Memorandum by Dr Robert Falkner, London
School of Economics
1. The evidence provided below focuses on
the regulatory framework for nanotechnologies in food. It is based
on research currently being carried out as part of an international
project on "Regulating Nanotechnologies in the EU and
US: Towards Effectiveness and Convergence", which is
funded by a grant from the European Commission and involves four
institutions: the London School of Economics and Chatham House
in the UK, and the Environmental Law Institute and the Project
on Emerging Nanotechnologies in the US.
Research assistance by Nico Jaspers and Carmen Gayoso is gratefully
acknowledged. Please note that the evidence below is given in
a personal capacity and does not represent the views of the project
consortium or the European Commission.
Q: Is the regulatory framework for nanotechnologies
and nanomaterials fit for purpose? How well are imported food
products containing nanotechnologies and nanomaterials regulated?
2. A clear-cut answer to this question is
not possible. The regulatory framework may be fit for purpose,
but given existing knowledge gaps about the presence of nanoscale
materials in commercial use, their environmental and health risks,
and methodologies for assessing such risks, changes to the regulatory
framework are likely to be needed. In any case, greater efforts
need to be undertaken to gain better knowledge about the potential
risks involved in the use of nanotechnologies in food and other
areas, as a first step towards a more robust regulatory environment.
3. Emerging nanotechnologies and nanomaterials
are being regulated through existing laws and regulations at UK
and EU level, in the fields of chemicals, food, cosmetics, pharmaceuticals,
Given that nanotechnologies are best conceived as enabling technologies
for a wide range of industrial applications, nanotechnology risks
are likely to be dealt with by sector-specific and product-based,
rather than comprehensive and process-based regulation. Current
regulatory efforts in the UK, the European Union and other industrialised
countries are focused on applying existing regulations to nanotechnologies
and amending these in order to fill any potential gaps in the
coverage of nanotechnology risks. Given existing knowledge gapsabout
health and environmental risks, appropriate methodologies for
risk assessment and the state of commercialisation of nanomaterialsit
is not possible to establish with sufficient certainty whether
the regulatory framework is fit for purpose.
4. A central problem in nanotechnology regulation
concerns the very definition of what constitutes the "nanoscale".
Efforts are underway to establish common scientific and technical
standards in this area, through the International Organization
for Standarization (ISO) and the OECD (see below, paragraphs 15-17).
However, the absence of reliable definitions has made it difficult
so far to establish precisely what types of nanomaterials are
in use in the food sector and whether these are adequately covered
by existing regulations. The food industry has failed to provide
comprehensive information about the size or properties of nanomaterials
it currently uses as food ingredients, in food processing and
in food packaging. Part of the problem is that, in the absence
of clear defintions, the use of the term "nano" or "nanoscale"
remains at the discretion of companies. Efforts are underway to
address the uncertainty and incoherence surrounding company reporting,
including by the European food and drinks industry association
CIAA, which has set up a Nanotechnology Task Force. But governments
will need to take the lead in removing uncertainty about definitions
and establish unambiguous disclosure requirements about the presence
of nanomaterials in food production and products.
5. In principle, imported food products
should be covered by existing regulations in the same way as domestically
produced food products. As with domestic producers, the main problem
at the moment is the absence of reliable market data. Governments
should therefore consider, as an immediate priority, the creation
of a comprehensive reporting system for nanomaterials in the food
industry, covering domestic and imported products. Given the limitations
of voluntary reporting initiatives in this area (see below, paragraphs
7-13), disclosure and reporting of nanomaterials in food should
6. The need to update and revise existing
food safety regulations in light of newly emerging nanotechnology
applications has recently been confirmed by the European Food
Safety Authority (EFSA). According to the agency's draft strategic
plan for the next five years, nanotechnology is seen as one of
the key "new challenges" that will require regulators
to "upgrade existing and design new risk assessment practices
to keep up with the pace of science and innovation".
More recently, EFSA emphasised that available data on risks relating
to exposure to specific nanomaterials in food is "extremely
limited". Given the limited knowledge of current usage levels
and likely exposure products in the food area, the agency warned
that lack of validated test methodologies could make risk assessment
of specific nanoproducts "very difficult and subject to a
high degree of uncertainty".
Q: How effective is voluntary self-regulation
either in the UK or EU or at an international level? What is the
take up by companies working in the food sector?
7. The short answer is "not very effective".
Industry has introduced a number of voluntary initiatives that
address issues relating to nanotechnologies risk, and some governments
have provided frameworks for reporting and codes of conduct for
research that are of a voluntary nature. Many of these schemes
have only recently been initiated, and little systematic evidence
exists on industry self-regulation, but first assessments of governmental
programmes for voluntary reporting suggest that such initiatives
are not sufficiently effective.
8. Preliminary findings of a study currently
being conducted at the LSE suggest that the majority of companies
that have initiated voluntary initiatives on nanotechnology risk
are to be found in the chemicals and pharmaceuticals sectors.
These companies have a long tradition of engaging in corporate
social responsibility initiatives and have been at the forefront
of developing commercial applications of nanotechnology. Such
CSR initiatives involve, for example, codes of conduct for nanotechnology
applications (eg BASF, Evonik), participation in international
research on environmental and health risks of nanotechnologies
(eg American Chemistry Council Nanotechnology Panel; Occupational
Safety & Health Consortium), nanotechnology-related statements
in CSR reporting (eg Novartis, Hoffman-LaRoche) and public and
stakeholder engagement activities. DuPont has recently developed
a Nano Risk Framework in partnership with the US environmental
organization Environmental Defense, which provides a guidance
document for nanotechnology users for identifying and reducing
potential risks as part of product stewardship programmes.
9. The food industry has been comparatively
slow to develop voluntary initiatives for dealing with nanotechnology
risk, but is faced with growing demands for greater transparency
about its use of nanomaterials. So far, no industry-wide system
of self-regulation has been created that could provide reliable
information on the use of nanomaterials in food production and
promote safety standards. Momentum is growing, however, for disclosure
initiatives as a first step towards industry self-regulation.
Investor activist groups in the US, for example, have filed resolutions
for the 2009 annual meetings of Avon Products, Kellogg Company,
Kraft Foods, and McDonald's Corporation and are requesting that
companies publish a report detailing their use of nanomaterials
in products and their overall nanomaterials policy.
In Europe, the food and drinks industry association CIAA is currently
developing an industry-wide Code of Conduct for Nanotechnologies,
which is expected to provide a first steps towards a self-regulatory
10. Governments have also sought to promote
voluntary initiatives. The UK has been at the forefront of developing
voluntary reporting schemes to improve the informational basis
for risk assessment and management of nanotechnologies. DEFRA
launched the UK Voluntary Reporting Scheme (VRS) for Engineered
Nanoscale Materials, the world's first such governmental reporting
scheme, in September 2006. Its two-year pilot phase of the project
came to an end in September 2008, and DEFRA is currently considering
how to develop a future reporting scheme. The record of the pilot
phase has raised concerns about the effectiveness of voluntary
reporting. Since its launch in 2006, DEFRA received only 12 submissions,
which represent about a third of the companies currently manufacturing
11. The UK's experience with voluntary reporting
is mirrored by the limited response to the US EPA's Nanoscale
Materials Stewardship Program (NMSP), which was launched in January
2008 and is also meant to run for two years. NMSP invites
voluntary reports on engineered nanoscale materials that are being
manufactured, imported, processed or used in the US. A separate
in-depth program invites producers to develop and submit data,
including testing, over a longer time frame.
In its interim report of January 2009, EPA states that 29 companies
or associations had submitted information to EPA covering 123 nanoscale
materials and a further seven companies have outstanding commitments
to do so. Four companies have so far agreed to participate in
the in-depth program.
12. Although EPA concludes that "the
NMSP can be considered successful", it notes that "a
number of the environmental health and safety data gaps the Agency
hoped to fill through the NMSP still exist". Few of the reports
received by NMSP contain information on health and environmental
aspects of nanomaterials and, as EPA states in its review, "approximately
90 per cent of the different nanoscale materials that are likely
to be commercially available were not reported". Furthermore,
commenting on the low take up of the more ambitious in-depth program
of NMSP, EPA notes that "most companies are not inclined
to voluntarily test their nanoscale materials". It is therefore
not surprising that the agency is now considering how to use existing
authorities under US chemicals legislation to fill those gaps,
which signals a move to strengthen mandatory requirements in the
13. Other governments have already concluded
that mandatory reporting is now needed to deal with the existing
and emerging information gaps. France proposed in January 2009 to
introduce a mandatory reporting requirement of manufactured and
imported nanomaterials, including environmental and health data.
Canada announced in February 2009 that will introduce a mandatory
reporting requirement for information relating to nanoscale materials.
In the absence of effective voluntary schemes, I would expect
more governments to follow the lead of France and Canada in creating
mandatory reporting requirements.
Q: Will current regulations be able adequately
to control the next generation of nanotechnologies and nanomaterials?
14. We cannot establish with any degree
of certainty that current regulations will be able adequately
to control the next generation of nanotechnologies and nanomaterials.
The nanosciences is a field of rapid innovation, and current indications
suggest that the convergence of nanotechnology with biotechnology,
information technology and the cognitive sciences will create
new challenges and risks that will require more fundamental changes
to existing regulatory frameworks. The project on "Regulating
Nanotechnologies in the EU and US: Towards Effectiveness and Convergence",
together with the Project on Emerging Nanotechnologies, commissioned
two new reports on next generation nanotechnology and synthetic
biology that shed further light on the regulatory challenges that
industrialised countries are likely to face in coming years.
Q: Is there any inter-governmental co-operation
on regulations and standards? What lessons can be learned from
regulatory systems in other countries?
15. The main forum for international cooperation
on nanotechnologies regulations and standards is the Organization
for Economic Cooperation and Development (OECD). Two OECD working
groups have been established with an explicit focus on nanotechnologies:
the Working Party on Manufactured Nanomaterials (WPMN) was created
in 2006 in the Environment Directorate and comprises 30 OECD
member countries, the European Commission, five non-OECD countries
and a small number of observers from international organizations,
industry and civil society. It focuses almost exclusively on co-operation
in safety assessments and on testing a representative set of nanomaterials.
The OECD's second group is the Working Party on Nanotechnology
(WPN), which was set up in 2007 in the OECD's Directorate
for Science, Technology, and Industry. Its remit is focused more
broadly on emerging policy-relevant issues in science, technology
and innovation, including nanotechnology research and development,
outreach and public dialogue.
16. The OECD working groups are widely seen
to be the most important forum for international coordination
in the field of nanotechnologies regulation. They are likely to
produce greater convergence in the development of the basic building
blocks for nanotechnology risk assessment. What is less clear,
however, is whether the OECD can serve as the basis for developing
a broader international framework for coordinated and convergent
risk management practices. Some observers have expressed concerns
about the OECD's suitability in this context, particularly with
regard to its limited membership basis as an industrialised countries
organization, its perceived lack of transparency and the limited
nature of stakeholder involvement particularly by civil society
17. The other main forum for developing
internationally harmonised standards is the International Organization
for Standardisation (ISO). Its technical committee on nanotechnologies
(TC 229) promotes the standardisation of terminology, definitions,
toxicity testing and environmental studies protocols, measurement
techniques, calibration procedures, and reference materials. Much
of this work will feed directly into regulatory developments at
national and international level, as ISO standards are likely
to be adopted in definitions of nanoscale materials and their
18. Other international organizations have
also begun to address policy issues arising from the rapid development
and commercialisation of nanotechnologies, but none has so far
provided a forum for inter-governmental cooperation on regulation
and standards. The WHO's Intergovernmental Forum on Chemical Safety
has issued the "Dakar Statement on Manufactured Nanomaterials",
which notes the "lack of an inclusive global policy framework"
and recommends increased efforts to fill gaps in scientific understanding,
promote information sharing, international cooperation on the
development of national codes of conduct, among others.
The United Nations Environmental Programme (UNEP) has called for
"swift action" by policy makers to properly evaluate
the new science of nanotechnology. UNEP's 2007 Geo Yearbook
identifies nanotechnology and the environment as a key emerging
challenge for international policy-making but stops short of outlining
an alternative vision for international nanotechnologies regulation.
13 March 2009
1 For further information, see the project website:
For a review of existing EU regulation and how it applies to nanotechnologies,
see Communication from the Commission to the European Parliament,
the Council and the European Economic and Social Committee on
Regulatory Aspects of Nanomaterials COM(2008) 366 final,
Michael Rodemeyer, "New Life, Old Bottles: Regulating First-Generation
Products of Synthetic Biology", Project on Emerging Nanotechnologies,
Woodrow Wilson International Center for Scholars, March 2009,
forthcoming; and J. Clarence Davies, "Oversight of Next Generation
Nanotechnology", Project on Emerging Nanotechnologies, Woodrow
Wilson International Center for Scholars, 2009, forthcoming. Back