In modern Western societies the societal emphasis on risk and the minimization of it frequently leads to a call for increasing risk regulation. This mechanism is referred to as the vicious circle of risk regulation, and might cause a variety of problems such as overregulation and breaches of individual privacy. Different solutions have been put forward to break the vicious circle: a greater emphasis on individual citizens’ responsibility, a more rational approach in which governments calculate the greatest safety yield for a given budget and greater democracy: citizen participation in risk and safety related decision making processes. As each approach involves serious disadvantages the authors argue that a well-considered, unhurried approach might be the best way forward. Leadership is largely about timing and with regard to risk management after critical events taking one's time seems crucial indeed.

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]) 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).

According to the World Health Organization (hereinafter, WHO), 38 million people die each year as a consequence of non-communicable diseases (hereinafter, NCDs). NCDs are mainly caused by diet-related factors, but also by physical inactivity and abuse of certain substances. In particular, overweight and obesity reportedly affect more than 10% of men and 14% of women globally and kill as many as 2.8 million people every year.

EU legislation on genetically modified organisms (GMOs) is the most stringent legislation governing the matter in the world, laying down strict conditions relating to labelling, traceability, threshold and release on the market. In light of a recent Commission proposal to amend Directive 2001/18, which currently regulates the release of GMOs on the European market, this article asks whether and on what basis such stringency is justified. This is done through an in depth analysis of the EU regulatory framework for GMOs while at the same time highlighting the multiple interests at stake (environmental, scientific, industrial, political, national and European).

This article argues that the European institutions should proceed to amend Directive 2001/18 on the basis of a detailed examination of the benefits as well as the risks that GMOs present. This article, however, raises concern that the European regulatory framework will focus exclusively on the risks or on political concerns relating to GMOs instead, for it is a fear of GMOs that seems to permeate the system from top to bottom.

Case C-160/09 Ioannis Katsivardas – Nikolaos Tsitsikas OE v. Ipourgos Ikonomikon

Article 4 of the Cooperation Agreement concluded between the European Economic Community, of the one part, and the Cartagena Agreement and the member countries thereof – Bolivia, Colombia, Ecuador, Peru and Venezuela – of the other part, approved by Council Regulation (EEC) No 1591/84 of 4 June 1984, is not such as to confer on individuals rights upon which they might rely before the courts of a Member State (official headnote).

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.

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official headnote).

This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.

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.

“Negative claims” can be defined as claims indicating that certain ingredients, nutrients or substances are not present in a foodstuff. Legitimate uses of regulated negative claims in the EU include some nutrition claims and “gluten-free” claims. Some EU Member States have legislated on “GM-free” claims. The article describes in more detail some cases (i.e., BPA-free, MSG-free, Aspartame-free and palm oil-free), where negative claims are used with an implied message that whatever is used instead of the often “demonised” substance is safer, healthier or greener. The article argues that EU and EU Member States’ legislators and regulators should ensure that consumers are not misled by astute marketing techniques that have no informative agendas, but simply aim at denigrating certain products in order to promote “free-from” products. This issue is particularly timely and important given the imminent application of the EU's Food Information Regulation and the additional costs that it will impose on the industry in the name of providing complete, reliable and evidence-based information to consumers.

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.

Regulation of critical infrastructure (CI) is in vogue; and accordingly every government presently develops legal governance regimes. In this paper, I try to analyse some of the present efforts to identify and govern CI. I argue that while the legal definitions introduced contribute little to the actual identification of critical infrastructure, they alter the responsibility and modus operandi of the identification. Political discretion is re-organized into administrative decisions. By relying on similar observations from risk sociology, I set out to criticize the present implementation for masking the hard political choices inherent in the work with CI, and thereby creating a dysfunctional governance regime for the protection of CI.

Most European countries’ constitutional obligations guarantee and protect public security and fundamental rights. One aspect and often a prerequisite for the protection of public security and individual rights is the protection of critical infrastructure (CIP). CIP is of great importance in Switzerland, which is inevitable in an economically and technologically sophisticated and densely populated country.

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.