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Notification report


General information

Notification Number
B/HU/05/01/2

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
01/02/2005

Title of the Project
Program of field agronomic trials and registration trials with NK603 maize varieties tolerant to glyphosate herbicide

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/05/01/03;

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 NK603 maize varieties has been made tolerant to glyphosate herbicide using Monsanto's event (NK603 maize; the OECD unique identifieris MON-00603-6).

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:
NK603 maize has been genetically modified by the introduction of the cp4epsps gene from Agrobacterium sp. strain CP4. The cp4epsps gene encodes for an enzyme (CP4 EPSPS, 5-enolpyruvylshikimate-3 phosphate synthase) that is naturally tolerant to glyphosate, the active ingredient of a broad-spectrum herbicide.

6. Brief description of the method used for the genetic modification:
NK603 maize, from Monsanto, has been modified by incorporation of a restriction fragment of plasmid DNA into the maize genome using a particle acceleration method.

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 genetically modified maize varieties tolerant to glyphosate herbicide. Two types of trials are planned:

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

- 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:
Pioneer Hi-Bred Magyarország Kft. 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:
The placing on the US market of NK603 maize has been authorized in September 2000 by the American regulatory administrations and subsequently NK603 maize has been commercialized in the USA, under the trade name Roundup Ready. In addition, NK603 maize has already been approved for import in Australia, Colombia, Korea, Japan, Mexico, the Philippines, Russia and Taiwan, and has received authorization for cultivation in Argentina, Bulgaria, Canada, Japan and South Africa.
It has also been applied for import and for cultivation of NK603 maize varieties in the European Union (notifications C/ES/00/01 and C/ES/03/01, respectively submitted by Monsanto). The placing on the market of NK603 maize for import and processing has been authorized by the Commission of the European Communities for feed use (Commission decision of 19 July 2004) and food use (Press release of 26 October 2004).
Also, many field trials have been carried out in Europe. No environmental problems were reported from these trials.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Environmental impact of the NK603 maize as stated in the notification:
1. Likelihood of the genetically modified plants becoming more persistent than parent or recipient plants in an agricultural habitat or more invasive in a natural habitat: maize is not persistent in an agricultural habitat and the tested transformation does not change this characteristic.
2. Selective advantages or disadvantages conferred to other sexually compatible plant species, that could result in transfer of genetic material from the genetically modified plant: there are no sexually compatible species as far as maize is concerned in Europe.
3. Other ecological impacts from the interaction of the genetically modified plant and target organisms: there are no organisms targeted by the genetic modification.
4. Potential effects on niche-reorganization: the genetically modified plants have no invasive potential and no wild relative. So no potential effects are expected on the plant environment.
5. Potential effects on non-target organisms: not applicable.

An environmental risk assessment has been carried out by Monsanto in accordance with Annex II of Directive 2001/18/EC (please see notification C/ES/03/01).
As stated in the Summary Notification Information Format for C/ES/03/01, available on web site http://gmoinfo.jrc.it/, analysis of the characteristics of NK603 maize has shown that the likelihood of potential adverse effects on human health and the environment in the European Union, resulting from its import and use as any other maize, including the cultivation of NK603 maize varieties and the use of this maize in animal feed, is consistently negligible. Therefore, the overall environmental risk posed by the genetically modified plant is also negligible, and strategies for risk management for NK603 maize would be the same as for traditional maize.


Brief description of any measures taken for the management of risks:
A 200 meter-isolation distance will be maintained between the transgenic tested varieties and any other commercial maize crop. In addition, the trial site 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.
Seed dispersal of individual kernels does not occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact.
For this trial, kernels might be collected for analysis needs. This will be done by sampling the whole ear and destroying the remaining ear and unused kernels.


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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known