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 leaked TTIP documents reveal that the EU and US are discussing the introduction of a detailed set of procedural requirements for the adoption of regulatory measures. Default provisions are set forth in the chapter on regulatory cooperation, applicable to goods and services. More specific provisions are being negotiated in the chapters on technical barriers to trade and on sanitary and phytosanitary measures. If they conflict with the regulatory cooperation chapter, they prevail.

This article analyses the regulatory cooperation chapter insofar as it pertains to trade in goods but to the exclusion of SPS matters and anything provided in the TBT chapter itself. The questions this article examines are to what extent the TTIP proposals expand upon the obligations the two parties have already taken on under WTO law and to what extent the resulting regulatory coordination is consistent withWTO law. It will be shown that the US proposals on procedure may constrain substantive regulatory discretion beyond what applies under the GATT and TBT Agreement of the WTO. It will alsobe shown that the needs to conduct trade impact assessments and a detailed explanation of the necessity of measures anticipate a legal challenge to necessity and will provide information of much use to complainants in meeting their burden of proof.

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

1. 1. The Member States determine, in compliance with the objective of transparency pursued by Council Directive 89/105/EEC and the requirements laid down by Article 4(1) of that Directive, the criteria on the basis of which the review of macro-economic conditions which is referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors (author's headnote).

2. 2. Article 4(1) of Directive 89/105, so far as its subject matter is concerned, is not sufficiently precise to have direct effect for the purposes of the national legal systems of the Member States (author's headnote).

3. 3. Article 4(1) of Directive 89/105 must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision (official headnote).

This contribution evaluates whether European Union State aid policy could play a role in achieving deeper and more solidary integration in the area of public health. According to Article 107 TFEU, the powers of Member States to grant aid to help their economies are seriously limited. Exceptions to the general prohibition to grant State aid are authorised by the European Commission, which enjoys wide discretion in weighing national objectives against European integration goals. The area of public health has been shielded from the application of these rules, with activities such as the provision of health insurance failing to be considered of economic nature (see most recently the Dôvera judgment). The COVID-19 experience shows that, in cases of major health crises, State aid provisions are practically suspended, with interventions allowed in the name of the fight against the pandemic. The eventual creation of a Health Union will require the re-evaluation of the application of the State aid rules to healthcare. This paper questions whether these rules should evolve as a reflective function of strengthened competences in healthcare or whether existing regulatory powers are enough to determine the interaction between national spending policies, a solidary European Health Union and fair competition.

The World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) relies on scientific evidence as a conclusive risk assessment criterion, which ignores the inherent limitations of science. This article highlights certain trade-restrictive effects of scientific evidence and comments on the Agreement’s aversions to precautionary measures and the consumer concern of the harmful effects of biotech products that may be necessary to protect public health and biosecurity in many WTO Member States. These measures and concerns have become pressing issues due to surging consumer awareness and vigilance concerning environmental protection and food safety. The Agreement is yet to overcome the weaknesses of its endorsed international standardising bodies, the problematic definition of scientific evidence and treatment of justification for scientific risk assessment methods and the implementation difficulties faced by most developing states. This article analyses these issues under the provisions of the Agreement and the interpretations of the WTO Dispute Settlement Body in disputes involving SPS matters, which fall short of addressing scientific uncertainty surrounding biotech products and their associated risks.

On 22 January 2014, the Grand Chamber of the Court of Justice confirmed the validity of the powers entrusted to the European Securities Markets Agency under Article 28 of Regulation (EU) No 236/2012, upholding their compatibility with the principle of institutional balance, the Lisbon Treaty and established case law of the CJEU.

This case note gives an overview of the ruling and analyses its implications for ESMA and the broader Union institutional setting, with particular regard to the interplay between EU Institutions and agencies. It concludes by highlighting some reasons for potential constitutional concerns resulting from the combination of politically unchecked agencies and highly controlled Institutions.

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

This case note relates to the recent judgement (23 October 2012) by the Court of Justice of the European Union in the case No C-300/10 concerning interrelation of the European Union motor insurance law and the national civil liability regulation. As the civil liability arising from motor traffic accidents is not approximated by the European Union law, its regulation falls within the national law. Yet, application of the national civil liability law shall not undermine the obligation to provide insurance coverage for victims of road traffic accidents. The discussed case concerns a situation when a victim who was not fastened by a seat belt at the moment of a motor traffic accident was injured, and this raises a question whether such victim may be compensated due to contributory negligence. This note provides a brief summary of the previous case law, facts, review of Advocate's General Opinion and the judgment and their analysis.

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

While it is a consumer’s prerogative to be offered all kinds of food products they can choose from, it is also a consumer’s own responsibility as to what kind of products they choose. It is still argued that free choice is only an illusion due to the general decline in food quality; in this context, the extent of free choice that the consumer has is considered, as well as the factors affecting it. These include fundamental European Union principles that demand strong science to prove safety, observe the lowest applicable quality standards and by extent offer a wide leniency range to food manufacturers when it comes to food quality. Another main factor stems from a food law that intensely focuses on securing food safety, while somehow disregarding quality. In addition to that, major efforts have been concentrated on strengthening food information for the purpose of enabling consumers to make healthier choices by both simplifying information on the front of packaging and increasing it on the back, while no direct changes targeting the composition of food have been proposed. As a result, what healthy food choices are left on the market and how accessible are they to consumers?

The scandal involving the Volkswagen group broke out last Fall, at the dawn of the very delicate UN Conference on Climate Change (COP21) held in Paris, and the posting of an unofficial version of the Comprehensive Economic and Trade Agreement (CETA). This so, just when a leaked version Transatlantic Trade and Investment Partnership (TTIP) ran through the veins of the Internet and the Trans-Pacific Partnership (TPP) was just about to be signed in New Zealand, fostering market integration by pushing further national treatment and mutual recognition, against the backdrop -albeit one small step at a time- of an increasing demand for environmental protection through the setting, among other regulation tools, of emission thresholds.

This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.

Within the area of electricity market regulation, a practice has emerged in which the chain of delegation has gone beyond the European Commission, resulting in double delegation. During 2015–2017, the European Commission adopted implementing regulations requiring detailed European terms, conditions and methodologies (TCMs) for electricity markets and system operation to be jointly adopted by national energy regulators. Should the latter fail to agree within a predefined time limit, rule-making would move to the Agency for the Cooperation of Energy Regulators. This rule-making procedure entails that, depending on the dynamic within the procedure, different actors would adopt the TCMs. This article examines how double-delegated rule-making unfolds in a novel and emerging practice, evolving beneath implementing acts. By analysing the factors behind whether TCMs are adopted jointly by national agencies or not, the study investigates whether this form of delegated rule-making in a network setting delivers decisions or whether rule-making by a European Union agency is needed.

This work has the aim of dissecting the legal and policy dress designed for the new “Green” Common Agricultural Policy (CAP 2023–27) across the proposed CAP Strategic plans (CSPs) of the EU member states. The analysis is carried out through the lens of a special inquiry: the consistency and coherence between the CAP and the perspective of the Green Deal and its satellite strategies, among all the Farm to Fork Strategy (F2F) and Biodiversity Strategy for 2030, for transition to a resilient and Sustainable food system. The F2F proposes a roadmap of interventions and sets specific goals to reach such a transition. Within these interventions, a renewed CAP is the first stage through which the direction undertaken by the EU can be measured. Following the new CAP delivery model, this work will investigate the national CSPs and address the consistency of the CAP financial instruments utilised to fulfill the social, economic and environmental objectives of the CAP according to the ambition of the F2F and other key strategies.