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Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017

机译:通知EFSA 7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2017年9月

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摘要

The qualified presumption of safety ( ) concept was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by 's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, considered to be ‘qualifications’ which should be assessed at the strain level by the 's scientific Panels. No new information was found that would change the previously recommended taxonomic units and their qualifications. The Panel confirms that the approach can be extended to a genetically modified production strain if the recipient strain qualifies for the status, and if the genetic modification does not indicate a concern. Between April and September 2017, the notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had status and 16 were not included as they are filamentous fungi or enterococci. One notification of K‐61 (notified as former ) and four of were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current mandate. Eight notifications of and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: which had not been evaluated before, and , previously notified as included due to a change in the taxonomic identity cannot be granted status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species can be recommended for the list when used for enzyme production.
机译:提出了合格的安全性推定()概念,以提供统一的通用预评估,以支持科学专家小组对生物制剂进行安全风险评估。评估了有效分类单位的身份,知识体系,安全性和抗菌素耐药性。在可能的范围内和合理数量上,为一个分类单位确定的安全问题被认为是“资格”,应由“科学专家组”在菌株级别进行评估。没有发现新的信息会改变以前推荐的分类单位及其资格。专家小组确认,如果受体菌株符合资格,并且该基因修饰没有引起关注,则该方法可扩展至基因修饰的生产菌株。在2017年4月至2017年9月之间,通知列表更新了46个市场授权申请。从这些中,已经有14种生物制剂处于状态,并且由于丝状真菌或肠球菌而没有包括16种。一份K‐61通知(通知为以前的通知)和四个K‐61通知未考虑进行评估,因为它们属于生物分类单位,被排除在当前任务范围之内。卵菌的八个通知和一个卵菌的通知正等待接收完整的申请。对两个分类单位进行了评估:之前未进行评估,并且由于缺乏分类生物学信息以及可能产生有毒次生代谢产物,因此由于生物分类身份发生变化而先前被通知为包括在内,因此无法授予其地位。当用于酶生产时,可以推荐该物种。

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