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Notification report


General information

Notification Number
B/ES/08/31

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
11/02/2008

Title of the Project
Field trials of genetically modified herbicide tolerant maize event GA21 (Continuation).

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

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:
France; Portugal; Czech Republic; Romania;

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

If yes, notification number(s):


Other notifications
Syngenta has performed field trials of GA21 in Spain, France, Czech Republic , Romania and Brazil. Syngenta has approval to perform field trials in South Africa.
NOTE: Event GA21 has been approved for commercial cultivation in the USA, Canada, Argentina and Japan. The event is currently cultivated in Argentina, Canada and the USA.


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 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 the agronomic performance, and to the use of herbicide products containing glyphosate under Spanish conditions and to produce maize for comparative analysis.

2. Geographical location of the site:
Aragón:
- Urrea de Jalón: 5000 m2

Castilla La Mancha:
- Barrax (Albacete): 5000 m2
- Villaseca de Henares (Guadalajara): 5000 m2

Castilla y León:
- Toral de los Guzmanes (León): 5000 m2
- Melgar de Fernamental (Burgos): 5000 m2
- Castrillo de la Vega (Burgos): 2000 m2

Cataluña:
- Alcarras (Lleida): 2000 m2
- Bellpuig (Lleida): 1000 m2
- Lleida-26 (Lleida): 1000 m2
- Lleida-30 (Lleida): 1500 m2


3. Size of the site (m2):
See previous question.

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 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 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 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:
All the fields will be sowed at a distance of at least 200 m from commercial maize fields.
A border of at least 8 rows of conventional maize will be planted surrounding the GM maize field.
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 the following planting season, commercial 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 on the agronomic, compositional analysis and on the use of herbicide products containing glyphosate under European and Spanish conditions.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
20/02/2008 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Castilla-La Mancha: 20/02/2008.
- Aragón: 25/03/2008.
- Cataluña: 25/03/2008.
- Castilla y León: 22/04/08.