Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Abstract

The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re‐evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.

Safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: Rebaudioside M produced via enzyme‐catalysed bioconversion of purified stevia leaf extract

“…The parental microorganism is the yeast K. phaffii ATCC20864. K. phaffii is recommended for the Qualified Presumption of Safety (QPS) status, with the qualification that the species is used for production purposes, as is the case here (EFSA BIOHAZ Panel, ). K. phaffii ATCC20864 was selected based on tolerance towards 10% steviol glycosides in liquid media.…”

Safety and efficacy of l‐isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80189 for all animal species

“…The L-isoleucine under assessment is highly purified (less than 1% unidentified material). The production strain KCCM 80189 belongs to a species, Corynebacterium glutamicum, that qualifies for the qualified presumption of safety (QPS) approach to safety assessment (EFSA, 2007) when used for production purposes (EFSA BIOHAZ Panel, 2019). The strain was unambiguously identified as C. glutamicum, was shown to be susceptible to the relevant antibiotics.…”

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species

“…For both strains, the recipient organism belongs to a species, C. glutamicum , that is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment when used for production purposes (EFSA, ; EFSA BIOHAZ Panel, ).…”

“…Safety of L-lysine HCl and concentrated liquid L-lysine (base) produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535 3.4.1. Safety of the production strains For both strains, the recipient organism belongs to a species, C. glutamicum, that is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment when used for production purposes (EFSA, 2007;EFSA BIOHAZ Panel, 2019).…”