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Recommendation 2017 (2013) Final version
Nanotechnology: balancing benefits and risks to public health and the environment
1. Nanotechnology is the manipulation
of matter on an atomic and molecular scale. Nanomaterials involve structures
having dimensions of nanometres (nm), that is one billionth (or
10-9) of a metre, typically between 1 and
100 nm in size. At such dimensions, materials can show significantly
different physical, biological and/or chemical properties from materials
at bigger dimensions, which opens up a range of new possibilities
for technology.
2. Nanotechnology and its myriad applications have the potential
for enormous benefits (in particular in the field of “nanomedicine”),
but also for serious harm. As with most emerging technologies, many
risks, both to public health and to the environment, are as yet
poorly understood. However, commercial applications of nanotechnology
are already in widespread use. Regulations have struggled to keep
up with the pace of scientific innovation.
3. For years, the Parliamentary Assembly and the Committee of
Ministers of the Council of Europe have been advocating the need
for a culture of precaution incorporating the precautionary principle
into scientific and technological processes, with due regard for
freedom of research and innovation. In 2005, the Heads of State and
Government of the Council of Europe gave undertakings in the Final
Declaration of the 3rd Summit of the Council of Europe “to ensure
security for our citizens in the full respect of human rights and
fundamental freedoms” and to meet, in this context, “the challenges
attendant on scientific and technical progress”.
4. The Assembly believes that, in keeping with these undertakings,
the Council of Europe, as the only pan-European body with a human
rights protection mandate, should set legal standards on nanotechnology
based on scientific knowledge and the precautionary principle which
will protect 800 million Europeans from risk of serious harm, while
encouraging nanotechnology’s potential beneficial use.
5. 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:
5.1. respect the precautionary principle
while taking into account freedom of research and encouraging innovation;
5.2. allow for consistent application to all nanomaterials
under regulation across borders and regardless of their origins
(synthetic, natural, accidental, manufactured, engineered), functional
uses or biological fate;
5.3. seek to harmonise regulatory frameworks, including in
the areas 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 reporting
and registration requirements, in order to lay down a common standard;
5.4. 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 geographical
area of the Council of Europe;
5.5. can be used as a model for regulatory standards worldwide;
5.6. 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 wish, for example in the form of
an additional protocol to the 1997 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 (ETS No. 164, “Oviedo Convention”);
5.7. allow for the creation of an international, interdisciplinary
centre to be the world’s knowledge base in the field of nanosafety
in the near future, without prejudice to the continued support,
even in financial terms, for ongoing research projects aimed at
determining potential risks of nanomaterials;
5.8. 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.
6. The Assembly recommends that the Council of Europe’s 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 multi-stakeholder approach. This
study should include, in any case, ongoing scientific research at
international level to learn about the risks of nanotechnological
material. Thus, the scientific community will be actively involved
in the drafting of any proposal for standardisation and/or legislation.