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)

Abstract

The qualified presumption of safety (QPS) was developed to provide a safety pre‐assessment within EFSA for microorganisms. Strains belonging to QPS taxonomic units (TUs) still require an assessment based on a specific data package, but QPS status facilitates fast track evaluation. QPS TUs 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 EFSA units. The lowest QPS TU is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the QPS 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 TUs were excluded from the QPS assessment: filamentous fungi, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and bacteriophages. The list of QPS‐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 TUs previously recommended for 2016 QPS list had their status reconfirmed as well as their qualifications. The TUs related to the new notifications received since the 2016 QPS opinion was periodically evaluated for QPS status in the Statements of the BIOHAZ Panel, and the QPS list was also periodically updated. In total, 14 new TUs received a QPS status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists.

Safety and efficacy of Axtra® XAP 104 TPT (endo‐1,4‐xylanase, protease and alpha‐amylase) as a feed additive for chickens for fattening, laying hens and minor poultry species

“…Regarding the other two production strains, B. licheniformis ATCC SD 6525 and B. subtilis ATCC SD 2107, their parental strains belong to species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment (EFSA, 2007a;EFSA BIOHAZ Panel, 2020). This approach requires the identity of the strain to be conclusively established and evidence that the strain lacks toxigenic potential and does not show acquired resistance to antibiotics of human and veterinary importance and for genetically modified strains the safety of the genetic modification needs to be established.…”

Evaluation of existing guidelines for their adequacy for the microbial characterisation and environmental risk assessment of microorganisms obtained through synthetic biology

“…The Chapter describes a specific approach for the risk assessment that applies to those species of microorganisms included in the list of recommended biological agents for the QPS status (EFSA, 2007;EFSA BIOHAZ Panel, 2020). The QPS evaluation is based on extensive literature searches to discover the body of knowledge and possible safety concerns for humans, animals and the environment related to their release.…”

Viruses of protozoan parasites and viral therapy: Is the time now right?

“…The specificity of bacteriophages, absence of adverse effects on the normal bacterial flora (unlike antibiotics), their greater efficacy than some antibiotics [111] and little evidence of them causing harm on administration are major advantages for their application. However, bacteriophages as a generic group are not yet considered to have a qualified presumption of safety (QPS) by the EU [112] although they have been used several times in the US for untreatable infections [113].…”