APPENDIX B: Microbiological Requirements:

28[Table
1A
Microbiological Requirements for Fish and Fishery products -Hygiene Indicator Organisms

Sl. Product Aerobic Plate Count Coagulase positive Yeast &mold count Stage where Action in case of
No. Category* Staphylococci criterion applies unsatisfactory
results
Sampling Plan Limits (cfu/g) Sampling Limits (cfu/g) Sampling Limits
Plan Plan (cfu/g)

n c m M n c m M n c m M

1. Chilled/Frozen After Improvement in

Finfish Chilling/Freezing. hygiene; Time-
Temperature Control
5 3 5x105 1x107 - - - - - - - - along value chain

2. Chilled/Frozen After Improvement in

Crustaceans Chilling/Freezing hygiene; Time-
Temperature Control
5 3 1x106 1x107 - - - - - - - - along value chain

3. Chilled/Frozen After Improvement in

Cephalopods Chilling/Freezing hygiene; Time-
Temperature Control
5 2 1x105 1x106 - - - - - - - - along value chain

4. Live Bivalve
Molluscs# - - - - - - - - - - - - - -

1|Version 2 (04.11.2024)
5. Chilled/Frozen After Improvement in
Bivalves Chilling/Freezing hygiene; Time-
Temperature Control
5 2 1x105 1x106 - - - - - - - along value chain

6. Frozen Cooked End of Improvement in

Crustaceans/Frozen Manufacturing hygiene; Selection
Heat Shucked process of raw material;
Mollusc 5 2 1x105 1x106 5 2 1x102 1x103 - - - - Time-Temperature
Control along value
chain; process
control

7. Dried/Salted and End of Improvement in

Dried Fishery Manufacturing hygiene; Selection
Products process of raw material;
5 0 1x105 - - - - 5 2 100 500
Adequate drying
(water activity ≤
0.78)

8. Thermally End of Revalidation of

Processed Fishery Commercially Sterile** - - - - - - - - Manufacturing thermal process
Products process

9. Fermented Fishery End of Improvement in

2 3
Products - - - - 5 1 1x10 1x10 5 0 100 Manufacturing hygiene; Selection
process of raw material

10. Smoked Fishery End of Improvement in

5 2 3
Products 5 0 1x10 5 2 1x10 1x10 - - - - Manufacturing hygiene; Time-
process

2|Version 2 (04.11.2024)
 Temperature Control
along value chain

11. Accelerated Freeze End of Selection of raw

Dried Fishery Manufacturing material:
Products 5 0 1x104 5 0 100 - - - - process Improvement in
hygiene; along value
chain

12. Fish Mince/Surimi End of Selection of raw

and Analogues Manufacturing material:
5 2 1x105 1x106 5 2 1x102 1x103 - - - -
process Improvement in
hygiene

13. Fish Pickle End of Improvement in

manufacturing hygiene; Control of
5 0 1x103 5 1 1x102 1x103 5 0 100
process (before pH/acidity, selection
packing) of ingredients

14. Battered and End of Improvement in

5 7 2 3
Breaded Fishery 5 2 1x10 1x10 5 1 1x10 1x10 5 0 100 Manufacturing hygiene; Time-
Products process Temperature Control

15. Convenience End of Improvement in

Fishery Products Manufacturing hygiene; Time-
5 2 1x103 1x104 5 2 1x102 1x103 - - -
process Temperature control
of batter mix

16. Powdered Fish End of Improvement in

4 5 2
Based Products 5 2 1x10 1x10 5 2 1x10 1x10 5 0 100 Manufacturing hygiene; Selection
process of raw material

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 Test method IS 5887 : Part 2 or
IS 5887 Part 8 (Sec 1)/
IS: 5402/ISO 4833 ISO: 6888-1 or IS:5403/ISO 21527
IS 5887 Part 8 (Sec
2)/ISO 6888-2
**Commercial sterility should be established as per APHA (2015). Canned Foods—Tests for Commercial Sterility. Compendium of Methods for the
Microbiological Examination of Food.

# No hygienic indicators are currently prescribed for the Live Bivalve Molluscs

4|Version 2 (04.11.2024)
 Table 1B

Microbiological Requirements for Fish and Fishery products –Safety Indicator Organisms

Sl. No. Product Category* Vibriocholerae Listeria Clostridium

Escherichia coli Salmonella
(O1 and O139) monocytogenes botulinum

Sampling Limits Sampling Limits Sampling Limits Sampling Limits Sampling Limits(MPN
Plan (MPN/g) Plan Plan Plan Plan /g)
n c m M n c m M n c m M n c m M n c m M
1. Chilled/Frozen Finfish 5 3 11 500 5 0 Absent/25g 5 0 Absent/25g - - - - - - - -
2. Chilled/Frozen 5 3 11 500 5 0 Absent/25g 5 0 Absent/25g - - - - - - - -
Crustaceans
3. Chilled/frozen 5 0 20 5 0 Absent/25g 5 0 Absent/25g - - - - - - - -
Cephalopods
4. Live Bivalve Molluscs 5 1 230 700 - - - - - - - - - - - - - - - -
/100g /100g
5. Chilled/Frozen Bivalves 5 0 46 10 0 Absent/25g 5 0 Absent/25g - - - - - - - -
6. Frozen cooked 5 2 1 10 5 0 Absent/25g 5 0 Absent/25g 5 0 Absent/25g - - - -
crustaceans/Frozen heat
shucked mollusca
7. Dried/ Salted and dried 5 0 20 5 0 Absent/25g - - - - - - - - - - - -
fishery products

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8. Thermally processed - - - - - - - - - - - - - - - - Absence of viable spores
fishery products or vegetative cells of
Clostridium botulinum
and absence of
botulinum toxin.
9. Fermented Fishery 5 2 4 40 10 0 Absent/25g - - - - - - - - Absence of viable spores
Products or vegetative cells of
Clostridium botulinum
and absence of
botulinum toxin.
10 Smoked fishery products 5 3 11 500 5 0 Absent/25g 5 0 Absent/25g 5 0 Absent/25g - - - -

11 Accelerated Freeze Dried 5 0 20 5 0 Absent/25g 5 0 Absent/25g 5 0 Absent/25g - - - -

Fishery Products

12 Fish Mince/Surimi and 5 0 20 5 0 Absent/25g 5 0 Absent/25g 5 0 Absent/25g - - - -

analouges

13. Fish Pickle 5 0 20 5 0 Absent/25g - - - - - - - - - - - -

6|Version 2 (04.11.2024)
14. Battered and Breaded 5 2 11 500 5 0 Absent/25 5 0 Absent/25g 5 5 Absent/25g - - - -
fishery products g

15. Convenience fishery 5 2 1 10 5 0 Absent/25 5 0 Absent/25g 5 0 Absent/25g - - - -

products g

16. Powered fish based - - - - 5 0 Absent/25g - - - - - - - - - - - -

products

Test Methods IS: 5887 Part 1 or ISO IS: 5887 Part 3/ ISO Vibrio, IS: 14988, Part IS: 5887, Part 4 or ISO
16649-2 6579 Bacteriological 1&2/ISO 11290-1 &2 17919
Analytical Manual,
Chapter 9. USFDA
BAM Online, May,
2004

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.

m = Microbiological limit that may be exceeded number of units c.

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M = Microbiological limit that no sample unit may exceed.

Product Definitions:

(1) Chilled/Frozen Finfish includes clean and wholesome finfish, which are either in raw, chilled or frozen condition and handled in accordance with
good manufacturing practices. Chilling is the process of cooling fish or fish products to a temperature approaching that of melting ice. Chilling can
be achieved either by using ice, chilled water, ice slurries of both seawater and freshwater or refrigerated seawater. Similarly, freezing is the process
which is sufficient enough to reduce the temperature of the whole product to a level low enough to preserve the inherent quality of the fish and that
have been maintained at this low temperature during transportation, storage and distribution up to and including the time of final sale. Freezing
process that is carried out in appropriate equipment in such a way that the range of temperature of maximum crystallization is passed quickly. The
quick freezing process shall not be regarded as complete unless and until the product temperature reached –18oC (0oF) or lower at the thermal centre
after thermal stabilization.

(2) Chilled/Frozen Crustaceans includes clean, whole or peeled crustaceans (shrimp/prawn, crabs and lobster) which are either in raw, chilled or frozen
condition and handled in accordance with good manufacturing practices.

(3) Chilled/Frozen Cephalopods includes cleaned, whole or de-skinned cephalopods (squid, cuttlefish and octopus) which are either in raw, chilled or
frozen condition and handled in accordance with good manufacturing practices.

(4) Live Bivalve Molluscs includes Oyster, Clam, Mussel, Scallop, Abalone which are alive immediately prior to consumption. Presentation includes
the shell. Live bivalve molluscs are harvested alive from a harvesting area either approved for direct human consumption or classified to permit
harvesting for an approved method of purification, like relaying or depuration, prior to human consumption. Both relaying and depuration must be
subject to appropriate controls implemented by the official agency having jurisdiction.

(5) Chilled/Frozen Bivalves includes clean, whole or shucked bivalves, which are live either in chilled or frozen condition and handled in accordance
with good manufacturing practices. This product category includes filter feeding aquatic animals such as oysters, mussels, clams, cockles and
scallops.

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(6) Frozen cooked Crustaceans or Frozen heat shucked Mollusca means clean, whole or peeled crustaceans, which are cooked at a defined temperature
and time and subsequently frozen. Cooking of crustaceans must be designed to eliminate six log reduction of most heat resistant vegetative bacteria
i.e. Listeria monocytogenes. Frozen heat shucked mollusca includes bivalves where meat is removed from the shell by subjecting the animals to mild
heat before shucking to relax the adductor muscle and subsequently frozen.

(7) Dried or Salted and Dried fishery Products means the product prepared from fresh or wholesome finfish or shellfish after drying with or without
addition of salt. The fish shall be bled, gutted, beheaded, split or filleted and washed prior to salting and drying. Salt used to produce salted fish shall
be clean, free from foreign matter, and has no visible signs of contamination with dirt, oil, bilge or other extraneous materials.

(8) Thermally Processed Fishery Products means the product obtained by application of heat or temperature for sufficient time to achieve commercial
sterility in hermetically sealed containers.

(9) Fermented Fishery Products includes any fish product that has undergone degradative changes through enzymatic or microbiological activity either
in presence or absence of salt. Non-traditional products manufactured by accelerated fermentation, acid ensilage and chemical hydrolysis also belong
to this category.

(10) Smoked Fishery Products means fish or fishery product subjected to a process of treatment with smoke generated from smouldering wood or plant
materials. Here the product category refers to hot smoked fish where fish is smoked at an appropriate combination of temperature and time sufficient
to cause the complete coagulation of the proteins in the fish flesh.

(11) Accelerated Freeze dried Fishery Products means fish, shrimp or any fishery product subjected to rapid freezing, followed by drying under high
vacuum so as to remove the water by sublimation to a final moisture content of less than two percent.

(12) Fish Mince/Surimi and analogues means comminuted, mechanically removed meat which have been separated from and are essentially free from
bones, viscera and skin. Surimi is the stabilized myofibrillar proteins obtained from mechanically deboned fish flesh that is washed with water and
blended with cryoprotectants. Surimi analogues are variety of imitation products produced from surimi with addition of ingredients and flavor.

(13) Fish Pickle means an oily, semi-solid product with spices and acidic taste obtained from maturation of partially fried fish with vinegar. It is produced
by frying edible portions of fish, shrimp or mollusc, followed by partial cooking with spices, salt and oil and maturing for 1-3 days with added
organic acids. The product is intended for direct human consumption as a seasoning, or condiment for food.

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 (14) Battered and Breaded Fishery Products include fish portions, fillets or mince coated with batter and/or breading. Batter means liquid preparation
from ground cereals, spices, salt, sugar and other ingredients and/or additives for coating. Typical batter types are non-leavened batter and leavened
batter. Breading means dry breadcrumbs or other dry preparations mainly from cereals with colourants and other ingredients used for the final coating
of fishery products.

(15) Convenience Fishery Products are tertiary food products made of fish, which are in ready to eat form and also includes snack based items prepared
from fish and fishery products meant for direct human consumption such as extruded fishery products, fried items namely fish wafers, crackers, fish
cutlets, fish burgers and other such products. These products can be consumed directly after minimal handling and processing. This category includes
Sous‐vide cooked products, surimi‐based products cooked (in‐pack), pasteurized crab meat, pasteurized molluscs which are distributed as
refrigerated, but meant for direct human consumption with minimal or no cooking.

(16) Powdered Fish based Products include the products which are prepared from finfish/shellfish or parts thereof, with or without other edible ingredients
in powdered form, suitable for human consumption. These may be consumed directly or as supplements and also after hydration and this category
includes powdered and dried fish products generally used as ingredients in food preparations such as fish soup powder, fish chutney powder, ready
to use fish-mix, and such other food.]

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 21[Table
2
Microbiological Standards for Milk and Milk Products

Table-2A Microbiological Standards for Milk and Milk Products –Process Hygiene Criteria

Staphylococcus aureus
Aerobic Plate Count Coliform Count4 Yeast and Mold Count Escherichia coli
(Coagulase positive)

Sr. Product Description1 Samplin

Sampling Sampling Sampling Samplin
No. g Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan g plan
Plan
n c m M n c m M n c m M n c m M n c m M
4
Pasteurized/boiled Milk/ 3x10 / 5x
1 5 3 4 5 0 <10/ml NA NA NA NA NA NA NA NA NA NA NA NA NA
Flavored Milk ml 10 /ml
4
3 5x10 /g 7.5x10
4
2 Pasteurized Cream 5 5 0 <10/g NA NA NA NA NA NA NA NA NA NA NA NA NA
/g
Sterilized milk /UHT milk
3 NA
/ Evaporated Milk

4 Sterilized / UHT Cream NA

Sweetened Condensed 2 3
5 5 3 5x10 /g 1x10 /g 5 0 <10/g NA 5 0 <10/g NA 5 0 <10/g NA NA NA NA NA
Milk
4
Absent/
3 2.5x10 / 5x10 /g 5
2 4
6 Pasteurized Butter 5 2 10/g 20/g 5 2 10/g 50/g 5 3 20/g 50/g 5 0 NA
g g

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 Staphylococcus aureus
Aerobic Plate Count Coliform Count4 Yeast and Mold Count Escherichia coli
(Coagulase positive)

Sr. Product Description1 Samplin

Sampling Sampling Sampling Samplin
No. g Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan g plan
Plan
n c m M n c m M n c m M n c m M n c m M

Milk Powder ; SMP, Partly

SMP ; Dairy Whitener ;
Cream Powder ; Ice Cream
4 4 2
7 Mix Powder ; Lactose ; 5 2 3x10 /g 5x10 /g 5 2 10/g 50/g 5 2 10/g 1x10 /g 5 0 50/g NA NA NA NA NA
Whey based Powder
;Butter Milk Powder ;
3
Casein Powder

82[InfantMilk Substitute,
Infant Formula, Food for
special medical purpose
intended for infants4]

2 3
8 5 2 5x10 /g 5x10 /g NA NA NA NA 5 0 <10/g NA 5 0 <10/g NA NA NA NA NA

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 Staphylococcus aureus
Aerobic Plate Count Coliform Count4 Yeast and Mold Count Escherichia coli
(Coagulase positive)

Sr. Product Description1 Samplin

Sampling Sampling Sampling Samplin
No. g Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan g plan
Plan
n c m M n c m M n c m M n c m M n c m M

Follow Up Formula
82[Cereal Based
Complimentary food, Food 5 3 4 Absent/
2 1x10 /g 1x10 /g 10 0 <10/g NA 5 0 <10/g NA 5 0 <10/g NA 10 0 NA
for infants based on g
traditional food
ingredients]

2
Ice Cream, Frozen Dessert, 5 5 1x10 / 5 2 Absent/
9 5 3 1x10 /g 2x10 /g 5 3 10/g 2 10/g 1x10 /g NA NA 5 0 NA
Milk Lolly, Ice Candy g NA NA g

4
Processed Cheese/
2 2.5x10 / 5x10 /g 5
4
10 5 0 <10/g NA 5 0 <10/g NA NA NA NA NA NA NA NA NA
Cheese Spread g

All other cheeses

2 2 2
categories including fresh N 2 5x10 / 5 2 1x10 5x10
11 NA NA NA 5 3 1x10 /g 3 10/g 1x10 /g 5 3 5 0 <10 /g NA
cheeses / Cheddar / A g /g /g
Cottage /Soft /Semi Soft5
2 2
N 1x10 / 5 2 1x10 Absent/
12 Fermented Milk Products NA NA NA 5 2 10/g 2 10/g 1x10 /g 5 3 50/g 5 0 NA
A g /g g
5 5 2 2
Paneer/ Chhana/ chhana
3 1.5x10 / 3.5x10 1x10 / 5 50/g 1.5x10 5
2
13 5 5 3 10/g 3 10/g 1x10 /g 5 3 0 <10/g NA
based sweets g /g g /g

13 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Staphylococcus aureus
Aerobic Plate Count Coliform Count4 Yeast and Mold Count Escherichia coli
(Coagulase positive)

Sr. Product Description1 Samplin

Sampling Sampling Sampling Samplin
No. g Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan g plan
Plan
n c m M n c m M n c m M n c m M n c m M
4 4 2
3 2.5x10 / 7.5x10 1x10 / 5 2
14 Khoa/ Khoa based sweets 5 5 2 50/g 3 10/g 1x10 /g 5 3 10/g 50/g 5 0 <10/g NA
g /g g
IS 5887: Part 2 or
IS 5887 Part 8 (Sec 1)/
IS 5887: Part 1
Test Methods7 IS 5402/ ISO: 4833 IS 5401 Part 1/ISO : 4832 ISO: 6888-1 or IS:5403 or ISO : 6611
or ISO : 16649-2
IS 5887 Part 8 (Sec 2)/
ISO 6888-2

14 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table-2B: Microbiological Standards for Milk and Milk Products – Food Safety Criteria

Sulphite Reducing
Enterobacter sakazakii
Salmonella sp. Listeria monocytogenes Bacillus cereus Clostridia
(Cronobacter sp.
(SRC)
Sr.
Product Description1
No Sampling Sampling Sampling Sampling Sampling
Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan plan plan

n c m M n c m M n c m M n c m M n c m M

Pasteurized/boiled Absent/ Absent/

1 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
milk/ Flavored Milk 25 ml 25ml

Absent/ Absent/
2 Pasteurized Cream 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
25g 25g

Sterilized milk /UHT

Sterilized /UHT milk products shall comply with a test for commercial sterility as per IS: 4238
3 milk / Evaporated
(Appendix C or Appendix D)
Milk

4 Sterilized/ UHT Cream Sterilized/UHT cream product shall comply with a test for commercial sterility as per IS : 4884

Sweetened Condensed Absent/ Absent/

5 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
Milk6 25g g

Absent/ Absent/
6 Pasteurized Butter2 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
25g g

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 Sulphite Reducing
Enterobacter sakazakii
Salmonella sp. Listeria monocytogenes Bacillus cereus Clostridia
(Cronobacter sp.
(SRC)
Sr.
Product Description1
No Sampling Sampling Sampling Sampling Sampling
Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan plan plan

n c m M n c m M n c m M n c m M n c m M

Milk Powder; SMP,

PSMP; Dairy
Whitener; Cream
Powder ; Ice Cream 2 3 2
Absent/ Absent/ 5x10 / 1x10 /
7 Mix Powder; Lactose; 5 0 NA 5 0 NA 5 3 5 3 50/g 1x10 NA NA NA NA
25g g g g /g
Whey based Powder;
Butter Milk

Powder; Casein Powder

82[InfantMilk
Substitute, Infant
Formula, Food for
special medical
purpose intended for
2 2 2
infants] Absent/ Absent/ 1x10 / 5x10 / Absent
8 60 0 NA 10 0 NA 5 2 5 2 10/g 1x10 30 0 NA
25g 25g g g /g /10g

16 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Sulphite Reducing
Enterobacter sakazakii
Salmonella sp. Listeria monocytogenes Bacillus cereus Clostridia
(Cronobacter sp.
(SRC)
Sr.
Product Description1
No Sampling Sampling Sampling Sampling Sampling
Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan plan plan

n c m M n c m M n c m M n c m M n c m M
2 2 2
15 Absent/ Absent/ 1x10 / 5x10 /
Follow Up Formula 0 NA 0 NA 5 2 5 2 10/g 1x10 NA NA NA NA
25g 10 25g g g /g
82[Cereal Based
Complimentary food,
Food for infants based
on traditional food
ingredients]
2 2 2
Absent/ Absent/ 1x10 / 5x10 /
15 0 NA 0 NA 5 2 5 2 10/g 1x10 NA NA NA NA
25g 10 25g g g /g

Ice Cream, Frozen

Absent/ Absent/
9 Dessert, Milk Lolly, 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
25g g
Ice Candy

Processed Cheese/ Absent/ Absent /

10 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
Cheese Spread 25g 25g

17 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Sulphite Reducing
Enterobacter sakazakii
Salmonella sp. Listeria monocytogenes Bacillus cereus Clostridia
(Cronobacter sp.
(SRC)
Sr.
Product Description1
No Sampling Sampling Sampling Sampling Sampling
Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu) Limit (cfu)
plan plan plan plan plan

n c m M n c m M n c m M n c m M n c m M
All other cheeses
categories including
Absent/ Absent/
11 fresh cheeses / 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
25g 25 g
Cheddar / Cottage
/Soft /Semi Soft etc
Fermented Milk Absent/ Absent/
12 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
Products- 25g g

Paneer/ Chhana/
Absent/ Absent/
13 chhana 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA NA
25g g
based sweets
Khoa/ Khoa based Absent/ Absent/
14 5 0 NA 5 0 NA NA NA NA NA NA NA NA NA NA NA NA
sweets 25g g
IS 5887 : Part 3/ IS 14988: Part 1/ ISO:
Test Methods7 IS 5887 (Part 6) /ISO:7932 ISO : 15213 ISO/TS 22964
ISO : 6579 11290-1

ISO : 11290-1 or 2, as
NA- Not Applicable applicable
1
Microbiological 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
2
The microbiological specifications for ripened butter are the same as for pasteurized butter excluding the requirements of Aerobic Plate Count.

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3
The yeast and mold count of 50/g as specified in dried product categories shall be applicable only to casein powder
4
For 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.
5
The yeast and mold counts is not applicable in mold ripened cheeses
6
The 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.
63[
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.]

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,

 63[
Ensure that all food safety criteria as specified in Table-2B are complied with.]

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

19 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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. 63[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]. 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 h
aving 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
1. Satisfactory, if all the values observed are ≤ m 2. Acceptable, if a maximum of c values are between m and M and
2. Unsatisfactory, if one or more of the values observed the rest of the values are observed as ≤ m
are >m or more than c values are > 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.

20 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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. 63[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].

Sr. no. Parameter Reference Test Methods

Microbiology of the food chain -- Horizontal method for the enumeration of microorganisms -- Part 1:
1.
Aerobic Plate Count Colony count at 30 degrees C by the pour plate technique- IS 5402/ ISO:4833
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
2.
Coliforms Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of Coliforms -
Colony-count technique- ISO 4832
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
3. Enterobacteriaceae 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. 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
Staphylococcus Enumeration of Coagulase-Positive Staphylococci/ (Staphylococcus aureus and other species) Section 1
aureus 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

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Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of coagulase-
positive staphylococci (Staphylococcus aureus and other species) -- Part 1: Technique using Baird-Parker
 Method for Yeast and Mould Count of Food Stuffs and Animal feed- IS 5403
Yeast and Mould
6.
Count Milk and milk products -- Enumeration of colony-forming units of Yeasts and/or Moulds -- Colony-count
technique at 25 degrees C- ISO 6611

Methods for Detection of Bacteria Responsible for Food Poisoning - Part I : Isolation, Identification and
Enumeration of Escherichia coli- IS 5887 : Part 1
7. Escherichia coli
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

Methods for Detection of Bacteria Responsible for Food Poisoning - Part 3: General Guidance on Methods
for the Detection of Salmonella- IS 5887: Part 3
8. Salmonella
Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella
spp.- ISO 6579
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
9. 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

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

Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of presumptive
10. Bacillus cereus
Bacillus cereus -- Colony-count technique at 30 degrees C- IS 5887 (Part 6) /ISO:7932

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 Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of sulfite-
11. Sulfite-reducing bacteria
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.”.]

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 70[Table:
3 Microbiological Standards for Spices and Herbs
Table -3A Microbiological Requirements for Spices and Herbs –Process Hygiene Criteria

Sr. Product Categoryi Aerobic Colony Count Yeast and Mold Count Enterobacteriaceae
No. Staphylococcus aureus

Sampling Limits Sampling Limits Sampling Limits Sampling

Limits (cfu/g)
Plan (cfu/g) Plan (cfu/g) Plan (cfu/g) Plan

n C m M n c m M n c m M n c m M

1. Freshii

2. Dried or 5 2 1x106 1x107 5 2 1x104 1x105 5 2 1x102 1x103 5 2 1x102 1x103

Dehydrated
3. Ground or 5 2 1x106 1x107 5 2 1x 104 1x 105 5 2 1x102 1x103 5 2 1x102 1x103
Powdered
4. Extracted 5 2 1x103 1x 104 5 2 1x102 1x 103 5 1 1x101 1x 102 5 1 1x101 1x102

5. Wet ground
(Paste)/ preserved 5 2 1x 103 1x 104 5 2 1x 103 1x 104 5 2 1x102 1x 103 5 2 1x101 1x102
or pickled
Method of IS: 5402/ ISO 4833 IS: 5403/ ISO 21527 Part IS/ISO:7402/ ISO 21528 IS:5887, Part 2 and IS 5887
analysisiii 1 and Part 2 Part 2 part 8 (Sec 1)/ ISO 6888-1 or
IS:5887 Part 8 (Sec2)/ISO
6888-2

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 Table -3B Microbiological Requirements for Spices and Herbs – Food Safety Criteria

Sr. No. Product Salmonella Sulphite Reducing Clostridia Bacillus cereus

Categoryi

Sampling Limits Sampling Limits Sampling Limits

Plan (cfu/g) Plan (cfu/g) Plan (cfu/g)

N c m M n c m M N c m M

1. Freshii

2. Dried or 5 0 Absent/25 g NA 5 2 1x102 1x103 5 2 1x103 1x104

Dehydrated
3. Ground or 5 0 Absent/25 g NA 5 2 1x102 1x 103 5 2 1x103 1x104
Powdered
4. Extracted 5 0 Absent/25 g NA 5 1 1x101 1x 102 5 1 1x101 1x 102

5. Wet ground 5 0 Absent/25 g NA 5 2 1x101 1x 102 5 2 1x101 1x 102

(Paste)/
preserved or
pickled
6. Method of IS: 5887 Part 3/ISO:6579 ISO 15213 IS:5887,Part 6
analysisiii ISO 7932

NA-Not applicable
i.Definitions:

a. Fresh: The spices and herbs that are consumed fresh.

25 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 b. Dried or dehydrated: The product obtained by drying/ removal of most of the moisture by any suitable method which ensures
characteristics of fresh spices on rehydration or pre-cooking.
c. Ground or powdered: Ground or powdered product obtained by grinding or crushing of clean dried/dehydrated fruits, capsules, buds,
seeds, rhizomes, aril, kernel, berries and stigmas etc.
d. Extracted: Products of the spices and herbs which are produced by extracting in a concentrated form including oleoresins.
e. Wet ground (paste)/preserved or pickled: Semi solid, preserved product using brine, vinegar and other permitted preservatives or physical
methods.
For detailed product definition, refer to Food Safety & Standards (Food Product Standards & Food Additives) Regulations, 2011.

ii.
The category “Fresh” shall be regulated in accordance with the Good Manufacturing Practices and Code of Good Hygiene Practices notified
under Schedule 4 of FSS (Licensing and Registration of Food Businesses) Regulations, 2011.

Stage where the Microbiological Standards shall apply:

The microbiological standards with respect to the product categories specified in Table-3A (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 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. The Microbiological Standards in Table-3B (Food Safety Criteria) define the acceptability of a batch/lot
and shall be met in respect of the products at the end of manufacturing process and the products in the market during their shelf- life.

Action in case of unsatisfactory result:

In case of non-compliance in respect of Process Hygiene Criteria specified in Table- 3A, the FBO shall:

 check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing and Registration of Food Businesses)
Regulations; and,

 Ensure that all food safety criteria as specified in Table -3B are complied with.

26 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Sampling Plans and Guidelines;

For Regulator: The sampling for different microbiological standards specified in Table-3A and 3B 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 in frozen condition at -18°C(±2°C) or under refrigerated conditions at 2-5°C as applicable 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-3A & 3B shall be
taken from same batch/lot and shall be submitted to the notified laboratory. Three sets, each containing ‘n’ number of samples (n as defined in the
sampling planeg if n=5, then total no. of samples to be drawn is 15) shall be drawn. Each of these three sets shall be tested in three different
accredited laboratories. The final decision shall be based on the results of three accredited laboratories. In the case of food safety criteria (Table
8B), results from all the three laboratories should indicate compliance with specified criteria. There will be no provision for retesting or resampling
for microbiological testing. The testing in laboratory shall be ensured as per reference test methods given below in reference test methods for
regulatory compliance.
For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-3A & 3B to ensure
validation and verification of compliance with the microbiological requirements. FBO shall decide themselves subject to minimum prescribed under
FSSR (Licensing and Registration of Food Businesses), 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)

27 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 1. Satisfactory, if all the values observed are ≤ m 1. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of the values observed are >m. 2. Acceptable, if a maximum of c values are between m and M.
3. Unsatisfactory, if one or more of the values observed are > M or more
than prescribed c values are >m

iii.
Reference test methods: The following test methods shall be applied as reference methods. Test methods prescribed in FSSAI Manual of Method
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. Latest version of test methods 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. Parameter Reference Test methods

No.

Aerobic Plate Microbiology of the food chain -- Horizontal method for the enumeration of microorganisms -- Part 1: Colony count
1.
Count at 30 °C by the pour plate technique- IS 5402/ ISO:4833

Method for Yeast and Mold Count of Food Stuffs and Animal feed- IS 5403
Yeast and Microbiology of food and animal feeding stuff- Horizontal method for the enumeration of yeasts and moulds-Part1:
2. Mold Count Colony count technique in products with water activity greater than 0.95-ISO 21527-1
Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-Part2:
Colony count technique in products with water activity less than 0.95-ISO 21527-2

Microbiology - General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation - MPN Technique
Enterobacteri and Colony-count Technique- IS/ISO 7402
3. aceae
Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of
Enterobacteriaceae- Part 2:Colony- count method-ISO 21528-2

28 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 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

Staphylococcus Methods for Detection of Bacteria Responsible for Food Poisoning Part 8 Horizontal Method for Enumeration of
aureus Coagulase-Positive Staphylococci/ (Staphylococcus aureus and other species) Section 1 Technique using baird-parker
4. 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
Methods for Detection of Bacteria Responsible for Food Poisoning - Part 3: General Guidance on Methods for the
Detection of Salmonella- IS 5887: Part 3
5. Salmonella
Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella spp.- ISO6579
Sulfite-
Reducing Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of sulfite-reducing bacteria
6.
Bacteria Microbiology of anaerobic
growing under food andconditions-
animal feeding stuffs -- Horizontal method for the enumeration of coagulase-positive
ISO 15213
staphylococci (Staphylococcus aureus and other species) -- Part 1: Technique using Baird-Parker agar medium
Microbiology of Food and Animal Feeding Stuffs-Horizontal Method for the Enumeration of Preservative Bacillus Cereus,
Bacillus cereus Part 6 Colony –count Technique at 30°C- IS 5887-6
7. Microbiology of food and animal feeding stuffs- Horizontal method for the enumeration of presumptive Bacillus cereus-
Colony- count technique at 30degrees C.-ISO 7932.]

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 46[Table 4A: Microbiological Standards for Fruits and Vegetables and their Products – Process Hygiene Criteria

Sl. Product Aerobic Plate Count Yeast and Mold Count Enterobacteriaceae Staphylococcus aureus
No. description 1
(Coagulase +ve)

Sampling Limit (cfu) Sampling Limit (cfu) Sampling Limit (cfu) Sampling Limit (cfu)
Plan Plan Plan Plan

n c m M n c m M n c m M n c m M

1. Fresh2 NA

2. Cut or minimally 5 2 1x10 /g

6 7
1x10 /g 5 1 1x102/g 4
1x10 /g 5 2 2 4
1x10 /g 1x10 / 5 1 2
1x10 / 1x10 /g
3

processed and g
g
packed, including
juices (Non-
thermally
processed)
3. Fermented3 or NA 5 1 1x102/g 3
1x10 /g 5 2 2 3
1x10 /g 1x10 / 5 1 10/g 2
1x10 /g
pickled or
g
acidified or with
preservatives
4. Pasteurized 5 2 1x102/ml 1x104/ 5 1 1x102/ 3
1x10 /ml 5 0 Not detectable 5 0 Absent/25ml
Juices4 ml ml as per
Carbonated Fruit 5 1 50/ml 5x102/ 5 0 <10/ml 5 0 prescribed 5 0 Absent/25ml
beverages4 ml method

30 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
5. Frozen 5 2 4x10 /g
4 5
5x10 /g 5 1 1x102/g 3
1x10 /g 5 2 2 2
1x10 /g 3x10 / 5 1 20/g 1x102/g
g
6. Dehydrated or 5 1 4x10 /g
4 5
1x10 /g 5 1 1x102/g 4
1x10 /g 5 1 2 3
1x10 /g 1x10 / 5 1 10/g 2
1x10 /g
dried
g
2 3 2
7. Thermally 5 1 1x10 /g 1x10 /g 5 1 50/g 1x10 /g 5 0 Not detectable 5 0 Absent/25g
processed (other as per
than pasteurization
prescribed
at less than 100°C)
8. Retort processed5 5 0 50/g NA 5 0 method 5 0 Absent/25g
Test Methods6 IS: 5402/ISO:4833 IS: 5403/ ISO 21527 Part 1 and IS/ISO 7402/ ISO 21528 IS:5887, Part 2 and
Part 2 Part 2 IS 5887 part 8 (Sec
1)/ ISO 6888-1 or
IS:5887 Part 8
(Sec2)/ISO 6888-2

31 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table 4B: Microbiological Standards for Fruits and Vegetables and their Products-Food Safety Criteria

Sl. N. Product Salmonella Listeria Sulphite E. Coli 0157 and Vibrio cholerae
description1 monocytogenes Vero or Shiga toxin
Reducing Clostridia producing E coli
(SRC)

Sampling Limit Sampling Limit Sampling Limit Sampling Limit Sampling Limit
Plan Plan Plan Plan Plan
(cfu) (cfu) (cfu) (cfu) (cfu)

n c m M n c m M n c m M n c m M n c m M

1. Fresh2 NA NA NA NA NA

2. Cut or 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25

minimally 25 g g g g
processed and
packaged,
including juices
(Non-thermally
processed)
3. Fermented3 or 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25
pickled or 25 g g g g
acidified or
with
preservatives
4. Pasteurized 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25
Juices4 25 ml ml ml ml

32 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Sl. N. Product Salmonella Listeria Sulphite E. Coli 0157 and Vibrio cholerae
description1 monocytogenes Vero or Shiga toxin
Reducing Clostridia producing E coli
(SRC)

Sampling Limit Sampling Limit Sampling Limit Sampling Limit Sampling Limit
Plan Plan Plan Plan Plan
(cfu) (cfu) (cfu) (cfu) (cfu)

n c m M n c m M n c m M n c m M n c m M

Carbonated 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25

fruit beverages4 25 ml ml ml ml
5. Frozen 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25
25 g g g g

6. Dehydrated or 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25

dried 25 g g g g

7. Thermally 5 0 Absent/ 5 0 Absent/25 NA NA NA NA 5 0 Absent/25 5 0 Absent/25

processed 25 g g g g
(other than
pasteurization
at less than
100°C
8. Retort 5 0 Absent/25 5 0 Absent/25 5 0 Absent/25 5 0 Absent/25 5 0 Absent/25
processed5 g g g g g

33 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Sl. N. Product Salmonella Listeria Sulphite E. Coli 0157 and Vibrio cholerae
description1 monocytogenes Vero or Shiga toxin
Reducing Clostridia producing E coli
(SRC)

Sampling Limit Sampling Limit Sampling Limit Sampling Limit Sampling Limit
Plan Plan Plan Plan Plan
(cfu) (cfu) (cfu) (cfu) (cfu)

n c m M n c m M n c m M n c m M n c m M

Test Methods6 IS: 5887 Part3 / IS: 14988, Part 1 / ISO 15213 IS: 14397 IS:5887, (Part V)/ ISO
ISO:6579 ISO 11290-1 21872 Part 1

Note- ‘ml’ will be applicable in place of ‘g’ in case of liquid product.

NA-Not applicable
1
Definitions of fruits and vegetables and their products

(a) Fresh: The whole fruits and vegetables that are sold fresh.
(b) Cut or minimally processed and packaged including juices: Fruits and vegetables which are washed or sanitized or peeled or cut up and
made in to juice and packed.
(c) Fermented or pickled or acidified or with preservatives: Fruits and vegetables including their products which are preserved using living
ferments like yeast, bacterium, mold, enzyme or in brine to produce lactic acid or marinating and storing it in an acid solution,
usually vinegar (acetic acid), salt and sugar.
(d) Pasteurized Juices: Fruit and vegetable juices that are subjected to pasteurization to destroy or inactivate harmful microorganisms.

34 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 (e) Carbonated fruit beverages (and fruit drinks): Any beverage or drink which is prepared from fruit juice and water or carbonated water
and containing sugar, dextrose, invert sugar or liquid glucose either in single or in combination which may contain peel oil and fruit
essences. It may also contain any other ingredients appropriate to the products.
(f) Frozen: Fruits and vegetables including their products which are subjected to a freezing process and maintained at temperature of -180C.
(g) Dehydrated or dried: Fruits and vegetables including their products which are preserved by removing most of their water content following
an appropriate dehydrating process.
(h) Thermally processed (other than pasteurization at less than 100°C): Fruits and vegetables including their products which are processed
by heat in an appropriate manner before or after being sealed in a container so as to prevent spoilage.
(i) Retort processed: Fruits and vegetables including their products which are canned or flexible packaged, processed by retorting.

For detailed product description, refer to regulation 2.3 related to Fruit & Vegetable Products of these regulations.

2
The category “Fresh” shall be regulated in accordance with the Good Manufacturing Practices and Good Hygiene Practices specified under Schedule 4
of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
3
In case of fermentation process involving yeast/ mold the respective standard for yeast and mold count does not apply.

4
Carbonated fruit beverages and pasteurized fruit juices can be excluded for testing of Listeria, where the pH is below 4.4.

5
The retort processed foods shall be tested after incubation at 37°C for 10 days and at 55°C for 7 days.

Stage where the Microbiological Standards shall apply:

The microbiological standards with respect to the products categories specified in Table-4A (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 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.

35 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
63
[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.]

Action in case of unsatisfactory result:

In case of non-compliance in respect of process hygiene criteria specified in Table- 4A, the FBO shall:

 check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing and Registration of Food Businesses)
Regulations; and,
 Ensure that all food safety criteria as specified in Table -4B (Food Safety Criteria) are complied with.

63[Omitted]

Sampling Plans and Guidelines;

For Regulator: The sampling for different microbiological standards specified in Table-4A and 4B 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 in frozen
condition at -18°C (±2°C) or under refrigerated conditions at 2-5°C as applicable 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-4A & 4B shall be taken from same batch/lot and
shall be submitted to the notified laboratory. 63[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.] The testing in laboratory
shall be ensured as per reference test methods given below in reference test methods for regulatory compliance.

For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-4A & 4B 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.

36 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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)

3. Satisfactory, if all the values observed are ≤ m 4. Satisfactory, if all the values observed are ≤ m
4. Unsatisfactory, if one or more of the values observed are >m or 5. Acceptable, if a maximum of c values are between m and M and
more than c values are >m the rest of the values are observed as ≤m
6. 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.
6Reference 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. 63[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.]

Sl. Parameter Reference Test Methods

No
Aerobic Plate Count Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 1:
1. Colony count at 30°C by the pour plate technique- IS 5402/ ISO:4833

37 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Sl. Parameter Reference Test Methods
No
Method for Yeast and Mold Count of Food Stuffs and Animal feed- IS 5403
Yeast and Mold Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-
Count Part1: Colony count technique in products with water activity greater than 0.95-ISO 21527-1
2.
Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-
Part2: Colony count technique in products with water activity less than 0.95-ISO 21527-2
Microbiology - General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation - MPN
Technique and Colony-count Technique- IS/ISO 7402
3 Enterobacteriaceae
Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of
Enterobacteriaceae- Part 2: Colony- count method-ISO 21528-2
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

Staphylococcus 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-
4 aureus 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)

E. Coli 0157 and

Vero or Shiga
5 toxin producing Methods for detection, isolation and identification of pathogen i.e. E.coli in foods- IS :14397
E Coli

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Sl. Parameter Reference Test Methods
No
Methods for detection of bacteria responsible for food poisoning - Part 3: General Guidance on Methods for the
Detection of Salmonella- IS 5887: Part 3
6 Salmonella
Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp.-
ISO 6579

Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria
7 Listeria
monocytogenes monocytogenes and other Listeria spp. - Part 1: Detection method – IS: 14988, Part 1 / ISO 11290-1

Sulfite-Reducing Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of sulfite-reducing
8 Bacteria bacteria growing under anaerobic conditions- ISO 15213

Isolation, identification and enumeration of Vibrio cholerae and Vibrio parahaemolyticus - IS:5887, (Part V)
Vibrio cholerae

9 Microbiology of food and animal feeding stuff-Horizontal method for the detection of potentially
enteropathogenic Vibrio spp.-Part 1: Detection of Vibrio parahaemolyticus and Vibrio cholerae-ISO/TS
21872-1]

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 21[Table
5
Microbial Standards for Meat and Meat Products

Table 5A: Microbiological Standards for Meat and Meat Products- Process Hygiene Criteria

S. Product Aerobic Plate Count Yeast and Mold Count Escherichia coli Staphylococcus aureus
No. Category1 (Coagulase +ve)
Sampling Sampling Sampling Sampling
Limits (cfu/g) Limits (cfu/g) Limits (cfu/g) Limits (cfu/g)
Plan Plan Plan Plan
n c m M n c m M n c m M n c m M
Fresh meat/ 6 6 4 4 2 3 2 3
1. 5 3 1x10 5x10 5 2 1x10 5x10 5 2 1x10 1x10 5 2 1x10 1x10
Chilled meat2
5 6 3 4 2 2
2. Frozen meat2 5 2 1x10 5x10 5 2 1x10 1x10 5 2 1x10 1x10 5 2 10 1x10
Raw
marinated/minced 5 6 57 2 3 2 3
3. 5 2 5x10 5x10 5 2 [1x104] 57
[5x104] 5 2 1x10 1x10 5 2 1x10 1x10
/comminuted
meat2
Semi-cooked
/Smoked Meat/ 4 5 2 2 2
4. 5 2 1x10 1x10 5 2 10 1x10 5 2 10 1x10 5 2 10 1x10
meat food
2
Product
Cured/Pickled 2 2 3 2 2 3
5. 5 2 5x10 5x103 5 2 1x10 1x10 5 2 10 1x10 5 1 1x10 1x10
meat
Fermented meat 2 2 3
6. NA NA NA NA NA NA NA NA 5 2 10 1x10 5 1 1x10 1x10
products
Dried/dehydrated 3 4 2 3 2 2
7. 5 2 1x10 1x10 5 2 1x10 1x10 5 2 10 1x10 5 1 10 1x10
meat products

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 Cooked Meat 3 4 2 2 2
8. 5 2 1x10 1x10 5 1 10 1x10 5 2 10 1x10 5 1 10 1x10
Products
Canned/Retort
9. pouch Meat NA NA NA NA NA NA NA NA 5 0 Absent NA 5 0 Absent NA
Products
IS 5887 : Part 2 or IS 5887
IS: 5887 Part1 or ISO Part 8 (Sec 1)/ ISO : 6888-
Test Methods3 IS: 5402/ISO 4833 IS: 5403/ISO 21527
16649-2 1 or IS 5887 Part 8 (Sec
2)/ISO 6888-2

Table 5B: Microbiological Standards for Meat & Meat Products- Food Safety Criteria

Sr. Product 63[Salmonella$] Listeria Sulphite Reducing Clostridium Campylobacter Spp*

No Category1 monocytogenes Clostridia Botulinum
.
Sampling Limits Sampling Limits Sampling Sampling Limits Sampling Limits
Limits (cfu/g)
Plan (cfu/25g) Plan (cfu/25g) Plan Plan (cfu/g) Plan (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 /
5 0 Absent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Chilled meat2
2. Frozen meat2 5 0 Absent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
3. Raw
marinated/mince
5 0 Absent NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
d/comminuted
meat2
4. Semi-cooked
/Smoked
5 0 Absent NA NA NA NA NA NA NA NA NA NA NA 5 0 Absent
Meat/meat food
Product2
41 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 5. Cured/Pickled 2 3
5 0 Absent 5 0 Absent 5 2 5x10 5x10 NA NA NA NA NA NA NA NA
meat
6. Fermented meat 2 3
5 0 Absent 5 0 Absent 5 2 5x10 5x10 NA NA NA NA NA NA NA NA
products
Dried/dehydrated 2 3
7. 5 0 Absent 5 0 Absent 5 2 5x10 5x10 NA NA NA NA NA NA NA
meat product
Cooked Meat 2 3
8. 5 0 Absent 5 0 Absent 5 1 1x10 1x10 NA NA NA NA 5 0 Absent
Products
Canned/ Retort
9. pouch Meat 5 0 Absent 5 0 Absent 5 0 Absent 5 0 Absent 5 0 Absent
Products
IS: 5887 Part 3/ IS: 14988, Part 1 ISO 15213 IS:5887, Part 4 or ISO 10272-1&2
Test Methods3
ISO 6579 &2/ISO 11290-1 & 2 ISO 17919
NA- Not Applicable
63 $
[ For poultry meat the requirement shall be applicable for Salmonella enterica serovars Typhi, Typhimurium and Entritidis.]

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.
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 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.
63
[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.]

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,
 63
[Ensure that all food safety criteria’s as specified in Table -5B are complied with.]
43 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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 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. 63[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.] 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.

44 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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
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
2. Unsatisfactory, if one or more of the values observed are >m of the values are observed as ≤ m
or more than c values are > 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. 63[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.]

S.No Parameter Reference Test Method

Microbiology of the food chain -- Horizontal method for the enumeration of microorganisms -- Part 1:
1. Aerobic Plate Count
Colony count at 30 degrees C by the pour plate technique- IS 5402 /ISO 4833

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-
2. Yeast and Mould Count 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
45 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 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
Staphylococcus aureus and Enumeration of Coagulase-Positive Staphylococci/ (Staphylococcus Aureus and other species) Section 1
3.
Faecal streptococci 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
Methods for Detection of Bacteria Responsible for Food Poisoning - Part I: Isolation, Identification and
Enumeration of Escherichia coli- IS 5887: Part 1
4. Escherichia coli
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

Methods for Detection of Bacteria Responsible for Food Poisoning - Part 3: General Guidance on Methods
for the Detection of Salmonell- IS 5887: Part 3
5. Salmonella spp.
Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella
spp.- ISO 6579

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
6. Listeria monocytogenes
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

46 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Microbiology of Food and Animal Feeding Stuffs - Horizontal Method for the Detection and Enumeration
of Campylobacter spp- Part 1: Detection Method- ISO 10272-1
7. Campylobacter spp
Microbiology of food and animal feeding stuffs -- Horizontal method for detection and enumeration of
Campylobacter spp. -- Part 2: Colony-count technique- ISO 10272-2

Sulphite-Reducing
8. Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of Sulphite-
Bacteria
Reducing Bacteria growing under anaerobic conditions- ISO 15213

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
63[
9. Clostridium botulinum] 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.”.]

47 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 27[TABLE 6

MICROBIOLOGICAL REQUIREMENTS OF OTHER PRODUCTS

Food Products Parameters Limits

Baker’s Yeast

Baker’s Yeast Total bacterial count, CFU/g (on dry basis), Max 7.5X105
(Compressed)
E. coli, CFU Absent in 1g

Salmonella, Shigella species Absent in 25 g

Coliform count, CFU/g, Max 10

Rope spore count, CFU/g, Max 10

Baker’s Yeast (Dried) Total bacterial count, CFU/g (on dry basis), Max 8 X106

E. coli, CFU Absent in 1g

Salmonella, Shigella species Absent in 25g

Coliform count, CFU/g, Max 50

Rope spore count, CFU/g, Max 100.]

48 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Amendment for substitution of highlighted provision

[Table 6A: Microbiological Standards for Baker’s Yeast- Process Hygiene Criteria
83

S. No. Product description Escherichia coli

Sampling plan Limit (cfu)

n c m M

1 Baker’s Yeast 5 0 Absent/25g

(Compressed and Dried)
Test Methods IS: 5887 Part 1 or ISO 16649-3

Table 6B: Microbiological Standards for Baker’s Yeast- Food Safety Criteria

S. No. Product description Salmonella Listeria monocytogenes

Sampling plan Limit (cfu) Sampling plan Limit (cfu)

n c m M n c m M
1 Baker’s Yeast 5 0 Absent/25g 5 0 Absent/25g
(Compressed and
Dried)
Test Methods IS: 5887 Part 3 / ISO:6579 IS: 14988 Part 1 / ISO 11290-1

Note: In high value low volume (less than 100 g) and large retail pack (pack more than 1 kg) sizes, the sample plan may be modified (e.g. Absence of
Salmonella in 10g or 5g in the case of former or ‘n’ number of samples to be taken from different sites of one large pack) accordingly on case to case
basis with the prior approval of Food Safety and Standards Authority of India.

49 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Definition: Definition of Baker’s Yeast (Compressed and Dried) are the same as provided in these regulations.

Stage where the Microbiological Standards shall apply: The microbiological standards (food safety criteria) specified above define the acceptability of a
batch or lot and shall be met in respect of the products at the end of the manufacturing process and the products in the market during their shelf- life.

Food Business Operator shall ensure that all food safety criteria as specified above are complied with.

Sampling Plan and Guidelines

For Regulator: The sampling for different microbiological standards specified above shall be ensured aseptically at manufacturing units and/or at retail
points, as applicable, by a trained person with specialised knowledge in the field of microbiology following guidelines in the Food Safety and Standards
(Food Products and Food Additives) Regulations, 2011 and ISO: 17728:2015 (Confirmed in 2019). The samples shall be stored and transported in frozen
condition at -18°C (±2°C) or under refrigerated conditions at 2-5°C as applicable except for 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 the table above shall be taken from same batch or lot and
shall be submitted to the notified laboratories. Three sets, each containing ‘n’ number of samples (n as defined in the sampling plan e.g. if n=5, then total
number of samples to be drawn is 15) shall be drawn. Each of these three sets shall be tested in three different accredited laboratories. The final decision
shall be based on the results of three accredited laboratories. In the case of Food Safety Criteria, the results from all the three laboratories should indicate
compliance with the specified criteria. There will be no provision for retesting or re-sampling for microbiological testing. The testing in laboratory shall
be ensured as per the methods given in the table “reference test methods”.

For Food Business Operator: Food Business Operator shall perform testing as appropriate as per the microbiological standards in Table above to ensure
verification of compliance with the microbiological requirements. Food Business Operator shall decide themselves subject to minimum prescribed under
Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, the necessary sampling and testing frequencies to ensure
compliance with the specified microbiological requirements. Food Business Operator 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, namely:-

50 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 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 1. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of the values observed are 2. Acceptable, if a maximum of c values are between m and M.
>m 3. Unsatisfactory, if one or more of the values observed are > M or more than
prescribed c values are >m

Reference test methods: The following test methods shall be applied as reference methods. Test methods prescribed in Food Safety and Standards Authority
of India Manual of Method of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISO methods specified for Food Safety
Criteria. Latest version of test methods 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.

51 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 S. No. Parameter Reference Test methods
1 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 betaglucuronidase- positive
Escherichia coli -- Part 2: Colony-count technique at 44 degrees C using 5-bromo-4-chloro-3-indolyl beta-D-glucuronide-
ISO: 16649-3
2 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
3 Listeria Microbiology of the food chain -- Horizontal method for the detection and enumeration of Listeria monocytogenes and
monocytogenes of Listeria spp. -- Part 1: Detection method –ISO 11290-1
Microbiology of Food and Feeding Stuffs - Horizontal method for Detection and Enumeration of Listeria Monocytogenes,
Part 1: Detection Method -IS 14988-1]

[This amendment shall come into force on 1st May, 2025]

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 35[Table
7
Microbiological Requirements for Non-Carbonated Water Based
Beverages (Non Alcoholic)

S.No. Parameters Limits

1. Total Plate count per ml. Not more than 50 CFU per ml.
2. Yeast and mould count per ml Not more than 2 cfu per ml.
3. Coliform count Absent in 100 ml.

Note: - Non-carbonated beverages shall be free from pathogens]

73[Table-8 Microbiological Standards of Eggs and Egg Products

Table 8A: Microbiological Standards of Eggs and Egg Products – Process Hygiene Criteria

Sr. Product Description Aerobic Plate Count Enterobacteriacae

No. (cfu/g) (cfu/g)
Sampling Plan Limit (cfu) Sampling Plan Limit (cfu)
n c m M n c m M
1. Table Egg NA
2. Pasteurized Liquid egg products 5 2 104 105 5 2 101 102
(whole, yolk or albumin liquid)
3. Frozen /dried/ 5 2 104 105 5 2 101 102
egg products
4. Cooked/ready-to-eat egg products 5 2 104 105 5 2 101 102
including mayonnaises
Test Methods IS: 5402/ISO:4833 IS/ISO 7402/ISO 21528 Part 2

53 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table 8B

“Table 8B: Microbiological Standards of Eggs and Egg Products – Food Safety Criteria

Sr. No. Product Description Salmonella Listeria monocytogenes (cfu/g)

Sampling Plan Limit (cfu) Sampling Plan Limit (cfu)
n c m M n c m M
1. Table Egg NA
2. Pasteurized Liquid egg products 5 0 Absent/25 g 5 0 Absent/25 g
(whole, yolk or albumin liquid)
3. Frozen /dried/ 5 0 Absent/25 g 5 0 102 /g
egg products
4. Cooked/ready-to-eat egg products 5 0 Absent/25 g 5 0 Absent/25 g
including mayonnaises
Test Methods IS: 5887 Part3 / ISO:6579 IS: 14988, Part 1 & Part 2 / ISO 11290-
1& 2

Definition.- Definition related to egg and egg products are the same as provided in Food Safety and Standards (Food Products Standards and
Food Additives) Regulations 2011. The category “Table egg” shall be regulated in accordance with the good manufacturing practices and code
of good hygiene practices notified under Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses)
Regulations, 2011.

Stage where the Microbiological Standards shall apply.- The microbiological standards with respect to the products categories specified in
Table-8A (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 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. The microbiological standards in
Table-8B (Food Safety Criteria) define the acceptability of a batch/lot and shall be met in respect of the products at the end of the manufacturing
process and the products in the market during their shelf- life.

Action in case of unsatisfactory result:

54 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 In case of non-compliance in respect of process hygiene criteria specified in Table- 8A, the FBO shall:
 check and improve process hygiene by implementation of guidelines in Schedule 4 of Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations; and,
 Ensure that all food safety criteria as specified in Table -8B (Food Safety Criteria) are complied with.

Sampling Plans and Guidelines

For Regulator.- The sampling for different microbiological standards specified in Table-8A and 8B 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 in frozen condition at -18°C(±2°C) or under refrigerated conditions at 2-5°C as applicable 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-8A and 8B shall be taken from same batch/lot and shall be submitted to the notified laboratory. Three sets, each containing
‘n’ number of samples (n as defined in the sampling plan eg if n=5, then total number of samples to be drawn is 15) shall be drawn. Each
of these three sets shall be tested in three different accredited laboratories. The final decision shall be based on the results of three accredited
laboratories. In the case of food safety criteria (Table 8B), results from all the three laboratories should indicate compliance with specified
criteria. There will be no provision for retesting or resampling for microbiological testing. The testing in laboratory shall be ensured as per
reference test methods given below in reference test methods for regulatory compliance.
For FBO.- Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-8A and 8B to
ensure validation and verification of compliance with the microbiological requirements. FBO shall decide themselvessubject to minimum
prescribed under FSSR (Licensing and Registration of Food Businesses), 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:

55 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 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 1. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of 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 prescribed c values are >m

Reference test methods: The following test methods shall be applied as reference methods. Test methods prescribed in FSSAI Manual of
Method 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. Latest version of test methods 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 methods

1. Microbiology of the food chain -- Horizontal method for the enumeration of microorganisms --
Aerobic Plate Part 1: Colony count at 30 °C by the pour plate technique- IS 5402/ ISO:4833
Count
2. Microbiology - General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation
- MPN Technique and Colony-count Technique- IS/ISO 7402
Enterobacteriaceae
Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and
3. enumeration
Methods of Enterobacteriaceae-
for Detection Part 2:Colony-
of Bacteria Responsible for count method-ISO
Food Poisoning 21528-2
- Part 3: General Guidance on
Methods for the Detection of Salmonella- IS 5887: Part 3
Salmonella
Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of
Salmonella spp.- ISO6579

56 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 4. Microbiology of the food chain -- Horizontal method for the detection and enumeration of Listeria
Listeria monocytogenes and of Listeria spp. -- Part 1: Detection method –ISO 11290-1
monocytogenes
Microbiology of the food chain -- Horizontal method for the detection and enumeration of Listeria
monocytogenes and of Listeria spp. -- 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 14988-1

Microbiology of Food and Animal Feeding Stuffs - Horizontal Method for the Detection and
Enumeration of Listeria monocytogenes, Part 2: Enumeration Method- IS 14988-2]

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 77[Table-9 Microbiological Standards of Food Grain Products

Table 9A: Microbiological Standards of Food Grain Products – Process Hygiene Criteria

Sr. Product Description Staphylococcus aureus count Enterobacteriaceae count(cfu/g)

No.
(cfu/g)

Sampling Limit Sampling plan Limit

plan

n c m M n c m M

1. Sprouted grains, sweet corn cob or NA 5 2 10 102

packed wet grains for direct
consumption

2. Batters and doughs (Ready to Cook) 5 2 102 103 5 2 102 103

3. Fermented products other than batters NA 5 2 10 102

and doughs (ready to cook) including
bread, cakes and doughnuts, other ready
to eat grain products, malted milk food,
instant noodles, and pasta products

Test Methods IS:5887, Part 2 and IS 5887 part IS/ISO 7402/ ISO 21528 Part 2
8(Sec 1)/ ISO 6888-1 or
IS:5887Part 8 (Sec2)/ISO 6888-2

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 Table 9B: Microbiological Standards of Food Grain Products – Food Safety Criteria

Sr. Product Description Salmonella Listeria monocytogenes

No. Sampling plan Limit Sampling plan Limit
n c m n c m
1. Sprouted grains, sweet corn cob or 5 0 Absent/25 g 5 0 Absent/25 g
packed wet grains for direct consumption
2. Batters and Doughs (Ready to Cook) NA NA
3. Fermented products other than batters 5 0 Absent/25 g 5 0 Absent/25 g
and doughs (ready to cook) including
bread, cakes, doughnuts, other ready to
eat grain products, malted milk food,
instant noodles* and pasta products*
Test Methods IS: 5887 Part3 / ISO:6579 IS: 14988, Part 1 / ISO 11290-1
* Instant noodles and pasta products shall be tested for Salmonella but not for Listeria monocytogenes.

Definitions

Definitions related to Cereal and Cereal Products are as provided in FSS (Food Products Standards and Food Additives) Regulations 2011.

Stage where the Microbiological Standards shall apply:

The microbiological standards with respect to the product categories specified in Table-9A (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 values
above which corrective actions are required in order to maintain the hygiene of the process in compliance with the food law. These shall be applicable
at the end of the manufacturing process. The Microbiological Standards in Table-9B (Food Safety Criteria) define the acceptability of a batch/lot
and shall be met in respect of the products at the end of the manufacturing process and the products in the market during their shelf- life.

Action in case of unsatisfactory result:

In case of non-compliance in respect of process hygiene criteria specified in Table- 9A, the FBO shall:
 check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing and Registration of Food Businesses)
Regulations; and,
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  ensure that all food safety criteria as specified in Table -9B (Food Safety Criteria) are complied with

Sampling Plan and Guidelines:

For Regulator: The sampling for different microbiological standards specified in Table-9A and 9B 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 in frozen condition at -18°C (±2°C) or under refrigerated conditions at 2-5°C as applicable 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-9A & 9B shall be
taken from same batch/lot and shall be submitted to the notified laboratory. Three sets, each containing ‘n’ number of samples (n as defined in the
sampling plan eg if n=5, then total no. of samples is 15) shall be drawn. Each of these three sets shall be tested in three different accredited
laboratories. The final decision shall be based on the results of three accredited laboratories. In the case of food safety criteria (Table 9B), results
from all the three laboratories should indicate compliance with specified criteria. There will be no provision for retesting or resampling for
microbiological testing. The testing in laboratory shall be done as per the methods given in the Table “Reference Test Methods”

For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-9A & 9B to ensure
verification of compliance with the microbiological requirements. FBO shall decide themselves, subject to the minimum prescribed under FSSR
(Licensing and Registration of Food Businesses), 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 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.

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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 1. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of the values observed are >m 2. Acceptable, if a maximum of c values are between m and M
3. Unsatisfactory, if one or more of the values observed are > M or more
than prescribed c values are >m
Reference Test Methods: The following test methods shall be applied as Reference Test Methods. Test methods prescribed in FSSAI Manual of
Method 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.

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 methods

Microbiology - General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation - MPN Technique and
Enterobacteriaceae Colony-count Technique- IS/ISO 7402
1.
count Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of Enterobacteriaceae-
Part 2:Colony- count method-ISO 21528-2

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 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
Staphylococcus Methods for Detection of Bacteria Responsible for Food Poisoning Part 8 Horizontal Method for Enumeration of Coagulase-
Aureuscount Positive Staphylococci/ (Staphylococcus aureus and other species) Section 1 Technique using baird-parker agar medium -
2.
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)
Methods for Detection of Bacteria Responsible for Food Poisoning - Part 3: General Guidance on Methods for the Detection of
3. Salmonella Salmonella- IS 5887: Part 3
Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella spp.- ISO 6579
Microbiology of the food chain -- Horizontal method for the detection and enumeration of Listeria monocytogenes and of
Listeria Listeria spp. -- Part 1: Detection method –ISO 11290-1
4.
monocytogenes Microbiology of Food and Feeding Stuffs - Horizontal method for Detection and Enumeration of Listeria Monocytogenes, Part
1: Detection Method -IS 14988-1]

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 82[Table-10 Microbiological Standards for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical
Purpose, Functional Food and Novel Food

Table 10A: Microbiological Standards for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical
Purpose, Functional Food and Novel Food – Process Hygiene Criteria

S. Product description Aerobic Plate Count Yeast and Mold Count Enterobacteriaceae count
No.
Sampling Limit Samplin Limit Samplin Limit
plan g plan g plan
(cfu/g or ml) (cfu/g or ml) (cfu/g or ml)

n c m M n c m M n c m M

1. Health Supplements, Nutraceuticals, Food for 5 3 1x106 1x107 5 3 1x104 1x105 5 3 1x103 1x104
Special Dietary Use, Food for Special Medical
Purpose and Novel Food for consumption after
processing
2. Health Supplements, Nutraceuticals, Food for 5 2 1x104 1x105 5 2 1x102 1x103 5 2 1x102 1x103
Special Dietary Use, Food for Special Medical
Purpose and Novel Food for direct consumption
3. Probiotics and products containing specified live NA NA NA
microorganisms*
Test Methods IS 5402/ISO 4833 IS 5403/ ISO 21527 Part ISO 21528 Part 2
1 and Part 2

Note:- *Should contain only the specified microorganism(s) at the level claimed on the label. The counts have to be determined using methodology
appropriate for the organisms. e.g. For Lactic acid bacteria ISO 15214/IS 16068, for Bifidobacteria ISO 29981

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 Table 10B: Microbiological Standards for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical
Purpose, Functional Food and Novel Food – Food Safety Criteria

S. Product description Salmonella Listeria monocytogenes

No.

Sampling plan Limit Sampling plan Limit

(cfu) (cfu)

n c m M n c m M

1. Health Supplements, Nutraceuticals, Food for Special NA NA

Dietary Use, Food for Special Medical Purpose,
functional food and Novel Food and not for direct
consumption

2. Health Supplements, Nutraceuticals , Food for Special 5 0 Absent/25g 5 0 Absent/25g

Dietary Use, Food for Special Medical Purpose,
functional food and Novel Food for direct consumption

3. Probiotics and products containing specified live micro 5 0 Absent/25g 5 0 Absent/25g

organisms

Test Methods IS 5887 Part3 / ISO 6579 IS 14988 Part 1 / ISO 11290-1

64 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Note: In high value low volume (less than 100 g) and large retail pack (pack more than 1 kg) sizes, the sample plan may be modified (e.g. absence
of Salmonella in 10 g or 5 g in the case of former or n number of samples to be taken from different sites of one large pack) accordingly on case
to case basis with the prior approval of Food Safety and Standards Authority of India (FSSAI).

Definition

Definition related to Nutraceutical Products are the same as provided in Food Safety and Standards (Health Supplements, Nutraceuticals, Food
for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.

Stage where the Microbiological Standards shall apply:

The microbiological standards with respect to the products categories specified in Table-10A (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
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. The Microbiological Standards in Table-10B (Food Safety Criteria) define the acceptability
of a batch or lot and shall be met in respect of the products at the end of the manufacturing process and the products in the market during their
shelf- life.

Action in case of unsatisfactory result:

In case of non-compliance in respect of process hygiene criteria specified in Table- 10A, the Food Business Operator (FBO) shall-

 check and improve process hygiene by implementation of guidelines in Schedule 4 of Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations, 2011; and
 ensure that all food safety criteria as specified in Table -10B (Food Safety Criteria) are complied with.

Sampling Plan and Guidelines

For Regulator: The sampling for different microbiological standards specified in Table-10A and 10B shall be ensured aseptically at
manufacturing units and/or at retail points, as applicable, by a trained person with specialised knowledge in the field of microbiology following
guidelines in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and ISO: 17728:2015 (confirmed
in 2019). The samples shall be stored and transported in frozen condition at -18°C (±2°C) or under refrigerated conditions at 2-5°C as applicable

65 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
except for 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-10A and 10B shall be taken from same batch or lot and shall be submitted to the notified laboratories. Three
sets, each containing ‘n’ number of samples (n as defined in the sampling plan e.g. if n=5, then total no. of samples to be drawn is 15) shall be
drawn. Each of these three sets shall be tested in three different accredited laboratories. The final decision shall be based on the results of three
accredited laboratories. In the case of Food Safety Criteria (Table 10B), the results from all the three laboratories should indicate compliance with
the specified criteria. There will be no provision for retesting or resampling for microbiological testing. The testing in laboratory shall be ensured
as per the methods given in the table “reference test methods”.

For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-10A & 10B to ensure
verification of compliance with the microbiological requirements. FBO shall decide themselves subject to minimum prescribed under Food Safety
and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, 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.

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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 7. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of the values observed are >m 8. Acceptable, if a maximum of c values are between m and M.
9. Unsatisfactory, if one or more of the values observed are > M or more than
prescribed c values are >m

Reference Test Methods: The following test methods shall be applied as reference methods. 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. Latest version of test methods 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 Methods

Aerobic Plate Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 1: Colony count at 30 °C by the
1.
Count pour plate technique- IS 5402/ ISO 4833

Method for Yeast and Mould Count of Food Stuffs and Animal feed- IS 5403

Microbiology of food and animal feeding Stuff-Horizontal method for the enumeration of yeasts and moulds-Part1: Colony count
Yeast and Mold
2. technique in products with water activity greater than 0.95-ISO 21527-1
Count
Microbiology of food and animal feeding Stuff-Horizontal method for the enumeration of yeasts and moulds-Part2: Colony count
technique in products with water activity less than 0.95-ISO 21527-2

67 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Enterobacteriaceae Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of Enterobacteriaceae-
3.
count Part 2: Colony- count method - ISO 21528-2

Methods for Detection of Bacteria Responsible for Food Poisoning - Part 3: General Guidance on Methods for the Detection of
4. Salmonella Salmonella- IS 5887 Part 3

Microbiology of food and animal feeding stuffs -- Horizontal method for the detection of Salmonella spp.- ISO 6579
Microbiology of Food and Feeding Stuffs - Horizontal method for Detection and Enumeration of Listeria monocytogenes, Part 1:
Listeria Detection Method -IS 14988-1
5.
monocytogenes
Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria
spp. - Part 1: Detection method –ISO 11290-1.]

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 Insertion of Provision
83
[Table 11A: Microbiological Standards for Neera – Process Hygiene Criteria

S. Product Aerobic Plate Count Escherichia coli Staphylococcus aureus

No. description (Coagulase +ve)
Sampling Plan Limit (cfu) Sampling Limit (cfu) Sampling Plan Limit (cfu)
Plan

n c m M n c m M n c m M

1 Neera 5 2 1x102/ 1x104/ 5 0 Absent/25ml 5 0 Absent/25ml

(Pasteurized) ml ml

Test Methods IS: 5402/ISO:4833 IS: 5887 Part 1 or ISO 16649- IS:5887 Part 2 and IS 5887 Part 8 (Sec 1)/
3 ISO 6888-3 or IS:5887 Part 8 (Sec 2)/ ISO
6888-3

Table 11B: Microbiological Standards for Neera- Food Safety Criteria

S. No. Product description Salmonella Listeria monocytogenes

Sampling Plan Limit (cfu) Sampling Plan Limit (cfu)

n c m M n c m M

1 Neera (Pasteurized) 5 0 Absent/25 ml 5 0 Absent/25 ml

Test Methods IS: 5887 Part 3 / ISO:6579 IS: 14988 Part 1 / ISO 11290-1

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 Definitions of Neera: Definition of ‘Processed Neera’ is the same as provided in these regulations.

Stage where the Microbiological Standards shall apply:

The microbiological standards with respect to the products categories specified in Table-11A (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 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. The Microbiological Standards in Table-11B (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.

Action in case of unsatisfactory result:

In case of non-compliance in respect of process hygiene criteria specified in Table - 11A, the Food Business Operator shall:

 check and improve process hygiene by implementation of guidelines in Schedule 4 of Food Safety and Standards (Licensing and Registration of
Food Businesses) Regulations, 2011; and,
 Ensure that all food safety criteria as specified in Table -11B (Food Safety Criteria) are complied with.

Sampling Plans and Guidelines

For Regulator: The sampling for different microbiological standards specified in Table-11A and 11B 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: 17728:2015 (Confirmed in 2019). The samples shall be stored and
transported in frozen condition at -18°C (±2°C) or under refrigerated conditions at 2-5°C as applicable except the products that are recommended to be
stored at room temperature by the manufacturer to enable initiation of analysis within twenty four 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-11A and 11B shall be
taken from same batch/lot and shall be submitted to the notified laboratory. 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. The testing in laboratory shall be ensured as per reference test methods given below in reference test methods for regulatory compliance.

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For Food Business Operator: Food Business Operator shall perform testing as appropriate as per the microbiological standards in Table-11A and 11B to
ensure validation and verification of compliance with the microbiological requirements. Food Business Operator shall decide themselves the necessary
sampling and testing frequencies to ensure compliance with the specified microbiological requirements. Food Business Operator 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)
Satisfactory, if all the values observed are ≤ m Satisfactory, if all the values observed are ≤ m
Unsatisfactory, if one or more of the values observed are >m or more Acceptable, if a maximum of c values are between m and M and the
than c values are >m rest of the values are observed as ≤m
Unsatisfactory, if one or more of the values observed are > M or more
than c values are >m

71 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
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. Test methods prescribed in Food Safety and Standards Authority of India 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.
S. Parameter Reference Test Methods
No.
1 Aerobic Plate Count Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 1: Colony count at 30°C by
the pour plate technique- IS 5402/ ISO:4833
2 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 betaglucuronidase -positive
Escherichia coli -- Part 2: Colony-count technique at 44 degrees C using 5-bromo-4-chloro-3-indolyl beta-D-glucuronide- ISO:
16649-3
3 Staphylococcus Methods for detection of bacteria responsible for food poisoning: Part 2 Isolation, identification and enumeration of Staphylococcus
aureus 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 6888-3)
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 6888-3
4 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.- ISO6579
5 Listeria Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and other
monocytogenes Listeria spp. - Part 1: Detection method – IS: 14988, Part 1 / ISO 11290-1]

[This amendment shall come into force on 1st May, 2025]

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