Draft Sanitation Standard for Microorganisms  in Foods  
 
Article 1    
This Standard is prescribed in accordance with the provisions of Article 
17 of the Act Governing Food Safety and Sanitation (herein referred to 
as "this Act" ). 
 
Article 2    
The scopes of this standard include  food microorganisms and their 
toxins or metabo lites, do not include fungi and mycotoxins . 
 
Article 3    
The limits for food microorganisms and their toxins or metabolites shall  
meet the requirements in the table in Annex . 
 
Article 4  
Non-compliant  under the jurisdiction of subparagraphs 4 of paragraph 1 
of Article 15 of this Act and Article 6 of Rules for the Implementation 
of this Act , shall be sanctioned in accordance with violating Article 15 
of this Act.  
 
Article 5    
This Standard shall be implemented from July 1 , 2021 .  
Annex  
1. Milk and dairy products  
Food category  Microorganisms 
and their toxins 
or metabolites  Sampling 
plan  Limits  
n c m M 
1.1 Milk, flavored milk and 
milk drink  
1.2 Milk powder, flavored 
milk powder and whey 
powder as raw material 
for food processing.  
1.3 Fermented milk 
1.4 Condensed milk, except 
of canned condensed 
milk listed in 1.6  Enterobacteriaceae  5 0 10 CFU/mL (g)  
Salmonella   5 0 Negative  
Listeria 
monocytogenes  5 0 Negative  
Staphylococcal 
enterotoxins  5 0 Negative  
1.5 Cheese , butter and 
cream  Escherichia coli1 5 2 10 
MPN/g  
(mL)  100 
MPN/g  
(mL)  
Salmonella  5 0 Negative  
Listeria 
monocytogenes  5 0 Negative  
Staphylococcal 
enterotoxins  5 0 Negative  
1.6 Canned food2: Sterilized 
milk, sterilized flavored 
milk, sterilized milk 
drink and condensed 
milk 
- 5 0 Passes 
inspection by 
incubation test 
(37℃ for 10 
days): Shall not 
show sign of 
swelling, 
transform or 
abnormal pH 
value causing by 
growth of 
microorganisms.  
2. Infant foods 3 
Food category  Microorganisms 
and their toxins 
or metabolites  Sampling 
plan  Limits  
n c m M 
2.1 Infant formula  
2.2 Follow -up infant Enterobacteriaceae  10 0 10 CFU/g (mL)  
Salmonella  10 0 Negative   
formula  
2.3 Infant formula for 
special medical 
purposes  
 Listeria 
monocytogenes  10 0 Negative  
Cronobacter  spp. ; 
Enterobacter 
sakazakii  4 10 0 Negative  
2.4 Other infant  food5, 
except list in 2.5  Coliform  5 2 Negative  10 
MPN/g  
(mL)  
Salmonella  5 0 Negative  
Listeria 
monocytogenes  5 0 Negative  
2.5 Canned food2: Other 
ready -to-eat canned 
infant foods. F or 
example, the  ready -to-
feed liquid infant 
formula , meat puree , 
fruit puree , vegetable 
puree . - 5 0 Passes 
inspection by 
incubation test 
(37℃ for 10 
days): Shall not 
show sign of 
swelling, 
transform or 
abnormal pH 
value causing by 
growth of 
microorganisms.  
3. Raw ready -to-eat foods6 and ready -to-eat foods contain both raw and 
processed food ingredient at once7 
Food category  Microorganisms 
and their toxins 
or metabolites  Limits  
3.1 Raw ready -to-eat 
aquatic products  
3.2 Ready -to-eat foods 
contain both raw 
aquatic products and 
processed food 
ingredient at once  Salmonella  Negative  
Vibrio 
parahaemolyticus  100 MPN /g 
Listeria 
monocytogenes  Negative  
3.3 Fresh /raw ready -to-eat 
fruit and vegetables  
3.4 Ready -to-eat foods 
contain both  fresh/raw 
fruit or vegetables and 
processed food 
ingredient at once  Escherichia coli  10 MPN/g  
Escherichia coli 
O157 :H78 Negative  
Salmonella   Negative  
Listeria 
monocytogenes  Negative   
3.5 Ready -to-eat not fully 
cooked eggs, and ready -
to-eat foods that contain 
not fully cooked eggs  Salmonella  Negative  
4. Packaged/containerized drinking water and beverage  
Food category  Microorganisms 
and their toxins 
or metabolites  Limits  
4.1 Packaged drinking 
water and containerized 
drinking water  Coliform  Negative  
Fecal Streptococci  Negative  
Pseudomonas 
aeruginosa  Negative  
4.2 Carbonated beverages, 
for example, the soft 
drinks, cola and other 
sugary carbonated 
beverages  Enterobacteriaceae  Negative  
4.3 Reconstituted fruit and 
vegetable juices, fruit 
and vegetable juice 
drinks, puree9 and other 
similar , except listed in 
4.7, 4.8  
4.4 Beverages containing 
coffee, cocoa, tea or 
cereals, legumes and 
other food materials, 
except listed in 4.7, 4.8  Enterobacteriaceae  Negative  
4.5 Unpasteurized  fresh 
fruit and vegetable 
juices. Un pasteurized  
fresh fruit and vegetable 
juices containing milk 
less than 50%  Escherichia coli  10 MPN/ mL 
Escherichia coli 
O157 :H78 Negative  
Salmonella  Negative  
4.6 Fermented fruit and 
vegetable juice , 
flavored  acidic 
beverages containing 
lactic acid  or 
fermentation broth  
(contain active 
probiotics ) , except 
listed in 4.7 Enterobacteriaceae  Negative   
4.7 Beverages that is made 
on the spot , 
unpasteurized, and the 
shelf -life less than 24 
hours, except listed in 
4.5 Enterobacteriaceae  10 CFU/mL  
Salmonella  Negative  
4.8 Canned foods2: Canned 
beverages  Passes inspection by incubation test (37 ℃ for 10 
days): Shall not show sign of swelling, transform 
or abnormal pH value causing by growth of micro -
organisms.  
5. Frozen foods and ice products  
Food category  Microorganisms 
and their  toxins 
or metabolites  Limits  
5.1 Ice cubes, food grade  
5.2 Frozen ready -to-eat 
foods6,include:  
    -Ice products  include 
ice cream, gelato, 
popsicle, shaved ice, 
sundae, sorbet, 
smoothie etc.   
    -Frozen fruits  
5.3 Frozen cooked10 foods, 
may provide ready -to-
eat after thawing or re-
heat,  except listed in 
5.6, include:  
-Frozen cooked 
vegetables  
 Enterobacteriaceae  10 CFU/g  (mL)  
Salmonella  Negative  
5.4 Frozen non ready -to-eat 
foods  
-Frozen food that must 
be cooked10 before  
provide .  
-Frozen raw aquatic 
products that not 
provide ready -to-eat. Escherichia coli  50 MPN/ g 
5.5 Frozen raw aquatic 
products that provide 
ready -to-eat. Salmonella  Negative  
Vibrio 
parahaemolyticus  100 MPN /g  
5.6 Frozen cooked10 aquatic 
products, may provide 
ready -to-eat after 
thawing or re-heat. Vibrio 
parahaemolyticus  Negative  
6. Other ready -to-eat foods  
Food category  Microorganisms 
and their toxins 
or metabolites  Limits  
6.1 Foods that can eat after 
rehydration list other 
than food category 1 to 
5. 
6.2 Ready -to-eat foods that 
stored at hot holding or 
room temperature  list 
other than food 
category  1 to 5.  
6.3 Ready -to-eat foods that 
stored at refrigeration  
or below room 
temperature list other 
than food category  1 to 
5, include:  
-Ready -to-eat foods 
that stored at 
refrigeration or below 
room temperature, 
can re -heat before eat.  
For example, 18 ℃ 
delicatessen.  
-dessert , sauces etc.  Staphylococcus 
aureus  100 CFU/g  (mL)  
Salmonella  Negative  
Listeria 
monocytogenes11 100 CFU/g  (mL)  
6.4 Canned foods2 list 
other than  food 
category  1 to 5. Passes inspection by incubation test (37 ℃ for 10 
days): Shall not show sign of swelling, transform 
or abnormal pH value causing by growth of micro -
organisms.  
7. Liquid eggs 12 
Food category  Microorganisms 
and their toxins 
or metabolites  Limits  
7.1 Pasteurized liquid eggs 
(refrigeration or 
freezing)  Salmonella  Negative   
7.2 Unpasteurized liquid 
eggs (refrigeration or 
freezing)  Total plate count  106 CFU/g  
Note.  
1. The meaning of the symbol in the "sampling plan ” and “Limits ”: 
“n” means  number of units comprising the sample . 
“c” means  number of sample units giving values between m and M . 
“m” means a  microbiological limit that acceptable quality . 
“M” means a microbiological limit above which sampling results are 
unacceptable.  
2. The detected results allowable between m and M from ≦ c sample quantity. 
Unacceptable  ≧ M for any sample.  
3. If "m=M", means u nacceptable  ≧ m or M for any sample.  
1 The test item  of Escherichia coli  here, not applicable to cheese . 
2 Canned food here refers to those canned food meet the commercial sterility 
requirements in Re gulations on Good Hygiene Practice for Foods. 
3 Infant  food referred to in this table means the food sold exclusively for infants 
less than  12 months of age . 
4 The test item  of Cronobacter  spp. (Enterobacter sakazakii ) here, just applicable 
food sold exclusively for infants less than 6 months of age.  
5 Other i nfant foods mean other foods sold exclusively for infants less than 12 
months of age, include cereal -based foods, milk -based drinks and similar 
products.  
6 Ready -to-eat food means food intended by the producer or the  manufacturer for 
direct human consumption without the need for cooking or  other processing 
effective to eliminate or reduce to an acceptable level  the microorganisms of 
concern.  
7 Ready -to-eat foods contain raw aquatic products, fresh/raw fruit and vegetables, 
and eggs not fully cooked, must merge all related inspection items.  
8 Escherichia coli  test results  if negative , do not need to test Escheric hia coli  
O157:H7.  
9 Fruit juice syrup (which contain reconstituted fruit juices or natural fruit juices 
above 50 %, sugary  and t otal soluble solids  above 50°Brix , m ust be diluted 
drink ) not applicable . 
10 Cooked means heat-treated food thoroughly to make sure foods keep the 
minimum internal temperature above 75 ℃ and may provide ready -to eat.  
11 The test item of  Listeria monocytogenes  is not applied the  sugar, honey,  
confectionery (including cocoa and chocolate products ) and food grade salt.  
12 The raw materials of liquid eggs  shall meet the “Act Governing Food Safety 
and Sanitation” , and m eet one of the following conditions : 
 (1) The egg shell is intact without crack ; or 
 (2) The egg shell is damaged but the shell  membra ne is intact, without egg shell 
surface contamination and  contents leakage.  
 