This second issue of the EJRR opens with a symposium devoted to the ongoing debate about whether regulators should base their risk regulatory policies on intrinsic hazard or risk assessment. In other words, should regulators ban or phase out substances that have an in-built ability to cause harm, or should they examine whether there is a real probability that this substance will actually cause this harm?

The case discusses the “Test-Achats” judgment of the ECJ in the overall context of the EU-non-discrimination principle in relations traditionally governed by private law and party autonomy. This principle has come from employment law and has been extended to consumption matters, at least with regard to such incriminated characteristics as gender, ethnic origin, and nationality. Even if the consequences of the ECJ judgment on the insurance market, including protection of insured persons themselves, by imposing “unisex”-tariffs from 21.12.2012 on may be viewed critically, the Court only draws the legal consequences of a prior decision of the EU legislator which cannot be delayed for an indefinite time span by the Member States (author’s headnote).

Article 30(2) of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive [USD])2 is to be interpreted as obliging the national regulatory authority to take account of the costs incurred by mobile telephone network operators in implementing the number portability service when it assesses whether the direct charge to subscribers for the use of that service is a disincentive. However, it retains the power to fix the maximum amount of that charge levied by operators at a level below the costs incurred by them, when a charge calculated only on the basis of those costs is liable to dissuade users from making use of the portability facility (official headnote).

Case T-29/05, Deltafina SpA v. Commission and Alliance One International, Inc., formerly Standard Commercial Corp. and Others v. Commission1 The General Court partially annuls the Commission’s decision on Case COMP/C.38.238/B.2 and reduces the amount of the fine imposed by the Commission on Deltafina SpA from EUR 1 188 000 to EUR 6 120 000 (author’s headnote).

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.

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.

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

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.

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.1 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.

On 17 January 2011, the European Commission launched , a monitoring exercise of patent settlements in the pharmaceutical sector for the second time after the Pharmaceutical sector inquiry of 2009.

Good regulation is essential, to protect employees, consumers and the public, as well as the environment. To argue that the market should be allowed to be the determinant of working conditions, together with a bit of exhortation to employers to behave decently, is to accept the Victorian approach that allowed children to work in coal mines.

On 14 April 2010 the Icelandic volcano, Eyjafjallajökull, erupted resulting in a volcanic ash cloud across European airspace. The ash cloud caused a moratorium on flying and concerns over health effects to vulnerable populations. Not even a year since the volcanic ash cloud; on 11 March 2011 a massive 9.0-magnitude earthquake occurred near the northeastern coast of Japan, creating extremely destructive tsunami waves which hit Japan just minutes after the earthquake, triggering evacuations and warnings across the Pacific Ocean.

In the recent Grand River Enterprises case, United States public health regulations on protection from tobacco products successfully withstood a challenge by Canadian Native American investors under NAFTA chapter 11 arbitration. The arbitrators carefully weighed the investors’ rights and the regulatory freedom of the host state under the NAFTA rules. The treatment of other norms of international law on the protection of indigenous peoples, however, merits some criticism.

Council Decision 2008/633/JHA on access for consultation of the Visa Information System for the purposes of prevention, detection and investigation of terrorist offences and other serious criminal offences must be read as a development of the Schengen acquis and not merely as a measure as to police cooperation, preventing the United Kingdom and Ireland from participating in adopting the measure (author’s headnote).

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor David Hornsby

Despite the initial delay in Spain in the adoption and development of a better regulation policy compared to other OECD countries, in the last few years significant advances have taken place, as pointed out in the 2010 OECD report “Better Regulation in Europe. Spain”.

Andreas Meisterernst and Bernd Haber are well known not only amongst food lawyers as true experts regarding Claims Regulation (EC) No. 1924/2006. This piece of legislation is currently tormenting food business operators and their advisors all over Europe with many problems. Meisterernst and Haber published the very first commentary on the Regulation as early as 2007, a comprehensive and continuously updated loose-leaf practitioners’ handbook which has quickly found its proper place in the world of German food law – as a reliable guidance to scientists and marketing specialists, a welcome assistance for lawyers and a reference work regularly quoted by the competent courts.