L322/12ENOfficialJournaloftheEuropeanUnionCOMMISSIONREGULATION(EC)No1441/2007of5December20077.12.2007amendingRegulation(EC)No2073/2005onmicrobiologicalcriteriaforfoodstuffs(TextwithEEArelevance)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No852/2004oftheEuropeanParliamentandoftheCouncilof29April2004onthehygieneoffoodstuffs(1),andinparticularArticle4(4)thereof,Whereas:(1)CommissionRegulation(EC)No2073/2005of15November2005onmicrobiologicalcriteriaforfood-stuffs(2)laysdownmicrobiologicalcriteriaforcertainmicro-organismsandtheimplementingrulestobecompliedwithbyfoodbusinessoperatorswhenim-plementingthegeneralandspecifichygienemeasuresreferredtoinArticle4ofRegulation(EC)No852/2004.Regulation(EC)No2073/2005alsoprovidesthatfoodbusinessoperatorsaretoensurethatfoodstuffscomplywiththerelevantmicrobiologicalcriteriasetoutinAnnexItothatRegulation.(2)Chapters1and2ofAnnexItoRegulation(EC)No2073/2005setoutfoodsafetycriteriaandprocesshygienecriteriaregardingdriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelowsixmonthsofage(driedinfantformulaeanddrieddietaryfoods).Part2.2ofChapter2ofthatAnnexprovidesthatwheredriedinfantformulaeanddrieddietaryfoodsaretestedandEnterobacteriaceaearedetectedinanyofthesampleunits,thebatchistobetestedforEnterobactersakazakiiandSalmonella.(3)On24January2007,theScientificPanelonBiologicalHazards(BIOHAZPanel)oftheEuropeanFoodSafetyAuthority(EFSA)issuedanopinionwithregardtoEnterobacteriaceaeasindicatorsofSalmonellaandEnterobactersakazakii.Itconcludedthatitisnotpossible(1)OJL139,30.4.2004,p.1,ascorrectedbyOJL226,25.6.2004,p.3.(2)OJL338,22.12.2005,p.1.toestablishacorrelationbetweenEnterobacteriaceaeandSalmonella,andnouniversalcorrelationbetweenEntero-bacteriaceaeandEnterobactersakazakiiexists.Atindividualplantlevel,acorrelationbetweenEnterobacteriaceaeandEnterobactersakazakiimayhoweverbeestablished.(4)ThereforetherequirementlaiddowninRegulation(EC)No2073/2005asregardsthetestingofdriedinfantformulaeanddrieddietaryfoodsforSalmonellaandEnterobactersakazakiiwhereEnterobacteriaceaearedetectedinanyofthesampleunitsshouldnolongerapply.Part2.2ofChapter2ofAnnexItothatRegu-lationshouldthereforebeamendedaccordingly.(5)Inlinewiththeopiniononthemicrobiologicalrisksininfantformulaeandfollow-onformulaeissuedbytheBIOHAZPanelofEFSAon9September2004,micro-biologicalcriteriaonSalmonellaandEnterobacteriaceaeshouldbelaiddownfordriedfollow-onformulae.(6)TheBIOHAZPanelofEFSAissuedanopiniononBacilluscereusandotherBacillusspp.infoodstuffson26and27January2005.Itconcludedthatoneofthemajorcontrolmeasuresistocontroltemperatureandtoestablishasystembasedonhazardanalysisandcriticalcontrolpointprinciples.Dehydratedfoods,inwhichthepresenceofsporesofpathogenicBacillusspp.isfrequent,mightpermitthegrowthofBacilluscereusoncerehydratedinwarmwater.Somedehydratedfoods,includingdriedinfantformulaeanddrieddietaryfoods,areconsumedbypotentiallyfragileconsumers.InlinewiththeEFSAopinion,thenumbersofBacilluscereussporesindriedinfantformulaeanddrieddietaryfoodsshouldbeaslowaspossibleduringprocessingandaprocesshygienecriterionshouldbelaiddowninadditiontogoodpracticesdesignedtoreducedelaybetweenpreparationandconsumption.(7)Chapter1ofAnnexItoRegulation(EC)No2073/2005providesfortheanalyticalreferencemethodforstaphy-lococcalenterotoxinsincertaincheeses,milkpowderandwheypowder.ThatmethodhasbeenrevisedbytheCommunityreferencelaboratoryforcoagulasepositivestaphylococci.Thereferencetothatanalyticalreferencemethodshouldthereforebeamended.Chapter1ofAnnexItothatRegulationshouldthereforebeamendedaccordingly.7.12.2007ENOfficialJournaloftheEuropeanUnionL322/13(8)Chapter3ofAnnexItoRegulation(EC)No2073/2005setsoutsamplingrulesforcarcassesofcattle,pig,sheep,goatsandhorsesforSalmonellaanalyses.Pursuanttothoserulesthesamplingareaistocoveraminimumof100cm2persiteselected.However,neitherthenumberofsamplingsitesnortheminimumtotalareaofsamplingisspecified.InordertoimprovetheimplementationoftheserulesintheCommunity,itisappropriatetofurtherspecifyinRegulation(EC)No2073/2005thattheareasmostlikelytobecontaminatedshouldbeselectedforsamplingandthatthetotalsamplingareashouldbeincreased.Chapter3ofAnnexItothatRegulationshouldthereforebeamendedaccordingly.(9)IntheinterestsofclarityofCommunitylegislation,itisappropriatetoreplaceAnnexItoRegulation(EC)No2073/2005bythetextsetoutintheAnnextothisRegulation.(10)ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheStandingCommitteeontheFoodChainandAnimalHealth,HASADOPTEDTHISREGULATION:Article1AnnexItoRegulation(EC)No2073/2005isreplacedbythetextintheAnnextothisRegulation.Article2ThisRegulationshallenterintoforceonthe20thdayfollowingitspublicationintheOfficialJournaloftheEuropeanUnion.ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.DoneatBrussels,5December2007.FortheCommissionMarkosKYPRIANOUMemberoftheCommissionL322/14ENChapter1.Chapter2.OfficialJournaloftheEuropeanUnionANNEX‘ANNEXIMicrob