EC-2073-2005微生物限量标准

Thisdocumentismeantpurelyasadocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents

►BCOMMISSIONREGULATION(EC)No2073/2005

of15November2005

onmicrobiologicalcriteriaforfoodstuffs

(TextwithEEArelevance)

(OJL338,22.12.2005,p.1)

Amendedby:

►M1CommissionRegulation(EC)No1441/2007of5December2007

Correctedby:►C1Corrigendum,OJL278,10.10.2006,p.32(2073/2005)►C2Corrigendum,OJL283,14.10.2006,p.62(2073/2005)

OfficialJournalNo

pagedateL322

12

7.12.2007

2005R2073—EN—27.12.2007—001.001—2

▼BCOMMISSIONREGULATION(EC)No2073/2005

of15November2005

onmicrobiologicalcriteriaforfoodstuffs

(TextwithEEArelevance)

THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No852/2004oftheEuropeanParliamentandoftheCouncilof29April2004onthehygieneoffoodstuffs(1),andinparticularArticles4(4)and12thereof,Whereas:

(1)

Ahighlevelofprotectionofpublichealthisoneofthefunda-mentalobjectivesoffoodlaw,aslaiddowninRegulation(EC)No178/2002oftheEuropeanParliamentandoftheCouncilof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety(2).Microbiologicalhazardsinfoodstuffsformamajorsourceoffood-bornediseasesinhumans.

Foodstuffsshouldnotcontainmicro-organismsortheirtoxinsormetabolitesinquantitiesthatpresentanunacceptableriskforhumanhealth.

Regulation(EC)No178/2002laysdowngeneralfoodsafetyrequirements,accordingtowhichfoodmustnotbeplacedonthemarketifitisunsafe.Foodbusinessoperatorshaveanobli-gationtowithdrawunsafefoodfromthemarket.Inordertocontributetotheprotectionofpublichealthandtopreventdifferinginterpretations,itisappropriatetoestablishharmonisedsafetycriteriaontheacceptabilityoffood,inparticularasregardsthepresenceofcertainpathogenicmicro-organisms.

Microbiologicalcriteriaalsogiveguidanceontheacceptabilityoffoodstuffsandtheirmanufacturing,handlinganddistributionprocesses.TheuseofmicrobiologicalcriteriashouldformanintegralpartoftheimplementationofHACCP-basedproceduresandotherhygienecontrolmeasures.

Thesafetyoffoodstuffsismainlyensuredbyapreventiveapproach,suchasimplementationofgoodhygienepracticeandapplicationofproceduresbasedonhazardanalysisandcriticalcontrolpoint(HACCP)principles.MicrobiologicalcriteriacanbeusedinvalidationandverificationofHACCPproceduresandotherhygienecontrolmeasures.Itisthereforeappropriatetosetmicrobiologicalcriteriadefiningtheacceptabilityoftheprocesses,andalsofoodsafetymicrobiologicalcriteriasettingalimitabovewhichafoodstuffshouldbeconsideredunacceptablycontaminatedwiththemicro-organismsforwhichthecriteriaareset.

AccordingtoArticle4ofRegulation(EC)No852/2004,foodbusinessoperatorsaretocomplywithmicrobiologicalcriteria.Thisshouldincludetestingagainstthevaluessetforthecriteriathroughthetakingofsamples,theconductofanalysesandtheimplementationofcorrectiveactions,inaccordancewithfoodlawandtheinstructionsgivenbythecompetentauthority.Itisthereforeappropriatetolaydownimplementingmeasures

(2)

(3)

(4)

(5)

(6)

(1)OJL139,30.4.2004,p.1,correctedbyOJL226,25.6.2004,p.3.

(2)OJL31,1.2.2002,p.1.RegulationasamendedbyRegulation(EC)No12/2003(OJL245,29.9.2003,p.4).

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▼Bconcerningtheanalyticalmethods,including,wherenecessary,themeasurementuncertainty,thesamplingplan,themicrobio-logicallimits,thenumberofanalyticalunitsthatshouldcomplywiththeselimits.Furthermore,itisappropriatetolaydownimplementingmeasuresconcerningthefoodstufftowhichthecriterionapplies,thepointsofthefoodchainwherethecriterionapplies,aswellastheactionstobetakenwhenthecriterionisnotmet.Themeasurestobetakenbythefoodbusinessoperatorsinordertoensurecompliancewithcriteriadefiningtheacceptabilityofaprocessmayinclude,amongotherthings,controlsofrawmaterials,hygiene,temperatureandshelf-lifeoftheproduct.

(7)

Regulation(EC)No882/2004oftheEuropeanParliamentandoftheCouncilof29April2004onofficialcontrolsperformedtoensuretheverificationofcompliancewithfeedandfoodlaw,animalhealthandanimalwelfarerules(1)requirestheMemberStatestoensurethatofficialcontrolsarecarriedoutregularly,onariskbasisandwithappropriatefrequency.Thosecontrolsshouldtakeplaceatappropriatestagesoftheproduction,processinganddistributionoffoodtoensurethatthecriterialaiddowninthisRegulationarecompliedwithbyfoodbusinessoperators.

TheCommunicationfromtheCommissionontheCommunityStrategyforsettingmicrobiologicalcriteriaforfoodstuffs(2)describesthestrategytolaydownandrevisethecriteriainCommunitylegislation,aswellastheprinciplesforthedevel-opmentandapplicationofthecriteria.Thisstrategyshouldbeappliedwhenmicrobiologicalcriteriaarelaiddown.

TheScientificCommitteeonVeterinaryMeasuresrelatingtoPublicHealth(SCVPH)issuedanopinionon23September1999ontheevaluationofmicrobiologicalcriteriaforfoodproductsofanimaloriginforhumanconsumption.Ithighlightedtherelevanceofbasingmicrobiologicalcriteriaonformalriskassessmentandinternationallyapprovedprinciples.Theopinionrecommendsthatmicrobiologicalcriteriashouldberelevantandeffectiveinrelationtoconsumerhealthprotection.TheSCVPHproposed,whileawaitingformalriskassessments,certainrevisedcriteriaasinterimmeasures.

TheSCVPHissuedatthesametimeaseparateopiniononListeriamonocytogenes.ThatopinionrecommendedthatitbeanobjectivetokeeptheconcentrationofListeriamonocytogenesinfoodbelow100cfu/g.TheScientificCommitteeonFood(SCF)agreedwiththeserecommendationsinitsopinionof22June2000.

TheSCVPHadoptedanopiniononVibriovulnificusandVibrio-parahaemolyticuson19and20September2001.ItconcludedthatcurrentlyavailablescientificdatadonotsupportsettingspecificcriteriaforpathogenicV.vulnificusandparahaemo-lyticusinseafood.However,itrecommendedthatcodesofpracticeshouldbeestablishedtoensurethatgoodhygienepracticehasbeenapplied.

TheSCVPHissuedanopiniononNorwalk-likeviruses(NLVs,noroviruses)on30-31January2002.Inthatopinionitconcludedthattheconventionalfaecalindicatorsareunreliablefordemon-stratingthepresenceorabsenceofNLVsandthattherelianceonfaecalbacterialindicatorremovalfordeterminingshellfishpuri-ficationtimesisunsafepractice.ItalsorecommendedusingE.

(8)

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(1)OJL165,30.4.2004,p.1,correctedbyOJL191,28.5.2004,p.1.

(2)SANCO/1252/2001DiscussionpaperonstrategyforsettingmicrobiologicalcriteriaforfoodstuffsinCommunitylegislation,p.34.

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▼Bcoliratherthanfaecalcoliformstoindicatefaecalcontaminationinshellfishharvestingareas,whenapplyingbacterialindicators.

(13)

On27February2002theSCFadoptedanopiniononspecifi-cationsforgelatineintermsofconsumerhealth.ItconcludedthatthemicrobiologicalcriteriasetinChapter4ofAnnexIItoCouncilDirective92/118/EECof17December1992layingdownanimalhealthandpublichealthrequirementsgoverningtradeinandimportsintotheCommunityofproductsnotsubjecttothesaidrequirementslaiddowninspecificCommunityrulesreferredtoinAnnexA(I)toDirective/662/EECand,asregardspathogens,toDirective90/425/EEC(1)intermsofconsumerhealthwereexcessive,andconsidereditsufficienttoapplyamandatorymicrobiologicalcriterionforsalmonellaonly.

TheSCVPHissuedanopiniononverotoxigenicE.coli(VTEC)infoodstuffson21and22January2003.Initsopinionitconcludedthatapplyinganend-productmicrobiologicalstandardforVTECO157isunlikelytodelivermeaningfulreductionsintheassociatedriskfortheconsumers.However,microbiologicalguidelinesaimedatreducingthefaecalcontam-inationalongthefoodchaincancontributetoareductioninpublichealthrisks,includingVTEC.TheSCVPHidentifiedthefollowingfoodcategorieswhereVTECrepresentsahazardtopublichealth:raworundercookedbeefandpossiblymeatfromotherruminants,mincedmeatandfermentedbeefandproductsthereof,rawmilkandrawmilkproducts,freshproduce,inparticularsproutedseeds,andunpasteurisedfruitandvegetablejuices.

On26and27March2003theSCVPHadoptedanopiniononstaphylococcalenterotoxinsinmilkproducts,particularlyincheeses.Itrecommendedrevisingthecriteriaforcoagulase-positivestaphylococciincheeses,inrawmilkintendedforprocessingandinpowderedmilk.Inaddition,criteriaforstaphy-lococcalenterotoxinsshouldbelaiddownforcheesesandpowderedmilk.

TheSCVPHadoptedanopiniononsalmonellaeinfoodstuffson14and15April2003.Accordingtotheopinion,foodcategoriespossiblyposingahighrisktopublichealthincluderawmeatandsomeproductsintendedtobeeatenraw,rawandundercookedproductsofpoultrymeat,eggsandproductscontainingraweggs,unpasteurisedmilkandsomeproductsthereof.Sproutedseedsandunpasteurisedfruitjuicesarealsoofconcern.Itrecom-mendedthatthedecisionontheneedformicrobiologicalcriteriashouldbetakenonthebasisofitsabilitytoprotecttheconsumersanditsfeasibility.

TheScientificPanelonBiologicalHazards(BIOHAZPanel)oftheEuropeanFoodSafetyAuthority(EFSA)issuedanopiniononthemicrobiologicalrisksininfantformulaeandfollow-onformulaeon9September2004.ItconcludedthatSalmonellaandEnterobactersakazakiiarethemicro-organismsofgreatestconcernininfantformulae,formulaeforspecialmedicalpurposesandfollow-onformulae.Thepresenceofthesepathogensconstitutesaconsiderableriskifconditionsafterreconstitutionpermitmultiplication.Enterobacteriaceae,whicharemoreoftenpresent,couldbeusedasanindicatorforrisk.MonitoringandtestingofEnterobacteriaceaewasrecommendedinboththemanufacturingenvironmentandthefinishedproductbytheEFSA.However,besidespathogenicspeciesthefamilyEntero-bacteriaceaeincludesalsoenvironmentalspecies,whichoftenappearinthefoodmanufacturingenvironmentwithoutposing

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(1)OJL62,15.3.1993,p.49.DirectiveaslastamendedbyCommissionRegu-lation(EC)No445/2004(OJL72,11.3.2004,p.60).

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▼Banyhealthhazard.Therefore,thefamilyEnterobacteriaceaecanbeusedforroutinemonitoring,andiftheyarepresenttestingofspecificpathogenscanbestarted.

(18)

Internationalguidelinesformicrobiologicalcriteriainrespectofmanyfoodstuffshavenotyetbeenestablished.However,theCommissionhasfollowedtheCodexAlimentariusguideline‘Principlesfortheestablishmentandapplicationofmicrobio-logicalcriteriaforfoodsCAC/GL21—1997’andinaddition,theadviceoftheSCVPHandtheSCFinlayingdownmicro-biologicalcriteria.ExistingCodexspecificationsinrespectofdriedmilkproducts,foodsforinfantsandchildrenandthehistaminecriterionforcertainfishandfisheryproductshavebeentakenaccount.TheadoptionofCommunitycriteriashouldbenefittradebyprovidingharmonisedmicrobiologicalrequirementsforfoodstuffsandreplacingnationalcriteria.ThemicrobiologicalcriteriasetforcertaincategoriesoffoodofanimalorigininDirectivesthatwererepealedbyDirective2004/41/ECoftheEuropeanParliamentandoftheCouncilof21April2004repealingcertainDirectivesconcerningfoodhygieneandhealthconditionsfortheproductionandplacingonthemarketofcertainproductsofanimaloriginintendedforhumanconsumptionandamendingCouncilDirectives/662/EECand92/118/EECandCouncilDecision95/408/EC(1)shouldberevisedandcertainnewcriteriasetinthelightofthescientificadvice.

ThemicrobiologicalcriterialaiddowninCommissionDecision93/51EECof15December1992onthemicrobiologicalcriteriaapplicabletotheproductionofcookedcrustaceansandmolluscanshellfish(2)areincorporatedinthisRegulation.ItisthereforeappropriatetorepealthatDecision.SinceCommissionDecision2001/471/ECof8June2001layingdownrulesfortheregularchecksonthegeneralhygienecarriedoutbytheoperatorsinestablishmentsaccordingtoDirective/433/EEConhealthconditionsfortheproductionandmarketingoffreshmeatandDirective71/118/EEConhealthproblemsaffectingtheproductionandplacingonthemarketoffreshpoultrymeat(3)isrepealedwitheffectfromthe1January2006,itisappropriatetoincorporatemicrobiologicalcriteriasetforcarcasesinthisRegu-lation.

Theproducerormanufacturerofafoodproducthastodecidewhethertheproductisreadytobeconsumedassuch,withouttheneedtocookorotherwiseprocessitinordertoensureitssafetyandcompliancewiththemicrobiologicalcriteria.AccordingtoArticle3ofDirective2000/13/ECoftheEuropeanParliamentandoftheCouncilof20March2000ontheapproximationofthelawsoftheMemberStatesrelatingtothelabelling,presen-tationandadvertisingoffoodstuffs(4),theinstructionsforuseofafoodstuffarecompulsoryonthelabellingwhenitwouldbeimpossibletomakeappropriateuseofthefoodstuffintheabsenceofsuchinstructions.Suchinstructionsshouldbetakenintoaccountbyfoodbusinessoperatorswhendecidingappro-priatesamplingfrequenciesforthetestingagainstmicrobiologicalcriteria.

Samplingoftheproductionandprocessingenvironmentcanbeausefultooltoidentifyandpreventthepresenceofpathogenicmicro-organismsinfoodstuffs.

(19)

(20)

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(1)OJL157,30.4.2004,p.33,correctedbyOJL195,2.6.2004,p.12.(2)OJL13,21.1.1993,p.11.

(3)OJL165,21.6.2001,p.48.DecisionasamendedbyDecision2004/379/EC(OJL144,30.4.2004,p.1).4()OJL109,6.5.2000,p.29.DirectiveaslastamendedbyDirective2003//EC(OJL308,25.11.2003,p.15).

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▼B(23)

FoodbusinessoperatorsshoulddecidethemselvesthenecessarysamplingandtestingfrequenciesaspartoftheirproceduresbasedonHACCPprinciplesandotherhygienecontrolprocedures.However,itmaybenecessaryincertaincasestosetharmonisedsamplingfrequenciesatCommunitylevel,particularlyinordertoensurethesamelevelofcontrolstobeperformedthroughouttheCommunity.

Testresultsaredependentontheanalyticalmethodused,andthereforeagivenreferencemethodshouldbeassociatedwitheachmicrobiologicalcriterion.However,foodbusinessoperatorsshouldhavethepossibilitytouseanalyticalmethodsotherthanthereferencemethods,inparticularmorerapidmethods,aslongastheuseofthesealternativemethodsprovidesequivalentresults.Moreover,asamplingplanneedstobedefinedforeachcriterioninordertoensureharmonisedimple-mentation.Itisneverthelessnecessarytoallowtheuseofothersamplingandtestingschemes,includingtheuseofalternativeindicatororganisms,onconditionthattheseschemesprovideequivalentguaranteesoffoodsafety.

Trendsintestresultsshouldbeanalysed,astheyareabletorevealunwanteddevelopmentsinthemanufacturingprocessenablingthefoodbusinessoperatortotakecorrectiveactionsbeforetheprocessisoutofcontrol.

ThemicrobiologicalcriteriasetinthisRegulationshouldbeopentoreviewandrevisedorsupplemented,ifappropriate,inordertotakeintoaccountdevelopmentsinthefieldoffoodsafetyandfoodmicrobiology.Thisincludesprogressinscience,technologyandmethodology,changesinprevalenceandcontaminationlevels,changesinthepopulationofvulnerableconsumers,aswellasthepossibleoutputsfromriskassessments.

Inparticular,criteriaforpathogenicvirusesinlivebivalvemolluscsshouldbeestablishedwhentheanalyticalmethodsaredevelopedsufficiently.Thereisaneedfordevelopmentofreliablemethodsforothermicrobialhazardstoo,e.g.Vibrioparahaemolyticus.

Ithasbeendemonstratedthattheimplementationofcontrolprogrammescanmarkedlycontributetoareductionoftheprevalenceofsalmonellainproductionanimalsandproductsthereof.ThepurposeofRegulation(EC)No2160/2003oftheEuropeanParliamentandoftheCouncilof17November2003onthecontrolofsalmonellaandotherspecifiedfood-bornezoonoticagents(1)istoensurethatproperandeffectivemeasuresaretakentocontrolsalmonellaatrelevantstagesofthefoodchain.Criteriaformeatandproductsthereofshouldtakeintoaccounttheexpectedimprovementinthesalmonellasituationatthelevelofprimaryproduction.

Forcertainfoodsafetycriteria,itisappropriatetogranttheMemberStatesatransitionalderogation,enablingthemtocomplywithlessstringentcriteriabutprovidedthatthefoodstuffswouldonlybemarketedonthenationalmarket.TheMemberStatesshouldnotifytheCommissionandotherMemberStateswherethistransitionalderogationisused.

ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheStandingCommitteeontheFoodChainandAnimalHealth,

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(1)OJL325,12.12.2003,p.1.

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▼BHASADOPTEDTHISREGULATION:

Article1

Subject-matterandscope

ThisRegulationlaysdownthemicrobiologicalcriteriaforcertainmicro-organismsandtheimplementingrulestobecompliedwithbyfoodbusinessoperatorswhenimplementingthegeneralandspecifichygienemeasuresreferredtoinArticle4ofRegulation(EC)No852/2004.ThecompetentauthorityshallverifycompliancewiththerulesandcriterialaiddowninthisRegulationinaccordancewithRegulation(EC)No882/2004,withoutprejudicetoitsrighttoundertakefurthersamplingandanalysesforthepurposeofdetectingandmeasuringothermicro-organisms,theirtoxinsormetabolites,eitherasaverificationofprocesses,forfoodsuspectedofbeingunsafe,orinthecontextofariskanalysis.

ThisRegulationshallapplywithoutprejudicetootherspecificrulesforthecontrolofmicro-organismslaiddowninCommunitylegislationandinparticularthehealthstandardsforfoodstuffslaiddowninRegulation(EC)No853/2004oftheEuropeanParliamentandoftheCouncil(1),therulesonparasiteslaiddownunderRegulation(EC)No8/2004oftheEuropeanParliamentandoftheCouncil(2)andthemicrobiologicalcriterialaiddownunderCouncilDirective80/777/EEC(3).

Article2Definitions

Thefollowingdefinitionsshallapply:

(a)‘micro-organisms’meansbacteria,viruses,yeasts,moulds,algae,

parasiticprotozoa,microscopicparasitichelminths,andtheirtoxinsandmetabolites;(b)‘microbiologicalcriterion’meansacriteriondefiningtheaccept-abilityofaproduct,abatchoffoodstuffsoraprocess,basedontheabsence,presenceornumberofmicro-organisms,and/oronthequantityoftheirtoxins/metabolites,perunit(s)ofmass,volume,areaorbatch;(c)‘foodsafetycriterion’meansacriteriondefiningtheacceptabilityof

aproductorabatchoffoodstuffapplicabletoproductsplacedonthemarket;(d)‘processhygienecriterion’acriterionindicatingtheacceptablefunc-tioningoftheproductionprocess.Suchacriterionisnotapplicabletoproductsplacedonthemarket.Itsetsanindicativecontaminationvalueabovewhichcorrectiveactionsarerequiredinordertomaintainthehygieneoftheprocessincompliancewithfoodlaw;(e)‘batch’meansagrouporsetofidentifiableproductsobtainedfrom

agivenprocessunderpracticallyidenticalcircumstancesandproducedinagivenplacewithinonedefinedproductionperiod;(f)‘shelf-life’meanseithertheperiodcorrespondingtotheperiod

precedingthe‘useby’ortheminimumdurabilitydate,asdefinedrespectivelyinArticles9and10ofDirective2000/13/EC;(g)‘ready-to-eatfood’meansfoodintendedbytheproducerorthe

manufacturerfordirecthumanconsumptionwithouttheneedforcookingorotherprocessingeffectivetoeliminateorreducetoanacceptablelevelmicro-organismsofconcern;

(1)OJL139,30.4.2004,p.55,correctedbyOJL226,25.6.2004,p.22.(2)OJL139,30.4.2004,p.206,correctedbyOJL226,25.6.2004,p.83.(3)OJL229,30.8.1980,p.1.

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▼B(h)‘foodintendedforinfants’meansfoodspecificallyintendedfor

infants,asdefinedinCommissionDirective91/321/EEC(1);(i)‘foodintendedforspecialmedicalpurposes’meansdietaryfoodfor

specialmedicalpurposes,asdefinedinCommissionDirective1999/21/EC(2);(j)‘sample’meansasetcomposedofoneorseveralunitsoraportion

ofmatterselectedbydifferentmeansinapopulationorinanimportantquantityofmatter,whichisintendedtoprovideinfor-mationonagivencharacteristicofthestudiedpopulationormatterandtoprovideabasisforadecisionconcerningthepopulationormatterinquestionorconcerningtheprocesswhichhasproducedit;(k)‘representativesample’meansasampleinwhichthecharacteristics

ofthebatchfromwhichitisdrawnaremaintained.Thisisinparticularthecaseofasimplerandomsamplewhereeachoftheitemsorincrementsofthebatchhasbeengiventhesameprob-abilityofenteringthesample;(l)‘compliancewithmicrobiologicalcriteria’meansobtainingsatis-factoryoracceptableresultssetinAnnexIwhentestingagainstthevaluessetforthecriteriathroughthetakingofsamples,theconductofanalysesandtheimplementationofcorrectiveaction,inaccordancewithfoodlawandtheinstructionsgivenbythecompetentauthority.

Article3Generalrequirements

1.FoodbusinessoperatorsshallensurethatfoodstuffscomplywiththerelevantmicrobiologicalcriteriasetoutinAnnexI.Tothisendthefoodbusinessoperatorsateachstageoffoodproduction,processinganddistribution,includingretail,shalltakemeasures,aspartoftheirproceduresbasedonHACCPprinciplestogetherwiththeimplemen-tationofgoodhygienepractice,toensurethefollowing:

(a)thatthesupply,handlingandprocessingofrawmaterialsandfood-stuffsundertheircontrolarecarriedoutinsuchawaythattheprocesshygienecriteriaaremet,(b)thatthefoodsafetycriteriaapplicablethroughouttheshelf-lifeof

theproductscanbemetunderreasonablyforeseeableconditionsofdistribution,storageanduse.2.Asnecessary,thefoodbusinessoperatorsresponsibleforthemanufactureoftheproductshallconductstudiesinaccordancewithAnnexIIinordertoinvestigatecompliancewiththecriteriathroughouttheshelf-life.Inparticular,thisappliestoready-to-eatfoodsthatareabletosupportthegrowthofListeriamonocytogenesandthatmayposeaListeriamonocytogenesriskforpublichealth.

Foodbusinessesmaycollaborateinconductingthosestudies.GuidelinesforconductingthosestudiesmaybeincludedintheguidestogoodpracticereferredtoinArticle7ofRegulation(EC)No852/2004.

Article4

Testingagainstcriteria

1.FoodbusinessoperatorsshallperformtestingasappropriateagainstthemicrobiologicalcriteriasetoutinAnnexI,whentheyare

(1)OJL175,4.7.1991,p.35.(2)OJL91,7.4.1999,p.29.

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▼BvalidatingorverifyingthecorrectfunctioningoftheirproceduresbasedonHACCPprinciplesandgoodhygienepractice.

2.Foodbusinessoperatorsshalldecidetheappropriatesamplingfrequencies,exceptwhereAnnexIprovidesforspecificsamplingfrequencies,inwhichcasethesamplingfrequencyshallbeatleastthatprovidedforinAnnexI.FoodbusinessoperatorsshallmakethisdecisioninthecontextoftheirproceduresbasedonHACCPprinciplesandgoodhygienepractice,takingintoaccounttheinstructionsforuseofthefoodstuff.

Thefrequencyofsamplingmaybeadaptedtothenatureandsizeofthefoodbusinesses,providedthatthesafetyoffoodstuffswillnotbeendangered.

Article5

Specificrulesfortestingandsampling

1.TheanalyticalmethodsandthesamplingplansandmethodsinAnnexIshallbeappliedasreferencemethods.

2.Samplesshallbetakenfromprocessingareasandequipmentusedinfoodproduction,whensuchsamplingisnecessaryforensuringthatthecriteriaaremet.InthatsamplingtheISOstandard18593shallbeusedasareferencemethod.

Foodbusinessoperatorsmanufacturingready-to-eatfoods,whichmayposeaListeriamonocytogenesriskforpublichealth,shallsampletheprocessingareasandequipmentforListeriamonocytogenesaspartoftheirsamplingscheme.

FoodbusinessoperatorsmanufacturingdriedinfantformulaeordriedfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthswhichposeanEnterobactersakazakiiriskshallmonitortheprocessingareasandequipmentforEnterobacteriaceaeaspartoftheirsamplingscheme.

3.ThenumberofsampleunitsofthesamplingplanssetoutinAnnexImaybereducedifthefoodbusinessoperatorcandemonstratebyhistoricaldocumentationthathehaseffectiveHACCP-basedprocedures.

4.Iftheaimofthetestingistospecificallyassesstheacceptabilityofacertainbatchoffoodstuffsoraprocess,thesamplingplanssetoutinAnnexIshallberespectedasaminimum.

5.Foodbusinessoperatorsmayuseothersamplingandtestingprocedures,iftheycandemonstratetothesatisfactionofthecompetentauthoritythattheseproceduresprovideatleastequivalentguarantees.Thoseproceduresmayincludeuseofalternativesamplingsitesanduseoftrendanalyses.

Testingagainstalternativemicro-organismsandrelatedmicrobiologicallimitsaswellastestingofanalytesotherthanmicrobiologicalonesshallbeallowedonlyforprocesshygienecriteria.

TheuseofalternativeanalyticalmethodsisacceptablewhenthemethodsarevalidatedagainstthereferencemethodinAnnexIandifaproprietarymethod,certifiedbyathirdpartyinaccordancewiththeprotocolsetoutinEN/ISOstandard16140orotherinternationallyacceptedsimilarprotocols,isused.

Ifthefoodbusinessoperatorwishestouseanalyticalmethodsotherthanthosevalidatedandcertifiedasdescribedinparagraph3themethodsshallbevalidatedaccordingtointernationallyacceptedprotocolsandtheiruseauthorisedbythecompetentauthority.

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▼BArticle6

Labellingrequirements

1.WhentherequirementsforSalmonellainmincedmeat,meatpreparationsandmeatproductsintendedtobeeatencookedofallspeciessetdowninAnnexIarefulfilled,thebatchesofthoseproductsplacedonthemarketmustbeclearlylabelledbythemanu-facturerinordertoinformtheconsumeroftheneedforthoroughcookingpriortoconsumption.

2.Asfrom1January2010labellingasreferredtoinparagraph1inrespectofmincedmeat,meatpreparationsandmeatproductsmadefrompoultrymeatwillnolongerberequired.

Article7Unsatisfactoryresults

1.WhentheresultsoftestingagainstthecriteriasetoutinAnnexIareunsatisfactory,thefoodbusinessoperatorsshalltakethemeasureslaiddowninparagraphs2to4ofthisArticletogetherwithothercorrectiveactionsdefinedintheirHACCP-basedproceduresandotheractionsnecessarytoprotectthehealthofconsumers.

Inaddition,theyshalltakemeasurestofindthecauseoftheunsatis-factoryresultsinordertopreventtherecurrenceoftheunacceptablemicrobiologicalcontamination.Thosemeasuresmayincludemodifi-cationstotheHACCP-basedproceduresorotherfoodhygienecontrolmeasuresinplace.

2.WhentestingagainstfoodsafetycriteriasetoutinChapter1ofAnnexIprovidesunsatisfactoryresults,theproductorbatchoffood-stuffsshallbewithdrawnorrecalledinaccordancewithArticle19ofRegulation(EC)No178/2002.However,productsplacedonthemarket,whicharenotyetatretaillevelandwhichdonotfulfilthefoodsafetycriteria,maybesubmittedtofurtherprocessingbyatreatmentelimi-natingthehazardinquestion.Thistreatmentmayonlybecarriedoutbyfoodbusinessoperatorsotherthanthoseatretaillevel.

Thefoodbusinessoperatormayusethebatchforpurposesotherthanthoseforwhichitwasoriginallyintended,providedthatthisusedoesnotposeariskforpublicoranimalhealthandprovidedthatthisusehasbeendecidedwithintheproceduresbasedonHACCPprinciplesandgoodhygienepracticeandauthorisedbythecompetentauthority.3.Abatchofmechanicallyseparatedmeat(MSM)producedwiththetechniquesreferredtoinChapterIII,paragraph3,inSectionVofAnnexIIItoRegulation(EC)No853/2004,withunsatisfactoryresultsinrespectoftheSalmonellacriterion,maybeusedinthefoodchainonlytomanufactureheat-treatedmeatproductsinestablishmentsapprovedinaccordancewithRegulation(EC)No853/2004.

4.IntheeventofunsatisfactoryresultsasregardsprocesshygienecriteriatheactionslaiddowninAnnexI,Chapter2shallbetaken.

Article8

Transitionalderogation

1.Atransitionalderogationisgranteduntil31December2009atthelatestpursuanttoArticle12ofRegulation(EC)No852/2004asregardscompliancewiththevaluesetinAnnexItothisRegulationforSalmonellainmincedmeat,meatpreparationsandmeatproductsintendedtobeeatencookedplacedonthenationalmarketofaMemberState.

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▼B2.TheMemberStatesusingthispossibilityshallnotifytheCommissionandotherMemberStatesthereof.TheMemberStateshall:(a)guaranteethattheappropriatemeans,includinglabellinganda

specialmark,whichcannotbeconfusedwiththeidentificationmarkprovidedforinAnnexII,SectionItoRegulation(EC)No853/2004,areinplacetoensurethatthederogationappliesonlytotheproductsconcernedwhenplacedonthedomesticmarket,andthatproductsdispatchedforintra-CommunitytradecomplywiththecriterialaiddowninAnnexI;(b)providethattheproductstowhichsuchtransitionalderogation

appliesshallbeclearlylabelledthattheymustbethoroughlycookedpriortoconsumption;(c)undertakethatwhentestingagainsttheSalmonellacriterion

pursuanttoArticle4,andfortheresulttobeacceptableasregardssuchtransitionalderogation,nomorethanoneoutoffivesampleunitsshallbefoundtobepositive.

Article9Analysesoftrends

Foodbusinessoperatorsshallanalysetrendsinthetestresults.Whentheyobserveatrendtowardsunsatisfactoryresults,theyshalltakeappropriateactionswithoutunduedelaytoremedythesituationinordertopreventtheoccurrenceofmicrobiologicalrisks.

Article10Review

ThisRegulationshallbereviewedtakingintoaccountprogressinscience,technologyandmethodology,emergingpathogenicmicro-organismsinfoodstuffs,andinformationfromriskassessments.Inparticular,thecriteriaandconditionsconcerningthepresenceofsalmonellaincarcasesofcattle,sheep,goats,horses,pigsandpoultryshallberevisedinthelightofthechangesobservedinsalmonellaprevalence.

Article11Repeal

Decision93/51/EECisrepealed.

Article12

ThisRegulationshallenterintoforceonthe20thdayfollowingitspublicationintheOfficialJournaloftheEuropeanUnion.Itshallapplyfrom1January2006.

ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.

2005R2073—EN—27.12.2007—001.001—12

▼M1ANNEXI

Microbiologicalcriteriaforfoodstuffs

Chapter1.Chapter2.

2.12.22.32.42.5

Chapter3.

3.13.2

Foodsafetycriteria............................................Processhygienecriteria.........................................Meatandproductsthereof.......................................Milkanddairyproducts.........................................Eggproducts................................................Fisheryproducts..............................................Vegetables,fruitsandproductsthereof...............................Rulesforsamplingandpreparationoftestsamples......................Generalrulesforsamplingandpreparationoftestsamples.................Bacteriologicalsamplinginslaughterhousesandatpremisesproducingmincedmeatandmeatpreparations..........................................

▼M1Chapter1.FoodsafetycriteriaFoodcategoryncmMMicro-organisms/theirtoxins,metabolitesSamplingplan(1)Limits(2)Analyticalreferencemethod(3)Stagewherethecriterionapplies1.1Listeriamonocytogenes100Absencein25gEN/ISO11290-1Ready-to-eatfoodsintendedforinfantsandready-to-eatfoodsforspecialmedicalpurposes(4)Listeriamonocytogenes50100cfu/g(5)EN/ISO11290-2(6)Productsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-lifeBeforethefoodhaslefttheimmediatecontrolofthefoodbusinessoperator,whohasproduceditProductsplacedonthemarketduringtheirshelf-life1.2Ready-to-eatfoodsabletosupportthegrowthofL.monocytogenes,otherthanthoseintendedforinfantsandforspecialmedicalpurposes50Absencein25g(7)EN/ISO11290-11.3Listeriamonocytogenes50100cfu/gReady-to-eatfoodsunabletosupportthegrowthofL.monocytogenes,otherthanthoseintendedforinfantsandforspecialmedicalpurposes(4)(8)Salmonella50Absencein25gEN/ISO11290-2(6)1.4MincedmeatandmeatpreparationsintendedtobeeatenrawSalmonella50From1.1.2006Absencein10gFrom1.1.2010Absencein25gAbsencein10gEN/ISO6579Productsplacedonthemarketduringtheirshelf-lifeEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.5Mincedmeatandmeatpreparationsmadefrompoultrymeatintendedtobeeatencooked1.6MincedmeatandmeatpreparationsmadefromotherspeciesthanpoultryintendedtobeeatencookedSalmonella50Salmonella50EN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.7Mechanicallyseparatedmeat(MSM)(9)Absencein10gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life2005R2073—EN—27.12.2007—001.001—13

1.8Meatproductsintendedtobeeatenraw,excludingproductswherethemanufacturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonella▼M1Micro-organisms/theirtoxins,metabolitesStagewherethecriterionappliesncmMSamplingplan(1)Limits(2)Analyticalreferencemethod(3)Foodcategory1.9MeatproductsmadefrompoultrymeatintendedtobeeatencookedSalmonella50From1.1.2006Absencein10gFrom1.1.2010Absencein25gAbsencein25gAbsencein25gEN/ISO6579EN/ISO6579EN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.10GelatineandcollagenSalmonella50Salmonella50Productsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-life1.11Cheeses,butterandcreammadefromrawmilkormilkthathasundergonealowerheattreatmentthanpasteurisation(10)SalmonellaSalmonella50Absencein25g50Absencein25gEN/ISO6579EN/ISO65791.12Milkpowderandwheypowder1.13Icecream(11),excludingproductswherethemanu-facturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonella50Absencein25g1.14Eggproducts,excludingproductswherethemanu-facturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonella50EN/ISO6579Productsplacedonthemarketduringtheirshelf-lifeEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.15Ready-to-eatfoodscontainingrawegg,excludingproductswherethemanufacturingprocessorthecompositionoftheproductwilleliminatethesalmonellariskSalmonellaSalmonellaSalmonellaSalmonella55500050Absencein25gorml1.16CookedcrustaceansandmolluscanshellfishAbsencein25gAbsencein25gAbsencein25gAbsencein25gEN/ISO6579EN/ISO6579EN/ISO6579EN/ISO6579Productsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-lifeProductsplacedonthemarketduringtheirshelf-life1.17Livebivalvemolluscsandliveechinoderms,tunicatesandgastropods1.18Sproutedseeds(ready-to-eat)(12)2005R2073—EN—27.12.2007—001.001—14

1.19Precutfruitandvegetables(ready-to-eat)▼M1Micro-organisms/theirtoxins,metabolitesStagewherethecriterionappliesncmMSamplingplan(1)Limits(2)Analyticalreferencemethod(3)Foodcategory1.20Unpasteurisedfruitandvegetablejuices(ready-to-eat)Salmonella50Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.21Cheeses,milkpowderandwheypowder,asreferredtointhecoagulase-positivestaphylococcicriteriainChapter2.2ofthisAnnexStaphylococcalentero-toxins50Notdetectedin25gEuropeanscreeningmethodoftheCRLforcoagulasepositivestaphy-lococci(13)Productsplacedonthemarketduringtheirshelf-life1.22DriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofageSalmonella300Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.23Driedfollow-onformulaeSalmonella300Absencein25gEN/ISO6579Productsplacedonthemarketduringtheirshelf-life1.24Driedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofage(14)Enterobactersakazakii300Absencein10gISO/TS229Productsplacedonthemarketduringtheirshelf-life1.25Livebivalvemolluscsandliveechinoderms,tunicatesandgastropodsE.coli(15)1(16)0230MPN/100goffleshandintra-valvularliquidISOTS169-3Productsplacedonthemarketduringtheirshelf-life2005R2073—EN—27.12.2007—001.001—15

1.26Fisheryproductsfromfishspeciesassociatedwithahighamountofhistidine(17)Histamine9(18)2100mg/kg200mg/kgHPLC(19)Productsplacedonthemarketduringtheirshelf-life▼M1Micro-organisms/theirtoxins,metabolitesStagewherethecriterionappliesncmMSamplingplan(1)Limits(2)Analyticalreferencemethod(3)Foodcategory1.27Fisheryproductswhichhaveundergoneenzymematurationtreatmentinbrine,manufacturedfromfishspeciesassociatedwithahighamountofhistidine(17)Histamine92200mg/kg400mg/kgHPLC(19)Productsplacedonthemarketduringtheirshelf-lifen=numberofunitscomprisingthesample;c=numberofsampleunitsgivingvaluesbetweenmandM.Forpoints1.1-1.25m=M.Themostrecenteditionofthestandardshallbeused.Regulartestingagainstthecriterionisnotrequiredinnormalcircumstancesforthefollowingready-to-eatfoods:—thosewhichhavereceivedheattreatmentorotherprocessingeffectivetoeliminateL.monocytogenes,whenrecontaminationisnotpossibleafterthistreatment(forexample,productsheattreatedintheirfinalpackage),—fresh,uncutandunprocessedvegetablesandfruits,excludingsproutedseeds,—bread,biscuitsandsimilarproducts,—bottledorpackedwaters,softdrinks,beer,cider,wine,spiritsandsimilarproducts,—sugar,honeyandconfectionery,includingcocoaandchocolateproducts,—livebivalvemolluscs.(5)Thiscriterionshallapplyifthemanufacturerisabletodemonstrate,tothesatisfactionofthecompetentauthority,thattheproductwillnotexceedthelimit100cfu/gthroughouttheshelf-life.Theoperatormayfixintermediatelimitsduringtheprocessthatmustbelowenoughtoguaranteethatthelimitof100cfu/gisnotexceededattheendofshelf-life.(6)1mlofinoculumisplatedonaPetridishof140mmdiameteroronthreePetridishesof90mmdiameter.(7)Thiscriterionshallapplytoproductsbeforetheyhavelefttheimmediatecontroloftheproducingfoodbusinessoperator,whenheisnotabletodemonstrate,tothesatisfactionofthecompetentauthority,thattheproductwillnotexceedthelimitof100cfu/gthroughouttheshelf-life.(8)ProductswithpH≤4,4oraw≤0,92,productswithpH≤5,0andaw≤0,94,productswithashelf-lifeoflessthanfivedaysshallbeautomaticallyconsideredtobelongtothiscategory.Othercategoriesofproductscanalsobelongtothiscategory,subjecttoscientificjustification.(9)Thiscriterionshallapplytomechanicallyseparatedmeat(MSM)producedwiththetechniquesreferredtoinparagraph3ofChapterIIIofSectionVofAnnexIIItoRegulation(EC)No853/2004oftheEuropeanParliamentandoftheCouncil.(10)Excludingproductswhenthemanufacturercandemonstratetothesatisfactionofthecompetentauthoritiesthat,duetotheripeningtimeandawoftheproductwhereappropriate,thereisnosalmonellarisk.(11)Onlyicecreamscontainingmilkingredients.(12)PreliminarytestingofthebatchofseedsbeforestartingthesproutingprocessorthesamplingmustbecarriedoutatthestagewherethehighestprobabilityoffindingSalmonellaisexpected.(13)Reference:Communityreferencelaboratoryforcoagulasepositivestaphylococci.Europeanscreeningmethodforthedetectionofstaphylococcalenterotoxinsinmilkandmilkproducts.(14)ParalleltestingforEnterobacteriaceaeandE.sakazakiishallbeconducted,unlessacorrelationbetweenthesemicro-organismshasbeenestablishedatanindividualplantlevel.IfEnterobacteriaceaearedetectedinanyoftheproductsamplestestedinsuchaplant,thebatchmustbetestedforE.sakazakii.ItshallbetheresponsibilityofthemanufacturertodemonstratetothesatisfactionofthecompetentauthoritywhethersuchacorrelationexistsbetweenEnterobacteriaceaeandE.sakazakii.(15)E.coliisusedhereasanindicatoroffaecalcontamination.(16)Apooledsamplecomprisingaminimumof10individualanimals.(17)Particularlyfishspeciesofthefamilies:Scombridae,Clupeidae,Engraulidae,Coryfenidae,Pomatomidae,Scombresosidae.(18)Singlesamplesmaybetakenatretaillevel.InsuchacasethepresumptionlaiddowninArticle14(6)ofRegulation(EC)No178/2002,accordingtowhichthewholebatchistobedeemedunsafe,shallnotapply.(19)References:1.MalleP.,ValleM.,BouqueletS.Assayofbiogenicaminesinvolvedinfishdecomposition.J.AOACInternat.1996,79,43-49.2.DuflosG.,DervinC.,MalleP.,BouqueletS.Relevanceofmatrixeffectindeterminationofbiogenicaminesinplaice(Pleuronectesplatessa)andwhiting(Merlangusmerlangus.J.AOACInternat.1999,82,1097-1101.(1)(2)(3)(4)2005R2073—EN—27.12.2007—001.001—16

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dteolonospieahotnesrhefwerrottiamreilpeohstseerneishwub,idloocof.Egngicnu:eitdgsaeortpfootesnhthotfintoaolleomrrt6nnioscwdoloetepaboirdstetsnamagmfndiinerahtofssttlefdutaelescdeisnrnauhetttnsie,dtso:oeseemffishreotdelh-fprfotlon:euisehrspnhesol:oco.fe.aiesesc.esntpth.stitiaeribttiitvuntnndieilpuseuuuendirmutsipdlaenoeehrnclehe:lllsaeaipgglcpipftd,nsmoupts,c,ayo,rmmaIc.emummaemmoats)schlu1mulus.psn(itusilreoroissuitlodlaehngeeto/thmree,ireuthmeittccctdnrethoseafmucteaeuotfcmftafaofaf.cbovbocesboeebtpllvsyL0eyaelvetpdhahenf0hnihyevcrhttoao1tabtnadmoeygohniaftahiaffftsbbdonhtffioonieonoyfnaevineroiivenedwtelecdhahtetecdtiihaceoridltsntnneeietrfntwiegftecgmcnetieccaelsesodecsnonsabteti,eed:ltbtsiehebedyfadtoiaenydbtutnthadcm.dineeedteiaiietitxardalllsreiedeil.lsoscifcarhiodhsixuotEitemhtnhiolioidtsueqfetmppetedhltemre,uucetmdldanetutdnaetmsfeauaeaecisxauia≤hacintirercdietircecirsatoecireisdttsee:etsealeetiegnnctdtdr>dnctetdstoetiaeonclblniaoaiaceunccttbboebuhtdmiaenrbpseionidfdrdnialdlieeeadeosteodubest:erfeemodverhsdwvrhavrssvhritpnavhhetrtsrereteeeerulcosfoettsf-sfneiimpioocboobuiersloysasffurenmmfbofuttoeooaobilifbotde-vgoeeapxnomq≤eiersiaeascaoscystcdcorshe-enerendeeasnmotdse-htoueopueauhceenaoenfgendlseltulsisriucetls-atadarlssietat-eavfeeeayveryhverroovrsetdardpdtprpnhnvecwvrreoitenpuoedlslotsaeateetnehehyfeexlieheoobrtheahehttnthrtrhhtattontholeitttihrfoeonllloahtllelktpleefiafinlaffrnfirlemieafniiteaieiialfhutzaiyrtlaredsf,saf,f,f,af,eineiyeriyseyffiiynf,iykiyhfivesn,rnts,r,rd,rea,rsvtleeyonyool,rsyoi,rttyotfynaigyortgnrtegusoococnyriocartrrcrttaooocgttaotatacoceotanoesecffctatfitrycfymcfttcasiasacsocfiliasiccscmiceasyiftlatcmt.oftsaodftcsaosaefaoftsaaaieaftesniibsanfeishiniletsnsislilptotsanootstannanotnytsoitsranmittsemsumesuomumasuhanpsuesuaa.ts1hmelltTah..sTL——Lba——.L——ansiS——atS——E——H—.ssecorpehtfoerudecorpeneigyhdoogroselpicnirptnioplortnoclacitircdnasisylanadrazahehtfossenevitceffeehtgnitartsnomedrofosladesuebyamstlusertsetehT)1(▼M1___________▼M12.amaximumofc/nvaluesobservedarebetweenmandM3.novaluesobservedexceedthelimitofM,—unsatisfactory,ifthemeanvalueobservedexceedsmormorethanc/nvaluesarebetweenmandMoroneormoreofthevaluesobservedare>M.2005R2073—EN—27.12.2007—001.001—18

▼M1Chapter2.Processhygienecriteria2.1MeatandproductsthereofSamplingplan(1)ncmMAnalyticalreferencemethod(3)StagewherethecriterionappliesLimits(2)FoodcategoryMicro-organismsActionincaseofunsatisfactoryresults2.1.1Carcasesofcattle,sheep,goatsandhorses(4)3,5logcfu/cm2dailymeanlog5,0logcfu/cm2dailymeanlog2,5logcfu/cm2dailymeanlog5,0logcfu/cm2dailymeanlog3,0logcfu/cm2dailymeanlogEN/ISO6579ISO21528-2ISO4833ISO21528-2CarcasesafterdressingbutbeforechillingISO4833Carcasesafterdressingbutbeforechilling1,5logcfu/cm2dailymeanlog4,0logcfu/cm2dailymeanlog2,0logcfu/cm2dailymeanlog50(5)2(6)AbsenceintheareatestedpercarcaseAerobiccolonycountImprovementsinslaughterhygieneandreviewofprocesscontrolsImprovementsinslaughterhygieneandreviewofprocesscontrolsImprovementsinslaughterhygieneandreviewofprocesscontrolsImprovementsinslaughterhygieneandreviewofprocesscontrolsEnterobacteriaceae2.1.2Carcasesofpigs(4)AerobiccolonycountCarcasesafterdressingbutbeforechillingEnterobacteriaceaeCarcasesafterdressingbutbeforechilling2.1.3Carcasesofcattle,sheep,goatsandhorsesSalmonellaCarcasesafterdressingbutbeforechillingImprovementsinslaughterhygiene,reviewofprocesscontrolsandoforiginofanimalsEN/ISO6579CarcasesafterdressingbutbeforechillingImprovementsinslaughterhygieneandreviewofprocesscontrols,originofanimalsandofthebiosecuritymeasuresinthefarmsoforiginEN/ISO6579CarcasesafterchillingImprovementsinslaughterhygieneandreviewofprocesscontrols,originofanimalsandbiosecuritymeasuresinthefarmsoforigin2.1.4Carcasesofpigs5(6)Salmonella50(5)Absenceintheareatestedpercarcase2005R2073—EN—27.12.2007—001.001—19

2.1.5Poultrycarcasesofbroilersandturkeys7(6)Salmonella50(5)Absencein25gofapooledsampleofneckskin▼M1Samplingplan(1)ncmMAnalyticalreferencemethod(3)StagewherethecriterionappliesActionincaseofunsatisfactoryresultsLimits(2)FoodcategoryMicro-organisms2.1.6Mincedmeat52ISO4833EndofthemanufacturingprocessAerobiccolonycount(7)5×105cfu/g5×106cfu/gImprovementsinproductionhygieneandimprovementsinselectionand/ororiginofrawmaterialsImprovementsinproductionhygieneandimprovementsinselectionand/ororiginofrawmaterialsImprovementsinproductionhygieneandimprovementsinselectionand/ororiginofrawmaterialsImprovementsinproductionhygieneandimprovementsinselectionand/ororiginofrawmaterialsImprovementsinproductionhygieneandimprovementsinselectionand/ororiginofrawmaterialsE.coli(8)5250cfu/g500cfu/gISO169-1or2Endofthemanufacturingprocess2.1.7Mechanicallyseparatedmeat(MSM)(9)52ISO4833Aerobiccolonycount5×105cfu/g5×106cfu/gEndofthemanufacturingprocessE.coli(8)5250cfu/g500cfu/gISO169-1or2Endofthemanufacturingprocess2.1.8Meatpreparations52500cfu/gorcm25000cfu/gorcm2ISO169-1or2E.coli(8)Endofthemanufacturingprocess(1)(2)(3)(4)(5)(6)2005R2073—EN—27.12.2007—001.001—20

(7)(8)(9)n=numberofunitscomprisingthesample;c=numberofsampleunitsgivingvaluesbetweenmandM.Forpoints2.1.3-2.1.5m=M.Themostrecenteditionofthestandardshallbeused.Thelimits(mandM)shallapplyonlytosamplestakenbythedestructivemethod.Thedailymeanlogshallbecalculatedbyfirsttakingalogvalueofeachindividualtestresultandthencalculatingthemeanoftheselogvalues.The50samplesshallbederivedfrom10consecutivesamplingsessionsinaccordancewiththesamplingrulesandfrequencieslaiddowninthisRegulation.Thenumberofsampleswherethepresenceofsalmonellaisdetected.Thecvalueissubjecttoreviewinordertotakeintoaccounttheprogressmadeinreducingthesalmonellaprevalence.MemberStatesorregionshavinglowsalmonellaprevalencemayuselowercvaluesevenbeforethereview.Thiscriterionshallnotapplytomincedmeatproducedatretaillevelwhentheshelf-lifeoftheproductislessthen24hours.E.coliisusedhereasanindicatoroffaecalcontamination.Thesecriteriaapplytomechanicallyseparatedmeat(MSM)producedwiththetechniquesreferredtoinparagraph3ofChapterIIIofSectionVofAnnexIIItoRegulation(EC)No853/2004oftheEuropeanParliamentandoftheCouncil.▼M1InterpretationofthetestresultsThelimitsgivenrefertoeachsampleunittested,excludingtestingofcarcaseswherethelimitsrefertopooledsamples.Thetestresultsdemonstratethemicrobiologicalqualityoftheprocesstested.Enterobacteriaceaeandaerobiccolonycountincarcasesofcattle,sheep,goats,horsesandpigs:—satisfactory,ifthedailymeanlogis≤m,—acceptable,ifthedailymeanlogisbetweenmandM,—unsatisfactory,ifthedailymeanlogis>M.Salmonellaincarcases:—satisfactory,ifthepresenceofSalmonellaisdetectedinamaximumofc/nsamples,—unsatisfactory,ifthepresenceofSalmonellaisdetectedinmorethanc/nsamples.Aftereachsamplingsession,theresultsofthelasttensamplingsessionsshallbeassessedinordertoobtainthennumberofsamples.E.coliandaerobiccolonycountinmincedmeat,meatpreparationsandmechanicallyseparatedmeat(MSM):—satisfactory,ifallthevaluesobservedare≤m,—acceptable,ifamaximumofc/nvaluesarebetweenmandM,andtherestofthevaluesobservedare≤m,—unsatisfactory,ifoneormoreofthevaluesobservedare>Mormorethanc/nvaluesarebetweenmandM.2005R2073—EN—27.12.2007—001.001—21

▼M12.2MilkanddairyproductsSamplingplan(1)ncmMAnalyticalreferencemethod(3)StagewherethecriterionappliesLimits(2)FoodcategoryMicro-organismsActionincaseofunsatisfactoryresults2.2.1Pasteurisedmilkandotherpasteurisedliquiddairyproducts(4)52<1/ml5/mlISO21528-1Endofthemanufacturingprocess52100cfu/g1000cfu/gISO169-1or2AtthetimeduringthemanufacturingprocesswhentheE.colicountisexpectedtobehighest(6)EnterobacteriaceaeCheckontheefficiencyofheattreatmentandpreventionofrecontaminationaswellasthequalityofrawmaterialsImprovementsinproductionhygieneandselectionofrawmaterials2.2.2Cheesesmadefrommilkorwheythathasundergoneheattreatment552100cfu/g1000cfu/gEN/ISO6888-1or22104cfu/gEN/ISO6888-2105cfu/gE.coli(5)2.2.3CheesesmadefromrawmilkCoagulase-positivestaphylococci2.2.4Cheesesmadefrommilkthathasundergonealowerheattreatmentthanpasteurisation(7)andripenedcheesesmadefrommilkorwheythathasundergonepasteurisationora7strongerheattreatment()5210cfu/g100cfu/gEN/ISO6888-1or2Coagulase-positivestaphylococciAtthetimeduringthemanufacturingprocesswhenthenumberofstaphy-lococciisexpectedtobehighestImprovementsinproductionhygieneandselectionofrawmaterials.Ifvalues>105cfu/garedetected,thecheesebatchhastobetestedforstaphylococcalenterotoxins.2.2.5Unripenedsoftcheeses(freshcheeses)madefrommilkorwheythathasundergonepasteuri-sationorastrongerheattreatment(7)5210cfu/g100cfu/gCoagulase-positivestaphylococciEndofthemanufacturingprocessImprovementsinproductionhygiene.Ifvalues>105cfu/garedetected,thecheesebatchhastobetestedforstaphylo-coccalenterotoxins.ISO169-1or2EndofthemanufacturingprocessImprovementsinproductionhygieneandselectionofrawmaterials2.2.6Butterandcreammadefromrawmilkormilkthathasundergonealowerheattreatmentthanpasteurisation50E.coli(5)2005R2073—EN—27.12.2007—001.001—22

2.2.7Milkpowderandwheypowder(4)Enterobacteriaceae10cfu/gISO21528-2EndofthemanufacturingprocessCheckontheefficiencyofheattreatmentandpreventionofrecontamination▼M1Samplingplan(1)ncmMAnalyticalreferencemethod(3)StagewherethecriterionappliesActionincaseofunsatisfactoryresultsLimits(2)FoodcategoryMicro-organismsCoagulase-positivestaphylococci5210cfu/g100cfu/gEN/ISO6888-1or2EndofthemanufacturingprocessImprovementsinproductionhygiene.Ifvalues>105cfu/garedetected,thebatchhastobetestedforstaphylococcalenterotoxins.ImprovementsinproductionhygieneImprovementsinproductionhygienetominimisecontami-nation(9)2.2.8Icecream(8)andfrozendairydesserts5100Absencein10gISO21528-1Endofthemanufacturingprocess210cfu/g100cfu/gISO21528-2EndofthemanufacturingprocessEnterobacteriaceae2.2.9Driedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofage50Absencein10gISO21528-1Enterobacteriaceae2.2.10Driedfollow-onformulaeEnterobacteriaceaeEndofthemanufacturingprocessEndofthemanufacturingprocessImprovementsinproductionhygienetominimisecontami-nationImprovementsinproductionhygiene.Preventionofrecon-tamination.Selectionofrawmaterial.2.2.11DriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofagePresumptiveBacilluscereus5150cfu/g500cfu/gEN/ISO7932(10)(1)(2)(3)(4)(5)(6)(7)(8)(9)2005R2073—EN—27.12.2007—001.001—23

(10)n=numberofunitscomprisingthesample;c=numberofsampleunitsgivingvaluesbetweenmandM.Forpoints2.2.7,2.2.9and2.2.10m=M.Themostrecenteditionofthestandardshallbeused.Thecriterionshallnotapplytoproductsintendedforfurtherprocessinginthefoodindustry.E.coliisusedhereasanindicatorforthelevelofhygiene.ForcheeseswhicharenotabletosupportthegrowthofE.coli,theE.colicountisusuallythehighestatthebeginningoftheripeningperiod,andforcheeseswhichareabletosupportthegrowthofE.coli,itisnormallyattheendoftheripeningperiod.Excludingcheeseswherethemanufacturercandemonstrate,tothesatisfactionofthecompetentauthorities,thattheproductdoesnotposeariskofstaphylococcalenterotoxins.Onlyicecreamscontainingmilkingredients.ParalleltestingforEnterobacteriaceaeandE.sakazakiishallbeconducted,unlessacorrelationbetweenthesemicro-organismshasbeenestablishedatanindividualplantlevel.IfEnterobacteriaceaearedetectedinanyoftheproductsamplestestedinsuchaplant,thebatchhastobetestedforE.sakazakii.ItshallbetheresponsibilityofthemanufacturertodemonstratetothesatisfactionofthecompetentauthoritywhethersuchacorrelationexistsbetweenEnterobacteriaceaeandE.sakazakii.1mlofinoculumisplatedonaPetridishof140mmdiameteroronthreePetridishesof90mmdiameter.▼M1InterpretationofthetestresultsThelimitsgivenrefertoeachsampleunittested.Thetestresultsdemonstratethemicrobiologicalqualityoftheprocesstested.Enterobacteriaceaeindriedinfantformulae,drieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofageanddriedfollow-onformulae:—satisfactory,ifallthevaluesobservedindicatetheabsenceofthebacterium,—unsatisfactory,ifthepresenceofthebacteriumisdetectedinanyofthesampleunits.E.coli,Enterobacteriaceae(otherfoodcategories)andcoagulase-positivestaphylococci:—satisfactory,ifallthevaluesobservedare≤m,—acceptable,ifamaximumofc/nvaluesarebetweenmandM,andtherestofthevaluesobservedare≤m,—unsatisfactory,ifoneormoreofthevaluesobservedare>Mormorethanc/nvaluesarebetweenmandM.PresumptiveBacilluscereusindriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofage:—satisfactory,ifallthevaluesobservedare≤m,—acceptable,ifamaximumofc/nvaluesarebetweenmandM,andtherestofthevaluesobservedare≤m,—unsatisfactory,ifoneormoreofthevaluesobservedare>Mormorethanc/nvaluesarebetweenmandM.2005R2073—EN—27.12.2007—001.001—24

yd--csinniamtaesitancntiustfenlffemocouteseearersherfttoaycrontnntoaeoiciashtnfknoceenitehvocAhteitCfraopnsgeinliprpuatcnaofiurentaircmehtehetrehwfosseegadctSnoErpdo2-lhat8ce2itm5y)2le1a(c2nnAerOefSeIrlmrosgt/cMuuf.dcMor0dps0nt1agigmimELlne3me.2rwotebmg/suefucla0v1gnivi)g1(snc2tianlpueglnpilmpamn5safSorebem.dsauemensuscia=eniarcbgelt;lreaocl-aphobrmscoadirsrMeatnedEhntatgsneishitrpfmooncoistytiidronegutesfnttacoeccureerddbooormtsFpuonmgg=eEhnT1.3.))212((2005R2073—EN—27.12.2007—001.001—25

.,mMd≤naeramdneeverewtsebobesreaulsaevuleahvtnf/octsn.eadrhtetesheetrtodssnmearco,orMpMdehn>atefomrayndteeievlauwre,ts.dqmebboelta≤esscreieaeutgralstoailenoduvuilbevaeeorvhtlrepcsnfmi:sb/tcoamcoseusfeorohhdetcouaerlmmetpauravormotgitsgeehxetrnaneofnlmofemilareeai,ndafifiyeservtc,,olayietguirlcsroetbasetcaftrcatsipitmtafsbseaiecsltoitracnaeeesuthhnTTE———▼M1InterpretationofthetestresultsnnyooriiotttcccauufddsiootrrappsnusnntiifloussseettsrannceenmmienveeeoonvnireoetcpiriAmgpgyyIhmIhsggeinnliiprrpuuattccnaaoffiuurenntaaircmmehteehhettrehwffosossseeegadcdctSnonoErpErp2ec3rn-9oere)4126-f(e68rd18lo8ahctS6ietTymOlaOSnSI/sAINtcEudorg.p/uMgfy/cdreM0nh10as0i0mFsti1ne4me.i2Lwtge/bugfsmce/1u0la0v1gnivi)g1(nc22stianlpugelnpilpmman55safSorebesvm.dmiuetnsiussinoi=eapcbg-ccreol;loscea-oaolphllsricluymioMcghadra.opsaaedECtshntatgssneitdshcnituarpfdomorsonpncoiyastrtiodeidgecneekathuttsacsifncuufoehrlclredsceeroohbsFdndmtsaeknuoanmdoceos=eh1lcunTll.l4e.hfo))2Som12((2005R2073—EN—27.12.2007—001.001—26

..,mM,dmMd≤na≤naerameramdneednveeerewvertewtsesebobbeobesreasru:ealshuaeslsvuiaef:llvulhealsveeaihhhvftlnstnlf/eocnf/haocstsnctassn.ednrhuealtlrhteatceeoesshrheeuttlomtroldsomdndsnnmemaracoar,so,odrnMpaMnaMdeMes>cdhnnan>ataetaeersfauocmrmraatdcysnendteiuevdeelrreevacekuw,tsowre.dbo,tsdqemebocmebboelkta≤esd≤sconesreioeraeaeaetgcruruallstofadasailnoodeveelduvuillbseultvaeeeaeeocrvhthvrvhtlresepcusfsmidobn/onbnf/iamroceocoisepsfreoocsfehhceorotdceulmouaekamclmmetoauracuvurolvorymothemitsshxeheitphxetrnanoeodaanltlfnlmslmoemaafafreaif,eainddifvf,iiyifesel,rtiyri,vtlly,osy,oieretguoretlcsholcstbapotbasecaf-tratsiecaftsinfptsamtissaafpitsiielieaieltcsltoacnutcssagacneecuasauhh.oTTE———C———▼M1Interpretationofthetestresultsnnyowowiaiartrtrocctcuuaddfsofofirorotappsnnnusnonotiifltiitouccseeeeslslsrteteacnsnseenime,sm,snveleeloionaivnaitreroercpierieAmgtgtyapyaIhmmIhmseilppassnssoeeircceootirrrcppegghnntiirreuurttecchaawffuuenngaaatSMMe22cnrreoore)2f11e(--rfd99olo44eah66rcteie66thym11tlasnOOtSScAIIudorggp//uu.dffccMndaM00n00ast00iusmt11rinfmeie,sLeggwtl//ebuubafftccsemeg00ule00aV11vg5n.i2)v1i(gnc22satlipnugneillppmmn55aasSforesbmm.dsueinnsuag=erocb-iiolll;lrooeacccliphsM..EEmadsraedsedhnln)tattbaagsaent-eieoshtgtir-fetviypoudmraonyfecorritod(stignideasneteuacdctt)iteifnduasuoecijorerrerof-ueeFotelb-tbmtstuysaatuocdeapenmreng=ePr(UehvnT12..55..))2212((2005R2073—EN—27.12.2007—001.001—27

.:),tamMed-≤noat-eyramdadneeer(versewtesecbiobuejsreealublsaaetvuelgeaehvvtnf/docnatsn.eadtirhteutresfheetrtdodsessnmierarcuo,oertMpsMadephnn>atuefonmraiydndteeinevlaauwre),tst.dqamebboeleta-≤esscoeiteraetg-yrualstoaildnoadevuiebreul(vaeeorvhtlrsepcesfmilbbn/oamaocesetesfreoohhtgceulmaevametavurdoortnemitsahxetrnanoeotilflmemuafrerfaif,ndtifiyesu,rvtlcy,oieretgusrpolctbasecaftratsiinfptmtissaiieieltcsltoacnaeecsuhh.TTE———▼M1Interpretationofthetestresults2005R2073—EN—27.12.2007—001.001—28

▼M1Chapter3.Rulesforsamplingandpreparationoftestsamples3.1Generalrulesforsamplingandpreparationoftestsamples

Intheabsenceofmorespecificrulesonsamplingandpreparationoftestsamples,therelevantstandardsoftheISO(InternationalOrganisationforStan-dardisation)andtheguidelinesoftheCodexAlimentariusshallbeusedasreferencemethods.

3.2Bacteriologicalsamplinginslaughterhousesandatpremisesproducing

mincedmeatandmeatpreparationsSamplingrulesforcarcasesofcattle,pigs,sheep,goats

andhorsesThedestructiveandnon-destructivesamplingmethods,theselectionofthesamplingsitesandtherulesforstorageandtransportofsamplesaredescribedinstandardISO17604.

Fivecarcasesshallbesampledatrandomduringeachsamplingsession.Samplesitesmustbeselectedtakingintoaccounttheslaughtertechnologyusedineachplant.

WhensamplingforanalysesofEnterobacteriaceaeandaerobiccolonycounts,foursitesofeachcarcaseshallbesampled.Fourtissuesamplesrepresentingatotalof20cm2shallbeobtainedbythedestructivemethod.Whenusingthenon-destructivemethodforthispurpose,thesamplingareashallcoveraminimumof100cm2(50cm2forsmallruminantcarcases)persamplingsite.

WhensamplingforSalmonellaanalyses,anabrasivespongesamplingmethodshallbeused.Areasmostlikelytobecontaminatedshallbeselected.Thetotalsamplingareashallcoveraminimumof400cm2.

Whensamplesaretakenfromthedifferentsamplingsitesonthecarcase,theyshallbepooledbeforeexamination.

Samplingrulesforpoultrycarcases

FortheSalmonellaanalyses,aminimumof15carcasesshallbesampledatrandomduringeachsamplingsessionandafterchilling.Apieceofapproxi-mately10gfromneckskinshallbeobtainedfromeachcarcase.Oneachoccasiontheneckskinsamplesfromthreecarcasesshallbepooledbeforeexaminationinordertoform5×25gfinalsamples.

Guidelinesforsampling

Moredetailedguidelinesonthesamplingofcarcases,inparticularconcerningthesamplingsites,maybeincludedintheguidestogoodpracticereferredtoinArticle7ofRegulation(EC)No852/2004.

Samplingfrequenciesforcarcases,mincedmeat,meat

preparationsandmechanicallyseparatedmeatThefoodbusinessoperatorsofslaughterhousesorestablishmentsproducingmincedmeat,meatpreparationsormechanicallyseparatedmeatshalltakesamplesformicrobiologicalanalysisatleastonceaweek.Thedayofsamplingshallbechangedeachweektoensurethateachdayoftheweekiscovered.

AsregardsthesamplingofmincedmeatandmeatpreparationsforE.coliandaerobiccolonycountanalysesandthesamplingofcarcasesforEnterobacter-iaceaeandaerobiccolonycountanalyses,thefrequencymaybereducedtofortnightlytestingifsatisfactoryresultsareobtainedforsixconsecutiveweeks.InthecaseofsamplingforSalmonellaanalysesofmincedmeat,meatpreparationsandcarcases,thefrequencymaybereducedtofortnightlyifsatis-factoryresultshavebeenobtainedfor30consecutiveweeks.Thesalmonellasamplingfrequencymayalsobereducedifthereisanationalorregionalsalmonellacontrolprogrammeinplaceandifthisprogrammeincludestestingthatreplacesthesamplingdescribedinthisparagraph.Thesamplingfrequencymaybefurtherreducedifthenationalorregionalsalmonellacontrolprogrammedemonstratesthatthesalmonellaprevalenceislowinanimalspurchasedbytheslaughterhouse.

However,whenjustifiedonthebasisofariskanalysisandconsequentlyauthorisedbythecompetentauthority,smallslaughterhousesandestablishmentsproducingmincedmeatandmeatpreparationsinsmallquantitiesmaybeexemptedfromthesesamplingfrequencies.

2005R2073—EN—27.12.2007—001.001—29

▼BANNEXII

ThestudiesreferredtoinArticle3(2)shallinclude:

—specificationsforphysico-chemicalcharacteristicsoftheproduct,suchaspH,aw,saltcontent,concentrationofpreservativesandthetypeofpackagingsystem,takingintoaccountthestorageandprocessingconditions,thepossi-bilitiesforcontaminationandtheforeseenshelf-life,and—consultationofavailablescientificliteratureandresearchdataregardingthegrowthandsurvivalcharacteristicsofthemicro-organismsofconcern.Whennecessaryonthebasisoftheabovementionedstudies,thefoodbusinessoperatorshallconductadditionalstudies,whichmayinclude:

—predictivemathematicalmodellingestablishedforthefoodinquestion,usingcriticalgrowthorsurvivalfactorsforthemicro-organismsofconcernintheproduct,—teststoinvestigatetheabilityoftheappropriatelyinoculatedmicro-organismofconcerntogroworsurviveintheproductunderdifferentreasonablyforeseeablestorageconditions,—studiestoevaluatethegrowthorsurvivalofthemicro-organismsofconcernthatmaybepresentintheproductduringtheshelf-lifeunderreasonablyforeseeableconditionsofdistribution,storageanduse.Theabovementionedstudiesshalltakeintoaccounttheinherentvariabilitylinkedtotheproduct,themicro-organismsinquestionandtheprocessingandstorageconditions.