bluuebunny/crossref_metadata_2025 huggingface dataset:
Fukushima Fixation – The Media Focus on Radiation Risk in Tsunami-Stricken Japan
Authors: Burgess Adam
Published: February 2017

Twenty five years on from Chernobyl, the tragic events in Japan of March 2011 seem to reaffirm the ‘risk society’ perspective which the 1986 nuclear accident in the former Soviet Union did so much to popularise. It was amidst widespread predictions of mass harm – projected both across Europe and into the future – that German sociologist Ulrich Beck’s book of the same name found such a receptive audience. Beck wrote of a new era defined by the greater risk posed by ‘manufactured’, technological risk than natural, ‘external’ ones. The way in which the possible, nuclear threat from the damaged Fukushima nuclear plant looms larger than the devastation and the thousands actually killed by the ‘natural’ earthquake and tsunami reminds us of Beck's distinction.
Faced with a Recall – How good is your Insurance?
Authors: Ekstrand Susie Stærk , Nilsson Kristine Lilholt
Published: February 2017

Any business having experienced a product recall knows how costly this can be. Sometimes the main costs of the recall are concentrated around counteracting bad publicity, but if several or large numbers of batches are affected by the recall, the costs of the recall itself can mount up considerably.

In many large companies the overall responsibility for quality assurance and product safety is placed in a different part of the organization from the one responsible for product liability insurance and recall insurance.

As a consequence inside the organization there is not always a common understanding of what the insurance should cover and what the insurance actually does cover – or of whether and when the insurance company should become involved in the process.
Smoke Without Fire – The Spanish Raw Tobacco Cartel Cases
Authors: Coelho Gonçalo Miguel Banha
Published: February 2017

Case T-29/05, Deltafina SpA v. Commission and Alliance One International, Inc., formerly Standard Commercial Corp. and Others v. Commission

The General Court partially annuls the Commission's decision on Case COMP/C.38.238/B.2 and reduces the amount of the fine imposed by the Commission on Deltafina SpA from EUR 1 188 000 to EUR 6 120 000 (author's headnote).
“Beyond Mobistar” – Assessment of the Deterrent Effect of Direct Charges to Telephone Subscribers under Article 30(2) of the Universal Service Directive
Authors: Berliner Markus
Published: February 2017

Article 30(2) of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive [USD]) is to be interpreted as obliging the national regulatory authority to take account of the costs incurred by mobile telephone network operators in implementing the number portability service when it assesses whether the direct charge to subscribers for the use of that service is a disincentive. However, it retains the power to fix the maximum amount of that charge levied by operators at a level below the costs incurred by them, when a charge calculated only on the basis of those costs is liable to dissuade users from making use of the portability facility (official headnote).
Eating the Cake Too – Access for Consultation of the Visa Information System and the UK's Partial Schengen Opt-Out
Authors: Zhang Xiaolu
Published: February 2017

Council Decision 2008/633/JHA on access for consultation of the Visa Information System for the purposes of prevention, detection and investigation of terrorist offences and other serious criminal offences must be read as a development of the Schengen acquis and not merely as a measure as to police cooperation, preventing the United Kingdom and Ireland from participating in adopting the measure (author's headnote).
La Regolazione del Rischio e il Sistema degli Standard. Elementi per una Teoria dell’Azione amministrativa attraverso i Casi del Terrorismo e dell’Ambiente, by Marta Simoncini. Naples: Editoriale Scientifica, 2010, 368 pp., € 20.00, Paperback.
Authors: Pinto Maria Olimpia Barros
Published: February 2017

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at david.hornsby@wits.ac.za.
Origination and Distribution of Debt: Risks and Regulatory Solutions
Authors: Lenhard Anselm
Published: February 2017

This article focuses on misaligned incentives in the lending process caused by the shift from the traditional relationship banking model to a more transaction-oriented ‘originateto-distribute’ model of bank finance as one of the major factors contributing to the financial crisis of the years 2007–2009. Based on a theoretical analysis of banks as financial intermediaries and the agency costs involved if banks distribute assets they have created to other parties in the financial system, empirical studies are reviewed which demonstrate that market mechanisms apparently contain these agency costs in loan syndications and loan sales, but failed to do so in securitisations during the years before the onset of the financial crisis. The EU has already reacted to this breakdown of market mechanisms by an amendment to the Capital Requirements Directive with the purpose of aligning incentives in securitisation transactions by getting more securitiser ‘skin in the game’. Similar legislation has been adopted in the US. This article places the EU and US response to perceived shortcomings in securitisations in the context of the theoretical and empirical literature and discusses alternative regulatory solutions.
The Icesave Dispute in the Aftermath of the Icelandic Financial Crisis: Revisiting the Principles of State Liability, Prohibition of State Aid and Non-discrimination in European Law
Authors: Méndez-Pinedo Maria Elvira
Published: February 2017

This study focuses on the Icesave dispute and Icesave agreements between Iceland, the UK and The Netherlands in the light of European law (EU and EEA law) and explores two main issues: 1) the State liability for breaches of EU/EEA law on the basis of Directive 94/19/EC following a systemic bank collapse in Iceland; and 2) the principle of non-discriminatory interplay between the nationalisation of Icelandic banks (State aid) and the payment of the minimum guarantee of €20.887 to depositors of Icesave accounts in the branches of Landsbanki in the UK and The Netherlands. This dispute was handled through diplomatic negotiations. The author is highly critical of the methodology followed. This cross-border dispute brought to light new complex problems in a grey area of European law which should have been brought before the highest European courts. Icesave also seems to have turned Icelanders against the process of European integration and the EU.
First Fundamental Decision of the Federal Supreme Court of Switzerland on Cost-Effectiveness in the Area of Human Healthcare
Authors: Kesselring Felix
Published: February 2017

In rendering this decision, the Federal Supreme Court of Switzerland entered for the first time into a detailed analysis of questions relating to the cost-effectiveness of human healthcare. The decision, concerned with the availability of a drug for a rare genetic disease, makes it clear that the maximum amount available from a public health insurance provider for the medical treatment in a particular case has been reached once the amount requested by the individual patient cannot also be provided to all other persons in a comparable situation. It remains unclear, however, how cost-effectiveness is to be assessed below this maximum amount (author's headnote).
Direct or Indirect Regulation of Hedge Funds: A European Dilemma
Authors: Dardanelli Giorgio Tosetti
Published: February 2017

This paper deals with the debate on the methods to regulate hedge funds, with a particular focus on direct or indirect regulation. After having briefly examined the pros and the cons of directly regulating these investment schemes, it comes to the conclusion (largely shared by most scholars) that hedge funds should not be directly regulated, while regulation should concern their management companies and, most of all, their counterparts (lenders in the first place) with a view to managing systemic risk. In addition, regulation should also set precise thresholds for access which should aim at protecting unsophisticated investors from hazardous moves, without, however, falling into the trap of regulating hedge fund themselves.

The attention is then turned to the European Union and to its Alternative Investment Fund Managers Directive (AIFMD). An analysis is conducted on some of the most significant approaches to hedge fund regulation which have fuelled (and are partly still fuelling) the debate within EU institutions in its struggle to provide Member States with a valid response to the financial crisis, and on some key provisions of the first level AIFMD. In this light the author concludes that, despite the declared intent to regulated fund managers, the directive often seems to regulate hedge fund themselves. This does not seem to be in line with the thoughts of most scholars and market operators on hedge fund regulation and also looks at odds with other pieces of EU legislation (in particular with the so-called “Newcits”).
The Financial Crisis in the European Union: An Impact Assessment and Response Critique
Authors: Welch Jennifer
Published: February 2017

This article assesses the impact of the global economic crisis on the European Union and analyzes the recently enacted and future legislative response to repair the EU financial sector. It closely discusses and critiques the main initial response legislation, the European Economic Recovery Plan, finding that the central regulation contained short-term measures, yet managed to remain within the EU's long-term goals. The article also closely examines the significant risk regulation considerations highlighted by the economic crisis, notably those considerations contained in the De Larosiere Report and the Basel III Framework, and discusses the importance of implementing financial risk regulations to stabilize and revitalize the EU financial sector. Ultimately, the article concludes that the EU's recently enacted legislative measures are consistent with, but also must continue in tandem with, the longterm policies of the EU, while including new and crucial financial risk regulatory measures.
The System of Financial Supervision in Europe – Origin, Developments and Risk of Overruling
Authors: Poto Margherita
Published: February 2017

The article depicts the general framework in which the regulatory bodies in financial sector have been operating. After an introductory outline of the financial system and its objectives, the analysis shifts to the framework of the financial business operators and of the regulatory bodies. The market is organised and fragmented in financial conglomerates, where cross activities take place and where potentially it is easier for the regulatory bodies to exercise their control. In this context, the different models of supervision will be scrutinised, together with the attempts, made at European level, to comply with the international standards. The final part is dedicated to the description of global dynamics and to the current situation to overcome the systemic crisis affecting the market. With some –bitter – concluding remarks we will try to prospect possible different solutions to the crisis, solutions that don't necessarily coincide with the actual decisions to reform the system taken at European level.
Different Actors, Different Factors – Science and Other Legitimate Factors in the EU and National Food Safety Regulation
Authors: Szajkowska Anna
Published: February 2017

According to the principle of risk analysis established by Regulation 178/2002, food safety measures in the EU and Member States must be based on scientific risk assessment. Apart from science, however, decision makers should take into account other legitimate factors, such as societal, ethical or traditional concerns. The extent to which risk managers can deviate from scientific evaluations in considering these factors depends on how much discretion is conferred on public authorities. This article compares the discretion at both national and Union levels of food safety regulation in the context of the internal market mechanism by analysing the standard review applied to food safety measures by the European judiciary.
Biotechnology
Authors: Mereu Claudio
Published: February 2017

Regulation n. 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14 December 2009 and applies as of 14 June 2011, subject to some transitional measures set out in Article 80. It shall replace gradually the current legislation on plant protection products which is laid down in Council Directive 91/414/EEC and related implementing Regulations.

Broadly speaking, the harmonized authorization system for active substances used in plant protection products, as originally set out in Directive 91/414/ EEC, is maintained. Indeed, the placing on the market of plant protection products is still subject to a two-steps process whereby active substances are approved at the EU-level (with the inclusion into a “positive list” – Annex I to the new Regulation) while formulated products are authorised at the national level based on “Uniform Principles” laid down in a new implementing Regulation 546/2011. However, the criteria underlying each of these two steps have changed remarkably.
Food
Authors: Träsch Jennifer
Published: February 2017

In 2006 the Hungarian system of food safety regulation was described as “chaotic” , fragmented and lacking accountability. Now, five years later and almost seven years after Hungary's accession to the European Union (EU) it is time to take stock again. Food safety regulation has undergone a “threefold change” and follows a separated model. Competences for risk assessment, risk management and risk communication are well distributed and the Hungarian Food Safety Office (HFSO)/Magyar Élelmiszer-biztonsági Hivatal (MÉBiH) fits into the overall structure now. But there are still problems concerning its legal position, weak status and especially insufficient independence.

This report shows the evolution of the Hungarian system and highlights the brand new developments and the current situation, challenges and organisation of the HFSO.
Science and the Precautionary Principle in International Courts and Tribunals, by Caroline E. Foster. Cambridge: Cambridge University Press, 2011, 400 pp., £70.00, Hardback.
Authors: Nappert Sophie
Published: February 2017

Beneath the calm and measured prose of Dr. Caroline Foster lies a tsunami for the field of risk assessment in international adjudication.

Dr. Foster, a senior lecturer at the Faculty of Law, University of Auckland, looks boldly in the eye the difficult question of the influence of scientific evidence on international courts and tribunals. In an era where international law is endeavouring to come to terms with environmental protection, sustainable development, and public health and safety regulations and policies, international tribunals are called upon to adjudicate matters of extreme scientific complexity and, in this context, to understand the scientific approach to risk. One can no longer escape the realisation that judges and arbitrators on international tribunals rely on scientific expertise, and that this has a significant impact on their decision-making. This is one of the central tenets of Dr. Foster's book, and the basis for her analysis.
‘Nudging’ Healthy Lifestyles: The UK Experiments with the Behavioural Alternative to Regulation and the Market
Authors: Burgess Adam
Published: February 2017

This article critically reflects upon the introduction of behavioural, ‘nudging’ approaches into UK policy making, the latest in a series of regulatory innovations. Initiatives have focused particularly upon correcting lifestyle risk behaviours, marking a significant continuity with previous ‘nannying’ policy. On the other hand, nudging represents a departure, even inversion of previous approaches that involved the overstating of risk, being based partly upon establishing a norm that bad behaviours are less, rather than more common than supposed. Despite substantive similarities, its attraction lies in the reaction against the former approach but must also be understood in the context of the economic crisis and a diminished sense of liberty and autonomy that makes intimate managerial intervention seem unproblematic. Problems are, in fact, substantial, as nudging is caught between the utility of unconscious disguised direction and the need to allow some transparency, thereby choice. Further, it assumes clear, fixed ‘better outcomes’ but encourages no development of capacity to manage problems, contradicting a wider policy intent to build a more responsible and active citizenry. More practically, nudging faces considerable barriers to becoming a successfully implemented programme, in the context of severe, Conservativeled austerity with which it is now associated.
Nudging Cannot Solve Complex Policy Problems
Authors: Selinger Evan , Whyte Kyle Powys
Published: February 2017

We deepen Adam Burgess’ insight that under current conditions nudging cannot solve complex policy problems reliably and without controversy. We do so by integrating his concerns about nudging into Braden Allenby and Daniel Sarewitz's three-leveled model of the basic problems technology can address and generate. We use this model to explain why the UK experiment with nudging has revolved around techno-fixes with limited policy potential, and conclude that nudging is best seen as an emerging form of soft law.
Shackles for Bees? The ECJ's Judgment on GMO-Contaminated Honey
Authors: Lamping Matthias
Published: February 2017

Case C-442/09, Bablok and Others (not yet reported)

An old German proverb says: What the farmer doesn't know he doesn't eat. In the case of the Bablok decision delivered by the European Court of Justice on 6 September 2011, it is not the farmers, but the judges who seem to be wary about the unknown. According to their judgement, substances derived from genetically modified plants require market authorisation to be placed on the market as food, even if the substance itself is not fertile anymore. Since the Court takes the view that pollen is an ingredient of honey rather than a natural component, honey contaminated with pollen from genetically modified organisms will fall within the classification of foodstuffs requiring marketing authorisation. So whenever a bee collects pollen from a genetically modified plant, this can make the entire honey harvest unmarketable. Not even the slightest contamination will be tolerated, irrespective of whether it was intentional. Because the prohibition to put unauthorised honey on the market applies abstractly, regardless of whether there is a concrete risk for the health of consumers, the judgement will have considerable impact on the coexistence of conventional, ecological and genetically-modified farming.
Improving Regulatory Decisions through Targeted Research: A Case Study Concerning Amino Acids
Authors: Rogers Michael D. , Smriga Miro
Published: February 2017

This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.
Risk Governance and Risk Assessment – Key tools for an effective European Parliament
Authors: Harbour Malcolm
Published: February 2017

For more than 10 years, I have had the privilege of being Vice President of STOA, the European Parliament's Science and Technology Options Assessment arm. During that time, I have been part of the team that has refocused STOA towards the crucial role of monitoring trends in science and technology, commissioning research to examine the implications for policy makers, and organising events to disseminate results.

During the same period, my work as a legislator has made me more and more aware of the need to examine science and technological trends, in order to ensure that the legislation that we amend and approve is truly “fit for purpose”. We are not afraid to recommend changes where we think that technological developments will make suggested provisions redundant or ineffective. To give a recent example, in our review of the Directive on Consumer Rights, we insisted on including new provisions to safeguard consumers buying faulty digital products or services. These were not included in the original text, but were subsequently agreed by the Member States and the European Commission.
Appellate Body Report, United States – Clove Cigarettes
Authors: McGrady Benn
Published: February 2017

In September 2011, the World Trade Organization (WTO) released the report of a panel tasked with considering a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The panel concluded that the US violated WTO law and recommended that the US be asked to bring its laws into conformity with WTO law.

The US appealed the panel's decision. The Appellate Body of the WTO upheld the panel report on April 4, 2012. This case note gives a brief overview of the Appellate Body's report and examines the implications for tobacco control and public health more generally.
The Intractable Citizen and the Single-Minded Risk Expert – Mechanisms Causing the Risk Regulation Reflex Pointed Out in the Dutch Risk and Responsibility Programme
Authors: Helsloot Ira , Schmidt Arjen
Published: February 2017

Safety regulations are too often disproportional in the sense that their costs outweigh the benefits. Although this is well known, years of trying to reduce safety related regulatory pressure has not resulted in much success. Two important causes for this have not received much attention up to now. One of these is a faulty perception of how the general public regards risk. We argue that the intractable citizen's behaviour needs better understanding. The second cause is the single-mindedness of risk experts which calls for specific instruments to be harnessed.
Food Irradiation: The EU Regulatory Framework, Risk Assessment and International Trade Considerations
Authors: Carreño Ignacio , Vergano Paolo R.
Published: February 2017

This article looks at the different regulatory approaches on food irradiation, starting with international standards on food irradiation, describing the approach in the US and other third countries, and finally in the EU, where there has been a regulatory standstill since 1999. The current EU approach on food irradiation, which authorises irradiation of certain predefined product categories and sets upper dose limits, does not appear to be in line with the approach used under the relevant internationally-recognised standards, such as the Codex Alimentarius and the International Plant Protection Convention. There are potential legal conflicts between the current regulatory framework on food irradiation in the EU and the international trade framework of the World Trade Organization. Ultimately, the EU must base its measures on scientific principles, on relevant international standards, and choose the least trade-distortive measures that are available (i.e., ensure that they are applied only to the extent necessary to protect human, animal or plant life or health). In 2011, the European Food Safety Authority published new risk assessments on food irradiation, which the European Commission has requested in view of drafting new EU legislation on food irradiation, and which appear to open the way for a fundamental altering of the regulatory parameters (such that food irradiation regulations must be scientifically-justified and in line with the relevant international standards), and seem to weaken the EU stance vis-à-vis the possible instances where the current rules on food irradiation prevent (de jure or de facto) access to the EU market by third countries’ operators and products, particularly those of developing countries.
China's Food Standardization System, Its Reform and Remaining Challenges
Authors: Xiao Pinghui
Published: February 2017

The article examines China's food standardization system, its reform and remaining challenges. Upon examining China's general standardization system, the article argues that the food standardization institutional framework has originated from the general standardization, which has developed a four-level hierarchy mechanism. It further examines the most salient features of China's food standardization system, namely, top-down hierarchy and intensive government involvement, and suggests that these features caused a regulatory failure. Although China recently reformed this fi eld, and the food safety standard hierarchy has been streamlined, challenges remain. The article reviews China's current reform in the food standardization system by providing a description, analysis and comparison of approaches from Europe and China.
Risk Assessment, Science and Deliberation: Managing Regulatory Diversity under the SPS Agreement?
Authors: Reid Emily
Published: February 2017

The adoption by WTO Members of measures relating to the protection of health and life of animals, plants and humans is regulated by the WTO Sanitary and Phytosanitary (SPS)Agreement. A fundamental question in the application of this agreement concerns the distinction to be drawn between legitimate regulation and unlawful restriction of trade. This distinction can be difficult to discern, particularly since different communities have different levels of tolerance for risk, which leads to varying national regulatory decisions. This paper critically examines the approach taken to this question in rulings of the WTO dispute settlement panels and Appellate Body, highlighting and analysing three emergent issues:the role attributed to science, the two stage review process adopted and the application of the principle of mutual recognition. The importance of deliberative decision-making inthis context is emphasised, as is the need for recognition and acceptance of the regulatory diversity that this will bring.
Nanomaterials and Occupational Safety: An overview
Authors: Gazsó André , Fries René
Published: February 2017

Nanomaterials and products containing such materials are already in widespread use because they exhibit technologically interesting, nano-specific features such as increased tensile strength, improved electrical conductivity, special optical characteristics or special medico-chemical properties. Nonetheless, the same features that make these substances so interesting technologically potentially harbor risks for those persons who handle them. This is because small particle size, coupled with increased reactivity due to special surface features, determines their biological activity and therefore toxicity. The increasing applications are exposing ever more employees – especially those working in research laboratories or in industrial production and processing – to nanosubstances. This makes occupational safety a major issue from a regulatory standpoint. Based on the available literature on occupational safety, the following nanomaterial-relevant topics have been identifi ed: health risks, adaptation of detection and measurement methods, actual exposure scenarios at the workplace, defi nition and compilation of existing worksites for nanomaterials, recommendations for worker safety by the authorities and by industry, as well as preventive occupational medical care.
The Role of the Discount Rate in Cost–Benefit Analysis Between Theory and Practice: A Comparative Survey
Authors: Simonelli Felice
Published: February 2017

This study focuses on the role of the discount rate in cost–benefit analysis (CBA) of regulation, providing a systematic investigation into regulatory practice vis–à–vis the existing economic theories. In the first part, a quick survey of the main economic literature on the social discount rate (SDR) is presented. In the second part, the current institutional practice is investigated, firstly comparing the recommendations on discounting issued by institutional actors in the US (Office of Management Budget, Environmental Protection Agency) and the EU (Commission), and secondly examining the SDRs adopted in two samples of CBAs selected among Regulatory Impact Analyses of US EPA and Impact Assessments of EU Directorate–General for the Environment. A gap exists between economic theory and institutional practice in the selection of the SDR. Regulatory decisions which are based on CBA reflect the most workable economic literature on discounting rather than the most theoretically consistent one, thus yielding less reliable and less robust results. Scholars who aim at improving the quality of rule–making and at fostering the application of CBA in regulatory decisions should improve the “operational validity” of their research, thus providing practitioners with methods that are both consistent and workable.
The HOB–vín Judgment: A Failed Attempt to Standardise the Visual Imagery, Packaging and Appeal of Alcohol Products
Authors: Alemanno Alberto
Published: February 2017

National rules of a EEA State, such as those at stake in the present judgment, under which a State monopoly on the retail sale of alcohol, may refuse to accept for sale alcoholic beverages that are lawfully produced and marketed in another EEA State on the grounds that the labelling of the products contains loaded or unrelated information, are in breach of Article 18 of Directive 2000/13/EC (‘the labelling Directive’ or ‘Directive’), and cannot be justified by a public health objective. Another rule requiring alcoholic beverages to carry stickers stating that their contents are alcoholic, in addition to the mandatory indication of the actual alcoholic strength by volume, ‘cannot be considered effective’ if it has been adopted without regard to the notification procedure laid down in Article 19 of the labelling Directive. However, individuals and economic operators who have been harmed by the incorrect application of the Directive may rely on the free movement of goods in order to render the State liable for the breach of EEA law, regardless of whether such a directive is being made or has been made part of the legal order of Iceland, since it has been incorporated in the EEA Agreement. Failure to notify the second rule in accordance with the Directive qualifies as a sufficiently serious breach of EEA law. Such a breach entails State liability if the national court finds a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured party (author's headnote).
Incorporating Social Sciences in Public Risk Assessment and Risk Management Organisations
Authors: Wendling Cécile
Published: February 2017

The objective of the article is to analyse the use of Humanities and Social Sciences (HSS) in public risk assessment and risk management organisations in France, Germany, the UK, the Netherlands, Canada and the United States based on more than a hundred interviews conducted with social sciences experts employed by or working for these organisations. If the added value brought by the integration of social scientists is recognised, the use of social sciences differs from one organisation to another. The article compares the different positions given to social scientists inside and outside the organisation, the various methods used and the different contents produced. The survey highlights a set of initiatives that are scattered, differentiated and ultimately have little in common – except that they often play a marginal role in the main activities of the agencies concerned.
Extended Peer Evaluation of an Analytical Deliberative Decision Support Procedure in Environmental Health Practice
Authors: Keune Hans , Koppen Gudrun , Morrens Bert , Colles Ann , Springael Johan , Loots Ilse , Teughels Caroline , Chovanova Hana , Van Campenhout Karen
Published: February 2017

How can we assess the quality of an analytical deliberative decision support procedure in environmental health practice? Objectifying quality criteria is difficult for several reasons. Opening up evaluation to a diversity of critics is one approach to take into account different actor perspectives and complexity. We describe how social scientists organized extended peer evaluation of a participatory multi-criteria procedure that was applied in Flemish environmental health practice. International peer review was combined with local extended peer evaluation. Social scientists collaborated closely with natural scientists and policy representatives in designing several evaluative activities and in interpreting the results.We discuss how these different perspectives came to reach conclusions, with a special focus on methodological decision-making. A process of learning by doing and negotiating, finding a methodological path amidst practicalities, complexity and ambition.
A Sociological Checklist for Assessing Environmental Health Risks
Authors: Benamouzig Daniel , Borraz Olivier , Jouzel Jean-Noël , Salomon Danielle
Published: February 2017

The contribution of social sciences to risk assessment has often been confined to dimensions of risk perception and communication. This article relates an effort to promote knowledge from the social sciences that addresses other dimensions of risk issues. A sociological checklist produced for ANSES in France helps to identify and analyse social dimensions that should be given attention during the process of risk assessment.
What is the Best Way to Supervise the Quality of Medical Devices? Searching for a Balance Between ex-ante and ex-post Regulation
Authors: Singh Shanta Marjolein
Published: February 2017

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.
Regulatory Agencies of the European Union as International Actors
Authors: Groenleer Martijn , Gabbi Simone
Published: February 2017

EU agencies, such as the European Food Safety Authority (EFSA), are usually created in an environment that is replete with other organizations, not only other European bodies and member state agencies, but also international organizations and third country agencies. Through their interactionwith EUagencies, these international organizations and third country agencies may affect policies, policymaking processes, institutions and behaviour in the EU and its member states. But EU agencies do not necessarily serve as passive channels for the interaction between international organizations and third country agencies, on the one hand, and the EU institutions, on the other hand. They often seem to play an active role as policy entrepreneurs,making use of the opportunities offered by the policies and policymaking processes of these organizations and agencies to influence institutions and behaviour in the EU and its member states. The above raises the question of what international role EFSA actually has performed: has it, despite the formal-legal restrictions put in place by the EU institutions, been able to act relatively autonomously at the international level? In order to address this question, this article examines EFSA's international relations, notably those with international organizations and third country agencies in its field of action. It adopts a dynamic perspective, describing these relations throughout the agency's development. The article demonstrates that EFSA has developed a considerable international role, despite the relatively limited scope of action allowed by its legal framework, and shows that this development has been driven by both functional needs and strategic motives.
Epistemic Subsidiarity – Coexistence, Cosmopolitanism, Constitutionalism
Authors: Jasanoff Sheila
Published: February 2017

Harmonization is an essential instrument of international risk governance. It is the process through which disparities among national regulatory standards are ironed out, producing uniform outcomes that all participants in a regime can accept and that facilitate the free exchange of regulated goods in commerce. Contrary to conventional belief, however, harmonization requires not only technical but also political cooperation, since standards themselves are not direct mirrors of reality but are co-produced responses to technoscientific and political uncertainty. Attempts to harmonize standards across national borders therefore pit alternative political cultures and their systems of public reasoning against one another. Put differently, harmonization calls into question the underlying models of subsidiarity that provide the foundation for robust international regimes. This paper examines three models of epistemic subsidiarity – coexistence, cosmopolitanism, and constitutionalism – and discusses each scheme's capacity to protect a nation's fundamental political commitments while advancing the goals of international risk governance.
Governing Control over Human Genetic Resources: Promises and Risks
Authors: Lucchi Nicola
Published: February 2017

The purpose of the paper is to discuss how to regulate the access to and use of biochemical and human genetic material currently considered as part of the market framework. Looking beyond the protection of traditional public goods (such as land or water), the paper emphasizes the debate around the progressive commodification of human genetic resources facilitated by an improper use of intellectual property rights. The discourse around commons is used to evaluate alternative tools and strategies to the issue of private appropriation of human genetic resources and natural compounds
The EU Adventures of ‘Herculex’
Authors: Weimer Maria , Pisani Gaia
Published: February 2017

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.

This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.
The Role of Science in 21st Century EU Policy–Making
Authors: Girling Julie
Published: February 2017

Today,more than ever, citizens expect value formoney, not only from their elected representatives, but also from the laws and regulations passed to protect them. As the European economy faces continued challenges and limited economic growth, citizens rely on policy-makers to encourage innovation and stimulate growth and jobs. This requires flexible legislation which fosters start-ups, encourages SMEs during those early days, but which also simultaneously maintains the high levels of consumer health and safety that they have become accustomed to.

Public accountability is also increasing – and rightly so. Citizens don't just want legislation that delivers – they alsowant transparency and open dialogue. They want decision-makers to explain why certain policy choices weremade over others, and what benefits they can expect fromsuch choices. This requirement for information must also be seen against a backdrop of increasing demands on consumers’ time and a tendency to deal in “twitterati” style soundbites. This often results in consumers feeling the need for analysis and validation of information via a third party, sometimes a journalist, sometimes anNGOor government agency.
Better Use of Science for Better EU Regulation
Authors: Schrefler Lorna , Pelkmans Jacques
Published: February 2017

Risk regulation is a major task of the EU. In this context, scientific knowledge and advice is critical to the preparation, formulation, legislation and later revision of EU risk regulation. However and with some notable exceptions (e.g. some EU Agencies, DG SANCO), there seems to be no systematic view, let alone, organisation for the ‘use of science’ for EU policy–making. It is in this light that the new function of Chief Scientific Advisor (CSA) to the President of the European Commission can best be appreciated. The authors first sketch how ‘science’ is used in the EU regulatory regime and what is or has become problematic about it. Subsequently, an informal SWOT analysis of the ‘use of science’ for EU policy is conducted. The contribution ends with an attempt to evaluate the CSA's accomplishments to date and how it can contribute to improving EU regulation. This is followed by a few recommendations on how the role of the CSA could be strengthened in the near future.
Evaluation and the Salience of Infringement Data
Authors: Smith Melanie
Published: February 2017

The infringement process contained in Article 258 TFEU requires the Commission, as guardian of the treaties, to monitor the performance of member states in relation to the implementation and application of EU norms. As the Commission carries out this duty it amasses enormous amounts of data on the realisation of policy objectives through its discovery of (non) implementation of EU norms and the administrative operation of its ‘compliance promoting tools’. This article explores the Commission's duty as guardian of the treaties through the lens of smart regulation and examines the potential for infringement data, and the infringement process more widely, to play a contributory role in executing meaningful evaluation in the policy cycle. The article will explore the extent to which the Commission has included infringement data as part of its policy cycle and in particular the evaluation process. It considers the multiple dimensions of accountability and institutional learning associated with evaluations and how these might be supported by the infringement mechanism. It argues that the infringement process and evaluations can be considered symbiotic with each process contributing to the accountability and institutional learning of the other.
No Patents on Seeds Files an Opposition against Monsanto's Patent EP 2 134 870 B1 Covering the Selection of Soybean Plants and Seeds
Authors: Gambini Emanuela
Published: February 2017

On 25th November, 2014, the coalition “No Patents on Seeds” filed an opposition against the European patent EP 2 134 870 B1, held by the U.S. Company Monsanto Technology. The patent, granted on 26th February, 2014, by the European Patent Office, covers “utility of SNP [single nucleotide polimorfism] markers associated with major soybean plant maturity and growth habit genomic regions” and includes “methods for screening plants and seeds from the genus Glycine withmarkers associated with genomic regions that are related to the plant maturity and growth habit of Glycine plants”.

“No Patents on Seeds” claims that the patent should be completely revoked, as it falls within the exclusion of essentially biological processes for the production of plants from patentability under art. 53(b) of the European Patent Convention (EPC2000) and is not a patentable invention according to art. 52(2)(a) EPC. This case note gives an overview of the opposition and discusses its implications.
Some Reflections on EU Governance of Critical Infrastructure Risks
Authors: van Asselt Marjolein B.A. , Vos Ellen , Wildhaber Isabelle
Published: February 2017

Critical infrastructure (CI) sees to assets that are essential for the functioning of a society and economy, as they provide public services, enhance quality of life, sustain private profits and spur economic growth. Assets of CI differ considerably, ranging from hardware such as cables and wires, through to networks for the generation and supply of energy sources. Critical infrastructures encompass many sectors of the economy, such as banking and finance, transport and distribution, energy, utilities, health, food supply and communications, aswell as key government services.