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.

The 2017 glyphosate reauthorisation process has exposed key weaknesses of the EU’s institutional system. First, the role of Germany as Member State rapporteur and the subsequent decision to appoint a group of Member States to form the Assessment Group on Glyphosate (AGG) suggest that the nature of scientific assessments become blurred. These assessments are apparently not just purely objective, science-based and procedural elements of the authorization procedure, but require support from a significant number of Member States as well. Second, the arduous comitology trajectory in the glyphosate reauthorisation process has caused the Commission to initiate questionable changes to comitology. These changes would corrupt the coherence of the EU’s legislative system in general and the constitutional distinction between delegated and implementing acts in particular. Moreover, they would overlook the more obvious solution of relying more on discretion on the part of the Commission. Lastly, the glyphosate reauthorisation has questioned the dichotomy between legislation and executive rule-making, an equally central element of the EU’s constitutional order. This dichotomy is based on a distinction between essential elements that belong to the legislative domain and non-essential element which are more technical in nature. It has been claimed that weighing the economic benefits of pesticides against the health and environmental costs associated with their use is in essence a legislative choice. This claim highlights not so much the practical problem of how to draw the line between political and technical decision-making, but rather denies the very meaning of the dichotomy altogether. Yet, the current system on the placing on the market of plant protection products – based on the legislation providing the general framework and the executive applying this in concrete cases – is certainly not devoid of coherence and logic.

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.

This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.

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.

The recent reauthorisation of glyphosate in the European Union is a uniquely suitable opportunity to study the relationships between law and science because, unlike many other controversies that are commonly perceived through the science/democracy dichotomy, in this case the disagreement was between the “scientific” assessments of two purely “expert” bodies, the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). This paper takes a close look at some details of the two assessments to show how scientific assessments are shaped by the legal environment to such an extent that it is impossible to separate “legal” from “technical” issues at any level; they are entangled together “all the way down”. Furthermore, it identifies three side effects of this entanglement that were previously unnoticed. First, obscure legal rules may provide (usually unintended) leverage to some of the parties. In turn, this forces everybody into proxy wars on the issue where the leverage is, at the expense of all other concerns that they may legitimately have. Finally, despite the strict legal regimentation of the scientific assessment, significant space for judgment remains, and discretion is never removed, only shifted to different places or levels.

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement.

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

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.

Modern technologies enable traders to design more personal and comprehensive product labelling, as well as to improve product traceability through the supply chain. Personalised and comprehensive product information could raise consumers’ product awareness, shaping new consumers’ product and safety expectations. The improved product traceability through the supply chain could extend the producers’ control over the product, beyond the moment the product left the manufacturing process. This paper examines the impact of modern technologies on European rules of product liability. Specifically, it considers whether the recognition of a defective product in the currently reviewed Product Liability Directive should continue to follow the test of the public’s safety expectations, as well as whether producers could continue to rely on the defence of a product not being defective when they put it into circulation.

Banks are informational intermediaries whose efficient operation is strongly tied to the maintenance and continuance of the trust and confidence produced by them and by external sources. The literature on trust and confidence with relevance to banking has shown particular interest in their links with panics and bank runs, together with their wider resulting implications on the macro-stability of the financial system. However, on the micro level, an initial outcome emanating from a lack of trust and confidence would be the disruption of the information production that ultimately paves the way for further deterioration, leading to a vicious circle. To investigate this further, this article will shed light on this micro aspect of bank information production and its relationship with public trust and confidence.

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.

This short paper aims to unpack some of the assumptions underlying the “Policy and Investment Recommendation for Trustworthy AI” provided by the High-Level Expert Group on Artificial Intelligence (AI) appointed by the European Commission. It elaborates in particular on three aspects: on the technical-legal dimensions of trustworthy AI; on what we mean by AI; and on the impact of AI. The consequent analysis results in the identification, amongst others, of three recurrent simplifications, respectively concerning the definition of AI (sub-symbolic systems instead of “intelligent” informational processing systems), the interface between AI and institutions (neatly separated instead of continuity) and a plausible technological evolution (expecting a plateau instead of a potentially near-disruptive innovation).

Pharmaceutical science has provided humans with better and cheaper treatments. However, with improved access to medicines, the amount of pharmaceutical waste also grows. Pharmaceutical waste is regularly mismanaged by households, which is considerably and unnecessarily adding to the “pharmaceuticals in the environment” problem. Redesigning existing pharmaceutical takeback schemes and their regulation is a potential step towards a reduction of the problem. Interdisciplinary research between the fields of psychology, law, public health and medical science is necessary to tackle the issue and to design effective regulation steering responsible patient behaviours.

Administrative Tribunal of Guadeloupe 28 March 2020, case n° 2000295 (Judge for interim relief); French Council of State 4 April 2020, cases n° 439904, 439905 (Judge for interim relief)

Based on the precautionary principle and to protect the right to life under Article L. 521-2 of the French Code of Administrative Justice, the Administrative Tribunal of Guadeloupe (Judge for interim relief) ordered the Regional Health Agency of Guadeloupe and the University Hospital Centre of Guadeloupe to procure 200,000 COVID-19 screening tests corresponding to half of the population of Guadeloupe and to buy the doses necessary for the treatment of the COVID-19 epidemic with hydroxychloroquine and azithromycin for 20,000 patients. On appeal, the French Council of State, by disregarding the application of the precautionary principle and with controversial reasoning concerning the relationship between discretionary power and scientific uncertainty, annulled the decision of the Administrative Tribunal of Guadeloupe.