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Modern biotechnology
has many applications in the pharmaceutical and
agri-food industries. One example is the use of
GMOs in the food production chain. GMOs are
organisms such as plants, animals and
micro-organisms (bacteria, viruses, etc.), the
genetic characteristics of which have been
modified artificially in order to give them a
new property (a plant's resistance to a disease
or insect, improvement of a food's quality or
nutritional value, increased crop productivity,
a plant's tolerance of a herbicide, etc.). In
order to ensure that this development of modern
biotechnology, and more specifically of GMOs,
takes place in complete safety, the European
Union has established a legal framework
comprising various acts:
- The contained use of
genetically modified micro-organisms, e.g.
laboratory research (in a confined
environment), is regulated by
Directive 90/219/EC on the
contained use of genetically modified
micro-organisms;
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- The experimental
release of GMOs into the environment, in
other words the introduction of GMOs into the
environment for experimental purposes (e.g.
for field testing), is governed by
Directive 2001/18/EC on the
deliberate release into the environment of
genetically modified organisms (mainly Part B
thereof);
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- The placing on the
market of GMOs (products containing or
consisting of GMOs), e.g. for cultivation,
import or processing into industrial
products, is subject to
Directive 2001/18/EC on the
deliberate release into the environment of
genetically modified organisms (mainly Part C
thereof);
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- The placing on the
market of GMOs intended for food or feed and
of food or feed products containing,
consisting of or produced from GMOs is
governed by
Regulation (EC) 1829/2003
on genetically modified food and feed. Where
a food product contains or consists of GMOs,
the applicant has a choice: either the
application as a whole is subject solely to
Regulation (EC) 1829/2003, in application of
the principle of "one door, one key", in
order to obtain authorisation for the
deliberate release of a GMO into the
environment - in accordance with the criteria
laid down by Directive 2001/18/EC - and for
the use of this GMO in food products - in
accordance with the criteria laid down by
Regulation (EC) 1829/2003; or the application
- or part of it - is subject both to
Directive 2001/18/EC and to Regulation (EC)
1829/2003.
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- Unintentional
movements of GMOs between Member States and
exports of GMOs to third countries are
governed by
Regulation (EC) No
1946/2003 on transboundary movements of
genetically modified organisms.
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The above legislation
establishes the conditions under which a party
may develop, use or market a GMO or a food
product derived from GMOs.
GMOs and food
products derived from GMOs placed on the market
must also comply with labelling and
traceability requirements. These requirements
are found in Regulation (EC) 1829/2003 and in
Regulation (EC) 1830/2003
concerning the traceability and labelling of
genetically modified organisms and the
traceability of food and feed products produced
from genetically modified organisms and
amending Directive 2001/18/EC.
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