I am delighted to announce the birth of the European Journal of Risk Regulation. This new academic journal reflects the growing importance of both national and European regulations intended to protect health, safety, security and the environment – as well as the accompanying institutional challenges for the European Union governance.

This large body of law is known as risk regulation. It seeks to reduce the risks of harm to individuals and society, stemming from all threats whether industrial or natural, voluntary or involuntary. Arguably, this portion of EU legislation already represents the most important and widespread part of the internal market acquis and, due to its international success, it contributes to make the EU a de facto global regulator. As such, it provides a new and valuable lens through which to analyse the European integration process.

The long subtitle of this paper, appearing in the first issue of the EJRR – a publication which fills a serious gap in the scholarly literature of the old continent – identifies what I take to be the key terms of the current debate on risk regulation. It is impossible to understand the evolution of risk regulation over the last three decades in Europe and the United States without having a good grasp of how these concepts, and their corresponding practices, interact. How, for example, does a particular institutional design affect the way scientific uncertainties are resolved? What decision rules are appropriate in situations of high scientific uncertainty? Which constitutional principles facilitate policy learning and accountability in the regulation of risk?

This article reviews the way in which the concept of precaution, as commonly referenced in EU law, is received in the WTO. It argues that precaution is not a principle, but one facet of a principle of making rational judgments based on available information, the other facet of which is “that risk is worth taking”. Systematically pursuing high cost measures in response to low risks is not a balanced approach, and has probably contributed to the scepticism with which the concept is viewed in the WTO. However, this article goes on to argue that, without needing to be a principle, precaution is the determining legal feature in the SPS Agreement, because, unlike in the European Union, there is no legislative harmonisation of SPS measures at international level, WTO Members being free to set their own appropriate level of protection. In fact, the concept of precaution is relevant in the context of many other WTO provisions and is in some respects quite close to the concept of subsidiarity. Notwithstanding this, the first WTO SPS cases, driven by regulatory exporters and an interventionist WTO, have excessively emphasised scientific issues, masking policy judgments that the WTO has neither the legal nor the political authority to sustain. The article concludes that the proper way forward necessitates closer political, legal and administrative links between the WTO and other relevant international organisations, and a move away from consensus in the latter.

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe's regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU's trade partners). By considering the discussion on animal cloning in the broader context of EU's regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.

Comparative risk assessments in the chemical safety field sometimes adopt a lofty view of the purposes of legislation. This personal essay is not lofty, and it is not just another professor's comparison of the purposes of the European Union's REACH with American regulatory programmes. I write today as an individual, as the last active remaining participant of the small group of industry players in 1975–76 who helped to negotiate the details of the 1976 US Toxic Substances Control Act (“TSCA”). As advocates for industry we won the key arguments over the law's terms and conditions, but the decades since have not shown TSCA to be a triumph for anyone.

At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them. While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise. In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. It is the view of the authors that Member States cannot rely on the argument that REACH does not contain specific provisions on nanomaterials, nor require registration of substances manufactured or imported below 1 tonne, to consider that the matter is not totally harmonised under EU law and thus justify the adoption of national measures to regulate nanomaterials. However, Member States can use the REACH processes, including the evaluation, authorisation and restriction processes to propose conditions for or restrictions of the marketing and use of nanomaterials at the EU level, in the conditions specified in the Regulation. They can also trigger the application of the safeguard clauses of REACH and of the Treaty on the Functioning of the European Union. It is only within that strict framework that reference to the precautionary principle can be made to justify the introduction of national measures.

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.

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.

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.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

This section discusses issues related to risk communication across a range of publicly perceived highrisk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.

The Commission's task is to verify the legality of the national allocation plan while respecting the “margin for manoeuvre” granted to the Member State in the implementation of Directive 2003/87/EC in the context of the drawing up of that plan. Within this “margin of manoeuvre” Member States also have the right to choose the data and its method of evaluation (author's headnote).

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official headnote).