FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 23rd June, 2020
F. No. 1-110/SP (Biological Hazards)/Amendment-1/FSSAI/2018.— Whereas the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2018, 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 number F.No.1-110/SP (Biological Hazards)/Amendment-1/FSSAI/2018, dated the 12th December, 2018, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from persons likely to be affected thereby before the expiry of period of thirty 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 27th December, 2018;
And whereas 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 of the Food Safety and Standard Act, 2006, 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:-
Regulations
1. (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2020.
(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 by 1st January, 2021.
2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in Appendix B,-
(a) in Table 2B relating to Microbiological Standards for Milk and Milk products – Food Safety Criteria,-
(i) after the explanatory note relating to ‘Stage where the Microbiological Standards shall apply’, the following shall be inserted, namely:-
“The Microbiological Standards in Table-2B (Food Safety Criteria) define the acceptability of a batch or lot and shall be met in respect of the product at the end of the manufacturing process and the products in the market during their shelf- life.”;
(ii) under the explanatory note ‘’Action in case of unsatisfactory result’’, for the portion beginning with the words, figures and letters “Ensure that all food safety criteria”, and ending with the words “the products in the market during their shelf-life’’, the following shall be substituted, namely:-
“Ensure that all food safety criteria as specified in Table-2B are complied with.’’;
(iii) under the explanatory note ‘’sampling plans and Guidelines’’, –
(A) in the heading ’‘For Regulator’’, before the words “The final decision shall be drawn”, the following shall be inserted, namely:-
“A set (n) of five samples shall be tested from three different accredited laboratories and the final decision shall be drawn based on three test results. There will be no provision for retesting or re-sampling for microbiological testing”;
(B) in the heading relating to ‘‘Reference Test Methods’, in the entry, after the words’ ’shall apply’’, the following shall be inserted, namely, –
“Test methods prescribed in FSSAI Manual of Methods of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISO methods specified for Process Hygiene Criteria and Food Safety Criteria.”
(b) In Table 4B relating to ‘‘Microbiological Standards for Fruits and Vegetables and their Products – Food Safety Criteria’’, –
(i) after the explanatory note ‘‘Stage where the Microbiological Standards shall apply’’, after the words “end of the manufacturing process’’ the following shall be inserted,namely: –
“The Microbiological Standards in Table-4B (Food Safety Criteria) define the acceptability of a batch/lot and shall be met in respect of the product at the end of the manufacturing process and the products in the market during their shelf- life.”;
(ii) under the explanatory note ‘‘Action in case of unsatisfactory result’’, for the portion beginning with the words, figures ,brackets and letters ‘‘The Microbiological Standards in Table -4B ’’and ending with the words ‘’the products in the market during their shelflife’’, shall be omitted;
(iii) under the explanatory note ‘’sampling plans and Guidelines’’, –
(A) in the heading ‘‘For Regulator” before the words “The testing in laboratory shall be”, the following shall be inserted, namely:-
“A set (n) of five samples shall be tested from three different accredited laboratories and the final decision shall be drawn based on three test results. There will be no provision for retesting or re-sampling for microbiological testing”;
(B) in the heading relating to ‘‘Reference Test Methods ’,in the entry, after the words’ ’shall apply’’, the following shall be inserted, namely: –
“Test methods prescribed in FSSAI Manual of Methods of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISO methods specified for Process Hygiene Criteria and Food Safety Criteria.”;
(c) in Table 5B relating to “Microbiological Standards for Meat and Meat Products– Food Safety Criteria ’’
(i) in the Table, in Column(3), for the heading, “Salmonella”, the heading “Salmonellas” shall be substituted.
(ii) after the Table and the entries “NA-Not Applicable”, the following shall be inserted, namely:-
“$ For poultry meat the requirement shall be applicable for Salmonella enterica serovars Typhi, Typhimurium and Entritidis”;
(iii) after the explanatory note and the entries relating thereto “Stage where the Microbiological Standards shall apply”, following entry shall be inserted, namely:-
“The Microbiological Standards in Table-5B (Food Safety Criteria) define the acceptability of a batch/lot and shall be met in respect of the product at the end of the manufacturing process and the products in the market during their shelf- life.”;
(iv) under the explanatory note relating to “Action in case of unsatisfactory result”, for the portion beginning with the words, figures and letters “Ensure that all food safety criteria”and ending with the words “the products in the market during their shelf-life’’, the following shall be substituted, namely:-
‘‘Ensure that all food safety criteria’s specified in Table-5B are complied with’’,
(v) under the explanatory note relating to “sampling plans and Guidelines’’, –
(A) in the heading “For Regulator” before the words “The final decision shall be drawn”, the following shall be inserted, namely:-
“A set (n) of five samples shall be tested from three different accredited laboratories and the final decision shall be drawn based on three test results. There will be no provision for retesting or re-sampling for microbiological testing”;
(B) in the heading relating to ‘‘Reference Test Methods”,-
(i) in the entry ,after the words ‘‘shall apply’’, the following shall be inserted, namely: –
“Test methods prescribed in FSSAI Manual of Methods of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISO methods specified for Process Hygiene Criteria and Food Safety Criteria.”;
(ii) in the Table, against. S.No. 9, under column 2 relating to Parameter, for the entry, “Clostridium perfringens” the following entry shall be substituted, namely:-
“Clostridium botulinum”.
ARUN SINGHAL, Chief Executive Officer
[ ADVT.-III/4/Exty./139/2020]
Note: The principal regulations were published in the Gazette of India, Extraordinary Part III, Section 4 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) 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) 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) F. 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) F. 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) F. 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.
(liv) 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.
