14. Animal studies typically employed in toxicological evaluations also cannot be readily applied to testing potential risks associated with ingestion of microorganisms used for food production.用于毒理学评价的动物研究也不能轻易用于检验食品生产所用微生物潜在的风险。 Microorganisms are living entities, containing complex structures composed of many biochemicals, and therefore are not comparable to pure compounds.微生物是具有生命的实体, 含有复杂的结构，由众多生化因素构成，因此不能与纯的化合物相比较。 In some processed foods, they can survive processing and ingestion and can compete and, in some cases, be retained in the intestinal environment for significant periods of time.在一些加工的食品中,它们能存活，能摄食并且能够竞争，在一些情况下在肠道中的保留具有显著的周期性。. Appropriate animal studies should be used to evaluate the safety of recombinant-DNA microorganisms where the donor, or the gene or gene product do not have a history of safe use in food, taking into account available information regarding the donor and the characterization of the modified genetic material and the gene product.当供体，基因或基因产品没有在食品中使用的安全历史时， 恰当的动物研究应该能被用于评价重组DNA微生物的安全性，用以说明关于供体和更改遗传物质的特征以及基因产品的有用信息。 Further, appropriately designed studies in animals may be used to assess the nutritional value of the food or the bioavailability of the newly expressed substance in the food.此外, 设计适当的动物试验可用来进行食品的营养评价或评价食品中新表达物质的生物利用度。.
15. Due to the difficulties of applying traditional toxicological testing and risk assessment procedures to whole foods, a more focused approach is required for the safety assessment of foods produced using recombinant-DNA microorganisms.考虑到采用传统毒理学试验的困难和整个食品风险评定操作的困难，需要一种更加集中的方法对重组DNA微生物生产的食品进行安全性评价。 This has been addressed by the development of a multidisciplinary approach for assessing safety, that takes into account the intended effect, the nature of the modification, and detectable unintended changes that may occur in the microorganism or in its action on the food, using the concept of substantial equivalence6.随着安全性评价多学科的发展，这种方法已经出现，它考虑预期的效果，修饰的自然属性，可能存在于微生物的可探查的非预期改变或者利用本质等价概念对食品产生的作用。6.
华译网北京翻译公司翻译过大量有关食品安全评价指导的文件资料,Beijing Chinese Translation Service Company has translated many technical documents about INTRODUCTION TO FOOD SAFETY ASSESSMENT
16. While the focus of a safety assessment will be on the recombinant-DNA microorganism, additional information on its interaction with the food matrix should be taken into consideration when applying the concept of substantial equivalence, which is a key step in the safety assessment process.尽管安全性评价的焦点是重组DNA微生物，但当采用本质等价概念时，其与食品基质的相互作用的附加信息也应该被考虑，这是安全性评价过程中的关键步骤。 However, the concept of substantial equivalence is not a safety assessment in itself.然而, 本质等价概念本身并不是一种安全性评价。 Rather it represents the starting point that is used to structure the safety assessment of both a recombinant-DNA microorganism relative to its conventional counterpart and the food produced using recombinant-DNA microorganism relative to its conventional counterpart.它更像是代表一种起点，这个起点用于构成相对于传统方法而言的重组DNA微生物与相对于传统方法而言利用重组DNA微生物生产的食品的安全性评价。 This concept is used to identify for evaluation similarities and differences between a recombinant-DNA microorganism used in food processing as well as the food produced using the recombinant-DNA microorganisms and their respective conventional counterparts as defined in paragraph 9. It aids in the identification of potential safety and nutritional issues and is considered the most appropriate strategy to date for safety assessment of foods produced using recombinant-DNA microorganisms.这个概念用于区别评价食品加工过程中使用的重组DNA微生物以及使用重组DNA微生物生产的产品与在第9段描述的它们各自的传统概念之间的相似点与不同点，它帮助区分潜在安全性与营养问题，被认为是对利用重组DNA微生物生产的食品进行安全性评价的最佳策略。 The safety assessment carried out in this way does not imply absolute safety of the new product; rather, it focuses on assessing the safety of any identified differences so that the safety of the recombinant-DNA microorganism and the food produced using recombinant-DNA microorganism can be considered relative to their respective conventional counterparts.这种方法实行的安全性评价并不是意味着新产品绝对安全，它重点集中在所有经过鉴定的差别的安全性评价，因此重组DNA微生物以及使用重组DNA微生物生产的产品相对于它们各自的传统概念的安全性需要被考虑。.
6 The concept of substantial equivalence as described in the Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology- Safety aspects of genetically modified plants, 29 May – 2 June, 2000, Geneva, Switzerland, and Section 4.3 of the Joint FAO/WHO Expert Consultation of Foods Derived from Biotechnology,- Safety assessment of foods derived from genetically modified microorganisms, 24-28 September, 2001, Geneva, Switzerland.6本质等价概念在粮食农业组织与世界卫生组织联合生物技术食品安全专家会议上有详细描述 29 May – 2 June, 2000, Geneva, Switzerland, and Section 4.3 of the Joint FAO/WHO Expert Consultation of Foods Derived from Biotechnology,- Safety assessment of foods derived from genetically modified microorganisms, 24-28 September, 2001, Geneva, Switzerland.
