Responding to public fears and the loss of confidence in the aftermath of several food safety crises in the 1990s and 2000s, more and more regulatory laws have increasingly been affected by the precautionary principle. To clarify how those developments can have adverse consequences, we discuss two very different cases. First, at the molecular level we discuss the problems the system encounters by strictly applying the linear no-threshold (LNT) at low doses model, which was adopted in response to fears about the effects of ionizing radiations. Second, at a global scale, we discuss the problems associated with the precautionary regulation on Illegal, Unreported and Unregistered Fisheries that came into effect January 1, 2010. The technical aspects of food safety testing and their impacts are perhaps unknown to policy makers but they do dominate safety decisions. Both examples show that strict application of the precautionary principle produce deleterious side effects, which go against the very policy values that the precautionary regulation should protect. We show, in particular, that overly precautionary food safety regulation may harm food security. We conclude in the EU and other Western nations, problems of food security are much more relevant to human health and life expectancy than food safety. We recommend that current food safety regulation based on the precautionary risk-regulation reflex should normatively be re-evaluated with a complete regard for the values of food security – both within and outside the EU.

As parliamentarians it is our job to represent the people of Europe and to make laws that are in the people's best interest. This sounds simple at a first glance, but it is not as simple when you think about it twice. A law might be in the interest of the people now, because it has known positive effects in the short term. But sometimes the very same law might bear a risk in the long-term, especially for future generations, and sometimes we can't even tell yet how big that risk is. If we would follow a short-sighted approach which only aims at the expected positive effects without taking into account actual and potential adverse effects that might occur in the future, we would act irresponsibly towards the generations of our children and grandchildren. That is why risk governance and the precautionary principle rightfully play a major role in the daily work of the legislator.

The article examines China's food standardization system, its reform and remaining challenges. Upon examining China's general standardization system, the article argues that the food standardization institutional framework has originated from the general standardization, which has developed a four-level hierarchy mechanism. It further examines the most salient features of China's food standardization system, namely, top-down hierarchy and intensive government involvement, and suggests that these features caused a regulatory failure. Although China recently reformed this fi eld, and the food safety standard hierarchy has been streamlined, challenges remain. The article reviews China's current reform in the food standardization system by providing a description, analysis and comparison of approaches from Europe and China.

The novelty in Adam Burgess’ paper is that he assesses nudge policies in the context of the shift in the UK government's approach to risk from the nannying policies of Labour to the nudge policies of the Conservatives. There is a wealth of ideas in this paper. I find it useful to disentangle some of these ideas focusing on the following two questions:

1. 1. In what respects do Labour's nannying policies and the Conservatives’ nudge policies differ?

2. 2. What is problematic about Labour's nannying and the Conservatives’ nudge policies?

Subsequently I will reflect on how a particular strand of research in the social sciences can be made relevant to designing a more responsible way of dealing with societal risk and show how this approach can evade some of Burgess’ concerns.

Former Soviet republics and other countries of the ex-Communist “block” may seem unlikely places to look for inspiration in “better regulation”. In fact, their experience in moving away (with varying degrees of success) from an approach based on “total control” and complete risk-aversion (an absolute RRR, as it were) may be an opportunity to get many insights. Data from surveys conducted by the World Bank Group allows to shed light on trends in regulatory delivery, and in particular in inspections, which is the primary way in which the RRR is felt by businesses. This paper describes the starting situation, analyses the reform processes and their outcomes, and attempts to draw some lessons – as well as some comparisons with situations and experiences in EU and OECD countries. Tentative conclusions suggest both that addressing the inspections and control issue (and not just regulations themselves) is crucial to success in reform, and that reducing the “pressure” from total control through a “risk-focused” approach leads to real improvements in the business climate without negatively affecting public safety.

Nowadays, biotechnologies are among the most interesting areas of science. Their development, fostered by intellectual property (IP) rights’ protection, leads to useful progress. Nonetheless, when, as with biotech inventions, environmental protection is at stake, this progress is not without controversy. The present contribution aims at examining the interferences between IP and environmental protection, as emerging in the framework of the European Patent Convention. To this extent, it will focus on the function and on the limits of the ordre public exception clause, with the purpose of suggesting a new role for science in disputes for revocation of biotech patents.

For more than 10 years, I have had the privilege of being Vice President of STOA, the European Parliament's Science and Technology Options Assessment arm. During that time, I have been part of the team that has refocused STOA towards the crucial role of monitoring trends in science and technology, commissioning research to examine the implications for policy makers, and organising events to disseminate results.

During the same period, my work as a legislator has made me more and more aware of the need to examine science and technological trends, in order to ensure that the legislation that we amend and approve is truly “fit for purpose”. We are not afraid to recommend changes where we think that technological developments will make suggested provisions redundant or ineffective. To give a recent example, in our review of the Directive on Consumer Rights, we insisted on including new provisions to safeguard consumers buying faulty digital products or services. These were not included in the original text, but were subsequently agreed by the Member States and the European Commission.

Information dissemination across the supply chain to consumers about chemicals’ hazardous properties and presence in consumer products has been recognized as insufficient to improve to enable both producers and end-users to avoid hazardous chemicals and to manage risks to human health and the environment. A comparative analysis of the information requirements in four EU legislations (the CLP, the Cosmetics regulation, REACH, and the Toys Safety Directive) and three US legislations (California's Proposition 65 and Senate Bill 509, and the national TSCA) was conducted with the aim of studying to what extent existing regulatory information approaches require information to be disseminated to consumers. In general, the European legislations address and promote consumers’ access to information on chemicals in products more comprehensively than the American legislations, but the amount and type of information required to be disseminated to consumers varies widely. These differences include which chemicals are prioritised, if the chemical is used in a mixture or an article, what information dissemination strategies are used, and who is responsible for consumers accessing the information. It is recommended that chemical information policies should, at minimum, require chemical suppliers to inform consumers of hazardous chemicals present in their products and, if possible, recommend risk management measures to ensure a safe use of consumer products.

This article looks back at the history and legacy of the Risk and Regulation Advisory Council in the UK. The Council was the first government body to explicitly challenge a culture of overreaction to ‘public risk’, one of a number of ways in which it was a unique and interesting experiment in addressing the political dimension of contemporary regulation. Whilst the RRAC was ultimately unsuccessful in bringing about a change in how risk is managed by government it has, at least, left a useful intellectual legacy and, more practically, its work is effectively being taken forward by the Risk and Responsibility programme of the Dutch government.

Recent calls for transparency targeted towards regulatory bodies such as the US Food and Drug Administration has prompted investigation into the indubitable adoption of such measures. Specifically, the FDA's quarterly postings of AERS (Adverse Event Reporting System) signals on its CDER (Center for Drug Evaluation and Research) website, stemming from FDAAA legislation introduced in September 2007, is analysed from a risk perception and communication perspective. This paper consists of two qualitative studies examining public perceptions and subsequent reported behaviour related to increased transparency. Interviews were conducted on two separate samples of seventy respondents in both Pittsburgh and New York City. The results found that signals postings may prove counter productive in terms of increased public alarm and early or inappropriate termination of a drug appearing on the list. We also found communication from the FDA perceived as inaccessible or confusing, particularly that the AERS signals are posted strictly on the web, while the majority of our respondents cited their primary and secondary media sources as broadcast television. We recommend that the FDA reconsider its communication strategy of AERS to the public as it may prove to be a ‘transparency step too far.’

The adoption by WTO Members of measures relating to the protection of health and life of animals, plants and humans is regulated by the WTO Sanitary and Phytosanitary (SPS)Agreement. A fundamental question in the application of this agreement concerns the distinction to be drawn between legitimate regulation and unlawful restriction of trade. This distinction can be difficult to discern, particularly since different communities have different levels of tolerance for risk, which leads to varying national regulatory decisions. This paper critically examines the approach taken to this question in rulings of the WTO dispute settlement panels and Appellate Body, highlighting and analysing three emergent issues:the role attributed to science, the two stage review process adopted and the application of the principle of mutual recognition. The importance of deliberative decision-making inthis context is emphasised, as is the need for recognition and acceptance of the regulatory diversity that this will bring.

This article discusses a number of pitfalls of the US-Tuna II Panel Report. This Report is interesting because it offers an occasion to reflect on some provisions of the Technical Barrier to Trade (TBT) Agreement, which may be crucial for the assessment of the legality of environmental labelling regimes. The most troubling part of the Report is the one dealing with the trade-restrictive nature of the measure. The Panel seems to have relied on a test by which if a measure does not reach its objectives perfectly, any other ineffective measures adopted with allegedly the same goals can be judged as a valid less-trade restrictive alternative. In other words, two wrongs seem to make a right in the view of the Panel; a conclusion that, for obvious reasons, will not be greeted with enthusiasm by environmentalists.

The Rapid Alert System for Food and Feed (the socalled ‘RASFF’) is at the heart of food risk management within the European Union. It aims at providing authorities with an effective tool for exchanging information on measures taken to ensure food safety. It was created in 2002 by the General Food Law Regulation to help Member States to coordinate their food safety actions. Nearly ten years later, the adoption of Regulation 16/2011 of 10 January 2011, laying down implementing measures for the RASFF, intends to clarify the specific conditions and procedures applicable to the transmission of notifications through this tool, thus providing more legal certainty in the system.

On 2 March 2010 the European Commission authorised the cultivation of a BASF's genetically modified potato “Amflora” throughout the European Union. This came after a tortuous process commenced in 1996 and so far it is the only authorisation of a GMO for cultivation in EU since the current regulation was established. On 3 March 2010, President Barroso announced that the Commission intends to propose amendments to the current regulation to allow the Member States to prohibit the cultivation of GMO authorised for cultivation in the EU and it did so on June 13, 2010. This is one of the very few cases where decision-making power is effectively devolved back from Union to state level; it is even more impressive that this is happening on the initiative of the Commission and despite the obvious negative consequences for the internal market. In the meantime BASF botched the 2011 growing season for Amflora in Sweden and in 2012 announced that it withdraws its GM crops from the EU. This article follows the saga purports to find the reasons why it entailed an immediate change.

The requirements of free trade and economic globalisation and the respective international legal framework, namely in the context of the WTO, have led to a decrease of the regulatory power of the nation states which cannot be replaced by comparable public international law making – neither in content nor with respect to legitimacy considerations.

The Dutch Risk and Responsibility programme (DRRP), which builds on the pioneering work that the BRC and RRAC carried out in Britain, is nearing completion. This article describes the background and course of the programme and offers a glimpse of the preliminary results. DRRP has created awareness of the ‘risk regulation reflex’ among a wide array of people and organisations. That term originated during the Day of Risk, a landmark conference that took place in The Hague marking the start of a fertile international network.

Many European countries, including Switzerland, share deep suspicions about the broad commercial application of Genetically Modified Plants (GMP) in agriculture. Research in GMP, however, is mostly welcome. In Switzerland, nevertheless, an overprotective legal framework against risks of GMP results in regulatory spillovers for research. This article explores how such expanded legal protection in combination with the application of a strong precautionary principle hampers freedom of research in the field of green gene technology. The authors do not seek, on this occasion, to question the general risk assessment of Swiss legislators and their desire for a high level of protection. However, field trials with GMP will cease to take place if the procedural burdens for researchers are not reduced. In particular, it will be vital to establish research zones (“protected sites”) if research in GMP is to continue to take place in Switzerland.

Following the accident at the Fukushima nuclear plant on 11 March 2011, the European Union was informed that radioactive levels in certain food products originating in Japan, such as milk and spinach, exceeded the normal permitted levels under Japanese legislation. The European Commission judged that such levels of radioactivity could pose a threat to public health in the European Union and therefore began introducing specific additional import conditions for Japanese food products as a precautionary measure.

EU legislation on genetically modified organisms (GMOs) is the most stringent legislation governing the matter in the world, laying down strict conditions relating to labelling, traceability, threshold and release on the market. In light of a recent Commission proposal to amend Directive 2001/18, which currently regulates the release of GMOs on the European market, this article asks whether and on what basis such stringency is justified. This is done through an in depth analysis of the EU regulatory framework for GMOs while at the same time highlighting the multiple interests at stake (environmental, scientific, industrial, political, national and European).

This article argues that the European institutions should proceed to amend Directive 2001/18 on the basis of a detailed examination of the benefits as well as the risks that GMOs present. This article, however, raises concern that the European regulatory framework will focus exclusively on the risks or on political concerns relating to GMOs instead, for it is a fear of GMOs that seems to permeate the system from top to bottom.

With the Communication on Smart Regulation issued in October 2010, the European Commissiontried to foster a better management of the whole policy cycle. According to thatCommunication, amending policy proposals must be preceded by an ex-post assessmentof the current situation, allowing “closing the policy cycle”. This paper tries to answer thequestion whether the EU Impact Assessments System is fit to steer and close the policy cycle,and what is the relation between ex-ante IA and ex-post evaluation “on the ground” so far. This is done via a macro and micro analysis, based on scorecard approach and three casestudies, comparing the EU IA system performance with a theoretical benchmark derived from the EU policy document and process. The paper concludes that the EU Impact Assessmentsystem, as it is currently designed and implemented, is not yet fi t to steer and closethe policy cycle. To achieve this goal, all the analytical and empirical layers of the policycycle should be fully dealt with since the ex-ante phase.