When determining the Appropriate Level of Protection (ALOP) in food safety law, developed countries rely on the Food Safety Objective (FSO) to meet the requirements of World Trade Organization (WTO) law and to provide a high level of protection based on insights from food safety science. Implementing an FSO/ALOP is resource-intensive and costly. Developing countries who would like to provide similar levels of protection are restricted by limited resources and often face difficulties implementing such an FSO-based ALOP. As a consequence, developing countries may base their ALOP on other legally acceptable reasons, which are non-scientific and less effective. We illustrate a less resource-intensive way to implement the FSO in the ALOP, which enables developing countries to design an ALOP that is based on food safety science. Depending on the resources available in the respective country, we map different possibilities to determine a science-based FSO/ALOP concept for developing countries, which also takes into account the requirements of WTO law.

Alcohol is the sole major psychoactive substance with a huge negative public health and social impact without some form of international control grounded in a binding treaty. While existing rules of international law, in particular in the economic field, favour liberalisation and may hinder strong national alcohol control measures, we may be witnessing a turning of the tide due to the growing mobilisation against non-communicable diseases. The Framework Convention on Tobacco Control has been a ground-breaking development in this sense, and has led policymakers and advocates in a number of countries to raise the possibility of a similar convention on alcohol control. The present contribution compares tobacco and alcohol from this perspective and considers the feasibility of a dedicated international convention. It concludes that the political prospects of a movement in this direction are very dim at the present time; however, policy developments on other health problems and theoretical models emerging from constructivist international relations scholarship may open up promising perspectives for considering normative and institutional approaches that could strengthen the existing legal framework and facilitate political processes towards stronger forms of legalisation of global alcohol control.

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.

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.

While soft law is an integral part of the efficient and effective functioning of public administration in England & Wales, the extent to which it was deployed in response to COVID-19 is striking, with over 400 pieces of “guidance and regulations” created. In this article, we consider the general place of soft law in administrative law in England & Wales and the broad regulatory framework, including soft law, that governs the COVID-19 pandemic. This allows us to take a deep dive into COVID-19 and the criminal justice system, showing how the senior judiciary relied predominately on soft law (judicial guidance and protocols) to manage the system (set against the backdrop of targeted legislation and a limited number of Practice Directions, which have the force of law). We argue that the senior judiciary’s approach to the use of COVID-19 soft law has, in many ways, been more effective than that taken by the government. Yet there remains room for improvement, particularly in the nature of the judicial guidance issued and about what guidance was in place and when.

The fast development of technology and industrial processes during the last hundred years has caused increasing expectations by the public, customers and politics concerning the safety of operations and the risks of substances and activities related to production and consumption of goods. A highly differentiated and complex system of laws and regulations exists on the regional, national, and international level. In Germany alone, manufacturers are confronted with more than 10,000 regulations. Companies that trade all over the world are obliged to comply with a multitude of laws and regulations which partially are in conflict with each other.

In addition to the legal requirements, manufacturers of products and developers of technologies face increasing demands for more information and participation from the consumers, special stakeholder groups, and the public at large. The need for risk communication has been voiced since the late 1960s. The main targets have been large technical installations such as nuclear power plants or waste incinerators.

The latest Russian regulatory reform (2016) sought to introduce the risk-orientated approach – a move away from the “blanket inspections” (or the risk regulation reflex – a term coined by Blanc in 2011) method that has been criticised by the Russian business community. The present paper aims to assess its success using administrative data on federal watchdogs’ inspections. We argue that this reform ultimately failed in its goal regarding the overall number of inspections, and thus the volume of regulatory burden did not change significantly throughout the reform. This failure resulted from two mechanisms. First, the legal framing of the reform radically redefined risk as the probability of incompliance (as opposed to the likelihood of accident). Second, the watchdogs used key performance indicators that incentivised “street-level” inspectors to maintain the pre-reform regulatory burden levels.

Nowadays as political decision making involves such a huge range of complex matters, scientific experts have become more and more involved in European risk regulation. The support by so-called independent experts may, on the one hand, be seen as a guarantee of rational decision making, increasing the quality of decisions as well as the general acceptance of all people affected. On the other hand, the number of expert groups, scientific committees and agencies helping the Commission in fulfilling its duties is vast and confusing.

In addition, scientific advisory bodies often face the burden of unrealizable independence, as well as a lack of transparency and democratic control. This article sums up the central position of science-based risk regulation within the European Union (EU), referring to the necessity for expert opinion as well as to consequent problems concerning the involvement of these experts in risk regulatory actions.

The purpose of this paper is to use legal theory to clarify the nature and the components of effectiveness in legislation, in particular when it comes to choosing legislative policy, ie the legislative model used to tackle a certain issue via legislation. Part II is devoted to revealing the true meaning of the idea of effectiveness, ie as a functional link helping legislative drafters to move among three elements (ideals, situation, results) rather than as an absolute value that drafters should pursue in their work. Part III continues by investigating the problems that such confusion has produced within legislative discourse and practice, in particular by focusing upon two types of effectiveness as external and internal to the legislative process. Finally, Part IV proposes how this idea of effectiveness as a functional element of legislative work (and the consequent distinction between an external and an internal version) can (and should) affect the work of legislative drafters. This idea becomes particularly relevant in relation to the optimal location of the non-legal experts in the legislative process as a means of increasing the effectiveness of legislative policy.

Regulators can avert corporate behaviour that inflicts risks on society, but is nevertheless compliant with the law. Such regulatory interventions beyond the law evoke contentious questions about their objects, legitimacy, methods, and the norms employed. No framework yet exists to analyse these questions in conjunction. Therefore, this paper proposes a typology of the extralegal frontier. The typology is based on a range of discretionary attitudes of regulators towards their enforcement mandate. This range comprises four types of regulators, with an increasingly extensive attitude: Law Enforcer, Legislative Agent, Social Broker, and Public Architect. The typology integrates diffuse scholarly insights into a coherent framework, which offers regulators and their stakeholders a starting point for reflection on interventions beyond the law.

Joined Cases C-78/16 and C-79/16, Giovanni Pesce (et al) v Presidenza del Consiglio dei Ministri, [2016] EU:C:2016:428.

In Xylella, the Court of Justice of the European Union (CJEU) was called upon to assess how far policymakers can go in conditions of scientific uncertainty, and whether EFSA opinions can be indirectly subject to judicial review, despite not being legally binding. In particular, the Xylella case highlights the relevance of EFSA’s scientific authority over the Commission: since EFSA opinions are not directly reviewable by the CJEU – as they constitute an intermediate stage of a more complex administrative procedure – the political and legal liabilities relating to EFSA assessments are entirely shifted onto the Commission, whose discretion is reviewable by the EU judiciary. In this regard, the Xylella case confirms how difficult the judicial review of precautionary measures can be. It shows once again that a full assessment of these measures is impossible, as scientific uncertainty restricts the grounds for judicial review to the manifest appropriateness of the contested measures and the availability of less onerous and equally effective measures.