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European Food Safety Authority concludes that national bans on MON810 are not scientifically substantiated

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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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