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- Safety evaluation of pea fibre concentrate (FIPEA) 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, Reginald; 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; Gagliardi, Gabriele; Mech, Agnieszka; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota; Ruggeri, LauraThe EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pea fibre concentrate (FIPEA) as a food additive. FIPEA is a powder consisting mainly of dietary fibres (i.e. pectin and hemicellulose), and low amounts of protein, derived from yellow pea (P. sativum). The manufacturing process includes extensive heat treatments, (e.g. > 100°C for more than 40 min), conditions which lead to inactivation of lectins, that in FIPEA do not pose a safety concern. A specific α‐amylase is used in the manufacturing, and this should be included in the definition of the proposed specifications. The Panel considered that the additional contribution of FIPEA to the total fibre intake in adults and toddlers would be acceptable considering the levels that are considered adequate by the NDA Panel. The Panel recommended to lower the specification limits proposed for the toxic elements. The solubility test indicates that the material does not require specific assessment at the nanoscale. No toxicological data have been submitted on FIPEA. The Panel considered that, similarly to water‐soluble soybean polysaccharides, FIPEA is not absorbed intact but undergoes extensive fermentation by the intestinal microbiota in humans and is not of genotoxic concern. Dry peas (raw material) are a staple food, with a very long history of safe use in the EU. FIPEA is extracted with hot water from the insoluble fibrous material of dehulled yellow peas, therefore the structure of the fibres is not chemically modified, and no new by‐products or components of toxicological concern are expected from the manufacturing process. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that pea fibre concentrate (FIPEA) as a new food additive does not raise a safety concern at the proposed use and use levels.
- Workshop Implementation of Genomics in HealthcarePublication . Vicente, Astrid Moura; Cardoso, Maria LuisThe first B1MGPlus workshop, held in Bucharest, launched the activities of Work Package 3 (WP3) and Working Group 7 (WG7) of the 1+MG Initiative, focusing on the implementation of genomics in healthcare across Europe. The event gathered experts, policymakers, and stakeholders from multiple countries, providing a platform to discuss challenges, share national experiences, and explore strategies for integrating genomic medicine into healthcare systems. The workshop was structured to address key domains identified in the 1+MG maturity level model (MLM), which serves as a framework for countries to self-assess their readiness and progress in implementing genomic medicine. The agenda included sessions on governance, strategy, investment and funding, clinical implementation, workforce upskilling, and public engagement, ensuring a comprehensive overview of the multifaceted process of genomics adoption in healthcare. A keynote presentation by the Wellcome Sanger Institute highlighted the importance of policy and advocacy in genomics, emphasizing the need for capacity building, equitable data sharing, and public trust. The discussion underscored the global imbalance in genomic datasets and the necessity of demonstrating tangible benefits to citizens, especially when commercial actors are involved. National case studies provided practical insights into different implementation models. Slovenia’s approach, for example, integrated genomics within existing genetic services, leveraging established governance, reimbursement, and professional pathways. This facilitated a smoother transition and highlighted the value of adapting existing structures rather than creating entirely new ones. Other countries, including Denmark and Germany, shared diverse strategies regarding governance, funding, workforce development, and clinical integration. These examples illustrated the varying levels of maturity and unique challenges faced by European healthcare systems, reinforcing the importance of context-specific solutions and cross-country learning. Finland’s highlighted the country’s advanced integration of genomics into healthcare, namely Finland’s pioneering work in pharmacogenomics, the use of biobank resources for research and clinical applications, and the development of polygenic risk scores to support personalized medicine. These initiatives are supported by a well-established national biobank infrastructure, robust ethical and legal frameworks, and close collaboration between research and clinical practice, positioning Finland as a leader in translating genomic discoveries into healthcare benefits. Public engagement emerged as a critical theme, with discussions focusing on transparent communication, ethical considerations and mechanisms to ensure societal benefit from genomic initiatives. The need to build trust and demonstrate value to the public was repeatedly emphasized, particularly in relation to data use and commercial partnerships. The workshop also featured updates on the status of genomic medicine in several European countries, including Romania, Lithuania, Belgium and Portugal. These presentations highlighted ongoing pilot projects, national strategies, and the importance of aligning policy, infrastructure, and workforce capacity for successful implementation. In addition, the draft of the questionnaire developed to support the mapping exercise on the implementation of genomics in the clinical setting (Task 3.3) was presented. The questionnaire is structured on the Maturity Level Model, making use of its established domains and indicators while incorporating the necessary adaptations to meet the specific objectives of the exercise. In conclusion, Workshop 1 of B1MGPlus fostered a collaborative environment for sharing knowledge, benchmarking progress and identifying actionable recommendations. The insights and outcomes from this meeting will inform ongoing WG7 activities and contribute to the development of guidance materials for the European Commission, supporting the advancement of genomic medicine across Europe
- Multi-Level Model (MLM) Pilot in PortugalPublication . Cardoso, Maria LuisThe MLM (Multi-Level Model) Pilot is a demonstration initiative under the European project B1MGplus (Beyond 1 Million Genomes Plus, 2024–2026). Its main goal is to test secure, federated sharing and analysis of genomic and health data across European countries.