Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 13: suitability of taxonomic units notified to EFSA until September 2020

Abstract

The qualified presumption of safety ( QPS ) approach was developed to provide a regularly updated generic pre‐evaluation of the safety of biological agents, intended for addition to food or feed, to support the work of EFSA 's Scientific Panels. It is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit ( TU ) are, where possible, confirmed at 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 TU s. Of the 36 microorganisms notified to EFSA between April and September 2020, 33 were excluded; seven filamentous fungi (including Aureobasidium pullulans based on recent taxonomic insights), one Clostridium butyricum , one Enterococcus faecium , three Escherichia coli , one Streptomyces spp. and 20 TU s that had been previously evaluated. Three TU s were evaluated; Methylorubrum extorquens and Mycobacterium aurum for the first time and Bacillus circulans was re‐assessed because an update was requested in relation to a new mandate. M. extorquens and M. aurum are not recommended for QPS status due to the lack of a body of knowledge in relation to use in the food or feed chain and M. aurum, due to uncertainty concerning its pathogenicity potential. B. circulans was recommended for QPS status with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’.

Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)

“…In the context of the current application, new data have been provided supporting the previous identification and characterisation of the production strain and confirming the qualifications for the presumed safety status (QPS, EFSA 2007 and EFSA BIOHAZ Panel 2021 ) of the production strain (see Section 3.1.1 ). The applicant also provided new data on the presence of viable cells that would confirm the absence of viable cells in the additive, but insufficient data was submitted to conclude on the absence of DNA.…”

Lactobacilli Infection Case Reports in the Last Three Years and Safety Implications

“…Explanations can be the increased consumption of probiotics [ 7 ] and a higher percentage of the population with predisposing conditions. A question to answer is if these bacteria can still be considered to cause “rare” infections, innocuous for the general population, and what is the definition of “general population” [ 6 ]. Indeed, risk factors such as prosthetic heart valve implantation, immunosuppression for cancer or organ transplantation, as well as underlying conditions such as diabetes mellitus, regard a large percentage of individuals today.…”

“…Single strains of lactobacilli have well-recognized effectiveness in the prevention and treatment of diseases of infectious or other nature and hold the generally recognized as safe (GRAS) status conferred by the Food and Drug Administration (FDA) in the USA [ 5 ]. In Europe, all species belonging to the old genus Lactobacillus reclassified in 2020 and intended for use in food products hold the qualified presumption of safety (QPS) status recognized by the European Food Safety Authority [ 6 ]. The market of probiotic lactobacilli has been growing constantly and has perspectives of further increases in the years to come [ 7 ], since these bacteria are used for the production of probiotic foods, food supplements, and pharmaceutical preparations designated as “live biotherapeutic products” (LBPs) that are intended for treatment of specific medical conditions.…”

Safety and efficacy of a feed additive consisting of Bacillus velezensis DSM 15544 (Calsporin®) for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species (Asahi Biocycle Co.)

“…The species B. velezensis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment (EFSA, 2007b ; EFSA BIOHAZ Panel, 2021 ). This approach requires the identity of the strain to be conclusively established and evidence provided that it does not show acquired resistance to relevant antimicrobials, that it lacks toxigenic potential and that it does not produce aminoglycosides.…”