EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Avelino Alvarez‐Ordóñez, Valeria Bortolaia, Sara Bover‐Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Liesbeth Jacxsens, Maarten Nauta, Lapo Mughini‐Gras, Jakob Ottoson, Luísa Peixe, Fernando Perez‐Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Marianne Chemaly, Pier Sandro Cocconcelli, Pablo Salvador Fernández Escámez, Miguel Prieto Maradona, Querol Amparo, Lolke Sijtsma, Juan Evaristo Suárez, Ingvar Sundh, Fulvio Barizzone, Justine Dastouet, Nadya Doyle, Sandra Correia, Lieve Herman
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 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. During the period covered by this Statement, no new information warranted changes to the status of previously recommended QPS TUs. The QPS list was updated to verify the correctness of the names and the completeness of synonyms. Of the 47 microorganisms notified to EFSA between April and September 2025 (28 as feed additives, 11 as food enzymes or additives, 6 as novel foods, none as plant protection products and 2 as food contact materials), 43 were not evaluated. These latter included 9 filamentous fungi and 9 Escherichia coli (all excluded from the QPS evaluation), and 25 already present on the QPS list. One of the other four notifications, Heyndrickxia faecalis (previously known as Weizmannia faecalis), had been assessed recently within this 3‐years QPS cycle. The remaining 3 were assessed for a possible QPS status. Microchloropsis gaditana, Bacillus thermoamylovorans (both notified for the first time) and an additional TU, Aurantiochytrium acetophilum, not evaluated previously, which was included in response to an internal request. B. thermoamylovorans cannot be granted the QPS status due to the lack of body of knowledge. A. acetophilum cannot be granted the QPS status due to a limited body of knowledge. M. gaditana can be granted the QPS status with the qualification for ‘production purpose only’.