In Europe, debate as to whether one should regulate chemicals based on intrinsic hazard or assessment of risk, or possibly a combination of both, has been gaining momentum. This article first provides a brief history of this risk versus hazard debate. Secondly, it examines how European regulators are currently handling the regulation of two chemical compounds, namely Bisphenol A and Deca BDE (a brominated flame retardant), based on forty-five expert interviews with regulators, policy makers and industry representatives in eight Member States, as well as with European Commission officials. The paper shows that there is no clear consensus as to when risk or hazard considerations should be the basis for regulatory decision-making, with wide discrepancies between Member States (e.g. the UK is overall more risk based than Sweden) and between regulatory agencies within Member States. The penultimate section puts forward a series of recommendations to help regulators and policy makers develop more consistent and science based regulations for Europe.

When called upon to regulate risk, the EU carries the threefold onus to (i) protect its people(s); (ii) ensure the functioning of the internal market; and also (iii) to allocate the resources available wisely and efficiently.

This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.

According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.

The view that risks and hazards are distinct concepts is commonly held in the scholarly literature on risk especially in the English-speaking community. The dichotomy is also enshrined in key documents commissioned or developed by Governments to help regulators conceptualise, regulate and communicate harmful events. Yet, the implications of risk-based versus hazard-based regulations have often been overlooked. Scholars have only conducted limited discussions, in contrast to the extensive debates about the respective merits of evidence-based and precautionary-based regulation. Lofstedt's article “Risk versus Hazard – How to Regulate in the 21st Century” offers a new and important perspective on the relationship between science and regulatory decisions. Lofstedt essentially argues that the conceptual distinction between hazards (the potential for a substance, activity or process to cause harm or adverse effect) and risks (a combination of likelihood and the severity of a substance, activity or process to cause harm) presents a meaningful classification to analyse regulations.

The debate as to whether chemicals should be regulated according to hazard or risk is once again under the spotlight, this time commented by Ragnar Lofstedt, PhD, Professor and Director of the Kings Centre for Risk Management at Kings College in London. He takes the reader through the history of risk assessment and chemical control, presents two interesting current case studies and sheds light on the influence of politics on the implementation of regulation.

Professor Lofstedt's assumption that two different methods of assessment exist is not a complete statement. In fact this is a confusing way to describe the scientific and political processes involved in regulation. It is not a choice between two methods, but rather a balance between political ambition and scientific facts within one method. Examples can be found where science has been more influential than policy on the actual regulatory decision, and vice versa.

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.

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.

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.

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.

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.

The fast development of technology and industrial processes during the last hundred years has caused increasing expectations by the public, customers and politics concerning the safety of operations and the risks of substances and activities related to production and consumption of goods. A highly differentiated and complex system of laws and regulations exists on the regional, national, and international level. In Germany alone, manufacturers are confronted with more than 10,000 regulations. Companies that trade all over the world are obliged to comply with a multitude of laws and regulations which partially are in conflict with each other.

In addition to the legal requirements, manufacturers of products and developers of technologies face increasing demands for more information and participation from the consumers, special stakeholder groups, and the public at large. The need for risk communication has been voiced since the late 1960s. The main targets have been large technical installations such as nuclear power plants or waste incinerators.

It is frequently suggested that the EU in general and Parliament in particular suffer from an addiction to making rules and regulations on all things from chemicals to chocolates and from buses to booze. Classically, this is the first repost of the critic who sees the EU as legal procurator dressing up the legislative Christmas tree. Firstly, it is important to note that there are legitimate concerns that regulations passed in Europe are not always based on the best available science and perhaps even the best scientists. It is up to those with responsibility for making regulation to make it according to best verifiable evidence at hand. When you consider how important the potential implications are for industry and consumers alike then it is clearly of great importance to increase the use of risk analysis tools.

When asked to explain the difference between risk and hazard it is perhaps helpful to consider the life of a zoo keeper in charge of the Lions’ den. The animals themselves can be seen as a “hazard”, when the animals are free and uncaged, people in the surrounding area are exposed to the risk that they may be attacked. However, when the animal is caged, we’re dealing with altogether different beasts as only the zoo keeper (who knows how to handle the risk) could be exposed to certain dangers. It may remain “hazardous” but while those around it are protected there is no exposure to attack, therefore there is no risk.

Professor Lofstedt presents a convincing illustration of the inconsistencies inherent in a European system of regulation where Member States choose whether to regulate based on assessments of risks or hazards depending on the product concerned. Particularly striking is the candid comment of a Swedish official who seems to marvel at the conflicting positions of his own government. The quote reminds this author of an official in the Swedish Ministry of Environment who in an interview stated that the application of regulation would be widely different if the precautionary principle as included in the Swedish Environmental Code or the precautionary principle as included in the Swedish Planning Code were to be employed.1 For a lawyer – or anyone else with an interest in the rule of law – such inconsistencies pose serious problems with regard to legal certainty. Unfortunately, those who could reasonably be expected to be most concerned with issues relating to the rule of law – national and European courts – have thus far proven reluctant to second-guess, or even criticise, decisions in the area of risk regulation.

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.

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

The aim of this paper is to review the basic literature on scientific uncertainty in its statistical paradigm in order to provide enlightenment on one pivotal facet of the precautionary principle, i.e. the allocation of the burden of proof to demonstrate that an activity is not harmful to the environment. The purpose is not to explain a new theory of statistical inference, but to show how regulatory policymaking that is properly informed by scientific expertise and designed to avoid one type of error, may actually make other errors more likely and thus expose the public to danger. This problem is explained in terms of the conceptual as well as operational conflicts that arise when knowledge about statistical-inferential methods is applied to policymaking. The paper argues that this issue can be resolved by first reconsidering the burden of proof as a burden of uncertainty.

Cautious skepticism rather than euphoric joy surrounds the activities of the European Commission developing its new – flexible – approach towards cultivation of Genetically Modified Organisms (GMOs). Following its announcement in the summer of 2010, new elements of the reform unravel at the beginning of 2011.

GMO regulation has experienced a rather uneasy track in the European Union. The specificity of the sector, with its economic importance, its social controversies as well as the high levels of uncertainty as to the long-term effects, have all contributed to various political and regulatory troubles in Europe and worldwide. After the revision of the first wave of regulation in 2001-2003, the de facto moratorium, and ensuing conflicts under the WTO adjudication, the situation seemed to be settling down.

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.

The transfer of climate-friendly technologies from developed countries to developing countries has been identified in international forums as a key factor in efforts to mitigate climate change. Commentators and negotiators have argued, however, that efforts to transfer climate-friendly technologies from developed countries to developing countries have fallen far short of what is needed. Although a host of barriers play a role in the pace of transfer of clean technologies, such as lack of financial resources, inadequate infrastructure, trade barriers, and lack of skilled workers to name a few, intellectual property rights (IPRs) have been accused of being a particularly significant barrier. Developing countries have made strong proposals to severely curtail IPRs on clean technologies, particularly patent rights. These proposals present potential threats to patent rights on clean technologies in developing countries and include expanded compulsory licensing, excluding clean technologies from patenting, and revoking existing patent rights on clean technologies in developing countries. The motivation for such proposals stem largely from theoretical considerations, when, in fact, recent studies provide evidence that patent rights are not a barrier to the transfer of clean technologies to the developing world and, to the contrary, are more likely facilitating the diffusion of clean technologies in developing countries.

In November 2010, 171 Parties to the WHO Framework Convention on Tobacco Control (WHO FCTC) unanimously adopted the Punta del Este Declaration on implementation of the Convention. The Declaration follows the filing of an international investment claim against Uruguay by Philip Morris Products (Switzerland) and related companies. The Declaration reaffirms the commitment of the 171 WHO FCTC Parties to implementation of the Convention and addresses the relationship between the WHO FCTC and international trade and investment agreements, particularly in the context of intellectual property rights. This article outlines the Request for Arbitration, sets out the Declaration and the broader normative context in which it arose before touching briefly on the implications of the Declaration.