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Notification report


General information

Notification Number
B/ES/10/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/01/2010

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

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

Name of the Institute(s) or Company(ies)
Syngenta Seeds SAS, Syngenta Seeds SAS 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; Slovak 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/09/01; B/ES/06/04; B/ES/07/32; B/ES/08/30; B/ES/08/31; B/ES/09/39; B/ES/09/59; B/FR/06/01/12; B/FR/06/12/01; B/RO/07/02; B/RO/07/11; B/RO/08/02; B/RO/09/12; B/SE/07/11257;

Other notifications
Field trials performed by Syngenta:

Czech Republic: 30999/ENU/08

Denmark: B/DK/08/07

Romania: 108378/20.12.2005/64265/A.B./20.12.2005

Germany: Az.6786-01-0198


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 optimized 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 the nursery multiplication and observation, collect samples for expression analyses, to obtain additional data of agronomic and expression field performance and to gain further information of the use of herbicide products containing glyphosate under Spanish conditions.

2. Geographical location of the site:
The releases are planned at:

- Aragón:
Alagon-1: 4800 m2.
Alagon-2: 10200 m2.
Alagon-3: 3500 m2.
Alforque: 17500 m2.
Esplus: 24000 m2.
Sastago-1: 22000 m2.
Sastago-2: 10000 m2.

- Cataluña:
San Pere Pescador: 9100 m2.
Torroella de Montgrí-1: 6600 m2.
Torroella de Montgrí-2: 4300 m2.


3. Size of the site (m2):
The releases are planned at:

- Aragón:
Alagon-1: 4800 m2.
Alagon-2: 10200 m2.
Alagon-3: 3500 m2.
Alforque: 17500 m2.
Esplus: 24000 m2.
Sastago-1: 22000 m2.
Sastago-2: 10000 m2.

- Cataluña:
San Pere Pescador: 9100 m2.
Torroella de Montgrí-1: 6600 m2.
Torroella de Montgrí-2: 4300 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 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.

Food and food additives containing GA21 were approved by decision of the EU commission on January 13th, 2006 (2006/69/EC). Approval for products comprising as well as containing GA21 was granted on 28 March 2008 (2008/279/EC).


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.

Seeds lots will be packed in sealed paper bags in facilities authorized to carry out confined release of GMOs; the bags will remain closed until planting. Each paper bag will be clearly labeled with a unique identifier code and an indication that it is containing GM seeds. The name of the event will be also mentioned. All the bags containing the seeds lots will be contained into a sealed and labeled box.

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 been designed to allow the further assessment on the agronomic, compositional analysis and on the use of herbicide products containing glyphosate under European and Spanish conditions. However, if any unanticipated adverse effects on human health or the environment would be observed, it will be reported immediately to the Competent Authority.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
26/03/2010 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Aragón.