Update of the list of QPS‐recommended microbiological agents intentionally added to food or feed as notified to EFSA 16: suitability of taxonomic units notified to EFSA until March 2022

Abstract

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre‐evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge, safety concerns and occurrence of antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. Of the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium , 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris , being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re‐assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge , Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns .

Development of a Single-Chain Fragment Variable that Binds to the SARS-CoV-2 Spike Protein Produced by Genetically Modified Lactic Acid Bacteria

“…LAB, which are human intestinal symbiotic bacteria, have long been used in the production of fermented foods through lactic acid fermentation. As such, many LAB are generally recognized as safe by the US Food and Drug Administration [ 21 ] and given the qualified presumption of safety status by the European Food Safety Authority [ 22 ]. LAB, which do not produce endotoxins like those produced by E. coli , have certain advantages as expression hosts for recombinant proteins and are therefore an attractive platform, especially in the context of in vivo administration [ 23 , 24 ].…”

Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA

“…The qualification ‘absence of aminoglycoside production ability’ was withdrawn for Bacillus velezensis based on recent information that did not support possible aminoglycoside production, thereby contradicting the original data on which the qualification was based (EFSA BIOHAZ Panel, 2023).…”

Emerging issues in probiotic safety: 2023 perspectives

“…lactis and concluded that there was no new information that would require a modification of the subspecies’ qualified presumption of safety status. 11 …”

“… 6–10 A foundational initiative by the European Food Safety Authority established the Qualified Presumption of Safety approach for live microorganisms used in foods. 11 This guidance is useful for recognizing microbial species with a history of safe use in foods. Pariza and colleagues 12 proposed a 15-step decision tree to guide safety evaluations for products that lack an established history of safe use.…”