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.欧洲食品安全局（EFSA）委托生物危害专题小组（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方法由EFSA科学委员会制定，旨在提供统一通用的预评估，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，为相关科学专题小组和单位在市场准入框架内的工作提供支撑。本次评估涵盖生物制剂的分类学身份、相关知识库、安全性以及抗菌药物耐药性。针对各分类单元（TU）识别出的安全隐患，若数量合理且具备评估可行性，将以“限定条件”形式体现，此类条件需由EFSA各科学专题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，该评估工作改为每3年开展一次，不再每年进行。若通过扩展文献检索获取到可改变某分类单元（TU）QPS资格或其限定条件的新信息，相关内容将在专题小组声明中发布。专题小组声明还涵盖对在6个月期限内提交至EFSA、用于饲料添加剂、食品酶制剂、食品添加剂、调味料、新型食品或植物保护产品评估的微生物制剂的评估工作。每份专题小组声明最终都会更新<em>2016年EFSA科学专题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>，新增QPS资格推荐内容，并将该清单作为附件附于2016年QPS科学意见之后。