F3ANNEX IMicrobiological criteria for foodstuffs
Chapter 2.Process hygiene criteria
2.1Meat and products thereof
Food category | Micro-organisms | Sampling plan44 | Limits45 | Analytical reference method46 | Stage where the criterion applies | Action in case of unsatisfactory results | ||
|---|---|---|---|---|---|---|---|---|
n | c | m | M | |||||
| Aerobic colony count | 3,5 log cfu/cm2 daily mean log | 5,0 log cfu/cm2 daily mean log | F1EN ISO 4833-1 | Carcases after dressing but before chilling | Improvements in slaughter hygiene and review of process controls | ||
Enterobacteriaceae | 1,5 log cfu/cm2 daily mean log | 2,5 log cfu/cm2 daily mean log | F1EN ISO 21528-2 | Carcases after dressing but before chilling | Improvements in slaughter hygiene and review of process controls | |||
| Aerobic colony count | 4,0 log cfu/cm2 daily mean log | 5,0 log cfu/cm2 daily mean log | F1EN ISO 4833-1 | Carcases after dressing but before chilling | Improvements in slaughter hygiene and review of process controls | ||
Enterobacteriaceae | 2,0 log cfu/cm2 daily mean log | 3,0 log cfu/cm2 daily mean log | F1EN ISO 21528-2 | Carcases after dressing but before chilling | Improvements in slaughter hygiene and review of process controls | |||
| Salmonella | 5048 | 249 | F1Not detected in the area tested per carcase | F1EN ISO 6579-1 | Carcases after dressing but before chilling | Improvements in slaughter hygiene, review of process controls and of origin of animals | |
| Salmonella | 5048 | 349 | F1Not detected in the area tested per carcase | F1EN ISO 6579-1 | Carcases after dressing but before chilling | Improvements in slaughter hygiene and review of process controls, origin of animals and of the biosecurity measures in the farms of origin | |
| Salmonella spp.53 | 50 (5) | 7 (6) From 1.1.2012 c = 5 for broilers From 1.1.2013 c = 5 for turkeys | F1Not detected in 25 g of a pooled sample of neck skin | F1EN ISO 6579-1 | Carcases after chilling | Improvement in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin | |
| Aerobic colony count50 | 5 | 2 | 5 × 105 cfu/g | 5 × 106 cfu/g | F1EN ISO 4833-1 | End of the manufacturing process | Improvements in production hygiene and improvements in selection and/or origin of raw materials |
E. coli51 | 5 | 2 | 50 cfu/g | 500 cfu/g | ISO 16649-1 or 2 | End of the manufacturing process | Improvements in production hygiene and improvements in selection and/or origin of raw materials | |
| Aerobic colony count | 5 | 2 | 5 × 105 cfu/g | 5 × 106 cfu/g | F1EN ISO 4833-1 | End of the manufacturing process | Improvements in production hygiene and improvements in selection and/or origin of raw materials |
E. coli51 | 5 | 2 | 50 cfu/g | 500 cfu/g | ISO 16649-1 or 2 | End of the manufacturing process | Improvements in production hygiene and improvements in selection and/or origin of raw materials | |
| E. coli51 | 5 | 2 | 500 cfu/g or cm2 | 5 000 cfu/g or cm2 | ISO 16649-1 or 2 | End of the manufacturing process | Improvements in production hygiene and improvements in selection and/or origin of raw materials |
| Campylobacter spp. | 5048 | c = 20 From 1.1.2020 c = 15; From 1.1.2025 c = 10 | 1 000 cfu/g | EN ISO 10272-2 | Carcases after chilling | Improvements in slaughter hygiene, review of process controls, of animals' origin and of the biosecurity measures in the farms of origin | |
n = number of units comprising the sample; c = number of sample units giving values between m and M. | ||||||||
For points 2.1.3-2.1.5 and 2.1.9 m = M. | ||||||||
The most recent edition of the standard shall be used. | ||||||||
The limits (m and M) shall apply only to samples taken by the destructive method. The daily mean log shall be calculated by first taking a log value of each individual test result and then calculating the mean of these log values. | ||||||||
The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation. | ||||||||
The number of samples where the presence of salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the salmonella prevalence. Member States or regions having low salmonella prevalence may use lower c values even before the review. | ||||||||
This criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours. | ||||||||
E. coli is used here as an indicator of faecal contamination. | ||||||||
These criteria apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council. | ||||||||
Where Salmonella spp. is found, the isolates shall be further serotyped for Salmonella Typhimurium and Salmonella Enteritidis in order to verify compliance with the microbiological criterion set out in Row 1.28 of Chapter 1. | ||||||||
Interpretation of the test results
The limits given refer to each sample unit tested, excluding testing of carcases where the limits refer to pooled samples.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae and aerobic colony count in carcases of cattle, sheep, goats, horses and pigs:
satisfactory, if the daily mean log is ≤ m,
acceptable, if the daily mean log is between m and M,
unsatisfactory, if the daily mean log is > M.
Salmonella in carcases:
satisfactory, if the presence of Salmonella is detected in a maximum of c/n samples,
unsatisfactory, if the presence of Salmonella is detected in more than c/n samples.
After each sampling session, the results of the last ten sampling sessions shall be assessed in order to obtain the n number of samples.
E. coli and aerobic colony count in minced meat, meat preparations and mechanically separated meat (MSM):
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
F9Campylobacter spp. in poultry carcases of broilers:
satisfactory, if a maximum of c/n values are > m,
unsatisfactory, if more than c/n values are > m.
2.2Milk and dairy products
Food category | Micro-organisms | Sampling plan54 | Limits55 | Analytical reference method56 | Stage where the criterion applies | Action in case of unsatisfactory results | ||
|---|---|---|---|---|---|---|---|---|
n | c | m | M | |||||
Entero-bacteriaceae | 5 | 0 | 10 cfu/ml | F1EN ISO 21528-2 | End of the manufacturing process | Check on the efficiency of heat-treatment and prevention of recontamination as well as the quality of raw materials | ||
| E. coli58 | 5 | 2 | 100 cfu/g | 1 000 cfu/g | ISO 16649-1 or 2 | At the time during the manufacturing process when the E. coli count is expected to be highest59 | Improvements in production hygiene and selection of raw materials |
| Coagulase-positive staphylococci | 5 | 2 | 104 cfu/g | 105 cfu/g | EN/ISO 6888-2 | At the time during the manufacturing process when the number of staphylococci is expected to be highest | Improvements in production hygiene and selection of raw materials. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins. |
Coagulase-positive staphylococci | 5 | 2 | 100 cfu/g | 1 000 cfu/g | EN/ISO 6888-1 or 2 | |||
| Coagulase-positive staphylococci | 5 | 2 | 10 cfu/g | 100 cfu/g | EN/ISO 6888-1 or 2 | End of the manufacturing process | Improvements in production hygiene. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins. |
| E. coli58 | 5 | 2 | 10 cfu/g | 100 cfu/g | ISO 16649-1 or 2 | End of the manufacturing process | Improvements in production hygiene and selection of raw materials |
| Enterobacteriaceae | 5 | 0 | 10 cfu/g | F1EN ISO 21528-2 | End of the manufacturing process | Check on the efficiency of heat treatment and prevention of recontamination | |
Coagulase-positive staphylococci | 5 | 2 | 10 cfu/g | 100 cfu/g | EN/ISO 6888-1 or 2 | End of the manufacturing process | Improvements in production hygiene. If values > 105 cfu/g are detected, the batch has to be tested for staphylococcal enterotoxins. | |
| Enterobacteriaceae | 5 | 2 | 10 cfu/g | 100 cfu/g | F1EN ISO 21528-2 | End of the manufacturing process | Improvements in production hygiene |
| Enterobacteriaceae | 10 | 0 | F1Not detected in 10 g | F1EN ISO 21528-1 | End of the manufacturing process | Improvements in production hygiene to minimise contamination62 | |
| Enterobacteriaceae | 5 | 0 | F1Not detected in 10 g | F1EN ISO 21528-1 | End of the manufacturing process | Improvements in production hygiene to minimise contamination | |
| Presumptive Bacillus cereus | 5 | 1 | 50 cfu/g | 500 cfu/g | EN/ISO 793263 | End of the manufacturing process | Improvements in production hygiene. Prevention of recontamination. Selection of raw material. |
n = number of units comprising the sample; c = number of sample units giving values between m and M. | ||||||||
For points 2.2.1, 2.2.7, 2.2.9 and 2.2.10 m=M. | ||||||||
The most recent edition of the standard shall be used. | ||||||||
The criterion shall not apply to products intended for further processing in the food industry. | ||||||||
E. coli is used here as an indicator for the level of hygiene. | ||||||||
For cheeses which are not able to support the growth of E. coli, the E. coli count is usually the highest at the beginning of the ripening period, and for cheeses which are able to support the growth of E. coli, it is normally at the end of the ripening period. | ||||||||
Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins. | ||||||||
Only ice creams containing milk ingredients. | ||||||||
Parallel testing for Enterobacteriaceae and Cronobacter spp. shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch has to be tested for Cronobacter spp. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent authority whether such a correlation exists between Enterobacteriaceae and Cronobacter spp. | ||||||||
1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter. | ||||||||
Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae in dried infant formulae, dried dietary foods for special medical purposes intended for infants below six months of age and dried follow-on formulae:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
E. coli, Enterobacteriaceae (other food categories) and coagulase-positive staphylococci:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Presumptive Bacillus cereus in dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
2.3Egg products
Food category | Micro-organisms | Sampling plan64 | Limits | Analytical reference method65 | Stage where the criterion applies | Action in case of unsatisfactory results | ||
|---|---|---|---|---|---|---|---|---|
n | c | m | M | |||||
| Enterobacteriaceae | 5 | 2 | 10 cfu/g or ml | 100 cfu/g or ml | F1EN ISO 21528-2 | End of the manufacturing process | Checks on the efficiency of the heat treatment and prevention of recontamination |
n = number of units comprising the sample; c = number of sample units giving values between m and M. | ||||||||
The most recent edition of the standard shall be used. | ||||||||
Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae in egg products:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
2.4Fishery products
X1Food category | Micro-organisms | Sampling plan66 | Limits | Analytical reference method67 | Stage where the criterion applies | Action in case of unsatisfactory results | ||
|---|---|---|---|---|---|---|---|---|
n | c | m | M | |||||
| E. coli | 5 | 2 | 1 MPN/g | 10 MPN/g | ISO TS 16649-3 | End of the manufacturing process | Improvements in production hygiene |
Coagulase-positive staphylococci | 5 | 2 | 100 cfu/g | 1 000 cfu/g | EN/ISO 6888-1 or 2 | End of the manufacturing process | Improvements in production hygiene | |
n = number of units comprising the sample; c = number of sample units giving values between m and M. | ||||||||
The most recent edition of the standard shall be used. | ||||||||
Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
E. coli in shelled and shucked products of cooked crustaceans and molluscan shellfish:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Coagulase-positive staphylococci in shelled and cooked crustaceans and molluscan shellfish:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
2.5Vegetables, fruits and products thereof
Food category | Micro-organisms | Sampling plan68 | Limits | Analytical reference method69 | Stage where the criterion applies | Action in case of unsatisfactory results | ||
|---|---|---|---|---|---|---|---|---|
n | c | m | M | |||||
| E. coli | 5 | 2 | 100 cfu/g | 1 000 cfu/g | ISO 16649-1 or 2 | Manufacturing process | Improvements in production hygiene, selection of raw materials |
E. coli | 5 | 2 | 100 cfu/g | 1 000 cfu/g | ISO 16649-1 or 2 | Manufacturing process | Improvements in production hygiene, selection of raw materials | |
n = number of units comprising the sample; c = number of sample units giving values between m and M. | ||||||||
The most recent edition of the standard shall be used. | ||||||||
The term unpasteurised means that the juice has not been subjected to pasteurisation obtained by time-temperature combinations or to other processes validated to achieve an equivalent bactericidal effect to pasteurisation as regards its effect on E.coli. | ||||||||
Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
E. coli in precut fruit and vegetables (ready-to-eat) and in unpasteurised fruit and vegetable juices (ready-to-eat):
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Substituted by Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance).