More than 40 years after Cassis de Dijon, the mutual recognition in the field of goods is still a failure. The promise of this principle for ensuring both market access and regulatory diversity has not been kept. Therefore, today, businesses rarely rely on mutual recognition to sell their products in another Member State. In an attempt to stimulate this procedure further, the European Union legislator tried to simplify the procedures to be followed by businesses and public administrations through Regulation 2019/515. This article argues that, although the Regulation creates more legal certainty, it fundamentally fails to address the underlying problem of lack of trust that has stalled mutual recognition in the past.

In May of 2015, the European Commission released a package outlining the vision for its Better Regulation initiative, a program aimed at improving outcomes of European Union (EU) regulation. The move represents a step forward for regulatory reform in the EU, and signals a potential shift in world leadership roles among countries promoting evidence-based policy. The United States (US), once at the forefront of regulatory science and analysis, may now be lagging behind. If Better Regulation is implemented as its ambitious designers envision, this could signal a new role for the EU in advancing 21st century policymaking.

Better Regulation seeks to improve the EU regulatory process in several ways. The initiative allows for more meaningful citizen and stakeholder participation at all stages of the policymaking process; it seeks to institutionalize the use of economic analysis throughout the lifecycle of a policy; and it sets up a process for reviewing the existing stock of regulations to ensure old rules do not become excessively burdensome or obsolete. All this is done in a manner intended to inform legislators as they periodically review funding levels for new and existing programs.

This paper aims to demonstrate that the current application of the concepts of risk and unsafety in Regulation 178/2002 (GFL) results in a grey area within EU food safety regulation. By means of the food safety risk assessment of aspartame it is illustrated that “grey area foods”, although not “unsafe” according to legal definition, could compromise human health because of, i.e., their nutritional composition. It will be argued that the grey area emerges from a narrow focus of food safety risk assessment within the ambit of the GFL, which disregards certain types of hazard and causes an information gap with respect to how food consumption, eating behaviour and health are interconnected. At the same time, the scope of food safety in the GFL is restricted to what is considered “normal” consumer behaviour in view of the information provided on food labels or generally available in society. In doing so, the legislator has set rather high standards for what may be expected of the average consumer in terms of the understanding and avoidance of behavioural risks. As a result, the consumer bears the responsibility for the consequences of the information gap.

This short paper aims to unpack some of the assumptions underlying the “Policy and Investment Recommendation for Trustworthy AI” provided by the High-Level Expert Group on Artificial Intelligence (AI) appointed by the European Commission. It elaborates in particular on three aspects: on the technical-legal dimensions of trustworthy AI; on what we mean by AI; and on the impact of AI. The consequent analysis results in the identification, amongst others, of three recurrent simplifications, respectively concerning the definition of AI (sub-symbolic systems instead of “intelligent” informational processing systems), the interface between AI and institutions (neatly separated instead of continuity) and a plausible technological evolution (expecting a plateau instead of a potentially near-disruptive innovation).

The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.

The European Climate Pact provides opportunities for individuals, communities and organisations to declare their commitment to climate action. This study analyses the publicly available web profiles of the European Climate Pact Ambassadors (PAs) as of January 2023. First, it explores the extent to which people who volunteer as PAs demonstrate commitment to young and future generations. Second, it investigates whether PAs who self-identify as young people are more likely than other PAs to justify their mandate by referring to the interests of young and future generations. Third, it examines whether PAs who self-identify as young people are more likely to indicate other young people as the target audience of their activities. The manual coding and quantitative analysis of the PAs’ web profiles revealed that members of older generations as well as parents and grandparents are most likely to rationalise their engagement in the programme by referring to young and future generations. The data also showed that young people do target other young people when they act as PAs, but they are not the only group to do so. When compared to individuals with other professional identities, educators are also more likely to flag young people as their target audience.

The financial crisis in 2008 and the COVID-19 pandemic today have made it clear that both financial and medical crises spread pervasively across borders. The financial crisis proved that the health of the entire European banking system stands and falls with the health of a single systemically important bank. As such, in the past decade, European Union (EU)-wide cooperation and regulation have been strengthened to ensure financial health across Europe. Today, the COVID-19 crisis reveals the de facto existence of a European healthcare system, where Member States’ medical health is interlinked and challenged. It too highlights the need for a more coordinated approach. This paper will draw lessons from European financial regulation and stress testing to make recommendations for EU-wide healthcare. The paper will show the latent benefits that a stress test might have on healthcare performance through mechanisms of governmentality. Moreover, it will pinpoint shortcomings in the financial stress test that could pose looming dangers for a European Health Union, such as a lack of de facto risk sharing. The paper concludes with pragmatic suggestions for a way forward in European healthcare regulation.

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).

Not since 2018 and the “New Deal for Consumers” package has the European Union (EU) seemed so close to stepping up the enforcement of consumer protection rules. The European Commission is expected to unveil a new “consumer enforcement package” by the end of the year, which should include revisions of the Regulation on Consumer Protection Cooperation, the Directive on Consumer Alternative Dispute Resolution and the Regulation on EU Online Dispute Resolution. In parallel, the Representative Actions Directive came into force recently. This paper examines these different initiatives and assesses whether these evolutions can truly be the first steps towards a brighter future for the enforcement of consumer protection rules in the EU or whether they are likely to remain a series of missed opportunities.

Professor Lofstedt presents a convincing illustration of the inconsistencies inherent in a European system of regulation where Member States choose whether to regulate based on assessments of risks or hazards depending on the product concerned. Particularly striking is the candid comment of a Swedish official who seems to marvel at the conflicting positions of his own government. The quote reminds this author of an official in the Swedish Ministry of Environment who in an interview stated that the application of regulation would be widely different if the precautionary principle as included in the Swedish Environmental Code or the precautionary principle as included in the Swedish Planning Code were to be employed.1 For a lawyer – or anyone else with an interest in the rule of law – such inconsistencies pose serious problems with regard to legal certainty. Unfortunately, those who could reasonably be expected to be most concerned with issues relating to the rule of law – national and European courts – have thus far proven reluctant to second-guess, or even criticise, decisions in the area of risk regulation.

The Common Fisheries Policy (CFP) is one of the ever-increasing policy areas that have witnessed the creation of forms of “networked enforcement”, meaning enforcement structures in which several national and EU authorities cooperate. Amongst those are a number of legal requirements and applications for sharing data on fisheries between national and European competent authorities. This form of networked enforcement casts some questions as regards the existence of corresponding accountability mechanisms, which serve to legitimate the enforcement activities in the CFP. The aim of this paper is to examine the networked enforcement mechanisms arising from the CFP, with a special focus on the data-sharing activities and the role of European Fisheries Control Agency as pivotal to the cooperation between national authorities, with a view to assessing the gaps of accountability arising from them, and analysing the possible alternative ways to provide the enforcement phase with legitimacy.

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.

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).

The section on WTO law highlights the interface between international trade law and national risk regulation. It is meant to cover cases and other legal developments regarding the SPS, TBT and TRIPS Agreements and the general exceptions in both GATT 1994 and GATS as well as to inform about pertinent developments in recognized international standardization bodies and international law. Of recurrent interest in this area are questions of whether precautionary policies can be justified under WTO law, the standard of review with which panels and the Appellate Body assess scientific evidence and the extent to which policy can and should influence risk regulation.

European Administrative Networks are expected to strengthen the national enforcement of European legislation. The idea is that these networks organise national civil servants, and allow them to exchange best practices, negotiate guidelines and develop inventive solutions to common challenges faced during the implementation and enforcement of European Union regulations. This paper proposes a framework to evaluate European Administrative Networks on their potential to spur collaborative innovation concerning national enforcement of this common regulation. The framework is then applied to a particular network, the European Network for Prosecutors of the Environment. Results show that this network can be considered a resource for collaborative innovation.

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.

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.