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1、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,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,Codex Alimentarius-Food Hygiene,“Food safety”Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.Created in
2、 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.,Food Safety,Equipment/HardwareHygienic Design Criteria,ProcessHygiene Food Processing Criteria,-Regulation(EC)1935/2004-on materials and articles inte
3、nded 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 food,Machinery directive 2006/42/EC,EU-regulations:RE(EC)178/2002RE(EC)852/2004RE(EC)2073/2
4、005,Hygienic Design of Machinery vs.Hygienic Control of Process,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)178/2002 on the hygiene of foodstuffs,Basic hygiene principlesFood&feed business operator:legal responsibility for ensuring product safetyUnsafe foodstuffs may not be placed
5、 on the marketTraceability Consideration of long-term,cumulative effects,EU,2.Regulation(EC)852/2004 on the hygiene of foodstuffs,Primary production(Annex I)and further steps(Annex II)Analysis of potential food safety risks and determination of Critical Control Points(Hazard Analysis and Critical Co
6、ntrol Points-HACCP)HACCP based on principles of Codex AlimentariusControl and documentation requirement during the whole production process Registration is mandatory for all food manufacturing establishments,EU,Risk assessment-HACCP Conduct hazard analysisDetermine critical control points(CCPs)Estab
7、lish critical limit(s)Establish system to monitor CCPsEstablish corrective actionEstablish verification procedureEstablish documentation,2.Regulation(EC)852/2004 on the hygiene of foodstuffs,EU,Annex I(primary production)Articles,fittings and equipment must be able to be cleaned and,where necessary,
8、to be disinfected.,2.Regulation(EC)852/2004 on the hygiene of foodstuffs,Annex II(food business operators)Surfaces(including surfaces of equipment)will require the use of smooth,washable,corrosion resistant and non-toxic materials,(Chapter II)Articles,fitting and equipment must.(Chapter V)Be effecti
9、vely cleaned and,where necessary,disinfectedBe so constructed,be of such materials and be kept in such good order,repair and condition as to minimise any risk of contamination.Be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.,EU,3.Regulation(EC)85
10、3/2004Specific hygiene rules for food of animal origin(not about equipment),5.Regulation(EC)2073/2005 on microbiological criteria for foodstuffs Determining limits for safe foodFood safety criteria for best before date(BBD)Process hygiene criteria during manufacturing,4.Regulation(EC)854/2004 Specif
11、ic rules for the organization of official controls on products of animal origin intended for human consumption(not about equipment),EU,6.Regulation(EC)1935/2004 on materials and articles intended to come into contact with food,ScopeAll materials and articles intended to come(prospectively)into conta
12、ct with food:Processing machinery and filling equipment,Kitchen equipment,container,packaging material.,EU,Requirement on materials intended to come into contact with food:,No human health hazardsNo indefensible modification of food composition No detraction from organoleptic food properties No misd
13、irection of customersUse“for food contact”or the symbolTraceability on all manufacturing and distribution steps,EU,7.Regulation(EC)2023/2006Good manufacturing practice for materials and articles intended to come into contact with food,8.Regulation(EU)10/2011Plastic materials and articles intended to
14、 come into contact with food,revokes Directive 2002/72/EC,EU,9.GMP-Directive 2003/94/EC,Principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use.GMP:“Quality assurance system,which controls and manage
15、s manufacturing and quality control of foods,pharmaceutical products and medical devices.”GMP-Directive affects:Personnel,premises und equipment of production,Quality control and labeling,Contracted manufacturing and(self-)inspection,Complaints and product recall,EU,10.Directive(EC)2006/42 Annex I 2
16、.1.Food processing machinery and machinery for pharma-ceutical and cosmetic products,Principles 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/materia
17、ls in contact with food can be cleaned before each use.Where this is not possible disposable parts must be used.,EU,Requirements on machine conditions,All surfaces including their joining with product contact(exception:disposable parts)mustBe smooth,without ridges or crevices Reduce projections,edge
18、s and recesses to a minimumBe easily cleaned and disinfectedInside surfaces must have curves of a radius sufficient to allow sufficient cleaning,EU,Design requirements,It must be possible for liquids,gases and aerosols deriving from products as well as from cleaning,disinfecting and rinsing fluids t
19、o be completely discharged from the machinery.Machinery must be designed and constructed in such a way as to prevent any substances or living creatures,in particular insects,from entering,or any organic matter from accumulating.Machinery must be designed and constructed in such a way that no ancilla
20、ry substances,including the lubricants used,that are hazardous to health can come into contact with products.,EU,Technical file for machinery-2006/42/EC,General description of the machineryOverall drawings,accompanied by all calculation notes,test results Certificates etc.required to check the confo
21、rmity with the health and safety requirementsDocumentation on risk assessment demonstrating the procedure followedStandards and other technical specifications usedTechnical report giving the results of the tests carried outCopy of the instructions for the machineryInternal measures for serial produc
22、tionImplemented to ensure that the machinery remains in conformity with the provisions of this directive,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(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。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
23、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。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,Legal texts USA,Food and Drug Administration(FDA)Food codeUnited States Department of Agriculture(USDA)Legislation on machines processing agricultural products,USA,Fo
24、od and Drug Administration(FDA),US authorityMonitors and regulates manufacturing and trading of pharmaceuticals,cosmetics and foodMonitors by regular inspection(incl.NON-USA)No accreditation of machine components and equipment Demand for FDA-compliant materials according to 21CFR 174-178,USA,USA,美國食
25、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.110.40 Equipment and utensils.All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable,and shall be properly maintained.The design,construction,and use of equipment and utensils
26、 shall preclude the adulteration of food with lubricants,fuel,metal fragments,contaminated water,or any other contaminants.All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.Food contact surfaces shall be corrosion-resistant
27、when in contact with food.They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food,and,if applicable,cleaning compounds and sanitizing agents.Food contact surfaces shall be maintained to protect food from being contaminated by an
28、y source,including unlawful indirect food additives.Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles,dirt,and organic matter and thus minimize the opportunity for growth of microorganisms.Equipment that is in the manufacturing or
29、food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.,USA,Voluntary standardsNon-legal requirements,Standards are recommendationsReflect state of the technology,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
30、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American National Standards Institute,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
31、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,(http:/www.ansi.org),德國標準化學會Deutsches Institut fur Normung(German Institute for Standardization),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(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。大多數DIN標準為德國市場而制定，但在歐盟國家中最被
32、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/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“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,European Committee for Standardization,CEN/TC 153
33、:Machinery intended for use with foodstuffs and feedISO/TC 199:Safety of machineryEN 1672-2:2005,A1:2009:Food processing machinery Basic concepts Part 2:Hygiene requirementsOther technical CEN-commitees:TC 194 Utensils in contact with foodTC 197 PumpsTC 146 Packaging machines safetyTC 188 Conveyor b
34、elts,EN 1672-2:2005,A1:2009 Food processing machinery,Basic concepts-Part 2:Hygiene requirementsHazard analysis and measures during application of food processing machineryBasic concepts of hazards for food,caused by food processing machineryDistinguish between food area,splash area and non-food are
35、aAccomplishment of a risk analysis for food processing machinery based on hygienic aspectsHygienic requirements on materials and designExamples for hygienic and non-hygienic design and implementationVerification of hygiene requirementsInformation for use,Considering:equipment life,expected useTraini
36、ng level of the user,Severity and likelihood of occurrence,Are they significant?,Verify that hazard has been eliminated or the risk reduced due to design and hygienic measuresEnough and clear information accompanying theequipment(i.e.hygienic working practices),Basic concepts-Part 2:Hygiene requirem
37、ents-Risk assessment,Determination of the limits of the machinery,Estimation of the hygiene risks,Assessment of hygiene risks,Hygiene risks minimisation,EN 1672-2:2005,A1:2009 Food processing machinery,Other standards developed by CEN/TC 153,In total more than 60,available at European national stand
38、ardisation organization,ISO 14159:2002 Safety of machineryHygiene requirements for machinery design,Basic Regulation Equipment safety,Hygiene,Design,Consumer protection,Environmental cleanliness,Cleaning,Maintenance,Risk assessment,Biological hazards,Microorganisms,Grades(quality),Instructions for u
39、se Same approach as EN 1672-2,Standards/Recommendations,European Hygienic Engineering&Design Group,Founded in 1989,it is a consortium of equipment manufacturers,food companies,research and educational institutes and public health authorities.Objectives:Provides practical guidance on the hygienic eng
40、ineering aspects of manufacturing safe and wholesome food Identifies areas where knowledge of hygienic design in insufficientDevelops and publishes test methods for hygienic design assessmentSafe and hygienic production of food and guidance to equipment manufacturers and users on compliance with nat
41、ional and international legislation,Currently more than 600 membersEquipment certification by EHEDG-authorized institutesSubgroup clusters:Principles Equipment and Components Processing,Services and UtilitiesTraining and EducationCooperation with:3-A is a member of EHEDG and vice versa,European Hygi
42、enic Engineering&Design Group,EHEDG Subgroups,Each Subgroup is responsible for an area of expertise,and within each area certain specific scopes are defined.Subgroups with the same focus are pooled together in Subgroup cluster.The contact is the liaison for the cluster and member of theExecutive Com
43、mittee.,EHEDG Subgroups,Some published guidelines out of about 40,Doc 2:A method for assessing the in-place cleanability of food processing equipment,2004Doc 8:Hygienic equipment design criteria,2004Doc 14:Hygienic design of valves for food processing,2004Doc 27:Safe Storage and Distribution of Wate
44、r in Food FactoriesDoc 35:Hygienic welding of stainless steel tubing in the food processing industry,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
45、特性之挑戰測試方法,Third Party Certification Schemes,EHEDG may authorize the use of the EHEDG Certification logo for equipment complying with the EHEDG hygienic design criteria.EHEDG established a scheme in 2000 such that equipment intended to be cleaned with liquids(Type EL)could be certified(and a logo pla
46、ced on the equipment)if it met EHEDG Document No.8 Hygienic design criteria.This scheme was restructured in January 2009.,The 3-A SSI Mission,to enhance product safety for consumers of food,beverages,and pharmaceutical products through the development and use of 3-A Sanitary Standards and 3-A Accept
47、ed Practices.,The 3-A SSI Objectives,Develop,maintain and publish uniform standards and practices for the sanitary(hygienic)design,fabrication,installation and operation of equipment and machinery.Use state-of-the-art,science-based expertise for the development of sanitary standards and accepted pra
48、ctices.Harmonize with global standards and guidelines as appropriate.Promote the use of 3-A Sanitary Standards,3-A Accepted Practices,and the 3-A Symbol.Authorize use and maintain the integrity of the 3-A Symbol.Maintain a uniform system to regulate and enforce proper use of the 3-A Symbol to best e
49、nhance consumer product safety.Provide education concerning sanitary design principles,application of 3-A Sanitary Standards,3-A Accepted Practices,and use of the 3-A Symbol.,3-A Working Groups,The Working Groups(WGs)are the backbone of the 3-A SSI consensus document development process.The bulk of
50、the standards development work is carried out by the 13 WGs,either within each WG as a whole or by forming task groups within the WGs to accomplish specific projects.Each WG consists of experts representing fabricators of related types of equipment,systems,and materials and representatives of the us
