Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Testing of genetically modified maize tolerant to an herbicide and resistant to certain Lepidopteran insects (NK603xMON810 maize)

Proposed period of release:
01/04/2005 to 31/12/2008

Name of the Institute(s) or Company(ies)
Pioneer Genetique Sarl, Chemin de l'Enseigure
31840 Aussonne;

3. Is the same GMPt release planned elsewhere in the Community?

Has the same GMPt been notified elsewhere by the same notifier?

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysexperimental varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified maize hybrids that will be tested in these field trials are tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects. They have been obtained by crossing two genetically modified inbred lines: one inbred line has received an insert providing tolerance to glyphosate herbicide and the other inbred line has received an insert providing resistance to certain Lepidopteran insects.

Genetic modification

3. Type of genetic modification:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
The NK603xMON810 maize hybrids contain the genetic elements introduced in their parental lines. One parental line has been modified by the insertion of cp4epsps genes from Agrobacterium sp. CP4 that confer tolerance to glyphosate herbicide (NK603 maize). The other parental line has been modified by the insertion of the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis (MON810 maize).

6. Brief description of the method used for the genetic modification:
No genetic modification was made on the tested hybrids: they were obtained by traditional crossing of two genetically modified parental inbred lines. The two parental inbred lines were obtained by traditional breeding, from the original lines modified by Monsanto.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable.

Experimental Release

1. Purpose of the release:
Several types of trials will be carried out, to collect data on the agronomic value and insect resistance of NK603xMON810 maize varieties and to observe the plant behavior, which could enable to collect morpho-physiological data.

2. Geographical location of the site:
The releases are planned at several locations in France within the following areas: Aquitaine (Landes, Lot et Garonne), Centre (Eure et Loir, Loir et Cher, Indre, Indre et Loire, Loiret), Midi-Pyrénées (Haute-Garonne, Gers, Tarn, Tarn et Garonne), Languedoc-Roussillon (Aude).

3. Size of the site (m2):
Each year, there could be up to 10 sites, each sown with up to 5000 m² of genetically modified maize subject of this notification (NK603xMON810 maize), the total trial surface for each site (including all varieties and borders) being larger.

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
Many field trials have already been conducted at several locations and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize hybrids. They were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Lepidopteran insects, such as European Corn Borer, and tolerance to glyphosate herbicide, traits due to the genetic modifications.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from the deliberate release of genetically modified maize tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects are expected, as per information contained in the Summary Notification Information Format of notification C/ES/04/01.

Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other non experimental maize crop. In addition, the trial will be surrounded by four border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. When a few seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide, other than glyphosate, or by mechanical destruction and incorporation into the soil.
At the end of the release, all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil.
Volunteer maize will be monitored during the following year in order to ensure their destruction, if needed.
No commercial maize will be cultivated in the trial site the following year.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
27/04/2005 00:00:00