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

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 microbiological agents intentionally added to food or feed as notified to EFSA 18: Suitability of taxonomic units notified to EFSA until March 2023

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

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

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'

Why has the authorization of microbial biological control agents been slower in the EU than in comparable jurisdictions?

The aim of this study was to identify reasons why the authorization of microbial pest control agents is lengthier under regulatory frameworks of the European Union (EU) than in comparable jurisdictions. A main conclusion is that although the EU and apos;s regulatory processes have strong scientific foundations, the most appropriate scientific concepts, knowledge and expertise have not been applied in the safety assessment of microorganisms and biological control. Tradition and conceptual legacies from assessments of conventional chemical pesticides have likely contributed to this by steering the evaluations of microorganisms in less appropriate directions. According to our investigation, the current framework for microbial plant protection products complies poorly with the principles that legislation should have legal predictability, proportionality, and that it should be non-discriminative, for instance in comparison to corresponding regulations in comparable jurisdictions. We also found that existing possibilities to take non-safety and ethical considerations into account can probably be used more. To rationalize the EU and apos;s authorization of microbial control products, both the basic legislation and the evaluations of agents and products need stronger rooting in fundamental microbiological science. (c) 2020 The Authors. Pest Management Science published by John Wiley and Sons Ltd on behalf of Society of Chemical Industry

Probabilistic biases meet the Bayesian brain

Bayesian cognitive science sees the mind as a spectacular probabilistic inference machine. But Judgment and Decision Making research has spent half a century uncovering how dramatically and systematically people depart from rational norms. This paper outlines recent research that opens up the possibility of an unexpected reconciliation. The key hypothesis is that the brain neither represents nor calculates with probabilities; but approximates probabilistic calculations through drawing samples from memory or mental simulation. Sampling models diverge from perfect probabilistic calculations in ways that capture many classic JDM findings, and offers the hope of an integrated explanation of classic heuristics and biases, including availability, representativeness, and anchoring and adjustment

High-Impact Mechanical Loading Increases Bone Material Strength in Postmenopausal Women-A 3-Month Intervention Study.

Bone adapts to loading in several ways, including redistributing bone mass and altered geometry and microarchitecture. Because of previous methodological limitations, it is not known how the bone material strength is affected by mechanical loading in humans. The aim of this study was to investigate the effect of a 3-month unilateral high-impact exercise program on bone material properties and microarchitecture in healthy postmenopausal women. A total of 20 healthy and inactive postmenopausal women (aged 55.6 ± 2.3 years [mean ± SD]) were included and asked to perform an exercise program of daily one-legged jumps (with incremental number, from 3×10 to 4×20 jumps/d) during 3 months. All participants were asked to register their performed jumps in a structured daily diary. The participants chose one leg as the intervention leg and the other leg was used as control. The operators were blinded to the participant's choice of leg for intervention. The predefined primary outcome was change in bone material strength index (BMSi), measured at the mid tibia with a handheld reference probe indentation instrument (OsteoProbe). Bone microstructure, geometry, and density were measured with high-resolution peripheral quantitative computed tomography (XtremeCT) at the ultradistal and at 14% of the tibia bone length (distal). Differences were analyzed by related samples Wilcoxon signed rank test. The overall compliance to the jumping program was 93.6%. Relative to the control leg, BMSi of the intervention leg increased 7% or 0.89 SD (p = 0.046), but no differences were found for any of the XtremeCT-derived bone parameters. In conclusion, a unilateral high-impact loading program increased BMSi in postmenopausal women rapidly without affecting bone microstructure, geometry, or density, indicating that intense mechanical loading has the ability to rapidly improve bone material properties before changes in bone mass or structure. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc

Reaping the benefits of microorganisms in cropping systems: Is the regulatory policy adequate?

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

Reaping the Benefits of Microorganisms in Cropping Systems: Is the Regulatory Policy Adequate?

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

Feeding behaviour of felines in a Swedish zoo

I dagsläget är många av de vilda kattdjuren hotade i sina naturliga habitat. En viktig utmaning för zoon i Sverige och övriga världen är att bevara livskraftiga populationer av dessa arter för framtiden. Det är på vissa sätt problematiskt att hålla vilda kattdjur i fångenskap. Bland annat är det svårt att få dessa djur att reproducera sig tillfredställande och studier har visat att stressrelaterade beteenden, så kallade stereotypier förekommer. Av anledningen att stereotypa beteenden ofta observerats i tiden kring utfodringen fokuserade denna studie på att undersöka vilka beteenden kattdjur på zoo uppvisar innan, under och efter utfodring samt att utreda huruvida stereotypt vandrande förekommer. Studien innefattade de vuxna individerna av arterna amurleopard, sumatratiger, asiatiskt lejon, sandkatt samt fiskarkatt och utfördes på Parken Zoo i Eskilstuna under hösten 2015. Resultatet visade att flertalet aktiva beteenden såsom gå, springa samt stereotypt vandrande var signifikant vanligare innan utfodringen än under perioden från utfodringens början. Innan utfodringen utgjorde stereotypt vandrande totalt 4,1% av antalet observerade beteenden vilket kan jämföras med 0,2% under perioden från utfodringens början. De stora kattdjuren som utfodrades var tredje dag (jaguar, asisatiskt lejon samt sumatratiger) uppvisade beteendet mest frekvent, dock var skillnaden i beteendets förekomst stor mellan olika individer av samma art. Stereotypt vandrande observerades vanligen i närheten av det område där födan förbereddes alternativt på den plats där de senare skulle ges tillgång till den. Hos de mindre katterna (sandkatt, fiskarkatt) som utfodrades tre gånger dagligen var beteendet sällsynt eller förekom inte alls. Studien visar att vissa individer av de större kattdjuren uttrycker stereotypt vandrande innan utfodring, vilket kan vara ett uttryck för anspänning och frustration. En lämplig angreppspunkt för framtida forskning är att jämföra olika utfodringsregimers inverkan på stereotypa beteenden hos kattdjur på zoo.Many of the wild cats today are threatened in their wild habitats. An important task for zoos around the world is to sustain viable populations of these species. However, there are some problems with keeping wild cats in captivity. Many species do not breed well and some studies have shown that behavioural problems such as stereotypies are common. Other studies have pointed out that these behaviours increase around feeding time. Therefore, the aim of this study was to examine which behaviours were expressed before, during and after feeding and also to investigate whether behaviours linked with poor welfare occured. The study was performed during the autumn of 2015 at ’Parken zoo’ and included adult individuals from different species of wild cats ie amur leopard, sumatran tiger, jaguar, sand cat, asiatic lion and fishing cat. The results showed that most of the active behaviours eg walking, running and pacing were significantly more common in the pre-feeding period compared to the feeding and post-feeding period. In the pre-feeding period 4,1% of registered behaviours consisted of pacing, compared to 0,2% in the feeding and post-feeding period. Pacing was most commonly seen among the large cats that were fed thrice a week (jaguar, asiatic lion and sumatran tiger). However, there were large individual differences within these species, with only some individuals behaving highly stereotypical. This behaviour was most commonly seen in areas closely connected to the food preparation site. Among the smaller cats that were fed thrice a day stereotypic pacing was rare or abscent. The study shows that some individuals of the large cats displayed stereotypical behaviour which could be a sign of stress and frustration. In the post-feeding period more behaviours connected to processing and ingesting food were seen. Further studies are required to compare different feeding regiments impact on stereotypical behaviours of wild cats in zoos

<i>Lactobacillus reuteri</i> reduces bone loss in older women with low bone mineral density:a randomized, placebo-controlled, double-blind, clinical trial

Background: The importance of the gut microbiome for bone metabolism in mice has recently been demonstrated, but no studies are available in humans. Lactobacillus reuteri ATCCPTA 6475 (L. reuteri 6475) has been reported to increase bone mineral density (BMD) in mice but its effect on the human skeleton is unknown. The objective of this trial was to investigate if L. reuteri 6475 affects bone loss in older women with low BMD. Methods: In this double‐blind, placebo‐controlled study, women from the population who were 75 to 80 years old and had low BMD were randomized to orally receive 1010 colony‐forming units of L. reuteri 6475 daily or placebo. The predefined primary end‐point was relative change after 12 months in tibia total volumetric BMD (vBMD). Results: Ninety women were included and 70 completed the study. L. reuteri 6475 reduced loss of total vBMD compared to placebo both in the intention‐to‐treat (ITT) analysis [−0.83% (95% confidence interval [CI], −1.47 to −0.19%) vs. −1.85% (95% CI, −2.64 to −1.07%); mean difference 1.02% (95% CI, 0.02–2.03)] and per protocol analysis [−0.93% (95% CI, −1.45 to −0.40) vs. −1.86% (95% CI, −2.35 to −1.36); mean difference 0.93% (95% CI, 0.21–1.65)]. In general, similar but smaller effects were observed in the secondary bone variable outcomes, but these differences did not reach statistical significance in the ITT population. Adverse events did not differ between groups. Conclusions: Supplementation with L. reuteri 6475 should be further explored as a novel approach to prevent age‐associated bone loss and osteoporosis