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Notification report


General information

Notification Number
B/HU/05/01/3

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
03/02/2005

Title of the Project
Program of field agronomic trials and registration trials with NK603xMON810 maize varieties tolerant to glyphosate herbicide and resistant to certain lepidopteran insects

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

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Hungary Ltd., ;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

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

If yes, notification number(s):
B/FR/05/01/05;

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:
By traditional crossing of two genetically modified maize inbred lines, one being tolerant to glyphosate herbicide (NK603 maize, the OECD unique identifier assigned is MON-00603-6), the other one being resistant to certain Lepidopteran insects (MON810 maize, the OECD unique identifier assigned is MON-00810-6), the notifier obtained maize hybrids tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects.

Genetic modification

3. Type of genetic modification:
Insertion;

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 inbred lines. The NK603xMON810 maize hybrids are tolerant to herbicide ‘glyphosate’ due to the introduction of cp4 epsps genes isolated from Agrobacterium sp. strain CP4 (NK603 maize), and resistant to certain lepidopteran insect pests due to the introduction of the cry1Ab gene isolated from Bacillus thuringiensis subsp. kurstaki (MON810 maize)

6. Brief description of the method used for the genetic modification:
The NK603xMON810 hybrids were obtained by the traditional crossing of two genetically modified inbred lines: NK603 maize and MON810 maize.

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:
The purpose of the release is to evaluate NK603xMON810 maize hybrids tolerant to glyphosate herbicide and resistant to certain lepidopteran insect pests. Two types of trials are planned:

o trials to collect data on the agronomic value and insect resistance of the transgenic maize,

o trials in view of registration (VCU; Value for Cultivation and Use and DUS Distinctness, Uniformity, Stability) of the transgenic hybrids on the National List of Hungary.


2. Geographical location of the site:
The National Institute For Agricultural Quality Control (OMMI) is going to set in the trials in two counties in two locations. The trials will be in county Fejér and Pest.

County Fejér:
Enying, Agrár Rt., B-2 tábla
County Pest:
Sóskút, Sóskút Fruct Gyümölcstermelo; Kft., hrsz. 0106


3. Size of the site (m2):
Each of the 2 sites for 2005 will have 110 m2 sown with the genetically modified plants concerned by this application, the total surface area taken up by this trial (all varieties and borders included) is about 800 m2.

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 experiments have already been carried out, based on current knowledge, and the expression products of the introduced genes are not known to be toxic for human or potentially allergenic.
NK603xMON810 maize has been commercially grown in the U.S.A since 2002 and, to our knowledge, no harmful effects on human health were reported.
In addition, in Europe, cultivation of MON810 maize has been approved since 1998 (Commission decision of April 22, 1998, no 98/294/CE) and import of NK603 maize has been approved by Commission decision of July 19, 2004 (no 2004/643/CE).
NK603xMON810 maize grain, containing the NK603 and MON810 inserts, is as safe and nutritious as traditional maize hybrids, as stated in the SNIF relating to notification C/ES/04/01, which is available on web site http://gmoinfo.jrc.it/.
Nonetheless, the grain that may be harvested from these trials will not enter the food or the feed chain.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An environmental risk assessment has been carried out by Monsanto in accordance with Annex II of Directive 2001/18/EC (notifications C/GB/02/M3/3 and C/ES/04/01).
As stated in the Summary Notification Information Format relating to notification C/ES/04/01, available on website http://gmoinfo.jrc.it/, analysis of the characteristics of NK603xMON810 maize has shown that the likelihood of potential adverse effects on human health and the environment in the European Union, resulting from its cultivation and use as any other maize, is consistently negligible. Therefore, the overall environmental risk posed by the genetically modified plant is also negligible, and strategies for risk management for NK603xMON810 maize would be the same as for traditional maize, as stated in the notification. However, an insect resistance management (IRM) strategy will be developed in the context of product stewardship for the placing on the market of NK603xMON810 maize.
The overall environmental risk posed by the deliberate release of the genetically modified plant is also negligible.


Brief description of any measures taken for the management of risks:
Pollen flow from the genetically modified plants will be controlled by a 200-meter isolation distance to commercial maize crop. In addition, the trial will be surrounded by 4 border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.

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:
Not known