This report examines the pending Proposal for a directive on unfair trading practices in business-to-business relationships in the food supply chain, and its proposed amendments. It provides a general overview of the current content of the Proposal and analyses the proposed rules from a legal perspective. We find that: (1) the CAP legal basis may prove insufficient for regulation that covers the entire agri-food chain; and may (2) result in a strained relationship with the competition and consumer acquis; (3) the empirical basis for the prevalence of unfair trading practices, and the effect of their prohibition is relatively dire, which results in uncertainty with regard to the achievement of the future UTPD’s intended effect and effectiveness; (4) the choice for specific targeted prohibitions instead of general umbrella clauses may lead to ad hoc regulation that leaves large loopholes; (5) the institutional enforcement mechanism makes it likely that the Proposal contributes to the foundation for a new area of EU law, which will increasingly regulate practices in business-to-business relationships.

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution.

The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.

Since the adoption of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) in 2003, public health professionals have debated similar conventions covering other health risks, including potentially a Framework Convention on Alcohol Control. Much of this debate has focused on the merits of binding versus non-binding instruments in terms of commitments at the international level. In this paper, I draw on lessons from the WHO FCTC to discuss instead what the difference between binding and non-binding international legal instruments might mean for domestic legal frameworks for implementing regulatory measures for alcohol control. The paper looks at possible impacts on the authority of various national authorities to implement new measures, the ability of civil society to bring cases compelling more comprehensive regulatory measures and the defence of litigation brought by commercial-sector actors to prevent, delay or weaken the implementation of laws and regulations. It reflects on what lessons these might have for alcohol control governance.

On 23 October 2019 the European Union enacted the Whistleblower Protection Directive. The directive introduces important common standards of protection for whistleblowers reporting on breaches of EU law and significantly increases the level of protection afforded to whistleblowers in many EU Member States. Many of the features of the directive go further than pre-existing national whistleblower protection regimes, particularly in relation to the categories of persons who may benefit from the protections under the directive and in terms of the flexibility of the prescribed reporting procedures. Nevertheless, the directive's effectiveness may be limited by certain grey-areas and missed opportunities in the final text of the instrument.

Some EU agencies have been recently entrusted with enforcement powers, which imply a crucial extension of their regulatory reach. However, other comparable agencies did not receive such powers. This paper explores the case of energy regulation as an instance of these “negative” cases, and suggests that the lack of enforcement powers may have been partially determined by business interest groups. To illustrate this argument, this article firstly relies on official documentation to show that key interest groups were consistently opposed to the option of granting enforcement powers to the EU agency in charge (ACER). Secondly, it is suggested that these interest groups, which have been largely incorporated in regulatory networks during the prehistory of the agency, had access to, and exerted influence in, the governance of EU energy policy, and could plausibly have been able to concretise their preferences. A systematic examination of the representation of interest groups in the European network of energy regulators (CEER/ERGEG) during the period 2004–2011 is undertaken to corroborate this point. The conclusion draws attention to the fact that, although interest groups are less visible than other actors and their presence is less formalised, they could be very influential on decision-making processes within European networks and agencies.

In September 2011, the World Trade Organization (WTO) panel report in US – Clove Cigarettes was released. The report addressed a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The dispute is one of a number of contemporary disputes under the WTO Agreement on Technical Barriers to Trade (TBT Agreement). Given that relatively few disputes have been resolved under the TBT Agreement, the outcome may have significant implications for interpretation of the agreement and risk regulation through technical regulations. The panel report may also have more specific implications for risk regulation in the context of tobacco products (author's headnote).

In Fra.bo, it was held by the Court of Justice of the European Union (“CJEU”) that “Article 28 EC must be interpreted as meaning that it applies to standardisation and certification activities of a private-law body, where the national legislation considers the products certified by that body to be compliant with national law and that has the effect of restricting the marketing of products which are not certified by that body” (author's headnote).

COVID-19 emerged as a cross-cutting problem across governance sectors and levels, urging the creation of a European Health Union. There are already a number of integrated European governance strategies – such as the European Energy Union (2015) and the European Green Deal (2019) – adopted for overcoming problems of governance fragmentation and inadequacy of fragmented policy responses to cross-cutting policy challenges. Past studies focused on the interaction between crisis and policy change and investigated the activation of different mechanisms to enhance integration. This article contributes to the debate over the creation of a European Health Union by unpacking the acknowledged dimensions of policy integration – policy frame, subsystem involvement, policy goals and policy instruments – in order to assess their manifestations in the new EU4Health policy and to establish what contextual conditions triggered the activation of the integration-enabling mechanisms that led to a more integrated European Health Union. In so doing, it offers an analytical illustration and discusses implications for decision-making.

Under what conditions can artificial intelligence contribute to political processes without undermining their legitimacy? Thanks to the ever-growing availability of data and the increasing power of decision-making algorithms, the future of political institutions is unlikely to be anything similar to what we have known throughout the last century, possibly with parliaments deprived of their traditional authority and public decision-making processes largely unaccountable. This paper discusses and challenges these concerns by suggesting a theoretical framework under which algorithmic decision-making is compatible with democracy and, most relevantly, can offer a viable solution to counter the rise of populist rhetoric in the governance arena. Such a framework is based on three pillars: (1) understanding the civic issues that are subjected to automated decision-making; (2) controlling the issues that are assigned to AI; and (3) evaluating and challenging the outputs of algorithmic decision-making.

In the last twenty months, the Obama Administration has been taking an approach to regulation that is distinctive in three ways.

First, we have approached regulatory problems not with dogma or guesswork, but with the best available evidence of how people really behave.

Second, we have used cost-benefit analysis in a highly disciplined way, not to reduce difficult questions to problems of arithmetic, but as a pragmatic tool for cataloguing, assessing, reassessing, and publicizing the human consequences of regulation – and for obtaining public comment on our analysis. This emphasis on human consequences – on reducing or eliminating unjustified burdens on the private sector and on ensuring that high costs are justified by high benefits – is especially important in a period of economic difficulty. We have worked to put into place important safeguards while also making regulation compatible with the economic recovery, and while reducing the risk that costly regulations will have adverse effects on job creation, wages, prices, and economic growth as a whole.

This article addresses conceptional components of national strategies on critical infrastructure protection (CIP). In particular, it focuses on the Swiss CIP programme and its strategic components. As in other countries, Switzerland divides its national infrastructure into critical sectors, but rather distinctively it subdivides them into critical subsectors and even lists specific critical infrastructure objects in a classified inventory. The article stresses the importance of a pragmatic public private partnership in further strengthening the CI's resiliency, but also argues for a more explicit legal foundation to provide some clearer guidelines in this evolving field of collaboration.

Directive (EU) 2015/412 allows Member States to restrict the cultivation of genetically modified seed or propagating material, although their placing on the market has been authorized. This so-called opt-out is meant to resolve the current Member States’ conflict about gene technology by facilitating differences of states concerning cultivation regulations. The concept has at the same time the potential to pioneer a general reorientation of European and even global principles of free trade. Where as trade restrictions on grounds of health and environmental protection could thus far only be justified on a strict scientific basis, a variety of risk perceptions and evaluations are now made acceptable. The article explores what grounds may justify cultivation restrictions beyond those identified in a concrete environmental risk assessment. Two categories are suggested: general environmental concerns weighing systemic effects and uncertainty, and trans-environmental concerns such as the use-value of genetically modified plants, the avoidance of costs resulting from policies of coexistence with conventional plants, the halting of agricultural industrialisation, and ethical considerations. It is further examined if cultivation restrictions based on such grounds are compatible with the EU rules of free movement of goods and relevant WTO agreements. The pertinent report of a WTO-Panel on genetically modified plants is scrutinized for this purpose and a dissenting interpretation developed.

The Artificial Intelligence Act (AI Act) of the European Union (EU) claims to be based on a risk-based approach to avoid over-regulation and to respect the principle of legislative proportionality. This paper argues that risk-based regulation is indeed the right approach to AI regulation. At the same time, however, the paper shows that important provisions of the AI Act do not follow a truly risk-based approach. Yet, this is nothing that cannot be fixed. The AI Act provides for sufficient tools to support future-proof legislation and to implement it in line with a genuine risk-based approach. Against this background, the paper analyses how the AI Act should be applied and implemented according to its original intention of a risk-based approach, and what lessons legislators around the world can learn from the AI Act in regulating AI.

We shall first introduce the use of artificial intelligence (AI) in producing new intellectual creations, distinguishing approaches based on knowledge representation and on machine learning. Then we shall provide an overview of some significant applications of AI to the production of intellectual creations, distinguishing the extent to which they depend on pre-existing works, and the different ways in which such pre-existing works are used in the creative process. In addition, we shall discuss some methods to automatically assess the similarity of works and styles, in the context of AI technologies for text generation. Finally, we shall discuss the legal aspects of AI-reuse of copyrighted works, focusing on the rights of the authors of such works relative to the process and the outputs of AI.

Regulation by design is an increasingly common approach in the governance of digital technologies. Under this approach, the developers of digital systems must adopt technical measures that implement the specific requirements mandated by law in their software. Some jurisdictions, notably the European Union (EU), have turned to regulation by design as a mechanism to automatically enforce legal requirements, but this article argues that such an approach can have important implications for long-term governance. Drawing from examples of regulation by design in EU law, it shows that by-design provisions delegate rule-making power to software designers, whose interpretations of the law become entrenched in digital systems. This delegation process suffers from legitimacy deficits, which are compounded whenever digital systems continue to enforce the designer-made rules as they operate for years and, sometimes, decades. Yet, these legitimacy deficits are not unavoidable, as regulation by design can be used to force designers to adopt technical and organisational practices that mitigate the risks of rule entrenchment to future generations. By mapping the long-term risks of regulation by design and potential solutions to them, this article provides a first step towards approaches to regulation by design that do not sacrifice the future for present interests.

This report analyzes the tobacco carve-out clause (as well as the negotiations that led to its adoption) included in the final text of the Trans-Pacific Partnership Agreement, which permits the TPP Parties to deny investors that challenge their tobacco control measures access to the investor-state dispute settlement mechanism. The report also discusses the potential advantages and disadvantages of such a solution.

In February 2016, the Feasibility Report on options for an EU ecolabel scheme for fishery and aquaculture products was published. The study did not make a strong case for the introduction of a seafood EU Ecolabel and it is unlikely that the European Commission will pursue this policy option. We argue that sustainability information on seafood should not be framed through the EU Ecolabel debate. The more pressing issue concerns self-declared sustainability claims on seafood products. As a possible solution, we propose to address these by re-invigorating the labelling rules on seafood information in the Regulation on the Common Organisation of the Markets in Fishery and Aquaculture Products.