Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 19: Suitability of taxonomic units notified to EFSA until September 2023

Abstract

The qualified presumption of safety (QPS) process was developed to provide a safety assessment approach for microorganisms intended for use in food or feed chains. The QPS approach is based on an assessment of published data for each taxonomic unit (TU), with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a 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 71 microorganisms notified to EFSA between April and September 2023 (30 as feed additives, 22 as food enzymes or additives, 7 as novel foods and 12 from plant protection products [PPP]), 61 were not evaluated because: 26 were filamentous fungi, 1 was Enterococcus faecium, 5 were Escherichia coli, 1 was a bacteriophage (all excluded from the QPS evaluation) and 28 were TUs that already have a QPS status. The other 10 notifications belonged to 9 TUs which were evaluated for a possible QPS status: Ensifer adhaerens and Heyndrickxia faecalis did not get the QPS recommendation due to the limited body of knowledge about their occurrence in the food and/or feed chains and Burkholderia ubonensis also due to its ability to generate biologically active compounds with antimicrobial activity; Klebsiella pneumoniae, Serratia marcescens and Pseudomonas putida due to safety concerns. K. pneumoniae is excluded from future QPS evaluations. Chlamydomonas reinhardtii is recommended for QPS status with the qualification ‘for production purposes only’; Clostridium tyrobutyricum is recommended for QPS status with the qualification ‘absence of genetic determinants for toxigenic activity’; Candida oleophila has been added as a synonym of Yarrowia lipolytica. The Panel clarifies the extension of the QPS status for genetically modified strains.

Safety and efficacy of a feed additive consisting of inactivated selenised yeast (Saccharomyces cerevisiae CCTCC M 2022402) for all animal species (Phytobiotics Futterzusatzstoffe GmbH)

“…S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment (EFSA BIOHAZ Panel, 2024 ). The identity of the strain CCTCC M 2022402 as S. cerevisiae was confirmed.…”

Assessment of the feed additive consisting of Saccharomyces cerevisiae MUCL 39885 (Biosprint®) for cattle for fattening for the renewal of its authorisation (Prosol SPA)

“…In the present application, the applicant has provided up to date confirmation of the taxonomical identification of the active agent as S. cerevisiae and evidence that the strain is susceptible to the antifungal compounds amphotericin B and itraconazole. Therefore, the active agent MUCL 39885 meets the qualifications of the QPS approach for safety assessment (EFSA, 2007 ; EFSA BIOHAZ Panel, 2024 ).…”

Antimicrobial activity, genome analysis, and gene cluster encoding the plantaricin production of Lactiplantibacillus plantarum ZBK1-5

“…Furthermore, it should be noted that the bacterial species Lactobacillus probiotics have been identified as safe and are classified in the qualified presumptive of safety (QPS) system [39]. Hence, it is advisable to exercise general precautions when consuming Dlactic-producing bacteria, particularly for individuals at a heightened risk of developing D-lactic acidosis such as patients diagnosed with short-bowel syndrome or carbohydrate malabsorption.…”