Background

The safety assessment of foods and feeds from genetically modified (GM) crops includes the comparison of key characteristics, such as crop composition, agronomic phenotype and observations from animal feeding studies compared to conventional counterpart varieties that have a history of safe consumption, often including a near isogenic variety. The comparative compositional analysis of GM crops has been based on targeted, validated, quantitative analytical methods for the key food and feed nutrients and antinutrients for each crop, as identified by Organization of Economic Co-operation and Development (OCED). As technologies for untargeted metabolomic methods have evolved, proposals have emerged for their use to complement or replace targeted compositional analytical methods in regulatory risk assessments of GM crops to increase the number of analyzed metabolites.

Aim of Review

The technical opportunities, challenges and strategies of including untargeted metabolomics analysis in the comparative safety assessment of GM crops are reviewed. The results from metabolomics studies of GM and conventional crops published over the last eight years provide context to enable the discussion of whether metabolomics can materially improve the risk assessment of food and feed from GM crops beyond that possible by the Codex-defined practices used worldwide for more than 25 years.

Key Scientific Concepts of Review

Published studies to date show that environmental and genetic factors affect plant metabolomics profiles. In contrast, the plant biotechnology process used to make GM crops has little, if any consequence, unless the inserted GM trait is intended to alter food or feed composition. The nutritional value and safety of food and feed from GM crops is well informed by the quantitative, validated compositional methods for list of key analytes defined by crop-specific OECD consensus documents. Untargeted metabolic profiling has yet to provide data that better informs the safety assessment of GM crops than the already rigorous Codex-defined quantitative comparative assessment. Furthermore, technical challenges limit the implementation of untargeted metabolomics for regulatory purposes: no single extraction method or analytical technique captures the complete plant metabolome; a large percentage of metabolites features are unknown, requiring additional research to understand if differences for such unknowns affect food/feed safety; and standardized methods are needed to provide reproducible data over time and laboratories.

中文翻译：

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非靶向代谢组学在转基因作物安全性评估中的应用评价

背景

转基因 (GM) 作物食品和饲料的安全评估包括关键特征的比较，例如作物组成、农艺表型和动物饲养研究的观察结果与具有安全食用历史的传统对应品种相比，通常包括近等基因品种。转基因作物的比较成分分析基于经济合作与发展组织 (OCED) 确定的每种作物的关键食品和饲料营养素和抗营养素的有针对性的、经过验证的、定量分析方法。随着非靶向代谢组学方法技术的发展，

审查目的

综述了将非靶向代谢组学分析纳入转基因作物比较安全性评估的技术机遇、挑战和策略。过去八年发表的转基因和传统作物代谢组学研究结果提供了背景，可以讨论代谢组学是否可以实质性地改善转基因作物食品和饲料的风险评估，超越世界范围内使用的法典定义的做法超过 25 年。

审查的关键科学概念

迄今为止已发表的研究表明，环境和遗传因素会影响植物代谢组学特征。相比之下，用于制造转基因作物的植物生物技术过程几乎没有后果，除非插入的转基因性状旨在改变食物或饲料成分。转基因作物的食品和饲料的营养价值和安全性通过量化、经过验证的成分方法充分了解作物特定的经合组织共识文件定义的关键分析物清单。与已经严格的法典定义的定量比较评估相比，非靶向代谢分析尚未提供更好地为转基因作物安全评估提供信息的数据。此外，出于监管目的，技术挑战限制了非靶向代谢组学的实施：没有单一的提取方法或分析技术可以捕获完整的植物代谢组；大部分代谢物特征是未知的，需要额外的研究来了解这些未知物的差异是否会影响食品/饲料安全；需要标准化的方法来随时间和实验室提供可重复的数据。