CHAPTER 5: Regulatory Coverage
5.1. According to Dr Falkner, "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
covering of nanotechnology risks" (p 176). In this chapter
we consider whether the existing law is adequate to the task of
regulating current and future applications of nanotechnologies
in food in principle. In Chapter 6 we consider whether it can
be effectively applied in practice.
Current regulation
5.2. The food industry in the United Kingdom
is regulated by a range of legislation intended to ensure that
food products on the market have been appropriately evaluated
as to their potential risk to human health. Regulation is largely
decided at a European level.[59]
5.3. All food products have to meet a general
safety requirement under the General Principles of Food Law Regulation
(EC/178/2002). More specific legislation covers the use of novel
foods, food additives and food contact materials (see Box 1).
Nanomaterials used in the food sector may also be covered by REACH—European
Community legislation concerned with chemicals and their safe
use and dealing with the Registration, Evaluation, Authorisation
and restriction of CHemical substances.
5.4. The use of pesticides is regulated by the
United Kingdom Plant Protection Products Regulation 1995 (as amended)
which implements a two-tier European system: first, any active
ingredients used in pesticides have to be agreed at a European
level; and, secondly, having gained European approval, individual
products are then approved for use in the United Kingdom by the
Pesticide Safety Directorate. Fertilisers are covered principally
by the EC Fertiliser Regulation 2002/2003 (which specifies the
composition and definition of all fertilisers which may be freely
sold with the European Union) and the United Kingdom Fertilisers
Regulations 1991 (which allow fertilisers which are not covered
by the EC Regulation to be sold within the United Kingdom so long
as they comply with domestic legislation).
BOX 1
Food sector legislation
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NOVEL FOODS REGULATION
Regulation EC/258/97 applies to novel food and food
ingredients. Novel foods are defined as foods and food ingredients
that have not been used for human consumption to a significant
degree in the European Community before 15 May 1997 and the Regulation
subjects all novel foods and foods manufactured using novel processes
to a mandatory pre-market approval system (p 5). In January
2008, the European Commission published a proposal to revise and
update the Novel Foods Regulation. Various proposals have been
discussed by the Commission, Parliament and Council. (The draft
Regulation is currently going through the co-decision procedure.
A definition of nanomaterials has been introduced at the request
of the European Parliament, and supported by the Council (see
paragraph 5.20 below).) Discussions are continuing on how to bring
nanotechnologies specifically into the revised Regulation.
FOOD ADDITIVES
Food additives are regulated under Directive 89/107/EC
and associated legislation. The Directive is based on the principle
that only additives which are explicitly authorised may be used
in food. In the United Kingdom, legislation passed under the Directive
includes: the Sweeteners in Food Regulations 1995 (as amended);
the Miscellaneous Food Additives Regulations 1995 (as amended)
and the Smoke Flavourings (England) Regulations 2005.
In December 2008, a new Regulation was passed (Regulation
EC/1333/2008) which set out a common authorisation procedure for
additives, enzymes and flavourings. From early 2010, a list of
approved additives, including vitamins and minerals, will come
into force. Inclusion of additives on the list will be decided
by the Commission on the basis of an Opinion from the European
Food Safety Authority (EFSA). Those included will often have limits
set on their use, for example restrictions on the quantities permitted
for use. The new regulations also specify that where the starting
material used, or the process by which an additive is produced,
is significantly different (for example, through a change in particle
size), it must go through a fresh authorisation process, including
a new safety evaluation.[60]
FOOD CONTACT MATERIALS
Regulation EC/1935/2004 covers all materials which
are intended to come into contact with foodstuffs, either directly
or indirectly. The Commission or Member States may request the
EFSA to conduct a safety evaluation of any substance or compound
used in the manufacture of a food contact material. Certain materials,
including plastic, are subject to additional measures. The Commission
has proposed updating the Regulation governing food contact plastics
to specify that a deliberately altered particle size should not
be used, even behind a migration barrier, without specific authorisation.
FOOD SUPPLEMENTS
Food supplements are regulated under Directive 2002/46/EC
which states that only vitamins and minerals on an approved list
may be used as food supplements. New substances may be considered
for inclusion on the list, but only after a safety assessment
by EFSA.
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Adequacy of current legislation
5.5. In August 2008, the FSA published a report
entitled A review of potential implications of nanotechnologies
for regulations and risk assessment in relation to food. It
considered, among other things, the suitability of current regulations
relating to the use of nanotechnologies in the food sector. The
report did not identify "any major gaps in regulations",
although it noted that there was uncertainly in some areas as
to whether applications of nanotechnologies would be picked up
consistently. It concluded that "on the basis of current
information, most potential uses of nanotechnologies that could
affect the food area would come under some form of approval process
before being permitted for use".[61]
Dr Falkner generally agreed with this conclusion: "we
do have a range of laws and regulations in place … that we
can use to cover emerging risks from nanomaterials". But
he added: "there are some questions about regulatory coverage
in certain grey areas" (Q 317). Other witnesses (pp 294-297,
309-315, Q 291) shared Dr Falkner's view.
5.6. The areas of uncertainty relate to the following:
- Definitions of nanotechnologies
and nanomaterials;
- Variations in particle size of
nanoscale materials;
- Next generation nanotechnologies
and nanomaterials; and
- The role of REACH.
5.7. The evidence we received focused mainly
on the suitability or otherwise of food legislation, in particular
the Novel Foods Regulation. We received less evidence on other
areas such as food contact materials, pesticides or fertilisers.
For this reason, our comments focus on food legislation—although
the issues we raise about variations in particle size (paragraph
5.33) and next generation nanotechnologies (paragraph 5.34) may
well have relevance to the regulation of nanomaterials in these
areas as well. In addition, our observations about a regulatory
definition of nanomaterials, while made in the context of the
Novel Foods Regulation, would also apply to any definition that
may be may be considered for food additives or food packaging
legislation (p 298).
5.8. While some witnesses (p 77, Q 40)
considered that general legislation, such as the General Principles
of Food Law Regulation, provided a "safety net" for
consumers, others disagreed. Dr Falkner argued that the "uncertainty
that exists with regard to definition, methodologies, exposure
and hazard types is preventing that general safety provision from
working properly" (Q 331). The Economic and Social Research
Council Centre for Business Relationships, Accountability, Sustainability
and Society (BRASS), agreed (pp 296-297). Scientific uncertainty
about the potential health effects of nanomaterials prevents industry
from being able to say for certain which are safe and which are
not (see Chapter 6). While the general legislation prevents companies
from knowingly placing unsafe food on the market, it offers no
protection in situations where companies are not aware that their
product may be unsafe. (For example, supplements containing nanosilver
are likely to be withdrawn from sale in the European Union after
several years on the market since EFSA was unable to assess their
safety (QQ 27-28)). In the absence of effective protection
by such "safety net" legislation, the burden lies on
more specific legislation, such as the Novel Foods Regulation,
to protect consumers effectively.
Definitions of nanotechnologies
and nanomaterials
DOES LEGISLATION NEED TO DEFINE NANOTECHNOLOGIES
AND NANOMATERIALS?
5.9. While existing law may, by and large, cover
the use of nanotechnologies and nanomaterials in principle, there
is no single piece of legislation that specifically defines and
regulates nanotechnologies across all sectors, either in the United
Kingdom or the European Union (p 295). As a result, nanotechnologies
are currently regulated under sector-specific legislation (those
relevant to the food sector are listed in Box 1). These regulations
are meant to ensure that food containing substances which may
present a risk to human health are fully risk-assessed by regulatory
authorities before they are permitted on to the market. Witnesses
were concerned that, unless a definition of nanomaterials was
included in legislation, there might be circumstances where nanomaterials
that should be risk-assessed were not recognised as such by companies
or regulatory authorities (Q 549, pp 294-297, 313).
5.10. The FSA, whilst supporting the inclusion
of a definition in food regulations (Q 32), took the view
that, even without a definition, new applications of nanotechnologies
would fall within the Novel Foods Regulation:
"we do not rely on [a definition] … in
order to say that new nanomaterials fall within the scope of the
novel foods regulation and therefore need to go through the whole
requirements of pre-market application, evaluation and …
formal authorisation … The inclusion of a new definition
in the novel foods regulation provides welcome clarity in saying
yes, clearly these materials fall within scope, but I would argue
that even if you do not have a definition in that legislation
you are still covering virtually all the cases you can imagine"
(Q 610).
5.11. Dr Lawrie pointed out that current
regulations trigger pre-market approval and testing based on novelty
and changes in the properties of a material. New nanoscale materials
would be viewed as "novel ingredients", while familiar
materials which had been engineered to the nanoscale would be
covered under existing regulations as an example of novel processes
causing a change in the properties of an ingredient. Each case,
therefore, would be assessed as novel foods by regulatory agencies
(Q 611). Mr Roberts also felt that, if products contained
nanotechnologies, then there would have to be "an assessment
of the nanotechnology component ... you do not have to define
nanotechnology is legislative terms to achieve that" (Q 33).
5.12. A similar view is taken by the FDA in the
United States. The FDA does not intend to apply a standard definition
of nanotechnologies or nanomaterials because, in their view, the
science base is insufficiently complete to provide for a definition
of nanotechnologies suitable for the purposes of regulation. Instead
they intend to risk-assess nanoscale materials used in the food
sector on a case-by-case basis. It appears however that food can
bypass the regulatory process in the United States if the manufacturers
decide it can be deemed Generally Regarded As Safe (GRAS) (that
is, substantially equivalent to an existing, approved food). Given
the limitations of current scientific understanding of nanomaterials,
this might result in a nanoscale version of an existing food being
viewed as safe by the manufacture, thereby bypassing the risk
assessment process. The FDA told us that, in situations where
manufacturers were uncertain as to whether the GRAS rule applied,
they generally asked for an official view before applying the
rule. The FDA were confident that this process of dialogue, combined
with the power to declare food unlawful if they felt GRAS had
been misapplied, would provide consumers with sufficient protection
and regulatory coverage (see Appendix 6).
5.13. Other witnesses, however, saw a definition
as essential to ensure that the Novel Foods Regulation was applied
to all food products containing nanomaterials. Dr Peter Hatto,
Chair of the UK, European and International Standardisation Committees
for Nanotechnologies within the ISO, told us bluntly that if "you
cannot define it you certainly cannot regulate it" (Q 447),
while Professor Richard Owen, Professor of Risk Assessment
at the University of Westminster, said: "if you want to ensure
that your nanomaterial does not fall through a regulatory gap
… you have to be able to identify it as a substance to be
risk assessed in a nano form" (Q 459). Other witnesses
also supported the introduction of a definition (QQ 160,
481, p 80). In the United Kingdom, although it appears that
most uses of nanotechnologies in the food sector are likely to
be covered by existing legislation, there are gaps where a definition
could clarify whether the Novel Foods Regulation applies. We were
surprised to note that, unlike the Food Additives Regulation,
foods and ingredients regulated under the Novel Foods Regulation
which are already approved for use within the European Union may
not necessarily be re-evaluated if they are reformulated at the
nano-scale because, in the absence of a legal definition of nanotechnologies
or nanomaterials, it is left to industry and the regulators to
decide whether new, nano-scale formulations should be subject
to a renewed pre-market approval.
5.14. Under the Regulation pre-market approval
is required unless the novel foods are deemed by a national food
assessment body to be substantially equivalent to comparable traditional
foods (p 295). Substantial equivalence is determined by a
range of factors (such as the composition and structure of foods
and the nutritional value, metabolism and level of undesirable
substances),[62] but
there is no explicit reference to particle size or to nanomaterials.
This creates the possibility that a national food assessment body
may deem a food containing a nanomaterial (for example a nano-sized
version of a traditional ingredient) as substantially equivalent
to the larger form, even though it may, in fact, demonstrate novel
properties (p 295).
5.15. In 2007 the FSA published a report on the
implications of the use of nanomaterials as food additives or
food ingredients on consumer safety and regulation which described
this risk as follows:
"If a company responsible for placing a nanofood
product on the market did not recognise it to be novel (e.g. because
the ingredients already have a history of use at the macro-scale),
and/or did not consider the properties of the nanofood to be substantially
different from its macro-scale counterpart (e.g. because of a
lack of information … or the lack of a precise definition
of the term "substantially altered") then it is possible
that a safety evaluation under EC/258/97 [the novel foods regulation]
will not be carried out".[63]
5.16. A similar issue arises with food supplements.
From 2010, vitamins and minerals used as food supplements in the
EU will have to come from an approved list. However, individual
formulations of those substances are not regulated—so a
nano-formulation could alter the way those substances are absorbed
or interact with the body and it would be up to the industry to
decide whether or not the substance's properties had changed enough
for the Government to have to give further approval to it as a
novel product (Q 620). Dr Lawrie told us that in the
case of vitamins and minerals, "we do not regulate [the]
individual formulations of those substances and ... by making
a nano-formulation you could certainly alter the bioavailability
or the fate of the substance within the gut" (Q 620).
5.17. The IFST also made this point:
"the legislation is potentially deficient in
apparently failing to distinguish ENMs [engineered nanomaterials]
of food-approved materials and permitting their use, based on
safety guidelines and evaluations produced for macroparticles
… [The] replacement of already-permitted macroscopic materials
with ENMs of the same chemical composition … appears to have
been considered as a simple formulation change" (p 313).
5.18. Ms Merron recognised that the difficulties
caused by the absence of a legal definition impacted on industry
as well as consumers: "if we are asking food operators to
comply then we have to give them something to comply with that
they understand and where they do not find themselves accidentally
falling foul of compliance" (Q 609). We agree. We heard
an example of this while in the United States, albeit in the agricultural
sector. The EPA told us that they had approved a pesticide inadvertently,
without realising that it contained nanoscale materials. The manufacturer
had not informed them of this since the substance was simply a
nano-sized version of an existing, conventional pesticide ingredient.
5.19. Given the uncertainty about the potential
risks of nanomaterials, it is essential that any nanomaterial
used in a food product (with the exceptions set out in paragraph
5.32) should to be subject to a formal risk assessment process
through the European Food Safety Authority. We recommend, therefore,
that the Government should work within the European Union to promote
the amendment of current legislation to ensure that all nanomaterials
used in food products, additives or supplements fall within the
scope of current legislation. We recommend in particular that
the legislation should, for the avoidance of uncertainty, include
workable definitions of nanomaterials and related concepts.
DEFINING NANOMATERIALS FOR REGULATORY PURPOSES
5.20. The evidence we received included a number
of different definitions of 'nanomaterials' (for example, QQ 149,
160, 219, 481). Although existing legislation does not provide
a definition, a draft of the Novel Foods Regulation (which is
currently being revised, see Box 1) going through the co-decision
procedure and agreed by the Council of the European Union on 22
June 2009, proposed that "engineered nanomaterials"
be defined as:
"any intentionally produced material that has
one or more dimensions of the order of 100 nm or less or is composed
of discrete functional parts, either internally or at the surface,
many of which have one or more dimensions of the order of 100
nm or less, including structures, agglomerates or aggregates,
which may have a size above the order of 100 nm but retain properties
that are characteristic to the nanoscale. Properties that are
characteristic to the nanoscale include: (i) those related to
the large specific surface area of the materials considered; and/or
(ii) specific physico-chemical properties that are different from
those of the non-nanoform of the same material".
5.21. In formulating a definition, witnesses
suggested that two key issues needed to be addressed: the relationship
between size and functionality; and, whether 'natural' nanomaterials
should be included. Although our comments in this section refer
to a definition in European legislation, they are also relevant
to definitions at an international level (see paragraph 4.56).
FUNCTIONALITY AND SIZE
5.22. The definition of 'nanomaterials' proposed
for the Novel Foods Regulation focuses on the quantitative measure
of 100 nm. But, as we have already noted (see Chapter 2), the
defining feature of the point at which a material can be said
to be a "nanomaterial" is not strictly quantitative
- it is the point at which a material demonstrates novel properties
as a result of its small (nanoscale) size. According to the RCEP,
in its report Novel Materials: "it is not the particle
size or mode of production of a material that should concern us,
but its functionality".[64]
Professor Jones told us that the important factor was to
consider whether materials were exhibiting "new properties
by virtue of their size" (Q 484); and Dr Wadge
told us: "from our perspective it is not so much the exact
precise cut-off point in terms of size, it is far more around
the properties which will have a bearing on the risk assessment"
(Q 32). Since a definition in food legislation is used to
ensure that relevant nanoscale materials undergo pre-market risk
assessment, the meaning of functionality in this context is how
a nanomaterial interacts with the body, which is the crucial factor
in determining its potential risk.
5.23. Although nanoscale properties (and as a
consequence novel functionality) typically emerge at sizes below
100nm[65] (Q 487),
100nm as such has no toxicological significance—particles
larger than this may exhibit novel properties and should therefore
be considered nanomaterials for the purposes of risk assessment
(QQ 219, 276, 484). Including in a definition phrases such
as "of the order of 100nm" does not appear to assist.
In Ms Merron's view, using an approximate value of 100nm would
create "blurring" for regulators and industry (Q 609).
5.24. This strongly suggests that any definition
of "nanomaterial" should not be limited to an arbitrary
dimension of 100nm, but instead focus on any changes in properties
that emerge as a result of a material being at the nanoscale (smaller
than 1000nm). We recommend that the Government should work
towards ensuring that any regulatory definition of nanomaterials
proposed at a European level, in particular in the Novel Foods
Regulation, should not include a size limit of 100nm but instead
refer to 'the nanoscale' to ensure that all materials with a dimension
under 1000nm are considered. A change in functionality, meaning
how a substance interacts with the body, should be the factor
that distinguishes a nanomaterial from its larger form within
the nanoscale.
5.25. The proposed Novel Food Regulation definition
also includes materials over 100nm if they "retain properties
characteristic of the nanoscale". Ms Merron expressed some
concern about this provision on the ground that the state of the
science is such that "we do not know enough to say what is
characteristic" (Q 609). We recognise this difficulty.
However, given how little is known about how nanomaterials interact
with the body (see Chapter 4), we take the view that the definition
should cover any material that reveals a change in any property
that might affect how it behaves in the body as a result of being
nanoscale. In Chapter 4 (paragraph 4.2) we referred to a range
of physical and chemical properties which SCENIHR describe as
"the main parameters of interest with respect to nanoparticle
safety".[66] We
suggest that these properties should form a basis for a list of
properties that may change at the nanoscale, and affect the risk
a material may present. A change in any of these properties in
a material at the nanoscale should result in it being treated
as 'nano' for the purposes of risk assessment. As the scientific
community's understanding of nanomaterials increases, this list
may need modification to ensure it reflects the full range of
properties which should be considered by regulators when determining
whether or not a material should be considered as 'nano' by virtue
of a change in property at the nanoscale.
5.26. We recommend that Government should
work within the European Union to clarify the phrase "properties
that are characteristic to the nanoscale" through the inclusion
in the Regulation of a more detailed list of what these properties
might comprise. This list should be regularly reviewed, as the
understanding of nanomaterials develops, to ensure that it provides
comprehensive and up-to-date coverage of relevant properties.
'NATURAL' NANOMATERIALS
5.27. Professor Jones described one difficulty
encountered when defining nanomaterials in the food sector: "the
issue is that food is naturally nano-structured, so that too wide
a definition ends up encompassing much of modern food science,
and indeed, if you stretch it further, some aspects of traditional
food processing" (p 245). The IFST identified three
types of nanoscale materials present in food: naturally occurring
nanoscale substances (such as nanoscale protein, fat, or sugar
molecules or micelles); a proportion of nanosize materials in
the distribution of particle sizes derived from conventional processing
techniques; and substances deliberately engineered to confer novel
properties as a result of their nanoscale size. The IFST told
us that attempting to regulate the first two types of nanoscale
materials present in food would be difficult: "we consider
it is impossible to regulate/legislate for naturally-occurring
nanomaterials … and very difficult to legislate where the
nanoscale material is adventitious; we question how such presence
would be defined/identified/quantified or legal constraints be
enforced?" (p 312)
5.28. In addition to these three types of nanoscale
material, we identified a fourth source of nanoscale substances
present in food. Nanoscience allows food companies to improve
their understanding of the structure of food, and therefore to
use conventional processing techniques better to control the formation
of foods at the nanoscale, creating nanoscale structures deliberately
and not just as part of a distribution curve of particle sizes.
Professor Jones told us that while this might be considered
to be nanotechnology, it could be argued that, since traditional
processing methods are being used, "what makes this nanotechnology
... is simply knowledge" (pp 245-246). He gave the example
of ricotta cheese production (which we mention in Chapter 1).
If a company uses a new technique to produce ricotta cheese, it
could be argued that, given that the cheese contains nanomaterials
created during a manufacturing process, it should be assessed
under the Novel Foods Regulation.
5.29. Some witnesses suggested that nanoscale
materials created from existing food substances should be treated
differently in legislation. LFI argued that there needed to be
"a clear distinction" between "nanoparticles naturally
and currently present in foods (this will include ones made during
manufacture)" and those "not normally expected such
as persistent materials" (p 52), adding that naturally-occurring
modified materials modified at the nanoscale were unlikely to
require further safety or toxicological testing. Professor Morris
agreed (QQ 142, 153). The BRC also drew attention to the
issue of "whether manipulating existing ingredients such
as salt at a nano level is something that would be counted as
new technology or simply the better application of a known product"
(p 80).
5.30. However, while nanomaterials created from
'natural' food substances are less likely to pose a threat to
human health, Dr Powell told us the possibility cannot be
ruled out (Q 276). The Research Councils shared this view:
"for manufactured nanomaterials, even when derived from naturally-occurring
nanomaterials, appropriate assessments of risk and safety should
be made" (p 205). PEN agreed; in its opinion, the question
of whether a material was natural or engineered had "no direct
bearing on its safety", and the focus should instead be whether
the nanomaterials, whether natural or not, demonstrated properties
that may raise health and safety concerns. Ms Miller (Q 290)
and Professor Jones (Q 479) both argued that scientific
understanding of nanomaterials is not yet sufficiently developed
that the possibility of some risk from nanomaterials formed from
'natural' food substances, created by conventional food processing
techniques, can be excluded.
5.31. We acknowledge that nanomaterials created
from naturally-occurring materials may pose a potential risk to
human health. However, we also recognise also that it is impractical
to include all natural nanomaterials present in food under the
Novel Foods Regulation, and that many natural nanoscale substances
have been consumed for many years with no ill affects reported
(pp 52, 335). The question is therefore which nanoscale materials
created from natural food substances present sufficient risk to
mean that they should be treated as engineered nanomaterials and
go through a risk assessment before they are allowed on to the
market. The EFSA made the following distinction in its Opinion
on the risks arising from nanoscience and nanotechnologies: "'Natural'
nanoscale materials (e.g. micelles) will be considered if they
have been deliberately used e.g. to encapsulate bioactive compounds
or further engineered to retain their nanoscale properties"
while "'natural nanoscale components present as emulsions
(e.g. in homogenised milk, mayonnaise) will not".[67]
The FDF said that it: "draws a clear distinction between
naturally occurring nanoparticles and the presence of nanoparticles
in food from certain conventional processes, and nanoparticles
or nanomaterials that that have been deliberately engineered to
confer different properties" (p 77).
5.32. We consider that this is a sensible distinction
to make. If regulations are to be workable it is necessary to
distinguish nanomaterials that occur naturally in food, or that
are created during a conventional manufacturing process, from
those that are deliberately selected or engineered to take advantage
of properties appearing at the nanoscale. We recommend that,
for regulatory purposes, any definition of 'nanomaterials' should
exclude those created from natural food substances, except for
nanomaterials that have been deliberately chosen or engineered
to take advantage of their nanoscale properties. The fact that
they have been chosen for their novel properties indicates that
they may pose novel risks.
Distribution of particle size
5.33. A second issue concerning the adequacy
of current legislation is the variation of particle sizes within
a material. We heard from Dr Peter Hatto, Chair of the UK,
European and International Standardisation Committees for Nanotechnologies
within the International Organization for Standardization, that
nanoparticles cannot, at present, be manufactured uniformly (Q 464)
and that there will be a distribution of particle sizes around
the intended mean. The FDA raised the same issue (see Appendix
6), as did Dr Knowles (Q 180). This could lead to cases
where the mean size of particles may not be considered 'nano',
but where a proportion of particles towards the lower end of the
size distribution may be small enough to start exhibiting novel
properties. As stated above (paragraphs 5.27-5.32), we do not
intend for this to apply to a small proportion of nano-sized structures
created in natural food substances by traditional manufacturing
techniques; but we consider that this may justify a safety assessment
where significant proportion of a distribution of inorganic or
persistent materials are within the nanoscale. We recommend
that the Government should ensure that implementation guidelines
for legislation state clearly what proportion of a bulk material
has to be at the nanoscale for regulatory oversight to be triggered.
Next generation nanomaterials
5.34. Even if the current regulatory regime is
capable of addressing the current applications of nanotechnologies
and nanomaterials in the food sector, some witnesses questioned
whether this would remain the case as the science and applications
of nanotechnologies and nanomaterials developed. The BRASS centre,
for example, anticipated that "gaps in current legislation
will only grow to be more pronounced … current regulation
will, in our opinion, need to be amended to account for more sophisticated
nano-based products and processes" (p 296). Dr Falkner
also felt that it was not possible to "establish with any
degree of certainty that current regulations will be able adequately
to control the next generation of nanotechnologies", and
that advances in biotechnology and information technology would
create new challenges requiring "more fundamental changes"
to existing regulatory frameworks (p 178). The Research Councils
commented on the need for regulations to be regularly reviewed
to ensure that they remain "fit-for-purpose as new technologies
and materials are developed" (p 205). Given the pace
at which novel technologies develop we recommend that, in addition
to its on-going monitoring of the state of the science, the Food
Standards Agency should formally review the suitability of legislation
every three years to ensure that regulatory oversight and risk
assessment keeps pace with the development of these technologies.
REACH
5.35. REACH—European Community legislation
concerned with chemicals and their safe use—plays a role,
albeit limited, in regulating nanomaterials. Although materials
used solely in food production are excluded (Q 653), nanomaterials
used as chemicals in other sectors will fall with the scope of
REACH, as will substances used in food packaging (pp 290-291).
Some witnesses referred to REACH as an important first stage in
risk-assessing nanomaterials. Dr Falkner, for example, said
that most nanomaterials enter the regulatory framework when "they
are produced by chemical companies for use by other industries,
and that is where REACH kicks in … I think any consideration
of the food cycle would need to look at the chemical side as well"
(Q 318).
5.36. Concerns about the effectiveness of REACH
have, however, been expressed (QQ 318, 549). The RCEP report,
Novel Materials, considered the role of REACH and its suitability
for regulating nanomaterials in some depth and concluded that,
in principle, REACH could adequately regulate nanomaterials, although
the report stressed the need for future revisions of REACH to
move the focus of regulation from the size of nanomaterials to
their functionality.[68]
We have reached the same conclusion in relation to defining nanomaterials
for the food sector (see paragraph 5.24 above). Therefore, we
welcome the Government's decision, in response to the Royal Commission
on Environmental Pollution's report, to recognise that functionality,
as well as size, should be the focus of required revisions to
REACH.[69]
5.37. The RCEP report also commented on the one-tonne
threshold provision within REACH (chemicals produced in smaller
quantity than this are not covered by the Regulation). Because
of the very large number of particles present "even in tiny
quantities of a nanomaterial", one tonne may be "too
high a threshold to capture potentially problematic effects".[70]
Lord Drayson said that the Government was aware of the problem
and that they recognised that the one-tonne threshold was "not
… adequate in the case of nanomaterials" (Q 548).
It was, he said, a "loophole which needs to be closed"
(QQ 549, 550). We commend the Government's commitment
to address the issue of the one-tonne threshold for considering
the potential toxic effects of a substance under the REACH Regulations.
We ask the Government to update the Committee on the progress
they have made towards meeting this urgent need.
Self-regulation
5.38. We received evidence about a number of
voluntary self-regulation schemes covering nanotechnologies. They
included: an in-house initiative by BASF, the world's largest
chemical company; a code of conduct for nanoscience and nanotechnology
research by the European Commission; and the UK's Responsible
Nano Code, a joint initiative by the Royal Society, Insight Investment,
and the NIA.[71] These
schemes are intended to provide a "private governance mechanism
to manage potential risks and promote the technology".[72]
5.39. RCUK told us that "voluntary codes
cannot be considered as adequate replacements for effective regulation"
(p 205)—but they may have a role to play in parallel
with legislation, particularly where there are gaps in legislation.
Professor Pidgeon suggested that voluntary codes were "useful
where there is an absence of regulation or where the regulatory
framework has taken time to follow developments in industry and
elsewhere" (Q 359). Ms Hilary Sutcliffe, Director of
the Responsible Nano Forum, also felt that where regulation was
not clear or "fit for purpose", voluntary initiatives
could help "bridge that gap" (p 368). Dr Friedrichs
told us that, alongside regulation, voluntary codes of conduct
could help ensure that companies conformed to the same safety
requirements even when working across different regulatory regimes
(Q 513).
5.40. Ms Sutcliffe also suggested that the Responsible
Nano Code had the potential to be effective in "promoting
the issues of responsible nanotechnology" to a range of organisations
in "all parts of the supply chain" (p 367). Dr
Friedrichs thought that voluntary codes of conduct could help
promote awareness of the issues surrounding nanotechnologies even
within companies, for example by helping raise the profile of
nanotechnology safety issues within management: "the first
principle of [the Responsible Nanocode] is that it needs to be
signed off by a board or by management, it has to be taken into
consideration by all of them and they can all vouch for the fact
that it has helped multinational companies to raise the profile
of what they are doing in nanotechnology safety" (Q 512).
Ms Sutcliffe told us that voluntary codes allowed companies to
demonstrate their "compliance with good practice in a transparent
and easily understood way for the consumer". Providing the
public with information about voluntary initiatives may help "allay
concerns" about inadequate regulatory oversight (pp 367-368).
5.41. Others were less convinced of the effectiveness
of voluntary codes. The IFR suggested that it was difficult to
assess how well they were followed but "a general observation
might be that voluntary self-regulation is often open to abuse"
(p 57). Which? felt that it would be a "backward
step to rely on a voluntary approach to control the issues raised
by manufactured nanomaterials" in this "highly competitive"
area (p 137). Ms Sutcliffe also cautioned that the use of
voluntary codes of conduct could "provide a sort of 'fig
leaf' which is counter-productive to the responsible development
of the sector and the perception of responsibility with critical
stakeholders" (p 368). An examination of transnational
codes by Diana Bowman and Graeme Hodge in a report entitled Counting
on codes: An examination of transnational codes as a regulatory
mechanism for nanotechnologies concluded that "voluntary
nano-codes have weaknesses including a lack of explicit standards
… as well as no sanctions for poor compliance"—but
despite this, under uncertain regulatory regimes they offered
the potential to become the "first cut" of new governance
regimes for nanotechnologies.[73]
5.42. We recommend that the Government, in
collaboration with relevant stakeholders, support the development
of voluntary codes of conduct for nanotechnologies in order to
assist the continuing development of effective legislation for
this rapidly emerging technology. The Government should work to
ensure that voluntary codes are of a high standard, are subject
to effective monitoring processes and are transparent.
59 Food Standards Agency, A review of potential
implications of nanotechnologies for regulations and risk assessment
in relation to food, 2008, p 4, para 16. Back
60
See http://www.europarl.europa.eu/sides/getDoc.do?language=EN&type=IM-PRESS&reference=2008070
7IPR33563 Back
61
Food Standards Agency, A review of potential implications of
nanotechnologies for regulations and risk assessment in relation
to food, 2008, p 8. Back
62
Regulation (EC) No 258/97 concerning novel foods and novel foods
ingredients, Article 1(2)f. Back
63
Chaudhry et al., Assessment of the potential use of nanomaterials,
op. cit., p 20. Back
64
RCEP, Novel Materials, op. cit., p 4, para 1.17. Back
65
RS/RAEng, Nanoscience and nanotechnologies, op. cit., p
5. Back
66
SCENIHR, Risk assessment of the products of nanotechnologies,
op. cit., p 15, para 3.2.1. Back
67
EFSA, Scientific Opinion, op. cit., p 7. Back
68
RCEP, Novel Materials, op. cit., p 64. Back
69
Government response to RCEP report Novel Materials,
op. cit., p 19, para 2. Back
70
RCEP, Novel Materials, op. cit., p 62, para 4.37. Back
71
Bowman DM and Hodge GA, "Counting on codes: An examination
of transnational codes as a regulatory mechanism for nanotechnologies",
Regulation and Governance, 2009, 3, pp 145-164. Back
72
Ibid., Bowman, Counting on codes, p 145. Back
73
Ibid., Bowman, Counting on codes, p 145. Back
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