Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 17: suitability of taxonomic units notified to EFSA until September 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 and safety concerns. 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, new information was found leading to the withdrawal of the qualification ‘absence of aminoglycoside production ability’ for Bacillus velezensis. The qualification for Bacillus paralicheniformis was changed to ‘absence of bacitracin production ability’. For the other TUs, no new information was found that would change the status of previously recommended QPS TUs. Of 52 microorganisms notified to EFSA between April and September 2022 (inclusive), 48 were not evaluated because: 7 were filamentous fungi, 3 were Enterococcus faecium , 2 were Escherichia coli , 1 was Streptomyces spp., and 35 were taxonomic units (TUs) that already have a QPS status. The other four TUs notified within this period, and one notified previously as a different species, which was recently reclassified, were evaluated for the first time for a possible QPS status: Xanthobacter spp. could not be assessed because it was not identified to the species level; Geobacillus thermodenitrificans is recommended for QPS status with the qualification ‘absence of toxigenic activity’. Streptoccus oralis is not recommended for QPS status. Ogataea polymorpha is proposed for QPS status with the qualification ‘for production purposes only’. Lactiplantibacillus argentoratensis (new species) is included in the QPS list.

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

“…The assessments of the respective TUs were published in six Panel Statements, adopted every 6 months from July 2020 to December 2022 (see Table 6). In four of the six Statements Parts 13, 14, 15 and 17 (EFSA BIOHAZ Panel, 2021a,b, 2022a, 2023) produced during this period, six new TUs were recommended for the QPS status. In Panel Statement Part 13 (EFSA BIOHAZ Panel, 2021a), Bacillus 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 Bacillus paralicheniformis DSM 5749 and Bacillus subtilis DSM 5750 (BioPlus® 2B) for piglets, calves for fattening and other growing ruminants (Chr. Hansen A/S)

“…Both bacterial species are considered by EFSA to be eligible for the Qualified Presumption of Safety (QPS) approach (EFSA, 2007c; EFSA BIOHAZ Panel, 2020, 2023). This approach requires the identity of the strains to be conclusively established and evidence that they do not show acquired resistance to antibiotics of human and veterinary importance or toxigenic potential.…”

Safety and efficacy of a feed additive consisting of Streptococcus salivarius DSM 13084/ATCC BAA 1024 for dogs and cats (BLIS Technologies Limited)

“…The active agent was shown to belong to the species Streptococcus salivarius . S. salivarius is not a species eligible for the qualified presumption of safety (QPS) approach of safety assessment due to the ability of some strains to cause bacteraemia and systemic infections that result in a variety of morbidities (EFSA BIOHAZ Panel, 2023). Based on the data provided, the active agent does not harbour acquired AMR genes and is not expected to be virulent or to produce any toxic compounds.…”

“…For microorganisms not satisfying the requirements of the QPS approach to safety assessment (EFSA, 2007; EFSA BIOHAZ Panel, 2023), or when its biology is not sufficiently well known to allow pathogenic/toxigenic strains to be excluded by direct testing, data should be submitted to support the safety for the target species.…”