bluuebunny/crossref_metadata_2025 huggingface dataset:
La regulation des nanotechnologies. Clair-obscur normatif, by Stéphanie Lacour. Brussels: Larcier, 2010, 279 pp., € 55.00, Paperback.
Authors: Thoreau François
Published: February 2017

A ‘clair-obscur’ normativity. In French, Historians of art use it when they refer to an abrupt association of zones made out of very dark shadows together with dazzling lights, like da Caravaggio used to paint. It applies successfully to nanotechnologies, which points out to this set of technologies that are being developed at a billionth of a meter. At this scale, matter shows new and unexpected properties, which could potentially lead the way to numerous applications but how do we regulate it? Lacour's edited volume should be of interest to lawyers and regulators interested in this subject. It borrows this formula of the clair-obscur to characterize a fluctuating normative environment which surrounds nanotechnologies’ development.
Food
Authors: Nilsson Kristine Lilholt
Published: February 2017

Article 14 of EU General Food Law Regulation1 178/2002 provides that a food product may not be placed on the market if it is unsafe. Article 19 of the Regulation imposes an obligation on food business operators to withdraw a product if they have reason to believe that it poses a health risk. Though it seems obvious that unsafe foods should be withdrawn from the market, the matter of when exactly a food product can be considered unsafe often leads to discussion. How much room is there for doubt as to the safety of a product and how many obligations do the provisions impose on food business operators? While it is ultimately always up to the courts to decide, on a day-to-day basis food business operators need to navigate within the interpretations of these provisions made by national authorities.

This report will discuss the topic in the light of two recent Danish cases that have highlighted the problems that can arise in this context – especially concerning the legal rights of the food business operators involved.
Regulatory Impact Assessment
Authors: Allio Lorenzo
Published: February 2017

The Swiss Federal Council (FC, the Swiss government) published a report on reducing administrative burdens on business in August 2011, in which it addressed also the performance of Regulatory Impact Analysis (RIA) at the federal level. The report reviews the measures undertaken by the FC since 2007 and sketches initiatives to be launched throughout the next four years. Administrative simplification and the reduction of regulatory costs have gained on relevance in the Swiss policy and political debate in the past few months – not least as a part of the campaign for the national political elections held in October 2011, with the economic crisis as a background. A national political party has launched a popular initiative against over-bureaucratisation, and the issue is brought forward by a number of stakeholders too.

The August 2011 report also fits into a wider debate about the legitimacy of RIA systems and the right balance between their effectiveness and efficiency. This brief note draws from a comprehensive evaluation of the system of in-depth RIAs in Switzerland, which supported the government's report and developed some avenues for further investigating those dimensions.
Private Enforcement of the Public Interest and the Europeanisation of Administrative Law – The Trianel Judgment of the ECJ
Authors: Glinski Carola , Rott Peter
Published: February 2017

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).
Le Agenzie dell’Unione Europea. Profili istituzionali e tendenze evolutive (The Agencies of the European Union. Institutional Profiles and Evolutionary Tendencies), by Vincenzo Salvatore. Pavia, Italy: Jean Monnet Centre of Pavia, University of Pavia, 2011, available on the Internet at .
Authors: Alberton Mariachiara
Published: February 2017

This book, coordinated and supervised by Prof. Vincenzo Salvatore, is part of the output of the workshop organized by the Università dell’Insubria in Varese in November 2010 which gathered legal and economic scholars and experts of EU Institutions with the aim of presenting and discussing present problems and future challenges of the EU agencies. The diverse set of perspectives contained in the book contributes significantly to rethink the role and nature of the EU agency institutional model, by pointing out some of the most relevant legal issues such as the delegation of powers and the lack of homogeneity of the model, which reflect features and peculiarities of the EU integration process.
Environmental Risk in Biotech Patent Disputes: Which Role for Ordre Public before the European Patent Office?
Authors: Bonfanti Angelica
Published: February 2017

Nowadays, biotechnologies are among the most interesting areas of science. Their development, fostered by intellectual property (IP) rights’ protection, leads to useful progress. Nonetheless, when, as with biotech inventions, environmental protection is at stake, this progress is not without controversy. The present contribution aims at examining the interferences between IP and environmental protection, as emerging in the framework of the European Patent Convention. To this extent, it will focus on the function and on the limits of the ordre public exception clause, with the purpose of suggesting a new role for science in disputes for revocation of biotech patents.
The Challenging Marriage of Two Thorny Concepts
Authors: Giorgi Liana
Published: February 2017

The terms lifestyle and risk are so commonplace today that we tend to take their meaning (and social history) for granted. This is unfortunate, since neither of them is either value-free or unequivocal. Linking them – in an abstract sense as well as with regard to policy – is therefore bound to raise multiple questions regarding the definition of boundaries. If we recognise that lifestyle is not a matter of individual agency alone but also a question of structure and, similarly, if risk assessment is not just determining objects or incidences of risk but also about establishing the societal and environmental contexts within which specific negative outcomes are more likely to happen, then we are confronted with the challenge of how to approach the subject of lifestyle risk without falling prey to the temptation to impose normative expectations This paper takes issue with some of the ideas advanced in the article by Planzer and Alemanno published in EJRR 4/2010 “Lifestyle Risks: Conceptualization of an Emerging Category of Research” by considering the framing of the concept of lifestyle risk. The emergence of this concept is symptomatic of a general trend from both the right and the left of the political spectrum to re-emphasise individual responsibility for social welfare – what Planzer and Alemanno refer to as “financial solidarity”. Yet the best way to effect such financial solidarity, and more specifically to balance individual and state responsibility, is neither obvious nor uncontested. Accordingly, the notion of “lifestyle risk” is likely to become a battleground for determining the scope of state intervention, where one of the principal questions will be what gets classified as “lifestyle risk” and what does not, and how this changes over time.
Fundamental Freedoms Strengthen the Rights of Patients (again)
Authors: Weiss Alexander
Published: February 2017

Case C-255/09 Commission v Portugal

The Portuguese Republic has failed to fulfil its obligations under Article 49 EC (Article 56 TFEU) by making no provision for reimbursement of non-hospital medical care provided in another Member State which does not involve the use of major and costly equipment exhaustively listed in the national legislation, other than in the circumstances specified in Regulation (EEC) No 1408/71 […] or, to the extent that Decree-Law No 177/92 allows reimbursement in respect of such care, by making such reimbursement subject to prior authorization (official headnote).
Moving Away From Total Control in Former Communist Countries – the RRR in Inspections, and Lessons Learned from Reforming them
Authors: Blanc Florentin
Published: February 2017

Former Soviet republics and other countries of the ex-Communist “block” may seem unlikely places to look for inspiration in “better regulation”. In fact, their experience in moving away (with varying degrees of success) from an approach based on “total control” and complete risk-aversion (an absolute RRR, as it were) may be an opportunity to get many insights. Data from surveys conducted by the World Bank Group allows to shed light on trends in regulatory delivery, and in particular in inspections, which is the primary way in which the RRR is felt by businesses. This paper describes the starting situation, analyses the reform processes and their outcomes, and attempts to draw some lessons – as well as some comparisons with situations and experiences in EU and OECD countries. Tentative conclusions suggest both that addressing the inspections and control issue (and not just regulations themselves) is crucial to success in reform, and that reducing the “pressure” from total control through a “risk-focused” approach leads to real improvements in the business climate without negatively affecting public safety.
Corporate Governance as Risk Regulation in China: A Comparative View of Risk Oversight, Risk Management, and Accountability
Authors: Ho Virginia Harper
Published: February 2017

Risk management and oversight have long been recognized as core corporate governance issues and have gained renewed attention in the wake of the financial crisis. Recent corporate governance reforms in China follow these global trends. This article is the first to examine the intersections between corporate governance and risk regulation in China from a comparative perspective. It surveys corporate governance tools that have been adopted by Chinese regulators and firms to motivate effective risk oversight and risk management across the corporate enterprise, focusing on China's regulation of internal controls and risk management systems. These internal mechanisms are particularly important given the widely recognized limits of external monitoring and enforcement mechanisms in China.

This article observes that recent guidelines on enterprise risk management (ERM) and internal controls reflect international corporate governance standards and that China adopts a broad perspective on risk oversight that extends to both financial and non-financial risks. China's adoption of international models offers a new opportunity to reexamine longstanding debates on the potential for global corporate governance convergence. This article argues that China has adopted a regulatory approach to internal risk oversight and management that is consistent with its historical law reform trajectory, the reality of China's state-dominated equity markets, and the continued influence of the state on firm management. Its conclusions support the literature on the path dependency of corporate governance systems and prior comparative studies of corporate governance in China that find convergence of form but divergence of function.
EU Health Claims Regulation and the Marketing of Functional Foods: A Regulatory Void?
Authors: Lelieveldt Herman , Boonen Cris
Published: February 2017

This report evaluates the current regulatory regime for health claims in the EU on the basis of a case study of the marketing of Optimel Control, a yoghurt drink which was marketed in several EU member states as a functional food aimed at suppressing appetite and maintaining weight control. Our case study of the marketing of Optimel Control in the Netherlands reveals that the use of non-textual marketing claims was much more important than the use of textual health claims. Because the current EU regulatory regime emphasizes the evaluation of the wording of health claims, but lacks an evaluation of non-textual claims we conclude that there is a regulatory void that producers can use to market their products in ways that suggest more health effects than scientifi cally warranted. As a result the protective effect of the current EU regulatory regime on health claims is less strong than what legislators may have intended. While it might seem most logical to simply expand EFSA's remit by also letting it look at non-textual claims, we argue that a better solution to close this gap is through a stricter monitoring of unfair commercial practices at national level.
What we Know About the Impact of Advertising on Disordered Gambling
Authors: Planzer Simon , Wardle Heather
Published: February 2017

Towards the end of 2011, the (then) Responsible Gambling Fund published a report which, inter alia, offers an overview of the research gaps in relation to the impact of advertising on disordered gambling. In this article, the authors of the report summarise their main findings. They conclude that evaluating the impact of gambling advertising is highly complex. Nonetheless, advertising forms an important component of the broader environment in which behaviour and attitudes are shaped. The empirical evidence base is weak and therefore conclusions about whether gambling advertising is associated with increased levels of disordered gambling cannot be drawn. However, there is some evidence that advertising alters perceptions and attitudes towards gambling. Yet, evidence demonstrating translation of this into behavioural change is weak. Particular attention should be given to vulnerable population groups such as adolescents and disordered gamblers. In view of further research, a set of recommendations is provided.
On the Concept of Capacity of Exempted Insurance Institutions: Who's next?
Authors: Mantrov Vadim
Published: February 2017

Case C-82/10, European Commission v Ireland [2011] ECR I-00000

Article 4 of the First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance, as amended and repealed by the Solvency II Directive, OJ L – 228, of 16.08.1973. pp. 3–19. [First non-life Directive].

Ireland was found to have failed to fulfil its obligations under the non-life insurance directives by not covering the Voluntary Health Insurance Board, the main health insurer in Ireland, with the supervisory scheme envisaged by those directives. The Court of Justice of the European Union judgment raises vital questions important for the existing exempted insurance institutions.
The difficulties of Regulating Markets and Risks in Europe through Notified Bodies
Authors: Galland Jean-Pierre
Published: February 2017

Although scholars have described and commented on the European New Approach to standardisation principles, they have paid much less attention to the ways in which this innovative process and its follow-on, i.e. the Global Approach, have been implemented. In many cases, this comes through the day-to-day activity of a very specific population of European experts, the notified bodies. Notified bodies, whose role it is to certify that products, for a given sector, comply with the essential safety requirements set out in the corresponding directive, originate from the Member States, but also compete against each other within a European certification market. This article examines the technical and political difficulties encountered by the Commission and the Member States in ensuring both the independence and the competences of these certifiers. It describes and questions the organisational architecture devised in response to these problems.
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 Bush

Traditionally, 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.
From Status to Impact, and the Role of National Legislation: The Application of Article 34 TFEU to a Private Certification Organisation in Fra.bo
Authors: van Leeuwen Barend
Published: February 2017

In Fra.bo, it was held by the Court of Justice of the European Union (“CJEU”) that “Article 28 EC must be interpreted as meaning that it applies to standardisation and certification activities of a private-law body, where the national legislation considers the products certified by that body to be compliant with national law and that has the effect of restricting the marketing of products which are not certified by that body” (author's headnote).
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.
Scientific Expertise in Situations of Controversy: A Sociological Testimony
Authors: Barthe Yannick
Published: February 2017

While there is now a large amount of social science research on scientific expertise, testimonies made by sociologists who themselves participated in scientific expertise on a controversial topic remain rare. It is this type of feedback and testimony that this paper will articulate and discuss. The aim is to propose a series of reflections on scientific expertise from a personal experience: the participation of the author as a sociologist in an expert committee set up by the former French Agency for the Safety of Health, the Environment and Work (AFSSET) on the topic of radio-frequencies. Several problematic aspects of scientific expertise will thus be discussed from this concrete experience: the problem of the composition of the expert group and the issue of conflict of interest, the way in which the work of expertise is organized within the group, the effects of the presence of an observer from an association, and the differences between scientific work and scientific expertise.
Pay-for-Delay Agreements in the Pharmaceutical Sector: Towards a Coherent EU Approach?`
Authors: Barazza Stefano
Published: February 2017

This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.
A Victim of a Road Traffic Accident not Fastened by a Seat Belt and Contributory Negligence in the EU Motor Insurance Law
Authors: Mantrov Vadim
Published: February 2017

This case note relates to the recent judgement (23 October 2012) by the Court of Justice of the European Union in the case No C-300/10 concerning interrelation of the European Union motor insurance law and the national civil liability regulation. As the civil liability arising from motor traffic accidents is not approximated by the European Union law, its regulation falls within the national law. Yet, application of the national civil liability law shall not undermine the obligation to provide insurance coverage for victims of road traffic accidents. The discussed case concerns a situation when a victim who was not fastened by a seat belt at the moment of a motor traffic accident was injured, and this raises a question whether such victim may be compensated due to contributory negligence. This note provides a brief summary of the previous case law, facts, review of Advocate's General Opinion and the judgment and their analysis.
DSM-5: What's New?
Authors: Planzer Simon
Published: February 2017

The recently published 5th edition of the Diagnostic and Statistical Manual of Mental Disorders has incorporated significant changes. This report aims to outline the changes that are most relevant for readers with an interest in lifestyle risks.
Simple, Safe And Transparent(?): Preliminary Reflections on the Proposal for a New EU Regulation of Clinical Trials
Authors: Rizzi Marco
Published: February 2017

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.
Latest Procedural Developments Related to the WTO Dispute US – Clove Cigarettes
Authors: Laurenza Eugenia Costanza
Published: February 2017

On 13 August 2013, the Government of Indonesia requested a special meeting of the WTO Dispute Settlement Body (hereinafter, DSB) in order to obtain authorisation to suspend concessions or other obligations (i.e., to ‘retaliate’) against the United States (hereinafter, the US). This request stems from the US alleged failure to comply with the rulings and recommendations of the WTO DSB in the dispute US – Measures Affecting the Production and Sale of Clove Cigarettes (hereinafter, US – Clove Cigarettes). In that dispute, the WTO dispute settlement organs found that Section 907(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (hereinafter, the FFDCA), introduced by Section 101(b) of the Family Smoking Prevention and Tobacco Control Act discriminated against Indonesian clove cigarettes in favour of ‘like’ domestic menthol cigarettes, in a manner which was inconsistent with, inter alia, Article 2.1 of the WTO Agreement on Technical Barriers to Trade (hereinafter, TBT Agreement). The DSB recommended that the US bring its legislation relating to the ban on flavoured cigarettes into conformity with its obligations under the WTO. On 22 August 2013, the US objected to the level of suspension of concessions proposed by Indonesia and requested that the matter be referred to arbitration. Following such request from the US, the DSB agreed that the matter be referred to arbitration and informed WTO Members that arbitration would be carried out by the original panel.
Judgment of the General Court of the EU on Access to Information under Substance Law
Authors: von Holleben Horst
Published: February 2017

On 08 October 2013, the General Court of the European Union (hereinafter General Court) delivered a judgment based on the Aarhus Regulation 1367/2006 on the access to information on substances under plant protection law, which attracted considerable attention among experts with conflicting response from environmental associations and industry. The judgment – still appealable at the time this article was written – would in case of becoming unappealable result in extensive limitations to the protection of commercial and industrial secrets under plant protection law, but additionally also generally under substance law. The following article analyses the content of the decision.
Government Promotion of the Electric Car: Risk Management or Industrial Policy?
Authors: Lane Bradley W. , Messer–Betts Natalie , Hartmann Devin , Carley Sanya , Krause Rachel M. , Graham John D.
Published: February 2017

There are two prominent motivations for why governments seek to promote the electric car: risk management and industrial policy. This article provides operational definitions of these two motivations and uses them to characterize the public policies of six political jurisdictions: California, China, the European Union, France, Germany, and the United States. The article finds that while the European Union is focused primarily on risk management, China, Germany and the United States are primarily engaged in industrial policy. California and France are intermediate cases with a substantial blend of industrial policy and risk management. Future research into the ramifications of industrial policy for liberalized international trade is recommended.
Smart Regulation and European Private Law – What linkages?
Authors: De Smedt Kristel
Published: February 2017

Private law in Europe has undergone a significant transformation during the last two decades. From a branch of law that was scarcely affected by EU legislation, it has become the object of considerable harmonisation measures to facilitate free trade and protect European citizens. Simultaneously, there has been an increased attention for ‘better regulation’ in the EU. The efforts of the European Commission to improve regulatory quality and to reduce administrative burdens for industry have promoted a regulatory environment in which formal intervention is more limited and self–regulation and co–regulation have emerged as alternatives. The University of Maastricht organized a workshop on ‘Smart Regulation of European Private Law’ in January 2013 with the aim to assess how the Smart Regulation agenda has shaped/can shape European private law; investigate the contribution of different methodological approaches to achieve ‘smart regulation’; and explore opportunities and threats for European private law, in particular in respect with developments in self–regulation and co–regulation. This report shortly summarises the discussions.
Precaution, Proportionality, and Cost/Benefit Analysis: False Analogies
Authors: Rose–Ackerman Susan
Published: February 2017

The Politics of Precaution by David Vogel, and the edited volume, The Reality of Precaution each compare the United States with Europe over a range of regulatory areas. Vogel claims that the US and Europe changed places in recent years with Europe becoming more precautionary than the US. The edited volume covers a wider range of topics and finds that the results are mixed. The evidence of diversity in the edited volume appears convincing, but this essay argues that both volumes too narrowly focus on the precautionary principle. Rather it argues for a broader context that confronts precaution both with the proportionality principle, which is a mainstay of European Union law, and with the limitations of cost/benefit analysis and Impact Assessment. It unpacks the normative underpinnings of these concepts to suggest a broader frame for policy analysis.
Missing the Wood for the Trees?
Authors: Burgess Adam
Published: February 2017

There is little debate, particularly clear, ‘no bullshit’ debate within the risk and regulation community, much as there is a lack elsewhere within academia. Without it, much goes unclarifed and arguments aren't tested and pushed to their limits, which is generally where they need to go. On these grounds alone I would welcome the different approaches to European/American precaution set out by Vogel and Wiener. But there are more positive things to say about these competing representations, irrespective of which one prefers. This is a discussion rich in empirical detail but that goes beyond individual issues towards systemic patterns, relating the data to wider themes and an overall framework. What's more, it concerns a matter of real contemporary significance and interest that citizens generally – at least those of America and Europe – should know about, and even have a view upon. And it's genuinely interesting – irrespective of any engagement with the academic study of risk and regulation.
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.
Shrimp Export from Benin vs Food Safety in Europe: Reconcilable Interests?
Authors: Kindji Kévine , Faure Michael
Published: February 2017

In order to secure their fishery products market share in the EU, third countries, especially the developing ones, tend to transplant EU requirements into their domestic legal order. In reality, theses transplanted laws do not correspond to measures to reach a level of protection needed by the country of destination. Based upon the case of Benin, this paper intends to show that when these legal transplants are adversely made, they can in some cases have disastrous effects. It can be argued that an unintended result of EU policy was that it contributed to the collapse of the shrimp industry in Benin. The paper moreover argues that despite the stringency of the EU requirements, the implementation of its control policy might inadequately protect European consumers of shrimp.
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 167/1

1.

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).
Dealing with the Challenge of Evidence–based Decision–making in Situations of Uncertainty and Emergency
Authors: Florin Marie–Valentine
Published: February 2017

Collection and provision of scientific information for policy and decision-making is particularly important during emergencies or when uncertainty and ambiguity creates situation of fear and anxiety. This article offers two suggestions for addressing natural or technology risks, leveraging research by the International Risk Governance Council (IRGC) and project contributors. The first advice is that concepts and instruments for risk governance be recognised and used as intermediation between evidence and policy. The second is that the role of the Chief Scientific Adviser in public sector organisations includes those of the Chief Risk Officer. These suggestions could help address the challenge for policymakers to deal with uncertainty and emergency, when little or contradictory evidence is available.
Unconventional Gas Development in the U.S. States: Exploring the Variation
Authors: Schenk Olga , Lee Michelle H.W. , Paydar Naveed H. , Rupp John A. , Graham John D.
Published: February 2017

This article examines the large interstate variation in levels of unconventional gas development in the U.S. states. The following hypotheses are advanced to predict whether a state will be predisposed toward development: (H1) the availability of unconventional gas reserves; (H2) the availability of infrastructure to support development; (H3) a recent history of conventional oil and gas development; (H4) Republican party control of the Governor's office and state legislature; (H5) relatively low sensitivity to environmental issues; (H6) regulatory systems that treat UGD as a variant of conventional gas development; (H7) a pressing need for economic benefits as indicated by state and local measures of household income, unemployment and poverty; (H8) and public opinion supportive of development. To various degrees, each of the hypotheses is supported but important exceptions and surprises are uncovered in the qualitative and semi-quantitative analyses. Future research should continue the effort to explain the variation of development by expanding the geographical scope of inquiry and enlarging the sample of jurisdictions.
Minimum Unit Pricing for Alcohol in the Court of Justice
Authors: Robertson Aidan
Published: February 2017

Legislation passed by the Scottish Parliament in June 2012 to impose minimum unit pricing for alcohol sold in Scotland as part of a strategy to tackle alcohol-related harm has yet to be implemented pending the outcome of a challenge to its legality under EU law before the Scottish Courts brought by three associations of producers of wines and spirits, namely the Scotch Whisky Association, the Confédération Européenne des Producteurs de Spiritueux and the Comité de la Communauté économique européenne des Industries et du Commerce des Vins, Vins aromatisés, Vins mousseux,Vins de Liqueur et autres Produits de la Vigne. The first instance court in Scotland rejected the challenge in May 2013, but Scotland's appeal court decided in April 2014 that before ruling on the producers’ appeal, it should refer a number of questions to the Court of Justice of the European Union (“CJEU”). The CJEU is not expected to rule until late 2015 at the earliest and so the ultimate outcome before the Scottish courts is not likely to be known until 2016.
The Impact of Safety Culture on Systemic Risk Management
Authors: Gunningham Neil , Sinclair Darren
Published: February 2017

Notwithstanding impressive gains in occupational safety across the Australian coal mining sector, this research reveals that even within the same company, some mines substantially outperform others in terms of safety outcomes, raising questions as to why, notwithstanding the introduction of sophisticated and systemic risk management mandated by government, such variation still exists. Potential contributory variables are considered (technology, physical environment, management systems), and discarded, before examining the role of safety culture. Drawing on qualitative (interviews) and quantitative research (safety statistics and audit results) it was found that distinctive patterns of site and context specific cultural factors align to safety performance. The article provides insights as to whether, to what extent or in what circumstances site specific cultural variables, served to undermine or reinforce the effectiveness of the company's overall risk management strategy.
Iceland's New Plan for Debt Relief: Jubilee or Waiting for Godot?
Authors: Pinedo Maria Elvira Méndez
Published: February 2017

Despite Iceland's economic recovery, nearly 48% households continue to struggle to make ends meet. This study argues, first, that the main reason behind over-indebtedness in this country is a loan system without parallel in Europe, based on a triple cost of credit (fix/variable interest, indexation of credit to inflation and negative amortization). Second, the problem is examined in the context of European law as some alleged malpractices of indexation have been referred to the EFTA Court. Third, the focus shifts to the debt-relief programme presented by the Icelandic government in 2013/2014 after the relative failure of previous debt-relief measures. It is argued that this plan will fail in the long run as long as the indexation of credit to inflation is not abolished. The private pension system in Iceland relies indirectly on indexed mortgage credit issued by the public Housing Financing Fund. Since a ban on indexation and a holistic pension reform are not expected soon, all present debt write off benefits will surely be eaten up by higher inflation. As long as indexation of credit is legal, the future scenario resembles less a debt-relief jubilee and more the theater play “Waiting for Godot ”.
A New Tool in the Box?
Authors: Schrefler Lorna , Luchetta Giacomo , Simonelli Felice
Published: February 2017

The year 2013 has witnessed a new entry in the EU “better regulation” toolbox: the Cumulated Cost Assessment (CCA). The CCA is set to answer an apparently simple question: what is the cumulative cost imposed by a selection of EU rules and policies on a given economic sector? In this contribution we present the CCA methodology and its building blocks, as well as the results of the first two empirical applications of this tool. More importantly, we elaborate on two key features that make the CCA a valuable addition to the better regulation toolbox: it creates a methodological bridge between the policy and competitiveness assessment instruments, and it clarifies empirically how a wide array of policies interact with one another when and after they are actually implemented, an element that is often a weak link in policy–appraisal. We conclude with some remarks on how the CCA opens the avenue for a set of challenging and interesting methodological and policy considerations.
Pink Slime, Raw Milk and the Tweetification of Risk
Authors: Bobo Jack , Chakraborty Sweta
Published: February 2017

In a hot, flat, hyper–connected world, public perception of risk may determine if agriculture will save the planet by 2050 or destroy it. Science and technology options may hold the key to solving the situation, but, if media experience with “pink slime” and raw milk are any indication, society may be in for a bumpy ride. This article will examine global trends in food and agriculture, the interplay between food safety and public perceptions of risk, and the role of risk communication in addressing public perceptions.
The “Once an Article, Always an Article” Approach
Authors: Bergkamp Lucas , Herbatschek Nicolas
Published: February 2017

OPINION OF ADVOCATE GENERAL KOKOTT delivered on 12 February 2015 in Case C-106/14, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB) v Ministre de l’écologie, du développement durable et de l’énergie.
It Takes Two to Tango
Authors: Borchert Heiko
Published: February 2017

This article focuses on the information requirements of public and private stakeholders engaged in critical infrastructure protection (CIP).With its emphasis on information management rather than information sharing, the article builds on existing research suggesting that the notion of information sharing inadvertently renders cooperation more difficult as it evokes impressions of information “dominance” rather than joint information ownership. The article proposes a joint public-private information management agenda based on core issues providing actionable information to tackle immediate threats and crosscutting issues looking at the long-term issues that are relevant to understand the overall context in which critical infrastructure development occurs.
State Duties to Protect
Authors: Schweizer Rainer J.
Published: February 2017

Most European countries’ constitutional obligations guarantee and protect public security and fundamental rights. One aspect and often a prerequisite for the protection of public security and individual rights is the protection of critical infrastructure (CIP). CIP is of great importance in Switzerland, which is inevitable in an economically and technologically sophisticated and densely populated country.