Participation in European Union Rulemaking: A Rights-Based Approach (Oxford Studies in European Law)

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This means that it is not possible to have a general paradigm of risk assessment applicable in the case of nanomaterials i. In other words, there is no substantial equivalence with other common materials existing in nature, but we cannot generalize as regards nanotechnologies. For this reason it is more appropriate to talk of nanotechnologies in the plural, instead of simply nanotechnology Ruggiu, a: While it is appropriate to talk of a case-by-case approach as regards the risk assessment of nanotechnologies, on the governance on nanotechnologies this case-by-case approach is not the only possibility.

There are various possible approaches to this matter, ranging from the precautionary to the proactive, or the new model of Responsible Research and Innovation von Schomberg, ; ; Owen et al. Yet the case-by-case approach seems to be the leitmotiv of the EU regulatory framework on nanotechnologies Widmer et al. This approach seems to have led to a hybrid landscape where new forms of governance [3] coexist with more traditional tools, which appear to be the final stage of this process of evolution. From the standpoint of governance theories, it represents a case of coexistence of the new governance method and the classic Community Method with a slightly increased preference for the second style.

In this context, new tools of governance, characterized by informality and a-typicality, are aimed at involving stakeholders through a more accurate distribution of responsibilities. By thus enlarging participation, they work like a bellows in the framework of EU policy with a view to consolidating EU regulation.

Yet they seem to be merely provisional in favour of the more stable sectoral legislation. Besides, this approach with its unforeseen shifts reveals a lack of coherence since it largely depends on the incremental process of knowledge, and it is exposed to sudden changes of mood of public institutions. Finally, it shows weak anticipatory structures since its evolution broadly depends on sudden events that can cause the gradual stiffening of governance tools, by privileging those of a sectoral nature hard law.

This means that in future nanotechnologies will be regulated according to forms of more traditional regulation, but the cost in terms of rules, policy change, the restraint of innovative processes, and even economic factors of these abrupt unforeseen shifts has not been considered. In this paper I will follow the growth and the development of the European Union strategy on nanotechnologies from its premises the safe, integrated and responsible approach in the s to its subsequent consolidation in forms of hard legislation today.

Université du Luxembourg - Joana Mendes

In particular I will describe the initial agreement between the Commission and the European Parliament with the development of an adaptive, experimental and flexible model of governance, which had its climax with the Commission code of conduct on nanotechnologies, and the subsequent and abrupt direction change with the progressive adoption of a series of sectorial EU initiatives of a hard law nature in the field of cosmetics, nanofood and feed, and biocides.

I will argue that the current model of governance is a hybrid, which structurally mixes forms belonging to the new governance paradigm consultations, self-regulation, agency, networking with more traditional tools mainly directives, regulations in order to progressively reach a sectoral regulation of the rising sector of nanotechnologies. This model is characterized by the decreasing use of new governance tools, working like a bellows within the framework of the EU policy, in favour of the traditional governance method. Finally, I will argue that this model of governance based on a case-by-case approach runs the risk of incoherence since it is exposed to sudden changes of direction following the increase of knowledge and has a weak proactive dimension due to its excessive dependency on data collection and its insufficient use of upstream criteria, such as human rights, which would allow anticipated intervention with a less massive use of hard law solutions.

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First of all, I will describe the rise of the safe, integrated and responsible approach launched by the European Commission in Then, I will analyse the Commission code of conduct on nanotechnologies, developed through a set of consultation processes, which represent a significant innovation in the field of the governance of emerging technologies. I will then follow the change of direction given by the Parliament resolution with which the European Parliament broke its initial agreement with the Commission on the initiatives to be contained in the EU policy on nanotechnologies.

In this instance I will describe the progressive adoption of regulatory initiatives in several fields cosmetics, food, biocides of a traditional nature up until the start of the revision process of REACH. Finally, I will give an overview of the current arrangement of governance at the EU level as a mix of new governance and classic governance methods and assessing its strengths and its limits. The impossibility of encompassing all nanotechnologies under the same definitive positive or negative judgment prevents the regulator from adopting simplistic solutions of a trenchant nature, such as a general ban or a general green light.

Rulemaking in this field has become difficult due to the uncertainty which characterizes each emerging technology.


In this field, besides scientific uncertainty there is also a state of unavoidable regulatory uncertainty. The uncommon features of nanotechnologies leave some open questions, representing a limit for the regulator. In general terms, there is a lack of data regarding the implied risks of nanomaterials and the way to overcome them. There is no shared definition of nanomaterial; and there is great uncertainty with regard to terminology, classification and metrology there is the need for common standards with which to measure them Marchant, Sylvester and Abbott, ; Kearnes and Rip, ; von Schomberg, Moreover, although nanotechnologies do not act in a regulatory vacuum as some have noted, the existing regulations apply in this sector [van Calster, ] , given their novelty, there is uncertainty with regard to both their adequacy and efficacy.

There is also the need for further legal, ethical, and sociological studies on their implications Mandel, ; Rip, Without wishing to generalize or scaremonger, it is true that, along with their undoubted advantages, nanotechnologies imply a number of risks we need to consider. Indeed studies have revealed the existence of a criticality regarding the toxicology and the ecotoxicology of some engineered nanomaterials. For example, there are studies addressing the allegation that carbon nanotubes both single and multi-walled can cause lung inflammations Shvedova et al.

Nanotechnologies are not only promising future technologies: they are also a reality already present in our lives. Despite the multitude of current studies on nanotechnologies which promise to revolutionize medicine e. In this regard it is quite difficult to bring under identical regulation the whole range of the nanotechnologies world, which is made up of research and markets with very different needs.

This complex framework makes the task of regulating even more difficult since the legislator would have to create a toolkit able to give different responses to present and future needs and do different things Ruggiu, a. Taking into account the lesson learnt from the case of biotechnology Metha, ; von Schomberg, , in the s the EU strategy in the field of nanotechnologies was characterised by caution. At that time, although they had been discovered roughly fifteen years previously, nanotechnologies were at their infancy [6]. Uncertainty was so widespread at all levels scientific, ethical, regulatory so as to discourage any attempt at regulating this field by resorting to classic hard legislation measures Mandel, ; Pariotti and Ruggiu, Besides, there was the widespread belief that, given the increasing influence of private actors within global governance, it was increasingly difficult to ensure the success of any governance tool without the cooperative action of stakeholders Kooiman and Van Vliet, ; Kearnes and Rip, ; Pariotti and Ruggiu, In this context, in fact, there was a need for tools devised for strongly motivating actors beyond mere compliance with legal provisions.

Thus there was the need for tools other than those of hard legislation. The action of the European Union started from this recognition. The strategy adopted by the Commission was initially to wait and see: i whether there were risks and what they were; ii whether the existing regulation was adequate for this rising field; iii whether and how the principal actors were developing spontaneous forms of self-regulation. The EU authorities would then have adopted the necessary measures.

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In this context we can frame a number of tools such as communications, resolutions, recommendations that were aimed at increasingly giving responsibilities to stakeholders Dorbeck-Jung and Shelley-Egan, On the basis of this mix of wait and see and case-by-case logic Widmer et al. Yet, as we will see later, this initial agreement did not last indefinitely. Behind this strategy there was the hope of fostering a general climate of responsibility and cooperation among stakeholders, most of all for entrepreneurialism and industrial innovation.

At the core there was the belief that the market would be able to quickly develop and, if possible, self-regulate, at least until the moment when scientific data would be complete or sufficiently robust for developing a more stringent regulatory framework in this promising field. It was an adaptive, flexible and slightly inclusive approach of an experimentalist nature that would have had to accompany the growth of the entire sector until it reached its maturity Roco, ; Kearnes and Rip, ; Widmer et al.

This route starts with the Commission communication Towards a European Strategy for Nanotechnology where the Community authorities laid the basis of the safe, integrated and responsible approach [7] European Commission, The Commission communication adopted an integrated strategy able to build a bridge between the public and the private sector. This approach was thus aimed at fostering a process of responsibilisation by enlarging the involvement of all parties in order to create the premises of a general self-regulatory attitude Dorbeck-Jung and Shelley-Egan, ; Ruggiu, With the subsequent communication, the Commission elaborated 'a series of articulated and integrated actions for the immediate implementation of a safe, integrated and responsible strategy for' nanotechnologies European Commission, 3.

In sum, the main directions of the safe, integrated and responsible approach were i to boost networking infrastructures for research and development of the sector, ii to develop a better integration between research and its ethical dimension, iii to involve all stakeholders in the development of nanotechnologies and their regulation, and in the meantime iv to apply the current regulatory framework by checking its adequacy.

With the Parliament resolution, the approach proposed by the Commission was substantially accepted European Parliament, In particular, according to the European Parliament, a responsible strategy on nanotechnologies required integrating knowledge on social, health and safety aspects with technological development.

Inclusiveness, equality and public scrutiny

For this reason it was better to engage the Commission, member States and industry in an effective dialogue with all stakeholders in order to steer nanotechnology developments along a sustainable path. In this inclusive approach, industry needed to take into account risks posed to human health, to consumers, workers, and the environment during the whole lifecycle of nanoproducts, and contribute to the dissemination of information concerning their use and risks. In the same year the European Union launched the Seventh Framework Programme FP7 , which identified nanotechnologies as one of the key areas to be widely encouraged in order to build a 'strong industrial base' in Europe and improve industry competitiveness European Union, For this purpose, the FP7 built a broad ethics framework in which to develop European research and innovation.

Thus, for key enabling technologies, such as nanotechnologies, it tried to foster greater integration between disciplines and different areas by 'broadening the engagement of researchers and the public at large […] with scientific related questions, to anticipate and clarify political and societal issues, including ethical issues' European Union, In this regard any supported research was required to respect the 'fundamental ethical principles including those reflected in the Charter of Fundamental Rights of the European Union', as well as the EGE's opinions and the Protocol on the protection and welfare of animals European Union, In conformity with the direction initially adopted by the European Union, the anticipatory dimension of the EU policy rested mainly on a process of wide social inclusion in order to build the premises for a general dialogue regarding the social and ethical aspects of technological development.

In this it underlined 'the need to establish measures to verify the safety of nanomedical products' at both the national and the EU level EGE, 5. It expressed the need to launch wide public participation concerning uncertainties and the knowledge gap, and it addressed the opportunity of fostering interdisciplinary research in this field by also including ethical, legal and sociological studies according to the pattern developed by the Commission in s. In this regard it assessed the existing regulatory structures as adequate, but suggested the Commission should consider make changes within this framework, and addressed the risk of overlapping between different regulations EGE, 6.

The high point of this approach should have been a code of conduct on nanotechnologies Ruggiu, Yet, instead of dealing with the entire innovation cycle research, production, commercialization, recycling , the Commission code of conduct only dealt with research. The reason for this choice will become clearer later. It represents the final stage of the process of stakeholder engagement triggered by the Commission communication, the maximum effort of the European Union in involving a key group of stakeholders engaged in nanotechnologies: researchers.

Yet the outcome of this ambitious initiative was only partially successful.

Learning outcomes

The Commission code of conduct for responsible nanosciences and nanotechnologies research [8] EC CoC is the result of an experiment in governance, which adopts the new governance method in the field of emerging technologies for the first time, since it was reached through a consultation process launched by the Commission in Ruggiu, It can be also deemed as the first case of the application of Responsible Research and Innovation von Schomberg, ; ; Owen et al. In a landscape where risks are scattered Beck, and the relevant actors are distributed over the global sphere Stoke 21; Pariotti and Ruggiu, , responsibility also needs to be distributed von Schomberg 56 , especially in the face of the current process of erosion of the State capacity for global regulation Grande, In this regard, experiences of self-regulation, such as codes of conduct, are clearly part of 'responsibilisation phenomena', since they aim at distributing the responsibility among stakeholders Parker, ; Dorbeck-Jung and Shelley-Egan, ; Ruggiu, In this perspective, self-regulatory tools, such as codes, are a form of meta-regulation Coglianese and Mendelson , meaning 'a process of regulating the regulators, whether they are public agencies, private corporate self-regulators or third party gatekeepers' Dorbeck-Jung and Shelley-Egan, In other words, meta-regulatory tools enact norms regulating the process of regulation, namely, in the case of the code of conduct, self-regulation Parker Any tool aimed at steering the law-making process regulation, self-regulation such as codes of conduct , either public statute law or private societal dialogue, networking, consultations , belongs to the dimension of meta-regulation.

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In this sense, consultation processes aimed at drafting the EC CoC can represent an effective example of a meta-regulatory tool Ruggiu, Between and the Commission launched two consultations: one in aimed at drafting a code of conduct on nanotechnologies European Commission, b and one between and aimed at detecting stakeholders' opinions on this self-regulatory experience European Commission, The consultation processes launched both directly by the European Commission through its Directorate-General for Research and, indirectly, outside it e.

In this sense, the Commission code of conduct should be interpreted within the larger framework of the new governance method in the field of emerging technologies Ruggiu, ; The first consultation was launched on the basis of a document, called a 'consultation paper', that was meant to represent the starting point in the process of drafting the code European Commission a. In this drafting process stakeholders should have been actively involved. The consultation paper was thus the trigger for the process of the code formulation, as it was the basis of the subsequent consultation that led to the formation of the code principles by selected groups of stakeholders.

The aim of the consultation paper was to indicate EU goals the 'normative anchor points' according to the Responsible Research and Innovation terminology von Schomberg, that should have driven the whole process of code setting: techno-scientific advance, market competitiveness, the protection of human health and the environment, EU fundamental rights Ruggiu, ; Among these goals the code of conduct should have struck a fair balance.

In this document the Commission outlined reference points for future consultation '[i]n order to promote safe and responsible nanotechnology research and pave the wave to its safe and responsible application and use' European Commission a: 1. The Commission explained the reason for limiting the scope of the code on research: '[o]n the one hand it develops new technologies for application in industry […] on the other hand it investigates the potential risks and establishes the appropriate measures to take' European Commission a: 1.

In other words, research had an across-the-board nature, by being at the basis of both industrial advance and university inquiry. Yet, the outcome of this restriction of the scope of the code was to involve in the process of responsibilisation only researchers. The choice of restricting the scope of the code probably reflects a more concrete and realistic approach, avoiding excessively ambitious attempts that could have led to foreseeable failure for example, by providing a code for all emerging technologies or a code for overall research and innovation.

Yet it came at a remediable cost: the perception of an unfair distribution of responsibilities Ruggiu, 7. As noted on emerging technologies, the development of nanotechnologies depends on the involvement of many actors: public authorities EU and member States , enterprises and industry, research organizations both public and private , funding organizations both public, e.

In this sense, researchers represent only a small part of the entire audience of stakeholders in the field of nanotechnologies. It must be noticed, too, that the attention to fundamental rights has varied throughout the different stages of the whole process of code drafting. In the consultation paper, the role of fundamental rights and the precautionary approach emerge at the core of the Commission action since 'confidence in its safety' and 'public acceptance are preconditions for the application and commercialization of nanotechnology-based products' European Commission a: 1.

This centrality of fundamental rights was progressively weakened in the recommendation on a code of conduct where fundamental rights are not included in the set of principles of the CoC and are merely mentioned in some provisions of code guidelines. As a metaregulatory tool, consultations were successful. The relevance of the consultation process within the framework of this initiative was indeed very encouraging.

While there were three proposed principles of the consultation paper 'precaution', 'inclusiveness' and 'integrity' , this number rose to seven in the final version 'meaning', 'sustainability', 'precaution', 'inclusiveness', 'excellence', 'innovation', 'accountability' thanks to suggestions arising from the consultation participants European Commission, a: 3; European Commission, a; Ruggiu, 8. Moreover, some suggestions regarding the limitation of those applications aimed at enhancing human performance, nanofood and feed were also embraced, meaning that the consultation reached its goals Ruggiu, At the beginning of , the code of conduct was adopted with a recommendation European Commission, a.

The nature of the code was mainly practical. While we can distinguish between a code of conduct and a code of ethics Arrigo, , we have to conclude that the EC CoC belongs to the first type. In fact, by the first type, we mean a ruled-based tool, that is, a set of rules aimed at driving the conduct of recipients in order to solve the various problems in an enterprise's existence such as harassment in the workplace, mobbing, safety etc.

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