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Date: 29-Mar-2023 Category: Extra Ordinary State: Union Government Country: India

The following draft of certain regulations, further to amend the Food Safety and Standards Foods for Infant Nutrition Regulations, 2020, which the Food Safety and Standards Authority of India proposes to make with the previous approval of the Central Government

Issued by Food Safety and Standards Authority of India · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The gazette notification publishes draft amendments to the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.
  • These amendments propose changes to the permitted levels of certain nutrients in foods for infant nutrition.

Key Changes

  • The draft regulation is called the Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2023.
  • Regulation 7(1)(g) is amended to change the specified values for Selenium from “5-40” to “1-8.5” micrograms.
  • Regulation 8(1)(e) is amended to change the specified values for Selenium from “5-40” to “1-8.5” micrograms.
  • Regulation 9(1)(f) is amended to change the specified values for Iron from “2-5.65” to “0.40–1.20” milligrams.
  • Regulation 9(1)(f) is amended to change the specified values for Selenium from “5-40” to “1-8.5” micrograms.
  • Regulation 10(1)(h) is amended to change the specified values for Biotin from “7.50-50” to “1.60–10.60” micrograms.
  • Regulation 10(1)(h) is amended to change the specified values for Manganese from “5-175” to “1-37.20” micrograms and from “5-400” to “1-85.10” micrograms for lactose-free follow-up formula.
  • Regulation 10(1)(h) is amended to change the specified values for Selenium from “5-40” to “1-8.5” micrograms.
  • The public has 60 days from the date the gazette is available to submit objections or suggestions to the Chief Executive Officer, Food Safety and Standards Authority of India.

Impact Analysis

Manufacturers of Infant Nutrition Products

  • Action Items: Reformulate products as necessary, update labeling to reflect changes in nutrient content, and ensure compliance with the new regulations within the stipulated timeframe.

Consumers

  • Action Items: Monitor for additional guidance from FSSAI and healthcare organizations regarding the implications of these changes.

Food Safety and Standards Authority of India (FSSAI)

  • Action Items: Develop guidance documents and conduct outreach programs to educate manufacturers and consumers about the new regulations.

Key Entities Referenced

Food Safety and Standards Authority of India (FSSAI): The regulatory body responsible for setting and enforcing food safety standards in India. Food Safety and Standards Act, 2006: The primary legislation governing food safety and standards in India. Section 92 empowers FSSAI to make regulations. Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020: The principal regulations being amended by this notification, which specify the standards for foods intended for infant nutrition.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एxलxx.-GअID.-E3x1x0x 32023-244817 CG-DL-E-31032023-244817 असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 209] नई दिल्ली, बुधवार, माच च29, 2023/चत्रै 8, 1945 No. 209] NEW DELHI, WEDNESDAY, MARCH 29, 2023/CHAITRA 8, 1945 भारतीय खाद्य सरु क्षा एव ं मानक प्राजधकरण अजधसचू ना नई दिल्ली, 29 माचच, 2023 फा. स.ं स्ट्टैंडर्डस/चएसपी-05/टी(आईऍफ़आर-02).—कजतपय जवजनयमों का प्रारूप, खाद्य सुरक्षा और मानक (जिि ु पोषण के जलए खाद्य) जवजनयम, 2020 का और संिोधन करन े के जलए, जिसे भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केन्द्रीय सरकार के पूव च अनुमोिन से, खाद्य सुरक्षा और मानक अजधजनयम, 2006 (2006 का 34) की धारा 92 की उपधारा (2) खडं (ड़) द्वारा प्रित्त िजियों का प्रयोग करत े हुये बनान ेका प्रस्ट्ताव करता ह,ै उि अजधजनयम की धारा 92 की उपधारा (1) द्वारा यथा अपेजक्षत सभी स ंभाव्य प्रभाजवत व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै और सूचना िी िाती ह ै दक उि प्रारूप जवजनयमों पर उस तारीख से िब इन प्रारूप जनयमों दक रािपत्र की प्रजतयााँ आम िनता को उपलब्ध कराई िाती ह,ै से साठ दिन की अवजध की समाजि के पश्चात जवचार दकया िाएगा; आक्षेप या सुझाव,यदि कोई हो, तो मुख्य कायचकारी अजधकारी, भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, खाद्य और औषजध प्रिासन भवन, कोटला रोड, नई दिल्ली -110002 को भेिे या regulation@fssai.gov.in पीआर मेल दकए िा सकेंग;े उि प्रारूप जवजनयमों के संबंध में दकसी व्यजि से इस प्रकार जवजनर्िष्टच अवजध की समाजि से पूवच प्राि आक्षेपों और सुझावों पर खाद्य प्राजधकरण द्वारा जवचार दकया िाएगा; 2145 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] प्रारूप जवजनयम 1. इन जवजनयमों का संजक्षि नाम खाद्य सुरक्षा और मानक (जििु पोषण के जलए खाद्य) संिोधन जवजनयम, 2023 ह।ै 2. खाद्य सुरक्षा और मानक (जििु पोषण के जलए खाद्य) जवजनयम, 2020, म,ें - (1) जवजनयम7 म,ें उप जवजनयम (1) म,ें खंड(छ) कीसाररणी मेंक्रम संख्या 34 और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत:- “34. सेलेजनयम,g 5-40 1–8.5”; (2) जवजनयम 8 म,ें उप जवजनयम (1) म,ें खंड(झ) कीसाररणी मेंक्रम संख्या 11और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत:- “11. सेलेजनयम,g 5-40 1–8.5”; (3) जवजनयम 9 म,ें उप जवजनयम (1) के खडं (च) म,ें साररणी में,- (i) क्रम संख्या 15और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत :- “15. आयरन, mg 2-5.65 0.40–1.20”; (ii) क्रम संख्या 23 और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत :- “23. सेलेजनयम,g 5-40 1–8.5”; (4) जवजनयम 10 म,ें उप जवजनयम (1) के खंड (ि) म,ें साररणी में,- (i) क्रम संख्या 17 और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत :- “17. बायोरटन, g 7.50-50 1.60–10.60”; (ii) क्रम संख्या 28 और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत :- “28. मैंगनीि, g 5-175 1-37.20 5-400(लेक्टोस मुि फॉलो 1-85.10(लेक्टोस मुि अप फामलूच ा के जलए) फॉलो अप फामूचला के जलए)”;[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 (iii) क्रम संख्या 29 और सम्बंजधत प्रजवजष्टयो के जलए, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िायेगा, अथाचत :- “29. सेलेजनयम,g 5-40 1–8.5”. िी. कमलावधचन राव, मुख्य कायचकारी अजधकारी [जवज्ञापन-III/4/असा./737/2022-23] रटप्पण: मूल जवजनयम भारत के रािपत्र, असाधारण भाग III, खंड 4 म,ें अजधसूचना संख्या फा.स. स्ट्टैंडर्डसच/ 03/अजधसूचना (आईएफआर)/एफएसएसएआई-2017, दिनांक 4 दिसंबर, 2020 द्वारा प्रकाजित दकए गए थ े तत्पश्चात अजधसूचना संख्या स्ट्टैंडर्डसच/ एसपी-05/टी(आईएफआर-01) दिनांक 31 अगस्ट्त, 2022 द्वारा संिोजधत दकये गए थे । FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA NOTIFICATION New Delhi, the 29th March, 2023 F. No. Std/SP-05/T(IFR-02).—The following draft of certain regulations, further to amend the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which the Food Safety and Standards Authority of India proposes to make with the previous approval of the Central Government, in exercise of the powers conferred by sub- section (2) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), is hereby published as required by sub-section (1) thereof, for the information of all persons likely to be affected thereby; and notice is hereby given that the said draft regulations shall be taken into consideration after the expiry of a period of sixty days from the date on which copies of the Official Gazette in which this notification is published are made available to the public. Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation @fssai.gov.in. Objections or suggestions, which may be received from any person with respect to the said draft regulations before the expiry of the period so specified, shall be considered by the Food Authority. Draft Regulation 1. These regulations may be called the Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2023. 2. In the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020,- (1) In regulation 7,in sub-regulation (1), in clause (g), in the table for serial no 34and the entries relating thereto the following serial number and entry shall be substituted, namely:- “34. Selenium,g 5-40 1–8.5”; (2) In regulation 8,in sub-regulation (1), in clause (e), in the table for serial number 11 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “11. Selenium,g 5-40 1–8.5”; (3) In regulation 9,in clause (f) of sub-regulation (1), in the table,- (i) for serial number 15 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “15. Iron, mg 2-5.65 0.40–1.20”;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] (ii) for serial number 23 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “23. Selenium,g 5-40 1–8.5”; (4) In regulation 10,inclause (h) of sub-regulation (1), in the table,- (i) for serial number 17 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “17. Biotin, g 7.50-50 1.60–10.60”; (ii) for serial number 28 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “28. Manganese, 5-175 1-37.20 g 5-400(for Lactose 1-85.10(for free Follow up Lactose free Formula) Follow up Formula)”; (iii) for serial number 29 and the entry relating thereto, the following serial number and entry shall be substituted, namely:- “29. Selenium,g 5-40 1–8.5”. G. KAMALA VARDHANA RAO, Chief Executive Officer [ADVT.-III/4/Exty./737/2022-23] Note: The principal regulation were published in the Gazette of India, Extraordinary Part III, Section 4, vide notification number F. No. Stds./03/Notification (IFR)/FSSAI-2017, the dated 4th December, 2020 and subsequently amendedvide notification no. F. No. Std./SP-05/T(IFR-01) dated30th August, 2022. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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