
Article 1 
Annex I to Regulation (EC) No 2073/2005 is replaced by the text in the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 5 December 2007.
For the Commission
Markos KYPRIANOU
Member of the Commission
ANNEX


ANNEX I 
Chapter 1.

Food category Micro-organisms/their toxins, metabolites Sampling plan Limits Analytical reference method Stage where the criterion applies
n c m M
 1.1 Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposes
 Listeria monocytogenes 10 0 Absence in 25 g EN/ISO 11290-1 Products placed on the market during their shelf-life
 1.2 Ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes
 Listeria monocytogenes 5 0 100 cfu/g EN/ISO 11290-2 Products placed on the market during their shelf-life
5 0 Absence in 25 g EN/ISO 11290-1 Before the food has left the immediate control of the food business operator, who has produced it
 1.3 Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes
 Listeria monocytogenes 5 0 100 cfu/g EN/ISO 11290-2 Products placed on the market during their shelf-life
 1.4 Minced meat and meat preparations intended to be eaten raw
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.5 Minced meat and meat preparations made from poultry meat intended to be eaten cooked
 Salmonella 5 0 From 1.1.2006Absence in 10 gFrom 1.1.2010Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.6 Minced meat and meat preparations made from other species than poultry intended to be eaten cooked
 Salmonella 5 0 Absence in 10 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.7 Mechanically separated meat (MSM)
 Salmonella 5 0 Absence in 10 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.8 Meat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.9 Meat products made from poultrymeat intended to be eaten cooked
 Salmonella 5 0 From 1.1.2006Absence in 10 gFrom 1.1.2010Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.10 Gelatine and collagen
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.11 Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.12 Milk powder and whey powder
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.13 Ice cream, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.14 Egg products, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.15 Ready-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk
 Salmonella 5 0 Absence in 25 g or ml EN/ISO 6579 Products placed on the market during their shelf-life
 1.16 Cooked crustaceans and molluscan shellfish
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.17 Live bivalve molluscs and live echinoderms, tunicates and gastropods
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.18 Sprouted seeds (ready-to-eat)
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.19 Precut fruit and vegetables (ready-to-eat)
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.20 Unpasteurised fruit and vegetable juices (ready-to-eat)
 Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.21 Cheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of this Annex
 Staphylococcal enterotoxins 5 0 Not detected in 25 g European screening method of the CRL for coagulase positive staphylococci Products placed on the market during their shelf-life
 1.22 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age
 Salmonella 30 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.23 Dried follow-on formulae
 Salmonella 30 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life
 1.24 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age
 Enterobacter sakazakii 30 0 Absence in 10 g ISO/TS 22964 Products placed on the market during their shelf-life
 1.25 Live bivalve molluscs and live echinoderms, tunicates and gastropods
 E. coli 1 0 230 MPN/100 g of flesh and intra-valvular liquid ISO TS 16649-3 Products placed on the market during their shelf-life
 1.26 Fishery products from fish species associated with a high amount of histidine
 Histamine 9 2 100 mg/kg 200 mg/kg HPLC Products placed on the market during their shelf-life
 1.27 Fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine
 Histamine 9 2 200 mg/kg 400 mg/kg HPLC Products placed on the market during their shelf-life




















The limits given refer to each sample unit tested, excluding live bivalve molluscs and live echinoderms, tunicates and gastropods in relation to testing E. coli, where the limit refers to a pooled sample.

The test results demonstrate the microbiological quality of the batch tested.

L. monocytogenes in ready-to-eat foods intended for infants and for special medical purposes:


— 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.

L. monocytogenes in ready-to-eat foods able to support the growth of L. monocytogenes before the food has left the immediate control of the producing food business operator when he is not able to demonstrate that the product will not exceed the limit of 100 cfu/g throughout the shelf-life:


— 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.

L. monocytogenes in other ready-to-eat foods and E. coli in live bivalve molluscs:


— satisfactory, if all the values observed are ≤ the limit,
— unsatisfactory, if any of the values are > the limit.

Salmonella in different food categories:


— 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.

Staphylococcal enterotoxins in dairy products:


— satisfactory, if in all the sample units the enterotoxins are not detected,
— unsatisfactory, if the enterotoxins are detected in any of the sample units.

Enterobacter sakazakii in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age:


— 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.

Histamine in fishery products from fish species associated with a high amount of histidine:


— satisfactory, if the following requirements are fulfilled:
1.. the mean value observed is ≤ m
2.. a maximum of c/n values observed are between m and M
3.. no values observed exceed the limit of M,
— unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or more of the values observed are > M.

Chapter 2. 2.1 

Food category Micro-organisms Sampling plan Limits Analytical reference method Stage where the criterion applies Action in case of unsatisfactory results
n c m M
 2.1.1 Carcases of cattle, sheep, goats and horses
 Aerobic colony count   3,5 log cfu/cm2 daily mean log 5,0 log cfu/cm2 daily mean log ISO 4833 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 ISO 21528-2 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls
 2.1.2 Carcases of pigs
 Aerobic colony count   4,0 log cfu/cm2 daily mean log 5,0 log cfu/cm2 daily mean log ISO 4833 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 ISO 21528-2 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls
 2.1.3 Carcases of cattle, sheep, goats and horses
 Salmonella 50 2 Absence in the area tested per carcase EN/ISO 6579 Carcases after dressing but before chilling Improvements in slaughter hygiene, review of process controls and of origin of animals
 2.1.4 Carcases of pigs
 Salmonella 50 5 Absence in the area tested per carcase EN/ISO 6579 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
 2.1.5 Poultry carcases of broilers and turkeys
 Salmonella 50 7 Absence in 25 g of a pooled sample of neck skin EN/ISO 6579 Carcases after chilling Improvements in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin
 2.1.6 Minced meat
 Aerobic colony count 5 2 5 × 105 cfu/g 5 × 106 cfu/g ISO 4833 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials
E. coli 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
 2.1.7 Mechanically separated meat (MSM)
 Aerobic colony count 5 2 5 × 105 cfu/g 5 × 106 cfu/g ISO 4833 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials
E. coli 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
 2.1.8 Meat preparations
 E. coli 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










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.
 2.2 

Food category Micro-organisms Sampling plan Limits Analytical reference method Stage where the criterion applies Action in case of unsatisfactory results
n c m M
 2.2.1 Pasteurised milk and other pasteurised liquid dairy products
 Enterobacteriaceae 5 2 < 1/ml 5/ml ISO 21528-1 End of the manufacturing process Check on the efficiency of heat treatment and prevention of recontamination as well as the quality of raw materials
 2.2.2 Cheeses made from milk or whey that has undergone heat treatment
 E. coli 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 highest Improvements in production hygiene and selection of raw materials
 2.2.3 Cheeses made from raw milk
 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.
 2.2.4 Cheeses made from milk that has undergone a lower heat treatment than pasteurisation and ripened cheeses made from milk or whey that has undergone pasteurisation or a stronger heat treatment
 Coagulase-positive staphylococci 5 2 100 cfu/g 1 000 cfu/g EN/ISO 6888-1 or 2
 2.2.5 Unripened soft cheeses (fresh cheeses) made from milk or whey that has undergone pasteurisation or a stronger heat treatment
 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.
 2.2.6 Butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation
 E. coli 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
 2.2.7 Milk powder and whey powder
 Enterobacteriaceae 5 0 10 cfu/g 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.
 2.2.8 Ice cream and frozen dairy desserts
 Enterobacteriaceae 5 2 10 cfu/g 100 cfu/g ISO 21528-2 End of the manufacturing process Improvements in production hygiene
 2.2.9 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age
 Enterobacteriaceae 10 0 Absence in 10 g ISO 21528-1 End of the manufacturing process Improvements in production hygiene to minimise contamination
 2.2.10 Dried follow-on formulae
 Enterobacteriaceae 5 0 Absence in 10 g ISO 21528-1 End of the manufacturing process Improvements in production hygiene to minimise contamination
 2.2.11 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age
 Presumptive Bacillus cereus 5 1 50 cfu/g 500 cfu/g EN/ISO 7932 End of the manufacturing process Improvements in production hygiene. Prevention of recontamination. Selection of raw material.











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.
 2.3 

Food category Micro-organisms Sampling plan Limits Analytical reference method Stage where the criterion applies Action in case of unsatisfactory results
n c m M
 2.3.1 Egg products
 Enterobacteriaceae 5 2 10 cfu/g or ml 100 cfu/g or ml ISO 21528-2 End of the manufacturing process Checks on the efficiency of the heat treatment and prevention of recontamination



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.
 2.4 

Food category Micro-organisms Sampling plan Limits Analytical reference method Stage where the criterion applies Action in case of unsatisfactory results
n c m M
 2.4.1 Shelled and shucked products of cooked crustaceans and molluscan shellfish
 E. coli 5 2 1/g 10/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



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.
 2.5 

Food category Micro-organisms Sampling plan Limits Analytical reference method Stage where the criterion applies Action in case of unsatisfactory results
n c m M
 2.5.1 Precut fruit and vegetables (ready-to-eat)
 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
 2.5.2 Unpasteurised fruit and vegetable juices (ready-to-eat)
 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



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.

Chapter 3. 3.1 
In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO (International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used as reference methods.
 3.2 
The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and transport of samples are described in standard ISO 17604.

Five carcases shall be sampled at random during each sampling session. Sample sites must be selected taking into account the slaughter technology used in each plant.

When sampling for analyses of Enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non-destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant carcases) per sampling site.

When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. Areas most likely to be contaminated shall be selected. The total sampling area shall cover a minimum of 400 cm2.

When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.

For the Salmonella analyses, a minimum of 15 carcases shall be sampled at random during each sampling session and after chilling. A piece of approximately 10 g from neck skin shall be obtained from each carcase. On each occasion the neck skin samples from three carcases shall be pooled before examination in order to form 5 × 25 g final samples.

More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

The food business operators of slaughterhouses or establishments producing minced meat, meat preparations or mechanically separated meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered.

As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fortnightly testing if satisfactory results are obtained for six consecutive weeks.

In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella sampling frequency may also be reduced if there is a national or regional salmonella control programme in place and if this programme includes testing that replaces the sampling described in this paragraph. The sampling frequency may be further reduced if the national or regional salmonella control programme demonstrates that the salmonella prevalence is low in animals purchased by the slaughterhouse.

However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat and meat preparations in small quantities may be exempted from these sampling frequencies.

