Annex 4
EVIDENCE FROM GERMANY
1. Main potential applications and benefits
of nanotechnologies and nanomaterials in the food sector
Potential applications and benefits:
— improving the stability and durability
of food;
— improving the bioavailability of important
nutrients;
— better optical properties; improved flavour
and consistency;
— carrier material for other substances,
eg liposomes, micellas and vesicles;
— functional foods (nano-ceuticals);
— food packaging (with sensors to monitor
freshness);
— pesticides (carried by nanoparticles
to improve the absorption by plants); and
— food safety (eg synthetic nanoparticles
which irreversibly bind microorganisms).
Source: Federal Institute of Risk Assessment;
presentation given to the Nanotechnology Forum, Berlin, 10 November
2008
2. Market for, and the use of, food products
and food production processes involving nanotechnologies or nanomaterials
in Germany?
Current use of nanotechnology in food and dietary
supplements:
— Nano green tea—use of nanotechnology
to improve the bioavailability of selenium contained on tealeaves
and to enhance the antioxidant effect.
— Frying oil "Canola Active Oil"
with nano-phytosterole capsules (30 nm) to prevent the absorption
of cholesterol and reduce the risk of cardiac diseases.
— Dietary supplements, eg nano-vitamins,
nano-calcium, nano-magnesium and nano silicon (eg Neosino capsules).
— Carotenoid—nanostructured carotenoid
might overcome the problems with insolubility in water and bad
absorbability, improving the beneficial impact on health.
Product examples:
— NutraleaseTM—patent pending for
the Nano-sized Self-assembled Liquid Structures (NSSL) technology.
This uses nano-sized carriers to targeted compounds (such as nutraceuticals
and drugs). These carriers are expanded micelles with a size of
~30 nanometers, referred to as fortifying nano-vehicles (FNVs).
Further information available at http://www.nutralease.com.
— Aquanova—uses nanotechnology to
produce micellas to improve the solubility of insoluble substances
and to change the water/fat solubility of nutrients (eg vitamins
A, C, D, E, K, ß-carotene, omega fatty acids). The patent
protected NovaSOL® solutions is manufactured in ISO—and
GMP certified production plants and suitable for a variety of
applications in the area of food, dietary supplements, healthcare,
cosmetics and pharma. They can for example easily be filled into
softgels and are ready to use components for industrial processes
such as preservation. AQUANOVA in 2006 received the "Excellence
in Technology Award" (Frost&Sullivan) and is located
in Darmstadt near Frankfurt (Germany). Further information at
http://www.aquanova.de.
Use of inorganic compounds in food processing:
Use of synthetically amorphous silica (SiO2)
as food additive (E551), as auxiliary material to support the
flow of powder (eg tomato powder, salt, spices), or as dispersion
medium for vitamins.
Source: Federal Institute of Risk Assessment;
presentation given to the Nanotechnology Forum, Berlin, 10 November
2008
NANO-ENHANCED DIETARY SUPPLEMENTS AVAILABLE
IN GERMANY
Source: BUND (German branch of Friends of the Earth),
"Aus dem Labor auf den Teller—Nutzung der Nanotechnologie
im Lebensmittelsektor" (From the lab onto the plate—use
of nanotechnologies in food) (see http://www.bund.net/fileadmin/bundnet/publikationen/nanotechnologie/20080311_nanotechnologie_lebens
mittel_studie.pdf)—See page 51-61 for overview
of nano-enhanced food and beverages, food additives, dietary supplements,
food packaging and kitchen-utensils available in Germany and in
international markets.
NANO-FOOD ADDITIVES AND AUXILIARY MATERIALS
AVAILABLE IN GERMANY
|
| Manufacturer | Product
| Nanomaterial | Purpose
|
|
| Evonik Industries (formerly Degussa) | Aerosil, Sipernat
| Nano-Siliziumdioxid | Rieselhilfe für pulverförmige Inhaltsstoffe
|
| Rieselhilfe für pulverförmige Inhaltsstoffe
| AdNano | Nano-Zinkoxid |
für Mineralzubereitungen |
| AquaNova | NovaSOL | Nano-Mizellen
| Bessere Aufnahme aktiver Inhaltsstoffe in Zellen und (Kapseln) Organe durch Einschluss in Nanokapseln
|
| BASF | Solu E 200 | Vitamin E nanosolution based on NovaSOL (see above)
| Ermöglicht die Zusetzung von Vitamin E zu Getränken, ohne dass dadurch Farbe oder Geschmack
NovaSOL (s.o.) beeinträchtigt werden
|
| BASF | LycoVit | Synthetisches Lycopin Antioxidationsmittel
(<200 nm)
| |
|
| Source: BUND (German branch of Friends of the Earth), "Aus dem Labor auf den Teller—Nutzung der Nanotechnologie im Lebensmittelsektor" (From the lab onto the plate—use of nanotechnologies in food) (see http://www.bund.net/fileadmin/bundnet/publikationen/nanotechnologie/20080311_nanotechnologie_lebens mittel_studie.pdf)—See page 51-61 for overview of nano-enhanced food and beverages, food additives, dietary supplements, food packaging and kitchen-utensils available in Germany and in international markets.
|
3. Research and development in Germany regarding nanotechnologies
and nanomaterials which have or may have an application within
the food sector?
OVERVIEW
The Federal Government launched a number of projects in 2006 to
address health and environment related issues. A total of €
7.6 million (£ 5.2 million) has been allocated
to these projects for a three year period. The table below sets
out public-sector and industry allocations to research into the
risk of nanotechnology on human health and the environment.
|
| Project | Duration
| Public sector funding
| Industry's contribution
|
|
| NanoCare | 2006-08
| € 5 m | € 2.6 m
|
| Dialogue on Nanoparticles | 2004-06
| n/a | n/a
|
| NANOTOX/INOS | 2006-08
| > € 1 m |
n/a |
| NanoHealth | 2006-08
| n/a | n/a
|
| TRACER | 2006-08
| € 1.5 m | € 1.5 m
|
|
| Source: British Embassy Berlin—own research on various websites
|
The table below sets out the Federal Government overall allocations
to research into the ecological, ethical, social, and military
as well as consumer and health-related aspects of nanotechnology,
including—the above projects.
|
| 2002
in
€ m
| 2003
in
€ m
| 2004
in
€ m
| 2005
in
€ m
| 2006
in
€ m
|
|
Opportunities and risks
(eg technology assessment, INOS, NanoCare)
| 0.257 | 0.460
| 0.460 | 0.040
| 1.582 |
Support measures
(eg Nanotechnology Networks, Horizon Scanning)
| 1.840 | 2.189
| 3.048 | 2.929
| 3.780 |
| Education, further training, social aspects |
0 | 0.200
| 1.900 | 1.500
| 1.152 |
Total in € m
(£ m) |
2.097
(1.436) | 2.849
(1.951)
| 5.408
(3.704) |
4.429
(3.033) | 6.514
(4.461)
|
|
| Source: BMBF, Response to Parliamentary Question 16/2150, 31 July 2006
|
NANOCARE
The NanoCare project (first phase in 2006-09; second phase
to start in 2009), a collaborative project bringing together representatives
from industry, science and the wider public. Germany's government
allocated €5 million to the first phase of the project,
industry contributed a further €2.6 million. The project
involves 13 collaborative partners, including six companies
and seven research institutes. The project involves:
— publication of data on known and unknown impact of
nanomaterials on the environment and health;
— combination of industrial manufacturing and toxicity
research (BASF involved as key player);
— development of standardised processes for the use
of nanomaterials;
— generating knowledge into the synthesis and characterisation
of nanoparticles;
— in vitro and in vivo risk assessment;
— development of standard operating procedures for the
use of nanoparticles; and
— dialogue with the wider public.
While NanoCare initially focused on nanoparticles used in
skin care products, the later phase of the project now also includes
a wider range of aspects, including:
— research into potential exposition routes and barriers
(eg pulmonary tract, gastrointestinal tract, broken skin, blood-brain-barrier,
blood-plasma barrier;
— research into the link between materials properties
and human toxicity;
— identification of response mechanisms; and
— development of measuring strategies and testing systems.
A follow-up call for NanoCare was launched in October 2008,
the deadline for submitting further project proposals was late
February 2009.
Further information: http://www.bmbf.de/pub/flyer_nanocare-projekte_en.pdf
(English); NanoCare project website at http://www.nanopartikel.info;
NanoCare call for proposals October 2008 http://www.bmbf.de/foerderungen/13084.php
(German)
NANONATURE
Additionally, the BMBF funds the NanoNature programme project,
which was launched in August 2008. The projects are expected to
start in the first half of 2009. NanoNature focuses on the use
and impact of nanotechnology in environmental protection. Nanotechnologies
that may be used in clean processes and to protect the environment
include:
— water reprocessing; cleaning air and water and reprocessing
polluted soil;
— recycling processes including separation of different
types materials; and
— catalytic processes and materials separation in order
to reduce harmful emissions into the environment.
In terms of potential impact of the use of nanotechnologies
in clean processes and environmental protection, NanoNature will
investigate interaction between nanomaterials structure and impact
identify impact parameters, taking into account harmful substances
occurring naturally:
— development of reference materials, processes and
standardised testing;
— conduct research into the mobility and transformation
of nanoparticles;
— carry out risk assessment using real matrices; and
— develop characterisation processes for nanoparticles
in air, water and soil.
Source: Federal Ministry of Education and Research; presentation
given to BfR Nanotechnology Forum, 10 November 2008; NanoNature
call for proposals http://www.bmbf.de/foerderungen/12531.php
(German)
NANOTOX
NANOTOX is a joint initiative by several research institutes
and companies in Dresden and Leipzig (Saxony). It seeks to establish
a virtual laboratory specialising in the analysis of health and
environment aspects of nanotechnology. NANOTOX aim is to become
a service provider for SMEs and to carry out contract research
in to the potential risk of nano-scale particles. The members
of NANOTOX are:
— Fraunhofer Institute for Ceramic Technologies and
Systems.
— Max Bergmann Centre for Biomaterials.
— UFZ Centre for Environmental Research.
— University Clinic Dresden.
The members of NANOTOX launched the INOS research project
in February 2006. INOS stands for "Identification and Assessment
of Health and Environment Risks of Nano-scale Particles".
The projects aim to conduct a comprehensive analysis of the potential
adverse impact of nanoparticles on man and the environment. The
Federal Research Ministry provides € 1 million towards
the cost of the project. As a result of the project, a database
will be established, which provides information about the health
risks linked to individual types of nanoparticle. This will serve
as a guide to companies on developments in this area.
Links:
TRACER—TOXICOLOGICAL ASSESSMENT
AND FUNCTIONALISATION
OF CARBON
NANOMATERIALS
In March 2006 the BMBF launched TRACER, a toxicological
assessment of carbon nanomaterials. The participants in this €
3 million project include four companies (including Bayer
MaterialScience) and a public-sector research institute. The project
aims to investigate the biocompatibility and toxicity of carbon-nanotubes
and carbon nanofilaments along the whole value added chain—from
manufacture, processing and blanks to prototypes. On the basis
of research results, participants will make recommendations for
the production and processing of carbon-nanomaterials as well
as the use of relevant products.
Links:
Bayer News Release on the NanoCare project: http://www.presse.bayer.de/baynews/baynews.nsf/id/A87EF8F221792B54C12571180034DE8F/$File/2006-0058E.pdf
(English)
NANOHEALTH
PROJECT
The Helmholtz Association—the umbrella for Germany's
15 large science institutes—stated a project on nanotechnology-related
health risks in May 2006. This aims to develop preventive strategies
to minimise health risks linked to synthetic nanoparticles and
neuronal implants. The project is carried out by the Institute
for Technology Assessment and Systems Analysis (ITAS) at the Helmholtz
Research Centre in Karlsruhe. The key elements of the NanoHealth
project are:
— Analysis and summary of current state-of-the-art in
both areas, ie nanotechnology and neuronal implants.
— Development and test of an evidenced-based strategy
to analyse and assess the risk of synthetic nanoparticles.
— Debate on visions and ethical issues in the context
of neuronal implants.
— Discussion of key issues in 2x2 focus groups
involving experts and laymen; development of action strategies.
— Presentation of the results in the form of a workshop
open to the wider public.
Links:
FURTHER FEDERAL
GOVERNMENT INITIATIVES
The Federal Ministry of Food, Agriculture and Consumer Protection
(BMELV) organises conferences on consumer protection and a foresight
type study (based on the Delphi method of expert forecasts) into
nanomaterials in consumer goods. The BMELV will also conduct a
survey into nanomaterials in food.
BMELV Food Safety Strategies (in English)—Reference
to nanotechnology on page 35 http://www.bmelv.de/cln_045/nn_1299748/SharedDocs/downloads/__EN/01-Brochures/FoodSafety,templateId=raw,property=pblicationFile.pdf/FoodSafety.pdf
The Federal Environment Ministry (BMU) has been responsible
for driving the NanoDialogue initiative—an interdisciplinary
dialogue involving all stakeholders including government, industry,
research, NGOs, industry associations and the wider public. The
Federal Environment Agency (UBA) within the remit of the BMU will
conduct nanotechnology life cycle analysis and studies into toxicokinetic.
What lessons can be learned from public engagement activities
that have taken place during the development of other new technologies?
BMU NanoDialogue and NanoCommission English-language website:
http://www.bmu.de/english/nanotechnology/nanodialog/doc/37402.php
A number of German government agencies—including the
Federal Institute of Risk Assessment (BfR), the Federal Institute
for Occupational Medicine and Health (BAuA) and the Federal Environment
Agency (UBA) with input from others—have proposed a programme
of risk-related research into nanotechnology. This has not yet
led to the establishment of dedicated research funding in addition
to NanoCare and other risk-related nanotechnology research projects
(eg into CNTs).
English translation of the draft research strategy into nanotechnology
environment and health risks: http://www.baua.de/nn_7554/sid_61037A3BB139D43BBCE4BA5848D183C8/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/pdf/draft-research-strategy.pdf;
further information:
4. Barriers to the development of new nano-products or
processes in the food sector?
Poor public acceptance of nanotechnology in food
BfR study illustrates that only 20 per cent of respondents
consulted would buy nanotechnology-enhanced food products. Public
acceptance is much better in the area of surface treatment/cleaning
(86 per cent would buy such nano-based products), clothes (75
per cent) and skin care (36 per cent). In terms of risk perception,
the majority of respondents consider inhalation of nanoparticles
the greatest risk (78 per cent). Almost 12 per cent consider oral
intake as the biggest risk associated with nanotechnologies.
Source: Federal Institute of Risk Assessment (BfR) representative
opinion poll conducted in May 2008; Full report available at http://www.bfr.bund.de/cm/238/wahrnehmung_der_nanotechnologie_in_der_bevoelkerung.pdf
Issues with general safety of nanoparticles
Different toxicity of nutrients/bioactive substances due
to enhanced bioavailability or different distribution within the
human body; further research necessary on the impact on physiological
substances/matabolites transport in organisms; investigation needed
into whether nano-carriers affect epithelial tissue and intestinal
function; further research needs to be carried out into the bioavailability
of nanoparticles following oral exposition.
Source: Federal Institute of Risk Assessment; presentation
given to the Nanotechnology Forum, Berlin, 10 November 2008
Potential risks associated with synthetically amorphous silica
(SiO2)
There is some in-vitro evidence of impact on cell nuclei,
ie accumulation of 40-70 nm nanoparticles in nuclei; negative
impact on replication and transcription (but manufacturers doubt
that in nano-particles are present). New gel-based production
processes for SiO2 may require new safety assessment. This
BfR assessment has been endorsed by the Risk Assessment Working
Group of Germany's NanoCommission.
Open questions about the risk of nanoparticles in food
The physical and chemical properties of industrial nanoparticles
as potential food additives need to be investigated, especially
whether the nanoparticles bind with other food components or whether
they move freely through the gastrointestinal tract. Further questions
to be investigated are whether nanoparticles as food additives
affect the gastrointestinal function or the gastrointestinal microflora.
The risks through indirect contamination and migration from packages
need to be investigated as well as the status of nano-particle
enhanced food compared with novel food.
Methodology for risk assessment
The BfR recommends that methodologies be developed for a
risk assessment of nanoparticles in food, including definitions
and distinction between synthetic vs. natural nanoparticles; free
vs. matrix-bound nanoparticles. Further generation of toxicological
data, especially after oral exposition, is needed.
Sources: Federal Institute of Risk Assessment; presentation
given to the Nanotechnology Forum, Berlin, 10 November 2008;
Bericht und Empfehlungen der NanoKommission der deutschen Bundesregierung
2008 (in German only)—
http://www.bmu.de/gesundheit_und_umwelt/nanotechnologie/nanodialog/doc/42655.php
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