Frequently, decisions related to health protection are taken directly on the basis of scientific assessment and they are not clearly understood, as is highlighted in the Xylella example. Therefore, this article suggests that coherent processing of information in risk assessment may allow also a “third party” (who has not already expressed a specific interest in the procedure) to participate. In order to truly grasp the EU administration, an accountable way of communicating is helpful. Therefore, communication around the democratic process might be based on EU administrative principles and rules supporting a composite administrative system: it must not neglect the implications of compliance with the multilingual principle and its consequences for EU law, which would also lead to greater trust in risk assessment.

This article looks back at the history and legacy of the Risk and Regulation Advisory Council in the UK. The Council was the first government body to explicitly challenge a culture of overreaction to ‘public risk’, one of a number of ways in which it was a unique and interesting experiment in addressing the political dimension of contemporary regulation. Whilst the RRAC was ultimately unsuccessful in bringing about a change in how risk is managed by government it has, at least, left a useful intellectual legacy and, more practically, its work is effectively being taken forward by the Risk and Responsibility programme of the Dutch government.

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.

This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

Nanomaterials have been the object of numerous public and private initiatives aiming to manage their risks and maximise their benefits. Proponents of nanotechnology programmes argue that their potential negative impacts need to be dealt with appropriately, and wish to integrate these concerns early in the industrial development of these substances. Science policy programmes do not provide a clear definition of the term “nanomaterials”. Defining nanomaterials, however, has become a central concern. It is called for by manufacturers who wish to sell the “nano” quality of their products as well as by associations who wish to classify products in order to facilitate consumer choice or introduce constraints on production.

This is more than an obscure technical and legal issue for specialists. Indeed, science and technology studies has shown that technical classifications perform social order, and that the creation of new entities destabilises the conduct of democratic life. For instance, Sheila Jasanoff demonstrates that the “ontological uncertainty” of biotechnological objects leads to the construction of different political forms in the United States and Europe. Building a legal and technical framework for biotechnology objects allocates public roles, defines expertise objectivity, and identifies public concerns – in short, it shapes political organisations at the same time as it constructs technological definitions.

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).

In the World Trade Organization (WTO), the US approach to science-based risks and trade restrictions prevailed over that of the European Union (EU). The EU, dissatisfied with the margin of action available when “relevant scientific evidence is insufficient”, largely kept intact its internal practice on marketing and importing genetically modified (GM) crops and GM-containing products. The goal of this article is to ascertain whether these regulatory preferences of the US and the EU translate into their post-Biotech external trade efforts. US and EU preferential trade agreements are scanned for rules on trade in biotechnology goods or the use of precautionary elements in regulation. It transpires that neither bloc systematically tries (or manages) to bend trade agreements to accommodate its defensive or offensive trade interests in this field. Among the possible reasons for this apparent inertia are the US confidence in the WTO baseline and the EU preference for a “don’t ask, don’t tell” approach to its trade-restrictive policy in this area.

This work has the aim of dissecting the legal and policy dress designed for the new “Green” Common Agricultural Policy (CAP 2023–27) across the proposed CAP Strategic plans (CSPs) of the EU member states. The analysis is carried out through the lens of a special inquiry: the consistency and coherence between the CAP and the perspective of the Green Deal and its satellite strategies, among all the Farm to Fork Strategy (F2F) and Biodiversity Strategy for 2030, for transition to a resilient and Sustainable food system. The F2F proposes a roadmap of interventions and sets specific goals to reach such a transition. Within these interventions, a renewed CAP is the first stage through which the direction undertaken by the EU can be measured. Following the new CAP delivery model, this work will investigate the national CSPs and address the consistency of the CAP financial instruments utilised to fulfill the social, economic and environmental objectives of the CAP according to the ambition of the F2F and other key strategies.

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 scandal involving the Volkswagen group broke out last Fall, at the dawn of the very delicate UN Conference on Climate Change (COP21) held in Paris, and the posting of an unofficial version of the Comprehensive Economic and Trade Agreement (CETA). This so, just when a leaked version Transatlantic Trade and Investment Partnership (TTIP) ran through the veins of the Internet and the Trans-Pacific Partnership (TPP) was just about to be signed in New Zealand, fostering market integration by pushing further national treatment and mutual recognition, against the backdrop -albeit one small step at a time- of an increasing demand for environmental protection through the setting, among other regulation tools, of emission thresholds.

This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.

This contribution evaluates whether European Union State aid policy could play a role in achieving deeper and more solidary integration in the area of public health. According to Article 107 TFEU, the powers of Member States to grant aid to help their economies are seriously limited. Exceptions to the general prohibition to grant State aid are authorised by the European Commission, which enjoys wide discretion in weighing national objectives against European integration goals. The area of public health has been shielded from the application of these rules, with activities such as the provision of health insurance failing to be considered of economic nature (see most recently the Dôvera judgment). The COVID-19 experience shows that, in cases of major health crises, State aid provisions are practically suspended, with interventions allowed in the name of the fight against the pandemic. The eventual creation of a Health Union will require the re-evaluation of the application of the State aid rules to healthcare. This paper questions whether these rules should evolve as a reflective function of strengthened competences in healthcare or whether existing regulatory powers are enough to determine the interaction between national spending policies, a solidary European Health Union and fair competition.

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.

The rise of sharing economy platforms is ubiquitous throughout the world.1 Their success is attributed to the fact that they directly connect supply and demand by enabling individuals to share goods and personal services, with minimal initial barriers to entry. In addition, they outsource their workforce – making it less expensive and easier to expand internationally. Similar to other global supply chains, workers are mediated by a third party and technology is fundamental to that.2

This report analyses the outcome of the latest meeting of the Conference of the Parties to the Framework Convention on Tobacco Control. In this context, it concentrates on the adopted amendments to the partial guidelines for implementation of Articles 9 and 10 of the Framework Convention, recommendations on the regulation of e-cigarettes, and discussion on the interactions between international trade/investment obligations and implementation of the obligations of the Convention.