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向欧洲食品安全局(EFSA)通报的有意添加到食品或饲料中的QPS推荐生物制剂清单更新6:截至2017年3月向EFSA通报的分类单元的适用性。

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017.

作者信息

Ricci Antonia, Allende Ana, Bolton Declan, Chemaly Marianne, Davies Robert, Girones Rosina, Koutsoumanis Kostas, Lindqvist Roland, Nørrung Birgit, Robertson Lucy, Ru Giuseppe, Fernandez Escamez Pablo Salvador, Sanaa Moez, Simmons Marion, Skandamis Panagiotis, Snary Emma, Speybroeck Niko, Ter Kuile Benno, Threlfall John, Wahlström Helene, Cocconcelli Pier Sandro, Peixe Luisa, Maradona Miguel Prieto, Querol Amparo, Suarez Juan Evaristo, Sundh Ingvar, Vlak Just, Correia Sandra, Herman Lieve

出版信息

EFSA J. 2017 Jul 25;15(7):e04884. doi: 10.2903/j.efsa.2017.4884. eCollection 2017 Jul.

Abstract

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA'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, reflected as 'qualifications' which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between the end of September 2016 and March 2017, the QPS notification list was updated with 87 applications for market authorisation. From these, 32 biological agents already had a QPS status, and 37 were not included in the evaluation as they are filamentous fungi or enterococci. species (  and   (three notifications) and (seven notifications) were re-confirmed not suitable for QPS. and  , not evaluated within the previous mandate, were also not recommended for QPS. spp. and  will be excluded from further QPS evaluations within the current QPS mandate. which has never been evaluated before, was not recommended for the QPS list and for the QPS assessment was not applicable because it is not a validated species. was a new taxonomic unit recommended to have the QPS status.

摘要

合格安全性推定(QPS)概念的提出是为了提供一种统一的通用预评估,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。对有效分类单元的身份、知识体系、安全问题和抗菌药物耐药性进行了评估。为一个分类单元确定的安全问题,在可能且数量合理的情况下,会作为“限定条件”体现出来,应由EFSA的科学小组在菌株水平上进行评估。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。在2016年9月底至2017年3月期间,QPS通知清单更新了87份市场授权申请。其中,32种生物制剂已经具有QPS状态,37种由于是丝状真菌或肠球菌而未纳入评估。 种( 和 (三份通知)以及 (七份通知)被再次确认不适合QPS。 和 ,在前一个任务期内未进行评估,也不建议给予QPS。 属和 将在当前QPS任务期内被排除在进一步的QPS评估之外。 此前从未进行过评估,不建议列入QPS清单,对于 ,由于它不是一个已验证的物种,QPS评估不适用。 是一个被推荐具有QPS状态的新分类单元。

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