Jul 1, 2009

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EFSA report on MON810 maiz

Renewal application for MON810 maize: Positive assessment by EFSA

In its report published on 30 June, the European Food Safety Authority (EFSA) once again assesses genetically modified MON810 maize as safe for humans, animals and the environment. Non-target organisms like insects and earthworms are not at risk. Nevertheless, EFSA recommends measures for providing extra protection for butterfly and moth populations and to counter the emergence of resistant pests. According to EFSA, this means that from a scientific point of view there is no reason why approval of the maize line should not be renewed. The Spanish competent authority came to a similar decision in November 2008 and its report was taken into account in the EFSA report. The decision now lies with the EU Council of Ministers and the European Commission.

Genetically modified MON810 Bt maize produces Bt protein (Cry1Ab) for protection against the European corn borer. Whether this Bt protein also harms other insects has repeatedly been the subject of public debate over recent years.

EFSA’s scientific opinion cites various applications submitted by the seed manufacturer Monsanto for renewal of the authorisation for the use of genetically modified MON810 Bt maize both as food and feed and for cultivation. Renewal of the approval for the maize line became necessary under genetic engineering law when its marketing authorisation expired in April 2007. MON810 was approved in 1998 under the legislation in force at that time. A renewal application must be submitted within ten years for genetically modified plants and GM foods. They have to undergo another safety assessment that must take into account new scientific findings. Renewal decisions are based on current EU legislation, which has been agreed on by all member states. MON810 is the only genetically modified plant grown in Europe.

Key focus: environmental impacts of MON810

The EFSA panel of experts came to the conclusion that MON810 maize is not more toxic than conventional maize plants and that its food and feed quality is no different. Neither did MON810 maize present a higher allergenicity. Since this maize does not have higher multiplication or survival characteristics, negative environmental effects resulting from an uncontrolled spread of the maize were judged to be no greater than for conventional maize.

A key focus of the report is on possible impacts of MON810 maize on non-target organisms such as certain species of butterfly, various predatory insects and bees. The panel assessed the studies available on these topics. These included studies cited by the German Ministry of Agriculture as scientific grounds for the ban on MON810 cultivation in Germany. Based on the data available, the panel concluded that predatory insects are not affected by MON810 cultivation any more than by conventional maize cultivation with the use of insecticides. The same conclusion was drawn after assessing individual and metastudies on honeybees, water-dwelling insects and earthworms, among other organisms.

Model calculations: no danger to certain butterfly and moth species

Caterpillars could be harmed if MON810 pollen is blown by the wind onto their food plants in the vicinity of a Bt maize field. The experts investigated the extent of the risk using model calculations based on the literature data available. Calculations were carried out for the caterpillars of three different butterfly and moth species (peacock butterfly, admiral butterfly and diamond-back moth) for various maize-growing regions in Germany, Italy, Hungary and Spain. The diamond-back moth is regarded as particularly sensitive to the Bt protein contained in MON810 maize. The model calculations showed that MON810 cultivation could lead to the death of between 0.06 and 0.15 per cent of the peacock and admiral butterfly populations in a region, and between 0.3 and 0.8 per cent of a diamond-back moth population. Other individuals would not die, but could be harmed: between 0.18 and 2.5 per cent for the butterfly and moth species studied. The EFSA panel concluded from this data that MON810 cultivation would not lead to any significant risk to these species.

Nevertheless, the report recommends that cultivation regions with a high density of butterflies and moths carry out protective measures, such as planting rows of conventional maize around the edges of Bt maize fields to reduce the transfer of Bt maize pollen to the caterpillars’ food plants.