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1、1,General Principle & Application of Risk Analysis on Food Safety 危险性分析的原则及其在食品 安全中的应用,2,Food safety a global concern,Food ingredients and products sourced around the world 食物原料和产品来源于世界各地 Food control measures not the same everywhere 各地的食品安全控制措施不同 Food safety may be perceived differently in differen
2、t parts of the world 不同地域对食品安全的认识不同 Can obstruct international trade 国际贸易受阻,3,CAC & WTO,SPS和TBT协议是WTO成员在国际贸易中必须遵循的多边协定 应用卫生与植物卫生措施协定, SPS Sanitary / Phytosanitary Measures Agreement 贸易技术壁垒协议, TBT The Agreement on Technical Barriers to Trade,4,WHO要求各会员国： 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
3、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。,5,Risk analysis why ? 为什么要进行危险性分析,Food safety of increasing concern 食品安全被广为关注 Move towards a risk based approach 趋向于对危险性的研究 Decision making based on sound science 基于科学基础上的决策,6,Risk Analysis - what is it?,A process consisting of 3 components: risk as
4、sessment 危险性评估 risk management 危险性管理 risk communication 危险性信息交流,7,Risk Analysis Paradigm,Risk Assessment,Risk Management,Risk Communication, Science based, Policy based, Interactive exchange of information and opinions,8,Risk Assessment (CAC, 1997) 危险性评估,A scientifically based process 科学评估的程序 The ev
5、aluation 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) 评估食品、饮料、饲料中的添加剂、污染物、毒素或病原菌对人群或动物潜在副作用的科学程序。,9,Risk Management (CAC, 1997) 危险性管理,The process, disti
6、nct 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 co
7、ntrol options. 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。,10,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, i
8、ndustry, 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。,11,危险性评估程序 Risk Assessment,危害的确定 Hazard Identification,
9、危害的特征描述 Hazard Characterization,暴露量评估 Exposure Assessment,危险特征的描述 Risk Characterization,12,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. 食品中可能存在的影响人体健康的生物、化学、物理因素，或状况。,13,Hazards in Food,Microorganisms 细
10、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 潜在的环境有毒化学污染物,14,Hazard characterisation (CAC, 1997) 危害特征的描述,The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the haza
11、rd. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and their toxins. 微生物危害的定性（半定量）、定量评估,15,Exposure Assessment (CAC, 1997) 暴露评估,The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well a
12、s exposures from other sources if relevant. 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,16,Risk Characterization(CAC,1997) 危险性特征的描述,The process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adver
13、se health effects in a given population based on hazard identification, hazard characterization and exposure assessment. 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。,17,Risk management 危险性管理,4 Elements： Risk evaluation 危险性评价 Risk management options assessment 危险性管理选项评估 Implementati
14、on 执行 Monitoring and review 监测和回顾,18,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 执行将根据已定的决议采取不同形式 MRA may be useful in implementation information on product pathogen p
15、athway in particular exposure assessment can be a valuable information source MRA在执行中的作用 病原菌产生的途径 特别是暴露评估可作为有价值的信息来源,19,Monitoring and Review 监测与评议,Assess effectiveness of measures taken 评估所用方法的效率 provides more data 提供更多数据 provides information need to review risk management decision and if needed ri
16、sk assessment 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,20,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的信心-一体、共识、平等 At intern
17、ational level 国际水平 WTO - 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 used by standard setting bodies (Codex) 被国际标准指定团体所采用,21,CAC 常遇到的问题,Different opinions on methods or outputs of assessment, eg., using “As low as reasonably achievable (A
18、LARA) ” for contaminants 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 黄曲霉毒素（总量、B1、M1） When there is scientifically uncertainty 当存在科学不确定性时 食品中的单增李斯特菌（100cfu/g） 氯丙醇,JECFA，Joint FAO/WHO Expert Committee on Food Additives FAO/WHO联合食品添加剂专家委员会 JMPR，Joint FAO/WHO Meeting on Pesticide Residues FAO/WHO联合农药残留专家委员会 JEMRA, Jo
19、int FAO/WHO Expert Consultation on Microbiological Risk Assessment FAO/WHO联合微生物危险性评估专家咨询委员会,23,FAO/WHO专家咨询组织与CAC有关委员会关系 Relationship between expert consultation and Codex relevant committees,专家咨询（评估） 制定标准（管理） Expert consultation Standard formulation (assessment) (management) JECFA CCFAC CCRVDF JMPR
20、CCPR JEMRA CCFH,24,FAO/WHO activities on risk analysis FAO/WHO召开的危险性分析专家咨询会议,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 Sta
21、ndards and Safety Matters 危险性信息交流在食品标准和安全中的应用,25,1999 - Expert Consultation on Risk Assessment of Microbiological Hazards in Foods 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 Food 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 - Exp
22、ert Consultation on Exposure Assessment of Microbiological Hazards in foods 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 Standards 运用定量微生物危险性评估制订食品卫生标准,26,危险性评估(专家) 添加剂 ADI Risk Assessment 污染物 PTWI 兽药残留 ADI
23、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,27,CCFAC & JECFA Example: Aflatoxin B1,1994, CCFAC asked JECFA: (26th Session) to provide estimates of the toxicological potency of aflatoxins and to derive es
24、timates of the potential risks for different populations 1996, JECFA (46th meeting): Aflatoxins were considered 1997, JECFA (49th meeting): Aflatoxins were carried over,28,Quantitative risk assessment at 49th JECFA Meeting in 1997 JECFA 49次会议的定量危险性评价,致癌作用强度： HBsAg() :0.3个肝癌/年/10万人/ ng AF/ kg bw/天 HB
25、sAg () :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,29,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,30,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
26、 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20/10万,31,CCFH ACTIVITIES,32nd 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估，并提出暂定优先组合,32,CCFH Dr
27、afting groups 食品卫生法典委员会起草工作组,L. monocytogenes in ready-to-eat food (Germany) 即食食品中的单增李斯特菌 Salmonella spp. in poultry (Sweden) 禽肉中的沙门氏菌 Campylobacter spp. in poultry (Netherlands) 禽肉中的空肠弯曲菌 Vibrio spp. in seafood (United States) 海产品中的副溶血性弧菌 Enterohemorrhagic E. coli in meat (United States) 肉食品中的出血性大肠
28、杆菌,33,Why RA is needed in China？ 我国为什么要进行危险性分析？,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 生活质量的提高 对食品安全知识的需求,34,Case in China The Control of the Deteriorated Sugarcane Food Poisoning,Fr
29、esh 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,35,Sugarcane poisoning,The first outbreak of unknown causes sugarcane poisoning occurre
30、d 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,36,Etiology and risk assessment,Etiology and causes study were been carried out by the Chinese Academy of Preventive Med
31、icine 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,37,Decision making and management activities,Based on discov
32、ery 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 preventio
33、n and control of DSP to all provinces of China A national health campaign for prevention and control of the poisoning was launched,38,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!,39,FAO/W
34、HO Activates in China,Workshop on Microbiological Risk Assessment Sponsored by FAO/ ILSI /WHO/ MOH, May 10-11, 2002 Beijing Quantitative Microbiological Risk Assessment Training Course (David Vose) Sponsored by WHO/INFS, May 13-24, 2002 Beijing National Workshop on Introduction to Risk Analysis in t
35、he Fishery Industry Sponsored by FAO/INFOYU, Aug 12-23, 2002 Shanghai,40,Risk analysis - concluding summary,Risk analysis and its components Provide a tool for managing risks 提供管理危险的工具 Internationally recognized approach 国际公认的手段 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受,