The EJRR’s last issue of the year hosts a wealth of timely and risk-significant contributions. The symposium on the financial crisis in the EU whose first part was published and introduced to our readers by its editor in the previous issue is completed by three more essays. Additionally, another three articles are dealing with some of the most actual regulatory challenges facing policymakers: counter-terrorism, consumer-responsive food safety regulations as well as the impact of the EU risk regulation at the Member State level.

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”).

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 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.

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.

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.

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.

Article 14 of the EU’s General Food Law Regulation (178/2002) specifies that food may not be placed on the market if it is unsafe. Article 19 imposes an obligation on food business operators to withdraw products from the market if they have reason to suspect that there is a health risk. But how far do these provisions stretch in terms of providing a basis for ordering recalls? How much doubt, so to speak, needs to be raised as to the safety of a product before the food business operator must withdraw it? Focusing on two recent Danish cases, this report highlights some of the weaknesses of food safety regulations and the problems that can arise when the rules are applied in practice.

In 2006 the Hungarian system of food safety regulation was described as “chaotic” 1, fragmented and lacking accountability.2 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.3

This article examines the issue of risk in research and development (R&D) pertaining to new pharmaceuticals, especially those aimed at neglected diseases and/ or relevant primarily to the developing world. In particular, the article considers the role of patent pools and other forms of non-proprietary models as alternatives to patents (and other types of intellectual property rights) in R&D for new pharmaceuticals. The article concludes that that these mechanisms still achieve very little output and can therefore not currently be considered as viable alternatives to the use of patents in pharmaceutical R&D. Another relevant finding is that many of the existing collaborative initiatives and partnerships for R&D in neglected diseases actually rely on different forms of intellectual property rights.

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.1 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.2 This is not an entirely new idea – some theorists, starting with Arthur Pigou, a 20thcentury 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.3 Examples of Pigouvian taxes are duties on cigarettes, alcohol, gambling and

Nanomaterials have been the object of numerous public and private initiatives aiming to manage their risks and maximise their benefits. Proponents of nanotechnology programmes argue that their potential negative impacts need to be dealt with appropriately, and wish to integrate these concerns early in the industrial development of these substances. Science policy programmes do not provide a clear definition of the term “nanomaterials”. Defining nanomaterials, however, has become a central concern. It is called for by manufacturers who wish to sell the “nano” quality of their products as well as by associations who wish to classify products in order to facilitate consumer choice or introduce constraints on production.

The Swiss Federal Council (FC, the Swiss government) published a report on reducing administrative burdens on business in August 2011, in which it addressed also the performance of Regulatory Impact Analysis (RIA) at the federal level.1 The report reviews the measures undertaken by the FC since 2007 and sketches initiatives to be launched throughout the next four years. Administrative simplification and the reduction of regulatory costs have gained on relevance in the Swiss policy and political debate in the past few months – not least as a part of the campaign for the national political elections held in October 2011, with the economic crisis as a background.

Since the North American Free Trade Agreement (hereinafter NAFTA)1 was successfully negotiated in 1993, the provisions for investor-state arbitration under its Chapter 11 have put pressure on the regulatory spaces of the State Parties. Under Chapter 11, any investor alleging a breach of the treaty norms by a host State can file an arbitration claim. This diagonal dispute settlement mechanism has determined a growing stream of arbitrations, focusing inter alia on the interplay between the regulation of toxic chemicals by the host State and the substantive provisions of Chapter 11.2 The arbitration claims filed by inves

A visual display ban on tobacco products, imposed by national legislation of an EEA State, such as the one at issue in the case at hand, constitutes a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 11 EEA if, in fact, the ban affects the marketing of products imported from other EEA States to a greater degree than that of imported products which were, until recently, produced in Norway. It is for the national court to identify the aims which the legislation at issue is actually intended to pursue and to decide whether the public health objective of reducing tobacco use by the public in general can be achieved by measures less restrictive than a visual display ban on tobacco products (author’s headnote).

In September 2011, the World Trade Organization (WTO) panel report in US – Clove Cigarettes was released. The report addressed a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The dispute is one of a number of contemporary disputes under the WTO Agreement on Technical Barriers to Trade (TBT Agreement). Given that relatively few disputes have been resolved under the TBT Agreement, the outcome may have significant implications for interpretation of the agreement and risk regulation through technical regulations. The panel report may also have more specific implications for risk regulation in the context of tobacco products (author’s headnote).

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).

Case C-399/08 P European Commission v. Deutsche Post AG [2010], not yet published 1. The Commission is not entitled to assume that State resources constitute an advantage when it fails to examine whether: (i) the total amount of those resources exceeds the total amount of the net additional costs incurred by an undertaking providing an SGEI; (ii) that undertaking has other net additional costs associated with the provision of an SGEI for which it has the right to claim compensation. 2. The use of a method different from that arising from Altmark Trans is justified only when the Commission is prevented, for objective reasons, from undertaking an examination of the information provided by a Member State. 3. Even if the General Court is wrong in law when it examines information that was not subject to any analysis in the Commission’s decision, this did not affect the validity of its foregoing finding on the illegality of the contested decision (author’s headnotes).

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

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.

This book, coordinated and supervised by Prof. Vincenzo Salvatore, is part of the output of the workshop organized by the Università dell’Insubria in Varese in November 2010 which gathered legal and economic scholars and experts of EU Institutions with the aim of presenting and discussing present problems and future challenges of the EU agencies.