Intergovernmental Forum on Chemical Safety
Global Partnerships for Chemical Safety
Contributing to the 2020 Goal
01.TS
Agenda item 6
IFCS/FORUM-VI/01.TS
Original: English
31 March 2008
FORUM VI
SIXTH SESSION
OF THE
INTERGOVERNMENTAL FORUM ON CHEMICAL SAFETY
Dakar, Senegal
15 – 19 September 2008
**********************
THOUGHT STARTER
Nanotechnology and manufactured Nanomaterials:
Opportunities and Challenges
Prepared by: FSC Working Group, lead sponsor Switzerland
Secretariat: c/o World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland
Tel: +41 (22) 791 3873/3650; Fax: +41 (22) 791 4875; Email: ifcs@who.int; Website: www.ifcs.ch
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
31 March 2008
Nanotechnology and manufactured Nanomaterials:
Opportunities and Challenges1
IFCS Forum VI
THOUGHT STARTER2
Objective of the plenary session:
The objective is to exchange information in order to help raise the awareness of participants
to the potential new opportunities, the new challenges and the new risks posed by
nanotechnology.
The meeting will provide a forum to share information on known and emerging issues, on the
work of the OECD, ISO and UNESCO on nanotechnology and to foster an understanding of
issues (applications and implications).
The Forum will also be an opportunity to discuss the potential contributions of
nanotechnology to sustainable development and pollution prevention, and to discuss how to
achieve an equitable distribution of benefits and risks and role of responsible stewardship in
addressing nanotechnology.
1
As used in this paper, the terminology "nanotechnology and manufactured nanomaterials" includes,
as relevant, nanoscience and products containing manufactured nanomaterials.
2
Thought Starter papers are intended to provoke thought and bring about discussion. Thought Starter
papers are not an in depth analysis or comprehensive review of the topic.
3
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
31 March 2008
Table of Contents
1. Background .......................................................................................................... 5
2. Ethical considerations .......................................................................................... 6
3. Social utility of nanotechnology .......................................................................... 6
4. The state of the knowledge about the risks of nanomaterials .......................... 7
5. Communication and public dialogue ................................................................. 8
6. Activities of International Organisations........................................................... 8
7. Activities of non-governmental organizations ................................................. 10
8. National activities, interests and priorities on nanotechnology and
manufactured nanomaterials .................................................................................... 10
Belarus .................................................................................................................... 10
China ....................................................................................................................... 11
European Commission........................................................................................... 12
Germany ................................................................................................................. 17
Japan ....................................................................................................................... 18
Korea ....................................................................................................................... 20
Nigeria ..................................................................................................................... 21
Slovenia ................................................................................................................... 21
Switzerland ............................................................................................................. 22
Thailand .................................................................................................................. 23
United Kingdom ..................................................................................................... 24
9. Possible Forum actions ...................................................................................... 25
10.
Annex .............................................................................................................. 26
10.1 Definitions and types of manufactured nanomaterials .............................. 26
10.2 Health risks .................................................................................................... 27
10.3 Occupational health ..................................................................................... 28
10.4 Environmental risks..................................................................................... 29
10.5 Ethical issues................................................................................................. 30
4
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
1. Background
Nanotechnology is an enabling technology that is expected to result in major changes across
many industry sectors and to contribute to novel materials, devices and products. Depending
on the area of application there are different timelines for the beginning of industrial
prototyping and nanotechnology commercialization. First generation products are already on
the market such as paints, coatings and cosmetics. More products such as pharmaceuticals,
diagnostics and applications in energy storage and production are in development. Many
studies have tried to estimate the prospect of the nanotechnology market with different data.
In general the areas of nanoelectronics (semiconductors, ultra capacitors, nanostorage and
nanosensors) are estimated to be around 450 billion $ for 2015, and the areas of nanomaterials
(particles, coatings and structures) are estimated to account for 450 billion $ in 2010 3. Further
generations of nano-enabled products based on active nanoscale structures and nanosystems
will be developed in the future. Such developments will address innovations looking into
processes of technical modernization and changes in the interface between humans and
machines/products. Presently discussion on opportunities and challenges of nanotechnology
and manufactured nanomaterials focuses on 1st generation nanoproducts. It is incumbent on
governments to develop a regulatory framework which enables the responsible introduction of
manufactured nanomaterials through the scientific assessment and appropriate management of
the potential risks. This might also include measures such as labeling. The thought starter
gives an overview of the topics relevant for this discussion. The scope does not include the
area of medical diagnostics and treatment as this is being addressed in other fora.
Nanotechnologies and manufactured nanomaterials, as with any new technology, may bring
many advances to society and benefits for the environment, but also pose new challenges in
health, environment safety and possible impacts on society. Because of the very broad range
of potential applications using nanotechnology and the wide variety of characteristics
displayed by manufactured nanomaterials, detailed discussion of both benefits and of heath
and environmental risks should take place at the level of individual nanotechnology
applications.
As a result of nanotechnology’s rapidly burgeoning growth, it is important that all
stakeholders concerned (governments, international, regional and national organizations,
industry groups, public interest associations, labour organizations, scientific associations and
civil society) engage in discussions to identify and address policy issues. These can include
health, safety, moral, ethical, societal, legal and social utility concerns. In view of the
predicted great impact of nanotechnologies on the global economy, research and society, and
of the expected wide-spread use of nanomaterials, any possible risks should be studied by
comprehensive, proactive risk estimation and assessment.
Nanotechnology and manufactured nanomaterials have to be considered not only as a
chemical industry issue rather than an issue also related to other industrial sectors (textile-,
paint-, coating-, metal-industry), if not all. The main focus related to the impact of
nanomaterials on human health and the environment should be on the use across the value
chain, in particular for small and medium size enterprises (SMEs).
The nanotechnology agenda item at IFCS Forum VI is to provide an overview of current work
and debates on nanotechnology and inform stakeholders of where these discussions are
3
Hullmann A. Measuring and assessing the development of nanotechnology; Scientometrics 70(3):
739-758, 2007
5
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
occurring. The session will substantively contribute to implementation of the Strategic
Approach, achievement of the 2020 Goal, and the work of other chemicals-related
international organizations and institutions by supporting the achievement of the SAICM
Overarching Policy Strategy objective addressing new and emerging issues.
2. Ethical considerations
Only a few ethical committees have explored the ethical challenges posed by this technology.
As the Royal Society acknowledged, “These questions are not unique to nanotechnologies but
past experience with other technologies demonstrates that they will need to be addressed”4. A
number of prestigious reports (e.g. UK Royal Society) and coalitions (labour, environmental,
and civil society groups) have advocated for the precautionary approach to apply to
development and commercialization of manufactured nanomaterials. The precautionary
principle is often discussed in ethical committees. Other issues also identified as priorities for
discussion include: agreement on socially acceptable or unacceptable risks, the social and
global distribution of benefits and risks, ownership/patent issues, health and safety risks to
workers and the public, regulatory oversight, and moratorium on technological applications.
These, as well as whether and to what degree a precautionary approach should be adopted, are
often discussed in ethical committees (see Annex 9.5).
3. Social utility of nanotechnology
The way in which we use available natural resources has effects on our health and the
environment and is to a large part heavily influenced by cultural aspects and personal choices.
Natural resources are an important factor in the economy and an important element of our
welfare. Technological innovations, including those resulting from nanosciences and
nanotechnologies, can play a key role in the more efficient use of our resources.
Before the development or use of any application from nanotechnologies, the question of
social utility should be asked. To answer that question the potential contribution of specific
applications from nanotechnologies to solve a specific socially relevant problem such as
climate change, water shortages and starvation should be known. Health and environmental
risks and possible side effects on society and economy should be taken into account as well as
existing alternative solutions. The result of such an evaluation will always be a local decision
(country, region).
For the majority of developing countries, commodity production is the backbone of the
economy5. Historically, advances in science and technology have also had profound impacts
on commodity production and trade. There are concerns that nanotechnology will change the
commodity markets, disrupt trade and eliminate jobs. Worker-displacement brought on by
commodity obsolescence will hurt the poorest and most vulnerable, particularly those workers
in the developing world who don’t have the economic flexibility to respond to sudden
demands for new skills or different raw materials. Currently, nanotech innovations and
4
The Royal Society and the Royal Academy of Engineering: Nanoscience and nanotechnologies:
opportunities and uncertainties; 2004, page 8
5
The Potential Impacts of Nano-Scale Technologies on Commodity Markets: The Implications for
Commodity Dependent Developing Countries; Research Papers 4; ETC Group, South Center,
November 2005
6
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
intellectual property are being driven mainly from developed countries. The world’s largest
transnational companies, leading academic laboratories nanotech start-ups are seeking
intellectual property on novel materials, devices and manufacturing processes. Commodity
dependent developing countries must gain a fuller understanding of the direction and impacts
of nanotechnology-induced technological transformations, and participate in determining how
emerging technologies could affect their futures.
There are concerns as well that developed countries will benefit more from nanotechnology
and that developing countries will suffer more from potential risks (e.g occupational health
and safety standards may be lower, waste management and waste disposal infrastructure may
not be adequate for nanomaterials and nano-enabled products). This is one element in the
range of aspects that need to be fully considered. The potential of widening the development
gap requires due attention.
4. The state of the knowledge about the risks of nanomaterials
It has been known for many decades that inhaled particles cause damage to the lungs and also
to the lining of arteries. Recent research has shown that the majority of the damage appears to
be caused by the smallest particles. Classical toxicology examines the effects of single
molecules on living systems. We have known about the properties of bulk materials for a long
time. However the space in between, when bulk materials are made into very small particles
of just a few hundred atoms, leads to changes in their physical and chemical properties. That
is the reason why manufactured nanomaterials are of interest for many applications. We are
only just beginning to understand how nanomaterials impact human health and the
environment.
Various studies have shown that, because of their small size, unbound nanoparticles can be
inhaled and enter the bloodstream via the lungs, disperse throughout the body and penetrate
other organs, however it should be noted that many of these studies use instillation rather than
inhalation as a way to administer nanoparticles, and generally in a greater quantity dose than
reflects actual practical circumstances. It has also been shown that, depending on their
properties, some manufactured nanoparticles can be damaging to cells. Little data is available
on the toxicology, release, environmental behavior and safety of nanomaterials. Although a
few studies have been carried out, not all of their results are meaningful, since many of these
investigations were carried out using very high concentrations of particles, and with samples
or reference materials that had not been accurately characterized (see Annex 9.2, 9.3, 9.4).
Several countries have launched research programmes to reinforce independent risk research
(see point 7). Greater coordination of these programs could facilitate more efficient use of
time and resources.
In the literature it is often stressed that results for one nanoparticle cannot be generalised to
other nanomaterials. This is mainly because the characteristics that influence toxicity have not
yet been defined. Standardised test protocols and standardized reference compounds would
enable comparisons to be made between the different materials and studies. International
organizations such as OECD and ISO and national agencies have established programmes to
fill this gap (see point 6).
Based on the scientific and methodological principles currently available, no conclusive
requirements for the safety of manufactures nanomaterials can yet be formulated.
Nevertheless, safety precautions must be taken based on a precautionary estimation of hazard
7
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
and exposure risk, as with hazardous materials. As soon as the conditions for evidence-based
risk assessments of manufactured nanomaterials are present, existing statutory frameworks
need to be assessed, and, where necessary amended, to provide conditions for the safe
handling of such materials and of nano-enabled products throughout their life cycle. As more
knowledge becomes available, safe handling guidelines can be iteratively formulated and
revised.
5. Communication and public dialogue
Broad information on opportunities and risks of nanotechnology and nanomaterials is
important for public opinion making. Communication is a key prerequisite for the public
engagement with new technologies. This opinion-forming process may leave its mark on the
development of technologies and their application. Communication should therefore extend
further than the field of manufactured nanomaterials to encompass all of nanotechnologies. It
should reflect the current state of social, scientific and political knowledge and of public
engagement. Account should be taken of both the promise of nanotechnologies and the public
fear or rejection it may create.
The involvement of industry, authorities and the public in the debate on opportunities and
risks must be an integral part of technological development. For an integrated approach, this
debate should be as broad as possible and not restricted to individual levels or topics (e.g.
scientific, psychological, sociological). A challenge is to communicate information on risks
and benefits to enable a public dialogue and informed decisions; the challenge will be even
more difficult in developing countries. Dissemination of awareness of possible risks of
nanotechnology to the public of developed and developing countries should be coupled with
positive aspects of nanotechnology, particularly in development of monitoring tools. It should
be noted that nanoparticles are released in large quantities in industrial processes as
unintended by-product of combustion, welding, explosions, etc., but their detection is
currently very limited, mostly due to the lack of established detection mechanisms and
because of lack of awareness of the need for monitoring. Many different ways of detection of
nanoparticles of different kind can be foreseen.
6. Activities of International Organisations6
OECD has established under its Chemical Committee a Working Party on Manufactured
Nanomaterials (WPMN). It aims to promote human health and environmental safety
implications of manufactured nanomaterials in order to assist in their safe development
(limited to mainly the industrial chemicals sector). The following eight projects are in the
workplan of the WPMN:

Development of an OECD Database on Human Health and Environmental Safety
(EHS) Research

EHS Research Strategies on Manufactured Nanomaterials (including Occupational
Health and Safety)

Safety Testing of a Representative Set of Manufactured Nanomaterials
6
OECD has prepared for Forum VI a separate information paper on work ongoing and planned at the
OECD (IFCS/Forum VI/ 4 INF) and IOMC and ISO have agreed to do so. UNESCO has been invited
to provide a separate information paper on its ongoing and planned work and a response is awaited.
8
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008





IFCS/Forum-VI/01.TS
18 March 2008
Manufactured Nanomaterials and Test Guidelines.
Co-operation on Voluntary Schemes and Regulatory Programmes
Co-operation on Risk Assessment
The Role of Alternative Methods in Nano Toxicology
Exposure Measurement and Exposure Mitigation
OECD’s Committee for Scientific and Technological Policy has established a Working Party
on Nanotechnology (WPN). Its aim is to look at the responsible development and use of
nanotechnology and the potential benefits nanotechnology can bring to society, taking into
account public perceptions related to advances in nanotechnology and its convergence with
other technologies, without forgetting legal, social and ethical issues. The following projects
are in the work plan of the WPN:

Statistics and Measurement

Impacts and Business Environment

International Research Collaboration

Outreach and Public Engagement

Dialogue on Policy Strategies

The Contribution of Nanotechnology to Global Challenges
For information on ongoing and planned work of the other IOMC participating organizations
please see "Activities on Nanotechnologies in the IOMC Organizations".7
ISO has established Technical Committee 229. Currently the following 3 working groups
have been established: terminology and nomenclature; measurement and characterization; and,
health, safety and environmental aspects of nanotechnology. 10 work items spread across
these three work areas are currently under development.
UNESCO Ethics of Science and Technology Programme 8 was created in 1998 with the
establishment of the World Commission on the Ethics of Scientific Knowledge and
Technology (COMEST) to give an ethical reflection on science and technology and its
applications.
This programme aims to promote consideration of science and technology in an ethical
framework by initiating and supporting the process of democratic norm building. This
approach is founded upon UNESCO's ideal of "true dialogue, based upon respect for
commonly shared values and the dignity of each civilization and culture". Awareness raising,
capacity building and standard-setting are therefore the key thrusts of UNESCO's strategy in
this and all other areas.
UNESCO has invited well-known experts in nanotechnology to discuss the state of the art of
nanotechnology, examine the controversy surrounding its definition and explore related
ethical and political issues. A 2006 report “The Ethics and Politics of Nanotechnology” 9 ;
"outlines what the science of nanotechnology is, and presents some of the ethical, legal and
political issues that face the international community in the near future." UNESCO has
recently published a book on "Nanotechnologies, Ethics and Politics"10. The aim of the book
is to inform the general public, the scientific community, special interest groups and policy7
IFCS/FORUM-VI/5 INF
8
http://portal.unesco.org/shs/en/ev.php-URL_ID=10581&URL_DO=DO_TOPIC&URL_SECTION=201.html
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf)
10
http://portal.unesco.org/shs/en/ev.php-URL_ID=10883&URL_DO=DO_TOPIC&URL_SECTION=201.html
9
9
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
makers of the ethical issues that are salient in current thinking about nanotechnologies and to
stimulate a fruitful interdisciplinary dialogue about nanoscale technologies among these
stakeholders.
7. Activities of non-governmental organizations
International networks of non-governmental organisations play an important role in
supporting governmental actions, distribution of knowledge and facilitating democratic
participation in decision-making regarding new technologies, including nanotechnology. The
United Nations Environment Programme recognizes NGOs who work on international
"Chemicals Management" and many have experience supporting local, national, and
international progress on public understanding, technical management, policy development
and evaluation of nanomaterials. In addition, NGOs such as the International Society of
Doctors for the Environment (ISDE), Friends of the Earth (FOE), professional engineering,
medical, scientific and other associations, labour organizations, and others work globally to
carry out education and outreach to professionals and the general public, and provide
technical support in policy development for countries in all stages of economic development.
For example, educational and policy work on nanomaterials was carried out in many countries
by ISDE, FOE, ETUC and other organizations who provided workshops, legislative
development and review, and both technical and non-technical publications. An informed
public is key to sustainable and equitable development in all spheres. NGOs offer a diversity
of resources including essential support in policy development and public education. Their
role as organizing entities is critical to achieve democratic decisions regarding the equitable
development and management of nanotechnology.
8. National activities, interests and priorities on nanotechnology and manufactured
nanomaterials
The following information contributed by a select number of countries is presented to provide
a brief introduction to ongoing and planned work as a general indication of some approaches
being taken. An OECD document provides detailed information on current/planned activities
related to the safety of manufactured nanomaterials in OECD member countries, as well as
those non-member countries who are participating in OECD’s work11.
Belarus
Promotion of the use of new technologies including nanotechnologies is a priority in the
country, especially in the area of medicine. But currently the evaluation of the risks for human
health and the environment from the use of nanotechnologies, nanomaterials and
nanoproducts and the associated need to consider preventive measures is not a priority of
11
Current Developments/ Activities on the Safety of Manufactured Nanomaterials, Paris, 28-30
November 2007 http://www.oecd.org/env/nanosafety/
This document provides information on current/planned activities related to the safety of manufactured
nanomaterials in OECD member countries. Information was provided by delegations who participated
in the 3rd Meeting of OECD's Working Party on Manufactured Nanomaterials. There are also reports
on relevant current activities in other International Organisations such as the ISO. In addition,
delegations added a short list of highlights at the top of their submissions to give readers a general idea
of key events since the 2nd meeting of the Working Party. (web accessed 08.02.06)
10
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
decision-makers. This is mainly due to the lack of scientific information, relatively limited
use of nanotechnologies and nanomaterials at this time, and no apparent evidence of adverse
impacts on human health and the environment. On the other hand the growing number of
publications indicating a potential negative impact of some nanoparticles on human health
and the environment is raising public concern because of the free trade of nanoproducts.
There is an urgent need to facilitate scientific research on advantages and disadvantages of
nano-materials, technologies and products use. The assessment of risk should be carried out at
both the national and international levels. Sharing the information and experiences between
countries with different levels of economic development is a high priority. There should be
wide dissemination of information that will support the promotion of the use of new
technologies for sustainable development and also support the protection of human health and
the environment.
According to national legislation new products that can impact negatively human health and
environment should include safety information or to be tested to get permission to be sold in
the domestic market. There are similar rules covering workers' health protection in case of
the implementation of new technologies. Work has been initiated to establish a procedure for
the registration of nanomaterials and nanoproducts based on an analysis of existing
information.
The main areas for international cooperation are the development of standard procedures for
health and safety testing of nanomaterials and products, guidance and standards for
occupational health protection, rules for the provision of safety information for products and
materials (if it is necessary to label products with nanoparticles to protect consumers rights to
know).
China
1. The adjustment of government regulation concerning product classification for medical
devices made with nanometer biological materials
According to the notice of the State Food and Drug Administration of China (SFDA)
announced a notice (document number 146, 2006), the classification of medical devices made
with nanometer biological materials (for example medical instruments made with nanometer
metal silver material) will be adjusted from Class II medical devices to Class III medical
devices, and they should be subject to the administration of Class III medical devices.
2. The standards on nanotechnologies
Up to date China government has published 15 standards on nanotechnologies, of which 11
are national standards and 4 are industrial standards.
3. Research on the nanotechnology safety
With the rapid development of application fields of nanotechnologies, as has happened in
many other countries, the issue of nanotechnologies has given rise to serious public and
governmental concern. Researchers from the Chinese Academy of Sciences (CAS) initiated
activities to study the environmental and toxicological impacts of manufactured nanomaterials
in 2001, including recognition, identification and quantification of the biological and
environmental hazards resulting from exposure to diverse nanomaterials/ nanoparticles.
Currently, more than 30 research organizations in China have initiated their own research
11
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
activities studying the toxicological and environmental effects of nanomaterials/ nanoparticles,
and techniques of recovering nanoparticles from manufacturing processes.
European Commission12
1. Regulatory developments on human health and environmental safety including
recommendations or discussions related to adapting existing regulatory systems or the
drafting of laws/ regulations/ guidance materials
The Commission is performing a regulatory inventory, covering EU regulatory frameworks
that are applicable to nanomaterials (chemicals, worker protection, environmental legislation,
product specific legislation etc.). The purpose of this inventory is to "examine and, where
appropriate, propose adaptations of EU regulations in relevant sectors" as expressed in Action
6d) of the Commission Action Plan. Preliminary findings indicate that the regulatory
frameworks in principle give a good coverage; different aspects of production and products
are at the same time subject to various Community provisions. Implementation is facilitated
by different types of documents, adopted within this regulatory framework, such as
implementing legislation, European standards, regulatory and technical guidance documents
that may have to be adapted in order to cover HSE risks in relation to nanomaterials. However,
many of the knowledge gaps (toxicity thresholds, test schemes etc) will need to be addressed
to ensure implementation and adaptation of ‘supporting documents’. Those knowledge gaps
are in line with the ones earlier identified by EC and others and reported to the OECD. The
Commission’s report therefore will also indicate initiatives undertaken (e.g. Research
Framework Programmes, activities of Joint Research Center, cooperation within OECD,
standardisation, Scientific Committees) in order to improve knowledge levels, so as to allow a
proper implementation of the EU regulatory framework.
In the chemicals regulatory area, EU competent authorities (CAs) have decided that:
a. The decisive criterion whether a nanomaterial is a new or existing substances is the same
as for all other substances, i.e. whether or not the substance is on EINECS. When a
nanomaterial is derived from an existing substance, article 7.1 of the Existing Substances
Regulation 793/93 (ESR) on the updating of reported information applies.
b. Nanomaterials having specific properties may require a different classification and
labelling compared to the bulk material, also when the nanoform is derived from a bulk
substance.
c. They invite industry to provide a number of dossiers on different representative
nanomaterials, to show what kind of data is available, how risk assessment is being
performed and how the risks are controlled.
d. For the longer term, a review of the applicability of testing methods and risk assessment
methods should be carried out. This should be done at international level (e.g. within the
OECD chemicals programme) with active input from industry and contributions from the
EU.
OECD; 3rd Meeting of the Working Party on of Manufactured Nanomaterials, 28-30 November
2007, Current developments in delegations on the safety of manufactured nanomaterials – Tour de
Table
12
12
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
REACH (regulation (EC) No 1907/2006) was adopted on the 18 December 2006 and
published in the Official Journal of the European Union on 30.12.2006. REACH will
gradually revoke and replace several of the existing EU legislation on chemicals. REACH
entered into force on 1st June 2007. The European Chemical Agency ECHA in charge of
following-up the registration, the evaluation and the authorisation process under REACH, was
opened on the same day in Helsinki. Nanomaterials are covered by the provisions of this
Regulation.
2. Developments related to voluntary or stewardship schemes
The EC has not developed any voluntary or stewardship schemes at this stage. Issues
regarding information on nanomaterials will be discussed in the chemicals CAs working
group, also as a follow-up to 1.c. above.
3. Information on any risk assessment decisions
In relation to nanomaterials in chemicals legislation, risk assessment and management is
implemented at this moment as for other chemicals in the framework of the current legislation
on new and existing chemicals (see 1.a. above). More specific guidance and information may
be required in the future.
The EU Scientific Committee on Emerging and Newly Identified health Risks (SCENHIR)
has produced two Opinions in relation to nanomaterials risk assessment, respectively on 10
March 2006, and on 21-22 March 2007. In its first opinion, SCENHIR concluded that the
existing toxicological and ecotoxicological methods are appropriate to assess many of the
hazards associated with the products and processes involving nanoparticles, but that they may
not be sufficient to address all the hazards. Therefore the risk assessment needs to be done on
a case-by-case basis. The assays may need to be supplemented by additional tests, or replaced
by modified tests, as it cannot be assumed that current scientific knowledge has elucidated all
the potential adverse effects of nanoparticles. Specifically, attention needs to be given to the
mode of delivery of the nanoparticles to the test system to ensure that it reflects the relevant
exposure scenarios.
For exposure, SCENIHR also expressed that the use of mass concentration data alone to
express dose is insufficient, and the number concentration and/or surface area would need to
be used as well. Equipment that enables routine measurements for exposure to free
nanoparticles is not yet available. In particular, existing methods used for environmental
exposure assessment may not necessarily be appropriate for determining the environmental
fate of nanomaterials. Consequently, current risk assessment procedures may require
modification for nanoparticles both regarding test methods for hazard identification and
exposure assessment.
The SCENHIR suggested that there is insufficient knowledge and data concerning
nanoparticle characterisation, their detection and measurement, the fate (and especially the
persistence) of nanoparticles in humans and in the environment, and all aspects of toxicology
and environmental toxicology related to nanoparticles, to allow for satisfactory risk
assessments for humans and ecosystems to be performed.
In its second opinion, dealing particularly with the appropriateness of the risk assessment
methodology in accordance with the Technical Guidance Documents (“TGD”) for new and
existing (chemical) substances for assessing the risks of nanomaterials, the SCENHIR
13
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
concluded that current methodologies described in the TGDs are likely to identify certain
hazards, but modifications are required for the assessment of risks to human health and the
environment.. Furthermore, the opinion highlights needs to determine appropriateness of
current test procedures for the prediction of human health hazards and estimation of risks for
all types of nanoparticles. In particular, the SCENIHR focussed on the potential of
nanomaterials to reach new target organs in the body, when administered in similar ways than
bulk chemicals (translocation). This observation would lead to additional requirements of test
methods to demonstrate potential new hazards.
On 19 June 2007, the Scientific Committee for Consumer Products (SCCP) adopted an
Opinion for public consultation in June 2007 on safety of nanomaterials in cosmetic products.
For labile particles, conventional risk assessment methodologies based on mass metrics may
be adequate, whereas for the insoluble and slowly soluble particles other metrics, such as the
number of particles, and their surface area as well as their distribution are also required. It is
crucial when assessing possible risks associated with nanoparticles to consider their uptake. It
is primarily for the insoluble and slowly soluble particles that health concerns related to
possible uptake arise. Should they become systemically available, translocation/
transportation and eventual accumulation in secondary target organs may occur. The
Committee also identifies a number of knowledge gaps. More particularly as regards the ban
on animal testing with respect to cosmetics, the Committee takes note that at present no
methodology has been validated for nanomaterials. Finally, the Committee states that review
of the safety of the nanomaterials presently used in cosmetics is required.
4. Information on any developments related to good practice documents
The Commission is closely following the work in ISO and CEN. Both nanotechnology related
Technical Committees in ISO (TC 229) and in CEN (TC 352) are currently working on the
nomenclature and hence on the definition aspects. In ISO/TC 229, the working group on
Health, Safety and Environment is proposing a Technical Report on "Current Safe Practices
in Occupational Settings Relevant to Nanotechnologies". In addition, in ISO/TC 146 on Air
Quality, the SC2 subcommittee on Workplace atmospheres has released a technical report
ISO/TR 27628:2007 "Ultrafine nanoparticles and nano-structured aerosols – Inhalation
exposure characterization and assessment". In ISO/TC 24/SC4 (Sizing by methods other than
sieving), the particular issue of nanoparticle size measurements and the required reference
materials is considered with more care
5. Research programmes or strategies designed to address human health and/ or
environmental safety aspects of nanomaterials
As stated in Action Plan on Nanosciences and Nanotechnologies (N&N), the European
Commission aims at reinforcing N&N research and development in the seventh framework
programme for research, technological development and demonstration activities (FP7) and
has proposed a significant increase of the budget compared to FP6.
It has also committed itself to boost support for collaborative R&D into the potential impact
of N&N on human health and the environment via toxicological and ecotoxicological studies
as well as developing appropriate methodologies and instrumentation for monitoring and
minimising exposure in the workplace.
Activities in FP7 have been started: In the first call for proposals, several topics were
launched specifically addressing the safety of nanomaterials. The proposals received in these
14
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
topics have all now been evaluated and the research projects will begin by the start of 2008
(except for one that has already started).
NMP-2007-1.3- 1
(Large
scale
projects)
integrating
Specific, easy-to-use portable devices for measurement and
analysis
NMP-2007-1.3- 2
(Small
or
medium-scale
focused research projects)
NMP-2007-1.3- 3
(Coordination and support
actions)
Impact of engineered nanoparticles on health and environment
NMP-2007-1.3- 4
(Coordination and support
actions - only one database and
support action will be funded)
NMP-2007-1.3- 5
(Coordination and support
actions)
HEALTH-2007-1.3- 4
(Small
or
medium-scale
focused research projects) Call
coordinated with NMP-20074.1.3-2/4.4-4
Creation of a critical and commented database on the impact
of nanoparticles
Critical review on the data and studies on the potential impact
on environment and health of nanoparticles
Coordination in studying the environmental and health impact
of nanoparticles and nanotechnology based materials and
products
Alternative testing strategies for the assessment of the
toxicological profile of nanoparticles used in medical
diagnostics
Dedicated calls are foreseen among the next actions of the FP7.
The JRC is developing a research activity in collaboration with EU partners on risk
assessment of engineered nanomaterials. The activities in FP7 focus on the development and
harmonization of methods for toxicity testing of nanomaterials, the in vitro test of a
representative set of MN on critical cell lines and encompass related studies on
nanometrology and reference materials as well as the development of databases and studies
on the applicability of 'in silico' methods adapting the traditional QSAR paradigm.
The Commission is considering supporting the development of a database containing
substance information specific to nanomaterials. IUCLID could serve as a basis and could be
further developed and adapted to the requirements related to nanomaterials datasets.
6. Information on any public/ stakeholder consultation
On 18 July 2007, the European Commission announced a public consultation on a
Recommendation on a Code of Conduct for Responsible Nanosciences and Nanotechnologies
Research. The consultation, that was open until 21 September, will provide input for a
Recommendation on governance of this emerging area of science, which the Commission will
put forward later this year. Contributions were received from a broad cross-section of
European society, including the scientific community, industry, civil society, policy-makers,
media and the general public.
15
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
The European Commission also open a Open Consultation on the Strategy on communication
outreach in nanotechnology; The public and other stakeholders were invited to comment on
the report and results from a workshop held by the European Commission it Brussels,
February 6th 2007. This paper shaped operative recommendations for future European
funding on appropriate communication and innovative approaches to engage the European
civil society into a dialogue on nanotechnology. Experts in the field of science
communication share success, best practices and challenge stories, to give to different
audiences a "voice" in the policy making process. As a result, a set of recommended activities
for Europe were outlined, which could be commented
The opinions from EU Scientific Committees, SCENIHR and SCCP are always submitted to
public consultations before final adoption.
Several conferences on nanotechnology have been organised by different organisations
throughout the EU and by recent EU Presidencies. The Finnish Presidency of the EU
organized a conference on “Nanotechnologies: Safety for Success” in September 2006. In
October 2007 the European Commission organised the another stakeholder dialogue related to
consumer products.
7. Additional Information
The European Group on Ethics in Science and New Technologies (EGE) is a high-level group
of independent experts on ethics appointed by President Barroso. The EGE advises the
Commission on ethical issues related to science and technology or other relevant EU policies.
The Group adopted an Opinion on ethical aspects of Nanomedicine in January 2007
(http://ec.europa.eu/european_group_ethics/index_en.htm).
Several research projects funded by the European Commission are related to innovation,
ethical aspects and societal implications of nanotechnology. Additional information can be
found at http://cordis.europa.eu/nanotechnology/. Linked to the European Technology
Platform on Sustainable Chemistry, several documents are becoming available such as a code
of conduct on nanotechnology; a guide on safe manufacturing and for activities involving
nanoparticles at workplaces; and detailed information on the characterisation of nanomaterials.
Moreover, the recent Nanosafety Hub event organised by the European Technology Platform
on Industrial Safety (ETPIS) on the 23rd March 2007 in Brussels, BE provided an overview of
progress on the development of detection and monitoring technologies and the state-of-the-art
in the fields of toxicity of nanoparticles, secured integrated processes as well as workplace
health, safety and environmental safety all linked to nanomaterials (more information are
available
on
http://www.industrialsafety-tp.org/
&
http://euvri.risktechnologies.com/events/event_3/default.htm).
A standardization mandate is currently in consultation with Member States to formally
convey priorities to the European standards bodies and to request feedback on their activities.
The European standards bodies are invited to forward a program of activities to the European
Commission and Member States that subsequently can be endorsed by Commission and
national authorities. The mandate states that European standardisation efforts will preferably
be elaborated in cooperation with the international standards bodies.
16
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
Germany
The German Government has bundled its various activities in the “NanoInitiative 2010”
(coordinated by the Federal Ministry of Education and Research, BMBF13) to provide for an
uniform frame of objectives and activities in this new policy area. In August 2007, the
German Government published a report on nanotechnologies with a comprehensive overview
on objectives, activities as well as further issues on chances and challenges of
nanotechnologies.
Eight Ministries work cooperatively together to promote a German “Nanoinitiative – Action
Plan 2010” taking into account the various aspects on chances and risks of a responsible
handling of this new key technology and related nanomaterials, notably (1) research projects
re environmental and health implications of nanoparticles, (2) nanos in food regarding their
safety and health impacts, (3) guidelines on nanos at work, (4) an assessment on chances and
risks of nano-related applications in the context of pharmaceutical products and (5) a research
strategy with suitable research projects of the Federal Government aiming at the prevention of
health and environment damage of nanos.
The German Environment Minister initiated in autumn 2006 the “NanoDialogue 2006 to
200814” to further consider chances and risks of nanotechnologies and nanomaterials and
prepare recommendations by the end of 2008 for a responsive application of nanotechnologies
and nanomaterials. A nano-commission and three working groups (involving governmental
and various relevant civil society representatives) currently consider questions in the context
of “chances for health and environment”, “risks and safety research“ and „guidelines for a
responsible use of nanomaterials”.
One of those activities is the launch of the NanoDialogue project in autumn 2006 by the
Federal Ministry for Environment, Nature Conservation and Nuclear Safety (BMU) on behalf
of the Federal Government. The aim is to provide support through the NanoCommission, to
the sustainable development and use of nanomaterials. The NanoCommission is made up of
academics, industry representatives, environmental and consumer associations, employees'
representatives, federal representatives and the Länder. The NanoCommission has set itself
three tasks. For these tasks, special working groups were installed:
1. The 1st working group concentrates on the question: How can using nanomaterials
contribute to sustainable economic and social development in Germany, in particular
as regards environmental/health and consumer protection? For instance,
nanomaterials are already being used to improve photovoltaics installations; they also
promise to make improvements to energy storage equipment and batteries.
The "Opportunities for the Environment and Health" Working Group wants to
identify and describe select nano-enabled products or applications from which we can
derive a special benefit for the environment, for consumers and as regards health
protection. Because in some areas nanomaterials are still at an early stage of
development, future potentials also need to be identified for this sector in Germany.
2. Where do we need to do risk and safety research to clarify the possible impacts on
the environment and health from using nanomaterials? A second working group is
13
14
http://www.bmbf.de/en/nanotechnologie.php
http://www.bmu.de/english/nanotechnology/general_information/doc/37323.php
17
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
called "Risks and Safety Research" and consequently deals with the possible risks
posed by nanomaterials, especially the gaps in our knowledge, which we need to fill
as soon as possible.
The aim is to work out a joint programme for future safety research plus suggestions
for concrete projects. Since many products with nanomaterials are already on the
market and we expect a further increase in the future, this working group wants also
to give first recommendations regarding risk assessment for nanomaterials.
One key difficulty in assessing the possible risks posed by nanomaterials is that in
some cases new test and evaluation methods need to be developed. These include
suitable means for measuring nanoparticles in environmental media and on/in the
human body, as well as developing appropriate measuring and assessment strategies.
3. In order to provide preventive protection to employees, consumers and the
environment, a third group is working on "Guidelines on the Responsible Use of
nanomaterials". The group started the work on existing Guidelines for employment
protection and is now working on basic principles on which Guidelines should be
based and on indicators, for checking their implementation.
Possibly the result will be recommendations for dealing with lack of knowledge,
possible “no-go areas” for release of nanomaterials into the environment or for
potential damages for humans will be identified. But “No-go areas” could otherwise
mean that there are also some kind of “innovation-spaces”, where the experts see few
risks and where the advantages preponderate. The aim of working group 3 is that
Industry and user Companies adopt this Guidelines as a “Code of Good Practice”.
The NanoCommission is very interested in initiatives of the OECD, the EU and other states in
this area and wants to incorporate this into its work. In addition, different
Government/Industry funded projects are ongoing where nanomaterials are tested like
Nanocare, Inos and Tracer and some Government or industry funded work in this area. This is
embedded in activities of the EU. The NanoCommission will present the results of its work in
form of recommendations in late November 2008.
Japan
1. Introduction
The promotion and the social acceptance of nanotechnology has been considered as an
important issue, and the R&D for the social acceptance of nanotechnology has been focused
as a strategic Science and Technology Priorities in the 3rd Science and Technology Basic
Plan in Japan.
In fiscal year 2006, the Ministry of Economy, Trade and Industry (METI) had a preliminary
discussion on the health and environmental safety issues of manufactured nanomaterials as
one of the emerging issues to be addressed in the near future within the framework of
chemical management in METI’s Policy Council on Chemical Issues. However, no proposal
regarding concrete measures restricting manufactured nanomaterials has been put on the table
yet.
18
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
The Cabinet Office has also decided to establish a committee that coordinates research and
development policy on nanotechnology. One of its targets is to establish the information
infrastructure to accelerate innovation, by facilitating research and development of
nanotechnology and research for public acceptance of nanotechnology in a focused and
strategic manner.
The Ministry of Health, Labour and Welfare decided to launch two committees, on the safety
of manufactured nanomaterials, which will be held jointly where appropriate. The committees
will focus on the safety of nanomaterials at occupational settings and in consumer products in
general, respectively. It is expected that each committee publish a report before the end of
2008.
2. Research programmes
In fiscal year 2005, four national institutes, namely The National Institute of Advanced
Industrial Science and Technology (AIST), the National Institute of Health Science (NIHS),
the National Institute for Environmental Studies (NIES), the National Institute of Materials
Science (NIMS), and some universities have jointly conducted research and surveys to
facilitate public acceptance of nanotechnology. They focused on 1) risk assessments of
nanomaterials, 2) health issues of nanomaterials, 3) environmental issues of nanomaterials, 4)
ethical and societal issues of nanotechnology, and 5) technology assessment for promoting the
public acceptance of nanotechnology and its economic effects through funding by the
Ministry of Education, Culture, Sports, Science and Technology (MEXT). The survey team
has issued a report which contains a series of recommendations to public institutes, the private
sector and the government. These survey results may possibly be used as a guide for future
national measures by the government.
In fiscal year 2006, funded by MEXT, a project named “The multidisciplinary experts panel
for nanotechnology implication” was started. The project is composed of the above institutes
and the university researchers, and focuses on “what are preferential tasks with reference to
clarifying the nanotechnology implication for health, environment and social acceptance.”
The additional objective is the establishment of a researchers’ network on the implications of
nanotechnology.
METI has launched a five-year project named “Evaluation of the Potential Risks of
Manufactured Nanomaterials based on Toxicity Tests with Precise Characterization.” The
project focuses on toxicity test protocols (mainly an inhalation test) and a risk assessment
methodology of manufactured nanomaterials, based on developing: characterization
methods/apparatuses and sample preparation protocols for nanomaterials themselves and for
organs or cells etc. which contains nanomaterials; inhalation test apparatus for nanomaterials;
non-invasive in vivo imaging protocols and apparatus to measure biological reductive ability;
biological reaction profiles of in vitro tests; methods of evaluation of protective equipment
(e.g. masks), and also based on surveillance of amounts and types of nanomaterials released
from/inside facilities. Fullerene and carbon nanotubes are given priority in this project.
Literature research of nanomaterials toxicity, together with social and legal scientific studies
is also implemented.
MHLW also conducted a preliminary project in 2005, and has launched a subsequent threeyear project named “Research on the hazard characterization and toxico-kinetic analysis of
manufactured nanomaterials for the establishment of health risk assessment methodology” led
by NIHS from 2006. The project has been focusing on detecting methodologies of
19
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
nanomaterials in biological samples, ADME analysis, dermal exposure experiments, longterm health implication analysis using genetically modified animals, and the development of a
transpulmonary/inhalation experiment system. In addition, MHLW has started a survey on
nanomaterials used for consumer products in 2007.
The National Institute of Occupational Safety and Health Japan (JNIOSH) has started a threeyear project study on possible health issues due to exposure to manufactured nanomaterials in
the workplace since April 2007. This project includes 1) a questionnaire survey on
occupational health practices for handling and use of nanomaterials in the workplace, 2)
studies on sampling and analytical methods, and 3) toxicological studies in vitro with human
cultured cell lines and in vivo by intratracheal administration.
In 2006, NIES launched a nanotoxicology programme where both in vitro and in vivo
toxicities of nano-structured particulate materials are to be revealed. The programme includes
(1) interaction of nano-fibers including CNT with cell membranes, (2) transepithelial and
transpulmonary migration of nanoparticles, (3) in vitro and in vivo toxicity assay of
nanomaterials using heat-treated asbestos as reference samples. Recently, a nose-exposure
chamber has been installed to investigate in vivo effects of nanomaterials in a doubly-shielded
room. NIES will soon start an inhalation study for in vivo toxicity test for nanomaterials using
rats or mice.
3. Developments related to good practice documents
METI has conducted a preliminary survey on safe handling of nanomaterials at manufacturing
sites and research laboratories in fiscal year 2006. Through the survey, METI has reviewed
existing good practices both from domestic and overseas sites and has drafted basic guidelines.
These draft guidelines are to be reviewed by industry stakeholders for implementation.
On February, 2008, MHLW released precautionary guidance on safe handling of
manufactured nanomaterials at workplace to prevent exposure to workers.
Korea
The Korean government well recognized the importance of potential risks of nanomaterials,
and is conducting several projects on human health and environmental safety of nanomaterials.
Ministry of Environment (MOE) implemented a new project on the safety of manufactured
nanomaterials in the framework of Ecotechnopia 21 project which has been conducted to
promote the development of environmental technologies since 2001. Ministry of Science &
Technology (MOST) has performed a research project named environmental implications
assessment of nanomaterials from 2006. Ministry of Commerce, Industry and Energy
(MOCIE) has conducted research designated in ISO/ TC 229. Korea Food & Drug
Administration (KFDA) has carried out a series of research projects on the toxicity of
nanomaterials from 2007 to 2015 with the aim of the development of a toxicological
assessment of nanomaterials and guidelines for the areas such as food, drug, medical product
and cosmetics. In order to harmonize the policy on the safety of nanomaterials in Korea,
MOE, MOST, KFDA and MOCIE established an inter-ministerial consultation body on the
safety of nanomaterials in March 2007. The consultation body will play an important role to
perform effective research and to develop harmonious policy in the nanosafety.
Issues covered by MOE, MOST, MOCIE and KFDA
- to characterise nanomaterials
20
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
- to establish test guidelines for the areas such as food, drug, medical product, and
cosmetics.
- (eco) toxicological assessment of nanomaterials
- environment exposure and fate of nanomaterials
- risk management of nanomaterials
- survey the domestic and overseas trends on nanomaterial hazards
Nigeria
Nigeria has made progress in Science and Technology policy issues relating to
Nanotechnology and Advanced Materials since the last two years. A Nigeria Nanotechnology
Initiative was launched in 2006 under the coordination of the National Agency for Science
and Engineering Infrastructure (NASENI). This involves a network of Research Institutes and
University Research Groups in specific areas of nanotechnology. The initiative was geared
towards the applications of nanotechnology in areas that will fast-track technology
development relevant to developing economies such as Nigeria.
Notwithstanding the progress made in science and technology in Nigeria, national activities
are still very limited with a low level of awareness amongst the public and key
stakeholders. It is expected that the Forum session will provide an avenue for Nigeria and
other developing nations to obtain information on accessing available opportunities for
capacity development in nanotechnology at the national and regional levels.
Some of the key areas of interest and challenges will be to: raise awareness on the subject
matter, justify the relevance and import of nanotechnology to developing economies, identify
any ongoing activities and expertise in this area, identify key stakeholders for capacity
development, develop programmes of action for public and private sector buy-in with the
main considerations for accruing benefits to the environment and human health.
Slovenia
Slovenia launched the first activities in the field of nanosafety in 2004 with participation in
EU Accompanying Measure (GROWTH PROGRAMME): NANOSAFE - Risk Assessment
in Production and Use of Nanoparticles with Development of Preventive Measures and
Practice Codes) and its continuation as Integrated project: NANOSAFE 2 - Safe production
and use of nanomaterials (2005-2009) and Co-ordination action IMPART - Improving the
understanding of the impact of nanoparticles on human health and the environment (20052008). A partner in all these EU projects is Jozef Stefan Institute (www.ijs.si ).
On 4th and 5th September 2006 National Chemicals Bureau organized the International
Conference on Chemical Safety and Safety of Nanomaterials. The conference was the final
step of an intensive project Phare Twinning “Chemical Safety II”, No. SI 03 IB EC 02, which
had been supported by the European Commission. The main twinning partners Slovenia and
Austria with about 60 short term experts from 10 EU Member States had worked together
with numerous experts from the Slovene working groups in different intersectoral priority
areas of chemical safety. After the conference work went further and the book "Slovenia is
made for nanotechnology" was published. Transition Facility Twinning "Advanced Chemical
Safety - Third Stage Project" (in short “Chemical safety 3”), No. SI 06 IB EC 02, which
started on 4th June 2007, expects that a brochure on safety of Nanomaterials in Slovene
language might be prepared and published, that national strategy for nanomaterials is
prepared, and that safety and that overall awareness on risks posed by nanomaterials is raised.
21
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
The first national workshop on toxicity of nanoparticles organized by University in Ljubljana,
Faculty for biotechnology, Jozef Stefan Institute, National institute for chemistry, and
National institute for biology, was held on January 30, 2007 in Ljubljana. We have
established a network of all researchers focused on the interaction of nanoparticles with living
cells. The report was published as an article on literature survey in the topic including our
research results in national journal Delo with 65.000 subscribers.
Public lectures about toxicity of nanoparticles and basic recommendations for their safe
production and use have been given at two basic research institutions (Jozef Stefan Institute Febr. 2007, National Institute for Chemistry – March 2007), where nanotechnology studies
already started and at the Chamber of Craft of Slovenia – February 2007, with emphasis on
nanoparticles released in industry as a side product or pollution. Résumé of the lecture was
published in national journal Delo with 65.000 subscribers and in journal Obrtnik (specialized
journal for Chamber of Craft) with 53.000 subscribers. Basic information on concerns relating
to health risks of nanoparticles was published also on the website www.energetika.net, April
30, 2007 and released by national radio station RTV Slovenia, February 1, 2007.
In 2006/2007 we created a technological platform I-TECHMED: Innovative and Supportive
Technologies for Medicine (http://www.itechmed.net/eng/index.aspx?menu=ep ).
The goal of the platform with 50 involved public and private organizations is to establish an
efficient public-private partnership and to unite key stakeholders, who have a joint vision of
technological development for a particular sector, under the leadership of industry. In the
work group titled: Nanotechnologies for medical applications, the partners are decided to
balance the positive and negative impacts of nanoparticles on health considering ethics risks
coupled with enhanced chemical activity with decreasing the size of nanoparticles used as
drug deliveries. Nanoparticles in medicine are either engineered if they are prepared for
specific purpose, as example in drugs or creams, or they can be a side product of friction, as
implant debris.
The first course of nanotoxicology at University in Ljubljana with the expected students in
school year 2008-2009 is currently in the preparation stage.
Jozef Stefan Institute is proposing the following actions to be taken on national level:
The action plan of Slovenia covers the following issues:
- To register all producers of mass quantities of engineered nanoparticles synthesizing for
the market
- To establish a national network on safe production and use of nanoparticles
- To prepare recommendations for producers and users of nanoparticles
- To recommend the size-distribution measurements of NPs at work place and in
environment
- To prepare the monitoring strategies at the production plants (personal sampling is
preferred to ensure an accurate representation of the worker’s exposure).
Switzerland
In Spring 2006 work on the Swiss Action Plan was officially launched. A work package is
developed in collaboration with experts and stakeholders in order to identify critical
applications of manufactured nanomaterials and to minimize possible detrimental effects on
human health and the environment. The coordination of this work package with international
22
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
organizations (OECD, ISO) and EU is important. The promotion of safety research on
manufactured Nanomaterials and the dialog with the public and stakeholders are other
objectives of the Action Plan. The first deliverable of the action plan was a basic report,
published in July 2007 (http://www.umwelt-schweiz.ch/nanotechnologie), containing an
overview of the current knowledge about the risks of manufactured nanoparticles. Topics
discussed are toxicity and ecotoxicity of nanomaterials, occupational health and safety,
regulation and standardisation, the assessment of the consequences of technology and
communication. Finally, a list of risk research needs is presented.
Present Swiss legislation does not take the specific properties of manufactured nanomaterials
into account. The action plan of Switzerland which was approved by the Federal Council in
April 2008 covers the following issues:
- Product information for consumers
- Guidance for self-supervision
- Information about manufactured nanomaterials on the material safety data sheets
- Maximum tolerable concentrations at the workplace
- Regulation of waste disposal
- Obligations to report, notify or authorisation (test requirements, special procedures for the
registration of nanoparticles)
- Limitation of emissions into the environment
- Regulation on major accidents (tonnage thresholds)
- Development and market launch of sustainable applications of nanotechnology
Thailand15
In 2003 the Royal Thai Government established the National Nanotechnology Center
(NANOTEC) under the umbrella of the National Science and Technology Development
Agency (NSTDA), a non-government public institution. NANOTEC has a mandate to
formulate a National Nanotechnology Strategic Plan (2004 - 2013) for Thailand as well as to
establish nanotechnology operational plans and the guidelines. NANOTEC's main objectives
are: to conduct and promote nanotechnology research in order to improve the competitiveness
of Thai industries, to develop well trained human resources in the field of nanotechnology, to
establish networks and collaborations with other research centers, academics, industrial
sectors national and internationally, and to promote public awareness and understanding of
nanotechnology. NANOTEC with the collaboration of the Office of the Consumer Protection
Board is developing a nano-label (or nanomark) to verify properties and improvement on a
nanoproduct. NANOTEC as a funding agency has urged researchers to add the safety aspects
to all nanomaterial R&D grant proposals. Safety data should be available through NANOTEC
after the research works are completed. Nevertheless, there has never been a research program
specifically designed to address human health and/ or environmental safety aspects of
nanomaterials as such.
A national policy body to handle nanosafety issues has been established and called for the
drafting of a nanosafety and nanoethics guideline. NANOTEC has engaged Chulalongkorn
University to prepare the nano-safety and nano-ethics guideline that will covered
nanotechnology research, development, manufacturing, transport, usage, consumption, and
the treatment/ disposal of wastes arising from any of the mentioned activities. The project was
Information taken from: OECD; 3rd Meeting of the Working Party on of Manufactured
Nanomaterials, 28-30 November 2007, Current developments in delegations on the safety of
manufactured nanomaterials – Tour de Table
15
23
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
divided into 3 phrases with the first one starting in April 2007. The main objective of the first
phase is to gather international information on all aspects of nanosafety and nanoethics. Phase
1 aims to familiarize experts in various fields with nanotechnology. These experts from the
fields of environmental law, consumer protection law, economics, and political science, are
expected to contribute to the second and third phases of the project, where local status and
trends will be assessed and the nanosafety/ nanoethics guidelines will be drafted, respectively.
Chulalongkorn University has formed a forum of nanosafety with the objective of sharing
information among interested faculty members & researchers. In addition, a public hearing in
nanosafety and toxicity in nanomaterials was held in October 2007. The participants were
composed of researchers, public and government sector.
United Kingdom
The UK aims to promote the responsible development, use and fate of nanomaterials while
protecting people’s health and safety and protecting the environment. A key objective is
managing any potential risks to the environment and human health via the environment.
Implementation of Government activities on nanotechnologies is co-ordinated through the
Nanotechnology Issues Dialogue Group (NIDG) made up of Government departments,
agencies and the devolved administrations. Progress and delivery was independently reviewed
after two years and will be reviewed again after five years.
There is currently little evidence on which to determine the potential risks posed by
engineered nanoscale materials. It is therefore difficult to assess the extent to which current
controls and regulations cover these materials, or the type of additional measures that may be
necessary to control potential risks. To address this, the UK has developed a comprehensive
programme of research on potential risks and a Voluntary Reporting Scheme for engineered
nanoscale materials.
The UK Government funded around £10 million of Environment, Health and Safety related
research between 2005 and 2008. This sat alongside major funding for research into the
fundamental science behind the nanotechnologies through the UK Research Councils, which
provide the bedrock on which nanotechnology research is growing in the UK. The UK has
identified 19 Environmental, Health and Safety research objectives and developed action
plans to meet them. A second Government research report which places UK activities into an
international context was published in November 2007.
The UK Voluntary Reporting Scheme was established for industry and research organisations
to provide information relevant to understanding the potential risks posed by free engineered
nanoscale materials. The scheme is voluntary and will not replace existing legislation. It has
run from September 2006 to September 2008.
All policy activities are informed by an ongoing programme of stakeholder involvement,
centered around meetings of a Nanotechnologies Stakeholder Forum. This group is made up
of key stakeholders from industry, civil society groups and academia. Stakeholder
involvement is complemented by work to ensure wider public dialogue on the role and
management of nanotechnologies in society. As part of this, a Nanotechnology Engagement
Group was funded to draw together and reflect on a variety of public engagement projects,
and then feed key conclusions back to Government.
24
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
The UK recognises that the challenges posed in ensuring the responsible development of
nanotechnologies is too great to be solved by any one country alone. This is why we have
been working with international partners, in particular, the European Commission and the
OECD to share efforts and avoid duplication.
Further details may be found at: www.defra.gov.uk/environment/nanotech/index.htm
9. Possible Forum actions
To address this new and emerging issue, the Forum may wish
-
to exchange information in order to help raise the awareness of participants and other
stakeholders to the potential new opportunities, challenges and risks posed by
nanotechnology and manufactured nanomaterials;
-
to share information on the ongoing work of international organizations such as OECD
(and where appropriate other IOMC participating organizations), ISO and UNESCO and
encourage progress in these programmes;
-
to share information on ongoing national and regional approaches including those of
NGOs and other stakeholders to foster common understanding of the issues;
-
to discuss the potential contributions of nanotechnology and manufactured nanomaterials
to sustainable development and pollution prevention taking into account the full life cycle;
-
to promote and share information on research and research strategies in support of better
analysis on potential hazards and risks on human health and the environment, especially
for vulnerable and highly exposed groups;
-
to promote and share information on product-related monitoring systems;
-
to identify gaps in knowledge that may be necessary to evaluate effectively the potential
risks and benefits of nanotechnology
-
to discuss how to achieve an equitable distribution of benefits and a minimization of risks
and role of responsible stewardship including adequate application of precaution in
addressing these issues;
-
to consider actions to enable further progress in these areas while taking into account the
special situation of developing countries and countries in economic transition, including
international cooperation for capacity building and technology transfer.
Any recommendations and actions the Forum may wish to propose could be prepared by an
ad hoc working group established at Forum VI.
The Forum may wish to consider bringing forward recommendations and actions in the form
of a declaration.
25
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
10. Annex
10.1 Definitions and types of manufactured nanomaterials
The definition of nanotechnology should be capable of identifying nanomaterials, nanointermediates and all nano-enabled products where they are purposefully engineered to
achieve size-dependent properties and functions. A definition should exclude accidental,
natural, and incidental nanomaterials. Currently, several organizations have proposed and
published definitions and descriptions.
Definitions of Nanotechnology16
"There are currently dozens of different definitions of what nanotechnology is or could be;
and it is important to realize that none has been agreed upon. Definitions are also political and
ethical – they can determine what people will pay attention to, worry about, ignore or
investigate. The fact that there are many definitions is a good indication that nanotechnology
(like other emerging sciences such as biotechnology) will likely confuse the settled categories
of pure and applied research, and of publicly and privately funded research. Different
disciplinary backgrounds and different national scientific establishments will bring different
concerns and ideas to bear on what nanotechnology will become."
The UNESCO publication describes at least five definitions in use and notes that "Different
groups define nanotechnology differently, depending on what they hope it will achieve …..
These definitions also vary according to the interests of nations and social actors interested
in nanotechnology…"
In a the review carried out for ECETOC the following definitions and descriptions of the
different types of manufactured nanomaterials, nano-tools and nano-devices are mentioned17:
Nanoscience is the study of phenomena and manipulation of materials at atomic, molecular
and macromolular scales, where the properties differ significantly from those at a larger scale;
Nanotechnologies are the design, characterisation, production and application of structures,
devices and systems by controlling shape and size at nanometre scale 18.
Nanotechnology: the manipulation, precision placement, measurement, modelling or
manufacture of sub-100 nanometre scale matter 19.
16
The Ethics and Politics of Nanotechnology (UNESCO, 2006)
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf
17
Borm PJA, Robbins D, Haubold S, Kuhlbusch T, Fissan H, Donaldson K, Schins R, Stone V,
Kreyling W, Lademann J, Krutmann J, Warheit D, Oberdörster E: The potential risks of nanomaterials:
a review carried out for ECETOC. Part Fibre Toxicol. 2006, 3:1-35.
18
The Royal Society and the Royal Academy of Engineering: Nanoscience and nanotechnologies:
opportunities and uncertainties; 2004.
19
Meyer M, Kuusi O: Nanotechnology: Generalizations in an Interdisciplinary Field of Science and
Technology (2002), Vol., No.2 (2004), pp. International Journal for Philosophy of Chemistry; 2002, 10:
153-168.
26
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
Nanotechnology is dealing with functional systems based on the use of sub-units with
specific size dependent properties of the individual sub-units or of a system of those 20.
Nanomaterials, nanotools and nanodevices
Nanomaterials:
Materials with one or more components that have at least one dimension in the range of 1 to
100 nm and include nanoparticles, nanofibres and nanotubes, composite materials and nanostructured surfaces. These include nanoparticles as a subset of nanomaterials currently defined
by consensus as single particles with a diameter < 100 nm. Agglomerates of nanoparticles can
be larger than 100 nm in diameter but will be included in the discussion since they may break
down on weak mechanical forces or in solvents. Nanofibres are a sub-class of nanoparticles
(include nanotubes) which have two dimensions <100nm but the third (axial) dimension can
be much larger.
Nanotools:
Tools and techniques for synthesising nanomaterials, manipulating atoms and fabricating
device structures, and - very importantly - for measuring and characterising materials and
devices at the nanoscale.
Nanodevices:
Devices at the nanoscale, important in microelectronics and optoelectronics at the present
time, and at the interface with biotechnology where the aim is to mimic the action of
biological systems such as cellular motors. This latter area is the most futuristic, and excites
the greatest public reaction.
10.2 Health risks
In addition to the dose and the elemental composition of the nanoparticles, factors such as
their surface area, the function of the surface, tendency to aggregate, the form of the particles
and their surface charge all play decisive roles in their distribution through the body, and their
possible (genetic) toxicity. In aqueous systems, the solution pH and the presence of adsorbing
molecules and ions affect their surface charge and, hence, strongly influence aggregation
behavior. The rate of dissolution is proportional to particle surface area, and consequently
nanoparticulate materials should dissolve faster than larger-sized bulk materials. Nanoparticle
toxicity is strongly coupled with chemical toxicity of particular elements composing a
nanoparticle. Quantum size effects through changes in electron level distribution and
ionization energy of the smallest nanoparticles influence the electro-magnetic interaction with
a cell organelles as well.
For most nanoparticles it is not clear whether and how they are taken up in the body,
distributed, metabolised, accumulated and secreted. Kinetic models can help in the estimation
of realistic doses of particles in target organs that could be affected. Thus, the question can be
resolved of which exposure paths are relevant for various nanoparticles and whether certain
target organs can be excluded (for the moment), when setting the first priorities. In addition to
20
Schmidt G, Decker M, Ernst H, Fuchs H, Grunwald W, Grunwald A et al. Small dimensions and
material properties. Europaische Akademie Graue Reihe. A definiton of nanotechnology; 134; 2003.
Bad Neuenahr.
27
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
particles themselves, the potential health and ecological impacts of their breakdown products
(metabolites in biological systems, and degradates in ecosystems) also have to be considered.
The lungs are the primary target site for inhaled nanoparticles, although there is also evidence
of some inhaled nanoparticles being transported from the nasal passages into the brain
(discussed below). Lungs have an enormous exposed area, and inhaled and deposited
nanoparticles can get into the bloodstream through the extremely thin air-blood-tissue barrier.
From the bloodstream, some nanoparticles have been shown to penetrate lipid bi-membranes
and get into organelles such as mitochondria and nuclei, which can cause oxidative stress or
damage to DNA. Many studies using animals or cell cultures have reported oxidative stress,
inflammatory responses and cell membrane disruption through lipid peroxidation following
nanoparticles exposure. In addition to the lungs, the skin provides a potential uptake surface
following dermal exposures (such as for cosmetics, sunscreens, and nanoparticle-impregnated
clothing). Studies have demonstrated that the intact skin protects the body efficiently and
effectively against nanoparticles (TiO2 in sunscreens). However very specifically engineered
particles might penetrate, and a generic conclusion regarding skin penetration does not exist.
Access from the dermis to lymphatic and blood circulation is considered possible or likely.
Penetration into the skin especially in the case of inflammatory or traumatic lesions is very
likely as it was even demonstrated for larger particles.
Oral ingestion of nanomaterials has not been adequately tested to date. Once ingested, some
scientific studies report that nanoparticles are excreted efficiently through the intestine for
small particles (< 100 nm) increased uptake through the intestinal wall has been observed in
rats.
A number of studies have demonstrated that some nanomaterials are efficiently transported
directly from olfactory neurons into the central nervous system, crossing the blood-brain
barrier. Data on translocation between organs are based on different approaches, so they
cannot yet be considered to have been confirmed. According to various studies surfacemodified nanoparticles crossed the blood-brain barrier. It has not yet been reported in the
public literature whether the blood-testis barrier or the placental barrier can also be crossed,
but it is suspected that these things are possible, in view of the fact that the particles are in the
range of nm.
10.3 Occupational health
At the workplace, according to our present knowledge, exposure to nanoparticles occurs
primarily through handling nanoparticles that were produced for a specific purpose, and
through working practices that generate nanoparticles as unintended by-products. Although
there is not yet an overview of the types, quantities, or forms of application of nanoparticles,
as by-products they are considered to be the most widespread source of exposure in the
workplace (aka: ultra-fine particles).
There have not yet been any epidemiological studies on the health risks of modern
manufactured nanomaterials. Concentrations at the workplace have begun to be measured,
and it is not clear whether the current models for local and temporal concentration profiles
apply in the case of new nanomaterials. At present apart from a convention between a few
European institutes of occupational safety there are no international standards on methods for
measuring nanoparticles and for estimating exposure to them. ISO has created a committee on
28
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
nanotechnology21, in order to produce norms based on scientific knowledge in the areas of
health, safety and the environment. Until norms in this area become available, exchanges of
experience between measuring engineers and scientists will be particularly important.
The known strategies to reduce exposure in the workplace also apply to dealing with
nanomaterials. Appropriate protection measures are evaluated and defined by specialists in
occupational health and safety as part of an assessment of risks throughout the company. In
some countries the principle applies that new substances with unknown properties should be
treated as potentially dangerous. Organisational protection measures should primarily be
taken, supported by technical protection measures and the substitution of preparations that
form powders.
Personal protection equipment can occasionally supplement these measures, but it should not
replace them. Current recommendations are firmly based on analogy with handling larger
particles. A number of studies exist showing that correct use of technical protection systems
and personal protection equipment is effective22.
Until more is known, there is still a lack of the scientific informationand methodological basis
to carry out a robust risk assessment of nanomaterials. Several large-scale programmes are
running or being planned in various countries and at the international level. These will deal
with different aspects of risk research on nanomaterials. In this context, it is critical to have a
coordinated, strategic approach to deal with the most important issues.
10.4 Environmental risks
At present, only a few studies have been carried out on the ecotoxicity and environmental
behaviour (fate and transport) of nanomaterials. So far, numerous studies have reported on the
highly toxic impacts of nanomaterials on aquatic organisms, however many of these studies
are limited because the test material was inadequately characterized , and some findings have
been challenged.
There are not yet any reliable estimates of possible environmental inputs that could occur
during the production, use and disposal of nanomaterials or products containing nanomaterials.
In particular there is a lack of suitable methods to measure nanomaterials in the environment.
Similarly, scarcely any studies have been carried out on by-products and breakdown products
of nanomaterials. The basic aspects of the behaviour of micrometre-range particles in the air
or in aqueous solutions have been clearly described and they can be understood in terms of
quantitative models. As far as possible, nanoparticles should be introduced into these existing
models, or appropriate new models should be developed. Normally, nanoparticles in gases
can be removed relatively simply by rapid agglomeration to bigger structures by diffusion
filtration or depth filtration. In liquids this may be difficult under certain circumstances if
there are stabilized dispersions. The effectiveness of breakdown in wastewater treatment
works has barely been examined so far. Preliminary investigations show that the present
treatment process may not be sufficient, but the literature is not all in agreement. So far, there
are few studies exploring bioaccumulation and the possibility of the accumulation of
nanoparticles in the food-chain. However, investigations show that nanoparticles can be taken
21
ISO Technical Committee (TC) 229 «Nanotechnologies».
See studies presented at http://nano-taiwan.sinica.edu.tw/2007_EHS2007/index.htm and the NIOSH
June 2007 Report http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf
22
29
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
up by organisms in the environment. We have to consider on one hand the storage of
lipophilic nanoparticles in fatty tissues, and the resultant concentration in the food-chain, and
on the other hand the accumulation of persistent nanoparticles in ecosystems and organisms if
there are no pathways for their breakdown or excretion.
The specific physical and chemical properties of nanoparticles compared with larger particles
can present unexpected safety risks. The most important physico-chemical dangers are the
risks of fire or explosion and of unexpectedly increased catalytic activity. So far, these
dangers have been classified as relatively low for many manufactured nanomaterials, as
nanoparticles are produced in relatively small quantities. However, this is likely to change
rapidly in the future.
In clouds of dust, the size of the particles and the related specific surface area are critical for
the explosion characteristics. Basically, the smaller the particles are, the greater the risk of a
dust explosion will be. However, the physico-chemical properties of many particles are still
only partly understood, so it is difficult to estimate these risks.
10.5 Ethical issues
A 2006 UNESCO publication23 states "... ethical issues in relation to nanotechnology should
be identified and analyzed so that the general public, specialized groups and decision-makers
can be made aware of the implications of the new technology. Since nanotechnology is
developing quickly, an anticipatory approach to ethical issues is necessary." … "From the
perspective of UNESCO, even if nations are not actively pursuing research in nanotechnology,
they should nonetheless have a stake in defining the proposed outcomes and actual course of
research according to norms of equity, justice and fairness. ……. At this early stage, citizens
of every nation have a stake in understanding what nanotechnology is becoming and could
be."
The UNESCO publication presents a number of ethical issues that the international
community will face in the near future. The report states that as the use of nanomaterials and
nanoscale production processes is commercialized new ethical and political issues can be
generated and old ones will be activated. It further states that "nanotechnologists are hyperaware of the need to study both potential uses and potential harms well in advance of their
commercialization. This recognition and precautionary direction to corporate research is
novel." It notes that the institutional and organizational framework for address the concerns
across competing interests associated with creating and adoptions of standards and
international best practices are not yet well developed.
The report states that the ease of communication and access to information by experts in most
countries would indicate that nanotechnology will be an international scientific project and
the "knowledge divide" between countries may look different from the past with the
possibility of the greatest divide within nations rather than between nations. Relevant to this is
the question of how nanotechnology research that could benefit the poorest should be
promoted, for example research on applications that could address the Millennium
Development Goals.
23
The Ethics and Politics of Nanotechnology (UNESCO, 2006)
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf
30
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
A related question is the extent to which all nations will benefit equally from the new
scientific knowledge – on nanotechnology and innovative research more generally. The report
notes the issues of intellectual property rights and rewards, public scrutiny of scientific
research, accountability of research and the use of scientific information in the context of
antiterrorism efforts all may impact the kind and quality of science. The lack of the necessary
infrastructure to manage good science may result in developing countries unable to obtain the
best and most reliable scientific knowledge and practices.
Manufactured nanomaterials and the precautionary approach:
Even though there are uncertainties and gaps in our knowledge of possible adverse impacts of
manufactured nanomaterials (cf. 8.2, 8.3, 8.4), we are not in a situation of complete ignorance.
For initial toxicological tests indicate that at least some manufactured nanomaterials may
cause serious harm to humans and the environment if inappropriately used through their
lifecycle.
If this is an adequate description of the current state of knowledge the question arises of how
we should assess the risks of manufactured nanomaterials from an ethical viewpoint and what
we should do with regard to the regulation of these materials. Concerning this question one
finds, roughly speaking, two opposing views in current literature:
1. There are those who argue that, although some indications of the potential risks of
some manufactured nanomaterials for humans and the environment can be
recognized, we are used to using all kinds of potentially dangerous
materials/products on a daily basis, and have learned how to manage the risks
involved and benefit from these materials/products. In particular there is no factual
reason to assume that these risks are of a kind that would justify the application of the
strong precautionaryapproach, especially the reversal of burden of proof. That does
not mean that the production and utilization of manufactured nanomaterials for
commercial or scientific purposes does not require any kind of state regulation or an
adaptation of existing regulatory frameworks to cover the specific properties of
manufactured nanomaterials . For instance, asking producers of nanomaterials and
nano-enabled products containing free manufactured nanoparticles to carefully
analyse the risks associated with these particles or asking them to reduce the
exposure in the workplace as much as possible may be perfectly warranted. (Risk
research, i.e. research to reduce uncertainty, premarket testing, reduction of
exposure etc. are all precautionary measures.) Nevertheless, manufactured
nanomaterials may be used in scientific research as well as in commercial products
even if there is some – as yet inconclusive – evidence that they may not be completely
harmless.
2. There are those who claim that for the time being at least the use of free
manufactured nanoparticles in commercial products and the deliberate release of
those particles in the environment should be prohibited. In order to justify this they
invoke the strong version of the precautionary approach. In particular they argue
that the risks associated with these particles warrant a reversal of the burden of proof:
rather than proof of risk by the State, a product must be proved harmless by its
producer. This does not mean that proof of zero risk is required; it is enough to
produce solid scientific evidence that the risks are able to be identified and
managed/mitigated effectively,
31
Intergovernmental Forum on Chemical Safety
Sixth Session – Forum VI
15 – 19 September 2008
IFCS/Forum-VI/01.TS
18 March 2008
The main theoretical question in this context is: Which conditions must be met for the
adoption of precautionary measures? More specifically: What kind of empirical evidence
regarding the risks of manufactured nanomaterials justifies what kind of precautionary
measure? There seems to be agreement that some nanomaterials such as carbon nanotubes
and buckyballs do have the potential to cause considerable harm in humans and the
environment. But given the knowledge gained from in vitro- and in vivo research thus far
what kind of regulatory measures are most suitable to manage exposure to hazard? At the
moment this is hard to tell. The reason is that it depends on how one interprets the available
and limited scientific data. How do we draw the line between reasonable precaution and
excessive precaution?
Yet there is one point where there is unanimity: Because it is clear that at least some (free)
manufactured nanomaterials are not harmless and because the occurrence of harm must be
avoided as far as possible there is a moral obligation to press ahead with risk research.
32