The Society for Risk Analysis (SRA) has kindly authorised the EJRR to publish the comments of SRA Past Presidents on the Deepwater Horizon oil spill. Going beyond news media accounts, these comments offer a first hand analysis of the effects of the oil spill on the field of risk analysis and risk regulation. Following the call for a moratorium on deep-sea drilling in Europe by Gunther Oettinger, the European Commissioner for Energy, the publication of these comments seems particularly timely. (AA)

This paper focuses on those parts of the regulatory environment that are designed to encourage scientific and technological innovation. Patent law is the obvious example; but tax law can also signal encouragement for particular activities. The key question is whether regulators will, or should, withhold tax incentives where there are some, but not universal, moral reservations about an innovation. In order to earth this question, three recent cases at the ECJ, two involving the controversial practice of cord-blood banking, are examined. Insofar as these cases offer any evidence of the prevailing regulatory approach, it seems to be similar to that found in patent law – that is, moral reservations do not count against the applicability of a tax exemption so long as they are not universally recognised.

Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level has triggered the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects, and would such competition lead to desirable outcomes? In this paper I will first show that, due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs. I will then contrast these findings with EU pharmaceutical law and show that it tends to avoid competition. Also, in practice, competition among agencies is still exceptional for European pharmaceutical regulation. Finally, I conclude these findings and hint at the limits of the desired process for further coherence. Although a move towards even greater convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Article 5 (1, 2) EU read in conjunction with the areas of shared competence and the competence to support, coordinate and supplement.

Hazard is the potential of something to cause harm; risk is the likelihood of harm occurring. Chemicals regulation is largely focused on minimising risks associated with chemicals — and rightly so. However, in the EU the hazard classification of individual chemicals can impact significantly the regulation of products containing those chemicals, regardless of the actual risks that the products may pose to human health or the environment. This can lead to undesirable consequences, such as restrictions on the use of safe products, substitution towards less safe products, and disincentives to innovate. Such hazard-based regulation tends to be at odds with World Trade Organization rules and has raised significant concern with EU trading partners. This journal is an ideal forum for discussing how the EU can move towards a better and more coordinated legal framework for the regulation of chemicals.

In times of low economic growth and post-Copenhagen climate talks, a number of reasons for regulatory competition and cooperation between the United States and the European Union coexist. This paper discusses the role of Impact Assessment between the US and the EU on responses to the economic downturn and climate change. It is argued that, in the future, IAs will be an instrument through which it will be possible to read the level of cooperation and competition between the US and the EU, particularly on economic trade and environmental regulation.

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

The free movement of goods is a fundamental principle under EU law: a product lawfully manufactured and/or marketed in one Member State is, in principle, entitled to be marketed in another EU Member State. Indeed, Article 34 of the Treaty on the Functioning of the European Union (TFEU) prohibits any quantitative restrictions on imports between Member States and all measures having equivalent effect.

EU consumers are becoming increasingly concerned about not only the characteristics and qualities of the food products that they are buying but also their origin. To address these concerns, the EU is considering – similarly to other countries – the introduction of mandatory country of origin labelling (COOL) for both unprocessed and processed food.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, the Member States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking at methodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.

Case C-218/09 SGS Belgium NV v. Belgisch Interventieen Restitutiebureau and Others [2010] nyr

Article 5(3) of Commission Regulation (EEC) No 3665/87 of 27 November 1987 laying down common detailed rules for the application of the system of export refunds on agricultural products, as amended by Commission Regulation (EC) No 1384/95 of 19 June 1995, must be interpreted as meaning that damage to a consignment of beef in the conditions described by the national court does not constitute force majeure within the meaning of that provision (official headnote).

Case C-246/07 Commission v. Sweden nyr

1. 1. Unilateral proposals in the context of an international legal framework regarding alterations of that framework may be interpreted as dissociation from the common strategy within the Council (author’s headnote).

2. 2. If such dissociation has (legal) consequences for the Union, it compromises the principle of unity in the international representation of the Union and its Member States and weakens their negotiating power with regard to other parties to the Convention concerned. In such a case, there is a breach of the duty of cooperation in good faith under Article 10 EC (author’s headnote).

3. 3. By unilaterally proposing that a substance be listed in Annex A to the Stockholm Convention on Persistent Organic Pollutants, the Kingdom of Sweden failed to fulfil its obligations under Article 10 EC** (official headnote).

Case C-392/08 European Commission v. Kingdom of Spain nyr

Failing to draw up external emergency plans for all relevant establishments in accordance with Directive 96/82/EC on the control of major accident hazards involving dangerous substances may result in a Member State being deemed to have failed to fulfil its obligations under Article 11(1)(c) thereof (author's headnote).

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

1. 1. The Member States determine, in compliance with the objective of transparency pursued by Council Directive 89/105/EEC and the requirements laid down by Article 4(1) of that Directive, the criteria on the basis of which the review of macro-economic conditions which is referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors (author's headnote).

2. 2. Article 4(1) of Directive 89/105, so far as its subject matter is concerned, is not sufficiently precise to have direct effect for the purposes of the national legal systems of the Member States (author's headnote).

3. 3. Article 4(1) of Directive 89/105 must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision (official headnote).