Executive Summary:
This notification from the Food Safety and Standards Authority of India (FSSAI) announces draft amendments to the Food Safety and Standards (Fortification of Foods) Regulations, 2018. It includes changes to regulations concerning iron-fortified foods, iodine content, fortified milk powder, and fortified raw rice. The draft regulations are open for public comment for 60 days following the gazette publication, with consideration by the Food Authority after the period.
Key Points / Main Content:
General Amendments:
* These regulations are called the Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2020.
* The regulations will be effective either January 1 or July 1, with a minimum of 180 days from the final publication date.
Iron Fortification:
* Iron-fortified food packages must state: "People with Thalassemia may take under medical supervision and persons with Sickle Cell Anemia are advised not to consume iron-fortified food products."
Iodine Content:
* The iodine content should be 15-30 parts per million on a dry weight basis, using Potassium Iodate as the source of nutrients.
Fortified Milk Powder:
* Vitamin A and D levels in fortified milk powder must ensure that reconstituted milk complies with micronutrient levels specified in Clause 3 of Schedule I.
* It is restricted for use in Government Funded Programs for preparing Reconstituted Fortified Milk.
* Label must include: "NOT RECOMMENDED FOR DIRECT CONSUMPTION," "ONLY FOR USE UNDER [Name of the Government Funded Programme]," "TO BE CONSUMED ONLY AFTER RECONSTITUTION OF THE ENTIRE CONTENT AS PER THE DIRECTIONS ON THE LABEL," and "PACK ONCE OPENED, TO BE CONSUMED ON THE SAME DAY."
Fortified Raw Rice:
* Clause 6 related to Fortified Raw Rice is substituted (details not provided in the summary).
Impact Analysis:
Food Manufacturers:
* Impact: Need to update labeling and fortification processes to comply with the new regulations for iron-fortified foods, iodine content, fortified milk powder, and fortified raw rice.
* Action Required: Review and adjust product formulations, labeling, and manufacturing processes to meet the amended regulations; ensure compliance by the effective date.
Consumers:
* Impact: Increased awareness of the suitability of iron-fortified foods for individuals with Thalassemia and Sickle Cell Anemia; access to fortified milk powder through government programs.
* Action Required: Take note of the warning on iron-fortified foods if they have Thalassemia or Sickle Cell Anemia; follow label instructions for fortified milk powder.
Government and Regulatory Bodies (FSSAI):
* Impact: Responsible for enforcing the amended regulations and ensuring compliance among food manufacturers.
* Action Required: Review and consider public comments on the draft regulations; finalize and publish the amended regulations; monitor compliance.
Government Funded Programs:
* Impact: To use Fortified Milk Powder as per the stated guidelines.
* Action Required: Adhere to labeling guidelines; Use the product only for its intended purpose under the program and ensure proper reconstitution as per the label instructions.
Key Entities Referenced
Food Safety and Standards Authority of India: An authority proposing amendments to the Food Safety and Standards Fortification of Foods Regulations.
Food Safety and Standards Act, 2006: The Act under which the Food Safety and Standards Authority of India exercises its powers.
Food Safety and Standards Fortification of Foods Regulations, 2018: The regulations being amended by this notification.
Central Government: The approving authority for the proposed regulations.
Ministry of Health and Family Welfare: The ministry under which the Food Safety and Standards Authority of India operates.
New Delhi: The location of the Food Safety and Standards Authority of India and place of publication of the notification. Specifically, Kotla Road, New Delhi110002.
ARUN SINGHAL: Chief Executive Officer of the Food Safety and Standards Authority of India.
Government Funded Programs: Programs for which the fortified milk powder is intended to be used.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-12112020-223058
xxxGIDHxxx
CG-DL-E-12112020-223058
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 482] नई ददल्ली, बुधवार, नवम्बर 11, 2020/कार्ततक 20, 1942
No. 482] NEW DELHI, WEDNESDAY, NOVEMBER 11, 2020/KARTIKA 20, 1942
स्ट्व ास्ट्् य एव ं पररवार कल्य ाण मरं ालय
(भारतीय खाद्य सुरक्षा एव ंमानक प्राजधकरण)
अजधसचू ना
नई ददल् ली, 10 नवम् बर, 2020
फा. स.ं स्ट्ट ैंड्सपसएसपी-18पए-1.12पएन-1.—खाद्य सुरक्षा और मानक (दढृ ीकृत खाद्य) जवजनयम, 2018 में और
आग े संिोधन, िो भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केंद्र सरकार के पूवासनुमोदन स,े खाद्य सुरक्षा और मानक
अजधजनयम, 2006 (2006 का संख यांक 34) का धारा 92 का उप-धारा (2) के खंड (ङ) द्वारा प्रदत् त िजतियय का प्रयोग
करते हुए करना चाहती ह,ै करने के जलए इन जवजनयम का प्रारूप इससे प्रभाजवत हो सकन े वाले सभी व् यजतियय का सूचना
के जलए उक्त अजधजनयम का धारा 92 का उप-धारा (1) का अपेक्षा के अनुसार एतदद्वारा प्रकाजित करती ह ैऔर एतदद्वारा
नोरटस ददया िाता ह ै दक उक्त प्रारूप जवजनयम पर उस जतजथ स े साठ ददन का अवजध समाप् त होने के बाद जवचार दकया
िाएगा, जिस जतजथ को इस अजधसूचना को प्रकाजित करन ेवाल े रािपर का प्रजतया ाँ िनता को उपलब्ध कराई िाएाँगी।
यदद कोई आपज् ा या सुवाव हो तो उसे मुखय कायसकारी अजधकारी, भारतीय खाद्य सुरक्षा और मानक प्राजधकरण,
एफडीए भवन, कोटला रोड, नई ददल् ली-110002 को अथवा regulation@fssai.gov.in पर ई-मेल स े भेिा िा सकता
ह।ै
उक्त प्रारूप जवजनयम के संबधं म ें दकसी व् यजतिय स े इस प्रकार जनधासररत जतजथ तक प्राप् त आपजतियय और सुवाव
पर भारतीय खाद्य सुरक्षा और मानक प्राजधकरण द्वारा जवचार दकया िाएगा।
5475 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
प्रारूप जवजनयम
1. (1) इन जवजनयम को ‘खाद्य सुरक्षा और मानक (दढृ ीकृत खाद्य) सिं ोधन जवजनयम, 2020 कहा िा सकता ह।ै
(2) ये रािपर म ें अंजतम प्रकािन का जतजथ स े प्रवृतिय) ह गे तथा खाद्य कारोबार चालक को इनके अंजतम
प्रकािन का तारीख से न्यनू तम 180 ददन के पश्चात 1 िनवरी या 1 िुलाई से, जवजनयम के सभी
उपबंध का अनपु ालन करना होगा।
2. (क) जवजनयम 7 के उप-जवजनयम (4) का िगह जनम्न जलजखत उप-जवजनयम प्रजतस्ट् थाजपत दकया िाएगा,
अथासत,् -
‘‘(4) लौह से पौजिकाकृत प्रत् येक खाद्य पैकेि पर ‘‘थलै सेजमया रोग स े ग्रस्ट् त व् यजतिय डॉक्ट री जनगरानी म ेंल े सकत े ह ैं
और जसकल सेल अनीजमया स े ग्रस्ट् त व् यजतियय को लौह पौजिकाकृत खाद्य उत् पाद का सेवन न करन े का
सलाह दी िाती ह‘ै’ स्ट् टेटमटें दी िाए।
3. अनुसूची-1 के,-
(क) खंड 1 का सारणी के कॉलम (1) के नीच े क्रम स.ं 1 पर ‘’आयोडीन अंि’’ स े संबंजधत कॉलम (2) से (4) तक का
प्रजवजिय का िगह जनम्न जलजखत प्रजवजियााँ प्रजतस्ट् थाजपत का िाएाँगी:-
क्रम स.ं सघं टक पोषक तत्व का स्ट्त र पोषक तत्व का स्रोत
‘‘1. आयोडीन अंि 15-30 भाग प्रजत दस लाख (िुष्क भार आधार पोटाजियम आयोडेट’’;
पर)
(ख) ‘सुदढृ ीकृत दधू ’ से संबंजधत खडं 3 का मौिूदा सारणी के बाद जनम्न जलजखत सामग्री िो़ी ी िाएगी, अथासत,् -
‘’3क. पौजिकाकृत दग्ु ध पाउडर:
(i) दग्ु ध पाउडर, िब पौजिकाकृत दकया िाए, को जवटाजमन ए और डी के ऐसे स्ट् तरो से पौजिकाकृत दकया िाए
दक उत् पाद के लेबल पर ददए गए जनदोि के अनुसार संघरटत दकए िाने पर अंजतम रूप से पुन: संघरटत
पौजिकाकृत दधू ‘पौजिकाकृत दधू ’ से संबंजधत अनुसूची-1 के खंड 3 में जवजहत सूक्ष्म पोषक तत व् के स्ट् तर
का अनुपालन करे।
(ii) इसका प्रयोग ‘पुन: संघरटत पौजिकाकृत दधू ’ तैयार करने के जलए केवल सरकार द्वारा जवत् तपोजषत कायसक्रम
में दकया िाएगा।
(iii) खाद्य सुरक्षा और मानक जवजनयम के अंतगसत उजल्लजखत लेबललग उपबंध के अजतररक्त पौजिकाकृत दग्ु ध
पाडर के लेबल पर जनम्न जलजखत स्ट् टेटमेंटभी हो:
(क) सीधे सेवन के जलए अनुिंजसत नहीं;
(ख) केवल ......................... (सरकार द्वारा जवत् तपोजषत कायसक्रम का नाम) के तहत उपयोग के जलए;
(ग) केवल लेबल पर ददए गए जनदोि के अनुसार पूरी सामग्री के पुन: संघटन के बाद सेवन के जलए;
(घ) खोले गए पैक का उसी ददन प्रयोग करें’’.
(ग) ‘पौजिकाकृत कच् चा चावल’ से संबंजधत खंड 6 का िगह जनम् नजलजखत सामग्री प्रजतस्ट्थ ाजपत का िाएगी, अथासत,् -
‘’6. पौजिकाकृत चावल’’।
अरुण लसघल, मुखय कायसकारी अजधकारी
[जवज्ञापन.-IIIप4पअसा.प343प2020-21]
रटप्प णी.- मलू जवजनयम भारत के रािपर, असाधारण, भाग III, खडं 4 म ें अजधसूचना संखय ा फा. स.ं 11प03पजवजनयमप
अजधसूचनाप2014, ददनांक 2 अगस्ट्त , 2018 द्वारा प्रकाजित दकए गए थे।[भाग III—खण् ड 4] भारत का रािपर : असाधारण 3
MINISTRY OF HEALTH AND FAMILY WELFARE
(Food Safety and Standards Authority of India)
NOTIFICATION
New Delhi, the 10th November, 2020
F. No. Stds/SP-18/A-1.12/N-1.—The following draft of certain regulations further to amend the Food Safety
and Standards (Fortification of Foods) Regulations, 2018, which the Food Safety and Standards Authority of India
proposes to make, with the previous approval of the Central Government in exercise of powers conferred by clause (e)
of sub-section (2) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006) is hereby published as
required by the said sub-section (1) of section 92, for the information of persons likely to be affected thereby and
notice us hereby given that the said draft regulations will be taken into consideration after expiry of a period of sixty
days from the date on which the 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, Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002, or may be sent
at regulation@fssai.gov.in:
The objection or suggestion which may be received from any person with respect to said draft regulations,
before the expiry of the period specified above, will be considered by the Food Authority.
Draft Regulations
1. (1) These regulations may be called the Food Safety and Standards (Fortification of Foods) Amendment
Regulations, 2020.
(2) They shall come into force with effective date for implementation to be either 1st January or 1st July
subject to a minimum of 180 days from the date of their final publication in the official Gazette.
2. (A) for sub-regulations (4) of regulations 7, the following shall be substituted, namely:
“(4) Every package of food, fortified with Iron shall carry a statement “People with Thalassemia may take
under medical supervision and persons with Sickle Cell Anemia are advised not to consume iron fortified
food products.”;
3. in Schedule-I, -
(A) in clause 1, in table, under column (1), at serial number 1, for the entries under column (2) to (4),
relating to “Iodine Content” , the following shall be substituted, namely:-
S.No. Component Level of nutrients Source of Nutrients
“1. Iodine content 15-30 part per million (on dry Potassium Iodate”;
weight basis.
(B) in Clause 3, related to the „Fortified Milk‟, after the exiting table, the following shall be inserted,
namely:-
“3A. Fortified Milk Powder:
(i) Milk powder, when fortified, shall be fortified with such levels of Vitamin A and D, so that the final
reconstituted fortified milk shall comply with the levels of micronutrients specified in Clause 3 of
Schedule-I related to „Fortified Milk‟, when constituted as per the directions mentioned on the product
label.
(ii) It shall only be used in the Government Funded Programs for the purpose of preparation of
„Reconstituted Fortified Milk‟;
(iii) In addition to the labeling provisions mentioned under Food Safety and Standards Regulations, the
label of Fortified Milk Powder shall also carry the following statement:
(a) NOT RECOMMENDED FOR DIRECT CONSUMPTION;
(b) ONLY FOR USE UNDER ______________ (Name of the Government Funded Programme);4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
(c) TO BE CONSUMED ONLY AFTER RECONSTITUTION OF THE ENTIRE CONTENT AS
PER THE DIRECTIONS ON THE LABEL.
(d) PACK ONCE OPENED, TO BE CONSUMED ON THE SAME DAY.”;
(C) for clause 6, related to „Fortified Raw Rice‟, the following shall be substituted, namely:-
“6. Fortified Rice”.
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./343/2020-21]
Note. - The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4 vide
notification number File No. 11/03/Reg/Fortification/2014, dated the 2st August, 2018.
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.