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, Prieto-Maradona Miguel, Querol Amparo, Sijtsma Lolke, Evaristo Suarez Juan, Sundh Ingvar, Vlak Just, Barizzone Fulvio, Hempen Michaela, Herman Lieve
EFSA J. 2022 Jan 27;20(1):e07045. doi: 10.2903/j.efsa.2022.7045. eCollection 2022 Jan.
The qualified presumption of safety (QPS) approach was developed to provide a generic pre-evaluation of the safety of biological agents. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. The QPS list was updated in relation to the revised taxonomy of the genus , to synonyms of yeast species and for the qualifications 'absence of resistance to antimycotics' and 'only for production purposes'. has been reclassified as . In the period covered by this statement, no new information was found that would change the status of previously recommended QPS taxonomic units (TU)s. Of the 70 microorganisms notified to EFSA, 64 were not evaluated: 11 filamentous fungi, one oomycete, one , one , five , one sp., one and 43 TUs that already had a QPS status. Six notifications, corresponding to six TUs were evaluated: was reassessed because an update was requested for the current mandate. synonym , synonym , , synonym and synonym were assessed for the first time. The following TUs were not recommended for QPS status: due to a limited body of knowledge, synonym due to potential safety concerns, synonym , and synonym , due to lack of a body of knowledge on its occurrence in the food and feed chain. synonym is recommended for QPS status with the qualification 'for production purposes only'.
合格安全推定(QPS)方法旨在对生物制剂的安全性进行一般性预评估。QPS方法基于对每种制剂已发表数据的评估,涉及分类学身份、相关知识体系和安全问题。安全问题在可能的情况下在物种/菌株或产品层面得到确认,并通过“限定条件”体现。QPS清单已根据该属的修订分类法、酵母物种同义词以及“对抗真菌药无抗性”和“仅用于生产目的”的限定条件进行了更新。 已重新分类为 。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(TU)状态的新信息。在向欧洲食品安全局通报的70种微生物中,64种未进行评估:11种丝状真菌、1种卵菌、1种 、1种 、5种 、1种 菌、1种 以及43个已具有QPS状态的TU。对对应6个TU的6份通报进行了评估: 因当前任务要求更新而重新评估。 同义词 、 同义词 、 、 同义词 和 同义词 首次进行评估。以下TU不建议授予QPS状态: 因知识体系有限, 同义词 因存在潜在安全问题, 同义词 、 和 同义词 因缺乏其在食品和饲料链中出现情况的知识体系。 同义词 建议授予QPS状态,限定条件为“仅用于生产目的”。