This mini-symposium of the European Journal of Risk Regulation focuses on the Paris Agreement on Climate Change, which was concluded at COP-21 in December 2015. It has been called the ‘world's greatest diplomatic success’ and a ‘historic achievement,’ but also an ‘epic failure’ and even a ‘fraud’ and ‘worthless words.’ Disappointed with the Paris Agreement, a group of eleven climate scientists signed a declaration stating that it suffers from “deadly flaws” and gives “false hope;” they argue that the time for “wishful thinking and blind optimism” is over, and “the full spectrum of geo engineering” should be considered. The broad disagreement over the outcome of COP-21 in Paris (in particular, over its binding effect) illustrates not only the diverging expectations of interest groups, but also the antagonisms that arise in all areas of policy-making between the dogmatic and the pragmatic, the idealistic and the realistic, and the internationalists and nationalists.

Case C-221/15 Criminal proceedings against Etablissements Fr. Colruyt NV [2016] ECLI:EU:C: 2016:704

In Fra.bo, it was held by the Court of Justice of the European Union (“CJEU”) that “Article 28 EC must be interpreted as meaning that it applies to standardisation and certification activities of a private-law body, where the national legislation considers the products certified by that body to be compliant with national law and that has the effect of restricting the marketing of products which are not certified by that body” (author's headnote).

This article addresses conceptional components of national strategies on critical infrastructure protection (CIP). In particular, it focuses on the Swiss CIP programme and its strategic components. As in other countries, Switzerland divides its national infrastructure into critical sectors, but rather distinctively it subdivides them into critical subsectors and even lists specific critical infrastructure objects in a classified inventory. The article stresses the importance of a pragmatic public private partnership in further strengthening the CI's resiliency, but also argues for a more explicit legal foundation to provide some clearer guidelines in this evolving field of collaboration.

On Tuesday, January 18, 2011 President Obama issued a new executive order and two somewhat related memoranda which embody some of the principles discussed by the Office of Information and Regulatory Affairs (OIRA) Administrator Cass Sunstein in this Journal. Building on three decades worth of practice in the United States with regulatory review, the new order and memoranda maintain significant continuity with past experience, while emphasizing both “humanizing” and rationalizing elements in the practice of regulatory impact analysis.

Causal inference lies at the heart of many legal questions. Yet in the context of complicated disease litigation, in particular, the causal inquiry is beset with difficulties due to gaps in scientific knowledge concerning the precise biological processes underlying such diseases. Civil courts across the globe, faced with increased litigation on such matters, struggle to adhere to their judicial fact-finding and decision-making role in the face of such scientific uncertainty. An important difficulty in drawing evidentially sound causal inferences is the binary format of the traditional legal test for factual causation, being the ‘but for’ test, which is based on the condicio-sine-qua-non principle. To the question ‘would the damage have occurred in the absence of the defendant's wrongful behaviour’ the ‘but for’ test requires a simple yes or no answer. This is increasingly deemed unsatisfactory in cases in which, given the state of science, true causation cannot possibly be determined with certainty.

On March 10, 2014, the U.S. District Court of Utah, Central Division, decided in University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, holding that “Plaintiffs are not entitled to a preliminary injunction”, as they “are unable to establish that they are likely to succeed on the merits of the claims” nor “that the equitable factors support issuance of the requested injunction”.

This case note gives an overview of the U.S. District Court's of Utah memorandum decision and order denying plaintiffs’ motion for preliminary injunction and discusses its implications for the implementation of the criterion of isolation to “synthetic” DNA sequences, such as primers and probes.

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.

This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

In an article that made waves when it was first published in 1996, judge Easterbrook scorned the idea that the technological reality of cyberspace justified talk about or a need for ‘Cyber Law’. Just as there is no need for a ‘Law of the Horse’ merely because horses give rise to legal claims, he argued, conventional legal principles and reasoning are sufficiently accommodating to absorb new legal challenges that arise in the wake of cyberspace. We may likewise doubt the need for a ‘Law of the Mammoth’, even though technologies emerge that harbour the prospect of bringing back the woolly mammoth from extinction, reversing climate change, and creating new life forms. Cyber Law is now firmly established, of course, and Easterbrook also appears to have lost the academic debate from the likes of Lawrence Lessig. That fact notwithstanding, the onus to show that the time has come for a Law of the Mammoth clearly is on those staking the claim.

Former Soviet republics and other countries of the ex-Communist “block” may seem unlikely places to look for inspiration in “better regulation”. In fact, their experience in moving away (with varying degrees of success) from an approach based on “total control” and complete risk-aversion (an absolute RRR, as it were) may be an opportunity to get many insights. Data from surveys conducted by the World Bank Group allows to shed light on trends in regulatory delivery, and in particular in inspections, which is the primary way in which the RRR is felt by businesses. This paper describes the starting situation, analyses the reform processes and their outcomes, and attempts to draw some lessons – as well as some comparisons with situations and experiences in EU and OECD countries. Tentative conclusions suggest both that addressing the inspections and control issue (and not just regulations themselves) is crucial to success in reform, and that reducing the “pressure” from total control through a “risk-focused” approach leads to real improvements in the business climate without negatively affecting public safety.

At first sight, the new “better regulation package” probably appears as one of the most ambitious and comprehensive set of measures on the quality of EU regulation developed in recent years. It introduces relevant innovations as far as both better regulation tools(impact assessment-IA, ex post evaluation, consultation) and governance (the Regulatory Scrutiny Board-RSB, the REFIT Platform and the proposal on the new Inter-institutional agreement on Better Lawmaking-IIA)are concerned. Moreover, the package is a clear demonstration of the Commission's political commitment towards the relaunch of the smart regulation agenda, already proved by its inclusion within the scope of the mandate of the First Vice President, Mr. Timmermans.

Nonetheless, ambition and wideness are not the only relevant criteria to judge the package. It could indeed be assessed also from a different perspective, i.e. by analysing the possible effects it could produce and the incentives it could provide for some key players: EU institutions, Member States (MS) and stakeholders.

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.

The article examines the field of legal automation, its advantages and drawbacks, the ways in which legal constraints and safeguards can be embedded into technology and how the law may govern human behaviour through codes, IT architectures, and design. By stressing both benefits and shortcomings of legal automation, the article does not suggest that the latter is something “neutral”. Rather, making legal reasoning and enforcement automatic, so that even a machine can process and understand this information, should be conceived as a set of constraints and affordances that transform, or reshape, the environment of people’s interaction and moreover, the interplay of human and artificial agents, thereby affecting basic pillars of the (rule of) law. The overall aim is to flesh out goals and values that are at stake with choices of technological dependence, delegation and trust, so as to determine the good mix between legal automation and public deliberation.

The Society for Risk Analysis (SRA) has kindly authorised the EJRR to publish the comments of SRA Past Presidents on the Deepwater Horizon oil spill. Going beyond news media accounts, these comments offer a first hand analysis of the effects of the oil spill on the field of risk analysis and risk regulation. Following the call for a moratorium on deep-sea drilling in Europe by Gunther Oettinger, the European Commissioner for Energy, the publication of these comments seems particularly timely. (AA)