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Notification report


General information

Notification Number
B/HU/06/12/1

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
01/02/2007

Title of the Project
Field trials with genetically modified glyphosate tolerant maize event GA21 to be carried out between 2007 and 2010.

Proposed period of release:
04/01/2007 to 30/11/2010

Name of the Institute(s) or Company(ies)
Syngenta Seeds Kft. Hungary, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; France; Portugal; Czech Republic; Romania;

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

If yes, notification number(s):
B/CZ/05/02; B/ES/06/04; B/FR/06/01/12; B/FR/06/12/01;

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
A gene encoding a protein capable of conferring a herbicide tolerant characteristic

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:
Regulatory sequences: Promoter, intron and exon sequences derived from rice. The
function of these sequences is to control expression of the herbicide tolerance gene.

Optimized transit peptide: N-terminal optimised transit peptide sequence constructed based on transit peptide sequences from maize and sunflower.

Herbicide tolerance gene: epsps (5-enolpyruvylshikimate-3-phosphate synthase) gene derived from maize. The function of the product of this gene
is to confer tolerance to herbicide products containing glyphosate.

NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this
sequence is to signal termination of the herbicide tolerant gene expression.


6. Brief description of the method used for the genetic modification:
Event GA21 was produced via microprojectile bombardment of maize suspension
culture cells.


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 as the recipient or parental plant is not a forest tree species

Experimental Release

1. Purpose of the release:
The objective of these field trials of genetically modified glyphosate herbicide tolerant event GA21 maize to be carried out between 2007 and 2010 in Hungary is to gain further information relating to the use of herbicide products containing glyphosate under European and Hungarian conditions.
One GM variety of GA21 herbicide tolerant maize will be tested in the field trials which will compare treated and untreated plants with products containing glyphosate and conventional products.


2. Geographical location of the site:
In Hungary, the studies will be at one location site: The testing site is located in the city of
Bicske, Hungary.


3. Size of the site (m2):
The field trials will take place between 2007 and 2010. No more than 35,000 GA21 maize plants will be grown to maturity. One GM variety of GA21 herbicide tolerant maize will be tested in the field trials which will compare treated and untreated plants with products containing glyphosate and conventional products. The total area of GA21 maize plants sown is no more than 5700 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:
Results obtained from previous field trials in the USA and Europe suggests that the genetically modified lines do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant. Event GA21 has been approved for commercial cultivation in the USA, Canada, Argentina and Japan. The event is currently cultivated in the USA and Canada with no adverse effects to the environment or on human health reported.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment study has been completed and submitted with the
application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment have been identified.


Brief description of any measures taken for the management of risks:
The field trials will be no less than 500 m from other commercial maize fields and will be surrounded by a border of conventional maize.
The products from the trials may be used for analysis and will not be used for
human food or animal feed. Plant material remaining after harvest will be ground and incorporated into the soil. The sites will be monitored for one year after the release and any volunteer maize appearing will be eliminated before flowering. During this year, maize will not be grown on the trial sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have not been designed to specifically gain new data on the environment and human health impact of the release. They will allow the further assessment of the use of herbicide products containing glyphosate under European and Hungarian conditions.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known