bluuebunny/crossref_metadata_2025 huggingface dataset:
Regulating New Risks: Emergency Contexts, Institutional Reform and the Difficulties of Europeanisation – Case Studies from Portugal
Authors: Gonçalves Maria Eduarda
Published: February 2017

The expression “risk regulation” conveys the idea of normalisation of the way in which the State deals with the problems raised by risk, through rules, institutions and procedures set up to either prevent risk or manage it once it materialises. It must be conceded, however, that there is a tension between risk regulation (understood as a means of bringing risk under control) and the fact that the emergence of new risks has persistently caused turmoil. For this reason, risk is proving to be a serious test of the State's ability to pursue the public interest when dealing with issues which are characteristically complex, both technically and socially.

The European Union has responded to the BSE and GMO crises by developing a truly European risk regulation system which has been a major driver of legal and institutional reform. Implementation has been far from homogeneous across the Member States, however, my premise being that the objective of normalisation has met perhaps unexpected obstacles in Southern European countries like Portugal, raising the question of the kind of local conditions which may either favour or hinder Europeanisation processes. This paper discusses the topic based on the analysis of three case studies illustrating the way the Portuguese state has tackled environmental and public health risks, and the impact of EU law and policy on the whole question.
Fat Taxes in the EU Between Fiscal Austerity and the Fight Against Obesity
Authors: Alemanno Alberto , Carreño Ignacio
Published: February 2017

To discourage unhealthy eating and limit the population's intake of fatty foods, thereby alleviating the current obesity “epidemic”, an increasing number of countries across the industrialised world are considering levying taxes on unhealthy food. A “fat tax” may be defined as a tax or surcharge placed upon fattening foods, beverages or individuals with the aim to decrease consumption of foods that are linked to obesity. This is not an entirely new idea – some theorists, starting with Arthur Pigou, a 20th century English economist, have long presented the arguments for imposing special taxes on goods and services whose prices do not reflect the true social cost of their consumption. Examples of Pigouvian taxes are duties on cigarettes, alcohol, gambling and environmental emissions. Support for another such tax, a fat tax, is now spreading across the European Union. On 1 October 2011, Denmark introduced a tax on foods by targeting those products that are high in saturated fat. The Danish Act (hereinafter, Act) confirms the trend in various EU Member States to tax certain foods or consider taxing them in the future.
Organismos Genèticamente Modificados y Riesgos Sanitarios y Medioambientales (Genetically Modified Organisms and Sanitary and Environmental Risks) by Justo Corti Varela. Madrid: Editorial Reus, 2010, 406 pp., € 41.50, Softcover.
Authors: Orellana Marcos A.
Published: February 2017

Biotechnology is one of the great innovations of our time. While Genetically Modified Organisms (GMOs) present an advance in food safety and other fields, GMOs also pose risks to human health and biodiversity that are still subject to scientific uncertainty. Given the scientific uncertainty about the risks to people and the environment, the precautionary principle acquires a central role in the debate on these organisms. At the same time, the existence of an adequate regulatory framework that allows the management of those risks becomes critical.
Liberalism and Lifestyle: Informing Regulatory Governance with Behavioural Research
Authors: Amir On , Lobel Orly
Published: February 2017

Behavioural economics is helping illuminate the limits of rational individual choice. At the same time, even as research identifies failures in rationality, policy must inquire about the possibility and legitimacy of government intervention. In ‘Nudging’ Healthy Lifestyles: The UK Experiments with the Behavioural Alternative to Regulation and the Market, Adam Burgess critically describes the introduction of behavioural approaches into UK policy making. In particular, Burgess is concerned with the wholesale adoption of nudge-style programmes to promote healthier living among citizens. Unsurprisingly, the UK developments find equivalent developments in the United States. In January 2009, President Barack Obama suggested that “the principles governing regulation … be revisited.” Envisioning a ‘behavioural dream team’ of economists and psychologists to help lead the way, President Obama appointed Cass Sunstein, the co-author of Nudge, as Administrator of the White House Office of Information and Regulatory Affairs.1 President Obama further ordered the US Office of Management and Budget to “clarify the role of the behavioral sciences in formulating regulatory policy.” The parallels between the countries are striking. The new UK leadership has consulted with Nudge's other co-author, Richard Thaler. The new leadership has guided top administrators to read behavioural research and a “Behavioural Insight Team” has been newly formed within the Prime Minister's Cabinet Office. More operationally, each of the governments has adopted initiatives to nudge citizens to better behaviour, physically and financially.
Nudging Smokers The Behavioural Turn of Tobacco Risk Regulation
Authors: Alemanno Alberto
Published: February 2017

At a time when policy makers want to change the behaviour of citizens to tackle a broad range of social problems, such as climate change, excessive drinking, obesity and crime, a promising new policy approach has appeared that seems capable of escaping the liberal reservations typically associated with all forms of regulatory action. After having relied on the assumption that governments can only change people's behaviour through rules and regulations, policy makers now seem ready to design policies that better reflect how people really behave, not how they are assumed to behave as rational agents. The approach, which stems from the increasingly ubiquitous findings of behavioural research, is generally captured under the evocative concept of ‘nudge’. Inspired by ‘libertarian paternalism’, it suggests that the goal of public policies should be to steer citizens towards making positive decisions as individuals and for society while preserving individual choice. Acting as ‘choice architects’ policy makers organize the context, process and environment in which individuals make decisions. In so doing, they exploit some patterns of irrationality, often called ‘cognitive biases’, to manipulate people's choices. Thus, in the famous Cafeteria example, the school's management might try to affect students’ diet by rearranging the display of food to make it more likely that students will choose the healthy option. This innovative approach to policy making is part of a broader shift from traditional regulation to regulatory governance that is generally referred to as New Governance.
Clear-cut Legal Basis for the RASFF: Mere Formalisation or a Concrete Move Forward?
Authors: Mahy Aude
Published: February 2017

The Rapid Alert System for Food and Feed (the socalled ‘RASFF’) is at the heart of food risk management within the European Union. It aims at providing authorities with an effective tool for exchanging information on measures taken to ensure food safety. It was created in 2002 by the General Food Law Regulation to help Member States to coordinate their food safety actions. Nearly ten years later, the adoption of Regulation 16/2011 of 10 January 2011, laying down implementing measures for the RASFF, intends to clarify the specific conditions and procedures applicable to the transmission of notifications through this tool, thus providing more legal certainty in the system.
A Brief Comment on Science-based Risk Regulation Within the European Union
Authors: Stibernitz Barbara
Published: February 2017

Nowadays as political decision making involves such a huge range of complex matters, scientific experts have become more and more involved in European risk regulation. The support by so-called independent experts may, on the one hand, be seen as a guarantee of rational decision making, increasing the quality of decisions as well as the general acceptance of all people affected. On the other hand, the number of expert groups, scientific committees and agencies helping the Commission in fulfilling its duties is vast and confusing.

In addition, scientific advisory bodies often face the burden of unrealizable independence, as well as a lack of transparency and democratic control. This article sums up the central position of science-based risk regulation within the European Union (EU), referring to the necessity for expert opinion as well as to consequent problems concerning the involvement of these experts in risk regulatory actions.
Long Awaited Guidance on the Meaning of “Regulatory Act” for Locus Standi Under the Lisbon Treaty
Authors: Buchanan Camilla
Published: February 2017

Case T-262/20 Microban International Ltd and Microban (Europe) Ltd v. Commission

The conditions for bringing direct actions before the EU General Court have been opened under Article 263, fourth paragraph, of the Treaty on the Functioning of the European Union (“TFEU”) through the introduction of less restrictive rules on legal standing for private applicants challenging regulatory acts. The term “regulatory act” covers all acts of general application apart from legislative acts and includes implementing measures adopted by the European Commission under the comitology procedure. Initial case law provides welcome guidance on the application of the new rules on standing but questions still remain (author's headnote).
The Changing Face of Risk Governance: Moving from Precaution to Smarter Regulation
Authors: Rübig Paul
Published: February 2017

STOA, the European Parliament's Technology Assessment body, which I had the honour to chair, has a mission to: (i) assess the impact of introducing and promoting new technologies, and (ii) identify the relevant policy options. In the context of its work, STOA has to address many different issues. One of the issues deserving STOA's attention is the changing face of risk governance: “Moving from precaution to smarter regulation”.

This is currently being debated on various levels, including that of the WTO (World Trade Organization), where science-based decision-making has always played an important role. The JRC (Joint Research Centre) is very active in this field and has developed, among others, a science-based approach to risk assessment in the area of nanotechnology. With the comitology procedure becoming more and more important, the European Parliament and its members have to assume their role with respect to risk management and explain it to the public.
The Problem of Low and Uncertain Risks: Balancing Risks and Benefits
Authors: Hudig Dirk
Published: February 2017

Both the Lisbon Treaty and the new Inter-Institutional Agreement strengthen the role of the European Parliament (EP) as co-legislator. At the same time, European Union (EU) officials increasingly recognise the need for broader acceptance of the principles and agreements of the Better (Smart) Regulation strategy, as proposed in an October 2010 Commission Communication. There is a need to make high quality risk management decisions in a more risk averse environment and a changed policy framework. Indeed, principles supporting better regulation have become more widely adopted by all EU institutions, notably with the Impact Assessment Board (IAB) of the European Commission, which now screens all new proposals. Due to the broad diffusion of these principles, risk assessment techniques have become more widely understood. This trend is particularly salient in four areas of application: (1) the on-going debate between regulating by hazard and regulating by risk; (2) a better understanding of the nature of risk/risk trade-offs, (3) use of benefit/risk assessment, and (4) the Commission Communication regarding the precautionary principle.
Risk Governance and the Precautionary Principle: Recent Cases in the Environment, Public Health and Food Safety (ENVI) Committee
Authors: Leinen Jo
Published: February 2017

As parliamentarians it is our job to represent the people of Europe and to make laws that are in the people's best interest. This sounds simple at a first glance, but it is not as simple when you think about it twice. A law might be in the interest of the people now, because it has known positive effects in the short term. But sometimes the very same law might bear a risk in the long-term, especially for future generations, and sometimes we can't even tell yet how big that risk is. If we would follow a short-sighted approach which only aims at the expected positive effects without taking into account actual and potential adverse effects that might occur in the future, we would act irresponsibly towards the generations of our children and grandchildren. That is why risk governance and the precautionary principle rightfully play a major role in the daily work of the legislator.
Can Science Tame Politics: The Collapse of the New GMO Regime in the EU
Authors: Paskalev Vesco
Published: February 2017

On 2 March 2010 the European Commission authorised the cultivation of a BASF's genetically modified potato “Amflora” throughout the European Union. This came after a tortuous process commenced in 1996 and so far it is the only authorisation of a GMO for cultivation in EU since the current regulation was established. On 3 March 2010, President Barroso announced that the Commission intends to propose amendments to the current regulation to allow the Member States to prohibit the cultivation of GMO authorised for cultivation in the EU and it did so on June 13, 2010. This is one of the very few cases where decision-making power is effectively devolved back from Union to state level; it is even more impressive that this is happening on the initiative of the Commission and despite the obvious negative consequences for the internal market. In the meantime BASF botched the 2011 growing season for Amflora in Sweden and in 2012 announced that it withdraws its GM crops from the EU. This article follows the saga purports to find the reasons why it entailed an immediate change.
How to Escape the Vicious Circle: The Challenges of the Risk Regulation Reflex
Authors: Trappenburg Margo , Schiffelers Marie-Jeanne
Published: February 2017

In modern Western societies the societal emphasis on risk and the minimization of it frequently leads to a call for increasing risk regulation. This mechanism is referred to as the vicious circle of risk regulation, and might cause a variety of problems such as overregulation and breaches of individual privacy. Different solutions have been put forward to break the vicious circle: a greater emphasis on individual citizens’ responsibility, a more rational approach in which governments calculate the greatest safety yield for a given budget and greater democracy: citizen participation in risk and safety related decision making processes. As each approach involves serious disadvantages the authors argue that a well-considered, unhurried approach might be the best way forward. Leadership is largely about timing and with regard to risk management after critical events taking one's time seems crucial indeed.
The Diva and Destiny: Can the Voter Be Appeased With Fatalism?
Authors: van Eeten Michel , Bouder Frederic
Published: February 2017

Over recent years there has been a growing concern for the tendency of modern Western public administrators and regulators to overregulate risk – also coined the risk-regulation-reflex (RRR). Too often public decision-makers react to instances of risk with knee-jerk interventions such as increased regulation and inspections. The underlying assumption behind this response is that fatalism, in the sense of accepting risk, is no longer tolerated by citizens and has no place in the current political discourse. This paper challenges that assumption and suggests, on the contrary, that political messages about accepting risk deserve a revival. A balanced perspective can help Western society avoid the pitfall of overreacting to risk.
The Dutch Risk and Responsibility Programme
Authors: van Tol Jan
Published: February 2017

The Dutch Risk and Responsibility programme (DRRP), which builds on the pioneering work that the BRC and RRAC carried out in Britain, is nearing completion. This article describes the background and course of the programme and offers a glimpse of the preliminary results. DRRP has created awareness of the ‘risk regulation reflex’ among a wide array of people and organisations. That term originated during the Day of Risk, a landmark conference that took place in The Hague marking the start of a fertile international network.
What We Know about the Comparative Effectiveness of Gambling Regulation
Authors: Planzer Simon , Wardle Heather
Published: February 2017

Towards the end of 2011, the Responsible Gambling Fund published a report which, inter alia, offers an overview of the research gaps in relation to the comparative effectiveness of gambling regulation. In the present article, the authors of the report provide a summary of the main findings. They conclude that hardly any empirical evidence is available that addresses, directly or indirectly, this subject. In view of further research, a set of recommendations is provided.
Hazardous Substances in Electronics: The Effects of European Union Risk Regulation on China
Authors: Biedenkopf Katja
Published: February 2017

This article argues that European Union (EU) risk regulation of hazardous substances in electrical and electronic equipment (EEE) was both a trigger and formative factor in the development of similar Chinese regulation. The attractiveness and global interdependence of the EU market in EEE impelled a response from Chinese policy-makers. Fostering the domestic industry's global competitiveness was one of the driving factors behind Chinese substance restriction regulation. Additionally, symbolic emulation and growing domestic environmental problems related to waste EEE infl uenced the Chinese policy agenda. Chinese substance restriction rules are not, however, a mere copy of EU regulation. The limited domestic capacity of the Chinese economy, administration, and legal structure to adopt policies similar to those of the EU explains, to a large extent, the emergence and partial persistence of differences between EU and Chinese risk regulation. In the course of the implementation and evaluation of Chinese substance restriction regulation, lessons learned from the EU’s experience increasingly contributed to shaping the policy, leading to growing convergence.
Market Surveillance in the People's Republic of China
Authors: Binding Jörg , Heuschkel Ulrich
Published: February 2017

This paper provides a holistic review of market surveillance in China from a legal perspective, supplemented by the authors’ practical knowledge. The fundamental legal bases of market surveillance, namely the Law on Product Quality, the Law on Import and Export Commodity Inspection and the Law on Standardization, along with their associated implementation regulations, are thoroughly examined. Thereby the special features of market surveillance in the Chinese context are presented. This, in particular, includes the differentiation between market surveillance on the production and circulation stages (pre-marketand post-market) and an introduction of the two major competent authorities, the GeneralAdministration of Quality Supervision, Inspection and Quarantine, the State Administrationfor Industry and Commerce, and their respective statutory functions specified by a range of laws and administrative regulations as well as the demarcation of their competencies. The authors also take efforts to explore market surveillance on two spe cial markets, foodand pharmaceuticals, which also includes the legal basis, legal instruments and competent authorities, representing different supervision approaches compared with ordinary products.In the end, market surveillance on and by conformity assessment bodies are briefl yreviewed to provide another angle for the observation of the Chinese system.
EU and US Regulatory Approaches to Information on Chemicals in Products: Implications for Consumers
Authors: Molander Linda , Cohen Alison K.
Published: February 2017

Information dissemination across the supply chain to consumers about chemicals’ hazardous properties and presence in consumer products has been recognized as insufficient to improve to enable both producers and end-users to avoid hazardous chemicals and to manage risks to human health and the environment. A comparative analysis of the information requirements in four EU legislations (the CLP, the Cosmetics regulation, REACH, and the Toys Safety Directive) and three US legislations (California's Proposition 65 and Senate Bill 509, and the national TSCA) was conducted with the aim of studying to what extent existing regulatory information approaches require information to be disseminated to consumers. In general, the European legislations address and promote consumers’ access to information on chemicals in products more comprehensively than the American legislations, but the amount and type of information required to be disseminated to consumers varies widely. These differences include which chemicals are prioritised, if the chemical is used in a mixture or an article, what information dissemination strategies are used, and who is responsible for consumers accessing the information. It is recommended that chemical information policies should, at minimum, require chemical suppliers to inform consumers of hazardous chemicals present in their products and, if possible, recommend risk management measures to ensure a safe use of consumer products.
Private Norms as International Standards? – Regime Collisions inTuna-Dolphin II
Authors: Glinski Carola
Published: February 2017

The requirements of free trade and economic globalisation and the respective international legal framework, namely in the context of the WTO, have led to a decrease of the regulatory power of the nation states which cannot be replaced by comparable public international law making – neither in content nor with respect to legitimacy considerations.
Sustainability Requirements for Biofuels in the EU: A New Trade and Environment Concern for the WTO?
Authors: Laurenza Eugenia
Published: February 2017

At the meeting of the WTO Committee on Technical Barriers to Trade (hereinafter, TBT Committee) held on 13–14 June 2012, Argentina voiced its concerns over a measure adopted by Spain restricting imports of biodiesel products into its territory. These concerns were reiterated, jointly with Indonesia, at the meeting of the WTO Council for Trade in Goods of 22 June 2012. On 17 August 2012, Argentina fi led a request for WTO consultations with the European Union (hereinafter, the EU) and Spain, targeting Spain’s restrictions.
Not Entirely Reliable: Private Scientific Organizations and Risk Regulation – The Case of Electromagnetic Fields
Authors: Pascual Gabriel Doménech
Published: February 2017

Private scientific organizations exert a great deal of influence in the regulation of some technological risks. The high level of expertise of their members is arguably a good reason for them to participate in making and monitoring risk regulations, in order to adjust these to scientific progress. Nevertheless, there are also sound reasons why governments shouldn’t uncritically follow the views expressed by such organizations. Taking the role played by the International Commission on Non–Ionizing Radiation Protection in the regulation of electromagnetic fields as an illustrative example, this paper shows that private scientific organizations such as these are structurally less well suited than democratic authorities when it comes to managing those risks.
The EU's Cybercrime and Cyber-Security Rulemaking: Mapping the Internal and External Dimensions of EU Security
Authors: Fahey Elaine
Published: February 2017

By taking the EU Cyber Strategy as a case in point, this contribution examines how the distinction between external and internal security in contemporary EU law manifests itself in large-scale risk regulation and in particular, how the EU relies upon external norms to regulate risk. This article also maps the evolution of the rule-making processes themselves.
A “Win-Win-Win” Scenario – Reaping the Benefits of an EU Law on Administrative Procedure
Authors: Meads Richard , Allio Lorenzo
Published: February 2017

A Law on Administrative Procedure (LAP) is an essential institutional feature of democratic and effective governments. It is a general law on executive law-making, setting out how laws and regulations should be made. The need for a LAP at EU-level is growing – to counter the EU's legitimacy deficit and to make the regulatory process more predictable and robust. At the same time, the EU regulatory “machine” faces new challenges and pressures, as it seeks to implement highly complex (risk management) regulation. Greater regulatory effectiveness depends on more transparency, evidence quality standards and participation. As such, an EU LAP appears to be the natural culmination of the EU Smart Regulation agenda. Since the European Parliament in 2013 called for the Commission to adopt a LAP-related legislative proposal, the debate has gained in visibility and political salience. This article makes the case for an EU LAP for the EU institutions, citizens and businesses – provided the Law enshrines the four key principles of good administration (transparency and consistency; public participation; public record; and accountability); it establishes clear and legally binding procedural standards; and it covers as a principle also rule-making and adjudication decisions by all EU institutions and bodies involved in the preparation, adoption, implementation and repeal of secondary legislation.
“Think small first in the EU”? A Reality Check
Authors: Typhaine Beaupérin
Published: February 2017

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.
Are We Wasting a Good Crisis? The Revision of the EU Medical Devices Directives and the Impact of Health Data Rules
Authors: Denoon Alex , Vollebregt Erik
Published: February 2017

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.
Principles and Structures of European Risk Governance, or: How (not) to Play a Trust Game
Authors: van Aaken Anne
Published: February 2017

Ever more risky service activities are carried out across borders, creating spillovers and externalities. At the same time, if freedom to provide services is legally enabled, states can cooperate in multiple ways to mitigate the potential risks accruing from crossborder activities. Global Administrative Law Scholarship distinguishes five types of administrative regulation: “administration by formal international organizations; administrations based on collective action by transnational networks of governmental officials; distributed administration conducted by national regulators under treaty regimes, mutual recognition arrangements or cooperative standards; administration by hybrid intergovernmental–private arrangements; and administration by private institutions with regulatory functions. In practice many of these layers overlap or combine […]”. In the area of risky cross–border service provision, the EU has moved from a more decentralised version of networks and mutual recognition characterised by coordination and minimum harmonization of rules and standards to a more centralized commandand–control system with European authorities and supervision.
Against the Failures of Risk Regulation Liability and Safety in Air Traffic Management (ATM)
Authors: Simoncini Marta , Contissa Giuseppe
Published: February 2017

This article aims to analyse liability issues as a further means to regulate risks, in case the precautionary measures of the delivered safety system fail. Through liability, the risk that cannot be prevented can be transferred onto those parties who are in the best position to spread them. The allocation of liability thus works as an incentive to the correct functioning of the preventive measures. Liability rules appear to be a key legal remedy which can ensure both tort reparation and a fair and efficient distribution of burdens in a legal order. In this vein, air traffic management (ATM) is addressed as a case study, which shows the main issues and the gaps that liability rules face when dealing with the trade off between risk and safety as conveyed by technology.

After having clarified the nature of the relations between risk and liability on the one hand, and automation and liability on the other hand, this article analyses liability issues in the framework of ATM by approaching this topic in a comparative way between the National Airspace System (NAS) of the United States of America (USA) and the Single European Sky (SES) of the European Union (EU).
Scientists and Earthquake Risk Prediction: “Ordinary” Liability in an Extraordinary Case?
Authors: Notaro Domenico
Published: February 2017

This article aims to consider whether classic criminal offences (such as manslaughter) are adequate to reprove the scientists’ behaviour when major calamities are being judged to have caused the death of people and wide destructions. The fundamental problem hinges on the role of risk-assessment and consultancy carried out by the scientists, as well as on the unknown state of major risks. Then, to establish a link of causality between the defendants’ behaviour and the death-events affecting the victims, it must be proved that: a) the scientists “psychically” influenced the victims to leave any safety precaution in relation to the risk; b) the deaths of the inhabitants are not to be considered an “extraordinary” circumstance, even by experts. The difficulties faced by the Judge to fulfil these tasks prompt us to wonder whether other types of criminal charges would be more appropriate for sanctioning scientists who are found to be derelict in their duty of risk-assessment to authorities and citizens.
Frankenburgers, Risks and Approval
Authors: Petetin Ludivine
Published: February 2017

This piece critically analyses the development of a novel food technology: the Frankenburger, a type of cultured/in vitro meat (or ‘shmeat’, which stands for ‘sheet of meat’). It assesses the risks raised by cultured meat as well as the role it could play to alleviate environmental and food security concerns. The article argues that the current EU regulatory structures for cultured meat, and for novel foods more generally, ought to be strengthened. There is a necessity to transfer and develop food innovations in partnerships with all the relevant stakeholders (the public, scientists, the food industry, policy-makers and regulators). Including interested parties from the inception of a technology as well as within the decision-making process would provide a supporting framework for cultured meat.
What Role – if any – for a Chief Scientist in the European Union System for Scientific Advice?
Authors: Alemanno Alberto
Published: February 2017

At a time of increasing recognition worldwide of the role of Chief Science Advisers as of critical importance in improving dialogue between science and policy, the European Union, notably the European Commission, is currently considering – under the pressure of civil society organisations – whether to maintain or scrap this recently–created position. After contextualizing this debate within the broader efforts undertaken by the Barroso Commission to strengthen science in EU policymaking, this article discusses what role, if any, a Chief Scientist may play within the EU systemof scientific advice. After denouncing the lack of a public debate about the merits of this post at the time of its creation, the article takes as a point of departure the criticisms made against this position and assesses them in the light of the mandate entrusted to the Chief Scientist Advisor. It argues that the major point of disagreement on this post revolves around the question of whether the Chief Scientist Advisor, as it currently stands, helps or hinders the EU incorporating the ‘best science’ into policy. After identifying the flaws of the actual mandate and the challenges faced by the first holder of the position, it argues that the burden of proof rests with the EU Commission to prove the merits, and more specifically, the rationale for having yet another source of scientific advice in the EU.
The Draft Trans–Pacific Partnership Agreement and its Implications for Public Health and Access to Medicines: The UNITAID Report
Authors: Barazza Stefano
Published: February 2017

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health
Food, Safety and the Behavioural Factor of Risk
Authors: Edinger Wieke Huizing
Published: February 2017

This paper aims to demonstrate that the current application of the concepts of risk and unsafety in Regulation 178/2002 (GFL) results in a grey area within EU food safety regulation. By means of the food safety risk assessment of aspartame it is illustrated that “grey area foods”, although not “unsafe” according to legal definition, could compromise human health because of, i.e., their nutritional composition. It will be argued that the grey area emerges from a narrow focus of food safety risk assessment within the ambit of the GFL, which disregards certain types of hazard and causes an information gap with respect to how food consumption, eating behaviour and health are interconnected. At the same time, the scope of food safety in the GFL is restricted to what is considered “normal” consumer behaviour in view of the information provided on food labels or generally available in society. In doing so, the legislator has set rather high standards for what may be expected of the average consumer in terms of the understanding and avoidance of behavioural risks. As a result, the consumer bears the responsibility for the consequences of the information gap.
Synthetic Marijuana Not a “Medicinal Product”
Authors: Luzak Joasia
Published: February 2017

Joined Cases C-358/13 and C-181/14, Markus D. and G.

Substances which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health do not fall within the scope of the definition of a “medicinal product” in the Directive 2001/83 (official headnote).

Consumer safety and medicines control legislation is not suitable to penalise the introduction of new psychoactive substances on European markets (author's headnote).

Art 1(2)(b) Directive 2001/83
EU Foreign Relations Law: Litigating to Incite Openness in EU Negotiations
Authors: Fahey Elaine
Published: February 2017

Case C350/12 P Council of the European Union v. Sophie in't Veld Judgment of the Court (First Chamber) of 3 July 2014
Bringing Evaluation into the Policy Cycle
Authors: Bozzini Emanuela , Hunt Jo
Published: February 2017

This contribution seeks to overcome the isolation of evaluation studies fromthe broader field of public policy analysis. Using as a case study the hybrid regulatory tool of cross compliance under the Common Agricultural Policy, the article charts the ongoing incorporation of ex ante and ex post evaluation processes over a ten year period, during which three major legislative reforms were undertaken. Anchoring its approach in the public policy work of Kingdon, the article emphasises the significance of the plurality of actors involved in the evaluation processes, the importance of timing, as well as the challenge to models of policy processes based on assumptions of rational linearity. In particular, the article demonstrates how the dis–ordering which may be observed in the stages of the policy process may equally be seen in the stages of policy appraisal. A particular focus is placed on the way in which objectives and indicators are defined and re–defined over time. The case study demonstrates that through policy appraisal, policy makers may learn what is, and what is not capable of being measured, which feeds back into the re–setting of objectives.
Reconciling Audit and Evaluation?
Authors: Stephenson Paul
Published: February 2017

In the last twenty years, the European Court of Auditors has placed increasing importance on the production of “special reports” examining the economy, efficiency and effectiveness of EU spending (the three “E”s). This institutional focus on performance audit, alongside traditional financial and compliance audit, has occurred at a time when the European Union is increasingly evaluating its own policies and programmes, under political pressure to demonstrate their added value. With performance audit, the EU's external auditors make value judgements on what was achieved through the EU budget, arguably bringing a greater political dimension to the Court as it works to deliver conclusions and recommendations meant to assist the legislature (European Parliament) in carrying out its scrutiny role and the executive (European Commission) in shaping better future policy. This raises questions about how financial accountability is interpreted, and whether it depends on the quality of audit reports or on the forums to which they are delivered, and subsequently, how they act upon them. This article analyses the factors that explain the increased use of special reports by the Court, questioning if they resemble evaluation studies. It examines their focus and impact, as well as the institutional challenges implicit in performance audit.
Risk and the Precautionary Principle in the Implementation of REACH
Authors: Klika Christoph
Published: February 2017

The adoption of the REACH regulation, setting out to reformchemicals policy of the European Union (EU), was accompanied by intense controversy over the role of the precautionary principle. Analysing decision making on so called Substances of Very High Concern (SVHCs), this article demonstrates that despite legal underpinning, precaution plays a limited role in the implementation of the REACH authorisation procedure. Due to ambiguous legislative provisions, the controversiesof the legislativeprocessare carriedover tothe implementationprocess.
Internet–Based Communication: Rights, Risks and Opportunities
Authors: Lucchi Nicola
Published: February 2017

The aim of this paper is to recognize and discuss the inherent risks associated with Internet regulation and control over digital content. The key point of this analysis is that Internet regulation can present human rights risks. In particular, the paper examines how restrictions over Internet content are posing regulatory issues directly related to the growing importance of an equitable access to digital information. It also considers the relevance and impact of computer–mediated communication, its potential on democratization of freedom of expression and the problem of conflicting rights. Drawing upon comparative and case study material, the paper finally discusses and investigates the potential risks and vulnerabilities related to communication technologies focusing on legislative reforms in the area of digital communications and their implications for fundamental freedoms.
On Obesity as a Disability
Authors: Cathaoir Katharina Ó
Published: February 2017

Case C-354/13, Fag og Arbejde (FOA) v Kommunernes Landsforening (KL) [2014] (not yet reported)

There is no general principle under European Union law prohibiting discrimination on the basis of obesity in regard to employment and occupation. Obesity alone is not a disability but can constitute a disability where it is accompanied by a limitation resulting from long term physical, mental or psychological impairments which in interaction with various barriers may hinder the full and effective participation of the individual in professional life on an equal basis with other workers (official headnote).

In December 2014, the Court of Justice of the European Union (CJEU) issued a preliminary ruling addressing, firstly, whether obesity is a protected ground of non–discrimination, and, secondly, whether obesity can amount to a disability. This piece begins with an introduction to the topic of obesity, followed by the facts of the case, the CJEU's judgment and a comment on the decision.
Mere Retailers May be Penalised for Salmonella Contaminations in Fresh Poultry
Authors: Michl Walther
Published: February 2017

Case C-443/13, Ute Reindl v Bezirkshauptmannschaft Innsbruck, ECLI:EU:2014:2370

1. Fresh poultry must be free from salmonella contaminations at all the stages of distribution including the retail stage.

2. National law may impose a penalty on a food business operator which is active only at the distribution stage for placing salmonella–contaminated foodstuff on the market. It is for the national courts to determine whether such a penalty observes the principle of proportionality as laid down in Article 17 para. 2 of Regulation No 178/2002.
Clean Labels and “Self-evident” and “Flagrantly Misleading” “Palm Oil-free” Claims
Authors: Carreño Ignacio , Vergano Paolo
Published: February 2017

This report addresses the legal concept of “self-evident” and “flagrantly misleading” advertising established in Article 7(1)(c) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (hereinafter, the Food Information Regulation, FIR). Since 13 December 2014 (since the specific origin of vegetable oils must be declared), “palm oil-free” claims on, e.g., a product containing sunflower oil or any other vegetable oil (and mandatorily indicating it in the list of ingredients) are arguably obvious, unnecessary and irrelevant (and in legal terms “selfevident” and “flagrantlymisleading”). Compared to similar foods that possess the same characteristics, but do not claim to be “palm oil-free”, these products are in no way “special”.
Obesity Epidemics, the State, the Individual, and the Private in Public-Private Partnerships
Authors: Benje Ana
Published: February 2017

The report aims to illustrate how weakening of the statehood is reflected in the way EU and its member-states manage obesity epidemics. Private interests and behavioural turn in policy mechanisms call for more state involvement and rigorous democratic deliberation not only of nudges coming from the state, but those coming from the industry as well. The potential of nudging does not lie in the behavioural interventions it is capable of producing, but rather in the discourse it kick-started, as behavioural law and economics are paving their way into policy-making.
Pinpointing the Appropriate Legal Basis for External Action
Authors: Butler Graham
Published: February 2017

Case C-658/11, European Parliament v Council of the European Union [2014] (not yet reported)

CFSP acts can be challenged before the Courtwhen the arguments relate to procedural points outside of the CFSP articles in Title V TEU. The Court can annul Council CFSP acts when the proper notification procedures to the Parliament stemming from Article 218 TFEU have not been followed. The effects of CFSP acts can remain in place, even after the Court annuls them, until such a time when the act has been replaced.
Regulatory Scrutiny in Transition
Authors: Meuwese Anne
Published: February 2017

So none of the wild rumours came true in the end. Those expecting representatives of Parliament and Council on the Regulatory Scrutiny Board, or seats for ‘main stakeholders’ were likely either disappointed or relieved when the European Commission's reinforced Better Regulation package was published on 19 May 2015. As it turns out the transformation of the Impact Assessment Board, which had been in the air for a while is a partial one only, for the moment at least. Indeed, the former Impact Assessment Board got a stronger mandate and a broader reach, apart from a new name, yet it retains very much the character of an ‘in–house’ body. The long-awaited ‘external members’ of the Regulatory Scrutiny Board will be recruited as temporary agents, turning ‘independence’ to some extent into an issue of labour law.
Sealed with a Doubt
Authors: Mavroidis Petros C.
Published: February 2017

In EC–Seal Products, the WTO Appellate Body (AB) issued a(nother) controversial report. This paper argues that the analysis followed by the AB is wrong. To prove this point, we ask two questions. Would the AB have concluded the same way if it had constructed the EU measure as two separate measures and not one? Did the AB adequately control for the regulatory intent of the EU, indeed the quintessential element for deciding whether the EU was indeed pursuing a societal preference of no commercial character? We responded in the negative to both questions.
Competition, Not Regulation – or Regulated Competition?
Authors: Herwig Alexia
Published: February 2017

GATT Article III:4 aims at equal treatment in respect of competitive opportunities of imports and competing domestic products by preventing protectionism. A key question is whether regulations with heavier burdens on imported products than on domestic products and a valid regulatory purpose are consistent with Article III:4. Inquiry into regulatory purpose under Article III:4 would allow by-passing Article XX whose list of regulatory objectives is a closed one and which puts the burden of proof on the defending WTO member. In EC-Seal Products, the Appellate Body has rejected any role for the regulatory purpose inquiry under Article III:4. This article shows why a purely empirical definition of likeness and less favourable treatment as disparate impact cannot logically lead to a finding of a violation of Article III:4. It then argues that regulatory purpose continues to play a role under Article III:4 because of the centrality of the notion of competition. It proposes to frame that competition as perfect competition. It shows that the adoption of perfect competition as the evaluative benchmark for all of Article III:4 makes better legal sense than starting from imperfect competition for the likeness analysis and perfect competition for the less favourable treatment standard, as is proposed in the literature. It also shows that even in case where imperfect competition is used as the sole benchmark for both parts of Article III:4, an assessment of how regulation interacts with competition continues to play some role.