CHAPTER 6: Regulatory Enforcement
6.1. To be effective, regulations must have appropriate
scope and must be enforceable. We have described how the scope
of the current regulatory framework appears to be sufficiently
broad to address the use of nanotechnologies in the food sector.
We now turn to enforceability, which is carried out by individual
Members States within the European Union (p 300). On this
aspect, two issues of concern were drawn to our attention: risk
assessment, and imports and products sold over the internet. In
addition we consider government guidance to industry on the implementation
of legislation; regulation in an international context; and the
provision of information to the public about food products containing
nanomaterials.
6.2. We have concluded that legislation needs
to define nanomaterials used in the food sector and to require
that all nanomaterials undergo a risk assessment by the EFSA before
they are approved for human consumption. By the same token, a
definition is an important precondition to the enforcement of
that legislation. Without a clear definition regulators will find
it hard to determine companies' compliance with legislation. Dr Falkner
told us: "if you have no means to distinguish clearly between
a nanomaterial and a non-nanomaterial, and if you are therefore
uncertain whether existing laws apply, that restricts the application
of the [regulatory] framework" (Q 317).
Risk assessment
6.3. Our witnesses assured us that consumer safety
is of paramount importance to both industry and Government, and
that until products can be adequately risk assessed they will
not be brought to market (QQ 3, 156). The only food company
to give written evidence to the Committee, Cargill, told us that
until there was a "clear science-based regulatory regime"
that could properly assess the potential environmental, health
and safety impact of nanomaterials, "Cargill will not incorporate
intentionally-engineered nano-materials into its products"(p 294).
6.4. As with many new technologies, long-term
risks can be hard to assess. Insurance can play an important role
in ensuring that companies are willing to explore the potential
of new technologies. Yet Lloyd's told us that the difficulty in
quantifying some risks associated with nanotechnologies has lead
to some insurers withdrawing cover: "at least one US company
… has excluded all aspects of nanotechnology; others are
actively avoiding providing direct cover to this industry"
(p 223). There is, therefore, a clear need for effective
risk assessment frameworks to be put in place. Until this is done,
not only will products be unable to play a significant role in
the food market, but research into their potential applications
may be affected.
6.5. At present, food products must be assessed
as safe before they can be approved for use (see paragraph 5.2).
Where food products contain nanomaterials, data have to be presented
to the relevant authority (usually the EFSA) and that authority
carries out a risk assessment. There are two components to the
effectiveness of risk assessment of food products: first, whether
the risk assessment framework correctly determines when a product
poses a threat to human health; and, secondly, whether the organisation
carrying out the risk assessment is able to apply the framework
effectively.
THE RISK ASSESSMENT PROCESS
6.6. The risk assessment process will usually
include the following elements:
- Hazard identification (recognition
of what the nanomaterials is capable of doing at any dose)
- Hazard characterisation (assessment
of the relevance to humans of each adverse effect including dose-response
analysis for relevant effects in order to predict safe intake
levels for humans)
- Intake assessment (estimation
of potential human exposures and intakes based on real data or
predictions)
- Risk characterisation (comparison
of the potential human exposure with the predicted safe intake
for humans)
6.7. The EFSA's scientific opinion found that
this risk assessment paradigm is "considered applicable for
ENMs [Engineered Nanomaterials]".[74]
Similarly, in 2005, COT, COM and COC concluded that "current
approaches to risk assessment should be appropriate for nanomaterials".[75]
APPLICATION OF THE RISK ASSESSMENT FRAMEWORK
6.8. Whatever the applicability of standard risk
assessment frameworks to nanomaterials, some witnesses questioned
whether the risk assessment process worked in practice given the
knowledge gaps in the scientific understanding (see Chapter 4).
The FSA, for example, cited the following problems: difficulties
in characterising, detecting and measuring engineered nanomaterials
in food; limited data on exposure analysis; and limited data on
oral exposure and toxicity (pp 3-4). Dr Wadge told us: "the
challenges and difficulties will lie … around the precise
nature of risk assessment and the toxicological testing"
(Q 47). The EFSA has concluded that, although the framework
is theoretically appropriate, "the adequacy of currently
existing toxicological tests to detect all aspects of potential
toxicity of ENMs has yet to be established" and "any
individual risk assessment is likely to be subject to a high degree
of uncertainty"[76],
while the 2005 joint statement by COT, COM and COC said that:
"in the absence of [hazard identification data] it was not
possible to derive conclusions about the spectrum of toxicological
effects which might be associated with nanomaterials".[77]
Similar points were made in the RCEP report[78]
and the EMERGNANO report[79].
The European Parliament Committee on the Environment, Public Health
and Food Safety has recently concluded in its report on Regulatory
Aspects of Nanomaterials that:
"[The Committee] does not agree, in the absence
of any nano-specific provisions in Community law, with the Commission's
conclusion that current legislation covers in principle the relevant
risks relating to nanomaterials, when due to a lack of appropriate
data and methods to assess the risks relating to nanomaterials
it is effectively unable to address their risks".[80]
6.9. Given doubts about the workability of the
risk assessment process, Friends of the Earth Australia and the
Soil Association have called for a moratorium on the use of nanotechnologies
and nanomaterials in food. Others are against this. Ms Sue Davies
of Which? said: "we do not think a moratorium is very
meaningful. We have issues around definition, it is very difficult
to find out what is actually happening, so even if we thought
that a moratorium was useful we do not understand how it would
practically be enforced and applied" (Q 287). Dr Falkner
told us that to be effective any moratorium would have to be a
"broad-brush instrument" and so cover a "wide range
of nanomaterials that perhaps do not deserve to be covered under
a moratorium" (Q 319).
6.10. We also have doubts about imposing a moratorium.
In Chapter 5 we referred to potential gaps in regulatory coverage
as a result of difficulties in defining nanomaterials. In the
absence of an agreed definition, a moratorium would present similar
problems. If, however, a workable definition were formulated (thereby
making a moratorium practicable), then a moratorium would be unnecessary
since the definition could be used within food legislation to
ensure that any products containing nanotechnologies would have
to go through mandatory pre-market approval processes.
6.11. EFSA assesses products on a case-by-case
basis. Where there is a lack of information about the risk a product
may pose to human health, that product will not receive approval.
Nanosilver supplements have failed to obtain approval from the
EFSA on these grounds (p 3). David Carlander, Scientific
Officer at the EFSA, told us that EFSA was not able to make a
decision on the risk posed by nanosilver because the uncertainties
were "so clear" that "additional information would
have been needed to perform the risk assessment". He concluded
that consumers' safety was protected because "if there is
no data we cannot perform a risk assessment … such products
would then not be risk assessed and therefore in future would
likely not be on the market" (Q 520).
6.12. We endorse the case-by-case approach
taken by the European Food Safety Authority in assessing the safety
of products. It allows the responsible development of low-risk
products where safety data are available and is, in effect, a
selective moratorium on products where safety data are not available.
It provides consumers with the greatest security and ensures that
unless a product can be fully safety assessed, on its own merits,
it will not be allowed on to the market.
Imports
6.13. Products imported into the European Union
can only be marketed within Member States if they meet food safety
requirements which are equivalent to those in the European Union.
Companies have a legal duty to ensure that all food products they
import meet these requirements (p 5, Q 8). Whilst this
provides a level of protection against the importation of unsafe
food products, there are weaknesses.
6.14. The first concerns the internet. According
to the FSA, "food products ordered from a non-EU country
by members of the public in limited quantities for their personal
use, for example over the Internet, may not be subject to the
protection of UK food safety requirements" (p 5). Professor Morris
agreed: "the worry is about what is available on the Internet"
since in many cases it "is not regulated" (Q 114).
In these circumstances, we consider that providing consumers with
information about products containing nanomaterials, and their
potential risks, is the only practical action the Government can
take to help protect the public. We consider this further in Chapter
7.
6.15. A second problem area relates to the capability
of the enforcement authorities. In the United Kingdom, local authorities
and port health authorities have power to check all imported food
for compliance with food safety requirements. But inspectors do
not, at present, have the means to detect the use of nanomaterials
in imported food (QQ 346, 504, 673, p 300). The European
Commission Directorate General for Health and Consumers (DG SANCO)
told us that "as there are currently no validated …
methods to detect nanomaterials in food, the possibility for Member
States to control imported foods … is limited" (p 300).
Although it is unlikely that food containing nanomaterials is
being imported into the United Kingdom, the possibility cannot
be ruled out (QQ 505-506, 675). DG SANCO told us that, on
different occasions, Finnish border control officers stopped "a
product that contained vitamin C in nanoform and a product that
contained nanosilver, both on the basis of non-compliance with
the Novel Foods legislation" (p 300). Given this, we
welcome the participation of the Food Standards Agency in a European
Union project which will investigate methods for detecting and
measuring nanomaterials in the food (Q 672). Ensuring
that this research results in practical tests that can be used
by enforcement agents will be an important step in securing the
safety of food imports.
6.16. Which?
expressed some doubt about whether enforcement authorities regarded
nanomaterials as a particular priority at the moment (Q 291).
Ms Merron agreed, although she added: "that is the result
of being at a very early stage. I can assure the Committee that
we will have in process the necessary alerts to those said authorities"
(Q 676). We welcome this assurance.
6.17. We recommend that the Government should
ensure that research into methods of measuring nanomaterials in
food results in the development of practical tests for enforcement
authorities to use on imported food, and develop a plan to inform
and educate enforcement authorities once such tests have been
developed.
Guidance for companies
6.18. A number of witnesses, including Dr Knowles
and the NIA, called for the Government to provide guidance to
industry on the legislative meaning of the term "nanomaterials"
and on the tests required by EFSA for the safety assessment of
nanomaterials (Q 170). Campden BRI, an independent membership-based
organisation carrying out research and development for the food
and drinks industry, told us: "questions from industry indicate
a difficulty in understanding the meaning of the term 'nanotechnologies'…
there is confusion over whether … [certain] products are
to be considered as 'nano-products'" (p 292). Dr Friedrichs
thought that small companies were in particular need of guidance
(Q 488) and said that uncertainty about the current (and
future) regulatory burden creates a fear that they will be faced
with "the introduction of a demanding and costly approval
process [which] will render their … core technologies non-viable"
(p 242). Dr John Wand, Head of the EPSRC's Nanotechnology
Programme, also felt that uncertainty over how regulation will
operate may cause companies to be "cautious" when they
consider "investing potentially large sums of money"
in developing new products (Q 429).
6.19. Dr Knowles stressed that industry
and the academic community should contribute to the development
of guidance: "It is nothing that the Government in itself
can do alone. It needs to work with all of the stakeholders to
provide that guidance. All of the regulators and academics need
to work together with the Government to provide that information
to allow suppliers and manufacturers of nanomaterials to carry
out the appropriate safety testing" (Q 211). We agree.
The FSA argued that it was "the responsibility of food businesses
to ensure that the products they market are safe, and this includes
considering the effect of changes to manufacturing processes and
reformulation of existing ingredients, even where such changes
do not trigger a formal regulatory review" (p 42). While
this responsibility lies with industry, the FSA should make every
effort to assist industry in ensuring that they have as much information
as possible to help them fulfil this responsibility.
6.20. In view of these calls for guidance, we
were pleased to be told by the Minister, Ms Merron, that the European
Commission would be providing more formal guidance to companies
on the application of current food laws to nanotechnologies and
that if revisions to food legislation included a special category
in respect of nanomaterials, then the FSA would publishing that
in its formal guidance (Q 671). The EFSA has set up a working
group on nanotechnologies, which will be looking specifically
at the guidance to provide to companies (Q 525). This guidance
will cover not only situations where engineered nanomaterials
have been added to products by manufacturers, but also those where
nanomaterials result from the production process (p 298).
6.21. We recommend that the Government work
with the European Food Safety Authority as it develops guidance
on the implementation of the Novel Foods Regulation and other
relevant legislation. We urge the Government to state what steps
they will take to ensure that industry and academia are involved
in the development of this guidance.
International harmonisation
6.22. The food industry is a global market, and
many new products containing nanomaterials will be developed outside
the United Kingdom. Dr Falkner reminded us that "we
approach many of these issues from a national or European perspective,
but any regulatory system that we end up with for nanotech food
will have an impact on the global food trade" (Q 343).
Some witnesses argued in favour of trying to harmonise regulations
governing these technologies with other nations to ensure a consistent
approach to risk assessment and reporting. Which?, for
example, said "it is essential that there is international
co-operation on this issue"—although it warned that
the process might be slow: "experience from the development
of standards for other emerging technologies has been that these
bodies can take many years to reach agreement" (p 137)
6.23. The relevant body for converging international
regulation is the Codex Alimentarius, an intergovernmental agency
created by the Food and Agriculture Organisation (FAO) and the
World Health Organisation (WHO) to help develop and promote the
coordination of food standards and guidelines. Ms Merron said
that any efforts at the international harmonisation of food safety
legislation would be through this body. The Codex Alimentarius
held an expert consultation on the food safety implications of
nanomaterial use in agriculture and food sectors in June 2009,
and is due to report in the near future (Q 651).
6.24. Other witnesses stressed the need for informed
discussion and knowledge transfer between nations, rather than
looking for international harmonisation of regulations. Mr Roberts,
for example, told us that, "it would be wrong to say there
is scope for international global regulation of nanotechnology
in the immediate term. We are trying to raise awareness of the
issues in countries, not only those producing nanotechnologies
but those which may also import products containing nanotechnologies
and therefore have to deal with waste streams that may require
specialist handling; at least raise awareness, spread the science
and begin to get cooperative action going" (Q 73). The
recent report by Chatham House on transatlantic regulatory cooperation
(see paragraph 4.55) supported this view, stating that there is
"little if any interest in pursuing the more ambitious objective
of creating an international treaty on nanomaterials regulation".[81]
Ms Merron told us that "there have not been [any] moves really
at an international level to harmonise regulations for nanotechnologies
and nanomaterials"; at present efforts were instead focused
on securing a better common understanding of nanomaterials before
moving on to look at possible areas of harmonisation (Q 651).
6.25. Dr Falkner felt that at this early
stage the emphasis should be on preventing regulatory approaches
diverging, rather than trying to develop an international set
of regulations:
"If existing national regulations in the US
and in Europe—but also think of the emerging economies (Brazil,
China)—go in different directions, there will be a need
for harmonisation. We are not at that point yet. I think much
more needs to be done there to, in a sense, prevent regulatory
divergence" (Q 345).
6.26. The OECD plays an important role in coordinating
the characterisation and risk assessment of nanomaterials (see
Chapter 4). Dr Falkner described the OECD as "a bit
of a gentlemen's club for intergovernmental co-operation. It works
well, in the sense that it creates space for regulators to talk
to each other and to learn from each other, but it certainly will
not be the main platform for developing internationally harmonised
regulations" (Q 345). Friends of the Earth Australia
pointed out that many countries are not represented at the OECD,
in particular developing nations (Q 304).
6.27. International bodies are beginning to address
common policy issues arising from the commercialisation of nanotechnologies.
The United Nations Environmental Programme (UNEP) and the WHO
may yet play an important role in their respective areas of responsibility,
but the Chatham House report noted that "they are only just
beginning to identify the EHS [environmental, health and safety]
risks of nanomaterials as emerging areas of concern".[82]
Which? mentioned the Transatlantic Economic Council (TEC),
established in 2007 to strengthen transatlantic economic integration.
The framework for the TEC, setting out a multi-year programme
of cooperation, includes a commitment to "exchange views
on policy options for emerging technologies ... in particular
in the field of nanotechnology"[83].
The framework applies to the United States and European Union
only.
6.28. We agree that it is too early for serious
attempts to be made to harmonise legislation across the international
community in this area, and that at present the Government should
focus their efforts on coordinating with the international community
on areas of common concern such as risk assessment and standards.
6.29. We recommend that the Government continue
to push for continued international dialogue and information exchange
on appropriate approaches to regulating the applications of nanotechnologies
in the food sector, and seek to ensure that all relevant international
organisations are aware of the emerging implications of the development
of nanotechnologies.
A register of applications of
nanotechnologies in the food sector
6.30. A number of witnesses raised the question
of the establishment of a register or database of food products
containing nanomaterials, and the FSA told us they were considering
various options for developing a UK-based register of nano-derived
foods and food contact materials (p 2).
6.31. Which?
and Lloyd's informed us that such a register could be used as
an information tool to help clarify the state of the market (QQ 298,
445). Ms Davies thought that it would be "essential because
at the moment … it is very difficult to get a sense of exactly
what is happening in this area" (Q 298). Dr Wadge
agreed that "in terms of really understanding what is happening
in the market, a register clearly could be very useful" (Q 37).
Mr Simon Burall, Director of Involve, felt "the last
thing you want is rumours about nanotechnology in this or that
food" so a register would be "a sensible idea"
(Q 378). Professor Pidgeon, considered that a register
would be "a good thing to have" (Q 376). Ms Davies,
Ms Miller and Professor Howard, agreed (QQ 300, 301,
302). Dr Kellie also thought that a register was an important
way of building public confidence in the technology (Q 182).
6.32. Industry appeared to be less enthusiastic.
Dr Knowles said a register would be "premature"
given that most products were still at the development stage.
He also questioned whether a register would have any value. Products
had to go through a safety evaluation by the EFSA before being
allowed on to the market and, at that point, the information would
be in the public domain in any event (Q 183). Mr Opie
took the same view: "if all the products have been through
the regulatory framework, the products are safe for the market.
… Why would we then need a subsequent register on top of
that?"(Q 184) Mr Opie also feared that a register
might become a "blacklist" for consumers (Q 185).
Ms Davies disagreed: "we do not think that would be the case.
The danger is more in not being open about what is happening in
relation to nanotechnologies" (Q 300). Ms Miller went
further, suggesting that, even if a register were to become a
"blacklist", that was no reason not to have one given
that people had a right to choose not to buy food containing nanotechnologies
(Q 302). Professor Morris agreed (Q 93).
6.33. Some witnesses proposed that a register
could hold a greater range of information—such as covering
details of nanomaterials used through the food chain rather than
simply the final products. Dr Falkner thought that "we
need to move in the direction of greater transparency in global
food chains", not only in terms of products on the market
but also in terms of food ingredients and materials (Q 332),
a point echoed by Mr Maynard who thought a register "should
include the companies involved in the full supply chain, including
those outside the UK or EU" (Q 445). Ms Davies also
supported a register which did more than set out a simple list
of marketed products: "we think the regulators … need
to be much more proactive in actually going out and seeking the
information … including talking to the chemical companies
who are producing food additives or food pesticides and understanding
exactly how much they are producing and who they are supplying"
(Q 298).
6.34. Industry representatives were not convinced
of the need for regulators to monitor the food chain. They were
clear that if their suppliers used nanomaterials, they would be
informed (QQ 189,190). Although they conceded that "no
system is 100 per cent perfect", they argued that nanotechnologies
were still novel and that the chance of them being used in the
supply chain without food companies being aware of it was "remote"
(Q 193). Dr Friedrichs said that, since nanomaterials
were expensive to produce, it was unlikely that they would be
used in the food chain without companies "wanting to cash
in on the benefits claimed" (Q 506).
6.35. The European Commission has announced that
work would begin in 2009 on a European Union inventory of nanomaterials
(p 2). According to the FSA, however, "they have taken
no action to date and officials understand from their Commission
contacts that nothing is currently planned, at least in the food
area" (p 291). Ms Merron said:
"our view is that it would be useful to have
an inventory. We need to clarify what is or is not on the market
and so if it is not going to happen at an EU level then we want
to do it at a UK level. The FSA is going to be working on this
in the next few months … but I think it is important that
we do have this before others who have more vested interests do
so, so I am keen that we get on with this area of work" (Q 647).
6.36. Dr Clair Baynton, Head of Novel Foods,
Additives and Supplements at the Food Standards Agency, was not
willing to say what type of register it would be—whether
it would simply provide information to the public about marketed
products or whether it would seek more detailed information from
industry (Q 648). Dr Lawrie thought that designing a
register should wait until the FSA had a "clearer idea of
the range of so-called nanomaterials" (Q 650). Some
witnesses, such as Dr Friedrichs (Q 507) and Mr Opie
(Q 184), argued that developing a register would run into
practical difficulties because of the absence, at present, of
an appropriate definition of nanomaterials. We acknowledge these
concerns, but we consider that compiling a list of marketed products
containing nanomaterials should not prove too difficult given
that these products will have been identified by the EFSA during
the pre-market risk assessment process.
6.37. In Chapter 4 we recommended that the FSA
develop a confidential database of information on nanomaterials
in development in the food sector to assist in the development
of appropriate risk assessment procedures. This would not monitor
the use of nanomaterials throughout the supply chain, but at present
the likelihood of nanomaterials entering the food chain without
the knowledge of the industry is remote. We therefore do not feel
it is necessary for the FSA to monitor the presence of nanomaterials
throughout the food chain. We judge, however, that a register
of publicly available products containing nanomaterials would
be valuable, both to clarify the state of the market and to build
public confidence by ensuring that information is freely available.
This information will be made publicly available through the EFSA
as products go through pre-market approval processes, but in the
interests of transparency and accessibility we believe this information
should be gathered together into a single source for consumers
to access. We recommend therefore that the Food Standards Agency
create and maintain an accessible list of publicly-available food
and food packaging products containing nanomaterials that have
been approved by the European Food Safety Authority.
74 EFSA, Scientific Opinion, op. cit., p 2. Back
75
COT, COM, COC, Joint Statement, op. cit., p 6. Back
76
EFSA, Scientific Opinion, op. cit., p 2. Back
77
COT, COM, COC, Joint Statement, op. cit., p 4. Back
78
RCEP, Novel Materiols, op. cit., p 48. Back
79
Aitken et al., EMERGNANO, op. cit., p 146. Back
80
European Parliament, Report on regulatory aspects of nanomaterials,
(2008/2208(INI), p 10, para 3. Back
81
Falkner R et al., Securing the Promise of Nanotechnologies,
op. cit., p xiii. Back
82
Ibid., Falkner et al., Securing the Promise of Nanotechnologies,
p xiii. Back
83
See http://trade.ec.europa.eu/doclib/docs/2007/may/tradoc_134654.pdf Back
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