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Draft Regulation On Microbiological Standards Milk and Milk Products 31-08-2015
Draft Regulation On Microbiological Standards Milk and Milk Products 31-08-2015
, 2015
In the Food Safety and Standards (Food Products Standards and Food Additives)
Regulations, 2011, in APPENDIX B relating to Microbiological Requirements, for
TABLE 2 and the entries relating thereto, the following TABLE and the entries shall be
substituted, namely:-
Product Description
Sampling
plan
n
c
1
Pasteurized Cream
3
4
6
7
Pasteurized Butter
10
11
12
Sampling
plan
n
c
30 x10 /ml
50x 10 /ml
5(3)
Absent/0.1ml
5(3)
50x103/g
75x103/g
5(3)
10/g
5(3)
5x102/g
1x103/g
5(3)
25x10 /g
3
50x10 /g
3
5(3)
Absent/0.1g
5(3)
Absent/0.1g
5(3)
30x10 /g
50x10 /g
5(3)
Absent/ 0.1g
5(3)
5x102/g
5x103/g
10
(10)
Absent/0.1g
5x102/g
5x103/g
1x10 /g
10x103/g
Limit (cfu)
20/g
50/g
Sampling
plan
n
c
Limit (cfu)
5(3)
10/g
5(3)
10/g
5(3)
10/g
5(3)
Absent/0.1g
5(3)
10/g
5(3)
10/g
Sampling
plan
n
c
Limit (cfu)
m
5(3)
10/g
50/g
5(3)
20/g
5(3)
5/0.1g
5(3)
Absent/0.1g
1x10 /g
2x105/g
5(3)
10/g
5(3)
25x103/g
50x103/g
5(3)
10/g
5(3)
1x102/g
5x102/g
5(3)
10/g
1x102/g
5(3)
50/g
250/g
5(3)
10/g
1x102/g
5(3)
10/g
1x102/g
5(3)
50/g
1x102/g
5(3)
10/g
1x102/g
5(3)
10/g
1x102/g
5(3)
50/g
150/g
5(3)
50/g
1x102/g
5(3)
10/g
1x102/g
5(3)
10/g
50/g
5(3)
15x104/g
14
5(3)
25x103/g
IS 5402
35x104/g
75x103/g
IS 5401, Part 1
Sampling
plan
n
c
Limit (cfu)
m
50/g
1x105/g
Absent/0.1g
1x102/g
. Pasteurized milk shall be stored at manufacturing unit and at retail points in such a way that temperature of milk shall not exceed 8C as recommended in IS I3688: 1999
. The microbial specifications for ripened butter are the same as for pasteurized butter excluding the requirements of total plate count.
3
.The yeast and mold count of 5/0.1g as specified in dried product categories shall be applicable only to casein powder
4
.The yeast and mold counts in all other cheese category will be applicable except mold ripened cheeses.
5
.The standard requirements of lactic counts of one million c.f.u./g min as specified by BIS (IS:12898:1989) in such products/ or such products containing probiotic organisms shall be applicable
( ) figures in parenthesis indicate no. of samples required for testing at retail points.
2
Faecal streptococci
13
1x102/g
5(3)
Method of Analysis
1
Limit (cfu)
5(3)
Coliform Count
IS 5403
Table-2B: Microbiological Requirements For Milk and Milk Products -Safety Indicator Organisms
Salmonella / Shigella
E.coli
Sampling
plan
n
c
1
2
3
4
5
6
7
10
11
12
13
14
Pasteurized
Milk/Flavored Milk
5(3)
Pasteurized Cream
Sterilized/UHT/Flavored
Milk / Evaporated Milk
Sterilized/ UHT Cream
5(3)
5(3)
0
0
5(3)
Sweetened Condensed
Milk6
Pasteurized Butter
Milk powder; SMP,
PSMP; Dairy Whitener;
Cream powder ; Ice
Cream Mix powder;
Lactose; Whey based
powder; Butter Milk
powder; Casein powder
Infant Milk Food, Infant
Formulae, Infant Milk
Substitute
Follow Up Formula
Cereal Based
Complimentary Food
Ice Cream, Frozen
Dessert, Milk Lolly, Ice
Candy etc
Processed Cheese/
Cheese Spread 7 (Ready
To Eat Products)
All
Other
Cheeses
Categories
including
Fresh Cheeses / Cheddar
/ Cottage /Soft /Semi Soft
etc (Not Ready To Eat
Products)
Fermented milk products
: Yoghurt, Dahi, Chakka,
Shrikhand etc
Paneer/ Chhana/ chhana
based sweets
Khoa/ khoa based sweets
Method of analysis
5(3)
Limit (cfu)
m
Samplin
g plan
n
c
5(3)
Absent/ 0.1ml
L. monocytogenes
Limit (cfu)
m
Sampling
plan
n
c
B. cereus
Limit (cfu)
m
Sampling
plan
n
c
Limit (cfu)
m
Enterobacter sakazakii
Sampling
plan
n
c
Limit (cfu)
m
5(3)
0
5
0
Phosphatase test shall be negative as per IS 8479 (Parts
Absent/25
Absent/25ml
I -1977) before release of product in the market
ml
0 Absent/25g
5(3)
0
Absent/25g
Sterilized milk products shall comply with a test for commercial sterility as per BIS (IS: 4238-1967)
Absent/0.1g
5(3)
Absent/0.1g
5(3)
Absent/25g
5(3)
Absent/g
5(3)
5(3)
0
0
Absent/0.1g
Absent/0.1g
5(3)
5(3)
0
0
Absent/25g
Absent/25g
5(3)
5(3)
0
0
Absent/g
Absent/25g
5 (3)
1x102/g
1x103/g
5 (3)
10/g
1x102/g
10
(5)
Absent/0.1g
15
(5)
Absent/25g
10
(5)
Absent/25g
5 (3)
1x102/g
5x102/g
5 (3)
10/g
1x102/g
5(3)
Absent/g
5(3)
Absent/25g
5(3)
Absent/g
5(3)
Absent/g
5(3)
Absent/25g
5(3)
Absent / 25g
5(3)
Absent/0.1g
5(3)
Absent/g
5(3)
Absent/25g
5(3)
Absent/g
5(3)
Absent/25g
5(3)
Absent/g
5(3)
Absent/0.1g
5(3)
Absent/g
5(3)
Absent/g
5(3)
0
Absent/0.1g
IS 5887, Part 1
5(3)
0
Absent/g
IS 5887, Part 3& 7
5(3)
0
Absent/g
IS 14988-Part 1
Sterilized cream product shall comply with a test for commercial sterility as per BIS (IS : 4884:1968
5 (3)
5 (3)
IS 5887, Part 6
ISO 15213:2003
30
(10)
Absent/10g
ISO / TS 22964:2006
The Sweetened Condensed milk product shall comply accelerated storage test as per IS: 1166-1986 where sample shall be stored at 37 1C for 14 days.
7
Processed cheese packed in canned shall comply accelerated storage test when incubated at 30C for 14 days as per IS: 2785:19 64 and should give no bulging.
() figures in parenthesis indicate no of samples required at retail points.
Sampling Guidelines: The sampling for different microbiological parameters specified in Table-2A and B shall be ensured aseptically at manufacturing units as well as at retail points as per the sampling plan given in Table-2C by a trained person with specialised
knowledge in the field of microbiology following guidelines given in IS 11546:1999 /ISO 707:1985 (Reaffirmed 2010). The samples shall be stored and transported under appropriate temperature conditions and insulations within 24 hrs of sampling to
accredited laboratories for analysis as per the approved sampling plan 8 and test methods 9. A large sample size may be drawn (if desired) according to the tests required and the type of product. Preservatives shall not be added to samples intended for
microbiological examination. The desired number of samples as per sampling plan given in Table-2A & B shall be taken from full production batches and will be submitted to accredited laboratory in original unopened packaging, sealed at the time of sampling
maintained in their original physical state. The final decision shall be drawn based on results with no provision for r e t e s t i n g f o r microbiological p a r a m e t e r s .
Sampling plan 8: The following terms, as used by the International Commission on Microbiological Specifications of Foods (ICMSF) are defined and used in this standard:
n= the number of sample units which must be examined from the batch or lot of food to satisfy the requirements of a particular sampling plan.
m= Represents an acceptable level and values above it are marginally acceptable in terms of the sampling plan .
c= the maximum allowable number of defective sample units in 3-class sampling plan applicable at manufacturing units only.
M= A microbiological criterion which i n d i c a t e unsatisfactory or potentially hazardous quality. Values above M are unacceptable in terms of the sampling plan and detection of one or more samples exceeding this level would be cause for
rejection of the lot and will attract prosecution by the concerned food safety authorities.
Table-2C Sampling plan for compliance of microbiological parameters at manufacturing units and at retail points
Sampling area
Sampling Plan
2-Class
Manufacturing unit
n
n=5-30
c
c=0
Retail point
n=3-10
c=0
m
Values of m specified for all testing
parameters for different products as
specified Table-2A &B will be
applicable
Values of m specified for all testing
parameters for different products as
specified Table-2 A&B will be
applicable
n
5-30
c
c= 2,3
3-10
c=0
3-Class
m
M
Values of m specified for all testing
Values of M specified for all testing parameters for different products as
parameters for different products as
specified Table- 2A & B will be applicable
specified Table- 2A&B will be applicable
Not applicable
Microbiological criteria and their interpretation: Following three categories of microbiological quality have been assigned in standard based on h y g i e n e a n d s a f e t y i n d i c a t o r o r g a n i s m s . These are satisfactory, unsatisfactory and potentially
hazardous.
1. Satisfactory: if the test values of m or M or both applicable within the sampling plan are conforming the specified limits, the microbiological quality o f p r o d u c t i s c o n s i d e r e d s a t i s f a c t o r y and no action is required.
2. Unsatisfactory: if the test values of m or M or both applicable within the sampling plan are not conforming the specified limits of hygiene indicators i . e . aerobic count, c oliform count , coagulase positive S. aureus, faecal streptococci and yeast and
mold count etc w h i c h indicates poor hygiene or poor handling practices , the microbiological quality o f p r o d u c t w i l l b e c o n s i d e r e d u n s a t i s f a c t o r y . Under these conditions the premises producing such unsatisfactory product(s) shall be
investigated for nonconformity or non-compliance and legal action on defected products will be notified by the food safety authority . The subsequent release of such product shall be subject to HACCP / GMP audit clearance of the premises / finished
products b y the food safety authority.
3. Potentially hazardous: if the test values of m / or M or both applicable within the sampling plan are not conforming the specified limits of safety indicators i.e. , E. coli, Salmonella / Shigella, B. cereus, Sulphite Reducing Clostridia (SRC), Enterobacter
sakazakii, L. monocytogenes and sterility tests etc. which indicates serious food safety concern, the microbiological quality o f p r o d u c t w i l l b e c o n s i d e r e d a s potentially hazardous. Under these conditions the premises producing such
unsatisfactory product(s) shall be s t o p p e d and legal actions on potentially hazardous products will be notified by the food safety authority. The recall action on withdrawal of any of such food still available for sale or distribution shall be initiated and
release of subsequent batches of such hazardous products will be under hold by the food manufacturers. Failure by an owner to either cease manufacture of product or withdraw/recall product from sale when requested to do so shall result in seizure of that
product where the officer has reason to believe that it is contaminated with pathogenic bacteria. A detail risk assessment will be carried out to determine b y t h e f o o d s a f e t y a u t h o r i t y t o i n v e s t i g a t e the source or cause of the problem so that
remedial action can commence and the approval for restart of such products under non-conformity will be allowed only after compliance of manufacturing unit for food safety standards requirements or guidelines set by the Authority.
Test reference
References
Microbiology - general guidance for the enumeration of micro-organisms- colony count technique at 30C (first revision)
Microbiology - general guidance for the enumeration of coliforms: Part 1 colony count technique (first revision)
Methods for detection of bacteria responsible for food poisoning: Part 8 Horizontal method for enumeration of coagulase-positive reaffirmed
staphylococci (Staphylococcus aureus and other species) Section 1 Technique using Baird-Parker Agar Medium
Isolation, identification and enumeration of Staphylococcus aureus and faecal streptococci (first revision )
Method for yeast and mould count of food stuffs and animal feeds(first revision)
Methods for detection of bacteria responsible for food poisoning: isolation, identification and enumeration of Escherichia coli (first revision)
Methods for detection of bacteria responsible for food poisoning: Part 3:general guidance on methods for detection of Salmonella/Shigella (second
revision) Methods for detection
Methods for detection of bacteria responsible for food poisoning-Part 7: general guidance on methods for isolation and identification of Shigella
10
Microbiology of food and animal feeding stuffs horizontal method for detection and enumeration of Listeria monocytogenes : Part 1 Detection method
11
Methods for detection of bacteria responsible for food poisoning: Part 6 identification, enumeration and confirmation of B.cereus
12
Microbiology of food and animal feeding stuffs- Horizontal method for the enumeration of sulfite reducing bacteria growing under anaerobic conditions
13
Methods of test for dairy industry part III bacteriological analysis of milk ( first revision )
14
15
16
IS I3688: 1999
17
18
Specification for condensed milk, partly skimmed and skimmed condensed milk ( second revision )
19
IS :2785:1964
20
21