EU Regulatory Framework Research Articles

Pluralising the European energy landscape: Collective renewable energy prosumers and the EU's clean energy vision

To fulfil the European Union's (EU) goal of providing ‘Clean Energy for All Europeans', a transformative shift from centralised, fossil-fuel based systems to decentralised systems based on renewable energy sources (RES) is envisaged. Keen to lead the clean energy transition while embedding technological innovation and elements of justice and equitability into the envisioned ‘Energy Union’, EU Member States need their citizens on board as active participants. Prosumerism or self-consumption is an important part of this citizen involvement. While the new EU regulatory framework for energy now recognises civic-inspired prosumer initiatives such as energy communities, little is known about the full range and diversity of collective actors in renewable energy self-consumption as well as how they engage with the changing energy system. This paper presents an exploratory categorisation of the different collective social actors that produce and consume energy from renewable sources, referred to as ‘collective RES prosumers’, aiming to clarify their participation in the energy landscape. We find six categories with different engagement and needs, which we relate to the EU's current framing of collective energy actors. We recommend fine-tuning policies to the different actors to support a true-to-vision transposition of the recently completed Clean Energy Package (CEP).

Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology.

Synthetic Biology (SynBio) is an interdisciplinary field at the interface of engineering and biology aiming to develop new biological systems and impart new functions to living cells. EFSA has been asked by the European Commission to evaluate SynBio developments in agri‐food with the aim of identifying the adequacy of existing guidelines for risk assessment and determine if updated guidance is needed. The scope of this opinion covers the molecular characterisation and environmental risk assessment of such genetically modified plants obtained through SynBio, meant to be for cultivation or food and feed purposes. The previous work on SynBio by the non‐food scientific Committees (2014, 2015) was used and complemented with the output of a horizon scanning exercise, which was commissioned by the EFSA to identify the most realistic and forthcoming SynBio cases of relevance to this remit. The horizon scan did not identify other sectors/advances in addition to the six SynBio categories previously identified by the non‐food scientific committees of the European Commission. The exercise did show that plant SynBio products reaching the market in the near future (next decade) are likely to apply SynBio approaches to their development using existing genetic modification and genome editing technologies. In addition, three hypothetical SynBio case studies were selected by the working group of the Panel on Genetically Modified Organisms (GMO), to further support the scoping exercise of this Scientific Opinion. Using the selected cases, the GMO Panel concludes that the requirements of the EU regulatory framework and existing EFSA guidelines are adequate for the risk assessment of SynBio products to be developed in the next 10 years, although specific requirements may not apply to all products. The GMO Panel acknowledges that as SynBio developments evolve, a need may exist to adjust the guidelines to ensure they are adequate and sufficient.

EU Personal Data Protection Standards and Regulatory Framework

The purpose of the study is to identify the prospects and challenges that arise in the application of the current EU legislation in field of personal data protection. Legal historical method and method of legal forecasting used in work made it possible to analyze advantages of modern instruments of legal regulation. The advantages and disadvantages of the Regulation were analyzed. The analysis indicated a lack of legal certainty of the conceptual apparatus and procedural mechanism of the Regulation, different visions of legislator and representatives of the scientific community regarding the conclusions made by artificial intelligence systems using personal data.

The Global Relevance of the EU Single Market on Insurance After the Insurance Distribution Directive (IDD)

The amount of insurance premiums collected within the European Union places this market among the world leaders. Although insurance regulation is still partly national, the European Union's effort to introduce harmonized rules between the Member States has intensified since the financial crisis. This essay intends to highlight the global relevance assumed by the regulatory framework of the European Union. The introduced set of rules arises from the principles established internationally and, in turn, influences these principles. Thus, the EU regulatory framework on insurance is relevant to understand the potential evolution of the international standards on insurance. The analysis focuses on the rules protecting the policyholders, as this is the main objective of the insurance regulation and supervision of the European Union. Therefore, this study examines the recent Insurance Distribution Directive (IDD) salient features in light of the overall regulatory framework governing the insurance business in the European Union. In addition, the study also tests the resilience of new rules to the COVID-19 pandemic and digital transformation, which were not at the core of the IDD.

Prospects and contradictions of the electrification of the European automotive industry: the role of European Union policy

The article analyses the role that the EU regulatory framework for the reduction of CO2 emissions in the transport sector has played during the last twenty years in moving the industry away from what it was supposed to do: reduce weight, mass and size of the cars sold to make them less polluting. It shows that the current race towards electrification can be seen as the result of this paradox. It argues that under the ongoing upmarket drift in new car sales the social, economic and political costs of electrification increase, while its environmental benefits decrease.

Green Bonds: The Sovereign Issuers’ Perspective

This paper aims at providing an assessment of green bonds from the perspective of sovereign issuers. After a brief depiction of green bonds’ features, we describe the market evolution, present the EU regulatory framework and identify the main benefits and costs for sovereign issuers. We focus on the financial performance of these securities in primary and secondary markets. First, we compare the yields at issuance of sovereign green bonds with non-green bonds of the same issuer with the same maturity. Then we analyse the secondary market performance of green bonds issued by France, Belgium, Ireland and the Netherlands, and we do not find, any remarkable price difference between green and conventional bonds, even after controlling for their different degree of liquidity. Nevertheless, this should not discourage Sovereigns from entering the market since the reason for issuing these securities does not simply hinge upon short-term financial convenience. Green bonds can actually help Sovereigns to mitigate environmental risks and to cope with the intergenerational trade-off in climate-related policies.

The European Commission’s proposed Data Governance Act: some initial reflections on the increasingly complex EU regulatory puzzle of stimulating data sharing

As part of the European strategy for data, the European Commission published its proposal for a Data Governance Act (DGA) in November 2020. The legislative instrument aims at stimulating the exchange of data by increasing trust in data intermediaries and by strengthening data-sharing mechanisms across the EU. This chapter reflects on how the proposed DGA will relate to other parts of the EU regulatory framework applicable to data sharing, including the General Data Protection Regulation, EU competition law and the proposed Digital Markets Act. We illustrate that the new governance institutions established by the proposed DGA create some legal uncertainty, which potentially put its data sharing objectives at jeopardy and can undermine the relationship with other areas of law. To address these concerns, we recommend the EU legislator to provide clearer guidance upfront about how the DGA interacts with other legal fields.

Prospects and contradictions of the electrification of the European automotive industry: the role of European Union policy

The article analyses the role that the EU regulatory framework for the reduction of CO2 emissions in the transport sector has played during the last twenty years in moving the industry away from what it was supposed to do: reduce weight, mass and size of the cars sold to make them less polluting. It shows that the current race towards electrification can be seen as the result of this paradox. It argues that under the ongoing upmarket drift in new car sales the social, economic and political costs of electrification increase, while its environmental benefits decrease.

Detection Methods Fit-for-Purpose in Enforcement Control of Genetically Modified Plants Produced with Novel Genomic Techniques (NGTs)

The comprehensive EU regulatory framework regarding GMOs aims at preventing damage to human and animal health and the environment, and foresees labelling and traceability. Genome-edited plants and products fall under these EU GMO regulations, which have to be implemented in enforcement control activities. GMO detection methods currently used by enforcement laboratories are based on real-time PCR, where specificity and sensitivity are important performance parameters. Genome editing allows the targeted modification of nucleotide sequences in organisms, including plants, and often produces single nucleotide variants (SNVs), which are the most challenging class of genome edits to detect. The test method must therefore meet advanced requirements regarding specificity, which can be increased by modifying a PCR method. Digital PCR systems achieve a very high sensitivity and have advantages in quantitative measurement. Sequencing methods may also be used to detect DNA modifications caused by genome editing. Whereas most PCR methods can be carried out in an enforcement laboratory with existing technical equipment and staff, the processing of the sequencing data requires additional resources and the appropriate bioinformatic expertise.

Botanical ingredients: Intakes, regulations, risks and attitudes

AbstractBotanical ingredients have been used for centuries in food and in medicines, typically to support and maintain physiological functions and as remedies for many ailments. Today, botanical ingredients are still ingested as part of food supplements or herbal medicines (HM). Industry reports suggest growing global sales of and revenue from HM and food supplements containing botanicals, hereafter called botanical food supplements (BFS). In the context of this suggested growing popularity, this article will introduce both BFS and HM and then explore the available data on BFS intakes and consumer attitudes to their use. It will describe the EU regulatory framework within which BFS sit and mention research suggesting possible interactions between botanical ingredients, HM and traditional medicines. It is intended as a brief overview rather than a comprehensive review of the area.

REGULATORY STANDARDS OF HONEY SAFETY AND QUALITY

Modern beekeeping industry globalization leads to an increase in competition between countries for the foreign market. The products that provide the appropriate level of safety and quality following international requirements would be able to gain a competitive advantage. Establishing a competitive advantage for honey on the world market and improving exports/import process with the guaranteed observance of consumers’ rights and interests require a systematic revision of regulatory documentation for beekeeping products. The study aimed to analyze the current international and national regulations governing the safety and quality of honey. Critical analysis of normative documentation, a comparison of international, European, and Ukrainian requirements for physicochemical indicators of honey quality and content of dangerous contaminants, as well as the study of the organic beekeeping regulation was made. It was found that the national regulatory framework for the safety and quality of honey needs to be optimized. Order of the Ministry of Agrarian Policy and Food (Ukraine) of June 19, 2019, № 330 contains requirements that are more adapted to international and European standards for honey quality criteria compared to current national requirements. Order of the Ministry of Agrarian Policy and Food (Ukraine) of June 19, 2019, № 330 still needs to be improved for items governing the value of moisture content and mineral content as well as diastasis activity of honey components. Concerning the production of organic beekeeping products, the Cabinet of Ministers of Ukraine introduced the current EU regulatory framework for organic beekeeping.

Fishery spatial plans and effort displacement in the eastern Ionian Sea: A bioeconomic modelling

The management of fisheries requires well-planned approaches that consider the socio-ecological costs and benefits of management options while minimising conflicts among fishing practices. We developed a framework to anticipate the cost-effectiveness of several fisheries management options, including space-time closures, gear selectivity improvements, and fishing effort reduction of eastern Ionian Sea fisheries. We also examined to what extent these fisheries could be influenced by placing new aquaculture sites into specific areas. We used a dynamic space-time model considering the effect of possible fishing effort displacement on alternative marine areas. A fine-scale distribution of 6 species of high commercial importance, for the eastern Ionian fisheries (central Mediterranean), was used together with the fishing effort distribution of trawlers, purse-seines, and small-scale fisheries to track the implications on several bio-economic indicators. The study revealed that the stocks and the fisheries economics benefited from a 10% reduction in fishing effort for all fishery sectors, while the unwanted fish catch was slightly higher. Thus, although there are notable advantages, this management option is not sufficient to support an EU regulatory framework aiming to promote more selective fishing practices and mitigate unwanted catches. However, we showed that the protection of juveniles, by imposing selectivity improvements or space-time closures on trawlers, slightly reduced the unwanted catch. Nevertheless, the benefit for the majority of stocks and fisheries economics, during the five-year simulation period, was limited. In the case of space-time closures, this is attributed to the offset due to the fishing effort displacement towards other areas. While the benefit on fish populations by improving trawl selectivity, it depends on the species. Finally, the establishment of new aquaculture units could lead to a slight re-allocation of fishing effort along the border of the new sites without substantially affecting the profit of small-scale fisheries. Such findings are useful for fisheries management and broader spatial planning in the Ionian Sea. They will provide insight to policymakers and different fishing sectors, thus enabling a more transparent and participatory decision–making process.

From ‘mad cow’ crisis to synthetic biology: challenges to EU regulation of GMOs beyond the European context

This paper provides a historical and legal perspective of EU regulation on genetically modified organisms (GMOs)—through its initial development to its current position—in view of major advancements of modern molecular biotechnologies used for agriculture. We argue that the emergence and development of EU regulation of GMOs were shaped by antecedent events, notably bovine spongiform encephalopathy (BSE) or ‘mad cow disease’ and the public fears that ensued around food safety. These regulatory emergencies were a key factor prompting national governments and EU institutions to work out the framework for the application of the precautionary principle to agricultural biotechnology. Moreover, while modern biotechnology techniques eliminate many of the perceived health and safety risks of earlier predecessors, the EU regulatory framework has been slow to keep up, lacking the proper regulatory tools that allow for a balanced policy approach towards the techniques underlying genome editing and synthetic biology. Difference in approaches to the regulation of GMOs between the EU and US, to a large extent, precipitated the transatlantic conflict over agricultural biotechnology. Specifically, a significant incompatibility between the application of the precautionary principle in the EU and the substantial equivalence in the US to assess GM food and feed risk was the main reason for the international trade dispute. The ruling of the Court of Justice of the European Union that genome editing techniques will not be warranted exemption from authorisation process suggests that EU policy on agricultural biotechnology is likely to remain stringent. This may complicate the progress of synthetic biology and render the EU vulnerable to future food security and economic contingencies.

A comparative analysis of US and EU regulatory frameworks of crowdfunding for the cultural and creative industries

ABSTRACT In the face of the dramatic shrinking of public and private funding, the arts, culture and creative industries are increasingly relying on crowdfunding (CCCF). Furthermore, crowdfunding is relevant for its informative, promotional, co-creative and democratizing features. Yet CCCF is still a fragmented and below-potential market. Main reasons for this untapped potential include a lack of transparency and trust affected by national regulatory frameworks. We first assess the series of benefits and barriers of CCCF, and we propose and estimate a simple model of startup firms raising capital, pointing to the importance of how CCCF is regulated. We then critically analyze and compare the regulatory frameworks that may enhance CCCF benefits and limit its barriers and risks in both the United States and the European Union. We finally suggest some policy recommendations and future research in this field.

EU food legislation impacts innovation in the area of plant-based dairy alternatives

BackgroundDairy alternatives are foods that are made from plant-based milk instead of their usual animal products, such as cheese and yoghurt. Over the past few years, consumers increasingly choose to go dairy-free, which leads to a growth in available dairy alternatives product on the market. Although it is easiest for consumers to identify these products by the use of protected dairy terms (‘yoghurt’ or ‘milk’), these protected terms may not be used by food business operators to designate their plant-based products. Scope and approachThis article will examine the positive and negative impact of the EU regulatory framework on innovation in the dairy alternative industry and its consumers. Furthermore, potential solutions to overcome the identified barriers are explored. Key findings and conclusionsThe EU regulatory framework has positively affected innovation in the dairy alternatives industry by establishing legal clarity, and ensuring a high level of food safety and consumer protection. However, the same legislation negatively impacts innovation in the industry, namely due to: (i) the varying interpretation of the Regulation (EU) 1308/2013 (CMO); (ii) the different level of consumer protection between sectors; (iii) the absence of a legal definition of vegan food; and (iv) the narrow definition of ‘milk’ and ‘milk products’ as defined in the CMO. Either amending the definition of milk and milk products in the CMO, or expanding the list of exceptions to the definitions are identified as possible solutions to deal with the identified barriers.

Italy

This note presents a targeted review of selected aspects concerning the regulation and supervision of banks in Italy and their governance framework. The review was carried out as part of the 2019 Italy Financial Sector Assessment Program (FSAP) and was based on the regulatory framework in place and the supervisory practices employed as of March 2019. Since the regulation and supervision of significant banking institutions (SIs), including Italian SIs, was extensively covered as part of the 2018 Euro Area FSAP, this note focuses on the prudential regulation and supervision of less significant institutions (LSIs). In addition, the note reviewed regulatory and supervisory areas not covered by the wider EU regulatory framework, such as the supervision of anti-money laundering and countering the financing of terrorism (AML/CFT) and related party transactions, which apply to both SIs and LSIs in Italy.

Supporting Active Pharmacovigilance via IT Tools in the Clinical Setting and Beyond: Regulatory and Management Aspects.

Information Technology (IT) could have a prominent role towards the "Active Pharmacovigilance" (AP) paradigm by facilitating the analysis of potential Adverse Drug Reactions (ADRs). PVClinical project aims to build an IT platform enabling the investigation of potential ADRs in the clinical environment and beyond. In this paper, we outline the respective EU regulatory framework and the related Business Processes (BPs), elaborated based on input from clinicians and PV experts as part of the project's "user requirements analysis" phase, highlighting their potential pivotal role in the design of IT tools aiming to support AP.

OTT regulation framework in the context of CJEU Skype case and European Electronic Communications Code

The telecommunications services sector is one of the most dynamically developing segments of the contemporary economy. At the same time, it is undergoing constant change, the result of its adaptation to the needs of modern digital services and the expectations of users. In practice, traditional telecommunications services are being increasingly replaced by those that offer equivalent functionality but are provided via the Internet. Examples of this type of service are VoIP telephony, instant messengers and online chat. This group of services is collectively referred to as OTT.The growing popularity of OTT services not only affects the shape of the telecommunications market, but, from the point of view of legislatures and market regulators, has also led to a number of practical problems. One of them is how to apply a EU regulatory framework established for the electronic communications sector to modern OTT services. Recently, this problem has become an object of interest to both the CJEU and the EU legislature.The purpose of this article is to discuss the effects of the recent Skype adjudication on the regulation of the OTT sector, including the pending entry into force of the European Electronic Communications Code. The analysis considers the technical and regulatory background of issues relating to the judgment, the ongoing legislative work and the importance of the judgment in practice. Ambiguities in interpretation are also identified and discussed, in particular those relating to the attempt to apply the Skype judgment and the entire regulatory framework to OTT services.These aspects will be discussed from the perspective of the protection of users' privacy, an important part of the provision of electronic communications services. The choice of this aspect of OTT services regulation would seem to be particularly apt in light of the ongoing reform of the EU data protection model, which will include the new e-privacy regulation currently being drafted.

Towards food platforms? An analysis of online food provisioning services in Italy

This paper makes use of a unique dataset on the population of online food provisioning services to shed light on the organization of the food e-commerce in the Italian context. Building on the opposition between pipelines and platforms, we propose a categorization of the different forms of organization within each business model and examine how they differ. Hence, we concentrate on food platforms to discuss the implications this new business model may have for both producers and consumers. We highlight three critical areas that warrant further attention. First, in view of the EU regulatory framework, we discuss the potential implications for consumer protection; second, we reflect on the ways the potential success of the platform model could change labour market relations between producers and platform owners; third, we point out the differences and similarities platforms have with alternative food networks (AFNs). In the conclusion, we reflect on future research developments and on the possible trajectories that online grocery shopping could take in light of the disruption caused by COVID19.

Zasady organizacji i działania Organu Europejskich Regulatorów Łączności Elektronicznej. Wybrane aspekty porządku instytucjonalnego w sektorze łączności elektronicznej

Podstawowym zadaniem Organu Europejskich Regulatorów Łączności Elektronicznej (Body of European Regulators in Electronic Communications — BEREC) jest doradzanie Komisji Europejskiej oraz organom regulacyjnym krajów członkowskich wchodzącym w jego skład, a po-nadto wspieranie Parlamentu Europejskiego i Rady w sprawach dotyczących stosowania unijnych ram regulacyjnych dotyczących łączności elektronicznej. Jego działalność pozwala zapewnić uczci-wą konkurencję i spójność regulacji na rynku wewnętrznym w dziedzinie łączności elektronicznej, z korzyścią dla europejskich konsumentów. Obecnie BEREC ma status niezależnego organu regula-cyjnego, skupiającego w swej strukturze decyzyjnej krajowe organy regulacyjne, czerpiąc w swojej działalności z ich wiedzy eksperckiej i doświadczeń regulacyjnych. Jakkolwiek regulacja w sektorze telekomunikacyjnym w dalszym ciągu leży w gestii krajowych organów regulacyjnych, ponieważ to one są najbliżej rynków, które mogą lepiej regulować. W artykule zostały omówione zasady organizacji oraz funkcjonowania Organu Europejskich Regulatorów Łączności Elektronicznej w kontekście zgodności przepisów regulujących jego dzia-łalność z zasadami dobrego zarządzania jako wartościami administracyjnymi i organizacyjnymi, które powinny determinować sposób korzystania przez instytucje unijne z uprawnień udzielonych im przez obywateli. W tekście zwrócono także uwagę na planowaną kompleksową reformę regu-lacji w sektorze łączności telekomunikacyjnej jako niezwykle ambitny projekt w ramach strategii Jednolitego Rynku Cyfrowego.