The European Court of Justice (ECJ) rendered a decision regarding supplementary protection certificates (SPCs) for plant protection products and provisional marketing authorisation. The ECJ clarified that SPCs for patented plant protection products may also be based on provisional marketing authorizations pursuant to Article 8(1) Directive 91/114 (author's headnote).

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.

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.

This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.

According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.

Disputes over food safety standards –what in the language of trade policy are called sanitary and phytosanitary standards (SPS) – have been at the heart of many transatlantic trade rows between the US and the EU. Examples include the EU bans on the import of hormone–treated beef, on pork treated with growth–promoting additives, or on poultry washed in antimicrobial rinses to reduce the amount of microbes on meat. As a result, the potential impact of the ongoing negotiations to reach a Transatlantic Trade and Investment Partnership (TTIP) free trade agreement between the US and EU on EU food standards has, rightly, attracted a lot of attention and no little anxiety. Opposition to “Chlorhühnchen” has become the rallying–call for anti–TTIP activists in many countries. NGOs argue that “TTIP will sacrifice food safety for faster trade”. Critics highlight possible procedural rules requiring transparency of decision–making and early warning mechanisms which would give interested parties (including of course business firms and lobby groups) the opportunity to comment on planned rule–making which it is argued are likely to lead to ‘regulatory chill’.

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. 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.

In 2006 the Hungarian system of food safety regulation was described as “chaotic” , fragmented and lacking accountability. Now, five years later and almost seven years after Hungary's accession to the European Union (EU) it is time to take stock again. Food safety regulation has undergone a “threefold change” and follows a separated model. Competences for risk assessment, risk management and risk communication are well distributed and the Hungarian Food Safety Office (HFSO)/Magyar Élelmiszer-biztonsági Hivatal (MÉBiH) fits into the overall structure now. But there are still problems concerning its legal position, weak status and especially insufficient independence.

This report shows the evolution of the Hungarian system and highlights the brand new developments and the current situation, challenges and organisation of the HFSO.

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 at david.hornsby@wits.ac.za.

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.

Nanosciences and nanotechnologies are a field of blooming technological applications, developed or manufactured at the nanoscale (a billionth of a meter). At this scale, matter shows new and unexpected properties. These may significantly differ from one case to the other, which results in a great diversity of different industrial applications, and eventually in very heterogeneous end-user products. As a matter of fact, the generic dimension of nanotechnologies, understood as a platform or enabling technology, drives their diversity, and potentially affects almost every industrial sector.

This article engages with two themes of contemporary EU governance: the role of evaluations within an effective and coherent policy–making process and the EU's constitutionalised commitment to promoting gender equality in all its activities (Article 8 TFEU). It focuses on the interface between ex ante and ex post evaluation and the contribution of evaluations to policy learning, with particular attention to the promotion of gender equality. A case study approach is followed, with EU research policy as the object of analysis.

Research in lifestyle risks is becoming more and more important, particularly with reference to what is generally known as “unhealthy diets”. The Law is now firmly established as a prominent instrument of Public Health. There are several distinctive methods of legal intervention targeted at counteracting overweight and promoting healthier lifestyles. In this paper we examine several measures that have been adopted and discuss whether Law should foster healthy diets. Our purpose is to examine the threats of falling into a paternalistic attitude when devising any regulatory intervention aimed at promoting a healthier lifestyle.

The view that risks and hazards are distinct concepts is commonly held in the scholarly literature on risk especially in the English-speaking community. The dichotomy is also enshrined in key documents commissioned or developed by Governments to help regulators conceptualise, regulate and communicate harmful events. Yet, the implications of risk-based versus hazard-based regulations have often been overlooked. Scholars have only conducted limited discussions, in contrast to the extensive debates about the respective merits of evidence-based and precautionary-based regulation. Lofstedt's article “Risk versus Hazard – How to Regulate in the 21st Century” offers a new and important perspective on the relationship between science and regulatory decisions. Lofstedt essentially argues that the conceptual distinction between hazards (the potential for a substance, activity or process to cause harm or adverse effect) and risks (a combination of likelihood and the severity of a substance, activity or process to cause harm) presents a meaningful classification to analyse regulations.