This year’s last issue of EJRR begins with a timely symposium devoted to the ongoing reform of the EU GMO regime. Following Sara Poli’s lead, an analysis of the latest Commissions’ approach to the cultivation of GMOs in Europe is offered by Maria Weimer, Justo Corti Varela and Shane Morris, by focusing not only on the so called re-nationalisation proposal but also on the new coexistence recommendation.

The title of our new section inevitably evokes a most basic question: What are lifestyle risks? While it is not that simple to define this broad term, in this editorial we aim at introducing the EJRR readership to this fascinating emerging area of risk studies. We shall attempt to describe the nature of lifestyle risks by identifying their main features and by raising some of the fundamental questions that are inherent to any discussion on this topic.

I. Introduction The Commission has proposed to legitimise the renationalization of the cultivation of GMOs (Genetically Modified Organisms) accepting the request of a group of Member States1 who raised concerns at the Environment Council of June 2009 regarding the EU-wide decisions on GMO2 cultivation. Based on subsidiarity grounds, they requested the Commission give the freedom to decide on the cultivation of GM plants to both national and local authorities.

I. Introduction “After a reform is before another reform.” This paraphrasing of a famous saying from the world of football1 seems to be a very fitting way to describe the status quo of the European policy on genetically modified organisms (GMOs). The functioning of the EU legal framework on GMOs has since its initial establishment in the 1990s been troubled by political disagreement, deadlocks in decision-making, strong public opposition in the Member States, and considerable delays in the process of authorisation of genetically engineered products on the internal market of the EU. Despite previous reform efforts, especially the significant reshaping and tightening of EU rules in the period of 2001 to 2003, these problems still remain. This makes EU authorisation of GMOs one of the most controversial and politically intractable policy areas. At the same time the EU institutions experience considerable pressure from the biotech industry and the EU’s trading partners supported by the framework of the World Trade Organisation (WTO) to install a functioning authorisation system compliant with the EU’s internal market as well as WTO law.

I. Introduction: What is coexistence? – From moratorium to partial moratorium The European Union tried to establish a “coexistence” policy for the cultivation and processing of GM and non-GM products after the political agreement that put an end to the 1999-2004 moratorium. Consequently, coexistence is part of this gentlemen’s agreement between States with pro and anti-GMO positions. Anti-GMO States unblocked proceedings of authorisation of new products by accepting the sound science criteria of the risk assessments of the EFSA as almost the only element to open the doors of the internal market. In exchange, these States got the opportunity to decide on how GMO would be cultivated in their jurisdiction, mainly under the pretext of guaranteeing the isolation of the three chains in “coexistence”2. As this article will demonstrate, this basic agreement has not changed.

I. Introduction 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. Recent proposed regulatory changes announced by the European Union Commission (July 13, 2010) aim to allow member states to enact restrictive measures on cultivation of GM crops based on broadly scoped non-scientific criteria1. In light of the European Union Commission’s proposal, this paper reviews the EU’s past efforts to effectively regulate GM crops, critically assesses the impacts of the new regulatory proposals, and examines some of the key outstanding issues with the current EU regulatory framework that will need to be considered as the EU moves forward into its next phase of GM crop governance.

“[…] an office Archimboldi would never forget, because with every shelf crammed full, books and manuscripts collected on the floor in stacks and towers, some so precarious that they in turn spilled over, a chaos that was a reflection of the world, rich and magnificent despite war and injustice, a library of glorious books that Archimboldi would have given anything to read […]”

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.

I. Introduction “Three letters lie at the heart of our modern world: BPA”. “Bisphenol A, commonly known as BPA, may be among the most vilified chemicals”. While the former statement appeared in the New Scientist1, the latter was the incipit of a wonderful piece entitled “The Plastic Panic – How worried should we be about everyday chemicals?” published in The New Yorker last May2. Besides shedding some light on the pitfalls of epidemiological research in general, both articles witness the centrality of the debate surrounding this chemical substance in today’s world. The narrative surrounding BPA sounds familiar to any risk regulation observer. In particular, the classic story of phthalates comes to mind. Today, the use of BPA in certain packaging materials such as polycarbonate

I. Introduction The debate about food additives is not new to the European Union (EU). Indeed, previous Directives and Decisions state that food additives can be used provided certain requirements are met1. What is new however, is the increased concern amongst all relevant stakeholders to ensure the safe use of food additives in foodstuffs by means of adequate labelling and approval procedures with the objective of ensuring a high level of consumer protection and protection of human health. Recently, Regulation (EC) No 1333/2008 on food additives2 (the “Additives Regulation”) entered into force on the 20th of January 2010. It repeals the above-mentioned previous legislation and aims at harmonizing the use of food additives in foods or in other additives or food enzymes on a EU level, and particularly at simplifying the approval procedure for food additives.EJRR 4|2010 Reports 401 Safe Use of Food Additives under EU Law Ioana Ratescu* I. Introduction The debate about food additives is not new to the European Union (EU). Indeed, previous Directives and Decisions state that food additives can be used provided certain requirements are met1. What is new however, is the increased concern amongst all relevant stakeholders to ensure the safe use of food additives in foodstuffs by means of adequate labelling and approval procedures with the objective of ensuring a high level of consumer protection and protection of human health. Recently, Regulation (EC) No 1333/2008 on food additives2 (the “Additives Regulation”) entered into force on the 20th of January 2010. It repeals the above-mentioned previous legislation and aims at harmonizing the use of food additives in foods or in other additives or food enzymes on a EU level, and particularly at simplifying the approval procedure for food additives. Its Preamble clarifies the reasons why this Regulation was approved: “The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.” (Recital 1) and “a high level of protection of human life and health should be assured in the pursuit of Community policies” (Recital 2). The main targets pursued by the Additive Regulation are therefore food safety and consumer protection. It is worthwhile to have a look at the definition of food additive provided by Article 3(2)(a) Additives Regulation: “any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods”. According to this definition therefore, food additives are substances that are not usually consumed as food itself, but that are added to food intentionally for a technological purpose, e.g. the preservation of food. The Additives Regulation covers all kinds of food additives including acidifiers, acidity regulators, anti-caking agents, anti-foaming agents, antioxidants, bulking agents, carriers, colorants, preserving agents and sweeteners. Article 3(2)(a) Additives Regulation contains a list of certain substances that are not considered as food additives: –– foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect; –– substances used in covering or coating materials which do not form part of foods and are not intended to be consumed together with those foods; –– chewing gum bases; –– blood plasma, edible gelatine or protein hydrolysates. The Additives Regulation should be read in conjunction with other EU provisions governing the presentation, commercialization and labelling of foodstuffs: i.e., Directive 2000/13/EC3 as well as Regulation (EC) * Attorney at Law, Schoenherr, Bucharest, Romania. 1 See Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption; Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption; Council Directive 78/663/EEC laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs; Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption; Commission Directive 81/712/ EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity; Council Directive 89/107/EEC of 21December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption; European Parliament and Council Directive 94/35/ EC of 30 June 1994 on sweeteners for use in foodstuffs; European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs; European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners; Decision 292/97/EC of the European Parliament and of the Council of 19 December 1996 on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs; Commission Decision 2002/247/EC of 27 March 2002 suspending the placing on the market and import of jelly confectionery containing the food additive E 425 konjac. 2 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, published in the Official Journal of the European Union L354/16 dated 31.12.2008. 3 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. EJRR 4|402 Reports 2010 No 178/20024 which lay down the general principles and requirements of food law, with the latter establishing at the same time the European Food Safety Authority (or EFSA) and stipulating procedures in matters of food safety. To sum up, (i) the use of food additives must be safe, (ii) there must be a technological need for their use and (iii) their use must not mislead consumers. Indeed, incorrect labelling, advertising and presentation of foods could mislead consumers as to the nature, freshness, and quality of the ingredients used, the naturalness of a product or of the production process, and finally the product’s nutritional quality, including its actual fruit and vegetable content. II. Safe use of food additives through their approval Under the Additives Regulation, food additives may only be placed on the market and added to food if they have been previously approved by the European Commission and have subsequently been included in a Community list of authorised substances. The list will be regularly updated by the European Commission and shall comprise only those substances that comply with the respective sectoral food laws provided for in the Additives Regulation. Food additives can only be approved and included in such lists if they fulfil certain standards. They must not cause any safety concerns to consumer health, their application must be justified by a reasonable technological need that cannot be fulfilled in another economically and technologically feasible way and their use may not be misleading to consumers. Food additives authorised before the 20th of January 2009 are also subject to an assessment5 by the EFSA (so far the EFSA has adopted respective guidance documents on food additives6), and the Community food additives lists should be complete by the 1st of January 2011. Until such date, the Annexes to Directives 94/35/EC, 94/36/EC and 95/2/EC on colours, sweeteners and food additives other than colours and sweeteners for use in foodstuffs, as well as the respective national legislation based thereon, will remain in force and be regularly updated. Additionally, the composition of all food additives placed on the market must comply with the conditions laid down in the Directives 2008/84/EC7, 2008/60/EC8 and 2008/128/EC9 which stipulate specific purity criteria concerning sweeteners, colours and food additives other than colours and sweeteners for use in foodstuffs. Once a food additive has been included in a Community list, any considerable change in its raw materials or in its production methods will result in the additive being considered as a new and different one. The additive must then be submitted to the EFSA all over again for a separate health risk assessment before being allowed on the market. The Community list can be updated either by a direct initiative of the Commission or through an application from a Member State or an interested party. Such an application has to be submitted to the European Commission and will then be forwarded to the EFSA for risk assessment. The EFSA shall give an opinion on the application within a time limit of nine months from the receipt of the application. The time period may be extended in case the EFSA requires further information from the applicant. The standard procedure usually ends with the adoption of a Commission Regulation that updates the Community list within nine months of receipt of the EFSA’s opinion10. In case the Commission requests further information about risk management aspects, this period may be extended. Currently, the Panel on food additives and nutrient sources added to food (ANS) deals with safety issues related to the use of food additives, nutrient sources and other substances deliberately added to food, excluding flavourings and enzymes. Prior to 4 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 5 See Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. 6 Scientific Statement of the Panel on Food Additives and Nutrient Sources added to Food on data requirements for the evaluation of food additives applications following a request from the European Commission, EFSA Journal (2009) 1188, pp. 1–7. 7 Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners. 8 Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs. 9 Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs. 10 See Commission Regulation (EU) No 238/2010 of 22 March 2010 amending Annex V to Regulation (EC) No 1333/2008 of the European Parliament and of the Council with regard to the labelling requirement for beverages with more than 1,2 % by volume of alcohol and containing certain food colours. EJRR 4|2010 Reports 403 the 10th of July 2008 there was a single Panel on food additives, flavourings, processing aids and materials in contact with food (AFC Panel), which was later replaced by two separate Panels: (i) the Panel on food additives and nutrient sources added to food (ANS) and (ii) the Panel on food contact materials, enzymes, flavourings and processing aids (CEF). The two new panels were created in order to further increase EFSA’s pool of expertise and to enhance processes in a field where output is particularly high. Following requests from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers scientific opinions that re-evaluate the safety of certain specific substances already used as food additives11. In line with the European Commission’s request, the EFSA started carrying out assessments of colours as part of its ongoing re-evaluation of the safety of all food additives authorised for use in the EU. In particular, the European Commission asked EFSA to prioritise the assessment of azo dyes colours following publication of a study12 that suggested there is a possible link between certain mixtures of colours (including five azo dyes) and the preservative sodium benzoate and hyperactivity in children. In addition to the above, the approval procedure of food additives must take into account other relevant factors such as societal, economic, traditional, ethical and environmental issues, and of course the precautionary principle and the feasibility of controls. Moreover, the intake of food additives from other sources and the exposure to the food additive by special groups of consumers (e.g. allergic consumers) must be taken into consideration. III. Safe use of food additives through labelling Pursuant to Article 22(1)(a) Additives Regulation, food additives must be labelled with their “name and/or E-number”. The correct name or E-number must be the one as “laid down in this Regulation”. It can be assumed that these names will be those that are already regulated under current national laws on additives. Alternatively, the indication of “a sales description that includes the name and/or E-number” is also allowed. In case several additives are sold in a mix with others, the relevant indication must be provided for “each food additive”. Additionally, Article 22(2) of the Additives Regulation imposes the indication of “a list of all ingredients” which must include other potential food ingredients “in descending order of their percentage by weight of the total”. This provision should be read in conjunction with Article 6(5) Directive 2000/13/ EC relating to the labelling of foodstuffs’ ingredients. Finally, Article 22(3) Additives Regulation provides that substances “added to food additives to facilitate their storage, sale, standardisation, dilution or dissolution” must also be labelled “in descending order of their percentage by weight of the total”. It is worthwhile to note that Article 23(1) Additives Regulation expressly refers to the labelling requirements that are applicable to foodstuffs as provided by Article 3 Directive 2000/13/EC, Directive 89/396/ EEC on indications or marks identifying to which lot a foodstuff belongs and if necessary in line with GMO labelling provisions. Moreover, in the case of additives intended for sale to food businesses it is compulsory to include a mandatory name and the indication “for food” or the statement “restricted use in food” or a more specific reference to its intended food use. Article 23(5) of the Additives Regulation is also noteworthy, since it provides that these indications must be labelled and “easily visible, clearly legible and indelible” and not be “hidden, obscured or interrupted by other written or pictorial matter” in accordance with Article 13(2) Directive 2000/13/EC. In addition, Article 23(2)–(4) of the Additives Regulation provides that the sales description of the products in question “shall include the term ‘...-based tabletop sweetener’, using the name(s) of the sweetener(s) used in its composition”. Besides, this provision specifies that the old compulsory warnings13 related to the use of sweeteners (such as “excessive consumption may induce laxative effects” for sweeteners containing polyols and “contains a source of phenylalanine” for sweeteners containing aspartame/aspartame-acesulfame salt) shall remain in force and manufacturers of the relevant sweeteners “shall make available by appropriate means the necessary information to allow their safe use”. The Additives Regulation also imposes the obligation to inform the Commission immediately of any 11 See Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. 12 McCann et al. in 2007[6]. 13 See European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs. EJRR 4|404 Reports 2010 new scientific or technical information that might affect the assessment of the safety of a food additive on manufacturers or users. Furthermore, Member States shall maintain systems to monitor the consumption and use of food additives on a risk-based approach and report their findings with appropriate frequency to the Commission and the EFSA. IV. Conclusions It would appear therefore that adequate protection systems are in place and that said systems are capable of ensuring a safe use of food additives in foodstuffs. Moreover, the continued surveillance and regular reevaluation of food additives in the light of changing conditions of use and new scientific information will help to further define the needs and the setting of the order of priorities for the competent authorities visà- vis the assessment of the safety of food additives. However, a proper assessment of the actual achievement of the objectives pursued by the Additives Regulation will only be conducted over the next few years. Intellectual Property 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. Seizures of In Transit Generics at the EU Borders: India and Brazil v. the EU Enrico Bonadio and Carlo Maria Cantore* I. Introduction The row between India and Brazil on the one hand and the European Union (EU) on the other regarding customs detentions of Indian generic drugs headed for developing countries may soon come to an end. Indeed, negotiations between the parties are on going and there are constant rumours of an upcoming settlement of the dispute. Yet it remains interesting to analyse this dispute as other countries could take measures similar to those of the EU. In this case, WTO adjudicatory bodies might soon be called upon to assess the compatibility of these measures with TRIPS and GATT provisions. The case was brought to the attention of the WTO on May 2010 by India and Brazil1. These states pointed out that customs rules in the EU, Regulation 1383/2003 in particular, allowed customs authorities to detain certain lots of Indian generics in transit to non-EU states2. From the point of view of India and Brazil, these measures contradict relevant TRIPS and GATT provisions3. The case has spurred a debate because these measures could affect or impede the protection of public health in some countries, namely the African and Latin American states that are usually the final destination of the Indian manufactured generics. Indeed – as India and Brazil have put it – most of these countries are in dire need of reason- * Enrico Bonadio (City University London); Carlo Maria Cantore (Scuola Superiore Sant’Anna, Pisa). Comments are welcome and should be sent to and . 1 Two separate complaints have been filed on May and June 2010, respectively, by India (DS 408, EU – Seizure of Generic Drugs in Transit) and Brazil (DS 409, EU – Seizure of Generic Drugs in Transit) against the EU and one of its Member States (The Netherlands). Hereinafter, for ease of reference, when referring to the defendants we will mention just the EU. Summaries of the two complaints are available on the Internet (India – EU, at ; Brazil – EU, at , both last accessed on 22 October 2010). 2 Regulation 1383/2003 (Council Regulation (EC) No. 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights, OJ 2003, L 196/7). India and Brazil also objected to other EU legislative acts (i.e. Commission Regulation (EC) No. 1891/2004 laying down provisions for the implementation of Council Regulation (EC) No 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights, OJ 2004 L 328/16; Council Regulation (EEC) No 2913/92 establishing the Community Customs Code, OJ 1992, L 302/1; Directive 2004/48 (EC) of the European Parliament and of the Council on the enforcement of intellectual property rights, OJ 2004, L 195/16; Regulation (EC) No 816/2006 of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, OJ 2006, L 157/1) and Dutch provisions (e.g., certain provisions of the Dutch Patents Act and the General Customs Act of the Netherlands) as well as other relevant Dutch regulations, guidelines and administrative practices. 3 Namely Articles V and X of the GATT 1994 and various provisions of the TRIPs Agreement, namely, Article 28 read together with Article 2, Articles 41 and 42, and Article 31 read together with the provisions of the August 2003 Decision on TRIPs and Public Health.

I. Introduction The row between India and Brazil on the one hand and the European Union (EU) on the other regarding customs detentions of Indian generic drugs headed for developing countries may soon come to an end. Indeed, negotiations between the parties are on going and there are constant rumours of an upcoming settlement of the dispute. Yet it remains interesting to analyse this dispute as other countries could take measures similar to those of the EU. In this case, WTO adjudicatory bodies might soon be called upon

I. Introduction Increasing energy consumption and rising greenhouse gas (GHG) emissions have led up to one of the most pressing challenges of the 21st century: climate change. Alarmed by the tangible changes in the climate, both developed and developing countries are making conscious efforts to explore technologies that would help mitigate this phenomenon. International bodies such as the United Nations Framework Convention on Climate Change (UNFCCC), the United Nations Environment Programme (UNEP) and lead-

I. Introduction The regulation of gambling and the national frameworks that govern this particular sector have always been rooted in the inherent social risks associated with this activity. Still today the regulation of gambling in Europe is firmly aimed at the protection of players; protection from addiction, protection from fraud and more generally the protection of public order. For example, the 2005 British Gambling Act mentions in its first article the objective of: “[p]reventing gambling from being a source of crime or disorder … [e]nsuring that gambling is conducted in a fair and open way, and … [p]rotecting children and other vulnerable persons from being harmed or exploited by gambling”. Other national legislations and legislation

In late May 2010, the United Nations (UN) General Assembly passed a resolution to convene a highlevel meeting of the General Assembly on the prevention and control of non-communicable diseases. The meeting will be held in September 2011 and it is envisaged that it will involve heads of state and heads of government. While the exact scope of the issues to be discussed will be the subject of consultations throughout 2010, the meeting can be expected to give political impetus to further risk regulation in this field and may transform the way in which the international community approaches non-communicable diseases (NCDs).

I. Introduction Nanotechnologies use techniques, processes and materials in the approximate range of 1-100 nanometres (nm) in order to create novel properties and to stimulate particular desired functionalities. Nanotechnologies and various nanomaterials are likely to profoundly affect a wide range of industrial sectors, including energy production and storage, health care, consumer products, textiles, and agriculture amongst others.1 Despite the perceived benefits of the technology, there has been an increasing number of calls for governments and other stakeholders to evaluate the adequacy of current health and safety regulatory regimes so as to ensure the effective regulation of current and anticipated applications. In response to these calls, governments in several jurisdictions have initiated in-house or commissioned independent regulatory reviews, each of which has been designed

Case T-212/06, Bowland Dairy Products Ltd v. Commission The Commission, as co-ordinator of the Rapid Alert System for Food and Feed (RASFF), is not entitled to refuse the circulation of a supplementary notification made by a Member State to the system, regardless of its own reservations about the content of that notification. This is in accordance with the non-hierarchical nature of RASFF as a form of risk information exchange envisaged in Article 50 of Regulation 178/2002. However, as the Commission itself is also a member of this network it may legitimately make notifications to the system which directly conflict with notifications made by Member States (author’s headnote).

I. Introduction: The approval of pandemic flu vaccines Authorities sometimes face the tricky decision of reducing the needed extensive research and testing before granting a drug marketing authorization. This is sometimes necessary to make a vaccine available to the public faster (while continuing to conduct extensive pharmacovigilance activity after market approval1).

I. The importance of scientific names of drugs The external presentation of medicinal products is fundamental in ensuring their safe use from a regulatory perspective. Indeed, the primary purpose of labeling and packaging of medicine is the clear identification of the conditions for safe use.

Communicating risks related to public health and safety issues requires careful consideration before widespread dissemination. Communications must first be tested before being released to the public in order to ensure that they are received as intended.1 Designing and dispensing risk communications is a careful process that has evolved over time resulting in current guidelines that are widely accepted among academics. These guidelines are being increasingly acknowledged as an effective regulatory tool in the United States if properly utilized by health and safety regulatory bodies, such as the US Food and Drug Administration. This perspective examines the risk communication best practice guidelines and discusses their potential as an effective health and safety regulatory tool for the European Union.

I. Introduction The recent Panel report in Australia – Apples1 is an important decision that clarifies (but also obscures) a number of interpretative issues arising under the SPS Agreement.2 The report is particularly relevant for the issue of the standard of review applicable under different SPS provisions (i.e. Articles 2.2, 5.1, 5.5 and 5.6), for the participation of scientific experts in the proceeding (regarding both procedural and substantive dimensions), for the content of the required risk assessment as provided by Articles 5.1 and 5.2 and finally for the quasi-consistency requirement of Article 5.5 as well as the extent of the obligation of the least-trade-restrictive alternative (Article 5.6).

Case C-428/08, Monsanto Technology [2010] The Biotech Directive does not provide for absolute patent protection of DNA sequences. Protection is subject and restricted to the disclosed function (or purpose) of a gene; if the function is not fulfilled at the time of the alleged infringement the protection is therefore suspended. National law may not depart from the protection conferred by the Directive due to its exhaustive character (author’s headnote).

Case T-429/05 Artegodan GmbH v. Commission The infringement of Article 11 of Directive 65/65/EEC** and of the proportionality principle are not per se sufficient to require the Commission to provide the applicant with compensation for the damages suffered if they are the result of a decision on the withdrawal of a marketing authorisation should this authorisation be deemed illegitimate and subsequently annulled by the Court (author’s headnote).

Case C-160/09 Ioannis Katsivardas – Nikolaos Tsitsikas OE v. Ipourgos Ikonomikon Article 4 of the Cooperation Agreement concluded between the European Economic Community, of the one part, and the Cartagena Agreement and the member countries thereof – Bolivia, Colombia, Ecuador, Peru and Venezuela – of the other part, approved by Council Regulation (EEC) No 1591/84 of 4 June 1984, is not such as to confer on individuals rights upon which they might rely before the courts of a Member State (official headnote).

Case C-333/08 Commission v. French Republic ‘processing aids’ [2010] ECR-0000 French prior authorisation scheme for processing aids in food production infringes upon Article 34 TFEU** 1. A prior authorisation scheme not complying with the principle of proportionality, infringes upon Article 34 TFEU. 2. A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research. 3. A Member State cannot justify a systematic and untargeted prior authorisation scheme by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of products which may be used or by reason of the fact that manufacturing processes are constantly changing. (author’s headnotes)

Case T-16/04, Arcelor SA v. European Parliament and Council of the European Union nyr 1. The applicant has failed to demonstrate that, in adopting the contested Directive, the Community legislature acted unlawfully or committed a sufficiently serious breach of a rule of law designed to confer rights on the applicant. 2. Consequently, the application for damages must be rejected without there being any need to rule on the other conditions giving rise to non-contractual liability on the part of the Community or on the plea of inadmissibility raised by the Council in relation to certain annexes to the reply. (official headnotes)

This is an excellent book of a legal scholar that examines the cultural dimensions of risk regulation in the EU, the US and Japan. Cross-country comparisons are always welcome, mainly because they are rare. However, this book’s comparative analysis goes beyond that. Firstly, because Ferrari offers a particularly lucid and sharp comparison that, far from becoming a mere description of three different national contexts, brings forward a theoretically informed analysis of

Science and technology are integral parts of public decision-making. The process of expert input represents the sway of knowledge over authority and spans many different situations. Specialists play an important role in communicating knowledge that enables a third person to make an enlightened decision, either in the narrow field of law or in the broad field of politics. Even though the role of experts in public decision-making on an issue that incorporates technical aspects is not something new, the use of expertise

Science and technology are integral parts of public decision-making. The process of expert input represents the sway of knowledge over authority and spans many different situations. Specialists play an important role in communicating knowledge that enables a third person to make an enlightened decision, either in the narrow field of law or in the broad field of politics. Even though the role of experts in public decision-making on an issue that incorporates technical aspects is not something new, the use of expertise by local, national and international decision-making bodies has increased through recognition of the “risk society”. However, between the requirements of democracy and the upheaval in legal rulings, this explosion of expertise entails a whole range of issues. The climate change regime is probably the best example of proliferation of scientific expertise at international level. It is therefore a suitable area to study the links between science and decision-making under uncertainty. The regime itself is indeed based entirely on the warnings and projections of scientists studying different subjects (climate change, economics etc.) under the aegis of a single institution, the Intergovernmental Panel on Climate Change (IPCC). This organ’s successive reports have encouraged the construction, reinforcement and reconsideration of the legal regime for climate change. Thus issues surrounding this phenomenon are as deep as they are numerous: how can a scientific “truth” validly appear at the international level? Are scientists truly free to play their parts? What are the available means for