EJRR 3/2010



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Issue 3/2010.

Table of Contents
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Alberto Alemanno

Editorial
European Journal of Risk Regulation 3/2010: pp. 207-209
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This third issue of the EJRR is loaded with contents that touch upon virtually all aspects of risk regulation. The issue begins with a mini-symposium devoted to the recent Deepwater Horizon oil spill, the largest marine oil spill in the history of the petroleum industry. The Society for Risk Analysis’s (SRA) Past Presidents share their views on the impact of this man-made catastrophe on the disciplines of risk analysis and risk regulation.



Mini-Symposium on the Deepwater Horizon Oil Spill
European Journal of Risk Regulation 3/2010: pp. 211-217 [Article]
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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 1. 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 Günther Oettinger, the European Commissioner for Energy, the publication of these comments seems particularly timely. (AA)

Roger Brownsword

Tax Exemption, Moral Reservation, and Regulatory Incentivisation
European Journal of Risk Regulation 3/2010: pp. 219-225 [Article]
[Click here to show Abstract]


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.

Kai P. Purnhagen

Competition of Agencies in European Pharmaceutical Law – Does It Exist, Is It Desirable and How to Handle It?
European Journal of Risk Regulation 3/2010: pp. 227-238 [Article]
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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.

Kristina Nordlander, Carl-Michael Simon and Hazel Pearson

Hazard v. Risk in EU Chemicals Regulation
European Journal of Risk Regulation 3/2010: pp. 239-250 [Article]
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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.

Jacopo Torriti and Ragnar Lofstedt

The Role of Regulatory Impact Assessment in Fighting Climate Change and the Economic Downturn: A EU-US Perspective
European Journal of Risk Regulation 3/2010: pp. 251-257 [Article]
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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.

Justo Corti Varela

Biotechnology: Synthetic Cells and Their Regulatory Challenges
European Journal of Risk Regulation 3/2010: pp. 259-263 [Report]
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On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science1 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.

Alberto Alemanno

Food: Country of Origin Labelling: The Last Frontier of the Geographic Perceptions of Food
European Journal of Risk Regulation 3/2010: pp. 266-267 [Report]
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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.

Nicole Coutrelis and Isabelle Weber

Food: The Free Movement of Goods Principle Facing the Protection of National Public Health in the Absence of Harmonised Legislation: The Case of Processing Aids Used in the Manufacture of Foodstuffs
European Journal of Risk Regulation 3/2010: pp. 263-265 [Report]
[Click here to show Abstract]


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)1 prohibits any quantitative restrictions on imports between Member States and all measures having equivalent effect.

Alberto Alemanno and Enrico Bonadio

Intellectual Property: The Case of Plain Packaging of Cigarettes
European Journal of Risk Regulation 3/2010: pp. 268-270 [Report]
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In a bid to reduce smoking rates, Australia is set to become the first country in the world to introduce legislation requiring “plain packaging” for cigarettes. “Plain packaging” (also known as “generic packaging”) means that all forms of tobacco branding are required to be labelled exclusively with simple unadorned text. This means that trademarks, graphics and logos are removed from cigarette packs with the exception of the brand name which is displayed in a standard font.

Nico Jaspers

Nanotechnology: Nanomaterial Safety: The Regulators’ Dilemma
European Journal of Risk Regulation 3/2010: pp. 270-274 [Report]
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Nanotechnologies have been hyped as bringing about another industrial revolution. But they have also caused concern about their potential adverse effects on human health and the environment, misuse for military purposes, and excessive corporate control of intellectual property. Policy-makers find themselves in the difficult position of promoting the development of nanotechnologies while at the same time securing public trust in their safe commercial application.

Sabine Brosch and Alessandro Spina

Pharmaceuticals: International Conference on Harmonisation and Standardisation Initiatives in the Pharmaceutical Domain
European Journal of Risk Regulation 3/2010: pp. 274-276 [Report]
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The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established nearly two decades ago. ICH is a joint regulatory/ industry project to make new pharmaceutical development and registration processes more efficient in the interests of patients, public health and cost-effectiveness.

Klaus Jacob

Regulatory Impact Assessment: Regulatory Impact Assessment and Sustainable Development: Towards a Common Framework?
European Journal of Risk Regulation 3/2010: pp. 276-280 [Report]
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In May 2009, the German Federal Government introduced the requirement to perform a sustainability assessment on new legislation as part of its general Regulatory Impact Assessment (RIA). New legislation must now be assessed on its likely impacts on the 21 priority areas of the German national strategy for sustainable development.

Frederic Bouder

Risk Communication: Can Practitioners Do Better at Risk Communication? Using Evidence to Develop Best Practice
European Journal of Risk Regulation 3/2010: pp. 280-285 [Report]
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The best way for practitioners to improve their skills in effective risk communication is to take on board the decades of research in this area. Risk communication has its roots in risk perception studies and has evolved as a rich and diversified research field. It has undergone an evolutionary process from topdown information towards two-way and proactive exchanges.

Alessandra Arcuri, Lukasz Gruszczynski and Alexia Herwig

WTO: Global Governance of Risks: WTO, Codex Alimentarius and Private Standards – Report on the SRA-Europe 19th Annual Conference
European Journal of Risk Regulation 3/2010: pp. 285-287 [Report]
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The Society for Risk Analysis (SRA) is a scientific society, established in 1980, which provides a multidisciplinary forum for scholars interested in risk research. The European section of the SRA recently organized its 19th annual conference, hosted by King’s College London (21-23 June 2010).

Simon Planzer

The ECJ on Gambling Addiction – Absence of an Evidence-Oriented Approach
European Journal of Risk Regulation 3/2010: pp. 289-295 [Case Note]
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Case C?203/08 Sporting Exchange Ltd, trading as ‘Betfair’, v. Minister van Justitie, intervening party: Stichting de Nationale Sporttotalisator [2010] nyr1

Case C?258/08 Ladbrokes Betting & Gaming Ltd, Ladbrokes International Ltd v. Stichting de Nationale Sporttotalisator [2010] nyr2

1. The principles of equal treatment and transparency do not apply in situations where a licence is granted or renewed to a (single) private operator whose activities are subject to strict control by the public authorities.

2. Implementing measures (e.g. injunction for interim relief) are an indispensable element to ensure the effectiveness of the national law on games of chance. They do not need to be separately assessed on their proportionality, indispensible of their nature (here, civil action).

3. The Court continues to rely on assumptions regarding the mechanisms of gambling addiction. The absence of an evidence-oriented approach prevents an adequate

Stefania Baroncelli

Risk of Bacterial Infection Does Not Constitute Force Majeure in Export Refunds
European Journal of Risk Regulation 3/2010: pp. 297-300 [Case Note]
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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).

Josephine van Zeben

The Principle of Unity under Article 10 EC and the International Representation of the Union and its Member States
European Journal of Risk Regulation 3/2010: pp. 301-305 [Case Note]
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Case C-246/07 Commission v. Sweden1 nyr

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. 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. 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).

Sonya Walkila

Member States under a Strict Obligation to Draw Up External Emergency Plans
European Journal of Risk Regulation 3/2010: pp. 307-309 [Case Note]
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Case C-392/08 European Commission v. Kingdom of Spain1 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).

Anna-Miria Fuerst

On the Review of Macro-Economic Conditions in the Case of a Price Freeze for Medicinal Products
European Journal of Risk Regulation 3/2010: pp. 311-315 [Case Note]
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Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

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. 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. 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).

Cymie R. Payne

Environmental Impact Assessment as a Duty under International Law: The International Court of Justice Judgment on Pulp Mills on the River Uruguay
European Journal of Risk Regulation 3/2010: pp. 317-324 [Case Note]
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On April 20, 2010, the International Court of Justice (ICJ) announced its judgment in a high-stakes environmental dispute between Argentina and Uruguay, concerning Uruguay’s authorization for pulp mills on the banks of the Uruguay River, which forms the international boundary between the two countries. Over strenuous objections from Argentina, Uruguay authorized construction of one of the largest pulp mills in the world in 2005 and it has been converting wood chips into paper pulp on the banks of the River since 2007.

Johannes Saurer

Transition to a New Regime of Judicial Review of EU Agencies
European Journal of Risk Regulation 3/2010: pp. 325-327 [Case Note]
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Case T-70/05 Evropaïki Dynamiki v. European Maritime Safety Agency (EMSA)

The general principle to be elicited from the Les Verts v. Parliament [1986] ECR 1339 judgment is that any act adopted by a body such as EMSA which is intended to have legal effects vis-à-vis third parties must be amenable to review by the Courts. That solution is confirmed by the first paragraph of Article 263 TFEU, pursuant to which the Court of Justice of the European Union has jurisdiction to review the legality of acts of bodies, offices or agencies of the Union intended to produce legal effects vis-à-vis third parties (author’s headnote).

Morten Broberg

van der Meulen/van der Velde: European Food Law Handbook
European Journal of Risk Regulation 3/2010: pp. 329-330 [Book Review]
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The European Union has undergone considerable changes since its inception half a century ago. Perhaps the best illustration of this is the regulation of food. In the early days immediately after World War II, the main objective was to secure sufficient and stable supplies of food stuffs.

Dario Bevilacqua

Gabbi: L’Autorità Europea per la Sicurezza Alimentare: Genesi, Aspetti Problematici e Prospettive di Riforma
European Journal of Risk Regulation 3/2010: pp. 330-332 [Book Review]
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The European Food Safety Authority (EFSA) is an independent regulatory agency of the European Union that is responsible for two phases of the risk analysis procedure concerning food and feed products: risk assessment and risk communication.


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