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Notification report


General information

Notification Number
B/SK/10/02

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
28/12/2009

Title of the Project
Application to perform field trials with GA21 maize in Slovakia (2010-2013).

Proposed period of release:
01/04/2010 to 31/12/2013

Name of the Institute(s) or Company(ies)
Plant Production Research Center Piestany, Bratislavska cesta, 122, 921 68 Piestany, Slovak Republic.;


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

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysSyngenta propriety line

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
GA21 maize has been genetically modified to express the 5-enolpyruvylshikimate-3-phosphate synthase enzyme (mEPSPS) that confers tolerance to herbicide products containing glyphosate.

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:
Genetic material derived from GA21 maize:
- Promoter 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:
GA21 maize was produced by 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 objective of the proposed field trial releases is to gain information relating to the performance of GA21 maize products and the herbicide formulations containing glyphosate under European and Slovakian conditions.

2. Geographical location of the site:
Geographical location of the site: Locations in Borovce, Špacince, Sokolce, Gabcíkovo, Milhostov and Víglaš-Pstruša (Slovak Republic).

Remark - without prolongation of validity, the authorization was amended in this way:
one geographical location of the release site were added – Šaľa (Slovak Republic), and
the size of the sites was changed – the total surface of site per location will not exceed 45 000 m², including the borders.


3. Size of the site (m2):
The size of the site: A maximum of 7 locations will be sown every year. The total surface per location will not exceed 45 000 m² including the borders.

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:
GA21 maize has been approved for cultivation in the USA, Canada, Argentina, Brazil and Japan. It is grown commercially in the USA, Canada and Argentina with no adverse effects reported.
GA21 maize is approved for import, food and feed use in the EU under Regulation (EC) No 1829/2003 (Commission Decision of 28 March 2008/280/EC).
In addition, no products from the trials will be used as human food or animal feed.


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 200 m from other 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 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 however allow the further assessment of the event in the environment and the use of herbicide products containing glyphosate under European and Slovakian conditions.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/04/2010 00:00:00
Remarks: