Date: 2022-04-22 Category: Extra Ordinary State: Union Government Country: India

The following draft of certain regulations further to amend the Food Safety and Standards

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

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Executive Summary & Key Takeaways

                    Here's the policy analysis report based on the provided text:

**1. Executive Summary:**

This report analyzes a draft amendment to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. The core purpose of this amendment is to modify the regulations concerning processed nuts, specifically including pan masala and arecanut-based mouth fresheners within this category and imposing restrictions on the use of synthetic food colors in these products. The key finding is a stricter regulatory stance on the composition and additives permitted in pan masala and arecanut-based mouth fresheners.

**2. Introduction:**

This report provides an overview and analysis of a draft amendment to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, as published by the Food Safety and Standards Authority of India (FSSAI). This analysis is based solely on the information presented within the provided policy text.

**3. Policy Overview:**

This document is an amendment to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

The core objective of this amendment, as inferred from the text, is to regulate the production and composition of pan masala and arecanut-based mouth fresheners more specifically, focusing on permissible additives, particularly synthetic food colors.

**4. Background and Rationale:**

The amendment appears to be driven by a need to specifically address the standards and permissible additives in pan masala and arecanut-based mouth fresheners. The specific reason for this amendment could stem from concerns about the potential health impacts of unregulated additives, particularly synthetic food colors, in these products.

**5. Key Provisions / Changes:**

This amendment introduces the following changes to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011:

*   **Inclusion of Pan Masala and Arecanut-Based Mouth Fresheners in Food Category 15.2:** The amendment explicitly includes "pan masala and arecanut based mouth fresheners" within the category of "Processed nuts including coated nuts and nuts mixtures." This expands the scope of this category to include these products.
*   **Restriction on Synthetic Food Colors:** The amendment prohibits the use of any synthetic food colors in pan masala and arecanut-based mouth fresheners. This is a new restriction that did not previously exist, based on the information provided.
*   **GMP Table Update:** The amendment includes "Processed nuts including coated nuts and nuts mixtures only pan masala and arecanut based mouth fresheners" under serial number 87 in the ANNEX TO GMP Table.

The effect of these changes is to subject pan masala and arecanut-based mouth fresheners to the same standards and regulations as processed nuts, but with the additional restriction of prohibiting synthetic food colors.

**6. Target Audience and Stakeholders:**

The primary target audience and stakeholders directly affected by these changes are:

*   Manufacturers of pan masala and arecanut-based mouth fresheners.
*   Suppliers of ingredients (particularly food colors) to these manufacturers.
*   Consumers of pan masala and arecanut-based mouth fresheners.

**7. Implementation Aspects (Inferred):**

*   **Responsible Agency:** The Food Safety and Standards Authority of India (FSSAI) is the responsible body for implementing and enforcing these regulations. The Chief Executive Officer of FSSAI is specifically mentioned as the point of contact for objections and suggestions.
*   **Timelines:** The text specifies a 60-day period for public comment and consideration of objections or suggestions. After this period, the draft regulations will be taken into consideration. No further specific timelines for implementation are provided in the text.
*  **Specific Implementation to changes:** Manufacturers must reformulate their products to comply with the restriction on synthetic food colors.

**8. Expected Outcomes / Impact of Changes:**

The likely intended outcomes of these changes are:

*   **Improved safety of pan masala and arecanut-based mouth fresheners:** By prohibiting synthetic food colors, the amendment aims to reduce the potential health risks associated with these products.
*   **Greater regulatory oversight:** By including these products within the "Processed nuts" category, the FSSAI can apply existing standards and monitoring procedures.
*   **Shift in manufacturing practices:** Manufacturers will need to reformulate their products to comply with the new regulations, potentially leading to the use of natural or permitted coloring alternatives.

**9. Conclusion:**

This amendment to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 represents a significant regulatory development for the pan masala and arecanut-based mouth freshener industry. By including these products within the category of "Processed nuts" and prohibiting the use of synthetic food colors, the FSSAI seeks to enhance the safety and quality of these products. This amendment signifies a stricter stance on permissible additives in this industry.

Key Entities Referenced

Food Safety and Standards Authority of India: A regulatory body responsible for food safety and standards in India. It is the primary organization proposing the amendments to the regulations. Food Safety and Standards Act, 2006: The primary legislation governing food safety and standards in India, under which the Food Safety and Standards Authority of India operates. Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011: The set of regulations being amended by this notification. It outlines the standards for food products and additives. Central Government: The government of India, which provides prior approval for the amendments proposed by the Food Safety and Standards Authority of India. New Delhi: The location where the notification is issued and the address of the Food Safety and Standards Authority of India is located. (New Delhi, Delhi) FDA Bhawan, Kotla Road, New Delhi 110002: The address of the Food Safety and Standards Authority of India where objections or suggestions regarding the draft regulations can be sent. Food Safety and Standards Food Products Standards and Food Additives Amendment Regulations, 2022: The title of the amending regulations. Pan Masala: A specific food product affected by the amendment, with restrictions on synthetic food colors. Arecanut based mouth fresheners: A specific food product affected by the amendment, with restrictions on synthetic food colors. The Gazette of India: The official government publication in which the principal regulations were published. Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi 110064: The entity responsible for uploading the document. Controller of Publications, Delhi110054: The entity responsible for publishing the document. Arun Singhal: Chief Executive Officer of Food Safety and Standards Authority of India

Official Source Record View Original Source →

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                रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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सी.जी.-डी.एलxx.x-GअID.-E2x2xx0 42022-235318
CG-DL-E-22042022-235318
असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
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अरुण ससघल, मुख्य काययककारी अजधकारी
[जवज्ञापन III/4/असा./33/2022-23]
टिप्प ण : मूल जवजनयम भारत के रािपत्र, असाधारण, भाग III, खंड 4 म ें अजधसूचना सख्ं या फा. सं. 2-
15015/30/2010, ददनांक 1 अगस्ट् त, 2011 द्वारा प्रकाजित दकए गए थ े और उनका बाद म ें जनम्न जलजखत
अजधसूचनाओं द्वारा संिोधन हुआ था:
1. फा. सं. 4/15015/30/2011, ददनांक 7 िून, 2013;
2. फा. सं. पी 15014/1/2011-पी.एफ.ए/एफ.एस.एस.ए.आई, ददनांक 27 िून, 2013;
3. फा. सं. 5/15015/30/2012, ददनांक 12 िुलाई, 2013;
4. फा. सं. पी 15025/262/2013-PA/एफ.एस.एस.ए.आई, ददनांक 5 ददसंबर, 2014;
5. फा. सं. 1-83F/Sci. Pan- नोटिदफकेिन/एफ.एस.एस.ए.आई-2012, ददनांक 17 फरवरी, 2015;
6. फा. सं. 4/15015/30/2011, ददनांक 4 अगस्ट्त , 2015;
7. फा. सं. पी 15025/264/13-पीए/एफ.एस.एस.ए.आई, ददनांक 4 नवंबर, 2015;
8. फा. सं. पी 15025/263/13-पीए/एफ.एस.एस.ए.आई, ददनांक 4 नवंबर, 2015;
9. फा. सं. पी 15025/261-पीए/एफ.एस.एस.ए.आई, ददनांक 13 नवंबर, 2015;
10. फा. सं. पी 15025/208/2013-पीए/एफ.एस.एस.ए.आई, ददनांक 13 नवंबर, 2015;
11. फा. सं. 7/15015/30/2012, ददनांक 13 नवंबर, 2015;[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
12. फा. सं. 1-10(1)/स्ट् िैंड्स/यक एस पी ( दफि एंड दफिरीि प्रोडक्‍् स)/एफ.एस.एस.ए.आई-2013, ददनांक
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13. फा. सं. 3-16/स्ट् पेसीफाइड फू्स/नोटिदफकेिन (फूड एजडटिव् ि)/एफ.एस.एस.ए.आई-2014, ददनांक 3
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2016;
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21. फा. सं. 1-110(2)/एसपी(बायोलोजिकल हिै ाड)यक /एफ.एस.एस.ए.आई/2010, ददनांक 10 अक्‍ िूबर,
2016;
22. फा. सं. स्ट् िैंड्स/यक एसपी (वािर एंड बीवरेि)/नोटिदफकेिन(2)/एफ.एस.एस.ए.आई-2016, ददनांक 25
अक्‍ िूबर, 2016;
23. फा. सं. 1-11(1)/स्ट् िैंड्सयक/एसपी (वािर एंड बीवरेि)/एफ.एस.एस.ए.आई-2015, ददनांक 15 नवंबर,
2016;
24. फा. सं. पी 15025/93/2011-पी.एफ.ए/एफ.एस.एस.ए.आई, ददनांक 2 ददसंबर, 2016;
25. फा. सं. पी 15025/6/2004-पीएफएस/एफ.एस.एस.ए.आई, ददनांक 29 ददसंबर, 2016;
26. फा. सं. स्ट् िैंड्स/यक ओ और एफ/नोटिदफकेिन(1)/एफ.एस.एस.ए.आई-2016, ददनांक 31 िनवरी, 2017;
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28. फा. सं. 1-10(7)/स्ट् िैंड्सयक/एसपी (मत्‍ स्ट् य और मत्‍ स्ट् य उत्‍ पाद)/एफ.एस.एस.ए.आई-2013, ददनांक 13
फरवरी, 2017;
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2017;
30. फा. सं. स्ट् िैंड्सयक/03/नोटिदफकेिन(एलएस)/एफ.एस.एस.ए.आई-2017, ददनांक 19 िनू , 2017;
31. फा. सं. 1/एजडटिव्स /स्ट् िैंड्सयक/14.2/नोटिदफकेिन/एफ.एस.एस.ए.आई/2016, ददनांक 31 िलु ाई,
2017; और
32. फा. सं. स्ट् िैड्सयक/एफएडं वीपी/नोटिदफकेिन(01)/एफ.एस.एस.ए.आई-2016, ददनांक 2 अगस्ट्त , 2017.
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जसतंबर, 2017;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
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40. फा. सं. 2/स्ट् िैंड्सयक/सीपीएलएडं सीपी/नोटिदफकेिन/एफएसएसएआई-2016(पाि)यक , ददनांक 24 अक्‍ िूबर,
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अप्रैल, 2018.
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49. फा.स.ं स्ट् िैंड्स/यक एसपी(एससीएसएसएच)/आईसलोजलि नोटिदफकेिन/एफएसएसएआई-2018,ददनांक
20 िुलाई, 2018;
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66. फा.सं. स्ट् िेंडड/यक(सीपीएल एंड सीपी)/नोटिदफकेिन/01/एफएसएसएआई-2017 ददनांक 9 िलु ाई 2020
67. फा.सं. ए-1/स्ट् िेंडड/यकएग्म ाकयक/2012-एफएसएसएआईI(पी1) ददनांक 23 िूलाई 2020
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FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 21st April, 2022
F. No. Stds/Pan Masala Issue/FSSAI/2019.—The following draft of certain regulations further to
amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,
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 (e) of sub-section (2) of section 92 read
with section 16 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 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 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 (Food Products Standards and Food
Additives) Amendment Regulations, 2022.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,
(hereinafter referred to as the said regulations), -
(1) in the said regulations, in Chapter 3,- in Appendix A,-
(a) Under the heading “II. FOOD CATEGORY DESCRITPTIONS” in the description of the food category
system “15.2 Processed nuts including coated nuts and nuts mixtures”, at the end of the paragraph the
following shall be inserted, namely. -
“This category also includes pan masala and arecanut based mouth fresheners”;
(b) In the Table 15, in column (1) under the heading food category system, against items 15.2,-
(i) in column (2), for entries “Processed nuts including coated nuts and nut mixtures”, the following entries
shall be substituted, namely. -
“Processed nuts including coated nuts and nut mixtures*”;
(ii) in column (3), (4) and (5) after the food additive “SORBATES” and the entries relating thereto
following shall be inserted, namely. -
Food Additive INS No. Recommended Maximum Level
“* No synthetic food colour permitted in pan masala and arecanut based mouth fresheners.”;
(c) In the said regulations, in the “ANNEX TO GMP Table” after serial number 86 and the entries relating
thereto, the following shall be inserted, namely. -
“87 15.2 Processed nuts including coated nuts and nuts mixtures (only pan masala and arecanut based
mouth fresheners)”.
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./33/2022-23]
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:
1. F. No. 4/15015/30/2011, dated 07th June, 2013;
2. F. No. P. 15014/1/2011-PFA/FSSAI, dated 27th June, 2013;
3. F. No. 5/15015/30/2012, dated 12th July, 2013;
4. F. No. P. 15025/262/2013-PA/FSSAI, dated 05th December, 2014;
5. F. No. 1-83F/Sci. Pan- Noti/FSSAI-2012, dated 17th February, 2015;
6. F. No. 4/15015/30/2011, dated 04th August, 2015;
7. F. No. P.15025/264/13-PA/FSSAI, dated 04th November, 2015;
8. F. No. P. 15025/263/13-PA/FSSAI, dated 04th November, 2015;
9. F. No. P. 15025/261-PA/FSSAI, dated 13th November, 2015;
10. F. No. P. 15025/208/2013-PA/FSSAI, dated 13th November, 2015;
11. F. No. 7/15015/30/2012, dated 13th November, 2015;
12. F. No. 1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated 11th January,
2016;
13. F. No. 3-16/Specified Foods/Notification(Food Additives)/FSSAI-2014, dated 03rd May,
2016;
14. F. No. 15-03/Enf/FSSAI/2014, Dated 14th June, 2016;
15. F. No. 3-14F/Notification (Nutraceuticals)/FSSAI-2013, dated 13th July, 2016;
16. F. No. 1-12/Standards/SP (Sweets, Confectionery)/FSSAI-2015, dated 15th July, 2016;[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 7
17. F. No. 1-120(1)/Standards/Irradiation/FSSAI-2015, dated 23rd August, 2016;
18. F. No. 11/09/Reg/Harmoniztn/2014, dated 05th September, 2016;
19. F. No. Stds/CPLQ.CP/EM/FSSAI-2015, dated 14th September, 2016;
20. F. No. 11/12 Reg/Prop/FSSAI-2016, dated 10th October, 2016;
21. F. No. 1-110(2)/SP (Biological Hazards)/FSSAI/2010, dated 10th October, 2016;
22. F. No. Stds/SP (Water & Beverages)/Notif (2)/FSSAI-2016, dated 25th October, 2016;
23. F. No. 1-11(1)/Standards/SP (Water & Beverages)/FSSAI-2015, dated 15th November, 2016;
24. F. No. P.15025/93/2011-PFA/FSSAI, dated 02nd December, 2016;
25. F. No. P. 15025/6/2004-PFS/FSSAI, dated 29th December, 2016;
26. F. No. Stds/O&F/Notification(1)/FSSAI-2016, dated 31st January, 2017;
27. F. No. 1-12/Standards/2012-FSSAI, dated 13th February, 2017;
28. F. No. 1-10(7)/Standards/SP (Fish & Fisheries Products)/FSSAI-2013, dated 13th February,
2017;
29. F. No. Stds /SCSS&H/ Notification (02)/FSSAI-2016, dated 15th May, 2017;
30. F. No. Stds/03/Notification (LS)/ FSSAI-2017, dated 19th June, 2017;
31. F. No. 1/Additives/Stds/14.2Notification/FSSAI/2016, dated 31st July, 2017;
32. F. No. Stds/F&VP/Notification (01)/FSSAI-2016, dated 02nd August, 2017;
33. F. No. 1-94(1)/FSSAI/SP(Labelling)/2014, dated 11th September, 2017;
34. F. No. Stds/M&MPIP (1)/SP/FSSAI-2015, dated 15th September, 2017;
35. F. No. Stds/SP (Water & Beverages)/Noti(1)/FSSAI-2016, dated 15th September,2017;
36. F. No.1-10(8)/Standards/SP (Fish and Fisheries Products)/FSSAI-2013, dated 15th September,
2017;
37. F. No. 2/Stds/CPL & CP/Notification/FSSAI-2016, dated 18th September, 2017;
38. F. No. A-1 (1)/Standard/MMP/2012, dated 12th October, 2017;
39. F. No. Stds/O&F/Notification (3)/FSSAI-2016, dated 12th October, 2017;
40. F. No. 2/Stds/CPL & CP/Notification/FSSAI-2016(part), dated 24th October, 2017;
41. F. No. A-1/Standards/Agmark/2012-FSSAI(pt.I), dated 17th November, 2017;
42. F. No. 1/Additives/Stds/BIS Notification/FSSAI/2016, dated 17th November, 2017;
43. F. No. Stds/O&F/Notification (5)/FSSAI-2016, dated 20th February, 2018;
44. F. No. Stds/01-SP (fortified & Enriched Foods)-Reg/FSSAI-2017, dated 13th March, 2018;
45. F. No. 1/Infant Nutrition/Stds/Notification/FSSAI/2016, dated 13th March, 2018;
46. F. No.1-110(3)/SP (Biological Hazards)/FSSAI/2010, dated 21st March, 2018;
47. F. No. Stds/SCSS&H/ Notification (03)/FSSAI-2016, dated 10th April, 2018;
48. F. No. Stds/CPL&CP/Notification/FSSAI-2016, dated 04th May, 2018;
49. F. No. Stds/SP(SCSSH)/Ice lollies notification/FSSAI-2018, dated 20th July,2018;
50. F. No. Stds/SP (Water & Beverages)/Notif(3)/FSSAI-2016, dated 20th July,2018;
51. F. No. Stds/CPL&CP/ Draft Notification/FSSAI-2017, dated 31st July, 2018;
52. F. No. 1/Additional Additives/Stds/Notification/FSSAI/2016, dated 08th November, 2018;
53. F. No. Stds/03/Notification (CFOI&YC)/FSSAI-2017, dated 16th November, 2018.
54. F. No. Stds/O&F/Notification (7)/FSSAI-2017, dated 19th November, 2018;
55. F. No. Stds/M&MP/Notification (02)/FSSAI-2016, dated 19th November, 2018;8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
56. F. No. Stds/F&VP/Notifications (04)/FSSAI-2016, dated 19th November, 2018;
57. F. No. 1-116/Scientific Committee (Noti.)/2010-FSSAI, dated 26th November, 2018;
58. F. No. 02-01/Enf-1(1)/FSSAI-2012, dated 29th January, 2019;
59. F. No. Stds/F&VP/Notification (07)/FSSAI-2018, dated 05th July, 2019;
60. F. No. Stds/O&F/Notification (10)/FSSAI-2017, dated 05th July, 2019;
61. F. No. Stds/SP (Water & Beverages)/Notification (5) FSSAI-2018, dated 30th October, 2019;
62. F. No. M&MP/Misc. Stds/Notification (03)/FSSAI-2018, dated 28th November, 2019;
63. F. No.1-110/SP (Biological Hazards)/Amendment-1/FSSAI/2018, dated 23rd June, 2020;
64. F. No. Stds/CPL & CP/Notification/01/FSSAI-2018, dated 09th July, 2020;
65. F. No. Stds/CPL & CP/Notification/01/FSSAI-2017, dated 09th July, 2020;
66. F. No. Stds/ M&MPIP (3)/SP/FSSAI-2018, dated 09th July, 2020;
67. F. No. A-1/Standards/Agmark/2012-FSSAI (p+1), dated 23rd July, 2020;
68. F. No. Stds./M&MP/Notification (04)/FSSAI-2019, dated 02nd September, 2020;
69. F. No. Stds/Additives-1/Notification/FSSAI/2018, dated 16th September, 2020;
70. F. No. 1/Additional Additives-III/Stds/Notification/FSSAI/2017, dated 09th October, 2020;
71. F. No. Stds/Processing aids/Notification/FSSAI/2018, dated 09th October, 2020;
72. F. No. 1-116/Scientific Committee/Notif./2010-FSSAI, dated 29th December, 2020;
73. F. No. 1-116/Scientific Committee/Notif.27/2010-FSSAI(E), dated 04th March, 2021;
74. F. No. Stds/O&F/Notification (5)/FSSAI-2017, dated 18th March, 2021;
75. F. No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(1), dated 26th July, 2021;
76. F. No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(1) (Pt.F), dated 03rd November,
2021;
77. F. No. Stds/SC/A-1.34/N-1, dated 15th November, 2021 and
78. F. No. M&MP/Notification(05)/FSSAI-2019, dated 27th December, 2021.
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