Ricci Antonia, Allende Ana, Bolton Declan, Chemaly Marianne, Davies Robert, Fernández Escámez Pablo Salvador, Girones Rosina, Koutsoumanis Konstantinos, Lindqvist Roland, Nørrung Birgit, Robertson Lucy, Ru Giuseppe, 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, Barizzone Fulvio, Correia Sandra, Herman Lieve
EFSA J. 2018 Jul 17;16(7):e05315. doi: 10.2903/j.efsa.2018.5315. eCollection 2018 Jul.
The qualified presumption of safety (QPS) was developed to provide a harmonised generic pre-evaluation procedure 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 by 'qualifications' which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The Panel clarified that the qualification 'for production purpose only' implies the absence of viable cells of the production organism in the final product and can also be applied for food and feed products based on microbial biomass. Between September 2017 and March 2018, the QPS notification list was updated with 46 microorganisms from applications for market authorisation. From these, 28 biological agents already had QPS status, 15 were excluded of the QPS exercise from the previous QPS mandate (10 filamentous fungi and one bacteriophage) or from further evaluations within the current mandate (two notifications of spp. and one of ), and one was excluded where confirmatory data for the risk assessment of a plant protection product (PPP) was requested ( sp.). Three taxonomic units were (re)evaluated: and had been previously evaluated in 2008 and 2014, respectively, and were now re-evaluated within this mandate, and which was evaluated for the first time. and cannot be granted QPS status due to lack of scientific knowledge. is recommended for QPS status, but only for production purpose.
合格安全推定（QPS）旨在提供一种统一的通用预评估程序，以支持欧洲食品安全局（EFSA）各科学小组对生物制剂进行安全风险评估。对有效分类单元的身份、知识体系、安全问题和抗微生物耐药性进行了评估。针对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，由“限定条件”体现，EFSA各科学小组应在菌株水平对这些限定条件进行评估。在本次评估中，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。该小组澄清，“仅用于生产目的”这一限定条件意味着最终产品中不存在生产生物体的活细胞，也可适用于基于微生物生物质的食品和饲料产品。2017年9月至2018年3月期间，QPS通知清单因市场授权申请中的46种微生物而更新。其中，28种生物制剂已具有QPS状态，15种被排除在先前QPS任务的QPS评估之外（10种丝状真菌和1种噬菌体）或当前任务的进一步评估之外（两种 spp. 通知和一种 通知），还有一种因要求提供植物保护产品（PPP）风险评估的确证数据而被排除（ sp.）。对三个分类单元进行了（重新）评估： 和 分别在2008年和2014年进行过评估，现在此任务范围内重新评估， 是首次评估。由于缺乏科学知识， 和 不能被授予QPS状态。 建议授予QPS状态，但仅用于生产目的。
