1、L 322/12 EN Official Journal of the European UnionCOMMISSION REGULATION (EC) No 1441/2007of 5 December 20077.12.2007amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establis
2、hing the EuropeanCommunity,Having regard to Regulation (EC) No 852/2004 of the EuropeanParliament and of the Council of 29 April 2004 on the hygieneof foodstuffs (1), and in particular Article 4(4) thereof,Whereas:(1) Commission Regulation (EC) No 2073/2005 of 15November 2005 on microbiological crit
3、eria for food-stuffs (2) lays down microbiological criteria for certainmicro-organisms and the implementing rules to becomplied with by food business operators when im-plementing the general and specific hygiene measuresreferred to in Article 4 of Regulation (EC) No852/2004. Regulation (EC) No 2073/
4、2005 alsoprovides that food business operators are to ensurethat foodstuffs comply with the relevant microbiologicalcriteria set out in Annex I to that Regulation.(2) Chapters 1 and 2 of Annex I to Regulation (EC) No2073/2005 set out food safety criteria and processhygiene criteria regarding dried i
5、nfant formulae anddried dietary foods for special medical purposesintended for infants below six months of age (driedinfant formulae and dried dietary foods). Part 2.2 ofChapter 2 of that Annex provides that where driedinfant formulae and dried dietary foods are tested andEnterobacteriaceae are dete
6、cted in any of the sampleunits, the batch is to be tested for Enterobacter sakazakiiand Salmonella.(3) On 24 January 2007, the Scientific Panel on BiologicalHazards (BIOHAZ Panel) of the European Food SafetyAuthority (EFSA) issued an opinion with regard toEnterobacteriaceae as indicators of Salmonel
7、la andEnterobacter sakazakii. It concluded that it is not possible(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.to establish a correlation between Enterobacteriaceae andSalmonella, and no universal correlation between Entero-bacteriaceae and E
8、nterobacter sakazakii exists. At individualplant level, a correlation between Enterobacteriaceae andEnterobacter sakazakii may however be established.(4) Therefore the requirement laid down in Regulation(EC) No 2073/2005 as regards the testing of driedinfant formulae and dried dietary foods for Salm
9、onellaand Enterobacter sakazakii where Enterobacteriaceae aredetected in any of the sample units should no longerapply. Part 2.2 of Chapter 2 of Annex I to that Regu-lation should therefore be amended accordingly.(5) In line with the opinion on the microbiological risks ininfant formulae and follow-
10、on formulae issued by theBIOHAZ Panel of EFSA on 9 September 2004, micro-biological criteria on Salmonella and Enterobacteriaceaeshould be laid down for dried follow-on formulae.(6) The BIOHAZ Panel of EFSA issued an opinion on Bacilluscereus and other Bacillus spp. in foodstuffs on 26 and 27January
11、 2005. It concluded that one of the major controlmeasures is to control temperature and to establish asystem based on hazard analysis and critical controlpoint principles. Dehydrated foods, in which thepresence of spores of pathogenic Bacillus spp. isfrequent, might permit the growth of Bacillus cer
12、eusonce rehydrated in warm water. Some dehydratedfoods, including dried infant formulae and dried dietaryfoods, are consumed by potentially fragile consumers. Inline with the EFSA opinion, the numbers of Bacillus cereusspores in dried infant formulae and dried dietary foodsshould be as low as possib
13、le during processing and aprocess hygiene criterion should be laid down inaddition to good practices designed to reduce delaybetween preparation and consumption.(7) Chapter 1 of Annex I to Regulation (EC) No 2073/2005provides for the analytical reference method for staphy-lococcal enterotoxins in ce
14、rtain cheeses, milk powder andwhey powder. That method has been revised by theCommunity reference laboratory for coagulase positivestaphylococci. The reference to that analytical referencemethod should therefore be amended. Chapter 1 ofAnnex I to that Regulation should therefore beamended accordingl
15、y.7.12.2007 EN Official Journal of the European Union L 322/13(8) Chapter 3 of Annex I to Regulation (EC) No 2073/2005sets out sampling rules for carcasses of cattle, pig, sheep,goats and horses for Salmonella analyses. Pursuant tothose rules the sampling area is to cover a minimumof 100 cm2per site
16、 selected. However, neither thenumber of sampling sites nor the minimum total areaof sampling is specified. In order to improve theimplementation of these rules in the Community, it isappropriate to further specify in Regulation (EC) No2073/2005 that the areas most likely to be contaminatedshould be
17、 selected for sampling and that the totalsampling area should be increased. Chapter 3 ofAnnex I to that Regulation should therefore beamended accordingly.(9) In the interests of clarity of Community legislation, it isappropriate to replace Annex I to Regulation (EC) No2073/2005 by the text set out i
18、n the Annex to thisRegulation.(10) The measures provided for in this Regulation are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:Article 1Annex I to Regulation (EC) No 2073/2005 is replaced by thetext in the Annex to this Regu
19、lation.Article 2This Regulation shall enter into force on the 20th day followingits 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 CommissionMarkos KYPRI
20、ANOUMember of the CommissionL 322/14 ENChapter 1.Chapter 2.Official Journal of the European UnionANNEXANNEX IMicrobiological criteria for foodstuffsFood safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Process hygie
21、ne criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207.12.20072.1 Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202.2 Milk and dairy products . .
22、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232.3 Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262.4 Fishery products . . . . . . . . . . . . . . .
23、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272.5 Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Chapter 3. Rules for sampling and preparation of test samples . . . . . .
24、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.1 General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meatpreparations . . . . . .
25、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297.12.2007 EN Official Journal of the European Union L 322/15Chapter1.FoodsafetycriteriaFoodcategoryMicro-organisms/theirtoxins,metabolitesSamplingplan( 1 )Limits( 2 )Analyticalreferen
26、cemethod( 3 )StagewherethecriterionappliesncmM1.1Ready-to-eatfoodsintendedforinfantsandready-to-eatfoodsforspecialmedicalpurposes( 4 )Listeriamonocytogenes100Absencein25gEN/ISO11290-1Productsplacedonthemarketduringtheirshelf-life1.2Ready-to-eatfoodsabletosupportthegrowthofL.monocytogenes,otherthanth
27、oseintendedforinfantsandforspecialmedicalpurposesListeriamonocytogenes50100cfu/g( 5 )EN/ISO11290-2( 6 )Productsplacedonthemarketduringtheirshelf-life50Absencein25g( 7 )EN/ISO11290-1Beforethefoodhaslefttheimmediatecontrolofthefoodbusinessoperator,whohasproducedit1.3Ready-to-eatfoodsunabletosupportthe
28、growthofL.monocytogenes, otherthanthoseintendedforinfantsandforspecialmedicalpurposes( 4 )( 8 )Listeriamonocytogenes50100cfu/gEN/ISO11290-2( 6 )Productsplacedonthemarketduringtheirshelf-life1.4MincedmeatandmeatpreparationsintendedtobeeatenrawSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarke
29、tduringtheirshelf-life1.5MincedmeatandmeatpreparationsmadefrompoultrymeatintendedtobeeatencookedSalmonella50From1.1.2006Absencein10gFrom1.1.2010Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.6MincedmeatandmeatpreparationsmadefromotherspeciesthanpoultryintendedtobeeatencookedSa
30、lmonella50Absencein10gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.7Mechanicallyseparatedmeat(MSM)( 9 )Salmonella50Absencein10gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.8Meatproductsintendedtobeeatenraw,excludingproductswherethemanufacturingprocessorthecompositionofthepr
31、oductwilleliminatethesalmonellariskSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-lifeL 322/16 EN Official Journal of the European Union 7.12.2007FoodcategoryMicro-organisms/theirtoxins,metabolitesSamplingplan( 1 )Limits( 2 )Analyticalreferencemethod( 3 )Stagewherethecri
32、terionappliesncmM1.9MeatproductsmadefrompoultrymeatintendedtobeeatencookedSalmonella50From1.1.2006Absencein10gFrom1.1.2010Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.10GelatineandcollagenSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.11Che
33、eses,butterandcreammadefromrawmilkormilkthathasundergonealowerheattreatmentthanpasteurisation( 10)Salmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.12MilkpowderandwheypowderSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.13Icecream( 1
34、1),excludingproductswherethemanufacturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.14Eggproducts,excludingproductswherethemanufacturingprocessorthecompositionoftheproductwilleliminatethesalmonell
35、ariskSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.15Ready-to-eatfoodscontainingrawegg,excludingproductswherethemanufacturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonella50Absencein25go r mlEN/ISO6579Productsplacedonthemarketduringthe
36、irshelf-life1.16CookedcrustaceansandmolluscanshellfishSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.17Livebivalvemolluscsandliveechinoderms,tunicatesandgastropodsSalmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.18Sproutedseeds(read
37、y-to-eat)( 12)Salmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life7.12.2007 EN Official Journal of the European Union L 322/17FoodcategoryMicro-organisms/theirtoxins,metabolitesSamplingplan( 1 )Limits( 2 )Analyticalreferencemethod( 3 )StagewherethecriterionappliesncmM1.19
38、Precutfruitandvegetables(ready-to-eat)Salmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.20Unpasteurisedfruitandvegetablejuices(ready-to-eat)Salmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.21Cheeses,milkpowderandwheypowder,asreferredto
39、inthecoagulase-positivestaphylococcicriteriainChapter2.2ofthisAnnexStaphylococcalentero-toxins50Notdetectedin25gEuropeanscreeningmethodoftheCRLforcoagulasepositivestaphylococci( 13)Productsplacedonthemarketduringtheirshelf-life1.22Driedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesinten
40、dedforinfantsbelowsixmonthsofageSalmonella300Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.23Driedfollow-onformulaeSalmonella300Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.24Driedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedfori
41、nfantsbelowsixmonthsofage( 14)Enterobactersakazakii300Absencein10gISO/TS22964Productsplacedonthemarketduringtheirshelf-life1.25Livebivalvemolluscsandliveechinoderms,tunicatesandgastropodsE.coli( 15)1( 16)0230MPN/100go ffleshandintra-valvularliquidISOTS16649-3Productsplacedonthemarketduringtheirshelf
42、-life1.26Fisheryproductsfromfishspeciesassociatedwithahighamountofhistidine( 17)Histamine9( 18)2100 mg/kg200 mg/kgHPLC( 19)Productsplacedonthemarketduringtheirshelf-lifeL 322/18 EN Official Journal of the European Union 7.12.2007FoodcategoryMicro-organisms/theirtoxins,metabolitesSamplingplan( 1 )Lim
43、its( 2 )Analyticalreferencemethod( 3 )StagewherethecriterionappliesncmM1.27Fisheryproductswhichhaveundergoneenzymematurationtreatmentinbrine,manufacturedfromfishspeciesassociatedwitha highamountofhistidine( 17)Histamine92200 mg/kg400 mg/kgHPLC( 19)Productsplacedonthemarketduringtheirshelf-life( 1 )
44、n=numberofunitscomprisingthesample;c=numberofsampleunitsgivingvaluesbetweenmandM.( 2 ) Forpoints1.1-1.25m=M.( 3 ) Themostrecenteditionofthestandardshallbeused.( 4 ) Regulartestingagainstthecriterionisnotrequiredinnormalcircumstancesforthefollowingready-to-eatfoods:thosewhichhavereceivedheattreatment
45、orotherprocessingeffectivetoeliminateL.monocytogenes,whenrecontaminationisnotpossibleafterthistreatment(forexample,productsheattreatedintheirfinalpackage),fresh,uncutandunprocessedvegetablesandfruits,excludingsproutedseeds,bread,biscuitsandsimilarproducts,bottledorpackedwaters,softdrinks,beer,cider,
46、wine,spiritsandsimilarproducts,sugar,honeyandconfectionery,includingcocoaandchocolateproducts,livebivalvemolluscs.( 5 ) Thiscriterionshallapplyifthemanufacturerisabletodemonstrate,tothesatisfactionofthecompetentauthority,thattheproductwillnotexceedthelimit100cfu/gthroughouttheshelf-life.Theoperatorm
47、ayfixintermediatelimitsduringtheprocessthatmustbelowenoughtoguaranteethatthelimitof100cfu/gisnotexceededattheendofshelf-life.( 6 ) 1mlofinoculumisplatedonaPetridishof140mmdiameteroronthreePetridishesof90mmdiameter.( 7 ) Thiscriterionshallapplytoproductsbeforetheyhavelefttheimmediatecontroloftheprodu
48、cingfoodbusinessoperator,whenheisnotabletodemonstrate,tothesatisfactionofthecompetentauthority,thattheproductwillnotexceedthelimitof100cfu/gthroughouttheshelf-life.( 8 ) ProductswithpH4,4ora w0,92,productswithpH5,0anda w0,94,productswithashelf-lifeoflessthanfivedaysshallbeautomaticallyconsideredtobe
49、longtothiscategory.Othercategoriesofproductscanalsobelongtothiscategory,subjecttoscientificjustification.( 9 ) Thiscriterionshallapplytomechanicallyseparatedmeat(MSM)producedwiththetechniquesreferredtoinparagraph3o f ChapterIIIofSectionVo f AnnexIIItoRegulation(EC)No853/2004oftheEuropeanParliamentandoftheCouncil.( 10)Excludingproductswhenthemanufacturercandemonstratetothesatisfactionofthecompetentauthoritiesthat,duetotheripeningtimeanda woftheproductwhereappropriate,thereisnosalmonellarisk.( 11)Onlyicecreamscontainingmilkingredients.( 12)Preliminarytestingofthebatchofseedsbeforestar
