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.

Since first embarking on the road of risk management options for the regulation of recombinant DNA (rDNA) activities and use in 1978, the European Union (EU) has largely failed to create a regulatory and policy environment regarding genetically modified (GM) crops and their cultivation that is (a) efficient, (b) predicable, (c) accountable, (d) durable or (e) interjurisdictionally aligned.

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.

In times of low economic growth and post-Copenhagen climate talks, a number of reasons for regulatory competition and cooperation between the United States and the European Union coexist. This paper discusses the role of Impact Assessment between the US and the EU on responses to the economic downturn and climate change. It is argued that, in the future, IAs will be an instrument through which it will be possible to read the level of cooperation and competition between the US and the EU, particularly on economic trade and environmental regulation.

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.

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

This article deals with complex systems. It takes the reader on a journey to the origins of the paradigm shift which has taken place in the sciences since the path breaking works of Edward N. Lorenz, Benoît B. Mandelbrot, Mitchell J. Feigenbaum, and others. Gradually, linear “twodimensional” thinking has been replaced by non-linear “multi-dimensional” reasoning and multi-factorial genesis, risk, and uncertainty have come into focus. The article looks at the beginnings of the conception of complex systems — chaos theory — and reveals the implications for the law and legal science. Having explained the premises of chaos theory by means of a metaphor (the kneading of dough) the article proposes to look at the law through the lens of chaos: the law, especially case law, is perceived as a system which is itself subject to the phenomenon of chaos. The power of the image of chaos is illustrated by means of a study of the case law of the European Court of Justice on family reunification of moving persons and its projection to Switzerland in an attempt to create parallel regimes. The article also takes advantage of chaos theory to portray the broader implications for society and the law, tentatively illustrating them by thoughts on the Lisbon judgment of the German Federal Constitutional Court of 30 June 2009 and on UN Security Council Resolution 1244 of 10 June 1999 (on Kosovo).

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.

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 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 free movement of goods is a fundamental principle under EU law: a product lawfully manufactured and/or marketed in one Member State is, in principle, entitled to be marketed in another EU Member State. Indeed, Article 34 of the Treaty on the Functioning of the European Union (TFEU) prohibits any quantitative restrictions on imports between Member States and all measures having equivalent effect.

Alfalfa is one of the most important legumes used in agriculture and the fourth most cultivated plant behind corn, soybeans and wheat in the US. It has been grown in almost all federal states, occupies 9 million hectares and is primarily used in feed for dairy cows and beef cattle. US consumers also eat GM alfalfa as sprouts in salads and other foods. Roundup Ready alfalfa was developed by the agrobiotechnology firms Monsanto and Forage Genetics. It was originally approved in June 2005 for commercial sale by the US Department of Agriculture (USDA). Alfalfa is designed to tolerate the leading active substance in Monsanto’s trademark Roundup herbicide, glyphosate. It is also the first genetically modified perennial crop to be commercialized. As a result, its cultivation poses special environmental, agricultural and economic risks.

EU consumers are becoming increasingly concerned about not only the characteristics and qualities of the food products that they are buying but also their origin. To address these concerns, the EU is considering – similarly to other countries – the introduction of mandatory country of origin labelling (COOL) for both unprocessed and processed food.

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 aims at updating readers on the latest developments of risk-related aspects of food law at EU level, giving information on legislation and case law on various matters, such as food safety, new diseases, animal health and welfare and food labelling.

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 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 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 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.