## Policy Analysis Report: Food Safety and Standards Packaging Amendment Regulations, 2021
**1. Executive Summary:**
This report analyzes the Food Safety and Standards Packaging Amendment Regulations, 2021, as notified by the Food Safety and Standards Authority of India (FSSAI) on September 6, 2021. This amendment modifies the Food Safety and Standards Packaging Regulations, 2018. The core purpose of the amendment is to introduce new limits for antimony and phthalic acid (bis 2-ethylhexyl ester - DEHP) in food packaging materials. Key findings highlight the addition of these substances and their maximum permissible limits to Table 1 of regulation 4, subregulation 4.
**2. Introduction:**
This report aims to provide a comprehensive overview of the Food Safety and Standards Packaging Amendment Regulations, 2021, based solely on the provided policy text. It focuses on understanding the changes introduced by this amendment and their potential implications.
**3. Policy Overview:**
* **Amendment to:** Food Safety and Standards Packaging Regulations, 2018 (File No. 195StdsPackagingSPLCAFSSAI2017, dated the 24th December, 2018).
* **Core Objective(s):** The objective, inferred from the text, is to enhance food safety standards by regulating the permissible levels of specific chemicals (antimony and phthalic acid) in food packaging materials. This is achieved through amendments to existing packaging regulations.
**4. Background and Rationale:**
This is an amendment to existing regulations. The rationale for this *specific* amendment, inferred from the text, is to address potential risks associated with the migration of antimony and phthalic acid (DEHP) from packaging materials into food. By setting maximum limits, the amendment likely aims to minimize consumer exposure to these substances, ensuring a higher level of food safety. The specific need for these particular additions is not stated, but we can infer a perceived or demonstrated risk that warranted their inclusion.
**5. Key Provisions / Changes:**
This section focuses specifically on the *changes* introduced by the amendment text:
* **Specific Part of Original Policy Changed:** Regulation 4, subregulation 4, Table 1 of the Food Safety and Standards Packaging Regulations, 2018.
* **New Rule/Provision:** Two new entries are *inserted* into Table 1 after Sl. No. 7:
* Sl. No. 8: Antimony with a limit of 0.04
* Sl. No. 9: Phthalic acid, bis 2-ethylhexyl ester (DEHP) with a limit of 1.5
* **Difference/Effect of Change:** The amendment introduces *new limits* for antimony and phthalic acid (DEHP) that were previously not specified in Table 1. This means that food packaging materials must now adhere to these specific limits for these substances. Packaging exceeding these limits would likely be deemed non-compliant.
**6. Target Audience and Stakeholders:**
The target audience and stakeholders directly affected by *these changes* include:
* Manufacturers of food packaging materials.
* Food processors and manufacturers who use these packaging materials.
* Potentially, importers of food products using the concerned packaging.
* Consumers, who benefit from increased food safety.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Food Safety and Standards Authority of India (FSSAI) is responsible for implementing and enforcing these amended regulations.
* **Timelines or Procedures:** The text specifies a period of sixty days from the date of gazette notification (September 6, 2021) for stakeholders to submit objections or suggestions. This indicates a period for consultation before the regulations become fully effective. We can infer that after this consultation period, there will be enforcement of the updated standards, though specific procedures are not detailed in the text. The specific date on which the changes come into force, is not included.
* **Implementation Specific to Changes:** Packaging manufacturers will need to ensure their products are compliant with the new limits for antimony and DEHP. Testing and quality control processes will need to be updated to monitor these substances.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome *of these specific changes* is:
* Reduced consumer exposure to antimony and phthalic acid (DEHP) from food packaging.
* Enhanced food safety due to stricter control over potentially harmful chemicals in packaging materials.
* Increased responsibility and vigilance on the part of packaging manufacturers and food processors to ensure compliance with the new standards.
**9. Conclusion:**
The Food Safety and Standards Packaging Amendment Regulations, 2021, represent a significant update to the existing food packaging regulations. The addition of limits for antimony and phthalic acid (DEHP) demonstrates a proactive approach by FSSAI to address potential chemical migration risks and enhance food safety. This amendment is significant for packaging manufacturers and food processors who must now ensure their products and processes comply with these new requirements. Further clarification on implementation timelines and specific testing protocols from FSSAI would be beneficial for stakeholders.
Key Entities Referenced
Food Safety and Standards Authority of India: The regulatory authority proposing amendments to the Food Safety and Standards Packaging Regulations.
Central Government: The entity whose approval is required for the Food Safety and Standards Authority of India to make regulations.
Food Safety and Standards Act, 2006: The act under which the Food Safety and Standards Authority of India is exercising its powers.
Food Safety and Standards Packaging Regulations, 2018: The regulations being amended by the Food Safety and Standards Authority of India.
New Delhi: Location of the Ministry of Health and Family Welfare and the Food Safety and Standards Authority of India, Delhi, India.
Ministry of Health and Family Welfare: The ministry under which the Food Safety and Standards Authority of India operates.
Food Safety and Standards Packaging Amendment Regulations, 2021: The name of the amendment regulations.
Kotla Road: Location of Food and Drug Administration Bhawan, New Delhi, India.
ARUN SINGHAL: Chief Executive Officer, Food Safety and Standards Authority of India.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E0x6xx0 92021-229449
CG-DL-E-06092021-229449
असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 373] नई ददल्ली, सोमवार, जसतम्ब र 6, 2021/भाद्र 15, 1943
No. 373] NEW DELHI, MONDAY, SEPTEMBER 6, 2021/BHADRA 15, 1943
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(भारतीय खाद्य सरु क्षा और मानक प्राजधकरण)
अजधसचू ना
नई ददल् ली, ददनांक 6 जसतम्बर, 2021
फा. स.ं स्ट् टैंड्स /एसपी-20/टी(माइग्रेिन-एन).—खाद्य सुरक्षा और मानक (पैकेजिग) जवजनयम, 2018 में और
आगे संिोधन, िो भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केंद्र सरकार के पूवा नुमोदन से, खाद्य सुरक्षा और मानक
अजधजनयम, 2006 (2006 का संखय ांक 34) की धारा 23 के साथ परित धारा 92 की उप-धारा (2) के खंड (ट) द्वारा प्रदत् त
िजियों का प्रयोग करते हुए करना चाहती ह,ै करने के जलए इन जवजनयमों का मसौदा इससे प्रभाजवत हो सकने वाल े सभी
व्य जियों की सूचना के जलए उक् त अजधजनयम की धारा 92 की उप-धारा (1) की अपेक्षा के अनुसार एतदद्वारा प्रकाजित
करती ह ै और एतदद्वारा नोरटस ददया िाता ह ै दक उक् त प्रारूप जवजनयमों पर उस जतजथ से साि ददनों की अवजध समाप्त
होन े के बाद जवचार दकया िाएगा, जिस जतजथ को इस अजधसूचना को प्रकाजित करने वाले रािपत्र की प्रजतयााँ िनता को
उपलब्ध कराई िाएाँगी।
यदद कोई आपजि या सुझाव हो तो उस े मुख य काय कारी अजधकारी, भारतीय खाद्य सुरक्षा और मानक प्राजधकरण,
एफडीए भवन, कोटला रोड, नई ददल् ली-110002 को अथवा regulation@fssai.gov.in पर ई-मेल से भेिा िा सकता
ह।ै
उक् त मसौदा जवजनयमों के संबंध में दकसी व् यजि से इस प्रकार जनधा ररत जतजथ तक प्राप् त आपजियों और सुझावों
पर भारतीय खाद्य सुरक्षा और मानक प्राजधकरण द्वारा जवचार दकया िाएगा।
4942 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
प्रारूप जवजनयम
1. (1) इन जवजनयमों को खाद्य सुरक्षा और मानक (पैकेजिग) संिोधन जवजनयम, 2021 कहा िा सकता ह।ै
2. जवजनयम 4 के उप-जवजनयम (4) की सारणी 1 की क्रम संखय ा 7 और उसस े संबंजधत प्रजवजियों के बाद जनम् नजलजखत
सामग्री िोडी िाएगी, अथा त,् —
‘’8. एंटीमनी 0.04
9. थैजलक एजसड, जबस(2-एजथलहजे क्सल) एस्ट्ट र (डीईएचपी) 1.5’’
अरुण जसघल, मुख य काय कारी अजधकारी
[जवज्ञापन-III/4/असा./237/2021]
रटप् पणी: मूल जवजनयम भारत के रािपत्र, असाधारण, भाग III, खंड 4 में अजधसूचना संखय ा फा. सं. 1-
95/स्ट्ट ैंड्स /पैकेिबंदी/एसपी(एलएंडसी/ए)/एफएसएसएआई-2017, ददनांक 24 ददसंबर, 2018 द्वारा प्रकाजित
दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)
NOTIFICATION
New Delhi, the 6th September, 2021
F. No. Std/SP-20/T(Migration-N).—The following draft of certain regulations further to amend the Food
Safety and Standards (Packaging) Regulations, 2018, 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 (k)
of sub- section (2) of section 92 read with section 23 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 the period of sixty days from the date on which the 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, Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002 or send on
email regulation@fssai.gov.in.
Objections or suggestions, 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. (1) These regulations may be called the Food Safety and Standards (Packaging) Amendment Regulations, 2021.
2. In regulation 4, in sub-regulation (4), in Table 1, after Sl. No. 7 and the entries relating thereto, the following shall
be inserted, namely—
“8. Antimony 0.04
Phthalic acid, bis (2-ethylhexyl) ester
9. 1.5”
(DEHP)
ARUN SINGHAL, Chief Executive Officer
[ADVT.—III/4/Exty./237/2021]
Note: The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4 vide
notification number File No. 1-95/Stds/Packaging/SP(L&C/A)/FSSAI-2017, dated the 24th December, 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.