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The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past.

ABSTRACT: Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms. Unambiguously defined biological taxonomic units (TUs) are assessed for their body of knowledge, their safety and their end use. Identified safety concerns for a certain TU can be, where reasonable in number and not universally present, reflected as 'qualifications.' Strains belonging to TUs having QPS status may benefit of a fast track evaluation. The lowest TU for which the QPS status is granted is the species level for bacteria and yeasts and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes. Based on the current body of knowledge and/or the ambiguous taxonomic position, some TUs, such as filamentous fungi, bacteriophages, Enterococcus faecium, Escherichia coli, Streptomyces spp. and Oomycetes, are not considered liable for QPS status.

SUBMITTER: Herman L

PROVIDER: S-EPMC6311724 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past.

Herman Lieve L Chemaly Marianne M Cocconcelli Pier Sandro PS Fernandez Pablo P Klein Günter G Peixe Luisa L Prieto Miguel M Querol Amparo A Suarez Juan Evaristo JE Sundh Ingvar I Vlak Just J Correia Sandra S

FEMS microbiology letters 20190101 1

Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms ...[more]

PMID: 30535073

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Project description:Background: In 2005, Network for Therapy in Rare Epilepsies (NETRE)-was initiated in order to share treatment experiences among clinicians in patients with rare epilepsies. Here we describe the structure of the rapidly growing NETRE and summarize some of the findings of the last 15 years. Methodology/Structure of NETRE: NETRE is organized in distinct groups (currently >270). Starting point is always a patient with a rare epilepsy/ epileptic disorder. This creates a new group, and next, a medical coordinator is appointed. The exchange of experiences is established using a data entry form, which the coordinator sends to colleagues. The primary aim is to exchange experiences (retrospectively, anonymously, MRI results also non-anonymously) of the epilepsy treatment as well as on clinical presentation and comorbidities NETRE is neither financed nor sponsored. Results: Some of the relevant results: (1) first description of FIRES as a new epilepsy syndrome and its further investigation, (2) in SCN2A, the assignment to gain- vs. loss-of-function mutations has a major impact on clinical decisions to use or avoid treatment with sodium channel blockers, (3) the important aspect of avoiding overtreatment in CDKL5 patients, due to loss of effects of anticonvulsants after 12 months, (4) pathognomonic MRI findings in FOXG1 patients, (5) the first description of pathognomonic chewing-induced seizures in SYNGAP1 patients, and the therapeutic effect of statins as anticonvulsant in these patients, (6) the phenomenon of another reflex epilepsy-bathing epilepsy associated with a SYN1 mutation. Of special interest is also a NETRE group following twins with genetic and/or structural epilepsies [including vanishing-twin-syndrome and twin-twin-transfusion syndrome) [= "Early Neuroimpaired Twin Entity" (ENITE)]. Discussion and Perspective: NETRE enables clinicians to quickly exchange information on therapeutic experiences in rare diseases with colleagues at an international level. For both parents and clinicians/scientist this international exchange is both reassuring and helpful. In collaboration with other groups, personalized therapeutic approaches are sought, but the present limitations of currently available therapies are also highlighted. Presently, the PATRE Project (PATient based phenotyping and evaluation of therapy for Rare Epilepsies) is commencing, in which information on therapies will be obtained directly from patients and their caregivers.

Project description:BACKGROUND AND OBJECTIVES: The therapy and outcome of HIV infection have dramatically changed over the last 15 years, resulting in a change in renal complications. This study analyzed the characteristics of HIV-infected patients and biopsy-proven tubulointerstitial nephropathies to define disease patterns and therapeutic implications. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A clinico-pathologic retrospective study of 59 consecutive renal biopsies showing predominant tubular and/or interstitial lesions in HIV-infected patients referred to the nephrology department between 1995 and 2011 was performed. HIV-associated nephropathy and vascular diseases were excluded from the study. RESULTS: Tubulointerstitial nephropathies accounted for 26.6% of 222 native renal biopsies performed in HIV-infected patients. Two pathologic groups were analyzed, tubulopathy and interstitial nephritis, which represented 49% and 51% of tubulointerstitial nephropathies, respectively. Most patients presented with AKI (76.3%) and high-grade proteinuria (57.7%). Drug-related nephrotoxicity was the leading cause (52.5%). Alternative etiologies included infections (15.2%), dysimmune disorders (8.5%), malignancies (3.4%), and chronic (10.2%) and acute (10.2%) tubulointerstitial nephropathies of undetermined origin. Tubulopathy was strongly associated with antiretroviral drug toxicity (75.9%) and mostly caused by tenofovir (55.2%), which was associated with proximal tubular dysfunction (87.5%), overt Fanconi's syndrome (37.5%), and nephrogenic diabetes insipidus (12.5%). Interstitial nephritis was associated with a broader spectrum of pathologic lesions and etiologies. CONCLUSIONS: In this series, tubulointerstitial nephropathies accounted for 26.6% of renal diseases in HIV-infected patients. Considering the therapeutic implications of diagnoses of drug toxicity, infection, and dysimmune syndromes, this study underscores the importance of monitoring renal parameters in HIV-infected patients and points to the relevance of kidney biopsy to allow an accurate diagnosis.

Project description:PurposeOur objectives were primarily to review the published literature on complications in neuromuscular scoliosis (NMS) surgery and secondarily, by means of a meta-analysis, to determine the overall pooled rates (PR) of various complications associated with NMS surgery.MethodsPubMed and Embase databases were searched for studies reporting the outcomes and complications of NMS surgery, published from 1997 to May 2011. We focused on NMS as defined by the Scoliosis Research Society's classification. We measured the pooled estimate of the overall complication rates (PR) using a random effects meta-analytic model. This model considers both intra- and inter-study variation in calculating PR.ResultsSystematic review and meta-analysis were performed for 68 cohort and case-control studies with a total of 15,218 NMS patients. Pulmonary complications were the most reported (PR = 22.71 %) followed by implant complications (PR = 12.51 %), infections (PR = 10.91 %), neurological complications (PR = 3.01 %) and pseudoarthrosis (PR = 1.88 %). Revision, removal and extension of implant had highest PR (7.87 %) followed by malplacement of the pedicle screws (4.81 %). Rates of individual studies have moderate to high variability. The studies were heterogeneous in methodology and outcome types, which are plausible explanations for the variability; sensitivity analysis with respect to age at surgery, sample size, publication year and diagnosis could also partly explain this variability. In regard to surgical complications affiliated with various surgical techniques in NMS, the level of evidence of published literature ranges between 2+ to 2-; the subsequent recommendations are level C.ConclusionNMS patients have diverse and high complication rates after scoliosis surgery. High PRs of complications warrant more attention from the surgical community. Although the PR of all complications are affected by heterogeneity, they nevertheless provide valuable insights into the impact of methodological settings (sample size), patient characteristics (age at surgery), and continual advances in patient care on complication rates.

Project description:BackgroundPhysiological sagittal spinal curvatures play an important role in health and performance in sports. For that reason, several scientific studies have assessed spinal morphology in young athletes. However, to our knowledge, no study has assessed the implications of Inline Hockey (IH) practice on sagittal integrative spinal morphotype in adolescent players.ObjectivesThe aims of the present study were to describe habitual sagittal spinal posture in young federated IH players and its relationship with training load and to determine the sagittal integrative spinal morphotype in these players.MethodsAn observational analysis was developed to describe the sagittal spinal morphotype in young federated IH players. A total of 74 IH players from the Technification Plan organized by the Skating Federation of the Valencian Community (aged from 8 to 15 years) participated in the study. Thoracic and lumbar curvatures of the spine were measured in a relaxed standing position (SP), in a slump sitting position (SSP) and in maximum flexion of the trunk (MFT) to determine the "Sagittal Integrative Morphotype" of all players. An unilevel inclinometer was used to quantify the sagittal spinal curvatures. The Hip Joint Angle test was used to quantify the Lumbo-Horizontal angle in flexion (L-H fx) of all participants with a goniometer.ResultsWhen thoracic curvature was analyzed according to normality references, it was found that 64.9% of IH players had thoracic hyperkyphosis in a SSP, while 60.8% and 74.3% of players were classified as normal in a SP and in MFT, respectively. As for the lumbar curve, 89.2% in a SP and 55.4% in MFT were normal, whereas 68.9% of IH players presented lumbar hyperkyphosis in a SSP. Regarding the "Sagittal Integrative Morphotype," only 17.6% of players were classified as "Normal" in the three measured positions for the thoracic curve, while 37.8% had "Thoracic Hyperkyphosis" and 41.8% presented "Functional Thoracic Hyperkyphosis." As for the "Sagittal Integrative Lumbar Morphotype," only 23% of athletes had a normal curve in the three positions, whereas 66.2% presented "Functional Lumbar Hyperkyphosis." When the L-H fx was evaluated, the results showed that only 16.2% of the athletes were classified as normal.ConclusionsFederative IH practice seems to cause specific adaptations in spinal sagittal morphotype. Taking into account the "Sagittal Integrative Morphotype" only 17.6% IH players presented "Normal Morphotype" with a normal thoracic kyphosis in the three measured positions, while only 23% IH players presented "Normal Morphotype" with a normal lumbar curvature in the three assessed positions. Furthermore, only 16.2% of IH players showed normal pelvic tilt. Exercise programs to prevent or rehabilitate these imbalances in young IH players are needed.

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The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past.

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The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past.

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