Checkmating the Nutri-Score: Will Food Patriotism Prevent the Harmonization of Front-of-Pack Labeling Schemes within the EU?

Front-of-pack labeling schemes are an effective but contested regulatory approach to nudge consumers towards healthy food choices. The Nutri-Score, being implemented by seven European countries, is one of the most elaborated and evidence-based examples. Therefore, the Nutri-Score has been deemed as the frontrunner within the EU Commission's attempt to harmonize front-of-pack labeling among EU member states under its Farm-to-Fork strategy (F2F) by the end of 2022. However, the endeavor is on the brink of failure due to massive resistance by Mediterranean member states and parts of the food industry capitalizing on patriotic narratives (e.g. Made in Italy). This comment investigates the Nutri-Score saga from a political and commercial determinants of health lens. It argues that an EU-wide roll-out of the label hinges on the specific interplay between political structures and stakeholder agency. As shown, the EU's weak decision-making power has been exploited by the No-Nutri-Score alliance.

The Regulatory Challenges of Placing Dietary Ingredients on the European and US Market.

The DSHEA is 30 years old and its place in providing legitimate protections for public health through relevant agency oversight has created a patchwork of legal and scientific requirements. In contrast, the European Union has rules on supplements and permitted ingredients. Given the context of a global supply chain for food ingredients any conflict between the legality of ingredients between the U.S/EU can inhibit the economic viability of international trade. The purpose of this review is to contrast these different systems of legislative oversight. The analysis of both markets demonstrates a fragmentation in what are considered legal food ingredients between country wide harmonization and state rules and related interpretation. There are many commonalities in this regard between the U.S/EU, from borderline medicinal classifications to their resultant preclusion from food use. However, the codified legal system existing within the EU and excessive guidance can be viewed as time consuming and inflexible, especially for placing new ingredients on the market. The US in contrast is in a holding pattern for legislative interpretation regarding NDIs, GRAS and possible drug preclusion laws. As we hit the anniversary of the DSHEA recent commentary from U.S./EU central authorities point to increased international co-operation in ingredient safety assessments but whether this results in friction-free access between markets is to be determined.

Everyday Digital Literacy Questionnaire for Older Adults: Instrument Development and Validation Study.

BACKGROUND: The need for digital literacy in aging populations is increasing in the digitalizing society. Digital literacy involves the identification, evaluation, and communication of information through various digital devices or relevant programs. OBJECTIVE: The aims of this study were to develop an Everyday Digital Literacy Questionnaire (EDLQ), a digital literacy assessment scale, and subsequently evaluate its psychometric properties using a population of community-dwelling older adults in South Korea. METHODS: The EDLQ was developed using an instrument development design. A nationwide survey was conducted, and the study included 1016 community-dwelling older adults (age ≥60 years). To evaluate the psychometric properties, the participants were randomly divided into 2 groups (n=508 each), and the internal consistency (Cronbach α and McDonald ω), structural validity (exploratory factor analysis and confirmatory factor analysis), hypothesis-testing construct validity using the eHealth Literacy Scale (eHEALS), and measurement invariance were analyzed. RESULTS: Among the initial 30 items of the EDLQ, 22 items with a 3-factor solution had a total explained variance of 77%. The domains included "information and communication" (9 items), "content creation and management" (4 items), and "safety and security" (9 items). Confirmatory factor analysis was conducted with this 3-factor solution (χ2206=345.1; normed χ2206=1.7; comparative fit index=0.997; Tucker-Lewis index=0.997; root-mean-square error of approximation=0.036; standardized root-mean-square residual=0.050; composite reliability=0.903-0.959; average variance extracted=0.699-0.724; R2=0.616-0.773). Hypothesis-testing construct validity with the eHEALS revealed a strong correlation (r=0.75). Cronbach α and McDonald ω coefficients were .98 and 0.98, respectively. The fit indices for measurement invariance, including the configural, metric, and scalar invariance models, demonstrated a satisfactory fit to the data. Our findings suggest that the psychometric properties of the 22-item EDLQ are valid and reliable for assessing digital literacy among older Korean adults. CONCLUSIONS: In this study, we developed a digital literacy measure with strong psychometric properties that made it suitable for assessing the digital literacy of community-dwelling older adults in Korea. To broaden its applicability, however, further assessment of its feasibility for use with different languages and cultures is necessary. Moreover, more empirical research on digital literacy and related factors in older adults can facilitate the development of personalized digital health care services and educational interventions in the digital society.

EFSA Health Claims-Based Virgin Olive Oil Shelf-Life.

The consumption of extra virgin olive oil (EVOO) has been linked to various health benefits, including a reduced risk of cardiovascular disease. EVOO contains triglycerides and unsaturated fatty acids, as well as minor compounds, such as polar phenols and tocopherols, which play a crucial nutritional and biological role. The composition of these minor compounds is affected by various factors that distinguish EVOOs from lower-quality olive oils. The European Parliament approved Regulation 1924/2006 that governs the use of health claims on food products based on EFSA reports. Currently, there are several authorized health claims related to unsaturated fatty acids, vitamin E, and polyphenol content that can be used for commercial reasons on EVOO labels. Consumers can easily take enough grams of EVOO per day to receive the beneficial effects of the nutrient in question; nevertheless, the use of these health claims is subject to a required concentration of specific nutrients throughout the shelf life of olive oil. Few studies have examined the evolution of these compounds along the shelf life of EVOO to meet health claims. This work aims to evaluate the nutritional profile of several EVOOs with potential health claims and the evolution of related nutrients during storage in darkness at different temperatures. This study proposes an accelerated method to determine the end of the EVOO shelf life based on the loss of its nutraceutical capacity and the inability to comply with the stated health claims.

Identifying the origin of acrylamide in Peruvian panela production to inform strategies for its reduction.

Maximum levels of acrylamide have been set by the European Commission (EU) 2017/2158 for several food products due to its carcinogenic properties. Although not regulated yet, European buyers are requesting maximum levels of 0.8 mg kg-1 in artisanal panela (raw cane sugar) from northern Peru. Panela in this area is produced by 600 small holder farmers and exportation guarantees a respectable price in an area with a high index of poverty. The objective here was to determine the cause of high acrylamide concentrations in panela to inform cost effective minimisation strategies. We monitored panela production from field to final product to understand the scale of the problem, identify the cause of acrylamide formation, as well as the effect of storage on its concentration. We also determined the utility of rapid kits for asparagine quantification. Our results indicate that high acrylamide levels are a widespread problem (85% of samples analysed) and there was a correlation between acrylamide and asparagine of R2 = 0.58 (p < 0.001), but not with any post-harvest processing variable. We estimate that with a concentration of asparagine of <0.1 g l-1 in sugarcane juice, the threshold set by buyers for acrylamide can be met. Potential solutions to reduce asparagine include varietal selection, improved agronomic practices and the use of asparaginase during panela production. However, any proposed measure should be applicable in the context of the rural Peru. Additionally, we confirm the utility of rapid and low-cost kits for measuring asparagine. This pioneering study provides a baseline for effective management for acrylamide minimization in panela.

Is the EU chemicals strategy for sustainability a green deal?

A fully integrated Chemicals Strategy for Sustainability (CSS) in respect of chemicals is crucial and must include: • An objective evaluation of the present situation including impacts of 'chemicals of concern' throughout their life cycle, that incorporates sustainability issues. • A framework that facilitates innovation of chemistry-based approaches to tackle each of the key sustainability issues. The EU CSS only addresses adverse impacts and mainly focusses on one aspect of risk assessment, the hazard to humans from individual industrial chemicals. The proposal removes consideration of the nature and amount of exposure, which is a critical determinant of risk. It can be presumed that this is solely to simplify, and hence speed up, regulatory decisions thereby enabling more chemicals to be assessed. The linkage of this proposed approach to address any of the major sustainability issues, such as environmental pollutants is obscure. For example, the well-recognised environmental problems caused by polymers such as plastics are not considered. The proposed change in the assessment methodology lacks any scientific justification and fails to address the sustainability issues the EU and the rest of the world are facing. The authors critically discuss a comprehensive innovative evaluation methodology for the impact of chemicals.

The European Kidney Health Alliance (EKHA) and the Decade of the KidneyTM.

The European Kidney Health Alliance (EKHA) is an advocacy organization that defends the case of the kidney patients and the nephrological community at the level of the European Union (EU), and from there, top to bottom, also at the national level of the EU member states and the EU-associated countries. The Decade of the KidneyTM is a global initiative launched by the American Association of Kidney Patients (AAKP) to create greater awareness and organize patient demands for long overdue innovation in kidney care. This article describes the medical and patient burden of kidney disease, the history of EKHA, its major activities and tools for policy action, and the need for innovation of kidney care. We then describe the Decade of the KidneyTM initiative, the rationale behind why EKHA joined this activity to emanate parallel action at the European side, the novel professionalized structure of EKHA, and its immediate targets. The final aim is to align all major stakeholders for an action plan on kidney disease comparable to Europe's successful Beating Cancer Plan, with the additional intent that the EKHA model is applied also by the respective national kidney-related societies to create a broad mobilization at all levels. The ultimate aims are that the EU considers chronic kidney disease (CKD) as a major health and health-economic problem, to consequently have CKD included as a key health research target by the European Commission, and to improve quality of life and outcomes for all kidney patients.

American and European legislation on border medical devices.

INTRODUCTION: Borderline medical devices are products in a 'gray area,' this means due to their characteristics, they could belong to different 'legal products.' In addition, regulation is a controversial topic and may change depending on the country which may put public health at risk and distort the market. AREAS COVERED: This article analyzes how borderline medical devices are managed in the American and the European legislation. We compared the decisions made by both regulations on the devices of the Manual on Borderline and Classification Medical Devices of the European Commission for the first three sections, those which deal exclusively with medical devices. EXPERT OPINION: Borderline medical devices do not have to be understood as something specific to each country. The different classification of products creates international borders. It is necessary to create working groups in international organizations in which global consensus is reached. Although a priori it seems that the American system could be more efficient, studies with quantitative data from authorized devices are needed to show that. Until EUDAMED is not fully operational and open access, it will not be possible to develop them.

Borderline products do not have a simple product classification and can be managed differently depending on different countries. The different classification between countries has economic consequences for companies and patients. In this article, the American and European regulations system is compared, specifically borderline products, using as a tool the Borderline and Classification Manual of the European Commission. Results show the international consensus is necessary to avoid barriers to trade and contribute to innovation. Although both regulations have points of improvement, with the data from the Manual (EU), it seems that American regulatory system could be more efficient, although copying some of its strengths could be complicated due to the intrinsic characteristics of the European system. However, studies with quantitative data are needed to corroborate this statement.

The process of building European university alliances: a rhizomatic analysis of the European Universities Initiative.

Drawing upon French philosophy, this study offers a novel empirical and conceptual understanding of the newly launched European Universities Initiative. In 2019, higher education institutions across the European Union created 17 new alliances as part of the first pilot phase of the initiative. This is an experiment in European and global higher education. This paper offers a conceptual contribution to the field of higher education studies, making use of a rhizomatic analysis to explore how university alliances build what the European Commission refers to as the 'European universities of the future.' Based on the conceptual reflection and findings from a small-scale empirical study, this paper concludes that the alliances within the European Universities Initiative rely on pre-existing higher education and research partnerships while at the same time experimenting to foster a diversity of institutional forms to achieve the ambitious goal of creating 'European Universities.'

Land use efficiency of functional urban areas: Global pattern and evolution of development trajectories.

The application of last-generation spatial data modelling, integrating Earth Observation, population, economic and other spatially explicit data, enables insights into the sustainability of the global urbanisation processes with unprecedented detail, consistency, and international comparability. In this study, the land use efficiency indicator, as developed in the Sustainable Development Goals, is assessed globally for the first time at the level of Functional Urban Areas (FUAs). Each FUA includes the city and its commuting zone as inferred from statistical modelling of available spatial data. FUAs represent the economic area of influence of each urban centre. Hence, the analysis of land consumption within their boundary has significance in the fields of spatial planning and policy analyses as well as many other research areas. We utilize the boundaries of more than 9,000 FUAs to estimate the land use efficiency between 1990 and 2015, by using population and built-up area data extracted from the Global Human Settlement Layer. This analysis shows how, in the observed period, FUAs in low-income countries of the Global South evolved with rates of population growth surpassing the ones of land consumption. However, in almost all regions of the globe, more than half of the FUAs improved their land use efficiency in recent years (2000-2015) with respect to the previous decade (1990-2000). Our study concludes that the spatial expansion of urban areas within FUA boundaries is reducing compactness of settlements, and that settlements located within FUAs do not display higher land use efficiency than those outside FUAs.

Analysis of Content, Social Networks, and Sentiment of Front-of-Pack Nutrition Labeling in the European Union on Twitter.

In recent years, concerted political efforts have been made at the national and European Union (EU) level to promote the consumption of healthy foods. The European Commission (EC) expressed the need for a harmonized and mandatory front-of-pack nutrition labeling (FOPL) system at the EU level. The EC will adopt the proposal by the end of 2022. Our research work aims to understand the public discourse on FOPL in the EU via Twitter, by analyzing tweet content, sentiment, and mapping network characteristics. Tweet search and data collection were performed using the Twitter application programming interface (API), with no time or language restrictions. The content was coded with the QRS Nvivo software package and analyzed thematically. Automatic sentiment analysis was performed with QSR Nvivo, and network analysis was performed with Gephi 0.9.2. A total of 4,073 tweets were posted, mostly from the UK, Spain, and France. Themes that have emerged from the discussion on Twitter include the types of food labeling, food industry, healthy vs. unhealthy foods in the context of food labeling, EU regulation, political conflicts, and science and education. Nutri-Score dominated the discussion on Twitter. General topics were perceived negatively by Twitter users with more positive sentiments toward the food industry, while negative sentiments were observed toward the discourse of political conflicts. The network analysis showed that a centralized communication was hardly existed between countries. Our results reveal that the discussion of FOPL on Twitter is limited to a very limited group of people, and it seems necessary to inform a wide range of consumers about existing and upcoming FOPL schemes. Educational programs should empower consumers to understand what a healthy diet is and how it relates to FOPL, regardless of the existing labeling system.

Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.

Introduction: Autologous chondrocytes (ACs) are Human cell/tissue-based products used for the treatment of joint cartilage defects. Regulatory agencies have established regulations related to ACs to ensure their safety and efficacy. This study investigated the status and characteristics of ACs approved worldwide. Furthermore, the AC-related regulations were compared by country to provide reference materials for the development of product approval procedures. Methods: This study reviewed the current status of global AC products over the past 20 years by referring to the AC approval list provided on the International Society for Cell & Gene Therapy (ISCT) website. Based on the review report provided by the regulatory agencies that approved the products, major nonclinical/clinical data and product characteristics were reviewed; and the classification and definition of ACs and the approval review procedures were compared through the regulatory agencies' websites. The development status of ACs was also analyzed using a clinical trial registration site. Results: Eight ACs were approved during the study period in Europe, the US, Japan, Australia, and Korea. Two products were withdrawn owing to marketability problems. Human cell/tissue-based products in each country are classified and defined distinguished from biopharmaceuticals, but the approval process for both products is the same. The approval period differs by country, with an average of 282.4 days and the shortest being in Korea (115 days). On Clinical Trials.gov, we screened 46 clinical trials related to ACs, which were conducted in Europe (41%), Korea (20%), and the US (17%). The knee accounted for the largest portion of the indication (37/46, 80%), followed by the ankle or hip joints. Measurements of improvements in function and pain were the main endpoints used to evaluate the efficacy of ACs. Observational studies were conducted to confirm the long-term safety of these products. Conclusions: This is the first study comparing the current status and characteristics of globally approved AC products, as well as their classification and definition by country. In the past two decades, clinical trials have been conducted on the application of ACs in tissue engineering to treat joint cartilage defects. ACs are expected to be used for the treatment of cartilage defect diseases.

Artificial intelligence in laboratory medicine: fundamental ethical issues and normative key-points.

The contribution of laboratory medicine in delivering value-based care depends on active cooperation and trust between pathologist and clinician. The effectiveness of medicine more in general depends in turn on active cooperation and trust between clinician and patient. From the second half of the 20th century, the art of medicine is challenged by the spread of artificial intelligence (AI) technologies, recently showing comparable performances to flesh-and-bone doctors in some diagnostic specialties. Being the principle source of data in medicine, the laboratory is a natural ground where AI technologies can disclose the best of their potential. In order to maximize the expected outcomes and minimize risks, it is crucial to define ethical requirements for data collection and interpretation by-design, clarify whether they are enhanced or challenged by specific uses of AI technologies, and preserve these data under rigorous but feasible norms. From 2018 onwards, the European Commission (EC) is making efforts to lay the foundations of sustainable AI development among European countries and partners, both from a cultural and a normative perspective. Alongside with the work of the EC, the United Kingdom provided worthy-considering complementary advice in order to put science and technology at the service of patients and doctors. In this paper we discuss the main ethical challenges associated with the use of AI technologies in pathology and laboratory medicine, and summarize the most pertaining key-points from the guidelines and frameworks before-mentioned.

Forging Unity: European Commission Leadership in the Brexit Negotiations.

This article explains why the European Union has remained strikingly cohesive during the Brexit withdrawal negotiations by focussing on the role played by its negotiator: the European Commission''s Task Force 50. The analysis demonstrates that the Task Force 50 set out to forge unity among the EU27 by exercising both subtle instrumental and direct political leadership. The Commission significantly influenced the outcome of the negotiations by shaping the agenda and process, brokering deals, and ultimately achieving a withdrawal agreement that all member states signed up to. Its transparent and consultative behaviour generated trust among member states, which allowed the Commission to play such a prominent role. These findings challenge the prevailing view that the EU has become increasingly intergovernmental at expense of the Commission. Drawing on original interviews, the article substantiates this argument by tracing the Commission's leadership activities in the run-up to and throughout the withdrawal negotiations (2016-20).

The current status of uptake of European Basic Safety Standard (2013/59/Euratom) requirements: results of a follow-up survey in European radiology departments.

The recently implemented European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom lays down core radiation protection standards for European radiology departments, including a mandatory requirement for supporting processes of clinical audit. A repeat survey on behalf of the European Society of Radiology (ESR) was undertaken in February 2021, involving the ESR EuroSafe Imaging Star department network, to re-assess compliance with selected key BSSD requirements following an initial survey in 2018 where variable compliance was demonstrated. 61% (78/128) of eligible departments participated and overall the survey results revealed a mixed picture in terms of implementation of BSSD requirements when compared to the 2018 survey with both improvement and deterioration observed. This pattern was seen also in relation to supporting processes of regulatory audit and re-audit. Higher levels of "skipping" of responses were also observed in 2021. These findings were unexpected in light of the interventions in relation to audit (clinical and regulatory) and radiation protection undertaken by the ESR and other organisations in recent years, but can reasonably be explained by the onset of the COVID-19 pandemic, with consequent significant disruption of radiology services. The 2021 survey results do serve to highlight again the need for co-ordinated intervention involving relevant European bodies, organisations and governmental agencies to address the important issues raised by this survey. The European Commission clinical audit and radiation protection initiatives, QuADRANT, led by the ESR, and SAMIRA will act as important drivers for improvement in patient safety, experience and outcomes across Europe.

Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis.

Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (https://eur-lex.eur-opa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L0079&qid=1628781352814) to IVDR 2017/746 https://eur-lex.europa.eu/eli/reg/2017/746. Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its "droit d'exister".

Reactions of euro area government yields to Covid-19 related policy measure announcements by the European Commission and the European Central Bank.

This paper evaluates the impact of announcements of Covid-19 related monetary and fiscal policy measures by the European Central Bank and the European Commission. Applying an event study, we find that the announcements predominantly affect the government bond yields of more solvent countries such as Germany and the Netherlands. Since this finding mainly holds for the announcements of fiscal measures, we conclude that the investors are primarily concerned about the future fiscal burden that has to be shouldered by those solvent countries within the euro area.

Contextual differences considered in the Tunisian ADOLOPMENT of the European guidelines on breast cancer screening.

BACKGROUND: Breast cancer is a common disease in Tunisia and is associated with high mortality rates. The "Instance Nationale de l'Evaluation et de l'Accréditation en Santé" (INEAS) and the Tunisian Society of Oncology decided to develop practice guidelines on the subject. While the development of de novo guidelines on breast cancer screening is a demanding process, guideline adaptation appears more appropriate and context sensitive. The objective of this paper is to describe the adaptation process of the European Guidelines on Breast Cancer Screening and Diagnosis to the Tunisian setting in terms of the methodological process, contextual differences between the source and adoloped guideline, and changes in the recommendations. METHODS: We used the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE)-ADOLOPMENT methodology to prioritize the topic, select the source guideline, and prioritize the questions and the outcomes. Once the source guideline was selected-the European Breast Cancer Guidelines-the European Commission´s Joint Research Centre shared with the project team in Tunisia all relevant documents and files. In parallel, the project team searched for local studies on the disease prevalence, associated outcomes' baseline risks, patients' values and preferences, cost, cost-effectiveness, acceptability, and feasibility. Then, the adoloping panel reviewed the GRADE evidence tables and the Evidence to Decision tables and discussed whether their own judgments were consistent with those from the source guideline or not. They based their judgments on the evidence on health effects, the contextual evidence, and their own experiences. RESULTS: The most relevant contextual differences between the source and adoloped guidelines were related to the perspective, scope, prioritized questions, rating of outcome importance, baseline risks, and indirectness of the evidence. The ADOLOPMENT process resulted in keeping 5 out of 6 recommendations unmodified. One recommendation addressing "screening versus no screening with ultrasound in women with high breast density on mammography screening" was modified from 'conditional against' to 'conditional for either' due to more favorable ratings by the adoloping panel in terms of equity and feasibility. CONCLUSION: This process illustrates both the feasibility of GRADE-ADOLOPMENT approach and the importance of consideration of contextual evidence. It also highlights the value of collaboration with the organization that developed the source guideline.