{
  "url": "https://openlegislation.uk/eu-regulation-2007-1441/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2007-1441/annex.json",
  "legislation": "eur/2007/1441",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2007-1441",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "ANNEX I\nMicrobiological criteria for foodstuffs\nChapter 1.\nFood safety criteria\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nFor points 1.1-1.25 m = M.\nThe most recent edition of the standard shall be used.\nRegular testing against the criterion is not required in normal circumstances for the following ready-to-eat foods:\nthose 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),\nfresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds,\nbread, biscuits and similar products,\nbottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products,\nsugar, honey and confectionery, including cocoa and chocolate products,\nlive bivalve molluscs.\nThis 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.\n1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.\nThis 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.\nProducts 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.\nThis 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.\nExcluding 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.\nOnly ice creams containing milk ingredients.\nPreliminary 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.\nReference: Community reference laboratory for coagulase positive staphylococci. European screening method for the detection of staphylococcal enterotoxins in milk and milk products.\nParallel 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.\nE. coli is used here as an indicator of faecal contamination.\nA pooled sample comprising a minimum of 10 individual animals.\nParticularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.\nSingle 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.\nReferences: 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.\nFood category\nMicro-organisms/their toxins, metabolites\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nn\nc\nm\nM\n1.1\nReady-to-eat foods intended for infants and ready-to-eat foods for special medical purposes\nListeria monocytogenes\n10\n0\nAbsence in 25 g\nEN/ISO 11290-1\nProducts placed on the market during their shelf-life\n1.2\nReady-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes\nListeria monocytogenes\n5\n0\n100 cfu/g\nEN/ISO 11290-2\nProducts placed on the market during their shelf-life\n5\n0\nAbsence in 25 g\nEN/ISO 11290-1\nBefore the food has left the immediate control of the food business operator, who has produced it\n1.3\nReady-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes\nListeria monocytogenes\n5\n0\n100 cfu/g\nEN/ISO 11290-2\nProducts placed on the market during their shelf-life\n1.4\nMinced meat and meat preparations intended to be eaten raw\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.5\nMinced meat and meat preparations made from poultry meat intended to be eaten cooked\nSalmonella\n5\n0\nFrom 1.1.2006\nAbsence in 10 g\nFrom 1.1.2010\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.6\nMinced meat and meat preparations made from other species than poultry intended to be eaten cooked\nSalmonella\n5\n0\nAbsence in 10 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.7\nMechanically separated meat (MSM)\nSalmonella\n5\n0\nAbsence in 10 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.8\nMeat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.9\nMeat products made from poultrymeat intended to be eaten cooked\nSalmonella\n5\n0\nFrom 1.1.2006\nAbsence in 10 g\nFrom 1.1.2010\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.10\nGelatine and collagen\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.11\nCheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.12\nMilk powder and whey powder\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.13\nIce cream, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.14\nEgg products, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.15\nReady-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk\nSalmonella\n5\n0\nAbsence in 25 g or ml\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.16\nCooked crustaceans and molluscan shellfish\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.17\nLive bivalve molluscs and live echinoderms, tunicates and gastropods\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.18\nSprouted seeds (ready-to-eat)\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.19\nPrecut fruit and vegetables (ready-to-eat)\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.20\nUnpasteurised fruit and vegetable juices (ready-to-eat)\nSalmonella\n5\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.21\nCheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of this Annex\nStaphylococcal enterotoxins\n5\n0\nNot detected in 25 g\nEuropean screening method of the CRL for coagulase positive staphylococci\nProducts placed on the market during their shelf-life\n1.22\nDried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age\nSalmonella\n30\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.23\nDried follow-on formulae\nSalmonella\n30\n0\nAbsence in 25 g\nEN/ISO 6579\nProducts placed on the market during their shelf-life\n1.24\nDried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age\nEnterobacter sakazakii\n30\n0\nAbsence in 10 g\nISO/TS 22964\nProducts placed on the market during their shelf-life\n1.25\nLive bivalve molluscs and live echinoderms, tunicates and gastropods\nE. coli\n1\n0\n230 MPN/100 g of flesh and intra-valvular liquid\nISO TS 16649-3\nProducts placed on the market during their shelf-life\n1.26\nFishery products from fish species associated with a high amount of histidine\nHistamine\n9\n2\n100 mg/kg\n200 mg/kg\nHPLC\nProducts placed on the market during their shelf-life\n1.27\nFishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine\nHistamine\n9\n2\n200 mg/kg\n400 mg/kg\nHPLC\nProducts placed on the market during their shelf-life\nInterpretation of the test results\nThe 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.\nThe test results demonstrate the microbiological quality of the batch tested.\nL. monocytogenes in ready-to-eat foods intended for infants and for special medical purposes:\nsatisfactory, if all the values observed indicate the absence of the bacterium,\nunsatisfactory, if the presence of the bacterium is detected in any of the sample units.\nL. 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:\nsatisfactory, if all the values observed indicate the absence of the bacterium,\nunsatisfactory, if the presence of the bacterium is detected in any of the sample units.\nL. monocytogenes in other ready-to-eat foods and E. coli in live bivalve molluscs:\nsatisfactory, if all the values observed are ≤ the limit,\nunsatisfactory, if any of the values are > the limit.\nSalmonella in different food categories:\nsatisfactory, if all the values observed indicate the absence of the bacterium,\nunsatisfactory, if the presence of the bacterium is detected in any of the sample units.\nStaphylococcal enterotoxins in dairy products:\nsatisfactory, if in all the sample units the enterotoxins are not detected,\nunsatisfactory, if the enterotoxins are detected in any of the sample units.\nEnterobacter sakazakii in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age:\nsatisfactory, if all the values observed indicate the absence of the bacterium,\nunsatisfactory, if the presence of the bacterium is detected in any of the sample units.\nHistamine in fishery products from fish species associated with a high amount of histidine:\nsatisfactory, if the following requirements are fulfilled:\n1.. the mean value observed is ≤ m\n2.. a maximum of c/n values observed are between m and M\n3.. no values observed exceed the limit of M,\nunsatisfactory, 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.\nChapter 2.\nProcess hygiene criteria\n2.1\nMeat and products thereof\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nFor points 2.1.3-2.1.5 m = M.\nThe most recent edition of the standard shall be used.\nThe 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.\nThe 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation.\nThe 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.\nThis criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours.\nE. coli is used here as an indicator of faecal contamination.\nThese 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.\nFood category\nMicro-organisms\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nAction in case of unsatisfactory results\nn\nc\nm\nM\n2.1.1\nCarcases of cattle, sheep, goats and horses\nAerobic colony count\n3,5 log cfu/cm2 daily mean log\n5,0 log cfu/cm2 daily mean log\nISO 4833\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene and review of process controls\nEnterobacteriaceae\n1,5 log cfu/cm2 daily mean log\n2,5 log cfu/cm2 daily mean log\nISO 21528-2\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene and review of process controls\n2.1.2\nCarcases of pigs\nAerobic colony count\n4,0 log cfu/cm2 daily mean log\n5,0 log cfu/cm2 daily mean log\nISO 4833\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene and review of process controls\nEnterobacteriaceae\n2,0 log cfu/cm2 daily mean log\n3,0 log cfu/cm2 daily mean log\nISO 21528-2\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene and review of process controls\n2.1.3\nCarcases of cattle, sheep, goats and horses\nSalmonella\n50\n2\nAbsence in the area tested per carcase\nEN/ISO 6579\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene, review of process controls and of origin of animals\n2.1.4\nCarcases of pigs\nSalmonella\n50\n5\nAbsence in the area tested per carcase\nEN/ISO 6579\nCarcases after dressing but before chilling\nImprovements in slaughter hygiene and review of process controls, origin of animals and of the biosecurity measures in the farms of origin\n2.1.5\nPoultry carcases of broilers and turkeys\nSalmonella\n50\n7\nAbsence in 25 g of a pooled sample of neck skin\nEN/ISO 6579\nCarcases after chilling\nImprovements in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin\n2.1.6\nMinced meat\nAerobic colony count\n5\n2\n5 × 105 cfu/g\n5 × 106 cfu/g\nISO 4833\nEnd of the manufacturing process\nImprovements in production hygiene and improvements in selection and/or origin of raw materials\nE. coli\n5\n2\n50 cfu/g\n500 cfu/g\nISO 16649-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene and improvements in selection and/or origin of raw materials\n2.1.7\nMechanically separated meat (MSM)\nAerobic colony count\n5\n2\n5 × 105 cfu/g\n5 × 106 cfu/g\nISO 4833\nEnd of the manufacturing process\nImprovements in production hygiene and improvements in selection and/or origin of raw materials\nE. coli\n5\n2\n50 cfu/g\n500 cfu/g\nISO 16649-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene and improvements in selection and/or origin of raw materials\n2.1.8\nMeat preparations\nE. coli\n5\n2\n500 cfu/g or cm2\n5 000 cfu/g or cm2\nISO 16649-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene and improvements in selection and/or origin of raw materials\nInterpretation of the test results\nThe limits given refer to each sample unit tested, excluding testing of carcases where the limits refer to pooled samples.\nThe test results demonstrate the microbiological quality of the process tested.\nEnterobacteriaceae and aerobic colony count in carcases of cattle, sheep, goats, horses and pigs:\nsatisfactory, if the daily mean log is ≤ m,\nacceptable, if the daily mean log is between m and M,\nunsatisfactory, if the daily mean log is > M.\nSalmonella in carcases:\nsatisfactory, if the presence of Salmonella is detected in a maximum of c/n samples,\nunsatisfactory, if the presence of Salmonella is detected in more than c/n samples.\nAfter each sampling session, the results of the last ten sampling sessions shall be assessed in order to obtain the n number of samples.\nE. coli and aerobic colony count in minced meat, meat preparations and mechanically separated meat (MSM):\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\n2.2\nMilk and dairy products\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nFor points 2.2.7, 2.2.9 and 2.2.10 m = M.\nThe most recent edition of the standard shall be used.\nThe criterion shall not apply to products intended for further processing in the food industry.\nE. coli is used here as an indicator for the level of hygiene.\nFor 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.\nExcluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins.\nOnly ice creams containing milk ingredients.\nParallel 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.\n1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.\nFood category\nMicro-organisms\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nAction in case of unsatisfactory results\nn\nc\nm\nM\n2.2.1\nPasteurised milk and other pasteurised liquid dairy products\nEnterobacteriaceae\n5\n2\n< 1/ml\n5/ml\nISO 21528-1\nEnd of the manufacturing process\nCheck on the efficiency of heat treatment and prevention of recontamination as well as the quality of raw materials\n2.2.2\nCheeses made from milk or whey that has undergone heat treatment\nE. coli\n5\n2\n100 cfu/g\n1 000 cfu/g\nISO 16649-1 or 2\nAt the time during the manufacturing process when the E. coli count is expected to be highest\nImprovements in production hygiene and selection of raw materials\n2.2.3\nCheeses made from raw milk\nCoagulase-positive staphylococci\n5\n2\n104 cfu/g\n105 cfu/g\nEN/ISO 6888-2\nAt the time during the manufacturing process when the number of staphylococci is expected to be highest\nImprovements 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.\n2.2.4\nCheeses 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\nCoagulase-positive staphylococci\n5\n2\n100 cfu/g\n1 000 cfu/g\nEN/ISO 6888-1 or 2\n2.2.5\nUnripened soft cheeses (fresh cheeses) made from milk or whey that has undergone pasteurisation or a stronger heat treatment\nCoagulase-positive staphylococci\n5\n2\n10 cfu/g\n100 cfu/g\nEN/ISO 6888-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins.\n2.2.6\nButter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation\nE. coli\n5\n2\n10 cfu/g\n100 cfu/g\nISO 16649-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene and selection of raw materials\n2.2.7\nMilk powder and whey powder\nEnterobacteriaceae\n5\n0\n10 cfu/g\nISO 21528-2\nEnd of the manufacturing process\nCheck on the efficiency of heat treatment and prevention of recontamination\nCoagulase-positive staphylococci\n5\n2\n10 cfu/g\n100 cfu/g\nEN/ISO 6888-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene. If values > 105 cfu/g are detected, the batch has to be tested for staphylococcal enterotoxins.\n2.2.8\nIce cream and frozen dairy desserts\nEnterobacteriaceae\n5\n2\n10 cfu/g\n100 cfu/g\nISO 21528-2\nEnd of the manufacturing process\nImprovements in production hygiene\n2.2.9\nDried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age\nEnterobacteriaceae\n10\n0\nAbsence in 10 g\nISO 21528-1\nEnd of the manufacturing process\nImprovements in production hygiene to minimise contamination\n2.2.10\nDried follow-on formulae\nEnterobacteriaceae\n5\n0\nAbsence in 10 g\nISO 21528-1\nEnd of the manufacturing process\nImprovements in production hygiene to minimise contamination\n2.2.11\nDried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age\nPresumptive Bacillus cereus\n5\n1\n50 cfu/g\n500 cfu/g\nEN/ISO 7932\nEnd of the manufacturing process\nImprovements in production hygiene. Prevention of recontamination. Selection of raw material.\nInterpretation of the test results\nThe limits given refer to each sample unit tested.\nThe test results demonstrate the microbiological quality of the process tested.\nEnterobacteriaceae in dried infant formulae, dried dietary foods for special medical purposes intended for infants below six months of age and dried follow-on formulae:\nsatisfactory, if all the values observed indicate the absence of the bacterium,\nunsatisfactory, if the presence of the bacterium is detected in any of the sample units.\nE. coli, Enterobacteriaceae (other food categories) and coagulase-positive staphylococci:\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\nPresumptive Bacillus cereus in dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age:\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\n2.3\nEgg products\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nThe most recent edition of the standard shall be used.\nFood category\nMicro-organisms\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nAction in case of unsatisfactory results\nn\nc\nm\nM\n2.3.1\nEgg products\nEnterobacteriaceae\n5\n2\n10 cfu/g or ml\n100 cfu/g or ml\nISO 21528-2\nEnd of the manufacturing process\nChecks on the efficiency of the heat treatment and prevention of recontamination\nInterpretation of the test results\nThe limits given refer to each sample unit tested.\nThe test results demonstrate the microbiological quality of the process tested.\nEnterobacteriaceae in egg products:\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\n2.4\nFishery products\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nThe most recent edition of the standard shall be used.\nFood category\nMicro-organisms\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nAction in case of unsatisfactory results\nn\nc\nm\nM\n2.4.1\nShelled and shucked products of cooked crustaceans and molluscan shellfish\nE. coli\n5\n2\n1/g\n10/g\nISO TS 16649-3\nEnd of the manufacturing process\nImprovements in production hygiene\nCoagulase-positive staphylococci\n5\n2\n100 cfu/g\n1 000 cfu/g\nEN/ISO 6888-1 or 2\nEnd of the manufacturing process\nImprovements in production hygiene\nInterpretation of the test results\nThe limits given refer to each sample unit tested.\nThe test results demonstrate the microbiological quality of the process tested.\nE. coli in shelled and shucked products of cooked crustaceans and molluscan shellfish:\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\nCoagulase-positive staphylococci in shelled and cooked crustaceans and molluscan shellfish:\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\n2.5\nVegetables, fruits and products thereof\nn = number of units comprising the sample; c = number of sample units giving values between m and M.\nThe most recent edition of the standard shall be used.\nFood category\nMicro-organisms\nSampling plan\nLimits\nAnalytical reference method\nStage where the criterion applies\nAction in case of unsatisfactory results\nn\nc\nm\nM\n2.5.1\nPrecut fruit and vegetables (ready-to-eat)\nE. coli\n5\n2\n100 cfu/g\n1 000 cfu/g\nISO 16649-1 or 2\nManufacturing process\nImprovements in production hygiene, selection of raw materials\n2.5.2\nUnpasteurised fruit and vegetable juices (ready-to-eat)\nE. coli\n5\n2\n100 cfu/g\n1 000 cfu/g\nISO 16649-1 or 2\nManufacturing process\nImprovements in production hygiene, selection of raw materials\nInterpretation of the test results\nThe limits given refer to each sample unit tested.\nThe test results demonstrate the microbiological quality of the process tested.\nE. coli in precut fruit and vegetables (ready-to-eat) and in unpasteurised fruit and vegetable juices (ready-to-eat):\nsatisfactory, if all the values observed are ≤ m,\nacceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,\nunsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.\nChapter 3.\nRules for sampling and preparation of test samples\n3.1\nGeneral rules for sampling and preparation of test samples\nIn 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.\n3.2\nBacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations\nSampling rules for carcases of cattle, pigs, sheep, goats and horses\nThe 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.\nFive 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.\nWhen 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.\nWhen 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.\nWhen samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.\nSampling rules for poultry carcases\nFor 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.\nGuidelines for sampling\nMore 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.\nSampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat\nThe 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.\nAs 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.\nIn 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.\nHowever, 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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "For points 1.1-1.25 m = M."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "The most recent edition of the standard shall be used."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "Only ice creams containing milk ingredients."
    },
    {
      "type": "footnote",
      "label": "f12",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f13",
      "text": "Reference: Community reference laboratory for coagulase positive staphylococci. European screening method for the detection of staphylococcal enterotoxins in milk and milk products."
    },
    {
      "type": "footnote",
      "label": "f14",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f15",
      "text": "E. coli is used here as an indicator of faecal contamination."
    },
    {
      "type": "footnote",
      "label": "f16",
      "text": "A pooled sample comprising a minimum of 10 individual animals."
    },
    {
      "type": "footnote",
      "label": "f17",
      "text": "Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae."
    },
    {
      "type": "footnote",
      "label": "f18",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f19",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f20",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f21",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f22",
      "text": "For points 2.1.3-2.1.5 m = M."
    },
    {
      "type": "footnote",
      "label": "f23",
      "text": "The most recent edition of the standard shall be used."
    },
    {
      "type": "footnote",
      "label": "f24",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f25",
      "text": "The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation."
    },
    {
      "type": "footnote",
      "label": "f26",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f27",
      "text": "This criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours."
    },
    {
      "type": "footnote",
      "label": "f28",
      "text": "E. coli is used here as an indicator of faecal contamination."
    },
    {
      "type": "footnote",
      "label": "f29",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f30",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f31",
      "text": "For points 2.2.7, 2.2.9 and 2.2.10 m = M."
    },
    {
      "type": "footnote",
      "label": "f32",
      "text": "The most recent edition of the standard shall be used."
    },
    {
      "type": "footnote",
      "label": "f33",
      "text": "The criterion shall not apply to products intended for further processing in the food industry."
    },
    {
      "type": "footnote",
      "label": "f34",
      "text": "E. coli is used here as an indicator for the level of hygiene."
    },
    {
      "type": "footnote",
      "label": "f35",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f36",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f37",
      "text": "Only ice creams containing milk ingredients."
    },
    {
      "type": "footnote",
      "label": "f38",
      "text": "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."
    },
    {
      "type": "footnote",
      "label": "f39",
      "text": "1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter."
    },
    {
      "type": "footnote",
      "label": "f40",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f41",
      "text": "The most recent edition of the standard shall be used."
    },
    {
      "type": "footnote",
      "label": "f42",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f43",
      "text": "The most recent edition of the standard shall be used."
    },
    {
      "type": "footnote",
      "label": "f44",
      "text": "n = number of units comprising the sample; c = number of sample units giving values between m and M."
    },
    {
      "type": "footnote",
      "label": "f45",
      "text": "The most recent edition of the standard shall be used."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2007/1441/annex",
    "retrieved_at": "2026-11-01T14:52:33.133775+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}