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, Suarez Juan Evaristo, Sundh Ingvar, Vlak Just, Barizzone Fulvio, Hempen Michaela, Herman Lieve
EFSA J. 2020 Jul 2;18(7):e06174. doi: 10.2903/j.efsa.2020.6174. eCollection 2020 Jul.
The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by 'qualifications'. No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five , two , two spp. and 19 TUs already evaluated. Six TUs were evaluated. was not recommended for QPS status due to safety concerns. was not recommended because some strains contain pathogenicity factors. This TU was excluded for further QPS evaluation. and were also rejected due to a lack of body of knowledge. The QPS status of (with the qualification 'for production purposes only') and of (with the qualification 'for enzyme production') was confirmed. In relation to the taxonomic revision of the genus, previously designated species will be reassigned to the new species and both the old and new names will be retained in the QPS list.
合格安全推定（QPS）旨在为生物制剂提供通用安全评估，以支持欧洲食品安全局（EFSA）的科学小组。它基于对分类学身份、知识体系、安全问题和抗菌药物耐药性的评估。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，以“限定条件”体现。未发现会改变2019年10月至2020年3月期间通知EFSA的39种微生物先前推荐的QPS TU的新信息，33种被排除，包括5种丝状真菌、5种、2种、2种 spp.以及19个已评估的TU。评估了6个TU。由于安全问题，未推荐其获得QPS地位。未被推荐是因为一些菌株含有致病因子。该TU被排除进行进一步的QPS评估。和也因缺乏知识体系而被否决。（限定条件为“仅用于生产目的”）和（限定条件为“用于酶生产”）的QPS地位得到确认。关于属的分类学修订，先前指定的种将被重新分配到新种，新旧名称都将保留在QPS列表中。
