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Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

机译:通知EFSA 9的有意添加到食品或饲料中的QPS推荐生物制剂清单的更新:通知EFSA的生物分类单位是否适用至2018年9月

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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 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 taxonomic units and their qualifications. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re‐evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.
机译:制定了合格的安全性推定(QPS)程序,以提供统一的通用预评估,以支持EFSA科学小组对生物制剂进行安全风险评估。评估了分类学身份,知识体系,安全性和抗菌素耐药性。对于分类单元确定的安全问题,在可能的范围内和合理的数量上,应通过“资格”反映出来,而“资格”应由欧洲食品安全局的科学小组在菌株级别进行评估。在当前评估期间,未发现任何新信息会改变以前推荐的QPS分类单位及其资格。在2018年4月至2018年9月之间,QPS通知列表更新了48种来自市场授权申请的微生物。在这些生物中,有30种已经具有QPS状态的生物制剂,有15种被先前的QPS任务(五种丝状真菌)排除在QPS锻炼之外,或者在当前任务范围内的进一步评估中被排除(两次通知是粪便肠球菌,一种是链霉菌属,另一种是七种)。 (大肠杆菌)。对一个分类单位进行了(重新)评估:荧光假单胞菌先前于2016年进行了评估,现在已在此任务范围内进行了重新评估。文献的修订支持了先前确定的安全问题(例如,生产具有抗菌活性和毒力特征的生物化合物),从而阻止了荧光假单胞菌列入QPS清单。首次评估了分枝杆菌和蔗糖发酵杆菌。由于存在重大的安全隐患,因此不能将M. setense用于QPS评估。蔗糖克鲁维酵母(木醋杆菌亚种sucrofermentans)可以被提议用于QPS清单,但仅用于生产目的。谷氨酸棒杆菌的QPS状态得到确认,其资格范围已扩展到其他生产目的。

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