EU Risk Research Articles

Overview of PFAS, toxicology, historical levels in EU vs. health effects and EU risk assessments

Overview of PFAS, toxicology, historical levels in EU vs. health effects and EU risk assessments

Standards made in Europe for global use

This commentary reflects on the contributions by Egan, Delimatsis and Verghese that provide historical accounts of ETSI’s origin and its dynamic evolution and attempt to explain its resilience. In this commentary, we place focus on ETSI’s unique attributes and their dynamic evolution to arrive at a better understanding of its resilience during critical moments and over time. We identify three such key attributes, namely ETSI’s institutional set-up and openness, its standard-setting activities and flexibility and the ETSI IPR policy. The article illuminates their importance, also in ETSI’s interactions with the European Commission and how these traits originated, were activated and evolved during critical moments. Taken together, these contributions suggest that the governance reforms proposed by the EU risk undermining the attractiveness of open European ICT standardization, a key ingredient of ETSI’s very success in ICT matters.

Why the EU risks missing its 2050 carbon neutrality target by focusing only on new (electric) car sales

In 2016, by signing and ratifying the Paris Agreement, the European Union committed to making the EU economy and society climate neutral by 2050. In 2016, partly because of this goal, the European Council endorsed an interim target of a 55% net domestic reduction in climate-changing gas emissions by 2030. The transport sector is among those called upon to make the greatest effort, both because of its percentage weight (25% of the EU's greenhouse gas emissions) and its progress to date (-10% from 1990 levels). Recent regulatory measures suggest that there is still much work to be accomplished to attain climate neutrality in the transportation sector. The paper examines the impact of vehicle emission performance stand- ards (443/2009/EC; 333/2014/EU; 2019/1242/EU; 2019/631/EU; 2023/851/EU) on the sup- ply and demand of cars in the EU automotive market and tests the consistency of the ongoing transformations with the Paris Agreement. Although changes in both production and purchase have been made in the direction desired (perhaps mandated) by policy makers, it appears that the scale of these is not meeting the required timeline. Much remains to be done to eliminate options, such as fuel decarbonization, which can effectively reduce the carbon footprint of the road fleet.

Regional crises and European fiscal preferences: how regional Covid-19, economic downturn, and migration shape support for EU risk sharing

ABSTRACT Economic suffering prompted by the Covid-19 pandemic, coming on the heels of earlier 2008 global-financial and 2015 migration crises, revived debate on citizen support for European fiscal integration policies. Such support can be expected to reflect not only individual-level characteristics but also the extent of crisis exposure in subnational regional contexts where individuals live and work. Unfortunately, existing studies of public support have said little about such regional contexts. This study hence explores how regional-level experience with ‘polycrisis’ affects support for EU fiscal capacities, combining regional-level crisis measures with a 2020 survey experiment on European citizens’ preferences towards fiscal capacity instruments in 5 European countries (DE, ES, FR, IT, NL). This allows tests of whether individual support for various European fiscal capacities reflect regional differences in covid suffering, growth losses after the 2008 global financial crisis, and migration spikes from the 2015 migration crisis. We expect and find that citizens in regions more heavily impacted by the pandemic, financial crisis, and (albeit less so) migration crisis – measured separately and as a composite – tend to more readily support European fiscal integration capacity that is redistributive between countries, financed through progressive taxation, refrains from budgetary conditionality, and is lenient towards reform non-compliance.

Carbon emissions from international trade and consumption: Assessing the role of cumulative risk for EU and Chinese economic development

The study examines the relationship between trade openness and carbon dioxide emissions in the cumulative risks context for China's economic development and the European Union. Hypotheses derived from a review of the literature substantiate the following key findings: (1) A reduction in CO2 emissions in developed countries due to restrictions on international trade may lead to an increase in CO2 emissions in developing and transitional economies. (2) Trade restrictions can reduce CO2 emissions in developed countries by shifting production to less developed nations. (3) The existing trade restriction policies do not effectively curb global CO2 emissions and may exacerbate social inequality between “wealthy” and “poor” countries. The study findings hold relevance for policymakers, academic researchers, experts in climate change mitigation.

Description and validation of an improved method to feed solitary bees (Osmia spp.) known amounts of pesticides

Pesticide exposure is an important driver of bee declines. Laboratory toxicity tests provide baseline information on the potential effects of pesticides on bees, but current risk assessment schemes rely on one species, the highly social honey bee, Apis mellifera, and there is uncertainty regarding the extent to which this species is a suitable surrogate for other pollinators. For this reason, Osmia cornuta and Osmia bicornis have been proposed as model solitary bee species in the EU risk assessment scheme. The use of solitary bees in risk assessment requires the development of new methodologies adjusted to the biology of these species. For example, oral dosing methods used with honey bees cannot be readily applied to solitary bees due to differences in feeding behaviour and social interactions. In this study, we describe the “petal method”, a laboratory feeding method, and validate its use in acute and chronic exposure oral tests with Osmia spp. We conducted five experiments in which we compared the performance of several artificial flowers combining visual and olfactory cues against the petal method, or in which variations of the petal method were confronted. We then use the results of these experiments to optimize the feeding arenas and propose standardized methods for both acute and chronic exposure tests. The petal method provides high levels of feeding success, thus reducing the number of bees needed. It works with a wide variety of petal species and with both female and male Osmia spp., thus ensuring reproducibility across studies. To validate the use of the petal method in ecotoxicology tests, we assess the toxicity of a standard reference insecticide, dimethoate, in O. cornuta adults and determine LD50 values for this species. The petal method should facilitate the inclusion of solitary bees in risk assessment schemes therefore increasing the protection coverage of pesticide regulation.

Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020.

To examine prescriptions of valproate and oral antiepileptic drugs (OAED) in Germany irrespective of the indication in women in general and particularly in women of childbearing age (13-49 years) and during pregnancy between 2010 and 2020, that is, before, during and after the implementation of the EU risk minimization measures (RMMs). Analysis of claims data. all women continuously insured with the AOK health insurance fund in the respective observation year (2010-2020) and the previous year. OAED were identified by ATC code N03. Period of pregnancy was calculated based on birth information in claims data. (i) prevalent use of valproate/OAED: number of women with at least one prescription of valproate/OAED per year divided by all women of the study population (rate per 1000 women); (ii) percentage of OAED recipients with at least one valproate prescription during pregnancy (13-49 years) in the respective observation year. Prevalence rate/1000 women for valproate use decreased by -31.33% across all age groups (2010-2014: -7.48%; 2014-2018: -16.47%; 2018-2020: -11,17%) with a strong reduction in women 13-49 years between 2014 and 2018 (-28.74%). The rate for OAED across all age groups rose from 33.43/1000 women in 2010 to 41.03/1000 (+22,73%). Valproate use during pregnancy of women with OAED declined from 1.29% in 2010 to 0.59% in 2020 (-54,26%) (2010-2014: -5.14%; 2014-2018: -42.31%; 2018-2020: -16.69%). Even if, due to the descriptive nature of the study, no causal relationship can be postulated between the RMMs and the strong decrease in valproate prescriptions, our results are compatible with the hypothesis that the measures have improved drug therapy safety.

Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study.

Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018. To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions. A multi-database, times series study of females of childbearing potential (12-55 years) was conducted using electronic medical records from five countries/regions (01.01.2010-31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of contraception coverage during valproate use, and occurrence of pregnancies during valproate exposure were estimated per month. Interrupted time series analyses were conducted to estimate the level or trend change in the outcome measures. We included 69,533 valproate users from 9,699,371 females of childbearing potential from the five participating centres. A significant decline in prevalent use of valproates was observed in Tuscany, Italy (mean difference post-intervention -7.7%), Spain (-11.3%), and UK (-5.9%) and a non-significant decline in the Netherlands (-3.3%), but no decline in incident use after the 2018 RMMs compared to the period before. The monthly proportion of compliant valproate prescriptions/dispensings with a contraceptive coverage was low (<25%), with an increase after the 2018 RMMs only in the Netherlands (mean difference post-intervention 12%). There was no significant increase in switching rates from valproates to alternative medicine after the 2018 intervention in any of the countries/regions. We observed a substantial number of concurrent pregnancies during valproate exposure, but with a declining rate after the 2018 RMMs in Tuscany, Italy (0.70 per 1000 valproate users pre- and 0.27 post-intervention), Spain (0.48 and 0.13), the Netherlands (0.34 and 0.00), and an increasing rate in UK (1.13 and 5.07). There was a small impact of the 2018 RMMs on valproate use in the studied European countries/regions. The substantial number of concurrent pregnancies with valproate exposure warrants a careful monitoring of implementation of the existing PPP for valproate in clinical practice in Europe, to see if there is any need for additional measures in the future.

Chronic oral exposure to Amistar fungicide does not significantly affect colour discrimination but may impact memory retention in bumblebees

BackgroundIntensive agriculture, including pesticides, is one of the many reasons for pollinator decline. The EU legislation on plant protection products (hereon pesticides) demands that the risks of active substances and their use in pesticide products are assessed for bees. However, the risk assessment is not always sufficient as shown, for example, in the case of the fungicide Amistar. The fungicide has been shown to cause lethal and sublethal effects on bumblebees at levels that, according to the EU risk assessment, do not require risk mitigation measures to protect bees. In order to understand the effects of chronic Amistar exposure on bumblebees, we studied whether 5 days of oral exposure to 0.015 µl Amistar (3.75 µg azoxystrobin/day) impairs bumblebees’ learning and memory performance in the 10-colour discrimination task.ResultsChronic Amistar treatment did not impair the learning of the bees, but a statistically non-significant negative trend was observed in memory retention between the final learning bout and the subsequent memory test.ConclusionsThe results of our study suggest that chronic sublethal exposure to Amistar fungicide did not significantly impair the learning ability of bumblebees. However, there was a trend towards impaired memory retention, although this was not statistically significant. These findings provide further support for the hypothesis that Amistar may have a negative effect on bee cognitive performance. It is important to continue studying the effects of widely used pesticides on pollinators, as their decline is a complex issue with multiple contributing factors. Understanding the effects of different pesticide residue levels on bumblebees can inform policymakers in making more sustainable pesticide legislation and help protect pollinators.

The EU Eastern Enlargement Policy Under the Pressure of Geopolitics. The Bulgarian Case (Russia’s Little Brother)

The Bulgarian case is symptomatic of the susceptibility of the EU enlargement policy under geopolitical pressure. The aim of this text is to add arguments to the statement that the dynamic of Bulgaria’s accession to the EU has been strongly influenced by external factors – mainly Yugoslavia’s disintegration and the subsequential Kososvo crisis. This crisis brought up the issue of the huge Russian influence over Bulgarian politics and societies and, as a result, predetermined the perception of Bulgaria as a high security risk for EU. In this situation, Bulgaria was an object of de-securitisation by the EU’s enlargement policy, but at the same time its main instrument, namely, the conditionality policy, was neglected. From this point of view, the Bulgarian case is important because: it illustrates the effects of this discrepancy to date; it is instructive in the context of EU enlargement policy towards the Western Balkans with huge Russian influence; and also in the context of the acceleration of the EU’s eastern enlargement policy toward Ukraine and Moldova because of the pressure of the ongoing Russian military invasion. The opportunity for accelerating the pre-accession process under the infl uence of unpredicted external events created prerequisites for politicising the whole process, including the political use of the conditionality and the consequently unfinished preaccession preparation of the newcomers. The research task is fulfilled by a synthesis of primary and secondary sources organised around three main questions – Which external circumstances? Why? and, How? The results of a discourse analysis of interviews with key participants in Bulgaria’s EU integration process are used as a starting point.

Transatlantic Divergencies in the Regulation of Uncertain Risks: Co-Production, Normative Frames and Ideal Evidence-Based and Socially Acceptable Risk Approaches

AbstractThis article analyses the US and the EU systems of risk regulation through the lens of two ideal models: evidence-based and socially acceptable risk approaches. The examination is conducted against the backdrop of these ideal regulatory paradigms, which broadly inform US and EU risk governance. The article employs an analysis of transatlantic divergencies in the regulation of pesticides and agricultural biotechnologies to illustrate that neither approach can lay claim to neutrality and objectivity; non-scientific normative frames are always at stake in the field of risk regulation. Through these case studies, the article thus challenges the narrative that transatlantic divergencies result from a focus on “risks” or “hazards,” “science” or “politics.” The US and the EU systems reflect different approaches to scientific uncertainty, the pursuit of different levels of protection, and consideration of different non-scientific factors. They also have very different implications. The conclusive section of the article sketches out some final considerations on the strategic vision of the Biden administration. Environmental and public health protection are high on President Biden’s agenda; further, public interest litigation is thriving in the US. Will this be sufficient to break regulatory path dependency and lay the foundations for a paradigm shift in US risk governance?

The transparency of EU agency science: Towards a new proactive approach

Recent health and environmental crises have emphasized the importance of transparency of agency science, i.e. the scientific information that underpins public regulation. Yet how EU law shapes the transparency of EU agency science and whether it contributes to publicly holding experts to account for the quality of their advice, remains an open question. This article analyses the transparency regimes of three EU agencies.We show that the EU legal approach to transparency of agency science is undergoing significant change, through legislative reform and agency practice. The traditional “passive” approach based on the Access Regulation is fragmented and reveals several shortcomings. Recent trends, such as the 2021 reform of the General Food Law, indicate that the EU is moving towards “proactive transparency”, which improves expert accountability. Our study contributes to debates on EU risk regulation and the general reform of the Access Regulation. The article offers an interdisciplinary perspective informed by political epistemology, namely the study of the role of experts in public decision-making.

Food safety and public health within the frame of the EU legislation

The purpose of this article is to examine some of the issues related to qualitative food safety within the framework of European Union legislation. The development of a multidimensional regulatory system at European level, which has necessarily included international sources, regulations and European Union laws, also relating to national and regional legislations, has rendered finding a balance between the legitimate interests of food producers and consumers problematic. In recent years, the ethical dimension of food has progressively developed, which has led to a greater attention to the way food is produced and consumed, while respecting health protection, food quality and European and international trade dynamics. On the consumer side, however, there has been a growing awareness of the possible risks linked to food and an attention to the issues of food safety. Such awareness is intensified by the use of certain technologies in the food sector. Consumers are increasingly looking to buy commercial products capable of minimizing damage to their health. Consumers consciousness has also influenced the industry, which has increasingly felt the need to pay greater attention to the entire production cycle, thus encouraging production carried out by following the correct methods of supply, processing, up to the final stages of packaging, storage, processing and distribution, in accordance with the “Good Agricultural Practices” (GAP). In conclusion, the important monitoring path of product traceability that has led to a significant increase in the commitment to EU legislative supervision, risk assessment and review of the substances used in food production.

The new European Transparency Regulation: a panacea for EU risk assessment?

The new European Transparency Regulation: a panacea for EU risk assessment?

Proposal of a ranking methodology for plant threats in the EU.

Following a request of the European Commission, EFSA and ANSES, beneficiary of the EFSA tasking grant on horizon scanning for plant pests (GP/EFSA/ALPHA/2017/02), developed a methodology to order by risk non‐regulated pests recently identified through the monitoring of media and scientific literature. The ranking methodology proposed at the end of the pilot phase was based on the scoring of pests under evaluation following 16 criteria related to the steps of the pest risk assessment scheme. The multicriteria matrix of scores obtained was then submitted to the multicriteria analysis method PROMETHEE. The pilot methodology was tested on a limited number of pests (14 pests identified during the monitoring activity, and 4 ‘control’ pests whose well‐known risk should be reflected either in a positive or negative score), then applied on all non‐regulated pests identified through the media and scientific literature monitoring in the first 2 years of the project. After having collected feedback from the targeted final users (EU risk managers), the methodology underwent a few refinements: (i) implementation of the methodology to a set of already assessed reference pests from EFSA opinions, (ii) exclusions of three criteria from the scoring phase, (iii) identification of pests proposed for further action (‘positive’ pests), using a threshold defined after scoring the reference pests.

Natural Fusarium Toxin Contamination of Wheat in Southern Part of Hungary

Fusarium head blight (FHB), primarily caused by a fungal plant pathogen Fusarium graminearum, is a devastating disease of wheat and other cereals. FHB reduces yield, but also the quality and feeding value of the crop. The fungus produces the mycotoxin deoxynivalenol (DON) that poses a significant threat to the health of domestic animals and humans. In 2019 Fusarium epidemic occurred not only the southern and eastern parts of Hungary, but affected other area of Central Europe. The mycotoxin patterns varied tremendously, depending on the geographic area, different resistance levels of wheat genotypes, weather and soil conditions and cropping factors. In this survey 192 samples of different bread wheat (Triticum aestivum L.) genotypes from three geographically different regions were tested for DON toxin contamination by HPLC-MS method. Average levels of mycotoxin contamination 3.80 mg/kg; it is three times higher than the European maximum limit for unprocessed cereals intended for human consumption. The content range is very wide (0.15 – 20.71 mg/kg), 76% of the samples exceeded the EU risk threshold level.

Sorbates and benzoates in meat and meat products: Importance, application and determination

Recent views on the use of preservatives sorbic and benzoic acids and their salts in meat products are presented from the point of accordance with current legislation in the Republic of Serbia and the EU, food safety and public health risks, and mainstreams in the methodology for their determination. These preservatives are permitted to be added individually or in combination, the maximum level is applicable to the sum and the levels are expressed as the free acid. Currently set values of the recommended daily intake of sorbate and benzoate are 25 mg/kg and 5 mg/kg, respectively. These values vary and depend on regulations in different countries. Considering control of the use of these additives, the most common methods for their determination are chromatographic methods based on high performance, or high pressure, liquid chromatography with diode array detectors.

EU health solidarity in times of crisis: explaining public preferences towards EU risk pooling for medicines

ABSTRACT The COVID-19 outbreak in Europe has brought attention to EU health policy as a focal point for solidarity, particularly as it concerns access to medicines. Against the backdrop of policy proposals for EU joint procurement of medicines, this article expands our understanding of public opinion towards this particular aspect of European integration. Drawing on data from a conjoint experiment in five EU countries, the study investigates the extent to which citizens’ preferences concerning alternative policy designs for EU joint procurement of medicines are either structured along a pro-EU versus anti-EU or ideological divide, or are crisis driven by the perceived COVID-19 threat. The analysis reveals that individual preferences over the design of EU risk pooling for medicines are most strongly explained by Euroscepticism, while egalitarian ideology plays only a modest role. How citizens’ perceived threat of COVID-19 affects their preferences for this form of EU risk pooling is dependent on the national context.

Risk evaluation in road tunnels based on CFD results

Approaches to risk assessment in tunnelling and underground spaces were introduced in 2004 as a result of several serious accidents in tunnels such as Mont Blanc and Tauern Tunnel in 1999. The EU has published the minimum safety requirements for tunnels over 500 m on Trans-European Road Network. The risk assessment is mandatory and should cover all components of the system, i.e. infrastructure, operation, users and vehicles. The professional community has started using the quantitative risk assessment approach, where the crucial issue is the consequence analysis of fire scenarios in a tunnel. Fire development is a complex physical phenomenon and its calculation is time consuming, therefore, complex models have rarely been used in quantitative risk assessment approaches. This paper presents the methodology of integrating fast-processing risk assessment methods with time-consuming CFD methods for fire consequence analysis in the process of tunnel safety assessment. The main variables are soot density and temperature, which are analyzed in one-minute time steps during the fire. Human behavior is considered with the evacuation model, which is needed to evaluate fatalities during the fire process. The application of the methodology is presented based on the evaluation of the national tolerable risk for tunnel transport and compared with referenced EU risk criteria. Furthermore, the presented methodology links CFD simulation results and the quantitative risk assessment approach, still representing the collective risk with F-N curves.

Judicial Review of Compliance with the Precautionary Principle from Paraquat to Blaise: “Quantitative Thresholds,” Risk Assessment, and the Gap Between Regulation and Regulatory Implementation

AbstractThis Article frames the precautionary principle as an inner limit to the EU institutions’ broad discretion in the field of EU risk regulation, contextualizing recourse to the principle against the more encompassing backdrop of socially acceptable risk approaches. On these grounds, it inquires to what extent the precautionary principle may be successfully invoked in challenges to acts which are deemed insufficiently protective. The opening sections set the ground for the analysis. The third section analyzes challenges to regulatory acts, arguing that the Court has followed a quantitative threshold approach. This is legally tenable and appropriate; however, it cannot do justice to the true nature of the precautionary principle. The following sections analyze cases involving legislative acts. This includes an in-depth examination of the recent Blaise case, which has put judicial review of compliance with the precautionary principle under the spotlight. Against this overall background, this Article concludes that judicial review can hardly do justice to the precautionary principle, as applicable to the risk management process and underpinning EU legislative frameworks. It will ultimately rest on EU risk managers and EU legislators to ensure that the principle is applied and that its overarching goals are pursued.