危险性分析的原则和其在食品安全中的应用

【WORKSHOPONAGRO-FOODSAFETYISSUES.10.9-11】

GeneralPrinciple&ApplicationofRisk

AnalysisonFoodSafety

危险性分析标准及其在食品

安全中应用1第1页Foodsafety–aglobalconcernFoodingredientsandproductssourcedaroundtheworld食物原料和产品起源于世界各地Foodcontrolmeasuresnotthesameeverywhere各地食品安全控制办法不一样Foodsafetymaybeperceiveddifferentlyindifferentpartsoftheworld不一样地域对食品安全认识不一样Canobstructinternationaltrade国际贸易受阻2第2页CAC&WTOSPS和TBT协议是WTO组员在国际贸易中必须遵照多边协定应用卫生与植物卫生办法协定,SPS

Sanitary/PhytosanitaryMeasuresAgreement

贸易技术壁垒协议,TBT

TheAgreementon

TechnicalBarrierstoTrade

3第3页 WHO要求各会员国：在食品安全行动之下，重点制订和评定国家控制战略，支持发展评定与食品相关风险科学，包含分析与食源性疾病相关高危原因；要最大可能利用发展中国家在食源性原因危险性评定方面信息以制订国际标准。4第4页Riskanalysis–why?

为何要进行危险性分析Foodsafetyofincreasingconcern食品安全被广为关注Movetowardsariskbasedapproach趋向于对危险性研究Decisionmakingbasedonsoundscience基于科学基础上决议5第5页RiskAnalysis-whatisit?Aprocessconsistingof3components:riskassessment 危险性评定

riskmanagement 危险性管理

riskcommunication 危险性信息交流6第6页RiskAnalysisParadigmRiskAssessmentRiskManagementRiskCommunication

Sciencebased

Policybased

Interactiveexchangeofinformationandopinions

7第7页RiskAssessment(CAC,1997)

危险性评定Ascientificallybasedprocess科学评定程序Theevaluationofthepotentialforadverseeffectsonhumanoranimalhealtharisingfromthepresenceofadditives,contaminants,toxins

ordisease-causingorganismsinfood,beveragesorfeedstuffs.(WTO)评定食品、饮料、饲料中添加剂、污染物、毒素或病原菌对人群或动物潜在副作用科学程序。8第8页RiskManagement(CAC,1997)

危险性管理Theprocess,distinctfromriskassessment,ofweighingpolicyalternatives,inconsultationwithallinterestedparties,consideringriskassessmentandotherfactorsrelevantforthehealthprotectionofconsumersandforthepromotionoffairtradepractices,and,ifneeded,selectingappropriatepreventionandcontroloptions.在危险性评定科学基础上，为保护消费者健康、促进国际食品贸易而采取预防和控制办法。9第9页RiskCommunication

危险性信息交流Theinteractiveexchangeofinformationandopinionsthroughouttheriskanalysisprocessconcerninghazardsandrisks,riskrelatedfactorsandriskperceptions,amongriskassessors,riskmanagers,consumers,industry,theacademiccommunityandotherinterestedparties,includingtheexplanationofriskassessmentfindingsandthebasisofriskmanagementdecisions在危险性评定者，危险性管理者，消费者，企业，学术团体和其它组织间就危害、危险性，与危险性相关原因和了解等进行广泛信息和意见沟通，包含危险性评定结论和危险性管理决议。

10第10页危险性评定程序

RiskAssessment危害确定HazardIdentification危害特征描述HazardCharacterization暴露量评定ExposureAssessment危险特征描述RiskCharacterization11第11页Hazard(CAC,1997)

危害Abiological,chemicalorphysicalagentin,orconditionof,foodwiththepotentialtocauseanadversehealtheffect.食品中可能存在影响人体健康生物、化学、物理原因，或情况。12第12页 HazardsinFoodMicroorganisms细菌Fungiandmycotoxins真菌和真菌毒素Virusesandparasites病毒和寄生虫Toxicplantsandanimals有毒动植物Potentialenvironmentaltoxicants潜在环境有毒化学污染物13第13页Hazardcharacterisation(CAC,1997)

危害特征描述Thequalitativeand/orquantitativeevaluationofthenatureoftheadversehealtheffectsassociatedwiththehazard.ForthepurposeofMicrobiologicalRiskAssessmenttheconcernsrelatetomicroorganismsandtheirtoxins.微生物危害定性（半定量）、定量评定14第14页ExposureAssessment(CAC,1997)

暴露评定Thequalitativeand/orquantitativeevaluationofthelikelyintakeofbiological,chemicalandphysicalagentsviafoodaswellasexposuresfromothersourcesifrelevant.从食物或相关起源摄入生物、化学和物理因子定性、定量评定15第15页RiskCharacterization(CAC,1997)

危险性特征描述Theprocessofdeterminingthequalitativeand/orquantitativeestimation,includingattendantuncertainties,oftheprobabilityofoccurrenceandseverityofknownorpotentialadversehealtheffectsinagivenpopulationbasedonhazardidentification,hazardcharacterizationandexposureassessment.在危害识别、危害特征描述和暴露评定基础上确定事件暴发概率和严重性，或对健康产生潜在不良影响定性和/定量评定过程。16第16页

Riskmanagement

危险性管理4Elements：Riskevaluation危险性评价Riskmanagementoptionsassessment危险性管理选项评定Implementation执行Monitoringandreview监测和回顾17第17页Implementation

执行Canbedonebybothgovernmentofficialsandthefoodindustry可被政府官方和食品企业执行Implementationwilltakedifferentformsdependingwhatdecisionshavebeentaken执行将依据已定决议采取不一样形式MRAmaybeusefulinimplementationinformationonproductpathogenpathwayinparticularexposureassessmentcanbeavaluableinformationsourceMRA在执行中作用病原菌产生路径尤其是暴露评定可作为有价值信息起源18第18页MonitoringandReview

监测与评议Assesseffectivenessofmeasurestaken评定所用方法效率providesmoredata提供更多数据providesinformationneedtoreviewriskmanagementdecisionandifneededriskassessment提供信息，方便评议危险性管理决议及是否需要危险性评定19第19页RiskAnalysis-whousesitAtoolforuseprimarilybygovernments 各国政府protectconsumerhealth 保护消费者健康 maintainconfidenceininternationallytradedfood(marketmaintenance)-harmonization,mutualrecognition,equivalence

维持在国际食品贸易中信心-一体、共识、平等Atinternationallevel 国际水平WTO-useriskassessmenttechniquesdevelopedbyrelevantinternationalorganizations

国际贸易中采取由相关国际组织建立危险性评定技术usedbystandardsettingbodies(Codex) 被国际标准指定团体所采取20第20页CAC常碰到问题Differentopinionsonmethodsoroutputsofassessment,eg.,using“Aslowasreasonablyachievable(ALARA)”forcontaminants对教授评价方法或结果有不一样看法，如污染物到达尽可能低水平

黄曲霉毒素（总量、B1、M1）Whenthereisscientificallyuncertainty当存在科学不确定性时

食品中单增李斯特菌（〈100cfu/g）氯丙醇21第21页JECFA，JointFAO/WHOExpertCommitteeonFoodAdditivesFAO/WHO联合食品添加剂教授委员会JMPR，JointFAO/WHOMeetingonPesticideResiduesFAO/WHO联合农药残留教授委员会JEMRA,JointFAO/WHOExpertConsultationonMicrobiologicalRiskAssessmentFAO/WHO联合微生物危险性评定教授咨询委员会22第22页FAO/WHO教授咨询组织与CAC相关委员会关系

RelationshipbetweenexpertconsultationandCodexrelevantcommittees教授咨询（评定） 制订标准（管理） Expertconsultation Standardformulation (assessment) (management)

JECFA CCFAC CCRVDF

JMPR CCPR

JEMRA CCFH23第23页FAO/WHOactivitiesonriskanalysis

FAO/WHO召开危险性分析教授咨询会议1995-ExpertConsultationonRiskAnalysisandFoodSafety危险性分析与食品安全1997-ExpertConsultationonRiskManagementandFoodSafety

危险性管理与食品安全1998-ExpertConsultationontheApplicationofRiskCommunicationtoFoodStandardsandSafetyMatters危险性信息交流在食品标准和安全中应用24第24页1999-ExpertConsultationonRiskAssessmentofMicrobiologicalHazardsinFoods

食品中微生物危害危险性评定-ExpertConsultationonInteractionbetweenRiskassessorsandriskmanagersofMicrobiologicalHazardsinFood食品中微生物危害危险性评定者与管理者间相互作用-ExpertConsultationonExposureAssessmentof MicrobiologicalHazardsinfoods食品中微生物危害暴露评定-ExpertConsultationonIncorporatingQuantitativeRiskAssessmentintheDevelopmentofMicrobiologicalFoodHygieneStandards利用定量微生物危险性评定制订食品卫生标准25第25页

危险性评定(教授) 添加剂—ADI RiskAssessment 污染物—PTWI 兽药残留—ADI

危险性管理(政府) 添加剂—范围,用量 RiskManagement 污染物—限量

危险性管理(政府) 兽药残留—限量RiskManagement

JECFACCFACRelationshipbetweenJECFAandCCFACorCCRVDCCRVD26第26页CCFAC&JECFA

Example:AflatoxinB11994,CCFACaskedJECFA:(26thSession)toprovideestimatesofthetoxicologicalpotencyofaflatoxinsandtoderiveestimatesofthepotentialrisksfordifferentpopulations1996,JECFA(46thmeeting):Aflatoxinswereconsidered1997,JECFA(49thmeeting):Aflatoxinswerecarriedover27第27页

Quantitativeriskassessmentat49thJECFAMeetingin1997

JECFA49次会议定量危险性评价致癌作用强度：HBsAg(＋):0.3个肝癌/年/10万人/ngAF/kgbw/天HBsAg(－):0.01个肝癌/年/10万人/ngAF/kgbw/天人群危险度=作用强度×摄入量28第28页例1.HBsAg(＋)1%;欧洲污染水平/欧洲膳食结构

摄入量人群危险度

(ng/人/天)(个肝癌/年/10万人)限量20µg/kg190.0041(0.0006-0.01)限量10µg/kg180.0039(0.0006-0.01)相差2个肝癌/年/亿人29第29页例2.HBsAg(＋)25%;中国污染水平/远东膳食结构

摄入量人群危险度

(ng/人/天)(个肝癌/年/10万人)限量20µg/kg1250.17(0.03-0.3)限量10µg/kg1030.14(0.02-0.3)相差300个肝癌/年/亿人*1990-92年全国肝癌死亡率20/10万30第30页CCFHACTIVITIES32ndCCFH（1999）

DecidedtoproceedinMRAonthebasisofpathogen/commoditycombinations；Elaboratedandagreedontentativeprioritylistofpathogen/commoditycombinations决定对病原食品组合进行微生物危险性评定，并提出暂定优先组合31第31页CCFHDraftinggroups

食品卫生法典委员会起草工作组L.monocytogenesinready-to-eatfood (Germany)即食食品中单增李斯特菌Salmonellaspp.inpoultry (Sweden)禽肉中沙门氏菌Campylobacterspp.inpoultry (Netherlands)禽肉中空肠弯曲菌Vibriospp.inseafood (UnitedStates)海产品中副溶血性弧菌EnterohemorrhagicE.coliinmeat (UnitedStates)肉食品中出血性大肠杆菌32第32页WhyRAisneededinChina？

我国为何要进行危险性分析？WTOCODEX/GBFOODINDUSTRY

FOODSAFETYCONTROLGovernmentConsumersHEALTHPROTECTIONLifequalityknowledge国际贸易食品法典/国家标准体系食品工业食品安全控制政府消费者保护消费者健康生活质量提升对食品安全知识需求33第33页CaseinChinaTheControloftheDeterioratedSugarcaneFoodPoisoningFreshsugarcanegrowninsouthernareaofChina

Shipped,storedandsoldthroughthewinterseasoninthenorthernpartsofChina

Contaminatedsugarcanecouldcausefatalfoodpoisoningwhensoldinthenextspring34第34页SugarcanepoisoningThefirstoutbreakofunknowncausessugarcanepoisoningoccurredinHenanProvincein1972From1972to1989:No.ofoutbreak:217No.ofcases:884No.ofdeaths:88Averagefatality:10%IdentifiedasaprioritytoassessandcontrolbyMOH35第35页

EtiologyandriskassessmentEtiologyandcausesstudywerebeencarriedoutbytheChineseAcademyofPreventiveMedicinein1980’sArthriniumspp.wasthepathogenicfungus;3-nitropropionicacid(3-NPA)producedbyA.spp.wasprovedtobethecausativecompoundAssessmentwasmadeaccordingtocase-basedstudies,epidemiologicalandlaboratorystudies36第36页DecisionmakingandmanagementactivitiesBasedondiscoveryandassessment,MOHpromulgated:Diagnosticcriteriaandprinciplesfortheman