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.

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.

Co-regulation presents an odd paradox in today's context of a shifting emphasis from government to governance. In the first place, co-regulation implies horizontal, ‘networked’ relations between government and industry. Yet at the same time, it has the hierarchical connotation inherent in regulation. The main concern addressed in this paper is what this ambiguity means for evaluations of co-regulation. What is failure here? Two contrasting interpretations of ‘governance’ are described, and a case study from the Dutch poultry sector is presented to seek explanations for failure. The two interpretations are found to provide complementary explanations for failure. This suggests that evaluations adopting a single perspective may produce all-too-easy – though misleading – conclusions.

Public food safety authorities in Europe and elsewhere have recently developed forms of coordination and collaboration with private compliance systems in the monitoring and enforcement of public food safety laws. Such policies bring with them the risk of regulatory capture, loss of transparency and fuzzy accountability relationships. In this paper we analyse how the Netherlands Food and Consumer Product Safety Authority (NVWA) assesses and monitors the functioning of private food safety control systems so it can use these private systems in its own enforcement activities. We do so by discussing two national private systems that have been formally accepted by the NVWA and are as such subject to its meta-control. The article examines the safeguards that the public enforcement agency uses while coordinating its own activities with private food safety controls, the advantages and risks involved in this strategy, and the extent to which this policy can be improved. From this we draw lessons for public agencies elsewhere willing to engage with private compliance mechanisms. The study is based on the analysis of policy documents, public and private regulation and open-ended interviews with representatives of the public and private sector in the Netherlands.

The environmental consequences of the increasing global seafood production and consumption are substantial and drive a search for providing more adequate governance responses. In recent years, market-based approaches to sustainable seafood governance have gained considerable traction. Born in part out of perceived failures of state-based regulations, a range of civil society-led governance approaches have emerged. Private seafood governance arrangements interact with public seafood regulations and this may lead to competition, collaboration or hybridity. This interaction should however not be assessed in general but more closely related to the different stages in the regulatory cycle: agenda setting/negotiation, implementation and monitoring/enforcement. Collaboration between public and private global seafood governance arrangements occurs primarily in the first phase of the regulatory cycle but gets much less prominent in later phases where competition or even separation prevails. Harmonization between public and private sustainable seafood governance arrangements in the near future is therefore unlikely.

Due to the astounding revolution sparked off by genetic engineering, the artificial modification of the genome through targeted alterations of DNA and RNA is now competing with the traditional phenotype use of living organisms (selective plant and animal breeding, consumption, manufacturing of products, energy production, etc.). Although until recently these were insurmountable obstacles, interspecies barriers to reproduction are fading away, and it is now possible to transfer genes from one species to the genome of another. In short, the artificial genetic engineering is replacing selective breeding. Furthermore, a new age is dawning – that of synthetic biology – in which man will no longer content himself with modifying existing organisms but, thanks to the radical modification of the genome, will be able to create new cells and new organisms.

The recently enacted Directive 2015/412 is a long waited piece of legislation. This legislation introduces a new provision in Directive 2001/18, Art. 26 b, which gives Member States the regulatory freedom to decide whether genetically modified organisms (“GMOs”) should be cultivated or not in their territory. One month after the publication of this act in the Official Journal of the EU, the Commission issued a Communication in which it illustrates further legislative changes to the legislation on genetically modified food and feed (“GM food and feed”). On the same day, the Commission has tabled a proposal for a Regulation, amending Regulation 1829/2003 (the “proposed reform of GM food and feed”) that envisages the possibility for the Member States to restrict or prohibit the use of GM food and feed on their territory. The proposed act is described as a complement to Directive 2015/412 and is inspired by the same principles.

On 22 April 2015 the European Commission published a review of the current GMO legislation (the GM Review) and tabled a proposal for its amendment (the GM Proposal). The GM Proposal aims to allow to the member states to ban on their territory the use of GMOs authorised under the EU legislation. This is very similar to the possibility for opting out from cultivation of authorised GMOs which was finally adopted earlier this year. While this may look like a new trend, all the more interesting in the context of possible Brexit, Grexit and Danish opt-out from the provisions on Justice and Home Affairs, the present article will focus only on the GM Review, which essentially admits that the existing GMO regime is a failure.

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.

The environmental and health effects of nanomaterials represent significant emergingrisks. 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.

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.

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).

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.

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.

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.

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.

On 27 May 2014, after two years of debates and extensive amendments by the EU’s law-making institutions, the EU Clinical Trial Regulation1 was published. The Regulation repeals and replaces the Clinical Trials Directive, an instrument described by the European Commission as “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”. The Clinical Trials Regulation is intended to improve the existing framework, and will become applicable at the earliest on 28 May 2016. This report reviews the most significant changes to the existing system brought about by the Clinical Trials Regulation, and how this Regulation purports to strike a balance between its objective of increasing clinical trial activity in the EU and the need to protect clinical trial subjects’ rights, safety and well-being.

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, theMember States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking atmethodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.