New Delhi, the 21st July, 2020

F. No. Stds/M&MP/Notification(05)/FSSAI-2019.-The draft 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 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 may be sent by e-mail at [email protected];

Objections or suggestions which may be received with respect to the said draft regulations within the period specified above 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 (Food Products Standards and Food Additives) Amendment Regulations, 2020.

(2) They shall come into force with effective date for implementation to be either 1st January or 1st July subject to a minimum of 180 days from the date of their final publication in the official Gazette.

2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 in regulation 2.1,

(1) in sub-regulation 2.1.1 related to the General Standards for Milk and Milk Products,

(i) in item 1, after sub-item (b), following shall be inserted, namely:

“(ba) Analogue in the dairy context means an imitation product that is designed or structured to mimic, or offered as an alternative/replacement to, a milk or milk product or composite milk product as defined in these regulations by partial or full substitution of selected milk components with other components from non-dairy sources, or prepared by using non-dairy ingredient(s) exclusively or in combination with dairy ingredients.”

(ii) in item 3 , after sub-item (e), following shall be inserted, namely:

“(ea) The nomenclature of an analogue product, defined in sub-item (ba) under item 1 of sub-regulation 2.1.1, as provided on the label shall be reflective of the true nature of the product.

Provided also that for such products, dairy term or phonetically similar or spell alike terms shall not be used in the nomenclature of the product. However, the name of the dairy ingredient used in the product shall be indicated in the list of ingredients, wherever applicable.

Provided further that the following declaration shall be made on the label of such products, namely:


(iii) in item 5, relating to labeling of pre-packaged foods, following shall be inserted, namely:

“All milk and milk products, including composite milk products, as defined in sub-item b,e,f,h and i of item 1 of this sub-regulation can exclusively use the following logo on the product label.


(2) in sub-regulation 2.1.8 related to the Standard for Milk Fat Products, in item 2 Essential Composition and Quality Factors,

(i) sub-item (a) related to Raw Material shall be substituted with following, namely:

“a) Milk fat, Butter oil, Anhydrous milk fat, Anhydrous butter oil : Milk and products obtained from milk.

b) Ghee : Milk, cream or butter.

The raw materials used shall be free from added flavor, colour or preservative.”

(ii) the existing tables and text under sub-item (b) Composition, shall be substituted with following, namely:

“Parameter Milk Fat, Butter Oil Anhydrous Milk Fat, Anhydrous Butter Oil Ghee
Moisture, maximum, %, (m/m) 0.4 0.1 0.5
Milk fat, minimum, %, (m/m) 99.6 99.8 99.5
Butyro-refractometer Reading at 40 ˚C 40.0 to 44.0 40.0 to 44.0 40.0 to 44.0
Reichert Meissl Value, minimum 26.0 26.0 26.0
Polenske Value 1.0-2.0 1.0-2.0 1.0-2.0
FFA as Oleic Acid, maximum, % 0.4 0.3 1.5
Peroxide Value (Milli- equivalent of Oxygen/Kg fat), maximum 0.6 0.3
Baudouin Test Negative Negative Negative
Iodine Value 25-38
Saponification value 205-235
Presence of β-sitosterol Absent* Absent* Absent*
Fatty acid profile The product shall meet the requirement of Table 1”

*Method for determination of adulteration of vegetable oil in ghee by RP-HPLC as notified vide FSSAI Office Order: File No. 1-90/FSSAI/SP (MS&A)/2009 dated 25th March, 2019

Table 1. The fatty acid composition of ghee as determined by GLC (expressed as percentage of total fatty acids)

Type of fatty acid Fatty acid composition (percentage)
Saturated fatty acids
C4:0, Butyric acid 1 – 4
C6:0, Hexanoic acid (Caproic acid) 0.5 – 2
C8:0, Octanoic acid (Cacprylic acid) 0.4 – 1
C10:0, Decanoic acid (Capric acid) 0.8-3.5
C12:0, Dodecanoic acid (Lauric acid) 1.5 – 4
C14:0, Tetradecanoic acid (Myristic acid) 6-10
C15:0, Pentadecanoic acid 0.5-1.2
C16:0, Hexadecanoic acid (Palmitic acid) 22-32
C17:0, Heptadecanoic acid 0.2-0.6
C18:0, Octadecanoic acid (Stearic acid) 10-16
Mono- unsaturated fatty acids
C16:1 (Cis 9), (Hexadecanoic acid (Palmitoleic acid) 0.9-1.8
C18:1 (cis 9) 9-Octadecenoic acid (Oleic acid) 19-32
C18:1 (cis 6) 6-Octadecenoic acid 0.3-0.9
C18:1 (cis 11) 11-Octadecenoic acid 0.5-2.5
Poly- unsaturated fatty acids
C18:2 (cis 9,12), 9,12-Octadecadienoic acid (Linoleic acid) 0.5-3.5
C18:2 (cis 9, trans 11), 9-cis,11-trans-octadecadienoate 0-3.0
C18:3 (cis 9,12,15) 9,12,15-Octadecatrienoic acid 0.3-1.0
C4:0, Butyric acid 1 – 4

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:

(i) F.No. 4/15015/30/2011, dated 7th June, 2013;

(ii) F.No. P. 15014/1/2011-PFA/FSSAI, dated 27th June, 2013;

(iii) F. No. 5/15015/30/2012, dated 12th July, 2013;

(iv) F. No. P. 15025/262/2013-PA/FSSAI, dated 5th December, 2014;

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

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

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

(viii) F. No. P. 15025/263/13-PA/FSSAI, dated 4th November, 2015;

(ix) F. No. P. 15025/261-PA/FSSAI, dated 13th November, 2015;

(x) F. No. P. 15025/208/2013-PA/FSSAI, Dated 13th November, 2015;

(xi) F. No. 7/15015/30/2012, dated 13th November, 2015;

(xii) F. No. 1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated 11th January, 2016;

(xiii) F. No. 3-16/Specified Foods/Notification(Food Additives)/FSSAI-2014, dated 3rd May, 2016;

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

(xv) F. No. 3-14F/Notification (Nutraceuticals)/FSSAI-2013, dated 13th July, 2016;

(xvi) F. No. 1-12/Standards/SP (Sweets, Confectionery)/FSSAI-2015, dated 15th July, 2016;

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

(xviii) F. No. 11/09/Reg/Harmoniztn/2014, dated 5th September, 2016;

(xix) F. No. Stds/CPLQ.CP/EM/FSSAI-2015, dated 14th September, 2016;

(xx) F. No. 11/12 Reg/Prop/FSSAI-2016, dated 10th October, 2016;

(xxi) F. No. 1-110(2)/SP (Biological Hazards)/FSSAI/2010, dated 10th October, 2016;

(xxii) F. No. Stds/SP (Water & Beverages)/Notif (2)/FSSAI-2016, dated 25th October, 2016;

(xxiii) F. No. 1-11(1)/Standards/SP (Water & Beverages)/FSSAI-2015, Dated 15th November, 2016;

(xxiv) F. No. P.15025/93/2011-PFA/FSSAI, Dated 2nd December, 2016;

(xxv) F. No. P. 15025/6/2004-PFS/FSSAI, dated 29th December, 2016;

(xxvi) F. No. Stds/O&F/Notification(1)/FSSAI-2016, dated 31st January, 2017;

(xxvii) F. No. 1-12/Standards/2012-FSSAI, dated 13th February, 2017;

(xxviii) F. No. 1-10(7)/Standards/SP (Fish & Fisheries Products)/FSSAI-2013, dated 13th February, 2017;

(xxix) F. No. Stds /SCSS&H/ Notification (02)/FSSAI-2016, dated 15th May, 2017;

(xxx) F. No. Stds/03/Notification (LS)/ FSSAI-2017, dated 19th June, 2017;

(xxxi) F. No. 1/Additives/Stds/14.2Notification/FSSAI/2016, dated 31st July, 2017;

(xxxii) F. No. Stds/F&VP/Notification(01)/FSSAI-2016, dated 2nd August, 2017;

(xxxiii) F. No. 1-94(1)/FSSAI/SP(Labelling)/2014, dated 11th September, 2017;

(xxxiv) F. No. Stds/M&MPIP(1)/SP/FSSAI-2015, dated 15th September, 2017;

(xxxv) No. Stds/SP (Water & Beverages)/Noti(1)/FSSAI-2016,dated 15th September,2017;

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

(xxxvii) File No. 2/Stds/CPL & CP/Notification/FSSAI-2016, dated 18th September, 2017;

(xxxviii) F. No. A-1 (1)/Standard/MMP/2012, dated 12th October, 2017;

(xxxix) F. No. Stds/O&F/Notification (3)/FSSAI-2016, dated 12th October, 2017;

(xl) F. No. 2/Stds/CPL & CP/Notification/FSSAI-2016(part), dated the 24th October, 2017;

(xli) F. No. A-1/Standards/Agmark/2012-FSSAI(pt.I), dated 17th November, 2017;

(xlii) F.No. 1/Additives/Stds/BIS Notification/FSSAI/2016, dated 17th November, 2017;

(xliii) F. No. Stds/O&F/Notification (5)/FSSAI-2016, dated 20th February , 2018;

(xliv) F.No. Stds/01-SP(fortified & Enriched Foods)-Reg/FSSAI-2017, dated 13th March, 2018;

(xlv) F. No. 1/Infant Nutrition/Stds/Notification/FSSAI/2016, dated 13th March, 2018;

(xlvi) F. No.1-110(3)/SP (Biological Hazards)/FSSAI/2010, dated the 21st March, 2018;

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

(xlviii) No. Stds/CPL&CP/Notification/FSSAI-2016, dated 4th May, 2018;

(xlix) F.No. Stds/SP(SCSSH)/Ice lollies notification/FSSAI-2018, Dated 20th July,2018;

(l) F.No. Stds/SP(Water & Beverages)/Notif(3)/FSSAI-2016, Dated 20th July,2018;

(li) Stds/CPL&CP/ Draft Notification/FSSAI-2017, Dated 31st July, 2018;

(lii) File No.1/Additional Additives/Stds/Notification/FSSAI/2016, Dated 8th November, 2018 and

(liii) F.No. Stds/03/Notification (CFOI&YC)/FSSAI-2017, Dated 16th November, 2018.

(lvi) F. No. Stds/O&F/Notification (7)/FSSAI-2017, dated 19th November, 2018;

(lv) F. No. Stds/M&MP/Notification (02)/FSSAI-2016, dated 19th November, 2018;

(lvi) F. No. Stds/F&VP/Notifications (04)/FSSAI-2016, dated 19th November, 2018;

(lvii) F. No. 1-116/Scientific Committee (Noti.)/2010-FSSAI, dated 26th November, 2018;

(lviii) F. No. 02-01/Enf-1(1)/FSSAI-2012, dated 29th January, 2019;

(lix) F.No. Stds/F&VP/Notification (07)/FSSAI-2018, dated 5th July, 2019;

(lx) F. No. Stds/O&F/Notification(10)/FSSAI-2017, dated 5th July, 2019;

(lxi) F.No. Stds/SP (Water & Beverages)/Notification(5) FSSAI-2018, dated 30th October, 2019 and

(lxii) F. No. M&MP/Misc. Stds/Notification(03)/FSSAI-2018, dated 28th November , 2019.


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