How can tort law contribute to a better understanding of the risk-based approach in the European Union’s (EU) Artificial Intelligence Act proposal and evolving liability regime? In a new legal area of intense development, it is pivotal to make the best use possible of existing regulation and legal knowledge. The main objective of this article is thus to investigate the relationship between traditional tort law principles, with a focus on risk assessments, and the developing legislation on artificial intelligence (AI) in the EU. The article offers a critical analysis and evaluation from a tort law perspective of the risk-based approach in the proposed AI Act and the European Parliament resolution on a civil liability regime for AI, with comparisons also to the proposal for a revised and AI-adapted product liability directive and the recently proposed directive on civil liability for AI. The discussion leads to the illumination of both challenges and possibilities in the interplay between AI, tort law and the concept of risk, displaying the large potential of tort law as a tool for handling rising AI issues.

Both the waste regulation and chemicals regulation of the European Union are based on the precautionary principle. The main objective of the chemicals regulation is to protect human health and the environment from the risk caused by hazardous chemicals. The modern waste regulation aims, among other things, at fostering the recovery of waste. These material circulation aims have been recently emphasised by introducing the ambitious circular economy objectives. Many of the waste streams contain hazardous substances that may pose risks to human health and the environment. This article examines the role of the precautionary principle in the circular economy. We argue that sustainable material circulation can only be achieved through a case-by-case application of the precautionary principle, but this also requires participatory discourse in which competing arguments, beliefs and values are openly discussed.

Drones represent a rapidly developing industry. Devices initially designed for military purposes have evolved into a new area with a plethora of commercial applications. One of the biggest hindrances in the commercial developments of drones is legal uncertainty concerning the legal regimes applicable to the multitude of issues that arises with this new technology. This is especially prevalent in situations concerning autonomous drones (ie drones operating without a pilot). This article provides an overview of some of these uncertainties. A scenario based on the fictitious but plausible event of an autonomous drone falling from the sky and injuring people on the ground is analysed from the perspectives of both German and English private law. This working scenario is used to illustrate the problem of legal uncertainty facing developers, and the article provides valuable knowledge by mapping real uncertainties that impede the development of autonomous drone technology alongside providing multidisciplinary insights from law as well as software electronic and computer engineering.

There is much to be welcomed concerning the role blockchain technology can play in modernising and enhancing international trade, creating a more level playing field and reducing costs. However, it goes without say that the technology also brings with it the risk of abuse leading to trade-based money laundering. This article explores how anti-money-laundering legislation should respond to the use of blockchain technology in shipping and trade. Maritime trade poses unique challenges because of several significant factors: the fact that it concerns large sums but many linked trading transactions over the same goods; its use of documents and involvement of numerous faceless entities; and its cross-border setting. Drawing on tried and tested forms of blockchain technology-based trade transactions, this work examines the fault lines in the current regulatory system and questions how best these gaps should be remedied. It also stresses that even states that have banned the issue and trade of cryptoassets might not be immune to these new challenges.

The COVID-19 pandemic transformed our understanding of the state’s role during a public health crisis and introduced an array of unprecedented policy tools: ever-stricter travel restrictions, lockdowns and closures of whole branches of the economy. Evidence-based policymaking seems to be the gold standard of such high-stakes policy interventions. This article presents an empirical investigation into the regulatory impact assessments accompanying sixty-four executive acts (regulations) introducing anti-pandemic restrictions in Poland over the first year of the pandemic. To this end, the study utilises the so-called scorecard methodology, which is popular in regulatory impact assessment research. This methodology highlights the shallowness of these documents and the accompanying processes, with an absence not only of a sound evidence base behind specific anti-pandemic measures or estimates of their economic impacts, but even of the comparative data on restrictions introduced in other European Union/Organisation for Economic Co-operation and Development (OECD) countries. Overall, the collected data support the hypothesis that the ad hoc pandemic management process crowded out the law-making process through tools such as regulatory impact assessments and consultations. In other words, the genuine decision-making occurred elsewhere (with the exact process being largely invisible to public opinion and scholars) and drafting legal texts simply codified these decisions, with the law-making process becoming mere window-dressing.

The European Commission’s 2020 draft Chemicals Strategy for Sustainability set the ambitious goal of achieving a “Toxic-Free Environment”. Those ambitions were harshly criticised by a team based in Germany’s Federal Institute for Risk Assessment (or BfR); they claimed that toxicological risks from chemicals had already been minimised and were optimally regulated. This paper outlines evidence to support the Commission’s implication that the European Union’s chemicals regulatory regime is suboptimal. It also criticises the BfR team’s contentions by reference to empirical findings (eg concerning tumours, congenital anomalies and the toxicity of mixtures) and by disentangling their conceptual confusions.

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques.

This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation of powers plays in emergency management and how this system can impact health risk assessment. An explanation of the risk management system in Italian and European Union (EU) law is provided and the following key legal issues are addressed: (1) the notion and features of emergency risk regulation from a pandemic perspective, distinguishing between risk and emergency; (2) the potential and limits of the precautionary principle in EU law; and (3) the Italian constitutional scenario with respect to the main provisions regulating central government, regional and local powers. Specifically, this article argues that the administrative strategy for effectively implementing emergency risk regulation based on an adequate and correct risk assessment requires “power sharing” across the different levels of government with the participation of all of the institutional actors involved in the decision-making process: Government, Regions and local authorities.

COVID-19 has demonstrated the fragility of EU free movement rules when we are faced with an unknown virus of such magnitude and strength that it threatens our lives, health systems, economies and society. The aim of this text is to show the dynamics between the threat of COVID-19 and the rules imposed as a response to the pandemic, which have impacted the functioning of the EU internal market and the Schengen area. The text will concentrate on the application of the precautionary principle and public health restrictions, caused by COVID-19, to free movement of persons in the EU. The analysis will lead to three conclusions. First, it will be shown that the decisions to apply free movement restrictions and the logic followed in the EU COVID-19-related documents can be viewed as a triumph of the precautionary principle. Second, it will be argued that implementing the precautionary principle has a transformative effect on the application of the principle of proportionality in EU law. Finally, it will be shown that COVID-19 has emphasised and increased the difference between the conditions for the applicability of public health restrictions when compared to restrictions based on public policy and public security grounds.

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the authorisation of plant protection products. Many legal issues are unclear in this respect due to the lack of European and national case law. The German Administrative Court of Braunschweig had to decide in an urgent procedure on the effects of Brexit with regards to the authorisation of a plant protection product in the mutual recognition procedure.

External evaluations by an international committee of the scientific risk assessment and decision-making processes of the Netherlands Competent Authority for the authorisation of plant protection products and biocides (Ctgb) were conducted in 2013 and 2018. Based on the experience drawn from them, a general guidance for such visitations is suggested. An international visitation committee examined the structure and management of the Authority, its human resources and staff policy, the scientific processes and output, the documentation and communication of its decisions and the mechanisms for keeping up to date with international scientific developments. Attention was paid to the degree of openness and transparency throughout the organisation and in particular when dealing with confidential information. From the experience gained it can be concluded that visitations not aiming at finding mistakes and omissions but instead focusing on recommendations and constructive suggestions will result in cooperation, mutual trust and acceptance of the recommendations made. A follow-up visitation after a few years can be effective in maintaining a traceable, high-level scientific output. In view of the strong drive towards the European Union-wide harmonisation of the regulatory practices of hazardous chemicals, a voluntary evaluation of regulatory authorities’ scientific performance is recommended as a means for organisational learning.

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution.

Climate change emergency requires rapide and determined action. The procrastination of the French state is not without consequences. One of them is that the High Administrative Court (Conseil d'Etat) found that climate risk is not taken seriously enough and is insufficiently addressed. In two decisions ruled in 2020 and 2021, the Conseil d'Etat in France had the opportunity to express itself on these issues. This is the case known as “Grande Synthe”, referring to the city that filed the petition before the High Court, in an appeal for “exces de pouvoir” –exces of power -, asking the administration to take further action in the fight against climate change. Civil society in France is indeed becoming impatient and taking legal action challenging the lack of ambition of the State in climate matters. The decision commented here will no doubt serve as a model for other similar decisions and for other European countries. It will lead to an increase of climate litigation in France and abroad.