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Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,*,【WORKSHOP ON AGRO-FOOD SAFETY ISSUES.10.9-11】,General Principle&Application of Risk Analysis on Food Safety,危险性分析标准及其在食品安全中应用,1,食品安全中危险性分析的原则及应用,第1页,Food safety a global concern,Food ingredients and products sourced around the world,食物原料和产品起源于世界各地,Food control measures not the same everywhere,各地食品安全控制办法不一样,Food safety may be perceived differently in different parts of the world,不一样地域对食品安全认识不一样,Can obstruct international trade,国际贸易受阻,2,食品安全中危险性分析的原则及应用,第2页,CAC&WTO,SPS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/Phytosanitary Measures Agreement,贸易技术壁垒协议,TBT,The Agreement on,Technical Barriers to Trade,3,食品安全中危险性分析的原则及应用,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,食品安全中危险性分析的原则及应用,第4页,Risk analysis why?,为何要进行危险性分析,Food safety of increasing concern,食品安全被广为关注,Move towards a risk based approach,趋向于对危险性研究,Decision making based on sound science,基于科学基础上决议,5,食品安全中危险性分析的原则及应用,第5页,Risk Analysis-what is it?,A process consisting of 3 components:,risk assessment,危险性评定,risk management,危险性管理,risk communication,危险性信息交流,6,食品安全中危险性分析的原则及应用,第6页,Risk Analysis Paradigm,Risk Assessment,Risk Management,Risk Communication,Science based,Policy based,Interactive exchange,of information and opinions,7,食品安全中危险性分析的原则及应用,第7页,Risk Assessment,(CAC,1997),危险性评定,A scientifically based process,科学评定程序,The 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),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,食品安全中危险性分析的原则及应用,第8页,Risk Management,(CAC,1997),危险性管理,The 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 protection of consumers and for the promotion of fair trade practices,and,if needed,selecting appropriate prevention and control options.,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,食品安全中危险性分析的原则及应用,第9页,Risk Communication,危险性信息交流,The interactive exchange of information and opinions 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 management decisions,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,食品安全中危险性分析的原则及应用,第10页,危险性评定程序,Risk Assessment,危害确定,Hazard Identification,危害特征描述,Hazard Characterization,暴露量评定,Exposure Assessment,危险特征描述,Risk Characterization,11,食品安全中危险性分析的原则及应用,第11页,Hazard,(CAC,1997),危害,A biological,chemical or physical agent in,or condition of,food with the potential to cause an adverse health effect.,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,食品安全中危险性分析的原则及应用,第12页,Hazards in Food,Microorganisms,细菌,Fungi and mycotoxins,真菌和真菌毒素,Viruses and parasites,病毒和寄生虫,Toxic plants and animals,有毒动植物,Potential environmental toxicants,潜在环境有毒化学污染物,13,食品安全中危险性分析的原则及应用,第13页,Hazard characterisation,(CAC,1997),危害特征描述,The qualitative 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.,微生物危害定性(半定量)、定量评定,14,食品安全中危险性分析的原则及应用,第14页,Exposure Assessment,(CAC,1997),暴露评定,The 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.,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,食品安全中危险性分析的原则及应用,第15页,Risk Characterization,(CAC,1997),危险性特征描述,The 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 exposure assessment.,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,食品安全中危险性分析的原则及应用,第16页,Risk management,危险性管理,4 Elements,:,Risk evaluation,危险性评价,Risk management options assessment,危险性管理选项评定,Implementation,执行,Monitoring and review,监测和回顾,17,食品安全中危险性分析的原则及应用,第17页,Implementation,执行,Can be done by both government officials and the food industry,可被政府官方和食品企业执行,Implementation will take different forms depending what decisions have been taken,执行将依据已定决议采取不一样形式,MRA may be useful in implementation,information on product pathogen pathway,in particular exposure assessment can be a valuable information source,MRA,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,食品安全中危险性分析的原则及应用,第18页,Monitoring and Review,监测与评议,Assess effectiveness of measures taken,评定所用方法效率,provides more data,提供更多数据,provides information need to review risk management decision and if needed risk assessment,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,食品安全中危险性分析的原则及应用,第19页,Risk Analysis-who uses it,A tool for use primarily by governments,各国政府,protect consumer health,保护消费者健康,maintain confidence in internationally traded food(market maintenance)-harmonization,mutual recognition,equivalence,维持在国际食品贸易中信心-一体、共识、平等,At international level,国际水平,WTO-use risk assessment techniques developed by relevant international organizations,国际贸易中采取由相关国际组织建立危险性评定技术,used by standard setting bodies(Codex),被国际标准指定团体所采取,20,食品安全中危险性分析的原则及应用,第20页,CAC,常碰到问题,Different opinions on methods or outputs of assessment,eg.,using“As low as reasonably achievable(ALARA)”for contaminants,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),When there is scientifically uncertainty,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,食品安全中危险性分析的原则及应用,第21页,JECFA,,J,oint FAO/WHO,E,xpert,C,ommittee on,F,ood,A,dditives,FAO/WHO,联合食品添加剂教授委员会,JMPR,J,oint FAO/WHO,M,eeting on,P,esticide,R,esidues,FAO/WHO,联合农药残留教授委员会,JEMRA,J,oint FAO/WHO,E,xpert Consultation on,M,icrobiological,R,isk,A,ssessment,FAO/WHO,联合微生物危险性评定教授咨询委员会,22,食品安全中危险性分析的原则及应用,第22页,FAO/WHO教授咨询组织与CAC相关委员会关系,Relationship between expert consultation and Codex relevant committees,教授咨询(评定)制订标准(管理),Expert consultation Standard formulation,(assessment)(management),JECFA,CCFAC,CCRVDF,JMPR,CCPR,JEMRA,CCFH,23,食品安全中危险性分析的原则及应用,第23页,FAO/WHO,activities on risk analysis,FAO/WHO,召开危险性分析教授咨询会议,1995,-Expert Consultation on Risk Analysis and Food Safety,危险性分析与食品安全,1997,-Expert Consultation on Risk Management and Food Safety,危险性管理与食品安全,1998-,Expert Consultation on the Application of Risk Communication to Food Standards and Safety Matters,危险性信息交流在食品标准和安全中应用,24,食品安全中危险性分析的原则及应用,第24页,1999-,Expert Consultation on Risk Assessment of Microbiological Hazards in Foods,食品中微生物危害危险性评定,-Expert Consultation on Interaction between Risk assessors and risk managers of Microbiological Hazards in Food,食品中微生物危害危险性评定者与管理者间相互作用,-Expert Consultation on Exposure,Assessment of Microbiological Hazards in foods,食品中微生物危害暴露评定,-Expert Consultation on Incorporating Quantitative Risk Assessment in the Development of Microbiological Food Hygiene Standards,利用定量微生物危险性评定制订食品卫生标准,25,食品安全中危险性分析的原则及应用,第25页,危险性评定(教授)添加剂 ADI,Risk Assessment,污染物 PTWI,兽药残留 ADI,危险性管理,(政府),添加剂 范围,用量,Risk Management污染物 限量,危险性管理,(政府),兽药残留 限量,Risk Management,JECFA,CCFAC,Relationship between JECFA and CCFAC or CCRVD,CCRVD,26,食品安全中危险性分析的原则及应用,第26页,CCFAC&JECFA,Example:,Aflatoxin B,1,1994,CCFAC asked JECFA:,(26,th,Session)to provide estimates of the toxicological potency of aflatoxins and to derive estimates of the potential risks for different populations,1996,JECFA,(46,th,meeting):Aflatoxins were considered,1997,JECFA,(49,th,meeting):Aflatoxins were carried over,27,食品安全中危险性分析的原则及应用,第27页,Quantitative risk assessment at 49,th,JECFA Meeting in,1997,JECFA 49,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/,ng AF/kg bw/,天,HBsAg(,):0.01,个肝癌/年/10万人/,ng AF/kg bw/,天,人群危险度=作用强度 摄入量,28,食品安全中危险性分析的原则及应用,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20,g/kg 19 0.0041(0.0006-0.01),限量10 g/kg 18 0.0039(0.0006-0.01),相差 2个肝癌/年/亿人,29,食品安全中危险性分析的原则及应用,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,食品安全中危险性分析的原则及应用,第30页,CCFH ACTIVITIES,32,nd,CCFH(1999),Decided to proceed in MRA on the basis of pathogen/commodity combinations;Elaborated and agreed on tentative priority list of pathogen/commodity combinations,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,食品安全中危险性分析的原则及应用,第31页,CCFH Drafting groups,食品卫生法典委员会起草工作组,L.monocytogenes,in ready-to-eat food(Germany),即食食品中单增李斯特菌,Salmonella spp.,in poultry (Sweden),禽肉中沙门氏菌,Campylobacter spp.,in poultry (Netherlands),禽肉中空肠弯曲菌,Vibrio spp.,in seafood(United States),海产品中副溶血性弧菌,Enterohemorrhagic E.coli,in meat(United States),肉食品中出血性大肠杆菌,32,食品安全中危险性分析的原则及应用,第32页,Why RA is needed in China?,我国为何要进行危险性分析?,WTO,CODEX/GB,FOOD INDUSTRY,FOOD SAFETY CONTROL,Government,Consumers,HEALTH PROTECTION,Life quality,knowledge,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,食品安全中危险性分析的原则及应用,第33页,Case in China,The Control of the Deteriorated Sugarcane Food Poisoning,Fresh sugarcane grown in southern area of China,Shipped,stored and sold through the winter season in the northern parts of China,Contaminated sugarcane could cause fatal food poisoning when sold in the next spring,34,食品安全中危险性分析的原则及应用,第34页,Sugarcane poisoning,The first outbreak of unknown causes sugarcane poisoning occurred in Henan Province in 1972,From 1972 to 1989:,No.of outbreak:217,No.of cases:884,No.of deaths:88,Average fatality:10%,Identified as a priority to assess and control by MOH,35,食品安全中危险性分析的原则及应用,第35页,Etiology and risk assessment,Etiology and causes study were been carried out by the Chinese Academy of Preventive Medicine in 1980s,Arthrinium spp.,was the pathogenic fungus;,3-nitropropionic acid(3-NPA)produced by,A.spp.,was proved to be the causative compound,Assessment was made according to case-based studies,epidemiological and laboratory studies,36,食品安全中危险性分析的原则及应用,第36页,Decision making and management activities,Based on discovery and assessment,MOH promulgated:,Diagnostic criteria and principles for the management of deteriorated sugarcane poisoning(WS/T10-1996);,Methods for the isolation and identification of Arthrinium strains and analyzing 3-nitropropionic acid(GB47689.16),MOH issued a notification on the prevention and control of DSP to all provinces of China,A national health campaign for prevention and control of the poisoning was launched,37,食品安全中危险性分析的原则及应用,第37页,Good results,As a result of these efforts,sugarcane poisoning has been satisfactory controlled,No typical cases were reported in China in the last 10 years!,38,食品安全中危险性分析的原则及应用,第38页,FAO/WHO Activates in China,Workshop on Microbiological Risk Assessment,Sponsored by FAO/ILSI/WHO/MOH,May 10-11,Beijing,Quantitative Microbiological Risk Assessment Training Course(David Vose),Sponsored by WHO/INFS,May 13-24,Beijing,National Workshop on Introduction to Risk Analysis in the Fishery Industry,Sponsored by FAO/INFOYU,Aug 12-23,Shanghai,39,食品安全中危险性分析的原则及应用,第39页,Risk analysis-concluding summary,Risk analysis and its components,Provide a tool for managing risks,提供管理危险工具,Internationally recognized approach,国际公认伎俩,Protect consumer health,保护消费者健康,Food products could be accepted by international market,产品被国际市场所接收,40,食品安全中危险性分析的原则及应用,第40页,
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