National rules of a EEA State, such as those at stake in the present judgment, under which a State monopoly on the retail sale of alcohol, may refuse to accept for sale alcoholic beverages that are lawfully produced and marketed in another EEA State on the grounds that the labelling of the products contains loaded or unrelated information, are in breach of Article 18 of Directive 2000/13/EC (‘the labelling Directive’ or ‘Directive’), and cannot be justified by a public health objective. Another rule requiring alcoholic beverages to carry stickers stating that their contents are alcoholic, in addition to the mandatory indication of the actual alcoholic strength by volume, ‘cannot be considered effective’ if it has been adopted without regard to the notification procedure laid down in Article 19 of the labelling Directive. However, individuals and economic operators who have been harmed by the incorrect application of the Directive may rely on the free movement of goods in order to render the State liable for the breach of EEA law, regardless of whether such a directive is being made or has been made part of the legal order of Iceland, since it has been incorporated in the EEA Agreement. Failure to notify the second rule in accordance with the Directive qualifies as a sufficiently serious breach of EEA law. Such a breach entails State liability if the national court finds a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured party (author's headnote).

There are two prominent motivations for why governments seek to promote the electric car: risk management and industrial policy. This article provides operational definitions of these two motivations and uses them to characterize the public policies of six political jurisdictions: California, China, the European Union, France, Germany, and the United States. The article finds that while the European Union is focused primarily on risk management, China, Germany and the United States are primarily engaged in industrial policy. California and France are intermediate cases with a substantial blend of industrial policy and risk management. Future research into the ramifications of industrial policy for liberalized international trade is recommended.

Case C-333/08 Commission v. French Republic ‘processing aids’ [2010] ECR-0000

French prior authorisation scheme for processing aids in food production infringes upon Article 34 TFEU

1. 1. A prior authorisation scheme not complying with the principle of proportionality, infringes upon Article 34 TFEU.

2. 2. A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research.

3. 3. A Member State cannot justify a systematic and untargeted prior authorisation scheme by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of products which may be used or by reason of the fact that manufacturing processes are constantly changing. (author's headnotes)

Emboldened by the Spitzenkandidaten process, the new European Commission emerges as the most political yet. The Commission asks EU citizens to judge its operation by its ability ‘to deliver solutions to the big issues that cannot be addressed by the Member States alone’. The Better Regulation Package translates this political commitment into an actionable approach assuring EU citizens that the Commission will remain ‘big on big things, small on small things’. To deliver on this promise, the Commission extends the Impact Assessment system, renews its consultation procedures and adds a few institutional mechanisms so as to enhance its ‘ability to deliver’ throughout the policy cycle. But in order to do so the Commission needs to bind – and somehow control – the European Parliament and the Council, on the one hand, and the Member States, on the other, in relation to their commitment to openness, participation and evidence-based policymaking. While legitimate, this attempt raises serious doubts about the compatibility of this reform with the principle of separation of powers and, in particular, that of institutional balance. A closer look at the Better Regulation Package reveals an entirely new understanding of the Commission's own prerogatives and the way it intends to exercise its legislative and regulatory powers. And this in spite of the apparent continuity between the new and old Better Regulation initiatives and the instruments it had chosen to attain the declared objectives. With a view to lay out a future research agenda on EU Better Regulation, this article identifies the most immediate questions raised by the publication of the Package and makes a first timid attempt at addressing some of them. It aims at determining how much better, if any, is the new Better Regulation Package. It does so by discussing, first, the major novelties enacted by the Commission within its own Better Regulation system and, second, those proposed in the framework of the IIA on Better Regulation.

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.

International investment agreements (IIAs) emerged in the 1960's as an instrument to lower political risk for foreign investors and to facilitate political risk insurance when investing in developing countries with weak governance structures. Political risk is constituted by interferences to the investment by host states once the investor has entered the market and which would render the execution of the investment unduly burdensome, deprive the investor of the control or enjoyment of the investment or discriminate or treat the foreign investor arbitrarily. The legal provisions in IIAs include non–discrimination provisions, fair and equitable treatment, full protection and security, rights to compensation in case of expropriations, including indirect regulatory ones with the effect of depriving the investor of the control and benefits of the investment, provisions on free transfer of capital and, occasionally, non–precluded measures clauses as well as stabilization clauses in which the host state promises not to change the regulatory environment affecting the investment.

STOA, the European Parliament's Technology Assessment body, which I had the honour to chair, has a mission to: (i) assess the impact of introducing and promoting new technologies, and (ii) identify the relevant policy options. In the context of its work, STOA has to address many different issues. One of the issues deserving STOA's attention is the changing face of risk governance: “Moving from precaution to smarter regulation”.

This is currently being debated on various levels, including that of the WTO (World Trade Organization), where science-based decision-making has always played an important role. The JRC (Joint Research Centre) is very active in this field and has developed, among others, a science-based approach to risk assessment in the area of nanotechnology. With the comitology procedure becoming more and more important, the European Parliament and its members have to assume their role with respect to risk management and explain it to the public.

This article assesses the impact of the global economic crisis on the European Union and analyzes the recently enacted and future legislative response to repair the EU financial sector. It closely discusses and critiques the main initial response legislation, the European Economic Recovery Plan, finding that the central regulation contained short-term measures, yet managed to remain within the EU's long-term goals. The article also closely examines the significant risk regulation considerations highlighted by the economic crisis, notably those considerations contained in the De Larosiere Report and the Basel III Framework, and discusses the importance of implementing financial risk regulations to stabilize and revitalize the EU financial sector. Ultimately, the article concludes that the EU's recently enacted legislative measures are consistent with, but also must continue in tandem with, the longterm policies of the EU, while including new and crucial financial risk regulatory measures.

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.

At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

The article depicts the general framework in which the regulatory bodies in financial sector have been operating. After an introductory outline of the financial system and its objectives, the analysis shifts to the framework of the financial business operators and of the regulatory bodies. The market is organised and fragmented in financial conglomerates, where cross activities take place and where potentially it is easier for the regulatory bodies to exercise their control. In this context, the different models of supervision will be scrutinised, together with the attempts, made at European level, to comply with the international standards. The final part is dedicated to the description of global dynamics and to the current situation to overcome the systemic crisis affecting the market. With some –bitter – concluding remarks we will try to prospect possible different solutions to the crisis, solutions that don't necessarily coincide with the actual decisions to reform the system taken at European level.

The Commission's new Better Regulation package represents a step forward in the European Union’s decade–long journey to bringing coherence and rationality to its legislative and regulatory process. But as the Communication on the package itself suggests, the journey is far from over.

The Communication consistently emphasizes the key aspects of good regulation: quality over quantity; taking time to get proposals right; evidence–based decision making; open and continuous consultation to gather evidence from all stakeholders; rigorous impact assessments and cost–benefit analysis; applying these tools to regulatory measures as well as legislation; and implementing a robust ex–post evaluation program. It is important as well that the Secretariat General published unified and detailed guidance for Commission officials on how each step of the regulatory process should work, with a “tool–box” to elaborate further on these steps.

All of this is good. Yet in some areas, the Commission misses opportunities to go farther down the good governance road, and in others the guidance needs to be made much more explicit.

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.

Case C-443/13, Ute Reindl v Bezirkshauptmannschaft Innsbruck, ECLI:EU:2014:2370

1. 1. Fresh poultry must be free from salmonella contaminations at all the stages of distribution including the retail stage.

2. 2. National law may impose a penalty on a food business operator which is active only at the distribution stage for placing salmonella–contaminated foodstuff on the market. It is for the national courts to determine whether such a penalty observes the principle of proportionality as laid down in Article 17 para. 2 of Regulation No 178/2002.