Annex 6
EVIDENCE FROM THE UNITED STATES OF AMERICA
STATE OF
THE SCIENCE
AND USE
OF NANOTECHNOLOGY
IN THE
FOOD SECTOR
What are the main potential applications and benefits
of nanotechnologies and nanomaterials in the food sector, either
in products or in the food production process?
— Use of nanotechnologies in food products
or in food production is considered to fall in one of two categories—nano-inside
vs. nano-outside. Nano-inside indicates use of nanotechnology
as food additives, and nano-outside indicates the use of nanotechnology
in the production of food packaging.
— Applications and benefits in food products—In
food additives, improvements could be made in food shelf life,
texture, flavor, or nutrient composition. Some additives can also
be used to detect food pathogens, or used as food quality indicators.
— Applications and benefits in food production
process—In food packaging—nanotechnologies in this
area are considered to be of use to increase product shelf life,
provide indication of spoilage (though nanosensors), or generally
increase product quality (eg by inhibiting gas flow across packaging
materials.)
What is the current state of the market for, and
the use of, food products and food production processes involving
nanotechnologies or nanomaterials, either abroad or in the UK?
— Current State of the Market—According
to Lux Research, sales of products containing nanotechnology (in
general) generated $30 billion of sales in 2005. In the food
industry, some experts predict that nanotechnology will be incorporated
into $20 billion worth of consumer products by 2010 (Helmut
Kaiser Consultancy). Five out of the 10 world's largest food
companies are pursuing research in exploring use of nano in their
food products or packaging. According to the Woodrow Wilson Project
on emerging nanotechnologies consumer products list there are
around products in the food and beverage field—around 10
per cent of the total products in their database. www.nanotechproject.org/inventories/consumer/analysis_draft/
— Examples of current items on the market
are: Canola oil that contains nanomaterials which block cholesterol
from entering the bloodstream (Canola Active Oil by Shemen Industries).
Another is a chocolate "slim" shake which is supposedly
tastier and more nutritious due to the properties of nanoparticles
designed to carry nutrition more efficiently into cells (Nanoceuticals
Slim Shake Chocolate by RBC Life Sciences). There are beer bottles
on the market from Hite Brewery Beers (Honeywell) whose bottles
are created using nanoparticles which block the transmission of
oxygen into the beer, thus keeping it fresher for longer periods
of time. Nanotea is another product, which claims to use nanoparticles
to increase absorption of selenium in the body from the tea, which
purportedly boosts selenium's natural activity in the body by
10x (Shenzen Become Industry & Trade Co, Ltd).
What might the "next-generation" of
nanotechnologies and nanomaterials look like? How might they be
applied in the food sector, and when might they enter the market?
— According to the report above, there
are several examples of next generation nanomaterials which could
be used in future food products. Some nanoparticles are being
designed to block substances in food (like the canola oil example),
but could also include blocking food allergens. Other nanomaterials
are being developed to be given to livestock, in order to detect
and neutralize animal pathogens before they reach consumers (Clemson
is designing a nanoparticle to neutralize the poultry pathogen
campylobacter). There are additional nanoparticles being developed
in order to deliver nutrients to human cells that either had previously
low or no absorption. In the area of food packaging, nanosensors
would be embedded in food packages designed to alert consumers
that a product has spoiled, and is no longer safe to eat.
What is the current state of research and development
in the UK regarding nanotechnologies and nanomaterials which have
or may have an application within the food sector? How does it
compare to research and development in other countries?
— R&D in U.S.—A project by Dr.
Jennifer Kuzma and Peter VerHage (detailed in the report above)
included the creation of a database of all available food-related
nanotechnology applications and products that are likely to appear
on the market in the coming years. It compiles information about
food nanotechnologies that are still in the developmental stage,
but includes only those from companies or labs that have agreed
to release the information. Most of these are being made/developed
within the United States. The website for the database is: www.nanotechproject.org.
— Beyond this database, which the creators
admitted only "scratches the surface" of food related
nanotechnology products, there are many products under development
which are being kept secret, mostly by industries, due to varying
concerns regarding public opinion, regulation, or duplication.
What are the barriers to the development of new
nano-products or processes in the food sector?
— Currently, there are few methodologies
or guidelines in the industry sector on how to asses potential
risks from certain nanomaterials/particles, which can complicate
risk assessment in the food sector. Future regulation spurred
by these perceived risks could limit or inhibit use of nanotechnology
in food products, especially if all nanomaterials are required
to go through the review phase (see below), and not be eligible
to be considered as a material Generally Recognized As Safe (GRAS)
if the parent material had that classification.
REGULATORY FRAMEWORK
Is the regulatory framework for nanotechnologies
and nanomaterials fit for purpose? How well are imported food
products containing nanotechnologies and nanomaterials regulated?
— The legislation regulating nanotechnology
in food is currently the Food Additives Amendment of 1958, which
has been subsequently renewed and added to. The regulatory agency
in charge of this is the Food and Drug Administration (FDA). This
law states that any new substance added to food must undergo formal
pre-market review and approval by the FDA through a food additive
petition process which results in a regulation which specifies
the conditions by which the additive can be safely used in food.
http://www.fda.gov/nanotechnology/regulation.html
— However, circumventing the approval process
occurs because some nanoparticles are just drastically reduced
sizes of familiar Generally Recognised as Safe (GRAS) substances.
This could allow a manufacturer to assert that the new particle
has a "reasonable" certainty that a particular additive
will have no harm, if the parent material is considered safe.
However, the reduced size actually changes the particles physical
properties, which could necessitate a case-by-case scientific
evaluation of all nanoparticles, which could inhibit or slow innovation
of new particles if all nanoparticles/materials must go through
a new extensive regulatory process.
— A new bill that just passed in the House,
which has yet to be introduced in the Senate, will attempt to
further coordinate nanotechnology information. H.R. 554 mandates
that the Nanoscale Science, Engineering, and Technology Subcommittee
of the National Science and Technology Council (NSTC) develop
and maintain a publically accessible database of projects falling
under the various existing categories. This database will be "official",
and is not related to the nanotech project database referred to
in the fourth question. This bill still needs to be approved by
the Senate prior to becoming law.
How are imported food products regulated?
— Currently, all imported food products
containing nanomaterials are subject to the same levels of regulation
that U.S. products undergo. However, the House has just introduced
a bill, called the "Food and Drug Globalization Act of 2009",
sponsored by Representative John Dingell (D-MI) which would greatly
increase U.S. oversight on imported food products. This Act focuses
on all food and drug imports, but will affect those including
nanotechnology as well. This Act will require that ALL foreign
food manufacturers to be certified as meeting all U.S. food safety
requirements (including nanotechnology safety requirements) by
third parties accredited by the FDA. All testing would need to
be done by facilities certified by the FDA, and the results provided
to the FDA. Uncertified facilities and their uncertified products
would be banned from being imported in the U.S.
How effective is voluntary self-regulation either
in the UK or EU or at an international level? What is the take
up by companies working in the food sector?
— The FDA could be unaware of nanomaterials
used in a product if the company does not report it. Also, some
small particles can be derived from existing substances and still
be above the 100nm size range required to be considered a nanoparticle,
and therefore not technically qualify as "nanotechnology"
and thus would not require reporting.
Will current regulations be able adequately to
control the next generation of nanotechnologies and nanomaterials?
— The 1958 Act which governs food
additives has done a comprehensive, albeit limited, job of providing
regulation for nanomaterials so far. The current regulations are
not seen as adequate for the future, according to the testimony
of Dr. Michael R. Taylor of the George Washington University of
Public Health at a public meeting discussing nanotechnology materials
in FDA regulated products. http://www.nanotechproject.org/publications/archive/statement_michael_taylor_at_fda/
— Others like him have expressed their
concerns that the current regulatory system will prove to be inadequate
to deal with the predicted high number of new food and food packaging
nanotechnologies that will be forthcoming. Many experts believe
that more regulations need to be put in place, and that the FDA
is also not currently adequately funded to review the potentially
large number of new products coming under review, or even to handle
more in-depth checking of current nanotechnology used in the food
sector. A listing of additional papers on this subject can be
found on the Woodrow Wilson's Project on Emerging Technologies
website—http://www.nanotechproject.org/publications/page4/
— The FDA itself claims that through coordination
with other agencies, future regulation of nanotechnology should
not pose a problem. The FDA regulation policy for nanotechnology
can be found at the following link: http://www.fda.gov/nanotechnology/regulation.html
Is there any inter-governmental co-operation on
regulations and standards? What lessons can be learned from regulatory
systems in other countries?
— Currently, there does not appear to be
any inter-governmental co-operation on regulations and standards
for nanotechnology in the food and food packaging sector. Many
critics of the FDA system of regulation in the U.S. have cited
the regulatory system in Europe as being equally as good, but
faster. Recent trends indicate that regulations are becoming more
globalized, which could prove useful for the development of future
regulations for nanotechnology.
March 2009
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