## Report on the Food Safety and Standards (Prohibition and Restrictions on Sales) Second Amendment Regulations, 2021
**1. Executive Summary:**
This report analyzes the Food Safety and Standards (Prohibition and Restrictions on Sales) Second Amendment Regulations, 2021, as published in the Gazette of India. This amendment focuses on restricting the amount of industrial trans fatty acids (iTFA) in food products where edible oils and fats are used as ingredients. Effective January 1, 2022, these products must not contain iTFA exceeding 2% by mass of the total oils/fats present. This report details the specific changes introduced by this amendment, its intended impact, and implications for food business operators (FBOs).
**2. Introduction:**
This report provides an overview and analysis of the Food Safety and Standards (Prohibition and Restrictions on Sales) Second Amendment Regulations, 2021 (hereafter referred to as "the Amendment"), based solely on the provided policy text. The purpose is to inform affected industry stakeholders about the specific changes introduced by this amendment and their implications.
**3. Policy Overview:**
* **Original Policy:** The Amendment modifies the Food Safety and Standards Prohibition and Restrictions on Sales Regulations, 2011.
* **Core Objective(s):** The core objective of this amendment, as inferred from the text, is to improve public health by limiting the amount of industrial trans fatty acids in food products.
**4. Background and Rationale:**
This amendment appears to address concerns about the health effects of industrial trans fatty acids in food. By setting a limit on iTFA content, the aim is to reduce consumer exposure to these potentially harmful fats.
**5. Key Provisions / Changes:**
This amendment introduces specific changes to the Food Safety and Standards Prohibition and Restrictions on Sales Regulations, 2011.
* **Specific Part of Original Policy Changed:** Regulation 2.3, in subregulation 2.3.14, after clause 20.
* **New Rule/Provision:** A new clause 21 is inserted, stating: "Food Products in which edible oils and fats are used as an ingredient shall not contain industrial trans fatty acids more than 2% by mass of the total oils/fats present in the product, on and from 01st January, 2022." An earlier clause 1.2 is also updated to provide a definition for "Industrial trans fatty acids" as "all the geometrical isomers of monounsaturated and polyunsaturated fatty acids having nonconjugated, interrupted by at least one methylene group, carbon carbon double bonds in the trans configuration. It excludes transfatty acids from dairy, meat, fish and their products."
* **Effect of Change:** This amendment sets a legally binding limit of 2% iTFA by mass in food products containing edible oils and fats. This limit requires FBOs to reformulate products and ensure compliance. The provided definition ensures clarity on what constitutes iTFAs that are covered under the regulation.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this amendment are:
* Food Business Operators (FBOs) involved in the manufacturing, processing, and sale of food products that use edible oils and fats as ingredients.
* Consumers, who will be indirectly affected by changes in food formulations.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies:** The Food Safety and Standards Authority of India (FSSAI) is the responsible body for implementing and enforcing these regulations.
* **Timelines:** FBOs must ensure compliance with this regulation for all products manufactured on or after January 1, 2022.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of this amendment is a reduction in consumer exposure to industrial trans fatty acids. This could lead to:
* Reformulation of food products by FBOs to meet the new iTFA limit.
* Potential health benefits for consumers due to reduced iTFA intake.
* Increased scrutiny and monitoring of food products by FSSAI to ensure compliance.
**9. Conclusion:**
The Food Safety and Standards (Prohibition and Restrictions on Sales) Second Amendment Regulations, 2021, represents a significant step towards reducing industrial trans fatty acids in the Indian food supply. By setting a clear limit on iTFA content, the amendment is likely to drive product reformulation and improve public health outcomes. FBOs need to proactively implement the changes required to comply with this regulation by the January 1, 2022 deadline.
Key Entities Referenced
Food Safety and Standards Authority of India: The regulatory body issuing the notification regarding amendments to food safety standards.
Food Safety and Standards Act, 2006: The primary legislation under which the regulations are being amended.
Food Safety and Standards Prohibition and Restrictions on Sales Regulations, 2011: The specific regulations being amended by this notification.
New Delhi: Location of the Food Safety and Standards Authority of India, where the notification was issued.
Food Safety and Standards Prohibition and Restrictions on Sales Second Amendment Regulations, 2021: The title of the amendment regulations.
Official Gazette: The official publication in which the regulations are published.
Industrial trans fatty acids: The specific type of fatty acids targeted by the regulation.
ARUN SINGHAL: Chief Executive Officer of Food Safety and Standards Authority of India
Government of India Press, Ring Road, Mayapuri, New Delhi: The location of the printing press.
Controller of Publications, Delhi: Publisher of the Gazette of India.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-04022021-224925
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असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 54] नई दिल्ली, र्बुधवार, फरवरी 3, 2021/माघ 14, 1942
No. 54] NEW DELHI, WEDNESDAY, FEBRUARY 3, 2021/MAGHA 14, 1942
भारतीय खाद्य सरु क्षा और मानक प्राजधकरण
अजधसचू ना
नई दिल्ली, 2 फरवरी, 2021
फा. स.ं मानक/ओएडं एफ/अजधसचू ना(13)/एफएसएसएआई-2019.—खाद्य सुरक्षा और (मानक जवक्रय प्रजतषेध
और जनर्बंधन) जवजनयम, 2011 और संिोधन करने के जलए कजतपय जवजनयमो का प्रारूप खाद्य सुरक्षा और मानक
अजधजनयम, 2006 (2006 का जवजनयम 34) की धारा 92 की उप-धारा (1) की अपेक्षानुसार,भारतीय खाद्य सुरक्षा और
मानक प्राजधकरण की अजधसचू ना स.ं फा. स.ं मानक/ओ और एफ/अजधसूचना(13)/एफएसएसएआई-2019, तारीख
28 अगस्ट्त, 2019 द्वारा भारत के रािपत्र, असाधारण, भाग III, खंड 4 म ें प्रकाजित दकया गया था,जिसम ें ऐसे सभी
व्यजियों स े जिनके उनस े प्रभाजवत होने की संभावना थी, उस तारीख स े जिसको उि अजधसूचना म ें अंतर्विष्ट रािपत्र की
प्रजतयााँ िनता को उपलब्ध कराई गई थी तीस दिन की अवजध की समाजि स े पूवि आक्षपे और सुझाव आमंजत्रत दकए गए थ;े
और उक्त रािपत्र की प्रजतया ाँिनता को तारीख 30 अगस्ट्त, 2019 को उपलब् ध करा िी गई थीं;
और उक्त जवजनयमों के प्रारूप पर िनता स े प्राप् त आक्षेपों और सुझावों पर भारतीय खाद्य सुरक्षा और मानक
प्राजधकरण द्वारा जवचार कर जलया गया ह;ै
698 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
अत: अर्ब भारतीय खाद्य सुरक्षा और मानक प्राजधकरण उि अजधजनयम की धारा 16 के साथ पठित धारा 92 की
उप-धारा (2) के खंड (ङ) द्वारा प्रित्त िजियों का प्रयोग करत े हुए, खाद्य सुरक्षा और मानक (जवक्रय प्रजतषेध और जनर्बंधन)
जवजनयम, 2011 का और संिोधन करने के जलए जनम्न जलजखत जवजनयम र्बनाता ह,ै अथाति ्:-
1.सजं क्षप्त नाम और प्रारंभ.- (1) इन जवजनयमों का संजक्षि नाम खाद्य सुरक्षा और मानक (जवक्रय प्रजतषेध और जनर्बंधन)
जद्वतीय संिोधन जवजनयम, 2021 ह।ै
(2) यह रािपत्र में इनके प्रकािन की तारीख को प्रवत्त होंगे और खाद्य कारोर्बार चालक को 1 िनवरी 2022 को
या उसके र्बाि जनर्मित सभी उत्पािों के जलए इन जवजनयमों के सभी उपर्बंधों का अनुपालन करना होगा।
2. खाद्य सुरक्षा और मानक (जवक्रय प्रजतषेध और जनर्बंधन), जवजनयम, 2011 म,ें-
(1) जवजनयम 1.2 म,ें खंड 1 के पश् चात, जनम्नजलजखत खडं अंत:स्ट्थाजपत दकया िाएगा, अथाित-
“2. “औद्योजगक रांस फैटी एजसड” स े मोनोअनसैचुरेटेड और पॉलीअनसेचुरेटेड फैटी एजसड के सभी ज्याजमतीय
समावयवों, जिनमेंगैर-संयुजममत िो कम स े कम एक जमथाइलीन समूह स े र्बाजधत, कार्बिन-कार्बिन युमम आर्बंध रांस
कॉजफ़िगरेिन म े होत े ह।ैं इनमिें मु ध उघोग, मांस, मछली और उनके उत्पािों से रांस-फैटी एजसड िाजमल नहीं ह।ै ”
(2) जवजनयम 2.3 के, उपजवजनयम 2.3.14 म,ें खंड (20) के पश् चात, जनम्न जलजख त को अत: स्ट्थाजपत दकया िाएगा,
अथाित-्
“(21) खाद्य उत्पाि, जिसम ें खाद्य तेलों और वसा का उपयोग एक सघं टक के रूप म ें दकया िाता ह,ै 1 िनवरी,
2022 स े उत्पाि म ेंरांस ़िैटी एजसड कुल तले ों/वसा के भार स े2% स े अजधक नहीं होगा।”
अरुण ससंघल, मुख्य कायिकारी अजधकारी
[जवज्ञापन-III/4/असा./488/2020-21]
ठटप्पण: मूल जवजनयम भारत के रािपत्र, असाधारण म ें अजधसूचना संख्या एफ. स.ं 2-15015/30/2010 तारीख
1 अगस्ट्त, 2011 द्वारा प्रकाजित दकए गए और पश् चातवत जनम्न अजधसूचना संख्याकों द्वारा संिोजधत दकए गएः–
(i) फा. स.ं 4/15015/30/2011, तारीख 8 फरवरी, 2013;
(ii) फा. स.ं स्ट्टैंडडिस्/ओ एडं एफ/अजधसूचना(2)/एफएसएसएआई-2016, तारीख 23 अगस्ट्त, 2016;
(iii) फा. स.ं स्ट्टैंडडिस्/एफ एडं वीपी/अजधसूचना(02)/एफएसएसएआई-2016, तारीख 23 अगस्ट्त, 2016;
(iv) फा. स.ं स्ट्टैंडडिस्/ओ एडं एफ/अजधसूचना(8)/एफएसएसएआई-2017, तारीख 31 िुलाई, 2018;
(v) फा. स.ं स्ट्टैंडडिस्/सहयोज्य-2/अजधसूचना/एफएसएसएआई/2018, तारीख 25 िून, 2019;
(vi) फा. स.ं स्ट्टैंडडिस्/साल्ट/जवजवध/01/एफएसएसएआई-2016(भाग-1), तारीख 25 िून, 2019;
(vii) फा. स.ं स्ट्टैंडडिस्/सहयोज्य-3/अजधसूचना/एफएसएसएआई/2018, तारीख 21 िुलाई, 2020;
(viii) फा. स.ं मानक/एगमाकि-र्बीआईएस/02/एफएसएसएआई-2018, तारीख 20 अक्टूर्बर, 2020;
(ix) फा. स.ं स्ट् टैंड्सि/ओ एण्ड एफ/अजधसूचना(12)/एफएसएसएआई-2019, तारीख 26 अक्टूर्बर, 2020; और
(x) फा. स.ं जवजनयम/स्ट्टैंडडिस-् केसरी िाल/एफ.एस.एस.ए.आई.-2020, तारीख 12 िनवरी, 2021.[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 2nd February, 2021
F. No. Stds/O&F/Notification(13)/FSSAI-2019.—Whereas the draft of certain regulations further to amend
the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, was published as required
by sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food
Safety and Standards Authority of India number File No. Stds/O&F/Notification(13)/FSSAI-2019, dated the 28th
August, 2019, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the
persons likely to be affected thereby, before the expiry of the period of thirty days from the date on which the copies
of the Official Gazette containing the said notification were made available to the public;
And whereas the copies of the said Gazette were made available to the public on the 30th August, 2019;
And whereas the objections and suggestions received from the public in respect of the said draft regulations
have been considered by the Food Safety and Standards Authority of India;
Now, therefore, in exercise of the powers conferred by clause (e) of sub-section (2) of section 92 read with
section 16 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations
further to amend the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, namely :-
1. Short title and commencement.—(1) These regulations may be called the Food Safety and Standards
(Prohibition and Restrictions on Sales) Second Amendment Regulations, 2021.
(2) They shall come into force on the date of their publication in the Official Gazette and Food Business
Operator shall ensure compliance to all the provisions of these regulations for all the products manufactured on
or after 1st January, 2022.
2. In the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011,-
(1) in regulation 1.2, after clause 1, the following clause shall be inserted, namely-
“2. “Industrial trans fatty acids” means all the geometrical isomers of monounsaturated and
polyunsaturated fatty acids having non-conjugated, interrupted by at least one methylene group, carbon-
carbon double bonds in the trans configuration. It excludes trans-fatty acids from dairy, meat, fish and their
products.”;
(2) in regulation 2.3, in sub-regulation 2.3.14, after clause (20), the following clause shall be inserted, namely-
“(21) Food Products in which edible oils and fats are used as an ingredient shall not contain industrial
trans fatty acids more than 2% by mass of the total oils/fats present in the product, on and from 01st
January, 2022.”.
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./488/2020-21]
Note : The principal regulations were published in the Gazette of India, Extraordinary vide notification number
F. No. 2-15015/30/2010, dated the 1st August, 2011 and subsequently amended vide notification numbers:
i. F. No. 4/15015/30/2011, dated the 8th February, 2013;
ii. F. No. Stds/O&F/Notification (2)/FSSAI-2016, dated the 23rd August, 2016;
iii. F. No. Stds/F&VP/Notification (02)/FSSAI-2016, dated the 23rd August, 2016;
iv. F. No. Stds/O&F/Notification (8)/FSSAI-2017, dated the 31st July, 2018;
v. F. No. Stds/Additives-2/Notification/FSSAI/2018, dated the 25th June, 2019;
vi. F. No. Stds/Salt/Misc/01/FSSAI-2016 (pt-1), dated the 25th June, 2019;
vii. F. No. Stds/Additive-3/notification/FSSAI/2018, dated 21st July, 2020;
viii. F. No. Stds/Agmark-BIS/02/FSSAI-2018, dated 20th October, 2020:
ix. F. No. Stds/O&F/Notification(12)/FSSAI-2019, dated 26th October, 2020: and
x. F. No. Reg/Stds-Khesari dal/FSSAI-2020, dated 12th January, 2021.
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and Published by the Controller of Publications, Delhi-110054.