CAC_GL 45-2003 Draft Guideline For The Conduct Of Food Safety Assessment Of Foods Derived From Recombinant-Dna Plants
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ID： |
2A4A997BFC2744CE89A057252C369CC1 |
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文件大小(MB)： |
0.19 |
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页数： |
14 |
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日期： |
2004-12-24 |
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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）：
CAC/GL 45 Page 1 of 14,DRAFT GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF,FOODS DERIVED FROM RECOMBINANT-DNA PLANTS,CAC/GL 45 - 2003,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, plants 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 traits.,2. This document does not address animal feed or animals fed with the feed. This document also,does not address environmental risks.,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 have been assessed scientifically in,a manner that would fully characterise all risks 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 plant varieties,including recombinant-DNA plants, 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 Draft Principles,for the Risk Analysis of Foods derived from Modern Biotechnology.,7. The Guideline describes the recommended approach to making safety assessments of foods,derived from recombinant-DNA plants where a conventional counterpart exists, and identifies,the data and information that are generally applicable to making such assessments. While this,Guideline is designed for foods derived from recombinant-DNA plants, the approach described,could, in general, be applied to foods derived from plants that have been altered by other,techniques.,SECTION 2 - DEFINITIONS,8. The definitions below apply to this Guideline:,CAC/GL 45 Page 2 of 14,“Recombinant-DNA Plant” - means a plant in which the genetic material has been changed,through in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA),and direct injection of nucleic acid into cells or organelles.,“Conventional Counterpart” - means a related plant variety, its components and/or products for,which there is experience of establishing safety based on common use as food1.,SECTION 3 - INTRODUCTION TO FOOD SAFETY ASSESSMENT,9. Traditionally, new varieties of food plants have not been systematically subjected to extensive,chemical, toxicological, or nutritional evaluation prior to marketing, with the exception of foods,for specific groups, such as infants, where the food may constitute a substantial portion of the,diet. Thus, new varieties of corn, soya, potatoes and other common food plants are evaluated by,breeders for agronomic and phenotypic characteristics, but generally, foods derived from such,new plant varieties are not subjected to the rigorous and extensive food safety testing,procedures, including studies in animals, that are typical of chemicals such as food additives or,pesticide residues that may be present in food.,10. The use of animal models for assessing toxicological endpoints is a major element in the risk,assessment of many compounds such as pesticides. In most cases, however, the substanc……
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