The Case for Regulating Nanotechnologies: International, European and National
Perspectives*
Sekai Ngarize , Karen E. Makuch and Ricardo Pereira
Introduction
The debate concerning the regulation of nanomaterials (hereinafter, ‘NMs’ or ‘NM’)1 has been
focused on whether NMs could harm the environment and human health, much along the
lines of the biotechnology debate of the 1990s and early 2000s2, yet concerted regulation in this
area is lacking. As NMs are arguably only recently gaining public prominence, and the regulation
of them is still in its infancy, this article examines some of the issues faced by regulators, offers
insights into potential methods for regulation and critiques the current state of international,
European and national laws and policies.
A key issue in the regulation of nanotechnologies is that the deliberate exploitation of
properties at nanoscale is central to their application and may cause NMs to exhibit very
different properties from their conventional bulk substances. Benefits of this technology could
include: vast product, industrial and technological applications, wealth generation, job creation
and societal advances3. On the converse, risks associated with this technology could include
potential serious risks to human health and environment4 as NMs may be discharged directly
into rivers or the atmosphere by industry or escape when products are used or disposed of in
the environment. The fate and effects of NMs and their toxicological impacts on human
health and the environment are still not fully understood.5
*This paper is an adapted and updated version of our chapter published as ‘the Regulation of
Nanotechnologies’ in K. Makuch and R. Pereira (eds.) Environmental and Energy (Wiley-Blackwell,
2012). We would like to thank Wiley-Blackwell for allowing us to reproduce part of the original work
used in the book chapter.
1
In the absence of a generally accepted definition, the term nanomaterial (NM) is used in this article to
cover commonly used terminology such as manufactured (or engineered) nanosized and nanostructured
nanomaterials.
2
See further, for example, Boisson de Chazournes, Laurence and Urs P. Thomas, Editors. 2006. WTO
Law, Science and Risk Communication. Economic Policy and Law, Vol. 3 Special Edition, 115
p. http://www.ecolomics-international.org/ecolomic_policy_and_law.htm; and Boisson
de Chazournes, Laurence and Makane Moïse Mbengue.. ‘GMOs and Trade: Issues at Stake in the EC
Biotech Dispute’. Review of European Community and International Environmental Law (RECIEL).
(2005) 13 (3): 289-305.
3
For example, nanomaterials are used to create very fine membranes which act as effective filters and
magnetic nanoparticles remove heavy metal contaminants from waste water. Nanotechnologies have also
revolutionised manufacturing processes in the consumer sector, creating a new generation of NM products
such as resistant glass, water repellents and anti-odour, crease-free fabrics. Nanotechnology is a multibillion
dollar industry expected to grow to 1 trillion US$ by 2015. See Chaudhry . Q, et al ‘A scoping study into
the manufacture and use of nanomaterials in the UK.’ Central Science Laboratory (2005), Sand Hutton,
York UK.
4
Relatively large surface area means NMs are potentially more reactive and toxic compared to
their conventional bulk substances. See: Thomas, K, et al. (2006). Research strategies for
safety evaluation of nanomaterials, Part VIII: International efforts to develop risk-based
safety evaluations for nanomaterials. Toxicol Sci 92(1): 23–32.
5
Current Developments in Delegations on the Safety of Manufactured Nanomaterials - Tour de Table
at the 10th Meeting of the Working Party on Manufactured Nanomaterials (WPMN ) Paris, France, 2729 June 2012 , No 37, available at
http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2013)2&doclanguag
e=en (accessed on 15 April 2013) Kendall M, and Holgate S (2012) Health impact and toxicological
effects of nanomaterials in the lung Respirology, Vol 17 Issue 5 pages 739-883, available at
1
Rapid commercialisation suggests that the potential for human and environmental exposure
will increase dramatically6. The pace of regulatory progress lags behind the speed at which
NMs are being introduced in the market.7 Arguably, regulatory challenges are related to a
series of uncertainties with regards to the development and commercial applications of NM,
hazards and exposure pathways, speed of technological change and effectiveness of existing
regulatory frameworks. As was the case with the biotechnology debate of the 1990’s, lack of
scientific certainty about the behaviour of some types of nanomaterials in the environment
or risks they pose for human health is a cause for concern. Some reviews on toxicity are
beginning to indicate that NMs are more reactive and toxic than their unadulterated
counterparts. 8
Furthermore, the transboundary movement and trade of nanotechnologies across countries
and sectors means that a number of existing international institutions and instruments will be
relevant to the regulation of nanotechnology. A global approach to regulation is arguably
necessary both in terms of institutional frameworks, standards and policies in addressing
nano-regulation issues and the potential transboundary environmental impacts.
The aim of this paper is to assess whether (and if so, the extent to which) nano-specific
regulation is necessary in order to address the recognized and perceived threats to health
and the environmental posed by NMs. The first section of the paper discusses the
precautionary principle as the basis for nanotechnology regulation. The paper then reviews
the approaches to the regulation of nanotechnologies at the international, European and
national levels. The final part of the paper assesses options for reform of the regulatory
regimes currently in force, and discusses whether nano-specific regulation is necessary. The
paper concludes that in order to address the current regulatory gaps and to address
environmental and health safety concerns surrounding NMs, nano-specific regulation setting
product-specification, notification, public disclosure and risk assessment requirements is
necessary.
THE BASIS FOR NANOTECHNOLOGY REGULATION: THE PRECAUTIONARY
PRINCIPLE
The regulation of the nanotechnology industry presents an opportunity for application of the
precautionary principle. The precautionary principle has been incorporated into international,
regional and national environmental law and policy instruments.9 It is a useful policy making and
decision making tool and has been discussed at length in its own right10. The implication of the
adoption of the precautionary principle or ‘approach’ in the regulation of nanomaterials is that
http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1843.2012.02171.x/pdf (accessed on 15 April 2013)
6
Floroni, K. et al. (2006). Nanotechnology: getting it right the first time. Sustainable Development Law
and Policy 6: 46-53.
7
Ibid.
8
See further Holgate, S.T. (2010) Exposure, uptake, distribution and toxicity of nanomaterials in
humans. Journal of Biomedical Nanotechnology 1: 1-19; Maynard, A.D. (2006) Safe handling of
nanotechnology, Nature 444: 267-269; and Royal Commission on Environmental Pollution (RCEP)
(2008). Twenty-seventh Report. Novel Materials in the Environment: The Case of Nanotechnology.
9
For example, Principle 15 of the Rio Declaration on the Environment and Development (1992);
Article 3, UN Framework Convention on Climate Change (New York,1992: in force 21 March 1994);
and the Cartagena Protocol on Transboundary Movement on Living Modified Organisms (2000; in
force 2003), Art.1; Treaty on the Functioning on the European Union, Article 191 (2).
10 See further e.g. Nicolas de Sadeleer (ed) Implementing the Precautionary Principle: Approaches
from the Nordic Countries, EU and USA (Earthscan, 2007); E Fisher et al (eds), Implementing the
Precautionary Principle: Perspectives and Prospects (Edward Elgar 2006); M. Fitzmaurice,
Contemporary Issues in International Environmental Law (Edward Elgar, 2009); E. Hey, ‘The
Precautionary Concept in Environmental Policy and Law: Institutionalizing Caution’ 4 Geo. Int'l
Envtl. L. Rev. (1992) 303.
2
NMs could be placed in the highest hazard category unless sufficient evidence or
information is available to justify a lower level of hazard classification. Another implication of
the precautionary principle is that the burden of proof of demonstrating risk would normally lie
on the promoter of a potentially harmful activity, who must prove that there is no risk of harm.
Hence the precautionary principle shifts the burden of prove from the regulator to the
producer.11
According to the precautionary principle, where there are threats of serious or irreversible
damage, lack of full scientific certainty should not be used as a reason for postponing such
measures’.12 It thus gives policy makers leeway to move forward and tighten environmental
regulatory controls despite the lack of scientific consensus regarding nature and seriousness
of the ‘perceived’ threat to the environment or human health. However, precautionary
measures must be based on more than a mere hypothesis or purely theoretical assessments.
So there must be some ‘reason to believe’ or ‘reasonable ground for concern.’ 13
In the UK, the Royal Society/Royal Academy of Engineers recommended in 200414 that
factories and research laboratories treat manufactured nanoparticles and nanotubes as if they
were hazardous and seek to reduce or remove them from waste streams and that industry
should assess the risk of release of nanomaterials from products or processes throughout
their life cycle. The 'innovation' versus 'precaution' debate evolves into a question of whether the
benefit of nanotechnology is worth the risk taken and ventures into the realm of the debate
over the (un)certainty of the risk. It is suggested that in the light of scientific uncertainty and
considering the costs of (in)action, law and policy-makers must apply the principle of precaution
and "err on the safe side" is a better policy option than to face the consequences considering
the magnitude of the risks taken.
Hence the debate resembles that regarding the authorisation of release of GMOs, in which two
major global markets players – chiefly the United States and the European Union – have taken
opposing views on legal implications of the precautionary ‘principle’ or ‘approach’.15 Despite
11
This is the approach taken, for example, under the EU chemical regulations, discussed below. Yet in
the ICJ Case Concerning Pulp Mills on the River Uruguay (Argentina v Uruguay), Judgment of 20
April 2010 (ICJ Report 2010), the ICJ rejected the Argentinean contention ‘that the 1975 Statute [a
treaty signed in 1975] adopts an approach in terms of precaution whereby the burden of proof will be
placed on Uruguay for it to establish that, the mill will not cause significant damage to the environment’.
It stated that ‘while a precautionary approach may be relevant in the interpretation and application of the
provisions of the statute, it does not follow that it reverses the burden of proof’ (para. 164). Hence the
ICJ reiterated that the burden of proof still lies with the claimant State, and that the precautionary
approach could not be used to reverse the burden of proof in cases where serious risk cannot be
established by the claimant State. Available at http://www.icj-cij.org/docket/files/135/15877.pdf
(accessed on 13 April 2013).
12
See Principle 15 of the Rio Declaration on the Environment and Development (1992) and Article 3,
UN Framework Convention on Climate Change (UNFCCC,1992).
13
See the EU Commission Communication on the Precautionary Principle, Brussels, 02.02.2000
COM(2000) 1.
14
Royal Society and Royal Academy of Engineering (RS/RAEng) (2004). Nanoscience and
Nanotechnologies: Opportunities and Uncertainties. RS/RAEng. London. Summary of the report is
available at: http://www.nanotec.org.uk/report/summary.pdf (accessed 0904/2013) or link to the full
report here: http://www.nanotec.org.uk (accessed 09/04/2013).
15
The United States insists in using the term precautionary ‘approach’, in the belief that it is
less expansive than the term ‘principle’ and hence gives it lesser legal weight. While the EU
system of GMO authorization places more emphasis on the precautionary approach, the US places
greater emphasis on sound science and risk assessment. On the transatlantic trade disputes applying
and interpreting the precautionary principle, see in particular WTO 'Hormones Case': European
Communities - Measures Concerning Meat and Meat Products (Hormones) (Complainant:
United States of America) 26 January 1996 and European Communities - Measures Concerning
Meat and Meat Products (Hormones) (Complainant: Canada) 28 July 1996 (disputes WT/ DS26,
WT/DS48). at http://www.wto.org/english/ tratop_e/sps_e/sps_agreement_cbt_e/c5s3p1_e.htm
(accessed on 14 April 2013). And WTO GMO cases: European Communities - Measures
Affecting the Approval and Marketing of Biotech Products (complainants, USA, Canada,
3
these opposing views, the precautionary principle is gradually evolving into the corpus of
customary international law,16 as has been recently opined by the International Tribunal on the
Law of the Sea.17
INTERNATIONAL REGULATION OF NANOTECHNOLOGY – INSTITUTIONS,
STANDARDS AND TRADE
The transboundary nature of nanotechnologies across countries and sectors suggests
that a number of international institutions and instruments will be relevant to the
regulation of nanotechnology. Therefore a global approach to regulation may be
necessary both in terms of institutional frameworks and policies in addressing nanoregulation issues and their environmental impacts. In addition, economic globalization
and the creation of international institutions have been powerful driving forces behind the
growth of globally harmonised standards in areas from technical product specification to
consumer, health and environmental protection.18
Presently, nanotechnology is not specifically subject to any single international regulatory
instrument and many nano-products fall within pre-existing international regulations and under
national regulatory models.19 Yet the development of harmonised international standards is
essential in facilitating trade across many jurisdictions and for regulating NM. The absence of a
consensus on definitions, common nomenclature and standards for classification and testing of
nanotechnology and nanomaterials makes it very difficult to define or classify the objects or
processes that are to be regulated.
A number of international soft-law standards have been adopted in the context of NMs,
including codes of conduct and risk management standards. 20 They have been adopted by
the International Organisation for Standardization (ISO),21 the Strategic Approach to
International Chemicals Management (SAICM) (which considers nanotechnologies as an
Argentina) 13 May 2003 (disputes DS291, DS292, DS293). http://www.wto.org/english/
tratop_e/dispu_e/cases_e/ds291_e.htm (accessed 14 April 2013).
16
This requires the fulfilment of the two conditions for establishment of customary international law,
namely that there is general and consistent practice of states accompanied by a sense of legal obligation
(opinio iuris). See Article 38 1 (b) of the International Court of Justice Statute.
17
The Seabed Disputes Chamber of International Tribunal on the Law of the Sea (ITLOS) opined that
the precautionary approach may have reached the status of customary law. See Case no. 17,
Responsibilities and obligations of States sponsoring persons and entities with respect to activities in
the Area (Feb 2011) (Request for Advisory Opinion submitted to the Seabed Disputes Chamber) (in
particular para. 131 and 135). This is the first time that there is a clear statement from an international
tribunal regarding the legal status of the precautionary principle. Compare it with the Nuclear Test
Case (Australia v France) Judgment of 20 December 1974 (ICJ Reports, 1974) and the EC Biotech
(2003) and Beef Hormones (1996) WTO cases, n. 15 above.
Vogel, D. ‘The Politics of Risk Regulation in Europe and the United States’. Yearbook of
European Environmental Law, (2003). Oxford University Press, Oxford.
19
See further D.M., Bowman, and G.A. Hodge,‘A small matter of regulation - An international review
of nanotechnology regulation.’ The Columbia Science and Technology Law and Review (2007). Vol
VIII pages 1-36.
20
An example is the EC Code of Conduct for responsible nanoscience and nanotechnologies research
(February, 2008). This provides principles and guidelines that should direct the research activity in the
field; key principles of the code are: (a) sustainability, (b) precaution, (c) inclusiveness and (d)
accountability. The Commission published a revised Code in 2010 following a public consultation in
2009.
21
A voluntary standards development body, established the ISO/TC 229 Nanotechnologies Technical
Committee in 2005 with the aim to develop international standards for nanotechnologies. The work on
standards represents an important first stage in both national and international regulatory development
processes. See the Technical Committee TC 229 on nanotechnologies
http://www.iso.org/iso/iso_technical_committee?commid=381983 (accessed on 15 April 2013). See
further, Borwan and Hodge (2007), n. 19 supra.
18
4
emerging issue),22 the ISO Technical Committee (TC) 229 in conjunction with International
Electrotechnical Commission (IEC) TC 11323 The work on standards represents an important
first stage in both national and international regulatory development processes.24 Although
they are non-binding, these initiatives are important in building a firm knowledge base to
support policy and regulatory decisions and are may become an essential prerequisite to
appropriate regulation.
One of the main fora through which states have sought to create common approaches on
scientific building blocks for nanotechnology to date is the Organisation for Economic
Cooperation and Development (OECD). The focus of activity regarding nanotechnology within
the OECD has been driven by the network of multidisciplinary experts within the Chemicals
Committee and has led to the establishment of a Working Party on Manufactured
Nanomaterials25 to promote international cooperation in health- and environmental safetyrelated aspects of manufactured NM. Guidelines of the Committee are not binding on member
countries but could form the basis for an emerging consensus on a global regulatory
framework. Note that the OECD is not a regulatory institution but can assist in the development of
coordinated regulatory framework among its Member States. Its focus is on information
gathering and sharing including addressing technical issues of scientific building blocks
including risk assessment and management to the broader political questions concerning the
member countries.
The main international treaties regulating trade in chemicals are the Stockholm Convention on
Persistent Organic Pollutants (POPS, 2001)26 and the Rotterdam Convention on Prior
Informed Consent in Pesticides and Industrial Chemicals (1998).27 Despite the fact
nanotechnologies are not expressly mentioned in the Stockholm or the Rotterdam
Conventions nor listed in their Annexes, the Conventions do not use particle size to define
their scope or obligations and hence they do in fact regulate trade NMs which meet the
chemical composition and product characteristics regulated in those conventions. 28 Moreover,
22
The Strategic Approach to International Chemicals Management (SAICM) is a non-binding policy
framework to promote chemical safety around the world. It was adopted by the International
Conference on Chemicals Management (ICCM) in Dubai in February 2006. SAICM has as its overall
objective the achievement of the sound management of chemicals throughout their life cycle so that, by
2020, chemicals are produced and used in ways that minimize significant adverse impacts on human
health and the environment. This “2020 goal” was adopted by the World Summit on Sustainable
Development in 2002 as part of the Johannesburg Plan of Implementation. See further,
http://www.saicm.org (accessed on 15 April 2013).
23
They direct activities on nanotechnologies standards at the international level. Work on standards
developed quite rapidly between 2009 and 2010, in particular work focusing on terminology,
nomenclature, measurement, and characterisation of NM.
24
See further Bowman, D.M. and Hodge, G.A. n. 19 above.
25
Organisation for Economic Co-operation and Development (2006). Environment Directorate Joint
Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and
Biotechnology. Current Developments/ Activities on the Safety of Manufactured Nanomaterials. The
OECD WPMN is gathering reference data and information on characterisation and safety of NM in
liaison with the ISO TC 229.
26
Stockholm Convention on Persistent Organic Pollutants (2001), available at http://chm.pops.int
(accessed on 14 April 2013). Persistent Organic Pollutants (POPs) are organic chemical substances,
that is, they are carbon-based. They possess a particular combination of physical and chemical
properties such that, once released into the environment, they remain intact for exceptionally long
periods of time. See Oleksiy Kharlamov, Ganna Kharlamova, Natalia Kirillova, Veneamin Fomenko,
The Fate of Organic Pollutants in the Environment, NATO Science for Peace and Security Series,
2008 pp 425-441.
27
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals
and Pesticides in International Trade. Available at http://www.pic.int (accessed on 14 April 2013)
28
Anne Petitpierre-Sauvain (ed.) The Basel, Rotterdam and Stockholm Conventions on Chemicals and
Wastes – Regulation, Sound Management and Governance (Special Edition 2008-2010) Journal of
Trade and Environment Studies. available at http://www.ecolomicsinternational.org/epal_2008_2010_special_edition_ruig_geneva_based_chemicals_and_wastes_conven
tions.pdf (accessed on 15 April 2013).
5
they could in theory be used to address some issues linked to the release of NMs into the
environment.29
The Stockholm Convention entered into force in May 2004, and at the time of writing has 179
ratifications.30 Although the convention has been successful in attracting a high number of
ratifications, the USA, a major producer of nanotechnologies,31 has not ratified the Stockholm
Convention. The objective of the Stockholm Convention is to protect human health and the
environment from persistent organic pollutants based on a precautionary approach. 32 As with
other international environmental trade-restrictive treaties, the Convention contains Annexes
with the lists of prohibited, restricted and regulated substances.33 Trade in chemical
substances listed in Annexes I, II and III are prohibited, restricted or regulated respectively,
depending on their toxicity levels. 34 However, POPS lacks the mechanisms of advanced
informed consent (AIC)35 and risk assessment procedures,36 which are at the heart of the
safeguards present in other environmental trade-restrictive treaties, such as the Cartagena
Protocol on Transboundary Movement of Living Modified Organisms which regulates the
trade in GMOs37 or the Rotterdam Convention (discussed below). Moreover, unlike the
Cartagena Protocol, no permanent compliance committee38 or international civil liability
regime for environmental damage39 have been formally adopted by the parties.
29
Ibid.
Status of ratifications, http://chm.pops.int/Countries/StatusofRatifications/tabid/252/Default.aspx
(accessed on 12 April 2013).
31
Currently at 49%, the United States has the largest share of the nanotechnology market, followed by
the European Union’s 30%, and the rest of the world’s 21%. Within the European Union, the United
Kingdom is said to account for close to one third of the European 30% nanotechnology market share.
Nanotechnology is a multibillion dollar industry expected to grow to 1 trillion US$ by 2015. See
Chaudhry . Q, et al, (2005), n. 3 above.
32
Article 1, POPS.
33
See e.g. Washington Convention on International Trade in Endangered Species (CITES, 1973) and
the Basel Convention on Transboundary Movement of Hazardous Wastes (1989).
34
Parties must take measures to eliminate the production and use of the chemicals listed under Annex
A and must take measures to restrict the production and use of the chemicals listed under Annex B.
Parties must take measures to reduce the unintentional releases of chemicals listed under Annex C with
the goal of continuing minimization and, where feasible, ultimate elimination. The Persistent Organic
Pollutants Review Committee (POPRC) is a subsidiary body to the Stockholm Convention established
for reviewing chemicals proposed for listing in Annex A, Annex B, and/or Annex C.
35
Arts. 8-10 and 12, Cartagena Protocol. It requires that, before the first transboundary movement of a
LMO, that the Party of import is notified of the proposed transboundary movement and is given an
opportunity to decide whether or not the import shall be allowed and upon what conditions.
36
Article 15 of the Cartagena Protocol states that “the Party of import shall ensure that risk
assessments are carried out... It may require the exporter to carry out the risk assessment”.
37
The parties to the 1992 Convention on Biological Diversity (CBD, 1992) had from the outset
recognized the need for a protocol on genetically modified organisms which was adopted on 29 January
2000 and entered into force on 11 September 2003. The Protocol implements the obligations of the
parties regarding biodiversity protection within the context of the transboundary movement of LMOs.
The Protocol has attracted 166 ratifications (with the latest ratification by Afghanistan on 20 February
2013),
38
The Cartagena Protocol standing compliance committee established under decision BS-1/7 –
COP/MOP According to Article 17 of the Stockholm Convention, the Conference of the Parties shall
develop and approve procedures and institutional mechanisms for determining non-compliance with
the provisions of the Convention and for the treatment of Parties found to be in non-compliance. To
prepare draft procedures on non-compliance for its consideration, the Conference of Parties established
an ad hoc open-ended working group on non-compliance that met in April 2006 and April 2007. See
COP Decisions on Non-Compliance http://chm.pops.int/Convention/Compliance/tabid/61/Default.aspx
(accessed on 14 April 2013)
39
The Nagoya-Kuala-Lumpur supplementary Protocol on Liability and Redress, adopted in COP10/MOP-5, provides international rules and procedure on liability and redress for damage to
biodiversity resulting from living modified organisms (LMO). The Protocol has been signed by 53
30
6
The international legal framework relating to trade in dangerous chemicals is further
complemented by the Rotterdam Convention on Prior Informed Consent (PIC) in Hazardous
Chemicals and Pesticides, adopted in September 1998 and entered into force on 24 February
2004.40 The aims of the 1998 PIC Convention are to promote shared responsibility and cooperative efforts among parties in the international trade of certain hazardous chemicals in
order to protect human health and the environment from potential harm; to contribute to the
environmentally-sound use of certain hazardous chemicals by facilitating information
exchange about their characteristics and providing for a national decision-making process on
their import and export. At the heart of the Protocol is the voluntary advanced informed
procedure before the trade in dangerous chemical substances listed in Annex III.41 Conference
of the Parties (COP) decisions may add further chemicals to Annex III and hence the
regulatory regime is not static and may evolve in light of new scientific evidence. Once a
chemical is included in Annex III, a "decision guidance document" (DGD) containing
information concerning the chemical and the regulatory decisions to ban or severely restrict
the chemical for health or environmental reasons, is circulated to all Parties. 42 The
Convention also further provisions on information exchange, which require the Parties to
prepare a response concerning the future import of the chemical within nine months.43
In light of the fact that the WTO General Agreement on Tariffs and Trade 44 is the key
international institution concerned with the liberalisation of trade rules as provided under the World
Trade Organisation Agreement (WTOA),45it will have an interest and considerable leverage in the
States but at the time of writing has only received 10 ratifications (with the latest ratification by Ireland
on 14th January 2013), hence it is not in force as 40 ratifications are required.
40
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals
and Pesticides in International Trade. Available at http://www.pic.int (accessed on 14 April 2013). For
more detailed analysis of the Rotterdam Convention, see e.g. Barrios, Paula, ‘The Rotterdam
Convention of Hazardous Chemicals: A Meaningful Step toward Environmental Protection’ 16 Geo.
Int'l Envtl. L. Rev. (2003) 679.
41
Articles 10 and 11, PIC. The PIC procedure is a mechanism for formally obtaining and disseminating
the decisions of importing Parties as to whether they wish to receive future shipments of those
chemicals listed in Annex III of the Convention and for ensuring compliance with these decisions by
exporting Parties. For each of the chemicals listed in Annex III and subject to the PIC procedure a
decision guidance document (DGD) is prepared and sent to all Parties. The DGD is intended to help
governments assess the risks connected with the handling and use of the chemical and make more
informed decisions about future import and use of the chemical, taking into account local
conditions. The Chemical Review Committee (CRC), a subsidiary body of the COP, review
notifications and proposals from Parties, and make recommendations to the COP on the addition of
chemicals to Annex III. See further
http://www.pic.int/TheConvention/Overview/Howitworks/tabid/1046/language/en-US/Default.aspx
(accessed on 14 April 2013)
42
The response can consist of either a final decision (to allow import of the chemical, not to allow
import, or to allow import subject to specified conditions) or an interim response. Decisions by an
importing country must be trade neutral (that is, decisions must apply equally to domestic production
for domestic use as well as to imports from any source). The import decisions are circulated and
exporting country Parties are obligated under the Convention to take appropriate measure to ensure that
exporters within its jurisdiction comply with the decisions. See further, http://www.pic.int (accessed on
15 April 2013)
43
The Convention requires each Party to notify the Secretariat when taking a domestic regulatory
action to ban or severely restrict a chemical. All Parties receive summaries of these notifications and
proposals on a regular basis via the PIC Circular. See further
http://www.pic.int/TheConvention/Overview/Howitworks/tabid/1046/language/en-US/Default.aspx
(accessed on 14 April 2013)
44
See GATT (Uruguay Round) Agreement 1994: http://www.wto.org/english/docs_e/legal_e/06gatt_e.htm (accessed 09/04/2013) and agreements establishing the WTO:
http://www.wto.org/english/docs_e/legal_e/legal_e.htm#wtoagreement (accessed 09/04/2013)
45
Ibid.
7
governance of all nanotechnology products, in so far as domestic regulatory frameworks impact on
trade. However, the WTO does not consider itself to be the venue for international regulatory coordination for products of biotechnology and so some argue that this is equally true for products of
nanotechnology.46 It is important to note that, in the event that the provisions of the Stockholm or
Rotterdam Conventions are more trade-restrictive than would appear permissible under WTO
law, the general rules on the laws of treaties must be applied to resolve the conflict.47
The WTO requires non-discrimination in matters of trade between countries and particularly, under
Article III, between 'like products' 48 whether imported or domestically produced. However, GATT
Article XX permits exemptions for the national measures that are necessary to protect human
health, animals and plants or relate to conservation of exhaustible natural resources, provided they
do not entail 'arbitrary and unjustifiable discrimination', between countries or constitute a disguised
restriction on international trade.49 Moreover, the state has to justify the measure as ‘necessary’,
i.e. it would have to be the least trade restrictive measure reasonable available to fulfill an
environmental objective and all other trade restrictive options would have been exhausted.
The burden is falls on the country imposing measures to justify the exemptions. Some will argue
that product that contains NM is 'like' the equivalent product that does not have NM and so should be
approved. Others will argue the opposite and may claim the NM could harm health or the
environment and therefore are not ‘like products’. 50 NM are often derived from common
substances that are not new and many industry stakeholders have taken the view that
nanoparticles are no different from the bulk materials from which they are derived and so are 'like'
normal products. 51 Contrary to this notion is that NM are of special interest precisely because they
possess physical and chemical properties different from their parent compound. The fact that
patents have been granted for numerous products containing NM undermines the contention that
engineered NM should not be treated as new materials or new substances.52
Two key WTO agreements dealing with standards are the Agreement on Technical Barriers
to Trade (TBT) and the Agreement on Sanitary and Phytosanitary Measures (SPS) (often
cited in relation to biotechnology matters). The SPS Agreement deals with measures designed
46
Fisher et al, 2006 n.10 above.
The Vienna Convention on the law of Treaties (1969: in force in 1980) deals with the question of
conflicts between international treaties. On this question within the context of the Cartagena Protocol
and WTO law, see e.g. Qureshi, A. H. ‘The Cartagena Protocol on Biosafety and WTO – Co-existence
or Incoherence?’ (2000) 49 International and Comparative Law Quarterly 835.
48
See GATT (Uruguay Round) Agreement 1994: http://www.wto.org/english/docs_e/legal_e/06gatt_e.htm (accessed 09/04/2013) PART II, Section V. Article III (4). “The products of the territory of
any contracting party imported into the territory of any other contracting party shall be accorded
treatment no less favourable than that accorded to like products of national origin in respect of all laws,
regulations and requirements affecting their internal sale, offering for sale, purchase, transportation,
distribution or use. […]”
47
49
See GATT (Uruguay Round) Agreement 1994: http://www.wto.org/english/docs_e/legal_e/06gatt_e.htm (accessed 09/04/2013) XXII. Article 20: General Exceptions: “Subject to the requirement
that such measures are not applied in a manner which would constitute a means of arbitrary or
unjustifiable discrimination between countries where the same conditions prevail, or a disguised
restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption
or enforcement by any contracting party of measures: […] (b) necessary to protect human, animal or
plant life or health; […]”
50
E.g. in the first Tuna-Dolphin WTO case (1992), which involved the US ban on Mexican exports of
tuna which were caught applying ‘unsustainable’ fishing techniques, the Panel established that US
could only rely on properties of ‘product’ not on the ‘process’ of production. The Panel objected to
extra-territorial enforcement of environmental laws under Art. XX (b) GATT, as otherwise any country
would be able to apply trade restriction unilaterally. Available at
http://www.wto.org/english/tratop_e/envir_e/edis04_e.htm (accessed on 15 April 2013).
51
See further, Weiss, R. (2004). For Science, Nanotech Poses Big Unknowns. Washington Post at A1.
52
See Vaidhyanathan, S. (2006). Nanotechnologies and the law of patents: a collision course. In Hunt,
G., and Mehta, M., (eds.). Nanotechnology: Risk, Ethics and Law, Earthscan, London.
8
to protect: human life or health; animal life or health and plant life or health. The TBT
Agreement covers other technical standards not regulated by the SPS Agreement. 53
Although neither agreement obliges countries to adopt minimum standards, they create rules
that are to be respected to ensure that market access rights are not undermined through
regulations that are disguised restrictions on trade.54 They also recognise that, for many
reasons, common harmonised standards, far from being barrier to trade, work to promote trade.
Their implications on the development of regulations on nanotechnologies were reviewed
elsewhere.55
A number of arguments have been raised for further harmonization of international standards
relating to nanotechnologies. It has been suggested that harmonization would facilitate
international trade, avoiding the disputes and inefficiencies experienced as a result of, for
example, the inconsistent US and European Union (EU) interpretations of the principle of
precaution.56 Moreover, internationally consistent standards could avoid the ‘race to the
bottom’ and could constrain national regulators from yielding to protectionist or alarmist
demands with the view of shielding domestic producers from foreign competition.57 Moreover,
international regulatory coordination would act to regulate the release of engineered
nanomaterials into the environment in one country and also control their cross-border
movement, and therefore the potentially adverse effect that their release would have on other
states or to areas beyond national jurisdiction. 58
Despite these potentially positive outcomes, the extent to which states may be willing to
cooperate for harmonization of nanotechnology standards and to improve safety in trade in
nanotechnologies will be balanced against the interests of advancing trade and technology
innovation, development and dissemination. The following sections suggest that there are
further disparities in national/regional regulatory regimes relating to nanotechnologies, which
are likely to hinder any further attempts for international cooperation.
EUROPEAN AND NATIONAL REGULATORY STANDARDS
While the commercialisation of nanotechnology is under way, market entry to date has been
relatively unconstrained due to a distinct absence of nano-specific regulatory frameworks. A
significant regulatory loop-hole exists in the guise of chemicals regulations.
Much of the recently adopted chemical regulatory frameworks for the EU/UK, Australia/New
Zealand and USA are primarily focused on 'new chemicals'. However, at present existing chemicals
produced at nanoscale are not considered to be "new". For example, nanoscale versions of titanium
dioxide already in widespread use in sunscreen products are treated the same way as the equivalent
bulk material even if they have different properties.59 The failure of each country to address this
gap raises some concern because, while commercialisation of products containing manufactured
nano-particles continues to escalate, work to understand the human and environmental impacts is
53
Environmental regulations may be technical barriers to trade and the TBT Agreement specifically
recognises that environmental protection could allow deviation from international standards.
54
Article II (1) of the WTO Technical Barriers to Trade Agreement (TBT Agreement) could be
justified in a similar way to the GATT Article III. Article II of the TBT Agreement, which deals with
‘Preparation, Adoption and Application of Technical Regulations by Central Government Bodies,’
requires WTO members to ensure that in respect of technical regulations, products imported from the
territory of any Member shall be accorded treatment no less favorable than that accorded to ‘like
products’ of national origin and to like products originating in any other country.
55
See Bowman, D.M. and Hodge, G.A. (2006), n. 19 above.
56
Mansour, M. and Key, S. ‘From farm to fork: the impact on global commerce of the new European
Union biotechnology regulatory scheme,’ The International Lawyer (2004), 38(1), 55-70.
57
Kenneth W. Abbott, Douglas S. Sylvester and Gary E. Marchant, Transnational Regulation of
Nanotechnology: Reality or Romanticism? International Handbook on Regulating Nanotechnologies,
(Edward Elgar, 2009)
58
Ibid.
59
See Royal Commission on Environmental Pollution (RCEP) (2008). Twenty-seventh Report. Novel
Materials in the Environment: The Case of Nanotechnology.
9
lagging behind. Consequently, our review of the national and EU regulatory efforts to develop a
sound governance structure suggests that they remain fundamentally weak in all the five
jurisdictions. A cursory examination of EU/UK, United States and Australia/New Zealand
shows that none of those countries/jurisdictions have enacted nano-specific regulations,
although there have been recent proposals for reform of the current regulatory regimes.
a) European Union
Within the European Union (EU), there are two main types of environmental legislation
relating to chemicals; 1.environmental legislation concerning the protection of air, water and
soil quality from pollution, and, 2.specific regulations concerning manufacture and
commercialisation of chemical substances. The specific chemical substances regulation
substances can: prohibit or restrict the use of certain substances; limit the use of utilities (water,
air and energy); impose controls over the production process by creating emission standards,
efficiency goals or impose adoption of the latest 'end of pipe' technology; impose controls on the
final product, that is, new substances must be notified for use and commercialisation.
As there are currently no specific regulations for nanotechnologies or nanomaterials in the EU,
the manufacturers use and disposal of nanomaterials are covered at least in principle by a
complex set of existing regulatory regimes. In addition to the Regulation on Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH, 2006), discussed below,
these include integrated pollution prevention and control (IPPC) now regulated under the
Industrial Emissions Directive60 and other consumer and environmental protection regimes.
Particular product types are covered by a series of vertical legislation which include: product or
sector-specific regulations for pharmaceuticals,61 veterinary medicines,62 pesticides63 and
biocides.64 There is specific legislation for toys, 65 cosmetics66 and 'end of life’ products such
as Waste Electrical and Electronic Equipment Directive.67
New chemicals were (until 1st June 2008) covered in the EU by regulations on the Notification
of New Substances (NONS). This has been superseded by the EU REACH regulation, in
force from June 2007.68 REACH constitutes the EU framework legislation for the management,
Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on
industrial emissions (integrated pollution prevention and control) (Recast)
60
61
See e.g. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011
amending Directive 2001/83/EC on the Community code relating to medicinal products for human
use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
62
Directive 2001/82/EC - Directive 2001/82/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to veterinary medicinal products (Official Journal L
311, 28/11/2001 p. 1 - 66). (consolidated version : 18/7/2009) and Directive 2009/9/EC - Commission
Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament
and of the Council on the Community code relating to medicinal products for veterinary use (Official
Journal L 44, 14/2/2009 p. 10 - 61).
63
Directive 91/414/EEC was published by the EU on 24 November 2009 as Regulation (EC) No
1107/2009 concerning the placing of plant protection products on the market and repealing Council
Directives 79/117/EEC and 91/414/EEC .
64
Biocides Regulation (EU) 528/2012
65
Directive (2009/48/EC) on Toy Safety, published in the Official Journal of the European Union
(OJEU) on 30 June 2009.
66
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009
on cosmetic products (recast)
67
Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste
electrical and electronic equipment (WEEE)
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
68
10
control and use of chemicals, replacing much of the previous patchwork of over 40 separate pieces
of legislation. Besides replacing a number of existing directives, REACH intends to simplify the
extensive regulatory framework. The purpose of REACH is to ensure a high level of protection
of human health and the environment, including the promotion of alternative methods for
assessment of hazards of substances as well as the free circulation of substances on the internal
market while enhancing competitiveness and innovation. 69 REACH also created the European
Chemicals Agency (ECHA) which is responsible for the scientific, technical and administrative
and management functions of the REACH system throughout the EU.
The effect of the REACH regulation is to impose responsibility on those who manufacture and
sell the products and understand potential threats to human health and environment in order
to minimise the risk of adverse effects.70 However, in the context of nanotechnology, given the
speed of technological developments there will always be a gap between innovation and
knowledge of possible 'new' hazards, making it difficult to resolve issues of safety of new
materials using traditional risk-based regulatory frameworks.
REACH has a major innovation, bringing to an end the different treatments between 'new' and
'existing' substances. It is important to note that although under REACH there is no distinction
between new and existing chemicals, it distinguishes between non-phase-in (new) and phasein (existing) for purposes of registration time frames and in some cases data requirements. 71
Eventually all chemicals that fall within its scope will be subject to registration requirements
and data sets will be prepared. It is the compilation of data which will be useful in tracking and
assessing the potential risks associated with nanotechnologies.72 However, whether such data
under REACH will be comprehensive enough remains to be seen. The European Parliament’s
resolution (2009) called for an inventory of nanomaterials on the market to address the fact that
such information is not otherwise yet available. According to a recent Commission
Communication, as of February 2012, 7 substance registrations and 18 CLP notifications had
selected "nanomaterial" as the form of the substance in voluntary fields, while a further
assessment identified additional substances with nanoforms. 73
REACH also transfers responsibility of carrying out risk assessment from Member States to the
producers and importers of a chemical substance.74 Risk assessment will be 'use specific'; i.e.
(REACH)30.12.2006 L 396/267
69
The registration of substances and articles under REACH is being 'phased-in' over an 11-year period
between 2007 and 2018, with chemicals manufactured or imported in large volumes and certain
'substances of very high concern' (i.e., with particular hazardous properties) being registered first, followed
by those manufactured or imported in smaller volumes. The deadlines for substance registration are as
follows: 1 December 2010: Substances supplied in quantities of more or equal to 1000 tonnes per annum;
substances classified under the Chemical (Hazard Information and Packaging For Supply) Regulations
2002 (CHIP) as very toxic to aquatic organisms and supplied at quantities greater than or equal to 100
tonnes per annum; and substances classified under CHIP as Carcinogenic, Mutagenic or Toxic to
Reproduction and supplied in quantities of 1 or more tonnes per annum. 1 June 2013: Substances
supplied in quantities of 100 tonnes or more per annum. 1 June 2018: Substances supplied in quantities
of 1 tonne or more per annum.
70
See Article 1(3), REACH. “This Regulation is based on the principle that it is for manufacturers,
importers and downstream users to ensure that they manufacture, place on the market or use such
substances that do not adversely affect human health or the environment. Its provisions are
underpinned by the precautionary principle.”
71
Preamble (20), REACH; Art. 60 (2), REACH
72
Annex II REACH, Guide to the Compilation of Data Sheet.
73
Communication from the Commission to the European Parliament, the Council and The European
Economic And Social Committee Second Regulatory Review on Nanomaterials, Brussels, 3.10.2012
COM(2012) 572 final, available at
http://ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials__com(2012)_572.pdf (accessed on 14 April 2013)
74
The World Health Organisation has recently commissioned a report on the initiatives and activities
11
each downstream user is required to declare how it uses the chemical substance, and the
manufacturer is required to produce a risk assessment document with specific instructions for
each use situation.75 The regulation also requires information about risks associated with
chemicals to be set out and provided to users in 'safety data sheets'.76 Those chemicals that pose
a serious hazard may be banned or restricted i.e. may be used only following the grant of a
specific 'authorisation'. 77 REACH only applies to substances as well as substances in articles
that are produced or imported in an amount over one tonne per year.
The European Commission's Nanosciences and Nanotechnologies Action Plan, published in
June 2005,78 recognises the Commission's co-ordinating role in responding to such regulatory
issues. The Action Plan specified that all applications and use of nanosciences and
nanotechnologies must comply with the high level of public health, safety, consumers and
worker protection and environmental protection chosen by the Union. In support of this
agenda, the Commission's Scientific Committee on Emerging and Newly Identified Health
Risks (SCENIHR) issued for consultation an opinion on the appropriateness of existing
methodologies to assess the potential risks associated with engineered and products of
nanotechnologies. The European Commission subsequently published a Communication:
Regulatory Aspects of Nanomaterials in 200879 which concluded that current legislation covers to
a large extent risks in relation to nanomaterials and that risks can be dealt with under the
current legislative framework. The Commission further notes that 'however, current legislation may
have to be modified in the light of new information becoming available, for example as regards
thresholds used in some legislation'. The conclusions of the Commission’s 2008 report has
been challenged by a non-binding resolution adopted in April 2009 by the European Parliament,
following a detailed report on NM presented by the European Parliament's Environment
relevant to risk assessment and risk management of nanotechnologies in the food and agricultural
sector, which highlights the divergent methods applied to risk assessment in a number of jurisdictions.
See State of the art on the initiatives and activities relevant to risk assessment and risk management of
nanotechnologies in the food and agriculture sectors, Draft version for public review, 30 November
2012. available at
http://www.who.int/foodsafety/biotech/FAO_WHO_Nano_Paper_Public_Review_20120608.pdf
(accessed on 14 April 2013)
75
According to Article 70 REACH, ’Agency opinion: Committee for Risk Assessment Within nine
months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall
formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to
human health and/or the environment, based on its consideration of the relevant parts of the dossier.
This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency
at the request of the Commission, and the views of interested parties referred to in point (a) of Article
69(6).’
76
Article 31 REACH.Annex II, Guide to the Compilation of Safety Data Sheets, REACH
Substances of very high concern such as CMRs (carcinogenic, mutagenic, or toxic to
reproduction), PBTs (persistent, bio-accumulative and toxic), vPvBs (very persistent and
very bio-accumulative) and other substances of 'equivalent concern' are not only subject to
registration, but also authorisation under REACH before they can be placed on the market.
There is no limit on production volume for substances of very high concern although all
materials with these properties will require authorisation. REACH, Preamble (22) and (69).
REACH foresees the gradual substitution of substances of high concern. Art. 55, REACH.
78
European Commission Action Plan " Nanosciences and nanotechnologies: An action plan for
Europe 2005-2009" 7th June 2005 (COM(2005) 243).
79
Communication from the Commission to the European Parliament, the Council and the European
Economic and Social Committee, Regulatory Aspects of Nanomaterials [sec(2008) 2036], Brussels,
17.6.2008 com(2008) 366 final
77
http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf June, 2008
(accessed 09/04/13)
12
Committee.80 The resolution asks for tighter controls on nanotechnologies, in particular with
respect to legislation on chemicals, food, waste, air, water and worker's protection.
In response, the Commission reviewed all relevant legislation in 2011 with a view to proposing
regulatory change whenever necessary and to developing nano-specific instruments for the
implementation of regulation. The recent recast of the EU Cosmetic regulation81 and the ongoing
discussion on the novel foods regulation are also taking into consideration the position of the
EU Parliament.
In October 2012 the Commission published their Second Regulatory Review on
Nanomaterials 82 . The Review highlighted the role of nano as a Key Enabling Technology,
providing the basis for innovation and growth and a key to solving major societal challenges. It
recognises the need to balance the protection of health and the environment with promoting
competitiveness and capturing benefits and stresses the need for international cooperation and
responsible development.The Commission Review confirms that the REACH remains the best
possible framework for the risk management of NMs and chemicals which are not the subject
of more specific legislation, but that further detailed guidance is needed to clarify how NMs
should be identified and addressed in the registration process. In particular there is an issue
over whether NMs should be registered as forms of, or distinct from, their corresponding bulk
substance. The Commission has established a Working Group 83 to explore the related
technical and scientific issues and develop best practice.
Similar findings were presented by the Commission in its 2012 REACH review, in which it concluded that
the existing legal framework was sufficient to address nanotechnologies, yet suggested that future reviews
are likely to be forthcoming.84 In particular, the Commission suggest that it will launch an impact
assessment of relevant regulatory options, including possible amendments of REACH
Annexes, to ensure further clarity on how nanomaterials are addressed and safety
demonstrated in registration dossiers. If appropriate, the Commission suggests that it will
come forward with a draft implementing act by December 2013.85
Limitations of REACH in addressing nanomaterials are considerable. The classification of
nanoscale materials as 'existing substances' [i.e., substances listed in the European
Inventory of Existing Commercial Chemical Substances (EINECS) and placed on the market
before September 1981] is a recurrent regulatory gap identified in the UK Defra report.86 This
arises if it is considered that the chemical structure of the nanoscale form is no different from
its bulk equivalent, in which case it would be treated as an existing substance. The concern
here is that the nanoscale substance may pass through its life cycle without additional scrutiny
of its unique properties, possibly leading to a situation in which measures cannot be taken to
80
European Parliament resolution of 24 April 2009, Regulatory Aspects of Nanomaterials
(2008/2208(INI)), available at
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-328
(assessed on 14 April 2013)
81
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009
on cosmetic products (recast)
82
Communication from the Commission to the European Parliament, The Council And The European
Economic And Social Committee, Second Regulatory Review On Nanomaterials, Brussels, 3.10.2012
83
GAARN: Group Assessing Already Registered Nanomaterials.
Report from the Commission to the European Parliament, The Council, The European Economic
And Social Committee and The Committee of the Regions in Accordance with Article 117(4) of
REACH and Article 46(2) of CLP, and a Review of certain Elements of REACH in Line with Articles
75(2), 138(2), 138(3) And 138(6) of REACH. General Report on REACH, (2013) available at
Http://Ec.Europa.Eu/Environment/Chemicals/Reach/Pdf/Reach_2013_En.Pdf (Accessed On 13 April
2013)
84
85
86
Ibid.
Chaudhry, Q., et al. (2005) n. 3 above.
13
reduce potential risks.
There are a number of areas of uncertainty regarding the scope of REACH in respect of
nanomaterials. Crucially, there are no provisions for NM in REACH. Areas of uncertainty
include the above-mentioned annual production/importation thresholds which potentially
prevent the registration of nanomaterials manufactured, used or imported in quantities of less
than 1 tonne. However, the European Commission has provided the following points of
clarification:87 REACH requirements apply to nanomaterials, even though there are no specific
provisions for nanomaterials; When an existing chemical substance is introduced on the market
at the nanoscale, the registration dossier will have to be updated to include specific properties
of the nanoform of the substance; The additional information, including different classification
and labelling of the nanoform and additional risk management measures, will need to be
included in the registration dossier. Although these Commission Communication guidelines
have not amended REACH itself, they provide an important interpretative tool of the
legislation and helps to bring an element of clarity and certainty for the regulated industries.
b) The United Kingdom
The United Kingdom (UK) is recognised as one of the EU member states which has taken a
leading role in generating a discussion on nano-regulation. In the majority of cases, UK law
generally implements measures that have been agreed and harmonised at EU level, and it
is therefore for the UK and other Member States to seek to address any regulatory shortfalls
through the European Commission. Although there is evidence88 suggesting that present
regulatory frameworks at the EU/UK level are sufficiently broad and flexible enough to
handle nanotechnologies at the current stage of their development, some regulations may
need to be modified on a precautionary basis.
The reviews of the UK regulatory framework have identified regulatory gaps that were a
result of (a) legislative thresholds and definitions more designed to capture risks associated
with bulk chemicals, (b) from exemptions (on tonnage basis) under legislative frameworks
(c) or from lack of information or uncertainties over: current scientific knowledge and
understanding of hazards and risks from exposure to NM; agreed dose units that can be used
in hazard and exposure assessments; reliable and validated methods for measurement and
characterisation that can be used in monitoring potential exposure to NM; and potential
impacts of NM on human and environmental health. 89
In order to address these regulatory gaps, the Royal Society and Royal Academy of
Engineering (RS/RAEng 2004), 90 which reviewed the general terms of a regulatory
approach to chemicals in the United Kingdom, has recommended91 that all relevant
regulatory bodies consider whether existing regulations are appropriate to protect humans
and the environmental hazards outlined in the report and publish their review and details of
how they will address any regulatory gaps. Moreover, RS/RAEng (2004)Report indicates
that establishment of a regulation requires assessment of hazard and assessment of the
likelihood or duration of exposure, these factors combining to produce the risk to any
exposed biological or human population. The overall aim is to determine the risk
management measures needed to eliminate the risks or (in practice) reduce them to
acceptable levels. It is recognised that this process of evidence gathering is informed by
factual evidence, usually obtained from toxicological, environmental or epidemiological
studies.
Communication from the Commission to the European Parliament, the Council and the European
Economic and Social Committee, Regulatory Aspects of Nanomaterials [SEC (2008) 2036], Brussels,
17.6.2008 com(2008) 366 final.
88
See e.g. Holgate, S.T. (2010), n. 8 above; Maynard, A.D. (2006) Safe handling of nanotechnology,
Nature 444: 267-269; Royal Commission on Environmental Pollution (RCEP) (2008), above n. 59.
89
Recommended by Royal Society and Royal Academy of Engineering, 2004 inquiry into
nanotechnology, n. 14 above. See Chaudhry, Q., et al. (2005), above n. 3.
90
Royal Society and Royal Academy of Engineering (RS/RAEng) (2004), n. 14 above.
91
Ibid.
87
14
The UK government supported the RS/RAEng (2004) recommendation that nanomaterials
are considered 'new chemicals' under existing UK and EU REACH regulation.92 Moreover,
in their response, the UK government noted that 'it considers it likely that sector-specific
regulations in addition to REACH may be required. The UK Government plans to call for
regulation of NM at European level whilst continuing to use REACH and keeping the
regulatory situation under review as more evidence and information becomes available.
c) Developments in other jurisdictions: USA, Australia and New Zealand
In the United States, the regulators maintain that the unique size and properties of nanoscale
materials do not warrant new regulation. 93 At present the 1976 Toxic Substances Control Act
(TSCA) is the principal statute that provides authority to regulate chemicals and, therefore,
has been the primary vehicle used by the Environmental Protection Agency (EPA) to regulate
nanomaterials. In contrast to other environmental laws in the United States, which govern only
release into environment, TSCA gives EPA the broad authority to regulate the entire life cycle
of a chemical substance. EPA has regulatory authority in three key areas (a) regulating
chemicals that present health or environmental risks, (b) screening new chemicals and
significant new uses of existing chemicals (c) testing chemicals where risks are unknown.
However, the statute does not specifically address nanomaterials.
It has been argued94 that the TSCA and other legislation are inadequate for regulating
nanoproducts, with 'all of these laws either having serious short-comings of legal authority, or
from lack of resources or both'.95 The TCSA has low-volume exemptions and there is the
implicit assumption that no information on risk of a chemical means there is no risk. Note that
on volume exemptions, TCSA contain exemptions for new chemicals or significant new uses
of chemicals produced in volumes of 10 000 kg or less per year, although this threshold does
not apply if the EPA determines that a chemical may pose serious environmental effects.
This threshold would exclude most NMs. A very basic difference with respect to the EU
approach is that under the TSCA the burden of proof regarding the safety of a substance is
on the regulatory authority ( and not the manufacturer as within REACH).
Secondly, substances whose effects are uncertain are treated the same as substances that
demonstrably pose no unreasonable risk. This presents a particularly difficult challenge to the
regulation of nanotechnology because of the vast uncertainty regarding its impact on health
and safety. Currently, the EPA has not issued rules or guidance as to which nanoscale materials
are 'new chemical substances' or 'significant new uses' such that they could be subject to TSCA
notification requirements. Nor has the EPA amended the regulatory exemption for new
chemicals produced in low volumes. 96 More recently, EPA has issued in 2012 a series of
actions to ensure the notification and registration of nanomaterials in particular,
“Significant new use rules SNUR” which requires companies to provide notifications of
new use of existing chemicals on basis of specific use and type of nanomaterials
( mainly carbon nanotubes,, titanium and silica based compounds).97 EPA plans to adopt
such procedures for any new nanomaterials before they are put on the market. 98
UK Government’s Response to the joint Royal Society and Royal Academy of Engineering report nanoscience and nanotechnologies: opportunities and uncertainties, published on 25 February 2005.
93
See A.C. Lin ‘Size matters: regulating nanotechnology’. Harvard Environmental Law Review
(2007) 31: 350-407.
94
See Davies, J. (2006). Managing the effects of nanotechnology, Washington DC. Project on Emerging
Nanotechnologies, Woodrow Wilson International Centre for Scholars, and, J. M Davis. ‘How to assess
the risks of nanotechnology: learning from past experience’. Journal of Nanoscience and
Nanotechnology. (2007) 7: 402-409.
95
See Lin (2007), supra n. 93 and Davies (2006), supra n. 94.
96
See Bell, C.L. et al. (2006). Regulation of Nanoscale Materials under the Toxic Substances Control
Act 8-11. [Online] Available at http://www.abanet.org/environ/nanotech/pdf/TSCA.pdf (accessed 15
April 2013) and Lin, 2007, supra n. 93. and Davies (2006), supra n. 94.
97
Environment Protection Agency –Nanotechnolgies, at http://www.epa.gov/nanoscience/ (accessed on
15 April 2013)
98
Ibid.
92
15
Australia and New Zealand are also considering regulatory reforms. However, the two
countries are at different stages of development depending on what the societal concerns are
in terms of risk perception. Australia has commissioned a review of its regulatory structure with
respect to emerging risks related to nanotechnologies. According to the findings of the review
Australia's regulatory frameworks are 'generally well suited to allowing adequate management
and control of risk posed by engineered NM and products incorporating NM and their
manufacture, use and handling'.99 The Food Standards Australia and New Zealand - a binational regulatory body - released a proposal in October 2008 which required food companies
to provide information on 'particle size, size distribution and morphology' when using
nanotechnology in food additives, processing aids and novel foods. However, the review
outlined a few potential gaps, including whether NM would be considered as new or existing
substances and whether weight and volume thresholds are applicable. More recently
Australia has developed a strategy for the regulation of nanomaterials supported by an indepth stakeholder consultation which concluded in 2010. 100 Since January 2011 Australia has
implemented a guidance for “Requirement for Notification of new nanomaterials” making it
mandatory for pre-market notification and submission of safety information for new
nanomaterials to be placed on the market.
POLICY AND REGULATORY RECOMMENDATIONS FOR THE REGULATION OF
NANOTECHNOLOGY
As a general approach, risk regulation ensures that scientific uncertainty does not hamper
decision-making and seeks to eliminate or reduce the possibility of harm. In the context of
nanotechnology the policy goal should be of optimal precaution against risks, that is, the point
at which the marginal benefits of intervention are equal to its marginal costs.101
For example, if the exposure to certain NM in the workplace is known to cause serious harm to
health and that harm could be eliminated at acceptable cost to society, protective measures
ought to be put in place. However, costs alone should not determine course of action. Though
at present considerable uncertainties make it difficult to carry out a cost-benefit appraisal of
the different regulatory interventions, the authors present below various regulatory options to
aid future development of a governance framework for NM.
As discussed above, the precautionary principle comes into play when there is a lack of full
scientific certainty about the threat of harm from the substance. On this basis, assumptions
are made about the potential hazard, followed by as assessment of the risk of exposure, for
example in workplace or to general public from use of products. For those substances that
pose the most serious risk, regulatory measures are necessary to prevent harm to people or
the environment. Identifying appropriate responses to uncertain risks is a difficult task for
policy makers and regulatory agencies, as they are faced with a high degree of scientific
uncertainty and the need to balance the costs and benefits of regulation as well as seeking a
reasonable compromise between scientific freedom, technological innovation, consumer safety
and environmental protection..Given that free NM presents a more immediate risk of exposure as
opposed to those NM embedded in composite materials, the proposed regulatory options should
reflect this distinction by regulating products containing free NM more closely. There are a
number of possibilities for regulation including: workplace controls; classification and labelling
measures; control of emissions to air, water and land; waste disposal restrictions; marketing
and use restrictions; and prohibition.
99
National Industrial Chemicals Notification and assessment Scheme (NICNAS) webpage
http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp_nicnas_review.htm (accessed on
15 April 2013).
100
National Industrial Chemicals Notification and assessment Scheme (NICNAS) webpage- ,
nanomaterials- requirements for notification of new industrial nanomaterials., available at
http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp_nicnas_review.htm (accessed on
15 April 2013)
101
See Stokes, E. (2009). Regulating nanotechnologies: sizing up options. Legal
Studies 20: 281-304.
16
This section of the paper analyses four main potential regulatory options which could be
proposed for the regulation of nanotechnology: (1) Maintain the existing regulations; (2)
Introduce a system of ‘grandfathering’ in which the new regulations apply to new market
entrants only (3) Develop nano-specific and process-based regulation; or (4) Develop nanospecific and product-based regulations.
Option 1: maintaining existing regulations to govern risks posed by
nanotechnologies
Maintaining existing regulation is synonymous with retaining the 'status quo'. There are
advantages of using existing regulations to manage the risks posed by nanotechnologies in that
there are systems in place already to ensure enforcement and compliance. Other benefits
include low operational costs due to the fact that frameworks are already established, and
there are no costs associated with the introduction and administration of new regulations. This
helps to explain why in the EU both industry and government alike are in favour of using REACH
and other existing regulations to govern NM.102
Given the regulatory gaps identified during our research for this work, using existing regimes could
in particular be costly where a plausible risk of harm exists. For example, if we apply the distinction
between free and fixed/embedded NM, free NM are more hazardous than fixed NM. In cases where
free NM are used in workplaces (aerosol form) there is cause for concern if they are inhaled or
absorbed through the skin as in cosmetic products. It follows that the type of NM and its application
are key determinants in the potential harm. Therefore, for current uses and applications of NM
where there is direct exposure - such as worker exposure or some food applications - a
precautionary approach should be invoked. The costs of potential liabilities to industry and costs of
recovering environmental damage103 is likely to outweigh the costs of improving safety under the existing
regulations. Indeed, as nanotechnology enterprises grow, issues of civil liability (and indeed,
criminal liabilities) 104 will become increasingly relevant. It has been argued that, as the
commercial applications of nanotechnology increase, so will the relevance of civil liability for
defective products, and any damage caused by the release of nanoparticles into the
environment.105 Moreover, Hunt points out that legal claims arising out of nanotechnology may
be generated by personal injury claims whether arising directly out of, for example,
nanomedical applications, or possibly caused by toxicity of nanoproducts, for example,
nanoparticles in the environment. 106 Parallels can be drawn from the experiences with
asbestos-related claims in the United States.107
102
See Stokes (2009), n. 101 above.
See the Directive 2004/35 on Environmental Liability with Regard to the Prevention and Remedying
of Environmental Damage [2004] OJ L 143/56.
104
See the Directive 2008/99/EC of the European Parliament and of the Council of 19 November
2008 on the protection of the environment through criminal law. Although the pollution offences
under the environmental crime directive could cover instances of environmental damage cause from
the release of NMs into the environment, REACH does not appear in the Apppedix to the
environmental crime directive which lists key pieces of EU environmental legislation, serious
violations of which must be criminalized in the EU member states. For comments on the EU
environmental crime directive and the original proposal, see e.g. Pereira, R. The legal basis for
harmonisation of environmental criminal law in the EU: past and future challenges. In: Andenas , Mads
and Andersen, Camilla Baasch, (eds.) Theory and Practice of Harmonisation. (Edward Elgar, 2011);
and Pereira, R., Environmental criminal law in the first pillar: a positive development for
environmental protection in the European Union? European Energy and Environmental Law Review
(2007), 16 (10). pp. 254-26.
103
Hannah, A. Hunt, G (2006) “ Nanotechnology and Civil Liability.” In Geoffrey Hunt and Michael
Mehta, eds., Nanotechnology: Risk, Ethics and Law, (London: Earthscan) at 237
106
Hunt, G (2006) “The Global Ethics of Nanotechnology”, in Geoffrey Hunt and Michael Mehta, eds.,
Nanotechnology: Risk, Ethics and Law (London: Earthscan) at 183
107
There are two parallel points to make here; firstly although asbestos fibres and engineered
nanoparticles such as carbon nanotubes, fullerenes and metallic nanoparticles are in many ways different
105
17
Governments in leading industrial countries are currently relying on existing regulatory
frameworks for environmental, health and safety regulation to cover nanotechnology risks.
For example, EU and US regulators have generally concluded that any risks posed by NM
can be addressed using existing frameworks but minor adjustments to specific regulations
and their implementation are currently being made in order to close any gaps and eliminate
uncertainties. This is in line with the recent European Commission studies on
nanotechnologies,108 discussed above, which concluded that current legislation covers to a large
extent risks in relation to nanomaterials and that risks can be dealt with under the current
legislative framework.
Although the ‘status quo’ option appears to be the preferred option by regulators and the
industry alike, other stakeholders, such as NGOs, fear that the failure to address the current
loop-wholes in nanotechnologies regulation goes against the principle of precaution and
potentially heightens the risks to the environment and human health posed by certain types of
nanotechnologies.109
Option 2: a ‘grandfathering’ system: new regulations for new market entrants only
Instead of revamping the current system in its entirety, there is a middle-ground option that
suggests that it might be more appropriate to introduce a system of 'grandfathering' in which
existing firms can continue to operate under existing laws, while new legal provisions are
applied to market entrants. A key drawback of this approach is that it may encourage firms to
take advantage of their 'grandfathered' status by increasing production and use of NM, which they
can do at a lower cost than new entrants who are subject to more stringent legal standards.
This approach could act as disincentive for new firms wishing to engage in nanotechnology;
thus reducing the number of nano-manufacturers and suppliers and consequently consumer
choice110. Thus decision makers need to consider these challenges so that a collaborative
approach with industry is adopted. Collaboration is needed to demonstrate the technology and
overcome challenges between governments, industry and the public who need assurance
that the technology and its products are safe. A ‘grandfathering’ system, which segregates
new and existing market participants and favours one over the other, is less likely to lead to
collaborative outcomes.
Option 3: nano-specific and process-based regulation
A key feature of a process-based regime is the belief that the process of nanotechnology is
itself a potential hazard which presents unique risks that must be regulated. The assumption is
that the risk lies in the technique of nanotechnology, not its specific applications. This contrasts
with a product- based approach, which addresses questions of regulation on a product-by
from each other, there are similarities which should warn us to adopt a precautionary approach (Hannah
and Hunt 2006, supra). Consequently, more future research work should focus on answering the
questions on what are the relevant health implication differences and similarities between asbestos
particles and engineered nanoparticles. Indeed, there is ongoing work to address this issue (see section
on human health impacts in the HARN study 2008). The total corporate liability costs for asbestos-related
diseases in the US has been estimated at $30 billion, far more than the product ever earned its
manufacturers Dunphy, A. Griffiths and S Benn, “Organizational Change for Corporate Sustainability”
2003. Moreover, asbestos litigation in the USA is the longest running mass tort litigation in history.
Asbestos has not only injured hundreds of people but caused increased burden on public health systems,
loss of jobs and company bankruptcy. See Hannah, A. Hunt, G (2006), n. 105 above.
108
See for example, Communication: Regulatory Aspects of Nanomaterials (June, 2008), available at
http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf (accessed 09/04/13) However, the
Commission further notes ‘(…)current legislation may have to be modified in the light of new information
becoming available, for example as regards thresholds used in some legislation'.
109
See Greenpeace Environmental Trust Report 'Future Technologies, Today's Choices:
Nanotechnology, Artificial Inteligence and Rebotics' (July 2003), available at
http://www.greenpeace.org.uk/MultimediaFiles/Live/FullReport/5886.pdf (accessed on 15 April 2013).
110
Stokes (2009), n. 101 above.
18
product basis. Measures adopted under this regulatory framework seek to regulate the different
uses of nanotechnologies in a uniform manner. This approach has been adopted in the
regulation of GMOs in a number of jurisdictions, including the EU.111 Implicit in this approach
is the belief that the process of genetic modification is in itself a potential hazard which
presents unique risks that must be regulated. However, application of a process-based
approach to nanotechnologies is complicated by the fact that nanotechnologies have a wide
remit of application and encompass various stages of technological development.
Such regime can apply horizontally across different industrial and commercial sectors and also
vertically to products at different stages of their life cycle. The benefits of such an approach will be
the significant reduction in risks and improved regulatory clarity and hence best applies the
precautionary principle. However, this approach has high administrative and compliance costs
due to the introduction of new rules and requirements at the very early stages of the
development of nanotechnologies.112 Another major drawback of this regime is the fast pace
of development for nanotechnologies and a lack of common nomenclature means that an
overarching regime would require frequent revisions of the regulations to deal with
applications not envisaged at the time of drafting.113
Option 4: nano-specific and product-based regulations.
A key feature of a nano-specific product-based approach is that it recognises that risks posed
by NM can vary and therefore proceeds on a case-by-case basis. In contrast to process-based
regulations that treat nanotechnology as an entity, this regime promotes a product-based or
substance-based approach to regulation by addressing risks posed by particular uses of NM
in specific products, in specific sectors, and/or at specific stages in their life cycle. In other
words this approach allows regulatory measures to be introduced on an incremental basis
targeting certain risks (and firms) when necessary. Some authors have called this approach
'differentiated' to denote it may be realised through adoption of new legislation and the
introduction of policy to supplement existing legislative measures.114
Proponents of this approach have highlighted that this is particularly relevant in the
harmonised areas of EU law such as food or chemicals regulation where it is possible to adopt a
nano- and product-specific legislation.115 Options for nano-specific regulation includes product
licensing; labelling schemes and notification requirements, discussed in turn.
a) Product licencing
Command and control regulation tend to specify the required or prohibited conduct, and
includes prohibitions or limitations on discharge of certain pollutants or wastes, adoption of
certain technologies or the setting of specific standards.116 Command-and-control regulatory
measures that can be employed in context of nanotechnologies include interventionist measures
such as restricting market entry of nanoproducts through product-specific licensing.
A licensing regime could prohibit the manufacture or supply of certain products containing NM
unless minimum quality or safety conditions are met and authorisation has been obtained. Yet
high costs are associated with the requirement for firms to acquire a licence prior to market
The EU and its Member States have adopted a process-based regulatory regime for GMOs,
underpinned by the adoption of a strict interpretation of the precautionary principle. See
futher, Guehlstorf, N., Hallstrom, L.K.. ‘The role of culture in risk regulation: a comparative
case study of genetically modified corn in the United States of America and European Union’,
Environmental Science Policy (2005) 8: 327-333.
112
Stokes (2009), n. 101 above.
113
Ibid.
114
Ibid
115
Ibid
116
See E. Blanco and J. Razzaque, Globalisation and Natural Resources Law (Edward Elgar, 2011).
Pereira, R. ‘Environmental Regulation, Business Competitiveness and Corporate Responsibility’, in K.
Makuch and Pereira, R., Environmental and Energy Law (Wiley-Blackwell, 2012)
111
19
entry and post market monitoring and enforcement.117 The high costs to industry due to
compliance with licensing conditions could also prevent smaller start up companies from using
nanotechnologies, thus inhibiting the placing of NM on the market. The benefits of such an
interventionist product-specific regulation are that high costs could be justified by increased
public confidence in the safety of high-risk products due to ex-ante scrutiny.118
b) Regulatory market-based
incentives
Other authors119 have proposed less interventionist market-based measures for regulating
NM which are more palatable to the regulated community and therefore would be more
easily justified. Market-based legal instrument aim to establish a price to environmental
goods that reflects the true costs of pollution and natural resources use, and include
tradable permits, taxation schemes and labelling schemes.120
A labelling requirement for NM would enable consumers to decide whether to purchase
conventional products whose risks are better known, or products containing NM whose
effects are more uncertain. The legislation requires that certain nanoproducts are labelled
with warnings or instructions for use. In this vein, some authors have suggested that all
products containing NM should be subject to mandatory labelling requirements.121
Mandating public disclosure of presence of NM in products would be in the long term interests of
the nanotechnology industry, by building public trust that the biotechnology industry never
established when GMOs become available on the market. Eco-labelling and provision of
environmental information has been positively correlated with product and process
innovations; more so than the introduction of environmental management systems. 122 Some
commentators123 have highlighted that eco- labelling and product labelling systems that
address health and environmental concerns are becoming a more widespread phenomenon in
consumer societies the world over; and have argued that if the European legislation concerning
traceability and labelling of products containing GMOs is to harness the considerable potential
of consumer markets to advance environmental protection policy, then there needs to be a
balance between the international trade law and consumer opinion which drove the traceability
and labelling requirements in the EU. 124
However, this approach also had some drawbacks. Labelling requirements impose some
financial and regulatory burden in terms of administrative costs, although lower than the
mandatory controls typical of command-and-control regulations.125 Concerns have been
raised regarding the effectiveness of labelling; warnings may not be noticeable and may
convey little information.126 Furthermore, the environmental impact of labelling often depends
117
Stokes (2009), n. 101 above.
Ibid.
119
See Lin, 2007, n. 93 above.
120
Economists tend to take a strong view that environmental protection is better achieved in many cases
through market-incentive legal mechanisms than through command-and-control regulations. See
further, Pereira, R. ‘Environmental Regulation, Business Competitiveness and Corporate
Responsibility’, in K. Makuch and Pereira, R., Environmental and Energy Law (Wiley-Blackwell,
2012).
121
See for example, Lin, 2007 n.93 above.
122
Wagner, 2007. Empirical influence of environmental management on innovation: Evidence from
Europe . Ecological Economics, Volume 66, Issues 2-3, 15 June 2008, Pages 392-402
118
See e.g. Makuch, Z. ‘TBT or not TBT, that is the question: the International Trade Law
implications of European Community GM traceability and labelling legislation’. European
Environmental Law Review (2004) 13: 225-256.
124
Ibid.
125
Pedersen, W.F. (2005). Regulating Nanotechnology by Information Disclosure. [Online] Available
at http://www.eli.org/pdf/research/nanotech/presentations/pedersen.pdf (accessed on 15
April 2013).
126
Lin, 2007, n. 93 above.
123
20
upon the scope and type of environmental information provided to consumers, e.g. for a
particular product, and whether this environmental information will influence consumer or
supplier behaviour. Most eco-labelling schemes have also received considerable industry
opposition as there are costs associated with national broad-based schemes.127 Potential
conflicts with WTO law may emerge as the labelling scheme may be used as a trade
protectionist measure.128
C) Notification and Monitoring Requirements
Notification requirements are a common feature in international environmental agreements.129
Hence in transboudary situations, states have a general duty under customary international law
to ‘to notify’ and ‘consult with’ other affected states before the start of an activity or project
with transboundary implications,130 in particular when activities in a state territory can cause
environmental damage in another state or in areas beyond national jurisdiction, based on the
no-harm rule.131
More narrowly within the confines of national law, a nano-specific notification scheme serves a
similar function as the labelling of information disclosure. Under a notification scheme manufacturers
or suppliers of NM are required to submit information relating to their toxicity to a designated
regulatory authority, prior to manufacture or supply. Submission of data by manufacturers is a
key element of REACH because it shifts the burden of proof on the safety of a substance to
manufacturers, importers and producers, as opposed to regulator. In the EU, the REACH
regulation is an example where a notification procedure is used. However, in light of the limitations
of REACH in dealing with risks posed by NM, a nano-specific notification procedure would be
more appropriate132 Notification requirements are also at the heart of EU GMO legislation.133
Besides the EU, notification of new substances (NONS) requirements are followed in other
countries, such as Japan, although the classification is made before the substance can be
manufactured. The main difference in data requirements is that mandatory base sets are
127
Gunningham, N., Grabosky, P., & Sinclair, D., 2004. Smart Regulation: Designing Environmental
Policy. Oxford University Press; Wright and Pereira, ‘A Legal Framework for Clean Technology
Transfer and Finance’, in Environmental and Energy Law, (Wiley-Blackwell, 2012)
128
See e.g. the recent WTO dispute (DS381) between Mexico and the United States — Measures
Concerning the Importation, Marketing and Sale of Tuna and Tuna Products (2012), between Mexico
and the United States regarding the legality of the US labelling standards requrements that tuna
products made from tuna caught by “setting on” dolphins (that is, chasing and encircling dolphins with
a net in order to catch the tuna associating with them) are not eligible for a “dolphin-safe” label in the
United States. Available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds381_e.htm
(accessed on 15 April 2013)
129
In addition to the Stockholm and Rotterdam Conventions (discussed above), see e.g. the Convention
on the Law of Non-Navigational Uses Of International Watercourses (UN: 1997), Article 12 (not yet in
force); In the nuclear law field, see e.g. the 1986 Convention on Early Notification of a Nuclear
Accident 1997; and the Joint Convention on the Safety of Spent Fuel of Radioactive Waste
Management (Joint Safety Convention), Article 27.
130
ICJ Case Concerning Pulp Mills on the River Uruguay (Argentina v Uruguay), Judgment of 20
April 2010 (ICJ Report 2010); and the Lake Lanoux arbitration (1957) (France v. Spain), R.I.A.A.
281; 24 I.L.R. 101.
131
The no harm-rule is elaborated in the Principle 2 of the Rio Declaration on Environment and
Development (1992) and Principle 21 of the Stockholm Declaration (1972).
132
Stokes (2009), n. 101 above.
133
Under the EU ‘Deliberate Release’ Directive, before a GMO or a combination of GMOs as or in
products is placed on the market, a notification shall be submitted to the competent authority of the
Member State where such a GMO is to be placed on the market for the first time. The notification must
contain a range of information, including the environmental risk assessment carried out by the
applicant, and a plan for monitoring the GMO following its release into the environment. See Article
13 (1) and Annex II of ‘Deliberate Release Directive’. Directive 2001/18/EC on the Deliberate Release
into the Environment of Genetically Modified Organisms, Official Journal L106/1, 17.4.2001,
repealing Council Directive 90/220/EEC OJ L117/15.
21
required under the EU and Japanese law, both of which lead to an element of classification or
categorisation. The USA US Toxic Substances Control Act (TSCA) by contrast does not
specify a base set and does not lead to classification. TSCA requires the Environmental
Protection Agency (EPA) to keep an inventory of all substances regulated under the Act and
requires new substances to be notified to EPA before manufacture or importation. However,
by contrast with EU and Japan, since the Act does not specify a base data set, this leaves
EPA with the responsibility of demonstrating that a chemical may pose an unreasonable
risk.134Moreover, as mentioned above, Australia has since January 2011 implemented a
guidance for “Requirement for Notification of new nanomaterials” making it mandatory for
pre-market notification and submission of safety information for new nanomaterials to be
placed on the market.135
The advantage of such a notification scheme is that it imposes lower financial and regulatory
burden on manufacturers because much of the information sought would be generated in the
development of new products. However, such a notification system would not be effective
without a standard system of nomenclature and metrology. Given the current diversity and
complexity of NMs, current nomenclature may not be adequate to characterise them.Both
accurate labelling and notification systems rely on standardised, globalised nomenclature.
In addition, existing regulatory provisions regarding chemicals and materials have started to
include NM in their listings and the requirements to provide monitoring and control before and
after their introduction to the market. Indeed, there appears to be a strong case for products
containing free NM should be subject to a screening process, post market monitoring and
reporting requirements. Indeed, in the UK government response136 to the RCEP report137, the
government agreed with Commission recommendations on environmental monitoring and the
development of a simple checklist as part of an early warning system to facilitate greater
partnership between industry, government and the science community. The details of the simple
checklist should include information on manufacturers and importers, information on quantities
produced and how they are used in wider industry.
Various regulatory agencies in Europe (EC/ECHA), United States (EPA), Canada
(Environment Canada) and Australia (NICNAS) are considering such specific notification
requirements In the United States, since 2009, EPA has been evaluating a series of actions
to ensure an appropriate regulation of NM within TSCA, including specific notification and
registration procedures for NM, in particular carbon nanotubes.138 More recently (April 2010),
debate of the US Senate on the Safe Chemical Act of 2010, which includes a proposal for a
reform of the TSCA that would introduce relevant changes to this statute and could lead to an
approach similar to the one used under REACH (burden of proof of risk falling on the
producer).139 The developments in NMs monitoring following their market release are very
much in line with the EU GMO regulations, which require that Member States take measures
134
In this vein, in December (2006) Berkeley City Council, USA became the first US city to introduce
legislation specifically regulating NM on the premise that firms or individuals have a 'right to know' the
hazardous properties of NM they buy or use. Under the Berkeley regulations, all those handling manufactured
NM would have to produce a separate written disclosure of the current toxicology of materials to the extent
known and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases
and mitigate such materials
135
National Industrial Chemicals Notification and assessment Scheme (NICNAS) webpage- ,
nanomaterials- requirements for notification of new industrial nanomaterials.
http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp_nicnas_review.htm (accessed on
15 April 2013)
136
UK Government Response to The Royal Commission on Environmental Pollution (RCEP) Report on
Novel Materials in the Environment: A Case of Nanotechnologies Cm 7620, 2 June 2009, The Stationery
Office, available at http://www.official-documents.gov.uk/document/cm76/7620/7620.pdf (accessed on
April 2013).
137
Royal Commission on Environmental Pollution (RCEP) (2008), n. 59 above.
138
Environment Protection Agency –Nanotechnolgies, at http://www.epa.gov/nanoscience/ (accessed
on 15 April 2013)
139
Ibid.
22
to ensure traceability, in line with the requirements laid down in Annex IV, at all stages of the
placing on the market of GMOs that have been authorized. 140 It requires that following the
placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring
and reporting on it are carried out in according to the conditions specified in the consent. 141
CONCLUSIONS
To date, nanotechnology is not regulated as a sector per se as it represents an emerging
family of heterogeneous technologies enabling manipulation of matter at atomic level. While
nanotechnology presents many benefits to society in areas as wide-ranging as consumer
products, healthcare, chemicals, cosmetics and waste treatment, as is the case with many new
technologies, we currently have only a limited understanding of the potential risks of NM and
some studies suggest certain NM may have negative impacts on human health and the
environment if exposure or release into the environment occurs. However, information on
toxicological impacts is still limited. It is precisely on account of this limitation of knowledge that
the application of the precautionary principle would make sense. Further, the development of a
governance system for nanoscience and nanotechnologies that is both effective and
proportional to potential risks is therefore of utmost importance, if policy makers and
stakeholders recognise the full benefits of the technology's potential.
Whilst there is need to clarify existing uncertainties and address the gaps in scientific
knowledge and the different stances on regulatory approaches in different countries, there is
also an increasing recognition that nano-regulation is needed. In the past few years, the
debate has focused on the first attempts to introduce adjustments for NM in regulatory
provisions, particularly in the EU. The most relevant example of this action is the recast of the
Cosmetic regulation in the EU. 142The adjustments/amendments to the existing regulation
relate to the inclusion of a definition of NM, improved notification and registration procedures,
specific guidelines for safety assessment, labelling and inventories of the use of nano-related
products. Progress and responses towards regulation of NM is varied: some authorities are
focused on amendments of existing instruments and adoption of mandatory reporting
schemes whilst others prefer the use of voluntary measures or a combination of both.
Governments in leading industrial countries are currently relying on existing regulatory
frameworks for environmental, health and safety regulation to cover nanotechnology risks.
For example, EU and US regulators have generally concluded that any risks posed by NM
can be addressed using existing frameworks but minor adjustments to specific regulations
and their implementation are currently being made in order to close any gaps and eliminate
uncertainties. Identifying appropriate responses to uncertain risks is a difficult task for policy
makers and regulatory agencies, as they are faced with a high degree of scientific uncertainty
and the need to balance the costs and benefits of regulation as well as seeking a reasonable
compromise between scientific freedom, technological innovation, consumer safety and
environmental protection.
Yet a cursory examination of existing regulations has indicated that there are significant
regulatory gaps and extensive amendments are required to address the risks posed by
nanomaterials. Hence a trend has been seen in which various regulatory agencies in the EU
and a number of other countries are already applying or considering introducing nano-specific
legislation, including legislation pertaining to notification, monitoring, labelling and licensing
140
Lee, M., EU Regulation of GMOs: Law and Decision Making for a New Technology, (Edward
Elgar, 2008).
141
See Directive 2001/18/EC on the Deliberate Release into the Environment of Genetically Modified
Organisms (“The Deliberate Release Directive”) Official Journal L106/1, 17.4.2001, repealing Council
Directive 90/220/EEC OJ L117/15; and Regulation (EC) No 1946/2003 on Transboundary Movements
of Genetically Modified Organisms; Regulation 1829/2003 on Genetically Modified Food and Feed
[2003] OJ L 268/1.
142
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November
2009 on cosmetic products (recast)
23
schemes. It encouraging that, at present, European and national regulatory regimes are
under review and could be subject to reforms.
Further, due to the transboundary nature of NM, the international efforts to develop
harmonised tools through bodies such as the OECD and WTO are critical. Successful efforts
in transnational cooperation have sought to promote high levels of protection whilst enabling
science and industries to operate freely in a transatlantic economic space. In some cases,
difficulties have arisen due to differences in regulatory frameworks, regulatory cultures and
societal perception of risk and this has contributed to the divergence of regulatory responses
across different jurisdictions. Classic cases are the high profile transatlantic disputes over hormone
143
treated beef and GMOs144 which resulted in some negative impacts on trade relations.
These experiences serve to demonstrate why the development of regulation for NM needs to
consider and technological risks need to be identified whilst promoting international
cooperation at the early stage of policy processes. Regulators across a number of jurisdictions
have acknowledged the challenges in ascertaining adequate information both to allow
evaluation of the safety of NM and the presence of products containing NM.
In sum, different jurisdictions take different approaches to regulation, including differences in
policies, authorities and requirements. Nevertheless, many factors will influence the extent to
which these differences in approach result in disparate regulatory actions. These factors
include resources for implementation, interpretation of regulatory authorities, subsequent
reforms and perhaps most importantly, the extent to which regulators coordinate and share
information at this critical juncture in the regulation of nanoscale materials.
The regulation of biotechnology provides an interesting approach to regulation that
could be replicated in the case of NMs, though further comparative analysis is beyond
the scope of this work.145Social, political and economic factors influence views on
nanotechnology. There are proponents and opponents of nanotechnologies. A
regulatory approach needs to account for these opposing views. For now, it is
recommended by us that law-makers, regulators and standard-setting bodies find the
appropriate balance between soft and hard law standards, command-and-control
regulations and market-based incentives, which should include nano-specific
standards (in particular as regards notification and monitoring requirements),146 as well
as that risk assessment, sound-scientific approaches and application of the
precautionary principle ought to provide the basis for the regulation of NMs.
Biographies:
Sekai Ngarize (MSc, Ph.D.) is Senior Science and Policy Advisor at the UK Department of
Energy and Climate Change (DECC), where she is responsible for developing policy on
Land use and land use change and Forestry including Reducing emissions form
Deforestation and Degradation (REDD) policy and R&D programme for LULUCF/REDD
under the UNFCCC, UK Carbon Budgets and EUMM. She has previously worked at the
Department of Environment Food and Rural Affairs (DEFRA) for 5 and half years where
was responsible for policy development of the UK International and Domestic Policy for
Persistent Organic Pollutants under the International Treaty Stockholm Convention, and the
UNECE. Her work involved representing the UK and participating in international
negotiations under the UNEP and EU. Prior to that, She worked at the UK Food Standards
143
See WTO 'Hormones Case': European Communities - Measures Concerning Meat and Meat
Products (Hormones), n. 15 above.
144
See WTO GMO cases: European Communities - Measures Affecting the Approval and Marketing
of Biotech Products, n. 15 above.
145
On this question, see further Ngarize, Makuch, K. and Pereira, R. ‘The Regulation of
Nanotechnologies’ in K. Makuch and R. Pereira (eds.) Environmental and Energy (Wiley-Blackwell,
2012).
146
This type of nano-specific legislation should include amendments to existing legislation, such as
REACH in the EU.
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Agency, where was responsible for Risk Assessment of food and environmental
contaminants.
Email: sekai.ngarize@decc.gsi.gov.uk
Karen Makuch (LL.B. LL.M.) is Lecturer in Environmental Law, Centre for Environmental
Policy, Imperial College, London, UK. She teaches postgraduate students on the MSc in
Environmental Technology. Karen has a wide-range of experience in the practical application
of EU Environmental Law and its implementation including in new and potential EU Member
States and has worked in many Central and Eastern European countries on matters related
to the approximation of EU environmental law including the drafting of environmental
legislation. Karen has published papers and chapters, inter alia, on the approximation of
environmental law, on human rights law and the environment, on climate change and on
pollutant release and transfer registers, and co-edited and co-wrote Environmental and
Energy (Wiley-Blackwell, 2012).
Email: k.e.makuch@imperial.ac.uk
Ricardo Pereira (LL.M., Ph.D.) is Senior Lecturer in Law and Sustainability at Westminster
Business School, University of Westminster, London, UK, where he teaches and conduts
research on sustainability, environmental, finance and corporate law. He also convenes and
lectures in the LL.M. courses on the International Natural Resources Law and International
Law of the Sea at Queen Mary, University of London. He was previously Lecturer in
Environmental & Energy Law in the Centre for Environmental Policy, Imperial College
London (2009-2012). He is author of articles and chapters in books in the fields of
environmental, energy, criminal and human rights law, and co-edited and co-wrote
Environmental and Energy (Wiley-Blackwell, 2012).
Email: r.m.pereira@westminster.ac.uk
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