January 30, 2008
The
European Food Safety Authority (EFSA) is
working closely with Member States on GMO
risk assessment. At a meeting organised by
EFSA, more than 60 GMO experts from national
regulatory risk assessment bodies from
across the European Union discussed best
scientific approaches to evaluate the safety
of GMOs at national and European level.
EFSA is pro-actively working to keep at the
forefront of risk assessment methodologies
and approaches to GMOs and is working with
Member States to draw on the best scientific
minds in Europe on these issues.
Scientists from the European food safety
watchdog, including a number from its GMO
Panel, and the national experts nominated by
the national food safety agencies met in
November 2007 to examine EFSA’s risk
assessment procedures and its Guidance
Documents. EFSA subjects each individual GMO
application to rigorous review carried out
according to internationally agreed
guidelines.
Most experts agreed at the meeting on the
general approach on risk assessment
methodologies and approaches to GMOs. EFSA
is building on the exchange of views to
continue to strengthen its risk assessment
approach and will take a number of
recommendations to the Advisory Forum for
further discussion.
One key issue addressed at the meeting was
the Environmental Risk Assessment of GM
plants intended for cultivation in Europe.
Several experts asked EFSA to develop
guidance further, particularly concerning
field trials, regional specificity and
potential effects on non-target organisms.
EFSA will pursue its work in this area in
co-operation with Member States and in light
of a question recently received from the
European Commission (DG Environment) on
Environmental Risk Assessment.
The use of statistics in GMO risk
assessments, to estimate biological
differences between a GM plant and its
conventional counterpart, was discussed in
detail. EFSA has a working group looking at
new statistical methods that could help
further advance harmonisation in risk
assessment. The majority of Member State
experts agreed that statistics had an
important role to play in GMO risk
assessment but emphasised that biological
relevance should drive the dynamics of the
risk assessment rather than statistical
significance.
On animal feeding trials, the majority of
Member State experts was satisfied with
present EFSA risk assessment guidance which
requires a 90-day feeding trial study
whenever evidence indicates significant
differences in the GM plant which requires
further investigation . However, one Member
State expert asked for animal feeding trials
to be conducted as a matter of routine.
EFSA’s GMO Panel has adopted a Report on
animal feeding trials which will be
published in a peer-reviewed scientific
journal over the coming months.
[1] All
EU Member States, Norway and Switzerland and
representatives of the European Commission.
[2] The animal feeding trial report says
that in cases where molecular,
compositional, phenotypic, agronomic and
other analyses have demonstrated differences
between the GM plant derived food and feed
and their conventional counterpart, apart
from the inserted trait(s), or if there are
any indications or remaining uncertainties
for the potential occurrence of unintended
effects, animal feeding studies with rodents
should be considered
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