Technological innovations are crucial drivers of economic, social, and environmental progress. While innovations lead the evolution of our societies and permeate all domains of human life, they also pose significant risks both to humans and the environment. Law and regulation are expected to enable innovation, while at the same time protecting society from unintended consequences. However, assessing new technological risks confronts deep uncertainty and limited knowledge. In contrast to simple risks (e.g. car accidents), technological risks (such as risks stemming from new health technologies, nanotechnology, biotechnology, or robotics as discussed in this special issue) cannot be calculated according to traditional technocratic models, namely as a statistically foreseeable function of probability and effects. It is widely recognised that regulating new and emerging technologies is challenging for law due to problems of uncertainty and limited knowledge in the assessment and management of technological risks. To address this challenge it is crucial to study the ways in which law and regulation can successfully respond and adapt to technological progress.

The dialectic between the technically (or scientifically) possible and the legally possible, which is implied in decision-making in conditions of uncertainty, raises crucial issues from a constitutional perspective. In particular, the emergence of a new factor of legitimacy – which could be envisaged as a form of “scientific legitimacy” – can be detected and needs to be integrated within the constitutional discourse.

Through an overview of the case law of the Italian Constitutional court, the paper aims at highlighting the possible approaches to the need of a deeper integration of technical and scientific knowledge within the public decision-making processes, in an attempt to strike a balance capable of avoiding the two extremes of scientifically weak decisions on one hand, and of “technical deference” to experts on the other.

Cars will become more autonomous and intelligent in the near future. Eventually, Autonomous Intelligent Cars (AICs) will contribute to road safety, will enable the mobilisation of disabled citizens and a will lead to a decrease of CO2 emissions. The European Union aims to stimulate responsible innovation in the field of AICs, in a way that (ethical) acceptability, sustainability and societal desirability are taken into account. The current legal frameworks are not observed to optimally facilitate innovation or successful societal deployment of AICs. This article explores challenges for both innovation and acceptance that follow from the current legal regimes on product liability, liability for motor vehicles and information privacy of consumers of AICs, and discusses these challenges in view of a regulatory balance that is to be reached between stimulation of innovation and consumer protection in the European Union.

The regulation of nanomaterials is still surrounded by scientific uncertainty regarding their potential human health risks. It is therefore useful to consider learning approaches in the process of regulation. Effective regulation is conceptualised with regard to collaborative activities of state and non-state actors that enable mutual learning regarding the health risks of nanomaterials. A theoretical framework is offered for studying learning processes in the area of occupational safety and health. Drawing on the network governance literature, three learning types (namely substantive, strategic, and institutional learning) are distinguished. Analytical conditions are proposed and applied to the case of nanomaterials in Germany, thereby offering insights into learning processes in industry-initiated collaborative activities. It is concluded that the development of trust among network collaborators is decisive for learning processes. Accordingly, a proposal for research into specific stages of trust development is made.

Ulrich Beck's Risk Society: Towards a New Modernity provides a lens through which we can analyze contemporary debates over risk regulation of agricultural biotechnology. This article establishes the political and cultural context into which genetically modified organisms (GMOs) were introduced in the European Union, by reviewing the HIV-contaminated blood scandal, mad cow crisis, and dioxin contamination episode. These public health and food safety scandals exemplify the side effects of modernization as outlined by Beck. Beck also predicted the development of a solidarity arising from the public's anxiety over the global distribution of modernization's risks. The impact of these cases on risk regulation illustrates the political and social reaction to the invisible, global risks of late modernity. The subsequent response to this reaction in European risk regulation further demonstrates the tension between a globalizing market and public anxiety in risk society.

There has been an increasing interest in making legal decision-making and scholarship scientific or inter-disciplinary, without there being any interrogation of how or why this should be done. This has resulted in polarised views of the importance of science on one hand, and the primacy of democracy on the other. Such polarisation is not helpful primarily because both ‘science’ and ‘democracy’ remain unintelligible to those who do not have access to the particular epistemology that supports their usage. In this article, I seek to reconceptualise the conflict between democracy and science as the association of legal decision-makers and scholars with expert inquiry. I further conceptualise such association as a process that involves normative reductionism of testimonial exchange. Despite a claim to ‘a culture of justification’ in legal systems such as the European Union, the process of normative reductionism is essentially arbitrary. I seek to articulate a framework where this process may be approached in a disciplined manner, concentrating on the role of mediation and moderation of expert knowledge.

Standing determines a person's ability to obtain judicial review of a legal act by the government. Judicial review of EU measures, including risk regulatory measures, is an important device to ensure that the rule of law is respected. Even after the changes brought about by the Lisbon Treaty, private parties still have limited standing rights under EU law to challenge EU risk regulations. While they are able to challenge “decisions” addressed to them (or, in some cases, addressed to others), they generally have been unable to claim standing at the European courts to seek review of generally binding rules. These restricted standing rights for private parties have been the subject of debate and criticism, both before and after the changes brought about by the Lisbon Treaty.

The European Securities and Markets Authority (ESMA) has received considerable academic attention for its newly acquired regulatory powers and the issues of legitimacy and controls concerning its far-reaching powers. ESMA's supervisory tasks are not less impressive but they are underinvestigated. In light of the recent English judgment on the exercise of ESMA's inspection powers in the UK, this article focuses on the question of judicial control over inspection power of ESMA. It shows that judicial control has been established in principle. However, the existing legal framework based on different national procedures allows ESMA escaping judicial control by chance or on purpose. This article argues for the necessity of addressing the identified controlling gap by, for instance, eliminating the differences or conditioning inspection-related discretion and promoting judicial cooperation. Since EU and national enforcement powers have become increasingly shared, the system of control cannot remain completely separated, as it is the case today. How the EU supervisor is to be controlled should not be up to the EU supervisor to choose.

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.

According to the World Health Organization (hereinafter, WHO), 38 million people die each year as a consequence of non-communicable diseases (hereinafter, NCDs). NCDs are mainly caused by diet-related factors, but also by physical inactivity and abuse of certain substances. In particular, overweight and obesity reportedly affect more than 10% of men and 14% of women globally and kill as many as 2.8 million people every year.

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.

Case T-521/14, Kingdom of Sweden v European Commission, Judgment of the General Court (Third Chamber) of 16 December 2015, ECLI:EU:T:2015:976

Case T-521/14 is a new stop on the perilous journey towards the appropriate regulation of endocrine disrupting chemicals. The Biocidal Product Regulation required the Commission to adopt criteria defining endocrine disrupting properties by 13 December 2013; the deadline was not respected. Even though the failure to act was obvious, the Court's reasoning in T-521/14 matters greatly. It exposes a structural weakness in the EU's risk governance system by reminding the Commission that strong private opposition to regulatory action does not justify tampering with the level of environmental or health protection set by the legislator. The now adopted criteria indicate that this lesson was not taken to heart.

Case C-19/15 Verband Sozialer Wettbewerb eV v Innova Vital GmbH (ECJ, 14 July 2016)

On 14 July 2016, the Court of Justice delivered its judgment on a request for a preliminary ruling concerning the interpretation of Article 1(2) of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The Court ruled for the first time that the Regulation applies to nutrition and health claims made in commercial communications exclusively addressed to health professionals. This represents a major breakthrough as – in a climate of uncertainty – the established industry practice was to interpret Article 1(2) in the sense that the Regulation only applied to commercial communications addressed to final consumers. From now on, food business operators will need to take further precautionary steps to ensure that any information they communicate to health professionals either qualifies as non-commercial or complies with the Regulation. The following case note analyses the content of the judgment and its main implications (authors' summary).