INSA - Artigos em revistas internacionais
URI permanente para esta coleção:
Navegar
Entradas recentes
- Flavouring Group Evaluation 87, Revision 3 (FGE.87Rev3): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and related esters evaluated in FGE.47Rev1Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernández, María José; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Benigni, Romualdo; Degen, Gisela; Engel, Karl‐Heinz; Carfí, Maria; Martino, CarlaThe Panel on Food Additives and Flavourings (FAF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No. 1565/2000. The present consideration concerns a group of 19 bicyclic secondary alcohols, ketones and related esters evaluated by JECFA at the 63rd meeting. This revision of FGE.87 is made due to new information on annual production volume, allowing the calculation of maximised survey‐derived daily intake (MSDI) for 4,4a,5,6‐tetrahydro‐7‐methylnaphthalen‐2(3H)‐one [FL‐no: 07.136]. In addition, new data on uses and use levels for the substances [FL‐no: 07.089, 07.0136, 07.153 and 07.159] have been provided and considered for the estimation of exposure (mTAMDI approach). For [FL‐no: 07.136], the Panel agrees with the Procedure as applied by JECFA and with JECFA conclusion: ‘No safety concern at estimated levels of intake as flavouring substance’, when based on the MSDI approach. For the other 18 substances considered in FGE.87Rev3, the same conclusion was already drawn in FGE.87Rev2. For [FL‐no: 07.136], the mTAMDI exposure estimate is below the TTC for structural class II substances. Accordingly, no further data are required in the context of the current evaluation programme. For [FL‐no: 07.089, 07.153, 07.159], mTAMDI exposure estimates are above the TTC for structural class II substances; therefore, more reliable data on uses and use levels should be provided in order to refine the exposure assessment and to finalise their safety evaluation. For the remaining 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation. Information on specifications for the materials of commerce is considered adequate for all 19 substances.
- Safety evaluation of the modification of the food additive enzymatically produced steviol glycosides (E 960c)Publication . 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; Herman, Lieve; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Civitella, Consuelo; Dino, Borana; Lunardi, Simone; Mech, Agnieszka; Multari, Samuele; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a modified manufacturing process for the food additive enzymatically produced steviol glycosides (E 960c). The new process converts purified steviol glycosides extracted from Stevia rebaudiana leaves through enzymatic bioconversion catalysed by glucosyltransferase and sucrose synthase enzymes, both produced using three newly developed genetically modified strains of Escherichia coli (CDX‐044 W3110‐TKO, CDX‐045 W3110‐TKO and CDX‐047 W3110‐TKO). This modification of the manufacturing process yields two distinct preparations of steviol glycosides: SBP1, composed predominantly of rebaudioside M, and SBP2, composed predominantly of rebaudioside D. The modification leads to changes in the definition of the food additive, residual protein, residual solvents, microbiological criteria and particle size. The Panel concurred with the applicant's proposal to introduce two new entries in Commission Regulation (EU) No. 231/2012 corresponding to SBP1, predominantly rebaudioside M, and SBP2, predominantly rebaudioside D. The manufacturing process does not raise a safety concern since no viable cells nor DNA of the production strains remained in the final product; in addition, the food enzyme–total organic solid (TOS) are removed to at least 99%, and consequently, the exposure to the food enzyme–TOS via consumption of SPB1 and SPB2 can be considered negligible. The Panel considered that rebaudioside M and D produced by this new manufacturing process have the same physicochemical characteristics as the corresponding rebaudioside M and D present in E 960c(i), (ii) and (iii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of SBP1 and SBP2. The Panel concluded that there is no safety concern with respect to the proposed modification of the food additive enzymatically produced steviol glycoside E 960c related to the use of the new genetically modified strains of E. coli in the production process of SBP1 and SBP2.
- Variation in reporting of heatstroke mortality: evidence from a multi-country studyPublication . Tobias, Aurelio; Honda, Yasushi; Madaniyazi, Lina; Alhamad, Barrak; Lavigne, Erik; Roye, Dominic; Tong, Shilu; de Sousa Zanotti Stagliorio Coelho, Micheline; Huber, Veronica; Urban, Ales; das Neves Pereira da Silva, Susana; Achilleos, Souzana; Parks, Robbie M.; Iñiguez, Carmen; Masselot, Pierre; Vicedo-Cabrera, Ana M.; Armstrong, Ben; Gasparrini, Antonio; Hashizume, Masahiro; Multi-City Multi-Country Collaborative Research NetworkBackground: Heatstroke represents the most severe manifestation of heat exposure. Heatstroke is rare and under-reported, resulting in limited empirical data on its global incidence and burden. This study aimed to examine geographical variations and temporal trends in reported heatstroke mortality across multiple countries. Methods: We collected annual heatstroke mortality data from 34 countries participating in the Multi-Country Multi-City Collaborative Research Network between 2000 and 2022, using the ICD-10 code X30. Country-specific mortality rates were estimated using Poisson regression, alongside analyses of annual trends and associations with mean warm-season temperature. We also assessed the proportion of heatstroke deaths relative to both overall heat and extreme heat-attributable all-cause mortality. Findings: Heatstroke mortality rates varied widely across countries, with Japan reporting the highest rate (5·81 per 1 million population; 95% CI 4·43-7·62), followed by Cyprus (2·51; 1·36-4·61), and China (2·42; 1·21-4·85). By contrast, most countries in Europe, South America, and southeast Asia reported rates of less than one death per 1 million population. Heatstroke mortality increased over time in several countries and was associated with warm-season temperatures in most regions. The proportion of heatstroke deaths relative to overall heat-attributable mortality ranged from less than 1% in many countries to as close to 24% in Japan. When analyses were restricted to deaths attributable to extreme heat, the proportion of heatstroke deaths increased substantially. Interpretation: Our broad international assessment of heatstroke mortality highlights its distinct patterns compared with overall heat-attributable mortality. The observed variability likely reflects differences in recognition, reporting, and diagnostic practices, while climate exposure and health system capacity influence whether heat-related deaths are identified and recorded as heatstroke.
- COVID-19 Vaccine Effectiveness among older adultsPublication . Laniece Delaunay, Charlotte; Mateo-Urdiales, Alberto; Pérez-Gimeno, Gloria; O'Reilly, Karen; Uras, Marina; Erdwiens, Annika; Mlinaric, Ivan; Túri, Gergo; Martínez-Baz, Iván; Meijer, Adam; Rodrigues, Ana Paula; Lazar, Mihaela; Latorre-Margalef, Neus; Lucaccioni, Héloïse; Verdasca, Nuno; Bella, Antonino; Rafael de la Cruz Lopez, Maria Angeles; Kelly, Eva; Enouf, Vincent; Tolksdorf, Kristin; Puzelli, Simona; Ibáñez Pérez, Ana Carmen; Fitzgerald, Margaret; Masse, Shirley; Oh, Djin-Ye; Kaczmarek, Marlena; Bacci, Sabrina; Kissling, Esther; VEBIS Primary Care Vaccine Effectiveness GroupIntroduction: From September to November 2025, many European countries launched COVID-19 vaccination campaigns, when SARS-CoV-2 incidence was decreasing after a period of high circulation.1 These campaigns targeted specific groups, including older adults (ie, individuals aged at or above a minimum threshold that varied from age 60 to 70 years across countries). We estimated the effectiveness of COVID-19 vaccines administered during these seasonal vaccination campaigns in Europe against medically attended, symptomatic SARS-CoV-2 infection among older adults, from September 29, 2025, to January 10, 2026.
- Global Survey Of Genetic Testing Methods For Familial Hypercholesterolaemia: A Study And Recommendations From The European Atherosclerosis Society Familial Hypercholesterolaemia Studies Collaboration RegistryPublication . Chora, Joana Rita; Karungi, Irene; Elshorbagy, Amany; Stevens, Christophe A.T.; Vallejo-Vaz, Antonio J.; Dharmayat, Kanika I.; Abifadel, Marianne; Aguilar-Salinas, Carlos A.; Alhabib, Khalid F.; Almahmeed, Wael; Alnouri, Fahad; Alonso, Rodrigo; Al-Rasadi, Khalid; Al-Sarraf, Ahmad; Arca, Marcello; Ashaat, Engy A.; Ashavaid, Tester F.; Averna, Maurizio; Banach, Maciej; Becker, Marianne; Binder, Christoph J.; Brunham, Liam R.; Catapano, Alberico L.; Corral, Pablo; Descamps, Olivier S.; Drogari, Euridiki; Durst, Ronen; Ezhov, Marat; Groselj, Urh; Harada-Shiba, Mariko; Holven, Kirsten B.; Hovingh, G. Kees; Khovidhunkit, Weerapan; Lalic, Katarina; Latkovskis, Gustavs; Laufs, Ulrich; Liberopoulos, Evangelos; Lin, Jie; März, Winfried; Mata, Pedro; Matthias, Anne Thushara; Miserez, André R.; Mitchenko, Olena; Nawawi, Hapizah Mohd; Nordestgaard, Børge G.; Panayiotou, Andrie G.; Paragh, György; Petrulioniene, Zaneta; Postadzhiyan, Arman; Reyes, Ximena; Sadiq, Fouzia; Sahebkar, Amirhossein; Santos, Raul D.; Sawhney, J.P.S.; Schunkert, Heribert; Shah, Swarup A.V.; Shek, Aleksandr B.; Soran, Handrean; Su, Ta-Chen; Subramaniam, Tavintharan; Tilney, Myra; Tomlinson, Brian; Truong, Thanh Huong; Tybjærg-Hansen, Anne; Viigimaa, Margus; Vohnout, Branislav; Watts, Gerald F.; Yamashita, Shizuya; Ray, Kausik K.; Raal, Frederick J.; Humphries, Steve E.; Freiberger, Tomas; Bourbon, Mafalda; EAS FHSCBackground and aims: Familial hypercholesterolemia (FH), primarily caused by pathogenic LDLR, APOB, or PCSK9 variants, results in elevated LDL-C and increased cardiovascular risk. Genetic testing offers the definitive diagnosis, yet global approaches to FH genetic testing remain unstandardized. We investigate current testing practices worldwide and provide relevant recommendations. Methods: A survey was distributed to national lead-investigators (NLIs) of 68 countries in the FH-Studies Collaboration, assessing referral criteria, assay methodologies, target genes, and pathogenicity interpretation methods. Results: NLIs from centres in 55/68 countries (81%) responded, spanning Africa (N=2), Americas (N=6), Asia (N=20), Europe (N=26), and Oceania (N=1). DLCN scores were the most common reason for referral to genetic testing (adults:72%; children:57%). Simon Broome and MEDPED criteria were reported only by centres from high-income countries (adults: 7% and 2%; children: 12% and 2%). Methods for testing in index versus non-index cases were significantly different (p <0.001). Next-generation sequencing (NGS) was the predominant assay method for index cases (62%), while Sanger sequencing was favoured for non-index (71%). However, these testing techniques did not differ between centres from high- and non-high-income countries for index cases (p=0.74) and non-index cases (p=0.49). Copy-number variants (CNVs) were assessed by 65% of centres, with most integrating CNV analysis into NGS platforms (86%) and others (14%) using multiplex ligation-dependent probe-amplification (MLPA) or microarrays. Screening encompassed LDLR (100%), APOB (97%), PCSK9 (95%), and other genes. Most centres (96%) incorporated pathogenicity interpretation into their reports, adhering largely to American College of Medical Genetics and Genomics guidelines. Conclusions: FH genetic testing practices vary widely across countries surveyed, emphasizing the need for global standardization to enhance accuracy and comparability of FH diagnoses worldwide. We suggest that genetic testing should include the three FH-causing genes and ideally the five associated/phenocopy genes.
- Data Privacy, Ownership, and Secondary Use of Clinical Data Generated by Continuous Glucose Monitors and Mobile Health Applications: A ReviewPublication . Dario, PauloThe growing use of continuous glucose monitors (CGMs) and mobile health (mHealth) applications has changed how diabetes is managed, allowing real-time tracking of glycemic patterns and remote clinical decision-making. These technologies also generate large volumes of sensitive health data, raising questions about who owns this information, how it is protected, and under what conditions it may be repurposed for research or commercial objectives. This review examines the regulatory frameworks governing CGM and mHealth data in major jurisdictions, with particular attention to the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union. Significant regulatory gaps exist, particularly for consumer-grade devices and direct-to-consumer mHealth applications that fall outside traditional healthcare data-protection frameworks. Data ownership remains legally ambiguous in most jurisdictions, with patients, healthcare providers, device manufacturers, and app developers each holding competing claims. The secondary use of clinical data for research, while it could materially advance diabetes care, raises ethical concerns around informed consent, data de-identification, and the boundaries between clinical care and commercial exploitation. Emerging approaches, including the European Health Data Space, federated learning, and differential privacy, may help balance data utility with individual rights. The review recommends changes to regulation, industry practice, and consent models aimed at reconciling data-driven diabetes research with patient autonomy and privacy.
- Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008Publication . 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; Gundert-Remy, Ursula; Ursula Gundert‐Remy; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barmaz, Stefania; Carfì, Maria; Civitella, Consuelo; Gagliardi, Gabriele; Lodi, Federica; Martino, Carla; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana Maria; Ruggeri, Laura; Smeraldi, Camilla; Tard, Alexandra; Zakidou, PanagiotaThis guidance document applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food additive, submitted under Regulation (EC) No 1333/2008. It defines the scientific data required to evaluate if the food additive is safe under the proposed conditions of use, in accordance with Articles 1 and 6 of Regulation (EC) No 1333/2008. The data requirements pertain to the characterisation of the proposed food additive, including the description of its identity, manufacturing process, specifications, stability, reaction and fate in foods and methods of analysis in food; the proposed uses and use levels and the dietary exposure; the safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should provide data in accordance with this guidance document to support the safety assessment of the proposed food additive. Based on the submitted data, EFSA will assess the safety of the food additive in line with the risk assessment principles described in this document and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.
- A multi-stakeholder perspective on Barriers to the adoption of personalized prevention in European healthcare systemsPublication . Costa, Alexandra; Cardoso, Maria Luís; Carvalho, Adriana Reimão; Osti, Tommaso; Farina, Sara; Taha, Abdelrahman; Savoia, Cosimo; Russo, Luigi; Maio, Alessandra; Scarsi, Nicolò; Flodkvist, Evelina; Gyllenberg, Alexandra; Boccia, Stefania; Vicente, Astrid MouraIntroduction: Personalized prevention is an important component of personalized medicine, tailoring interventions to the biological, behavioral, sociocultural and environmental characteristics of individuals for the prevention of disease onset, progression and recurrence. Despite its potential, personalized preventive interventions (PPI) remain less commonly implemented in clinical practice. This study explored the main barriers to a broader adoption of PPI in European healthcare systems. Methods: A multi-stakeholder consultation involving citizens/patients, health professionals, researchers, and policymakers was conducted using a sequential mixed-methods approach. In the first phase, semi-structured interviews with key informants representing different stakeholder groups were conducted. The thematic analysis of interview findings, complemented by insights from a review of the literature, informed the development of an online survey implemented in the second phase of the study. Twenty-six interviews and 270 complete surveys were analyzed. Stakeholders identified barriers across three main domains: (1) healthcare systems, (2) implementation, and (3) awareness, education, and literacy. Key barriers associated with limited PPI adoption included the predominant focus of health strategies on treatment over prevention, unresolved ethical, legal, and social issues (ELSI), limited awareness and knowledge of personalized prevention among both professionals and citizens, and the lack of appropriate cost–benefit evaluation models. Findings highlight interconnected barriers that may impact a broader PPI adoption across healthcare system, governance, implementation, and awareness-related domains. Continued stakeholder dialogue and engagement, alongside efforts to address awareness and governance-related challenges, may support the broader integration of PPI into European healthcare systems.
- Cancer Prevention Literacy Questionnaire (CPL-Q): development and validation within the World Code Against Cancer FrameworkPublication . Feliu, Ariadna; Islam, Rubana; Romeo-Cervera, Paula; Bouaoun, Liacine; Whitelock, Victoria; Pirvan, Mirela; Roxo, Luis; Carvalho da Silva Santos, Ana João; Espina, CarolinaBackground: Health literacy is a key determinant of health, shaping individuals ability to understand and act on health information. Low cancer literacy is associated with fatalistic beliefs and reduced participation in prevention and screening programmes. Although around 40% of all cancers are preventable, public awareness of modifiable risk factors remains low. The European Code Against Cancer (ECAC), developed under the World Code Against Cancer Framework, aims to strengthen prevention knowledge; however, tools to measure cancer prevention literacy, and therefore evaluate its impact, are lacking. This study aimed to develop and validate a questionnaire to assess ‘cancer prevention literacy’ in adults from the general population. Methods: We conducted a methodological study to develop a questionnaire measuring ‘cancer prevention literacy’ in adults from the general population using the Integrative Model of Behavioural Prediction as theoretical framework. Questionnaire development followed a three-stage process: (1) a literature review and two-round Delphi process to select and refine items; (2) a third Delphi round, complemented by readability checks, face-validity assessment, and cognitive testing to evaluate item relevance, clarity, and representativeness; and (3) a pre-test and psychometric analysis to assess construct validity. Results: The final Cancer Prevention Literacy Questionnaire (CPL-Q) consists of a 10-question validated instrument comprising 58 items, with selected items incorporating the verbatim wording of the recommendations from the ECAC, 4th edition. Strong expert agreement was achieved through an iterative Delphi process, and content and face validity indicated that the items were comprehensible, relevant, and appropriate. Psychometric analyses, including exploratory and confirmatory factor analysis, provide preliminary support for the instrument’s construct validity, with initial evidence suggesting acceptable reliability. Conclusion: The CPL-Q provides a standardised instrument to measure ‘cancer prevention literacy’ and to assess the impact of Regional Codes Against Cancer through monitoring and benchmarking changes over time. It also offers a practical tool to identify gaps in ‘cancer prevention literacy’ within specific populations and to support international comparisons and longitudinal evaluations, thereby contributing to the evidence base for cancer prevention policies.
- COVID-19 vaccination and antibody response in healthcare workers: a longitudinal serological study following the 2023-2024 COVID-19 vaccination campaignPublication . Almeida Santos, João; Henriques, Camila; Amaral, Palmira; Guiomar, Raquel; Machado, Ausenda; Gaio, VâniaBackground: Healthcare workers (HCWs) are essential frontline responders to public health emergencies and are one of the risk groups targeted by annual vaccination campaigns. Serological studies are valuable for high-risk groups such as HCWs, as they contribute to assess vulnerability, monitor infection control measures, and guide vaccination strategies in high-risk settings. This study aimed to assess humoral response at baseline, 3 and 6 months after the 2023–2024 COVID-19 vaccination campaign in HCWs, and to identify demographic and clinical factors associated with variations in antibody levels over time. Methods: Prospective cohort study of vaccinated HCWs at a central hospital in Portugal (September 2023–May 2024). Serial serological tests to assess anti-spike receptor-binding domain (anti-RBD/S) and anti-nucleocapsid protein (anti-N) IgG antibodies were used to monitor the immune response and SARS-CoV-2 infection history, respectively. Wilcoxon signed-rank tests were used to assess changes in antibody levels over time, and linear regression models were used to identify factors associated with variations in SARS-CoV-2 anti-RBD/S IgG concentrations, on the basis of available demographic and clinical data. Results: In a cohort of 166 HCWs who received the 2023–2024 COVID-19 booster vaccine, anti-RBD/S IgG antibody levels significantly increased at 3 months post-vaccination (16 007.4 vs. 30 572.9 AU/mL) before declining by 6 months (18 327.3 AU/mL), nearing baseline levels. Previous infection (β = 1.92, 95% CI: 1.33-2.77) and older age (β = 2.65, 95%CI: 1.64‐4.29) were associated with higher antibody concentrations at baseline, whereas smoking was linked to lower antibody levels at 6 months (β = 0.32, 95%CI: 0.11–0.88). Other factors, such as sex and chronic conditions, had no consistent significant impact over time. Conclusions: Although SARS-CoV-2 anti-RBD/S IgG antibody concentrations declined significantly six months after the 2023–2024 COVID-19 booster vaccination, they remained at relatively high concentrations over the follow-up period. This study provides new insight into these dynamics in a highly vaccinated and exposed HCWs cohort during a later post-pandemic phase, highlighting the influence of prior infection, age, and smoking on antibody persistence and reinforces the relevance of ongoing immune monitoring of this risk group to guide tailored control strategies. However, vaccine effectiveness studies in highly exposed and vaccinated populations, such as HCWs, are needed to better inform the role of antibody monitoring in this context, especially given the ongoing trend of annually updated vaccines.