Abstract
The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre‐evaluation 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, considered to be ‘qualifications’ which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panel confirms that the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K‐61 (notified as former S. griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatospora paracochleata, which had not been evaluated before, and Komagataella phaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatospora paracochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataella phaffii can be recommended for the QPS list when used for enzyme production.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
