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
Field trials with genetically modified glyphosate tolerant maize event GA21 to be carried out between 2008 and 2012 in Germany.

Proposed period of release:
01/04/2008 to 30/11/2012

Name of the Institute(s) or Company(ies)
Syngenta Seeds GmbH, Betriebsstätte Zum Knipkenbach 20, D-32107 Bad Salzuflen, Germany on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies.;

3. Is the same GMPt release planned elsewhere in the Community?
Germany; Denmark; Spain; France; Portugal; Sweden; Czech Republic; Romania;

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

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/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

NOTE: Event GA21 has been approved for commercial cultivation in the USA, Canada, Brazil, Argentina and Japan. The event is currently cultivated in the USA, Canada and Argentina. In addition, Syngenta has performed field trials in many countries outside of the EU.

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:

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

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 2009 and 2012 in Germany is to gain further information relating to the use of herbicide products containing glyphosate and variety performance under European and German 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. Different maize varieties expressing event GA21 will be grown to compare own properties.

2. Geographical location of the site:
The release sites will be located in Sachsen-Anhalt and Brandenburg.

Flurstücke 75-78, Flur 8, Gemarkung Eichenbarleben, Landkreis Börde, 39167 Eichenbarleben, Sachsen-Anhalt.
Flurstück 17, Flur 3, Gemarkung Weesow, Landkreis Barnim, 16356 Werneuchen, Brandenburg.
Flurstück 73/1, Flur 15, Gemarkung Herzberg (Elster), Landkreis Elbe-Elster, 04916 Herzberg (Elster), Brandenburg.

3. Size of the site (m2):
The total area of GA21 maize plants sown is no more than 9000 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, Brazil and Japan. The event is currently cultivated in the USA, Canada and Argentina 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 200 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 at least 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 and different maize varieties expressing event GA21 under European and German conditions.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known