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 ’.

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 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. Of the 99 microorganisms notified to EFSA between October 2025 and March 2026 (47 as feed additives, 32 as food enzymes or additives, 5 as novel foods and 15 as plant protection products), 85 were not evaluated. These latter included 22 filamentous fungi, 6 Escherichia coli and 2 streptomyces (all excluded from the QPS evaluation), and 55 already present on the QPS list. Of the remaining 14 notifications, corresponding to 11 TUs, 7 were already assessed in the previous QPS 3-years cycle Bacillus thuringiensis, Ensifer adhaerens, Enterococcus lactis, Heyndrickxia faecalis, Hyphomicrobium denitrificans, Microbacterium foliorum and Papiliotrema terrestris and 4 TUs were assessed for the first time: Listeria innocua, Pseudomonas protegens, Lactococcus cremoris (new species, previously a subspecies, which was part of the QPS species Lactococcus lactis) and Companilactobacillus pabuli (new species 'split' of a previous QPS species Companilactobacillus farciminis). L. cremoris, H. faecalis and C. pabuli are recommended for the QPS list, E. adhaerens also but only for production purposes. B. thuringiensis, E. lactis, P. protegens and L. innocua are not recommended for the QPS list due to safety concerns. B. thuringiensis is excluded from further QPS assessment. M. foliorum, P. terrestris and H. denitrificans are not recommended for the QPS list due to the limited body of knowledge.

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.

The qualified presumption of safety (QPS) process was developed to assess the safety of microorganisms used in food and feed chains. During the period covered by this Statement, no new information warranted changes to the status of previously recommended QPS taxonomic units. 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 October 2024 and March 2025 (25 as feed additives, 7 as food enzymes or additives, 6 as novel foods, 8 as plant protection products and 1 as food contact materials), 41 were not evaluated. These latter included 11 filamentous fungi, 4 Escherichia coli and 1 Streptomyces spp. (all excluded from the QPS evaluation), and 25 already on the QPS list. Two of the other six notifications, Bacillus thuringiensis and Ensifer adhaerens, had been previously assessed. The remaining four were assessed for a possible QPS status. Bacillus sonorensis is recommended for the QPS list with the qualifications: 'absence of bacitracin production ability' and 'absence of toxigenic activity'. Vibrio natriegens is also recommended but for 'production purposes only'. Corynebacterium stationis is not recommended due to a limited body of knowledge on its occurrence in the food and feed chain and possible safety concerns in relation to human and animal health. Papilotrema terrestris is not recommended due to a limited body of knowledge. Furthermore, Lactobacillus paragasseri (formerly included in Lactobacillus gasseri) is recommended for the QPS list. The QPS approach can also be followed if the qualifications for QPS are met due to the removal of a gene(s) of concern, by means of genetic modification. For QPS yeasts, used as active agents (viable cells), the qualification 'for production purposes only' was added for when they are used as production strains or as biomass (non-viable cells).

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. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. The TUs in the QPS list were updated based on a verification, against their respective authoritative databases, of the correctness of the names and completeness of synonyms. A new procedure has been established to ensure the TUs are kept up to date in relation to recent taxonomical insights. Of 83 microorganisms notified to EFSA between October 2023 and March 2024 (47 as feed additives, 25 as food enzymes or additives, 11 as novel foods), 75 were not evaluated because: 15 were filamentous fungi, 1 was Enterococcus faecium, 10 were Escherichia coli, 1 was a Streptomyces (all excluded from the QPS evaluation) and 48 were TUs that already have a QPS status. Two of the other eight notifications were already evaluated for a possible QPS status in the previous Panel Statement: Heyndrickxia faecalis (previously Weizmannia faecalis) and Serratia marcescens. One was notified at genus level so could not be assessed for QPS status. The other five notifications belonging to five TUs were assessed for possible QPS status. Akkermansia muciniphila and Actinomadura roseirufa were still not recommended for QPS status due to safety concerns. Rhizobium radiobacter can be recommended for QPS status with the qualification for production purposes. Microbacterium arborescens and Burkholderia stagnalis cannot be included in the QPS list due to a lack of body of knowledge for its use in the food and feed chain and for B. stagnalis also due to safety concerns. A. roseirufa and B. stagnalis have been excluded from further QPS assessment.

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.

This is the list of “Microbiological agents as notified to EFSA” from 2007, in the context of technical dossiers to EFSA Units, for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products (PPPs) for safety assessment. This is supplementing the QPS statements part 11, part 12, part 13, part 14, part 15, part 16, part 17 and the 2022 Scientific Opinion of the BIOHAZ Panel of EFSA - see related identifiers. EFSA topic on QPS: https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps

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.

The qualified presumption of safety (QPS) provides a generic pre-assessment of the safety of microorganisms intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units (TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs are assessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected, when possible, as 'qualifications', which should be tested at strain and/or product level. Based on the possession of potentially harmful traits by some strains, filamentous fungi, bacteriophages, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and Clostridium butyricum are excluded from the QPS assessment. Between October 2019 and September 2022, 323 notifications of TUs were received, 217 related to feed additives, 54 to food enzymes, food additives and flavourings, 14 to plant protection products and 38 to novel foods. The list of QPS-recommended TUs is reviewed every 6 months following an extensive literature search strategy. Only sporadic infections with a few QPS status TUs in immunosuppressed individuals were identified and the assessment did not change the QPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. The qualification 'absence of aminoglycoside production ability' was withdrawn for Bacillus velezensis. Six new TUs received the QPS status: Bacillus paralicheniformis with the qualification 'absence of toxigenic activity' and 'absence of bacitracin production ability'; Bacillus circulans with the qualifications for 'production purposes only' and 'absence of cytotoxic activity'; Haematococcus lacustris (synonym Haematococcus pluvialis) and Ogataea polymorpha, both with the qualification 'for production purposes only'; Lactiplantibacillus argentoratensis; Geobacillus thermodenitrificans with the qualification 'absence of toxigenic activity'.

Biological control has developed into a realistic alternative to replace chemical pesticides. A long-awaited paradigm shift is now adopted by the European Commission through a proposed new Regulation on sustainable use of plant protection products. Unfortunately, the scientific framework underpinning biocontrol is seriously neglected, impeding transition to sustainable plant production.

The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific Opinion on the maintenance of the list of qualified presumption of safety (QPS) biological agents. The QPS approach was developed by the EFSA Scientific Committee to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents intentionally introduced into the food and feed chain, in support of the concerned scientific Panels and Units in the frame of market authorisations. The taxonomic identity, body of knowledge, the safety concerns in relation to pathogenicity and virulence, and the safety for the environment of those microbiological agents are assessed. Safety concerns identified for a respective taxonomic unit (TU) are, where possible and reasonable in number, reflected as ‘qualifications’ that are assessed at the strain level by the EFSA’s scientific Panels. The “list of microorganisms with QPS status” first established in 2007, has been revised and updated annually until 2014 via QPS Opinions; since 2014 the updates are carried out and published every 3 years. If new information is retrieved from extended literature searches (ELS) that would change the QPS status of a TU or its qualifications, this is also published in the Panel Statement covering the previous 6-months period. The ELS protocol can be found at https://doi.org/10.5281/zenodo.3607190 and the Search strategies are available at: https://doi.org/10.5281/zenodo.3607192. The QPS Panel Statement also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for an assessment for feed additives, food enzymes, food additives and flavourings, and novel foods or plant protection products for a possible QPS status. The new QPS status recommendations are incorporated into the 2019 updated “list of microorganisms with QPS status” is available in this upload. The list of “Microbiological agents as notified to EFSA” from 2007, in the context of technical dossiers to EFSA Units, for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products (PPPs) for safety assessment can be found at https://doi.org/10.5281/zenodo.3607183. Useful links on EFSA QPS EFSA topic on QPS: https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps Link to the virtual issue on QPS on Wiley Online Library: https://efsa.onlinelibrary.wiley.com/doi/toc/10.1002/(ISSN)1831-4732.QPS Versions history: Versions 1 and 2 were substituted by version 3 – all are associated with the QPS Panel statement EFSA 7: suitability of taxonomic units notified to EFSA until September 2017: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131 Version 4 is associated with the QPS Panel statement EFSA 8: suitability of taxonomic units notified to EFSA until March 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315 Versions 5 and 6 were substituted by version 7 – all are associated with the QPS Panel statement EFSA 9: suitability of taxonomic units notified to EFSA until September 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555 Version 8 is associated with the QPS Panel statement EFSA 10: suitability of taxonomic units notified to EFSA until March 2019: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5753 Version 9 is associated with the QPS Panel statement EFSA 11: suitability of taxonomic units notified to EFSA until September 2019: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5965 and with the Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017-2019): https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5966 Version 10: updates version 9 following the update of the qualification of Bacillus velezensis as: ‘absence of toxigenic potential and absence of aminoglycoside production ability’ - applied in the QPS Statement part 11 (ON-5965) and in the 2019 Scientific Opinion (ON-5966). Version 11: updates version 10 following the addition of the Bacillus circulans ‘for production purposes only’ - applied in the QPS Statement part 13 (ON-6377) and in the 2019 Scientific Opinion (ON-5966). Version 12 updates version 11 following the addition of the Bacillus paralicheniformis with the qualifications 'absence of toxigenic activity’ and ‘absence of genetic information to synthesize bacitracin'; and adding Schizochytrium limacinum, which is a synomym for Aurantiochytrium limacinum, - applied in the QPS Statement part 14 (ON-6689) and in the 2019 Scientific Opinion (ON-5966). Version 13 updates version 12 following the addition of Haematococcus lacustris synonym Haematococcus pluvialis, recommended for QPS status with the qualification ‘for production purposes only’. Some other changes related to taxonomy and qualifications are described in the QPS Statement part 15 (ON-7045). Version 14, update of version 13, is related to QPS Statement part 16 (ON-7408). Version 15 is related to QPS Statement part 17 (ON-7746). Version 16 is related to QPS Statement part 18 (ON-8092). Note: As of January 2022 the updated list is provided only as excel file format.

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, no new information was found that would change the status of previously recommended QPS TUs. Of 38 microorganisms notified to EFSA between October 2022 and March 2023 (inclusive) (28 as feed additives, 5 as food enzymes, food additives and flavourings, 5 as novel foods), 34 were not evaluated because: 8 were filamentous fungi, 4 were Enterococcus faecium and 2 were Escherichia coli (taxonomic units that are excluded from the QPS evaluation) and 20 were taxonomic units (TUs) that already have a QPS status. Three of the other four TUs notified within this period were evaluated for the first time for a possible QPS status: Anaerobutyricum soehngenii, Stutzerimonas stutzeri (former Pseudomonas stutzeri) and Nannochloropsis oculata. Microorganism strain DSM 11798 has also been notified in 2015 and as its taxonomic unit is notified as a strain not a species, it is not suitable for the QPS approach. A. soehngenii and N. oculata are not recommended for the QPS status due to a limited body of knowledge of its use in the food and feed chains. S. stutzeri is not recommended for inclusion in the QPS list based on safety concerns and limited information about the exposure of animals and humans through the food and feed chains.

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, safety concerns and occurrence of antimicrobial resistance. 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, no new information was found that would change the status of previously recommended QPS TUs. Of the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium, 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris, being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re-assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge, Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of biological agents, intended for addition to food or feed, to support the work of EFSA's Scientific Panels. It is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at 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 the 36 microorganisms notified to EFSA between April and September 2020, 33 were excluded; seven filamentous fungi (including Aureobasidium pullulans based on recent taxonomic insights), one Clostridium butyricum, one Enterococcus faecium, three Escherichia coli, one Streptomyces spp. and 20 TUs that had been previously evaluated. Three TUs were evaluated; Methylorubrum extorquens and Mycobacterium aurum for the first time and Bacillus circulans was re-assessed because an update was requested in relation to a new mandate. M. extorquens and M. aurum are not recommended for QPS status due to the lack of a body of knowledge in relation to use in the food or feed chain and M. aurum, due to uncertainty concerning its pathogenicity potential. B. circulans was recommended for QPS status with the qualifications for 'production purposes only' and 'absence of cytotoxic activity'.

Within food plant cropping systems, microorganisms provide vital functions and ecosystem services, such as biological pest and disease control, promotion of plant growth and crop quality, and biodegradation of organic matter and pollutants. The beneficial effects of microorganisms can be achieved and/or enhanced by agricultural management measures that target the resident microbial biodiversity or by augmentation with domesticated and propagated microbial strains. This study presents a critical review of the current legislation and regulatory policies pertaining to the utilization of plant-beneficial microorganisms in the European Union (EU). For augmentative approaches, the nature of the intended effect and the product claim determine how a microbiological product is categorized and regulated, and pre-market authorization may be mandatory. Typically, microbial products have been incorporated into frameworks that were designed for evaluating non-living substances, and are therefore not well suited to the specific properties of live microorganisms. We suggest that regulatory harmonization across the sector could stimulate technical development and facilitate implementation of crop management methods employing microorganisms. Possible scenarios for regulatory reform in the longer term are discussed, but more investigation into their feasibility is needed. The findings of this study should serve as a catalyst for more efficient future use of plant-beneficial microorganisms, to the benefit of agriculture as well as the environment.

Biological control , or biocontrol , is the exploitation of living agents (incl. viruses) to combat pestilential organisms (incl. pathogens, pests, and weeds) for diverse purposes to provide human benefits. Thus, during the last century the practices and concepts involved have evolved in separate streams associated with distinct scientific and taxonomic disciplines. In parallel developments, there have been increasing references to biological control in industrial contexts and legislation, resulting in conceptual and terminological disintegration. The aim of this paper is to provide a global conceptual and terminological platform that facilitates future development of the field. We review use of previously suggested terms in key fields (e.g., phytopathology, entomology, and weed science), eliminate redundant terminology, identify three principles that should underpin the concept, and then present a new framework for biological control, rooted in seminal publications. The three principles establish that (1) only living agents can mediate biological control, (2) biological control always targets a pest, directly or indirectly, and (3) all biocontrol methods can be classified in four main categories depending on whether resident agents are utilized, with or without targeted human intervention ( conservation biological control and natural biological control , respectively) or agents are added for permanent or temporary establishment ( classical biological control and augmentative biological control , respectively). Correct identification of what is, and is not, biological control can help efforts to understand and optimize biological pest control for human and environmental benefits. The new conceptual framework may contribute to more uniform and appropriate regulatory approaches to biological control, and more efficient authorization and application of biocontrol products.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of biological agents, intended for addition to food or feed, 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, safety concerns and occurrence of antimicrobial resistance. 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, no new information was found that would change the status of previously recommended QPS TUs. Schizochytrium limacinum, which is a synonym for Aurantiochytrium limacinum, was added to the QPS list. Of the 78 microorganisms notified to EFSA between October 2020 and March 2021, 71 were excluded; 16 filamentous fungi, 1 Dyella spp., 1 Enterococcus faecium, 7 Escherichia coli, 1 Streptomyces spp., 1 Schizochytrium spp. and 44 TUs that had been previously evaluated. Seven TUs were evaluated: Corynebacterium stationis and Kodamaea ohmeri were re-assessed because an update was requested for the current mandate. Anoxybacillus caldiproteolyticus, Bacillus paralicheniformis, Enterobacter hormaechei, Eremothecium ashbyi and Lactococcus garvieae were assessed for the first time. The following TUs were not recommended for QPS status: A. caldiproteolyticus due to the lack of a body of knowledge in relation to its use in the food or feed chain, E. hormaechei, L. garvieae and K. ohmeri due to their pathogenic potential, E. ashbyi and C. stationis due to a lack of body of knowledge on their occurrence in the food and feed chain and to their pathogenic potential. B. paralicheniformis was recommended for the QPS status with the qualification 'absence of toxigenic activity' and 'absence of genetic information to synthesize bacitracin'. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.