危險(xiǎn)性分析的原則和其在食品安全中的應(yīng)用

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

GeneralPrinciple&ApplicationofRisk

AnalysisonFoodSafety

危險(xiǎn)性分析標(biāo)準(zhǔn)及其在食品

安全中應(yīng)用1第1頁(yè)Foodsafety–aglobalconcernFoodingredientsandproductssourcedaroundtheworld食物原料和產(chǎn)品起源于世界各地Foodcontrolmeasuresnotthesameeverywhere各地食品安全控制辦法不一樣Foodsafetymaybeperceiveddifferentlyindifferentpartsoftheworld不一樣地域?qū)κ称钒踩J(rèn)識(shí)不一樣Canobstructinternationaltrade國(guó)際貿(mào)易受阻2第2頁(yè)CAC&WTOSPS和TBT協(xié)議是WTO組員在國(guó)際貿(mào)易中必須遵照多邊協(xié)定應(yīng)用衛(wèi)生與植物衛(wèi)生辦法協(xié)定,SPS

Sanitary/PhytosanitaryMeasuresAgreement

貿(mào)易技術(shù)壁壘協(xié)議,TBT

TheAgreementon

TechnicalBarrierstoTrade

3第3頁(yè) WHO要求各會(huì)員國(guó)：在食品安全行動(dòng)之下，重點(diǎn)制訂和評(píng)定國(guó)家控制戰(zhàn)略，支持發(fā)展評(píng)定與食品相關(guān)風(fēng)險(xiǎn)科學(xué)，包含分析與食源性疾病相關(guān)高危原因；要最大可能利用發(fā)展中國(guó)家在食源性原因危險(xiǎn)性評(píng)定方面信息以制訂國(guó)際標(biāo)準(zhǔn)。4第4頁(yè)Riskanalysis–why?

為何要進(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)性研究Decisionmakingbasedonsoundscience基于科學(xué)基礎(chǔ)上決議5第5頁(yè)RiskAnalysis-whatisit?Aprocessconsistingof3components:riskassessment 危險(xiǎn)性評(píng)定

riskmanagement 危險(xiǎn)性管理

riskcommunication 危險(xiǎn)性信息交流6第6頁(yè)RiskAnalysisParadigmRiskAssessmentRiskManagementRiskCommunication

Sciencebased

Policybased

Interactiveexchangeofinformationandopinions

7第7頁(yè)RiskAssessment(CAC,1997)

危險(xiǎn)性評(píng)定Ascientificallybasedprocess科學(xué)評(píng)定程序Theevaluationofthepotentialforadverseeffectsonhumanoranimalhealtharisingfromthepresenceofadditives,contaminants,toxins

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

危險(xiǎn)性管理Theprocess,distinctfromriskassessment,ofweighingpolicyalternatives,inconsultationwithallinterestedparties,consideringriskassessmentandotherfactorsrelevantforthehealthprotectionofconsumersandforthepromotionoffairtradepractices,and,ifneeded,selectingappropriatepreventionandcontroloptions.在危險(xiǎn)性評(píng)定科學(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)易而采取預(yù)防和控制辦法。9第9頁(yè)RiskCommunication

危險(xiǎn)性信息交流Theinteractiveexchangeofinformationandopinionsthroughouttheriskanalysisprocessconcerninghazardsandrisks,riskrelatedfactorsandriskperceptions,amongriskassessors,riskmanagers,consumers,industry,theacademiccommunityandotherinterestedparties,includingtheexplanationofriskassessmentfindingsandthebasisofriskmanagementdecisions在危險(xiǎn)性評(píng)定者，危險(xiǎn)性管理者，消費(fèi)者，企業(yè)，學(xué)術(shù)團(tuán)體和其它組織間就危害、危險(xiǎn)性，與危險(xiǎn)性相關(guān)原因和了解等進(jìn)行廣泛信息和意見(jiàn)溝通，包含危險(xiǎn)性評(píng)定結(jié)論和危險(xiǎn)性管理決議。

10第10頁(yè)危險(xiǎn)性評(píng)定程序

RiskAssessment危害確定HazardIdentification危害特征描述HazardCharacterization暴露量評(píng)定ExposureAssessment危險(xiǎn)特征描述RiskCharacterization11第11頁(yè)Hazard(CAC,1997)

危害Abiological,chemicalorphysicalagentin,orconditionof,foodwiththepotentialtocauseanadversehealtheffect.食品中可能存在影響人體健康生物、化學(xué)、物理原因，或情況。12第12頁(yè) HazardsinFoodMicroorganisms細(xì)菌Fungiandmycotoxins真菌和真菌毒素Virusesandparasites病毒和寄生蟲(chóng)Toxicplantsandanimals有毒動(dòng)植物Potentialenvironmentaltoxicants潛在環(huán)境有毒化學(xué)污染物13第13頁(yè)Hazardcharacterisation(CAC,1997)

危害特征描述Thequalitativeand/orquantitativeevaluationofthenatureoftheadversehealtheffectsassociatedwiththehazard.ForthepurposeofMicrobiologicalRiskAssessmenttheconcernsrelatetomicroorganismsandtheirtoxins.微生物危害定性（半定量）、定量評(píng)定14第14頁(yè)ExposureAssessment(CAC,1997)

暴露評(píng)定Thequalitativeand/orquantitativeevaluationofthelikelyintakeofbiological,chemicalandphysicalagentsviafoodaswellasexposuresfromothersourcesifrelevant.從食物或相關(guān)起源攝入生物、化學(xué)和物理因子定性、定量評(píng)定15第15頁(yè)RiskCharacterization(CAC,1997)

危險(xiǎn)性特征描述Theprocessofdeterminingthequalitativeand/orquantitativeestimation,includingattendantuncertainties,oftheprobabilityofoccurrenceandseverityofknownorpotentialadversehealtheffectsinagivenpopulationbasedonhazardidentification,hazardcharacterizationandexposureassessment.在危害識(shí)別、危害特征描述和暴露評(píng)定基礎(chǔ)上確定事件暴發(fā)概率和嚴(yán)重性，或?qū)】诞a(chǎn)生潛在不良影響定性和/定量評(píng)定過(guò)程。16第16頁(yè)

Riskmanagement

危險(xiǎn)性管理4Elements：Riskevaluation危險(xiǎn)性評(píng)價(jià)Riskmanagementoptionsassessment危險(xiǎn)性管理選項(xiàng)評(píng)定Implementation執(zhí)行Monitoringandreview監(jiān)測(cè)和回顧17第17頁(yè)Implementation

執(zhí)行Canbedonebybothgovernmentofficialsandthefoodindustry可被政府官方和食品企業(yè)執(zhí)行Implementationwilltakedifferentformsdependingwhatdecisionshavebeentaken執(zhí)行將依據(jù)已定決議采取不一樣形式MRAmaybeusefulinimplementationinformationonproductpathogenpathwayinparticularexposureassessmentcanbeavaluableinformationsourceMRA在執(zhí)行中作用病原菌產(chǎn)生路徑尤其是暴露評(píng)定可作為有價(jià)值信息起源18第18頁(yè)MonitoringandReview

監(jiān)測(cè)與評(píng)議Assesseffectivenessofmeasurestaken評(píng)定所用方法效率providesmoredata提供更多數(shù)據(jù)providesinformationneedtoreviewriskmanagementdecisionandifneededriskassessment提供信息，方便評(píng)議危險(xiǎn)性管理決議及是否需要危險(xiǎn)性評(píng)定19第19頁(yè)RiskAnalysis-whousesitAtoolforuseprimarilybygovernments 各國(guó)政府protectconsumerhealth 保護(hù)消費(fèi)者健康 maintainconfidenceininternationallytradedfood(marketmaintenance)-harmonization,mutualrecognition,equivalence

維持在國(guó)際食品貿(mào)易中信心-一體、共識(shí)、平等Atinternationallevel 國(guó)際水平WTO-useriskassessmenttechniquesdevelopedbyrelevantinternationalorganizations

國(guó)際貿(mào)易中采取由相關(guān)國(guó)際組織建立危險(xiǎn)性評(píng)定技術(shù)usedbystandardsettingbodies(Codex) 被國(guó)際標(biāo)準(zhǔn)指定團(tuán)體所采取20第20頁(yè)CAC常碰到問(wèn)題Differentopinionsonmethodsoroutputsofassessment,eg.,using“Aslowasreasonablyachievable(ALARA)”forcontaminants對(duì)教授評(píng)價(jià)方法或結(jié)果有不一樣看法，如污染物到達(dá)盡可能低水平

黃曲霉毒素（總量、B1、M1）Whenthereisscientificallyuncertainty當(dāng)存在科學(xué)不確定性時(shí)

食品中單增李斯特菌（〈100cfu/g）氯丙醇21第21頁(yè)JECFA，JointFAO/WHOExpertCommitteeonFoodAdditivesFAO/WHO聯(lián)合食品添加劑教授委員會(huì)JMPR，JointFAO/WHOMeetingonPesticideResiduesFAO/WHO聯(lián)合農(nóng)藥殘留教授委員會(huì)JEMRA,JointFAO/WHOExpertConsultationonMicrobiologicalRiskAssessmentFAO/WHO聯(lián)合微生物危險(xiǎn)性評(píng)定教授咨詢委員會(huì)22第22頁(yè)FAO/WHO教授咨詢組織與CAC相關(guān)委員會(huì)關(guān)系

RelationshipbetweenexpertconsultationandCodexrelevantcommittees教授咨詢（評(píng)定） 制訂標(biāo)準(zhǔn)（管理） Expertconsultation Standardformulation (assessment) (management)

JECFA CCFAC CCRVDF

JMPR CCPR

JEMRA CCFH23第23頁(yè)FAO/WHOactivitiesonriskanalysis

FAO/WHO召開(kāi)危險(xiǎn)性分析教授咨詢會(huì)議1995-ExpertConsultationonRiskAnalysisandFoodSafety危險(xiǎn)性分析與食品安全1997-ExpertConsultationonRiskManagementandFoodSafety

危險(xiǎn)性管理與食品安全1998-ExpertConsultationontheApplicationofRiskCommunicationtoFoodStandardsandSafetyMatters危險(xiǎn)性信息交流在食品標(biāo)準(zhǔn)和安全中應(yīng)用24第24頁(yè)1999-ExpertConsultationonRiskAssessmentofMicrobiologicalHazardsinFoods

食品中微生物危害危險(xiǎn)性評(píng)定-ExpertConsultationonInteractionbetweenRiskassessorsandriskmanagersofMicrobiologicalHazardsinFood食品中微生物危害危險(xiǎn)性評(píng)定者與管理者間相互作用-ExpertConsultationonExposureAssessmentof MicrobiologicalHazardsinfoods食品中微生物危害暴露評(píng)定-ExpertConsultationonIncorporatingQuantitativeRiskAssessmentintheDevelopmentofMicrobiologicalFoodHygieneStandards利用定量微生物危險(xiǎn)性評(píng)定制訂食品衛(wèi)生標(biāo)準(zhǔn)25第25頁(yè)

危險(xiǎn)性評(píng)定(教授) 添加劑—ADI RiskAssessment 污染物—PTWI 獸藥殘留—ADI

危險(xiǎn)性管理(政府) 添加劑—范圍,用量 RiskManagement 污染物—限量

危險(xiǎn)性管理(政府) 獸藥殘留—限量RiskManagement

JECFACCFACRelationshipbetweenJECFAandCCFACorCCRVDCCRVD26第26頁(yè)CCFAC&JECFA

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

Quantitativeriskassessmentat49thJECFAMeetingin1997

JECFA49次會(huì)議定量危險(xiǎn)性評(píng)價(jià)致癌作用強(qiáng)度：HBsAg(＋):0.3個(gè)肝癌/年/10萬(wàn)人/ngAF/kgbw/天HBsAg(－):0.01個(gè)肝癌/年/10萬(wàn)人/ngAF/kgbw/天人群危險(xiǎn)度=作用強(qiáng)度×攝入量28第28頁(yè)例1.HBsAg(＋)1%;歐洲污染水平/歐洲膳食結(jié)構(gòu)

攝入量人群危險(xiǎn)度

(ng/人/天)(個(gè)肝癌/年/10萬(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/年/億人29第29頁(yè)例2.HBsAg(＋)25%;中國(guó)污染水平/遠(yuǎn)東膳食結(jié)構(gòu)

攝入量人群危險(xiǎn)度

(ng/人/天)(個(gè)肝癌/年/10萬(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)肝癌/年/億人*1990-92年全國(guó)肝癌死亡率20/10萬(wàn)30第30頁(yè)CCFHACTIVITIES32ndCCFH（1999）

DecidedtoproceedinMRAonthebasisofpathogen/commoditycombinations；Elaboratedandagreedontentativeprioritylistofpathogen/commoditycombinations決定對(duì)病原食品組合進(jìn)行微生物危險(xiǎn)性評(píng)定，并提出暫定優(yōu)先組合31第31頁(yè)CCFHDraftinggroups

食品衛(wèi)生法典委員會(huì)起草工作組L.monocytogenesinready-to-eatfood (Germany)即食食品中單增李斯特菌Salmonellaspp.inpoultry (Sweden)禽肉中沙門(mén)氏菌Campylobacterspp.inpoultry (Netherlands)禽肉中空腸彎曲菌Vibriospp.inseafood (UnitedStates)海產(chǎn)品中副溶血性弧菌EnterohemorrhagicE.coliinmeat (UnitedStates)肉食品中出血性大腸桿菌32第32頁(yè)WhyRAisneededinChina？

我國(guó)為何要進(jìn)行危險(xiǎn)性分析？WTOCODEX/GBFOODINDUSTRY

FOODSAFETYCONTROLGovernmentConsumersHEALTHPROTECTIONLifequalityknowledge國(guó)際貿(mào)易食品法典/國(guó)家標(biāo)準(zhǔn)體系食品工業(yè)食品安全控制政府消費(fèi)者保護(hù)消費(fèi)者健康生活質(zhì)量提升對(duì)食品安全知識(shí)需求33第33頁(yè)CaseinChinaTheControloftheDeterioratedSugarcaneFoodPoisoningFreshsugarcanegrowninsouthernareaofChina

Shipped,storedandsoldthroughthewinterseasoninthenorthernpartsofChina

Contaminatedsugarcanecouldcausefatalfoodpoisoningwhensoldinthenextspring34第34頁(yè)SugarcanepoisoningThefirstoutbreakofunknowncausessugarcanepoisoningoccurredinHenanProvincein1972From1972to1989:No.ofoutbreak:217No.ofcases:884No.ofdeaths:88Averagefatality:10%IdentifiedasaprioritytoassessandcontrolbyMOH35第35頁(yè)

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