bluuebunny/crossref_metadata_2025_split huggingface dataset:
Global-Regulation: Drawing Future Regulatory Tools from the Experience of the Past
Authors: Goltz Nachshon , Nikolic Aleksandar 
Published: February 2017

“Man of science should turn to the massive task of making more accessible our bewildering store of knowledge”Vannevar BushTraditionally, theories on regulation have suggested choosing the “right” regulatory tool for a given situation of desired behavioral steering, using a broad theoretical approach of understanding the factors involved in the regulatory realm and speculating from it toward the efficient choice.By contrast, this paper will argue that the process of choosing the “right” regulatory tool should be guided by an opposite process, in which a searchable database of regulatory case studies (“Global-Regulation”) will be created. The institution (i.e., governments, regulation agencies, etc.) seeking to steer behavior using regulatory tools (“The Regulator”) will search Global-Regulation using the specific characters of its situation (i.e., industry, regulationmethod, country, etc.), to find relevant case-studies that will lead to the best regulatory solution.It is assumed that this approach will establish regulation and regulatory tools as an empirical process of selection guided by a global accumulated body of knowledge, that will eventually create amore efficient and successful regulation and hence, desired behavior. The first part of this paper will provide an overview of regulatory learning. The second part will describe the Global-regulation database. The third partwill develop an example of the way in which case studies will be indexed into the Global-Regulation database. The fourth part will discuss the benefits of Global-Regulation to scholars and its symbiotic relationship with the research in the regulatory field. Finally, this paper will address possible problemswith the suggested system.
Emerging Food Chemical Contaminants from Industry Pollution
Authors: Tognon Gianluca 
Published: February 2017

In May 2011, the illegal use of the plasticizer di(2-ethylhexyl) phthalate in clouding agents for use in foods and beverages was reported in Taiwan. This food scandal has caused shock and panic among the majority of Taiwanese people and has attracted international attention raising once again concern regarding the contamination of food by chemical toxic compounds. However, although these accidents cause a lot of concern, it is worth remembering that governments throughout the world are intensifying their efforts to improve food safety. In Europe in particular, food policy is based on high safety standards, aimed to protect and promote consumers’ health. EU legislation specifies that food containing a level of contaminants that is unacceptable from a public health viewpoint, cannot be put on the market.Currently, one of the great challenges in food safety is the control of risks associated with mixtures of contaminants, which are constantly changing. Food may be contaminated by chemical substances through production practices, packaging, transport, or storage. The contamination might also result from environmental pollution through contaminated air, water, soil, and accumulation in the food chain. Among the most prominent groups of emerging food contaminants, those from industrial sources (perfluorinated compounds (PFCs), polybrominated biphenyls (PBBs) and, partially, nanomaterials) cause particular concern. Many of these can be associated with severe damage to human health, for example some are suspected to be cancer promoters. Other compounds have been associated with endocrine disruptor effects, or can be accumulated and biomagnified through the food chain.
Precautionary Schemes
Authors: Winn Jane K. 
Published: February 2017

“And remember you’re in France: The customer is always wrong!”Many years ago, there was intense debate about what the Precautionary Principle (“PP”) is, or is not. More recently, as the battle lines in that debate have ossified, academic attention seems to have shifted to a focus on the somewhat more subtle question of how the term PP, whatever it may mean, is used by different actors in different contexts. David Vogel’s recent book, The Politics of Precaution: Regulating the Environmental Risks in Europe and the United States (2012) (hereafter “Politics”), is a good recent example of such commentary. Vogel's approach recognizes the diversity of relevant developments, he seeks to impose a coherent narrative framework on those developments.
“It's the Politics, Stupid.” Or is Reality more Complex?
Authors: Weimer Maria 
Published: February 2017

Reality is complex, and often does not lend itself to generalization or simplifying explanations. Yet at the same time, explaining reality often requires the shaping of notions and concepts of it through generalization and the reduction of complexity. This tension between complexity and particularity on the one hand and generalization and the search for abstracting explanatory patterns on the other is beautifully illustrated by two recently released publications on precaution and risk regulation in the United States and Europe, namely “The Politics of Precaution” by David Vogel1 and “The Reality of Precaution” edited by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand.Both books together can be seen as the latest significant contribution to the ongoing debate on the role of the precautionary principle in risk regulation in a comparative EU-US perspective. Both contributions are significant in that they consolidate the trend towards an empirically informed analysis of the actual practice of the application of precaution in risk regulation.
When Science Meets Responsibility: The Major Risks Commission and the L’Aquila Earthquake
Authors: Simoncini Marta 
Published: February 2017

This article aims to analyse the role of law in the identification of the responsibility domain of ‘regulatory science’ (Jasanoff, 1990) within the risk regulatory process. The main research question is therefore,what kindof relationshipbetween science andpolicy-making lawshould design in risk regulation.In order to address this issue, this contribution focuses on the recent verdict of the Tribunal of L’Aquila. After the earthquake occurred in L’Aquila on the 6th April 2009, six Italian scientists that had participated in the Major Risks Commission's meeting have been condemned for the multiple manslaughter of 29 people who were among the 309 victims of the earthquake, ‘for having assessed the risks related to seismic activity in the L’Aquila territory in an inaccurate, generic and ineffective way’ and for having provided ‘information which was imprecise, incomplete and contradictory as to the nature, the causes and the hazardousness and on the future development of the seismic activity’.As far as risk assessment and risk communication are concerned, firstly the tasks of the Major Risks Commission under the Italian Civil Protection law will be analysed. Against this backdrop, the issues related to this expert body's responsibility will be addressed and the gaps in the current accountability regime will be pointed out.
From Procrastination to Procedural Perfectionism – A Short Story of the Long Amflora Authorisation Process
Authors: Ehnert Tanja 
Published: February 2017

In this judgment, the General Court annulled two Commission decisions authorising the placing on the market of the GM potato Amflora. The Court did not base its decision on the arguments put forward by the applicant Hungary, which contested the underlying scientific assessment of the European Food Safety Authority, but found of its own motion a breach of an essential procedural requirement in the applicable comitology procedure.Whilst the Court’s proactive role in scrutinising the Commission's behaviour in the authorisation procedure of GMOs is to be welcomed, the Court arguably missed an opportunity to exercise its role as a deliberative forum for normative controversies underlying the scientific risk assessment.Directive 2001/18 on the deliberate release into the environment of genetically modified organisms, OJ 2001 L 106;Regulation 1829/2003 on geneticallymodified food and feed,OJ 2003 L 268; Article 5 of Commission Decision 1999/468 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ 1999 L 184.
The Principle of Institutional (Un)Balance after Lisbon
Authors: Gabbi Simone 
Published: February 2017

On 22 January 2014, the Grand Chamber of the Court of Justice confirmed the validity of the powers entrusted to the European Securities Markets Agency under Article 28 of Regulation (EU) No 236/2012, upholding their compatibility with the principle of institutional balance, the Lisbon Treaty and established case law of the CJEU.This case note gives an overview of the ruling and analyses its implications for ESMA and the broader Union institutional setting, with particular regard to the interplay between EU Institutions and agencies. It concludes by highlighting some reasons for potential constitutional concerns resulting from the combination of politically unchecked agencies and highly controlled Institutions.
The Conferral of Power to the Commission Put to the Test
Authors: Buchanan Camilla 
Published: February 2017

Case C-427/12 Commission v European Parliament and Council (not yet reported)- Article 290 TFEU- Article 291(2) TFEU- Article 80(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ 2012 L 167/11.The EU legislature has discretion when it decides to confer a delegated power on the Commission pursuant to Article 290(1) TFEU or an implementing power pursuant to Article 291(2) TFEU. Consequently, judicial reviewis limited tomanifest errors of assessment (official headnote)2.The Commission appears to have more liberty under Article 290 TFEU than Article 291(2) TFEU, however this may be misleading. The difference between adding “further details” (implementing act) and supplementing or amending non-essential elements to a basic act (delegated act) is difficult to gauge. Furthermore, the control foreseen to be exercised by the Member States and the Parliament and Councilmay not function as planned (author's headnote).
Private Liability and Critical Infrastructure
Authors: Faure Michael 
Published: February 2017

Private liability can potentially play a crucial role in protecting critical infrastructure. Traditional liability rules will especially play their deterrent and therefore preventive effect in the case of so-called man-made “technological” disasters. By using a strict liability role and by providing solvency guarantees potential tort-feasors can be provided with incentives to take optimal preventivemeasures.However, the case of nuclear accidents, addressed inmore detail, makes clear that in practice those efficient liability rules that would be needed to generate this preventive effect are often not implemented at the legislative level. The legislator rather imposes financial limits on liability and provides for public funding, thus effectively granting a subsidy to operators. Those type of inefficient rules laid down in international conventions are obviously often the result of interest group politics.As far as natural disasters are concerned liability rules can play less of a role given the fact that those are considered an “act of God”. One could then only consider public authority liability.However, this is not often accepted in practice and there may also be theoretical reasons to be careful with the imposition of public authority liability. Public authorities are multitask agents which need a substantial amount of discretion. That explains that many legal systems award (partial) immunity from liability to public authorities. This leads generally to the conclusion that although liability rules can play a role in the protection of critical infrastructure those rules may have important limits as well. As a result the primary instrument to protect critical infrastructure will in practice often be safety regulation rather than liability rules.
Enforcing EU Environmental Law against Member States: Air Pollution, National Courts and the Rule of Law
Authors: Ryall Áine 
Published: February 2017

Case C-404/13, The Queen, on the application of Client Earth v Secretary of State for the Environment, Food and Rural Affairs EU:C:2014:2382, OJ C – 26 of 26.1.2015, p. 6.When a Member State finds that the limit values cannot be respected before the deadline fixed by the Air Quality Directive and wishes to postpone that deadline for a maximum of five years, that Member State is required to make an application for the postponement of the deadline by drawing up an air quality plan demonstrating how those limits will be met before the new deadline (official headnote).
Is There a Defect in the European Court's Defect Test? Musings about Acceptable Risk
Authors: Bergkamp Lucas 
Published: February 2017

Judgment of the Court (Fourth Chamber) of 5 March 2015 In Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston ScientificMedizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13)On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive, which imposes objective, no-fault or strict liability, but not absolute liability, for defective products. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive. As in other civil law cases, the question arises whether the Court's light treatment will provide a sound basis for the further development of product liability in Europe. The Court did not answer the questions posed by the referring court, but in some respects went beyond these questions and in other respects avoided the difficult issues raised thereby. As discussed in this note, the Court paints with a broad brush, and the test set forth in its judgment to determine whether a product is defective, may itself be defective.
Which Results? Better Regulation and Institutional Politics
Authors: Wegrich Kai 
Published: February 2017

How can one not applaud the renewed better regulation agenda launched by the First Vice President Timmermans? Finally this fuzzy reform field is in the hands of a strong executive politician with the authority to make substantial progress on an agenda that always appeared good on paper, but somehow did not deliver against the expectations it defined for itself. ‘Better regulation for better results’ not only promises tangible results, but it combines this with the ambition of ‘changing how we work at the European level’. This ambition should provide us – as citizens, stakeholders and scholars – with an opportunity to essentially present a scorecard concerning these results in the near future. And, indeed, experts and other stakeholders in the better regulation game do welcome the initiative.My view on this agenda is that the promise of ‘better results’ will be hard to deliver, whereas the ambition of ‘changing how we work’ is more likely to materialize in one way or another.
Repercussions of the European Commission’s Better Regulation Agenda on Consumer Interests and Policy
Authors: Pachl Ursula 
Published: February 2017

On the face of it, ‘better regulation’ sounds like a concept that no one could object to. But in contrast to past attempts to cut red tape for business and thus reduce unnecessary bureaucracy, the objective of the Juncker Commission's Better Regulation Agenda is to reduce “regulatory burden”.The package, adopted on May 9th 2015, foresees the establishment of an impressive apparatus and toolbox for implementing the Agenda. Existing structures and procedures, such as the Regulatory Scrutiny Board and the Impact Assessment Guidelines, are being modified, and new elements such as the two REFIT Platforms, one for stakeholders and one for Member States, and the new Interinstitutional Agreement on better law-making, will be introduced.The Agenda raises many questions and concerns From the perspective of a public interest organisation such as The European Consumer Organisation (BEUC). Several aspects of this new institutional and procedural architecture suggest that it is not designed to provide society–wide benefits by generating better regulation for all. Rhetoric about the need to reduce costs is the dominant theme throughout the entire package, framed by the ‘jobs and growth’ narrative.
What the TTIP Leaks Mean for the On–going Negotiations and Future Agreement?
Authors: Alemanno Alberto 
Published: February 2017

On 1May 2016,GreenpeaceNetherlands released 248 pages of TTIP negotiating texts stemming from previous negotiating rounds. Although it is not the first (and will not be the last) leak since the inception of the negotiation in 2013, this is the first to reveal the US negotiating position regarding 13 out of the 24 TTIP chapters.As such, the TTIP leaks provide an unprecedented opportunity to not only analyse the contrasting positions of the EU and US on several issues in the ongoing negotiations, but also to test the veracity of the competing narratives devised by opponents and proponents of the agreement. To what extent do their respective storylines find support in the actual texts?Supporters of TTIP have proposed fact-checking as an antidote against them is information around TTIP. Yet, having been predominantly advocated and provided for by the EU Commission rather than by the media, institutional fact-checking failed to counter the massive misinformation characterizing the public and political discourse surrounding the negotiations. Unfortunately, when it comes to public perception, the line between pedagogy and propaganda is fuzzy.
Introduction to the Special Issue on the Man and the Machine
Authors: Burri Thomas , Wildhaber Isabelle 
Published: February 2017

This special issue assembles five articles ensuing from a conference on “The Man and the Machine: When Systems Take Decisions Autonomously”, which took place on June 26 and 27, 2015, at the University of St. Gallen in Switzerland.The aim of the conference was to explore the broader implications of artificial intelligence, machine learning and autonomous robots and vehicles. Alphabet's Deep Mind is just one example about Whom we know, at least a little, and who, we are told, will be good. Autonomous vehicles are also about to enter the market and our phones have begun to verbalize at us. Private drones are being regulated by the US Federal Aviation Administration. The five papers in this special issue address some of the legal issues the broader development raises.The first article is on “The Implications of Modern Business-Entity Law for the Regulation of Autonomous Systems” and is written by Shawn Bayern.
Promoting the Off–label Use of Medicines: Where to Draw the Line?
Authors: Forwood Genevra , Killick James 
Published: February 2017

In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.
Trademark Use and Liability of Referencing Service In Keyword Advertising – Google AdWords and Trademark Law
Authors: Volkmann Christian 
Published: February 2017

Cases C-236/08 to C-238/08 Google France SARL, Google Inc. v. Louis Vuitton Malletier SA (C.236/08) and Google France SARL v. Viaticum, Luteciel SARL (C-237/08) and Google France SARL v. Centre national de recherche en relations humaines (CNRRH) SARL, Pierre-Alexis Thonet, Bruno Raboin, Tiger SARL (C-238/08)1. The proprietor of a trade mark is entitled to prohibit an advertiser from advertising, on the basis of a keyword identical with that trade mark which that advertiser has, without the consent of the proprietor, selected in connection with an internet referencing service, goods or services identical with those for which that mark is registered, in the case where that advertisement does not enable an average internet user, or enables that user only with difficulty, to ascertain whether the goods or services referred to therein originate from the proprietor of the trade mark or an undertaking economically connected to it or, on the contrary, originate from a third party.
Beyond Uncertainties in the Sharing Economy: Opportunities for Social Capital
Authors: Ferrari Mariana Zuleta 
Published: February 2017

AbstractThe sharing economy phenomenon is expected to expand and grow steadily in the coming years. Yet, this sector lacks solid regulation, which raises concerns about its potential risks. However, users continue to engage in sharing economy practices, as opportunities appear to outweigh the perceived risks. This article argues that it is important to look beyond regulatory frameworks, and unravel the social embeddedness of sharing practices in order to provide complementary approaches to risk analysis. In particular, the focus of this article will be placed on the opportunities for building and deploying social capital in the sharing economy and its fundamental role in the development of new sharing economy practices.
Risk Regulation and the European Convention on Human Rights
Authors: Seminara Letizia 
Published: February 2017

AbstractEuropean law of risk regulation is commonly intended to be limited to the European regulation in the internal market. However, risk is also regulated in Europe by human rights law, which is often left aside in this area. In fact, disregard for the risk entailed by certain manmade activities as well as by natural events, may imply restrictions to, inter alia, the right to life and the right to respect for private and family life enshrined in the European Convention on Human Rights. This article aims at studying the manner in which this Convention regulates risk through human rights norms. It provides an overview of the standards set by the European Court of Human Rights in this field.