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- Plano de Atividades 2026Publication . Instituto Nacional de Saúde Doutor Ricardo Jorge; Rama, PatríciaPlano de Atividades do Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA) para o ano de 2026. O INSA é um organismo público integrado na administração indireta do Estado, sob a tutela do Ministério da Saúde. Enquanto Instituto Público de interesse estratégico nacional, tem por missão contribuir para ganhos em saúde pública, enquanto Laboratório do Estado e Laboratório Nacional de Referência. Tendo por contexto o Plano Estratégico 2024-2026 e os desafios estratégicos identificados, o Plano de Atividades para 2026, reflete as prioridades institucionais e respetivos indicadores, enquanto instrumento orientador para as atividades a desenvolver no corrente ano.
- Scientific opinion on the amendment of the specifications for vegetable carbon (E 153) as a food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Furst, Peter; Gaffet, Eric; Loeschner, Katrin; Mast, Jan; Mirat, Manuela; Oomen, Agnes; Undas, Anna; Mech, Agnieszka; Smeraldi, Camilla; Rincon, Ana MariaThe food additive vegetable carbon (E 153) was re‐evaluated by the EFSA ANS Panel in 2012. During that re‐evaluation, data gaps were identified, in particular with respect to impurities and particle characterisation. Following a European Commission call for data to address these gaps, one interested business operator (IBO) submitted analytical data on toxic elements, polycyclic aromatic hydrocarbons (PAHs) and particle size distribution of commercial samples of E 153. The present opinion deals with the assessment of the data provided by the IBO in response to the European Commission call. Based on the analytical data provided, the Panel concluded that the information on toxic elements supports a revision of the current EU specification limits for arsenic, cadmium, mercury and lead, and the introduction of a limit for aluminium. Regarding PAHs, the Panel assessed the risks associated with benzo[a]pyrene and PAH4 under several scenarios and concluded that the resulting margins of exposure (MOE) were above the level of concern but recommended lowering the current limit for benzo[a]pyrene and introducing a limit for PAH4 in the EU specifications for E 153. For what concerns the data on particle size distribution and morphology, the Panel considered that, due to methodological limitations, these data did not allow a full characterisation of the materials used as a food additive and did not adequately support an amendment of the specifications in relation to particle properties. Nevertheless, the Panel concluded that a fraction of small particles, including nanoparticles, is present in vegetable carbon (E 153) and noted that the substance is insoluble in water. Therefore, in line with the EFSA Guidance on Particles‐TR, the Panel concluded that the risk assessment of E 153 performed by the EFSA ANS Panel in 2012 should be complemented with nanoscale considerations.
- Safety evaluation of pectin‐rich extract derived from Coffea arabica as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Mech, Agnieszka; Tard, Alexandra; Zakidou, Panagiota; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pectin rich extract derived from Coffea arabica L. as a food additive. The proposed food additive consists of 70%–85% dietary fibres (of which the major part is pectin), 4%–6.5% proteins and substances of potential concern including caffeine, chlorogenic acid, ■■■■■, caffeic acid, ■■■■■, trigonelline. The Panel integrated all available information including existing EFSA evaluations on pectins, coffee fruit pulp, and conducted a new quantitative structure–activity relationship (QSAR) analysis for the substances of potential concern. Studies from literature confirmed that the pectins are not absorbed intact but extensively fermented by intestinal microbiota. No adverse effects were reported in two 90‐day toxicity studies in rats up to 7.8 g/kg body weight (bw) per day and in one human study on sugar beet pectin at 0.2 g/kg bw per day for 4 weeks. The calculated MOE for ■■■■■ indicated that there is a low concern from a public health point of view. The Panel considered that the exposure to caffeine, caffeic acid, ■■■■■, chlorogenic acid, ■■■■■ and trigonelline from use of the proposed food additive would contribute only to a minimal increase over existing dietary exposure and is not of safety concern. Considering the composition of the proposed food additive, the absence of genotoxic concern of its components and lack of adverse effects of the major component (i.e. pectins), the Panel considered that there was no need for a numerical acceptable daily intake. The Panel concluded that the use of pectin‐rich extract derived from Coffea arabica as a new food additive does not raise a safety concern at the proposed use and use levels.
- Cross-sectional study on protective antibodies against influenza A virus subtypes and cross-protection against influenza A(H3N2) subclade K, Portugal, August 2025Publication . Guiomar, Raquel; Henriques, Camila; Pereira da Silva, Susana; Gomes, Licínia; Dias, Daniela; Verdasca, Nuno; Portuguese Laboratory Network for the Diagnosis of Influenza and Respiratory Viruses; Nunes, Baltazar; Rodrigues, Ana PaulaThe 2025/26 season was marked by co-circulation of influenza A subtypes, with the first detection of A(H3N2) subclade K in September 2025. In August 2025 in Portugal, 14.8% (95% CI: 12.2-17.8) of 886 persons tested had cross-protective antibodies against this subclade. The overall seroprevalence against circulating A(H1N1)pdm09 strains was 28.1% (95% CI: 24.4-32.0). These data highlight the presence of previous cross-reactive antibodies and the possible advantage of vaccination in the extent of detectable antibodies against influenza viruses.
- Rapid drug resistance prediction in positive clinical samples using an extensive targeted next-generation sequencing panelPublication . Rosendal, Ebba; Isidro, Joana; Carneiro, Sofia; Gomes, João Paulo; Macedo, RitaTuberculosis (TB) remains a global health challenge, exacerbated by the emergence of drug-resistant strains. Most methods for drug susceptibility testing (DST) are culture-dependent and time consuming, possibly delaying optimal TB-treatment. This study aimed to develop an extensive targeted next-generation sequencing (tNGS) approach for rapid genotypic DST directly from clinical samples. We designed a tNGS panel comprising 30 amplicons targeting 19 genomic regions associated with resistance to 20 antibiotics. This method was applied to 71 smear-positive (0-3+) pulmonary TB clinical samples collected at the Portuguese National Reference Laboratory. DNA was extracted and amplified using multiplex PCRs, followed by sequencing on Oxford Nanopore Technologies MinION platform. Sequencing data were using TB-Profiler and the tNGS results compared to phenotypic DST and whole genome sequencing (WGS) data from corresponding isolates. The tNGS demonstrated high concordance with both phenotypic and WGS-based DST across different sample types and smear positivity levels. For first-line drugs, tNGS showed 88% categorical agreement (CA) with pDST, increasing to 97% when excluding undetermined results. Compared to WGS across all analysed antibiotics, tNGS achieved 92% CA, increasing to >99% when excluding undetermined results. Validation of the tNGS panel showed 90% (1,895/2,076) of amplicons reaching >10x coverage at all analysed positions and 43 (61%) samples with all complete amplicons above this threshold. Non-specific amplification of contaminant bacterial DNA was minimal, with most mapped off-target reads being of human origin. This method enables comprehensive resistance prediction directly from clinical samples and signifies an important development in TB diagnostics and resistance monitoring.
- Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery waresPublication . EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Fernandez, Maria Jose Frutos; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Dourus, Antonios; Chipman, James; Crebelli, Riccardo; Fürst, Peter; Halldorsson, Thorhallur; Mirat, Manuela; Mortensen, Alicja; Wright, Matthew; Lindtner, Oliver; Barmaz, Stefania; Civitella, Consuelo; Horvath, Zsuzsanna; Levorato, Sara; Mazzoli, Elena; Rasinger, Josef Daniel; Rincon, Ana Maria; Smeraldi, Camilla; Tard, Alexandra; Lodi, FedericaThe present opinion deals with the re‐evaluation of sucralose (E 955) as food additive and with the safety of a proposed extension of use in food category (FC) 7.2 ‘Fine bakery wares’. Based on the available data, no safety concerns arose for genotoxicity of sucralose (E 955) and its impurities and degradation products. Based on the weight of evidence (WoE), the Panel considered the decrease in body weight observed in rats as the relevant endpoint for the derivation of a reference point (RP). The Panel performed a benchmark dose (BMD) analysis on the data from the longest study (combined chronic and carcinogenicity study) with a modified benchmark dose response to account for the poor palatability of sucralose. The resulting RP was 55 mg/kg bw per day (benchmark dose lower confidence limit; BMDL). The Panel considered it appropriate to derive chemical‐specific assessment factor for sucralose and concluded that there is no need to revise the current ADI of 15 mg/kg bw per day of sucralose (E 955) previously established by the Scientific Committee on Food. The exposure estimates considering the currently authorised uses did not exceed the ADI. Therefore, the Panel concluded that there is no safety concern at the reported uses and use levels of sucralose (E 955). The overall exposure did not increase substantially when considering the proposed extension of use. However, based on the available data and the identified uncertainties regarding the potential formation of chlorinated compounds under the wide range of baking processes that may be applicable for FC 7.2, the Panel could not conclude on the safety of the proposed extension of use of E 955 in this FC. The Panel issued recommendations to the European Commission, primarily to consider a revision of the EU specifications for sucralose.
- Vigilância Laboratorial da Tuberculose em Portugal: relatório 2025Publication . Laboratório Nacional de Referência de MicobactériasRelatório de Vigilância Laboratorial da Tuberculose em Portugal referente ao ano de 2025, elaborado pelo Laboratório Nacional de Referência de Micobactérias (LNR-TB) do Departamento de Doenças Infeciosas do INSA. O documento apresenta a análise da vigilância molecular das estirpes do complexo Mycobacterium tuberculosis (MTC), com base em dados acumulados desde 2020, incluindo a caracterização genómica e a identificação de relações filogenéticas relevantes para a deteção de cadeias de transmissão. Na sequência da implementação de metodologias baseadas em sequenciação do genoma total (WGS), o LNR-TB consolidou a sua capacidade para realizar, de forma sistemática, a caracterização genómica das estirpes de MTC. Esta abordagem permite a previsão do perfil de suscetibilidade aos antibacilares, incluindo de primeira linha, com elevado grau de fiabilidade, bem como a identificação precoce de eventos de transmissão. A utilização do WGS constitui, assim, uma ferramenta central para apoiar a decisão clínica e reforçar a resposta das Autoridades de Saúde, em linha com as recomendações europeias para países de baixa incidência de tuberculose. A vigilância laboratorial das micobactérias foi ainda alargada, incluindo de forma continuada a monitorização de Mycobacterium leprae, já integrada desde 2023, e, pela primeira vez, a caracterização de casos de micobactérias não tuberculosas (MNT), refletindo a crescente relevância destas infeções no contexto clínico e epidemiológico. Dos resultados apresentados no relatório, destacam-se os seguintes pontos: - A confirmação bacteriológica da tuberculose mantém-se essencial para a monitorização da doença e para a determinação do perfil de suscetibilidade aos antibacilares, devendo ser sempre complementada com exames laboratoriais adequados; - Os casos de tuberculose resistente à rifampicina ou multirresistente (TB-RR/MR) mantêm-se em vigilância, com variações anuais que justificam acompanhamento contínuo; - A distribuição geográfica dos casos evidencia maior concentração nas regiões de Lisboa e Vale do Tejo e do Norte, à semelhança do observado em anos anteriores; - A análise genómica permitiu identificar múltiplos clusters moleculares, incluindo cadeias de transmissão com persistência temporal, reforçando a importância da vigilância molecular contínua; - Desde 2023, que se confirmam anualmente casos de infeção por Mycobacterium leprae, todos com enquadramento epidemiológico compatível, evidenciando a importância da capacidade diagnóstica instalada; - A inclusão da vigilância das micobactérias não tuberculosas (MNT) constitui um avanço relevante, permitindo uma abordagem mais abrangente das infeções por micobactérias em Portugal; - Em alinhamento com as mais recentes recomendações europeias, nomeadamente do European Reference Laboratory Network for Tuberculosis (ERLTB-Net), está em curso a transição para a utilização sistemática da sequenciação do genoma total (WGS) em todos os isolados de Mycobacterium tuberculosis, com o objetivo de substituir progressivamente os testes fenotípicos de suscetibilidade aos antibacilares de primeira linha. Esta abordagem permitirá uma resposta diagnóstica mais rápida, integrada e preditiva, reforçando a eficiência do sistema e a qualidade da informação disponibilizada a clínicos e autoridades de saúde. Este relatório reforça o papel do INSA enquanto laboratório nacional de referência, evidenciando a importância da integração de ferramentas genómicas na vigilância laboratorial e no apoio à decisão clínica e em saúde pública.
- Core Measure Set for Patient Safety in Perioperative Care: A Clinical Practice-Oriented Consensus StudyPublication . Nunes, Ana Beatriz; Teixeira, José Pedro; Leite, Andreia; Schäfer, Willemijn; Valli, Claudia; Martínez-Nicolas, Ismael; Paixão, Margarida; Seyfulayeva, Ayshe; Abelenda, Daniel Treviño; Rodríguez, Anna; Carvalho, Pedro Casaca; Heideveld-Chevalking, Anita; Emond, Yvette; Põlluste, Kaja; Calsbeek, Hiske; Arnal-Velasco, Daniel; Žaludek, Adam; Garel, Pascal; Wagner, Cordula; Groene, Oliver; Orrego, Carola; Sousa, Paulo; SAFEST Scientific Advisory Group; SAFEST Scientific Executive Group; SAFEST ConsortiumObjectives: To develop a consensus-based EU-wide Core Measure Set (CMS), including patient-reported measures, for evaluating perioperative patient safety in routine adult care. Methods: A four-phase approach was applied: 1) identification of candidate structure, process, and outcome measures through three literature reviews; 2) synthesis into an initial list via deduplication and merging; 3) consensus process using a two-round modified eDelphi technique, with subject-matter and lived-experienced experts rating the importance and feasibility of each measure (consensus: ≥75% rating 7–9, ≤15% rating 1–3), followed by an online Consensus Conference addressing measures highly valued by patients but lacking feasibility consensus; 4) refinement of the CMS for patient safety in perioperative care (CMS-PSPC). Results: Out of 9,717 records identified, 340 studies were included, yielding 1,305 measures. After refinement, 247 measures were consolidated; 84 reached consensus, and ten more were added via the Consensus Conference. The final CMS-PSPC comprised 76 measures: 22 outcome, 18 process, and 36 structure measures. Conclusion: The CMS-PSPC provides a standardised, patient-centred framework for evaluating, monitoring and benchmarking perioperative patient safety in routine clinical care, supporting EU-wide quality improvement efforts.
- Predicted no effect concentrations of antifungals for wastewater management and agricultural usePublication . Gil, D.; José, S.; Ascenso, A.; Babič, M. Novak; Segal, E.; Meletiadis, J.; Gangneux, J.P.; Weiskerger, C.J.; Solo-Gabriele, H.M.; Valério, E.; Brandão, J.Antifungal resistance is an on-growing public health concern due to the difficulty in managing or treating medical conditions that often favour fatal fungal infections. The changing climate and globalisation, which increase fungal persistence and propagation, adds to that concern. Wastewater disposal is one potential source to the environment as antifungals are released into it. Considering that most fungal infections originate from the environment and considering the One Health principle, introducing antifungals through wastewater effluents has the potential to promote the emergence and dissemination of antifungal resistance. The objective of this study was to generate knowledge that can assist regulating the release of antifungals in the environment by quantifying predicted no-effect concentrations (PNECs) that would not promote antifungal resistance. For this purpose, a systematic review was performed to consolidate information on antifungals released to the environment and respective concentrations. The systematic literature review followed Preferred Reporting Items for Systematic literature reviews and Meta Analyses extension for Scoping Reviews (PRISMA-SLR). The analysis of 122 reviewed articles using this approach showed high concentrations and dispersion of antifungals in water, wastewater or soil. This highlights their potential dispersion in the environment, thus increasing the potential of fungal antimicrobial resistance. Due to the lack of PNEC values using fungi as model organisms in this review, PNECs for 17 antifungals were calculated using as model, as it is done for clinical purposes. We consider that the antifungal PNECs calculated and consolidated from the literature can be used to prioritise them for regulation and to determine acceptable levels in wastewater effluents.
- Gender-based violence against women and girls aged ≥15 years presenting to European emergency departments: a multinational, cross-sectional analysisPublication . Carannante, Anna; Pitidis, Alessio; Fondi, Gianni; Fian, Tabea; Alves, Tatiana; Valkenberg, Huib; Nijman, Susanne; Giustini, Marco; IDB groupBackground: Gender-based violence (GBV) is an important public health issue in Europe, yet standardised cross-national data remain scarce. Emergency departments (EDs) are often the first point of contact for an individual who has been assaulted. This study aimed to analyse GBV-related ED presentations using data from the European Injury Database (IDB). Methods: This cross-sectional study analysed IDB data from 16 European countries (Jan 1, 2008, to Dec 14, 2023), defining GBV as intentional injuries inflicted by male perpetrators, involving female individuals aged ≥15 years. Descriptive analyses compared GBV with other female injuries (female victims in whom the perpetrator was recorded as female or was not specified). Multivariable logistic regression assessed GBV-associated injury severity compared with other violence against girls and women, adjusting for age, period, and country. Findings: Of 5 643 295 injury-related ED attendances, 1 960 096 were other female injuries and 21 048 were violence cases, of which 10 315 were GBV. Mean age was 38·2 years (SD 15·7) for individuals subjected to GBV and 55·3 years (41·5) for those with other female injuries. There were higher rates of head and face injuries, contusions, and asphyxiation-related injuries in cases of GBV than other female injuries, but there were lower rates of fractures. Most GBV events occurred in domestic settings (5802 [56·3%] of 10 315 GBV cases) and during night-time hours (3931 [41·9%]), involving physical force (7340 [73·1%]); perpetrators were most commonly intimate partners (4906 [47·6%]) or strangers (1546 [15·0%]). Hospital admission was more frequent in GBV than in other female injuries (2210 [21·4%] of 10 315 vs 366 765 [18·7%] of 1 960 096; p<0·0001). GBV was associated with higher injury severity compared with other female injuries after adjustment (odds ratio 1·22, 95% CI 1·12-1·34; p<0·0001). Interpretation: GBV-related ED cases show distinct features that characterise the visible spectrum of violence against girls and women in emergency settings. These patterns highlight the need for improved documentation and greater awareness of less visible presentations. Cross-national variability underscores the need for harmonised surveillance protocols to capture the true burden of GBV in Europe.
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