The European Union is increasingly moving toward an integrated policy approach, which also acknowledges linkages between public health and (external) security policy. This introduction to the Special Issue sets out a research agenda on the emerging health-security nexus. It analyses recent policy developments with respect to the public health and security, and discusses interactions along the health-security nexus in the context of the European Union. It suggests drivers behind the integrated approach and it critically examines the health-security nexus from the perspective of effectiveness and legitimacy.

The regulatory literature has long been concerned with the challenges of technological innovation, yet it says relatively little about what we understand as “innovative” and how innovation “types” impact on regulation. This article unpacks the concept of “innovation” and analyses its significance for the development of regulatory strategy. It shows that innovation types – such as “incremental” and “radical” innovation – are not clear-cut, but involve differences of interpretation. This interpretive flexibility makes them powerful discursive resources in regulatory decision-making. Through a study of the EU’s regulation of nanotechnology, the article shows how arguments of “incremental” and “radical” innovation can be mobilised to very different effect. These different ways of conceptualising new technology affect decisions on: (i) the desirability of legislative reform; (ii) the evidence-base for regulation; and (iii) the use of the precautionary principle. The study also shows how the framing of technology as “incrementally” innovative can contribute to a strategy of “deliberate regulatory ignorance”. The article concludes by arguing that the incremental/radical distinction can be put to more positive use, so that regulatory choices take account of the different techno-scientific and socio-economic dimensions of innovation.

This report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

I begin with two admissions. First, I am relatively new to risk regulation, and indeed academia in general, so this piece is based on still quite nascent views. Second, I fell into risk regulation scholarship almost by accident – therefore I hope this piece will provide an illustration of how strong the intellectual draw of the field is, having already captured my imagination at least!

In the following three sections I set out my risk regulation journey, and the understanding of the field I have developed so far. After summarising how I was drawn to risk regulation, I attempt to reflect philosophically on the purposes of risk regulation research, after which I outline the questions that I believe risk regulation scholars should be asking now and in future years, along with my corresponding research priorities.

On 08 October 2013, the General Court of the European Union (hereinafter General Court) delivered a judgment based on the Aarhus Regulation 1367/2006 on the access to information on substances under plant protection law, which attracted considerable attention among experts with conflicting response from environmental associations and industry. The judgment – still appealable at the time this article was written – would in case of becoming unappealable result in extensive limitations to the protection of commercial and industrial secrets under plant protection law, but additionally also generally under substance law. The following article analyses the content of the decision.

In recent years the concepts of ‘nudge’ and ‘libertarian paternalism’ have become popular theoretical as well as practical concepts inside as well as outside academia. But in spite of the widespread interest, confusion reigns as to what exactly is to be regarded as a nudge and how the underlying approach to behaviour change relates to libertarian paternalism. This article sets out to improve the clarity and value of the definition of nudge by reconciling it with its theoretical foundations in behavioural economics. In doing so it not only explicates the relationship between nudges and libertarian paternalism, but also clarifies how nudges relate to incentives and information, and may even be consistent with the removal of certain types of choices. In the end we are left with a revised definition of the concept of nudge that allows for consistently categorising behaviour change interventions as such and that places them relative to libertarian paternalism.

In Nudge (2008) Richard Thaler and Cass Sunstein suggested that public policy–makers arrange decision–making contexts in ways to promote behaviour change in the interest of individual citizens as well as that of society. However, in the public sphere and Academia alike widespread discussions have appeared concerning the public acceptability of nudgebased behavioural policy. Thaler and Sunstein's own position is that the anti–nudge position is a literal non–starter, because citizens are always influenced by the decision making context anyway, and nudging is liberty preserving and acceptable if guided by Libertarian Paternalism and Rawls’ publicity principle. A persistent and central tenet in the criticism disputing the acceptability of the approach is that nudging works by manipulating citizens’ choices. In this paper, we argue that both lines of argumentation are seriously flawed. We show how the anti–nudge position is not a literal non–starter due to the responsibilities that accrue on policy–makers by the intentional intervention in citizens’ life, how nudging is not essentially liberty preserving and why the approach is not necessarily acceptable even if satisfying Rawls’ publicity principle. We then use the psychological dual process theory underlying the approach as well as an epistemic transparency criterion identified by Thaler and Sunstein themselves to show that nudging is not necessarily about “manipulation”, nor necessarily about influencing “choice”. The result is a framework identifying four types of nudges that may be used to provide a central component for more nuanced normative considerations as well as a basis for policy recommendations.

The EU's new approach to policy evaluation is characterised by a focus on closing the policy cycle (linking ex ante and ex post appraisal) and by applying evaluation to all types of policy intervention, whether expenditure or regulatory policy. This article analyses the main features and challenges of this new approach. It first studies the conceptual and interdisciplinary challenge of such an encompassing approach to evaluation. It then assesses the new approach in the light of four key objectives of ex ante and ex post appraisal; ensuring evidence and learning; accountability, transparency and participation; policy coherence; and reducing the regulatory burden.

The Transatlantic Trade and Investment Partnership (“TTIP”) has been hailed as an opportunity for the world's two largest consumer markets to expand inter- regional trade, investment and jobs, and to secure greater regulatory convergence that could considerably reduce costly and market-distorting extra-territorial non-tariff regulatory trade barriers. As fears of potential adverse effects on the World Trade Organization’s multilateral trading system have abated after the Doha round stalled, the initiation of the TTIP has been welcomed by the business communities on both sides of the Atlantic.

Notwithstanding the anticipated benefits, questions arise with respect to both the way the negotiations are conducted and the topics covered. The TTIP negotiating mandate covers three main elements: (i) market access, (ii) regulatory convergence, and (iii) trade rules addressing shared global challenges.

Directive (EU) 2015/412 allows Member States to restrict the cultivation of genetically modified seed or propagating material, although their placing on the market has been authorized. This so-called opt-out is meant to resolve the current Member States’ conflict about gene technology by facilitating differences of states concerning cultivation regulations. The concept has at the same time the potential to pioneer a general reorientation of European and even global principles of free trade. Where as trade restrictions on grounds of health and environmental protection could thus far only be justified on a strict scientific basis, a variety of risk perceptions and evaluations are now made acceptable. The article explores what grounds may justify cultivation restrictions beyond those identified in a concrete environmental risk assessment. Two categories are suggested: general environmental concerns weighing systemic effects and uncertainty, and trans-environmental concerns such as the use-value of genetically modified plants, the avoidance of costs resulting from policies of coexistence with conventional plants, the halting of agricultural industrialisation, and ethical considerations. It is further examined if cultivation restrictions based on such grounds are compatible with the EU rules of free movement of goods and relevant WTO agreements. The pertinent report of a WTO-Panel on genetically modified plants is scrutinized for this purpose and a dissenting interpretation developed.

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.

This article engages with two themes of contemporary EU governance: the role of evaluations within an effective and coherent policy–making process and the EU's constitutionalised commitment to promoting gender equality in all its activities (Article 8 TFEU). It focuses on the interface between ex ante and ex post evaluation and the contribution of evaluations to policy learning, with particular attention to the promotion of gender equality. A case study approach is followed, with EU research policy as the object of analysis.

“Negative claims” can be defined as claims indicating that certain ingredients, nutrients or substances are not present in a foodstuff. Legitimate uses of regulated negative claims in the EU include some nutrition claims and “gluten-free” claims. Some EU Member States have legislated on “GM-free” claims. The article describes in more detail some cases (i.e., BPA-free, MSG-free, Aspartame-free and palm oil-free), where negative claims are used with an implied message that whatever is used instead of the often “demonised” substance is safer, healthier or greener. The article argues that EU and EU Member States’ legislators and regulators should ensure that consumers are not misled by astute marketing techniques that have no informative agendas, but simply aim at denigrating certain products in order to promote “free-from” products. This issue is particularly timely and important given the imminent application of the EU's Food Information Regulation and the additional costs that it will impose on the industry in the name of providing complete, reliable and evidence-based information to consumers.