The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the world. Its stated objectives are to ensure an independent, objective and transparent assessment of pesticides and achieve a high level of protection for health and environment. However, a growing body of evidence shows that pesticides that have passed through this process and are authorised for use may harm humans, animals and the environment. The authors of the current paper – experts in toxicology, law and policy – identified shortcomings in the authorisation process, focusing on the EU assessment of the pesticide active substance glyphosate. The shortcomings mostly consist of failures to implement the hard or soft laws. But in some instances the law itself is responsible, as some provisions can only fail to achieve its objectives. Ways to improve the system are proposed, requiring changes in hard and soft laws as well as in administrative and scientific practices.

Frequently, decisions related to health protection are taken directly on the basis of scientific assessment and they are not clearly understood, as is highlighted in the Xylella example. Therefore, this article suggests that coherent processing of information in risk assessment may allow also a “third party” (who has not already expressed a specific interest in the procedure) to participate. In order to truly grasp the EU administration, an accountable way of communicating is helpful. Therefore, communication around the democratic process might be based on EU administrative principles and rules supporting a composite administrative system: it must not neglect the implications of compliance with the multilingual principle and its consequences for EU law, which would also lead to greater trust in risk assessment.

Roundup, and other glyphosate-based herbicides, are the most heavily used pesticides in the history of the USA and globally. In March 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as a “probable human carcinogen”. A portion of the 695,000 Americans then living in 2015 with non-Hodgkin lymphoma (NHL) became aware of IARC’s decision. Several thousand Roundup–NHL lawsuits had been filed by the end of 2017, rising to 18,400 by July 2019 and 42,000 by November 2019. Three cases have gone to trial, each won by the plaintiffs. The author has served as an expert witness for the plaintiffs in this litigation and has been compensated for his time spent. The impact of the litigation on the independent assessment of the science useful in determining whether glyphosate and glyphosate-based herbicide exposures are linked to NHL is reviewed, as is why the US Environmental Protection Agency (EPA) and IARC reached such different judgements regarding glyphosate human cancer hazard and risk. Two important “lessons learned” regarding the EPA versus IARC assessment of glyphosate cancer hazard and risk are highlighted. The first arises from differences in the magnitude of applicator risks from mostly dermal exposures to formulated glyphosate-based herbicides compared to just dietary exposures to technical glyphosate. The second relates to missed opportunities to markedly lower applicator exposures and risks with little or no impact on sales via reformulation, added warnings and worker safety provisions, company-driven stewardship programmes and greater determination by the EPA in the 1980s to compel Monsanto to add common-sense worker protection provisions onto Roundup labels (eg “wear gloves when applying this product”). Policy reforms designed to alleviate systemic problems with how pesticide hazards, exposures and risks are analysed, regulated and mitigated are described.

Understanding of the causes and correlations for algorithmic decisions is currently one of the major challenges of computer science, addressed under an umbrella term “explainable AI (XAI)”. Being able to explain an AI-based system may help to make algorithmic decisions more satisfying and acceptable, to better control and update AI-based systems in case of failure, to build more accurate models, and to discover new knowledge directly or indirectly. On the legal side, the question whether the General Data Protection Regulation (GDPR) provides data subjects with the right to explanation in case of automated decision-making has equally been the subject of a heated doctrinal debate. While arguing that the right to explanation in the GDPR should be a result of interpretative analysis of several GDPR provisions jointly, the authors move this debate forward by discussing the technical and legal feasibility of the explanation of algorithmic decisions. Legal limits, in particular the secrecy of algorithms, as well as technical obstacles could potentially obstruct the practical implementation of this right. By adopting an interdisciplinary approach, the authors explore not only whether it is possible to translate the EU legal requirements for an explanation into the actual machine learning decision-making, but also whether those limitations can shape the way the legal right is used in practice.

Glyphosate’s authorisation will expire in 2022 and its re-approval will take place in a changed legal and political landscape: the national phase of risk assessment is entrusted to a taskforce of four Member States, and, from 2021, the reform of the general food law will apply, imposing, inter alia, more ambitious transparency standards. Taking stock of these developments, this contribution analyses, from a legal perspective, whether and how the glyphosate dispute has contributed to the development of the EU’s regulatory epistemology, with specific regard to food governance. It identifies the “manifesto” of the EU’s regulatory epistemology in the 2002 guidelines on the collection and use of expertise and reads them in the light of the glyphosate dispute. In particular, it focuses on the legal arrangements reflecting the principles established in the 2002 guidelines (quality, openness, effectiveness) and analyses them against the tensions that emerged throughout the dispute with regard to the sources, levels and purposes of EU regulatory knowledge-making. It then considers whether and how such tensions have been addressed by legislative reform and whether this has resulted in a further refinement of the EU’s regulatory epistemology.

New financial technology holds the promise of innovation and competition, challenging established products and services and frequently improving market processes. However, regulation of these new services faces a double challenge: to keep pace with innovation and facilitate new market entries while at the same time understanding and managing the regulatory risks that are involved.

At this stage, the existing EU regulatory framework is of little help: the bulk of the present body of financial regulation stems from a different time, with different regulatory problems in mind. EU regulation is also very slow to change and to adapt. Therefore, this paper proposes a regulatory “sandbox” – an experimentation space – as a step towards a regulatory environment where such new business models can thrive. A sandbox would allow market participants to test fintech services in the real market, with real consumers, but under the close scrutiny of the supervisor. The benefit of such an approach is that it fuels the development of new business practices and reduces the “time to market” cycle of financial innovation, while simultaneously safeguarding consumer protection. At the same time, a sandbox allows for mutual learning in a technical field which is sometimes poorly understood, both for firms and for the regulator. This would help to reduce the prevalent regulatory uncertainty for all market participants.

In the particular EU legal framework with various layers of legal instruments, the implementation of such a sandbox is not straightforward. In this paper, we propose a “guided sandbox”, operated by the EU Member States, but with endorsement, support, and monitoring by EU institutions. This innovative approach would be somewhat uncharted territory for the EU, and thereby also contribute to the future development of EU financial market governance as a whole.

This article discusses the development of a more supranational EU approach to regulate risks of “serious cross-border threats to health” such as pandemic disease outbreaks. It argues that the EU’s public health measures to prevent and tackle pandemics could affect individual patients’ rights, because the rights of individual European citizens are balanced against the importance of protecting the European community as a whole. This results in a tension between public health and individual rights in the EU, especially with regard to the right to informed consent, a central right in health law. In response to the 2013–2016 Ebola outbreak in West Africa, the EU introduced several preventive and responsive measures in the Member States to prevent the pandemic from spreading to the EU. The case study analysis of Dutch pandemic policies established in reaction to this outbreak shows that national pandemic policies are substantially shaped by EU actions, which has implications for the protection of the individual right to informed consent in the Member States.

Next to Member States, European Union (EU) level organisations have come to play a larger role in enforcement in the EU during the last two decades. Analysing the roles of Member States, networks of national authorities and EU agencies in this stage of the policy cycle through multiple academic lenses could lead to a more comprehensive understanding and assessment of their design. This article sets elementary steps towards a framework that brings together prominent theoretical insights from the legal and political disciplines, to discuss their combined leverage for understanding the EU legislator's choice for these enforcement regimes.