The list of QPS status recommended biological agents for safety risk assessments carried out by EFSA

The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific Opinion on the maintenance of the list of qualified presumption of safety (QPS) biological agents. The QPS approach was developed by the EFSA Scientific Committee to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents intentionally introduced into the food and feed chain, in support of the concerned scientific Panels and Units in the frame of market authorisations. The taxonomic identity, body of knowledge, safety and antimicrobial resistance of biological agents are assessed. Safety concerns identified for the respective taxonomic unit (TU) are, where possible and reasonable in number, reflected as ‘qualifications’ which should be assessed at the strain level by the EFSA’s scientific Panels. The list of QPS status recommended biological agents, first established in 2007, has been continuously revised and updated through a scientific Opinion but since 2014 the evaluation is undertaken every 3 years and no longer carried out annually. If new information is retrieved from extended literature searches that would change the QPS status of a TU or its qualifications, this is published in the Panel Statement. The Panel Statement also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for an assessment for feed additives, food enzymes, food additives and flavourings, novel foods or plant protection products. In result of each Panel Statement, the ‘<em>2016 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA scientific Panels and Units</em>’ is updated with the inclusion of new recommendations for QPS status and is appended to the 2016 QPS scientific opinion. <strong>Versions history:</strong> Versions 1 and 2 were substituted by version 3 – all are associated with the QPS Panel statement EFSA 7: suitability of taxonomic units notified to EFSA until September 2017: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131 Version 4 is associated with the QPS Panel statement EFSA 8: suitability of taxonomic units notified to EFSA until March 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315 Versions 5 and 6 were substituted by version 7 – all are associated with the QPS Panel statement EFSA 9: suitability of taxonomic units notified to EFSA until September 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555欧洲食品安全局（EFSA）委托生物危害专家小组（BIOHAZ）就合格推定安全（QPS）生物制剂清单的维护工作出具科学意见。QPS方案由EFSA科学委员会制定，旨在提供统一的通用预评估，以支持对有意引入食品和饲料链的生物制剂开展安全风险评估，同时为相关科学专家小组和单位在市场授权框架内的工作提供支撑。该方案将对生物制剂的分类学身份、知识体系、安全性以及抗菌耐药性进行评估。针对各分类单元（TU）所识别出的安全隐患，若数量合理且具备评估可行性，则会以“限定条件”的形式予以体现，此类条件需由EFSA各科学专家小组在菌株层面开展评估。QPS资格推荐生物制剂清单于2007年首次确立，此后通过科学意见持续修订更新；自2014年起，评估工作改为每3年开展一次，不再逐年进行。若通过扩展文献检索获取的新信息会改变某一分类单元的QPS资格或其限定条件，则会在专家小组声明中发布。专家小组声明还涵盖了在6个月期限内通知EFSA的、用于饲料添加剂、食品酶制剂、食品添加剂、食品调味剂、新型食品或植物保护产品评估的微生物制剂的评估工作。每一份专家小组声明所形成的<em>2016年EFSA科学专家小组及单位开展安全风险评估所用QPS资格推荐生物制剂更新清单</em>都会纳入新的QPS资格推荐内容，并作为附件追加至2016年QPS科学意见中。<strong>版本沿革：</strong>版本1与版本2已由版本3替代，三者均关联EFSA第7号QPS专家小组声明：2017年9月前通知EFSA的分类单元适用性：https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131。版本4关联EFSA第8号QPS专家小组声明：2018年3月前通知EFSA的分类单元适用性：https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315。版本5与版本6已由版本7替代，三者均关联EFSA第9号QPS专家小组声明：2018年9月前通知EFSA的分类单元适用性：https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555