食品過敏源的學習課件第1頁/共33頁Foodallergyversusfoodintolerance食品過敏源與食品不耐性Foodallergy:theimmune-mediatedstateofhypersensitivityresultingfromexposuretoafood-borneallergen(usuallyaproteinorglycoprotein).Normallydevelopingseriousreactionsandevencausingdeaths.食品過敏癥：高度敏感性的免疫調節狀態，系由接觸食品攜帶的過敏源（一般為蛋白質或糖原蛋白）而產生。通常發展為系列反應，甚至導致死亡。Foodintolerance:arenon-toxic,nonimmune-relatedmainlyduetonaturallyoccurringtoxicants(e.g.gluten),microbialorchemicalfoodcontaminants(e.g.phenylanaline)andinheritedmetabolicdisorders(e.g.lactoseintolerance).Rarelylife-threatening.食品不耐性：非毒性的、與免疫無關，主要由于自然生成的毒性物質（例如面筋），微生物或化學性食品污染（如苯胺）以及遺傳新陳代謝失調（如乳糖不耐）。很少危及生命。第2頁/共33頁Principalsoffoodallergy：Prevalence

食品過敏癥的原則:流行Thetrueprevalenceisunknown.真正流行不為人知。Itisestimatedthat1%ofadultsand5-6%ofchildrenhaveatruefoodallergy.據估算，1%成人、5-6%兒童有真正的食品過敏癥。Approximately950severereactionstofoodsrequiringhospitalisationoccurannuallyintheUS.(AccordingtotheUSDA15%oftheUSpopulationmaybeallergictosomefoodingredients).美國每年發生大約950例對食品嚴重的反應,需要住院治療。(根據USDA調查,15%的美國人口對一些食品原料過敏)IntheUKitisestimatedthatthereareatotalof15millionsufferersfromallergiestovarioussubstances-notonlyfoodstuffs-(1in4ofthepopulation).英國估計有總數達1500萬人對各種物質-不只是食品-過敏(人口總數的四分之一)。Allergicindividualsreacttotracelevelsoftheoffendingallergen.過敏群體對所引發過敏源痕跡有反應。第3頁/共33頁Consumercomplaints消費者投訴(KFIdatabase2000數據庫2000)Totalnumberofcomplaintsforconfectionery:5.996對糖果投訴總數為：5.996Totalnumberofcomplaintsforfood:11.077對食品投訴總數為:11.077第4頁/共33頁Keyplayersofallergenicresponse過敏源反應的關鍵因素Threeessentialcomponents三個關鍵部分:Antigen抗原(allergen過敏源)IgEAntibodies抗體Effectorcell效應基因細胞(mastcellorbasophil桿細胞或堿性細胞)IgEareproducedbyBcells(Lymphocytes)inresponsetoexposuretotheantigen.B細胞(淋巴細胞）遇到抗體時產生IgEGlycoproteinsthatareabsorbedduringdigestionanddistributedtothebodyviathebloodstream在消化時吸收的糖原蛋白質通過血流分送到全身Mastcellsarefoundintheconnectivetissue桿細胞發現于結締組織Basophilscirculateinthebloodstream堿性細胞在血流中循環Bothhavehigh-affinityIgEreceptorsonthesurface它們都與表面的IgE受體有密切關系第5頁/共33頁Clinicalmanifestations臨床表現Gastro-intestinal胃腸反應:Swellingofmouthparts,abdominalcramps,diarrhoea,nausea,vomiting.嘴部腫脹、腹部痙攣、腹瀉、惡心、嘔吐。Respiratory呼吸反應:runnynose,difficultybreathing,constrictionofthroat.鼻子流涕、呼吸困難、喉嚨堵塞。Cutaneous皮膚反應:swelling,hivesandskinrash.腫脹、蕁麻疹、皮疹。Systemic=Anaphylacticshock.全身=過敏中風。Deathoccursduetocardiaorespiratoryarrestandshock.Initialsymptomsusuallybeginwithin30minafterexposure.由于心臟和呼吸困難及中風導致死亡。通常在接觸過敏源30分鐘后出現初始癥狀。第6頁/共33頁Mostcommonfoodallergens最常見的食品過敏源Majorseriousallergensinclude主要嚴重的過敏源包括(IFST-1999):“Bigeight八大樣”:

eggs,cow′smilk,peanut,soybean,wheat,treenuts,fishandcrustacean蛋品、牛奶、花生、黃豆、小麥、樹木堅果、魚類和甲殼類食品“Secondeight八小樣”:

sesameseeds,sunflowerseeds,cottonseed,poppyseed,fruits,beansotherthangreenbeans,peasandlentils.芝麻籽、葵花子、棉籽、罌粟籽、水果、豆類（不包括綠豆）、豌豆和小扁豆Others其它:

tartrazine,sulphitesandlatex.第7頁/共33頁KFIfoodallergencategorylist*KFI食品過敏源類別清單Celery芹菜Eggs蛋類Cow′smilk牛奶Peanut花生Soybean大豆Sulphites亞硫酸鹽Wheat小麥Seeds種子Seafood海鮮

Treenuts樹木堅果Cottonseed棉籽poppyseeds罌粟子sesameseeds芝麻籽sunflowerseeds葵花子Crustacean甲殼類Fish魚類almond杏仁brazilnut巴西木堅果cashew賈如樹堅果chestnut栗子hazelnut榛子macadamianutpinenuts松子pistachio阿月渾子的果實pecan美洲山核桃walnut核桃*Someexemptionsareincludedinthelist-Example一些例外在-實例表中列出第8頁/共33頁FoodAllergensstability食品過敏源穩定性Resistancetothedigestivetract:抗消化系統能力Mostfoodallergensareresistanttoenzymes,acidsandbilesaltspresentinthestomach.大部分過敏源對胃中的酶、酸和膽汁鹽具有抵抗力。FreshfruitsandvegetablesareeasilydigestedintheGItractanddonotcausesystemiceffects.新鮮水果和蔬菜很容易在GI系統中消化并不會影響系統。Resistancetoproteolysis,hydrolysisanddigestion:抗水解蛋白質、水解和消化Foodallergensareresistanttoproteolysisanddigestion(e.g.codfish,eggwhite).食品過敏源對水解蛋白質和消化有抵抗力（如鱈魚、蛋白）。Extensivehydrolysisisnecessarytoeliminateallergenicpropertiesoffoodallergens(e.g.casein,wheyproteins,soybean).廣泛的水解對于消除食品過敏源的過敏特性是必要的（例如酪蛋白、乳清蛋白質和大豆）。Allergeninactivationdependsontheenzymaticorchemicaltreatmentusedduringhydrolysisandproteolysis.在水解或水解蛋白質時，可使用酶或者化學處理辦法使過敏源失去作用。第9頁/共33頁FoodAllergensstability食品過敏源穩定性Resistancetoheat:抗熱性Mostfoodallergensareresistanttoheat.Fruitandvegetablesareheat-labileandcanbeeatenafterheatingorcanning.大部分食品過敏源抗熱。水果和蔬菜遇熱不穩定，可加熱或制成罐頭食品食用。Peanutandeggallergensremainstablewhenheatedorboiledat100°C.當加熱或煮沸到100度時，花生和蛋類過敏源仍保持穩定。Milkretainsitsallergenicitythroughcondensation,evaporation,anddrying.牛奶在經過凝聚、蒸發和烘干后仍保留過敏性。Acidstability:酸穩定性Mostallergensarestabletomoderateacidtreatments.大部分過敏源經過溫和的酸處理仍保持穩定性。PeanutallergensarestableatpH2.8andeggovalbuminatpH3.0.花生過敏源在PH值2.8,蛋類過敏源在PH值3.0的情況下仍保持穩定.第10頁/共33頁Managementoffoodallergy食品過敏管理Thebesttherapyconsistofstricteliminationoftheoffendingfoodfromthediet…最好的處理辦法是將引發(過敏)的食品從食譜中去除...Theapplicationofduediligencebymanufacturers制造商在以下幾個方面應用時，應非常審慎：Intheuseofallergensasingredients.使用過敏源作為原料。Inwarningofthepresenceorpotentialpresenceofsuchallergensinfoods.警告此過敏源在食品中出現或可能出現。Inpreventingcross-contaminationofproductswithallergenspresentinotherproductsortheenvironment.通過防止過敏源出現在其它產品或環境中而防止產品的交叉感染。ALLERGENMANAGEMENTPROGRAMME過敏源管理計劃Thatmeans意味著...leadingto...第11頁/共33頁Allergenmanagementprogram過敏源管理計劃

:Across-functionaleffort各職責部門共同努力Purchasing:采購Wantsingredientsthatmeetspecificationsatlowcost.低成本采購滿足規格的原料。Legal/regulatory:合法/滿足規章制度Wantstodevelopspecificationswiththeminimumdeclaredallergenspossible.開發過敏源可能性最小的產品。Manufacturing:生產Wantsefficientchangeoversbetweenproductswithminimumdowntime.用最少時間進行產品間轉換。Engineering:工程Wantstodesignflexibilityintothelines.把機動性設計加入到生產線中。Marketing:市場營銷Wantsthebroadestmarketpossiblefornewimprovedproducts.為新開發產品提供盡可能廣闊的市場。第12頁/共33頁Allergenmanagementprogram過敏源管理計劃

:Across-functionaleffort各職責部門共同努力Auditors:審計師Wanttoobtainevidenceofpropermanagementofallergensattheprocessingfacility.從加工設備中取得恰當管理過敏源的證據。Consumerrelations:消費者聯系Wanttoreducethenumberofcomplaintsregardingallergens.減少關于過敏源的投訴數量。Suppliers/Co-Manufacturers:供應商/合作生產商WanttocomplywithKFIexpectationsandadditionallyincreaseturnover.滿足KFI期望，并另外增加營業額。Customers/Consumers:顧客/消費者Wanttohavesufficientandunderstandableinformationinthepackagingtomakeadecisionaboutwhetherornottoconsumetheproduct.詳細理解包裝上的說明，以決定是否消費此產品。第13頁/共33頁Allergenmanagementprogram過敏源管理計劃Basedonahierarchyofcontrols:基于控制等級：1.-Avoidtheintroductionofanallergenintoafacilitythatdid notalreadycontaintheallergen.避免把過敏源引入到不含過敏源的設備中去。 2.-Totaldedicationandsegregation(oflineswhere possible)orequipment.生產線（如可行）或設備完全專業化和隔離。3.-Extensive,well-documentedcleaningandinspectionprocedurestopreventallergencross-contactorcarryover.全面、詳細記錄清潔及檢查程序，以防止過敏源交叉接觸或產生遺留物。4.-Iftheriskstillpresentaprecautionarylabelstatementshouldbeused.如風險仍存在，應使用預先防范標簽聲明第14頁/共33頁1.-Avoidanceofintroduction避免引入Identificationofingredientsandothersourcesofallergens.識別原料和其它過敏源的來源。UseFormC:Ingredient/packagingassessment-Toidentifysourcesofallergens.使用表格C

：原料/包裝評估-以識別過敏源的來源。UseFormsE:AllergenCross-ContactAssessment-Toidentifywhetherproductscanintroduceundeclaredallergensinotherproductsruninthesameline.使用表格E：過敏源交叉接觸評估-以識別是否產品能傳入同一生產線上其它產品所攜帶的未發現的過敏源。Effectivetaggingorcodingproceduresforallergen-containingingredients,sub-ingredientsandrework.為含過敏源的原料、原料附件和重復產品制定有效的加注標簽或編碼程序。Formula/processrevisionsmustbereviewedforintroductionofnewallergens.

修改配方/工序必須進行新過敏源引入審核。第15頁/共33頁FORMC:INGREDIENT/PACKAGINGASESSMENT表格C：原料/包裝評估Listtherawmaterial(RM)numberandname列出原材料（RM）號碼和名稱Listthestoragecondition列出儲存條件:A=Ambient室溫,

F=Frozen冷凍,R=Refrigerated冷藏Describethehazards描述危害DeterminethecontrolmechanismCCPorPP決定控制機制CCP或PP第16頁/共33頁FormE-1IngredientAllergenAssessment表格E-1配料過敏源評估Listallingredientscontainingallergens列出所有含過敏源的原料-Example實例Listidentifiedallergens列出已識別的過敏源Listallingredientscontainingcarryover列出所有含遺留過敏源的原料Listidentifiedcarryoverallergens列出已識別的遺留過敏源第17頁/共33頁FormE-2IngredientAllergenAssessment表格E-2配料過敏源評估Listallproductsproducedonthemanufacturingline列出所有生產線出產的產品-Example舉例Areallidentifiedallergenslabelled是否所有已識別過敏源已作好標記?If“no”identifycontrolmechanism(s)如果“沒有”，按識別控制機制第18頁/共33頁1.-Avoidanceofintroduction避免引入Allergensshouldbedesigned-out:應在設計時剔除過敏源Usenon-allergenicsubstitutestoallergenicingredients.使用無過敏源替代物代替過敏源原料。Avoidcross-contaminationfromotherlinesorotherproductionareas.避免來自其它生產線或其它生產區域的交叉感染。Ensureasaferawmaterialssupply確保原材料供應安全:Auditsuppliers’allergenmanagementprogram.審計供應商的過敏源管理計劃。Contract/Specificationreview.合同/規格審核。Notificationofanyformulationchange.通知任何配方更換。Trainingofpersonnel人員培訓:Anallergenawarenesstrainingsessionshouldbeperformedatleasteveryyear.應至少每年舉行過敏源意識培訓會第19頁/共33頁2.Segregation隔離Physicalbarriers:物理屏障Separatereceptionandstorageareasforallergenicingredients.為過敏源原料單獨設立收貨和儲存區。Dedicatemanufacturingareaswithinthefactory在工廠內分離出生產區:Airextraction/filtrationsystemsshouldremoveanyairborneallergen.空氣抽取/過濾系統應去除任何空氣傳播過敏源。Controlofpersonnel:changeofoveralls,hairnetsandshoes.人員控制：更換衣服、發網和鞋。Trafficpatternsofpeople,ingredientsandfinishedproducts.人們的交通模式、原料和成品。Identificationofsharedequipmentanditsabilitytobedismantled識別共用設備及其拆卸能力:UseFormD使用表格D:Processstepevaluation工序階段評估Toidentifyallergensthatmaybeintroducedfromtheprocessand/orprocessingenvironment.識別有可能在加工或加工環境中進入的過敏源。Identifyallsharedequipmentandproductchangeovers.

識別所有的共用設備和產品轉換。第20頁/共33頁FORMD:Processingstepevaluation表格D：加工步驟評估Listallprocessingstepsfromrawmaterialstofinishedproductse.g.additionofingredients,rework,cooking,grinding,slicing,shredding,hydrating,mixing,etc.列出從原材料到成品的所有加工步驟，例如原料增加、再加工、烹調、磨碾、切片、切成碎片、溶解、混合等。Describethehazards描述危害DeterminethecontrolmechanismCCPorPP決定控制機制CCP或PP-Example舉例第21頁/共33頁2.Segregation隔離Productionscheduling/Sequencing生產計劃/排序:Avoidmanufacturingcarry-over.避免生產遺留物。Scheduleallergen-containingproductslastintheproductionsequence.將含有過敏源的產品排列在生產過程的最后程序。Scheduleallproductscontainingthesameallergeninthesamerun.將含有相同過敏源的所有產品排列在同一個隊列中。Schedulelongrunsofallergen-containingproducts將含有過敏源的產品排列成長序列。Providesufficienttimetodoathoroughallergenclean.提供充足時間，完全徹底清除過敏源。第22頁/共33頁2.Segregation隔離Reworkhandling再加工處理:Rework/holdovercontainersmustbeclearlylabelled(e.g.typeanddate)andsegregated.再加工/盛裝容器必須清晰標注標簽（如，類型及時間）并加以隔離。Establisheffectiveinventorycontrols.建立有效的庫存貨品檢查機制。Reworkusagewillbeclearlydocumentedtoassuretraceability.再加工使用必須清晰記錄在案，以便進行追蹤工作。Developrework/productmatrix:like-into-like.建立再加工/產品基質：同類-歸-同類。Monitoring:Theoriginofreworkisrecordedontheprocesssheet.追蹤：加工表上注明再加工原因。Correctiveaction:Ifallergenicreworkisaddedtoproductthatisnotincompliancewithrework/productmatrixplaceproductincategoryIhold.更正措施：如過敏源再加工品加入了與再加工/產品基質不符合的產品，將產品放入留置類別I。Documentation:Reworkrecordsmustbereviewedatleastmonthlyisrecommended.Rework/productmatrixmustbereviewedanytimethatnewingredientsareintroduced.記錄：建議至少每月檢查一次再加工記錄。無論何時加入新原料后，必須對再加工/產品基質進行檢查。第23頁/共33頁2.Segregation隔離Packaginghandling包裝:Usededicatedpackaginglineswheneverpossible如可能，使用專用包裝線。Makethepackagingmaterialvisuallydistinctive.包裝材料應醒目、易識別。Labelhandling標簽:Controlofsimilarlabelsfordifferentproducts不同產品使用相似標簽的控制措施:Labelsmustbecheckedpriortostart-uporchangeover.在開始或更換前，必須檢查標簽。Monitoring:Alabelfromeachcartonisvisuallycheckedpriortouse.Thischeckmustbelogged.追蹤：使用前，必須目測檢查每箱的標簽，并記錄在案。Correctiveaction:IfincorrectlabelisusedplacetheaffectedproductonCategoryIhold.更正措施：如使用了不正確的標簽，將受到影響的產品放入留置類別I。Documentation:Reworkrecordsmustbereviewedatleastmonthlyisrecommended.Thelabelapplicationproceduremustbereviewedanytimethatnewingredients/labelsareused.記錄：建議至少每月檢查一次再加工記錄。任何時候如使用了新的原料/標簽，必須核查標簽應用程序。第24頁/共33頁3.EquipmentCleaning設備清潔Definecleaningproceduresforeachsharedequipment對每臺共用設備制定清潔程序:Defineavalidatedcleaningproceduretoavoidcarryover.制定有效的清潔程序，防止遺留物。Developaproductsequencing/cleaningmatrix.指定產品排序/清潔基質。Monitoring:Reviewtheequipmentinspectionlogpriortostartup.基質：開機前，核查設備檢測記錄。Correctiveaction:Repeatcleaningwhenproductresiduesarevisible.更正措施：如有產品殘渣，再次進行清潔。Documentation:Recordsmustbereviewedonamonthlybasis.Thesequencing/cleaningmatrixmustbereviewedanytimethatanewproductisintroduced.記錄：記錄必須進行月檢。無論何時加入了某種新產品，必須檢查排序/清潔基質。Avoidcontaminationofnearbylines防止污染臨近工線:Usevacuumcleaningratherthanairhoses.使用真空清潔法，而不要使用空氣軟管。Usededicatedcleaningequipment.使用專用清潔設備。第25頁/共33頁3.EquipmentCleaning設備清潔Redesignorreconfigureequipmenttomakecleaningandinspectioneasier重新設計設備，便利清潔及檢測工作:Easilyopenedandinspected.開關方便，易于檢測。Allallergencontactsurfacesmustaccessibleforexamination.所有接觸過敏源表面必須易于檢查。Quickreleasefastenersshouldbeusedforremovablecovers.可移蓋必須使用快速開啟裝置。Avoidcrossoversofconveyorbeltsoruseshielding.防止輸送線發生交叉，或使用遮護板。Developanallergenspillageprocedure制定過敏源溢出處理程序:Defineisolationareas.規定隔離區域。Placeaffectedproductonhold.留置受到影響的產品。Cleanthecleaningequipment.對清潔設備進行清潔。Allpersonnelaffectedmustchangeoveralls.所有受到影響的人員必須更換工裝服。Inspecttoverifythatallallergencontainingproducthasbeenremoved.檢查核實已清除所有含有過敏源的產品。第26頁/共33頁3.EquipmentCleaning設備清潔Equipmentflushing設備沖洗(wetordrye.g.Sugar濕洗或干洗，如糖類):Defineavalidatedflushingproceduretoavoidcarryover.制定有效的沖洗程序，防止遺留物。Specifytimeand/oramountofflushingmaterialtobeused.規定使用沖洗物的時間和/或數量。Developaproductsequencing/flushingmatrix.制定產品排序/沖洗基質。Monitoring:Reviewtheequipmentinspectionlogpriortostartup.追蹤：開始前，檢查設備檢測記錄。Correctiveaction:Repeatflushingwhenproductresiduesarevisible.更正措施：如有產品殘渣，再次進行沖洗程序。Documentation:Recordsmustbereviewedonamonthlybasis.Thesequencing/flushingmatrixmustbereviewedanytimethatanewproductisintroduced.記錄：記錄必須進行月檢。無論何時加入某種新產品，必須核查排序/沖洗基質。Theequipmentcleaning/flushingproceduremustbevalidatedtodemonstratethatitremovesvisibleproductresiduesfromallproductcontactsurfaces.設備清潔/沖洗程序必須十分有效，可以從所有接觸產品表面清除可見的產品殘渣。第27頁/共33頁4.Labelling加注標簽1.-

Iftheallergenisincludedintheproductformulation如產品配制中包含過敏源:Itmustbedeclaredintheingredientlist.必須在原料表中標明。Allergensshouldbelabelledsotoavoidmisinterpretation過敏源必須加注標簽，防止產生曲解:Marketingensuresthatthelabelcommunicatesallallergens營銷部分保證標簽清楚傳達了所有的過敏源Sourcesofingredientsshouldbedeclared必須標明原料來源:Lecithincanbelabelled“soylecithin”卵磷脂可標注為“大豆卵磷脂”Flavourscanbelabelled“naturalflavour(containmilk)”調味品可標注為“天然調味品（含牛奶）”Processingaidsmustlabellediftheirpresenceinthefinishedproductisenoughtoelicitallergenicreactions如加工輔料在制成品中的含量足以引起過敏反應，則必須加注標簽:Declareprocessingaidsthatarelikelytobepresentinthefinishproduct.標明制成品中可能包含的加工輔料。Seekalternativenon-allergenicprocessingaids.尋求非過敏源加工輔料替代品。第28頁/共33頁Carryoverofcarryovershallnotrequirelabelling殘留物的殘留物無需加注標簽。4.Labelling加注標簽2.-

Iftheallergencannotbedesignedoutorassessedasunavoidable如過敏源在設計過程中無法去除，或被鑒定為不可或缺的物質:Theproductwillbeappropriatelylabelled(inaccordancewithregulationsandinternalguidelinesforlabelling)該產品應加注適當的標簽（遵照加注標簽規則和內部原則）:R&Dandmanufacturinginformmarketingofunavoidableall