July 17, 2008
Source:
GMO Compass
The national bans on maize MON810
by Hungary and Greece are not scientifically substantiated. This
is the conclusion of a safety reassessment by independent
scientists on behalf of the
European Food Safety Authority (EFSA).
Hungary and Greece both have made use of the safeguard clause
according to the EU Directive on the deliberate release of
genetically modified organisms (GMOs). In September 2007, Greece
extended a ban on the cultivation of the insect resistant GM
maize MON810. Currently, Hungary prohibits its use and sale.
In support of their doubts about the safety of the product,
authorities of the two Member States provided information
packages to the European Commission. Consequently, in April 2008
the Commission requested reviews by EFSA's Scientific Panel on
Genetically Modified Organisms (GMO Panel). Greece had raised
two main issues that were related to potential impacts of MON810
in bee colonies and to studies with animal feeding. Hungary had
expressed concern about negative effects on soil biology and on
target and non-target organisms. The GMO Panel considered these
concerns not only based on the documents provided by the Greek
and Hungarian authorities but also in the light of the most
recent scientific data and relevant peer-reviewed papers.
In invoking the safety clause, Greece had referred to toxicity
data on maize MON863 and primarily to US-American bee colony
studies on Colony Collapse Disorder (CCD). The GMO Panel
concluded that this information was insufficiently specific to
maize MON810 and was unrelated to particularities of Greek
farming or the Greek environment.
Consequently, the GMO Panel augmented their review with
additional scientific literature and concluded that low exposure
levels of bees to maize pollen, combined with the low toxicity
of the Cry1Ab protein in maize MON810, are unlikely to result in
adverse effects on bees. Further, the Panel concluded that the
Greek submission provides no new scientific data in support of
an adverse effect of the Bt-maize on human or animal health in
Greece that would justify a national safeguard measure.
In the case of Hungary, the EFSA's scientific experts already
had reviewed information submitted by the Member State in 2005.
At that time, the Panel had judged that the information did not
constitute new scientific evidence which would invalidate the
risk assessment of MON810. Subsequently, instead of lifting its
national ban, Hungary informed the European Commission in 2007
of its intent to conduct further studies.
The GMO Panel now has assessed four additional reports that are
categorised as "confidential" by Hungary. On soil biology, the
GMO Panel agreed with the authors of the respective report that
"[...] we have no data at all concerning whether the differences
found in some cases in the decomposition of organic material are
a consequence of differences in the chemical composition of the
two maize strains or of the presence of Bt-toxin". EFSA's
experts concluded that the concerns raised by Hungary towards
the persistence of Cry1Ab protein in soil are not substantiated
by the available scientific data. The GMO Panel also did not
identify any new scientific information or data subject to
scientific scrutiny that would change the previous risk
assessments concluded on maize MON810. In addition, the
Hungarian submission did not supply scientific evidence that the
environment of Hungary was sufficiently unique within the EU to
merit separate risk assessments to those conducted for other
regions.
The European Commission now is responsible for the drafting of a
proposal to the Member States for the repeal of their safeguard
measures. The Bt-maize MON 810 was first authorised in the
European Union in 1998. Last year, it was grown on a total of
approximately 110,000 hectares in Spain, France, Czech Republic,
Portugal, Germany and Slovakia. An application for the renewal
of its EU authorisation as an "existing product" was submitted
in April last year.
Request from the
European Commission related to the safeguard clause invoked by
Greece on maize MON810 according to Article 23 of Directive
2001/18/EC
Request from the
European Commission related to the safeguard clause invoked by
Hungary on maize MON810 according to Article 23 of Directive
2001/18/EC
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