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, Correia Sandra, Herman Lieve
EFSA J. 2022 Jul 25;20(7):e07408. doi: 10.2903/j.efsa.2022.7408. eCollection 2022 Jul.
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. 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, safety concerns and occurrence of antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/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 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 , 1 3 and 1 spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, and , being evaluated for the first time. The other three, and were re-assessed. None of these TUs were recommended for QPS status: and due to a limited body of knowledge due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and due to possible safety concerns
合格安全推定(QPS)方法的制定是为了对用于食品或饲料链的微生物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。QPS方法基于对每种微生物已发表数据的评估,涉及分类身份、相关知识体系、安全问题以及抗菌药物耐药性的发生情况。针对分类单元(TU)确定的安全问题,尽可能在物种/菌株或产品层面得到确认,并通过“限定条件”体现出来。在本声明所涵盖的期间,未发现会改变先前推荐的QPS分类单元状态的新信息。在2021年10月至2022年3月(含)通知EFSA的50种微生物中,41种未进行评估:10种丝状真菌、1种、1种、1种,因为它们被排除在QPS评估之外,还有25个已具有QPS状态的分类单元。对与7个分类单元相对应的9份通知进行了评估:其中4个,即和,是首次评估。另外3个,即和,进行了重新评估。这些分类单元均未被推荐授予QPS状态:和由于知识有限以及其导致菌血症和全身感染从而引发多种疾病的能力,由于缺乏知识以及对其可能产生的生物活性化合物安全性存在不确定性,以及由于可能存在的安全问题 。