Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, United States.
Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, United States.
Regul Toxicol Pharmacol. 2018 Jun;95:204-206. doi: 10.1016/j.yrtph.2018.03.022. Epub 2018 Mar 27.
The European Food Safety Authority (EFSA) oversees the safety evaluation of genetically modified (GM) crops in the European Union. EFSA requires inclusion of commercial non-GM reference lines and a non-GM isoline in crop composition studies with GM crops. Reference lines are used to construct equivalence limits for each compositional analyte. Results for the GM line are compared with these equivalence limits to assess compositional equivalence between the GM crop and the non-GM crop. If compositional equivalence cannot be concluded from this comparison, then results for the non-GM isoline can be used to determine if this finding is likely the result of the background non-GM genetics of the GM crop. If this latter comparison is not sufficient to assess the compositional safety of the GM crop, then a biological-relevance assessment for the analytes in question can be completed taking into account the greater body of knowledge of composition for the crop and diets. Thus, the isoline is a useful comparator but not required to assess the compositional safety of the GM crop, and therefore, unavoidable genotype differences between the isoline and GM line should not be grounds for rejection of compositional studies where the biological relevance of potential non-equivalence is addressed.
欧洲食品安全局（EFSA）负责监督欧盟内转基因（GM）作物的安全性评估。EFSA 要求在 GM 作物的组成研究中纳入商业非 GM 对照系和非 GM 近等基因系。对照系用于为每个成分分析物构建等效极限。GM 系的结果与这些等效极限进行比较，以评估 GM 作物与非 GM 作物之间的组成等效性。如果不能从这种比较中得出组成等效性的结论，那么可以使用非 GM 近等基因系的结果来确定这一发现是否可能是 GM 作物背景非 GM 遗传的结果。如果后一种比较不足以评估 GM 作物的组成安全性，则可以完成对所涉分析物的生物学相关性评估，同时考虑到作物和饮食中组成方面更广泛的知识体系。因此，近等基因系是一种有用的对照物，但并非评估 GM 作物组成安全性所必需的，因此，不应将近等基因系和 GM 系之间不可避免的基因型差异作为拒绝组成研究的理由，只要解决了潜在非等效的生物学相关性问题。
