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, Correia Sandra, Herman Lieve
EFSA J. 2019 Jul 15;17(7):e05753. doi: 10.2903/j.efsa.2019.5753. eCollection 2019 Jul.
The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit (TU) are, where possible and reasonable in number, reflected by 'qualifications' which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS TUs and their qualifications. The list of microorganisms notified to EFSA from applications for market authorisation was updated with 47 biological agents, received between October 2018 and March 2019. Of these, 19 already had QPS status, 20 were excluded from the QPS exercise by the previous QPS mandate (11 filamentous fungi) or from further evaluations within the current mandate (9 notifications of ) were evaluated for the first time. cannot be assessed for a possible QPS recommendation because it is not a valid species. and can be recommended for the QPS list with the qualification 'for production purposes only'. The following TUs cannot be recommended for the QPS list: due to its potential and confirmed ability to generate biologically active compounds and limited of body of knowledge; and due to lack of body of knowledge; , based on the lack of a safe history of use in the food chain and limited knowledge on its potential production of bioactive compounds with possible toxic effects.
合格安全推定(QPS)程序旨在提供统一的通用预评估,以支持欧洲食品安全局(EFSA)各科学小组对生物制剂进行的安全风险评估。对生物分类身份、知识体系、安全问题和抗菌耐药性进行了评估。针对一个分类单元(TU)识别出的安全问题,在可能且数量合理的情况下,通过“限定条件”体现,EFSA的科学小组应在菌株水平对这些限定条件进行评估。在本次评估中,未发现会改变先前推荐的QPS分类单元及其限定条件的新信息。2018年10月至2019年3月期间收到的47种生物制剂更新了向EFSA通报的市场授权申请中的微生物清单。其中,19种已经具有QPS状态,20种被先前的QPS任务排除在QPS评估之外(11种丝状真菌),或者被当前任务排除在进一步评估之外(9种通报)是首次评估。由于它不是一个有效物种,因此无法评估其是否可获得QPS推荐。 和 可以以“仅用于生产目的”的限定条件推荐列入QPS清单。以下分类单元不能推荐列入QPS清单: 因其具有产生生物活性化合物的潜在和已证实能力且知识体系有限; 和 因其知识体系不足; 基于其在食物链中缺乏安全使用历史且对其可能产生具有潜在毒性作用的生物活性化合物的知识有限。