In this article a synthesis of formal models for the economic interpretation of the precautionary principle is presented, with their virtualities, limitations and measures to overcome them.

The concept of precaution has great relevance in environmental regulation in the European Union. On the one hand, and despite the somewhat vague nature of legislation, the interpretation of the precautionary principle has seen recent progress with the development of some economic models and their application. There is, however, a need for a regulatory framework for the implementation of this principle in environmental decision-making, i.e., to clarify concepts and management procedures that are appropriate to the nature of environmental risks.

It is therefore important to know the most relevant economic approaches and models with the aim of identifying their contribution to the debate on precaution in the context of environmental risk management and discuss their practical relevance in public decision-making.

Critical Infrastructure (CI) provision is characterized by privatization of CI providers, transnational risks and a changing role of the state. We describe two paradigmatic systems of state liability with a view to CI liability, namely Germany as a fault system and Switzerland as a strict liability system. Both are unsatisfactory and not well adapted to the modern realities and exigencies of allocation of risks and liability in CI and show flaws from a functional, incentive-based perspective. Therefore, we make suggestions how those systems may be ameliorated, suggesting organizational, design and supervisory liability reforms.

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.

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).

While the introduction of GMOs in food is still being debated in many Member States of the European Union, a new field of discord just appeared around the issue of animal cloning.

In this report, the author, an IP scholar and entrepreneur, analyses how nanotechnology will pervade all industries and therefore how important it is to find a proper method to valuate and especially evaluate nanotechnology-related inventions. Attaching a value or evaluating a technology is a fundamental task nowadays, especially when innovations are supposed to be licensed or assigned. The report focuses on the different valuation and evaluation techniques professionals usually employ, and then delves into the world of nanotechnology. It tries to develop a novel method that takes environmental and health-related issues into due consideration when attaching a value or evaluating a technology in the nano world. The novel tool envisioned in the article is particularly suitable for nanotech innovations, but it can be used for the evaluation of other technologies and patents as well. The innovative idea consists of introducing the concept of Present Value After Evaluation, which takes qualitative variables into consideration and provides a figure for the analyzed technology or patent. This method and the accompanying tool are perfectly suited for evaluation purposes when environmental and human safety concerns are at stake, because they take these variables into consideration and throughout technology's life cycle.

Case C-354/13, Fag og Arbejde (FOA) v Kommunernes Landsforening (KL) [2014] (not yet reported)

There is no general principle under European Union law prohibiting discrimination on the basis of obesity in regard to employment and occupation. Obesity alone is not a disability but can constitute a disability where it is accompanied by a limitation resulting from long term physical, mental or psychological impairments which in interaction with various barriers may hinder the full and effective participation of the individual in professional life on an equal basis with other workers (official headnote).

In December 2014, the Court of Justice of the European Union (CJEU) issued a preliminary ruling addressing, firstly, whether obesity is a protected ground of non–discrimination, and, secondly, whether obesity can amount to a disability. This piece begins with an introduction to the topic of obesity, followed by the facts of the case, the CJEU's judgment and a comment on the decision.

Case C-44/17, Scotch Whisky Association v Michael Klotz, 7 June 2018 (Fifth Chamber)

The CJEU issued a preliminary ruling in a dispute between the protected indication of geographical origin Scotch Whisky and the disputed sign Glen Buchenbach over the right to use the designation Glen. The CJEU provided further clarification of the four protection norms for safeguarding protected indications of geographical origin. Commencing with interpreting the phrase “any direct or indirect commercial use”, the CJEU established that the term “use” refers to the visual appearance of a protected indication covering its use in either an identical or similar form in the disputed sign. The terms “direct” and “indirect” refer to the way in which appearance takes place: the former term covers affixing a disputed sign directly on the product (ie labelling); the latter term comprises other forms of use such as advertising or accompanying documents. Further, the CJEU held that “evocation” means evaluating whether an average European consumer thinks directly of a protected indication of geographical origin when confronted with an infringing sign. Finally, the CJEU averred that assessing whether a disputed sign is used either as an evocation or as a “false and misleading indication” does not depend on the context in which the sign is used.

Article 16 of Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89, OJ L - 8, of 13.2.2008, pp 16–54 [Spirits Regulation].

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.

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.

The regulation of e-vapour products is a relatively new topic. While the e-vapour product sector is fast evolving, the optimal regulation of these products is yet to be fully understood. Some wisdom may be borrowed from the regulation of cigarettes, but many tobacco-relevant policies may not be applied to these new products. Evaluations are underway on many aspects of e-vapour products, for example: their safety, potential health risks, illicit trade, taxation and advertising. This paper examines yet another dimension – one which arises at the intersection of international health and trade law – namely whether e-vapour products and cigarettes may be found “like” in a WTO dispute challenging trade restrictive measures applying to e-vapour products.

In particular, the analysis focuses on a hypothetical ban on the importation, distribution, sale and offering for sale of e-vapour products (referred to as a general ban) – a measure that is either being contemplated or already implemented in some domestic jurisdictions. It finds that e-vapour products and cigarettes may be “like” under WTO law. In the event that a positive finding is made on other remaining tests necessary to determine discrimination (importantly the “less favourable treatment”) and provided the regulating member finds no solid evidence to justify the ban under GATT Article XX, a general ban on e-vapour products risks being found WTO inconsistent.

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.

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.

In the context of the UK Supreme Court decision in Sienkiewicz v Greif (2011) this article discusses the question whether so-called “naked statistical evidence” can satisfy the civil standard of proof in English law, the “balance of probabilities”. It argues that what is required to satisfy the standard is a judicial belief that causation is more likely than not, rather than a categorical belief that causation occurred. Whether such a belief is justified depends on the weight of the evidence as well as the degree of probability it purports to establish, but there is no reason of principle why epidemiological evidence alone should not satisfy this standard.

The World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) disciplines WTO Members’ health regulations to prevent their misuse for protectionist purposes. In doing so, its obligations reflect several elements of the rule of law, including legal certainty, non-arbitrariness and non-discrimination, as well as a recognition of the rights of individuals. Through its obligations of non-discrimination, transparency and scientific justification and the scope it leaves for Members to prioritise the protection of health over trade liberalisation, the SPS Agreement can be regarded as entailing a rule-of-law approach. However, cognisant of the limits to the rule of law when transposed to the international level, it is important to avoid an overly “judicialised” approach to the disciplines of the SPS Agreement, and in particular its reliance on scientific justification to prevent arbitrariness in sanitary and phytosanitary regulation. Otherwise, there is a risk of intruding too far into the regulatory autonomy of States, weakening the “compliance pull” of the agreement and thus inadvertently undermining the rule of law in this area. An approach that instead recognises the inherent subjectivity and uncertainty in science and respects Members’ divergent priorities in health regulation would go further in engendering support for the rules-based system of international trade.