The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at david.hornsby@wits.ac.za.

Agrochemicals belong to the best tested and evaluated substances in Europe. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (“Regulation 1107”) sets forth the requirements regarding quality, safety and efficacy of agrochemicals and provides which documentation has to be submitted in order to obtain regulatory approval. The documents filed with the regulatory authorities contain proprietary information and know-how of the registrants. Accordingly, registrants have a legitimate interest in confidential treatment. Regulation 1107 thus contains specific confidentiality provisions.

On the other hand, EU legislation on transparency, in particular the legislation implementing the Aarhus Convention, provides for rights of access to information held by institutions. Recently, a number of legal actions related to the regulatory procedures for agrochemicals have been based on the transparency legislation.

This report analyses the relationship between the transparency legislation and Regulation 1107 with regard to rights of access to information provided in the regulatory process for agrochemicals.

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 plant protection law within the European Union has been continuously developed over the past two decades. Whereas harmonized provisions for the placing of plant protection products on the common market were introduced by Council Directive 91/414/EEC of 15 July 1991 (hereinafter the “Directive”), almost two decades later, a revision of the Directive has been passed which takes, in order to ensure consistency throughout the Member States and to provide for simplification, the form of a regulation. Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market (hereinafter the “Regulation”) was adopted on 21 October 2009.

REACH is a new European Community Regulation on chemicals and their safe use. This Regulation is a hybrid that combines hierarchy and heterarchy from a both a legal and an organisational perspective. Such hybridism is, however, not a feature that is particular to REACH. Rather the EU itself must be understood as a hybrid, thereby making REACH a hybrid operating within a hybrid. The hybrid structure of REACH reflects its societal function, which is to simultaneously separate and combine politics, science, economy, health and the environment within a single legal framework. The legitimacy of REACH reflects its hybrid structure in the sense that it is based on a combination of democratic, procedural and deliberative components.

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.

Under Section II of the Rules of Conduct for the DSU, the institutional affiliation of experts may be considered as an element that casts doubts on their impartiality and independence. Under Articles 5.1 and 5.7 of the SPS Agreement, the level of protection that a particular country is ready to tolerate may inform risk assessment and have an impact on the determination of insufficiency of scientific evidence. In a situation in which there is sufficient scientific evidence for performance of risk assessment in one of the international standard setting-organizations, one may still find insufficiency as provided by Article 5.7 if new data puts into question the relationship between the relevant scientific evidence and the conclusions in relation to risk, thereby not permitting the performance of a sufficiently objective assessment of risk (authors’ headnote).

This article explores the prospects for the EU to develop a coherent policy regarding climate engineering (CE). To this end, we explore the most significant legal parameters derived from EU law from which such a future EU policy would have to arise. Obviously, in view of the principle of conferral, it must first be established if the EU enjoys competences to initiate a discrete policy on climate engineering. The mere fact that the EU presides over a plethora of climate mitigation and adaptation instruments is not sufficient to conclude that it likewise has competence to initiate a policy of intentional environmental change. Rather, precisely because climate engineering is such a different response to climate change than anything undertaken before, we must establish whether that difference is of a nature so as to rule out a future EU policy on climate engineering.

Recent advancement in technology in the domain of Autonomous Intelligent Systems (AIS) shall eventually lead to autonomous technology that can perceive, learn, decide and create without any human intervention. Already now there are robots that create better versions of robots and computer programmes that produce other computer programmes. Although the ability to create is a quality that has traditionally been considered a human capacity, the sudden increase in the level of complexity of such systems as well as their learning abilities, shall ultimately render human intervention in the process of creation redundant. This makes the need to address creative agents and the challenges they bring ever more evident. This contribution assesses the output of AIS as Creative Agents and its relation to the EU framework for Intellectual Property.

The year 2013 has witnessed a new entry in the EU “better regulation” toolbox: the Cumulated Cost Assessment (CCA). The CCA is set to answer an apparently simple question: what is the cumulative cost imposed by a selection of EU rules and policies on a given economic sector? In this contribution we present the CCA methodology and its building blocks, as well as the results of the first two empirical applications of this tool. More importantly, we elaborate on two key features that make the CCA a valuable addition to the better regulation toolbox: it creates a methodological bridge between the policy and competitiveness assessment instruments, and it clarifies empirically how a wide array of policies interact with one another when and after they are actually implemented, an element that is often a weak link in policy–appraisal. We conclude with some remarks on how the CCA opens the avenue for a set of challenging and interesting methodological and policy considerations.

Occupational exposures of pregnant workers can give rise to foetal damage. Two major types of strategies against detrimental effects on the foetus are described: differentiated protection that reduces only the exposure of pregnant workers (or only of female workers) and unified protection that reduces the exposure of all workers to a level that is sufficiently low to protect against detrimental effects on the foetus. The former strategy is shown to be inefficient, as it does not provide the desired protection. Protection only of pregnant workers is insufficient since protection is needed early in pregnancy when it is not known, and in the case of substances that are accumulated in the woman's body even prior to conception. Protection of all women is also insufficient to protect the foetus since evidence indicates that preconception exposure of the father can also give rise to malformations. Furthermore, differentiated protection that requires more costly protective measures for women tends to aggravate the already prevalent discrimination of women on the labour market. It is therefore concluded that unified protection is the only efficient and non-discriminatory strategy against foetal damage.

More than twenty years after the EU eliminated its internal land borders, the Union still lacks an integrated airspace. This seems to be the most immediate regulatory lesson of the recent volcanic ash crisis. Yet more research is needed before establishing its net effects. In this brief report, I will provide a first-hand analysis of the regulatory answer developed across Europe in the aftermath of the eruption of the Icelandic volcano Eyjafjallajökull. While reconstructing the unfolding of the events and the procedures followed by the regulators, I will attempt to address some of the questions that I have repeatedly asked myself when stranded in Washington DC between 16 and 25 April 2010. Who did the assessment of the hazard posed by volcanic ash to jetliners? Who was competent to take risk management decisions, such as the controversial flight bans? Is it true that the safe level of volcanic ash was zero? How to explain the shift to a new safety threshold (of 2,000 mg/m3) only five days after the event? Did regulators overact? To what extent did they manage the perceived risk rather than the actual one? At a time when the impact of the volcanic ash cloud crisis is being closely scrutinised by both public authorities and the affected industries, it seems particularly timely to establish what happened during the worst aviation crisis in European history. This report was written one week after the event and relied on a limited number of sources available by 30 April 2010.

The autonomy robots enjoy is understood in different ways. On the one hand, a technical understanding of autonomy is firmly anchored in the present and concerned with what can be achieved now by means of code and programming; on the other hand, a philosophical understanding of robot autonomy looks into the future and tries to anticipate how robots will evolve in the years to come. The two understandings are at odds at times, occasionally they even clash. However, not one of them is necessarily truer than the other. Each is driven by certain real-life factors; each rests on its own justification. This article discusses these two “views of robot autonomy” in depth and witnesses them at work at two of the most relevant events of robotics in recent times, namely the Darpa Robotics Challenge, which took place in California in June 2015, and the ongoing process to address lethal autonomous weapons in humanitarian Geneva, which is spurred on by a “Campaign to Stop Killer Robots”.

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

On 26 June 2015, the Chilean Official Journal published Decree No. 13 of 16 April 2015 (hereinafter Decree 13/2015) amending Decree 977/1996 Reglamento sanitario de los alimentos (hereinafter, the Food Health Regulation, as it is widely referred to in English, although the correct translation would be Food Sanitary Regulation). In particular, Decree 13/2015 requires warning messages in the shape of a black octagon in the form of a STOP sign to be placed on the front-of-pack with the text ‘High in…’ when food products exceed certain levels of energy, sodium, sugars or saturated fats. Although novel in the food sector, Chile's measure is part of a trend of public policies aimed at tackling lifestyle risks by conveying certain information to the public. While warning messages that reduce the visual appeal of the packaging of products are ubiquitous in the tobacco sector, these types of messages are now also gradually being extended to the alcohol and food sectors.

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, the Member States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking at methodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.