(EC) No 1441/2007 食品的微生物标准，并修订条例(EC) No 2073/2005(Amending Regulation （EC） No 2073/2005 on microbiological criteria for foodstuffs)

　　THE COMMISSION OF THE EUROPEAN COMMUNITIES,

　　Having regard to the Treaty establishing the European Community,

　　Having regard to Regulation （EC） No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [1], and in particular Article 4（4） thereof,

　　Whereas:

　　（1） Commission Regulation （EC） No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs [2] lays down microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation （EC） No 852/2004. Regulation （EC） No 2073/2005 also provides that food business operators are to ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I to that Regulation.

　　（2） Chapters 1 and 2 of Annex I to Regulation （EC） No 2073/2005 set out food safety criteria and process hygiene criteria regarding dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age （dried infant formulae and dried dietary foods）. Part 2.2 of Chapter 2 of that Annex provides that where dried infant formulae and dried dietary foods are tested and Enterobacteriaceae are detected in any of the sample units, the batch is to be tested for Enterobacter sakazakii and Salmonella.

　　（3） On 24 January 2007, the Scientific Panel on Biological Hazards （BIOHAZ Panel） of the European Food Safety Authority （EFSA） issued an opinion with regard to Enterobacteriaceae as indicators of Salmonella and Enterobacter sakazakii. It concluded that it is not possible to establish a correlation between Enterobacteriaceae and Salmonella, and no universal correlation between Enterobacteriaceae and Enterobacter sakazakii exists. At individual plant level, a correlation between Enterobacteriaceae and Enterobacter sakazakii may however be established.

　　（4） Therefore the requirement laid down in Regulation （EC） No 2073/2005 as regards the testing of dried infant formulae and dried dietary foods for Salmonella and Enterobacter sakazakii where Enterobacteriaceae are detected in any of the sample units should no longer apply. Part 2.2 of Chapter 2 of Annex I to that Regulation should therefore be amended accordingly.

　　（5） In line with the opinion on the microbiological risks in infant formulae and follow-on formulae issued by the BIOHAZ Panel of EFSA on 9 September 2004, microbiological criteria on Salmonella and Enterobacteriaceae should be laid down for dried follow-on formulae.

　　（6） The BIOHAZ Panel of EFSA issued an opinion on Bacillus cereus and other Bacillus spp. in foodstuffs on 26 and 27 January 2005. It concluded that one of the major control measures is to control temperature and to establish a system based on hazard analysis and critical control point principles. Dehydrated foods, in which the presence of spores of pathogenic Bacillus spp. is frequent, might permit the growth of Bacillus cereus once rehydrated in warm water. Some dehydrated foods, including dried infant formulae and dried dietary foods, are consumed by potentially fragile consumers. In line with the EFSA opinion, the numbers of Bacillus cereus spores in dried infant formulae and dried dietary foods should be as low as possible during processing and a process hygiene criterion should be laid down in addition to good practices designed to reduce delay between preparation and consumption.

　　（7） Chapter 1 of Annex I to Regulation （EC） No 2073/2005 provides for the analytical reference method for staphylococcal enterotoxins in certain cheeses, milk powder and whey powder. That method has been revised by the Community reference laboratory for coagulase positive staphylococci. The reference to that analytical reference method should therefore be amended. Chapter 1 of Annex I to that Regulation should therefore be amended accordingly.

　　（8） Chapter 3 of Annex I to Regulation （EC） No 2073/2005 sets out sampling rules for carcasses of cattle, pig, sheep, goats and horses for Salmonella analyses. Pursuant to those rules the sampling area is to cover a minimum of 100 cm2 per site selected. However, neither the number of sampling sites nor the minimum total area of sampling is specified. In order to improve the implementation of these rules in the Community, it is appropriate to further specify in Regulation （EC） No 2073/2005 that the areas most likely to be contaminated should be selected for sampling and that the total sampling area should be increased. Chapter 3 of Annex I to that Regulation should therefore be amended accordingly.

　　（9） In the interests of clarity of Community legislation, it is appropriate to replace Annex I to Regulation （EC） No 2073/2005 by the text set out in the Annex to this Regulation.

　　（10） The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

　　HAS ADOPTED THIS REGULATION:

　　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

　　[1] OJ L 139, 30.4.2004, p. 1, as corrected by OJ L 226, 25.6.2004, p. 3.

　　[2] OJ L 338, 22.12.2005, p. 1.

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　　20071205

　　ANNEX

　　"

　　20071205

　　"ANNEX I

　　Microbiological criteria for foodstuffs

　　Chapter 1. Food safety criteria

　　Chapter 2. Process hygiene criteria

　　2.1 Meat and products thereof

　　2.2 Milk and dairy products

　　2.3 Egg products

　　2.4 Fishery products

　　2.5 Vegetables, fruits and products thereof

　　Chapter 3. Rules for sampling and preparation of test samples

　　3.1 General rules for sampling and preparation of test samples

　　3.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations

　　Chapter 1. Food safety criteria

　　Food category | Micro-organisms/their toxins, metabolites | Sampling plan [1] | Limits [2] | Analytical reference method [3] | Stage where the criterion applies |

　　n | c | m | M |

　　1.1Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposes [4] | Listeria monocytogenes | 10 | 0 | Absence in 25 g | EN/ISO 11290-1 | Products placed on the market during their shelf-life |

　　1.2Ready-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 [5] | EN/ISO 11290-2 [6] | Products placed on the market during their shelf-life |

　　5 | 0 | Absence in 25 g [7] | EN/ISO 11290-1 | Before the food has left the immediate control of the food business operator, who has produced it |

　　1.3Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes [4] [8] | Listeria monocytogenes | 5 | 0 | 100 cfu/g | EN/ISO 11290-2 [6] | Products placed on the market during their shelf-life |

　　1.4Minced 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 |

　　1.5Minced meat and meat preparations made from poultry meat intended to be eaten cooked | Salmonella | 5 | 0 | From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.6Minced 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 |

　　1.7Mechanically separated meat （MSM） [9] | Salmonella | 5 | 0 | Absence in 10 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.8Meat 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 |

　　1.9Meat products made from poultrymeat intended to be eaten cooked | Salmonella | 5 | 0 | From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.10Gelatine and collagen | Salmonella | 5 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.11Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation [10] | Salmonella | 5 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.12Milk powder and whey powder | Salmonella | 5 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.13Ice cream [11], 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 |

　　1.14Egg 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 |

　　1.15Ready-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 |

　　1.16Cooked crustaceans and molluscan shellfish | Salmonella | 5 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.17Live 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 |

　　1.18Sprouted seeds （ready-to-eat） [12] | Salmonella | 5 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.19Precut 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 |

　　1.20Unpasteurised 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 |

　　1.21Cheeses, 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 [13] | Products placed on the market during their shelf-life |

　　1.22Dried 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 |

　　1.23Dried follow-on formulae | Salmonella | 30 | 0 | Absence in 25 g | EN/ISO 6579 | Products placed on the market during their shelf-life |

　　1.24Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age [14] | Enterobacter sakazakii | 30 | 0 | Absence in 10 g | ISO/TS 22964 | Products placed on the market during their shelf-life |

　　1.25Live bivalve molluscs and live echinoderms, tunicates and gastropods | E. coli [15] | 1 [16] | 0 | 230 MPN/100 g of flesh and intra-valvular liquid | ISO TS 16649-3 | Products placed on the market during their shelf-life |

　　1.26Fishery products from fish species associated with a high amount of histidine [17] | Histamine | 9 [18] | 2 | 100 mg/kg | 200 mg/kg | HPLC [19] | Products placed on the market during their shelf-life |

　　1.27Fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine [17] | Histamine | 9 | 2 | 200 mg/kg | 400 mg/kg | HPLC [19] | Products placed on the market during their shelf-life |

　　Interpretation of the test results

　　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 [20].

　　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. Process hygiene criteria

　　2.1 Meat and products thereof

　　Food category | Micro-organisms | Sampling plan [21] | Limits [22] | Analytical reference method [23] | Stage where the criterion applies | Action in case of unsatisfactory results |

　　n | c | m | M |

　　2.1.1Carcases of cattle, sheep, goats and horses [24] | 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 |

　　2.1.2Carcases of pigs [24] | 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 |

　　2.1.3Carcases of cattle, sheep, goats and horses | Salmonella | 50 [25] | 2 [26] | 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 |

　　2.1.4Carcases of pigs | Salmonella | 50 [25] | 5 [26] | 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 |

　　2.1.5Poultry carcases of broilers and turkeys | Salmonella | 50 [25] | 7 [26] | 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 |

　　2.1.6Minced meat | Aerobic colony count [27] | 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 [28] | 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 |

　　2.1.7Mechanically separated meat （MSM） [29] | 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 [28] | 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 |

　　2.1.8Meat preparations | E. coli [28] | 5 | 2 | 500 cfu/g or cm2 | 5000 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 |

　　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.

　　2.2 Milk and dairy products

　　Food category | Micro-organisms | Sampling plan [30] | Limits [31] | Analytical reference method [32] | Stage where the criterion applies | Action in case of unsatisfactory results |

　　n | c | m | M |

　　2.2.1Pasteurised milk and other pasteurised liquid dairy products [33] | 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 |

　　2.2.2Cheeses made from milk or whey that has undergone heat treatment | E. coli [34] | 5 | 2 | 100 cfu/g | 1000 cfu/g | ISO 16649-1 or 2 | At the time during the manufacturing process when the E. coli count is expected to be highest [35] | Improvements in production hygiene and selection of raw materials |

　　2.2.3Cheeses 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. |

　　2.2.4Cheeses made from milk that has undergone a lower heat treatment than pasteurisation [36] and ripened cheeses made from milk or whey that has undergone pasteurisation or a stronger heat treatment [36] | Coagulase-positive staphylococci | 5 | 2 | 100 cfu/g | 1000 cfu/g | EN/ISO 6888-1 or 2 |

　　2.2.5Unripened soft cheeses （fresh cheeses） made from milk or whey that has undergone pasteurisation or a stronger heat treatment [36] | 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. |

　　2.2.6Butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation | E. coli [34] | 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 |

　　2.2.7Milk powder and whey powder [33] | 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. |

　　2.2.8Ice cream [37] 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 |

　　2.2.9Dried 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 [38] |

　　2.2.10Dried 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 |

　　2.2.11Dried 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 [39] | End of the manufacturing process | Improvements in production hygiene. Prevention of recontamination. Selection of raw material. |

　　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.

　　2.3 Egg products

　　Food category | Micro-organisms | Sampling plan [40] | Limits | Analytical reference method [41] | Stage where the criterion applies | Action in case of unsatisfactory results |

　　n | c | m | M |

　　2.3.1Egg 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 |

　　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.

　　2.4 Fishery products

　　Food category | Micro-organisms | Sampling plan [42] | Limits | Analytical reference method [43] | Stage where the criterion applies | Action in case of unsatisfactory results |

　　n | c | m | M |

　　2.4.1Shelled 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 | 1000 cfu/g | EN/ISO 6888-1 or 2 | End of the manufacturing process | Improvements in production hygiene |

　　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.

　　2.5 Vegetables, fruits and products thereof

　　Food category | Micro-organisms | Sampling plan [44] | Limits | Analytical reference method [45] | Stage where the criterion applies | Action in case of unsatisfactory results |

　　n | c | m | M |

　　2.5.1Precut fruit and vegetables （ready-to-eat） | E. coli | 5 | 2 | 100 cfu/g | 1000 cfu/g | ISO 16649-1 or 2 | Manufacturing process | Improvements in production hygiene, selection of raw materials |

　　2.5.2Unpasteurised fruit and vegetable juices （ready-to-eat） | E. coli | 5 | 2 | 100 cfu/g | 1000 cfu/g | ISO 16649-1 or 2 | Manufacturing process | Improvements in production hygiene, selection of raw materials |

　　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.

　　Chapter 3. Rules for sampling and preparation of test samples

　　3.1 General rules for sampling and preparation of test samples

　　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 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations

　　Sampling rules for carcases of cattle, pigs, sheep, goats and horses

　　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.

　　Sampling rules for poultry carcases

　　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.

　　Guidelines for sampling

　　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.

　　Sampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat

　　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."

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　　[1] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[2] For points 1.1-1.25 m = M.

　　[3] The most recent edition of the standard shall be used.

　　[4] Regular testing against the criterion is not required in normal circumstances for the following ready-to-eat foods:

　　- those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment （for example, products heat treated in their final package）,

　　- fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds,

　　- bread, biscuits and similar products,

　　- bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products,

　　- sugar, honey and confectionery, including cocoa and chocolate products,

　　- live bivalve molluscs.

　　[5] This criterion shall apply if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life.

　　[6] 1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.

　　[7] This criterion shall apply to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life.

　　[8] Products with pH ≤ 4,4 or aw ≤ 0,92, products with pH ≤ 5,0 and aw ≤ 0,94, products with a shelf-life of less than five days shall be automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.

　　[9] This criterion shall 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.

　　[10] Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and aw of the product where appropriate, there is no salmonella risk.

　　[11] Only ice creams containing milk ingredients.

　　[12] Preliminary testing of the batch of seeds before starting the sprouting process or the sampling must be carried out at the stage where the highest probability of finding Salmonella is expected.

　　[13] Reference: Community reference laboratory for coagulase positive staphylococci. European screening method for the detection of staphylococcal enterotoxins in milk and milk products.

　　[14] Parallel testing for Enterobacteriaceae and E. sakazakii 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 must be tested for E. sakazakii. 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 E. sakazakii.

　　[15] E. coli is used here as an indicator of faecal contamination.

　　[16] A pooled sample comprising a minimum of 10 individual animals.

　　[17] Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.

　　[18] Single samples may be taken at retail level. In such a case the presumption laid down in Article 14（6） of Regulation （EC） No 178/2002, according to which the whole batch is to be deemed unsafe, shall not apply.

　　[19] References: 1. Malle P., Valle M., Bouquelet S. Assay of biogenic amines involved in fish decomposition. J. AOAC Internat. 1996, 79, 43-49. 2. Duflos G., Dervin C., Malle P., Bouquelet S. Relevance of matrix effect in determination of biogenic amines in plaice （Pleuronectes platessa） and whiting （Merlangus merlangus. J. AOAC Internat. 1999, 82, 1097-1101.

　　[20] The test results may be used also for demonstrating the effectiveness of the hazard analysis and critical control point principles or good hygiene procedure of the process.

　　[21] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[22] For points 2.1.3-2.1.5 m = M.

　　[23] The most recent edition of the standard shall be used.

　　[24] 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.

　　[25] The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation.

　　[26] 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.

　　[27] This criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours.

　　[28] E. coli is used here as an indicator of faecal contamination.

　　[29] 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.

　　[30] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[31] For points 2.2.7, 2.2.9 and 2.2.10 m = M.

　　[32] The most recent edition of the standard shall be used.

　　[33] The criterion shall not apply to products intended for further processing in the food industry.

　　[34] E. coli is used here as an indicator for the level of hygiene.

　　[35] 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.

　　[36] 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.

　　[37] Only ice creams containing milk ingredients.

　　[38] Parallel testing for Enterobacteriaceae and E. sakazakii 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 E. sakazakii. 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 E. sakazakii.

　　[39] 1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.

　　[40] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[41] The most recent edition of the standard shall be used.

　　[42] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[43] The most recent edition of the standard shall be used.

　　[44] n = number of units comprising the sample; c = number of sample units giving values between m and M.

　　[45] The most recent edition of the standard shall be used.

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