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1、General Principle & Application of Risk Analysis on Food Safety 危危险性分析的原性分析的原则及其在食品及其在食品安全中的安全中的应用用1危险性分析的原则及其在食品安全中的应用Food safety a global concernnFood ingredients and products sourced around the worldn食物原料和产品来源于世界各地nFood control measures not the same everywheren各地的食品安全控制措施不同nFood safety may be per
2、ceived differently in different parts of the worldn不同地域对食品安全的认识不同nCan obstruct international traden国际贸易受阻2危险性分析的原则及其在食品安全中的应用CAC & WTOnSPS和TBT协议是WTO成员在国际贸易中必须遵循的多边协定n应用卫生与植物卫生措施协定, SPS Sanitary / Phytosanitary Measures Agreement n贸易技术壁垒协议, TBT The Agreement on Technical Barriers to Trade3危险性分析的原则及其在
3、食品安全中的应用WHO要求各会员国：n在食品安全行动之下，重点制定和评估国家的控制战略，支持发展评估与食品相关风险的科学，包括分析与食源性疾病相关的高危因素分析与食源性疾病相关的高危因素；要最大可能利用发展中国家在食源性因素危险性评估方面的信息以制定国际标准。4危险性分析的原则及其在食品安全中的应用Risk analysis why ?为什么要进行危险性分析为什么要进行危险性分析nFood safety of increasing concernn食品安全被广为关注食品安全被广为关注nMove towards a risk based approachn趋向于对危险性的研究趋向于对危险性的研究
4、nDecision making based on sound sciencen基于科学基础上的决策基于科学基础上的决策5危险性分析的原则及其在食品安全中的应用Risk Analysis - what is it?A process consisting of 3 components: nrisk assessment 危险性评估危险性评估 nrisk management 危险性管理危险性管理 nrisk communication 危险性信息交流危险性信息交流6危险性分析的原则及其在食品安全中的应用Risk Analysis ParadigmRisk Analysis ParadigmR
5、isk AssessmentRisk AssessmentRisk ManagementRisk ManagementRisk CommunicationRisk Communication Science Science basedbased Policy basedPolicy based Interactive exchange Interactive exchange of information and opinions of information and opinions 7危险性分析的原则及其在食品安全中的应用Risk Assessment Risk Assessment (C
6、AC, 1997)(CAC, 1997)危险性评估危险性评估nA scientifically based processn科学评估的程序nThe evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs. (WTO)n评估食品、饮料、饲料中的添加剂、污染物、毒素
7、或病原菌对人群或动物潜在副作用的科学程序。8危险性分析的原则及其在食品安全中的应用Risk Management Risk Management (CAC, 1997)(CAC, 1997) 危险性管理nThe process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protec
8、tion of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.n在危险性评估的科学基础上，为保护消费者健康、促进国际食品贸易而采取的预防和控制措施。 9危险性分析的原则及其在食品安全中的应用Risk CommunicationRisk Communication危险性信息交流危险性信息交流nThe interactive exchange of information and opinion
9、s throughout the risk analysis process concerning hazards and risks, risk related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk m
10、anagement decisionsn在危险性评估者，危险性管理者，消费者，企业，学术团体和其他组织间就危害、危险性，与危险性相关的因素和理解等进行广泛的信息和意见沟通，包括危险性评估的结论和危险性管理决策。 10危险性分析的原则及其在食品安全中的应用危险性评估程序危险性评估程序Risk AssessmentRisk Assessment危害的确定危害的确定Hazard IdentificationHazard Identification 危害的特征描述危害的特征描述Hazard CharacterizationHazard Characterization暴露量评估暴露量评估Exposu
11、re AssessmentExposure Assessment危险特征的描述危险特征的描述Risk CharacterizationRisk Characterization11危险性分析的原则及其在食品安全中的应用Hazard Hazard (CAC, 1997)(CAC, 1997)危害nA biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. n食品中可能存在的影响人体健康的生物、化学、物理因素，或状况。
12、12危险性分析的原则及其在食品安全中的应用Hazards in FoodnMicroorganismsn细菌nFungi and mycotoxinsn真菌和真菌毒素nViruses and parasitesn病毒和寄生虫nToxic plants and animalsn有毒动植物nPotential environmental toxicantsn潜在的环境有毒化学污染物13危险性分析的原则及其在食品安全中的应用Hazard characterisation Hazard characterisation (CAC, 1997)(CAC, 1997)危害特征的描述nThe qualita
13、tive and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and their toxins. n微生物危害的定性（半定量）、定量评估14危险性分析的原则及其在食品安全中的应用Exposure Assessment Exposure Assessment (CAC,
14、 1997)(CAC, 1997)暴露评估nThe qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well as exposures from other sources if relevant. n从食物或相关来源摄入生物、化学和物理因子的定性、定量评估15危险性分析的原则及其在食品安全中的应用Risk CharacterizationRisk Characterization(CAC,1997)(C
15、AC,1997)危险性特征的描述nThe process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and
16、exposure assessment. n在危害的识别、危害的特征描述和暴露评估的基础上确定事件暴发的概率和严重性，或对健康产生潜在不良影响的定性和/定量评估的过程。16危险性分析的原则及其在食品安全中的应用 Risk management 危险性管理4 Elements：nRisk evaluationn危险性评价危险性评价nRisk management options assessmentn危险性管理选项评估危险性管理选项评估nImplementation n执行执行nMonitoring and reviewn监测和回顾监测和回顾17危险性分析的原则及其在食品安全中的应用Implem
17、entationImplementation执行执行nCan be done by both government officials and the food industryn可被政府官方和食品企业执行nImplementation will take different forms depending what decisions have been takenn执行将根据已定的决议采取不同形式nMRA may be useful in implementationninformation on product pathogen pathwaynin particular exposur
18、e assessment can be a valuable information sourcenMRA在执行中的作用n病原菌产生的途径n特别是暴露评估可作为有价值的信息来源18危险性分析的原则及其在食品安全中的应用Monitoring and ReviewMonitoring and Review监测与评议监测与评议nAssess effectiveness of measures takenn评估所用方法的效率评估所用方法的效率nprovides more datan提供更多数据提供更多数据nprovides information need to review risk managem
19、ent decision and if needed risk assessmentn提供信息，以便评议危险性管理决议及是否需提供信息，以便评议危险性管理决议及是否需要危险性评估要危险性评估19危险性分析的原则及其在食品安全中的应用Risk Analysis-who uses itnA tool for use primarily by governments 各国政府 nprotect consumer health保护消费者健康nmaintain confidence in internationally traded food (market maintenance) - harmoni
20、zation, mutual recognition, equivalence 维持在国际食品贸易中的信心-一体、共识、平等nAt international level 国际水平nWTO - use risk assessment techniques developed by relevant international organizations 国际贸易中采用由相关国际组织建立的危险性评估技术nused by standard setting bodies (Codex)被国际标准指定团体所采用20危险性分析的原则及其在食品安全中的应用CAC 常遇到的问题常遇到的问题nDifferen
21、t opinions on methods or outputs of assessment, eg., using “As low as reasonably achievable (ALARA) ” for contaminantsn对专家评价方法或结果有不同看法，如污染物达到尽可能低的水平n黄曲霉毒素（总量、B1、M1）nWhen there is scientifically uncertaintyn当存在科学不确定性时n食品中的单增李斯特菌（100cfu/g） n氯丙醇21危险性分析的原则及其在食品安全中的应用nJECFA，Joint FAO/WHO Expert Committee
22、 on Food AdditivesnFAO/WHO联合食品添加剂专家委员会nJMPR，Joint FAO/WHO Meeting on Pesticide ResiduesnFAO/WHO联合农药残留专家委员会nJEMRA, Joint FAO/WHO Expert Consultation on Microbiological Risk AssessmentnFAO/WHO联合微生物危险性评估专家咨询委员会22危险性分析的原则及其在食品安全中的应用FAO/WHO专家咨询组织与专家咨询组织与CAC有关委员会关系有关委员会关系 Relationship between expert consu
23、ltation and Codex relevant committees 专家咨询（评估）专家咨询（评估） 制定标准（管理）制定标准（管理） Expert consultation Standard formulation (assessment) (management) JECFA CCFAC CCRVDF JMPR CCPR JEMRA CCFH23危险性分析的原则及其在食品安全中的应用FAO/WHO activities on risk analysisFAO/WHO召开的危险性分析专家咨询会议1995 - Expert Consultation on Risk Analysis a
24、nd Food Safetyn危险性分析与食品安全危险性分析与食品安全1997 - Expert Consultation on Risk Management and Food Safetyn 危险性管理与食品安全危险性管理与食品安全1998 - Expert Consultation on the Application of Risk Communication to Food Standards and Safety Mattersn危险性信息交流在食品标准和安全中的应用危险性信息交流在食品标准和安全中的应用24危险性分析的原则及其在食品安全中的应用1999 - Expert Cons
25、ultation on Risk Assessment of Microbiological Hazards in Foods n 食品中微生物危害的危险性评估2000 - Expert Consultation on Interaction between Risk assessors and risk managers of Microbiological Hazards in Foodn食品中微生物危害的危险性评估者与管理者间的相互作用2001 - Expert Consultation on Exposure Assessment of Microbiological Hazards
26、in foodsn食品中微生物危害的暴露评估食品中微生物危害的暴露评估2002 - Expert Consultation on Incorporating Quantitative Risk Assessment in the Development of Microbiological Food Hygiene Standardsn运用定量微生物危险性评估制订食品卫生标准运用定量微生物危险性评估制订食品卫生标准25危险性分析的原则及其在食品安全中的应用危险性评估(专家)添加剂 ADIRisk Assessment污染物 PTWI兽药残留 ADI 危险性管理(政府政府) 添加剂 范围,用量R
27、isk Management污染物 限量 危险性管理(政府政府) 兽药残留 限量 Risk ManagementJECFAJECFACCFACCCFACRelationship between JECFA and CCFAC or CCRVDCCRVD26危险性分析的原则及其在食品安全中的应用CCFAC & JECFACCFAC & JECFA Example: Aflatoxin B1n1994, CCFAC asked JECFA: (26th Session) to provide estimates of the toxicological potency of aflatoxins
28、and to derive estimates of the potential risks for different populationsn1996, JECFA (46th meeting): Aflatoxins were consideredn1997, JECFA (49th meeting): Aflatoxins were carried over 27危险性分析的原则及其在食品安全中的应用 Quantitative risk assessment at 49Quantitative risk assessment at 49thth JECFA Meeting in JEC
29、FA Meeting in 19971997JECFA 49JECFA 49次会议的定量危险性评价次会议的定量危险性评价致癌作用强度：致癌作用强度：nHBsAg() :0.3个肝癌/年/10万人/ ng AF/ kg bw/天nHBsAg () :0.01个肝癌/年/10万人/ng AF/kg bw/天n人群危险度 = 作用强度 摄入量28危险性分析的原则及其在食品安全中的应用例例1. HBsAg(HBsAg() 1%; ) 1%; 欧洲污染水平欧洲污染水平/欧洲膳食结构欧洲膳食结构 摄入量 人群危险度 (ng/人/天) (个肝癌/年/10万人)限量20 g/kg 19 0.0041 (0.0
30、006-0.01)限量10 g/kg 18 0.0039 (0.0006-0.01) 相差 2个肝癌/年/亿人29危险性分析的原则及其在食品安全中的应用例例2. HBsAg(HBsAg() 25%; ) 25%; 中国污染水平中国污染水平/远东膳食结构远东膳食结构 摄入量 人群危险度 (ng/人/天) (个肝癌/年/10万人)限量20 g/kg 125 0.17 (0.03-0.3)限量10 g/kg 103 0.14 (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危险性分析的原则及其在食品安全中的应用CCFH ACTIVITIESn32nd
31、 CCFH （1999） Decided to proceed in MRA on the basis of pathogen/commodity combinations；Elaborated and agreed on tentative priority list of pathogen / commodity combinationsn决定对病原食品组合进行微生物危险性评估，并提出暂定优先组合31危险性分析的原则及其在食品安全中的应用CCFH Drafting groups食品卫生法典委员会起草工作组nL. monocytogenes in ready-to-eat food(Germ
32、any)n即食食品中的单增李斯特菌nSalmonella spp. in poultry (Sweden)n禽肉中的沙门氏菌nCampylobacter spp. in poultry (Netherlands)n禽肉中的空肠弯曲菌nVibrio spp. in seafood(United States)n海产品中的副溶血性弧菌nEnterohemorrhagic E. coli in meat(United States)n肉食品中的出血性大肠杆菌32危险性分析的原则及其在食品安全中的应用Why RA is needed in China？我国为什么要进行危险性分析？我国为什么要进行危险性
33、分析？nWTOnCODEX / GBnFOOD INDUSTRYn nFOOD SAFETY CONTROLnGovernmentnConsumersnHEALTH PROTECTIONnLife qualitynknowledgen国际贸易n食品法典 / 国家标准体系n食品工业n食品安全控制n政府n消费者n保护消费者健康n生活质量的提高n对食品安全知识的需求33危险性分析的原则及其在食品安全中的应用Case in China The Control of the Deteriorated Sugarcane Food PoisoningnFresh sugarcane grown in so
34、uthern area of Chinan nShipped, stored and sold through the winter season in the northern parts of Chinan nContaminated sugarcane could cause fatal food poisoning when sold in the next spring34危险性分析的原则及其在食品安全中的应用Sugarcane poisoningnThe first outbreak of unknown causes sugarcane poisoning occurred in
35、 Henan Province in 1972nFrom 1972 to 1989:nNo. of outbreak: 217nNo. of cases: 884nNo. of deaths: 88 nAverage fatality: 10%nIdentified as a priority to assess and control by MOH35危险性分析的原则及其在食品安全中的应用Etiology and risk assessmentnEtiology and causes study were been carried out by the Chinese Academy of
36、Preventive Medicine in 1980snArthrinium spp. was the pathogenic fungus;n3-nitropropionic acid (3-NPA) produced by A. spp. was proved to be the causative compoundnAssessment was made according to case-based studies, epidemiological and laboratory studies36危险性分析的原则及其在食品安全中的应用Decision making and manage
37、ment activitiesnBased on discovery and assessment, MOH promulgated:nDiagnostic criteria and principles for the management of deteriorated sugarcane poisoning (WS/T10-1996);nMethods for the isolation and identification of Arthrinium strains and analyzing 3-nitropropionic acid (GB47689.16)nMOH issued
38、a notification on the prevention and control of DSP to all provinces of ChinanA national health campaign for prevention and control of the poisoning was launched37危险性分析的原则及其在食品安全中的应用Good results nAs a result of these efforts, sugarcane poisoning has been satisfactory controllednNo typical cases were
39、 reported in China in the last 10 years! 38危险性分析的原则及其在食品安全中的应用FAO/WHO Activates in ChinanWorkshop on Microbiological Risk Assessment nSponsored by FAO/ ILSI /WHO/ MOH, May 10-11, 2002 BeijingnQuantitative Microbiological Risk Assessment Training Course (David Vose)nSponsored by WHO/INFS, May 13-24,
40、2002 BeijingnNational Workshop on Introduction to Risk Analysis in the Fishery Industry nSponsored by FAO/INFOYU, Aug 12-23, 2002 Shanghai39危险性分析的原则及其在食品安全中的应用Risk analysis - concluding summarynRisk analysis and its componentsnProvide a tool for managing risksn提供管理危险的工具nInternationally recognized approach n国际公认的手段nProtect consumer health n保护消费者健康nFood products could be accepted by international marketn产品被国际市场所接受40危险性分析的原则及其在食品安全中的应用危险性分析的原则及其在食品安全中的应用
