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I(Actswhosepublicationisobligatory)COMMISSIONREGULATION(EC)No2073/2005of15November2005onmicrobiologicalcriteriaforfoodstuffs(TextwithEEArelevance)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No852/2004oftheEuropeanParliamentandoftheCouncilof29April2004onthehygieneoffoodstuffs(1),andinparticularArticles4(4)and12thereof,Whereas:(1)Ahighlevelofprotectionofpublichealthisoneofthefundamentalobjectivesoffoodlaw,aslaiddowninRegulation(EC)No178/2002oftheEuropeanParlia-mentandoftheCouncilof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety(2).Microbiologicalhazardsinfoodstuffsformamajorsourceoffood-bornediseasesinhumans.(2)Foodstuffsshouldnotcontainmicro-organismsortheirtoxinsormetabolitesinquantitiesthatpresentanunacceptableriskforhumanhealth.(3)Regulation(EC)No178/2002laysdowngeneralfoodsafetyrequirements,accordingtowhichfoodmustnotbeplacedonthemarketifitisunsafe.Foodbusinessoperatorshaveanobligationtowithdrawunsafefoodfromthemarket.Inordertocontributetotheprotectionofpublichealthandtopreventdifferinginterpretations,itisappropriatetoestablishharmonisedsafetycriteriaontheacceptabilityoffood,inparticularasregardsthepresenceofcertainpathogenicmicro-organisms.(4)Microbiologicalcriteriaalsogiveguidanceontheacceptabilityoffoodstuffsandtheirmanufacturing,handlinganddistributionprocesses.Theuseofmicro-biologicalcriteriashouldformanintegralpartoftheimplementationofHACCP-basedproceduresandotherhygienecontrolmeasures.(5)Thesafetyoffoodstuffsismainlyensuredbyapreventiveapproach,suchasimplementationofgoodhygienepracticeandapplicationofproceduresbasedonhazardanalysisandcriticalcontrolpoint(HACCP)principles.MicrobiologicalcriteriacanbeusedinvalidationandverificationofHACCPproceduresandotherhygienecontrolmeasures.Itisthereforeappropriatetosetmicrobiologicalcriteriadefiningtheacceptabilityoftheprocesses,andalsofoodsafetymicrobiologicalcriteriasettingalimitabovewhichafoodstuffshouldbeconsideredunacceptablycontaminatedwiththemicro-organismsforwhichthecriteriaareset.(6)AccordingtoArticle4ofRegulation(EC)No852/2004,foodbusinessoperatorsaretocomplywithmicrobiolo-gicalcriteria.Thisshouldincludetestingagainstthevaluessetforthecriteriathroughthetakingofsamples,theconductofanalysesandtheimplementationofcorrectiveactions,inaccordancewithfoodlawandtheinstructionsgivenbythecompetentauthority.Itisthereforeappropriatetolaydownimplementingmea-suresconcerningtheanalyticalmethods,including,wherenecessary,themeasurementuncertainty,thesamplingplan,themicrobiologicallimits,thenumberofanalyticalunitsthatshouldcomplywiththeselimits.Furthermore,itisappropriatetolaydownimplementingmeasuresconcerningthefoodstufftowhichthecriterionapplies,thepointsofthefoodchainwherethecriterionapplies,aswellastheactionstobetakenwhenthecriterionisnotmet.Themeasurestobetakenbythefoodbusinessoperatorsinordertoensurecompliancewithcriteriadefiningtheacceptabilityofaprocessmayinclude,amongotherthings,controlsofrawmaterials,hygiene,temperatureandshelf-lifeoftheproduct.22.12.2005ENOfficialJournaloftheEuropeanUnionL338/1(1)OJL139,30.4.2004,p.1,correctedbyOJL226,25.6.2004,p.3.(2)OJL31,1.2.2002,p.1.RegulationasamendedbyRegulation(EC)No1642/2003(OJL245,29.9.2003,p.4).(7)Regulation(EC)No882/2004oftheEuropeanParlia-mentandoftheCouncilof29April2004onofficialcontrolsperformedtoensuretheverificationofcompliancewithfeedandfoodlaw,animalhealthandanimalwelfarerules(1)requirestheMemberStatestoensurethatofficialcontrolsarecarriedoutregularly,onariskbasisandwithappropriatefrequency.Thosecontrolsshouldtakeplaceatappropriatestagesoftheproduction,processinganddistributionoffoodtoensurethatthecriterialaiddowninthisRegulationarecompliedwithbyfoodbusinessoperators.(8)TheCommunicationfromtheCommissionontheCommunityStrategyforsettingmicrobiologicalcriteriaforfoodstuffs(2)describesthestrategytolaydownandrevisethecriteriainCommunitylegislation,aswellastheprinciplesforthedevelopmentandapplicationofthecriteria.Thisstrategyshouldbeappliedwhenmicro-biologicalcriteriaarelaiddown.(9)TheScientificCommitteeonVeterinaryMeasuresrelatingtoPublicHealth(SCVPH)issuedanopinionon23September1999ontheevaluationofmicrobiologicalcriteriaforfoodproductsofanimaloriginforhumanconsumption.Ithighlightedtherelevanceofbasingmicrobiologicalcriteriaonformalriskassessmentandinternationallyapprovedprinciples.Theopinionrecom-mendsthatmicrobiologicalcriteriashouldberelevantandeffectiveinrelationtoconsumerhealthprotection.TheSCVPHproposed,whileawaitingformalriskassessments,certainrevisedcriteriaasinterimmeasures.(10)TheSCVPHissuedatthesametimeaseparateopiniononListeriamonocytogenes.ThatopinionrecommendedthatitbeanobjectivetokeeptheconcentrationofListeriamonocytogenesinfoodbelow100cfu/g.TheScientificCommitteeonFood(SCF)agreedwiththeserecommendationsinitsopinionof22June2000.(11)TheSCVPHadoptedanopiniononVibriovulnificusandVibrioparahaemolyticuson19and20September2