Okay, here is a policy analysis report based on the provided text, formatted as requested:
**Policy Analysis Report: Amendment to Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011**
**1. Executive Summary:**
This report analyzes an amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, as published in the Gazette of India on September 6, 2021. The amendment focuses on infant nutrition products, mandating Bureau of Indian Standards (BIS) certification for their manufacture, sale, storage, and exhibition for sale, wherever BIS standards are available. This change aims to enhance the safety and quality of infant nutrition products available in the market.
**2. Introduction:**
This report provides an overview and analysis of the amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, as detailed in the provided Government of India notification. The analysis focuses on the key changes, their potential impact, and relevant implementation aspects, based solely on the information presented in the document.
**3. Policy Overview:**
* **Original Policy:** Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011.
* **Core Objective(s):** While the full scope of the original policy isn't contained in the text, the core objective *of this amendment* is to ensure the safety and quality of food products through standardization and certification, specifically targeting infant nutrition.
**4. Background and Rationale:**
* **Amendment Rationale:** The amendment suggests a perceived need to strengthen the regulatory oversight of infant nutrition products. By mandating BIS certification, the aim is likely to address concerns regarding the quality, safety, and nutritional adequacy of these products available to consumers. The amendment implies that reliance solely on existing regulations was deemed insufficient, and a more stringent standard through mandatory BIS certification is required to safeguard infant health.
**5. Key Provisions / Changes:**
* **Specific Part of Original Policy Changed:** Regulation 2.3, sub-regulation 2.3.14, clause 4 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011.
* **New Rule/Provision:** The amendment substitutes the existing clause 4 with a new provision stating: "No person shall manufacture, sell, store or exhibit for sale food for infant nutrition, except under Bureau of Indian Standards BIS Certification Mark, wherever BIS standards available."
* **Difference/Effect of Change:** Previously, the regulation seemingly did not explicitly mandate BIS certification for infant nutrition products (based on the amendment implying a change). The amendment introduces a *mandatory* requirement for BIS certification. This means that manufacturers, sellers, storage providers, and exhibitors of infant nutrition products must now obtain BIS certification where applicable standards exist, effectively raising the bar for product quality and safety and creating a barrier to entry for non-compliant products.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this amendment include:
* Manufacturers of infant nutrition products.
* Sellers and distributors of infant nutrition products.
* Storage facilities for infant nutrition products.
* Retailers and exhibitors of infant nutrition products.
* Ultimately, consumers of infant nutrition products (infants and their parents/caregivers) will be indirectly affected.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:**
* Food Safety and Standards Authority of India (FSSAI) is responsible for implementing and enforcing the regulation.
* Bureau of Indian Standards (BIS) is responsible for providing the certification mark.
* **Timelines/Procedures:** The notification states that the draft regulations will be taken into consideration after 60 days from the date of publication in the Official Gazette. This suggests a 60-day period for stakeholders to submit objections or suggestions. The exact timeline for manufacturers to achieve BIS certification is not specified in this text.
* **Amendment Specific Implementation:** Manufacturers will need to apply for and obtain BIS certification for their infant nutrition products. Retailers and distributors will need to ensure that the products they sell and store are BIS certified.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this amendment are:
* Improved quality and safety of infant nutrition products available in the market.
* Increased consumer confidence in infant nutrition products bearing the BIS mark.
* Elimination of substandard or unsafe infant nutrition products from the market (where BIS standards exist).
* Potential increase in compliance costs for manufacturers.
* Possible temporary disruption in supply chains as manufacturers adjust to the new requirements.
**9. Conclusion:**
The amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, mandating BIS certification for infant nutrition products, represents a significant step towards enhancing the safety and quality of these products. By imposing a stricter regulatory standard, the FSSAI aims to protect infant health and ensure that only certified products are available to consumers. The impact of this amendment will be felt across the industry, from manufacturers to retailers, and ultimately benefit consumers by providing safer and more reliable infant nutrition options.
Key Entities Referenced
Food Safety and Standards Authority of India: An authority that proposes to amend the Food Safety and Standards Prohibition and Restrictions on Sales Regulations, 2011.
Food Safety and Standards Prohibition and Restrictions on Sales Regulations, 2011: A set of regulations being amended by the Food Safety and Standards Authority of India.
Central Government: The government that provides previous approval for the Food Safety and Standards Authority of India's actions.
Food Safety and Standards Act, 2006: The act under which the Food Safety and Standards Authority of India exercises its powers.
Chief Executive Officer, Food Safety and Standards Authority of India: The recipient of objections or suggestions regarding the draft regulations.
FDA Bhawan, Kotla Road, New Delhi: Address of the Food Safety and Standards Authority of India.
Food Safety and Standards Prohibition and Restrictions on Sales Amendment Regulations, 2021: The name of the amended regulations.
Bureau of Indian Standards: Certification mark required for food for infant nutrition.
BIS Certification Mark: Certification mark required for food for infant nutrition.
ARUN SINGHAL: Chief Executive Officer
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E0x7xx0 92021-229462
CG-DL-E-07092021-229462
असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 372] नई ददल्ली, सोमिार, जसतम्ब र 6, 2021/भार 15, 1943
No. 372] NEW DELHI, MONDAY, SEPTEMBER 6, 2021/BHADRA 15, 1943
भारतीय खाद्य सुरक्षा और मानक प्राजधकरण
अजधसचू ना
नई ददल्ली, 6 जसतम्बर, 2021
फा.स.ं स्ट्टैंडडडस/03/अजधसचू ना (आई एफ आर)/एफएसएसएआई-2017(पाटड-3).—कजतपय जिजनयमों में आगे
संिोधन हते ु खाद्य संरक्षा एिं मानक (जिक्रय पर प्रजतेेध और जनबबंधधन) जिजनयम, 2011, जिस में भारतीय खाद्य संरक्षा
एिं मानक प्राजधकरण, केन्द रीय सरकार के पूिड अनुमोदन के साथ जनम् न प्राुपप बनाने का प्रस्ट् ताि करता ह, खाद्य संरक्षा और
मानक अजधजनयम, 2006 (2006 का 34) की धारा 92 की उप-धारा (2) के अधीन अपनी िजियों का प्रयोग करते हुए,
एतदद्वारा प्रभाजित होने िाले संभाजित सभी व्य जियों को सूचना दने े के जलए उक् त अजधजनयम की धारा 92 की उप-धारा
(1) की अपेक्षा के अनुसार प्रकाजित करती ह और एतदद्वारा नोटटस ददया िाता ह दक उक् त प्राूपप जिजनयमों पर उस जतजथ
से साठ ददनों की अिजध समाप् त होने के बाद जिचार दकया िाएगा, जिस जतजथ को इस अजधसूचना को प्रकाजित करने िाले
रािपत्र की प्रजतयााँ िनता को उपलब्ध कराई िाएाँगी
आपजि अथिा सुझाि, यदद कोई हो, मुख् य कायडकारी अजधकारी, भारतीय खाद्य संरक्षा और मानक प्राजधकरण, एफडीए
भिन, कोटला रोड़, नई ददल् ली-110002 को अथिा ईमेल द्वारा regulation@fssai.gov.in पर भेिी िा सकती ह
आपजियां अथिा सुझाि, िो दकसी भी व्य जि से उक् त प्राुपप जिजनयमों के संबंध में प्राप् त दकए िाएंगे, उपरोक् त
जिर्ननददष्ट अिजध की समा जि से पहले, खाद्य प्राजधकरण द्वारा उन पर जिचार दकया िाएगा
4941 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
प्राूपप जिजनयम
1. इन जिजनयमों को खाद्य संरक्षा और मानक (जिक्रय पर जनबबंधधन और प्रजतेेध) संिोधन जिजनयम, 2021 कहा िा सकता
ह
2. खाद्य संरक्षा और मानक (जिक्रय पर जनबबंधधन और प्रजतेेध) जिजनयम, 2011 के जिजनयम 2.3 में, उप-जिजनयम 2.3.14
में, उपिाक्य (4) के स्ट्थान पर जनम्नजलजखत िब्दों को प्रजतस्ट्थाजपत दकया िाए, अथाडत ्ः
“भारतीय मानक ब्यूरो (बीआईएस) के प्रमाणन जचह्न, िहााँ भी बीआईएस मानक उपलब्ध हों, के अजतटरि कोई
भी व्यजि जििु पोेण के जलए खाद्य का उत्पादन, जिक्रय, संग्रह अथिा जिक्रय हते ु प्रदिडन नहीं करेगा ”
अुपण ससघल, मुख् य कायडकारी अजधकारी
[जिज्ञापन-III/4/असा./236/2021]
नोट - मुख् य जिजनयम भारत के रािपत्र, असाधारण में अजधसूचना सं. फाइल सं. 2-15015/30/2010, ददनांक 1 अगस्ट् त,
2011 के माध्य म से प्रकाजित हुए थ े और बाद में जनम् नजलजखत अजधसूचनां द्वारा संिोजधत दकए गए:
(i) फा. सं.4/15015/30/2011, ददनांक 8 फरिरी, 2013;
(ii) फा. सं. स्ट्टैंडर्डसड/ओ एि ं एफ/अजधसूचना (2)/एफएसएसएआई-2016, ददनांक 23 अगस्ट्त, 2016;
(iii) फा. सं. स्ट्टैंडर्डसड/एफ एि ं िीपी/अजधसूचना (02)/एफएसएसएआई-2016, ददनाक 23 अगस्ट्त, 2016;
(iv) फा. सं. ए-1(1)/मानक/एम.एम.पी/2012, ददनाक 12 अिूबर, 2017;
(v) फा. सं. स्ट्टैंडर्डसड/ओ एि ं एफ/अजधसूचना (8)/एफएसएसएआई-2017, ददनांक 31 िुलाई, 2018;
(vi) फा.सं. मानक/साल्ट/एमआईएससी (01)/ एफएसएसएआई-2016 (पीटी-1), ददनांक 25 िून, 2019;
(vii) फा.सं. मानक/सहयोज्य/2-अजधसूचना/एफएसएसएआई-2018, ददनांक 25 िून, 2019;
(viii) फा. स. स्ट्टैंडर्डसड/सहयोज्य-3/अजधसूचना/एफएसएसएआई/2018, ददनांक 21 िुलाई, 2020;
(ix) फा. सं. मानक/एगमाकक-बीआईएस/02/एफएसएसएआई-2018, ददनांक 20 अिूबर, 2020;
(x) फा. सं. मानक/ओएंडएफ/अजधसूचना(12)/एफएसएसएआई-2019, ददनांक 26 अिूबर, 2020;
(xi) फा. सं. जिजनयम/ स्ट्टैंडर्डसड-केसरी दाल/एफ.एस.एस.ए.आई.-2020, 12 िनिरी, 2021;
(xii) फा. सं. मानक/ओएंडएफ/अजधसूचना(13)/एफएसएसएआई-2019, 2 फरिरी, 2021; तथा
(xiii) फा. सं. स्ट्टैंडर्डसड/एसपी-15/टी(टी(आईएमएसटी), ददनांक 8 माचड, 2021[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 6th September, 2021
F. No. Stds/03/Notification(IFR)/FSSAI-2017(part-3).—The following draft of certain regulations, further
to amend the Food Safety and Standards (Prohibition and Restrictions on Sales ) 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) 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 Regulations
1. These regulations may be called the Food Safety and Standards (Prohibition and Restrictions on Sales)
Amendment Regulations, 2021.
2. In the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, in regulation 2.3,
in sub-regulation 2.3.14, for clause (4) the following shall be substituted, namely,-
“No person shall manufacture, sell, store or exhibit for sale food for infant nutrition, except under Bureau of
Indian Standards (BIS) Certification Mark, wherever BIS standards available”.
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./236/2021
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 8thFebruary, 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. A-1 (1)/Standards/MMP/2012, dated 12th October, 2017;
(v) F. No. Stds/O&F/Notification (8)/FSSAI-2017, dated the31st July, 2018;
(vi) F.No. Stds/Salt/Misc/01/FSSAI-2016 (pt-1), dated 25th June, 2019;
(vii) No. Stds/Additives-2/Notification/FSSAI/2018, dated 25th June, 2019;
(viii) F. No. stds/Additive-3/notification/FSSAI/2018, dated the21st July, 2020;
(ix) F. No. Stds/Agmark-BIS/02/FSSAI-2018, dated 20th October, 2020;
(x) No. Stds/O&F/Notification(12)/FSSAI-2019, dated 26th October, 2020;
(xi) F.No.Reg/Stds-Khesari dal/FSSAI-2020, dated 12th January, 2021;
(xii) F. No. Stds/O&F/Notification(13)/FSSAI-2019, dated 2nd February, 2021; and
(xiii) F. No. Stds/SP-15/T(T(IMST), dated the 8th March, 2021.
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.