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Date: 2022-11-18 Category: Extra Ordinary State: Union Government Country: India

The following draft regulations, which the Food Safety and Standards Authority of India proposes to make with previous approval

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

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Executive Summary & Key Takeaways

**Report on the Food Safety and Standards (Genetically Modified Foods) Regulations, 2022** **1. Executive Summary:** This report analyzes the Food Safety and Standards (Genetically Modified Foods) Regulations, 2022, as published in the Gazette of India on November 18, 2022. This new policy establishes a regulatory framework for the manufacture, storage, distribution, sale, and import of genetically modified (GM) foods and food ingredients in India. Key provisions include mandatory prior approval from the Food Authority for GM foods, specific labeling requirements, and adherence to other relevant food safety regulations. The policy directly impacts food business operators involved in the GM food sector, aiming to ensure food safety and provide consumers with information regarding GM content. **2. Introduction:** This report provides an overview and analysis of the Food Safety and Standards (Genetically Modified Foods) Regulations, 2022, based solely on the provided government policy text. The report aims to inform stakeholders, particularly those in the food industry, about the key provisions, implications, and requirements outlined in these regulations. **3. Policy Overview:** * This is a **New Policy**. * **Core Objective(s):** Based on the text, the primary objectives are to: * Regulate the manufacture, storage, distribution, sale, and import of GM foods and food ingredients. * Establish a process for prior approval from the Food Authority for GM foods. * Mandate labeling requirements for GM foods containing 1% or more of GM ingredients. * Ensure GM foods comply with existing food safety and standards regulations. **4. Background and Rationale:** As a new policy, the regulations likely address the increasing development and availability of GM foods and the need for a comprehensive regulatory framework to ensure food safety and consumer awareness. The absence of prior regulations likely necessitated this policy to provide a structured approach to managing GM foods in the Indian market. **5. Key Provisions / Changes:** As this is a **new policy**, this section details the main components, rules, and actions mandated by the provided text: * **Prior Approval Requirement:** No person can manufacture, pack, store, sell, market, distribute, or import any food or food ingredient produced from GMOs without prior approval from the Food Authority. * **Application Process:** Food business operators must submit an application to the Food Authority with necessary documents and fees. * **GEAC Clearance:** For GMOs referred to as in clause a of subregulation 2 of regulation 1 (Genetically Modified Organisms GMOs intended for food use) clearance from Genetic Engineering Appraisal Committee GEAC is required. * **Safety Assessment:** The Food Authority will assess the safety of the food for human consumption, potentially requiring additional information from the applicant. * **Approval/Rejection:** The Food Authority will either grant approval or reject the application based on the safety assessment. * **Licensing:** Approved food business operators must obtain a license according to the Food Safety and Standards Licensing and Registration of Food Businesses Regulations, 2011. * **Compliance:** Authorized holders must comply with any conditions or restrictions imposed in the approval. * **Appeal Process:** Food business operators can appeal a rejection to the Chairperson of the Food Authority within 30 days. * **Suspension/Revocation:** The Food Authority can suspend or revoke any approval granted. * **Recall Procedure:** If a GM food poses a risk to health, the food business operator must suspend operations and recall the product, informing the Food Authority. * **OECD Approval:** A GMO with a Unique Identifier Ninedigit Code of the Organisation for Economic Cooperation and Development OECD that is approved for food use by the Food Authority, will require no further approvals. * **Infant Foods:** GMOs as referred to in clause a and b of subregulation 2 of regulation 1 (Genetically Modified Organisms GMOs intended for food use and Food ingredients produced from GMOs that contain modified DNA.) shall not be used as ingredients in infant foods. * **Labeling Requirements:** Food products containing 1% or more of a GM ingredient must be labeled "Contains genetically modified organisms" on the front of the package. This applies even to adventitious or technically unavoidable presence of GM ingredients. The labeling requirement is not applicable to GMfood products in which the modified DNA is not detectable. * **Compliance with Other Regulations:** GM foods must comply with other relevant provisions under the Food Safety and Standards Act, including regulations on food product standards, food additives, contaminants, toxins, and residues. **6. Target Audience and Stakeholders:** Based on the text, the primary target audience and stakeholders include: * Food business operators involved in the manufacture, packing, storage, sale, marketing, distribution, or import of GM foods and food ingredients. * Consumers of GM foods. * The Food Safety and Standards Authority of India (FSSAI). * Genetic Engineering Appraisal Committee (GEAC). **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Food Safety and Standards Authority of India (FSSAI) is the primary responsible agency. The Genetic Engineering Appraisal Committee (GEAC) also plays a role in the approval process for certain GMOs. * **Timelines:** The Food Authority will endeavor to give its decision within six months from the receipt of a valid application, which can be extended if supplementary information is required. Food business operators have 30 days to file an appeal after receiving a rejection letter. * **Procedures:** The application process for prior approval involves submitting a prescribed format with necessary documents and fees to the Food Authority. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of this new policy are: * Enhanced regulatory oversight of GM foods in India. * Improved food safety through mandatory approval processes and safety assessments. * Increased consumer awareness through labeling requirements. * Standardized procedures for the manufacture, distribution, and import of GM foods. **9. Conclusion:** The Food Safety and Standards (Genetically Modified Foods) Regulations, 2022, represent a significant step towards regulating the GM food sector in India. By establishing clear guidelines for approval, labeling, and compliance, the policy aims to ensure food safety, promote transparency, and provide consumers with the information needed to make informed choices. The policy will significantly impact food business operators involved in GM foods and will require them to adapt their practices to comply with the new regulations.

Key Entities Referenced

NEW DELHI: The city where the notification was issued. Food Safety and Standards Authority of India: The authority proposing the draft regulations. Central Government: The government body whose approval is required for the Food Safety and Standards Authority of India to make regulations. Food Safety and Standards Act, 2006: The primary legislation under which the regulations are being made. Cited as '34 of 2006'. FDA Bhawan, Kotla Road, New Delhi 110002: Address of the Food Safety and Standards Authority of India. Food Safety and Standards Genetically Modified Foods Regulations, 2022: The title of the proposed regulations. Genetically Modified Organisms: Organisms whose genetic material has been altered using genetic engineering techniques, frequently referred to as GMOs. Genetic Engineering Appraisal Committee: The national competent authority for environmental risk assessment, abbreviated as GEAC, under Ministry of Environment, Forest and Climate Change. Ministry of Environment, Forest and Climate Change: The ministry under which GEAC operates, abbreviated as MoEFCC. Rules 1989: Rules for The manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells rules, 1989. Food Safety and Standards Licensing and Registration of Food Businesses Regulations, 2011: Regulations pertaining to the licensing and registration of food businesses. Food Safety and Standards Food Recall Procedure Regulations, 2017: Regulations pertaining to the procedure for recalling unsafe food products. Organisation for Economic Cooperation and Development: The international organization referred to by its acronym OECD. Food Safety and Standards Packaging Regulations, 2018: Regulations related to the packaging of food products. Food Safety and Standards Labelling and Display Regulations, 2020: Regulations related to the labelling and display of food products. Food Safety and Standards Food Product Standards and Food Additives Regulations, 2011: Regulations specifying standards for food products and food additives. Food Safety and Standards Contaminants, Toxins and Residues Regulations, 2011: Regulations related to contaminants, toxins, and residues in food. Government of India Press, Ring Road, Mayapuri, New Delhi110064: Address of the press that uploaded the document Delhi110054: Location of the Controller of Publications
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-19112022-240438 xxxGIDHxxx CG-DL-E-19112022-240438 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 591] नई दिल्ली, िुक्रवार, नवम्ब र 18, 2022/कार्तका 27, 1944 No. 591] NEW DELHI, FRIDAY, NOVEMBER 18, 2022/KARTIKA 27, 1944 भारतीय खाद्य सरु क्षा और मानक प्राजधकरण अजधसचू ना नई दिल्ली, 18 नवम्बर, 2022 फा.स ं 1/मानक/िीएमओ एंड एफ/एमआईएससी/एफएसएसएआई/2018.—जनम्नजलजखत प्रारूप जवजनयम, िो भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केद्रं सरकार के पूवाानुमोिन स,े खाद्य सुरक्षा और मानक अजधजनयम, 2006 (2006 का संखयांक 34) की धारा 22 की उप-धारा (2) के साथ पठित धारा 92 की उप-धारा (2) के खंड (v) द्वारा प्रित्त िजियों का प्रयोग करत े हुए करना चाहती ह,ै करने के जलए इन जवजनयमों का प्रारूप इससे प्रभाजवत हो सकने वाले सभी व् यजियों की सूचना के जलए उि अजधजनयम की धारा 92 की उप-धारा (1) की अपेक्षा के अनुसार एतिद्वारा प्रकाजित करती ह ै और एतिद्वारा नोठिस दिया िाता ह ै दक उक्त प्रारूप जवजनयमों पर उस जतजथ से साि दिनों की अवजध समाप् त होने के बाि जवचार दकया िाएगा, जिस जतजथ को इस अजधसूचना को प्रकाजित करने वाले रािपत्र की प्रजतयााँ िनता को उपलब् ध कराई िाएाँगी। यदि कोई आपजत्त या सुझाव हो तो उसे मखु य कायाकारी अजधकारी, भारतीय खाद्य सरु क्षा और मानक प्राजधकरण, एफडीए भवन, कोिला रोड, नई दिल्ल ी-110002 को अथवा regulation@fssai.gov.in पर ई-मेल स े भेिा िा सकता ह।ै उक्त प्रारूप जवजनयमों के संबधं म ें दकसी व् यजि स े इस प्रकार जनधााठरत जतजथ तक प्राप् त आपजत्तयों और सुझावों पर भारतीय खाद्य सुरक्षा और मानक प्राजधकरण द्वारा जवचार दकया िाएगा। 7692 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] प्रारूप जवजनयम अध्याय I सामान्य 1. सजं क्षप्त नाम और प्रारंभ—(1) इन जवजनयमों का संजक्षप्त नाम खाद्य सुरक्षा और मानक (िीन पठरवर्तता खाद्य) जवजनयम, 2022 ह।ै (2) य ेजनम्नजलजखत पर लाग ूहोंगे- (क) खाद्य के रुप म ेंप्रयोग के जलए िीन पठरवर्तात िीव (िीएमओ) । (ख) िीएमओ से उत्पन्न खाद्य संघिक जिसम ें संिोजधत डीएनए हो । (ग) िीएमओ से उत्पन्न खाद्य संघिक जिसमें संिोजधत डीएनए ना हो । इसमें िीएमओ से उत्पन्न संघिक, सहयोज्य, प्रसंस्ट्करण सहायक सामग्री सजम्मजलत ह।ै (3) य ेरािपत्र में इनके प्रकािन की तारीख स ेप्रवृत होंगे । (4) य ेएसडीएन1 और एसडीएन2 श्रणे ी के िीनोम एडीिेड क्रॉप्स के जलए प्रयोज्य नहीं होंग।े 2. पठरभाषाए—ाँ (1) इन जवजनयमों में, िब तक प्रसंग से अन्यथा अपेजक्षत न हो:— (क) “अजधजनयम” से खाद्य सुरक्षा और मानक अजधजनयम, 2006 (2006 का संखयांक 34) अजभप्रेत ह;ै (ख) “अनुमोिन” से अजभप्रेत िीएमओ स े उत्पादित दकसी भी खाद्य या खाद्य सामग्री िो प्रत्यक्ष या अप्रत्यक्ष या प्रत्यक्ष रूप से मानव उपभोग के जलए अपेजक्षत ह ै के जवजनमााण या आयात के जलए िी गई स्ट्वीकृजत से ह;ै (ग) “परम्परागत समकक्ष” स े अजभप्रेत समान रूप स े उत्पादित उस खाद्य से ह ै जिसमें दकसी भी प्रकार के अनुवााँजिक संिोधन का प्रयोग नहीं दकया एवं जिसके सुरजक्षत प्रयोग का एक अच्छा इजतहास रहा ह;ै (घ) “खाद्य प्राजधकरण” से खाद्य सुरक्षा और मानक अजधजनयम, 2006 की धारा 4 के अन्तगता स्ट्थाजपत भारतीय खाद्य सुरक्षा और मानक प्राजधकरण अजभप्रेत ह;ै (ङ) “िीईएसी” स े पयाावरण, वन और िलवायु पठरवतान मंत्रालय के अधीन िीन इंिीजनयररंग मूल्यांकन सजमजत अजभप्रेत ह;ै (च) “िीन पठरवर्तात खाद्य (िीएम-खाद्य)” स े वह खाद्य अथवा खाद्य संघिक अजभप्रेत ह,ै िो आधुजनक िैव प्रोद्योजगकी की सहायता से िीन पठरवर्तात अथवा इंिीजनयठरत िीवों से बना हुआ हो अथवा उनसे युि हो, अथवा वह खाद्य और खाद्य संघिक अजभप्रेत ह,ै िो आधजु नक िैव प्रोद्योजगकी की सहायता से िीन पठरवर्तात िीवों से उत्पन्न हो परंतु उनसे युि न हो; (छ) “िीन पठरवर्तता अथवा इंिीजनयठरत िीव (िीएमओ)” स े वह िीजवत िीव अजभप्रेत ह,ै जिसम ें आधुजनक िैव प्रोद्यौजगकी के माध्यम से उत्पन्न िीनी सामग्री का नवीन यग्ु मन होता ह;ै (ि) “खाद्य के रुप में प्रयोग के जलए िीन पठरवर्तात िीव” से वह िीएमओ अजभप्रेत ह ै जिसका उपयोग खाद्य या खाद्य के उत्पािन के जलए स्त्रोत सामग्री के रूप में दकया िाता हो; (झ) “आधुजनक िैव प्रोद्यौजगकी” से अजभप्रेत ह ै अनुप्रयोग (1) इन जवरो न्युजक्लक एजसड तकनीक, जिसमें पुन: संयोिक डीऑक्सीराइबोन्युजक्लक एजसड (डीएनए) एवं कोजिकाओं अथवा ओगने ेल म ें न्युजक्लक एजसड का सीधा इन्िेक्िन िाजमल ह ै अथवा (2) िैक्सोनोजमक मूल के अलावा कोजिकाओं का सजम्मश्रण िो प्राकृजतक िारीठरक प्रिनन या पुनः संयोिन अवरोधो को एवं ऐसे अवरोधी तकनीकी न हों तथा पारंपठरक प्रिनन एवं चयन में प्रयोग दकए िात े हों को िीक करता ह;ै (ञ) “संिोजधत डीएनए” से वह डीएनए अजभप्रते ह ै िो आधुजनक िैव प्रोद्यौजगकी के प्रयोग के फलस्ट्वरूप पारंपठरक समकक्षों म ेंमौिुि डीएनए से अलग हो; (ि) “िीएमओ स े उत्पादित” स े अजभप्रेत ह ै पूरी तरह या कुछ जहस्ट्सों म ें िीएमओ स े व्युतपन्न परन्त ु जिसम ें िीएमओ का एक भी अंि न हो ।[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 (2) यहााँ प्रयिु और अपठरभाजषत परंत ु अजधजनयम, जनयम या जवजनयम म ें पठरभाजषत िब्िों और अजभव्यजियों से वही अजभप्रेत होगा, िो उनसे अजधजनयम, जनयम या जवजनयम में अजभप्रेत ह।ै 3. जनमाणा , भडं ारण, जवतरण, जबक्री और आयात इत्यादि के जलए पवू ाना मु ोिन— (1) कोई व्यजि, खाद्य प्राजधकरण के पूवाानुमोिन के जसवाय, िीएमओ से व्युत्पन्न दकसी खाद्य या खाद्य संघिक का जनमााण, पैक, भंडारण, जबक्री, माकेि या अन्यथा जवतठरत या आयात नहीं करेगा। (2) इन जनयमों के उपबंध अजधजनयम के अतं गता बने अन्य जनयमों अथवा जवजनयमों के अजतठरि ह,ैं उनके जनराकरण में नहीं। 4. पूवाना मु ोिन िेन ेकी प्रदक्रया— (1) िीएम-खाद्य का खाद्य कारबार प्रचालक (जनमााता/आयातक) खाद्य प्राजधकरण द्वारा जनधााठरत प्रारूप के अनुसार आवश्यक िस्ट्तावेिों एवं िुल्क के साथ खाद्य प्राजधकरण को आवेिन प्रस्ट्ततु करेगा। (2) यदि आवेिन जवजनयम 1 के उप-जवजनयम (2) के खंड (क) में दिए गए िीएमओ अथाता पयाावरण िोजखम मूल्यांकन के जलए राष्ट्रीय सक्षम अजधकारी िेनेठिक इंिीजनयररंग अप्रैिल कजमठि (िीइएसी) स े जनकासी के संबंध म ें ह ै तो ऐसी अवस्ट्था म ेंआवेिन खाद्य प्राजधकरण को दिया िाना चाजहए। (3) जवजनयम 1, के उप-जवजनयम (2) की धारा (क) में जवजनर्िाष्ट िीएमओ के संिभा में उसका प्रयोग बीिों या अन्य पौध प्रसार सामग्री (कृजष) के जलए दकए िाने की जस्ट्थजत में खाद्य कारबार प्रचालक समान रूप से िीईएसी, पयाावरण, वन और िलवायु पठरवतान मत्रं ालय (एमओईएफएडंसीसी) को एक आवेिन खतरनाक सूक्ष्मिीवो, अनुवााँजिक रूप से इंिीजनयडा िीवों या कोजिकाओं के भंडारण, जनयाात, आयात, प्रयोग एवं जवजनमााण से संबंजधत जनयम 1989 के अनुपालन हते ु िमा करें। यह आवेिन िीईएसी के रांसिेजनक पौधे (िीन पठरवर्तात पौधे) हते ु पयाावरण सहमजत से संबंजधत प्रपत्र 11बी में िमा दकया िा सकता ह।ै (4) अपना मत रखने के जलए खाद्य प्राजधकरण यह सत्याजपत करेगा दक आवेिक द्वारा प्रस्ट्तुत जववरण और िस्ट्तावेि मागं ी गई सूचना के अनुसार ह ै और साथ ही यह भी िांच करेगा दक खाद्य मानव उपभोग के जलए सरु जक्षत ह ै या नहीं। (5) खाद्य प्राजधकरण आवेिक को एक जनजित समय सीमा के भीतर, यदि आवश्यक हो, अजतठरि सहायक िस्ट्तावेि, डािा या स्ट्पष्टीकरण प्रस्ट्तुत करन े का जनििे ि ेसकता ह।ै (6) अपना जनणाय िेत े समय, खाद्य प्राजधकरण वैध आवेिन की पावती की जतजथ के छह महीने से अजधक का समय नहीं ले सकता ह।ै यह समय सीमा उसी जस्ट्थजत में आगे बढाई िा सकती ह ै िब जवजनयम 4 के उप जवजनयम (4) के अधीन आवेिक से कोई अन्य पूरक सूचना माँगाई गई हो। (7) खाद्य प्राजधकरण खाद्य सरु क्षा मल्ू यांकन के आधार पर खाद्य प्राजधकरण द्वारा जनधााठरत प्रारूप के अनुसार आवेिन को स्ट्वीकृत अथवा जनरस्ट्त कर सकती ह।ै (8) खाद्य कारबार प्रचालक स्ट्वीकृजत प्राप्त होन े के बाि खाद्य सुरक्षा और मानक (खाद्य कारबार का अनुज्ञापन और रजिस्ट्रीकरण) जवजनयम, 2011 में जवजहत प्रदक्रया के अनुसार लाइसेंस प्राप्त करेगा। (9) इस जवजनयम के अनुसार िारी दकए गए सहमजत के पिात अजधकृत धारक और संबंजधत पािी स्ट्वीकृजत के साथ अजधरोजपत ितों और प्रजतबंधों का अनपु ालन करेग ें और साथ ही यह भी सुजनजित करेग ें दक ऐस े उत्पाि जिनपर स्ट्वीकृजत नहीं िी गई ह,ै को खाद्य के रूप में बािार में न उतारा िाए। (10) खाद्य कारबार प्रचालक अस्ट्वीकृजत पत्र प्राप्त होन े के 30 दिनों के भीतर खाद्य प्राजधकरण के अध्यक्ष के समक्ष अपील कर सकता ह।ै (11) खाद्य प्राजधकरण जलजखत में कारण बताते हुए दकसी खाद्य कारबार प्रचालक को दिए गए दकसी अनुमोिन का जनलंबन अथवा जनरसन कर सकती ह।ै (12) अनुमोिन होने के बाि दकसी खाद्य कारबार प्रचालक को यह जवश्वास हो िाने पर दक िीएम-खाद्य स्ट्वास्ट््य के जलए हाजनकर ह,ै ऐसी खाद्य वस्ट्तु का जनमााण, आयात, जवक्रय अथवा जवतरण तुरंत बंि करेगा और खाद्य सुरक्षा और मानक (खाद्य प्रत्याह्वान) जवजनयम, 2017 के उपबंधों के अनुसार, खाद्य प्राजधकरण को इस बात की सूचना िते े हुए, उस े वापस मंगाने के किम उिाएगा । (13) आर्थाक सहयोग और जवकास संगिन (ओईसीडी) के ‘जवजिष्ट पहचानकताा नौ-अंकीय कोड’ सजहत दकसी भी िीएमओ, जिसे खाद्य प्राजधकरण द्वारा खाद्य उपयोग के जलए अनुमोदित दकया गया ह,ै को अन्य दकसी प्रकार के अनुमोिन4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] की आवश्यकता नहीं होगी । हालांदक, यदि दकसी िीएमओ का प्रयोग बीि या पौध प्रसार सामग्री के रूप में दकया िाता ह ै तो ऐसी अवस्ट्था में िीईएसी स ेअनुमोिन आवश्यक ह।ै (14) जवजनयम 1 के उप-जनयम (2) के खंड (क) और (ख) में जवजनर्िाष्ट िीएमओ का उपयोग जिि ु आहार म ें सामग्री के रूप में नहीं दकया िाएगा। 5. लबे ललगं — (1) जवजनयम 1 के उप-जवजनयम (2) के खंड (क) और (ख) में संिर्भात सभी खाद्य उत्पािों पर ‘िीन पठरवर्तात िीव िाजमल ह’ैं िब्िों के साथ लेबल दकया िाना चाजहए यदि उत्पाि में अलग स े एक प्रजतित या अजधक िीएम संघिक मौिुि हो। (2) यह लेबल पहल े से पैक दकए गए उत्पािों के अग्र भाग पर दिखना चाजहए। (3) यह लेबललंग िीएम सामजग्रयों की तकनीकी या आकजस्ट्मक उपजस्ट्थजत की जस्ट्थजत में भी प्रयोज्य ह।ै (4) जवजनयम 1 के उप-जवजनयम (2) के खंड (ग) के अनुसार उन िीएम उत्पािों के जलए प्रयोज्य नहीं ह ै जिसम ें संिोजधत डीएनए का आसानी से पता ना लग पाए। (5) इसके अलावा, सभी िीएम-खाद्य, खाद्य सुरक्षा और मानक (पैकेलिंग) जवजनयम, 2018 एवं खाद्य सुरक्षा और मानक (लेबललंग और प्रििना ) जवजनयम, 2020 म ेंजवजनर्िाष्ट पकै ेलिंग और लेबललगं आवश्यकताओं का अनुपालन करेंगे। 6. अजधजनयम के तहत बनाए गए अन्य जवजनयमों के प्रावधानों का अपक्षे ाकृत अनपु ालन— इन जवजनयमों के प्रावधानों पर प्रजतकूल प्रभाव डाल े जबना सभी िीएम-खाद्य, खाद्य सुरक्षा और मानक (खाद्य उत्पाि मानक और खाद्य सहयोज्य) जवजनयम, 2011 के अंतगात आन े वाल े सभी संबंजधत प्रावधानों का अनुपालन करेगें। िीएम-खाद्य, खाद्य सुरक्षा और मानक (संिषू क, आजवष और अवजिष्ट) जवजनयम, 2011 के अंतगता आने वाले सभी संबंजधत प्रावधानों का भी अनपु ालन करेगें। एस गोपालकृष्णन, मुखय कायाकारी अजधकारी [जवज्ञापन-III/4/असा./414/2022-23] Food Safety and Standards Authority of India NOTIFICATION New Delhi, the 18 November, 2022 F. No. 1/Standards/GMO&F/Misc/FSSAI/2018.—The following draft regulations, which the Food Safety and Standards Authority of India proposes to make with previous approval of the Central Government, in exercise of the powers conferred by clause (v) of sub-section (2) of section 92 read with sub-section (2) of section 22 of the Food Safety and Standards Act, 2006 (34 of 2006) is hereby published as required under sub-section (1) of section 92 of the said Act 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 Gazette containing this notification 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 Safety and Standards Authority of India.[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5 Draft Regulations CHAPTER I General 1. Short title and commencement—(1) These regulations may be called the Food Safety and Standards (Genetically Modified Foods) Regulations, 2022. (2) They shall apply to- (a) Genetically Modified Organisms (GMOs) intended for food use. (b) Food ingredients produced from GMOs that contain modified DNA. (c) Food ingredients produced from GMOs that do not contain modified DNA. It includes ingredients/additives/processing aids derived from GMOs. (3) They shall come into force from the date of their publication in the Official Gazette. (4) They shall not apply to genome edited crops of SDN1 and SDN2 category. 2. Definitions— (1) In these regulations, unless the context otherwise requires: - (a) “Act” means the Food Safety and Standards Act, 2006 (34 of 2006); (b) “Approval” means a permission to manufacture or import any article of food or food ingredients produced from a GMO, intended directly or indirectly for human consumption; (c) “Conventional counterpart” means a similar food produced without the use of genetic modification and for which there is a well-established history of safe use; (d) “Food Authority” means the Food Safety and Standards Authority of India established under Section 4 of the Food Safety and Standards Act, 2006; (e) “GEAC” means Genetic Engineering Appraisal Committee under Ministry of Environment, Forest and Climate Change; (f) “Genetically Modified Food (GM-food)” means food and food ingredients composed of or containing genetically modified or genetically engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified organisms obtained through modern biotechnology; (g) “Genetically Modified or genetically engineered Organisms (GMO)” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; (h) “Genetically modified organism for food use” means a GMO that may be used as food or as a source material for the production of food; (i) “Modern Biotechnology” means the application of: (i) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (ii) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection; (j) “Modified DNA” means DNA, which as a result of the use of modern biotechnology, is different from the DNA present in the conventional counterpart; (k) “Produced from GMOs” means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] (2) The words and expressions used herein and not defined, but defined in the Act or rules or regulations made thereunder, shall have the meaning as assigned to them in the Act, rules or regulations. 3. Prior approval for manufacture, storage, distribution, sale and import etc.— (1) No person shall manufacture, pack, store, sell, market or otherwise distribute or import any food or food ingredient produced from GMOs, except with the prior approval of the Food Authority. (2) The provisions of these regulations are in addition to, and not in derogation of, any other rules or regulations made under the Act. 4. Procedure for grant of prior approval— (1) The food business operator (manufacturer/importer) of a GM-food shall submit an application as per the format prescribed by the Food Authority along with necessary documents and fee to the Food Authority. (2) If the application is for a GMO referred to as in clause (a) of sub-regulation (2) of regulation 1, clearance from Genetic Engineering Appraisal Committee (GEAC), the national competent authority for the environmental risk assessment shall be submitted to the Food Authority. (3) If a GMO referred to as in clause (a) of sub-regulation (2) of regulation 1 is to be used as seeds or other plant-propagating material (cultivation), food business operator shall parallelly submit an application to the GEAC, Ministry of Environment Forest and Climate Change (MoEF&CC) for compliance to Rules 1989 for ‘The manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells rules, 1989. The application may be submitted in the relevant Form IIB, Application for environmental approval of transgenic plants (Genetically Modified Plants) of GEAC. (4) In order to prepare its opinion, the Food Authority shall verify that the particulars and documents submitted by the applicant are in accordance with the information sought and examine whether the food is safe for human consumption. (5) The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required, within a specific time limit. (6) In giving its decision, the Food Authority shall endeavour to respect a time limit not exceeding six months from the receipt of a valid application. Such a time limit shall be extended whenever supplementary information from the applicant as provided for in sub-regulation (4) of regulation 4 is sought. (7) The Food Authority may either grant approval or reject the application as per the format prescribed by the Food Authority on the basis of the safety assessment of the food. (8) The food business operator shall, after grant of approval obtain a license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. (9) After an approval has been issued in accordance with this Regulation, the authorised holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the approval and shall in particular make sure that products not covered by the approval are not placed on the market as food. (10) The food business operator may file an appeal before the Chairperson of the Food Authority, within 30 days of receiving the letter of rejection. (11) The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator. (12) If a food business operator has reason to believe that the GM-food for which the approval was granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such an article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall Procedure) Regulations, 2017.[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 7 (13) A GMO, with a ‘Unique Identifier Nine-digit Code’ of the Organisation for Economic Cooperation and Development (OECD) that is approved for food use by the Food Authority, will require no further approvals. However, if the GMO is to be used as seed or other plant-propagating material, approval is required from GEAC. (14) GMOs as referred to in clause (a) and (b) of sub-regulation (2) of regulation 1 shall not be used as ingredients in infant foods. 5. Labelling— (1) All food products as referred to in clause (a) and (b) of sub-regulation (2) of regulation 1 must be labelled with the words ‘Contains genetically modified organisms’, if the product contains one percent or more of the GM ingredient considered individually. (2) This label must appear on the front of pack of pre-packaged products. (3) This labelling requirement also applies to adventitious or technically unavoidable presence of GM ingredients. (4) This labelling requirement is not applicable to GM-food products in which the modified DNA is not detectable as referred to in clause (c) of sub-regulation (2) of regulation 1. (5) In addition, all GM-foods shall comply with the packaging and labelling requirements specified under the Food Safety and Standards (Packaging) Regulations, 2018 and Food Safety and Standards (Labelling and Display) Regulations, 2020. 6. Requirement to comply with the provision of the other regulations made under the Act— Without prejudice to the provisions of these regulations, all GM-foods shall comply with the relevant provisions, as applicable, under the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. The GM-food shall also comply with relevant provisions, as applicable under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. S GOPALAKRISHNAN, Chief Executive Officer [ADVT.-III/4/Exty./414/2022-23] 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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