Koutsoumanis Kostas, Allende Ana, Alvarez-Ordóñez Avelino, Bolton Declan, Bover-Cid Sara, Chemaly Marianne, Davies Robert, De Cesare Alessandra, Hilbert Friederike, Lindqvist Roland, Nauta Maarten, Peixe Luisa, Ru Giuseppe, Simmons Marion, Skandamis Panagiotis, Suffredini Elisabetta, Cocconcelli Pier Sandro, Fernández Escámez Pablo Salvador, Maradona Miguel Prieto, Querol Amparo, Sijtsma Lolke, Suarez Juan Evaristo, Sundh Ingvar, Vlak Just, Barizzone Fulvio, Hempen Michaela, Herman Lieve
EFSA J. 2021 Jan 28;19(1):e06377. doi: 10.2903/j.efsa.2021.6377. eCollection 2021 Jan.
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of biological agents, intended for addition to food or feed, to support the work of EFSA's Scientific Panels. It is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at strain or product level, and reflected by 'qualifications'. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. Of the 36 microorganisms notified to EFSA between April and September 2020, 33 were excluded; seven filamentous fungi (including based on recent taxonomic insights), one , one , three , one spp. and 20 TUs that had been previously evaluated. Three TUs were evaluated; and for the first time and was re-assessed because an update was requested in relation to a new mandate. and are not recommended for QPS status due to the lack of a body of knowledge in relation to use in the food or feed chain and due to uncertainty concerning its pathogenicity potential. was recommended for QPS status with the qualifications for 'production purposes only' and 'absence of cytotoxic activity'.
合格安全推定(QPS)方法旨在对拟添加到食品或饲料中的生物制剂的安全性进行定期更新的通用预评估,以支持欧洲食品安全局(EFSA)各科学小组的工作。它基于对每种制剂已发表数据的评估,涉及分类学身份、知识体系、安全问题和抗菌药物耐药性。针对分类单元(TU)确定的安全问题,尽可能在菌株或产品层面得到确认,并通过“限定条件”体现。在本声明涵盖的期间内,未发现会改变先前推荐的QPS分类单元状态的新信息。在2020年4月至9月期间通知给EFSA的36种微生物中,33种被排除;7种丝状真菌(包括基于最近的分类学见解)、1种、1种、3种、1种 spp.以及20个先前已评估的分类单元。对3个分类单元进行了评估;和首次评估,以及由于新任务要求进行更新而重新评估。由于缺乏在食品或饲料链中使用的知识体系,以及由于其潜在致病性存在不确定性,不建议授予和QPS地位。建议授予QPS地位,但限定为“仅用于生产目的”和“无细胞毒性活性”。