国际食品机械设备卫生安全标准与重要法规.ppt

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1、1国际食品机械设备卫生安全标准与重要法规 Still waters run deep.流静水深流静水深,人静心深人静心深 Where there is life,there is hope。有生命必有希望。有生命必有希望2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3Codex Alimentarius-Food Hygieneq“Food safety”Assurance that food will not cause harm to the consumer when it

2、is prepared and/or eaten according to its intended use.Created in 1963 by FAO and WHO to develop food standards,guidelines and related texts such as codes of practice under the joint FAO/WHO Food Standards Program.4FoodSafetyEquipment/HardwareHygienicDesignCriteriaProcessHygieneFoodProcessingCriteri

3、a-Regulation(EC)1935/2004-on materials and articles intended to come into contact with food-Regulation(EU)10/2011 Plastic materials in food contact-Regulation(EC)2023/2006-on good manufacturing practice for materials and articles intended to come into contact with foodMachinery directive 2006/42/ECE

4、U-regulations:RE(EC)178/2002RE(EC)852/2004RE(EC)2073/20055HACCP,HACCP,GMPGMPHygienicHygienicDesignDesignmachineryprocessequipment,componentsinstallationfunctioncleanabilityequipment qualityproduction,processproductpersonalcleaningproduct qualityrisk assessment(machinery)risk assessment(product)Hygie

5、nic Design of Machinery vs.Hygienic Control of Process Hygienic Design of Machinery vs.Hygienic Control of Process 6工業級與食品級機械設計之差異工業級工業級食品級食品級工業級機械設計工業級機械設計工業級機械設計工業級機械設計食品級機械設計食品級機械設計食品級機械設計食品級機械設計設備功能性設備功能性材料選用材料選用質能傳送效率質能傳送效率機構設計機構設計機電整合機電整合程序控制程序控制操作安全性操作安全性僅需符合僅需符合功能功能功能功能需求！需求！設備功能性設備功能性選用無毒性材

6、料選用無毒性材料質能傳送效率質能傳送效率機構設計機構設計機電整合機電整合程序控制程序控制操作安全性操作安全性衛生設計衛生設計設備滅菌設備滅菌設備易清洗設備易清洗需符合需符合食用衛生食用衛生食用衛生食用衛生安全安全安全安全需求！需求！設備規格與衛生等級設備規格與衛生等級7歐美食品與設備衛生重要法規81.Regulation(EC)178/2002 on the hygiene of foodstuffslBasic hygiene principleslFood&feed business operator:legal responsibility for ensuring product sa

7、fetylUnsafe foodstuffs may not be placed on the marketlTraceability lConsideration of long-term,cumulative effectsEU92.Regulation(EC)852/2004 on the hygiene of foodstuffslPrimary production(Annex I)and further steps(Annex II)lAnalysis of potential food safety risks and determination of Critical Cont

8、rol Points(Hazard Analysis and Critical Control Points-HACCP)lHACCP based on principles of Codex AlimentariuslControl and documentation requirement during the whole production process lRegistration is mandatory for all food manufacturing establishmentsEU10qRisk assessment-HACCP Conducthazardanalysis

9、Determinecriticalcontrolpoints(CCPs)Establishcriticallimit(s)EstablishsystemtomonitorCCPsEstablishcorrectiveactionEstablishverificationprocedureEstablishdocumentation2.Regulation(EC)852/2004 on the hygiene of foodstuffsEU11Annex I(primary production)Articles,fittings and equipment must be able to be

10、 cleaned and,where necessary,to be disinfected.2.Regulation(EC)852/2004 on the hygiene of foodstuffsAnnex II(food business operators)qSurfaces(including surfaces of equipment)will require the use of smooth,washable,corrosion resistant and non-toxic materials,(Chapter II)qArticles,fitting and equipme

11、nt must.(Chapter V)lBe effectively cleaned and,where necessary,disinfectedlBe so constructed,be of such materials and be kept in such good order,repair and condition as to minimise any risk of contamination.lBe installed in such a manner as to allow adequate cleaning of the equipment and the surroun

12、ding area.EU123.Regulation(EC)853/2004Specifichygienerulesforfoodofanimalorigin(notaboutSpecifichygienerulesforfoodofanimalorigin(notaboutequipment)equipment)5.Regulation(EC)2073/2005 on microbiological criteria for foodstuffs DetermininglimitsforsafefoodFoodsafetycriteriaforbestbeforedate(BBD)Proce

13、sshygienecriteriaduringmanufacturing4.Regulation(EC)854/2004 SpecificrulesfortheorganizationofofficialcontrolsonSpecificrulesfortheorganizationofofficialcontrolsonproductsofanimaloriginintendedforhumanconsumptionproductsofanimaloriginintendedforhumanconsumption(notaboutequipment)(notaboutequipment)E

14、U136.Regulation(EC)1935/2004 on materials and articles intended to come into contact with foodqScopeScopeAllmaterialsandarticlesintendedtocome(prospectively)intocontactwithfood:Processingmachineryandfillingequipment,Kitchenequipment,container,packagingmaterial.EU14Requirement on materials intended t

15、o come into contact with food:No human health hazardsNo indefensible modification of food composition No detraction from organoleptic food properties No misdirection of customersUse“for food contact”or the symbolTraceability on all manufacturing and distribution stepsEU157.Regulation(EC)2023/2006Goo

16、dmanufacturingpracticeformaterialsandGoodmanufacturingpracticeformaterialsandarticlesintendedtocomeintocontactwithfoodarticlesintendedtocomeintocontactwithfood8.Regulation(EU)10/2011Plasticmaterialsandarticlesintendedtocomeintocontactwithfood,revokesDirective2002/72/ECEU169.GMP-Directive 2003/94/ECq

17、Principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use.qGMP:“Quality assurance system,which controls and manages manufacturing and quality control of foods,pharmaceutical products and medical device

18、s.”qGMP-Directiveaffects:Personnel,premises und equipment of production,Quality control and labeling,Contracted manufacturingand(self-)inspection,Complaints and product recallEU1710.Directive(EC)2006/42 Annex I 2.1.Food processing machinery and machinery for pharma-ceutical and cosmetic productsPrin

19、ciples So designed and constructed as to avoid any risk of infection,sickness or contagion.Materials,which are(prospectively)intended to come into contact with Food,Cosmetics,PharmaceuticalsMachine parts/materials in contact with food can be cleaned before each use.Wherethisisnotpossibledisposablepa

20、rtsmustbeused.EU18Requirements on machine conditionsAll surfaces including their joining with product contact(exception:disposable parts)mustBe smooth,without ridges or crevices Reduce projections,edges and recesses to a minimumBe easily cleaned and disinfectedInside surfaces must have curves of a r

21、adius sufficient to allow sufficient cleaningEU19Design requirementsqItmustbepossibleforliquidsliquids,gasesgasesandaerosolsaerosolsderivingfromproductsaswellasfromcleaning,disinfectingandrinsingfluidstobecompletelycompletelydischargedfromthemachinery.qMachinerymustbedesignedandconstructedinsuchaway

22、astopreventpreventanysubstancesorlivingcreatures,inparticularinsects,fromenteringentering,oranyorganicmatterfromaccumulatingaccumulating.qMachinerymustbedesignedandconstructedinsuchawaythatnoancillarysubstancesancillarysubstances,includingthelubricantsused,thatarehazardoustohealthhazardoustohealthca

23、ncomeintocontactwithproducts.EU20Technical file for machinery-2006/42/ECTechnical file for machinery-2006/42/ECGeneraldescriptiondescriptionofthemachineryOveralldrawings,accompaniedbyallcalculationnotes,testresultsCertificatesetc.requiredtocheckchecktheconformityconformitywiththehealthandsafetyrequi

24、rementsDocumentationonriskassessmentriskassessmentdemonstratingtheprocedurefollowedStandardsStandardsandothertechnicalspecificationsusedusedTechnicalreportgivingtheresultsofthetestscarriedoutCopyoftheinstructionsforthemachineryInternalmeasuresforserialproductionImplementedtoensurethatthemachineryrem

25、ainsinconformitywiththeprovisionsofthisdirectiveEU21歐盟食品機械衛生設計法規q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(European Community Machinery Directive)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。q機械衛生設計工程則由歐洲標準化委員會(European Committee for Standardization,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(ISO 14159)所規範。q任

26、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。EU22Legal texts USAqFood and Drug Administration(FDA)FoodcodeqUnited States Department of Agriculture(USDA)LegislationonmachinesprocessingagriculturalproductsFDAUSDA Work jointly together with other local,federal and nationa

27、l organizationsUSA23Food and Drug Administration(FDA)qUSauthorityqMonitorsandregulatesmanufacturingandtradingofpharmaceuticals,cosmeticsandfoodqMonitorsbyregularinspection(incl.NON-USA)qNoaccreditationofmachinecomponentsandequipmentqDemandforFDA-compliantmaterialsaccordingto21CFR174-178USA24USA25美國食

28、品機械衛生設計法規q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,anduseofequipmentandutensilsshallprecludetheadulterationoffoo

29、dwithlubricants,fuel,metalfragments,contaminatedwater,oranyothercontaminants.Allequipmentshouldbesoinstalledandmaintainedastofacilitatethecleaningoftheequipmentandofalladjacentspaces.Foodcontactsurfacesshallbecorrosion-resistantwhenincontactwithfood.Theyshallbemadeofnontoxicmaterialsanddesignedtowit

30、hstandtheenvironmentoftheirintendeduseandtheactionoffood,and,ifapplicable,cleaningcompoundsandsanitizingagents.Foodcontactsurfacesshallbemaintainedtoprotectfoodfrombeingcontaminatedbyanysource,includingunlawfulindirectfoodadditives.Seamsonfood-contactsurfacesshallbesmoothlybondedormaintainedsoastomi

31、nimizeaccumulationoffoodparticles,dirt,andorganicmatterandthusminimizetheopportunityforgrowthofmicroorganisms.Equipmentthatisinthemanufacturingorfood-handlingareaandthatdoesnotcomeintocontactwithfoodshallbesoconstructedthatitcanbekeptinacleancondition.USA26Voluntary standardsNon-legal requirementsNo

32、n-legal requirementslStandards are recommendationslReflect state of the technology27國際食品機械衛生標準制定機構q國際標準國際標準組織(ISO)及國際乳業聯合會(IDF)q區域標準歐洲標準化委員會(CEN)q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)q團體標準3A衛生標準、歐洲衛生設備設計組織(EHEDG)q公司標準Tri-Clover等，由各公司或企業制定與採行28美國國家標準學會American National Standards I

33、nstitute,ANSIAmerican National Standards Institute,ANSIq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)q1966年改為現名美國國家標準學會(ANSI)q3-A設備材料標準大多採用ASME與ASTM之規定(http:/www.ansi.org)29德國標準化學會DDeutsches eutsches I Institut fur nst

34、itut fur NNormungormung(German Institute for StandardizationGerman Institute for Standardization)q1975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。q關於衛生設計，德國聯邦衛生部(German Federal Ministry of Health)指示DIN與聯邦衛生局(Federal Board of Health)合作，共同建立衛生標準。q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。q標準內容包含商業、服務業、工業、科技等。q部分DIN標準已被

35、規為國際標準，標記為“DIN/ISO”。(http:/www.din.de)30q歐洲標準委員會(CEN)組合了不同國際組織來制定標準q“CEN/TC 153/4/”標準對於食品加工機械之安全及衛生要求有明確之定義q“CEN/TC 153 N 108 E”標準定義人類及動物食用產品之機械衛生要求q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European Committee for Standardization 31European Committee for StandardizationqCEN/TC153:Machinery intended for use wi

36、th foodstuffs and feedqISO/TC199:Safety of machineryqEN1672-2:2005,A1:2009:Food processing machinery Basic concepts Part 2:Hygiene requirementsqOthertechnicalCEN-commitees:lTC 194 Utensils in contact with foodlTC 197 PumpslTC 146 Packaging machines safetylTC 188 Conveyor belts32EN 1672-2:2005,A1:200

37、9 Food processing machineryBasic concepts-Part 2:Hygiene requirementsBasic concepts-Part 2:Hygiene requirementsHazardanalysisandmeasuresduringapplicationoffoodprocessingmachineryBasicconceptsofhazardsforfood,causedbyfoodprocessingmachineryDistinguishbetweenfoodarea,splashareaandnon-foodareaAccomplis

38、hmentofariskanalysisforfoodprocessingmachinerybasedonhygienicaspectsHygienicrequirementsonmaterialsanddesignExamplesforhygienicandnon-hygienicdesignandimplementationVerificationofhygienerequirementsInformationforuse33-Considering:equipment life,expected use-Training level of the user-Severity and li

39、kelihood of occurrence-Are they significant?-Verify that hazard has been eliminated or the risk reduced due to design and hygienic measures-Enough and clear information accompanying theequipment(i.e.hygienic working practices)Basic concepts-Part 2:Hygiene requirements-Risk assessmentDetermination of

40、 the limits of the machineryEstimation of the hygiene risksAssessment of hygiene risksHygiene risks minimisationEN 1672-2:2005,A1:2009 Food processing machinery34Other standards developed by CEN/TC 153In total more than 60,available at European national standardisation organizationStandardreferenceT

41、itleEN12331:2003Foodprocessingmachinery-Mincingmachines-SafetyandhygienerequirementsEN12463:2004Foodprocessingmachinery-Fillingmachinesandauxiliarymachines-SafetyandhygienerequirementsEN13570:2005Foodprocessingmachinery-Mixingmachines-SafetyandhygienerequirementsEN1678:1998Foodprocessingmachinery-Ve

42、getablecuttingmachines-SafetyandhygienerequirementsEN1974:1998Foodprocessingmachinery-Slicingmachines-Safetyandhygienerequirements35ISO 14159:2002 Safety of machineryHygiene requirements for machinery designHygiene requirements for machinery designqBasicRegulationqEquipmentsafety,Hygiene,Design,Cons

43、umerprotection,Environmentalcleanliness,Cleaning,Maintenance,Riskassessment,Biologicalhazards,Microorganisms,Grades(quality),InstructionsforuseqSameapproachasEN1672-236Standards/Recommendations37European Hygienic Engineering&Design GroupqFoundedin1989,itisaconsortiumofequipmentmanufacturers,foodcomp

44、anies,researchandeducationalinstitutesandpublichealthauthorities.qObjectives:Provides practical guidance on the hygienic engineering aspects of manufacturing safe and wholesome food Identifies areas where knowledge of hygienic design in insufficientDevelops and publishes test methods for hygienic de

45、sign assessmentSafe and hygienic production of food and guidance to equipment manufacturers and users on compliance with national and international legislation38qCurrentlymorethan600membersqEquipmentcertificationbyEHEDG-authorizedinstitutesqSubgroupclusters:lPrincipleslEquipmentandComponentslProcess

46、ing,ServicesandUtilitieslTrainingandEducationqCooperationwith:3-AisamemberofEHEDGandviceversaEuropean Hygienic Engineering&Design Group39EHEDG SubgroupsSubgroupclusterSubgroupsProcessing,services&utilitiesContact:Dr.JohnHolahlAirhandlinglElectricalinstallationslHeattreatmentslLubricantslProcesswater

47、lMeatprocessingTraining&EducationContact:KnuthLorenzenlFacilitatorlToolboxlTrainingqEachSubgroupisresponsibleforanareaofexpertise,andwithineachareacertainspecificscopesaredefined.qSubgroupswiththesamefocusarepooledtogetherinSubgroupcluster.qThecontactistheliaisonfortheclusterandmemberoftheExecutiveC

48、ommittee.40EHEDG SubgroupsSubgroupclusterSubgroupsEquipment&ComponentsContact:JacquesKasteleinlCoolingandChillinglFishprocessingequipmentlMeatprocessingequipmentlMechanicalsealslPackingmachineslPipeandcouplingslPumpslSensorslValvesPrinciplesContact:Dr.JrgenHofmannlBuildingDesignlDesignprincipleslDry

49、materialshandlinglHygienicsystemsintegrationlMaterialsofconstructionlTestingandCertificationlWelding41Some published guidelines out of about 40qDoc2:Amethodforassessingthein-placecleanabilityoffoodprocessingequipment,2004qDoc8:Hygienicequipmentdesigncriteria,2004qDoc14:Hygienicdesignofvalvesforfoodp

50、rocessing,2004qDoc27:SafeStorageandDistributionofWaterinFoodFactoriesqDoc35:Hygienicweldingofstainlesssteeltubinginthefoodprocessingindustry,200642GuidelinesDoc.Subjects1Microbiologicallysafecontinuouspasteurizationofliquidfood2Amethodforassessingthein-placecleanabilityoffoodprocessingequipment.3Mic