New Delhi, the 3rd November, 2021.

F. No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(1) (Pt.F).—Whereas the draft of the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2020, were 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, File No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(1), dated the 27th August, 2020, published in the Gazette of India, Extraordinary, Part III, section 4, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of the period of sixty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas copies of the said Gazette were made available to the public on the 3rd September, 2020;

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 (Food Products Standards and Food Additives) Regulations, 2011, namely:—


1. Short title and commencement.– (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Fourth Amendment Regulations, 2021.

(2) They shall come into force on the date of their publication in the Official Gazette and food business operator shall comply with all the provisions of these regulations with effect from 1st day of the June, 2022.

2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,—

(1) in sub-regulation 2.4.11, in clause (4) relating to ―Formulated Supplements for Children‖, under item (10), relating to “Method of sampling and analysis‘, for sub-item (ii), the following shall be substituted, namely:—

“(ii) A variation of minus 10.0 per cent from the declared value of the nutrients or nutritional ingredients on the label shall be allowed and the nutrient levels shall not exceed maximum limits as specified in the composition tables.”;

(2) for sub-regulation 2.4.12 relating to ―Rolled Oats”, the following shall be substituted, namely:—

“2.4.12 OAT PRODUCTS.—

1. (A) Rolled Oats.—Rolled/Flaked Oats (Quick Cooking Oats) means the product made from sound hulled oats(AvenaSativa).It shall be free from added colours, rancidity and flavoring agents. It shall be in form of flakes of uniform size having a light cream colour.

1. (B) Products containing oats.—(i) Means the product containing oats as the major ingredient including oat bran, oat flour, oat meal, oat-trim, kilned dehulled oats, Steel cut Oats, Oat flakes (various thickness, which may make them instant, quick cooking or whole oats) etc. These may be made by using various process such as kilning, drying, rolling, slitting, cutting, steel cutting, gritting, de-hulling, flaking, grinding etc.

(ii) It may contains edible common salt or salt substitutes, Dairy products and Analogues, natural and non-nutritive sweeteners, sugar and sugar products, honey, invert sugar, jaggery, dextrose, edible molasses, liquid glucose, fruits and vegetables and their products (including dried fruits and vegetables), cocoa and its products, Coconut and its products, egg and its products, gluten, nut and nut products, cereal, legumes, malt and malt extract, edible starches and edible flours, spices, condiments, herbs and their extracts, seasonings, vinegar, edible seeds, protein concentrates or isolates, enzymes, vitamins and minerals and other nutrients, edible fibres, maltodextrin and any other ingredients as specified in Food Safety and Standards Regulations.

(iii) The grains and other ingredients used in the processing of products containing oats shall be of good quality and shall possess a characteristic taste and odour and shall be free from rancid, musty, sour and other undesirable tastes and odors.

2. Rolled or Flaked Oats and Products containing oats shall be free from insects, rodent excreta and other such foreign matters and shall comply with the requirements given in the table below:

Parameter Rolled/Flaked Oats Products
Moisture % by mass, Not more than 12.0 Not more than 12.0
Ash insoluble in dilute HCl (on dry mass basis). Not more than 0.1 percent Not more than 0.5 percent
Protein content ( conversion factor 6.25) on dry mass basis Not less than 10.0 per cent
Crude Fibre on dry mass basis Not more than 2.0 percent
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, Not more than 0.18 percent Not more
than 0.18
Uric Acid, mg/kg, Not more than 100 Not more
than 100

3. Food Additives

The product may contain food additives permitted in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 in Appendix A under appropriate Food Category(s) and those listed in GMP Table as applicable. The product may also contain ‘Other substances for use in food products‘ permitted under regulation 3.3 as per appropriate Food category of the same regulation.”.

ARUN SINGHAL, Chief Executive Officer

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 7th 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 5th December, 2014;

5) F.No. 1-83F/Sci. Pan- Noti/FSSAI-2012, dated 17th February, 2015;

6) F.No. 4/15015/30/2011, dated 4th August, 2015;

7) F.No. P.15025/264/13-PA/FSSAI, dated 4th November, 2015;

8) F.No. P. 15025/263/13-PA/FSSAI, dated 4th 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) No. 3-16/Specified Foods/Notification (Food Additives)/FSSAI-2014, dated 3rdMay, 2016;

14) F.No. 15-03/Enf/FSSAI/2014, Dated 14th June, 2016;

15) 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;

17) F.No. 1-120(1)/Standards/Irradiation/FSSAI-2015, dated 23rd August, 2016;

18) F. No. 11/09/Reg/Harmoniztn/2014, dated 5th 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 2nd 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 2nd 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) No. Stds/SP (Water & Beverages)/Noti(1)/FSSAI-2016,dated 15thSeptember,2017;

36) F.No.1-10(8)/Standards/SP (Fish and Fisheries Products)/FSSAI-2013, dated 15thSeptember, 2017;

37) File 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 the 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 the 21st March, 2018;

47) File No. Stds/SCSS&H/ Notification (03)/FSSAI-2016, dated the 10th April, 2018;

48) F.No. Stds/CPL&CP/Notification/FSSAI-2016, dated 4th 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) Stds/CPL&CP/ Draft Notification/FSSAI-2017, Dated 31st July, 2018;

52) File No.1/Additional Additives/Stds/Notification/FSSAI/2016, Dated 8th 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;

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 29thJanuary, 2019;

59) F.No. Stds/F&VP/Notification (07)/FSSAI-2018, dated 5thJuly, 2019;

60) F.No. Stds/O&F/Notification (10)/FSSAI-2017, dated 5thJuly, 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 9thJuly, 2020;

65) F. No. Stds/CPL & CP/Notification/01/FSSAI-2017, dated 9thJuly, 2020;

66) F. No. Stds/ M&MPIP (3)/SP/FSSAI-2018, dated 9thJuly, 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 2ndSeptember, 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 9th October, 2020;

71) F. No. Stds/Processing aids/Notification/FSSAI/2018, dated 9th October, 2020;

72) F. No. 1-116/Scientific Committee/Notif./2010-FSSAI, dated the 29th December, 2020;

73) F. No. 1-116/Scientific Committee/Notif.27/2010-FSSAI(E), dated the 4th March, 2021;

74) F. No. Stds/O&F/Notification (5)/FSSAI-2017dated 18th March, 2021, and

75) File No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI (1), dated 26th July, 2021.


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