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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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摘要

The qualified presumption of safety ( ) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by '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 's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended taxonomic units and their qualifications. Between April and September 2018, the notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had status, 15 were excluded from the exercise by the previous mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of , one of spp. and seven of ). One taxonomic unit was (re)evaluated: 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 in the list. and were evaluated for the first time. cannot be considered for the assessment because there are significant safety concerns. ( subsp. ) can be proposed for the list but only for production purposes. The status of is confirmed with the qualification extended to other production purposes.
机译:制定了合格的安全性推定()程序,以提供统一的通用预评估,以支持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“科学小组”在菌株级别进行评估。在当前评估中,未发现任何新信息会改变先前推荐的分类单位及其资格。在2018年4月至2018年9月之间,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种已经具有状态,前一任务(五种丝状真菌)被排除在运动之外,或者在当前任务范围内的进一步评估中被排除在外(15次被通报,其中一个为通知,七个为通知)。对一个分类单位进行了(重新)评估:先前在2016年进行了评估,现在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,具有抗菌活性和毒力特征的生物化合物的生产),从而阻止了其列入清单。并进行了首次评估。由于存在重大安全问题,因此不能考虑进行评估。 (subsp。)可以用于清单,但仅用于生产目的。通过将资格扩展到其他生产目的来确认的状态。

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