Food Law News - EU - 2005

EFSA Press Release, 15 July 2005

GMOs - EFSA assesses safety of GM maize hybrids: no adverse effects expected on human and animal health and on the environment

The European Food Safety Authority’s (EFSA) Scientific Panel on Genetically Modified Organisms (GMO Panel) has published today four opinions on genetically modified (GM) maize hybrids relating to food and feed uses, import and processing [see * below]. Among these was the MON 863 x MON 810 hybrid maize which was already assessed by the Panel in 2004 [see ** below]. As the experts were divided over the need for data specific to this hybrid maize and could not conclude its safety evaluation, EFSA requested that an additional 90-day rat study be carried out for further consideration by the Panel. Following review of this study submitted by the applicant, the Panel concluded that neither the MON 863 x MON 810 maize nor the other GM maize hybrids [see *** below] which were evaluated will have adverse effects on human and animal health or the environment in the context of their proposed uses.

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 (e.g. 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 [see **** below]. 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

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:

MON 863 x MON 810:

MON 863 x NK 603:

MON 863 x MON 810 x NK 603:


* Under Regulation No 1829/2003
and Directive 2001/18/EC

** GMO Opinions on MON 863 and MON 863 x MON 810 for placing on the market at and for placing on the market, for import and processing at

*** MON 863 x NK 603 and MON 863 x MON 810 x NK 603

**** Guidance document for the risk assessment of genetically modified plants and derived food and feed at


Hybrid maize

The production of hybrid maize is a well established process in traditional maize breeding. It involves the production of separate lines that are subsequently crossed in order to produce hybrid seed used in agriculture. This process allows for the selection of desirable traits and the crossing of inbred lines in order to enhance agricultural performance.

GM maize hybrids : MON 863 x MON 810, MON 863 x NK 603 and
MON 863 x MON 810 x NK 603

GM maize hybrids were developed by crossing, through traditional breeding methods, the GM maize line MON 863 with GM maize lines MON 810 and /or NK 603 in order to combine their specific traits. No new genetic modification was involved. For instance, MON 863 x MON 810 was developed to combine the trait in MON 863 conferring protection against certain coleopteran pests (principally corn rootworm) with the trait in MON 810 protecting against lepidopteran pests. The combination with the NK 603 line provides tolerance to the herbicide glyphosate.

The single GM lines were previously evaluated in separate risk assessments. MON 863 was found to be safe by the EFSA GMO Panel. MON 810 and NK 603 have already been authorised by the European Commission following previous risk assessments. Where appropriate, the data used for the evaluation of the single GM lines were taken into account in the safety assessment of the GM maize hybrids

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