Scientific Opinion on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA (2017–2019)

摘要

The qualified presumption of safety ( ) was developed to provide a safety pre‐assessment within for microorganisms. Strains belonging to taxonomic units ( s) still require an assessment based on a specific data package, but status facilitates fast track evaluation. s are unambiguously defined biological agents assessed for the body of knowledge, their safety and their end use. Safety concerns are, where possible, to be confirmed at strain or product level, and reflected as ‘qualifications’. Qualifications need to be evaluated at strain level by the respective units. The lowest is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the status, and if the genetic modification does not indicate a concern. Based on the actual body of knowledge and/or an ambiguous taxonomic position, the following s were excluded from the assessment: filamentous fungi, oomycetes, streptomycetes , and bacteriophages. The list of ‐recommended biological agents was reviewed and updated in the current opinion and therefore now becomes the valid list. For this update, reports on the safety of previously assessed microorganisms, including bacteria, yeasts and viruses (the latter only when used for plant protection purposes) were reviewed, following an Extensive Literature Search strategy. All s previously recommended for 2016 list had their status reconfirmed as well as their qualifications. The s related to the new notifications received since the 2016 opinion was periodically evaluated for status in the Statements of the Panel, and the list was also periodically updated. In total, 14 new s received a status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists.