Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ‘Bisphenol A-free’ (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and children's toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.

Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EU's chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

In the recent Grand River Enterprises case, United States public health regulations on protection from tobacco products successfully withstood a challenge by Canadian Native American investors under NAFTA chapter 11 arbitration. The arbitrators carefully weighed the investors’ rights and the regulatory freedom of the host state under the NAFTA rules. The treatment of other norms of international law on the protection of indigenous peoples, however, merits some criticism.

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.

In this report, the author, an IP scholar and entrepreneur, analyses how nanotechnology will pervade all industries and therefore how important it is to find a proper method to valuate and especially evaluate nanotechnology-related inventions. Attaching a value or evaluating a technology is a fundamental task nowadays, especially when innovations are supposed to be licensed or assigned. The report focuses on the different valuation and evaluation techniques professionals usually employ, and then delves into the world of nanotechnology. It tries to develop a novel method that takes environmental and health-related issues into due consideration when attaching a value or evaluating a technology in the nano world. The novel tool envisioned in the article is particularly suitable for nanotech innovations, but it can be used for the evaluation of other technologies and patents as well. The innovative idea consists of introducing the concept of Present Value After Evaluation, which takes qualitative variables into consideration and provides a figure for the analyzed technology or patent. This method and the accompanying tool are perfectly suited for evaluation purposes when environmental and human safety concerns are at stake, because they take these variables into consideration and throughout technology's life cycle.

A national component is a necessary basis for a measure to freeze assets and once the Netherlands repealed the Sanctieregeling 2003 which formed the basis for Stichting Al Aqsa's asset freeze at the national level, the Community basis for the asset freeze also seized to exist (author's headnote).

In several ways, the revelations that Volkswagen used software to cheat on vehicle emissions tests echo common threads of greenwashing cases against car manufacturers. However, in one significant respect, the Volkswagen scandal is much more than just another example of greenwashing. That is, the German automaker's use of software to deceive brings a novel technological aspect to greenwashing. This article discusses the Volkswagen scandal in the context of automobile greenwashing cases and highlights this newhigh-tech greenwashing.

On 25th November, 2014, the coalition “No Patents on Seeds” filed an opposition against the European patent EP 2 134 870 B1, held by the U.S. Company Monsanto Technology. The patent, granted on 26th February, 2014, by the European Patent Office, covers “utility of SNP [single nucleotide polimorfism] markers associated with major soybean plant maturity and growth habit genomic regions” and includes “methods for screening plants and seeds from the genus Glycine withmarkers associated with genomic regions that are related to the plant maturity and growth habit of Glycine plants”.

“No Patents on Seeds” claims that the patent should be completely revoked, as it falls within the exclusion of essentially biological processes for the production of plants from patentability under art. 53(b) of the European Patent Convention (EPC2000) and is not a patentable invention according to art. 52(2)(a) EPC. This case note gives an overview of the opposition and discusses its implications.

In the context of the UK Supreme Court decision in Sienkiewicz v Greif (2011) this article discusses the question whether so-called “naked statistical evidence” can satisfy the civil standard of proof in English law, the “balance of probabilities”. It argues that what is required to satisfy the standard is a judicial belief that causation is more likely than not, rather than a categorical belief that causation occurred. Whether such a belief is justified depends on the weight of the evidence as well as the degree of probability it purports to establish, but there is no reason of principle why epidemiological evidence alone should not satisfy this standard.

Public food safety authorities in Europe and elsewhere have recently developed forms of coordination and collaboration with private compliance systems in the monitoring and enforcement of public food safety laws. Such policies bring with them the risk of regulatory capture, loss of transparency and fuzzy accountability relationships. In this paper we analyse how the Netherlands Food and Consumer Product Safety Authority (NVWA) assesses and monitors the functioning of private food safety control systems so it can use these private systems in its own enforcement activities. We do so by discussing two national private systems that have been formally accepted by the NVWA and are as such subject to its meta-control. The article examines the safeguards that the public enforcement agency uses while coordinating its own activities with private food safety controls, the advantages and risks involved in this strategy, and the extent to which this policy can be improved. From this we draw lessons for public agencies elsewhere willing to engage with private compliance mechanisms. The study is based on the analysis of policy documents, public and private regulation and open-ended interviews with representatives of the public and private sector in the Netherlands.

Article 88 (1) (a) of Directive 2001/83/EC must be interpreted as meaning that it does not prohibit the dissemination on a website, by a pharmaceutical undertaking, of information relating to medicinal products available on medical prescription only, where that information is accessible on the website only to someone who seeks to obtain it and that dissemination consists solely in the faithful reproduction of the packaging of the medicinal product, in accordance with Article 62 of Directive 2001/83, and in the literal and complete reproduction of the package leaflet or the summary of the product's characteristics, which have been approved by the authorities with competence in relation to medicinal products (official headnote).

The objective of the article is to analyse the use of Humanities and Social Sciences (HSS) in public risk assessment and risk management organisations in France, Germany, the UK, the Netherlands, Canada and the United States based on more than a hundred interviews conducted with social sciences experts employed by or working for these organisations. If the added value brought by the integration of social scientists is recognised, the use of social sciences differs from one organisation to another. The article compares the different positions given to social scientists inside and outside the organisation, the various methods used and the different contents produced. The survey highlights a set of initiatives that are scattered, differentiated and ultimately have little in common – except that they often play a marginal role in the main activities of the agencies concerned.

Case C-442/09, Bablok and Others (not yet reported)

An old German proverb says: What the farmer doesn't know he doesn't eat. In the case of the Bablok decision delivered by the European Court of Justice on 6 September 2011, it is not the farmers, but the judges who seem to be wary about the unknown. According to their judgement, substances derived from genetically modified plants require market authorisation to be placed on the market as food, even if the substance itself is not fertile anymore. Since the Court takes the view that pollen is an ingredient of honey rather than a natural component, honey contaminated with pollen from genetically modified organisms will fall within the classification of foodstuffs requiring marketing authorisation. So whenever a bee collects pollen from a genetically modified plant, this can make the entire honey harvest unmarketable. Not even the slightest contamination will be tolerated, irrespective of whether it was intentional. Because the prohibition to put unauthorised honey on the market applies abstractly, regardless of whether there is a concrete risk for the health of consumers, the judgement will have considerable impact on the coexistence of conventional, ecological and genetically-modified farming.

Joined Cases C-404/12P and C-405/12P

The Aarhus Convention was concluded in order to strengthen the rights of the public on access to information, public participation in decision-making and access to justice in environmental matters. The Convention provides that members of the public shall have access to administrative or judicial procedures to challenge measures by private persons and public authorities that contravene provisions of national law relating to the environment. At EU level, a regulation made the Aarhus Convention applicable to EU institutions. Pursuant to that regulation, review of measures adopted by EU institutions is limited to administrative acts. Two NGOs challenged the legality of that limitation and filed legal action. The case was related to the establishment of EU maximum residue levels for active substances contained in crop protection products. The Commission refused to review this measure which it considered to be no administrative act. The Court of Justice of the European Union has recently given its judgment in that case. The impact of the judgment goes beyond the crop protection sector as it concerns the scope of the internal review concept in general. Further, but not less important, the Court has clarified to which extent international treaties concluded by the EU can be relied upon by individuals.

There is little debate, particularly clear, ‘no bullshit’ debate within the risk and regulation community, much as there is a lack elsewhere within academia. Without it, much goes unclarifed and arguments aren't tested and pushed to their limits, which is generally where they need to go. On these grounds alone I would welcome the different approaches to European/American precaution set out by Vogel and Wiener. But there are more positive things to say about these competing representations, irrespective of which one prefers. This is a discussion rich in empirical detail but that goes beyond individual issues towards systemic patterns, relating the data to wider themes and an overall framework. What's more, it concerns a matter of real contemporary significance and interest that citizens generally – at least those of America and Europe – should know about, and even have a view upon. And it's genuinely interesting – irrespective of any engagement with the academic study of risk and regulation.

The impact of TTIPleaks on the negotiations of and debate about the Transatlantic Trade and Investment Partnership (TTIP) has been more limited than its name and announcement would lead us to expect. This is, first, because the leaked ‘consolidated documents’ only show the European Union's (EU) and United States’ (US) positions on a number of negotiating areas but does not unveil concessions made by either side in the pursuit of a compromise. Therefore, it contains little surprising information for observers of the negotiations. But a second reason for the lack of uproar is that for only about half of the expected chapters in TTIP a text has been leaked, either because there is no consolidated text yet for the other issues in the negotiations or because Greenpreace did not get hold of it. One of the chapters lacking in the TTIPleaks is on ‘Trade and Sustainable Development’. This is an interesting issue area because the advocates often argue that this chapter will help ensure that TTIP upholds and strengthens social and environmental standards.