Comparative risk assessments in the chemical safety field sometimes adopt a lofty view of the purposes of legislation. This personal essay is not lofty, and it is not just another professor's comparison of the purposes of the European Union's REACH with American regulatory programmes. I write today as an individual, as the last active remaining participant of the small group of industry players in 1975–76 who helped to negotiate the details of the 1976 US Toxic Substances Control Act (“TSCA”). As advocates for industry we won the key arguments over the law's terms and conditions, but the decades since have not shown TSCA to be a triumph for anyone.

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official 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.

This article examines the issue of risk in research and development (R&D) pertaining to new pharmaceuticals, especially those aimed at neglected diseases and/ or relevant primarily to the developing world. In particular, the article considers the role of patent pools and other forms of non-proprietary models as alternatives to patents (and other types of intellectual property rights) in R&D for new pharmaceuticals. The article concludes that that these mechanisms still achieve very little output and can therefore not currently be considered as viable alternatives to the use of patents in pharmaceutical R&D. Another relevant finding is that many of the existing collaborative initiatives and partnerships for R&D in neglected diseases actually rely on different forms of intellectual property rights.

In combating the coronavirus pandemic in Germany, soft law has played an important, albeit not a central, role. Its use basically corresponds with that of “normal circumstances”. In accordance with the German constitutional order, almost all substantial decisions are made in a legally binding form. However, these are often prepared through or supplemented by soft law. This article shows that soft law has played an important role in fighting the pandemic and its effects in Germany, although there cannot be any doubt that legally binding forms of regulation have prevailed. At the same time, the current pandemic has shed light on the advantages and effects of soft law in the context of the German legal order.

Rome is a complex metropolis. The city faces the challenge of imagining and shaping an inclusive and sustainable future for its inhabitants. On several occasions, city policies and interventions have not met the goal of preserving environmental resources. For their part, the inhabitants of Rome tend to doubt the ability of institutions to take care of the city’s resources. We focus on civic environmental monitoring led by the local independent association A Sud, aimed at assessing the environmental status of two of the city’s rivers. From a review of applicable literature on governance, environmental and social justice and climate urbanism, we build a theoretical frame to guide our analysis. We inquire how civic monitoring in a complex city can benefit urban resource governance and foster urban transitions. We also explore the extent to which these initiatives have the potential to inform or have actually informed the scientists and policymakers responsible for designing city adaptations. Our analysis demonstrates that citizen-gathered data can enrich the scientific knowledge base and trigger claims for interventions, bringing in information on local issues often overlooked by competent institutions. The initiatives also improved individual and collective attitudes towards the city and its resources, stimulating a sense of care and a watchful citizenship.

One important issue arising from EC–Seal Products is what constitutes a technical regulation in the TBT Agreement. This article argues that the Appellate Body's analytical approach to this issue has led to an arbitrary conclusion in EC–Seal Products. The article further examines to what extent PPMs, especially Non–product–related PPMs, are covered by the TBT Agreement. The article concludes that an important question to be answered is what special characteristics of a technical regulation distinguish it from other regulations and make it subject to more detailed obligations in the TBT Agreement.

The purpose of this contribution is to briefly present the content of the EU–US Data Privacy Framework recently adopted by the European Commission and then to assess whether it meets the expectations expressed by the Court of Justice of the European Union in its Schrems II judgment and related case law.

Today, there are a dozen labelling schemes pertaining to farm animal welfare in at least seven Member States. Despite the proliferation of animal welfare labels, European Union rules on food information to consumers concerning the treatment of farmed animals used in animal-source food production remain fragmented and incomplete. On the one hand, the rules contained in agricultural regulations primarily aim to harmonise marketing standards, but only for some products. On the other hand, consumer protection rules aim to protect consumers from misleading commercial claims but not misleading claims about animal treatment specifically. After examining the situation that has led to the proliferation of animal welfare food labels in the European Union, this article analyses the animal welfare food labelling landscape and presents different regulatory pathways to best harmonise consumer information on farm animal welfare.

This paper provides an analysis of the legal and policy foundations of the different approaches adopted by the European Union (EU) in relation to the 2015/2016 and 2022 refugee “crises”. Its main objective is to show how a risk-based biopolitical framework can bridge the gap between EU institutional narratives and the critique of Europe’s racialised governance schemes. The two “crises” have been largely shaped by a perceived need to manage risk, yet this has produced very different institutional responses, in ways that concealed their racialised dimension. Analysing how risk has been understood in the two contexts, the paper shows how their legal and policy foundations (re-)produce a racialised differential scheme. Amidst ongoing debates on reforming EU migration and asylum law, the paper also shows how the current proposals further consolidate this scheme.

European law of risk regulation is commonly intended to be limited to the European regulation in the internal market. However, risk is also regulated in Europe by human rights law, which is often left aside in this area. In fact, disregard for the risk entailed by certain manmade activities as well as by natural events, may imply restrictions to, inter alia, the right to life and the right to respect for private and family life enshrined in the European Convention on Human Rights. This article aims at studying the manner in which this Convention regulates risk through human rights norms. It provides an overview of the standards set by the European Court of Human Rights in this field.

This contribution explores the application of data science and artificial intelligence to legal research, more specifically an element that has not received much attention: the research infrastructure required to make such analysis possible. In recent years, EU law has become increasingly digitised and published in online databases such as EUR-Lex and HUDOC. However, the main barrier inhibiting legal scholars from analysing this information is lack of training in data analytics. Legal analytics software can mitigate this problem to an extent. However, current systems are dominated by the commercial sector. In addition, most systems focus on search of legal information but do not facilitate advanced visualisation and analytics. Finally, free to use systems that do provide such features are either too complex to use for general legal scholars, or are not rich enough in their analytics tools. In this paper, we motivate the case for building a software platform that addresses these limitations. Such software can provide a powerful platform for visualising and exploring connections and correlations in EU case law, helping to unravel the “DNA” behind EU legal systems. It will also serve to train researchers and students in schools and universities to analyse legal information using state-of-the-art methods in data science, without requiring technical proficiency in the underlying methods. We also suggest that the software should be powered by a data infrastructure and management paradigm following the seminal FAIR (Findable, Accessible, Interoperable and Reusable) principles.

Since the EU Directive (EC) No 128/2009 (SUD) was approved by the European Parliament, the establishment of a general framework aimed at securing the sustainable use of pesticides was laid down, and European Union (EU) Member States adopted National Action Plans in accordance with this Directive. Specifically, for EU Member States, pesticides, objectives and quantitative targets were created. Therefore, the EU Commission provided a methodology for risk assessment as the derivation of two harmonised risk indicators: HRI_1 and HRI_2. The present study focuses on HRI_1, as this can be implemented at the country level. Each EU Member State delivers annual harmonised risk indicators values to the Commission based on calculations using their own data and results. However, only the EU Commission can derive this HRI_1 (concatenated) indicator at the EU level. Therefore, the present study is an attempt to shed some light on the modus operandi used by the EU Commission to compile this HRI_1, and it also aims to clarify these calculations. Data originating from twenty-seven EU Member States were analysed. These data were compared to data published on the EU Commission website over time. Possible virtual developments including the modification and evolution of active substance statuses are envisaged.

C-547/14 Philip Morris Brands SARL and Others v Secretary of State for Health [2016] (not yet reported)

C-477/14 Pillbox 38 (UK) Ltd v Secretary of State for Health [2016] (not yet reported)

C-358/14 Poland v. Parliament and Council [2016] (not yet reported)

Article 114 TFEU provides an adequate legal basis for the adoption of the Tobacco Products Directive 2014 in full, including measures relating to flavoured tobacco, labelling and packaging, and electronic cigarettes. These measures also comply with the principles of proportionality, subsidiarity, legal certainty, equal treatment and free competition, and the rights of companies under the EU Charter. Member States may introduce further requirements in relation to packaging of tobacco products that are not harmonised by the Directive.