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Europe Daily Bulletin No. 9461
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GENERAL NEWS / (eu) eu/food safety

EFSA confirms its risk assessment that genetically modified maize MON 863 is safe for humans and animals and for the environment

Brussels, 04/07/2007 (Agence Europe) - The European Food Safety Authority (EFSA) is categorical: genetically modified maize MON 863 by Monsanto, authorised in the European Union, does not present any threat to human or animal health or to the environment.

After being consulted twice by the European Commission, EFSA, in an opinion published on 28 June, confirmed its original assessment, following a detailed review of the risks.

EFSA examined a paper by Séralini et al. on the statistical evaluation of a 90-day feeding study in animals with genetically modified maize MON 863. The paper presents an alternative statistical analysis of the 90-day rat study that was considered in the original risk assessment.

Following a detailed statistical review and analysis, EFSA's GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns.

EFSA's main conclusion sent to the Commission were: - the statistical analysis made by the authors of the paper did not take into account certain important statistical considerations, and the assumptions underlying the statistical methodology employed by the authors led to misleading results; - observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA, were considered not to be biologically relevant. In the absence of any indications that the observed differences are indicative of adverse effects, the GMO Panel does not consider that this paper raises new issues with respect to the safety of MON 863 maize. Therefore the GMO panel sees no reason to revise its previous opinion that this genetically modified maize would not have an adverse effect in the context of its proposed use.

MON 863 maize, is genetically modified to resist certain insects and is very controversial. Its detractors, such as Greenpeace, have mentioned health problems in rats identified by independent scientists (EUROPE 8790). This GMO was authorised in the EU by a European Commission decision in January 2006. Member states had failed, beforehand, to obtain the required qualified majority for authorising or refusing the marketing of MON 863. (an)

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