国际食品机械设备卫生安全标准与重要法规

國際食品機械設備衛生安全標準與重要法規,楊炳輝南台灣服務中心財團法人食品工業發展研究所2013.06.27,簡報大綱,一、食品機械設備與衛生安全之關聯二、歐美食品與設備衛生重要法規三、歐美自願性相關標準四、設備衛生設計相關建議或標準五、台灣相關設備衛生規範六、未來展望,CodexAlimentarius-FoodHygiene,“Foodsafety”Assurancethatfoodwillnotcauseharmtotheconsumerwhenitispreparedand/oreatenaccordingtoitsintendeduse.Createdin1963byFAOandWHOtodevelopfoodstandards,guidelinesandrelatedtextssuchascodesofpracticeunderthejointFAO/WHOFoodStandardsProgram.,FoodSafety,Equipment/HardwareHygienicDesignCriteria,ProcessHygieneFoodProcessingCriteria,-Regulation(EC)1935/2004-onmaterialsandarticlesintendedtocomeintocontactwithfood-Regulation(EU)10/2011Plasticmaterialsinfoodcontact-Regulation(EC)2023/2006-ongoodmanufacturingpracticeformaterialsandarticlesintendedtocomeintocontactwithfood,Machinerydirective2006/42/EC,EU-regulations:RE(EC)178/2002RE(EC)852/2004RE(EC)2073/2005,HygienicDesignofMachineryvs.HygienicControlofProcess,工業級與食品級機械設計之差異,工業級,食品級,設備規格與衛生等級,歐美食品與設備衛生重要法規,1.Regulation(EC)178/2002onthehygieneoffoodstuffs,BasichygieneprinciplesFood&feedbusinessoperator:legalresponsibilityforensuringproductsafetyUnsafefoodstuffsmaynotbeplacedonthemarketTraceabilityConsiderationoflong-term,cumulativeeffects,EU,2.Regulation(EC)852/2004onthehygieneoffoodstuffs,Primaryproduction(AnnexI)andfurthersteps(AnnexII)AnalysisofpotentialfoodsafetyrisksanddeterminationofCriticalControlPoints(HazardAnalysisandCriticalControlPoints-HACCP)HACCPbasedonprinciplesofCodexAlimentariusControlanddocumentationrequirementduringthewholeproductionprocessRegistrationismandatoryforallfoodmanufacturingestablishments,EU,Riskassessment-HACCPConducthazardanalysisDeterminecriticalcontrolpoints(CCPs)Establishcriticallimit(s)EstablishsystemtomonitorCCPsEstablishcorrectiveactionEstablishverificationprocedureEstablishdocumentation,2.Regulation(EC)852/2004onthehygieneoffoodstuffs,EU,AnnexI(primaryproduction)Articles,fittingsandequipmentmustbeabletobecleanedand,wherenecessary,tobedisinfected.,2.Regulation(EC)852/2004onthehygieneoffoodstuffs,AnnexII(foodbusinessoperators)Surfaces(includingsurfacesofequipment)willrequiretheuseofsmooth,washable,corrosionresistantandnon-toxicmaterials,(ChapterII)Articles,fittingandequipmentmust.(ChapterV)Beeffectivelycleanedand,wherenecessary,disinfectedBesoconstructed,beofsuchmaterialsandbekeptinsuchgoodorder,repairandconditionastominimiseanyriskofcontamination.Beinstalledinsuchamannerastoallowadequatecleaningoftheequipmentandthesurroundingarea.,EU,3.Regulation(EC)853/2004Specifichygienerulesforfoodofanimalorigin(notaboutequipment),5.Regulation(EC)2073/2005onmicrobiologicalcriteriaforfoodstuffsDetermininglimitsforsafefoodFoodsafetycriteriaforbestbeforedate(BBD)Processhygienecriteriaduringmanufacturing,4.Regulation(EC)854/2004Specificrulesfortheorganizationofofficialcontrolsonproductsofanimaloriginintendedforhumanconsumption(notaboutequipment),EU,6.Regulation(EC)1935/2004onmaterialsandarticlesintendedtocomeintocontactwithfood,ScopeAllmaterialsandarticlesintendedtocome(prospectively)intocontactwithfood:Processingmachineryandfillingequipment,Kitchenequipment,container,packagingmaterial.,EU,Requirementonmaterialsintendedtocomeintocontactwithfood:,NohumanhealthhazardsNoindefensiblemodificationoffoodcompositionNodetractionfromorganolepticfoodpropertiesNomisdirectionofcustomersUse“forfoodcontact”orthesymbolTraceabilityonallmanufacturinganddistributionsteps,EU,7.Regulation(EC)2023/2006Goodmanufacturingpracticeformaterialsandarticlesintendedtocomeintocontactwithfood,8.Regulation(EU)10/2011Plasticmaterialsandarticlesintendedtocomeintocontactwithfood,revokesDirective2002/72/EC,EU,9.GMP-Directive2003/94/EC,PrinciplesandguidelinesofGoodManufacturingPracticeinrespectofmedicinalproductsforhumanuseandinvestigationalmedicinalproductsforhumanuse.GMP:“Qualityassurancesystem,whichcontrolsandmanagesmanufacturingandqualitycontroloffoods,pharmaceuticalproductsandmedicaldevices.”GMP-Directiveaffects:Personnel,premisesundequipmentofproduction,Qualitycontrolandlabeling,Contractedmanufacturingand(self-)inspection,Complaintsandproductrecall,EU,10.Directive(EC)2006/42AnnexI2.1.Foodprocessingmachineryandmachineryforpharma-ceuticalandcosmeticproducts,PrinciplesSodesignedandconstructedastoavoidanyriskofinfection,sicknessorcontagion.Materials,whichare(prospectively)intendedtocomeintocontactwithFood,Cosmetics,PharmaceuticalsMachineparts/materialsincontactwithfoodcanbecleanedbeforeeachuse.Wherethisisnotpossibledisposablepartsmustbeused.,EU,Requirementsonmachineconditions,Allsurfacesincludingtheirjoiningwithproductcontact(exception:disposableparts)mustBesmooth,withoutridgesorcrevicesReduceprojections,edgesandrecessestoaminimumBeeasilycleanedanddisinfectedInsidesurfacesmusthavecurvesofaradiussufficienttoallowsufficientcleaning,EU,Designrequirements,Itmustbepossibleforliquids,gasesandaerosolsderivingfromproductsaswellasfromcleaning,disinfectingandrinsingfluidstobecompletelydischargedfromthemachinery.Machinerymustbedesignedandconstructedinsuchawayastopreventanysubstancesorlivingcreatures,inparticularinsects,fromentering,oranyorganicmatterfromaccumulating.Machinerymustbedesignedandconstructedinsuchawaythatnoancillarysubstances,includingthelubricantsused,thatarehazardoustohealthcancomeintocontactwithproducts.,EU,Technicalfileformachinery-2006/42/EC,GeneraldescriptionofthemachineryOveralldrawings,accompaniedbyallcalculationnotes,testresultsCertificatesetc.requiredtochecktheconformitywiththehealthandsafetyrequirementsDocumentationonriskassessmentdemonstratingtheprocedurefollowedStandardsandothertechnicalspecificationsusedTechnicalreportgivingtheresultsofthetestscarriedoutCopyoftheinstructionsforthemachineryInternalmeasuresforserialproductionImplementedtoensurethatthemachineryremainsinconformitywiththeprovisionsofthisdirective,EU,歐盟食品機械衛生設計法規,歐洲經濟共同體(EEC)在1998頒布的聯盟法規歐洲機械設備指導方針(EuropeanCommunityMachineryDirective)89/37/EEC為輸入歐盟之機械設備的法規依據，對機械衛生安全有原則上的要求。機械衛生設計工程則由歐洲標準化委員會(EuropeanCommitteeforStandardization,CEN)所頒布之食品加工機械基本概念中的安全條例EN1672-1和衛生條例EN1672-2(ISO14159)所規範。任何輸入歐盟的食品加工機械設備均須符合上述之法規，若經EU檢查單位查察不符合規定者，相關單位有權可沒收與銷毀其設備與產品，嚴重者可勒令設備商關廠停止生產。,EU,LegaltextsUSA,FoodandDrugAdministration(FDA)FoodcodeUnitedStatesDepartmentofAgriculture(USDA)Legislationonmachinesprocessingagriculturalproducts,USA,FoodandDrugAdministration(FDA),USauthorityMonitorsandregulatesmanufacturingandtradingofpharmaceuticals,cosmeticsandfoodMonitorsbyregularinspection(incl.NON-USA)NoaccreditationofmachinecomponentsandequipmentDemandforFDA-compliantmaterialsaccordingto21CFR174-178,USA,USA,美國食品機械衛生設計法規,美國針對食品機械設備設計尚無強制之法律規範；FDA亦僅對設備設計提出基本設計原則之要求。,Sec.110.40Equipmentandutensils.Allplantequipmentandutensilsshallbesodesignedandofsuchmaterialandworkmanshipastobeadequatelycleanable,andshallbeproperlymaintained.Thedesign,construction,anduseofequipmentandutensilsshallprecludetheadulterationoffoodwithlubricants,fuel,metalfragments,contaminatedwater,oranyothercontaminants.Allequipmentshouldbesoinstalledandmaintainedastofacilitatethecleaningoftheequipmentandofalladjacentspaces.Foodcontactsurfacesshallbecorrosion-resistantwhenincontactwithfood.Theyshallbemadeofnontoxicmaterialsanddesignedtowithstandtheenvironmentoftheirintendeduseandtheactionoffood,and,ifapplicable,cleaningcompoundsandsanitizingagents.Foodcontactsurfacesshallbemaintainedtoprotectfoodfrombeingcontaminatedbyanysource,includingunlawfulindirectfoodadditives.Seamsonfood-contactsurfacesshallbesmoothlybondedormaintainedsoastominimizeaccumulationoffoodparticles,dirt,andorganicmatterandthusminimizetheopportunityforgrowthofmicroorganisms.Equipmentthatisinthemanufacturingorfood-handlingareaandthatdoesnotcomeintocontactwithfoodshallbesoconstructedthatitcanbekeptinacleancondition.,USA,VoluntarystandardsNon-legalrequirements,StandardsarerecommendationsReflectstateofthetechnology,國際食品機械衛生標準制定機構,國際標準國際標準組織(ISO)及國際乳業聯合會(IDF)區域標準歐洲標準化委員會(CEN)國家標準美國國家標準協會(ANSI)、德國標準化學會(DIN)、瑞典國家標準(SMS)及日本工業規格協會(JIS)團體標準3A衛生標準、歐洲衛生設備設計組織(EHEDG)公司標準Tri-Clover等，由各公司或企業制定與採行,美國國家標準學會AmericanNationalStandardsInstitute,ANSI,成立於1918年，負責所有技術領域及國家標準之建立-美國材料試驗協會(ASTM)-美國機械工程師協會(ASME)-美國礦業與冶金工程師協會(ASMME)-美國土木工程師協會(ASCE)-美國電氣工程師協會(AIEE)共同成立美國工程標準委員會(AESC)1966年改為現名美國國家標準學會(ANSI)3-A設備材料標準大多採用ASME與ASTM之規定,(),德國標準化學會DeutschesInstitutfurNormung(GermanInstituteforStandardization),1975年，德國政府將DIN作為國家標準體系，主要任務為建立各技術領域之國家標準。關於衛生設計，德國聯邦衛生部(GermanFederalMinistryofHealth)指示DIN與聯邦衛生局(FederalBoardofHealth)合作，共同建立衛生標準。大多數DIN標準為德國市場而制定，但在歐盟國家中最被廣泛引用。標準內容包含商業、服務業、工業、科技等。部分DIN標準已被規為國際標準，標記為“DIN/ISO”。,(http:/www.din.de),歐洲標準委員會(CEN)組合了不同國際組織來制定標準“CEN/TC153/4/”標準對於食品加工機械之安全及衛生要求有明確之定義“CEN/TC153N108E”標準定義人類及動物食用產品之機械衛生要求定義衛生設備加工可能產生的危險性，並提出防範措施,歐洲標準化委員會EuropeanCommitteeforStandardization,EuropeanCommitteeforStandardization,CEN/TC153:MachineryintendedforusewithfoodstuffsandfeedISO/TC199:SafetyofmachineryEN1672-2:2005,A1:2009:FoodprocessingmachineryBasicconceptsPart2:HygienerequirementsOthertechnicalCEN-commitees:TC194UtensilsincontactwithfoodTC197PumpsTC146PackagingmachinessafetyTC188Conveyorbelts,EN1672-2:2005,A1:2009Foodprocessingmachinery,Basicconcepts-Part2:HygienerequirementsHazardanalysisandmeasuresduringapplicationoffoodprocessingmachineryBasicconceptsofhazardsforfood,causedbyfoodprocessingmachineryDistinguishbetweenfoodarea,splashareaandnon-foodareaAccomplishmentofariskanalysisforfoodprocessingmachinerybasedonhygienicaspectsHygienicrequirementsonmaterialsanddesignExamplesforhygienicandnon-hygienicdesignandimplementationVerificationofhygienerequirementsInformationforuse,Considering:equipmentlife,expecteduseTrainingleveloftheuser,Severityandlikelihoodofoccurrence,Aretheysignificant?,VerifythathazardhasbeeneliminatedortheriskreducedduetodesignandhygienicmeasuresEnoughandclearinformationaccompanyingtheequipment(i.e.hygienicworkingpractices),Basicconcepts-Part2:Hygienerequirements-Riskassessment,Determinationofthelimitsofthemachinery,Estimationofthehygienerisks,Assessmentofhygienerisks,Hygienerisksminimisation,EN1672-2:2005,A1:2009Foodprocessingmachinery,OtherstandardsdevelopedbyCEN/TC153,Intotalmorethan60,availableatEuropeannationalstandardisationorganization,ISO14159:2002SafetyofmachineryHygienerequirementsformachinerydesign,BasicRegulationEquipmentsafety,Hygiene,Design,Consumerprotection,Environmentalcleanliness,Cleaning,Maintenance,Riskassessment,Biologicalhazards,Microorganisms,Grades(quality),InstructionsforuseSameapproachasEN1672-2,Standards/Recommendations,EuropeanHygienicEngineering&DesignGroup,Foundedin1989,itisaconsortiumofequipmentmanufacturers,foodcompanies,researchandeducationalinstitutesandpublichealthauthorities.Objectives:ProvidespracticalguidanceonthehygienicengineeringaspectsofmanufacturingsafeandwholesomefoodIdentifiesareaswhereknowledgeofhygienicdesignininsufficientDevelopsandpublishestestmethodsforhygienicdesignassessmentSafeandhygienicproductionoffoodandguidancetoequipmentmanufacturersandusersoncompliancewithnationalandinternationallegislation,Currentlymorethan600membersEquipmentcertificationbyEHEDG-authorizedinstitutesSubgroupclusters:PrinciplesEquipmentandComponentsProcessing,ServicesandUtilitiesTrainingandEducationCooperationwith:3-AisamemberofEHEDGandviceversa,EuropeanHygienicEngineering&DesignGroup,EHEDGSubgroups,EachSubgroupisresponsibleforanareaofexpertise,andwithineachareacertainspecificscopesaredefined.SubgroupswiththesamefocusarepooledtogetherinSubgroupcluster.ThecontactistheliaisonfortheclusterandmemberoftheExecutiveCommittee.,EHEDGSubgroups,Somepublishedguidelinesoutofabout40,Doc2:Amethodforassessingthein-placecleanabilityoffoodprocessingequipment,2004Doc8:Hygienicequipmentdesigncriteria,2004Doc14:Hygienicdesignofvalvesforfoodprocessing,2004Doc27:SafeStorageandDistributionofWaterinFoodFactoriesDoc35:Hygienicweldingofstainlesssteeltubinginthefoodprocessingindustry,2006,Guidelines,Guidelines,EHEDG衛生設計之微生物驗證方法,文件2食品加工設備之定位清洗效能測試方法文件4食品加工設備之線上巴斯德消毒有效性測試方法文件5食品加工設備之線上蒸氣滅菌有效性測試方法文件5食品加工設備之微生物不可入侵有效性測試方法文件15中型尺寸食品加工設備之定位清洗效能測試方法文件19親水過濾膜之微生物不可滲透有效性測試方法文件21評估包裝機衛生設計特性之挑戰測試方法,ThirdPartyCertificationSchemes,EHEDGmayauthorizetheuseoftheEHEDGCertificationlogoforequipmentcomplyingwiththeEHEDGhygienicdesigncriteria.EHEDGestablishedaschemein2000suchthatequipmentintendedtobecleanedwithliquids(TypeEL)couldbecertified(andalogoplacedontheequipment)ifitmetEHEDGDocumentNo.8Hygienicdesigncriteria.ThisschemewasrestructuredinJanuary2009.,The3-ASSIMission,toenhanceproductsafetyforconsumersoffood,beverages,andpharmaceuticalproductsthroughthedevelopmentanduseof3-ASanitaryStandardsand3-AAcceptedPractices.,The3-ASSIObjectives,Develop,maintainandpublishuniformstandardsandpracticesforthesanitary(hygienic)design,fabrication,installationandoperationofequipmentandmachinery.Usestate-of-the-art,science-basedexpertiseforthedevelopmentofsanitarystandardsandacceptedpractices.Harmonizewithglobalstandardsandguidelinesasappropriate.Promotetheuseof3-ASanitaryStandards,3-AAcceptedPractices,andthe3-ASymbol.Authorizeuseandmaintaintheintegrityofthe3-ASymbol.Maintainauniformsystemtoregulateandenforceproperuseofthe3-ASymboltobestenhanceconsumerproductsafety.Provideeducationconcerningsanitarydesignprinciples,applicationof3-ASanitaryStandards,3-AAcceptedPractices,anduseofthe3-ASymbol.,3-AWorkingGroups,TheWorkingGroups(WGs)arethebackboneofthe3-ASSIconsensusdocumentdevelopmentprocess.Thebulkofthestandardsdevelopmentworkiscarriedoutbythe13WGs,eitherwithineachWGasawholeorbyformingtaskgroupswithintheWGstoaccomplishspecificprojects.EachWGconsistsofexpertsrepresentingfabricatorsofrelatedtypesofequipment,systems,andmaterialsandrepresentativesoftheusersandsanitarianstakeholdergroups.SupplierstoOEMs,orconsultantsofrecordtoOEMsmayalsobedesignated.,3-ASSIWorkingGroups,VesselsFillersValvesandFittingsPumpsandMixersHeatExchangersConveyorsandFeedersInstrumentsConcentratingEquipment,Farm/RawMilkCheeseandButterEquipmentProcessandCleaningSystemsPlantSupportSystemsMaterialsandMaterialsTesting,3-ASanitaryStandards,AccreditedbyANSI(AmericanNationalStandardsInstitute)First3-AstandardswerefocusedonhygienicdesignofmilkProcessingequipmentSince20023-ASanitaryStandards(3-ASSI)werecreatedFDAandUSDAareactivemembers,3-ASanitaryStandards,Revisionofstandardsevery5years3-Asymbolauthorisationbasedonthirdpartyevaluation(TPV)programVolunteerstandardscontaininginformationabout:MaterialsallowedtobeappliedFabricationanddesignConstructionofprocessequipment,3-ASanitaryStandards,Somejoinedpublishedstandards:NSF3A/ANSI14159-1-2002:HygienerequirementsforthedesignofmeatandpoultryprocessingequipmentNSF/3A/ANSI14159-2-2003:HygienerequirementsforthedesignofhandheldtoolsusedinmeatandpoultryprocessingequipmentNSF/3A/ANSI14159-3-2005:Hygienerequirementsforthedesignofmechanicalbeltconveyorsusedinmeatandpoultryprocessingequipment,3-ASanitaryStandards,Published3-AStandardsandacceptedpractices3-Asanitarystandardsformulti-userubberandrubber-likematerialsusedasproductcontactsurfacesindairyequipmentNo.18-03About723-Astandardsandacceptedpractices,NSF,AccreditedbytheANSIProvidescertificationforequipmentusedintheprocessingofmeatandpoultryagainststandardsthathavebeenspecifiedbytheUSDAfortheevaluationoftheseequipment,NSF,Somepublishedstandards:NSF/ANSI2-2005a:FoodEquipmentNSF/ANSI51-2005:FoodEquipmentMaterialsNSF/ANSI170-2005:GlossaryoffoodequipmentterminologyNSF/3A/ANSI14159-1-2002:HygieneRequirementsfortheDesignofMeatandPoultryProcessingEquipmentNSF/3A/ANSI14159-22003:Hygienerequirementsforthedesignofhandheldtoolsusedinmeatandpoultryprocessingequipment,NSF,Somepublishedstandards:NSF/3A/ANSI14159-32005:HygienerequirementsforthedesignofmechanicalbeltconveyorsusedinmeatandpoultryprocessingequipmentNSFStandard5:HotWaterSupply,BoilersandHeatRecoveryEquipment,Circulatingtank,andinstantaneouswaterheaters,steamheatexchangers.NSF/ANSIStandard6:DispensingFreezers,Dispensingfreezers,NSF/ANSIStandard7:CommercialRefrigeratorsandFreezers,Reach-in,undercounterandwalk-instoragerefrigeratorsandfreezers,rapidpulldownrefrigeratorsandrefrigeratedfoodpreparationunitsusedinthefoodserviceindustry.,台灣機械衛生設計概況,尚缺乏一套完整的食品機械衛生設計指引可依循，機械製造過程多憑經驗。製造商多能達到機械運轉效能之要求，卻少能將食品衛生安全之概念嵌入機