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.

Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ‘Bisphenol A-free’ (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and children's toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.

Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EU's chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

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.

In the casual political rhetoric about environmental regulation, it is often claimed that the U.S. government regulates on the basis of risk while the European Union (or EU member states) regulates on the basis of hazard. The implication is that the U.S. government relies on a more rigorous, scientific process of assessment than does the EU, which allegedly helps explain why the EU is more pro-regulation than is the United States.

An alternative view, advanced originally by the late Professor Aaron Wildavsky of the University of California-Berkeley and amplified in a recent book by Professor Jonathan Wiener of Duke University, and colleagues, is that societies engage in a process of “risk selection.” What worries some societies does not worry others.

An increased use of nuclear power is now accepted as inevitable by many people, but not without some unease, and the accidents at Chernobyl and Fukushima as described in the media bring little reassurance. So how dangerous is radiation exposure, for instance to those living within the influence of such accidents?

Professor Ragnar Lofstedt has written a very interesting and thought provoking paper “Risk versus Hazard Assessment – How to Regulate in the 21st Century”. The paper reflects upon the advantages and disadvantages of using risk assessments compared to hazard assessments of chemical compounds. It investigates the debate that has been going on in recent years in Europe between regulators, politicians, NGOs and industry on the subject.

This commentary will discuss some of the assumptions that the analysis rests on as well as some of the conclusions that are presented in the paper.

First, the commentary will discuss the definition and critique of the “risk assessment” approach that Lofstedt presents. The commentary here concludes that Lofstedt's analysis of risk assessment does not take sufficiently into account the fact that risks can not always be calculated in an exact way because uncertainty rather than certainty is the condition when analysing chemicals.

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.

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.

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.

The often referred to risk-hazard divide is commonly exaggerated. With some exceptions, few in the risk camp argue against hazard classification as basis for labelling of e.g. carcinogenic substances (which has been the case for decades) and few in the hazard camp criticise the use of risk assessments, once they are established. Agencies and politicians commonly look at both sides of the coin in practise. However, improved chemicals management would benefit from further bridging the risk-hazard divide. Professor Lofstedt does a good job in arguing from a risk perspective, but he leaves out much of the other side of the coin, so in the following, I will discuss his perspectives and try to complement his recommendations.

In this contribution we focus on the role of experts in the assessment of tort damages from an economic point of view. We distinguish two different aspects.

First, we examine the role which economists might play in assessing damages in tort cases. This approach focuses on the insights that Law and Economics provides regarding the correct assessment of damages. We pay specific attention to two problematic forms of losses where economic insights may play an important role: pure economic loss and personal injury damage (both loss of income and compensation for immaterial losses due to fatal and non-fatal accidents).

Second, we investigate from a Law and Economics point of view the role of experts in general (not only economists) in the assessment of damages. We discuss i.a. the question why experts may be involved in the assessment of damages, the potential problems (and the possible solutions) when using experts, and differences between party appointed experts and court appointed experts.

It turns out that the economic analysis can provide a different, insightful viewpoint in some respects, such as the fact that market based mechanisms may help to provide incentives to party appointed experts to provide an accurate and objective damage assessment.

The most remarkable recent development in EU administrative law is the widespread establishment of European agencies. Beginning in the early 1990s, EU agencies emerged as significant actors in a number of areas, including trademark law, pharmaceutical licensing and aviation safety. EU agencies are best understood, however, not as autonomous regulators at the federal level, but as the most recent expression of European governance through administrative networks. The regulatory intertwining of supranational and national authorities in the EU is significantly different from the division of authority between federal and state bureaucracies in the United States federal system Hence, the accountability of European agencies to the EU and to Member States has unique features that can be traced to the dynamics of European integration. Accountability is largely a function of networked institutional relations that link European administrative entities to both supranational and national forums of accountability This article concentrates on the second form of accountability through an in-depth exploration of the way Member States oversee EU agencies. Oversight, here, covers monitoring, hearings, budgetary reviews or judicial actions, as well as procedural constraints.

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

This report will discuss the topic in the light of two recent Danish cases that have highlighted the problems that can arise in this context – especially concerning the legal rights of the food business operators involved.

Professor Lofstedt's article makes an important contribution to the growing scholarship on risk regulation. He focuses on one of Europe's key challenges – how to ensure that European law and regulation is “smart” in the sense that it strikes the right balance between a high level of protection for human health and the environment while not being overly burdensome and enabling us to maintain our competitiveness and standard of living. The EU has taken a leading global role in chemicals regulation, which is welcome. However, as Professor Lofstedt's study clearly illustrates, much work remains to be done to ensure transparency, legal certainty, and sound science-based regulatory outcomes.

The debate around risk versus hazard is an important one. As Professor Lofstedt notes, these are not contradictory concepts, but rather build on each other. Hazard and the intrinsic capacity of a substance to cause harm is the starting point. The debate then centers on to what extent a risk assessment (taking actual or potential exposure into account) should be made before the uses of the substance in question are regulated. Put simply, if there is no exposure, there will be no risk, even when the hazard is high. There are many examples of substances that have known intrinsic hazards, but that pose virtually no risk to human health given how and in what quantities they are used. Ordinary table salt is a well-known example.

With the close of another round of United Nations Framework Convention on Climate Change (UNFCCC) treaty talks, this one held in Cancun from November 29–December 10, it is important to look at how green patents fared in the negotiations and the final agreement.

But first, some background is necessary to set the stage for Cancun.

Last year, when I became aware during the run up to the Copenhagen meeting that intellectual property IP) rights were being debated, the first question that popped into my mind was: why are IP rights even on the agenda in the climate change treaty discussions?

To me, IP seemed tangential at best to the problems of shaping policies to mitigate climate change, taking a back seat to a maximum temperature rise target, greenhouse gas emissions targets, carbon taxes, cap and trade, and other policy tools directed relating to climate change.

Over the past years, a series of milk crises in China — culminating in the melamine milk scandal in 2008 — have seriously undermined public confidence in food safety. Drawing on international experience to strengthen its regulatory system, China recently introduced elements of risk assessment in its two main Food Safety Laws, namely the Law on the Quality and Safety of Agricultural Products and the Food Safety Law, which represent its basic legislation and institutional framework in terms of food safety. The article explores this new Chinese risk assessment framework in an international context. Specifically, given the similarities between the melamine milk scandal in China and the bovine spongiform encephalopathy (BSE) crisis in Europe in the 1990s in terms of both severity and link to respective corresponding reforms, much of the article focuses on a comparison of the food risk assessment institutions of the two jurisdictions in the aftermath of the crises.

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.

In this issue of the journal, Dr. Ragnar Lofstedt examines the current state of the EU regulatory framework with respect to chemicals and illustrates how the hazard-based approach sealed the fate of two important chemicals in the EU market-place. He also explores how the attitudes, technical knowledge and economic influences of the individual member states determine the outcome of environmental and chemical regulations. Lastly, Dr. Lofstedt provides some recommendations to improve consistency in the European regulatory process and ensure greater scientific, as well as, risk-based regulations.

In this report, the author, an IP scholar and entrepreneur, analyses how nanotechnology will pervade all industries and therefore how important it is to find a proper method to valuate and especially evaluate nanotechnology-related inventions. Attaching a value or evaluating a technology is a fundamental task nowadays, especially when innovations are supposed to be licensed or assigned. The report focuses on the different valuation and evaluation techniques professionals usually employ, and then delves into the world of nanotechnology. It tries to develop a novel method that takes environmental and health-related issues into due consideration when attaching a value or evaluating a technology in the nano world. The novel tool envisioned in the article is particularly suitable for nanotech innovations, but it can be used for the evaluation of other technologies and patents as well. The innovative idea consists of introducing the concept of Present Value After Evaluation, which takes qualitative variables into consideration and provides a figure for the analyzed technology or patent. This method and the accompanying tool are perfectly suited for evaluation purposes when environmental and human safety concerns are at stake, because they take these variables into consideration and throughout technology's life cycle.

The plant protection law within the European Union has been continuously developed over the past two decades. Whereas harmonized provisions for the placing of plant protection products on the common market were introduced by Council Directive 91/414/EEC of 15 July 1991 (hereinafter the “Directive”), almost two decades later, a revision of the Directive has been passed which takes, in order to ensure consistency throughout the Member States and to provide for simplification, the form of a regulation. Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market (hereinafter the “Regulation”) was adopted on 21 October 2009.