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 ‘2016 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA scientific Panels and Units’ is updated with the inclusion of new recommendations for QPS status and is appended to the 2016 QPS scientific opinion.

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