The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance 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. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of , one of spp. and seven of ). One taxonomic unit was (re)evaluated: had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of in the QPS list. and were evaluated for the first time. cannot be considered for the QPS assessment because there are significant safety concerns. ( subsp. ) can be proposed for the QPS list but only for production purposes. The QPS status of is confirmed with the qualification extended to other production purposes.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328880 | PMC |
http://dx.doi.org/10.2903/j.efsa.2019.5555 | DOI Listing |
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