Supplementary memorandum by the Food Standards
Agency
At the evidence session on 31 March, the
Food Standards Agency was invited to provide additional information
in relation to a list of products reported to be available on
the market in Germany. Our comments on this list are given below.
In addition, we would like to provide supplementary
information in relation to products from non-EU countries (exemplified
by Brazil, as raised during the meeting on 31 March), and
on the FSA-funded review of public attitudes that was published
after our earlier evidence was submitted.
(a) Products on the German market
On investigation, it seems that not all of these
products are currently on sale and in many cases the presence
of nanoparticles has not been confirmed.
The information provided from the UK contact
in Germany (Annex 4 to the written evidence from DIUS) referred
to two sources, a presentation by a member of the Federal Institute
for Risk Assessment (BfR) and a list of products reported by BUND,
the German equivalent of Friends of the Earth, to be available
on the German market.
The first presentation was given at a forum
"Consumer Protection—Nanotechnology" that was
held at the BfR in November 2008. We have confirmed with the German
authorities that the examples in this presentation were given
as illustrations of potential future applications, rather than
examples of "nano-products" that were already available
on the German market. In the case of the nanoscale micelles manufactured
by the company Aquanova, this technology has been investigated
by the German authorities, who concluded that the coenzyme Q10 product
did not fall within the definition of "novel food" as
since the metabolism of the coenzyme Q10 in this formulation
was not different from common products already on the market.
The BUND lists were based on a global inventory
published earlier in 2008 by Friends of the Earth (FoE) in
Australia. In addition to the products in the original FoE inventory,
BUND reported that a number of additional products available in
Germany, largely via internet sites, were being marketed as containing
nanoparticles. In drawing up these lists, a size threshold 300nm
was applied (where particle size information was available). The
lists include products which are poorly described in the marketing
information, and which may or may not contain nanoparticles.
The list also includes a number of brands of
food supplements containing nanoparticles of silver, also known
as colloidal silver. This is a long-established substance and,
as explained in our original evidence (page 4), it is found also
on the UK market.
In the case of food additive silicon dioxide
(silica, E551), the German industry has confirmed that this substance
has a long history of use and the specification currently used
is the same that has already been assessed and authorised for
many years. Although nanoparticles occur during the manufacturing
process, these immediately aggregate and agglomerate into much
larger units and the dimensions of the silica particles used in
foodstuffs are typically in the range 2-12µm.
The presence of nanoparticles in other products
on the list, whether below 300nm or 100nm, has not been confirmed.
We would certainly agree with the point made
in the FoE and BUND reports, that the extent to which substances
are absorbed into the body is likely to differ when they are presented
in small particles compared with larger particles. This is true
whether the particles are in the nanoscale or of some larger dimension.
Indeed, the effect of different formulations, including different
particles sizes, on the bioavailability of active substances has
been a major area of investigation in the pharmaceutical industry
for many years. Similar investigations are also carried out by
the supplements industry. We would reiterate that it is 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.
(b) Products on the Brazilian market
At the evidence session on 31 March, the Committee
was concerned about the implications of product development in
countries like Brazil and whether such products could automatically
gain entry to the EU market.
We would like to emphasise that UK and EU regulations
apply equally to imported products as to domestic production.
World Trade Organisation rules are designed to prevent unfair
barriers to international trade but it is not the case that a
product that is legally marketed in one WTO member state must
be accepted in other WTO member states. Countries are free to
establish their own safety requirements, provided that these do
not discriminate against imports.
The UK contact in Brazil has confirmed that
their report (Annex 1 to the evidence submitted by DIUS)
refers to the absence of regulatory controls in relation to research
and not to the marketing of food. In other words, there are no
laws or directives preventing Brazilian scientists from conducting
research in nanotechnology applied to food. The same situation
applies in the UK. Brazil does however have a solid regulatory
framework that applies to the commercialisation of new products,
especially in the area of food, and there are standard food
safety + health and safety laws which are applicable for
all new products, including products obtained using nanotechnologies.
(c) Evidence review of public attitudes to
emerging food technologies
In September 2008 the Food Standards Agency
commissioned a review of existing studies on public attitudes
to a range of new technologies in relation to food, including
nanotechnologies. This report was published on 26 March 2009 and
a copy is attached [not printed] for the Committee's information.
The main findings in relation to nanotechnologies and food were
summarised on page 7 of our earlier evidence.
21 April 2009
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