EFSA further clarifies status of risk assessement concerning MON 863 and hybrid MON 863 X MON 810

EFSA's Scientific Panel on genetically modified organisms (GMO) has evaluated MON 863 maize and considered that this maize is as safe as its conventional counterpart. The experts considered that data and information provided by the applicant were sufficient to carry out a full risk assessment. The study quoted in certain press articles as a "1.139 page report" concerns a 13-week study conducted in rats with MON 863 maize which was reviewed by the GMO Panel in carrying out its risk assessment.   The GMO Panel adopted two opinions on MON 863 maize on 2 April 2004 under different regulatory frameworks  and, following review of an evaluation of the aforementioned study submitted by German authorities, reaffirmed its assessment of this GM maize on 29 October 2004.

There is apparently some confusion concerning the risk assessment carried out on another GM maize, the hybrid GM maize MON 863 X MON 810, which was also addressed in the opinions of 2 April 2004 concerning MON 863.

With respect to MON 863 X MON 810, the GMO Panel stated that they could not reach a conclusion with regard to the safety evaluation of this hybrid. As the Panel was divided as to the need for additional data specific to the hybrid maize MON 863 X MON 810, EFSA requested that a further study be conducted for submission and further consideration by the GMO Panel. This study has now been received and is currently under evaluation by the GMO Panel.

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