Regulatory inspections and enforcement are seen by many as a key instrument to ensure the effectiveness of regulations – it is broadly assumed to be essential to have supervision and “deterrence” to promote compliance with rules, and thus achievement of regulatory outcomes. However, this presupposes that rules are indeed adequate for reaching outcomes, and that control is what drives compliance with rules. A different approach suggests that compliance is more complex and driven by a combination of factors (ethics, social conformity, procedural justice and legitimacy etc), that rules are imperfect, and that risk-focused, risk-proportionate “regulatory delivery” will achieve better results, more “effectiveness”. Considering a case study of occupational safety inspections and outcomes in Britain, France and Germany, we observe that higher numbers of inspections are not correlated with less fatal incidents, and that, on the contrary, the best outcomes are achieved in the country having the least inspection visits, the most risk-focused system, and the broadest approach to “regulatory delivery”, combining engagement with regulated industries, guidance, responsive and risk-proportionate enforcement, and risk-based, targeted inspections.

This report examines the pending Proposal for a directive on unfair trading practices in business-to-business relationships in the food supply chain, and its proposed amendments. It provides a general overview of the current content of the Proposal and analyses the proposed rules from a legal perspective. We find that: (1) the CAP legal basis may prove insufficient for regulation that covers the entire agri-food chain; and may (2) result in a strained relationship with the competition and consumer acquis; (3) the empirical basis for the prevalence of unfair trading practices, and the effect of their prohibition is relatively dire, which results in uncertainty with regard to the achievement of the future UTPD’s intended effect and effectiveness; (4) the choice for specific targeted prohibitions instead of general umbrella clauses may lead to ad hoc regulation that leaves large loopholes; (5) the institutional enforcement mechanism makes it likely that the Proposal contributes to the foundation for a new area of EU law, which will increasingly regulate practices in business-to-business relationships.

Taking the Urgenda case on climate change liability as an example, this article researches the more general question into the legitimacy of risk regulation by civil courts. Which principles determine the legitimacy of a civil court’s participation, especially in the domain of societal risk regulation? The central claim is that these principles concern (amongst many other things) the position of the court, the tools of the court, and the attitude of the court. In other words, they have their source in constitutional law, civil (procedural) law, and professional ethics respectively. This claim is substantiated by an analysis of these principles, their interpretation, and the way they contribute to a normative/theoretical framework for the assessment of the legitimacy of judicial rulings.

EU network codes are legally binding rules related to cross-border and market integration issues and elaborated through a complex procedure set by the third energy package. This article comments on the experience accumulated so far and identifies future challenges by following the “life cycle” of EU network codes from their elaboration phase to the current stage of their implementation.

Over the last decade complexity has impaired financial regulators’ and supervisors’ ability to cope with informational asymmetries, moral hazards and other market failures. Recent regulatory responses have been to include external auditors in the range of “gatekeepers” and “watchdogs” that serve regulatory objectives. On the other hand, the compliance function gained greater prominence as a form of internalised law enforcement, being increasingly seen as facilitating the achievement of public regulatory needs in maintaining the safety and soundness of financial institutions. Yet, uncertainty has pervaded the issue of what modes of interaction supervisors, compliance and external auditors should be subject to. International experience and anecdotal evidence show, in fact, that the current informal, discretion-based, relationship between such gatekeepers brings about risks of knowledge fragmentation and ambiguity, calling for better gathering and use of “gatekeepers’ knowledge”. The objective of this article is to address and rectify problems of multiple centres of knowledge construction, by approaching questions pertaining to the interaction between the “internal” and “external” gatekeepers. A primary contribution of this article is to examine this problem by reconciling the strand of research concerning multiple gatekeepers´ liability and the developing legal scholarship on compliance as a delegated form of external enforcement. The explanatory nature of multiple gatekeepers’ liability is twofold: first, it contributes in emphasising the complexity stemming from the interactions between multiple gatekeepers; second, it offers a solid working hypothesis to detect the market failures that can arise from such complexity, namely relating to fragmentation – and construction – of knowledge.

This special issue provides several perspectives on the potential and limits of judicial risk regulation as a mechanism to redress actual and perceived regulatory failures. Central to this inquiry is the legitimacy of the court system to act as a risk regulator, specifically as compared to governmental actors. This article focuses on the question of institutional competency of juridical risk regulators from a law and economics (“L&E”) perspective. L&E scholarship will be used to help to understand the relative strengths and weaknesses of courts as risk regulators and helps us decide when courts may act as substitute risk regulators and when they are better positioned as complements.

This paper investigates traditional and new tools for increasing the effectiveness of rules and enforcement strategies. As a preliminary concern, it underlines that there are two sides to effectiveness that cannot be approached separately: effectiveness as perfect compliance with the terms of rules, and effectiveness as a result of rules which incentivise behaviours to meet the “spirit of the law”. In order to achieve this comprehensive approach to effectiveness, rules must be evidence-based, plain, understandable and accepted. Moreover, a clear understanding of compliance drivers is needed. Deterrence and all other possible motivations that go beyond the rational calculus should be assessed by decision-makers, such as internal motivation, procedural fairness, cooperation, social norms, heuristics and bias. Enriching the rationality assumption with other drivers of compliance does not mean dismissing traditional rules or enforcement tools, which conversely remain crucial for the purpose of supporting voluntary compliance and for preventing non-compliance. However, deterrence should be calibrated by a risk-based, responsive and proportional approach to (simplified) rules and enforcement strategies. Trust in public authorities, supportive and cooperative public administrations are also fundamental in order to increase voluntary compliance, and a cognitive-based approach should complement these views.

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].

The risk-based approach has been introduced to the General Data Protection Regulation (GDPR) to make the rules and principles of data protection law “work better”. Organisations are required to calibrate the legal norms in the GDPR with an eye to the risks posed to the rights and freedoms of individuals. This article is devoted to an analysis of the way in which this new approach relates to “tick-box” compliance. How can the law enhance itself? If handled properly by controllers and supervisory authorities, the risk-based approach can bring about a valuable shift in data protection towards substantive protection of fundamental rights and freedoms. While the risk-based approach has a lot of potential, it also has a risk of its own: it relies on controllers to improve compliance, formulating what it means to attain compliance 2.0.

The EU institutions and agencies have become increasingly involved in enforcing EU law directly vis-à-vis private actors. A number of such EU entities have also acquired the so-called emergency powers, which allow interference with the legal position of a private party. Given the lack of research in this area, the question that this article addresses is whether relevant safeguards have been introduced to ensure the rule of law in such situations to prevent the abuse of executive discretion by public authorities. What are the relevant safeguards in the emergency in the EU in the first place? Having analysed relevant EU legislation and case law, the article offers a complete overview of all the existing EU entities with the emergency powers and shows a great diversity in the extent to which the EU legislator has regulated procedural safeguards in relevant law. The article discusses what safeguards need to be ensured in an emergency and argues for clarity of legislative frameworks in this respect.

The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.

This commentary examines the recent Appellate Body Report in Russia – Pigs. This case is salient because it offers further clarification of the principle of regionalisation in the context of WTO law. By reading the different terms of Article 6 of the SPS Agreement in a holistic way, the Appellate Body has offered an interpretation of the legal text that arguably strengthens the principle.

In general, a functioning liability and insurance framework should ensure an adequate level of third party claimant protection and a reasonable and adequate final allocation of liability costs for the involved parties. This research examines whether the liability and insurance framework resulting from the amendment to German Road Traffic Act meets these two central objectives. The article shows that a reasonable and adequate allocation of liability costs is inhibited because of several barriers that hinder the shift of liability costs from the owner of the vehicle to the manufacturer. In particular, it is highly dependent on the practical application of subrogation claims. The ability and the motivation of motor insurers to conduct subrogation claims could be negatively affected because of a lack of required technical and engineering know-how and because a market-wide conduction of subrogation claims would erode the business model of motor insurance. This article proposes changes to the current framework particularly by removing specific exclusions of product liability and by easing the burden of proof of a product defect.