EFSA assesses safety of GM maize hybrids: no adverse effects expected on human and animal health and on the environment
This is the first time that EFSA has completed risk assessments for GM maize hybrids obtained by crossing individual GM lines (line MON 863 in combination with line MON 810 and/or line NK 603), in order to combine different traits (eg protection against different pests and/or herbicide resistance). The individual GM lines have already been found to be safe.
MON 863 x MON 810 maize was assessed by EFSA’s GMO Panel in 2004. However, in its initial evaluation the experts could not come to an agreement as they were divided over the need for data confirming the safety of the hybrid maize. On request of EFSA a new animal study (90-day feeding study in rats with MON 863 x MON 810 maize) has been conducted and results provided by the applicant for consideration by the Panel. The applicant also performed similar feeding studies for the other hybrids: MON 863 x NK 603; and MON 863 x MON 810 x NK 603 maize.
The GMO Panel assessed the GM maize hybrids with reference to their intended uses according to the principles described in the GMO Panel’s Guidance Document for the risk assessment of GM plants and derived food and feed****. This included: the characterization of the newly introduced DNA and proteins; a comparative analysis of agronomic traits and composition; and a safety evaluation of the new proteins and the whole food and feed notably concerning their possible toxicity and allergenicity. Furthermore, nutritional and environmental assessments were undertaken, including a review of the post-market monitoring plan.
Following these risk assessments, experts concluded that there are no concerns over the safety of the GM maize hybrids. These are not different from their conventional counterparts with regard to their safety and nutritional properties.
The monitoring plans provided by the applicant for the GMOs concerned were considered to be in line with their intended uses (i.e. import, processing, food and feed).
Finally, the Panel considered that the information available is sufficient to come to a conclusion and that the GM maize hybrids
- MON 863 x MON 810
- MON 863 x NK 603 and
- MON 863 x MON 810 x NK 603
will not have adverse effects on human and animal health or on the environment in the context of their proposed uses.
The full text of the opinions can be found at:
