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The Precautionary Principle in EC Health and Environmental Law

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Abstract

Envisaging anticipatory preventive action in response to uncertainty, the precautionary principle represents an important milestone in risk reduction. The question is no longer merely how to prevent assessable risks, but rather how to anticipate risks pervaded by uncertainty. By leaving behind the realm of "sound science," precaution necessarily gives rise to conflict. As regards the status and the implementation of that principle, the aim of this article is to explore some of the key issues arising in environmental and food safety cases brought before the Tribunal of First Instance, the European Court of Justice and the EFTA Court.

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... More specifically, under the framework set by Article 13, genetic interventions are considered to be medical acts of preventive, diagnostic, or therapeutic purpose, the performance of which presupposes the informed consent of the person concerned (Articles 5 and 6 of the Oviedo Convention and Article 3 of the EU Charter of Rights). If such interventions are performed in a clinical research context, they need to comply with the additional requirements set by the Oviedo Convention (Articles [15][16][17]. According to the latter, research is allowed if: (a) no alternative research method exists; (b) potential risks are not disproportionate to expected benefits; (c) scientific and ethical approval by competent bodies is in place; and (d) after fulfilling these terms, specific informed consent in written form has been obtained by the person concerned. ...
... Originating from environmental law (with regard to the management of genetically modified organisms, in particular), the so-called "precautionary principle" is now a legal standard [14,15] (pp. 141-144) that should be taken into account in medical applications as well [16]. ...
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To date, the legal aspects of the ongoing debate on the application of genome editing in human gametes and early embryos have attracted little attention. In Europe, this seems to have changed with a recent official position that clarifies the meaning of the relevant provision of the common legal instrument on Human Rights and Biomedicine (Oviedo Convention). This provision explicitly prohibits modifications to the genome of future persons and adoptes a precautionary stance with regard to genetic interventions in the human reproductive material. In this article, we examine relevant interpretative options, following the new official clarifications, focusing on the research/clinical application distinctions that characterize their approach. From this viewpoint, we propose an approach that favors basic research activities involving genome editing, even for exploring potential clinical applications under conditions of safety, which may justify a future legislative amendment. Furthermore, we explore the patenting issue, based on the current approach of European case law, and give reasons that may justify patent rights in this ethically sensitive area.
... More generally, divergences may be explained by the fact that the PP operates in a number of different contexts. According to De Sadeleer, within the EC jurisdiction, the development of clear and consistent jurisprudence is made difficult by the complexity of regulatory regimes and by the broad discretion in the application of the PP by decisionmakers (De Sadeleer, 2006). Some authors compared the approaches to risk regulation in the EU and in the United States and verified, that both jurisdictions partake in "occasional and selective application of precaution to different risks in different places and time" (Wiener, Rogers, Hammitt, & Sand, 2011). ...
... This may help to overcome the problem of assessing the suitability of precautionary interventions due to the difficulty in judging the likely outcome of events. This process should consider several methodological steps 1 Many studies of a conceptual or empirical nature have been dedicated to the PP and related issues in various scientific domains, such as international law, political science, ecological economics, and environmental governance (Myers & Raffensperger, 2005;De Sadeleer, 2006;Iverson & Perrings, 2012). ...
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This study intends to clarify how the precautionary principle (PP) has been interpreted and applied by the courts in Portugal in the analysis of conflicts associated with uncertain and serious potential risks to human health and the environment. It also aims to contribute to the debate of when and how to apply precautionary measures. To this end, recent court cases in the areas of waste incineration, high‐voltage power lines, as well as dam and wind farm construction were considered. The degree of consistency in the courts’ decisions and their reasons in the different judicial bodies was analyzed with the support of a theoretical framework based on three attributes: the level of seriousness of potential hazards, level of evidence required, and the severity of precautionary actions taken. Different positions among courts were observed, with contradictory arguments in the same case or in similar cases. A greater propensity for favorable decisions in the acceptance of restraining orders was verified in the courts of lower instances, where human health could be threatened. However, the decisions of the Supreme Administrative Court, which were always unfavorable to the restraining orders, seem to reflect the priority given to national economic and political interests over local or regional environmental interests. They may also reflect the Supreme Court's reluctancy to apply the PP in the absence of a firm legally binding PP in national legislation. To address this situation, more explicit legal requirements and criteria for the analysis of uncertain risks and the weighting of interests by area of activity are needed.
... Although the current approach has been conceptualised with reference to individuals' optimal risky choices, it can equally be employed for regulatory purposes such as the setting of risk tolerance standards. Applications of this kind may not seem obvious since administrative risk regulation is guided (albeit not exclusively, see Bowen & Panagiotopoulos, 2020) by the precautionary principle rather than principles of optimal choice (de Sadeleer, 2006;Fisher, 2007). But introducing x 0 as an aspiration level amounts to setting standards of positive and negative consequences for risk management decisions. ...
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The paper develops a conceptual framework for the analysis and management of catastrophic risk. The framework serves to assess rare extreme events in systematic, quantitative and consistent ways. It dispenses with probabilistic extreme value theory, concentrating on descriptive statistics and simple probability distributions. Risk assessment is based on a recently developed axiomatic approach to non-expected utility preferences defined on the set of risky alternative courses of action available to an agent. The utility values of catastrophic risks are given an explicit algebraic representation, which shows them to be highly unstable (“elastic”) in the sense that they respond disproportionately to small perturbations of the decision outcomes and their probabilities. Various elasticity coefficients are defined for the outcome variables and utility preferences attached to them. They indicate whether a variable possibly takes on large negative values. The coefficients can also be defined as sample statistics and, thus, computed from observed data. The approach admits various applications to practical problems of disaster risk management. The applications include estimations of the effectiveness and cost-efficiency of risk management, the specification of limits of acceptance of catastrophic risk for regulatory purposes, and safety and security systems design and dimensioning.
... 35 Uit het -in het internationaal recht erkende -voorzorgsbeginsel volgt dat, indien er, met enige onzekerheidsmarge, wetenschappelijk bewijs bestaat over de mogelijke risico's van bepaalde activiteiten voor de volksgezondheid, overheden preventieve maatregelen moeten nemen om schade te voorkomen. 36 Dit kan aan de orde zijn als de voedselomgeving erg ongezond is. Uit recent onderzoek volgt dat gemeenten in dit geval redelijkerwijs kunnen proberen om gebruik te maken van hun bevoegdheden in het omgevingsrecht, en bepaalde voedselaanbieders kunnen weren. ...
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De regulering van de leefomgeving als onderdeel van het gezondheidsrecht past in de trend van een meer expliciete verbreding, maar ook internationalisering van het Nederlandse gezondheidsrecht. In de loop der tijd is het gezondheidsrecht uitgedijd tot een gevarieerd terrein dat raakt aan vele dimensies van het internationale - Europese - en Nederlandse recht. De stijgende zorgkosten nopen tot een bredere kijk op gezondheid en tot een transitie van zorg naar gezondheid. Dit betekent onder meer dat preventie ook wordt gezien als een voorwaarde om de toegang tot zorg betaalbaar te houden. Preventie bestrijkt onder meer de noodzaak om de gedragsrisico’s voor chronische ziekten terug te dringen, waaronder roken, alcoholgebruik en ongezond voedsel. In deze bijdrage richten wij ons op de regulering van één van deze gedragsrisico’s, namelijk ongezond voedsel en met name fastfood. Ongeveer 60% van de volwassenen en één op de drie kinderen in de Europese Unie (EU) kampt met overgewicht of obesitas. In de afgelopen decennia is het aantal mensen met overgewicht en obesitas alleen maar gestegen, en geen enkel land in de EU is op weg om de doelstellingen voor het verminderen van overgewicht tegen 2025 te halen. We beginnen met een normatieve vraag: is er zoiets als een recht op gezond voedsel, en, – zo ja – hoe ziet dat recht eruit? Vervolgens bespreken wij de verschillende reguleringsopties die de overheid ter beschikking heeft om ongezond voedsel te reguleren, zoals prijsmaatregelen en het nader reguleren van de marketing. Tot slot richten wij ons specifiek op een van de dimensies van voedselregulering, te weten het reguleren van de gezonde voedselomgeving.
... Rather, it appears in European legislation applicable to technology, viz. in Article 23 (the Safeguard clause) of Directive 2001/18/EC on the release of genetically modified organisms (GMO) at the European Community level; and Article 34 of Regulation no. 1829/2003 on the consumption of GMOs as food or feed; and it has been invoked in technology cases before the European Court of Justice (Rogers 2011), such as in cases relating to food safety (Sadeleer 2006), plant fungicide (ECJ 2010), and the legal status of food containing trace amounts of genetically-modified DNA (ECJ 2011). And at least one researcher has argued that the Precautionary Principle appeared in U.S. legislation and related case law starting in 1970 (Ashford 2007: 354, 361). ...
Article
Since being globalized by inclusion in the 1980’s and 1990’s through several U.N. declarations and treaties, the Precautionary Principle has become a flashpoint internationally among scholars working in the fields of risk, international environmental law, European Union law and even U.S. federal law. The controversy surrounding the Precautionary Principle apparently arose and persists because the Principle is undertheorized. We revisit three fundamental questions: what is the Precautionary Principle, where did it come from, and how should we use it. Because the Precautionary Principle is a legal tool that is used internationally to manage technology, a comprehensive discussion of it is organically international and interdisciplinary. We argue that the Precautionary Principle is an index of formative measures of risk and fear; that its origins should be investigated specifically in relation to the particular legal instrument in question; and that it should be utilized only as an indicator of public perception and not as a prescriptive risk management tool. Because the Precautionary Principle is currently utilized internationally as a prescriptive tool, our recommendation is both controversial and non-trivial.
... Whereas Directive 85/374 strives to achieve not only compensation for the victim but also a balance of interests, it is conceivable that the rights and interests of the victim may, in certain cases, be sacrificed for the general interest of society and social welfare. Such a balance of public interests for the common good of society could be described in the context of risk as risk management, which, according to Sadeleer, is a process of deciding how safe is safe (Sadeleer, 2006). ...
Article
Purpose. Every day, the COVID-19 pandemic, which began more than a year ago, causes significant human and economic losses worldwide. It is reasonable to believe that the long-term solution to the pandemic crisis is an effective and safe vaccine. However, the development of such a vaccine is an extremely complex and lengthy process, which usually takes a few years and, in some cases, more than a decade. The COVID-19 vaccine strategy adopted by the European Commission (hereinafter in the text: the Strategy) states that its main objective is the development of a suitable vaccine within a period of 12-18 months (COM (2020) 245 final). Furthermore, in the Strategy it is stated that such vaccines should be effective, safe to use and of high quality.
... In such cases the definition of the precautionary principle as established by the Court is used to review whether the measure taken is based on an appropriate risk assessment and whether it is proportionate. 61 These cases often revolve around the standard of proof and how much or which type of evidence of risk is required to apply the precautionary principle. 62 This limited review due to a wide margin of discretion, which is not only to be found in EU law but also for example in common law courts, leads to a review that places substantive matters largely outside the remit of the review, while it focuses on procedural matters. ...
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The approval renewal of glyphosate as an active substance for pesticides in the EU has also kept the Court of Justice occupied. Within this line of case law, the Blaise case is the most recent one. In this preliminary reference procedure the Court was asked to review the validity of the Plant Protection Products Regulation 1107/2009, examined against the precautionary principle as benchmark. The case is relevant not only for the questions raised about the Regulation, but also as it sheds a light on the – albeit limited – use of the precautionary principle in the judicial review of EU legislative measure.
... Further, by formally informing patients about the defined parameters around which a particular vitalistic concept (e.g., aggravation) might be applied, they are likely to become more actively engaged participants in seeking out appropriate care as needed. Such a policy approach represents a regulatory application of the precautionary principle, which holds that where the risk of substantial harm exists, scientific uncertainty should not preclude pro-active measures being taken (de Sadeleer, 2006). This harm reduction principle has been widely applied in environmental and health law contexts across the globe, but to the author's knowledge has not yet been formally articulated in the context of T&CM professional regulation. ...
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While the principle of risk reduction increasingly underpins health professional regulatory models across the globe, concepts of risk are neither static nor epistemically neutral. Conventional biomedicine's risk conceptions are substantially rooted in principles of scientific materialism, while many traditional and complementary medicine systems have vitalistic epistemic underpinnings that give rise to distinctive safety considerations. The statutory regulation of traditional and complementary medicine providers has been identified by the World Health Organization as a strategy for enhancing public safety. However, complex risk-related questions arise at the intersection of medical epistemologies whose concepts are at best overlapping, and at worst incommensurable. Elaborating a theoretical concept of “paradigm-specific risk conceptions,” this work employs Bacchi's poststructural mode of policy analysis (“What's the Problem Represented to Be?”) to critically analyze risk discourse in government documents pertaining to the 2015 statutory regulation of homeopathic practitioners in Ontario, Canada. The Ontario government's pre-regulatory risk assessments of the homeopathic occupation discursively emphasized cultural safety principles alongside homeopathy-specific risk conceptions. These paradigm-specific concepts, rooted in homeopathy's epistemic vitalism, extend beyond materialist constructions of adverse events and clinical omission to address potential harms from homeopathic “proving symptoms”, “aggravation,” and “disruption,” all considered implausible from a biomedical standpoint. Although the province's new homeopathy regulator subsequently articulated safety competencies addressing such vitalistic concepts, the tangible risk management strategies ultimately mandated for practitioners exclusively addressed risks consistent with the scientific materialist paradigm. This policy approach substantially echoes the implicit biomedical underpinnings evident in Ontario's broader legislative context, but leaves a significant policy gap regarding the primary safety considerations originally articulated as substantiation for homeopath's statutory regulation. To optimally preserve patient safety and full informed consent, regulators of traditional and complementary medicine professionals should favor a pragmatic, epistemically-inclusive approach that actively negotiates paradigm-specific risk conceptions from both biomedicine and the occupation under governance.
... Under a socially acceptable risk approach, as enshrined in EU risk regulation, setting out the acceptable level of risk for society is an 'eminently political responsibility'; 135 EU risk managers have the political responsibility to decide whether to act, when is 'safe' safe enough 136 and how safe is 'safe'. 137 As already explained, this enshrines the superiority of democratic legitimacy and politics over functional legitimacy and technical expertise: 138 if the opposite were the case, the EFSA would be a European version of the American FDA. Nonetheless, the Commission has clearly taken a very different perspective throughout its handling of the glyphosate case. ...
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This article endeavours to explore the glyphosate saga through the prism of a socially acceptable risk approach to the governance of public health and environmental risks in the European Union. After a brief overview on the nature and rationale of socially acceptable risk approaches, the article analyses the controversial case of glyphosate’s renewal of approval, casting light on the position of the agencies and institutions involved throughout the risk assessment and risk management phases. Against this overall backdrop, the article deconstructs the European Commission’s artificial legal narrative on ‘sound’ science and glyphosate and contends that the Commission had scientific and legal grounds, as well as compelling political reasons, to accept the requests put forward by the ‘Ban Glyphosate’ European Citizens’ Initiative and the European Parliament. The Commission relied on a narrow evidence-based approach, disregarding the widespread public perception that the uncertain risks posed by glyphosate are socially unacceptable, and ignoring the argument that the existing risk management measures are insufficient to achieve the intended EU level of public health and environmental protection. In so doing, the Commission has ultimately lost a crucial opportunity to re-legitimise and re-democratise EU risk regulation.
... Their legal nature -and the opposability to States of the rules and standards that these principles embody -is therefore put at stake, depending on the texture of their obligations, the legal context where they appear and their implementation and enforcement, mostly at the domestic level but not only there since States invoke them in their claims 15 Wolfrum (1990). 16 Douma (2002), de Sadeleer (2006. 17 Barboza (2011), Fitzmaurice (2001. ...
... Their legal nature -and the opposability to States of the rules and standards that these principles embody -is therefore put at stake, depending on the texture of their obligations, the legal context where they appear and their implementation and enforcement, mostly at the domestic level but not only there since States invoke them in their claims 15 Wolfrum (1990). 16 Douma (2002), de Sadeleer (2006). 17 Barboza (2011), Fitzmaurice (2001. ...
Chapter
Environmental law principles and the general principles of international law are deeply interconnected as they interact as communicating vessels between international and domestic law systems. Despite the academic debate on their definitions and the indeter- minacy of their legal nature, they prescribe limits to state sovereignty to protect the envi- ronment, as well as playing different roles and functions. They inform norm-creation and policy-making at international and domestic levels, as well as norm-application. These principles are referential in dispute settlements between States as well as in domestic courts. Both help to solve the systemic tensions in the international legal system, building bridges to other sectorial regimes with which they intersect, such as international trade law or humanitarian law. This chapter will examine these issues and conclude with state- of-the-art principles that inspire the evolution of international environmental law.
... Their legal nature -and the opposability to States of the rules and standards that these principles embody -is therefore put at stake, depending on the texture of their obligations, the legal context where they appear and their implementation and enforcement, mostly at the domestic level but not only there since States invoke them in their claims 15 Wolfrum (1990). 16 Douma (2002), de Sadeleer (2006). 17 Barboza (2011), Fitzmaurice (2001. ...
Preprint
Environmental law principles and the general principles of international law are deeply interconnected as they interact as communicating vessels between international and domestic law systems. Despite the academic debate on their definitions and the indeter-minacy of their legal nature, they prescribe limits to state sovereignty to protect the environment , as well as playing different roles and functions. They inform norm-creation and policy-making at international and domestic levels, as well as norm-application. These principles are referential in dispute settlements between States as well as in domestic courts. Both help to solve the systemic tensions in the international legal system, building bridges to other sectorial regimes with which they intersect, such as international trade law or humanitarian law. This chapter will examine these issues and conclude with state-of-the-art principles that inspire the evolution of international environmental law.
... Precautionary principle also helped bring focus on the potential of public participation in ascertaining the appropriate level of risk that different governments might deem as acceptable within their polities (Foster, 2008), given the cultural specificities of risk among different societies (Douglas, 1992). Despite controversies about the acceptability and application of the principle in international law -starkly visible in the transatlantic regulatory disagreements about the use of GMOs, asbestos and Beef Hormones, precaution had become a ubiquitous feature in the stated ambitions of risk regimes across the world by the turn of the century (Applegate, 2002; The World Commission on the Ethics of Scientific Knowledge and Technology, 2005; de Sadeleer, 2006). Hence, to understand how knowledge production that is driven by large-scale automated aggregation of disparate data impacts contemporary risk regulation, it is important to place it within the trajectories of precautionary discourse. ...
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Automatic aggregation of large-scale data is increasingly conceived as central in the production of ecological knowledge. This article examines the implications of the employment of automation techniques and ‘data-driven analysis’ in long-term biodiversity monitoring. What are the pathways and paradoxes in the possible public acceptance of automated data-sets as a trustworthy source for use in global protection and regulation of biodiversity? This article suggests that the precautionary discourse aid topdown measures for the public acceptability of the use of such techniques. Automated biodiversity monitoring offers distinctive advantages to further precautionary goals in terms of a faster, cost-effective and less messy way of collecting data, at a large scale over long periods of time. However, it contradicts other values implied through precaution – for instance the opacity and reification of the construction of risk. How do the specific forms of data-making relate with specific forms of risk governance, and what implications does this have for helping us to understand appropriate ways of political representation in governance? Can paradoxes attendant to introducing a form of construction of data help understand the nature of the exercise of governmental power? [Box: see text]
... They criticize a lack of effort 14 The precautionary principle is a striking example of problems with operationalizing hypothetic knowledge for legal action: "The [European] Court of Justice and Court of First Instance, as well as the EFTA Courts, reply to this [speculative health risks] is that a preventative measure cannot properly be based on a purely hypothetical consideration of the risk, founded on mere conjecture that has not been scientifically verified. It follows that there must exist a threshold of scientific plausibility" [67]. by politicians to treat nanotechnology as a case of its own right, distinctive from standard chemical regulations [68,71]. ...
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Discussions about the appropriate way of assessing and managing new or emerging technologies—like nanomaterials—expose the problematic relationship between scientific knowledge production and regulatory decision-making. On one hand, there is a strong demand for scientific expertise to support decisions, especially by analyzing risks and hazards when uncertainties are prevalent and society’s stakes are high. On the other hand, science is criticized for its authoritative claim to objectivity and for keeping the inherent uncertainty, ambiguity, and selectivity of scientific observation latent. Requests for more transparency in science can lead to revealing, to risk managers and the public, the indeterminacy in knowledge production processes. This has consequences for the prevalence of scientific knowledge in decision-making, because it increases uncertainty on both sides of the breach between science and decisions: scientists lose confidence regarding the scientifically tested knowledge which they pass on, and risk managers lose confidence regarding their decisions based on this knowledge. Nonetheless, the concept of “probabilistic risk assessment” remains an important heuristic for dealing with potential future events. This paper addresses questions of the function of scientific risk assessment in organized risk management. The main argument in this paper is that knowledge alone no longer functions as a mechanism for absorbing uncertainty. Accordingly, the interaction between science and decisions must enable a temporarily stable commitment to manage new threats like products and applications coming from the field of nanoscience and nanomaterials.
... In a similar vein, the EU inspection system for aquatic products is based on science and risk-assessment with precautionary evaluation principles in mind. High-profiled WTO cases such as EC À Hormones, EC À Asbestos and EC e Genetically Modified Organisms (GMOs) stand as vivid reflection of the greatness of effort in preventing adulterated chemicals, industry contaminants and agricultural GMO-related hazards from entering the EU borders, sometimes even out of a perception of risks supported by insufficient scientific proof (Sadeleer, 2006). Fishery products have been a constant source of violation of the EU food safety laws, and its RASFF disseminates such information widely and instantly across member countries to facilitate and coordinate the work of individual state agencies in monitoring imported food products. ...
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The export growth of Chinese fisheries is reviving significantly after a chain of food safety incidents in 2007, but regulatory aspects associated with the scale and rapidity of this revival are far from optimal. Quality and safety problems of Chinese fishery products have remained as a primary impediment to consolidating the country's trade competitiveness in major foreign markets. Continual recurrence of safety scandals due to enterprises' wrongful production and processing practices has frustrated the importers' confidence in Chinese food safety control efficacy. This article attempts to offer some insights into the principal development dilemmas inherent in China's fisheries economic plan to explain the root of government regulatory failures. It further analyzes the opportunities and channels for Chinese government to graduate from a responsive approach tailored to foreign demands, and to take a more cooperative instance when dealing with ever-increasing international food safety standards related to fisheries.
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The misuse of emergency pesticide authorisations under Article 53 of Regulation 1107/2009 by EU Member States systematically undermines the Regulation’s core objective of prioritising health and environmental protection over improving plant production. The Member State authorities competent to decide on these authorisations lack independence and transparency safeguards and thereby frequently succumb to industry pressure, authorising pesticides without rigorous scientific scrutiny. With the intent to analyse how Article 53 can be realigned with the objective of Regulation 1107/2009, this article proposes leveraging the principles of good administration and the precautionary principle. To that end, it examines how the Court of Justice has interpreted and applied good administration principles to impose obligations of impartiality and transparency on Member States’ authorities when acting within the scope of EU law. Additionally, it examines how the Court has resorted to the precautionary principle to guide the discretion of national competent authorities towards higher health and environmental standards in the context of pesticide authorisation procedures. However, recognising the uneven application of these principles across national administrative systems, this article ultimately argues that the EU should translate these principles into specific measures.
Chapter
Due to the freezing of multilateralism in international trade, a change can be perceived in the external trade policy of the EU. In recent years, the EU has signed different bilateral and regional agreements (Free Trade Agreements—FTAs) with which it has tried to position itself as a key player in the international trading system. By doing so it also aims to relaunch a multilateral approach to world trade. Until 2006, EU bilateral agreements principally served non-economic purposes (neighborhood and development objectives), while EU economic interests were served by multilateral agreements. Since then, FTAs have largely been justified on economic interests. However, they also serve to promote EU values and principles, including the precautionary one. The “precautionary principle” ensures that the EU can continue to protect health and the environment even if this affects trade, in situations where scientific information is not conclusive or insufficient. This principle has been included in several recent FTAs concluded by the EU, namely the CETA; JETA and the EU/Mercosur agreement. Still, in some cases, the implementation of the precautionary principle has led to the creation of deadlocks in the negotiations of bilateral agreements—as in the case of TTIP—or to its implementation—as in the case of the EU/Mercosur. This Chapter aims to analyze the role of the precautionary principle in FTAs concluded or negotiated by the EU and whether the EU has been trying to expand its understanding thereof through FTAs.
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This chapter has a double focus. Firstly, it discusses the democratic legitimacy of the results of Regulatory Cooperation and of their impact on the EU legal order. For this, it uses the distinction of legitimacy in input, output and throughput. With input legitimacy, the chapter looks into the question whether the concrete results were taken by the right decision-makers. Output legitimacy answers whether the Regulatory Cooperation results respect constitutional values and principles. Throughput legitimacy is used to assess the presence or absence of procedural safeguards within the decision-making. On that basis, it assesses the presence or absence of legitimacy guarantees on the basis of a constitutional analysis of the idea of democracy in the EU legal order. Secondly, it proposes solutions to assess the identified shortcomings.
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Das Vorsorgeprinzip ist in der Rechtsprechung und Gesetzgebung der Europäischen Union (EU) fest verankert. Im Lebensmittelrecht wurde das Vorsorgeprinzip in Art. 7 der Lebensmittel-Basisverordnung (EG) Nr. 178/2002 (BasisVO) etabliert. Dennoch findet das Vorsorgeprinzip sowohl in der Überwachungspraxis als auch in der nationalen Rechtsprechung nicht die angemessene Beachtung. Neben der historischen Entwicklung und der Anwendung in der nationalen und europäischen Rechtsprechung werden in diesem Beitrag die Möglichkeiten und Grenzen der Anwendung des Vorsorgeprinzips nach Art. 7 BasisVO am Beispiel von cannabidiolhaltigen (CBD) Produkten beleuchtet. Im Ergebnis wird festgestellt, dass die Behörden im Sinne des Vorsorgeprinzips aufgrund eines wahrscheinlichen Gesundheitsrisikos prioritäre Schutzmaßnahmen ergreifen können, die über die ohnehin erforderlichen Maßnahmen der Novel Food-Verordnung hinausgehen. Schlüsselwörter Lebensmittelrecht · Vorsorgeprinzip · Risikobewertung · Cannabidiol · Hanfextrakt · CBD · Novel food
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The purpose of this article is to examine the causes of recurring doubts regarding the safety of plant protection products used in the European Union. Plant protection products are a particular subject of regulation. All standards concerning them require prior in-depth scientific research in the field of exact sciences. Achieving adequate safety of humans, animals and the environment in connection to the use of plant protection products requires not only good law, but a law based on representative research and scientific certainty. Bearing in mind the above, the authors undertook an analysis of what seems to be the cause of significant social doubts as to the actual achievement of the purposes of Regulation 1107/2009, i.e. inclusion of scientific research in the procedure of approval of active substances in plant protection products. First, the approval procedure for the active substance of the plant protection product was presented, and then the main shortcoming of the procedure was analyzed on the example of the approval of glyphosate. In the authors' opinion, guidance documents on literature review should be revised to reflect the best scientific practice, and their standards should be enforced, in particular, to ensure that there is no doubt about the objectivity of the literature review.
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Regulating self-driving cars poses a dilemma for policy-makers. Early testing of self-driving cars on public roads is necessary to accumulate data and driving experience. While approval procedures with high safety standards could harm manufacturers' ability to innovate by delaying tests, low safety standards could put human lives at risk. This study presents an issue framing experiment that directly addresses how citizens evaluate the alleged trade-off between safety and economic competitiveness. The experiment was conducted on representative online samples of citizens in the USA, Japan, and Germany. Results show that citizens' agreement to pilot self-driving cars on public roads is significantly higher in a safety frame, even if safety is explicitly associated with a loss in competitiveness. Socio-demographic characteristics and technology attitudes affect citizens' agreement to pilot self-driving cars primarily in a competitiveness frame, while political attitudes have no impact. Finally, the results show few country differences, indicating room to harmonize self-driving cars' safety regulations internationally.
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Paying particular attention to the institutional dimension of the EU legal framework for the placing on the market of Novel Foods, this chapter examines the main elements of Regulation 2015/2283, including the definition of Novel Food, the objectives of the legislative measure, and the procedure for the authorisation of Novel Foods. The analysis focuses especially on the roles of the diverse actors involved, and on the Regulation’s collocation in the broader context of EU food law and European integrated administration.
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The EU Treaties oblige the EU institutions to take health objectives and concerns into account in all policy fields. Nevertheless, this obligation is only marginally honoured in many EU policy areas at best. One problem is the lack of enforcement options to pursue further implementation. This paper examines the obligation to ‘mainstream’ health in Article 168 TFEU and demonstrates the difficulties in enforcing the obligation in more detail. It then offers a new, deeper interpretation of the contents of the mainstreaming obligation and discusses how this definition may be used to facilitate better enforcement in the future.
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This section provides a short review on perceptions and implementation of the precautionary principle in Bulgaria. It gives an overview of the legal status and applications of the concept and it explores how it is used in policies, strategies and administrative practices.
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This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.
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A Synthesis Report of case studies About the IPTS The Institute for Prospective Technological Studies (IPTS) is one of the eight institutes making up the Joint Research Centre (JRC) of the European Commission. It was established in Seville, Spain, in September 1994. The mission of the Institute is to provide techno-economic analysis support to the European decision-makers, by monitoring and analysing Science & Technology related developments, their cross-sectoral impact, their interrelationship in the socio-economic context and future policy implications and to present this information in a timely and synthetic fashion. Although particular emphasis is placed on key Science and Technology fields, especially those that have a driving role and even the potential to reshape our society, important efforts are devoted to improving the understanding of the complex interactions between technology, economy and society. Indeed, the impact of technology on society and, conversely the way technological development is driven by societal changes, are highly relevant themes within the European decision-making context. In order to implement this mission, the Institute develops appropriate contacts, awareness and skills for anticipating and following the agenda of the policy decision-makers. In addition to its own resources, IPTS makes use of external Advisory Groups and operates a Network of European Institutes working in similar areas. These networking activities enable IPTS to draw on a large pool of available expertise, while allowing a continuous process of external peer-review of the in-house activities. The inter-disciplinary prospective approach adopted by the Institute is intended to provide European decision-makers with a deeper understanding of the emerging S/T issues, and is fully complementary to the activities undertaken by other Joint Research Centre institutes.
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The Pfizer and Alpharma judgments, both delivered by the Court of First Instance (hereinafter “the Court”) on 11 September 2002, provide us with interesting precisions on the interpretation and scope, within the European Communities’ legal order, of the much discussed precautionary principle. In particular, they attest to the Court's willingness to leave the Community institutions a certain margin of appreciation in this field, while ensuring that the judicial review of such decisions is thorough enough to prevent abusive reliance on the precautionary principle.
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The regulation of health and environmental risks has generated transatlantic controversy concerning precaution and the precautionary principle (PP). Conventional wisdom sees the European Union endorsing the PP and proactively regulating uncertain risks, while the United States opposes the PP and waits for evidence of harm before regulating. Without favouring either approach, this paper critically analyses the conventional depiction of transatlantic divergence. First, it reviews several different versions of the PP and their different implications. Second, it broadens the transatlantic comparison of precaution beyond the typical focus on single-risk examples, such as genetically modified foods. Through case studies, including hormones in beef and milk production and mad cow disease in beef and in blood donations, as well as reference to a wider array of risks, the paper demonstrates that relative precaution varies enormously. Sometimes the EU is more precautionary than the US (such as regarding hormones in beef), while sometimes the US is more precautionary than the EU (such as regarding mad cow disease in blood). Thus, neither the EU nor the US can claim to be categorically 'more precautionary' than the other. The real pattern is complex and risk-specifc. Third, the paper seeks explanations for this complex pattern in five sets of hypotheses: optimal tailoring on the merits, political systems, risk perceptions, trade protectionism, and legal systems. None of these hypotheses fully explains the observed complex pattern of relative transatlantic precaution. The paper concludes that differences in relative precaution depend more on the context of the particular risk than on broad differences in national regulatory regimes.
note 5 supra, at 65. 183 Case T-13/99 Pfizer, para 468
  • Scott
182 Scott, op. cit. note 5 supra, at 65. 183 Case T-13/99 Pfizer, para 468. 184 Case T-13/99 Pfizer, para 410.
note 4 supra, at 299 ff
  • De Sadeleer
de Sadeleer, op. cit. note 4 supra, at 299 ff. Contra C. R. Sunstein, Risk and Reasons (Cambridge University Press, 2002).
ECR I-4512, para 39; Case C-9/00, Palin Granit Oy (2002) ECR I-3533, para 23; Case C-1/03, Paul Van de Walle, para 45. 30 Case C-67/97, Bluhme. 31 For a description of this procedure N. de Sadeleer
C-418/97 and C-419/97, ARCO Chemie Nederland, (2000), ECR I-4512, para 39; Case C-9/00, Palin Granit Oy (2002) ECR I-3533, para 23; Case C-1/03, Paul Van de Walle, para 45. 30 Case C-67/97, Bluhme. 31 For a description of this procedure N. de Sadeleer, 'Habitats Conservation in EC Law: From Nature Sanctuaries to Ecological Networks' (2005) 5 Yearbook of European Environmental Law 215–252.
note 172 supra, para 174 Later on the Court of First Instance proclaims an even broader principle , the principle that the protection of public health, safety and the environment is to take precedence over economic interests
  • Loc
  • Cit
173 Loc. cit. note 172 supra, para 174. Later on the Court of First Instance proclaims an even broader principle, the principle that the protection of public health, safety and the environment is to take precedence over economic interests (para 186).
EC-Hormones, paras 184-186
  • Body
Case C-180/96 v [1998] ECR I-2265, para 99; and Case C-236/01
  • C- Case
On this point see Case C-473/98
  • Case
Environmental legal experts have the impression that risk assessment is frequently used to stop or slow down restrictions on the use of products or substances
  • E G L Kramer
ECR I-6176, para 32; , cited above, para 97; Case C-120/97 [1999] ECR I-223
  • Case
On risk analysis in EC Law, see T. Christoforou, 'Science, Law and Precaution in Dispute Resolution on Health and Environmental Protection: What Role for Scientific Experts?
  • N Noiville
  • De Sadeleer
For an analysis of this subject, see
  • F Ackerman
  • L Heinzerling
para 16; Case C-42/90 [1990] ECR I-4863, para 11; and Case C-400/96 [1998] ECR I-5121
  • C- Case