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Posted: Nov 22, 2012

Nanotechnology - for or against? PACE Committee plans to draw up legal standards to protect European citizens

(Nanowerk News) As the debate intensifies between those for and against nanotechnology, the Committee on Social Affairs, Health and Sustainable Development of the Parliamentary Assembly proposed today that the Council of Europe should draw up legal standards which would be designed to protect citizens, while encouraging the potential beneficial use of nanotechnology.
In a draft report (pdf) by Valeriy Sudarenkov (Russian Federation, SOC), the committee acknowledges the potential for enormous benefits (particularly in the medical field) but also expresses concern about the as yet little known threats to public health and the environment despite the fact that nanotechnology is already widely used in commercial applications (such as sunscreen products).
The draft report therefore recommends drawing up guidelines based on the precautionary principle. It should be possible to apply these guidelines systematically regardless of the origin of the nanomaterials concerned and help to harmonise the relevant regulations, particularly with regard to risk assessment and risk management methods, protection of researchers, consumer protection and information, and reporting and registration requirements.
These are the recommendations put forward in the draft:
The Assembly thus recommends that the Committee of Ministers work out guidelines on balancing benefits and risks to public health and the environment in the field of nanotechnology which:
– respect the precautionary principle while taking into account freedom of research and encouraging innovation;
– allow for consistent application across borders, across the origins of nanomaterials (synthetic, natural, accidental, manufactured, engineered) and across the functional uses and biological fate of the nanomaterials under regulation;
– seek to harmonise regulatory frameworks, including of risk assessment and risk management methods, protection of researchers and workers in the nanotech industry, consumer and patient protection and education (including labelling requirements taking into account informed consent imperatives), as well as of reporting and registration requirements, in order to lay down a common standard;
– are negotiated in an open and transparent process, involving multiple stakeholders (national governments, international organisations, the Parliamentary Assembly, civil society, experts and scientists) in the framework of a dialogue which transcends the Council of Europe area;
– can be used as a model for regulatory standards worldwide;
– could first take the form of a Committee of Ministers Recommendation, but could also be transformed into a binding legal instrument if the majority of member states so wished, e.g. in the form of an Additional Protocol to the 1997 Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention);
– aspire to create an international interdisciplinary centre to be the world’s knowledge base in the field of nanosafety in the near future;
– will be able to promote the development of an assessment system of ethical rules, advertising materials and consumer expectations, regarding research projects and consumer products in the nanotechnology field impacting on human beings and the environment.
The Assembly recommends that the Council of Europe Committee on Bioethics (DH-BIO) be entrusted with a feasibility study on the elaboration of possible standards in this area based on paragraph 5 of the present Recommendation as a first step in the start of negotiations on the topic with a multiple stakeholder approach.
Source: Council of Europe
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