EFSA J. 2024 Aug 12;22(8):e8912. doi: 10.2903/j.efsa.2024.8912. eCollection 2024 Aug.
Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms.
无论是否经过基因改造，微生物都可以在食物链中作为活性剂、生物质或作为目标物质的生产生物体使用。此类微生物或其衍生物质/产品在欧洲市场的投放可能需要经过上市前授权程序。授权程序需要进行风险评估，以便确定微生物在食物链中作为此类、作为生物质或作为生产菌株使用时的安全性和/或有效性。这包括对所评估微生物进行全面的分子特征描述。对于某些受监管产品，将使用微生物的全基因组序列（WGS）数据作为风险评估的一项要求。在这方面，从WGS分析获得的数据可以提供有关菌株明确分类鉴定的信息、有关关注基因（例如编码毒力因子、对人类和动物具有临床相关性的抗菌药物的抗性、有害代谢产物或临床相关抗菌药物的产生）的信息以及有关基因改造（如适用）的特征信息。本文件就如何在受监管产品上市授权申请的背景下描述和报告WGS分析结果向申请人提供建议。说明了如何进行基因组测序以及应达到的质量标准/阈值，以及在需要时需要报告的数据和相关信息。本更新文件取代了欧洲食品安全局2021年声明，反映了用于生成和分析WGS数据以进行微生物风险评估的技术和方法的当前知识。
