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Date: 18-Feb-2025 Category: Extra Ordinary State: Union Government Country: India

The following draft of certain regulations further to amend the Food Safety and Standards Laboratory and Sample Analysis Regulations

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 (Laboratory and Sample Analysis) Regulations, 2011.
  • The amendments address procedures for food sample testing and analysis by laboratories.

Key Changes

  • Amendment to regulation 2.3.1: Specifies that the referral food laboratory director or the Food Analyst must provide a duly signed certificate or report to the sender immediately after testing or analysis, using the form prescribed under FSS Rules, 2011.
  • Amendment to regulation 2.3.1: For unspecified products, the quantity of sample drawn for testing will be as per the guidelines issued by the Food Authority from time to time.
  • Insertion of regulation 2.5: Mandates the use of analysis methods from manuals amended or adopted by the Authority for food sample analysis. If a method isn't available in these manuals, the Food Laboratory may adopt validated methods from specified internationally recognized regulatory agencies.
  • Insertion of regulation 2.6: Specifies timelines for analysis. Food Analysts must issue a signed report within 14 days of receiving a food sample for analysis under FSS Rules, 2011. If the 14-day timeline cannot be met, the analyst must inform the Designated Officer and the Commissioner of Food Safety, providing reasons and the estimated time for analysis.
  • Regulation 2.6.2: For appeals, referral laboratories must issue a director-signed report within 14 days of sample receipt, as per FSS Rules, 2011. A similar notification process is required if the timeline cannot be met.
  • Regulation 2.6.3: For imports, notified or referral laboratories must provide the laboratory analysis report within five days from the date of sample receipt, as per FSS (Import) Regulations, 2017. If the timeline cannot be met, the laboratory must provide a written explanation to the Authorised Officer.
  • Forms A and B are removed from the regulation.

Impact Analysis

Food Businesses

  • Action Item: Update internal processes to align with the new regulations, particularly regarding sample submission and expected turnaround times for analysis reports.

Food Laboratories

  • Action Item: Review and update laboratory procedures to comply with the new analysis methods and timelines. Implement a system for tracking sample analysis progress and notifying authorities of any delays.

Regulatory Authorities (FSSAI, Designated Officers, Commissioners of Food Safety)

  • Action Item: Develop and implement training programs for food safety officers and laboratory personnel on the new regulations. Establish a monitoring mechanism to ensure compliance with the specified timelines and procedures.

Consumers

  • Action Item: No direct action required, but increased transparency and faster analysis reporting will indirectly benefit consumers by ensuring safer food products.

Key Entities Referenced

Food Safety and Standards Authority of India (FSSAI): The primary authority responsible for food safety and standards in India. It proposes and implements regulations related to food safety. Food Safety and Standards Act, 2006: The principal legislation governing food safety and standards in India. Section 92 empowers FSSAI to make regulations. Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011: The regulations being amended by this notification, concerning procedures for food sample testing and analysis. FSS Rules, 2011: Rules under the Food Safety and Standards Act, 2006, which prescribe the form for analysis reports. FSS (Import) Regulations, 2017: Regulations governing the import of food items into India, including requirements for laboratory analysis. Referral Food Laboratory: A laboratory designated for resolving disputes related to food analysis results. Food Analyst: A qualified professional responsible for analyzing food samples in a laboratory. Designated Officer: An officer appointed by the Food Authority to oversee food safety matters in a specific area. Commissioner of Food Safety: The head of the food safety administration in a state or union territory. AOAC/ ISO / Pearson’s/ Jacob/ IUPAC/ Food Chemicals CODEX/ BIS/ Codex Alimentarius/ Woodmen/ Winton-Winton/ Joslyn: Internationally recognized regulatory agencies whose validated methods of analysis may be adopted by Food Laboratories.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-19022025-261172 xxxGIDHxxx CG-DL-E-19022025-261172 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 133] नई दिल्ली, मगं लवार, फरवरी 18, 2025/माघ 29, 1946 No. 133] NEW DELHI, TUESDAY, FEBRUARY 18, 2025/MAGHA 29, 1946 भारतीय खाद्य सरु क्षा और मानक प्राजधकरण अजधसचू ना नई दिल्ली, 17 फरवरी, 2025 फा. स.ं क्यएू /11023/31/2022-क्यएू -एफएसएसएआई(2).—कजतपय जवजनयमों का प्रारूप, खाद्य सरु क्षा और मानक (प्रयोगिाला और नमूना जवश्लेषण) जवजनयम, 2011 का और सिं ोधन करने के जलए, जिसे भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केन्द्रीय सरकार के पूवव अनुमोिन स,े खाद्य सुरक्षा और मानक अजधजनयम, 2006 (2006 का 34) की धारा 92 की उप–धारा (2) द्वारा प्रित्त िजियों का प्रयोग करत ेहुए बनाने का प्रस्ट्ताव करता ह,ै उक्त्त अजधजनयम की धारा 92 की उप–धारा (1) द्वारा यथा अपेजक्षत सभी संभाव्य 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 प्रजतया ाँ 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 मख्ु य कायवकारी अजधकारी, भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, एफडीए भवन, कोटला रोड, नई दिल्ली – 110002 को संबोजधत दकया िा सकता ह ै अथवा regulation@fssai.gov.in पर ई-मले के माध्यम से भेिा िा सकता ह।ै उि प्रारूप जवजनयमों के संबंध में दकसी व्यजि से इस प्रकार जवजनर्िवष्ट अवजध की समाजि से पूवव प्राि आक्षेपों और सूझावों पर भारतीय खाद्य सुरक्षा और मानक प्राजधकरण द्वारा जवचार दकया िाएगा । 1255 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] प्रारूप जवजनयम 1. इन जवजनयमों का संजक्षि नाम खाद्य सुरक्षा और मानक (प्रयोगिाला और नमनू ा जवश्लेषण) संिोधन जवजनयम, 2025 ह।ै 2. खाद्य सुरक्षा और मानक (प्रयोगिाला और नमूना जवश्लेषण) जवजनयम, 2011 के अन्द्तगवत, (1) जवजनयम 2.3 म,ें उप- जवजनयम 2.3.1 म,ें - (क) खंड 2 के स्ट्थान पर, जनम्नजलजखत को प्रजतस्ट्थाजपत दकया िाएगा, अथातव ्: - “2. एफएसएस अजधजनयम, 2011 के तहत परीक्षण या जवश्लेषण के पश्चात, रेफरल खाद्य प्रयोगिाला के जनिेिक द्वारा जवजधवत हस्ट्ताक्षररत प्रमाण पत्र या खाद्य जवश्लेषक द्वारा हस्ट्ताक्षररत ररपोटव जनधावररत प्रपत्र म ें प्रेषक को तरु ंत प्रिान की िाएगी।”; (ख) खंड 4 में “परन्द्तु यह और दक” से िुरू होने वाले और “खाद्य जवश्लेषक” पर समाि होने वाले प्रावधान के जलए जनम्नजलजखत का प्रजतस्ट्थापन दकया िाएगा, अथावत : - “परन्द्त ु यह और दक अजनर्िष्टव उत्पािों के संबंध में प्रयोग दक िान े वाली मात्रा खाद्य प्राजधकरण द्वारा समय – समय पर िारी दििा जनिेिों के अनुसार होगी।”; (2) जवजनयम 2.4 के पश्चात, जनम्नजलजखत जवजनयम को प्रजतस्ट्थाजपत दकया िाएगा, अथावत:् - “2.5 जवश्लषे ण की जवजध- 2.5.1 खाद्य पिाथ वनमूना जवश्लेषण के जलए प्राजधकरण द्वारा समय – समय पर संिोजधत या अपनाई गई जवश्लेषण पद्धजत की जनयम पुजस्ट्तका (मैनअु ल) का उपयोग दकया िाएगा। दकसी मानिंड का जवश्लेषण करने की जवजध इन जनयम पुजस्ट्तका (मनै ुअल) म ें उपलब्ध ना होन े की जस्ट्थजत म,ें खाद्य प्रयोगिाला एओएसी/ आईएसओ/ जपयसवन/िैकब/आईयपू ीएसी/खाद्य रसायन कोडक्े स/ बीआईएस/ कोडेक्स एजलमेंटेररयस/ वुडमेन/ववंटन– ववंटन/िोसजलन या अन्द्तराष्ट्रीय स्ट्तर पर मान्द्यता प्राि दकसी जनयामक एिेंसी की मान्द्य जवजध अपना सकती ह।ै ”; (3) जवजनयम 2.5 के पश्चात, जनम्नजलजखत जवजनयम को प्रजतस्ट्थाजपत दकया िाएगा, अथावत:् - “ 2.6 जवश्लषे ण की समय सीमा - 2.6.1 जवजनयामक नमनू :े- (1) एफएसएस जनयम, 2011 के तहत खाद्य जवश्लेषक, जवश्लेषण के जलए खाद्य पिाथ व प्राजि के 14 दिनों के भीतर जनर्िवष्ट प्रारूप म ेंएक हस्ट्ताक्षररत ररपोटव िारी करेगा। परन्द्तु यह दक पावजत प्राि होने के 14 दिनों के भीतर नमूना जवश्लेषण नहीं दकए िाने की जस्ट्थजत में खाद्य जवश्लेषक जवश्लेषण के जलए लगने वाले अजतररि समय को जनर्िवष्ट करत े हुए एवं उसका कारण बताते हुए अजभनाजमत अजधकारी और खाद्य सुरक्षा आयुि को सूचना प्रिान करेगा। (2) एफएसएस जनयम, 2011 के तहत अपील की जस्ट्थजत में रेफरल प्रयोगिाला जनर्िष्टव प्रारूप के अनुसार नमूना प्राि होन े के 14 दिनों के भीतर जनिेिक द्वारा हस्ट्ताक्षररत ररपोटव िारी करेगा। परन्द्तु यह दक पावजत प्राि होने के 14 दिनों के भीतर नमूना जवश्लेषण नहीं दकए िाने की जस्ट्थजत में खाद्य जवश्लेषक, जवश्लेषण के जलए लगन े वाले अजतररि समय को जनर्िवष्ट करते हुए एव ं उसका कारण बतात े हुए अजभनाजमत अजधकारी और खाद्य सुरक्षा आयुि को सूचना प्रिान करेगा। 2.6.2 आयात: एफएसएस (आयात) जवजनयम, 2017 के तहत अजधसूजचत या रेफरल प्रयोगिाला, जस्ट्थजत के अनुसार, नमनू े की पावजत प्राि होन े की जतजथ स े पााँच दिनों के भीतर जनर्िवष्ट प्रारूप के अनसु ार प्रयोगिाला जवश्लेषण ररपोटव प्रिान करेगा ।[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 परन्द्तु यह दक यदि नमूने का परीक्षण जनर्िष्टव समय के भीतर प्रयोगिाला द्वारा नहीं दकया िा सकता ह ै तो उसे प्राजधकृत अजधकारी को जलजखत रूप में इसका कारण बताना होगा।“; (4) जवजनयम के अन्द्तगवत प्रपत्र क और प्रपत्र ख को जवलोजपत कर दिया िाएगा । िी. कमलावधवन राव, मुख्य कायवकारी अजधकारी [जवज्ञापन-III/4/असा./990/2024-25] रटप्पण: मूल जवजनयम भारत के रािपत्र, असाधारण भाग 3 खंड 4 में, अजधसूचना संख्या फा. सं. 2–15015/30/2010 दिनांक 1 अगस्ट्त, 2011 द्वारा प्रकाजित हुई थी और अंजतम सिं ोधन अजधसूचना संख्या फा.स.ं 11023/24/2017- क्युए, दिनांक 15 अिुबर, 2020 के माध्यम स े की गई थी । FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA NOTIFICATION New Delhi, the 17th February, 2025 F. No. QA/11023/31/2022-QA-FSSAI(2).—The following draft of certain regulations further to amend the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011, 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) 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 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 Safety and Standards Authority of India. Draft Regulations 1. These regulations may be called the Food Safety and Standards (Laboratory and Sample Analysis) Amendment Regulations, 2025. 2. In the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011,- (1) in regulation 2.3, in sub-regulation 2.3.1,- (a) for clause 2, the following shall be substituted, namely: - “2. After test or analysis, the certificate thereof duly signed by the Director of the Referral Food Laboratory or the report signed by the Food Analyst shall be supplied forthwith to the sender in Form as prescribed under FSS Rules, 2011.”; (b) in clause 4, for the proviso starting with “Provided further that” and ending with “the Food Analyst”, the following shall be substituted, namely: - “Provided further that in case of the unspecified products, the quantity drawn shall be as per the guidelines issued by Food Authority from time to time.”; (2) after regulation 2.4, the following regulation shall be inserted, namely: - “2.5 Method of Analysis- 2.5.1 The manuals of the method of analysis, as amended or adopted by the Authority from time to time, shall be used for analysing the samples of food articles. However, in case the method for analysing any4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] parameter is not available in these manuals, the Food Laboratory may adopt a validated method of analysis prescribed by AOAC/ ISO / Pearson’s/ Jacob/ IUPAC/ Food Chemicals CODEX/ BIS/ Codex Alimentarius/ Woodmen/ Winton-Winton/ Joslyn or any other internationally recognized regulatory agencies.”; (3) after regulation 2.5, the following regulation shall be inserted, namely: - “2.6 Timeline for Analysis- 2.6.1 Regulatory samples:- (1) The Food Analyst shall issue the signed report within 14 days of the receipt of the article of food for analysis as per the format specified under FSS Rules, 2011. Provided that in case the sample cannot be analysed within 14 days of its receipt, the Food Analyst shall inform the Designated Officer and the Commissioner of Food Safety giving reasons and specifying the time to be taken for analysis. (2) In case of appeal, referral laboratory shall issue the report signed by the Director within 14 days of receipt of sample as per the format specified under FSS Rules, 2011. Provided that in case the sample cannot be analysed within 14 days of its receipt, the referral laboratory shall inform the Designated Officer and the Commissioner of Food Safety giving reasons and specifying the time to be taken for analysis. 2.6.2 Import: Notified laboratory or referral laboratory as the case may be, shall provide the laboratory analysis report as per the format specified under FSS (Import) Regulations, 2017 within five days from the date of receipt of the sample. Provided that in case the sample cannot be tested by the laboratory within the specified time it shall state the reasons for the same in writing to the Authorised Officer.”; (4) in regulation, the FORM A and FORM B shall be omitted. G. KAMALA VARDHANA RAO, Chief Executive Officer [ADVT.-III/4/Exty./990/2024-25] Note: The principal regulations were published in the Gazette of India, Extraordinary Part III, Section 4, vide notification number F. No. 2-15015/30/2010, dated 1st August, 2011 and last amended vide notification number F. No. 11023/24/2017-QA, dated 15th October, 2020. 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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