This Special Issue aims to develop a deeper understanding of the interplay between public and private actors in the regulatory governance of food. It starts from the observation that the traditional concept of law as command-and-control legislation and law enforcement by national governmental bodies, including inspectorates and courts, is not adequate to capture today's world of food governance. Nowadays, a broad range of public and private entities acting at national and international level seek to shape and influence the production, trade and handling of food and the risks involved therein. Drawing on data from Europe and the United States, the contributions to this Special Issue seek to unravel the intimate, yet complex ties between public and private actors within governance arrangements regulating food safety and sustainability. The articles are focused around the various phases of the policy cycle for food governance, thus addressing the interaction in stages of agenda-setting and rule-making, adoption and implementation, monitoring and enforcement, and evaluation and review. In descriptive terms, each contribution lays out the ‘who’ (actors), the ‘what’ (activity), the ‘why’ (rationale) and the ‘how’ (instruments) of food governance. In evaluative terms, the papers discuss and explain the results and challenges of the design of the public private governance arrangements. Jointly, the contributions offer original and invaluable empirical insights explaining the rise, design and challenges of mixed governance arrangements in the food sector.

This section discusses the regulation of “lifestyle risks” a term that can apply to both substances and behaviours. Lifestyle risks take place along the line of “abstinence - consumption - abuse - addiction”. This can concern substances such as food, alcohol or drugs, as well as behaviours such as gambling or sports. The section also addresses the question of the appropriate point of equilibrium between free choice and state intervention (regulation), as well as the question of when risks can be considered to be acceptable or tolerable. In line with the interdisciplinary scope of the journal, the section aims at updating readers on both the regulatory and the scientific developments in the field. It analyses legislative initiatives and judicial decisions and at the same time it provides insight into recent empirical studies on lifestyle risks.

Climate engineering in general and solar radiation management (SRM) in particular raise profound and complex political, legal, social, and ethical questions that go well beyond technical feasibility issues. We consider three such questions. First, can existing EU decision-making processes accommodate sufficient public engagement to ensure legitimate decisions on SRM? Second, does politics influence the choice of legislative procedure for SRM regulation? Third, does the choice of legislative procedure influence the likelihood of SRM implementation? Three main conclusions emerge from our analysis. First, existing EU decision-making processes can – given certain conditions – accommodate considerable public engagement and hence ensure legitimate decisions on SRM. Second, politics matters; indeed, the EU's choice of legislative procedure concerning SRM may well become subject to political negotiations. Finally, the choice of legislative procedure may substantially influence the likelihood of SRM implementation.

Since the North American Free Trade Agreement (hereinafter NAFTA) was successfully negotiated in 1993, the provisions for investor-state arbitration under its Chapter 11 have put pressure on the regulatory spaces of the State Parties. Under Chapter 11, any investor alleging a breach of the treaty norms by a host State can file an arbitration claim. This diagonal dispute settlement mechanism has determined a growing stream of arbitrations, focusing inter alia on the interplay between the regulation of toxic chemicals by the host State and the substantive provisions of Chapter 11. The arbitration claims filed by investors against host States regarding the regulation of toxic chemicals by the latter include those related to the adoption of discriminatory policies, the expropriation of investments and the violation of the fair and equitable standard (FET). In a nutshell, the question is how to reconcile environmental protection with the promotion of foreign direct investment (FDI). Can the host State adopt precautionary policies? To what extent can and should policy influence risk regulation? Should investors be compensated if their toxic chemicals are banned from the market? Which standard of review should arbitral tribunals adopt to assess scientific evidence? This note explores all of these issues through an analysis of the Chemtura award.

In September 2011, the World Trade Organization (WTO) released the report of a panel tasked with considering a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The panel concluded that the US violated WTO law and recommended that the US be asked to bring its laws into conformity with WTO law.

The US appealed the panel's decision. The Appellate Body of the WTO upheld the panel report on April 4, 2012. This case note gives a brief overview of the Appellate Body's report and examines the implications for tobacco control and public health more generally.

The United States’ Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders’ interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.

We live at a time where Smart is better than Better, and Better was not Smart enough. This is not a dull pun. It actually reflects the status in which regulatory reform finds itself nowadays. To many observers, the switch from Better to Smart just reflects the attempt to instil renewed commitment and faith in an agenda, which in some (European) countries has maybe exhausted its thrust. The European Commission also admits candidly that the choice of the new term largely serves as a refreshing slogan. But limiting it to a branding change, with little consideration of its content, would be a mistake in appreciation. And a missed opportunity. We do need “Smart Regulation” – and not only in the Commission. Above all, we need smart regulators.

How can one not applaud the renewed better regulation agenda launched by the First Vice President Timmermans? Finally this fuzzy reform field is in the hands of a strong executive politician with the authority to make substantial progress on an agenda that always appeared good on paper, but somehow did not deliver against the expectations it defined for itself. ‘Better regulation for better results’ not only promises tangible results, but it combines this with the ambition of ‘changing how we work at the European level’. This ambition should provide us – as citizens, stakeholders and scholars – with an opportunity to essentially present a scorecard concerning these results in the near future. And, indeed, experts and other stakeholders in the better regulation game do welcome the initiative.

My view on this agenda is that the promise of ‘better results’ will be hard to deliver, whereas the ambition of ‘changing how we work’ is more likely to materialize in one way or another.

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe's regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU's trade partners). By considering the discussion on animal cloning in the broader context of EU's regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.

Case T-262/20 Microban International Ltd and Microban (Europe) Ltd v. Commission

The conditions for bringing direct actions before the EU General Court have been opened under Article 263, fourth paragraph, of the Treaty on the Functioning of the European Union (“TFEU”) through the introduction of less restrictive rules on legal standing for private applicants challenging regulatory acts. The term “regulatory act” covers all acts of general application apart from legislative acts and includes implementing measures adopted by the European Commission under the comitology procedure. Initial case law provides welcome guidance on the application of the new rules on standing but questions still remain (author's headnote).

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.

At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them. While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise. In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. It is the view of the authors that Member States cannot rely on the argument that REACH does not contain specific provisions on nanomaterials, nor require registration of substances manufactured or imported below 1 tonne, to consider that the matter is not totally harmonised under EU law and thus justify the adoption of national measures to regulate nanomaterials. However, Member States can use the REACH processes, including the evaluation, authorisation and restriction processes to propose conditions for or restrictions of the marketing and use of nanomaterials at the EU level, in the conditions specified in the Regulation. They can also trigger the application of the safeguard clauses of REACH and of the Treaty on the Functioning of the European Union. It is only within that strict framework that reference to the precautionary principle can be made to justify the introduction of national measures.

The most remarkable recent development in EU administrative law is the widespread establishment of European agencies. Beginning in the early 1990s, EU agencies emerged as significant actors in a number of areas, including trademark law, pharmaceutical licensing and aviation safety. EU agencies are best understood, however, not as autonomous regulators at the federal level, but as the most recent expression of European governance through administrative networks. The regulatory intertwining of supranational and national authorities in the EU is significantly different from the division of authority between federal and state bureaucracies in the United States federal system Hence, the accountability of European agencies to the EU and to Member States has unique features that can be traced to the dynamics of European integration. Accountability is largely a function of networked institutional relations that link European administrative entities to both supranational and national forums of accountability This article concentrates on the second form of accountability through an in-depth exploration of the way Member States oversee EU agencies. Oversight, here, covers monitoring, hearings, budgetary reviews or judicial actions, as well as procedural constraints.

OPINION OF ADVOCATE GENERAL KOKOTT delivered on 12 February 2015 in Case C-106/14, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB) v Ministre de l’écologie, du développement durable et de l’énergie.

The May 2016 leak of draft texts produced within the context of the on–going Transatlantic Trade and Investment Partnership negotiations has provided an interesting insight into the positions of the EU and US with regard to different dimensions of regulatory cooperation, with some chapters being complete or near completion (as other articles in this mini–symposium discuss), and others still in a more rudimentary format. One such field of regulation, covered in the leaked ‘Tactical State of Play’ document, covers geographical indicators (hereafter GIs). However, this coverage is very brief, stating that ‘discussions focused on the preparation of an intersessional discussion prior to the next round’. GIs, marks identifying the geographical origin, and by extension (so the argument goes) quality of goods, have continued to be a source of consternation in international trade regulation, with states unable to see eye–to–eye on how they should be protected, if at all.

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health