Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 11: suitability of taxonomic units notified to EFSA until September 2019

Abstract

Qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance are assessed. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by ‘qualifications’. No new information was found that would change the previously recommended QPS TUs and their qualifications. The list of microorganisms notified to EFSA was updated with 54 biological agents, received between April and September 2019; 23 already had QPS status, 14 were excluded from the QPS exercise (7 filamentous fungi, 6 Escherichia coli, Sphingomonas paucimobilis which was already evaluated). Seventeen, corresponding to 16 TUs, were evaluated for possible QPS status, fourteen of these for the first time, and Protaminobacter rubrum, evaluated previously, was excluded because it is not a valid species. Eight TUs are recommended for QPS status. Lactobacillus parafarraginis and Zygosaccharomyces rouxii are recommended to be included in the QPS list. Parageobacillus thermoglucosidasius and Paenibacillus illinoisensis can be recommended for the QPS list with the qualification ‘for production purposes only’ and absence of toxigenic potential. Bacillus velezensis can be recommended for the QPS list with the qualifications; the absence of toxigenic potential and the absence of aminoglycoside production, including the genes encoding this. Cupriavidus necator, Aurantiochytrium limacinum and Tetraselmis chuii can be recommended for the QPS list with the qualification; for production purposes only. Pantoea ananatis is not recommended for the QPS list due to lack of body of knowledge in relation to its pathogenicity potential for plants. Corynebacterium stationis, Hamamotoa singularis, Rhodococcus aetherivorans and Rhodococcus ruber cannot be recommended for the QPS list due to lack of body of knowledge. Kodamaea ohmeri cannot be recommended for the QPS list due to safety concerns.

Criteria to Qualify Microorganisms as “Probiotic” in Foods and Dietary Supplements

“…The list is a reasonable basis for establishing safety of food strains when belonging to a QPS species, provided that the strain-specific testing described below is also conducted. The list results from historical data, from regular monitoring of the body of knowledge and through extensive scientific literature reviews, applied to a wide array of micro-organisms traditionally found in the food chain (EFSA, 2020b). It should be noted that the scope of QPS is food consumption by the general, healthy population and does not specifically take into consideration potential risks for vulnerable populations (EFSA, 2005) or non-food uses of probiotics.…”

The Many Faces of Enterococcus spp.—Commensal, Probiotic and Opportunistic Pathogen

“…According to the Food and Drug Administration, probiotic bacteria should "Generally be Recognized as Safe" [47]. In Europe, a "Qualified Presumption of Safety" is responsible for recommending biological agents intentionally added to food or feed, and information is available in the European Food Safety Authority scientific panels [48].…”

“…Benyacoub et al [77] confirmed an immunomodulatory role of E. faecium SF68 on the intestinal mucosa and the development of the digestive system in young dogs. Another preparation, Cylactin ® , containing the strain E. faecium NCIMB 10415, has been used in pig and poultry farming as a feed additive in European Union countries instead of supplementary avoparcin to stimulate animal growth [46,48,78].…”

Comparative Genomics and In Vitro Plant Growth Promotion and Biocontrol Traits of Lactic Acid Bacteria from the Wheat Rhizosphere

“…LAB are microaerophilic Gram-positive bacteria which play an important role in food fermentations but also include commensals of vertebrates and insects as well as pathogens [ 20 ]. Food fermenting LAB, particularly species grouped in the Lactobacillaceae , have a safe tradition of use in food [ 21 ], but this group also includes pathogens or opportunistic pathogens. For instance, Enterococcus faecium has evolved as vertebrate commensals and occur in food fermentations but specific lineages of E. faecium also are a leading cause of hospital-acquired infections with multi-drug resistant bacteria [ 22 , 23 ].…”