第1页：危险性分析的原则及其应用
危险性分析的原则及其应用
- 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
第2页：食品安全是全球共同关注的问题
食品安全是全球共同关注的问题
- 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 different 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
第3页：CAC与WTO的SPS、TBT协定
CAC与WTO的SPS、TBT协定
- 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, SPSSanitary / Phytosanitary Measures Agreement
- 贸易技术壁垒协议, TBTThe Agreement onTechnical Barriers to Trade
第4页：WHO对成员国的要求
WHO对成员国的要求
- 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；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。
第5页：为什么要进行危险性分析
为什么要进行危险性分析
- 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
第6页：危险性分析的三个组成部分
危险性分析的三个组成部分
- Risk Analysis -what is it?A process consisting of 3 components:
- risk assessment 危险性评估
- risk management 危险性管理
- risk communication 危险性信息交流
第7页：危险性分析范式
危险性分析范式
- Risk Analysis ParadigmRisk AssessmentRisk ManagementRisk Communication
- Science based
- Policy based
- Interactive exchange of information and opinions
第8页：危险性评估的定义
- 危险性评估的定义
- A scientifically based process 科学评估的程序 The evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxinsor 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。
第9页：危险性管理的定义
- 危险性管理的定义
- 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。
第10页：危险性信息交流
- 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。
第11页：危险性评估的四个步骤
危险性评估的四个步骤
- 危险性评估程序Risk Assessment危害的确定Hazard Identification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
第12页：危害的定义
- 危害的定义
- 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。
第13页：食品中的危害
食品中的危害
- 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
- 潜在的环境有毒化学污染物
第14页：危害特征的描述
- 危害特征的描述
- Hazard characterisation (CAC, 1997)危害特征的描述 Thequalitativeand/orquantitativeevaluationofthenatureoftheadversehealtheffectsassociatedwiththehazard.ForthepurposeofMicrobiologicalRiskAssessmenttheconcernsrelatetomicroorganismsandtheirtoxins. 微生物危害的定性（半定量）、定量评估
第15页：暴露评估
- 暴露评估
- 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 as 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
第16页：危险性特征的描述
- 危险性特征的描述
- 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 adverse 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。
第17页：危险性管理的四个要素
危险性管理的四个要素
- Risk evaluation
- 危险性评价
- Risk management options assessment
- 危险性管理选项评估
- Implementation
- 执行
- Monitoring and review
- 监测和回顾
第18页：危险性管理的执行
危险性管理的执行
- 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 pathway
- 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
第19页：监测与评议
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 risk 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
第20页：危险性分析的使用者
危险性分析的使用者
- 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 international 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
第21页：CAC常遇到的问题
CAC常遇到的问题
- Different opinions on methods or outputs of assessment, eg., using “As low as reasonably achievable (ALARA) ” 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、B
- 1、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
第22页：FAO/WHO专家咨询组织
FAO/WHO专家咨询组织
- 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, Joint FAO/WHO ExpertConsultation on Microbiological Risk Assessment
- FAO/WHO联合微生物危险性评估专家咨询委员会
第23页：专家咨询与法典委员会的关系
专家咨询与法典委员会的关系
- 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 consultationStandard formulation (assessment) (management)JECFA CCFACCCRVDFJMPR CCPRJEMRACCFH
第24页：FAO/WHO危险性分析专家会议
FAO/WHO危险性分析专家会议
- FAO/WHOactivities on risk analysisFAO/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 Standards and Safety Matters
- 危险性信息交流在食品标准和安全中的应用
第25页：FAO/WHO危险性分析会议（续）
FAO/WHO危险性分析会议（续）
- 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-Expert 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
第26页：危险性评估与管理的对应关系
危险性评估与管理的对应关系
- 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)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 ManagementJECFACCFACRelationship between JECFA and CCFAC or CCRVDCCRVD
第27页：黄曲霉毒素B1评估案例
黄曲霉毒素B1评估案例
- CCFAC & JECFAExample: Aflatoxin B1
- 1994,CCFACaskedJECFA:(26thSession)toprovideestimatesofthetoxicologicalpotencyofaflatoxinsandtoderiveestimatesofthepotentialrisksfordifferentpopulations
- 1996,JECFA(46thmeeting):Aflatoxinswereconsidered
- 1997,JECFA(49thmeeting):Aflatoxinswerecarriedover
第28页：JECFA第49次会议的定量危险性评价
JECFA第49次会议的定量危险性评价
- Quantitative risk assessment at 49thJECFA Meeting in 1997JECFA 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
- 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
第29页：欧洲人群黄曲霉毒素危险度
例1 欧洲污染水平/欧洲膳食结构下黄曲霉毒素的人群危险度（HBsAg阳性率1%）| 限量标准 | 摄入量（ng/人/天） | 人群危险度（个肝癌/年/10万人） |
|---|
| 20 µg/kg | 19 | 0.0041（0.0006-0.01） |
|---|
| 10 µg/kg | 18 | 0.0039（0.0006-0.01） |
|---|
注：限量由20 µg/kg降至10 µg/kg，人群危险度仅相差约2个肝癌/年/亿人，收益有限。
第30页：中国人群黄曲霉毒素危险度
例2 中国污染水平/远东膳食结构下黄曲霉毒素的人群危险度（HBsAg阳性率25%）| 限量标准 | 摄入量（ng/人/天） | 人群危险度（个肝癌/年/10万人） |
|---|
| 20 µg/kg | 125 | 0.17（0.03-0.3） |
|---|
| 10 µg/kg | 103 | 0.14（0.02-0.3） |
|---|
注：在HBsAg阳性率高、污染水平高的中国人群，限量由20 µg/kg降至10 µg/kg可相差约300个肝癌/年/亿人，显著高于欧洲人群；1990-1992年全国肝癌死亡率约20/10万。
第31页：CCFH的微生物危险性评估工作
CCFH的微生物危险性评估工作
- 32ndCCFH （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
第32页：CCFH起草工作组
CCFH起草工作组
- CCFH Drafting groups食品卫生法典委员会起草工作组
- L. monocytogenesin 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. coliin meat(United States)
- 肉食品中的出血性大肠杆菌
第33页：我国开展危险性分析的必要性
我国开展危险性分析的必要性
- 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
第34页：变质甘蔗食物中毒的控制
变质甘蔗食物中毒的控制
- Case in ChinaThe 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
第35页：甘蔗中毒的流行情况
甘蔗中毒的流行情况
- 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
第36页：甘蔗中毒的病因与危险性评估
甘蔗中毒的病因与危险性评估
- Etiology and causes study were been carried out by the Chinese Academy of Preventive Medicine in 1980’s
- 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
第37页：决策与管理措施
决策与管理措施
- 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
第38页：甘蔗中毒控制的成效
甘蔗中毒控制的成效
- As a result of these efforts, sugarcane poisoning has been satisfactory controlled
- No typical cases were reported in China in the last 10 years!
第39页：FAO/WHO在中国的活动
FAO/WHO在中国的活动
- 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 the Fishery Industry
- Sponsored by FAO/INFOYU, Aug 12-23, 2002 Shanghai
第40页：危险性分析总结
危险性分析总结
- 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
