食品安全中危險(xiǎn)性的原則及應(yīng)用

【W(wǎng)ORKSHOPONAGRO-FOODSAFETYISSUES2002.10.9-11】

GeneralPrinciple&ApplicationofRisk

AnalysisonFoodSafety

危險(xiǎn)性分析的原則及其在食品

安全中的應(yīng)用1Foodsafety–aglobalconcernFoodingredientsandproductssourcedaroundtheworld食物原料和產(chǎn)品來(lái)源于世界各地Foodcontrolmeasuresnotthesameeverywhere各地的食品安全控制措施不同F(xiàn)oodsafetymaybeperceiveddifferentlyindifferentpartsoftheworld不同地域?qū)κ称钒踩恼J(rèn)識(shí)不同Canobstructinternationaltrade國(guó)際貿(mào)易受阻2CAC&WTOSPS和TBT協(xié)議是WTO成員在國(guó)際貿(mào)易中必須遵循的多邊協(xié)定應(yīng)用衛(wèi)生與植物衛(wèi)生措施協(xié)定,SPS

Sanitary/PhytosanitaryMeasuresAgreement

貿(mào)易技術(shù)壁壘協(xié)議,TBT

TheAgreementon

TechnicalBarrierstoTrade

3 WHO要求各會(huì)員國(guó)：在食品安全行動(dòng)之下，重點(diǎn)制定和評(píng)估國(guó)家的控制戰(zhàn)略，支持發(fā)展評(píng)估與食品相關(guān)風(fēng)險(xiǎn)的科學(xué)，包括分析與食源性疾病相關(guān)的高危因素；要最大可能利用發(fā)展中國(guó)家在食源性因素危險(xiǎn)性評(píng)估方面的信息以制定國(guó)際標(biāo)準(zhǔn)。4Riskanalysis–why?

為什么要進(jìn)行危險(xiǎn)性分析Foodsafetyofincreasingconcern食品安全被廣為關(guān)注Movetowardsariskbasedapproach趨向于對(duì)危險(xiǎn)性的研究Decisionmakingbasedonsoundscience基于科學(xué)基礎(chǔ)上的決策5RiskAnalysis-whatisit?Aprocessconsistingof3components:riskassessment 危險(xiǎn)性評(píng)估

riskmanagement 危險(xiǎn)性管理

riskcommunication 危險(xiǎn)性信息交流6RiskAnalysisParadigmRiskAssessmentRiskManagementRiskCommunicationSciencebasedPolicybasedInteractiveexchangeofinformationandopinions

7RiskAssessment(CAC,1997)

危險(xiǎn)性評(píng)估Ascientificallybasedprocess科學(xué)評(píng)估的程序Theevaluationofthepotentialforadverseeffectsonhumanoranimalhealtharisingfromthepresenceofadditives,contaminants,toxins

ordisease-causingorganismsinfood,beveragesorfeedstuffs.(WTO)評(píng)估食品、飲料、飼料中的添加劑、污染物、毒素或病原菌對(duì)人群或動(dòng)物潛在副作用的科學(xué)程序。8RiskManagement(CAC,1997)

危險(xiǎn)性管理Theprocess,distinctfromriskassessment,ofweighingpolicyalternatives,inconsultationwithallinterestedparties,consideringriskassessmentandotherfactorsrelevantforthehealthprotectionofconsumersandforthepromotionoffairtradepractices,and,ifneeded,selectingappropriatepreventionandcontroloptions.在危險(xiǎn)性評(píng)估的科學(xué)基礎(chǔ)上，為保護(hù)消費(fèi)者健康、促進(jìn)國(guó)際食品貿(mào)易而采取的預(yù)防和控制措施。9RiskCommunication

危險(xiǎn)性信息交流Theinteractiveexchangeofinformationandopinionsthroughouttheriskanalysisprocessconcerninghazardsandrisks,riskrelatedfactorsandriskperceptions,amongriskassessors,riskmanagers,consumers,industry,theacademiccommunityandotherinterestedparties,includingtheexplanationofriskassessmentfindingsandthebasisofriskmanagementdecisions在危險(xiǎn)性評(píng)估者，危險(xiǎn)性管理者，消費(fèi)者，企業(yè)，學(xué)術(shù)團(tuán)體和其他組織間就危害、危險(xiǎn)性，與危險(xiǎn)性相關(guān)的因素和理解等進(jìn)行廣泛的信息和意見(jiàn)溝通，包括危險(xiǎn)性評(píng)估的結(jié)論和危險(xiǎn)性管理決策。

10危險(xiǎn)性評(píng)估估程序RiskAssessment危害的確定定HazardIdentification危害的特征征描述HazardCharacterization暴露量評(píng)估估ExposureAssessment危險(xiǎn)特征的的描述RiskCharacterization11Hazard(CAC,1997)危害Abiological,chemicalorphysicalagentin,orconditionof,foodwiththepotentialtocauseanadversehealtheffect.食品中可能能存在的影影響人體健健康的生物物、化學(xué)、、物理因素素，或狀況。12HazardsinFoodMicroorganisms細(xì)菌Fungiandmycotoxins真菌和真菌菌毒素Virusesandparasites病毒和寄生生蟲(chóng)Toxicplantsandanimals有毒動(dòng)植物物Potentialenvironmentaltoxicants潛在的環(huán)境境有毒化學(xué)學(xué)污染物13Hazardcharacterisation(CAC,1997)危害特征的的描述Thequalitativeand/orquantitativeevaluationofthenatureoftheadversehealtheffectsassociatedwiththehazard.ForthepurposeofMicrobiologicalRiskAssessmenttheconcernsrelatetomicroorganismsandtheirtoxins.微生物危害害的定性（（半定量））、定量評(píng)評(píng)估14ExposureAssessment(CAC,1997)暴露評(píng)估Thequalitativeand/orquantitativeevaluationofthelikelyintakeofbiological,chemicalandphysicalagentsviafoodaswellasexposuresfromothersourcesifrelevant.從食物或相相關(guān)來(lái)源攝攝入生物、、化學(xué)和物物理因子的的定性、定定量評(píng)估15RiskCharacterization(CAC,1997)危險(xiǎn)性特征征的描述Theprocessofdeterminingthequalitativeand/orquantitativeestimation,includingattendantuncertainties,oftheprobabilityofoccurrenceandseverityofknownorpotentialadversehealtheffectsinagivenpopulationbasedonhazardidentification,hazardcharacterizationandexposureassessment.在危害的識(shí)識(shí)別、危害害的特征描描述和暴露露評(píng)估的基基礎(chǔ)上確定定事件暴發(fā)發(fā)的概率和和嚴(yán)重性，，或?qū)】悼诞a(chǎn)生潛在在不良影響響的定性和和/定量評(píng)評(píng)估的過(guò)程程。16Riskmanagement危險(xiǎn)性管理理4Elements：Riskevaluation危險(xiǎn)性評(píng)價(jià)價(jià)Riskmanagementoptionsassessment危險(xiǎn)性管理理選項(xiàng)評(píng)估估Implementation執(zhí)行Monitoringandreview監(jiān)測(cè)和回顧顧17Implementation執(zhí)行Canbedonebybothgovernmentofficialsandthefoodindustry可被政府官官方和食品品企業(yè)執(zhí)行行Implementationwilltakedifferentformsdependingwhatdecisionshavebeentaken執(zhí)行將根據(jù)據(jù)已定的決決議采取不不同形式MRAmaybeusefulinimplementationinformationonproductpathogenpathwayinparticularexposureassessmentcanbeavaluableinformationsourceMRA在執(zhí)行中的的作用病原菌產(chǎn)生生的途徑特別是暴露露評(píng)估可作作為有價(jià)值值的信息來(lái)來(lái)源18MonitoringandReview監(jiān)測(cè)與評(píng)議議Assesseffectivenessofmeasurestaken評(píng)估所用方方法的效率率providesmoredata提供更多數(shù)數(shù)據(jù)providesinformationneedtoreviewriskmanagementdecisionandifneededriskassessment提供信息，，以便評(píng)議議危險(xiǎn)性管管理決議及及是否需要要危險(xiǎn)性評(píng)評(píng)估19RiskAnalysis-whousesitAtoolforuseprimarilybygovernments各國(guó)政政府protectconsumerhealth保護(hù)消消費(fèi)者者健康康maintainconfidenceininternationallytradedfood(marketmaintenance)-harmonization,mutualrecognition,equivalence維持在在國(guó)際際食品品貿(mào)易易中的的信心心-一一體、、共識(shí)識(shí)、平平等Atinternationallevel國(guó)際水水平WTO-useriskassessmenttechniquesdevelopedbyrelevantinternationalorganizations國(guó)際貿(mào)貿(mào)易中中采用用由相相關(guān)國(guó)國(guó)際組組織建建立的的危險(xiǎn)險(xiǎn)性評(píng)評(píng)估技技術(shù)usedbystandardsettingbodies(Codex)被國(guó)際際標(biāo)準(zhǔn)準(zhǔn)指定定團(tuán)體體所采采用20CAC常遇到到的問(wèn)問(wèn)題Differentopinionsonmethodsoroutputsofassessment,eg.,using““Aslowasreasonablyachievable(ALARA)””forcontaminants對(duì)專家家評(píng)價(jià)價(jià)方法法或結(jié)結(jié)果有有不同同看法法，如如污染染物達(dá)達(dá)到盡盡可能能低的的水平平黃曲霉霉毒素素（總總量、、B1、M1））Whenthereisscientificallyuncertainty當(dāng)存在在科學(xué)學(xué)不確確定性性時(shí)食品中中的單單增李李斯特特菌（（〈100cfu/g））氯丙醇醇21JECFA，JointFAO/WHOExpertCommitteeonFoodAdditivesFAO/WHO聯(lián)合食食品添添加劑劑專家家委員員會(huì)JMPR，，JointFAO/WHOMeetingonPesticideResiduesFAO/WHO聯(lián)合農(nóng)農(nóng)藥殘殘留專專家委委員會(huì)會(huì)JEMRA,JointFAO/WHOExpertConsultationonMicrobiologicalRiskAssessmentFAO/WHO聯(lián)合微微生物物危險(xiǎn)險(xiǎn)性評(píng)評(píng)估專專家咨咨詢委委員會(huì)會(huì)22FAO/WHO專家家咨詢?cè)兘M織織與CAC有關(guān)關(guān)委員員會(huì)關(guān)關(guān)系RelationshipbetweenexpertconsultationandCodexrelevantcommittees專家咨咨詢（（評(píng)估估）制制定定標(biāo)準(zhǔn)準(zhǔn)（管管理））ExpertconsultationStandardformulation(assessment)(management)JECFACCFACCCRVDFJMPRCCPRJEMRACCFH23FAO/WHOactivitiesonriskanalysisFAO/WHO召開(kāi)的的危險(xiǎn)險(xiǎn)性分分析專專家咨咨詢會(huì)會(huì)議1995-ExpertConsultationonRiskAnalysisandFoodSafety危險(xiǎn)性性分析析與食食品安安全1997-ExpertConsultationonRiskManagementandFoodSafety危險(xiǎn)性性管理理與食食品安安全1998-ExpertConsultationontheApplicationofRiskCommunicationtoFoodStandardsandSafetyMatters危險(xiǎn)性性信息息交流流在食食品標(biāo)標(biāo)準(zhǔn)和和安全全中的的應(yīng)用用241999-ExpertConsultationonRiskAssessmentofMicrobiologicalHazardsinFoods食品中中微生生物危危害的的危險(xiǎn)險(xiǎn)性評(píng)評(píng)估2000-ExpertConsultationonInteractionbetweenRiskassessorsandriskmanagersofMicrobiologicalHazardsinFood食品中中微生生物危危害的的危險(xiǎn)險(xiǎn)性評(píng)評(píng)估者者與管管理者者間的的相互互作用用2001-ExpertConsultationonExposureAssessmentofMicrobiologicalHazardsinfoods食品中中微生生物危危害的的暴露露評(píng)估估2002-ExpertConsultationonIncorporatingQuantitativeRiskAssessmentintheDevelopmentofMicrobiologicalFoodHygieneStandards運(yùn)用定定量微微生物物危險(xiǎn)險(xiǎn)性評(píng)評(píng)估制制訂食食品衛(wèi)衛(wèi)生標(biāo)標(biāo)準(zhǔn)25危險(xiǎn)性性評(píng)估估(專專家)添添加劑劑——ADIRiskAssessment污染物物——PTWI獸藥殘殘留——ADI危險(xiǎn)性性管理理(政府府)添加劑劑——范范圍,用量量RiskManagement污污染染物——限限量量危險(xiǎn)性性管理理(政府府)獸藥殘殘留——限限量量RiskManagementJECFACCFACRelationshipbetweenJECFAandCCFACorCCRVDCCRVD26CCFAC&JECFAExample:AflatoxinB11994,CCFACaskedJECFA:(26thSession)toprovideestimatesofthetoxicologicalpotencyofaflatoxinsandtoderiveestimatesofthepotentialrisksfordifferentpopulations1996,JECFA(46thmeeting):Aflatoxinswereconsidered1997,JECFA(49thmeeting):Aflatoxinswerecarriedover27Quantitativeriskassessmentat49thJECFAMeetingin1997JECFA49次會(huì)議的的定量危危險(xiǎn)性評(píng)評(píng)價(jià)致癌作用用強(qiáng)度：：HBsAg(＋):0.3個(gè)肝癌癌/年/10萬(wàn)萬(wàn)人/ngAF/kgbw/天HBsAg(－):0.01個(gè)肝癌/年/10萬(wàn)人人/ngAF/kgbw/天人群危險(xiǎn)險(xiǎn)度=作用用強(qiáng)度××攝攝入量28例1.HBsAg(＋)1%;歐洲污染染水平/歐洲膳膳食結(jié)構(gòu)構(gòu)攝入量人人群群危險(xiǎn)度度(ng/人/天天)(個(gè)肝癌癌/年/10萬(wàn)萬(wàn)人)限量20μg/kg190.0041(0.0006-0.01)限量10μg/kg180.0039(0.0006-0.01)相差2個(gè)肝癌癌/年/億人29例2.HBsAg(＋)25%;中國(guó)污染染水平/遠(yuǎn)東膳膳食結(jié)構(gòu)構(gòu)攝入量人人群群危險(xiǎn)度度(ng/人/天天)(個(gè)肝癌癌/年/10萬(wàn)萬(wàn)人)限量20μg/kg1250.17(0.03-0.3)限量10μg/kg1030.14(0.02-0.3)相差300個(gè)肝肝癌/年年/億人人*1990-92年全全國(guó)肝癌癌死亡率率20/10萬(wàn)萬(wàn)30CCFHACTIVITIES32ndCCFH（1999）DecidedtoproceedinMRAonthebasisofpathogen/commoditycombinations；Elaboratedandagreedontentativeprioritylistofpathogen/commoditycombinations決定對(duì)病病原食品品組合進(jìn)進(jìn)行微生生物危險(xiǎn)險(xiǎn)性評(píng)估估，并提提出暫定定優(yōu)先組組合31CCFHDraftinggroups食品衛(wèi)生生法典委委員會(huì)起起草工作作組L.monocytogenesinready-to-eatfood(Germany)即食食品品中的單單增李斯斯特菌Salmonellaspp.inpoultry(Sweden)禽肉中的的沙門(mén)氏氏菌Campylobacterspp.inpoultry(Netherlands)禽肉中的的空腸彎彎曲菌Vibriospp.inseafood(UnitedStates)海產(chǎn)品中中的副溶溶血性弧弧菌EnterohemorrhagicE.coliinmeat (UnitedStates)肉食品中中的出血血性大腸腸桿菌32WhyRAisneededinChina？我國(guó)為什什么要進(jìn)進(jìn)行危險(xiǎn)險(xiǎn)性分析析？WTOCODEX/GBFOODINDUSTRYFOODSAFETYCONTROLGovernmentConsumersHEALTHPROTECTIONLifequalityknowledge國(guó)際貿(mào)易易食品法典典/國(guó)國(guó)家標(biāo)標(biāo)準(zhǔn)體系系食品工業(yè)食品安全控控制政府消費(fèi)者保護(hù)消費(fèi)者者健康生活質(zhì)量的的提高對(duì)食品安全全知識(shí)的需需求33CaseinChinaTheControloftheDeterioratedSugarcaneFoodPoisoningFreshsugarcanegrowninsouthernareaofChinaShipped,storedandsoldthroughthewinterseasoninthenorthernpartsofChinaContaminatedsugarcanecouldcausefatalfoodpoisoningwhensoldinthenextspring34SugarcanepoisoningThefirstoutbreakofunknowncausessugarcanepoisoningoccurredinHenanProvincein1972From1972to1989:No.ofoutbreak:217No.ofcases:884No.ofdeaths:88Averagefatality:10%IdentifiedasaprioritytoassessandcontrolbyMOH35EtiologyandriskassessmentEtiologyandcausesstudywerebeencarriedoutbytheChineseAcademyofPreventiveMedicinein1980’sArthriniumspp.wasthepathogenicfungus;3-nitropropionicacid(3-NPA)producedbyA.spp.wasprovedtobethecausativecompoundAssessmentwasmadeaccordingtocase-basedstudies,epidemiologicalandlaboratorystudies36DecisionmakingandmanagementactivitiesBasedondiscoveryandassessment,MOHpromulgated:Diagnosticcriteriaandprinciplesf