CAC_GL 30-1999 Principles And Guidelines For The Conduct Of Microbiological Risk Assessment

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849ABC6D5D2E4D4D94E075880EFAE3E4

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0.03

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6

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pdf

日期:

2007-3-16

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CAC/GL 30 Page 1 of 6,PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK,ASSESSMENT,CAC/GL-30 (1999),Table of Contents,INTRODUCTION ..1,1. SCOPE1,2. DEFINITIONS ..1,3. GENERAL PRINCIPLES OF MICROBIOLOGICAL RISK ASSESSMENT3,4. GUIDELINES FOR APPLICATION.3,4.1 GENERAL CONSIDERATIONS 3,4.2 STATEMENT OF PURPOSE OF RISK ASSESSMENT .. 4,4.3 HAZARD IDENTIFICATION . 4,4.4 EXPOSURE ASSESSMENT .. 4,4.5 HAZARD CHARACTERIZATION 5,4.6 RISK CHARACTERIZATION 5,4.7 DOCUMENTATION .. 6,4.8 REASSESSMENT 6,INTRODUCTION,Risks from microbiological hazards are of immediate and serious concern to human health. Microbiological,Risk Analysis is a process consisting of three components: Risk Assessment, Risk Management, and Risk,Communication, which has the overall objective to ensure public health protection. This document deals with,Risk Assessment which is a key element in assuring that sound science is used to establish standards,guidelines and other recommendations for food safety to enhance consumer protection and facilitate,international trade. The Microbiological Risk Assessment process should include quantitative information to,the greatest extent possible in the estimation of risk. A Microbiological Risk Assessment should be conducted,using a structured approach such as that described in this document. This document will be of primary interest,to governments although other organizations, companies, and other interested parties who need to prepare a,Microbiological Risk Assessment will find it valuable. Since Microbiological Risk Assessment is a developing,science, implementation of these guidelines may require a period of time and may also require specialized,training in the countries that consider it necessary. This may be particularly the case for developing countries.,Although Microbiological Risk Assessment is the primary focus of this document, the method can also be,applied to certain other classes of biological hazards.,1. SCOPE,The scope of this document applies to Risk Assessment of microbiological hazards in food.,2. DEFINITIONS,The definitions cited here are to facilitate the understanding of certain words or phrases used in this document.,Where available the definitions are those adopted for microbiological, chemical, or physical agents and Risk,Management and Risk Communication on an interim basis at the 22nd Session of the Codex Alimentarius,CAC/GL 30 Page 2 of 6,Commission. The CAC adopted these definitions on an interim basis because they are subject to modification,in the light of developments in the science of risk analysis and as a result of efforts to harmonize similar,definitions across various disciplines.,Dose-Response Assessment - The determination of the relationship between the magnitude of exposure (dose),to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health,effects (response).,Exposure Assessment - 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.,Hazard - A biological, chemical or physical agent in, or condition of, food with the potential to cause an,adverse health effect.,Hazard Characterization - 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 relate to,microorganisms and/or their toxins.,Hazard Identification - The identification of biological, chemical, and physical agents capable of causing,adverse health effects and which may be present in a particular food or group of foods.,Quantitative Risk Assessment - A Risk Assessment that provides numerical expressions of risk and,indication of the attendant uncertainties (stated in the 1995 Expert Consultation definition on Risk Analysis).,Qualitative Risk Assessment - A Risk Assessment based on data which, while forming an inadequate basis,for numerical risk estimations, nonetheless, when conditioned by prior expert knowledge and identification of,attendant uncertainties permits risk ranking or separation into descriptive categories of risk.,Risk - A function of the probability of an adverse health effect and the severity of that effect, consequential to,a hazard(s) in food.,Risk Analysis - A process consisting of three components: risk assessment, risk management and risk,communication.,Risk Assessment - A scientifically based process consisting of the following steps: (i) hazard identification,(ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.,Risk Cha……

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