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1、1Food 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 different parts of the world 不同地域对食品安全的认识(rn shi)不同 Can obstruct international trade 国际贸易受阻第1页/共

2、40页第一页,共40页。2CAC & 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(wishng)与植物卫生(wishng)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第2页/共40页第二页,共40页。3WHO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(boku)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

3、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3页/共40页第三页,共40页。4Risk analysis why ?为什么要进行(jnxng)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(jch)上的决策第4页/共40页第四页,共40页。5Risk Analysis - what is it?A process consisting of 3 comp

4、onents: risk assessment 危险性评估 risk management 危险性管理(gunl) risk communication 危险性信息交流第5页/共40页第五页,共40页。6Risk Analysis ParadigmRisk AssessmentRisk ManagementRisk Communication Science based Policy based Interactive exchange of information and opinions 第6页/共40页第六页,共40页。7Risk Assessment (CAC, 1997)危险性评估(

5、pn ) A scientifically based process 科学(kxu)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, 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(kx

6、u)程序。第7页/共40页第七页,共40页。8Risk Management (CAC, 1997) 危险性管理(gunl) 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

7、 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(guj)食品贸易而采取的预防和控制措施。 第8页/共40页第八页,共40页。9Risk Communication危险性信息(xnx)交流 The interactive exchange of information and opinions throughout the risk analysis process concerning hazard

8、s 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、

9、危险性,与危险性相关的因素和理解等进行广泛的信息(xnx)和意见沟通,包括危险性评估的结论和危险性管理决策。 第9页/共40页第九页,共40页。10危险性评估(pn )程序Risk Assessment危害危害(wihi)的确定的确定Hazard Identification 危害危害(wihi)的特征描述的特征描述Hazard Characterization暴露量评估暴露量评估Exposure Assessment危险特征的描述危险特征的描述Risk Characterization第10页/共40页第十页,共40页。11Hazard (CAC, 1997)危害(wihi) A biolo

10、gical, 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(huxu)、物理因素,或状况。第11页/共40页第十一页,共40页。12Hazards in Food Microorganisms 细菌(xjn) 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 P

11、otential environmental toxicants 潜在的环境有毒化学污染物第12页/共40页第十二页,共40页。13Hazard characterisation (CAC, 1997)危害特征(tzhng)的描述 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 r

12、elate to microorganisms and their toxins. 微生物危害的定性(dng xng)(半定量)、定量评估第13页/共40页第十三页,共40页。14Exposure Assessment (CAC, 1997)暴露(bol)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 relev

13、ant. 从食物或相关来源摄入生物、化学和物理因子的定性、定量(dngling)评估第14页/共40页第十四页,共40页。15Risk Characterization(CAC,1997)危险性特征(tzhng)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 heal

14、th 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(jch)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15页/共40页第十五页,共40页。16 Risk management 危险性管理(gunl)4 Elements:Risk evaluation危险性评价Risk management options assessment危险性管理

15、选项评估Implementation 执行(zhxng)Monitoring and review监测和回顾第16页/共40页第十六页,共40页。17Implementation执行(zhxng)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 implement

16、ationinformation on product pathogen pathwayin particular exposure assessment can be a valuable information sourceMRA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(xnx)来源第17页/共40页第十七页,共40页。18Monitoring and Review监测(jin c)与评议 Assess effectiveness of measures taken 评估(pn )所用方法的效率 provides more data 提供更多数据 provides i

17、nformation 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(pn )第18页/共40页第十八页,共40页。19Risk 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 mainte

18、nance) - 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(u j mo y)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19页/共40页第十九页,共40页。2

19、0CAC 常遇到(y do)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(d do)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) 氯丙醇第20页/共40页第二十页,共40页。 JECFA,J

20、oint 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(nngyo)残留专家委员会 JEMRA, Joint 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第21页/共40页第二十一页,共40页。22FAO/WHO专家(zhunji)咨询组织与CAC有关委员会关系 Re

21、lationship between expert consultation and Codex relevant committees 专家咨询(评估) 制定(zhdng)标准(管理) Expert consultation Standard formulation (assessment) (management) JECFA CCFAC CCRVDF JMPR CCPR JEMRA CCFH第22页/共40页第二十二页,共40页。23FAO/WHO activities on risk analysisFAO/WHO召开的危险性分析专家(zhunji)咨询会议1995 - Expert

22、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(biozhn)和安全中的应用第23页/共40页第二十三页,共40页。241999 - Expert Consul

23、tation on Risk Assessment of Microbiological Hazards in Foods 食品中微生物危害的危险性评估(pn )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(pn )者与管理者间的相互作用2001 - Expert Consultation on Exposure Assessment of Microbiological Haz

24、ards in foods食品中微生物危害的暴露评估(pn )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(pn )制订食品卫生标准第24页/共40页第二十四页,共40页。25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(zhngf) 添加剂 范围,用量Risk Management污

25、染物 限量 危险性管理(政府(zhngf) 兽药残留 限量 Risk ManagementRelationship between JECFA and CCFAC or CCRVDCCRVD第25页/共40页第二十五页,共40页。26CCFAC & JECFA Example: Aflatoxin B1 1994, CCFAC asked JECFA: (26th Session) to provide estimates of the toxicological potency of aflatoxins and to derive estimates of the potentia

26、l risks for different populations 1996, JECFA (46th meeting): Aflatoxins were considered 1997, JECFA (49th meeting): Aflatoxins were carried over 第26页/共40页第二十六页,共40页。27 Quantitative risk assessment at 49th JECFA Meeting in 1997JECFA 49次会议(huy)的定量危险性评价致癌作用强度:HBsAg() :0.3个肝癌(n i)/年/10万人/ ng AF/ kg bw/

27、天HBsAg () :0.01个肝癌(n i)/年/10万人/ng AF/kg bw/天人群危险度 = 作用强度 摄入量第27页/共40页第二十七页,共40页。28例1. HBsAg() 1%; 欧洲污染水平(shupng)/欧洲膳食结构 摄入量 人群危险度 (ng/人/天) (个肝癌(n i)/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(n i)/年/亿人第28页/共40页第二十八页,共40页。29例2. HBsAg() 25%; 中国污染水平(shupng)/远东膳食结构

28、 摄入量 人群(rnqn)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20/10万第29页/共40页第二十九页,共40页。30CCFH ACTIVITIES 32nd CCFH (1999) Decided to proceed in MRA on the basis of pathogen/commodity combinations;Elaborated and agreed on tentative pri

29、ority 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(zn dn)优先组合第30页/共40页第三十页,共40页。31CCFH Drafting groups食品卫生法典(fdin)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V

30、ibrio spp. in seafood(United States)海产品中的副溶血性弧菌(h jn)Enterohemorrhagic E. coli in meat(United States)肉食品中的出血性大肠杆菌第31页/共40页第三十一页,共40页。32Why RA is needed in China?我国为什么要进行(jnxng)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

31、品法典(fdin) / 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32页/共40页第三十二页,共40页。33Case 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

32、sugarcane could cause fatal food poisoning when sold in the next spring第33页/共40页第三十三页,共40页。34Sugarcane 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: 1

33、0% Identified as a priority to assess and control by MOH第34页/共40页第三十四页,共40页。35Etiology and risk assessment Etiology and causes study were been carried out by the Chinese Academy of Preventive Medicine in 1980sArthrinium spp. was the pathogenic fungus; 3-nitropropionic acid (3-NPA) produced by A. spp

34、. was proved to be the causative compound Assessment was made according to case-based studies, epidemiological and laboratory studies第35页/共40页第三十五页,共40页。36Decision 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 s

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