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 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 frommodern 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.

The report aims to illustrate how weakening of the statehood is reflected in the way EU and its member-states manage obesity epidemics. Private interests and behavioural turn in policy mechanisms call for more state involvement and rigorous democratic deliberation not only of nudges coming from the state, but those coming from the industry as well. The potential of nudging does not lie in the behavioural interventions it is capable of producing, but rather in the discourse it kick-started, as behavioural law and economics are paving their way into policy-making.

In a hot, flat, hyper–connected world, public perception of risk may determine if agriculture will save the planet by 2050 or destroy it. Science and technology options may hold the key to solving the situation, but, if media experience with “pink slime” and raw milk are any indication, society may be in for a bumpy ride. This article will examine global trends in food and agriculture, the interplay between food safety and public perceptions of risk, and the role of risk communication in addressing public perceptions.

Case C-404/13, The Queen, on the application of Client Earth v Secretary of State for the Environment, Food and Rural Affairs EU:C:2014:2382, OJ C – 26 of 26.1.2015, p. 6.

When a Member State finds that the limit values cannot be respected before the deadline fixed by the Air Quality Directive and wishes to postpone that deadline for a maximum of five years, that Member State is required to make an application for the postponement of the deadline by drawing up an air quality plan demonstrating how those limits will be met before the new deadline (official headnote).

Case C-354/13, Fag og Arbejde (FOA) v Kommunernes Landsforening (KL) [2014] (not yet reported)

There is no general principle under European Union law prohibiting discrimination on the basis of obesity in regard to employment and occupation. Obesity alone is not a disability but can constitute a disability where it is accompanied by a limitation resulting from long term physical, mental or psychological impairments which in interaction with various barriers may hinder the full and effective participation of the individual in professional life on an equal basis with other workers (official headnote).

In December 2014, the Court of Justice of the European Union (CJEU) issued a preliminary ruling addressing, firstly, whether obesity is a protected ground of non–discrimination, and, secondly, whether obesity can amount to a disability. This piece begins with an introduction to the topic of obesity, followed by the facts of the case, the CJEU's judgment and a comment on the decision.

The current application of the hazardous substances provisions of Article 16 of the EU Water Framework Directive are in fundamental conflict with a number of other Directives and Regulations controlling the use of those hazardous substances that are currently essential to the wellbeing of the Community and its citizens. There is a simple solution to this conflict although reaching political agreement in such a polarised area may prove to be impossible.

This section discusses the regulation of “lifestyle risks”, a term that can apply to both substances and behaviours. Lifestyle risks take place along the line of “abstinence – consumption – abuse – addiction”. This can concern substances such as food, alcohol or drugs, as well as behaviours such as gambling or sports. The section also addresses the question of the appropriate point of equilibrium between free choice and state intervention (regulation), as well as the question of when risks can be considered to be acceptable or tolerable. In line with the interdisciplinary scope of the journal, the section aims at updating readers on both the regulatory and the scientific developments in the field. It analyses legislative initiatives and judicial decisions and at the same time it provides insight into recent empirical studies on lifestyle risks.

This section aims at updating readers on the latest developments of risk-related aspects of food law at the EU level, giving information on legislation and case law on various matters, such as food safety, new diseases, animal health and welfare and food labelling.

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.

Case C-443/13, Ute Reindl v Bezirkshauptmannschaft Innsbruck, ECLI:EU:2014:2370

1. 1. Fresh poultry must be free from salmonella contaminations at all the stages of distribution including the retail stage.

2. 2. National law may impose a penalty on a food business operator which is active only at the distribution stage for placing salmonella–contaminated foodstuff on the market. It is for the national courts to determine whether such a penalty observes the principle of proportionality as laid down in Article 17 para. 2 of Regulation No 178/2002.

Judgment of the Court (Fourth Chamber) of 5 March 2015 In Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston ScientificMedizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13)

On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive, which imposes objective, no-fault or strict liability, but not absolute liability, for defective products. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive. As in other civil law cases, the question arises whether the Court's light treatment will provide a sound basis for the further development of product liability in Europe. The Court did not answer the questions posed by the referring court, but in some respects went beyond these questions and in other respects avoided the difficult issues raised thereby. As discussed in this note, the Court paints with a broad brush, and the test set forth in its judgment to determine whether a product is defective, may itself be defective.

On 27 May 2014, after two years of debates and extensive amendments by the EU’s law-making institutions, the EU Clinical Trial Regulation1 was published. The Regulation repeals and replaces the Clinical Trials Directive, an instrument described by the European Commission as “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”. The Clinical Trials Regulation is intended to improve the existing framework, and will become applicable at the earliest on 28 May 2016. This report reviews the most significant changes to the existing system brought about by the Clinical Trials Regulation, and how this Regulation purports to strike a balance between its objective of increasing clinical trial activity in the EU and the need to protect clinical trial subjects’ rights, safety and well-being.

OPINION OF ADVOCATE GENERAL KOKOTT delivered on 12 February 2015 in Case C-106/14, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB) v Ministre de l’écologie, du développement durable et de l’énergie.

On 26 February 2014, the German Federal Court of Justice (Bundesgerichtshof, hereinafter, BGH) held, in the case Hipp v. Milupa, that trademarks can be health claims under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (hereinafter the Nutrition and Health Claims Regulation, NHCR). The BGH, therefore, confirmed the broad interpretation of the term ‘health claim’ and remanded the case back to the Frankfurt/Main Higher Regional Court (hereinafter, OLG Frankfurt). Products bearing trademarks that existed before 1 January 2005 and that do not comply with the NHCR may continue to be marketed until 19 January 2022. On 15 January 2015, the OLG Frankfurt handed down a new judgment in the proceedings between Hipp and Milupa, relating to the question as to whether a trademark had to be used with the identical and unchanged food product before January 2005 to fall under the transitional rule, or whether changes to the product were permissible.

Case C-658/11, European Parliament v Council of the European Union [2014] (not yet reported)

CFSP acts can be challenged before the Courtwhen the arguments relate to procedural points outside of the CFSP articles in Title V TEU. The Court can annul Council CFSP acts when the proper notification procedures to the Parliament stemming from Article 218 TFEU have not been followed. The effects of CFSP acts can remain in place, even after the Court annuls them, until such a time when the act has been replaced.

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 regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, theMember States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking atmethodologies 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.