STOA, the European Parliament's Technology Assessment body, which I had the honour to chair, has a mission to: (i) assess the impact of introducing and promoting new technologies, and (ii) identify the relevant policy options. In the context of its work, STOA has to address many different issues. One of the issues deserving STOA's attention is the changing face of risk governance: “Moving from precaution to smarter regulation”.

This is currently being debated on various levels, including that of the WTO (World Trade Organization), where science-based decision-making has always played an important role. The JRC (Joint Research Centre) is very active in this field and has developed, among others, a science-based approach to risk assessment in the area of nanotechnology. With the comitology procedure becoming more and more important, the European Parliament and its members have to assume their role with respect to risk management and explain it to the public.

The precautionary principle in public decision making concerns situations where following an assessment of the available scientific information, there are reasonable grounds for concern for the possibility of adverse effects on the environment or human health, but scientific uncertainty persists. In such cases provisional risk management measures may be adopted, without having to wait until the reality and seriousness of those adverse effects become fully apparent. This is the definition of the precautionary principle as operationalized under EU law. The precautionary principle is a deliberative principle. Its application involves deliberation on a range of normative dimensions which need to be taken into account while making the principle operational in the public policy context. Under EU law, any risk management measures to be adopted while implementing the precautionary principle, have to be proportionate to ensure the chosen high level of protection in the European Community.

This article will illustrate the established practice concerning the release of genetically modified organisms into the environment and how the principle is implemented under hard law. The article also provides an outlook on what this may imply for the relative new case of nanotechnology and the use of precautionary principle within the context of soft law (use of codes of conduct).

Both the Lisbon Treaty and the new Inter-Institutional Agreement strengthen the role of the European Parliament (EP) as co-legislator. At the same time, European Union (EU) officials increasingly recognise the need for broader acceptance of the principles and agreements of the Better (Smart) Regulation strategy, as proposed in an October 2010 Commission Communication. There is a need to make high quality risk management decisions in a more risk averse environment and a changed policy framework. Indeed, principles supporting better regulation have become more widely adopted by all EU institutions, notably with the Impact Assessment Board (IAB) of the European Commission, which now screens all new proposals. Due to the broad diffusion of these principles, risk assessment techniques have become more widely understood. This trend is particularly salient in four areas of application: (1) the on-going debate between regulating by hazard and regulating by risk; (2) a better understanding of the nature of risk/risk trade-offs, (3) use of benefit/risk assessment, and (4) the Commission Communication regarding the precautionary principle.

This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.

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.

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.

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.

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.

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.

In September 2011, the World Trade Organization (WTO) released the report of a panel tasked with considering a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The panel concluded that the US violated WTO law and recommended that the US be asked to bring its laws into conformity with WTO law.

The US appealed the panel's decision. The Appellate Body of the WTO upheld the panel report on April 4, 2012. This case note gives a brief overview of the Appellate Body's report and examines the implications for tobacco control and public health more generally.

Case C-442/10, Churchill Insurance Company Limited v Benjamin Wilkinson and Tracy Evans v Equity Claims Limited [2011] ECR I-00000

Article 3 No. 1 of Council Directive on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability, as amended, codified and repealed by Directive 2009/103/EC, OJ L - 103, of 02.05.1972. pp. 1–6. [First Motor Insurance Directive]

Article 2 No. 1 of Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 8, of 11.01.1984. pp. 17–20. [Second Motor Insurance Directive]

Article 1 No. 1 of Third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 129, of 19.05.1990. pp. 33–35. [Third Motor Insurance Directive]