CAC_GL 68-2008 动物源性DNA重组食品安全评估指导方针
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ID： |
FBF7CD177CC5499D9DF1AA6F8F78B80D |
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文件大小(MB)： |
0.1 |
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页数： |
13 |
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文件格式： |
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日期： |
2009-10-31 |
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购买： |
文本摘录（文本识别可能有误，但文件阅览显示及打印正常，pdf文件可进行文字搜索定位）：
-1-,GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS,DERIVED FROM RECOMBINANT-DNA ANIMALS,CAC/GL 68-2008,SECTION 1 - SCOPE,1. This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. It,addresses safety and nutritional aspects of foods consisting of, or derived from, animals that have a history of safe use,as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits1.,2. The development, raising and use of animals for human purposes, and in particular, for use for food, raise a variety,of issues beyond food safety. Without prejudice to their legitimacy or importance, or to whether or how the use of,recombinant-DNA methods in developing animals for food use might affect those issues, this Guideline addresses only,food safety and nutritional issues. It therefore does not address:,?animal welfare;,?ethical, moral and socio-economical aspects;,?environmental risks related to the environmental release of recombinant-DNA animals used in food,production;,?the safety of recombinant-DNA animals used as feed, or the safety of animals fed with feed derived from,recombinant-DNA animals, plants and microorganisms.,3. The Codex principles of risk analysis, particularly those for risk assessment, are primarily intended to apply to,discrete chemical entities such as food additives and pesticide residues, or a specific chemical or microbial contaminant,that have identifiable hazards and risks; they are not intended to apply to whole foods as such. Indeed, few foods,whatever their origin, have been assessed scientifically in a manner that would fully characterize all risk associated with,the food. Further, many foods contain substances that would likely be found harmful if subjected to conventional,approaches to safety testing. Thus, a more focused approach is required where the safety of a whole food is being,considered.,4. This approach is based on the principle that the safety of foods derived from new animal lines, including,recombinant-DNA animals, is assessed relative to the conventional counterpart having a history of safe use, taking into,account both intended and unintended effects. Rather than trying to identify every hazard associated with a particular,food, the intention is to identify new or altered hazards relative to the conventional counterpart.,5. This safety assessment approach falls within the risk assessment framework as discussed in Section 3 of the,Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. If a new or altered hazard, nutritional,or other food safety concern is identified by the safety assessment, the risk associated with it would first be assessed to,determine its relevance to human health. Following the safety assessment and, if necessary, further risk assessment, the,food would be subjected to risk management considerations in accordance with the Principles for the Risk Analysis of,Foods Derived from Modern Biotechnology before it is considered for commercial distribution.,6. Risk management measures such as post-market monitoring of consumer health effects may assist the risk,assessment process. These are discussed in paragraph 20 of the Principles for the Risk Analysis of Foods Derived from,Modern Biotechnology.,7. The Guideline describes the recommended approach for the food safety assessment of foods derived from,recombinant-DNA animals where a conventional counterpart exists, and identifies the data and information that are,generally applicable to making such assessments.2 In assessing the safety of food from recombinant-DNA animals, the,approach should take into account all of the following:,A) the nature of the recombinant-DNA construct and its expression product(s), if any;,B) the health status of the recombinant-DNA animal; and,C) the composition of foods produced from recombinant-DNA animals, including key nutrients.,1 This Guideline was developed primarily for animals bearing heritable recombinant-DNA constructs.,2 The approach to the safety assessment of foods derived from recombinant-DNA animals was first discussed at the 1991 Joint,FAO/WHO Consultation on Strategies for Assessing the Safety of Foods Produced by Biotechnology. Further elaboration of,the recommended approach was undertaken at the 2003 Joint FAO/WHO Expert Consultation on the Safety Assessment of,Foods Derived from Genetically Modified Animals, Including Fish.,-2-,While this Guideline is designed for foods derived from recombinant-DNA animals, the approach described could, in,general, be applied to foods derived from animals that have been ……
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