Update of the list of QPS-recommended biological agents intentionally added to food or feeds as notified to EFSA

Abstract

The qualified presumption of safety (QPS) process was developed to provide a harmonised safety assessment approach to support EFSA Scientific Panels and Units. The QPS approach assesses the taxonomic identity, body of relevant knowledge and safety concerns of microorganisms intentionally added to the food and feed chain. Safety concerns identified for a taxonomic unit (TU) are, where possible, reflected by ‘qualifications’ that should be assessed at the strain level by EFSA's Scientific Panels. In total, 340 notifications were received between October 2022 and September 2025, of which, 190 were of microorganisms used for the production of feed additives, 87 for the production of food enzymes, food additives and flavourings, 3 for food contact materials, 22 as Plant Protection Products (PPPs) and 38 for novel foods. Bacteriophages, previously ineligible for the QPS status, are now eligible at the species level. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. A BIOHAZ Panel Statement on how to interpret the QPS qualification on ‘acquired antimicrobial resistance genes’ was published and revised; the qualification ‘for production purposes only’ was extended to production strains or biomass; the qualification on genetic modified microorganisms (GMMs) was also extended to production strains, biomass or active agents, when the gene of concern is removed. Since 2023, Chlamydomonas reinhardtii, Microchloropsis gaditana, Candida oleophila, Vibrio natriegens and Agrobacterium radiobacter were recommended for QPS status with the qualification for ‘production purposes only’. Clostridium tyrobutyricum also but with the qualification ‘absence of genetic determinants for toxin production’. Lacticaseibacillus huelsenbergensis and Lactobacillus paragasseri (formerly included in Lactobacillus gasseri) were also included. Bacillus sonorensis was also recommended with the qualifications ‘absence of bacitracin production ability’ and ‘absence of toxigenic activity’. Bacillus thuringiensis was not recommended for the QPS list due to safety concerns.