Examination of Witnesses (Questions 40
- 59)
TUESDAY 31 MARCH 2009
Dr Andrew Wadge, Dr Stephen Axford and Mr John Roberts
Q40 Lord Crickhowell:
You made exactly the point I was going to put to you. Is there
not a real problem here because with the best will in the world
I am sure many of the best companies are doing some very serious
research and very responsible research and we have had an account
of one company doing just that. But one is extremely sceptical
about their willingness to reveal what they are doing, if it is
going to make a difference to them in the competitive market if
they suddenly have a smoother ice cream or dressing using much
less fat or whatever they are seeking to achieve and want to show
that it is of benefit to the customer and not just for themselves,
which is the big lesson learned from the GM disaster. So you have
quite a problem, have you not, in getting real material out of
companies about the research they are doing?
Dr Wadge: There is a genuine tension there is
there not? However, we do have regular dialogue, for example we
talk with beverage manufacturers around possible use of micelles
to put colours in and so forth so there are technical developments
which they are happy to discuss with us but they would not necessarily
want to discuss more widely because of commercial pressures. The
fundamental safeguard here is that these companies know and are
very familiar with the need to make sure that their products fall
within the requirements of general food safety and even wider
than that the general requirements of the public acceptability.
There will be a real caution amongst these companies about learning
the lessons from the GM experience in terms of simply thinking
that because they have some new bit of technical kit, somehow
this will be broadly welcomed by the public at large. They are
very, very cautious on that point.
Q41 Chairman:
In the evidence that DIUS submitted it mentions that in Germany
it appears from the table that there are 17 products on the market
which use nanotechnologies. Presumably de facto those are
also on the market in Britain because Europe operates as a single
market? What kind of approval process have they been through?
Dr Wadge: I am not sure. They would be permitted
under EU law but I am not sure whether they would be on sale in
the UK. I am not sure what 17 products are being referred to there.
I can refer to one specific product, which is the co-enzyme Q10,
where we had quite detailed conversations with our counterparts
in Germany around whether that particular product should fall
within the novel food requirements and they were quite clear that
the micelles which were being used were not changing the nature
of the properties of the coenzyme Q10 so it did not need to go
through that additional safety assessment. In a way that shows
the ability of regulatory bodies such as ourselves to communicate,
as we do regularly with counterparts across Europe, so that where
there are products on sale in one Member State we will talk and
discuss as to why those products are on sale and whether they
should or should not need to go through further assessments.
Q42 Lord O'Neill of Clackmannan:
In the case of the Federal Republic there are two quite substantial
supermarket chains, German owned and German directed. Has nobody
thought of looking at their range of products and sending anybody
to do that? This is quite a sizeable part of the supermarket market
share in the UK. I would have thought that major players like
that might well have been taking advantage of nanotechnology on
some of their products.
Dr Wadge: You referred earlier on to the reviews
that we are doing and two of the reviews were looking at the use
of nanomaterials, food contact materials and food ingredients
more generally and that showed very little is currently in use
in the UK market, but we fully expect that to change and that
is why we are so concerned about getting the regulatory framework
and the risk assessment frameworks right in anticipation of that
change.
Q43 Baroness O'Neill of Bengarve:
Do you have a sense of the timeframe? How urgent is it? It is
rather a different story, requiring the withdrawal of a large
number of products which have been on the shelves and would have
had bad effects on public confidence in the technology and preventing
them getting on the shelves until the assessment has been done.
How much time do you think you have to get this regulatory framework
in place?
Dr Wadge: The particular silver product that
we talked about earlier is an anomaly in the sense that it is
a product which has been around for some time, it is a rather
niche product, as a food supplement it will fall from the permitted
list and no longer be permitted. What I was trying to explain
earlier is that the regulatory framework is such that any nanoparticle
that is either changing the size or the nature of the property
of the material will need to go through additional safety checks
so that we will not be in a situation where we have lots and lots
of products out there on the market which then have to be withdrawn.
Q44 Baroness O'Neill of Bengarve:
The "we" there is European, is it?
Dr Wadge: Yes.
Q45 Baroness O'Neill of Bengarve:
So there is an expectation that a number of these products on
the market in Germany will quietly be withdrawn because they will
need to go through additional checks before they come back on
the shelves.
Dr Wadge: I would be very happy to look into
that and provide some additional information because I am not
familiar with the particular products that you are talking about.
I would rather not comment without being familiar with what they
are.
Q46 Chairman:
Perhaps you could follow that up. They were listed in an annex
to the DIUS submission in a table produced by the German Federal
Risk Assessment Institute.
Dr Wadge: Yes; okay.
Q47 Earl of Selborne:
I should like to take us back to the European regulatory framework
and in answer to Lord Haskel's question Dr Wadge helpfully referred
to the review which the FSA had conducted on the European regulatory
framework. I think you referred to the general safety requirements
of the EU food law regulation which would be the same whether
the food was nano-engineered or not. You referred to novel food
and food ingredients and noted that this is in course of revision.
The regulation for food additives has already been added. Then
there is provision under packaging regulations which presumably
are relevant, animal feed and the like. Would you like to comment
on whether you are satisfied that the amendments either in progress
or already in place put the regulatory framework in a fit-for-purpose
state?
Dr Wadge: I think that they do. I think that
they do provide the necessary regulatory framework. Where the
challenges and difficulties will lie will be far more around the
precise nature of the risk assessment and the toxicological testing
rather than the regulatory framework. It is there that more work
is needed. I feel reasonably confident around the regulatory framework
that products would need to go through additional safety testing.
Once a product has been developed then the nature of that safety
testing will be adapted on a case by case basis according to the
properties of the particular material that is being looked at
and that is one of the very specific bits of advice that we have
received from the independent toxicological experts.
Q48 Earl of Selborne:
You refer to the problem about the adequacy of current test methods.
In your evidence you refer to the International Risk Governance
Council's report which says that whether you are looking at Japan,
America, European Union, all seem to be approaching this in roughly
the same way but you point out that questions have been raised
about the adequacy of current test methods and the ability of
regulatory bodies to monitor and control measurements and risk
assessments. In other words, the technology does not appear to
be there to give the sort of assessments which are clearly going
to be needed. You have identified the problem. How do you see
this being resolved?
Dr Wadge: It is an area where we clearly have
a part to play and we have just put the call out for our first
particular project looking at toxicokinetics which will really
address one specific part of that. The MRC is starting to fund
projects and there is an international programme which is being
coordinated through OECD of risk assessment work. If I were a
budding young toxicologist then that is an area I would be getting
into because I think there will be considerable research funding
in that area over the next ten to 15 years and that is what is
required.
Q49 Earl of Selborne:
We have already talked about colloidal silver which has been around
for a long time. We are now realising that the EFSA is not likely
to list it as an approved supplement. At what moment does the
precautionary principle rear its head? Do we just wait until the
final review is listed and presumably there will be other such
products coming forward which eventually will be withdrawn but
meanwhile they could or could not be cumulatively toxic. Why do
we not take the precautionary principle seriously?
Dr Wadge: The precautionary principle is what
is going to lead to the colloidal silver being withdrawn because
the company has not produced the safety data to support the sale
of that particular product. The regulatory framework that is set
out requires a pre-market assessment of safety that would be approved
by independent experts on scientific committees. That is a precautionary
basis; it is one where the onus is on the manufacturer, the food
business, to demonstrate safety before it is put on the market.
Q50 Earl of Selborne:
It just seems surprising, as you can already anticipate that in
a year or so this will be withdrawn, that you do not enact the
principle sooner rather than later. Precaution usually means you
take it sooner rather than later, rather than just allow the process
to continue.
Dr Wadge: The area of food supplements is quite
a specific area apart and the UK in particular compared to other
Member States has a long history of quite large consumption of
a range of food supplements which are perhaps not consumed in
other parts of Europe and there are current measures under way
to bring the sale of those products under greater control and
assessment of safety. This particular product and a number of
other supplements have been on the market for a while and manufacturers
now have to provide the safety data to support their continued
use. These are not nanotechnology supplements in general but it
is just the nature of that area of legislation in relation to
supplements. In relation to food more generally, we have been
able to demonstrate that there is not currently a range of nanotechnology
materials on the UK market and that food businesses would need
to go through a pre-market assessment of safety that would be
considered by independent experts.
Q51 Earl of Selborne:
On the revision of the novel foods regulation, a 1997 regulation
which is to be updated, the European Parliament has proposed that
any new regulation should explicitly apply to all nanomaterials.
I gather that is under discussion by Member States and the European
Parliament. What is our position on this?
Dr Wadge: We support the additional controls
and requirements to assess safety of nanomaterials which would
have a different size or a different property compared with the
existing foods that are on the market. The whole way the novel
foods regulation works is that it makes a comparison and sets
a date back in 1997 where, if a food has been in continued use
for a period of time within Europe then it is not considered to
be novel. What this change in the legislation is ensuring is that
a change in the size or the properties due to nanotechnology would
make that a novel product and would require further assessment
before it is used.
Q52 Chairman:
Presumably that is going to involve a definition of nanotechnology.
You said earlier on that the definition is a bit woolly. So when
we talk about a new product being defined as a novel product,
I assume there will have to be a precise definition.
Dr Wadge: Yes.
Q53 Chairman:
As a related question, you talked about this product involving
a co-enzyme which was deemed not to be a novel product even though
it had nanotechnology in it. How does that square? Is that the
current situation which will change in future and will not be
able to slip under the radar screen in future?
Dr Wadge: In the end the debate was around the
properties of that particular material and although it was produced
by nanotechnology, under the current novel food regulations the
properties were not considered different, therefore it was not
considered novel. If the regulations are changed to include anything
produced by nanotechnology methods, then perhaps it may come under
that requirement in future.
Q54 Baroness O'Neill of Bengarve:
You have been telling us about the likely shape that the European
regulation will have. Will that put the European regulation on
a different track from the Japanese or US regulation? We have
been there before in other areas and it does create difficulties.
Dr Wadge: There are very specific differences
of approach and we have seen that clearly in relation to GM between
North America and Europe. In a sense that reflects the different
political and social environments that the regulations are derived
from. Probably what is most important from a scientific point
of view is that we have international agreement on the risk assessment
procedures and that is where the OECD work has a really important
part to play. There will always be an opportunity for a much wider
socio-political layer which is then put on top of the science
in terms of the types of controls which are required in one part
of the world compared with another part of the world. That is
just the nature of the differences between different parts of
the world.
Q55 Lord O'Neill of Clackmannan:
In your evidence in relation to project A03063 you give a helpful
description of the proposed changes to the food packaging regulations.
What is the attitude of the Government to this? You are rather
coy. I realise this is just a résumé of the regulations
but what is the Government's attitude to that? How do you envisage
implementing this on labels which are small enough to be acceptable
to the packaging requirements?
Dr Wadge: There are two questions there. One
is: what are the changes required to make sure that nanomaterials
are properly assessed and need to be assessed before they are
permitted for use such as nanoclays for example. Then the second
question is the question of labelling. At the moment labelling
is something which in broad terms is required where consumers
need information that is meaningful to them. The priority has
always been around information on safety and nutritional composition.
For genetically modified materials there is a requirement for
safety assessment and also labelling. Given that we are at such
an early stage in nanotechnology we have not had that debate yet
around what the nature of the labelling might be and how useful
it would be for consumers to have the word "nano" put
on one part of the label. That is certainly something where we
would be engaging with consumers to find what type of information
they would find useful. Once we get to a position where there
are very specific products which are much closer to coming onto
the market, of course we are in a position there where there are
competing demands of clarity and useful information and a very
small space on particular products to provide information around
safety and use-by dates and nutritional composition, some environmental
factors and possibly also information about the nanotechnology
as well. It is something we are going to need to engage in and
that is something we have done in the past. We will engage with
consumers quite broadly with deliberative research to find out
what sort of information they need and what is actually useful.
There is no point putting "nano" on a label if it does
not actually mean anything to anybody.
Q56 Lord O'Neill of Clackmannan:
One of the problems we have had so far is the debate about nutritional
information and whether it should be something which is imposed
or be the right of the manufacturer or provider of the food to
put down with their own particular spin. I find I am an avid reader
of breakfast cereal nutritional values and if there are more than
two cereals on the table I get totally bewildered. I understand
the problem and I wish you well in your endeavours.
Dr Wadge: Thank you.
Q57 Lord Haskel:
We have had a fair bit of discussion about the draft report on
Regulatory Aspects of Nanomaterials by the European Parliament
and indeed I think you told us you are conducting a review about
this. Can you tell us whether you think that this is going to
be a basis for having the same risk assessment procedures throughout
Europe? Are you working with your counterparts in Europe on this?
What is your general view about this draft report?
Mr Roberts: On many products we have European-wide
systems. If you look at chemicals generally, for example, we have
just introduced a major new regulation, which is European-wide,
to identify the risks around chemicals generally. If I may, I
will explain how I think that relates to nano which is why I think
some of the comments the European Parliament rapporteur has been
making are perhaps misfounded. REACH regulates substances other
than those which are regulated by other regimes such as the food
regime, the pesticide regime or the pharmaceuticals regime. Nanoparticles
are substances so they therefore fall within the scope of the
general European regulation. The question that we need to work
through is how we should apply that regime in the circumstances
of nanomaterials. The first question you have to ask is whether
a nanomaterial is the same substance as a larger material or not.
We are quite clear across Europe, both the Commission and the
Member States, that if someone is producing a nanomaterial then
the risk assessments they have to do under REACH would have to
deal with the risks which might be associated with the nanomaterial.
There are still big issues which we have to deal with because
the testing regime associated with chemicals was designed for
chemicals rather than nanotechnology. It may pick up many of the
risks but it may not pick up all of the risks and therefore we
do need to review how the tests are done to see whether there
are new risks or new tests which need to be added to the suite
to make sure we do capture the risks. We may also need to deal
with some of the issues such as the fact that for registration
under REACH there is a threshold of one tonne before a manufacturer
has to go to Europe. For most chemicals that is fine; for nanomaterials
a tonne may be rather a lot. It does not necessarily mean that
nanomaterials are exempt, because if a manufacturer produces,
for example, bulk titanium oxide and nano titanium dioxide, then
they have to register the whole of their production, so the nanomaterial
would be included. The principles which underlie general regulation
of chemicals, similarly pharmaceuticals or pesticides, that you
have to provide information, that you have to provide information
through the supply chain so they can be used safely and the regulator
has the opportunity to restrict the manufacturing use if there
are proven risks, apply to both bulk materials and nanomaterials
in the same way. The way I would see the regulatory regime going
forward is amendment of some of the detail to make sure the tests
are sufficiently comprehensive and any criteria in terms of thresholds
and so on may need to be adapted to reflect nano. However, the
principles that we use for regulation of chemicals, of foods,
of pesticides should apply to nano in the same way they apply
to the products generally.
Q58 Lord Haskel:
That is very helpful. Do you think that will be adopted throughout
Europe? REACH is a European system so we are working on this together
and whatever rules we come up with will apply throughout the market;
it will be part of REACH.
Mr Roberts: It will be part of the REACH system.
Q59 Chairman:
Just to be clear, in this report to which Lord Haskel is referring
from the Committee on the Environment, Public Health and Food
Safety, the European Parliament says in paragraph E " ...
in the context of REACH, it has so far not even been possible
to agree on guidance on the identification of nanomaterials, leaving
important decisions in the context of registration to economic
operators". I am assuming translated into English that means
that nanomaterials could slip through the net under REACH. Are
you saying that is wrong, that this committee are wrong?
Mr Roberts: It is more subtle than that. Some
guidance was published by the European Commission after agreement
with Member States a couple of weeks ago about how far we have
got in terms of the application of REACH to nanomaterial. I can
happily provide a copy of that, if that would be helpful; that
analyses the issue in rather more detail. What it says is that
if the nanomaterial is a new substance, if, for example, it is
a fullerene, then it is clearly a substance on its own and REACH
would apply to that substance. If it is the same as a bulk form,
then it is probably the same substance as the bulk form but the
chemical assessments and the safety data sheets would have to
reflect any particular risks that arise in the nanomaterial and
in terms of classification and labelling, the hazard symbols which
are put on products, if the nanoform has different risks, then
it might merit a different hazard symbol to the same chemical
in bulk form. The draft report from the rapporteur is an over-simplification
of a rather more complex situation.
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