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Notification report


General information

Notification Number
B/PT/06/06

Member State to which the notification was sent
Portugal

Date of acknowledgement from the Member State Competent Authority
28/11/2006

Title of the Project
Field trials of genetically modified herbicide tolerant maize event GA21 to be carried out between 2007 and 2009

Proposed period of release:
01/04/2006 to 30/09/2009

Name of the Institute(s) or Company(ies)
Syngenta Crop Protection AG, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; France; Czech Republic; Hungary; Romania;

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

If yes, notification number(s):
B/CZ/05/02; B/ES/06/04;

Other notifications
Romania

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
use of herbicide products containing glyphosate under European conditions.


2. Geographical location of the site:
Locations : Rio Maior, Salvaterra de Magos and Alcochete.

3. Size of the site (m2):
Less than 7500 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.


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 400 m from other maize fields and will be
surrounded by a border of at least 12 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 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 allow the further assessment of the use of herbicide products
containing glyphosate under European and Portuguese conditions.


Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
25/06/2007 00:00:00
Remarks:
The notifier didn't fulfil the field trial authorization conditions established by the competent authorities, namely the preservation of the required isolation distance.