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  MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) NOTIFICATION New Delhi, the 10th October, 2016   F. No.1-110(2)/SP   (Biological  Hazards)/FSSAI/2010.—Whereas  the  two  drafts  of  the  Food  Safety  and  Standards  (Food  Products  Standards  and  Food  Additives) Amendment  Regulations,  2015, were published as required under sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notifications  of the Food  Safety  and  Standards   Authority  of  India  number F. No.1-110(2)/SP   (Biological   Hazards)/FSSAI/2010 dated  the  30th July,  2015   and  F.No.  1-110(1)/SP(Biological Hazards)/FSSAI/2010 dated the 30th  July, 2015 in the Gazette of India, Extraordinary,  Part III, Section 4, inviting objections and suggestions from the 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 the copies of the said two Gazette notification were made available to the public on the 3rd September, 2015; And whereas the objections and suggestions received from the public in respect of the said two draft regulations have been considered by the Central Government; 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:-  Regulations  1.            (1) These regulations may be called the Food Safety and Standards (Food P r o d u c t s Standards a n d F o o d A d d i t i v e s ) Tenth Amendment R e g u l a t i o n s , 2016. (2) They shall come into force on the date of their publication in the Official Gazette: Provided microbiological  standards for milk and milk products and entries relating thereto in Table 2A and 2B and the related explanation,  shall come in to force after a period of one year from the date of publication of this notification. 2.       In the Food Safety and Standards (Food Products Standards and Food Additives)   Regulations,  2011,  in  APPENDIX  B    relating  to  “Microbiological   Requirements”,- (A)     for TABLE 2 and the entries relating thereto, the following TABLE and the entries shall be substituted, namely:- “Microbiological  Standards for Milk and Milk Products  Table-2A Microbiological   Standards  for Milk and Milk Products–Process Hygiene Criteria            Sr. No.           Product Description1   Aerobic  Plate Count Coliform Count4 Staphylococcus   aureus (Coagulase positive)   Yeast and Mold Count   Escherichia coli   Sampling Plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu) n c m M n c m M n c m M n c m M n c m M   1 Pasteurized/boiled   Milk/ Flavored Milk   5   3   3x104/ml 5x 104/ml   5   0   <10/ml   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA 2 Pasteurized  Cream 5 3 5x104/g 7.5x104/g 5 0 <10/g NA NA NA NA NA NA NA NA NA NA NA NA NA   3 Sterilized milk /UHT milk / Evaporated Milk   NA 4 Sterilized / UHT Cream NA   5 Sweetened Condensed Milk   5   3 5x102/g 1x103/g   5   0   <10/g   NA   5   0   <10/g   NA   5   0   <10/g   NA   NA   NA   NA   NA   6   Pasteurized Butter2   5   3   2.5x104/g   5x104/g   5   2   10/g   20/g   5   2   10/g   50/g   5   3   20/g   50/g   5   0   Absent/g   NA       7 Milk Powder ; SMP, Partly SMP ; Dairy Whitener ; Cream Powder ; Ice Cream Mix Powder ; Lactose ; Whey based Powder ; Butter Milk Powder ; Casein Powder 3       5       2       3x104/g       5x104/g       5       2       10/g       50/g       5       2       10/g       1x102/g       5       0       50/g       NA       NA       NA       NA       NA     8   Infant Milk Food, Infant Formulae, Infant Milk Substitute4     5     2     5x102/g     5x103/g     NA     NA     NA     NA     5     0     <10/g     NA     5     0     <10/g     NA     NA     NA     NA     NA                         Sr. No.           Product Description1   Aerobic  Plate Count Coliform Count4 Staphylococcus   aureus (Coagulase positive)   Yeast and Mold Count   Escherichia coli   Sampling Plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu) n c m M n c m M n c m M n c m M n c m M   Follow Up Formula     5     2     1x103/g     1x104/g     10     0     <10/g     NA     5     0     <10/g     NA     5     0     <10/g     NA   10   0     Absent/g     NA Cereal Based Complimentary food     9   Ice Cream, Frozen Dessert, Milk Lolly, Ice Candy     5     3     1x105/g     2x105/g     5     3     10/g     1x102/g     5     2     10/g     1x102/g     NA     NA     NA     NA     5     0     Absent/g     NA     10   Processed    Cheese/ Cheese Spread     5     2   2.5x104/g   5x104/g     5     0     <10/g     NA     5     0     <10/g     NA     NA     NA     NA     NA     NA     NA     NA     NA     11   All other cheeses categories including fresh cheeses / Cheddar / Cottage /Soft /Semi Soft 5     NA     NA     NA     NA     5     3     1x102/g     5x102/g     5     3     10/g     1x102/g     5     3     1x102/g     5x102/g     5     0     <10 /g     NA   12   Fermented Milk Products   NA   NA   NA   NA   5   2   10/g   1x102/g   5   2   10/g   1x102/g   5   3   50/g   1x102/g   5   0   Absent/g   NA   13   Paneer/ Chhana/ chhana based sweets   5   3   1.5x105/g   3.5x105/g   5   3   10/g   1x102/g   5   3   10/g   1x102/g   5   3   50/g   1.5x102/g   5   0   <10/g   NA   14   Khoa/ Khoa based sweets   5   3   2.5x104/g   7.5x104/g   5   2   50/g   1x102/g   5   3   10/g   1x102/g   5   3   10/g   50/g   5   0   <10/g   NA         Test Methods7       IS 5402/ ISO: 4833       IS 5401 Part 1/ISO : 4832   IS 5887 : Part 2 or IS 5887 Part 8 (Sec 1)/ ISO : 6888-1 or IS 5887 Part 8 (Sec 2)/ ISO 6888-2       IS:5403 or ISO : 6611     IS 5887 : Part 1 or ISO : 16649-2                                                                                                                                                                                                                                               Table-2B: Microbiological  Standards for Milk and Milk Products – Food Safety Criteria         Sr. No         Product Description1   Salmonella sp.   Listeria monocytogenes   Bacillus cereus Sulphite Reducing Clostridia (SRC)   Enterobacter sakazakii (Cronobacter sp.)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu)   Sampling plan   Limit (cfu) n c m M n c m M n c m M n c m M n c m M 1 Pasteurized/boiled milk/ Flavored Milk 5 0 Absent/25 ml NA 5 0 Absent/25ml NA NA NA NA NA NA NA NA NA NA NA NA NA 2 Pasteurized  Cream 5 0 Absent/25g NA 5 0 Absent/25g NA NA NA NA NA NA NA NA NA NA NA NA NA 3 Sterilized milk /UHT milk / Evaporated Milk     Sterilized /UHT milk products shall comply with a test for commercial sterility as per IS: 4238 (Appendix C or Appendix D) 4 Sterilized/ UHT Cream     Sterilized/UHT cream product shall comply with a test for commercial sterility as per IS : 4884 5 Sweetened Condensed Milk6 5 0 Absent/25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA NA 6 Pasteurized Butter2 5 0 Absent/25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA NA 7 Milk      Powder; SMP, PSMP; Dairy Whitener; Cream  Powder ; Ice Cream Mix Powder; Lactose; Whey based Powder; Butter Milk Powder;  Casein Powder 5 0 Absent/25g NA 5 0 Absent/g NA 5 3 5x102/g 1x103/g 5 3 50/g 1x102/g NA NA NA NA 8 Infant  Milk  Food, Infant Formulae, Infant    Milk Substitutes   60 0 Absent/25g NA 10 0 Absent/25g NA 5 2 1x102/g 5x102/g 5 2 10/g 1x102/g 30 0 Absent/10g NA Follow Up Formula 15 0 Absent/25g NA 10 0 Absent/25g NA 5 2 1x102/g 5x102/g 5 2 10/g 1x102/g NA NA NA NA   Cereal Based Complimentary Food 15 0 Absent/25g NA 10 0 Absent/25g NA 5 2 1x102/g 5x102/g 5 2 10/g 1x102/g NA NA NA NA 9 Ice Cream, Frozen Dessert, Milk Lolly, Ice Candy 5 0 Absent/25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA NA 10 Processed    Cheese/ Cheese Spread 5 0 Absent/25g NA 5 0 Absent / 25g NA NA NA NA NA NA NA NA NA NA NA NA NA 11 All other cheeses categories including fresh cheeses / Cheddar / Cottage /Soft /Semi Soft etc 5 0 Absent/25g NA 5 0 Absent/25 g NA NA NA NA NA NA NA NA NA NA NA NA NA 12 Fermented Mlk Products 5 0 Absent/25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA NA 13 Paneer/ Chhana/ chhana based sweets 5 0 Absent//25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA NA 14 Khoa/ Khoa based sweets 5 0 Absent/25g NA 5 0 Absent/g NA NA NA NA NA NA NA NA NA NA NA NA   Test Methods7 IS 5887 : Part 3/ ISO : 6579   IS 14988 : Part 1/ ISO: 11290-1 IS 5887 (Part 6) /ISO:7932 ISO : 15213 ISO/TS 22964   NA- Not Applicable 1Microbiological  standards shall also be applicable for proprietary dairy foods depending on their analogy as determined by FSSAI with the product categories specified in Table 2A and 2 B 2The microbiological  specifications for ripened butter are the same as for pasteurized butter excluding the requirements of Aerobic Plate Count. 3The yeast and mold count of 50/g as specified in dried product categories shall be applicable only to casein powder 4For products in this category (Infant  Milk  Food, Infant Formulae,      Infant     Milk Substitute),  the enterobacteriaceae shall be tested. The microbiological  criteria applicable is n=10; c=2; m= Absent/10g; M=Not Applicable.  Method of analysis is ISO 21528-1 and 21528-2, as appropriate. 5The yeast and mold counts is not applicable in mold ripened cheeses 6The Sweetened condensed milk product shall comply accelerated storage test as per IS: 1166 (latest version)  Stage where the Microbiological  Standards shall apply: The Microbiological  Standards in Table-2A (Process Hygiene Criteria) indicate the acceptable functioning of the production process. These are not to be used as requirements  for releasing  the products  in the market.  These are indicative  contamination  values above  which corrective  actions are required in order to maintain  the hygiene  of the process in compliance with food law. These shall be applicable at the end of the manufacturing process. Action in case of unsatisfactory  result:  In case of   non-compliance  in respect of process hygiene criteria specified in Table- 2A, the FBO shall:  check and improve process hygiene by  implementation  of guidelines in Schedule  4 (Part III)  of FSS (Licensing and Registration of  Food Businesses) Regulations; and, Ensure that all food safety criteria  as specified in Table -2B  are complied with  before releasing the product batch/lot in the market. The Microbiological  Standards in Table-2B (Food Safety Criteria) define the acceptability of a batch/lot and shall be met in respect of the product for  releasing it  in  the market. These shall be applicable to the products at the end of  the manufacturing process and the products in the market during their shelf- life.  Sampling Plans and Guidelines;  For Regulator: The sampling for different microbiological  standards with respect to the products specified in  Table-2A and 2B shall be ensured aseptically at manufacturing units and/or  at retail points, as applicable,  by a trained person with specialized knowledge in the field of  microbiology   following guidelines   in the  Food Safety and Standards(Food Products and Food Additives) Regulations,  2011 and  ISO: 707 (Latest version). The samples shall be stored and transported at a temperature  below 5°C (but not frozen), except the products that are recommended  to be stored at room temperature  by the manufacturer,  to enable initiation of analysis within 24 hours of sampling. Preservatives  shall not be added to sample units intended for microbiological  examination.  The desired number  of sample units as per sampling  plan given in  Table-2A  & 2B shall be taken from same batch/lot  and shall be submitted  to the notified  laboratory.  The testing in laboratory  shall be ensured  as per reference  test methods  given below  in reference  test methods  for regulatory compliance. The final decision shall be drawn based on results with no provision for retesting for microbiological  parameters. For FBO: Food Business Operator (FBO)  shall perform testing as appropriate as per  the microbiological  standards   with respect to the products specified in  Table-2A & 2B to ensure validation  and verification  of compliance  with the microbiological  requirements.  FBO shall decide themselves  the necessary  sampling  and testing frequencies  to ensure compliance  with the specified  microbiological  requirements.  FBO may use   analytical  methods  other than those described  in reference  test methods  given below for in-house testing only. However, these methods shall not be applicable for regulatory compliance purpose.  Sampling Plan: The terms n,c,m and M used in this standard have the following meaning:  n = Number of  units comprising a sample . c = Maximum allowable number of units having microbiological  counts above m for 2- class sampling plan and between m and M for 3- class sampling plan.. m = Microbiological  limit that  separates unsatisfactory from satisfactory in a 2- class sampling plan or acceptable from satisfactory in a 3-class sampling plan. M = Microbiological  limit that separates unsatisfactor y from satisfactory in a 3-class sampling plan. Interpretation  of Results:  2-Class Sampling Plan (where n, c and m are specified) 3-Class Sampling Plan (where n, c, m and M are specified) 1.    Satisfactory, if all the values observed are ≤ m 2.    Unsatisfactory,  if one or more of the values observed are >m or more than c values are >  m 1. Satisfactory, if all the values observed  are ≤ m 2.  Acceptable, if a maximum of c values are between m and M and the rest of the values are observed as ≤ m 3.  Unsatisfactory,  if one or more of the values observed are >M or more than c values are > m  Reference test methods: The following test methods shall be applied as reference methods.  Reference test methods- latest version shall apply. In case where an ISO method adopted by the BIS is specified (e.g IS XXXX / ISO YYYY), latest version of the ISO method (or its BIS equivalent, if available) shall apply.  Sr. No. Parameter Reference Test Methods   1.   Aerobic Plate Count Microbiology  of the food chain -- Horizontal  method for the enumeration  of microorganisms  -- Part 1: Colony count at 30 degrees C by the pour plate technique- IS 5402/ ISO:4833     2.     Coliforms Microbiology  of food and animal feeding stuffs -- Horizontal method for the Detection and Enumeration   of Coliforms – Part- 1 Colony-Count  Technique- IS: 5401 Part 1 Microbiology  of  food  and  animal  feeding  stuffs  --  Horizontal  method  for  the  enumeration  of  Coliforms  -  Colony-count technique- ISO 4832     3.     Enterobacteriaceae Microbiology of food and animal feeding stuffs -- Horizontal methods for the detection and enumeration of Enterobacteriaceae -- Part 1: Detection and enumeration by MPN technique with pre-enrichment-  ISO 21528 Part 1   Microbiology of food and animal feeding stuffs -- Horizontal methods for the detection and enumeration of Enterobacteriaceae -- Part 2: Colony-count  method- ISO 21528 Part 2   4.           Staphylococcus  aureus Methods  for  detection   of  bacteria  responsible   for  food  poisoning   :Part  2  Isolation,   identification   and  enumeration   of Staphylococcus  aureus  and Faecal  streptococci- IS 5887 : Part 2   Methods for Detection of Bacteria Responsible  For Food Poisoning Part 8 Horizontal Method For Enumeration  Of Coagulase- Positive  Staphylococci/  (Staphylococcus  aureus and other species) Section 1 Technique  using baird-parker  agar medium- IS 5887 (Part 8/Sec 1: / ISO 6888-1:  1999   Methods  For  Detection   Of  Bacteria  Responsible   For  Food  Poisoning  Part  8  Horizontal   Method   For  Enumeration   Of Coagulase-Positive Staphylococci/  (Staphylococcus  aureus  And Other  Species)  Section  2 Technique  using  rabbit  plasma fibrinogen agar medium- IS 5887 (Part 8/Sec 2)  /  ISO 6888-2: 1999 5. Enterobacter sakazakii Milk and milk products -- Detection of Enterobacter sakazakii- ISO/TS 22964     Sr. No. Parameter Reference Test Methods     6.     Yeast and Mould Count Method for Yeast and Mould Count of Food Stuffs and Animal feed- IS 5403 Milk  and milk  products  -- Enumeration  of colony-forming  units  of Yeasts  and/or  Moulds  -- Colony-count  technique  at 25 degrees C- ISO 6611       7.       Escherichia coli Methods  for  Detection  of  Bacteria  Responsible  for  Food  Poisoning  - Part  I : Isolation,  Identification  and Enumeration  of Escherichia coli- IS 5887 : Part 1 Microbiology  of  food  and  animal  feeding  stuffs  --  Horizontal  method  for  the  enumeration  of  beta-glucuronidase-positive Escherichia coli -- Part 2: Colony-count  technique at 44 degrees C using 5-bromo-4-chloro-3-indolyl beta-D-glucuronide- ISO: 16649-2     8.     Salmonella Methods for Detection of Bacteria Responsible  for Food Poisoning - Part 3 : General Guidance on Methods for the Detection of Salmonella- IS 5887 : Part 3 Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella spp.- ISO 6579           9.           Listeria monocytogenes Microbiology  of the food chain -- Horizontal method for the detection and enumeration  of Listeria monocytogenes  and other Listeria spp. -- Part 1: Detection method- ISO: 11290-1 Microbiology  of  food  and  animal  feeding  stuffs  --  Horizontal  method  for  the  detection  and  enumeration  of  Listeria monocytogenes  -- Part 2: Enumeration  Method- ISO: 11290-2 Microbiology of Food and Feeding Stuffs - Horizontal method for Detection and Enumeration of Listeria Monocytogenes  : Part 1 Detection Method- IS 14988 : Part 1 Microbiology   of  Food  and  Animal  Feeding  Stuffs  -  Horizontal  Method  for  the  Detection  and  Enumeration  of  Listeria monocytogenes  - Part 2 : Enumeration Method- IS 14988 : Part 2   10.   Bacillus cereus Microbiology  of food and animal feeding stuffs -- Horizontal method for the enumeration  of presumptive  Bacillus cereus - - Colony-count  technique at 30 degrees C- IS 5887 (Part 6) /ISO:7932   11.   Sulfite-reducing  bacteria Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration  of sulfite-reducing  bacteria growing under anaerobic conditions- ISO 15213   12.   Milk and milk products - Guidance on sampling- ISO:707 13.   Indian Standard Specification  for sterilized milk- IS: 4238 14.   Specification for sterilized cream- IS: 4884   15.   Specification  for condensed milk, partly skimmed and skimmed condensed milk - IS :1166.”.   (B) After TABLE 4 relating to “Microbiological  requirements of food products” the following table shall be inserted, namely-  “Microbial Standards for Meat and Meat Products  Table 5A: Microbiological  Standards for Meat and Meat Products- Process Hygiene Criteria    S. No. Product Category1 Aerobic  Plate  Count Yeast and Mold Count Escherichia coli Staphylococcus  aureus (Coagulase +ve) Sampling Plan   Limits (cfu/g) Sampling Plan   Limits (cfu/g) Sampling Plan   Limits (cfu/g) Sampling Plan   Limits (cfu/g) n c m M n c m M n c m M n c m M (1) Fresh meat/ Chilled meat2 5 3 1x106 5x106 5 2 1x104 5x104 5 2 1x102 1x103 5 2 1x102 1x103 (2) Frozen meat2 5 2 1x105 5x106 5 2 1x103 1x104 5 2 1x10 1x102 5 2 10 1x102     (3)   Raw marinated/minced/comminuted meat2     5     2     5x105     5x106     5     2     1x102     1x103     5     2     1x102     1x103     5     2     1x102     1x103   (4) Semi-cooked   /Smoked   Meat/ meat food  Product2   5   2   1x104   1x105   5   2   10   1x102   5   2   10   1x102   5   2   10   1x102 (5) Cured/Pickled meat 5 2 5x102 5x103 5 2 1x102 1x103 5 2 10 1x102 5 1 1x102 1x103 (6) Fermented meat products NA NA NA NA NA NA NA NA 5 2 10 1x102 5 1 1x102 1x103 (7) Dried/dehydrated  meat product 5 2 1x103 1x104 5 2 1x102 1x103 5 2 10 1x102 5 1 10 1x102 (8) Cooked Meat Products 5 2 1x103 1x104 5 1 10 1x102 5 2 10 1x102 5 1 10 1x102   (9) Canned/Retort     pouch    Meat Products   NA   NA   NA   NA   NA   NA   NA   NA   5   0   Absent   NA   5   0   Absent   NA     Test Methods3   IS: 5402/ISO 4833   IS: 5403/ISO 21527   IS: 5887 Part1 or ISO 16649-2 IS 5887 : Part 2 or IS 5887  Part 8  (Sec  1)/  ISO  :  6888-1  or  IS 5887 Part 8 (Sec 2)/ISO 6888-2  Table 5B: Microbiological   Standards  for Meat & Meat Products- Food Safety Criteria   Sr. No. Product Category1 Salmonella Listeria monocytogenes Sulphite Reducing Clostridia Clostridium Botulinum Campylobacter  Spp* Sampling Plan Limits (cfu/25g) Sampling Plan Limits (cfu/25g) Sampling Plan   Limits (cfu/g) Sampling Plan Limits (cfu/g) Sampling Plan Limits (cfu/g)   n   c m M   n   C m M   n   c   m   M   n   c   m   M   n   c   m   M 1. Fresh meat /  Chilled meat2 5 0 Absent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 2. Frozen meat2 5 0 Absent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 3. Raw marinated/minced/comminuted meat 2 $   5   0   Absent   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA 4. Semi-cooked                /Smoked Meat/meat food  Product2   5   0   Absent   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   5   0   Absent 5. Cured/Pickled meat 5 0 Absent 5 0 Absent 5 2 5x102 5x103 NA NA NA NA NA NA NA NA 6. Fermented meat products 5 0 Absent 5 0 Absent 5 2 5x102 5x103 NA NA NA NA NA NA NA NA   7.   Dried/dehydrated  meat product   5   0   Absent   5   0   Absent   5   2   5x102   5x103   NA   NA   NA   NA   NA   NA   NA 8. Cooked Meat Products 5 0 Absent 5 0 Absent 5 1 1x102 1x103 NA NA NA NA 5 0 Absent 9. Canned/   Retort   pouch   Meat Products   5   0   Absent   5   0   Absent   5   0   Absent   5   0   Absent   5   0   Absent   Test Methods3 IS: 5887 Part 3/ ISO 6579 IS:    14988,    Part    1 &2/ISO 11290-1 & 2 ISO 15213 IS:5887,  Part  4  or  ISO 17919 ISO 10272-1&2  NA- Not Applicable   1 Definition of meat and meat products:  Definition  of animal, carcass  , meat food product   and   slaughter  house   are the same as provided  in FSS ( Food Products  Standards  and Food Additives  ) Regulations  2011. Additionally the following definitions apply for the purpose of this regulation.  Canned/Retorted   meat product: Meat product packed in hermetically sealed containers which have been heat treated after sealing to such an extent that the product is shelf stable.  Chilled meat: Fresh meat which has been washed with potable water and  kept between 0-70C. Cooked Meat/meat product: Meat/meat product that is subjected to heat treatment, wherein minimum thermal core temperature of 75 0C is achieved. Cured/pickled meat products:  Product prepared after curing/pickling  meat in solution  containing  salt, nitrate/nitrite  and adjuncts for the purpose  of preservation  and obtaining desirable colour, flavour and shelf life.  Dried/Dehydrated meat/meat products: Meat/meat products in which part of free water has been removed by evaporation or sublimation.  Fermented meat product: Chopped or ground meat products that have under gone ageing process and developed characteristics low pH, unique flavour, taste, texture and long shelf life through action of desirable microorganisms.  Fresh meat: Meat that has not been treated in any way to ensure its preservation.  Frozen meat: Fresh meat which has been  washed with potable water, chilled and  subjected to freezing in an appropriate equipment in such a way that product attains a temperature of -180C or colder at the thermal centre after thermal stabilization.  Raw  marinated/minced/comminuted meat:  meat  with  or  without  bones  which  has  been  reduced  to  fragments  by cutting/grinding/dicing/chopping/milling and/or marinated  and with or without  additives.  Semi-cooked  /Smoked  Meat/meat  food   Product:  Partially  heat treated  and/ or smoked  meat and meat product,     that will require  additional  heat treatment  before consumption.  Slaughter:  Means killing of an animal for food employing  a human method not inconsistent  with the provisions of the prevention  of cruelty to Animal act, 1960 (54 of 1960) in an authorized slaughter house or abattoir where the animal is subjected to through ante- mortem and post-mortem examination”.  Raw processed whole, cut pieces or comminuted  meat Products:   Raw processed,  whole, cut pieces bone/ boneless and comminuted  meat products   with or without addition of other ingredients and additives as per  specified  in FSSAI standards.  2   Products  under  categories 1-5 to be cooked to make safe before consumption. Stage where the Microbiological  Standards shall apply: The Microbiological  Standards  with respect  to the product  categories  specified  in Table-5A  (Process  Hygiene  Criteria)  indicate  the acceptable  functioning  of the production process. These are not to be used as requirements for releasing the products in the market. These are indicative contamination  values above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law. These shall be applicable at the end of the manufacturing  process.  Action in case of unsatisfactory  result:  In case of non-compliance  in respect of process hygiene criteria specified in Table- 5A, the FBO shall:  check and improve process hygiene by  implementation  of guidelines in Schedule  4 (Part IV)  of FSS (Licensing and Registration of  Food Businesses) Regulations; and, Ensure that all food safety criteria as specified in Table -5B  are complied with  before releasing the product batch/lot in the market. 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 for  releasing it  in  the market. These shall be applicable to the products at the end of the manufacturing  process and the products in the market during their shelf- life.  Sampling Plans and Guidelines;  For  Regulator:  The  sampling  for  different  microbiological  standards  with  respect  to the  product  categories    specified  in  Table-5A  and  5B shall  be ensured  aseptically  at manufacturing  units  and/or  at retail points, as applicable, by a trained person with specialized knowledge in the field of  microbiology   following guidelines  in t Food Safety and Standards(Food  Products and Food Additives) Regulations,  2011 and  ISO: 707 (Latest version). The samples shall be stored and transported at a temperature  below 5°C (but not frozen), except the products that are recommended  to be stored at room temperature by the manufacturer,  to enable initiation of analysis within 24 hours of sampling. Preservatives shall not be added to sample units  intended for microbiological  examination.  The desired number of samples as per sampling plan given in  Table-5A & 5B shall be taken from same batch/lot and shall be submitted to the notified laboratory. The testing in laboratory shall be ensured as per reference test methods given below  in reference test methods  for regulatory compliance. The final decision shall be drawn based on results with no provision for retesting for microbiological  parameters.  For FBO: Food Business Operator (FBO)  shall perform testing as appropriate  as per  the microbiological  standards    in  Table-5A & 5B to ensure validation and verification  of compliance  with  the  microbiological   requirements.   FBO  shall  decide  themselves  the  necessary  sampling  and  testing  frequencies  to  ensure  compliance  with  the  specified microbiological  requirements.  FBO  may use   analytical  methods  other  than those  described  in reference  test methods  given  below  for in-house  testing  only.  However,  these methods shall not be applicable for regulatory compliance purpose.  Sampling Plan:  The terms n,c,m and M used in this standard have the following meaning:  n = Number of  units comprising a sample .  c = Maximum allowable number of units having microbiological  counts above m for 2- class sampling plan and between m and M for 3- class sampling plan. m = Microbiological  limit that  separates unsatisfactory from satisfactory in a 2- class sampling plan or acceptable from satisfactory in a 3-class sampling plan.  M = Microbiological  limit that separates unsatisfactory from satisfactory in a 3-class sampling plan.  Interpretation  of Results:     2-Class Sampling Plan (where n, c and m are specified)   3-Class Sampling Plan (where n, c, m and M are specified)   1. Satisfactory, if all the values observed are ≤ m   2.Unsatisfactory,  if one or more of the values observed are >m or more than c values are >  m   1. Satisfactory,  if all the values observed  are ≤ m   2. Acceptable,  if a maximum of c values are between m and M and the rest of the values are observed as ≤ m   3. Unsatisfactory,   if one or more of the values observed are >M or more than c values are > m 3Reference test methods: The following test methods shall be applied as reference methods.  Reference test methods- latest version shall apply. In case where an ISO method adopted by the BIS is specified (e.g IS XXXX / ISO YYYY), latest version of the ISO method (or its BIS equivalent, if available) shall apply.      S. No   Parameter   Reference Test  Method   1.   Aerobic Plate Count   Microbiology  of the food chain -- Horizontal  method for the enumeration  of microorganisms  -- Part 1: Colony count at 30 degrees C by the pour plate technique- IS 5402 /ISO 4833       2.       Yeast and Mould Count   Method for Yeast and Mould Count of Foodstuffs and animal feeds- IS:5403   Microbiology  of  food  and  animal  feeding  stuff-Horizontal   method  for  enumeration  of  Yeasts  and  Moulds-  part  1:  Colony  count technique in products with water activity greater than 0.95.- IS0 21527-1:   Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration  of Yeasts and Moulds -- Part 2: Colony count technique in products with water activity less than or equal to 0,95- IS0 21527-2           3.           Staphylococcus  aureus  and Faecal  streptococci   Methods for detection  of bacteria responsible  for food poisoning  :Part 2 Isolation, identification  and enumeration  of    Staphylococcus aureus  and faecal  streptococci- IS 5887 : Part 2   Methods for Detection of Bacteria Responsible  For Food Poisoning Part 8 Horizontal  Method For Enumeration  Of Coagulase-Positive Staphylococci/  (Staphylococcus  Aureus  and other  species)  Section  1 Technique  using  baird-parker  agar  medium-  IS 5887  (Part 8/Sec 1: / ISO 6888-1: 1999   Methods For Detection Of Bacteria Responsible  For Food Poisoning Part 8 Horizontal Method For Enumeration  Of Coagulase-Positive Staphylococci/  (Staphylococcus  Aureus And Other Species)   Section 2 Technique using rabbit plasma fibrinogen agar medium- IS 5887 (Part 8/Sec 2)  / ISO 6888-2: 1999       4.       Escherichia coli   Methods for Detection  of Bacteria Responsible  for Food Poisoning  - Part I : Isolation,  Identification  and Enumeration  of Escherichia coli- IS 5887 : Part 1   Microbiology  of food and animal feeding stuffs -- Horizontal  method for the enumeration  of beta-glucuronidase-positive Escherichia coli -- Part 2: Colony-count technique at 44 degrees C using 5-bromo-4-chloro-3-indolyl beta-D-glucuronide- ISO: 16649-2     5.     Salmonella spp.   Methods  for  Detection  of  Bacteria  Responsible  for  Food  Poisoning  - Part  3 : General  Guidance  on  Methods  for  the  Detection  of Salmonell- IS 5887 : Part 3   Microbiology  of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella spp.- ISO 6579       6.       Listeria monocytogenes   Microbiology  of  Food  and  Feeding  Stuffs  - Horizontal  method  for  Detection  and  Enumeration  of  Listeria  Monocytogenes-Part  1: Detection Method- IS 14988 : Part 1/ ISO: 11290-1   Microbiology  of Food and Animal Feeding Stuffs - Horizontal Method for the Detection and Enumeration  of Listeria monocytogenes  - Part 2 : Enumeration Method. IS 14988 : Part 2/ ISO: 11290-2     7.     Campylobacter   spp   Microbiology of Food and Animal Feeding Stuffs - Horizontal Method for the Detection and Enumeration  of  Campylobacter   spp- Part 1 : Detection Method- ISO 10272-1   Microbiology  of food and animal feeding stuffs -- Horizontal  method for detection and enumeration  of Campylobacter  spp. -- Part 2: Colony-count technique- ISO 10272-2   8.   Sulphite-Reducing  Bacteria   Microbiology  of food  and animal  feeding  stuffs  -- Horizontal  method  for the enumeration  of Sulphite-Reducing  Bacteria  growing under anaerobic conditions- ISO 15213     9.     Clostridium perfringens   Methods  for  Detection  of Bacteria  Responsible  for Food  Poisoning:  Part  4 Isolation  and Identification  of Clostridium  perfringens (Clostridium welchii) and Costridium botulinum and enumeration of Clostridium perfringens- IS:5887 Part 4   Microbiology of the food chain Polymerase Chain Reaction (PCR) for the detection of food borne  pathogens –Detection of botulinum type A, B, E & F- neurotoxin Producing clostridia.- ISO-TS 17919.”.   PAWAN AGARWAL, Chief Executive Officer   [ADVT. III/4/Exty./260  (187)]   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 the 7th June, 2013; (ii)          F.No. P.15014/1/2011-PFA/FSSAI, dated the 27th June, 2013; (iii)         F.No. 5/15015/30/2012,  dated the 12th July, 2013; (iv)         F.No. P.15025/262/13-PA/FSSAI dated the 5th December, 2014; (v)          F. No.1-83F/Sci.Pan-Noti/FSSAI-2012 dated the 17th February, 2015; (vi)         F.No. 4/15015/30/2011,  dated the 4th August, 2015; (vii)        F.No P. 15025/263/13-PA/FSSAI, dated the 4th November, 2015; (viii)       F.No. P.15025/264/13-PA/FSSAI, dated the 4th November, 2015; (ix)         F.No P.15025/261/2013-PA/FSSAI, dated the 13th November, 2015; (x)          F.No. P.15025/208/2013-PA/FSSAI, dated the 13th November,  2015; (xi)         F.No. 7/15015/30/2012,  dated the 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 Additive)/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, 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 and (xx)      F.No.11/12/Reg/Prop/FSSAI-2016, dated 10th October, 2016.