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- A regulatory perspective on the applicability of NAMs in genotoxicity and carcinogenicity assessment in EU: current practices and future directionsPublication . Bossa, Cecilia; Alivernini, Silvia; Andreoli, Cristina; Aquilina, Gabriele; Attias, Leonello; Benfenati, Emilio; Dusinska, Maria; El Yamani, Naouale; Louro, Henriqueta; Marcon, Francesca; Raitano, Giuseppa; Rundén-Pran, Elise; Russo, Maria Teresa; Silva, Maria João; Battistelli, Chiara LauraNew Approach Methodologies (NAMs) are gaining significant momentum globally to reduce animal testing and enhance the efficiency and human relevance of chemical safety assessment. Even with substantial EU commitment from regulatory agencies and the academic community, the full regulatory adoption of NAMs remains a distant prospect. This challenge is further complicated by the fact that the academic world, oriented toward NAMs development, and regulatory agencies, focused on practical application, frequently operate in separate spheres. Addressing this disconnect, the present paper, developed within the European Partnership for the Assessment of Risks from Chemicals (PARC), provides a clear overview of both the available non-animal tests and current evaluation practices for genotoxic and carcinogenic hazard assessment, while simultaneously highlighting existing regulatory needs, gaps, and challenges toward greater human health protection and the replacement of animal testing through NAMs adoption. The analysis reveals a complex landscape: while the EU is deeply committed to developing and adopting NAMs, as outlined in its Chemical Strategy for Sustainability and supported by initiatives like PARC, prescriptive regulations such as Classification, Labelling and Packaging (CLP) and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) still heavily mandate in vivo animal data for hazard classification, particularly for germ cell mutagenicity and carcinogenicity. This reliance creates a "too-short-blanket-problem," where efforts to reduce animal testing may impact human health protection because of the current in vivo-based classification criteria. In contrast, sectors such as cosmetics and certain European Food Safety Authority (EFSA)-regulated products demonstrate greater flexibility toward progressive integration of NAMs. While the deep mechanistic understanding of genotoxicity and carcinogenicity has significantly advanced the integration of alternatives to animal tests into regulatory chemical hazard assessment, their broader and full implementation faces considerable challenges due to both scientific complexities (i.e., the development and validation of fit-for-purpose NAMs) and existing legislative provisions.
- Towards safer edible insects: assessing contaminant bioaccumulation and depuration capacity in Tenebrio molitorPublication . Cardoso, Diogo N.; Alvito, Paula; de Boevre, Marthe; Silva, Ana Rita; Pinto, José; Rodrigues, Ana; Prodana, Marija; Silva, Patricia; Mostafaie, Amid; Loureiro, SusanaThe integration of insects into sustainable food and feed chains demands a robust evaluation of their capacity to accumulate and eliminate contaminants. Understanding these dynamics is fundamental to ensuring consumer safety and supporting the development of regulatory standards for insect-derived products. This study assessed the bioaccumulation and depuration kinetics of metal(loid)s (As, Cd, Pb) and mycotoxins (Aflatoxin B1, Ochratoxin A, Deoxynivalenol, and Zearalenone) in the yellow mealworm Tenebrio molitor, a species already authorized for human consumption in the EU. Larvae were reared on feed substrates artificially spiked at the maximum levels allowed for animal feed under EU legislation. The experimental design included 21 days of exposure followed by a 21-day elimination phase on uncontaminated substrate, to evaluate both uptake and depuration efficiency under realistic production conditions. Distinct toxicokinetic patterns were observed among metals. Arsenic displayed the highest accumulation potential, reaching internal concentrations of approximately 7 mg/kg dry weight (DW) at the end of exposure, with a progressive but incomplete decline during depuration. Cadmium accumulated steadily to ~2.5 mg/kg DW, exceeding the current feed limit, but was rapidly eliminated below regulatory thresholds within one day of clean feeding. Lead, in contrast, showed low assimilation and rapid clearance, remaining consistently below EU maximum levels. Mycotoxins and their metabolites were not detected above quantification limits in any treatment, confirming the species’ limited bioaccumulation potential for these compounds. Overall, the results highlight Tenebrio molitor’s high depuration capacity and resilience to transient contaminant exposure. These findings highlight the need to apply toxicokinetic principles in insect risk assessment to define effective depuration periods and ensure safe, circular production systems.
- Distribuição geográfica da prevalência de anomalias cardíacas congénitas em Portugal: dados do Registo Nacional de Anomalias Congénitas entre 2000 e 2023Publication . de Carvalho Aniceto, Carlos André; Braz, Paula; Matias Dias, CarlosAntecedentes/Objetivos: As anomalias cardíacas congénitas (ACC) afetam cerca de 1,8% dos nados-vivos (NV) em todo o mundo, e são uma das principais causas de mortalidade e morbilidade (1). A etiologia é complexa, e fatores ambientais são sugeridos como importantes contribuintes (2). É objetivo deste estudo analisar a distribuição geográfica da prevalência de ACC em Portugal Continental. Métodos: Estudo epidemiológico observacional, transversal. Dados: número anual ACC diagnosticadas em nados-vivos (NV)(Fonte: RENAC) e número total de NV (Fonte: INE) desagregadas por concelho e por ano entre 2000 e 2023. Para avaliar a distribuição espacial da PACC aplicaram-se métodos de autocorrelação espacial, calculando-se os seguintes indicadores para 2000-2010 e 2011-2023: (i) PACC, pelo método Bayesiano empírico; (ii) indicador de concentração espacial de PACC, pelo Índice Local de Moran I univariado (3). Resultados: Num total de 6656 NV, a prevalência de ACC para o período em estudo foi de 42,2 casos/10000 nados vivos. Entre 2000-2010 registaram-se PACC mais elevadas nos concelhos da região Oeste e Vale do Tejo, destacando-se Almeirim com a prevalência mais elevada (TPC = 145,4 casos / 104 nados-vivos). Identificaram-se 4 clusters de PAAC mais elevadas, estatisticamente significativos (p≤0,05), localizados em alguns concelhos das regiões Oeste e Vale do Tejo, Centro e Algarve. Entre 2011-2023 observaram-se PACC mais elevadas nos concelhos das regiões Oeste e Vale do Tejo e Centro, salientando-se o Sardoal com a prevalência mais elevada (TPC = 264,2 casos / 104 nados-vivos). Identificaram-se 2 clusters de PAAC mais elevadas, estatisticamente significativos (p≤0,05), em alguns concelhos das regiões Oeste e Vale do Tejo e Centro. Em todos os clusters identificados as anomalias dos septos cardíacos foram as mais frequentes. Discussão/Conclusão: A aplicação dos métodos de autocorrelação espacial, revelam-se úteis para identificar e comparar padrões geográficos de PACC. Em linha com estudos internacionais, observou-se uma concentração de prevalência de ACC em alguns concelhos do Continente, que poderá estar associada a exposições ambientais. Estes resultados mostram a necessidade de análises mais complexas, sendo fundamental que a georreferenciação dos casos no RENAC seja mais específica, permitindo realizar estudos que contribuam para estratégias de saúde pública na prevenção de ACC.
- Tracking Mycotoxin Exposure in Portugal: New Insights and Key DeterminantsPublication . Namorado, Sónia; Maris, Elias; Chen, A.; Pero-Gascon, Roger; de Boevre, Marthe; De Saeger, Sarah; Silva, Maria João; Alvito, Paula; .Human biomonitoring (HBM) is a vital tool for assessing exposure to environmental chemicals. Mycotoxins have been associated with various adverse health effects, including estrogenic, immunotoxic, nephrotoxic, and teratogenic outcomes. In this presentation an overview of two recent HBM studies on multiple mycotoxins exposure biomarkers conducted in Portugal will be given. The first study analyzed 37 mycotoxin biomarkers in urine samples from 94 adult participants (48.4 ± 15.2 years), as part of the National Food, Nutrition, and Physical Activity Survey (2015–2016). Six different mycotoxins -DON, ZEN, AOH, OTA, FB1, and CIT- was confirmed through the quantification of 12 urinary biomarkers in paired 24 h and first-morning urine samples. DON and its metabolites were among the most frequently detected biomarkers and AOH was identified for the first time in urine samples from a European population. Associations between urinary mycotoxin biomarkers and consumption of specific food items were also observed. More recently, a subset of 295 first-morning urine samples from adults (28–39 years) was collected between 2019-2020, as part of a cross-sectional study embedded within the Portuguese National Health Examination Survey (INSEF). These samples were analyzed using a newly optimized and validated LC-MS/MS method capable of detecting 40 mycotoxins and/or their metabolites in urine. DON and tenuazonic acid were the most frequently detected, with detection rates of 85% and 96%, respectively. Further investigations into key exposure determinants—including dietary habits, demographic factors, and geographical variations—are ongoing and will be presented. Altogether, these findings highlight the importance of continued surveillance and the integration of HBM into national food safety and public health strategies.
- Public genomic cohort analyses reveal bcl6 expression as a prognostic marker in luminal a breast cancerPublication . Barros, Patrícia; Gonçalves, Vânia; Jordan, Peter; Matos, PauloIntroduction: Breast cancer (BC) is the most common malignant neoplasm among women worldwide and remains a leading cause of cancer-related mortality. It is a heterogeneous disease classified into molecular subtypes with distinct prognostic and therapeutic implications. Luminal A is the most prevalent subtype, characterised by high expression of hormone receptors (oestrogen and progesterone), low proliferation rate, and generally favourable prognosis. However, consistent evidence indicates a significant risk of late recurrence and new neoplastic events, posing challenges for clinical follow-up strategies. Methodology: We analysed genomic data from the TCGA breast cancer cohort (n = 1247) to assess the prognostic value of the BCL6 gene, a transcriptional regulator previously implicated in tumour progression. Data on BCL6 expression, molecular subtyping (PAM50), and overall survival (OS) were retrieved. Results: Although BCL6 expression was globally reduced in tumours compared to normal tissue, it was significantly higher in Luminal A tumours than in other subtypes, with a subgroup (44%) maintaining expression levels similar to normal tissue. Importantly, within the Luminal A subtype, higher BCL6 expression was associated with poorer long term survival (p = 0.041). Discussion: These findings support the potential of BCL6 as a stratification biomarker for the risk of long term neoplasm recurrence within Luminal A breast cancer, with possible implications for tailoring the intensity and duration of clinical follow-up.