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Notification report


General information

Notification Number
B/DK/09/01

Member State to which the notification was sent
Denmark

Date of acknowledgement from the Member State Competent Authority
04/02/2009

Title of the Project
Field trials of genetically modified herbicide tolerant maize event GA21 to be carried out between 2009 and 2013.

Proposed period of release:
01/04/2009 to 30/11/2013

Name of the Institute(s) or Company(ies)
Syngenta Crop Protection A/S, Strandlodsvej 44
DK-2300 Copenhagen S
Denmark
On behalf of: Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Spain; France; Portugal; Sweden; 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/DK/08/02; B/ES/06/04; B/ES/07/32; B/ES/08/30; B/ES/08/31; B/FR/06/01/12; B/FR/06/12/01; B/HU/06/12/1; B/PT/06/06; B/PT/08/01; B/RO/07/02; B/RO/07/11; B/RO/08/02; B/SE/07/11257;

Other notifications
Romania: 108378/20.12.2005/64265/A.B./20.12.2005; ;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysGA21

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.
Optimised 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 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 the 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 purpose of the field releases is to gain further information relating to the use of herbicide products containing glyphosate under Northern European conditions.

2. Geographical location of the site:
Middelfart - the western part of the island Fyn.

3. Size of the site (m2):
In 2009, two trial sites of 10,000 m2 will be used that each contain 8,400 m2 GM maize.

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:
Evidence from previous field trials in the USA and Europe suggest 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, Brazil, Argentina and Japan. The event is currently cultivated in the USA, Argentina 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:
The field trials will be at least 200 meters from other maize fields and will be surrounded by a
border of four rows 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 chopped 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.


Brief description of any measures taken for the management of risks:
The trials have not been designed to specially 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 glyphosfate under Northern European conditions.

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 specially gain new data on the environment and human health impact of the release. They will allow the further assessment of the use of herbicideproducts containing glyphosfate under Northern European conditions.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
07/05/2009 00:00:00
Remarks: