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The EU legislation :
implementing the
precautionary
principle
EU legislation on GMOs has
been in place
since the early
1990s, with the
objectives of
protecting
health and the
environment and
of ensuring the
free movement of
safe GM products
in the EU. The
entire legal
framework of
GMOs has been
amended in 2003
and me be viewed
as a first and
ambitious
expression of
the
precautionary
principle in the
European law.
This principle
allows the
adoption of
preventive and
cost-effectives
measures to
avoid potential
risks, when
there are
threats of
serious or
irreversible
damage to health
or the
environment.
Precaution is an
attitude,
enforced in
legal norms,
which aims at
promoting the
innovation in a
cautious way,
ensuring that
knowledge of the
actual risk will
progress, that
post-consent
monitoring is
organized with
this aim, that
informed consent
of the consumer
is garanteed,
and that a
scientifically
sound cost/benefit
evaluation of
the new product
is achieved. By
no means it is a
principle of
banning the
innovation in
case some risk
may be
speculated.
Some major principles of the EU legal framework for the placing on the
market
of GMOs are the
following:
1.The
risk assessment
is done on a
case-by-case,
step-by-step,
and use-by-use
basis. This
means that
attention is
paid to the
peculiarities of
each individual
GM product,
depending on the
interaction
between its
novel trait and
a given
environment, and
considering its
intended uses (food,
feed,
cultivation,
processing
etc.). The step-by-step
approach means
that GMOs are
marketed only
after they have
been carefully
evaluated in a
contained
environment,
followed by
experimental
field releases.
2.Post-release
monitoring,
traceability and
labelling:
as a general
provision of the
precautionary
principle,
monitoring plans
need to be
approved before
issuing the
marketing
consent and the
traceability of
the product on
the market is
ensured by
labelling and
administrative
records
throughout the
food chain.
Marketing
approvals are
first granted
for a maximum of
10 years.
3.Public
information: in the course
of the approval
process,
information is
provided to the
public, via
abstracts of the
technical
dossiers
submitted by the
applicants, via
opinion papers
published by the
EFSA and via the
web sites of
national
authorities and
of the European
Commission
in-house
research Center
(JRC of Ispra).
4.Subsidiarity: although the
aim is the
promote the
European market
via common rules,
member states
may be requested
to develop
national answers
to questions
raised by GMOs.
This is true for
the «
co-existence
issue »,
which refers to
the need to
provide the
farmers with a
practical choice
between
conventional,
organic and GM
crop production.
Considering the
diversity of
crop and land
management
practices across
Europe,
legislators
estimated that
the member
states were in a
better position
to identify the
effective and
justified
measures for
achieving this
co-existence
objective, and
the Commission
only provided
guidelines via a
Recommandation
on that issue.
5.Compliance
with the
international
trade rules: The EU
regulation is in
line with the
international
trade
requirements of
WTO (it is clear,
transparent and
non
discriminatory)
and with the
transboundary
movement rules
of the UN
Cartagena
Protocol on
Biosafety.
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Briefs
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