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1、食品安全目标的建立及应用 Food Safety Objective,杨明亮 湖北省卫生厅 卫生监督局,Managing the Food Safety Cliff,HAZARD /RISK,FSO,Cliff HAZARD PROCESS VARIABILITY,FOODBORNE ILLNESS /DEATH,From Martin Cole,2002 年, 国际食品微生物标准委员会( The International Commission on Microbiological Specifications for Foods, ICMSF)在所出版的Microorganisms in
2、Food 7 volume中 介绍了一个新的食品安全管理概念：食品安全目标（Food safety Objective，FSO) 。2004 年, 国际食品卫生法典委员会( Codex Committee on Food Hygiene, CCFH) 第36次会议接受并建立了“食品安全目标”的定义 。 “食品安全目标”的概念提出后，得到国际社会的重视， 正在被广泛地接受及推广应用。,FSO： A FOOD SAFETY CONTROL CONCEPT,一、FSO的背景,随着全球食品贸易的发展，各国政府十分重视食品安全的管理与监督，一来加强进出口食品的管理，二来保护国民健康。根据WTO卫生和植物
3、卫生措施协定（ SPS ）规定, 允许WTO 成员在可获得的科学依据的基础上, 按有关情况对进口动植物风险进行评估, 确定适当的保护水平（the Appropriate Level of Protection (ALOP)，保护本国人民、动物或植物生命或健康。,一、FSO的背景,ALOP：WTO成员国通过保护本国人民、动物或植物生命或健康的卫生或植物措施以实现的被认为适当的保护水平。也就是可接受的风险水平(the acceptable level of risk) 。 The SPS Agreement defines the appropriate level of sanitary or
4、phytosanitary protection as the level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory. This concept is also referred to as the acceptable level of risk.,一、FSO的背景,在食品安全方面， ALOP 是通过食品安
5、全体系拟实现的公共卫生保护程度。 In the context of food safety, an ALOP is a statement of the degree of public health protection that is to be achieved by the food safety systems implemented in a country.,一、FSO的背景,具体讲， ALOP 是一个国家有关一种特别危害与食品结合并消费时所造成的疾病负担。 Typically an ALOP would be articulated as a statement relate
6、d to the disease burden associated with a particular hazard-food combination and its consumption in a country.,一、FSO的背景,ALOP 是 一个公共卫生目标，通常表述为一个特定时间段人群中的病例数（每年1/100，000）。 ALOPs can be expressed as a public health goal in terms of numbers of cases per given number of population over a specific time pe
7、riod, for example, 1 in 100,000 per annum.,一、FSO的背景,例如 美国Healthy People 2010确定了ALOP：以2007年的数字为始点，到2010年Campylobacter, Listeria onocytogenes,Escherichia coli O157:H7 的年发病率（每十万）减少50%。 In the United States, the documentHealthy People 2010 Using the numbers of illnesses in 1997 for infections associated
8、 with Campylobacter, Listeria monocytogenes, Escherichia coli O157:H7 and Salmonella spp. as a starting point, Healthy People 2010 seeks a 50% reduction in the numbers of cases per 100,000 population by the year 2010。,A L O P,一、FSO的背景,基于上述的理解， ALOP 是国家层面上的公共卫生目标，距离实际的食品安全管理甚远。ALOP is not a measure t
9、hat is meaningful for food safety management in practice.为了解决这个问题，国际食品微生物标准委员会(ICMSF) 提出了食品安全目标（FSO）的概念，作为ALOP 与实际操作（ performance）之间的桥梁（bridge)。 (ICMSF) have been exploring the concept of food safety objectives as a bridge between an ALOP and the various performance or process criteria routinely use
10、d in production and manufacture,一、FSO的背景,“桥”的意图是将ALOP转化成FSO，并具体到所关注的产品和危害上来。这样就能将公共卫生目标转化成对消费环节危害的数量描述（ ICMSF ）。 The intention is that an ALOP will be translated into an FSO that specifies the product and hazard combination concerned. In this way, the public health goal (the ALOP) can be translated
11、into a description of the amount of hazard at the point of consumption。,二、FSO的概念,FSO ：消费时/消费环节食品中微生物危害的最大频率和/或最高浓度，以提供适当健康保护水平（ ICMSF ）。 Food safety objectivethe maximum frequency and/or concentration of a microbiological hazard in a food at the time of consumption that provides the appropriate leve
12、l of health protection.（ICMSF ，2002),二、FSO的概念,FSO ：消费时/消费环节食品中所存在危害的最大频率和/或最高浓度，以提供适当健康保护水平（CAC）。 The maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection (CAC 2004). 最大频率:A frequency of Salmonella
13、 enteritidis in eggs not exceeding 1 egg per 100,000. 最高浓度:A concentration of salmonellae in powdered milk below 1 cfu/100 g.,二、FSO的概念,便于理解和应用，ICMSF 为FSO提出了一个概念性方程式 （conceptual equation ）： HoRIFSO Ho：初始危害水平； R ：总的危害下降值； I ：总的危害上升值(growth or recontamination)； FSO：食品安全目标。,二、FSO的概念,例如，当： （1）FSO for the
14、 pathogenproduct combination is 2（FSO level = 100 cfu L. monocytogenes per gramLm/g）； (2） Ho 0(level1 cfu/g); (3) R = 0; (4) I 2，或I 6 0022，或0062 结论：符合FSO，或不符合FSO,三、 FSO的工作原理,然而， FSO 也只是在公共卫生目标（ALOP）与实际操作（performance)之间构造了一座“桥梁”，确定了“消费时食品中危害的最大频率和/或最高浓度”，它本身不能向食品生产经营者提供如何降低疾病水平的信息。 FSO does not provi
15、de food processors, producers, handlers, retailers or trade partners with information about what they need to do to reach this lower level of illness.,三、 FSO的工作原理,FSO 必须结合食品安全管理的方法或措施的运用，才能实现公共卫生目标。,From Leon Gorris,三、 FSO的工作原理,为此，还应了解新的概念：Performance Objective PO) Performance Criterion (PC) Control
16、 Measures (CM) process criterion,From ICMSF,三、 FSO的工作原理,执行目标（Performance Objective) :消费前食物链特定环节食品中所存在（微生物）危害的最大频率和/或最高浓度，以实现FSO或ALOP。例如 Salmonellae and pathogenic E. coli 在包装果汁中不超过1 cfu/10 POs are equivalent to FSO, specifying hazard levels that are tolerable, but which 1 are set at one 2 or more sp
17、ecific steps earlier in the food chain (CAC, 2004). Performance Objective (PO)：The maximum frequency and/or concentration of a (microbial) hazard in a food at a specified step in the food chain before time of consumption that still provides or contributes to the achievement of an FSO or ALOP, as app
18、licable. Example Performance Objectives Salmonellae and pathogenic E. coli shall not exceed 1 cfu/10 l when fruit juice is packaged for distribution.,三、 FSO的工作原理,执行标准（ Performance Criterion ）：一项或多项控制措施拟达到的效果， 以满足执行目标和食品安全目标的要求。例如，确保低酸罐装食品中Clostridium botulinum 减少12 log;热加工汁液，使其中enteric pathogens减少5
19、log。 PC = 5D for E. coliO157:H7 Performance Criterion (PC)：The effect of one or more control measure(s) needed to meet or contribute to meeting a PO/FSO或the outcome of a process step or a combination of steps (change in the level of a microorganism or microbial toxin),三、 FSO的工作原理,D，指D值，即在特定的温度下减少90%
20、或1个对数值的微生物所需要的时间。 The D-value is defined as the time at a particular temperature required to reduce a known number of microorganisms by 90% or to result in a 1-log reduction.,三、 FSO的工作原理,Microbial death is an exponential process A graph of log N vs. time is a straight line The time taken to reduce t
21、he number of viable organisms by one log cycle is called the Decimal reduction time, D Many heat treatments achieve a hazard level of 1 cfu/106 g (6D).,at a particular temperature,？,For example, from App. A: (Beef) F Time to 6.5 D Time to 7.0D 130 112 121 140 12 1 2 150 67 72,三、 FSO的工作原理,三、 FSO的工作原理
22、,控制措施（Control Measures ）：任何预防或消除食品安全危害或将食品安全危害降至可接受水平的行动或活动。例如，选择不含传染性致病菌的原料成分；产品的pH控制在4.6以下。 the level of a hazard in a finished product is not only determined by the magnitude of the effect of a control measure, such as a heat treatment providing for a 6 D or 12 D reduction, but depends also on th
23、e initial level before the treatment.,三、 FSO的工作原理,加工标准（Process criterion）：一个实现执行标准的控制参数。例如，蛋白水解肉毒(杆)菌的煮沸须121C20分钟；无蛋白水解肉毒(杆)菌的煮沸须121C10分钟；巴斯德杀菌应为70C 2分钟。 Process criteriona control parameter (e.g. time, temperature, pH, aw water activity) at a step that can be applied to achieve a performance criter
24、ion. Example process criteria 20 minutes at 121C for proteolytic C. botulinum cook 10 min at 90C for non-proteolytic C. botulinum cook 2 minutes at 70C for pasteurisation,三、 FSO的工作原理,了解FSO、PO、CM、PC的概念后， 就能理解FSO的工作原理。,三、 FSO的工作原理,botulinum 减少12 log,pH控制在4.6以下,巴斯德杀菌70C 度2分钟。,A concentration of salmone
25、llae in powdered milk below 1 cfu/100 g.,pathogenic E. coli 在包装果汁中不超过1 cfu/10 升,From Leon Gorris,From Martin Cole,三、 FSO的建立,（一） 建立与执行FSO的科学考Scientific considerations for establishing And implementing FSO； （二）利用FSO方法，建立降低食源性李氏特病的案例分析 Case Study-use of food safety objectives as a tool for reducing foo
26、dborne listeriosis,Scientific considerations for establishing And implementing FSO,(1) 所关注的公共卫生问题及对管理需求的鉴别。Identification of a public health concern and the need for management actions. (2) 风险水平的评估Evaluation of the level of risk (e.g., by conducting a risk assessment). (3) 公共卫生目标的清晰度Articulation of
27、the public heath goal.,Scientific considerations for establishing And implementing FSO,(4) 实现公共卫生目标的最大暴露水平的确定Determination of the maximum level of exposure that would achieve the public health goal - this is the FSO. (5)执行或遵照FSO的可行性的评估Evaluation of the feasibility of complying with the FSO. (6) FSO在
28、食品企业的执行 Implementation of the FSO by the industry.,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,1、 关注的公共卫生问题public health concern Listeria monocytogenes is a foodborne pathogen that can cause listeriosis. there are an estimated 2500 cases of listeriosis in th
29、e USA per year 。Invasive listeriosis has an estimated fatality rate of 2030% of those who become ill 2、 风险水平the level of risk Many food products have been linked to listeriosis, including cold-smoked fish. Depending on the processing plant, between 3% and 100% of cold-smoked salmon samples can be po
30、sitive for the pathogen in 25 g samples.,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,3、公共卫生目标 the public heath goal In the USA, a public health objective of 0.25 cases of listeriosis per 100,000 population per year has been proposed（(Healthy People 2010） An
31、ALOP for an infectious agent should not be viewed as an absolute end point, i.e., once it is achieved, there should be continued efforts to reduce the impact of the disease on public health,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,4、确定实现公共卫生目标的最大暴露水平 Dete
32、rmination of the maximum level of exposure (FSO) -A total of 80,000 tons per year of cold-smoked salmon are consumed by the nations -The combined population of these countries is some 880 million people.,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,-If we ass
33、ume that the average serving size is 60 g, we can calculate that in one year the population consumes a total of 1330 million servings (80,000/60);about 1.5 servings per person per year(1330/ 880). - The FAO/WHO risk assessment on L. monocytogenes in RTE foods (2004) estimates the risk of listeriosis
34、 per serving of smoked fish to be high (2.110-8 cases per serving) .,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,-118 servings per year, from which the risk range is from 2.110-8 to 37.810-8. 1(2.110-8 cases per serving)2.110-8; 18 ( 2.110-8) cases per servi
35、ng) 37.810-8 or 0.03710-5 -WHO/FAO team concluded that 99% of all listeriosis cases would be eliminated if levels of L. monocytogenes (L.m.) were kept below 1000 cfu L.m./g at point of consumption (RTE) assuming a consumption pattern equivalent to that of the USA.,Case Study-use of food safety objec
36、tives as a tool for reducing foodborne listeriosis,-Setting a food safety objective for L. monocytogenes in ready-to-eat products is a societal decision and to date no government has officially announced a food safety objective for the organism. Considering the common occurrence and consumption of l
37、ow levels, ICMSF has used 100 cfu/g as an example of an FSO. - A 99% reduction in the number of illnesses will be obtained by setting a FSO at 100 L. monocytogenes per gram of food at the moment of consumption. .,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,-
38、FSO at 100 L. monocytogenes per gram of food at the moment of consumption. .- the serving size is 60 g. - 60 g 100 L. monocytogenes per gram of food 6000 L. monocytogenes / serving 103.6 / serving,ALOP:0.2510-5,104.5 per serving.,Martin Cole,From Martin Cole,FSO103.6 L. monocytogenes / serving,ALOP0
39、,00110-5 -0.000110-5,ALOP0,0110-5 -0.00110-5,FSO104.5 per serving,From Lone Gram,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,Performance Objectives and Criteria -the term “performance objective” has been introduced to describe an equivalent of the FSO furthe
40、r back the food processing chain. -the term performance criteria (PC) is describing the outcome (e.g. 12D reduction) for instance,if a shelf life limit of less than three weeks (at 5C) is used, the PC of 10 cfu L.m./g at the end of the processing line will allow the FSO to be met.,Setting Performanc
41、e Objective (PO) for the steos at food Chain,From Martin Cole,Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis,5、评估执行或遵照FSO的可行性 Evaluation of the feasibility of complying with the FSO. 6、交付食品企业或食品生产经营者执行FSO Implementation of the FSO by the industry. （GAM，GHP，GMP，
42、HACCP） 7、采样评价sampling plan for FSO,食品采样方案,根据ICMSF提出的采样基本原则，食品采样数应视食品中微生物 对人体的危害而定。 n:指一批产品的采样數 c:指该批样品中微生物含量超过限量的检样数 m:指合格微生物的限量 M:指附加条件后判定为合格的微生物含量限值（最大限量） Microbiological limit(s), m & M Acceptable ( m and M),微生物含量限制，m及M： -可接受(m與M)。 食品采样主要采用品值抽样法。品值抽样又兩類品值 （ m & m，C0）和三類品值抽樣（C within m and M，C0 ）
43、。 -如果食物樣本中不容許含有某種受關注的微生物，則兩類品值抽樣大致可取。 -倘若單位體積內容許一定數量的微生物，通常會採用三類品值抽樣方案,食品采样方案,sampling plan for FSO -If growth does not occur, n=10, m=100 cfu L.m./g (equivalent to FSO) and c=0 is used. -If extensive growth does occur, n=20, m=“absence in 25 g” and c=0) isused,食品采样方案,兩類品值抽樣方 Two-class attributes sa
44、mpling plans,食品采样方案,三類品值抽樣方案Three-class attributes sampling plans,三、 FSO的应用,FSO的概念受到了广泛的重视，但尚未被广泛地接受，欧盟还在对其进行评估。然而，FSO的应用范围在不断扩大，据资料报道，FSO已在以下方面的有效应用。 (一）FSO作为制定食品卫生标准、指南及相关内容的工具Food safety objectives as a tool in development of food hygiene standards, guidelines and related texts. （二）在国际食品贸易中确立食品安全目标。 Setting FSOs for foods in international trade. （三）在微生物的食品安全管理中建立食品安全目标。 Setting FSOs for microbiological food safety management. (四）食品安全目标改进街头食品安全。 Setting FSOs for Street-Vended Foods Improvement.建立,