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Notification report


General information

Notification Number
B/ES/06/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/11/2005

Title of the Project
Field trials of genetically modified herbicide tolerant maize event GA21 to be carried out between 2006 and 2009.

Proposed period of release:
01/04/2006 to 30/11/2006

Name of the Institute(s) or Company(ies)
Syngenta Seeds, S.A., 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:
Spain; France; Czech Republic;

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

If yes, notification number(s):


Other notifications
Syngenta has approval to perform field trials in South Africa and Brazil.
NOTE: 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.


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.
- 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 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 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
performance of the event under European conditions and to produce maize for
comparative analysis. They will also allow the further assessment of the event in the environment.


2. Geographical location of the site:
- L’Aldea (Tarragona)
- Deltebre(Tarragona)
- Lleida (Lleida)
- Tamarite de Litera (Huesca)
- Vic (Barcelona)
- Pollos (Valladolid)


3. Size of the site (m2):
- L’Aldea (Tarragona): 2500 m2
- Deltebre(Tarragona): 2500 m2
- Lleida (Lleida): 2500 m2
- Tamarite de Litera (Huesca): 2500 m2
- Vic (Barcelona): 2500 m2
- Pollos (Valladolid): 2500 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:
Evidence from previous field trials in the USA 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
reported.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment 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 when compared to non-modified maize have been identified.


Brief description of any measures taken for the management of risks:
The field trials will be no less than 220m from other maize fields to be used as
food or feed 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 also allow the
further assessment of the event in the environment.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
03/03/2006 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Aragón.