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1 June, 2016
New proposals to improve the regulation of nanotechnologies

Aratz Ramirez de la Piscina-nanotecnologia-UPV/EHU

Over recent decades nanotechnologies have seen considerable growth. In the view of the UPV/EHU researcher Aratz Ramirez de la Piscina, despite growing rapidly, knowledge remains low and full of scientific uncertainties with respect to the potential risks that different nanomaterials obtained from the manipulation and design of materials on a nanoscale could pose for health and the environment. So the UPV/EHU researcher has from the legal point of view made a reflection and has formulated a proposal about the various aspects that should be taken into consideration when it comes to agreeing on legal measures and taking decisions about the acceptability of these potential risks.


The typology of nanomaterials is expanding constantly, with the result that they are ending up being used in all kinds of industrial sectors, such as medicine, the chemical industry, food, the textile industry, the energy sector, and information technologies. Nanotechnology constitutes a field of research that is opening up a whole host of new channels and can be defined as revolutionary.


Nevertheless, in the view of certain sectors, there is another side to nanotechnology: it could pose new risks for health or the environment. “The level of knowledge about this aspect is low and full of scientific uncertainties; there is more and more scientific evidence about the scale of the risk that some (but not all) nanomaterials may entail,” said Ramirez de la Piscina.


Faced with this situation, the UPV/EHU researcher believes, from the legal standpoint, that the legal treatment of the supposed risks of nanomaterials needs to weigh up the legal assets, human rights and values at stake and needs to build legal certainties. “The regulatory strategy led by the European Commission is not valid for effectively addressing these environmental and health problems. In fact, besides failing to address challenges relating to human rights, or ethical, social or economic approaches, it does not guarantee the safe manufacture, use and marketing of nanomaterials,” she added.


So Ramirez de la Piscina has put forward various principles that could be applied to identify and overcome the shortcomings that emerge when assessing the supposed risks, as well as to make political-juridical decisions about these possible risks and to design legal measures that are commensurate with these risks. “The decisions about the acceptability of the possible risks posed by nanotechnologies need to be taken on the basis of three principles: the democratic principle, the principle of care, and the principle of transparency,” she declared.



Three principles

Firstly, “due to the fact that the potential advantages and harm resulting from the development of nanotechnologies could affect the wider society, —the current as well as future generations— the governance of nanotechnologies has to be built bearing in mind the opinions of the citizens and the various parties involved,” explained Ramirez de la Piscina. Secondly, “the principle of care should aim to structure a regulatory system that guarantees a high level of environmental and health protection,” explained the researcher, “and alongside other measures, the system has to anticipate administrative mechanisms for the purpose of transmitting information about nanomaterials, and has to get the nanotechnological industry to conduct research into the safety of nanomaterials”.


Finally, the researcher takes the view that the principle of transparency calls for the approval of administrative mechanisms that will tackle the low level of knowledge and information about nanotechnologies.


The researcher explained that the most important regulations that include specific safety measures applied to nanotechnology are the ones relating to cosmetics, biocides and food. These regulations provide, for example, for specific safety measures on the possible risks of nanomaterials, and refer to the obligation to label all products containing them, etc. “In the remaining sectors no other regulatory change has been accepted, and the European Commission has opted to give recommendations and guidelines. But failure to comply with all that does not have any legal consequence,” explained Ramirez de la Piscina. Therefore, “the Community regulatory framework applied to nanomaterials as a whole reveals significant shortcomings from the point of view of the principle of care, the democratic principle and the transparency principle,” she added.


In this respect, “the regulatory strategy carried out by the European Commission in favour of the nanotechnological industry requires a change of direction in the legal sphere,” concluded Ramirez de la Piscina.



Additional information

Aratz Ramirez de la Piscina-Arrillaga (Vitoria-Gasteiz, 1988) is a graduate in Law. He did his international PhD thesis entitled Nanoteknologien arauketa juridiko komunitarioa/The European Union regulation of nanotechnologies, at the UPV/EHU’s Law Faculty in Leioa, in the Department of Administrative and Constitutional Law and the Philosophy of Law under the supervision of Iñaki Lasagabaster-Herrarte. He wrote up his thesis within the joint supervision model with the Université de Pau et des Pays de L`Adour.

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