to existing regulations. The rationale for this specific amendment, as inferred from the provided text, appears to be the need to: * Align labeling requirements with updated Food Safety and Standards (Labelling and Display) Regulations, 2020. * Fine-tune the specifications for Vitamin B12 to ensure appropriate nutritional content. * Address scenarios where infant formula is manufactured without certain common ingredients, allowing for a different naming convention. * Clarify the permitted pH adjusting agents as Acidity regulators to reflect current acceptable food safety standards. * Permit the use of specific packaging gases, such as Carbon Dioxide and Nitrogen, under Good Manufacturing Practices (GMP) for preservation purposes. **5. Key Provisions / Changes:** This section details the changes introduced by the amendment text: * **Change 1: Labeling:** * **Original Policy (reference):** Regulation 4 of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 referenced "Food Safety and Standards Packaging and Labelling Regulations, 2011". * **New Rule:** The amendment replaces "Food Safety and Standards Packaging and Labelling Regulations, 2011" with "Food Safety and Standards Labelling and Display Regulations, 2020". * **Effect:** This change aligns the labeling requirements for infant nutrition products with the most current labeling standards established by the Food Safety and Standards Authority of India (FSSAI). * **Change 2: Vitamin B12 Specification:** * **Original Policy (reference):** In Regulation 7 (subregulation 1, clause g) and Regulation 10 (subregulation 1, clause h), serial numbers 19 and 15, relating to Vitamin B, are being altered. * **New Rule:** The row and subsequent entries at serial numbers 19 and 15 related to the parameter Vitamin B, respectively, are substituted with the following: "12, 19. Vitamin B12, g 0.25 4.0 0.05 0.90" and "12, 15. Vitamin B12, g 0.25 4.0 0.05 0.90". * **Effect:** This change explicitly clarifies that the parameter is Vitamin B12. The specifications (0.25, 4.0, 0.05, 0.90) likely refer to minimum, maximum, and other relevant values (units are grams), but without further context, the precise meaning cannot be determined. * **Change 3: "Infant Milk Food" Naming:** * **Original Policy (reference):** No specific naming convention existed for formulas lacking vegetable oil, linoleate, vitamin E, starch, specified food additive and optional ingredients. * **New Rule:** "where an infant formula in powder format is manufactured without use of any vegetable oil, linoleate, vitamin E, starch, specified food additive and optional ingredients, the product may be named as Infant Milk Food." * **Effect:** This provides an alternative naming option for manufacturers producing specialized infant formulas, potentially impacting marketing and consumer perception of these products. * **Change 4: pH Adjusting Agents:** * **Original Policy (reference):** Regulation 10, subregulation 2, in the table under clause a. * **New Rule:** The words pH adjusting agents shall be substituted with the words Acidity regulators. * **Effect:** This change replaces "pH adjusting agents" with "Acidity regulators," likely to align with internationally recognized terminology for these types of additives. * **Change 5: Packaging Gases:** * **Original Policy (reference):** Regulation 10, subregulation 2, in the table under clause a. * **New Rule:** Allows for the inclusion of Packaging gases Carbon dioxide (290 GMP) and Nitrogen (941). * **Effect:** This change permits the use of Carbon dioxide and Nitrogen under Good Manufacturing Practices (GMP), potentially improving the preservation and shelf life of infant formula products. **6. Target Audience and Stakeholders:** Based on the provided text, the primary target audience and stakeholders affected by these changes are: * Manufacturers of infant formula and infant milk food products. * Food safety and standards regulatory bodies. * Consumers of infant nutrition products (indirectly). **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Food Safety and Standards Authority of India (FSSAI) is responsible for implementing and enforcing these regulations. * **Timelines:** The regulations came into force on the date of their publication in the Official Gazette (September 22, 2021). The draft regulations were open for objections and suggestions for a period of sixty days from the date of publication. * **Specific to Changes:** Manufacturers need to update their labeling practices to comply with the updated "Food Safety and Standards Labelling and Display Regulations, 2020." They may also need to adjust their formulations to meet the revised Vitamin B12 specifications and to qualify for the "Infant Milk Food" naming option. The use of packaging gases needs to adhere to GMP. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of these specific changes introduced by the amendment text are: * **Improved clarity and consistency in labeling of infant nutrition products.** * **More precise control over the nutritional content of infant formulas, particularly regarding Vitamin B12.** * **Greater flexibility for manufacturers to produce and market specialized infant formulas.** * **Alignment of regulations with current scientific understanding and international standards for food additives.** * **Potentially improved preservation and shelf life of infant formula products through the use of permitted packaging gases.** **9. Conclusion:** The Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2021, represents a significant update to the existing regulatory framework for infant nutrition in India. The changes related to labeling, Vitamin B12 specifications, naming conventions, pH adjusters, and packaging gases are likely to have a direct impact on manufacturers of infant formula and infant milk food products, requiring them to adapt their practices to ensure compliance. These changes aim to enhance the safety, quality, and clarity of infant nutrition products available in the market.

Key Entities Referenced