食品安全目標的建立及應用PPT課件

1、食品安全目標的建立及應用食品安全目標的建立及應用Food Safety Objective湖北省衛(wèi)生廳食品安全目標的建立及應用Managing the Food Safety Cliff HAZARD /RISKFSO Cliff HAZARD PROCESS VARIABILITYFOODBORNE ILLNESS/DEATH From Martin Cole食品安全目標的建立及應用 2002 2002 年年, , 國際食品微生物標準委員會國際食品微生物標準委員會( The ( The International Commission on Microbiological Internati

2、onal Commission on Microbiological Specifications for Foods, ICMSF)Specifications for Foods, ICMSF)在所出版的在所出版的Microorganisms in Food 7 volumeMicroorganisms in Food 7 volume中中 介紹了一個新的介紹了一個新的食品安全管理概念：食品安全目標（食品安全管理概念：食品安全目標（Food safety Food safety ObjectiveObjective，F(xiàn)SO) FSO) 。2004 2004 年年, , 國際食品衛(wèi)生法典委員

3、會國際食品衛(wèi)生法典委員會( Codex Committee on Food Hygiene, CCFH) ( Codex Committee on Food Hygiene, CCFH) 第第3636次次會議接受并建立了會議接受并建立了“食品安全目標食品安全目標”的定義的定義 。 “ “食品食品安全目標安全目標”的概念提出后，得到國際社會的重視，的概念提出后，得到國際社會的重視， 正正在被廣泛地接受及推廣應用。在被廣泛地接受及推廣應用。FSO： A FOOD SAFETY CONTROL CONCEPT食品安全目標的建立及應用一、一、FSO的背景的背景 隨著全球食品貿(mào)易的發(fā)展，各國政府十分重視

4、食隨著全球食品貿(mào)易的發(fā)展，各國政府十分重視食品安全的管理與監(jiān)督，一來加強進出口食品的管理，品安全的管理與監(jiān)督，一來加強進出口食品的管理，二來保護國民健康。根據(jù)二來保護國民健康。根據(jù)WTOWTO衛(wèi)生和植物衛(wèi)生衛(wèi)生和植物衛(wèi)生措施協(xié)定措施協(xié)定（ SPS SPS ）規(guī)定）規(guī)定, , 允許允許WTO WTO 成員在可獲得成員在可獲得的科學依據(jù)的基礎上的科學依據(jù)的基礎上, , 按有關情況對進口動植物風按有關情況對進口動植物風險進行評估險進行評估, , 確定適當?shù)谋Ｗo水平（確定適當?shù)谋Ｗo水平（thethe Appropriate Level of Protection (ALOP)Appropriate L

5、evel of Protection (ALOP)，保護本國，保護本國人民、動物或植物生命或健康。人民、動物或植物生命或健康。食品安全目標的建立及應用一、一、FSO的背景的背景 ALOPALOP：WTOWTO成員國通過保護本國成員國通過保護本國人民、動物或植物生命或健康的衛(wèi)生或人民、動物或植物生命或健康的衛(wèi)生或植物措施以實現(xiàn)的被認為適當?shù)谋Ｗo水植物措施以實現(xiàn)的被認為適當?shù)谋Ｗo水平。也就是可接受的風險水平平。也就是可接受的風險水平( (the acceptable level of risk) 。 The SPS Agreement defines the appropriate level o

6、f sanitary or 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. 食品安全目標的建立及應用一、一

7、、FSO的背景的背景 在食品安全方面， ALOP 是通過食品安全體系擬實現(xiàn)的公共衛(wèi)生保護程度。 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.食品安全目標的建立及應用一、一、FSO的背景的背景 具體講，具體講， ALOP ALOP 是一個國家有關一是一個國家有關一種種特別危害特別危害與食品結合并消費時所

8、與食品結合并消費時所造成的疾病負擔。造成的疾病負擔。 Typically an ALOP would be articulated as a statement related to the disease burden associated with a particular hazard-food combination and its consumption in a country.食品安全目標的建立及應用一、一、FSO的背景的背景 ALOP 是 一個公共衛(wèi)生目標，通常表述為一個特定時間段人群中的病例數(shù)（每年1/100，000）。 ALOPs can be expressed as a

9、 public health goal in terms of numbers of cases per given number of population over a specific time period, for example, 1 in 100,000 per annum.食品安全目標的建立及應用一、一、FSO的背景的背景 例如例如 美國美國Healthy People 2010Healthy People 2010確確定了定了ALOPALOP：以：以20072007年的數(shù)字為始點，到年的數(shù)字為始點，到20102010年年Campylobacter, Listeria Camp

10、ylobacter, Listeria onocytogenes,Escherichia coli O157:H7 onocytogenes,Escherichia coli O157:H7 的的年發(fā)病率（每十萬）減少年發(fā)病率（每十萬）減少50%50%。 In the United States, the documentHealthy People 2010Using the numbers of illnesses in 1997 for infections associated with Campylobacter, Listeria monocytogenes,Escherichia

11、 coli O157:H7 and Salmonella spp. as a startingpoint, Healthy People 2010 seeks a 50% reduction inthe numbers of cases per 100,000 population by the year2010。食品安全目標的建立及應用ALOP食品安全目標的建立及應用一、一、FSO的背景的背景 基于上述的理解，基于上述的理解， ALOP ALOP 是國家層面上的公共衛(wèi)是國家層面上的公共衛(wèi)生目標，距離實際的食品安全管理甚遠。生目標，距離實際的食品安全管理甚遠。ALOP is not a mea

12、sure that is meaningful for food safety management in practice.為了解決這個問題，國際食品微生物標準委為了解決這個問題，國際食品微生物標準委員會員會(ICMSF) (ICMSF) 提出了食品安全目標（提出了食品安全目標（FSOFSO）的概念，）的概念，作為作為ALOP ALOP 與實際操作（與實際操作（ performanceperformance）之間的橋）之間的橋梁（梁（bridge)bridge)。 (ICMSF) have been exploring the concept of food safety objective

13、s as a bridge between an ALOP and the various performance or process criteria routinely used in production and manufacture食品安全目標的建立及應用一、一、FSO的背景的背景 “橋橋”的意圖是將的意圖是將ALOPALOP轉(zhuǎn)化成轉(zhuǎn)化成FSOFSO，并，并具體到所關注的具體到所關注的產(chǎn)品和危害產(chǎn)品和危害上來。這樣就上來。這樣就能將公共衛(wèi)生目標轉(zhuǎn)化成對消費環(huán)節(jié)危害能將公共衛(wèi)生目標轉(zhuǎn)化成對消費環(huán)節(jié)危害的的數(shù)量描述數(shù)量描述（ ICMSF ICMSF ）。 The intention i

14、s 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 into a description of the amount of hazard at the point of consumption。l 食品安全目標的建立及應用二、二、FSO的概念的概念 FSO ：消費時/消費環(huán)節(jié)食品中微生物危害的最大頻率和/或

15、最高濃度，以提供適當健康保護水平（ ICMSFICMSF ）。 Food safety objectivethe maximum frequency and/or concentration of a microbiological hazard in a food at the time of consumption that provides the appropriate level of health protection.（ICMSF ，2002)食品安全目標的建立及應用二、二、FSO的概念的概念 FSO ：消費時/消費環(huán)節(jié)食品中所存在危害的最大頻率和/或最高濃度，以提供適當健康保護

16、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).最大頻率最大頻率:A frequency of Salmonella enteritidis in eggs not exceeding 1 egg per 100,000.最高濃度最高濃度:A concentration of salmo

17、nellae in powdered milkbelow 1 cfu/100 g.食品安全目標的建立及應用二、二、FSO的概念的概念 便于理解和應用，ICMSF 為FSO提出了一個概念性方程式 （conceptual equation ）： HoRIFSO Ho：初始危害水平； R ：總的危害下降值； I ：總的危害上升值(growth or recontamination)； FSOFSO：食品安全目標。食品安全目標的建立及應用二、二、FSO的概念的概念例如，當：（1）FSO for the pathogenproduct combination is 2（FSO level = 100 c

18、fu L. monocytogenes per gramLm/g）；(2） Ho 0(level1 cfu/g);(3) R = 0;(4) I 2，或I 60022，或0062結論：符合FSO，或不符合FSO食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 然而， FSO 也只是在公共衛(wèi)生目標（ALOP）與實際操作（performance)之間構造了一座“橋梁”，確定了“消費時食品中危害的最大頻率和/或最高濃度”，它本身不能向食品生產(chǎn)經(jīng)營者提供如何降低疾病水平的信息。 FSO does not provide food processors, producers, handler

19、s, retailers or trade partners with information about what they need to do to reach this lower level of illness.食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 FSO FSO 必須結合必須結合食品安全食品安全管理的方管理的方法或措施法或措施的運用，的運用，才能實現(xiàn)才能實現(xiàn)公共衛(wèi)生公共衛(wèi)生目標。目標。From Leon Gorris食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 為此，為此，還應了解還應了解新的概念：新的概念：Performance Obje

20、ctive PO) Performance Criterion (PC) Control Measures (CM) process criterionFrom ICMSF食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 執(zhí)行目標（Performance Objective) :消費前食物鏈特定環(huán)節(jié)食品中所存在（微生物）危害的最大頻率和/或最高濃度，以實現(xiàn)FSO或ALOP。例如 Salmonellae and pathogenic E. coli 在包裝果汁中不超過1 cfu/10 POs are equivalent to FSO, specifying hazard level

21、s that are tolerable, but which 1 are set at one 2 or more specific 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 provide

22、s or contributes to the achievement of an FSO or ALOP, as applicable.Example Performance Objectives Salmonellae and pathogenic E. coli shall not exceed 1 cfu/10 l when fruit juice is packaged for distribution.食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 執(zhí)行標準（ Performance Criterion ）：一項或多項控制措施擬達到的效果， 以滿足執(zhí)行目標和食品安全目

23、標的要求。例如，確保低酸罐裝食品中Clostridium botulinum 減少12 log;熱加工汁液，使其中enteric pathogens減少5 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或或the outcome of a process step or a combination of steps (change in th

24、e level of a microorganism or microbial toxin)食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 D，指D值，即在特定的溫度下減少90%或1個對數(shù)值的微生物所需要的時間。 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. 食品安全目標的建立及應用三、三、 FSO的工作原理的工作原

25、理Microbial death is an exponential process A graph of log N vs. time is a straight line The time taken to reduce the number of viable organisms by one log cycle is called the Decimal reduction time, DMany heat treatments achieve a hazard level of 1 cfu/106 g (6D).Log NTimeOne log cycleD-valueat a pa

26、rticular temperature？食品安全目標的建立及應用For example, from App. A: (Beef)FTime to 6.5 DTime to 7.0D130 112 121140 12 1 2150 67 72三、三、 FSO的工作原理的工作原理食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理控制措施（Control Measures ）：任何預防或消除食品安全危害或?qū)⑹称钒踩：抵量山邮芩降男袆踊蚧顒?。例如，選擇不含傳染性致病菌的原料成分；產(chǎn)品的pH控制在4.6以下。the level of a hazard in a finished pro

27、duct 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 the initial level before the treatment.食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理加工標準（Process criterion）：一個實現(xiàn)執(zhí)行標準的控制參數(shù)。例如，蛋白水解肉毒(桿)菌的煮沸須121C20分鐘；無蛋

28、白水解肉毒(桿)菌的煮沸須121C10分鐘；巴斯德殺菌應為70C 2分鐘。Process criteriona control parameter (e.g. time, temperature, pH, aw water activity) at a step that can be applied to achieve a performance criterion.Example process criteria 20 minutes at 121C for proteolytic C. botulinum cook 10 min at 90C for non-proteolytic C

29、. botulinum cook 2 minutes at 70C for pasteurisation食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理 了解FSO、PO、CM、PC的概念后， 就能理解FSO的工作原理。食品安全目標的建立及應用三、三、 FSO的工作原理的工作原理botulinum 減少12 logpH控制在4.6以下巴斯德殺菌70C 度2分鐘。A concentration of salmonellae in powdered milk below 1 cfu/100 g.pathogenic E. coli 在包裝果汁中不超過1 cfu/10 升From Leo

30、n Gorris食品安全目標的建立及應用From Martin Cole食品安全目標的建立及應用三、三、 FSO的建立的建立 （一） 建立與執(zhí)行FSO的科學考Scientific considerations for establishing And implementing FSO； （二）利用（二）利用FSO方法，建立降低食源性李氏方法，建立降低食源性李氏特病的案例分析特病的案例分析 Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis食品安全目標的建立及應用Scienti

31、fic considerations for establishing And implementing FSO(1) 所關注的公共衛(wèi)生問題及對管理需求的鑒別。Identification of a public health concern and the need for management actions. (2) 風險水平的評估Evaluation of the level of risk (e.g., by conducting a risk assessment). (3) 公共衛(wèi)生目標的清晰度Articulation of the public heath goal.食品安全目

32、標的建立及應用Scientific considerations for establishing And implementing FSO(4) 實現(xiàn)公共衛(wèi)生目標的最大暴露水平的確定實現(xiàn)公共衛(wèi)生目標的最大暴露水平的確定Determination of the maximum level of exposure that would achieve the public health goal - this is the FSO. (5)執(zhí)行或遵照FSO的可行性的評估Evaluation of the feasibility of complying with the FSO. (6) FSO

33、在食品企業(yè)的執(zhí)行 Implementation of the FSO by the industry. 食品安全目標的建立及應用Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis1、 關注的公共衛(wèi)生問題public health concern Listeria monocytogenes is a foodborne pathogen that can cause listeriosis. there are an estimated 2500 cases of liste

34、riosis in the USA per year 。Invasive listeriosis has an estimated fatality rate of 2030% of those who become ill2、 風險水平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 sample

35、s can be positive for the pathogen in 25 g samples. 食品安全目標的建立及應用Case Study-use of food safety objectives as a tool for reducing foodborne listeriosis3、公共衛(wèi)生目標 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（(He

36、althy People 2010） An 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食品安全目標的建立及應用Case Study-use of food safety objectives as a tool for reducing foodborne lis

37、teriosis4、確定實現(xiàn)公共衛(wèi)生目標的實現(xiàn)公共衛(wèi)生目標的最大暴露水平 Determination 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.食品安全目標的建立及應用Case Study-use of food safety objectives as a

38、 tool for reducing foodborne listeriosis-If we assume 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 R

39、TE foods (2004) estimates the risk of listeriosis per serving of smoked fish to be high (2.110-8 cases per serving) . 食品安全目標的建立及應用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

40、-8 cases per serving)2.110-8; 18 ( 2.110-8) cases per serving) 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 equivale

41、nt to that of the USA.食品安全目標的建立及應用Case Study-use of food safety objectives 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

42、the organism. Considering the common occurrence and consumption of low 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.食品安全目標的建立及應用Case Study-

43、use of food safety objectives as a tool for reducing foodborne listeriosis -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食品安全目標的建立及應用ALOP:0.2510-5104.5

44、per serving.Martin ColeFrom Martin Cole食品安全目標的建立及應用FSO103.6L. monocytogenes / servingALOP0,00110-5 -0.000110-5ALOP0,0110-5 -0.00110-5FSO10104.5 per servingFrom Lone Gram,食品安全目標的建立及應用Case Study-use of food safety objectives as a tool for reducing foodborne listeriosisPerformance Objectives and Criter

45、ia-the term “performance objective” has been introduced to describe an equivalent of the FSO further 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.食品安全目標的建立及應用Setting Performance Objective (PO) for the steos at food ChainFrom Martin Cole食品安全目標的建立及應用Case Study-use of food safety objectives as