The EC-Seal Products case raises a number of interesting issues for scholars researching in the broad area of risk regulation. This symposium addresses a selection of them through innovative, analytical contributions whose goals are to test central assumptions and question the logic of the findings and to bring fresh solutions to problems faced by the Appellate Body and the panel. In keeping with this analytical focus, this introduction to the symposium will not just present a summary of the key legal findings. Instead, it attempts to draw some further conclusions from the different contributions, to place the contributions in their broader legal context and to make connections between aspects (not) decided in Seals and scholarship on risk regulation, more generally.

The scientific dimension of risk regulation is obvious. It is accepted that a measure banning a pesticide is to be based on toxicology studies and in particular on the data proving harmful effects for human health or the environment. A more subtle determinant of risk regulation is the ethical dimension of the decisions adopted to control the social risks emerging from new technologies. It is in this context that a document such as the Encyclical letter Laudato Si, on care of the common home of Pope Francis could offer important reflections on how public policy on science and technology could be enriched by including an ethical perspective. The Laudato Si encyclical letter has been accompanied by wide public attention, spurred on by both the huge popularity of Pope Francis and the announced choice of devoting, for the first time in the history of the Catholic Church, an entire document to environmental issues.

With respect to critical information and communication technologies (ICT), nations most often declare their national critical infrastructure to include telecommunication services and in some cases critical services offered by key Internet Service Providers (ISP). This paper debates whether nations, their policy-makers, legislation and regulation largely overlook and fail to properly govern the full set of ICT elements and services critical to the functioning of their nation. The related societal and economical risk, however, needs to be closely mitigated, managed and governed. Legal and regulatory obligations to increase the ICT resilience may sometimes encourage this process.

Designing a framework for evaluating laws, rules and policies within any given legal system is a daunting task. Comprehensive schemes risk ending up as mere paper realities because of the demands they place on evaluators as well as on the addressees of evaluations. More realistic evaluation frameworks on the other hand may not yield many results. The OECD has a long track record of encouraging member countries to deal with ‘regulation’ in the wider sense of the word in a rationalistic and systematic way. These encouragements tend to involve recommendations, peer reviews, and the use of country surveys in order to establish progress in what the OECD usually calls ‘regulatory policy’ or ‘regulatory management’ (‘better regulation’ in EU parlance and sometimes referred to as ‘meta-regulation’ in the literature). Recently a new tool has been added. In a move parallel to the EU's efforts to ‘complete the regulatory cycle’, the OECD has developed a new Framework for Regulatory Policy Evaluation (hereafter referred to as ‘Framework’).

The environmental and health effects of nanomaterials represent significant emerging risks. However, there is at present rather limited knowledge regarding the ways in which nanomaterials might be released from products and enter the environment or how they are transported and accumulate in ecosystems. Additional data is therefore needed to estimate the possible release of nanomaterials at various stages of the life- cycle to allow identification of potential pathways into the environment. Available tools for risk assessment of nanomaterials are reviewed with the aim of identifying unknowns and uncertainties and data requirements. To carry out risk assessment it is first necessary to determine where nanomaterials are likely to present hazards that are different from those of conventional chemicals and therefore where the challenges will be greatest. Some of the limitations of current risk assessment methodologies for nanomaterials are examined.

The risks of technological accidents in the energy sector and their potentially disastrous effects have been analyzed over the past decades, and are nowadays generally recognized to constitute a key factor in an encompassing assessment of energy security. In contrast, the issue of intentional attacks on energy infrastructures has received increased attentionmore recently, particularly due to growing dependence of energy imports fromand transit routes through regions considered less reliable and politically stable. Both types of risks, however, illuminate different vulnerabilities. Therefore, the focus of the present analysis was on these two risk categories: accidents and intentional attacks in the energy sector. Risk assessment resultswere based on quantitative data from the databases ENSAD (Energy-related Severe Accident Database) and EIAD (Energy Infrastructure Attack Database). Evaluations examined similarities and differences between technological accidents and intentional attacks in terms of frequencies and consequences, considering time-series trends and regional patterns. A key difference is that accidents are typically rare and independent events, whereas intentional attacks are often multiple events and concentrated both in time and space, resulting in distinct hotspots. Concerning consequences, the severity distribution for accidents generally stretches over a broad range, with low-probability high-consequence events being an important factor of both energy chain performance and as a measure of risk aversion. On the other hand, these types of consequences are usually less important for intentional attacks because targeted energy infrastructures are often of “linear” nature (e.g. pipelines and transmission lines) that are difficult to protect and usually lead through remote areas with low population density. However, when frequently attacked substantial business and supply disruptions can occur. In summary, the joint analysis of accidents and intentional attacks provides a comprehensive and complementary approach on two types of risks that have rather different properties, but are essential in an energy security perspective.

The adoption of the REACH regulation, setting out to reformchemicals policy of the European Union (EU), was accompanied by intense controversy over the role of the precautionary principle. Analysing decision making on so called Substances of Very High Concern (SVHCs), this article demonstrates that despite legal underpinning, precaution plays a limited role in the implementation of the REACH authorisation procedure. Due to ambiguous legislative provisions, the controversiesof the legislativeprocessare carriedover tothe implementationprocess.

In EC–Seal Products, the WTO Appellate Body (AB) issued a(nother) controversial report. This paper argues that the analysis followed by the AB is wrong. To prove this point, we ask two questions. Would the AB have concluded the same way if it had constructed the EU measure as two separate measures and not one? Did the AB adequately control for the regulatory intent of the EU, indeed the quintessential element for deciding whether the EU was indeed pursuing a societal preference of no commercial character? We responded in the negative to both questions.

Mass harm situations caused by corporate misbehaviour, defective products, harmful pharmaceuticals, accidents or environmental disasters nowadays multiply and create new challenges for legal actors and society at large. In its 2013 Recommendations, the EU Commission highlighted that ‘a key role should be given to courts in protecting the rights and interests of all the parties involved in collective redress actions as well as in managing the collective redress actions effectively’. The role of judges therefore turns out to be essential: they are expected to behave as watchdogs scrutinizing the overall admissibility of mass claims, as active case managers ensuring that cases make orderly progress, and as shepherds ensuring that all interests at stake are sufficiently protected. A key issue to be explored remains the influence of the mass context on decision-making which may potentially lead judges to depart from policy makers’ expectations. Interestingly, the mass context is nowadays an element often discarded by judges themselves. Yet, in the context of mass litigation, cases involve and consolidate in one lawsuit hundreds of represented claimants who have suffered a similar harm. The magnitude of the case - that is the number of people involved and/or the size of the loss at stake – is therefore likely to be considerable. Even though judges discuss and exchange with a limited number of protagonists during hearings – e.g. with representative bodies such as associations or leading counsels – judges must preserve the interests of absent parties. Behavioural studies have shed important light on ways groups are perceived by external observers, and on the impact of number and size on information processing. By investigating in greater details the effects associated with the case magnitude on decision-making, this paper aims at providing an alternative viewpoint on the issue of collective redress which will be of particular interest for courts and regulators at both national and European levels.

The aim of this paper is to recognize and discuss the inherent risks associated with Internet regulation and control over digital content. The key point of this analysis is that Internet regulation can present human rights risks. In particular, the paper examines how restrictions over Internet content are posing regulatory issues directly related to the growing importance of an equitable access to digital information. It also considers the relevance and impact of computer–mediated communication, its potential on democratization of freedom of expression and the problem of conflicting rights. Drawing upon comparative and case study material, the paper finally discusses and investigates the potential risks and vulnerabilities related to communication technologies focusing on legislative reforms in the area of digital communications and their implications for fundamental freedoms.

One important issue arising from EC–Seal Products is what constitutes a technical regulation in the TBT Agreement. This article argues that the Appellate Body's analytical approach to this issue has led to an arbitrary conclusion in EC–Seal Products. The article further examines to what extent PPMs, especially Non–product–related PPMs, are covered by the TBT Agreement. The article concludes that an important question to be answered is what special characteristics of a technical regulation distinguish it from other regulations and make it subject to more detailed obligations in the TBT Agreement.

This report addresses the legal concept of “self-evident” and “flagrantly misleading” advertising established in Article 7(1)(c) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (hereinafter, the Food Information Regulation, FIR). Since 13 December 2014 (since the specific origin of vegetable oils must be declared), “palm oil-free” claims on, e.g., a product containing sunflower oil or any other vegetable oil (and mandatorily indicating it in the list of ingredients) are arguably obvious, unnecessary and irrelevant (and in legal terms “selfevident” and “flagrantlymisleading”). Compared to similar foods that possess the same characteristics, but do not claim to be “palm oil-free”, these products are in no way “special”.

GATT Article III:4 aims at equal treatment in respect of competitive opportunities of imports and competing domestic products by preventing protectionism. A key question is whether regulations with heavier burdens on imported products than on domestic products and a valid regulatory purpose are consistent with Article III:4. Inquiry into regulatory purpose under Article III:4 would allow by-passing Article XX whose list of regulatory objectives is a closed one and which puts the burden of proof on the defending WTO member. In EC-Seal Products, the Appellate Body has rejected any role for the regulatory purpose inquiry under Article III:4. This article shows why a purely empirical definition of likeness and less favourable treatment as disparate impact cannot logically lead to a finding of a violation of Article III:4. It then argues that regulatory purpose continues to play a role under Article III:4 because of the centrality of the notion of competition. It proposes to frame that competition as perfect competition. It shows that the adoption of perfect competition as the evaluative benchmark for all of Article III:4 makes better legal sense than starting from imperfect competition for the likeness analysis and perfect competition for the less favourable treatment standard, as is proposed in the literature. It also shows that even in case where imperfect competition is used as the sole benchmark for both parts of Article III:4, an assessment of how regulation interacts with competition continues to play some role.

For many years, the EU's legislation on animal testing and marketing bans regarding cosmetic products and their ingredients has been giving rise to controversy. First, the bans were introduced under the regime of the Cosmetics Directive, which was subsequently replaced by Regulation (EC) No. 1223/2009 on cosmetic products (hereinafter “EU Cosmetics Regulation”). In this process, the animal testing and marketing bans of Article 4a of the Cosmetics Directive were transferred – with identical content and largely with the same wording – to Article 18 of the EU Cosmetics Regulation, so that the legal issues connected with the bans have basically remained the same. Since the transitional periods for the application of the bans ended on 11 March 2009 and 11 March 2013 (for details, see Article 18(2) of EU Cosmetics Regulation), and the bans as provided by Article 18(1) of the EU Cosmetics Regulation are binding and directly applicable in the EU Member States, they must be observed by the affected businesses as of now. Violations are to be sanctioned in the Member States in an effective, proportionate and dissuasive manner (Article 37 of EU Cosmetics Regulation).

The Appellate Body report in EC-Seal Products is a landmark decision in several respects: for its recognition that animal welfare is a matter of public morality that may justify a trade ban in response to cruelty; for the AB's new–found clarity with respect to the irrelevance of regulatory purpose in the determination of “treatment no less favourable” under the National Treatment and MFN provisions of the GATT; for its suggestion that trade measures not defined by product–related distinctions but other criteria are not covered by the TBT Agreement; and for its partial acknowledgement that a Member may maintain a measure consistent with Article XX even if the measure represents a complex trade–off between a main purpose and other purposes that may limit the extent the main purpose can be furthered. But the decision arguably raises as many questions as it answers, and some have already complained about the rather sphinx–like quality of the judgment.

On 25th November, 2014, the coalition “No Patents on Seeds” filed an opposition against the European patent EP 2 134 870 B1, held by the U.S. Company Monsanto Technology. The patent, granted on 26th February, 2014, by the European Patent Office, covers “utility of SNP [single nucleotide polimorfism] markers associated with major soybean plant maturity and growth habit genomic regions” and includes “methods for screening plants and seeds from the genus Glycine withmarkers associated with genomic regions that are related to the plant maturity and growth habit of Glycine plants”.

“No Patents on Seeds” claims that the patent should be completely revoked, as it falls within the exclusion of essentially biological processes for the production of plants from patentability under art. 53(b) of the European Patent Convention (EPC2000) and is not a patentable invention according to art. 52(2)(a) EPC. This case note gives an overview of the opposition and discusses its implications.

On 26 June 2015, the Chilean Official Journal published Decree No. 13 of 16 April 2015 (hereinafter Decree 13/2015) amending Decree 977/1996 Reglamento sanitario de los alimentos (hereinafter, the Food Health Regulation, as it is widely referred to in English, although the correct translation would be Food Sanitary Regulation). In particular, Decree 13/2015 requires warning messages in the shape of a black octagon in the form of a STOP sign to be placed on the front-of-pack with the text ‘High in…’ when food products exceed certain levels of energy, sodium, sugars or saturated fats. Although novel in the food sector, Chile's measure is part of a trend of public policies aimed at tackling lifestyle risks by conveying certain information to the public. While warning messages that reduce the visual appeal of the packaging of products are ubiquitous in the tobacco sector, these types of messages are now also gradually being extended to the alcohol and food sectors.