Risk regulation is a major task of the EU. In this context, scientific knowledge and advice is critical to the preparation, formulation, legislation and later revision of EU risk regulation. However and with some notable exceptions (e.g. some EU Agencies, DG SANCO), there seems to be no systematic view, let alone, organisation for the ‘use of science’ for EU policy–making. It is in this light that the new function of Chief Scientific Advisor (CSA) to the President of the European Commission can best be appreciated. The authors first sketch how ‘science’ is used in the EU regulatory regime and what is or has become problematic about it. Subsequently, an informal SWOT analysis of the ‘use of science’ for EU policy is conducted. The contribution ends with an attempt to evaluate the CSA's accomplishments to date and how it can contribute to improving EU regulation. This is followed by a few recommendations on how the role of the CSA could be strengthened in the near future.

1. The concept of ‘monomer substances’ in Article 6 (3) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, relates only to reacted monomers which are integrated in polymers (official headnote).

2. Article 6 (3) of Regulation (EC) No. 1907/2006 infringes neither the principle of proportionality nor the principle of equal treatment (author's headnote).

The problematic application of the precautionary principle by the European Courts has led Janssen and Van Asselt to identify patterns and inconsistencies in the Courts’ use of the principle. As a consequence, the principle runs the risk of becoming an empty tool. This paper examines new case law to determine whether these patterns have continued in the rulings of the Courts and discusses what can be done to stop the degradation of the precautionary principle.

Leather is one of the most efficient, natural and renewable resource, a unique and highly versatile material which contributes to the quality of everyday life and has done so for centuries. Due to its resilience, comfort and beauty, leather has played an important role since the beginning of times in satisfying man's clothing and decorative needs. Technically speaking, leather is a fundamental output of the leather tanning industry. Tanneries recover the hides and skins that are discarded by-products of the food industry producing meat for human consumption and convert them into leather, a stable material with a wide range of applications in downstream sectors of the consumer goods industry. Footwear, garment, furniture, automotive and leather goods industries are the most important outlets for EU tanners’ production. More specifically, the footwear Directive provides a definition of “leather”, which reserves the use of the word and its synonyms to products resulting from the processing of animal remains that retain the natural structure of the fibres undamaged.

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.

Private liability can potentially play a crucial role in protecting critical infrastructure. Traditional liability rules will especially play their deterrent and therefore preventive effect in the case of so-called man-made “technological” disasters. By using a strict liability role and by providing solvency guarantees potential tort-feasors can be provided with incentives to take optimal preventivemeasures.However, the case of nuclear accidents, addressed inmore detail, makes clear that in practice those efficient liability rules that would be needed to generate this preventive effect are often not implemented at the legislative level. The legislator rather imposes financial limits on liability and provides for public funding, thus effectively granting a subsidy to operators. Those type of inefficient rules laid down in international conventions are obviously often the result of interest group politics.

As far as natural disasters are concerned liability rules can play less of a role given the fact that those are considered an “act of God”. One could then only consider public authority liability.However, this is not often accepted in practice and there may also be theoretical reasons to be careful with the imposition of public authority liability. Public authorities are multitask agents which need a substantial amount of discretion. That explains that many legal systems award (partial) immunity from liability to public authorities. This leads generally to the conclusion that although liability rules can play a role in the protection of critical infrastructure those rules may have important limits as well. As a result the primary instrument to protect critical infrastructure will in practice often be safety regulation rather than liability rules.

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.

On 13 August 2013, the Government of Indonesia requested a special meeting of the WTO Dispute Settlement Body (hereinafter, DSB) in order to obtain authorisation to suspend concessions or other obligations (i.e., to ‘retaliate’) against the United States (hereinafter, the US). This request stems from the US alleged failure to comply with the rulings and recommendations of the WTO DSB in the dispute US – Measures Affecting the Production and Sale of Clove Cigarettes (hereinafter, US – Clove Cigarettes). In that dispute, the WTO dispute settlement organs found that Section 907(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (hereinafter, the FFDCA), introduced by Section 101(b) of the Family Smoking Prevention and Tobacco Control Act discriminated against Indonesian clove cigarettes in favour of ‘like’ domestic menthol cigarettes, in a manner which was inconsistent with, inter alia, Article 2.1 of the WTO Agreement on Technical Barriers to Trade (hereinafter, TBT Agreement). The DSB recommended that the US bring its legislation relating to the ban on flavoured cigarettes into conformity with its obligations under the WTO. On 22 August 2013, the US objected to the level of suspension of concessions proposed by Indonesia and requested that the matter be referred to arbitration. Following such request from the US, the DSB agreed that the matter be referred to arbitration and informed WTO Members that arbitration would be carried out by the original panel.

Critiques of global public health security (GPHS) and proposed solutions tend to overlook the potential of the individuals and groups that are subject to and governed by GPHS – “the governed” – to contribute their “on the ground” knowledge and experience to decision-making in order to improve regulatory responses. This article argues for the development of a more reflexive approach as a way of ensuring the epistemic integration of these knowledges with the scientific-technical knowledges that currently dominate decision-making processes. I identify human rights as the conceptual lens that is most likely to enable reflexivity by the governed and regulators, and understanding and communication between them. The governed can use perceived or actual breaches of human rights to articulate “on the ground” knowledges as institutional risks to reputation and standing and, in turn, threaten the production and legitimation of organisational identity, socio-political orders and projects of rule. The particular sensitivity of regulators to these risks could compel epistemic integration. This more reflexive approach to GPHS promises to improve the knowledge base, efficacy, accountability and legitimacy of decision-making at multiple levels: WHO, EU, national and “on the ground”.

Many European countries, including Switzerland, share deep suspicions about the broad commercial application of Genetically Modified Plants (GMP) in agriculture. Research in GMP, however, is mostly welcome. In Switzerland, nevertheless, an overprotective legal framework against risks of GMP results in regulatory spillovers for research. This article explores how such expanded legal protection in combination with the application of a strong precautionary principle hampers freedom of research in the field of green gene technology. The authors do not seek, on this occasion, to question the general risk assessment of Swiss legislators and their desire for a high level of protection. However, field trials with GMP will cease to take place if the procedural burdens for researchers are not reduced. In particular, it will be vital to establish research zones (“protected sites”) if research in GMP is to continue to take place in Switzerland.

Regulation n. 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14 December 2009 and applies as of 14 June 2011, subject to some transitional measures set out in Article 80. It shall replace gradually the current legislation on plant protection products which is laid down in Council Directive 91/414/EEC and related implementing Regulations.

Broadly speaking, the harmonized authorization system for active substances used in plant protection products, as originally set out in Directive 91/414/ EEC, is maintained. Indeed, the placing on the market of plant protection products is still subject to a two-steps process whereby active substances are approved at the EU-level (with the inclusion into a “positive list” – Annex I to the new Regulation) while formulated products are authorised at the national level based on “Uniform Principles” laid down in a new implementing Regulation 546/2011. However, the criteria underlying each of these two steps have changed remarkably.

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).

The European Climate Pact provides opportunities for individuals, communities and organisations to declare their commitment to climate action. This study analyses the publicly available web profiles of the European Climate Pact Ambassadors (PAs) as of January 2023. First, it explores the extent to which people who volunteer as PAs demonstrate commitment to young and future generations. Second, it investigates whether PAs who self-identify as young people are more likely than other PAs to justify their mandate by referring to the interests of young and future generations. Third, it examines whether PAs who self-identify as young people are more likely to indicate other young people as the target audience of their activities. The manual coding and quantitative analysis of the PAs’ web profiles revealed that members of older generations as well as parents and grandparents are most likely to rationalise their engagement in the programme by referring to young and future generations. The data also showed that young people do target other young people when they act as PAs, but they are not the only group to do so. When compared to individuals with other professional identities, educators are also more likely to flag young people as their target audience.

This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine the legal and institutional framework supporting such embryonic coordination efforts and offer a preliminary assessment of their implications for a European approach to epidemiological knowledge-making.

The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.

For some time, pressure was placed on the European Food Safety Authority concerning the manner in which it conducted risk assessments in relation to food safety. This pressure culminated in the introduction of Regulation (EU) No. 2019/1381 as the upshot to the European Citizens’ Initiative on glyphosate. Concerns were expressed in the initiative regarding the transparency of the scientific studies used to evaluate pesticides, and following a Fitness Check conducted by the European Commission. Effectively, the new Regulation seeks to impose an obligation on EFSA to publish industry studies at the beginning of the risk assessment process. However, the mandatory nature of this obligation raises a number of concerns as to whether the urge to increase the transparency of the work of the EU authorities is more important than keeping the research confidential, two converse ideals in the realm of European law and effective processes. The present article submits that this codified focus on the risk assessment process and its accessibility for European citizens is a new frontier for transparency within the EU risk assessment processes. Yet while the changes pioneered by this framework are laudable, the Regulation is not without its qualifications.