Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.

Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross-sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023. Our investigation extended to assessing the regulatory status of these accelerated approvals in the European Union (EU) and Japan, examining relevant regulatory documents and identifying factors contributing to the withdrawal in the United States. Comparing regions, we found that for 52% (12/23) and 30% (7/23) of withdrawn accelerated approvals in the United States, sponsors had also sought marketing authorization from the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), respectively. As of the April 30, 2023 study cutoff date, 83% (10/12) of drug-indication pairs remained approved by the EMA, while the PMDA retained 100% (7/7). For these indications, the time from FDA withdrawal until the study cutoff date ranged from 0.23 years to 11.45 years for EMA approvals (median: 1.28 years) and 1.10 years to 11.45 years for PMDA approvals (median: 3.22 years). These findings highlight substantial regulatory discrepancies concerning cancer drugs with unconfirmed benefits. Addressing these discrepancies may involve requiring pharmaceutical companies to confirm clinical benefits using more robust end points and fostering international harmonization in regulators' assessment.

Sepsis Research Using Omics Technology in the European Union and the United Kingdom: Maps, Trends, and Future Implications.

High-throughput omics technologies have become valuable tools for systems science research and clinical management of sepsis. This article analyzes sepsis research using omics technologies in the European Union (EU) and the United Kingdom from 1990 to May 2023 using bibliometric data from the Web of Science database. Using VOSviewer for network analysis, we examined the distribution patterns, funding characteristics, and collaborations among the states, noting trends of convergence and divergence. The analysis included 2078 articles, revealing an increasing rate of publications on sepsis research using omics approaches. The United Kingdom's research output is notably high, contributing 28.3% of the total research from the EU and United Kingdom combined. Germany, France, the Netherlands, and Italy together account for 56.9% of the publications from the EU member states. The United States is the leading international collaborator, particularly with the United Kingdom, followed by Germany and France. The EU-15 countries have significantly more publication outputs in this domain with growing but limited inclusion of the newer members of the EU. We suggest that the role of EU member states and the United Kingdom in sepsis research using omics technologies can be advanced by facilitating high-value, technology-driven health research, fostering collaboration, convergence, and equity in global health and biomedical research.

European Health Information Portal: a one-stop shop for health information.

BACKGROUND: Timely and high-quality population-level health information is needed to support evidence-informed decision-making, for planning and evaluation of prevention, care and cure activities as well as for research to generate new knowledge. FAIR (Findable, Accessible, Interoperable and Reusable) principles are one of the key elements supporting health research and making it more cost-effective through the reuse of already existing data. Currently, health data are in many countries dispersed and difficult to find and access. METHODS: Two EU Public Health Programmes co-funded Joint Actions, Information for Action (InfAct) and Population Health Information Research Infrastructure (PHIRI) have established a European Health Information Portal, a web-based service, to facilitate better findability, access, interoperability and reuse of existing health information. RESULTS: The European Health Information Portal (www.healthinformationportal.eu) has been established including sections on National Nodes, data sources, publications, health information projects within countries and across Europe, research networks and research infrastructures, ethical and legal issues for health information exchange and use, capacity-building activities in all areas of population health and a dedicated COVID-19 section. CONCLUSIONS: The European Health Information Portal, being a central place for a wide range of population health information from EU Member States, is an information source for researchers, policy-makers and other relevant stakeholders. It is important to ensure the sustainability of the portal, especially in light of the European Health Data Space (EHDS) Regulation proposal and its requirements regarding the secondary use of health data.

Delayed treatment in breast cancer patients during the COVID-19 pandemic: a population health information research infrastructure (PHIRI) case study.

BACKGROUND: The indirect impact of the coronavirus disease 2019 pandemic on healthcare services was studied by assessing changes in the trend of the time to first treatment for women 18 or older who were diagnosed and treated for breast cancer between 2017 and 2021. METHODS: An observational retrospective longitudinal study based on aggregated data from four European Union (EU) countries/regions investigating the time it took to receive breast cancer treatment. We compiled outputs from a federated analysis to detect structural breakpoints, confirming the empirical breakpoints by differences between the trends observed and forecasted after March 2020. Finally, we built several segmented regressions to explore the association of contextual factors with the observed changes in treatment delays. RESULTS: We observed empirical structural breakpoints on the monthly median time to surgery trend in Aragon (ranging from 9.20 to 17.38 days), Marche (from 37.17 to 42.04 days) and Wales (from 28.67 to 35.08 days). On the contrary, no empirical structural breakpoints were observed in Belgium (ranging from 21.25 to 23.95 days) after the pandemic's beginning. Furthermore, we confirmed statistically significant differences between the observed trend and the forecasts for Aragon and Wales. Finally, we found the interaction between the region and the pandemic's start (before/after March 2020) significantly associated with the trend of delayed breast cancer treatment at the population level. CONCLUSIONS: Although they were not clinically relevant, only Aragon and Wales showed significant differences with expected delays after March 2020. However, experiences differed between countries/regions, pointing to structural factors other than the pandemic.

[Solidarity : new paradigm for health data spaces?] / Solidarité : nouveau paradigme pour les espaces des données de santé ?

At the intersection of health promotion and health data sharing, a normative paradigm is emerging: solidarity. This principle became evident with the European Commission's proposal for the European Health Data Space in 2022, approved by the European Parliament in 2024, and Switzerland's DigiSanté project. This article examines health data spaces beyond traditional legal considerations, exploring the implications of increased reliance on solidarity. Highlighting public and private actors, it analyzes the use of health data for research, health surveillance, and profit. The article emphasizes the need for robust frameworks to balance data use for the common good and mitigate the risks of repression and exploitation.

À l'intersection entre promotion de la santé et partage de données de santé, un paradigme normatif émerge : celui de la solidarité. Ce principe s'est révélé avec la proposition de la Commission européenne pour l'espace européen des données de santé en 2022, approuvée par le Parlement européen en 2024, et le projet DigiSanté en Suisse. Cet article examine les espaces des données de santé au-delà des considérations juridiques traditionnelles, en explorant les implications d'un recours accru à la solidarité. En mettant en lumière les acteurs publics et privés, il analyse l'utilisation des données de santé à des fins de recherche, de surveillance sanitaire et de profit. L'article souligne la nécessité de cadres robustes pour équilibrer l'utilisation des données pour le bien commun et atténuer les risques de répression et d'exploitation.

PROTECTION OF CONFIDENTIAL MEDICAL INFORMATION IN UKRAINE: PROBLEMS OF LEGAL REGULATION.

The aim of the article is to analyze the legal aspects and mechanisms of confidential medical information protection about an individual in the health care sphere in Ukraine. During the scientific research, various methods of cognition of legal phenomena were used. Among the general scientific approaches, the dialectical method was primarily used, which allowed to identify trends in the development of patient information rights and formulate proposals for improving legislation in the field of medical data protection. The formal-legal method was used to provide a comprehensive characterization of the EU (European Union) and Ukrainian legislation in the sphere of confidential medical information protection. Additionally, general scientific logical methods (analysis and synthesis, comparison and analogy, abstraction, and modeling) were used in order to study the problems of information relations in the medical field and establish legal liability for violation of the confidentiality of such information. The definitions of medical data, medical information, confidential medical data, and medical confidentiality have been researched and compared. The article identified the legitimate grounds for disclosing confidential medical information about an individual in the healthcare sector. Authors revealed the gaps in Ukrainian legislation regarding the confidential medical data protection by healthcare professionals and electronic medical systems regulators. The necessity of expanding the list of subjects responsible for preserving confidential medical information has been substantiated. The study explored the case law of the European Court of Human Rights in the field of the medical data confidentiality violation. It has been outlined the potential judicial remedies and liability for violating the right to personal medical information confidentiality of an individual in the healthcare sector. The legal grounds and cases of possible lawful disclosure of confidential medical information have been analyzed. Attention has been drawn to the insufficient regulation of access to medical confidentiality during martial law. It has been emphasized that the mechanism for protecting the violated right to confidentiality of medical information involves appealing to the Ukrainian Parliament Commissioner for Human Rights or to the court. The increasing role of international legal acts in ensuring the protection of medical data in the European Union and Ukraine has been highlighted.

Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. METHODS: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. RESULTS: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. CONCLUSIONS: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

EU space security-An 8-Step online discourse analysis to decode hybrid threats.

Space security has emerged as a concern for the European Union (EU), given that space systems have become integral to ensuring the safety of all European society. This strategy reflects the interaction of geopolitical dynamics and the rising specter of hybrid threats. However, grappling with hybrid threats targeting the EU space presents distinct challenges, primarily owing to their elusive nature. Hence, our objective is to develop practical methodologies to identify and mitigate such threats effectively. To meet this objective, we propose an innovative 8-step process. This approach streamlines the systematic identification and analysis of discourses of hybrid threats within online platforms dedicated to EU space discussions. Our methodology underwent rigorous scrutiny, including a comprehensive literature review that prioritized peer-reviewed manuscripts from sources such as Web of Science and Elsevier Scopus. Additionally, we selected documents from Google Scholar to ensure comprehensive coverage of diverse scholarly contributions, enriching the depth of our analysis. Our research yielded a conceptual framework for Online Discourse Analysis (ODA) tailored to evaluate hybrid threats targeting EU space defense and security. The results highlight the importance of leveraging advanced ODA techniques to deepen our understanding of emerging threats. In conclusion, we advocate for the adoption of these innovative methods to enhance the robustness of EU space defense strategies in the face of evolving security scenarios. The establishment of the 8-step ODA framework marks a pivotal milestone, offering a structured approach to deciphering hybrid threats. Looking ahead, we aim to empirically validate this framework by creating and deploying custom-tailored software designed to identify potential hybrid threats jeopardizing the security of European space assets. Through continued research and practical implementation, we endeavor to fortify the EU's defenses against emerging threats in the space domain.

Which domestic refrigerator temperatures in Europe? - Focus on shelf-life studies regarding Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods.

Listeria monocytogenes (Lm) is a pathogenic bacteria able to grow at refrigerated temperatures, widely distributed in the environment. This bacteria is susceptible to contaminate various food products of which refrigerated ready-to-eat foods (RTEF) may pose a risk for public health. In Europe, food business operators (FBOs) shall ensure that foodstuffs comply with the relevant microbiological criteria set out in the Regulation (EC) N°2073/2005. Food safety criteria for Lm are defined in RTEF throughout their shelf-life. FBOs should implement studies to demonstrate that the concentration of Lm does not exceed 100 CFU/g at the end of the shelf-life, taking into account foreseeable conditions of distributions, storage and use, including the use by consumers. However, this last part of the cold chain for food products is the most difficult to capture and control. For this purpose, the European Union Reference Laboratory for Lm (EURL Lm) launched an inquiry to its National Reference Laboratory network and reviewed the scientific literature from 2002 to 2020. The outcomes were integrated in the technical guidance document of the EURL Lm to assess shelf-life of RTEF which resulted in the recommendation to use 10 °C as the reference temperature to simulate the reasonably foreseen storage conditions in domestic refrigerators.

Regulatory landscape and challenges in CAR-T cell therapy development in the US, EU, Japan, and India.

Chimeric Antigen Receptor-T cell (CAR-T) therapy has evolved as a revolutionary cancer treatment modality, offering remarkable clinical responses by harnessing the power of a patient's immune system to target and eliminate cancer cells. However, the development and commercialization of CAR-T cell therapies are accompanied by complex regulatory requirements and challenges. This therapy falls under the regulatory category of advanced therapy medicinal products. The regulatory framework and approval tools of regenerative medicine, especially CAR-T cell therapies, vary globally. The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. This work explores the unique requirements and considerations for preclinical studies, clinical trial design, manufacturing standards, safety evaluation, and post-marketing surveillance in each jurisdiction. Due to their complex nature, developers and manufacturers face several challenges. In India, despite advancements in treatment protocols and government-sponsorships, there are still several difficulties regarding access to treatment for the increasing number of cancer patients. However, India's first indigenously developed CAR-T cell therapy, NexCAR19, for B-cell lymphoma or leukemia, approved and available at a low cost compared to other available CAR-T therapies, raises great hope in the battle against cancer. Several strategies are proposed to address the identified hurdles from global and Indian perspectives. It discusses the benefits of aligning regulatory requirements across regions, eventually facilitating international development and enabling access to this transformative therapy.

A Nordic Perspective on Patient Online Record Access and the European Health Data Space.

The Nordic countries are, together with the United States, forerunners in online record access (ORA), which has now become widespread. The importance of accessible and structured health data has also been highlighted by policy makers internationally. To ensure the full realization of ORA's potential in the short and long term, there is a pressing need to study ORA from a cross-disciplinary, clinical, humanistic, and social sciences perspective that looks beyond strictly technical aspects. In this viewpoint paper, we explore the policy changes in the European Health Data Space (EHDS) proposal to advance ORA across the European Union, informed by our research in a Nordic-led project that carries out the first of its kind, large-scale international investigation of patients' ORA-NORDeHEALTH (Nordic eHealth for Patients: Benchmarking and Developing for the Future). We argue that the EHDS proposal will pave the way for patients to access and control third-party access to their electronic health records. In our analysis of the proposal, we have identified five key principles for ORA: (1) the right to access, (2) proxy access, (3) patient input of their own data, (4) error and omission rectification, and (5) access control. ORA implementation today is fragmented throughout Europe, and the EHDS proposal aims to ensure all European citizens have equal online access to their health data. However, we argue that in order to implement the EHDS, we need more research evidence on the key ORA principles we have identified in our analysis. Results from the NORDeHEALTH project provide some of that evidence, but we have also identified important knowledge gaps that still need further exploration.

2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on 19-23 June 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17th edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2023 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 2) covers the recommendations on Biomarkers, IVD/CDx, LBA and Cell-Based Assays. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 9 and 7 (2024), respectively.

Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures.

INTRODUCTION: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA. AREAS COVERED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan. EXPERT OPINION: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.

Resilience dimensions in health system performance assessments, European Union.

Objective: To explore the definition and operationalization of resilience in health system performance assessments in European Union countries. Methods: We conducted multiple empirical case study analyses. We identified relevant cases through a literature review from 2014 to 2023 using Google Scholar and through a snowball technique to retrieve additional information. We included only documents that explicitly mentioned resilience in health system performance assessments. We performed a content analysis to identify common patterns in defining resilience. Findings: The final sample consisted of six countries: Belgium, Croatia, Czechia, Estonia, Ireland and Italy. Each country adopted a distinct approach to conceptualizing resilience, with countries prioritizing specific aspects based on lessons learnt from the coronavirus disease 2019 (COVID-19) pandemic. Some countries focused on maintaining essential health-care services and protecting vulnerable groups. Other countries prioritized management capacity, staff preparedness, digital health utilization and strengthening of primary health care. Content analysis revealed six resilience definitions derived from the key performance indicators: addressing unmet needs and maintaining outcomes; protecting vulnerable groups; acquiring and using resources; having trained and prepared staff in place; using digital health; and strengthening primary health care. Conclusion: Integration of resilience into the health profiles of European Union countries preceded its inclusion in national health system performance assessments, the latter of which became more prominent after the COVID-19 pandemic. Variations in interpretations within health system performance assessments reflect differences in indicators and policy responses.

Landscape features support natural pest control and farm income when pesticide application is reduced.

Future trajectories of agricultural productivity need to incorporate environmental targets, including the reduction of pesticides use. Landscape features supporting natural pest control (LF-NPC) offer a nature-based solution that can serve as a partial substitute for synthetic pesticides, thereby supporting future productivity levels. Here, we introduce a novel approach to quantify the contribution of LF-NPC to agricultural yields and its associated economic value to crop production in a broad-scale context. Using the European Union as case study, we combine granular farm-level data, a spatially explicit map of LF-NPC potential, and a regional agro-economic supply and market model. The results reveal that farms located in areas characterized by higher LF-NPC potential experience lower productivity losses in a context of reduced synthetic pesticides use. Our analysis suggests that LF-NPC reduces yield gaps on average by four percentage points, and increases income by a similar magnitude. These results highlight the significance of LF-NPC for agricultural production and income, and provide a valuable reference point for farmers and policymakers aiming to successfully invest in landscape features to achieve pesticides reduction targets.

Theoretical design of blockchain-based traceability for organic egg supply chains according to regulation (EU) 2018/848.

The use of blockchain technology to establish food traceability chains has the potential to provide transparent information of food stuffs along the entire supply chain and also aid in the documentation or even execution of official food control processes. Particularly in instances where analytical methodologies cannot provide definitive data for food control questions under study, the certificate-based approach of a traceability chain may offer a way of regulatory control for state authorities. Given the rising importance of organic produce and the high share of eggs among the organic produce in the European Union as well as the new EU regulation on organic products and labelling that came into force in 2022, we analyze here how the control of egg production type and marketing standards can be represented within a blockchain-based traceability chain such as to maximize the traceability in compliance with the current relevant EU regulations. Intended for the use by the official food control authorities, a traceability chain for organically produced eggs in the EU would need to be implemented as a permissioned blockchain, since only select entities are allowed to participate. By combining a proof of authority consensus mechanism with issuance of soulbound tokens, we effectively suggest a 'proof of soulbound authority' consensus process. The soulbound tokens are issued throughout the administrative chain from the European Commission down to the official food control authorities in individual member states that ultimately certify the control bodies for organic produce. Despite the general limitation of not providing unambiguous proof of the organic status of individual products, the concept discussed here offers advantages with respect to allocation of authority at EU level and therefore might have positive effects beyond the traceability chain.

Mutual recognition of qualifications, health workforce migration, and graduate outcomes: a comparative mapping study of undergraduate dental education in Europe.

BACKGROUND: The resource needs of health services are served by the recognition of qualifications across borders which allows professionals to migrate between countries. The movement of dentists across the European Union (EU), especially into the United Kingdom (UK), has provided a valuable boost to workforce supply. Recent changes to policy recognising overseas qualifications have brought attention to the equivalence of qualifications awarded in EU countries. Professional regulators need to be confident that dentists who qualified elsewhere have the appropriate knowledge, skills and experience to practise safely and effectively. The aim of this study was to compare UK and EU dental curricula, identify any differences, and compare the extent of pre-qualification clinical experience. METHODS: This was a mixed methods study comprising a questionnaire and website searches to identify information about curricula, competences, and quality assurance arrangements in each country. The questionnaire was sent to organisations responsible for regulating dental education or dental practice in EU member states. This was supplemented with information obtained from website searches of stakeholder organisations for each country including regulators, professional associations, ministries, and providers of dental education. A map of dental training across the EU was created. RESULTS: National learning outcomes for dental education were identified for seven countries. No national outcomes were identified 13 countries; therefore, learning outcomes were mapped at institution level only. No information about learning outcomes was available for six countries. In one country, there is no basic dental training. Clinical skills and communication were generally well represented. Management and leadership were less represented. Only eight countries referenced a need for graduates to be aware of their own limitations. In most countries, quality assurance of dental education is not undertaken by dental organisations, but by national quality assurance agencies for higher education. In many cases, it was not possible to ascertain the extent of graduates' direct clinical experience with patients. CONCLUSIONS: The findings demonstrate considerable variation in learning outcomes for dental education between countries and institutions in Europe. This presents a challenge to decision-makers responsible for national recognition and accreditation of diverse qualifications across Europe to maintain a safe, capable, international workforce; but one that this comparison of programmes helps to address.

Toxicological evaluation of microbial secondary metabolites in the context of European active substance approval for plant protection products.

Risk assessment (RA) of microbial secondary metabolites (SM) is part of the EU approval process for microbial active substances (AS) used in plant protection products (PPP). As the number of potentially produced microbial SM may be high for a certain microbial strain and existing information on the metabolites often are low, data gaps are frequently identified during the RA. Often, RA cannot conclusively clarify the toxicological relevance of the individual substances. This work presents data and RA conclusions on four metabolites, Beauvericin, 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR), Leucinostatin A and Swainsonin in detail as examples for the challenging process of RA. To overcome the problem of incomplete assessment reports, RA of microbial AS for PPP is in need of new approaches. In view of the Next Generation Risk Assessment (NGRA), the combination of literature data, omic-methods, in vitro and in silico methods combined in adverse outcome pathways (AOPs) can be used for an efficient and targeted identification and assessment of metabolites of concern (MoC).

A Case Study of Ergonomic Risk Assessment in Slovakia with Respect to EU Standard.

Attention on work-related musculoskeletal disorders (WMSDs) involves statistical surveys showing an increasing trend in the incidence of WMSDs. Technological development has led to new tools and methods for the assessment of physical load at work. These methods are mostly based on the direct sensing of appropriate parameters, which allows more precise quantification. The aim of this paper is to compare several commonly used methods in Slovakia for the assessment of ergonomic risk reflecting current EU and Slovak legislative regulations. A Captiv wireless sensory system was used at a car headlight quality control assembly workplace for sensing, data acquisition and data processing. During the evaluation of postures and movements at work, we discovered differences in the applicable standards: Decree 542/2007 Coll. (Slovak Legislation), the STN EN 1005-4+A1, and the French standards default in the Captiv system. Standards define the thresholds for hazardous postures with significant differences in several evaluated body segments, which affects the final evaluation of the measurements. Our experience from applying improved risk assessment methodology may have an impact on Slovak industrial workplaces. It was confirmed that there is a need to create uniform standards for the ergonomic risk assessment of body posture, including a detailed description of the threshold values for individual body segments.

Trends and current food safety regulations and policies for functional foods and beverages containing botanicals.

Globally, the demand for functional foods and beverages has significantly increased due to socioeconomic changes, particularly in health consciousness to enhance their functionality. Functional ingredients derived from botanicals are widely used because of their phytochemical properties with health benefits. This study aims to (1) review the capabilities and challenges of botanical addition in functional foods, (2) review current policies and regulations for functional foods containing botanicals in the European Union (EU), Canada, Japan, the Republic of Korea, and Thailand, and (3) provide recommendations on effective food safety control measures for better consumer trust and trade facilitation. This critical review was analyzed from online publications and available guidelines, regulations, and control measures published by food industries and governments in the EU and the four selected countries. The result confirmed that potentialities of botanicals arise from numerous bioactive compounds with varieties of sources. However, the usage may potentially raise health risks through hazardous substances in different species or plant parts, contaminants from environments and uncontrolled processes. Inadequate knowledge of botanical formulation and the maximum limit for daily consumption may elevate health risks through food-drug interaction or adverse effect incidents. Current policies and regulations show that varieties of measures are implemented influencing both economic growth and consumer awareness. The novel finding is that countries that provide a comprehensive national food control system influence not only the growth of the functional food subsectors but also build trust in food safety among trade partners and consumers.